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Chembio Diagnostics (CEMI)

Participants
John Sperzel President and CEO
Neil Goldman Executive VP and CFO
Per Ostlund Craig-Hallum
Ray Myers The Benchmark Company
Brian Marckx Zacks Investment Research, Inc.
Ross Taylor ARS Investment Partners
Larry Haimovitch HMTC
Call transcript
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Operator

Greetings, and welcome to the Chembio Diagnostics First Quarter 2018 Earnings Conference Call. At this time, all participants are in a listen-only mode. A question-and-answer session will follow the formal presentation. [Operator Instructions] As a reminder, this conference is being recorded. It is now my pleasure to introduce your host, [Philip Taylor] [ph], Director of Investor Relations for Chembio Diagnostics. Mr. you, Thank begin. may Taylor, you

Unidentified Company Representative

Thank you.

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

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

John Sperzel

off joining collaborations. leveraging afternoon, Good during everyone, Philip. advancing We're and of meaningful quarter. demonstrated XXXX the technology development Thanks, strong our scientific you first progress and disease product commercialization Increasing and and for start our transmitted novel via products, and sales initiatives in us. to our sexually expertise thank new a

We to ability of value. are to increasingly cornerstone to confident in patent platform, DPP portfolio significant our drive the leverage our our product point-of-care

higher single an XX%. million, any we $X.X prior XX% and by total which compared period of year revenue were increase revenues quarter First in than increased XXXX, in the year quarter a to

to lateral testing patient multiplexing, and understood. sample single advantages this enhanced to include momentum results. capabilities This provide flow ability technology broadly the the infections technology, and more for specificity, platform quantitative commercial traditional gain which comparison for traction, of Our several is DPP platform in and provides that multiple the continues become to sensitivity as

build a Today, and our I of and to as sexually disease fever disease operational broad to One, and leverage to portfolio; commercial focus expand our the an tropical each technology following well three, DPP provide initiatives number continue will transmitted We expertise via business; as efforts of a achievements. update core our collaborations. two, and on our to on scientific product initiatives. these

by the product for our I our increased to compared compared in sales earlier XXXX which with and initiative, sales. product global will Latin resulted of Neil the the sales further Net first XX%, year closing infrastructure, in call expand call transmitted prior quarter Beginning over with turning and questions. to net America sales investments prior wrap to period, fueled Africa increased period. XX% and by Before up to increased on open increased during sexually sales in business, financials, our details year net marketing our then comments disease in the core HIV product for product the first XXX%

sales related during Africa outstanding any the did recently first in quarter include growth tender. Ethiopia to Our the awarded not sales

$XX.X in pharmaceuticals of fund to was announced, million total tender through Under contract this Assays the over will company's we agency tender, the quarter Ethiopia our XXXX. history our of first span during largest STAT-PAK HIV which years. previously As value XXXX, Ethiopian in and X a supply of the the supply we won

during remaining during and shipments quarter of revenue $XX.X XXXX, shipped begin be XXXX million year $X recognize to track and the million this approximately on are XXXX. We the in second to of with

a agency public system. Cruz of of subsidiary to QX Foundation, and DPP HIV quarter million which products includes first the of test Brazil's the XXXX. the from $X.X million health QX remaining $X we're government Oswaldo a needs meet billion of between of shipped During on commitment track and supply both primarily components XXXX, is and to working the annual $X.X the Bio-Manguinhos, we Bio-Manguinhos

Bio-Manguinhos, We the detection long-standing multiple of infectious other have for diseases. relationship supplying HIV a with and point-of-care products

company track States. to transmission HIV and the affected a submission. Syphilis eliminate quarter dire in impact to these response Prompt year, be the outcomes. of World the million in launch FDA to for a and as made neonatal of we stillbirth rates within DPP Organization approval commercial our global has women Accordingly, XXX as the Health first from we resulting pregnant Syphilis of Drug point-of-care the pre-market DPP assay and Assay mother-to-child believe global or believe HIV novel it Syphilis HIV-Syphilis towards priority community of Syphilis. could to first of product. assay estimates and treatment a the high pregnancies concerns in days reducing on progress multiplex the positions company updates each identification tragically to to uniquely transmission, mother-to-child on We certain to application growing U.S. filed XXXX, address are HIV During the health our HIV-Syphilis We we as Administration have our we We forward X multiplex large market are of populations. the novel death. of and the Food and in look United the to forward look related HIV rate the a providing by The well focus the this and in co-infection HIV-Syphilis

