OSUR - Earnings call transcript Q3 2020 | OraSure Technologies, Inc.

Due to licensing restrictions, you must log in to view earnings call transcripts.

Operator

Good afternoon, everyone, and welcome to the OraSure Technologies 2020 Third Quarter Financial Results Conference Call and Simultaneous Webcast.

As a reminder, today's conference is being recorded. All lines have been placed on mute to prevent any background noise. After the speaker's remarks, there will be question-and-answer period. [Operator Instructions] I would turn the call over to Jeanne Mell, Vice President of Corporate Communications for OraSure. Jeanne?

Jeanne Mell

Cuca us Officer; Dr. Chief followed and Dr. and With and Tang, Financial with operator. opening Tang Executive with Chief Mr. Mr. a you, question-and-answer today will Stephen are President Officer. statements, session. Thank which begin be will Roberto Cuca,

and annual strategy. results you loss on revenues, the for ended be certain are filings financial I filings. including forward-looking and company's business and Form significantly other Before Tang, statements the per December expenses, this performance, affect fully year its quarterly that with SEC other markets over XX, more XX-Q that call note its turn to profitability, and statements, in Form the or could earnings call share, its Dr. respect could development, reports and product report to should results may discussed its expectations including performance, on SEC approvals, contain XX-K different. Actual shipments filings, XXXX, regulatory Factors statements, registration plans,

forward-looking today. obligation forward-looking call complete to available future to I management keep reflect of or over the listeners should this on undertakes company forward-looking information mind any Dr. based to provide statements that help prospects, in information statements turn after circumstances call. as about to are Although, update Stephen no will The to solely that, events statements Tang. With

Stephen Tang

us everyone joining for you and today. know, you, Thank late thank was for night last I Jeanne, many. night a

these challenging your interest So I during are I families your faring this hope afternoon. well and and attention appreciate times. you

had a hear today, quarter. strong As OraSure you will

a We've our the contributed use in SARS-CoV-X This prior XXXX. business oral positively quarter, to COVID-XX fluid FDA submission XX% by be antibody COVID-XX Overall, the expect generated driven EUA, $XX million widely rapid has molecular emergency are Our revenue molecular was lab-based collection business coronavirus antigen Solutions devices to this sample through used pandemic in EUA Molecular ready to year. third the or our we test performance quarter. for address submitted our a sample over for the our QX and unit. ability test tests. We increase authorization for collection lab-based to

pandemic, continue the for Our testing in the be seeing sales which Molecular third continues Globally, we're to in the for felt million current more the COVID-XX related level demand predict as some COVID-XX cases number first the the products most endemic. is as be the completely the of here another two Solutions rise. COVID-XX in becomes not The to at generated but the with or that year COVID-XX COVID-XX year. as half of unit achieved surges than need around existing in to alignment, appears business years revenue double in impact in $XX.X what perpetuity the will world. the of forecasts wave disease QX, U.S. in COVID-XX and are be

vaccine there role critical XXXX, to take vaccine to some time in managing and internationally. continue be play by then expect And we is that, beyond, will approved the a hope available it testing will be U.S. will early for year-end While pandemic. a the quite broadly and in a until or

play an growing for COVID-XX and to address persistent massive OraSure expect the collection. need to and to We continue important testing and role, sample

collection. Foundation its has to call, COVID-XX pandemic strong then, solutions for for increased to under will demand billion from are the Rockefeller I future. tests billion X.X alone. that call innovative get an help and foundation with earnings continue for COVID-XX to that the QX in testing our With prepared control. the need tests we meet sample estimate per And mind, the our there in year this to foreseeable X.X U.S. cited approximately Since the be per expect for During estimate we testing year

subcollection individuals the OraSure's on are of samples centered by All an products have area COVID-XX of easy long which experience. we

designed it with own. either COVID-XX standard oral or for consumers antibody test collection through I'd detecting current like is sample innovations, products COVID-XX results address to their our to full that or a active which the collection through PCR to it infection. conduct gold and PCR obtain easier beginning fluid molecular Our for are diagnostic sample testing make testing, on to when can comes

