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Item 1. Business

2025-03-07 compared with 2024-03-11 · 140 added, 173 removed, 437 unchanged (42% of the section changed)

OraSure Technologies transforms health through actionable insight by powering the shift that connects people to healthcare wherever they are.

In February 2023, the Company announced a corporate restructuring to combine the commercial and innovation teams across two segments, being the "Diagnostics" segment and the "Molecular Solutions" segment, into one business unit with sales, marketing, product development and research teams covering multiple product lines.

This change is intended to accelerate innovation, enhance customer experience and result in operational synergies.

As a result, all products and services reside under one reporting hierarchy.

The Company's product portfolio is broadly divided into diagnostics products and sample management solutions.

OTI transforms health through actionable insight by powering the shift that connects people to healthcare wherever they are.

Our products and services reside under one reporting hierarchy, with commercial and innovation teams, which are part of a single business unit covering multiple product lines.

Our business is principally comprised of the development, manufacture, marketing, sale and distribution of (i) diagnostics products, and (ii) sample management solutions.

In January 2024, the Company completed an equity investment in KKR Sapphiros L.P.

("Sapphiros"), leading its Series B financing and entering into a wide-ranging strategic distribution relationship with Sapphiros, which secures exclusive distribution rights to certain products in Sapphiros' development pipeline, including self-collected blood test and diagnostic tests.

Sapphiros is a privately held consumer diagnostics portfolio company based in Boston.

In December 2024, the Company acquired Sherlock Biosciences, Inc.

and its subsidiaries ("Sherlock").

Sherlock is a global health company focused on next generation diagnostics.

Sherlock's molecular diagnostics platform aims to provide rapid results with strong sensitivity and specificity in a disposable format.

Sherlock's first test for Chlamydia Trachomatis (CT) and Neisseria Gonorrhoeae (NG) is currently in Phase 3 clinical studies and is expected to be submitted to the FDA for approval by the end of 2025.

Subject to regulatory approvals, this test is expected to expand the Company's portfolio for rapid diagnostics for sexually transmitted infections.

Products and Services

The Company's business consists of the development, manufacture, marketing and sale of simple, easy to use diagnostic products and specimen collection devices using its proprietary technologies, as well as other diagnostic products including immunoassays and other in vitro diagnostic tests that are used on other specimen types.

Our diagnostic products include tests for diseases including COVID-19, HIV and Hepatitis C that are performed on a rapid basis at the point of care, and tests for drugs of abuse that are processed in a laboratory.

The Company's business consists of the development, manufacture, marketing, sale and distribution of simple, easy to use diagnostic products and specimen collection devices using its proprietary technologies, as well as other diagnostic products including immunoassays and other in vitro diagnostic tests.

Our diagnostic products include tests for diseases including HIV, Hepatitis C, Syphilis and COVID-19 that are performed on a rapid basis at the point of care.

These products are sold in the United States and internationally to various clinical laboratories, hospitals, clinics, community-based organizations, and other public health organizations, distributors, government agencies, physicians’ offices, and commercial and industrial entities.

The Company's COVID-19 and HIV products are also sold in a consumer-friendly format in the over-the-counter (“OTC”) market in the U.S.

and, in the case of the HIV product, as a self-test to individuals in a number of other countries, including as an oral swab in-home test for HIV-1 and HIV-2 in Europe.

The Company's business also includes molecular sample management solutions and services that are used by clinical laboratories, direct-to-consumer laboratories, researchers, pharmaceutical companies, and animal health service and product providers.

The Company's HIV, HCV and COVID-19 products are also sold in a consumer-friendly format in the over-the-counter (“OTC”) market in the U.S.

and, in the case of the HIV and HCV products, as a self-test to individuals in a number of other countries, including, for the HIV products, as an oral swab in-home test for HIV-1 and HIV-2 in Europe.

The Company's business also includes sample management solutions and services that are used by clinical laboratories, direct-to-consumer laboratories, researchers, pharmaceutical companies, and animal health service and product providers.

The revenues from sample management solutions are derived from product sales to commercial customers and sales into the academic and research markets.

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This product is in its early stages, and initial sales are occurring primarily through distributors and collaborations in the liquid biopsy and sexually transmitted disease markets.

Additionally, the Company offers laboratory and bioinformatics services for both genomics and microbiome customers.

These services are primarily provided to pharmaceutical, biotech companies, and research institutions.

In 2020, the Company expanded its market focus by selling existing collection products for use with COVID-19 tests.

Beginning in 2022 and continuing through 2024, demand for COVID-19 PCR testing declined significantly, which was primarily driven by the availability of antigen tests, the reduction in the number of COVID-19 cases, and the wider availability of vaccines that negatively impacted the sales of the collection products.

Business Update Related to InteliSwab® Covid-19 Rapid Tests

In June 2021, the Company received three Emergency Use Authorizations ("EUA") from the FDA for its InteliSwab ® COVID-19 Rapid Tests (“InteliSwab ® ”) for non-prescription OTC, professional point-of-care use and prescription home use.

The Company began recording revenues on the sales of its InteliSwab ® tests during the third quarter of 2021.

In January 2022, the Company received FDA authorization for pediatric use of InteliSwab® tests for children ages 2 to 14.

In September 2023, the Company received FDA approval for extension of InteliSwab® test shelf-life from 18 months to 24 months.

In September 2021, the Defense Logistics Agency (“DLA”) awarded the Company a procurement contract for the InteliSwab® tests for OTC use, which the DLA estimated to have a value of $205 million and which would provide InteliSwab ® tests to up to 20,000 sites throughout the United States.

On November 22, 2022, the DLA awarded the Company a second procurement contract for the InteliSwab ® tests for OTC use.

In 2023, the Company delivered 18 million tests under the contract, which ran from November 2022 through November 2023.

In December 2022, the U.S.

Department of Health and Human Services ("HHS") awarded the Company a fully funded firm fixed price contract for a total of 3.2 million InteliSwab ® tests which were delivered in February 2023.

In September 2021, the Company entered into an agreement with Biomedical Advanced Research Development Authority ("BARDA"), which is part of the office of the Assistant Secretary for Preparedness and Response at HHS, pursuant to

which BARDA would provide up to $13.6 million in funding to obtain clearance of a premarket notification ("510(k)") and Clinical Laboratory Improvement Amendments of 1988 (“CLIA”) waiver of the InteliSwab ® tests.

The Company continued development work and analytical testing on this test throughout 2023.

However, in early 2024, the Company has communicated to BARDA that it does not intend to pursue further development of this product.

