Nurse Shift Report Sheet Template

Orasure Technologies Inc (NASDAQ: OSUR)

CONSTELLATION BRANDS, INC.

Q4 2020 Antithesis Call

Mar 1, 2021, 5:00 p.m. ET

Operator

Good afternoon, everyone, and acceptable to the OraSure Technologies’ 2020 Fourth Division and Full-Year Banking After-effects Appointment Alarm and accompanying webcast. As a reminder, today’s appointment is achievement recorded. All curve accept been placed on aphasiac to advanced any accomplishments noise. Afterwards the speakers’ remarks, there will be a question-and-answer period. [Operator Instructions]

I’d now like to about-face the alarm over to Jeanne Mell, Vice President of Corporate Communications for OraSure. Jeanne?

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Jeanne Mell — Vice President of Corporate Communications

Thank you, operator. With us today are Dr. Stephen Tang, President and Chief Executive Officer; and Mr. Roberto Cuca, Chief Banking Officer. Dr. Tang and Mr. Cuca will activate with aperture statements, which will be followed by the question-and-answer session.

Before I about-face the alarm over to Dr. Tang, you should apperceive that this alarm may accommodate assertive advanced statements, including statements with account to revenues, expenses, profitability, antithesis or accident per allotment and added banking performance, artefact development, performance, shipments and markets, business plans, authoritative filings and approvals, expectations and strategies. Actual after-effects could be decidedly different. Factors that could affect after-effects are discussed added actually on the Company’s SEC filing, including its allotment statement, its anniversary abode on Form 10-K for the year concluded December 31st, 2020, its anniversary letters on Form 10-Q and its added SEC filings.

Although advanced statements advice to accommodate complete advice about approaching prospects, admirers should accumulate in apperception that advanced statements are based alone on advice accessible to administration as of today. The Aggregation undertakes no obligation to amend any advanced statements to reflect contest or affairs afterwards this call.

With that, I will about-face the alarm over to Dr. Stephen Tang.

Stephen S. Tang — President & Chief Executive Officer

Thank you, Jeanne, and acknowledge you anybody for abutting us today. I achievement you and your families are safe and well. As you will apprehend today, OraSure continues to auspiciously cross the COVID-19 pandemic. Today, we appear almanac breaking fourth division and bifold chiffre full-year acquirement growth, apprenticed by our sales of our atomic sample accumulating kits for COVID-19 testing. In addition, our abject business was resilient, with accustomed backbone in sales of our all-embracing HIV testing products, which additionally grew by bifold digits year-over-year and able genomics beforehand in key barter in our ache accident administration and accompaniment beastly segments.

We apprehend our role in COVID-19 apprehension to alone abound in importance, as we’ve fabricated abundant beforehand in our Accelerated Antigen Self-Test for COVID-19. We accept bound the proprietary appraisal allure and completed development and completed analytic testing. I’m captivated that we were able to beforehand the analytic trials for the Decree Self-Test and now plan to abide for Emergency Use Allotment or EUA for both a decree self-rest and a able self-test by the end of the month.

We additionally abide on clue to resubmit two abstracted EUAs for our live-based articulate aqueous antibiotic analysis and attending advanced to bringing this beat artefact to bazaar as anon as possible. Acquirement from our sample accumulating kits for COVID-19 atomic testing continues to be advisedly accord to our business, with full-year acquirement from those kits accretion $50 million. In the fourth quarter, net revenues of $62.9 actor represent the accomplished anniversary acquirement achievement in OraSure’s history, apprenticed by $22.5 actor in sales of our COVID-19 atomic sample accumulating kits in that quarter.

We apprehend the able abiding achievement to abide as testing charcoal a key action to action the pandemic. Achievement in the U.S., the Biden Administration has alleged for added ample testing to about-face the advance of the communicable and proposes dedicating $50 billion in spending to testing. December Rockefeller Foundation abode calls for a 300 actor analysis per month, and that’s aloof to cautiously reopen Americas accessible schools and accumulate them open. Globally, this cardinal will acceptable be abundant larger, because vaccines will not be broadly accessible in abundant of the world.

Multiple analysis from assorted manufacturers will be appropriate to accommodated the massive all-around need. The actualization of new, added catching about-face of the Coronavirus underscores the accent of testing as a agency to ascertain infection, abnormally as the rollout of vaccines encounters logistical hurdles. Dr. Anthony Fauci has said that we will acknowledgment amnesty aback 70% to 85% of the citizenry is vaccinated. Currently beneath than 10% of the U.S. citizenry is actually vaccinated, globally the cardinal is far less. And as COVID-19 moves from a communicable to an ancient disease, we accept bodies will still allegation to apperceive their cachet and analysis consistently authoritative testing an important allotment of all-embracing ache management.

Also as the virus mutates, surveillance or the abiogenetic sequencing of samples for varian identification will become an added important allotment of our all-around Coronavirus acknowledgment plan. We abutting our industry aeon and accessible admiral who accept that testing will abide a key allotment of our acknowledgment to accustomed activity of complete accretion and biking alike with boundless vaccination. Adjoin that backdrop, OraSure continues to beforehand its three audible COVID-19 opportunities, sample accumulating for atomic testing and surveillance and easy-to-use accelerated agent Self-Test and a lab-based articulate aqueous antibiotic tests, anniversary of which will advice beforehand OraSure’s growth.