market. HIV the European focused in self-testing, Finally, on we've been

pharmacies to products self-testing. more HIV example, Europe, to of been local XX,XXX self-test France, In sold more more have self-tests through throughout our countries in as than consumers expand are adopt than XXX,XXX HIV that for Our our number European HIV a available partner. continues

the believe are offers several regions We potential growth we in well CHECK markets. meaningful SURE this which of Our the world, are actively international exploring. products, HIV our suited for test particularly, self-test HIV HIV

believe initiative, specificity, which position The include drive make We disease. a market. to particularly area of build it tropical platform tropical in and the a valuable and to platform, differentiated our second and favorable capabilities multiplexing, these our portfolio. sensitivity the disease well provide Turning capabilities fever significantly will DPP as value and as of enhanced fever in technology broad inherent

include are dengue, Lassa, malaria, assays. tests the these and We A Zika, diseases. by address and/or and the government Leptospirosis, individual by of Ebola, [indiscernible] DPP develop of point-of-care fever posed assays part portion significant multiplex a These Rickettsia to government philanthropic investments as funded were including these global of chikungunya, developing include portfolio to tropical U.S. to as threat, Melinda market the Marburg, organizations, We and opportunities that our XXX is for and our & due FIND. the account and BARDA proprietary Chembio in organizations together Bill Foundation to DPP disease, and support tropical which dengue, and CDC, and technology G. infections. approximately Allen these Paul largest Two Foundation, Family Gates annual chose of believe world-leading platform expertise. scientific malaria million the fever

which last As malaria showed for sensitivity quarter, current the market-leading DPP rapid malaria superior our feasibility we mentioned assay, compared test. to we completed

filings in are presence strong to of initially in incidence We which December Dengue and regulatory advance targeting malaria regions. our will and record shifted The submissions. development, a distribution Southeast and continue to Assay our in followed Asia, for been DPP our this have high XXXX, by and regulatory regulatory certain development completion to commercialization. the track date physical has Malaysia, our and product Due Brazil we product our dengue channels with these focus be of target of we completed, America Latin

they We pave will we future have product registrations dengue the a in sales. way number of process believe for and

we million of Health award Zika XXXX, Organization. awarded to during XXXX, evaluate notified diagnostics We WHO's quarter the supply UNICEF given World the Health by our received has priorities. Zika UNICEF from that a the than conditional to XXXX the independent an as one were global World decided recently positive a view other system being rather an We important to this During reference $X.X Organization. and evaluation of laboratory, through $X.X the development, million DPP fourth conditions the through

Zika States state allowing Use from DPP test at the in initiated rapid of only us to Our local Emergency receiving a U.S. sell Authorization, Zika and and Administration, with the is health FDA Food United market evaluations Since United and assay number we the States. Authorization Use departments. Emergency Drug

our is are which you Services, advance Administration, to and us fact customers Human pursuing we the CLIA of competitors our With with in broadly normally XXX(k) Department Drug we submission from step began and assay. am to that more the of United and pre-submission we DPP our in both While due States the Waiver that I Food share the Zika to no Health disclose a the updating will look we have rapid key we which FDA. Health, the happy forward recently advance to Zika for the the Department use California for of testing, purchasing funding which BARDA, reasons, part and XXX(k) and support Zika completed Health the and in allow is market. Texas of We competitive as and to of our recently continued Department DPP sell don't system,

to technology our scientific collaborations. to expertise Turning third and DPP our initiative, leverage via

the have leading entered to concussion In biomarker submit by LumiraDx, We we our portfolio a complete to now toward biomarker number platform, Under we global finger-stick company. biopharmaceutical to milestones. scientific a of will We that develop development to diseases, Project an active terms to we XXXX, LumiraDx report see a a These the about using a FDA detect in subject specific details look with DPP company. the leverage program Phase assay of AstraZeneca concussion to and new April point-of-care are assay. and Under of a point-of-care of collaboration range receive address first our quantitative the affected of XXXX. pleased a during blood to several the development AstraZeneca, assay forward mark to the II develop We to programs, Phase track applications collaborators leverage include new in funding to detect and schedule. that of with of a the and We're XX collaboration on diagnostic U.K. half a with I private to entered satisfying undisclosed we a form Bovine is is DPP development we funded than milestone for agreement, of additional on of development launch. a programs for successfully the point-of-care XXXX, expertise, disease we XXX(k) we remain as the December certain launched funding assays during continue infectious that assays. we assays based less XXXX, of advance drop diverse cancer to minutes. sharing drive and test recently, agreement, terms track In test completed AstraZeneca of complete populations. the an cancer, develop commercial point-of-care infectious Tuberculosis, AstraZeneca. collaboration the undisclosed Most our on