Through 2023, the Company maintained its expanded United States production capacity for InteliSwab ® tests to meet capacity targets, set out in its 2021 contract with the U.S.

Department of Defense ("DOD") (in coordination with the HHS), of more than 100 million tests annually.

In 2023, the Company announced that the FDA provided approval for a new packaging and labeling configuration for InteliSwab® tests.

The Company completed the transition to this new configuration in March 2023, which resulted in lower shipping costs, less packaging and reduced truckloads.

The following is a summary of the Company's principal products for the infectious disease and risk management markets as well as its sample management products:

InteliSwab ® COVID-19 Rapid Test

InteliSwab ® is the Company's rapid immunoassay product designed to test nasal samples for the presence of antigen from SARS-CoV-2.

The device uses an integrated swab to collect a specimen from the lower nostril.

After collection, the integrated swab is inserted into a vial containing a pre-measured amount of developer solution to facilitate flow of the sample into the device.

The specimen and developer solution flow through the test device and test results are observable in 30 minutes.

The InteliSwab ® test has received EUA from the FDA for non-prescription, OTC home use in individuals aged two years or older, with symptoms within the first seven (7) days of onset when tested at least twice over a three-day period with at least 48 hours between tests and without symptoms or epidemiological reasons to suspect COVID-19 when tested at least three times over a five-day period with at least 48 hours between tests.

InteliSwab ® COVID-19 Rapid Test Pro

The InteliSwab ® COVID-19 Rapid Test Pro is a version of InteliSwab ® intended for use by healthcare providers at the point of care.

The test is performed in the same manner as the OTC version, except that the test is run and interpreted by a healthcare provider.

This test has received EUA from the FDA for use by laboratories located in the United States certified under CLIA.

The Company has also received a CLIA waiver for use of the test, which enables the test to be used by numerous additional sites in the United States, which are not certified under CLIA, to perform high and moderately complex tests.

These additional sites include outreach clinics, community-based organizations and physicians’ offices.

This test is also indicated for individuals aged 2 years and older, with and without symptoms of COVID-19.

InteliSwab ® COVID-19 Rapid Test Rx

The InteliSwab ® COVID-19 Rapid Test Rx is the version of InteliSwab ® that has received EUA from the FDA for prescription home use with individuals aged 2 years or older who are suspected of COVID-19 infection by their healthcare provider within the first seven days of symptom onset.

OraQuick ® Rapid HIV Test

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The OraQuick ADVANCE® test has received premarket approval (“PMA”) from the FDA for the detection of antibodies to both HIV-1 and HIV-2 in oral fluid, finger-stick whole blood, venous whole blood and plasma.

The OraQuick® test has received World Health Organization ("WHO") pre-qualification and registration in other countries for the detection of HIV-1 and HIV-2 antibodies in oral fluid, whole blood (fingerstick and venous), serum and plasma.

The OraQuick® test has received World Health

Organization ("WHO") pre-qualification and registration in other countries for the detection of HIV-1 and HIV-2 antibodies in oral fluid, whole blood (fingerstick and venous), serum and plasma.

The device uses a porous flat pad to collect an oral fluid specimen.

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When blood-based specimens are to be tested, a loop collection device is used to collect a drop of the specimen and mix it in the developer solution, after which the collection pad is inserted into the solution and the test is allowed to develop.

The specimen and developer solution then flow through the testing device

where test results are observable between 20 and 40 minutes.

The specimen and developer solution then flow through the testing device where test results are observable between 20 and 40 minutes.

The OraQuick® device is a screening test and requires a confirmation test where an initial positive result is obtained.

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In addition, the Company has established toll-free, 365-day per year customer telephone support to provide additional information and referral services for consumers that use this product.

On January 7, 2025, the Company announced that the FDA had approved a premarket approval application supplement for a labeling change to include individuals 14 years of age and older.

The previous approval was available for individuals 17 years of age and older.

OraQuick ® HIV Self-Test

The OraQuick ® HIV Self-Test is sold for use by individuals in certain foreign countries, including under the CE mark in certain European countries, to meet the needs of those markets.

This product has received WHO pre-qualification and is eligible for procurement by purchasing entities entitled to access funding and other resources from the Global Fund, UNITAID and other agencies.

OraQuick ® HCV Rapid Antibody Test

The OraQuick ® HIV Self-Test is an in-vitro diagnostic home-use test for HIV (HIV-1 and HIV-2) in oral fluid, and is sold for use by individuals.

OraQuick ® HIV Self-Test is sold for use by individuals in certain foreign countries, including under the CE mark in certain European countries, to meet the needs of those markets.

This product has received WHO pre-qualification and is eligible for procurement by purchasing entities entitled to access funding and other resources from the Global Fund, PEPFAR and other agencies.

OraQuick ® HCV Rapid Antibody Test and Self-Test

Another test available on the OraQuick ® platform is the OraQuick ® HCV rapid antibody test.

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This CE-marked product is also registered and sold in other foreign countries and has received WHO pre-qualification.

Additionally, the OraQuick ® HCV Self-Test is an over the counter self-test that operates in substantially the same way as the OraQuick ® HCV rapid antibody test.

The OraQuick ® HCV self-test received WHO pre-qualification in 2024 and is the first hepatitis C self-test to earn this designation.

Diagnostics Direct Syphilis Health Check ™

In February 2024, the Company entered into a strategic agreement with Diagnostics Direct to distribute its Syphilis Health Check ™ rapid diagnostic test.

Syphilis Health Check ™ is the first CLIA-waived treponemal test.

The test, which uses fingerstick whole blood and delivers point of care results in 10 minutes, offers the ability to test in non-traditional

environments, such as outreach programs and mobile testing clinics.

Syphilis Health Check ™ is approved for use with people aged 13 years and older.

OraQuick ® Ebola Rapid Antigen Test

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The uses for this test are limited to individuals that meet certain criteria indicating they may be infected with the Ebola virus, so the test is not available for general screening of individuals that do not meet this criteria.

In September 2022, the Company entered into an agreement with BARDA, pursuant to which BARDA will provide up to $8.6 million in funding to the Company to develop a 2nd generation Ebola test on the OraQuick ® testing platform with the objective of developing increased sensitivity, utilizing sustainable raw materials and increasing shelf life, with new chemistry and higher degrees of automation in the test’s manufacturing process.

In September 2022, the Company entered into an agreement with the Biomedical Advanced Research and Development Authority ("BARDA"), pursuant to which BARDA will provide up to $8.6 million in funding to the Company to develop a 2nd generation Ebola test on the OraQuick ® testing platform with the objective of developing increased sensitivity, utilizing sustainable raw materials and increasing shelf life, with new chemistry and higher degrees of automation in the test’s manufacturing process.