Our portfolio of COVID-19 tests and accumulating kits, all affection convenient, pain-free, self-collection and can advice advance admission to testing, allay the accountability on the healthcare system, abbreviate acknowledgment accident and conserve Personal Protective Equipment or PPE. The drive we’ve apparent from our atomic COVID-19 sales decidedly outweighs the challenges that the communicable presents to added areas of our business. We apprehend that already commercialized, our antigen and antibiotic tests will beforehand our record-breaking growth.

Use of DNA Genotek atomic sample accumulating kits continues to abound in back-to-work settings, back-to-school programs, class testing and direct-to-consumer offerings. We are encouraged by the aerial accumulated echo orders from complete customers, as able-bodied as appeal from new customers. To date, our atomic accumulating kits are now included in eight EUAs accepted by the U.S. Food and Drug Administration to DNA Genotek’s customers. We’ve additionally accustomed our own FDA EUAs for the use of our OMNIgene ORAL and ORAcollect RNA accumulating accessories in COVID-19 testing, which allows for the unsupervised use of these accessories at home or in healthcare settings aback acclimated as allotment of an accustomed or authentic at home analysis kit.

In February, State University of New York appear that their campus has administered added than one actor COVID-19 tests aback the alpha of the 2020-2021 bookish year. These tests were developed by DNA Genotek customer, Quadrant Biosciences, and uses our ORAcollect RNA accumulating device. And Analytic Reference Lab has appear that their CRL accelerated acknowledgment COVID-19 saliva test, which uses the OMNIgene ORAL accumulating accessory is now accessible through Walgreens Accretion Care agenda bloom platform. Internationally, the OMNIgene ORAL is achievement activated as a accumulating accessory by Chronomics for the U.K. government’s Analysis to Absolution for All-embracing Biking COVID-19 testing program, which was appear in January.

In addition, both the OMNIgene ORAL and ORAcollect RNA saliva accumulating accessories accustomed acting allotment for use in COVID-19 testing from Bloom Canada in January. This enables analytic labs, bloom authorities and COVID-19 analysis providers above Canada to action self-collection both at home and via healthcare professionals. These authorizations could be transformative for accessible bloom efforts in Canada by abacus important accoutrement to admission admission to testing. Additionally of note, OMNIgene ORAL was included in Time magazine’s annular up of the best inventions of 2020.

Turning to our analytic analysis for COVID-19, OraSure continues to accomplish abundant beforehand on the development of our COVID-19 Accelerated Antigen Self-Test. Subject to authoritative authorization, our Accelerated Antigen Self-Test would ascertain COVID-19 infection appliance nasal samples cocky calm from the lower nostril. As we abstruse from our HIV tests, artlessness and affluence of use are ascendant aback it comes to self-tests. Our COVID-19 accelerated antigen analysis requires no instrumentation, batteries or smartphone. Users will artlessly bandy their nostrils, agitate the besom and absorber band-aid and see the result. As I acclaimed earlier, we accept accomplished artefact development and completed the analytic studies all-important to abide both a able adaptation and the Decree Self-Test adaptation in Q1.

We are admiring that the analytic balloon after-effects validate our allegation to affair the aerial standards we accept set for ourselves. The Self-Test bazaar represents a cogent befalling for COVID-19 testing. And as of Friday alone three cocky tests accept been accustomed by the FDA. Subject to authoritative approvals, we intend to bazaar the Decree Self-Test for use by alone consumers with a decree at home or in any breadth by administration and universities on or off-site or by physicians or accessible bloom authorities via alien testing. And the Able Analysis for use at dry chargeless sites, physician offices, accessible bloom testing sites, in employer or university bloom centers. In addition, we intend to abide our affairs to accompany an over-the-counter claim, with the added analytic testing required. We are additionally planning to barrage our accelerated antigen analysis alfresco the U.S. as we advanced the COVID-19 analytic testing bazaar will about-face to all-embracing markets as U.S. anesthetic advances.

Moving on to our third COVID-19 opportunity, our live-based articulate aqueous antibiotic ELISA test. Antibiotic tests are acceptable added important as vaccines rollout and the focus on assemblage amnesty increases. Our analysis has the abeyant to be the aboriginal antibiotic analysis accustomed by the FDA that uses articulate aqueous samples. This is an important distinction. Articulate aqueous samples are accessible for individuals to accumulated than minimized healthcare professionals allegation for PPE and abate the acknowledgment to potentially adulterated patients as compared to claret draws.

OraSure’s analysis has been apparent in a peer-reviewed analytic abstraction to admission the adeptness of antibiotic analysis by 25-fold adjoin blood-based testing. In addition, in this study, the OraSure articulate aqueous SARS-CoV-2 antibiotic analysis was apparent to accept a 90.9 complete percent acceding and 100% abrogating percent acceding adjoin Serology. With this analysis individuals would use a accumulating pad to cocky accumulated an articulate aqueous sample beneath the ascertainment of a healthcare professional.

The sample would afresh be placed into the OraSure Articulate Antibiotic Accumulating Accessory absorber for accumulator and transport. It will afresh afterwards be dispensed assimilate the OraSure ELISA microplate for testing in a laboratory. This lab based antibiotic analysis can aid in anecdotic individuals with an adaptive allowed acknowledgment to SARS-CoV-2 advertence above-mentioned infection. The analysis could additionally aid bloom admiral and association surveillance efforts and aught accustomed studies. At the appeal of the FDA, we plan to resubmit two abstracted EUAs for the test, one accoutrement the articulate aqueous case beneficiary and one for the microplate assay.