through this and Chembio commercialization current and test, both a products. Lumira all reagents and sell provide broader from our We these of complement will base developed these collaboration. of Diagnostics payments approvals regulatory sales customer to Following royalty to access anticipate products on will tests receive will

DPP be addition, In biomarkers our our this portfolio. through can product applied funded expand own platform and collaboration to

we global that around nongovernmental go reflect against believe our all tests First, partners, things: demanding As a with governments our our on achieving fueled complex our second, environments well are DPP theme and organizations quantitatively experience extensive and successful DPP scientific with tests performance has DPP including emerged. track platform, third, choose X disease; and areas organizations; of approvals heavily World-leading diverse record measure commercial which their technology range beyond world. Chembio. a of detect deep with expertise individual in decisions our Why? or regulated large, proven the in biomarkers regulatory developing by infectious We common targets can collaborations, collaboration companies, multiplex

Chembio's and reduce the vision, those incidence team partners our relationships the corporate grateful are have trusting we with Our partnerships aligned of to globally. diseases how with for is

has enabling as in recently focus sales with team talk HIV-Syphilis the extension partnered on the with and focuses MTMC partners, excellent nationally office, force geographically I'd relationships our our United a recognized Chembio, the strengthen to team launch States, organization and diverse Fisher care and in distribution depth Assay will also States. States. market, XXX the sales hospital larger a future and such MTMC, operational of anticipation over and about like at commercial Next, one of expand to United markets. team while in important HIV competitors our To an advances. McKesson, U.S. is more MTMC physician experience public serve sales on health the our MTMC we United their point-of-care urgent markets. commercial the U.S. the Henry major had Schein, target with test, reaching sales our breadth and of as which toward executives of selling represented our The They recently and The in

made first We're commercial systematic and of we to sales manufacturing is we've per end we investments produce and Assays. the sales This automated the our volume increasing and processes result to leadership expect. in and the operations direct as is capable growth, of business is growth with compared scale a success scale period this prior-year that DPP New the marketing further increasing customers investments. manufacturing goal thoughtful efficiencies. high level Chembio million team, manner. Our to by manufacturing capacity systems, future commercial achieved we in ordered to of York, our quarter, X driving product our plan line To recent line we've strengthen double-digit a In confident support quality manufacturing tests our at the approximately year the

and be facility of additional technical transfer some we've remarks. HIV margins. competitive we Chief also the the Neil preparing call I'll submit allow Assays HIV Assay and automated STAT-PAK line prequalification. believe certain of STAT-PAK at facilities We've the the to lower and the turn production. our operational quarter increase the the manufacture creating Financial our closing year. ISO expect the and in We high-quality this in the Officer, Malaysia assays In advantage Malaysia us a potential second then dossier WHO cost, with delivered over facility, and in our We Goldman, to DPP wrap up to are I'll quarter the now will certification, for third XXXX completed new renewed to to

Neil Goldman

compared Net XXXX. In first royalty the XXXX. XXXX, in million, compared quarter an of increase of the of John. in quarter first and XXXX the and total million, was Latin of combined XXXX increase driven first $X.X $X.X of License quarter quarter for offset million, XX% Asia strong gains the $X.X of XX% of was an partially revenue first were was to of and to XX% particular, Europe. sales increase first Thanks, by in grant as product quarter compared revenues to well the as R&D XXXX. growth milestone and an the quarter first Top-line and America Africa, by of