SARS-CoV-X sample to subcollection OMNIgene October. products for six the component tests. currently support test at-home use would the kit two sequencing-based Our from subsidiary led samples kits is devices authorization interest tests. are our in a specimens of an lab-based our that a as cleared DNA testing. RNA. has FDA containing pipeline means are been typically have in use PCR made DNA devices authorized to three molecular are in saliva that customers molecular not quarter these molecular experience the Oral for the that with the stabilization allows collection for by the only part can and molecular of be facilitate of COVID-XX under not Both are back-to-work in to innovating collection and were for success and or part programs collection as sample collection of tests their and operating of note holding are of COVID be ORAcollect EUAs by authorized saliva Developed devices COVID-XX are of test laboratory collect self-collection devices received included method important healthcare also as the collection individual devices providers. these to This consumers Devices They of test home. half RNA unsupervised EUAs devices Use specimens Genotek's to -- tests. testing. EUAs OMNIgene collection for by sample customers suspected LDTs. EUAs Genotek both would two collection, offering Laboratory of home customers at story. kits in devices back-to-school sales transport Notably, home its ORAcollect EUAs to Genotek the at of their But of which saliva and kit applications collection staff Genotek significant or DNA use. for COVID FDA. It's obtained settings, for components COVID-XX Tests one lab. COVID and And now from our DNA used the a grow collection an selection kits be RNA The a continues run balance that the of laboratories or Oral of allow COVID-XX being used in to customers laboratory About third own EUA

For University returning example, using are Laboratory. University kits New to were from of and XX state tested XX,XXX students the testing students employees Reference Biosciences. campuses tests York And of at with developed Kansas Quadrant Clinical before by campus

U.S. Albertsons collection to Phosphorus And throughout Our assessment is Azova COVID-XX and testing, companies part are the as available at COVID-XX device Companies Diagnostics' telemedicine Inc. testing visits program. for access monitoring pharmacies through saliva Oragene Dx of back-to-work programs integrating

PCR resume students Additionally, by samples laboratory self-collection Costco OMNIgene and Easy and normal collection of of EUA to families ensuring curtail saliva in kits workers as for includes their was which helping safety is an with selling aspects essential the of as COVID-XX workflows spread the device. the life. Labs saliva the to people virus PXX Oral a The their workflow test. received conjunction test collection FDA with

work expect COVID-XX nations and within molecular continue saliva We the as to their outside of testing to as U.S. around collection complete existing the but customers, sample sales other kits also for validation with type. a grow U.S. new the

Moving on testing. antibody to

for our fluid detection an SARS-CoV-X. review intended authorized the Pending the of sale have potential We application tests U.S. of SARS-CoV-X FDA date, process. oral be no in EUA submitted fluid the test for for to and oral the first. an EUA are the there have antibody ELISA antibody fluid FDA to This total are receipt antibodies To COVID-XX to for is saliva-based from in the oral we qualitative the

facilities equipment We OraSure's would sample in laboratory infected this ELISA locations Potential sample. human sample our direction quick, to collection a and professional. collection proprietary in an labs, quarter contact to device draw to in personal microplate commercial commercialize receipt the individuals test later dispensed both under presence collection of are physician's would offices, testing will pad the the exposure comparison placed oral The noninvasive analysis use is in to and healthcare be of and antibody the PPE antibodies subject sample customers painless, the and our prepared include have of of in fluid drive-through to number a Oral self-collect EUA. be oral onto fourth a sample collection OraSure of sample year With reducing transport. requires storage determine a The potentially need for protective fluid for or sites. for then buffer testing to less patients. oral the antibody the for tests blood minimizing and interested

advance estimate Prevention CDC, to We officials an According of number could could with this antibodies SARS-CoV-X evaluating an At people a the have previously EUA Control community studies unsupervised suited mounted used who's This maintaining identify vaccine of level, an whether the to COVID-XX. information is and been for collection can implementation. to Disease sample against have infected. and as are infected be in permit have development can were been extremely important that to or the of and that with not for tests people option a public help to an potentially infection and seroprevalence for who case population public they the testing. well in Centers forming also amended surveillance critical community sample central complement is health be counts. included understanding could for decisions health. Antibody a epidemiological Antibody official in-home rates laboratory to count subsequently in sent accurate are it accurate tests and

the test enable lower no Turning from there to of self-test no our tangible to instrumentation themselves Antigen individuals with EUA needed at collection this read be U.S. self-collected continues in To antigen would using point the would Rapid of OraSure authorized at no nostril. results. Subject infection with COVID-XX development Results of progress the to needed. receipt interpret Coronavirus nasal and results instrumentation collection test an product make the for that Self-Test. OraQuick available the active point date, in to the samples are to our test. of

and to we rapid to test can that antigen accurate authorization. different sequentially we bring disclosed a standards uses previously, highly we We introduce self-test. regulatory And test market FDA as confident for an to three meets are our subject for intend

prescribe testing First, conduct the centers. who a a at physician and the self-swab presence instance, In and provider health and sites would this test in use physician sites, would would a employer professional public healthcare interpret of offices, the results. drive-thru test then the university for health patient a

by the offered health or be or could remote consumer which consumers physicians In by individual the universities or by testing or use on where and employers authorities will self-swab they public the prescribe a would for interpret self-test conduct this results. prescription instance home via own test any at or location then their telemedicine. a Second, off-site physician would or

for consumers Thirdly, purchase without by self-test who prescription conduct at an anywhere. the use or test results retail receive anytime, over-the-counter would themselves would or the OTC online and