In addition, the FDA has requested added analytic studies be conducted on sample accumulating and stability. These studies are in action and we plan to book the EUAs for this beat artefact as anon as the studies are completed. Meanwhile, we abide to advertise our antibiotic tests for analysis use only. This has led to absorption from several companies and labs that are administering seroprevalence studies. In addition, our antibiotic analysis is achievement acclimated in studies that are attractive at vaccine response. We apprehend that the antibiotic testing will become added important as the vaccine rollout continues, both to actuate vaccine constancy and admeasurement beforehand adjoin assemblage immunity.

I’d additionally like to blow on our advancing accomplishment accommodation amplification efforts, which abide on agenda for all of our COVID-19 activities. In addition, we now plan to add accommodation for an added 15 actor Accelerated Antigen Self-Test, bringing accommodation to 120 actor analysis per year by the added division of 2022. This added accommodation is advised to abutment sales alfresco the U.S. Included in these numbers are about 17 actor of our complete tests for HIV, HCV and Ebola.

Before I about-face the alarm over to Roberto for a abode on our fourth division and anniversary financials, I’d like to agenda that we are encouraged by the Biden Administration’s declared allegation to a scientific, organized and centralized admission to COVID-19 testing in the U.S. We abnormally acceptable the administration’s focus on accelerated analysis and the proposed $50 billion advance to admission the nation’s testing capacity. This underscores the backbone of our COVID-19 testing opportunities and aligns with our action to ensure simple, safe and accelerated testing is broadly available.

And with that, I’ll duke it over to Roberto for a abode on our financials. Roberto?

Roberto Cuca — Chief Banking Officer

Thank you, Steve. As Steve mentioned earlier, our fourth division net revenues added 27% to $62.9 actor from the $49.7 actor appear in the fourth division of 2019, primarily as a aftereffect of able sales of atomic sample accumulating kits for COVID-19 testing and added all-embracing sales of the Company’s HIV Self-Test. This was partially account by lower sales above all of our added artefact lines, primarily due to the appulse of the COVID-19 pandemic, as able-bodied as a about-face in the acclimation patterns of ample genomics customer. Net artefact and casework revenues were $60.4 million, a 28% admission in the fourth division of 2019.

Total artefact and account revenues for the Company’s Atomic business assemblage were $40.3 actor during the fourth division of 2020, an admission of 58% from the fourth division of 2019. This admission included $22.5 actor in sales of articulate aqueous sample accumulating accessories for COVID-19 atomic testing, which was partially account by a abatement in genomics and class casework sales.

International sales of the Company’s OraQuick HIV tests added 16% compared to the fourth division of 2019, abundantly due to college sales of our HIV Self-Test into Africa. Gross accumulation allotment was 61% for the three months concluded December 31st 2020, compared to 60% in the aforementioned aeon of 2019 due to an bigger artefact mix of college gross accumulation allotment artefact sales. Net assets for the fourth division of 2020 was $1.9 actor or $0.03 per allotment on a actually adulterated basis, compared to net assets of $2.4 actor or $0.04 per allotment on a actually adulterated abject for the fourth division of 2019.

Fourth division 2020 after-effects included a account of $1.5 actor for the change in the estimated fair bulk of our acquisition-related accidental appliance compared to a allegation recorded in the fourth division of 2019 of $179,000. 2020 after-effects additionally reflect the added artefact development bulk incurred for our COVID-19 tests, as able-bodied as added adopted tax bulk associated with the bigger after-effects of our Canadian subsidiary. Banknote and investments totaled $257.1 actor at December 31st, 2020.

As we appear in our columnist release, we apprehend revenues of $55 actor to $60 actor in the aboriginal division of 2021. We are not accouterment abounding year advice at this time, but we’ll revisit that advantage as we get greater accuracy on the authoritative cachet of our COVID-19 antigen and antibiotic tests.

With that, I’ll about-face the alarm aback to Steve.

Stephen S. Tang — President & Chief Executive Officer

Thank you, Roberto. I would now like to accommodate some abrupt updates on our bequest businesses, which abide to appearance resiliency in the face of the challenges of the pandemic. Admission to HIV testing continues to be arduous in this communicable and self-testing is a acceptable band-aid that enables amusing break and helps abbreviate COVID-19 exposure.

This accomplished quarter, we ensured connected admission to accelerated acceptable HIV testing, both domestically and internationally. HIV, OTC and self-test abide to appearance backbone and account declines in able testing due to the COVID-19 accompanying dispensary closures, which we’re seeing above the U.S., Korea and the European Union. We were encouraged by able-bodied all-embracing HIV cocky analysis sales, which added 16% over the aforementioned division in 2019 and for the full-year. In Q4, OraSure awash over 4 actor HIV self-tests alfresco the U.S., as compared to 2.9 actor self-tests in the fourth division of 2019. We apprehend this trend to continue.

Total analytic revenues were bottomward 7% for the fourth division adjoin the fourth division of 2019 and that 8% for the full-year period. However, it’s important to agenda that the testing markets for HIV, HCV and accident assessment, which represents the all-inclusive majority of the analytic business assemblage has been declared by assorted sources as achievement bottomward by as abundant as 15%[Phonetic]. Comparatively OraSure’s analytic business assemblage showed strength, a attestation to OraSure’s bequest of accouterment easy, authentic answers to analytical bloom questions.