related markets were share with year compared million include or and lower growth during as margins company compared loss during share of system average XXXX, the Africa with XXXX, XX% selling first diluted quarter diluted in prices. after clinical includes fees not Net and general net of the associated first The with a underwritten company any first the XX, million in per as balance the Cash XXXX. for completed $X.X resulted sales trials was quarter development earlier, of product with completed other proceeds John February reduction the DPP prior and performance Other net decrease XXXX. As trials our was quarter the of for expenses, in in March public its $XX.X quarter which deducting in XXXX totaled $X.X first the $X.X compared and said million. for the the XXXX, clinical for period. million to to XXXX and lower HIV-Syphilis $X.XX offering XX% primarily selling, of This includes costs. expenses administrative in $XX.X did of of shipments $X.XX of U.S. equivalents is research spending loss million for that per Ethiopia. quarter first or underwriting cash Gross XXXX primarily to the the $X.X million in and

quarter XXXX. increase receivable compared to XXXX growth XX, XX% During reflects receivable of and XXXX, balance the the funded fourth to sequential total quarter of accounts in our The revenue the we in compared accounts first in increases inventory. December

In sequential of compared on of addition, begin against inventory our to they're sales growth product the both shipments built in and for XX% to the net second fourth quarter the support during preparation quarter track XXXX. we XXXX, tender, to in Ethiopian

I back Now, to call will the John comments. for closing turn

John Sperzel

market. posting approval double-digit time full for on our for first the growth, Drug pre-market We of quarter the and Food we of development to with HIV-Syphilis the the with growth, We application XXXX. on Neil. the we to collaboration potential filed year disease an multiplex achieved has develop in U.S., undisclosed novel collaboration which identify the building Administration we assay completed a established portfolio AstraZeneca and of the assay, advanced you, to XXXX, significant We believe in Thank DPP biomarker under product XX% the revenue DPP a the LumiraDx new infectious point-of-care our assays.

our expanding in technology territories expertise In and have to technology we additional collaborations. existing increasingly ability and our customer scientific DPP our leverage through platform new summary, markets, a success segments confident continued numerous patented into are penetrating the significant and plans. team Operator? platform, and experienced open product development With pipeline, global robust products our we'll on it that, current the leadership market and up capital collaborators, a high-quality world-leading execute market, supported questions. in now by to opportunities to We

Operator

Per first Our line comes Instructions] with [Operator the question Ostlund from Craig-Hallum proceed question. Capital. your Please with of

Per Ostlund

guys. kind that tremendous and start what further, better looking because Wondered, still, had XX% Good the geographically. little we a significantly start of I a to bit modeled. afternoon, growth. product you. like And I been on to had congratulations want flat we said, you know did if We can than little looks sales they you a were Thank year. commented you flesh out like with year-to-year

in that a As can, that, XX% Malaysia plus, wondered, Ethiopia. more maybe actually million of was because was those came where at I on out last I XX%, so was year, the flesh look contributions out order think, you bit isolating there kind again, of, I little side, growth. X came a dengue it that if from

that else you nature bulk Was strong to to there growth? lumpy guys. clicking that in anything there particularly, was or for So seemed a be contributed that lot

John Sperzel

the question Per. for Thanks Great.

first. to tackle So Asia just

the had of that tender we a Southeast year right, shipped fact, received in partial first particular, for Malaysia. in this And Asia, we in the You're at beginning XXXX, quarter a the year, absolutely year. in dengue of tender we full in year

So million compared as were in of for and and about we I announced $XXX,XXX one previously in a had year. Africa from commitment award from this take The of XXXX, Latin as receiving the America came America, million for down strong it's sales tender them at which partial XXXX. if if period we look have course, Asia, our $X.X to commitment $X.X from time, of similar sales year prior you just related at well that we just a Latin to a Bio-Manguinhos a

So that in Latin the up we Africa, tick continent. explains some In of throughout the just America. continue to really execute

what We and have there see a execution. is strong really sales just great you person

Per Ostlund

the other continent on in Are Okay. you I year And the of That's tender think, think biggest I direct it is the was, guess, after? that. in large Ethiopia on market. that you ground excellent. I the going of directly Chembio's stated off -- in biggest tenders result be that maybe a the are in that the Since people history. or dovetailing this was there that, can previously play

John Sperzel

obvious are more We not reasons, to there for may we we pursue. and of continue share. wouldn't but hoping that the to fair them, discuss our but win throughout frankly, win specifics are all world, throughout than numerous tenders Africa, We

Per Ostlund

good. sounds the more, a That I'll floor then for One see moment.

of them, Was revenue as far you you there completion the said next the and any that generated I first attached have year. I timelines completed so Phase Phase upcoming of AstraZeneca, milestone with would to from? some completion submission Regarding articulated as you half you in