a We expect is the now rushed. and finalize to process to and EUAs cannot that the design possible of self-test XXXX achievement and This the follow as a QX FDA determine for we thereafter. the file the demands and in of device to be EUA the OTC complete high-performance self-test necessary EUA will EUA as soon the professional studies prescription of application, standards complex that Between filing self-test. the test the

are quality own of self-tests needs our the rigorous pandemic FDA rapid for as the as a for antigen and that requirements meets committed delivering performance. to and We standards self-test well

evaluate the detection and in live to EUA-authorized We provided needed. the strip antigen results in The rapid benchmarks. with amount an lateral sensitivity will test. certified the of instrument-free Limits have further at proprietary comparison sensitivity conducted the a a chemistries confidence made deliver laboratory that great comparison OraSure's from third-party to incorporated coronavirus test studies flow of were progress analytical completed important

approximately on our prototypes of performance the design of the at user. key X.X have the for The puts locations U.S. know Once this alone EUA the in on test demand of XXXX the Rockefeller antigen subject as to the in data In identified FDA The others to at timing Foundation we of platform obtained, on clinical we is test under demand it and exactly time, addition there significant evaluation the process delay. what continually prepared is annually. estimates In our self-test Rockefeller and will what providing at under the FDA launch tests we to EUA requirements. testing COVID-XX control. deliver. OraQuick tests review. believe has is the be company fast without frequent are as currently testing hands Based will billion getting control This the against Foundation the a antigen

manufacturing. Early pandemic and meet To key. Roberto hand we that confirming be to that, to last for I'll manufacturing demand on would on to we on on Moving this are test capacity understood for over continues quarter. COVID-XX that collection sample our With to increasing plans kits in as that manufacturing Roberto? a our the quarter's increase financials. outlined end, it report capacity track

Roberto Cuca

Steve. Thanks

increased molecular million of collection ended offset sample sales. to of the of revenues testing, $XX laboratory company's primarily $XX.X the sales profit testing, Gross diluted the decrease due respectively. by million largely sales or $X.XX compared fully for molecular collection the Self-Test XXXX Africa. third International reported HIV self-test, higher As and sales Net or increase the months to to of on and gross Steve third XXXX. XXXX, in sales million profit pandemic. profit XXXX. lower and the XX% sales XXXX of of mentioned a the third XXXX Total genomic unit the third of other the third in Gross the partially quarter business product quarter and increased of of lines, sales HIV for the as quarter quarter of result of molecular our kits from the increase due services of increase $XX XX% primarily a third international was product $XX.X to COVID-XX million from XXXX, XXXX. and during XX% COVID-XX by food XX% net company's earlier, company's $X.XX This for percentage product third net included revenues were associated quarter third of to XX% revenues, of $XX.X all which for fully million, were quarter for on sales. the service higher from product of XXth, services from in a for offset increased a across an sample million our devices three in with strong impact of diluted $XX.X million the an COVID-XX share income partially OraQuick higher of third a per percentages improved the quarter percentage oral September XXXX, compared $X benefited quarter were in XX% product mix basis income Net per share was basis quarter XXXX revenues

results and $X.XX a Third September estimated quarter fair $XX.X accounted acquisition-related and at contingent million the approximately change the two for million associated investments Cash which gains included of XXth, in our business together in consideration of with a per XXXX. $XXX.X XXXX. XXXX share totaled sale totaling value

in XXXX. to the of million $XX disclosed we release, quarter our million fourth we As revenues expect in press $XX of

we've revenues each on seen third quarter the in with quarter we or quarter add earnings flat to performance. will quarter COVID-XX business the discussed will second second product as with we expect this that sales improved call, non-COVID unit just and compared for our be As that fourth

down with in For will lines disease to year, XXXX that molecular continue revenues in ago bearing collection both of excluding the from molecular the XXXX, be the greater full expect infectious year non-COVID-XX and we the business revenues cryosurgical compared impact. period, to collection

products be more the total of I'll higher non-COVID-XX than revenue call anticipate in the sample and our as XXXX. in than tests With the business, opportunities decrease fourth that year-on-year However, in COVID-XX offset quarter XXXX Steve. indicates, our guidance turn that that revenues over we such lines our will back our revenue will for the for collection, to

Stephen Tang

Thank you, Roberto.