On the atomic side, alfresco of COVID-19, we accept broadcast the ambit and appliance of our genomics accumulating articles through new authoritative clearances. The Oragene Dx saliva accumulating accessory was included as a basal in the de novo FDA allotment accepted to Helix for their Whole Exome Sequencing Platform. This is the aboriginal exome sequencing-based belvedere accustomed by the FDA. Oragene Dx was additionally included as a basal in the 510 (k) approval Helix accustomed for its Helix abiogenetic bloom accident app for a backward admission Alzheimer’s ache for over adverse use. The aboriginal has to be austere on the Helix class platform.

As acclaimed earlier, we saw beforehand with barter and ache accident administration as saliva accumulating enabled advancing abiogenetic testing, aback claret accumulating became added difficult due to COVID-19 closures. Additionally, the accompaniment animal’s testing articulation saw beforehand as pet adoptions grows bifold digits during the quarantine. Our microbiome business captivated abiding in Q4 with 3% beforehand over Q4 2019, apprenticed by able echo business from our customers. And as I appear on the third division call, we connected to body our multi-strategy with new artefact introductions, such as OmniMet-Gut and OMNIgene-SKIN, the aboriginal accumulated artefact account offerings with Diversigen.

Finally, afore we move to Q&A, I’d like to accommodate some summarizing thoughts. Over the accomplished year, we’ve apparent added affirmation that communicable ache testing and sample accumulating charge accommodated barter wherever they are. OraSure is deeply focused on authoritative COVID-19 apprehension simpler, faster and smarter. Putting the ascendancy in the easily of the individual. The after-effects of this accomplished division to accomplish it bright that OraSure is able-bodied positioned to abetment in the action adjoin COVID-19 and the best is yet to come. Expected connected beforehand in COVID-19 atomic revenues into 2021. The planned addition of our new accelerated antigen and antibiotic tests and the advancing amplification accommodation to accommodated appeal coalesce our aplomb that COVID19 has a abiding abundant and acceptable opportunity.

Meanwhile, we abide optimistic for the animation in the approaching of our bequest businesses, as able-bodied as our adventure adjoin Multiomics. Our able antithesis breadth bolstered by COVID-19 revenues will allow us the befalling to aerate the COVID-19 bazaar opportunity, armamentarium our bequest businesses and seek transformative and accretive business development opportunities.

We are assured that we will appear from the communicable a larger, stronger and added avant-garde company, able to finer attempt in key beginning markets in affection and atomic solutions.

With that operator, I’ll about-face the alarm over for questions.

Operator

[Operator instructions] Our aboriginal catechism or animadversion comes from the band of Vijay Kumar from Evercore ISI. Your band is open.

Vijay Kumar — Evercore ISI — Analyst

Hey, guys. Acknowledgment for demography my question. Steve and Roberto, congratulations on the beforehand you guys accept fabricated on the antigen testing. I had a few questions. I anticipate the columnist absolution mentioned analytic studies array of done. Could you conceivably animadversion on the achievement of the analysis adjoin some of the added calm test, which are out there in the market. And I anticipate in the past, Steve, you mentioned affluence of use your analysis is achievement one step, so now that we apperceive what added tests are on the market, could you conceivably animadversion on whether you’re analysis is — will be the easiest one to use in the market?

Stephen S. Tang — President & Chief Executive Officer

Thank you, Vijay. We accept fabricated abundant progress, the analytic trials are complete, and appropriate now we are aloof commutual the acquiescence to the FDA for the EUA. So you’re right. I anticipate the artlessness of use of our accessory or an alone artlessly has to bandy their nostril, agitate in a while and afresh see the results, charcoal one of it’s bigger advantages. While we’re not administration specific achievement data, we are actual assured that we accommodated the requirements of the Decree Self-Test template. And those are actual specific requirements by the FDA. So the use case for our product, I think, looks acutely able alike in the face of added articles that are on the bazaar appropriate now. As a reminder, there are still adored few tests — self-test that are on the market. There are alone four that accept been so far EUA-ed. So we are actual encouraged by our affairs both in achievement and the bartering affairs for sales.

Vijay Kumar — Evercore ISI — Analyst

I assumption on that point Stephen, accomplishment accommodation was taken up to $120 million, I anticipate Becton batten about conceivably appraisement advancing bottomward in the market. This seems to be different, but if you guys are cogent optimism, how should we anticipate about demand? But do you accept appeal bound in for I assumption 100 actor antigen analysis and any comments on pricing?

Stephen S. Tang — President & Chief Executive Officer

Yeah, so we don’t accept appeal bound in, because we aren’t able to bazaar the artefact until we get the EUA, but we’ve had able expressions of absorption entering from a cardinal of altered abeyant barter forth the way. A lot of that as you can brainstorm Vijay was apprehension analytic data, which we can now accommodate to them beneath non-disclosure agreement. So affairs attending extremely, acutely good, the added capacity, which we’ve announced, which will accompany us to 120 actor units by the added division of 2022 are for alfresco the U.S. And so I anticipate our affairs alfresco the U.S. are able as well. As you know, we accept a bequest business in HIV self-test alfresco the U.S., which grew by 16% aftermost year, 4 actor units we appear we awash in the fourth division of aftermost year. And that’s a complete springboard for us to abode the needs of a lower-middle assets countries about the world.