In September 2023, the agreement was modified to add an additional $6.8 million in funding to be used to obtain the appropriate regulatory approvals for the product.

InteliSwab ® COVID-19 Rapid Test

The InteliSwab ® COVID-19 rapid test ("InteliSwab") is the Company's rapid immunoassay product designed to test nasal samples for the presence of antigen from SARS-CoV-2.

The device uses an integrated swab to collect a specimen from the lower nostril.

After collection, the integrated swab is inserted into a vial containing a pre-measured amount of developer solution to facilitate flow of the sample into the device.

The specimen and developer solution flow through the test device and test results are observable in 30 minutes.

The InteliSwab ® test has received an Emergency Use Authorization ("EUA") from the FDA for non-prescription, OTC home use in individuals aged two years or older, with symptoms within the first seven (7) days of onset when tested at least twice over a three-day period with at least 48 hours between tests and without symptoms or epidemiological reasons to suspect COVID-19 when tested at least three times over a five-day period with at least 48 hours between tests.

Through 2024, the Company maintained its expanded United States production capacity for InteliSwab ® tests to meet capacity targets set out in its 2021 contract with the U.S.

Department of Defense ("DOD") (in coordination with the U.S.

Department of Health and Human Services ("HHS")), of more than 100 million tests annually.

InteliSwab ® COVID-19 Rapid Test Pro

The InteliSwab ® COVID-19 Rapid Test Pro is a version of InteliSwab ® intended for use by healthcare providers at the point of care.

The test is performed in the same manner as the OTC version, except that the test is run and interpreted by a healthcare provider.

This test has received EUA from the FDA for use by laboratories located in the United States certified under the Clinical Laboratory Improvement Amendments of 1988 (“CLIA”).

These additional sites include outreach clinics, community-based organizations and physicians’ offices.

This test is also indicated for individuals aged 2 years and older, with and without symptoms of COVID-19.

InteliSwab ® COVID-19 Rapid Test Rx

Intercept ® Drug Testing System

A collection device that is substantially similar to the OraSure ® collection device is sold under the name Intercept ® , and is used to collect oral mucosal transudate for oral fluid drug testing.

The Company has received FDA 510(k) clearance to use

the Intercept ® collection device with laboratory-based EIAs to test for drugs-of-abuse commonly identified by the National Institute for Drug Abuse (“NIDA”) as the NIDA-5 (i.e., tetrahydrocannabinol (“THC” or marijuana), cocaine, opiates, amphetamines/methamphetamines and phencyclidine (“PCP”)), and for barbiturates, methadone and benzodiazepines.

The Company has received FDA 510(k) clearance to use the Intercept ® collection device with laboratory-based EIAs to test for drugs-of-abuse commonly identified by the National Institute for Drug Abuse (“NIDA”) as the NIDA-5 (i.e., tetrahydrocannabinol (“THC” or marijuana), cocaine, opiates, amphetamines/methamphetamines and phencyclidine (“PCP”)), and for barbiturates, methadone and benzodiazepines.

Each of these EIAs is also FDA 510(k) cleared for use with the Intercept ® device.

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primarily through laboratory distributors.

The Company believes that the Intercept ® device has several advantages over competing urine and other drugs-of-abuse testing products, including its lower total testing cost, its non-invasive nature, mobility and accuracy, the ease of maintaining a chain-of-custody, the treatment of test subjects with greater dignity, no requirement for specially-prepared collection facilities and difficulty of sample adulteration.

The availability of an oral fluid test is intended to allow the Company's customers to test for drug impairment and eliminate scheduling costs and inconvenience, thereby streamlining the testing process.

The Company has also developed a next-generation collection device, which it is marketing under the trade name “Intercept i2 ® he ”.

This device offers several important advantages over the original Intercept ® device, including a sample adequacy indicator that provides a visual prompt when the appropriate volume of oral fluid has been collected, the ability to collect a larger sample required by current laboratory testing protocols and a more optimized chemistry that results in improved recovery of the targeted drug analytes.

The Intercept i2 ® he device is currently being sold as a forensic use only device within the criminal justice and drug treatment markets along with a panel of fully-automated high-throughput oral fluid drug assays that the Company distributes under an agreement with Thermo Fisher Scientific.

The Intercept i2 ® he device is sold as a forensic use only device within the criminal justice and drug treatment markets along with a panel of fully-automated high-throughput oral fluid drug assays that the Company distributes under an agreement with Thermo Fisher Scientific.

In November 2024, the Company announced that it intended to exit the substance abuse testing business.

Though the Company will continue to fulfill final orders for certain of its Intercept ® Drug Testing System products through the first half of 2025, it substantially ceased the production and sale of substance abuse testing products as of the end of 2024.

Immunoassay Tests and Reagents

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AUTO-LYTE ® tests are sold in the form of bottles of liquid reagents, are run on commercially available laboratory-based automated analytical instruments, and are typically used in high volume, automated, commercial reference insurance laboratories to detect certain drugs or chemicals in urine.

In November 2024, the Company announced that it intended to exit the substance abuse testing business.

Though the Company will continue to fulfill final orders for certain of its immunoassay products through the first half of 2025, it substantially ceased the production and sale of substance abuse testing products as of the end of 2024.

Genomic Products

The Company sells many genomic products that provide all-in-one systems for the collection, stabilization, transportation, and storage of DNA, RNA, as well as both DNA and RNA together from human and animal biological samples.

The Company sells genomic products that provide all-in-one systems for the collection, stabilization, transportation, and storage of DNA, RNA, as well as both DNA and RNA together from human and animal biological samples.

The Company's lead products are sold under the Oragene ® and ORAcollect ® brands and are used to collect genetic material from human saliva.

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This product is used in liquid biopsy applications for the prostate and bladder cancer markets and in the sexually transmitted infection screening market.

The Colli-Pee ® collection device is is registered as a class I urine collection device without a claim for preservative.

The Colli-Pee ® collection device is registered as a class I urine collection device without a claim for preservative.

The Colli-Pee ® collection device with preservative solution does not have FDA clearance and is labeled “For Research Use Only” in the U.S.

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Laboratory and Data Analytical Services

The Company also offers its customers microbiome laboratory testing and analytical services.

Its services focus on accelerating microbiome discovery for customers in the pharmaceutical, agriculture, and research communities.

The Company's goal is to help customers unleash the translational potential of the microbiome by providing fast and information-rich characterizations of microbial diversity and function paired with expert analytics.

The Company also offers comprehensive microbiome and metagenomics services to improve human, animal, and environmental health including its metatranscriptomics sequencing and analysis services for gut microbiome samples.