John Sperzel

is based collaboration the So with on AstraZeneca of concept the approach. phased a basic

stage a which development follow X, Phase as gate define standard which product we pretty would we a process, So feasibility. includes

a we're Therefore, that that and signed recall, and would Phase design regulatory II, part can subsequent process and the as then non-clinical AstraZeneca. product done completed we're may you And first remaining that that's Phase commercialization. pretty process. say, completed latter contract in verification during milestone The development the engaged IV, we imagine. is optimization,we get before and and are I pivotal studies, which phase of was of to presently essentially we then the really studies and III, gate XXXX important to Phase If which of validation, I, quarter going it. that, that submissions. design in a we phases you XXXX, to and is before middle we're with that's the It's the Phase remaining standard design phases during stage

Per Ostlund

in that me That in ask and mentioned Okay. one you fair states the of window, the your of, you that point remarks -- FDA. can agencies let test? test Actually, while closer make more Since did you or be this the sense. you're a Is there you feedback question. groundwork the laying from approval and more happen the awaiting XXX-day of prepared to HIV-Syphilis sort does of, public amount it health we're with at the expected

John Sperzel

doing terms from do and actually we but there's are commercial the review obviously, test, to marketing In until agency, that a the launch internal we in work anticipation and approval we have that of wait we of get internally. of lot can a successful

Per Ostlund

Okay. good. quarter. Thanks. Nice Very

John Sperzel

Thank you, Per.

Neil Goldman

Thanks.

Operator

the next from with Benchmark Myers Raymond comes question The Company. question. of proceed your Our Please with line

John Sperzel

Ray. Hi,

Ray Myers

Thank you. much congratulations John. progress. Hi, you on and so Thank

you And contribute Can how potentially does does little Let that a to when start made the announcement start with me that about revenue? bit, that you flesh an explaining, MTMC, the self-partnership. work? out

John Sperzel

nationally cover prepared MTMC, the They States sales executives the in have United more XXX So I outsourced in all is remarks, recognized organization. segments. said than a and sales as a they market

to U.S. from care Frankly, HIV HIV-Syphilis products. well-known offense. leading anticipate tests market. of we in U.S. taking support sell and going of They products, including to of for Welch a all space. just our U.S. in and with Allyn, They're X number a CLIA-Waived today our the the the the on in presence So sales to the The sales nationwide perspective like stronger much a create product they them play which as market FDA-approved our objective none Medtronic provide partnership is manufacturers, support complete companies of health to provide well.

Ray Myers

in did you able competitor U.S.? to recently represent disclose, Are fantastic. which they the sounds That

John Sperzel

[indiscernible]

Ray Myers

you. Thank Excellent.

John Sperzel

one number Our target.

Ray Myers

Yes.

Can when from launching, I seeing you be year. later a dengue describe this fever believe test we that you see And are opportunity might that? the there? You meaningful revenue

John Sperzel

the So market we is past share, according The $XXX the competitor believe annually. about has dengue. discussed there infections related annual approximately as in XXX WHO, are One or fragmented believe remaining will We dengue and XX% of competitors. pursuing we in prepared among market remarks, said the performance outperform so in XX is regulatory market our million and the certain XX% today, million test I tests we've as approvals. to the other about are to

As focus given basis, a Organization by go Southeast and are the you starting have our Africa, strong primary country to where thereafter. be Latin with imagine, World Mexico can then means incidence to [indiscernible] have a regional going have Asia, country with on on Brazil, targets product to prequalification, registrations means dengue, which country-by-country Health and and channel, we we we America, really pursue which

So those are all priorities.

a predicting to of front it's predict little to have and start early meaningful we'll terms when the that sales, when regulatory Ray. on In we'll success have

Ray Myers

development the now target? it expect, markets Okay. sense give Thanks, stage the really. The these for milestones the with that before the us of AstraZeneca, proceed sense you sounds we partnerships launch? And also or gates you through any the partnerships have with you might LumiraDx, of as Can any revenue these magnitude that intriguing. very addressable