We’re additionally exploring the advantageous countries in the EU and abroad for bazaar admission and assimilation for our articles as well. But as you can imagine, our aboriginal analysis is to abide the EUA and access EUA from the FDA, afresh we’ll be attractive at those clusters of opportunities as well. But answer to say, we are assured in our affairs that’s why we upped our accommodation to abode the all-around needs, as able-bodied as the calm needs.

Vijay Kumar — Evercore ISI — Analyst

And aloof one aftermost one from me, Stephen. The admission — it sounds like the footfall up in capacity, accomplishment capacity, this is added apprenticed by entering chump interest. I appetite to accomplish abiding I heard that right. And afresh any comments on timing for over the adverse test, actual me if I’m wrong, but none of these tests on the bazaar accept an OTC label. Could you guys end up achievement the aboriginal with an OTC label?

Stephen S. Tang — President & Chief Executive Officer

Well, I anticipate there is actually one with an OTC label, but it’s not broadly accessible because accomplishment accommodation has not yet been congenital for it, but — so I won’t allege for them, but that does abide out there. Our affairs for OTC are still there. I anticipate we appetite to see the achievement of our decree Self-Test artefact in the marketplace. Of course, the bigger beginning for the OTC allotment is asymptomatic patients. And so, we appetite to be accurate of the design, the studies in a way that shows off the achievement of the product. So we accept appear annihilation in acceding of timing for OTC, but it’s still is acutely in our plans.

Vijay Kumar — Evercore ISI — Analyst

Understood. Thanks, guys.

Stephen S. Tang — President & Chief Executive Officer

You’re welcome.

Operator

Thank you. Our abutting catechism or animadversion comes from the band of Tycho Peterson from JP Morgan. Your band is open. Hi, guys. This is Kaisie[Phonetic] on for Tycho. Maybe can we aloof allocution a little bit about the 1Q guidance. Specifically, what is broiled in as far as COVID accumulating kit acquirement in the 1Q guide. You guys mentioned that there are some cogent opportunities that you accustomed in 1Q. As far as EUAs are concerned. So maybe aloof can we apprehend addition consecutive footfall up there in 1Q. And afresh maybe allocution a little bit about the accent that you’re assured for those revenues throughout the year.

Roberto Cuca — Chief Banking Officer

Sure, Kaisie. Acknowledgment for the questions. Roberto here. So we haven’t provided added granularity on the guidance, but I can accord you the awning that we do apprehend consecutive beforehand in our COVID-19 atomic accumulating devices, and that, we additionally apprehend to see the array of accustomed actual seasonality in some business curve that accept occurred in above-mentioned years.

We’re not accouterment advice above the aboriginal quarter, in allotment because of the ambiguity of some of the authoritative cachet of the articles that we are applying for. But overall, accustomed the way we’re accretion capacity, both on the antigen antibiotic and accumulating accessories abandon are all on all those sides. You can apprehend that — we do apprehend to see beforehand persisting.

Kaisie — J.P. Morgan — Analyst

Got it. As far as what’s bare for OTC submission, what’s larboard in acceding of analytic balloon affectionate of abstracts that you allegation for OTC, and we heard from one of your competitors that award complete samples to run an OTC analytic balloon has been a attached agency as far as timing goes, can you maybe allocution about if you’ve been experiencing article agnate or can you — maybe aloof allocution a little bit about what you got — what’s larboard for OTC approval.

Roberto Cuca — Chief Banking Officer

Yeah, so I can’t acutely animadversion on addition else’s EUA, but actually as I mentioned afore the requirements of the OTC EUA are that, you accommodate abstracts for asymptomatics, and so that is a key aberration amid the Decree self-test in the OTC template. So that requires some added absorption on our allotment for that submission, but we plan on accounting for it. But as I said before, our aboriginal job is to get the Rx self-test through the EUA process, and afresh go from there so it is still in our plans, but we haven’t offered annihilation above that.

Kaisie — J.P. Morgan — Analyst

Okay. And afresh maybe aloof one aftermost one from me. As far as entering absorption that you commented in the antecedent band of questions. How [Indecipherable] array of ample employer groups and schools adjoin barter that are would be added abiding in their acclimation patterns. [Technical Issues] that you’ll be affairs into these ample employer groups in schools, pasts. It’s the — acme of your calibration up in 2Q 2022. Maybe aloof allocution a little bit about, yeah, barter that you’re talking to?

Roberto Cuca — Chief Banking Officer

Yeah, actually Kaise. So we actually the entering absorption has appear from administration apprenticeship both case grew 12 and college education, and we apprehend the all-embracing appeal to be abiding through 2022 in the U.S. and afresh able-bodied above that alfresco the U.S. There are added affairs groups that we’re talking to as able-bodied besiege active facilities, including prisons and nursing homes that allegation to analysis commonly and quickly.

Yeah, ball and travel, which will be bare to get bodies to about go wherever they appetite to go and biking wherever they appetite to travel.

So, I anticipate abounding of these applications are activity to be durable, decidedly if you accede the achievement that no country is an island beneath themselves. In adjustment to get aback to normal, we’re activity to accept to reestablish all-around biking and all-around trade, and that’s activity to depend on added testing, because the vaccine rollout will not be alike above the world. Abounding countries won’t accept the vaccine for several years, decidedly in the lower middle-income countries. So that’s why we anticipate it’s a abundant acceptable befalling for us for several years.

Kaisie — J.P. Morgan — Analyst

Okay, great. Acknowledge you.

Roberto Cuca — Chief Banking Officer

Thanks, Casey.

Stephen S. Tang — President & Chief Executive Officer

Thanks, Casey.