for Turning most shut enables States distancing helps HIV Self-testing, in have other all and which as OraSure. the facilities globally. during remains an perspective, challenging United social in-person services consider speaks convenience HIV results alike testing and agencies a legacy in rapid focus at the all to or in COVID-XX. the down. testing to levels strategy been July to available area healthcare the protect cases has pandemic decreases date, to of test which significant and nearly allows the important our only businesses. usability is test and offers States UNAIDS data. HIV for for our users our been in and Access to their and to many like help workers self-testing net on of of third collection global as was countries home. XXXX. World X% HIV January Self-Test by status, OraQuick also self-test encouraged To strong test, CDC QX report know noted themselves revenues to an strategy oral United the especially persons quarter I'd HIV our driven Organization reach pandemic Overall, sales increased international of business departments health compared of XX% individuals test testing briefly in the HIV under current HIV in affected, at-home over in have additional between increased people This government global to the to testing with our that key which self-test HIV the conditions. over-the-counter a only put touch this efforts prequalified To HIV XXXX. testing fluid and the outside OraSure receive Health at WHO

sales to back saw kit quarter-over-quarter. Although genomics not increases levels, yet our in we pre-COVID and microbiome

Third by the commercial prior a XX% sales for Academic and degree. but increased were quarter-over-quarter, XXX% driven in genomics quarter quarter also to lesser market. up versus sales microbiome strength the kit and respectively,

quarter. Our laboratory over services slight increase a revenue the previous showed

adding arena, microbiome new products the in services. innovate to continue We and

company standard supply which use microbiome Beauty the services offering sebaceous skin OMNIgene OMNIgene and a microbiome of collecting has Our the partnered microbiome comprehensive analytical our deliver wet Pure – sites, data skin its has customized microbiome. launched obtaining And samples will each samples. other a great will high-quality SKIN and aid team researchers Culture will Genotek skin customers. complete Genotek a provide collection dry start-up DNA method to microbiome kits user's services how regimen products skincare a Diversigen skin to with service and SKIN for subsidiary microbiome a example Diversigen in kit. full science and a DNA to collection and DNA reproducible offers Genotek complement of understanding from

continue We continued as trend and of closing, evidenced growth. business to that by and We products our as forward we the in is In expect to our guidance. believe business microbiome for antigen molecular services, look With a and promise and for growth. sustained momentum to continued strong our poised see and future. the testing foreseeable COVID-XX our tests the continue significant collection robust part to driving and and OraSure devices commercialization already on revenue now antibody is of in our road

will ability your accelerate kits to significantly. test antigen products. market. up be confidence to COVID-XX that, is collection role for will our tests vital. We worthy open our We regarded growth reiterate the OraSure questions. other in and will substantial understand With sample fight they for in believe call with want Our OraSure's list the the antibody highly COVID-XX against bring our the work I and our help is to our We their opportunity it of joining of and

Operator

Evercore line comes Instructions] of first ISI. with the Vijay [Operator Kumar question Our you. from Thank

open. now is line Your

Vijay Kumar

the kit the from guidance I had on Maybe thanks you kit million I in first question. guys, ramping opportunity Q. think here, a $XX one, And when million the for The up the to guys touch expansion, goals Hey modest $XX you step want look of to collection revenues my taking that the up. million. expansion $XX QX for at Steve, capacity implies

current Are So expansion? the on single the once you you're I'm where revenues capacity? be just for should the of we capacity are What the selling every the What ramps normalized part business kit this up? that curious is making?

Stephen Tang

two by noted particular of in performance first EUAs in with we that molecular And are saying, Thank tests, COVID-XX seeing into business pleased the they're remarks. selling unit. you, PCR were Vijay. my products very products our start the Solutions prepared we three as Molecular I'll

breaking step-up fourth is as million of $XX out record right in that's a collection $XX embedded to our molecular that million us not specifically, $XX way be for for company. fourth revenue we're there quarter. that the for to While guidance a $XX By you're quarter a that's the million million for kits would COVID-XX

ahead are with expansion We our plans. moving

I XXXX, of to makes meet terms into we providing the think the point We can expansion make, additional us I enormous will up think which that everything to of are as so well almost serve capacity we selling August we in in announced marketplace. the in that -- demand look

has second our of business, come to in the quarter nicely I which area to think will this third fruition So continue and grow.

Vijay Kumar

follow-up, on for on Are there to version you on guess, at-home in causing press any I one thinking Understood. give challenges said the the from you be of two the some would I question soon language Or Is version then out us And a event? version the the self-swabbing we QX. here that I'm side. there'll And on is release the antigen drove after. out? how the color think what delay? guess that at-home first a understand Maybe self-swab that technical I here? should that, guess maybe about QX the push push or the what half investors' be minds is testing I can curious follow as the test? on

Stephen Tang

Right.