These services generate a microbial community’s gene expression profile to provide information about the interactions between an individual and their microbiome, creating a holistic picture of a sample’s microbial functions and expression levels.

Diversigen has obtained the College of American Pathologists (“CAP”) accreditation at its laboratory facilities.

During the third quarter of 2024, the Company exited its microbiome laboratory testing and data analytical services, with the Company continuing to close out limited and modest final service orders.

These services focused on accelerating microbiome discovery for customers in the pharmaceutical, agriculture, and research communities.

Other Products

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Department of Transportation (“DOT”) has also approved the test.

COVID Collection Products

Since 2020, the Company has sold its ORAcollect® • RNA and OMNIgene® • ORAL collection devices for use in connection with COVID-19 molecular testing.

The Company has actively engaged with several laboratories and researchers to demonstrate the effectiveness of its existing collection products for use with COVID-19 molecular testing.

In November 2024, the Company announced that it intended to exit the substance abuse testing business.

Though the Company will continue to fulfill final orders for certain of its Q.E.D.® saliva alcohol test through the first half of 2025, it substantially ceased the production and sale of substance abuse testing products as of the end of 2024.

Products Under Development

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These programs typically focus on products related rapid tests for various diseases.

The Company is working to develop a 2 nd generation Ebola test on the OraQuick® testing platform with funds obtained under its contract with BARDA.

The Company is developing a 2 nd generation Ebola test on the OraQuick® testing platform with funds obtained under its contract with BARDA.

The Company is developing a single-use lateral flow immunoassay intended for the qualitative detection of antigens from viruses within the Marburg virus genus.

The Company is developing this test and hopes to achieve FDA 510(k) clearance in whole or in part with federal funds obtained from the HHS Administration for Strategic Preparedness and Response (ASPR);

BARDA under Other Transaction Number:

75A50123D00005.

Through its Sherlock subsidiary, the Company is developing a molecular self-test for Chlamydia Trachomatis (CT) and Neisseria Gonorrhoeae (NG), which is currently in clinical studies.

The Company acquired this program in connection with its acquisition of Sherlock.

Through its Sherlock subsidiary, the Company is also developing of a Covid/Flu molecular test, funded in part with Federal funds obtained from the HHS Administration for Strategic Preparedness and Response (ASPR) under contract number:

75A50124C00055.

The Company acquired this program in connection with its Sherlock acquisition.

Sample Management Solutions

In order to intersect evolving customer needs within the academic and commercial markets, the Company's molecular sample management solutions business product development pipeline is focused on extending offerings across different sample types and analytes within both the genomics and microbiome areas.

In order to intersect evolving customer needs within the academic and commercial markets, the Company's sample management solutions business product development pipeline is focused on extending offerings across different sample types and analytes within both the genomics and microbiome areas.

Genomic customers are demonstrating an increasing demand for collection and stabilization of cell-free nucleic acids, exosomes, DNA and RNA.

On the microbiome front, the Company continues to focus research and development work on collecting and stabilizing microbial DNA, RNA and metabolites from multiple sample types including gut, skin, vagina and saliva.

The field of microbiome services is fast paced with evolving biological understanding and development of new methodologies.

The Company's development efforts are focused on remaining at the forefront of laboratory and informatics technologies, as well as providing new and relevant services to its customers.

These include a focus on laboratory and informatics methods to integrate DNA, RNA and metabolites from microbial communities across different sample types.

The Company is working to develop a blood proteomics product, which, if approved, the Company expects will be used in emerging applications, like liquid biopsy, oncology and neurology, and in connection with chronic illnesses like Alzheimer's and diabetes.

Sales and Marketing

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The Company also sells this test in other countries through distributors.

The Syphilis Health Check ™ is a CLIA-waived professional test sold for use by clinicians, community health providers and public health agencies and can be used as an initial screening test or in conjunction with a nontreponemal laboratory test and clinical findings to aid in the diagnosis of syphilis infection.

Diagnostics - OTC and Self-Test

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The Company also sells its OraQuick ® HIV Self-Test in certain international markets.

The Company's OraQuick ® HIV Self-Test is the only oral fluid HIV test prequalified by the WHO.

The Company's OraQuick ® HIV Self-Test is the only oral fluid HIV test prequalified by the WHO and the Company's OraQuick ® HCV Self-Test is the first Hepatitis C self-test prequalified by the WHO.

WHO prequalification helps ensure that diagnostic tests for high burden diseases meet global standards of quality, safety, and efficacy in order to optimize use of health resources and improve health outcomes.

WHO prequalification enables governmental organizations implementing HIV Self-Test pilots and programs to access international funding to purchase the Company's test.

WHO prequalification enables governmental organizations implementing self-test pilots and programs to access international funding to purchase the Company's test.

Substance Abuse Testing

On November 6, 2024, the Company announced that it intended to exit the substance abuse testing business.

Though the Company will continue to fulfill final orders for certain of its substance abuse testing products, it substantially ceased the production and sale of such products as of the end of 2024.

The Company's substance abuse testing products are marketed to laboratories serving the workplace testing, forensic toxicology, criminal justice and drug rehabilitation markets in the U.S.

and certain international markets.

The Company has entered into agreements for the distribution of its Intercept ® collection device and associated MICRO-PLATE assays for drugs-of-abuse testing in the workplace testing market in the United States and Canada through several laboratory distributors and internationally for workplace, criminal justice and forensic toxicology testing through other distributors.

The Company also markets the Intercept ® collection device on its own and as a kit in combination with laboratory testing services.

To better serve its workplace customers, the Company has contracted with commercial laboratories to provide prepackaged Intercept ® test kits, with prepaid laboratory testing and specimen shipping costs included.

The criminal justice market in the United States for the Company's substance abuse testing products consists of a wide variety of entities in the criminal justice system that require drug screening, such as pre-trial services, parole and probation offices, police forces, drug courts, prisons, drug treatment programs and community/family service programs.

The forensic toxicology market consists of several hundred laboratories including federal, state and county crime laboratories, medical examiner laboratories and reference laboratories.

The Company also sells its next generation Intercept i2 ® he collection device with a panel of fully-automated high-throughput oral fluid assays developed with Thermo Fisher Scientific for the detection of PCP, THC, opiates, cocaine, methamphetamines, amphetamines, barbiturates, benzodiazepines, methadone and oxycodone.

These products are currently sold as forensic use only into the criminal justice and drug treatment markets.

The Company distributes its Q.E.D.

® saliva alcohol test primarily through various distributors in the United States and internationally.