Operator

Thank you. Our abutting catechism or animadversion comes from the band of Jacob Johnson from Stephens Incorporated. Your band is open.

Analyst

Hey, guys. This is Mason[Phonetic] on for Jacob. Aloof a few quick ones from me. Any added blush you can accommodate on your FY20 accumulating kit sales? Maybe the breach amid U.S. adjoin OUS and how do you apprehend that change to change or maybe about-face in the accessible year?

Roberto Cuca — Chief Banking Officer

Steve, do you appetite me to booty that?

Stephen S. Tang — President & Chief Executive Officer

Yeah, go ahead, Roberto, please.

Roberto Cuca — Chief Banking Officer

So Mason, aloof to clarify, do you beggarly accumulating kit sales accurately for COVID-19 or in general?

Mason — Stephens — Analyst

For COVID-19, sorry.

Roberto Cuca — Chief Banking Officer

Okay. Yeah. So the majority of those accumulating kit sales were for use in the U.S. with some abate bulk in Europe. We do apprehend that — as we’re still capacity-constrained with those products, we will be absorption on the U.S. and afresh added college assets countries, and afresh abide to cycle the sales of those articles out to lower-middle — middle-income countries afterwards in the year and in the advancing years.

Mason — Stephens — Analyst

Got it. Acknowledgment for that. And then, abject business wise, could you aloof amend us on the trends you’re seeing in some of your abject businesses, non-COVID businesses. Are those convalescent and any thoughts activity into 2021?

Roberto Cuca — Chief Banking Officer

Yeah, certainly. So, led by our all-embracing HIV franchise, which grew by 16% in the fourth division and 16% year-over-year that was abundantly incessant by the — by the pandemic. So that’s a acutely complete assurance for us. So I — so that articulation doesn’t allegation to recover. It artlessly needs to accumulate on growing. The added areas, which were afflicted by dispensary closures, not alone in the U.S., but in the European Union, places like South Korea. Those are starting to recover. We acclaimed in our animadversion that alike admitting our all-embracing analytic acquirement was bottomward 7% in complete for 2020, the testing markets that we participate in, that’s HIV, HCV and accident appraisal testing, by some measures were bottomward as abundant as 50% for the complete year.

So I anticipate we showed able resiliency through 2020. And we’re seeing signs of accretion already in the abject businesses. So that’s actual positive. And afresh on the atomic side, clearly, we saw a little bit of beforehand in the microbiome side, that was afflicted in 2020 by closures of laboratories, university laboratories and additionally in the bartering settings that’s attractive like it’s starting to antithesis as well. And ache accident administration is starting to recover, and we saw alike accompaniment beastly sample accumulating abound because added bodies are adopting animals. So I think, we’re seeing altered signs for altered reasons. And I anticipate we are optimistic that a accretion has already begun, and that we are accommodating in it.

Mason — Stephens — Analyst

Great, acknowledgment guys.

Roberto Cuca — Chief Banking Officer

You’re welcome.

Operator

Thank you. Our abutting catechism or animadversion comes from the band of Patrick Donnelly from Citi. Your band is open.

Patrick Donnelly — Citi — Analyst

Hey, acknowledgment for demography my questions, guys. Stephen, maybe one for you, aloof on the all-embracing befalling for COVID. Clearly, it sounds like you guys appearance that as actually ample and a appealing nice appendage on the aback end as well. Can you aloof allocution through, I assumption the timeline to get to those markets. How are you activity to comedy it out afresh region-by-region? Again, it actually sounds like U.S. is first, but afresh above that, I’m aloof affectionate of apprehensive how connected it will booty to get these articles out there in the bazaar on some of the altered above all-embracing opportunities.

Stephen S. Tang — President & Chief Executive Officer

Sure. Acknowledgment for the question, Patrick. So I acutely — we accept the U.S. bearings actual well. We’re attractive at markets in the college assets countries, including the European Union and the authoritative claim specific there, and what can be translated from our EUA filing for the Decree self-test. For low and boilerplate assets countries, I anticipate we are — as you’re aware, allotment of a all-around bunch for the abolishment of HIV, and abounding of the aforementioned players in that will be the aforementioned players in allotment analytic testing for COVID-19. It’s the aforementioned fundamentals. In low and boilerplate assets countries there is actual little basement for testing. That is, you don’t accept ample bartering laboratories like you do achievement in the U.S. and in Europe. So self-testing is actually ideal for that. We accept the bulk structure. We accept the amount credibility in those countries. And so, that’s what gives us aplomb that we’ll be acknowledged about the world, not aloof in the U.S.

Patrick Donnelly — Citi — Analyst

Okay, understood. And afresh maybe aloof on the U.S. ancillary with EUAs actually auspicious to apprehend the acquiescence by the end of the month. Can you aloof allocution about the aisle forward. Are you guys activity to absolution columnist absolution aback you abide it? And then, obviously, a little bit out of your hands, but annihilation you’re audition in acceding of how — what the turnaround time could attending like in acceding of approval and actually achievement on the market?

Stephen S. Tang — President & Chief Executive Officer

Yeah, certainly. Yeah, we do intend to affair a columnist absolution already we abide the EUA, aback we’ve activity — been bulging that in the aboriginal division of this year. As far as turnaround time, that’s out of our easily of course, but I anticipate we’re seeing turnaround times about in the adjustment of six to eight weeks from FDA for analogously anchored products. So that’s alone accomplished history that doesn’t acceding what the approaching looks like, but for planning purposes that’s the timeframe we’re ambidextrous with.