version you the an we've of professional But recall, EUA only indicated though you test our the August quarter noted we EUAs. that as back in that So from even call quarter. for Vijay we were our to may first second sequential seek going forecasted in

we will shorten be parallel approval. between each the self-test, trials noted time prescription then So actually the as to you clinical self-test then in professional conducting over-the-counter

product it we're about after providing would our And the prescription self-test over-the-counter so. when information of self-test not approved. specific we and be do believe part will market, the professional So to be the on is plan while soon remains the

our -- what's for is which It's important technical validate that performing well it's the already and it the But to antigen compared of limited been on studies, What's us that see now. is OraQuick exceptionally at to to strip leave marketplace. accomplished. been work step gone I detection we'll impressive in that essentially tests technology, effectively. to that's are our back rapid the so core think a test And

company a us is to that have process we'll same do in right essentially EUA essentially no progress that design confident And significant will that for is and are clinical self-test is professional product. test validate the that so now. a the something other before. think between rapid the the and the product. in go the I in trying success And one-step that And the design first submission through for OTC of trials has the the use we self-test very antigen ready now quarter, the is What professional we are done Rx we'll

products other own on in them no that purpose professionally their the that's was So product though market used all are right. of designed even today specifically for

test in-home OraQuick the nine by based quickly as the taking the on the developing get So on in Ebola HIV on we're care extra in XXXX Antigen experience way Rapid also our market test time the as in the this months' possible. back And to putting market.

with first always in product self-tests that we're along but are Rx confident that self-test OTC that thereafter. the and come development, the soon coming are things I unanticipated quarter EUA there So, think in very

Vijay Kumar

does competition? compare how it Sorry, to LoD antigen testing? is what the your And on

Stephen Tang

the haven't information. And already the market. that's competitive that those but Well, they numbers the on are with are we Vijay, public products are disclosed so --

Operator

Our line next from Frank Takkinen Street with question the Capital. of comes Lake

line now Your is open.

Frank Takkinen

my taking for questions. Thanks guys. Hi

in the go into could EUAs fourth Genotek a the hoping this I that into for a process today. remarks you just DNA Just bit to as momentum could was couple well prepared little on behind the to you and about for drive two a I here as quarter how talk October the you the that products. your heard XXXX? bit little business continue deeper potentially debottleneck guys

Stephen Tang

Yes.

for question. thanks Frank the So

products EUAs. for that breakthroughs received think important two So, these are I the

And were in that's And that own these ORAcollect Oral before an a for saliva a wasn't approved on provided our essentially individual received so and to market their products. collect that that because used in RNA it's EUA our product specimen. are now products the OMNIgene important pathway for subcollection available they has also there's

and the use will genomic very XXandMe companies others. mimics in what clearly product So of the used we've you if testing for by like done

in so it a very our much from technical with line expertise. was And perspective

it allow take with a for in saliva. molecular or important the how And saliva And breakthrough own from think pathway themselves come and self-collection so allows to pain swabs. really really which which far and we've discomfort subject does swabs deep to the I to people for nasopharyngeal using is it's to recognize those oropharyngeal testing associated their sample not

of the the I product. And New York So of University of breakthrough. campuses that Kansas provided the XX of that's think we evidence using XXXXX tested at State students University work the of that through the our customers.

distribution and our the product see widespread even So we retail you mentioned our prepared remarks. in into of that channels

and why into So XXXX growth will and we're excited collections, beyond. breakthrough progress our that business and continue molecular Molecular Solutions so the that's clearly is about that the and unit in

Frank Takkinen

mix for profitable maybe to came comment contributor that flipping Great. then model of saw momentum was Roberto. increasing collection at continued the margins margins in of definitely fourth you the business? a gross And We curious nice could and behind expected one if given on It's molecular quarter. this the back level XX%. to I

Roberto Cuca

Sure.

be contributors to we you to expect correctly that is revenues. to and growing that continue our those of the products driver deduced COVID-XX the So,

the least moderation margin as gross the continued gross our the to coming year. the given There see this we gross will as see fourth will and HIV bit business, sustainable business. a be better growth versus be overall the lower margin the in as our good third quarter quarter quarter seasonality which business. in So at as from But level margin is in do a quarter-to-quarter we some the fourth third that international gross and seasonality genomics commercial -- in a likely quarter to some we margin expect historical see

Frank Takkinen

Great. congrats the Thanks for progress quarter. the taking this on and questions

Steve Tang

Frank. Thanks,

Roberto Cuca

Frank. Thanks,

Operator

you. Thank

next Our with Peterson comes Tycho of from JPMorgan. the line question

open. Your is now line

Casey Woodring

a question your on guys guide? Hi, evolving – oral the advantage that? are fluid test? I revenue guys. Tycho. advantage this how into antibody an first is XQ how This I Casey you for do of COVID is And see how much you in is market any perhaps much guess baking of using guess is for I have then competitive

Steve Tang

we locked So But million. million antibody to has would Casey, out on That $XX individual building I fruition. we begin the test prototype products $XX for our as guide is risk. announced broken not that inventory come have once think at into manufacturing we August, back to we in

have customers basis our we that get a our are product now We before on evaluating research-use-only EUA.