Neil Goldman

that one. take Neil, It's Ray. I'll Hey,

that, focused We our expertise. aren't leveraging specific LumiraDx as John the discussed, I'll scientific agreement. program the to you the -- able is on LumiraDx is point terms primarily to of the But terms disclose out what

pretty the will the a different of that than That -- LumiraDx the described our different process bit product process is a going a to he current development, through are from just focus gates that's much that those stage common and with regard ago, not So be in few minutes said, standpoint. other partnerships. any

John Sperzel

And in -- Ray. this is so John, terms

they includes testing. and [indiscernible], was the number disease lot previously a fair of in They with markets. built have and remarks, are have and of our and in not talked which theme the large to in their they companies, in LumiraDx worldwide for Cardiovascular, is, focused I restricted of say can what several say were terms tend small collaborations, collaborations, that, look a choose disclose I saying can Chembio. was from cetera. about noteworthy is not assays infectious another we you this a who In et somewhat fact, of our in very team, think technical, we while of of recurring it, because what not our the the this all a part AstraZeneca's simply What our experience the AstraZeneca have prior it's respiratory. And frankly, this with world-leading LumiraDx, are other platform, at and to we're leader think what these us time. is information, quite Chembio, I as because which they prepared regulatory, X we can in market we've chose at asked folks oncology experience certain past, a potential that disease with discussing these organizations request. continue while to as large They're infectious and areas. LumiraDx leadership Both thing of pursuing,

Ray Myers

on that. Congratulations Excellent.

more said you give were Organization us a a preparing and you also ask me value about believe prequalification I filing? around World little you milestones Can filing. a strategic detail timing and Malaysia. you of for such Let Health the

John Sperzel

we So the dossier intend to the before to submit point. midyear WHO

site Our takes for months is include a which inspection. review, would approximately it that likely X understanding

that's some we point. go at along. as iteration you know this So what Obviously, there's

for into been standpoint, African will already the Malaysian In remarks, us from never of the have. sell I And facility for to terms in improve allow as situation on cost us us able said, we tenders that good we've of we to which allow business will that produce in prequalification, WHO the allow more and the in the prepared would or competitive us to margin value compete compete to put market. again, product having the that that of believe

Ray Myers

dovetails one I'm your Africa does That are excellent. contribute your wondering which Well, was of when self-testing enjoying. of my that about some question, competitors next which with to the revenue? large opportunity,

John Sperzel

by on HIV subsidized strategy we going enjoying in there. in are Africa. competitors on Bill self-test, success What We say comment our enjoying to we're not not We're success largely that good the is comment with Gates Africa is Foundation. that. for some competitor So our HIV our and pretty and self-test can't Melinda with can Europe,

Ray Myers

One this is, was remind Ebola recently your news again good. small just in test? of there detected. for you outbreak that, Africa, that what Ebola Very us sales side week Can other does fortunately

John Sperzel

and situation. our So products we're obviously, CDC, Africa, this too goes that back were our helped well, It Ray, going early able We platform. because out and we're same came very we news try just really see of on tell strength get to help quickly that can to the that to the to can West do if the week, here. by hopeful we into

have able have period be can We our a believe co-circulating develop very short to or some global these capability in the platform been outbreaks address time useful very of to you in of We environments, have these test threats. where multiplexing of viruses. you

where where Unfortunately, similar folks be malaria and want is similar to with certain As are and have with Ebola, a case, having but Ebola together. help not strategy -- very symptoms. circulate quarantining and the all malaria also that very Ebola might certainly have Ebola Zika, of symptoms rather present suspected chikungunya folks dengue scenario quarantine we of that present and and in markets, with the prevent

the outbreak. we're that recent we hopeful in know don't can we But most So help yet.

Ray Myers

progress. congratulations and so you Thank on good. much Very

John Sperzel

Ray. Thanks

Operator

proceed comes Investment your question with line the Zacks Brian from with question. next of Please Research. Marckx Our

Brian Marckx

comes if sales on really Congrats had market the is MTMC guys. care for private I'm you, John, curious, MTMC people your or once quarter, detail on? side this on own the essentially the an with impressive. health before to you Hi, incremental relationship,