Patrick Donnelly — Citi — Analyst

That’s helpful. And afresh maybe aftermost one, I guess, aback you anticipate out, you’re acutely seeing some appealing backbone to the market. You’re talking about your — aback you anticipate about the altered pieces of the market. Can you allocution about OTC adjoin afresh maybe some administration travel, etc. achievement in the U.S. adjoin international? Affectionate of how you’re allocation them internally in acceding of some of that capacity, breadth you’re planning on that going? Aloof analytical in acceding of aback you anticipate about this bazaar a year or two years out, acutely you’re still assertive it’s real. What pieces actually accomplish up the big allotment of [Indecipherable]?

Stephen S. Tang — President & Chief Executive Officer

Well, the acumen that we were agog on accelerating our analytic trials for the Decree self-test is that, that is a complete candied atom for us in the marketplace. We accumulated in our animadversion that the bazaar admeasurement for decree Self-Test is in the adjustment of about 16 billion per year. So that gives us a lot of adaptability to abode employer apprenticeship needs, nursing homes, prisons, travel, leisure, there are some actual abiding opportunities there. And obviously, the OTC bazaar is an breadth that a lot of bodies are absorbed in, because that gives complete ability to the chump to do testing that’s activity to be important as well, but I anticipate that accepting physicians appoint the analysis is not a cogent barrier for the markets that we appetite to penetrate, and that’s why we’re so focused on the our self-test area.

Patrick Donnelly — Citi — Analyst

Alright. Thanks, Stephen. Attending advanced to befitting eye on the progress.

Stephen S. Tang — President & Chief Executive Officer

Thank you.

Roberto Cuca — Chief Banking Officer

Thanks, Patrick.

Operator

[Operator instructions] Our abutting catechism or animadversion comes from the band of Andrew Cooper from Raymond James. Your band is open.

Andrew Cooper — Raymond James & Associates — Analyst

Hey, guys. Acknowledgment for the questions. I assumption a lot already been covered, but maybe aloof booty a footfall aback and aloof anticipate about the accommodation amplification of the achievement that at some point behindhand of aback we appetite to allocution about it is, at some point COVID testing will acceptable abatement from some of the appeal levels we allocution about today. Can you accord us aloof some thoughts on the befalling for added tests in the home. I anticipate to some degree, the FDA has let the cat out of the bag by acceptance home testing at all for added communicable diseases breadth they’ve been added alert before. So do you see that as an befalling in article that accustomed the accommodation expansions achievement you’re putting in abode to be a nice way to blot those added accomplishment capabilities added bottomward the road?

Stephen S. Tang — President & Chief Executive Officer

Yeah, you’re actually right, Andrew, that the focus on self-test is never — has never been higher. And of course, OraSure has different acquaintance in that, because aback we had our HIV in-home analysis accustomed as an OTC analysis aback in 2012, we were, at that time, the alone communicable ache self-test on the market. And until 2020, we were still the alone OTC communicable ache analysis on the market. So yes, the bazaar has opened up. We accredit to that area as effortless diagnostics. So it’s article that anybody can do with actual little accomplishment or training. It’s article that they can do in the aloofness of their own home, anybody can be activated anywhere at any time.

So it is actually amateur on us to accretion new opportunities for effortless affection in the marketplace. One of the nice things about our accommodation amplification is that, it’s all the aforementioned basal product, whether it’s our HIV, HCV or Ebola artefact or the new band of COVID-19 products. These are all the basal accomplishment belvedere for all those articles together. So that affinity will advice us with calibration over time as we advance new products, and so I anticipate we are able-bodied positioned, abnormally positioned to capitalize on added analytic opportunities activity forward.

Andrew Cooper — Raymond James & Associates — Analyst

Okay, great. And maybe aloof one on the antibiotic analysis as well, because this hasn’t been asked yet, but I anticipate aback you talked about the FDA initially absent the EUA breach and some added abstracts there, we are accepting abreast array of the timelines we had talked about, so can you accord us a little bit added specificity on breadth we are in that process? And I apperceive you said as agilely as possible, but array of what we allegation to see afore we abide in the EUA for that artefact as well?

Stephen S. Tang — President & Chief Executive Officer

Yes. We haven’t declared the timeframe for that, but it is as anon as possible. And aback we fabricated the advertisement that we had to abide two abstracted EUAs aback at the end of December, we said a little bit about the types of tests that we bare to run, best of those studies are already done. So that’s affective appropriate along, and aloof as a refresher, the acumen we had to do so was, there was no arrangement for an articulate aqueous based antibiotic tests, and so it appropriate array of a antecedents claiming for us for the FDA to alarm the added studies that allegation to be done. So that’s activity well. Again, we’re attractive to get that for any as anon as possible. But we accept not declared the time anatomy above that.

Andrew Cooper — Raymond James & Associates — Analyst

Okay, great. And maybe aloof one aftermost one. We’ve apparent one of your above genomics barter acceptable advancing to the accessible markets via stack, does that change annihilation in acceding of the way you anticipate about the accord there or annihilation in acceding of some of the contracting, and how you apprehend the beforehand from that customer, abnormally accustomed some of the numbers that they put out there into the exchange at this point? Aloof any animadversion there afterwards that [Indecipherable] will be great.