The markets for alcohol testing are relatively small and fragmented with a broad range of legal and procedural barriers to entry.

Markets range from law enforcement testing to workplace testing of employees in safety sensitive occupations.

Typical usage situations include pre-employment, random, post-accident, reasonable-cause and return-to-duty testing.

Molecular Sample Management Solutions and Molecular Services

Sample Management Solutions and Molecular Services

The Company's sample management products are sold directly to customers, primarily through its internal sales force in U.S.

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The Company is leveraging its existing sales force and global research connections to engage microbiome customers around the world and establish itself as among the leaders in ease-of-collection, stabilization and transport of microbiome communities in a variety of challenging sample types such as stool, skin, vaginal and oral.

The Company's products include the Colli-Pee ® device, a product developed and sold by its Novosanis subsidiary, for the volumetric collection of first void urine.

The Company's products include the Colli-Pee ® collection device for the volumetric collection of first void urine.

This product is in its early stages and initial sales are occurring primarily through distributors and collaborations for use in the liquid biopsy and sexually transmitted disease markets.

The Colli-Pee ® collection device is is registered as a class 1 urine collection device without a claim for preservative.

The Colli-Pee ® collection device is registered as a class I urine collection device without a claim for preservative.

The Colli-Pee ® collection device with preservative solution does not have FDA clearance and is labeled “For Research Use Only” in the U.S.

The Company also offers laboratory and analytical services for both genomics and microbiome customers in order to more fully meet the needs of customers.

These services are primarily provided to pharmaceutical and biotech companies and research institutions.

Significant Products and Customers

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2024 2023 2022

OraQuick® HIV $ 60,804 $ 60,823 $ 38,812

InteliSwab® 45,136 257,493 233,666

Genomics 44,861 47,005 54,335

OraQuick® HIV 60,823 38,812 42,144

COVID-19 collection kits 286 9,659 54,167

One customer accounted for approximately 63% of the Company's consolidated net revenues for the year ended December 31, 2023 and 58% for the year ended December 31, 2022.

No other individual customers accounted for more than 10% of the Company's consolidated net revenues for the years ended December 31, 2023 and 2022.

The Company had no customers that accounted for more than 10% of consolidated net revenues for the year ended December 31, 2021.

One non-commercial customer accounted for approximately 24% of the Company's consolidated net revenues for the year ended December 31, 2024 and 63% and 58% for the years ended December 31, 2023 and 2022, respectively.

The Company had no other customers that accounted for more than 10% of consolidated net revenues for the years ended December 31, 2024, 2023 and 2022.

Supply and Manufacturing

The Company manufactures its OraQuick ADVANCE ® Rapid HIV test, OraQuick ® In-Home HIV test, OraQuick ® HCV test, OraQuick ® Ebola test, OraSure ® , Intercept ® and Intercept i2 ® he collection devices, AUTO-LYTE ® and MICRO-PLATE assays and Q.E.D.

The Company manufactures its InteliSwab ® COVID-19 Rapid Test, OraQuick ADVANCE ® Rapid HIV test, OraQuick ® In-Home HIV test, OraQuick ® HCV test, OraQuick ® Ebola test, OraSure ® , Intercept ® and Intercept i2 ® he collection devices, AUTO-LYTE ® and MICRO-PLATE assays and Q.E.D.

® saliva alcohol test in its Bethlehem, Pennsylvania facilities.

The Company expects to continue to manufacture these products at this location for the foreseeable future.

With the exception of its substance abuse testing products, the Company expects to continue to manufacture these products at this location for the foreseeable future.

The Company has contracted with a third party in Thailand for the assembly of the OraQuick ® Rapid HIV test and the OraQuick ® HIV Self-Test in order to supply certain international markets.

The Company believes that other firms would be

able to assemble these OraQuick ® tests on terms no less favorable than those set forth in the agreement if the Thailand contractor would be unable or unwilling to continue assembling this product.

The Company believes that other firms would be able to assemble these OraQuick ® tests on terms no less favorable than those set forth in the agreement if the Thailand contractor would be unable or unwilling to continue assembling this product.

The Company has long-term agreements in place for the contract manufacturing in Thailand and one of its suppliers, which has been pre-qualified by the WHO, has been manufacturing for the Company for the past 20 years.

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The Company manufactures all of the proprietary chemistry and assay cards for its InteliSwab ® COVID-19 Rapid Tests in its Bethlehem, Pennsylvania facilities.

The Company significantly scaled up manufacturing capacity in the United States for its InteliSwab ® COVID-19 Rapid Tests and has achieved manufacturing capacity targets under its 2021 contract with the U.S.

DOD, in coordination with HHS.

All milestones under this contract have been achieved and the Company received corresponding milestone payments in 2023.

The Company significantly scaled up manufacturing capacity in the United States for its InteliSwab ® COVID-19 Rapid Tests and achieved manufacturing capacity targets under its 2021 contract with the U.S.

DOD, in coordination with the HHS.

The Company's Opus Way facility was customized to accommodate increased manufacturing capacity.

Throughout 2024, the Company made progress on consolidating its manufacturing footprint by using the Opus Way facility for a more significant portion of its manufacturing and distribution needs, including re-shoring of capacity to the United States.

One Pennsylvania facility was eliminated from the Company's sites.

The Company's MICRO-PLATE and AUTO-LYTE ® assays require the production of highly specific and sensitive antibodies corresponding to the analyte of interest.

Substantially all the Company's antibody raw materials are provided by contract suppliers.

Substantially all the Company's antibody raw materials are provided by

contract suppliers.

The Company believes that it has adequate reserves of antibody supplies and that it has access to sufficient raw materials for these products.

The fully-automated high-throughput oral fluid drug assays sold with the Company's new Intercept i2 ® he collection device are manufactured and supplied under a long-term agreement with Thermo Fisher Scientific.

There is no other supply source for these products.

DNAG has three long-term contract manufacturing relationships to supply virtually all of its products, including the Oragene ® product line.

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The Company is actively seeking to qualify other suppliers that can manufacture and supply the raw materials and components for the DNAG products.

All DNAG products are produced in Canada.

All DNAG products are produced in Canada and the United States.

The Company's Colli-Pee ® device is currently being manufactured in Canada by its existing contract manufacturers with components supplied by third party vendors.

The Company's genomic, microbiome and metatranscriptomics laboratory testing and analytical services are provided by its subsidiary, Diversigen.

Human Capital Resources

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As of December 31, 2024, the Company had 501 full-time employees, which compares to 638 employees as of December 31, 2023.

The decrease in employees during 2023 was primarily the result of the need to reduce manufacturing capacity for the Company's InteliSwab ® COVID-19 Rapid Test.