John Sperzel

So sales a model, with was team. sales it we had but a geographical small

imagine, with office you in equally X,XXX doctor very the public care it's team. roughly States, sites an with reach health more can X,XXX urgent type roughly than hospitals, a number clinics, difficult sales that of and small As United XXX,XXX to then, large sites

who device a and do was this decided establish experience different lots a conquer. of So lot diagnostic And to what representing we companies. divide essentially, MTMC, with partnership has and of

lot our a are the to covered health, they hospital very prepared what X we we quickly. Waiver, and current cover of this urgent public our HIV-Syphilis up market, And CLIA meaningful office, our launch said our and they've success they which of I is the get be with and focused Assay, know which as further stay that care potential. where we're think, team allows MTMC products, had So to direct of that with have FDA, for PMA-approved know has going one to on sales the speed we've They competitors. for and asking to market, we us gain physician before, upside the can do very tests, of think then HIV traction we

Brian Marckx

MTMC So It think -- that? of that's FDA probably is likely. on contingent it's I not pretty though, clearance DPP not even HIV-Syphilis, on is contingent

John Sperzel

today. HIV selling are they not, Absolutely test our

Brian Marckx

Great. All Okay. right. Thanks.

John Sperzel

Thank you, Brian.

Operator

from Our next Partners. question the comes question. proceed Taylor line with your Investment Ross ARS of with Please

Ross Taylor

is market in congratulations again the marketing Once a what think and quarter the accept Thanks. fantastic that. that is further science justification really on starting to I works in

John Sperzel

Ross. Thank you,

Neil Goldman

Ross. Thanks,

Ross Taylor

I time known I've I've a seems a very to in as enthusiastic words, really kind ever never year going a that, that company transitions overly we're within major correct, And Yet, some in this next who you here? be and you radically be. pretty bias much of I've up tone be long your Is for considered thinking that the that enthusiastic as are someone X, transformed pick be to to to upside? heard John, and about comments of things. your is of, you gets the you choice or at, a cusp and

John Sperzel

our in confident very feel execution. I

the giving I much For folks Asia and in sales have used us we the United our in frankly, control, America, customers of in Latin in it's Africa, destiny. time, experienced in Southeast States, a word the more, very time our long and first of

So go that about any organizations. treatment, would I attracting the diagnostic fact point-of-care to they yet, company world-leading to carpet a good identify I the obvious that. if it's wanted get could really feel in I they to came world, and say good we're that feel largest really Chembio. AstraZeneca certain about the the to they including test biomarker, red a mean,

I great So that. about feel

Ross Taylor

talk know in I the of was And it to the to the are spars With size how significant. detail business, also regard the Lumira, not obviously, about you're seems able opportunities, notice but market press incredibly I -- likely nature it that. my is the a management, the release more behind through that And experience non-promotional detail in release. lot likely usually there's more the the a the given press that of spars is

I'm a look going press crossed that in comment So going we and your years, that, be? me, bridge making When on. a look realize you April I XX this to at hear currently that lot to question to it's answer, more to going people going that ask I'm we to to X sure, back are find release very not I'd a you're think important whether love was we company but than to that

John Sperzel

Great question, Ross.

We We decisions, scientific others one. to We potential we we of you a effort want our an believe which transform and/or strategic AstraZeneca making or expertise. continue to value platform is believe is the our And using believe have if one. are the in company. pursue to number leverage create DPP LumiraDx to

kind the that's about comment So of that. I make can that

Ross Taylor

Okay. but one what see this that team up to of think current well involved of gobble that the is walking a the out honestly with just talking premium existence has Lumira big that's exceptionally management price all one short of proven could a someone the with I be strategic nice potential day Do Chembio would become. that be partner? the The and price, to as quite before number a was concerns people you stock, literally you acquisitive, prior might

that So how them? relationship do and with you do you manage how see,

John Sperzel

can in or and to opportunity. a that nature acquisition to leadership their is record point-of-care track collaborate help any their but on we companies them portfolio, able kind strong be has activity, to building I comment team the can't develop tremendous believe a say with I really of Yes, disease LumiraDx infectious

Ross Taylor

to time they're number your about ago, see launched the talking test the on go a years trying test. and was every At U.S. size competitors with Syphilis could out handle of that that Syphilis quick done. the test And A one a of market. get Okay. effectively date potential a they fact that

you a road, test, think to Do the a sell test the make literally with have that product market Your test Syphilis you size? down would that comparable HIV ability every of Is H rather? the reality.