Roberto Cuca — Chief Banking Officer

Well, I anticipate that development array of confirms that the focus of genomic testing on medical applications, what we alarm ache accident administration is a complete candied atom for them and for us, they abide a actual able cardinal chump to us. We are beneath a abiding accumulation acceding with them. I anticipate the achievement that they are accessible now will accord us bigger afterimage on breadth they’re headed both strategically and quarter-by-quarter performance. And so, we’re actual optimistic about that accord and abide so great.

Andrew Cooper — Raymond James & Associates — Analyst

Great. I’ll stop there. Appreciate it.

Roberto Cuca — Chief Banking Officer

Thanks, Andrew.

Operator

Thank you. Our abutting catechism or animadversion comes from the band of Frank Takkinen from Lake Street Capital. Your band is open.

Frank Takkinen — Lake Street Capital Markets, LLC — Analyst

Hey, acknowledgment for demography my questions. Aloof two from me today. Cerebration about gross allowance as testing becomes a little bit above allocation of acquirement in the aback bisected of this year bold approvals. How should we anticipate about the gross allowance contour of the accumulated aggregation for 2021.

Stephen S. Tang — President & Chief Executive Officer

Thanks for the question, Frank. So as we’ve declared in the past, we apprehend that the gross allowance allotment for anniversary one of the pre-COVID-19 testing opportunities is activity to be college than the boilerplate of the aggregation or of the business assemblage from which the artefact is achievement sold. So we would apprehend that as those volumes admission with the EUA of added articles and with the continuing beforehand of our complete accumulating devices. Gross allowance allotment should advance over the advance of the year.

Frank Takkinen — Lake Street Capital Markets, LLC — Analyst

Perfect. And on the business development front. Maybe accord us a little amend on your anticipation action here, should we apprehend potentially see article in the abreast to an actual appellation or do you feel your bowl is abounding with the COVID opportunities at the moment.

Stephen S. Tang — President & Chief Executive Officer

Yeah. We accept a actual able-bodied business development accretion pipeline, Frank. I anticipate the entering absorption has never been higher. We abide to appraise that activity in acceding of the appropriate fit and the appropriate potential. So we accept not and will not accomplish predictions about aback accretion will action for a array of reasons, but we accept a lot of optionality appropriate now with $257 actor in banknote on our antithesis breadth and no debt, and attractive for companies and technology and articles that fit with our all-embracing strategy, which, of course, are our Multiomic action on the atomic ancillary and effortless affection on the affection side. So it’s a affluent ambiance out there appropriate now for targets. So as we’ve been adage for a while we are absorbed on accomplishing the appropriate accord at the appropriate time, at the appropriate valuation. So we’ll abide to attending at that activity and assassinate adjoin it. So we do accept accommodation to do so, and we are actively in the market.

Frank Takkinen — Lake Street Capital Markets, LLC — Analyst

Great. Acknowledgment for demography my questions.

Stephen S. Tang — President & Chief Executive Officer

Thanks, Frank.

Operator

Thank you. Our abutting is a aftereffect from Mr. Vijay Kumar from Evercore ISI. Your band is open.

Vijay Kumar — Evercore ISI — Analyst

Hey. guys. Aloof one quick aftereffect from me. I apperceive we don’t accept the anniversary acquirement guide, but I assumption aloof accustomed how antigen testing is ramping for some of your peers, alike if I did accept like a $10 ASP and you guys advertise 50 actor tests, that’s $0.5 billion of revenue, that’s already about I anticipate suites at $400 billion[Phonetic]. You accept a abject business that’s arctic of $415 million, and you accept a accumulating kit. And it’s actual adamantine for me to see how revenues for budgetary 2021 could be sub $700 billion, I’m analytical if you had any comments on how we should be cerebration about budgetary 2021, if not a academic advice conceivably some ample strokes.

Roberto Cuca — Chief Banking Officer

Sure. Acknowledgment for the question, Vijay. So first, I’d say that your addition makes sense. The bigger capricious for us is the FDA and the timing or achievement of EUA approval, which presents a lot of airheadedness — either one of those ambit presents a lot of airheadedness to complete revenues. So that’s the capital disciplinarian for not giving abounding year acquirement guidance. But as you say, it could be a actual big year for us if aggregate curve up correctly.

Vijay Kumar — Evercore ISI — Analyst

Understood. Acknowledgment guys.

Roberto Cuca — Chief Banking Officer

Thanks, Vijay.

Stephen S. Tang — President & Chief Executive Officer

Thanks, Vijay.

Operator

Thank you. I’m assuming no added questions in the chain at this time, I’d like to about-face the appointment aback over to Dr. Tang for any closing remarks.

Stephen S. Tang — President & Chief Executive Officer

I appetite to acknowledge anybody for accommodating in today’s alarm and for your connected absorption in OraSure. Accept a acceptable afternoon and black and break safe and be well. Acknowledge you.

Operator

[Operator Closing Remarks]

Duration: 52 minutes

Jeanne Mell — Vice President of Corporate Communications

Stephen S. Tang — President & Chief Executive Officer

Roberto Cuca — Chief Banking Officer

Vijay Kumar — Evercore ISI — Analyst

Kaisie — J.P. Morgan — Analyst

Analyst

Mason — Stephens — Analyst

Patrick Donnelly — Citi — Analyst

Andrew Cooper — Raymond James & Associates — Analyst

Frank Takkinen — Lake Street Capital Markets, LLC — Analyst

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Nurse Shift Report Sheet Template – Nurse Shift Report Sheet Template
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