In February 2023, the Company announced an 11% reduction in its non-production workforce.

The decrease in employees during 2024 was the result of the need to reduce manufacturing capacity for the Company's InteliSwab ® COVID-19 Rapid Test, transition away from the microbiome molecular sequencing services business and close its Belgian operations.

In addition, the Company exited its risk assessment business.

The Company's employees are not currently represented by a U.S.

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The Company believes its employees are among its most important resources and are critical to its continued success.

The Company focuses significant attention on attracting and retaining talented and experienced individuals to manage and support its operations, and its management team routinely reviews employee turnover rates at various levels of the

organization.

Management also reviews employee engagement and satisfaction surveys to monitor employee morale and receive feedback on a variety of issues.

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OraSure believes a variety of perspectives are critical to achieving success, and that inclusion and belonging are key drivers to growth-based innovation and profitability.

The Company aims to create a culture where all people feel valued, supported, and inspired to be themselves fearlessly, without judgment.

The Company aims to create a culture where all people feel valued, supported, and inspired to be themselves authentically and fearlessly.

The Company believes that when all voices are heard, it honors and exemplifies its core values and best serves its communities.

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The Company's InteliSwab ® test competes in both the professional point-of-care and OTC segments with these products.

In the substance abuse testing market, the Company's Intercept ® drug testing system competes with laboratory-based drug testing products using sample matrices such as urine, hair, sweat and oral fluid.

The Company expects competition for its products to intensify, particularly from other domestic and international companies that have developed, or may develop, competing oral fluid drug testing products.

The Company's MICRO-PLATE oral fluid drug assays, which are sold for use with the original Intercept ® collector and the OraSure ® collection device, also continue to come under increasing competitive pressure from “home-brew” assays developed internally by the Company's laboratory customers.

The Company's oral fluid MICRO-PLATE assays also compete with urine-based homogeneous assays that are run on fully-automated, random access analyzers.

The Company's MICRO-PLATE drugs-of-abuse reagents sold in the forensic toxicology market are targeted to forensic testing laboratories where sensitivity, automation and “system solutions” are important.

The Company competes with both homogeneous and heterogeneous tests manufactured by many companies.

® competes against other semi-quantitative saliva-based alcohol tests that have received U.S.

Department of Transportation approval as well as breath alcohol tests.

Although there are lower priced tests on the market that use oral fluid or breath as a test medium, the Company believes that these tests are qualitative tests that are lower in quality and provide fewer benefits than OraSure's Q.E.D.

The Company's Oragene ® and ORAcollect ® collection systems compete against other types of collection devices used for molecular testing, such as blood collection devices and buccal swabs, which often are sold for prices lower than the prices charged for the Oragene ® and ORAcollect ® products.

Although the Company believes the Oragene ® and ORAcollect ®

devices offer a number of advantages over these other products, the availability of lower price competitive devices can result in lost sales and degradation in pricing and profit margin.

The Company's Oragene ® and ORAcollect ® products are also facing increasing competition from similarly designed collection systems which are beginning to enter the market.

Although the Company believes the Oragene ® and ORAcollect ® devices offer a number of advantages over these other products, the availability of lower price competitive devices can result in lost sales and degradation in pricing and profit margin.

The Company's Oragene ® and ORAcollect ® products are also facing increasing competition from similarly designed collection systems which have entered the market.

OMNIgene ® • GUT is being sold in the emerging microbiome market and competes with a variety of non-standard in-house solutions developed by various researchers, including simply freezing the sample after collection.

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United States patents generally have a maximum term of 20 years from the date an application is filed.

The Company has patents throughout its product and service lines.

Its patent portfolio includes pending applications and issued patents in diagnostics and testing, sampling tools, and services and analysis.

The Company's portfolio protects its innovative sampling tools, services and diagnostics that provide access to accurate, essential information that advances global health and well-being.

Diagnostics and testing products include the OraSure ® and Intercept ® collection devices that are covered by one utility and one design patent in each of the U.S., Canada, Japan, and throughout Europe.

The Company has patents throughout its product lines.

Its patent portfolio includes pending applications and issued patents in diagnostics and testing, sampling tools and sample preservatives.

The Company's portfolio protects its innovative sampling tools, sample preservatives, and diagnostics that provide access to accurate, essential information that advances global health and well-being.

The Company has numerous foreign patents for its collection devices and technology relating to oral fluid collection, containers for oral fluids, methods to test oral fluids, and methods to control the volume of oral fluids collected and dispersed.

The utility patents will expire in January 2028, and the design patents will expire in 2025.

Sampling tools are the subject of several other patents and pending applications, including U.S.

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The international applications entered their national phase in countries throughout the world beginning in October 2023.

Patents issuing from these applications will expire in March 2041.

Patents issuing from these applications are expected to expire in March 2042.

The Company has U.S.

and international PCT patent applications that are directed to a new developer solution vial for use with sampling and assay devices.

The international application entered its national phase in countries throughout the world in May 2023 and patents issuing from these applications will expire in December 2041.

Related design patent applications are pending in the U.S., Canada, and Europe.

The international application entered its national phase in countries throughout the world in May 2023 and patents issuing from these applications are expected to expire in December 2041.

One related design patent is issued in the U.S.

and will expire in November 2038, and other related design patent applications are pending in the U.S., Canada, and Europe.

The Company has additional pending applications directed to new direct sample collection pads for its InteliSwab ® COVID-19 Rapid Test.

These applications entered their national phase in countries throughout the world in October 2023, and patents issuing from these applications will expire in December 2042.

A related design patent issued in 2022 in the U.S.

Two related design patents issued in 2022 in the

and corresponding design applications were registered in Canada, China, India, and Europe.

These design patents will expire 2035.

The Company has registered design patents for a collection funnel and corresponding plunger device in Europe, China, and India and a corresponding U.S.

design patent application is pending.

The Company has pending patent applications throughout its product and service lines directed to assays, methods, devices, and reagents for monitoring adherence to HIV medications, such as nucleoside reverse transcriptase inhibitors used in PrEP regimens.

These design patents will expire 2038 and 2039.

The Company has registered design patents for a collection funnel and corresponding plunger device in Europe, Canada China, India, and the U.S.

The Company has two international families of patent applications filed in the United States and in numerous countries worldwide.

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Patents issuing from these applications will expire in October 2038 and December 2040.

The Company holds, through its subsidiary, DNAG, thirty granted United States patents and numerous foreign patents issued for compositions, methods and apparatuses for the collection, stabilization, transportation, and storage of nucleic acids (DNA and RNA) from oral fluid and other bodily fluids and tissues.