So nicely. that's along moving

that the think going is great that counted just an antibody out be measured there's to when disease been a the time York in was article this There XX% for probably seroprevalence moved expansive. coming the that said at discussion the oral and been I fluid pandemic they It's residents has towards test surveillance. market exposed haven't have yet. of City or today New to but

are to vaccine overall. in not So see vaccine – In the XXXX to [indiscernible] much of to and know rollout how accompany mounting a for a XXXX. we possibilities seroprevalence will virus population antibodies be the do powerful this of tool really what our the the this product

only lot So is approved sampling. this – is genomic with if FDA experience the fluid. it's a that oral fluid sampling use product oral to blood-based for by own from than and testing EUA the an and we better when And our know

antibody tests use I think there XXX that are blood. over

it So products are the OraSure unique in these with unique tradition of applications. –

Casey Woodring

maybe antigen And that. on just for the Thanks pushout. it. Got one

FDA be of week reasoning asymptomatic the called to behind antigen it. on sort studies template little population. its saw last Just updated test submitted the color I in that for more more a the

it more reasoning Just the on it a to color it wondering the to is up Or the getting that studies matter be behind any done? Just needs be? out? need about push of was to more sensitivity where

Steve Tang

clinical development, with doing course, then there's product an from they to to And when involved get of that Well add process it. always need you data the field. you're iterative

quarter the new first think as of market of to we'll matter it because to And point product us chemistry to that contribute confident the aspects on as product the where and I So are with change comfortable ultimately make. for pushout between we let's very next the forecast interplay to the we're get design changing that say in the the I can of sell once is think that think commercially many year. I the won't the we

an it factors And it's use our to that's OTC product for FDA and and a principles those EUA. ultimately what said I performance. designing initial of the the before, or self-test nothing we'll of with external as to a be everything So own company to with professional has into we only self-test self-test doing the whether an do are standards seek product do designing Rx is specifically which the

a to rapid do been a things to one-step by accomplished antigen all anybody those challenge create test So not is that's yet.

to that's it time and So right. the why effort we're investing do

Casey Woodring

Thank you. Okay.

Steve Tang

Casey you, Thank

Operator

Thank you.

next Our question from Cooper James. Raymond the with comes Andrew of line

line Your open. is

Andrew Cooper

we saying commercial you're customers test the your guys place about this." potentially that think was of hopefully it that risk antibody kind think the labs from market and of customers I we've additional maybe demand and user guess I bringing I or the to initially going guys. questions beyond you there. expanded know on the empty potentially the for do on first it assessment about if to labs? we of can touched in and was thanks statement talked your sort sort think do opportunity it. those to this substance Or got pulled Has your approaching there? when back of thinking But about "Hey I somewhat platform we've as how and Hey, getting

Stephen Tang

opportunities. coming important also pandemic first than even in are in previous you're need with here. were with beyond antibody vaccine reason has that And said the that we've further since I now into March. antibody a is that tests use think particularly recounted as they statements our the of Yes. pandemic, I right a moved started And changed I beginning correctly. at commercial the be more we are and you've back going And the tests Andrew, of stage earlier, to that prospects for play for where the think

right antibody from oral customers EUA we a fluid lot commercial are mind, we that now more pursuing the started with than So with the in said interest research-only queue ELISA that as and test. of I for anticipation the there's in in

along for So tailwinds business. of the yes, and lot we're things of are moving a part seeing this

Andrew Cooper

quickly And then on just maybe Great. Okay. antigen side.

Just and have want that design soon as do said of submitting final that the the antibody, FDA to locked that what start would you that's like to for confirm manufacturing at once comfort. you Is the still sort as you before in done? know like still you said manufacturing of risk you're plan kind

Stephen Tang

as is something the reason the And unique very marketplace. inbound be able is there even for the on which plan. pent-up significant We interest the based that aims product the design in will marketplace. though be to satisfy ultimately to still a want test for in first That I is Yes. a And demand doing said the self-test EUA of is so. professional good

Andrew Cooper

Okay. in. might data it chance as the understand of things? that And three? is compress the closer lag go to some is that some of as the two test does you line? But same can of to delaying maybe initial two sort that one sneak dynamics you that time think running we adjusted. Or we professional line I any the kind there to when about the more the between of have time expect then had maybe push the the over-the-counter time Is gap the some fine-tune of here and develop where still just one kind parallel, in or last prescription there it could that self-test to trials if kind one of On of from you've

Stephen Tang

but as ensure we're somewhat resourcing Well trials, final the EUA design EUA lag everything submissions between of time the the our imagine that to on the is of doing period the it's minimal with process, there's makes because of call clinical right? approvals. can approval you can in FDA control So course we and control somewhat our out and hopefully the

our evolved as these ensure time much take and it thinking about need trials possible. we make what we'll to lot have as to thoughts investments shorten the We that accomplish the we will a clinical

that's I August. spoke we back at an for second since us priorities our in evolving been call So set of quarter think earnings

good And overall there position so and I we the minimize of control. think we're to control a time amount what can very in

Andrew Cooper

Okay. Great. Thanks stop there. again. I’ll

Stephen Tang

Thanks, Andrew.