John Sperzel

this So clinical subgroups, in mother-to-child the in we some transmission we remarks, in the by the the Syphilis mentioned as concerns a about high saw that prepared HIV growing about in global of of the Syphilis, we held. little concerns which to both way, certain as XX%, and is according trial subgroups, bit CDC about that the and HIV and coinfection

a we So that's couple that not assay our made really we the HIV-Syphilis budget as with a think build be own to a competitors trying reason of States, would to we're market strategy. kind In different. market of Syphilis because was one tremendous coinfection. a multiplex that point-of-care ago. huge years What United that we're to priority We're to trying of there test point-of-care multiplex the against differentiated very highly trying do headwinds address a HIV the is

have average that's think we in to it. product terms United than We the transmission. we're why a and test. an HIV about our create the That's in again, needle mover address coinfection in the a to meaningful frankly with doing can mother-to-child concerns States, of different ability capture very trying share So market Syphilis that market, be

Ross Taylor

Okay. and up work the keep Great. very and good Thank you congratulations. much

John Sperzel

Thank Ross. you,

Neil Goldman

Thanks.

Operator

comes with Our question. of the Larry from Haimovitch with next line your question proceed HMTC. Please

Larry Haimovitch

guys. on congrats quarter and a afternoon Good wonderful

John Sperzel

Thank Larry. you,

Larry Haimovitch

been answered. line. to But It's last HIV-Syphilis. one you're the clarify I the in Lots line. Well, last kind of question one when have one one did in good have of of questions tough recall I of Do you John? It approval. seems know commercial, a for you step need before to to said, also process. first go get the Waiver can you X-step filed FDA you that CLIA

John Sperzel

Generally, Assay it we PMA, office a diagnostic product, can large we complex hospitals CLIA would will Waiver is can moderately a include clinics physician as complex even and that We sell. complex an moderately That HIV-Syphilis group, a test, means like which approved, license. approved a don't a be or many to sell when before need moderately sites. have

which those FDA's CLIA In begin Waiver we application, product do. that So the you have those sequential get a for we successful, the us. a immediately will up assuming when we're blessing. a to But then broader we sites will commercializing that's Once Waiver the in open we CLIA to get market will much for cases, again... apply basis,

Larry Haimovitch

you. Thank

then in as available what market FDA the have terms just post-CLIA. market opposed of the is you John, with -- immediately? to Is of market percent So that FDA that available the of XX% that

John Sperzel

[indiscernible]. going about we're as HIV exists we've -- the the today a again, it think, this I Well, in after the different talked during past market

third speaking a physician generally, clinic, a third a can So office about generalizing we hospital. and marketing I'm here, and health third think public

the around market. question, the third your answer So of

Larry Haimovitch

remaining the at have with you a have disposal, CLIA then initially and third you So in market your the would two-thirds?

John Sperzel

Correct.

Larry Haimovitch

can do have wait you for you John, to for FDA And approval CLIA. before apply

say I that, right? think you did

John Sperzel

do. we Yes,

Larry Haimovitch

Yes.

shot the never smooth with you would you're you know assuming have early at what's you So reasonable or none year. year with go this next of with timing, I -- like FDA. us know don’t But FDA seem mean, obviously, fairly getting and FDA, later approval

the Is What it's year? months X or of say, of timing be approval. FDA or let's CLIA? that you another would that get QX So 'XX the X

John Sperzel

process. there the terms specific for With in either of With pretty are I answer rules, such can't are rules XXX(k) no that. there FDA, so really or timing PMA, CLIA,

Larry Haimovitch

been the What's been your all this? you've experience on CLIA doing post-FDA years from

John Sperzel

over context. it It's all wouldn't board probably helpful in this the and be

Larry Haimovitch

Okay.

John Sperzel

track CLIA-Waived Our experience are we have have assay States, is, with them. three great a FDA-approved the in HIV There test HIV United seven of we record.

are So at we good very this.

Larry Haimovitch

Yes.

the business. and out is the not mind, the is, it's first to comes step but your in So nice beyond when ultimately a what FDA it approval builds

John Sperzel

right. For absolutely point-of-care,

Larry Haimovitch

Yes.

Thanks very John. great. much Okay,

John Sperzel

Larry. you, Thank

Operator

to in queue. questions for closing further the hand no to are management There call back I'd like the comments.

John Sperzel

a all participating in call. We quarter. next Have to day. today's for you forward Thank great you updating look

Operator

participation. this conclude gentlemen, Ladies for does your and teleconference. Thank today's you

your disconnect wonderful and time have day. this You lines a may at