Certain patents expired in June 2023, and others will expire through October 2037.

The Company holds through its subsidiary, Novosanis, one granted United States patent and numerous foreign patents covering a medical device for capturing a predetermined volume of first void urine.

This patent expires in September 2033.

The Company has also applied for additional patents, in both the United States and certain foreign countries, in novel urine collection devices.

The Company's subsidiary, Diversigen, has licensed one United States patent and several foreign patent applications from the University of Minnesota for analytical standards to detect and/or measure sampling, processing, and/or amplification errors in a biological sample containing polynucleotide molecules.

These patents will expire in May 2036.

This license also covers certain software and know-how related to laboratory and bioinformatics procedures and processes.

Diversigen has also licensed certain know-how and database assets from the Baylor College of Medicine related to laboratory processes for microbiome and metagenomics services.

The Company holds, through its subsidiary, DNAG, nineteen granted United States patents and numerous foreign patents issued for compositions, methods and apparatuses for the collection, stabilization, transportation, and storage of nucleic acids (DNA and RNA) from oral fluid and other bodily fluids and tissues.

Certain patents expired in June 2023, and others will expire through November 2040.

The Company holds one granted United States patent and numerous foreign patents covering a medical device for capturing a predetermined volume of first void urine.

This patent expires in April 2034.

The Company has also applied for additional patents and designs, in both the United States and certain foreign countries, in novel urine collection devices.

The Company requires its employees, consultants, outside collaborators and other advisors to execute confidentiality agreements upon the commencement of employment or consulting relationships with the Company.

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In the United States, the Company owns a number of trademarks, including the OraSure ® , Intercept ® , Intercept i2 ® he, Intercept i2 he ® , OraQuick ® , OraQuick ADVANCE ® , ORASURE QUICKFLU ® , SUREQUICK ® , Q.E.D.

® , InteliSwab ® , Oragene ® , DNA Genotek ® , OMNImet ® , ORAcollect ® , OMNIgene ® , Diversigen ® , CoreBiome ® , Boostershot ® , MetaGene ® , Benchmark TM , Novosanis ® , Colli-Pee ® , UCM ® , UAS TM , THINK OUTSIDE THE CUP ® , AUTO-LYTE ® , prepIT ® , and HEMAgene ® trademarks.

® , InteliSwab ® , Oragene ® , DNA Genotek ® , OMNImet ® , ORAcollect ® , OMNIgene ® , Diversigen ® , CoreBiome ® , Boostershot ® , MetaGene ® , Benchmark ® , Novosanis ® , Colli-Pee ® , UCM ® , UAS™, THINK OUTSIDE THE CUP ® , AUTO-LYTE ® , prepIT ® , and HEMAgene ® trademarks.

The Company also licenses the SHERLOCK™ mark from The Broad Institute, Inc.

The Company also owns many of these marks and others in several foreign countries and it is pursuing registration of several other trademarks.

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Some of the Company's products are used for research only or for other nonclinical or non-diagnostic purposes.

The Company's molecular sample management solutions are sold to many academic and research institutions for research purposes and the Company's drugs-of-abuse products are sold to laboratories and clinics for forensic or other non-medical uses.

The Company's sample management solutions are sold to many academic and research institutions for research purposes and the Company's drugs-of-abuse products are sold to laboratories and clinics for forensic or other non-medical uses.

The FDA does not currently regulate products used for these purposes, although other state and federal regulatory requirements may apply.

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In complying with the QSRs, manufacturers must continue to expend time, money and effort in the area of production, quality, and post-market surveillance to ensure full compliance.

Companies that market devices are also subject to other post-market and general requirements, including product listing and establishment regulations, which help facilitate FDA inspections and other regulatory action, post-market surveillance requests, restrictions imposed on marketed products, promotional standards and requirements for recordkeeping and reporting of certain adverse reactions and device malfunctions.

Companies that market devices are also subject to other post-market and general requirements, including product listing and establishment licenses, which help facilitate FDA inspections and other regulatory action, post-market surveillance requests, restrictions imposed on marketed products, promotional standards and requirements for recordkeeping and reporting of certain adverse reactions and device malfunctions.

Device reporting regulations require that manufacturers report if their device may have caused or contributed to a death or serious injury, or has malfunctioned in a way that would likely cause or contribute to a death or serious injury if the malfunction of the device or a similar device were to recur.

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Until then, manufacturers are required to comply with the QSR.

The Company believes that its facilities and procedures are in material compliance with the FDA’s OSR regulations, the European Union's Quality Management Systems requirements, ISO 13485:2016, and other post-market requirements, but the regulations are subject to change or may be unclear, and the Company cannot be sure that FDA investigators will agree with the Company's compliance with the FDA’s post-market requirements.

The Company believes that its facilities and procedures are in material compliance with the FDA’s QSR requirements, the European Union's Quality Management Systems requirements, ISO 13485:2016, and other post-market requirements, but the regulations are subject to change or may be unclear, and the Company cannot be sure that FDA investigators will agree with the Company's compliance with the FDA’s post-market requirements.

CLIA prohibits any facility that conducts laboratory testing on specimens derived from humans from providing information for the diagnosis, prevention or treatment of any disease or impairment of, or the assessment of, the health of human beings, unless there is in effect for such facility a certificate issued by the U.S.

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® alcohol saliva test and may seek similar waivers for certain other products.

In addition, the supplier of the OraSure Quick-Flu® test has obtained a CLIA waiver for that product.

The InteliSwab ® COVID-19 Rapid Test Pro is authorized for use in patient care settings operating under CLIA Certificate, Certificate of Compliance and Certificate of Accreditation.

The laboratory services provided by the Company's subsidiary, Diversigen, consist of microbiome, metatranscriptomics and metagenomics sequencing, bioinformatics and analysis.

Diversigen has elected to obtain a license from CLIA and has received a certificate of accreditation from the College of American Pathologists (CAP).

Certain of the Company's products may also be affected by state regulations in the United States, which can restrict the use and sale of certain diagnostic products.

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Although physicians are permitted to exercise medical judgment to use medical devices for indications other than those cleared or approved by the FDA, the Company may not promote its products for such “off-label” uses and can only market its products for cleared or approved uses.

Promotional activities for FDA-regulated products of other companies have also been the subject of enforcement actions brought under healthcare reimbursement laws and consumer protection

Promotional activities for FDA-regulated products of other companies have also been the subject of enforcement actions brought under healthcare reimbursement laws and consumer protection statutes.

In addition, under the federal Lanham Act and similar state laws, competitors and others can initiate litigation relating to advertising claims.