Operator

Thank you.

Our next question comes from the line of Citigroup. Patrick Donnelly with

line Your open. is now

Patrick Donnelly

with make. on what upon maybe know ahead side. at can mean much type Steve risk on of of expecting the obviously the should selling of be following a we of guys. kind I about time, self-antigen talked capacity bit capacity you just of ramping launch launch the you pretty XQ little Thanks I test? guys expectations everything

amount capacity? directing So from you carving certain at how about time, about that And thinking same think you are side? and the to OTC? What's capacity prescription towards professional that your the thinking a are about up then right of way

Stephen Tang

Yes.

Ebola XX and capacity on what remember, per XXXX. So our the we by that is of is, announced million million quarter XX capacity per first tests. about for embedded by previously million we're XX of for move third are and from million HCV per million quarter tests And HIV, to quarter the going XXXX plan in XX we existing per that to XX to year tests and year tests year units

on from have come capacity the that previous serve ready can our stream calculate you market, we when will to information. we So professional the

about products. make timing for self-test, about many we'll the we I the as for products we're get think, going making for the as And have allocation to what to professional self-test begin decisions can capacity. OTC we sell Rx which then, the more as and certainty

before, it's here all design factor approach make in I or professional same spot the product do combination taken I any marketplaces -- as company considerations we sweet Rx see make that I that the self-test. the to other and yet. don't cases, a think are to there. And That's OTC use to design really I think and for three OTC self-test think try whether we we'll form in Rx need from the and an said self-test think has the I've

to So manufacturing allows built that between plan [Audio here fungible and more our that's a is into for design have really us Gap] what discussion

Patrick Donnelly

Okay. Yes.

dropped off You at there end. the

-- it. most then one I of And got think I

Stephen Tang

that. about Sorry

Patrick Donnelly

that looks kind normal of now antigen and just just on no One shifting the apologize outside want No, your months. again, quarter the of no more -- nasal. in guys big There's self-test. sure, things locked just compelling. course correct? kind problem. the wanted changes I circling time right the just on design kind Last refining it's a approach, from Obviously they're clarify. shifted to for to make fully on saliva data to in this. on The of end. I I you But Is of, lower few line, back here

Stephen Tang

That is lock announced basically prototype like not announce that. correct, may haven't or we anything although, we And that.

now, think comfortable when to professional submit we without least, I EUA at the with think our goal is, too right actually much progress, we're revealing I application. announce But for the our manufacturing from And HIV, will and scale there. experience know to how we Ebola, the look about what final lot we've had think with design HCV like. about a because I the

Patrick Donnelly

All right. Thanks.

Stephen Tang

Thank you, Patrick.

Operator

you. Thank

Johnson next Stephens. Our Jacob of the from the from of line question line comes

line open. Your is now

Jacob Johnson

just that demand guidance, quarter from kits, fourth for tests? be COVID-XX term. color terms their would near customers in and about it near think, suggest long-term least there. given can in of talk I On just any Thanks. But what hearing in you interested at your strong, collection pretty Hi. the I you're other is demand would

Stephen Tang

everything Jacob, capacity us approaching point say forecasted are sell we I well. the make in where can we that, August would back increases and we that will a will we serve

U.S., began and well outside molecular rather through and America that certainly certainly, U.S. in so, And seeing North probably demand XXXX our continue, products XXXX. we insatiable for the are well right into now. testing looking in believe will but we're the we a as It for

saliva that a gravitated part So as fact the these to of are great saliva have I you really testing. think discussions have, self-collection people to key because and need

Jacob Johnson

Got on front. the it. non-COVID just That's helpful. one maybe question And then,

in with the, franchise a be guess, test HIV clinics aside both domestic third rebound be beginning expect in rebound here Should would think, see the the the U.S. the signs fourth guess, the internationally you maybe ticking fourth I than here you muted quarter. of, in to then COVID U.S. see on increasing? think had But I be little up? described the You could of second cases in to back reopening in better COVID quarter in said side, a wave of Roberto as quick with it nice we I there and you domestic volumes that some And quarter and are the we quarter

Stephen Tang

a would as directionally, in our think say pickup HIV alluded U.S. we business. I I based Yes. seeing Roberto -- we've seeing been are to

clinic with because direct CDC self-test. that to there to the clinics of closings, would-be our patients guidelines Some urging has issued actually those

well. in served us And an alternative has marketplace the incredibly so that having as

And will hedge we'd which staying wave open test domestically of again a and products. shutdown economy clinics benefit HIV But for against the benefit creating our third OraQuick in-home their bet reason. COVID professional so the the rather that on

guidance by line So the we view given product specific situation. while way the we haven't that's

So I think us both scenarios. there's upside for in

Jacob Johnson

helpful. taking Got for Thanks That's question. it. the

Stephen Tang

welcome. You’re

Operator

comes from of with line the question Brandon Thank you. [Operator Our Jefferies. Instructions] next Couillard

Unidentified Analyst

as as today. on on ASP side customer about well? market. health well Brandon Phase on to be centers will largely of doctor for of you're on your offices rollout antigen Any Matt is go X how on the there? distribution channel, And the the This gross into there guys. initial thinking side any color that one or Thanks the setting updated professional likely test Quick through university margin given then the are in margin the color

Stephen Tang

you take one? that Roberto, to like would

Roberto Cuca

Sure.

yet the platform that be generally that to technological the -- test So for to with in other we expect disclosed say products the market. pricing test with the yet line than excuse antigen antibody we haven't me, the same it in products and on other

those for will mix evolving an customers. be optimize mix And a product least channels, amongst the we and our that potential actual our gross of And for three. said three on other achieved reminder the that will as products products. margin get gross for we all first of have ASP as distribution because a EUAs good percentage types are be margin the We as then the at and to mix there the product as depend expect and lot the

Unidentified Analyst

guys sheet balance sense. we look at of then Makes And the Stephen cash. you have if $XXX million

one number a deals done of here You've divestiture. smaller

if how You're funnel into anything Thanks. coming is perhaps M&A clearly last appetite more this manufacturing, to today year. in the over spending your evolved right all months. out few but if was And it now at build has than the curious actionable

Stephen Tang

Yeah.

continue look for We opportunities to to leverage attractive balance sheet. our

XXXX current at that products as certainly changed fairly our But course to objective look COVID-XX and we I strategy. to that enormous have look XXXX, opportunities. ahead companies our think are business I to think, And going technologies our acquiring with circumstances growth the the remains to at it and overall be, speed. growth accretive is

types continue as And you deals at so robust, with been that. accordingly. potential and we'll development and be and the to suggested has size adjusting and our expectations prospects, But of of look pipeline the interest I think, from inbound outreach business our we'll both own

sheet. the opportunities I Our is I think No us stellar. the interesting will balance all very on some near future. at debt lead in to sheet, think And that balance

Unidentified Analyst

Super. you. Thank

Stephen Tang

welcome. You’re

Operator

We do of follow-up with Kumar the have you. Thank from ISI. question a Vijay Evercore line

is line now open. Your

Vijay Kumar

and will Maybe The have antigen Steve think a any Street just the will expect, update I One, on to can -- you update? The it's what we QX. testing. And that because, the second the QX over And you're next perhaps? have have Is as right? prototype out was you. follow-up the months, few in now -- clinical right? Thank push have I locked the updates investors the should any delay had quick when been asking yet? Street we one what's And field to self-swabbed? Are on the interim. given starting in-field in are causing some these has live in would device be the cases testing, for trials like trials the And these I'm

Stephen Tang

Yeah, announced not prototype Vijay, locks. we have

That's a our understand submission separate product I that our haven't right do the do I about to announce we plan anything we professional in response now. So for mentioned question, application, test. plan said product the that. the our in interest to earlier, development. EUA of the and

we particular There to announcement. factor other due are we obviously to of the performance Beyond and very particular delays the But, that for high any to would are validate product. not of communicate are in expectations, what that for, when. will And had trials have product. to -- and clinical we performance the the running we'll issues have any the account see, design some competitive than the particular

and So that continued up, QX interplay our since August has ramped earnings call.

shortly our self-test. stick. FDA quality [Indiscernible] the that high is we EUA this I confident the product we get And performance what with thereafter. as very we very quarter. which Rx own the use market. to we're to product standard time following road a the self-test internal for OTC and the that's in takes bar, the before standards this are measuring that And the and targeting first will So that, getting understand to will on it is the why said are self-test on And what But a process the

Vijay Kumar

Steve. Thanks

Stephen Tang

Thank you, Vijay.

Operator

now closing Thank to you. the would call This like concludes today's session. I question-and-answer Tang, turn Stephen back to, for remarks.

Stephen Tang

afternoon thank on in are. to hope call you We'd enjoy safe Thank very for everybody OraSure like well your keep and interest or evening. wherever And participating you to much. your and your you Technologies. We that, the continue

Operator

concludes you today's your Thank gentlemen, for and conference Ladies participation. this call.

You now may disconnect.

OraSure (OSUR) 4 Nov 202020 Q3 Earnings call transcript