If the FDA determines that the Company's promotional materials or training constitute promotion of an uncleared or unapproved use, it could request that the Company modify its training or promotional materials or subject the Company to regulatory or enforcement actions, including the issuance of an untitled letter, a notice of violation, a warning letter, injunction, seizure, civil fine or criminal penalties.

of violation, a warning letter, injunction, seizure, civil fine or criminal penalties.

Federal Trade Commission enforcement actions often result in consent decrees that constrain future actions.

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The EU IVDR became fully applicable on May 26, 2022.

There is a transitional period during which products that have a declaration of conformity issued under the IVDD prior to May 26, 2022 may continue to be placed on the EU market for a certain period before requiring certification under the IVDR (subject to compliance with certain requirements under the IVDR, including in respect of post-market surveillance);

however, class A non-sterile products do not benefit from such transitional provisions and have been required to be IVDR compliant since May 26, 2022, class D devices benefit from such transitional provisions until May 26, 2025.

On January 23, 2024, the European Commission introduced a legislative proposal to extend such transitional provisions for certain devices.

The European Commission has provided the legislative proposal to the European Parliament and the European Council for their review and approval.

Once the European Commission’s legislative proposal is approved (with or without amendment), it will be adopted into EU law.

In the EU, products that fall under the scope of the MDR and the IVDR may not be placed on the EU market without a valid CE mark.

There is a transitional period (which was extended in July 2024) during which products that have a declaration of conformity issued under the IVDD prior to May 26, 2022 may continue to be placed on the EU market for a certain period before requiring certification under the EU IVDR (subject to compliance with certain requirements under the EU IVDR, including in respect of post-market surveillance);

however, class A non-sterile products do not benefit from such transitional provisions and have been required to be EU IVDR compliant since May 26, 2022.

The transition deadline for other classes of devices ranges between December 21, 2027 and December 31, 2029, provided certain transitional activities are performed by earlier deadlines (e.g.

the manufacturer must sign a formal written agreement with a notified boy for assessment under the EU IVDR).

In the EU, products that fall under the scope of the MDR and the EU IVDR may not be placed on the EU market without a valid CE mark.

Approval of a regulatory authority is not required to obtain CE certification, but, depending on the class of product, conformity assessment by a notified body may be required.

Notified bodies are accredited and supervised by

national regulatory authorities to conduct conformity assessment procedures of medical devices or other products.

Notified bodies are accredited and supervised by national regulatory authorities to conduct conformity assessment procedures of medical devices or other products.

The conformity assessment procedure for medical devices and in vitro diagnostic devices is to assess whether the device is compliant with the general safety and performance requirements set forth in the EU MDR or EU IVDR (as applicable), and includes an examination of the product’s technical dossier and the manufacturer’s quality system.

ISO certification of the quality system in accordance with the relevant standard for medical devices or in vitro diagnostic devices creates a rebuttable presumption that the product satisfies the applicable requirements of the EU MDR or EU IVDR (as applicable) with respect to the quality management system.

with respect to the quality management system.

Compliance with these general safety and performance requirements allows the Company to complete the applicable conformity assessment procedure, involving a notified body where necessary, and to affix the CE mark to its products, without which they may not be placed on the market in the EU.

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Health Canada also requires all companies that market Class II, Class III and Class IV products in Canada to be certified as part of the Medical Device Single Audit Program ("MDSAP").

The Company has obtained WHO pre-qualification for its OraQuick ® HIV-1/Antibody Test, OraQuick® HIV Self-Test and OraQuick ® HCV.

The Company has obtained WHO pre-qualification for its OraQuick ® HIV-1/2 Antibody Test, OraQuick® HIV Self-Test, OraQuick ® HCV Rapid Antibody Test, and OraQuick ® HCV Self-Test.

Anti-Kickback and Other Fraud and Abuse Laws

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The Company is also subject to other federal and state laws targeting fraud and abuse in the healthcare industry, including marketing conduct laws, transparency laws, and laws that require the Company to adopt a compliance program.

together, these fraud and abuse laws constrain the sales, marketing and other promotional activities of manufacturers of medical devices by limiting the kinds of financial arrangements, including sales programs, such manufacturers can enter into with physicians, hospitals, laboratories and other potential purchasers of medical devices.

Taken together, these fraud and abuse laws constrain the sales, marketing and other promotional activities of manufacturers of medical devices by limiting the kinds of financial arrangements, including sales programs, such manufacturers can enter into with physicians, hospitals, laboratories and other potential purchasers of medical devices.

Violations of these laws may be punishable by criminal or civil sanctions, including substantial fines, imprisonment and exclusion from participation in government healthcare programs such as Medicare and Medicaid.

These laws and regulations are wide ranging and subject to changing interpretation and application.

In recent years, there has been greater scrutiny of marketing practices in the medical device industry which has resulted in several government investigations by various government authorities and the introduction and/or passage of federal and state legislation regulating interactions between medical device manufacturers and healthcare professionals and providers and requiring the disclosure by medical device manufacturers of payments to certain healthcare providers.

In recent years, there has been greater scrutiny of marketing practices in the

medical device industry which has resulted in several government investigations by various government authorities and the introduction and/or passage of federal and state legislation regulating interactions between medical device manufacturers and healthcare professionals and providers and requiring the disclosure by medical device manufacturers of payments to certain healthcare providers.

For example, under the Physician Payments Sunshine Act provisions of the Affordable Care Act, device manufacturers are subject to federal reporting and disclosure requirements with regard to payments or other transfers of value made to U.S.

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Among other things, REACH requires companies to obtain prior authorization to use substances of very high concern that are listed for authorization, and imposes bans on the marketing of products that contain specifically listed hazardous substances.

Companies marketing

medical devices in the EU may also be subject to expensive waste take back obligations under the EU Directive on Waste Electrical and Electronic Directive, the Packaging and Packaging Waste Directive, and the Batteries Directive.

Companies marketing medical devices in the EU may also be subject to expensive waste take back obligations under the EU Directive on Waste Electrical and Electronic Directive, the Packaging and Packaging Waste Directive, and the Batteries Directive.

Future environmental laws, rules, regulations or policies may require the Company to alter its manufacturing processes, thereby increasing its manufacturing costs, or may impose other additional obligations on the Company or its products.

The Company believes that its products and manufacturing processes at its facilities comply in all material respects with applicable environmental laws and worker health and safety laws;

The Company believes that its products and manufacturing processes at its facilities comply in all material respects with

applicable environmental laws and worker health and safety laws;

however, the risk of environmental liabilities cannot be completely eliminated.

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Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.

What changed 10-K

Item 1. Business