Trinity Biotech Stock

Trinity Biotech plc and its subsidiaries (Trinity Biotech) develop, acquire, manufacture, and market medical diagnostic products for the clinical laboratory and point-of-care (POC) segments of the diagnostic market.

The company's products are used to detect autoimmune, infectious and sexually transmitted diseases, diabetes and disorders of the liver and intestine. It also provides raw materials to the life sciences and research industries worldwide.

The company markets its portfolio of various products to customers in approximately 100 countries worldwide through its own sales force and a network of international distributors and strategic partners.

Principal Markets

The company sells raw materials to the life sciences industry and research institutes globally through its wholly owned subsidiary, Benen Trading Ltd., trading as Fitzgerald Industries.

The company sells its products through its direct sales organizations in the United States, Brazil and to an extent in the United Kingdom, France and Germany and then through its network of principal distributors and non-governmental bodies into approximately 100 countries globally.

POC

POC refers to diagnostic tests, which are carried out in the presence of the patient.

Uni-Gold Human Immuno-Deficiency Virus (HIV)

The company makes a very significant contribution to the global effort to meet the challenge of human immuno-deficiency virus, or HIV, with its principal product, Uni-Gold HIV. In Africa, Uni-Gold HIV has been used for many years in voluntary counselling and testing centers in the sub-Saharan region where it is a cornerstone to early detection and treatment intervention.

Trinscreen

The company's Uni-Gold HIV product is a leading confirmatory HIV test in the African market.

Point-Of-Care is key to the growth of the company. Central to this growth is the company's new HIV screening test, TrinScreen HIV, which received World Health Organisation approval in February 2022.

The company's strategy is to leverage the existing brand equity of Trinity Biotech in African markets to take market share in the screening market. This initiative will be supported by increased sales and marketing resources in the African market. Market opportunities for the TrinScreen HIV product also exist in other territories, in particular in emerging countries.

These point-of-care products will be sold through Trinity Biotech's sales and marketing organisation to a variety of customers including public health authorities, non-governmental organisations, clinical and reference laboratories directly in the United Kingdom, France and Germany and through independent distributors and strategic partners in other countries.

Clinical Laboratory

The company supplies the clinical laboratory segment of the in-vitro diagnostic market with a range of diagnostic tests and instrumentation, which detect infectious diseases; glycated hemoglobin (for diabetes monitoring and diagnosis) and hemoglobin variants for the detection of haemoglobinopathies (hemoglobin abnormalities); and autoimmune diseases. The company also supplies this market with other products through its clinical chemistry business.

Infectious Diseases

The company manufactures specialty and esoteric biomarkers of infectious diseases and other associated laboratory products. The products are used in processing patient samples whose results aid physicians in the diagnosis and clinical assessment of a range of infectious diseases. The key clinical laboratory disease areas that the company serves include sexually transmitted diseases, including Syphilis and Herpes; markers for Epstein Barr, Measles, Mumps, Toxoplasmosis, Cytomegalovirus, Rubella, Varicella and other viral pathogens; Lyme disease; and SARS-CoV-2.

The company develops, manufactures and distributes products primarily in enzyme-linked immunosorbent (ELISA) format. As a complement to its product range, the company also offers third party automated processors to its customers.

The majority of the infectious diseases product line of the company is the U.S. Food and Drug Administration (FDA) cleared for sale in the United States and CE marked in Europe. Products are sold in approximately 100 countries, with the focus on the Americas, Europe, and Asia. The infectious disease products are sold through the sales and marketing organization of the company to various customers, including public health authorities, clinical and reference laboratories directly in the U.S. and the U.K.; and through independent distributors and strategic partners in other countries.

Diabetes and Haemoglobinopathies

The company manufactures products for in-vitro diagnostic measurement of hemoglobin A1c (HbA1c) used in the monitoring and diagnosis of diabetes, as well identifying those who are at a high risk of developing diabetes (pre-diabetic). The Premier Hb9210 uses patented boronte affinity technology to test for HbA1c, which is a measure of a patient's average blood sugar control over the last 100 to 120 days.

The company manufactures its own A1c instrument, the Premier Hb9210, which was launched in Europe and obtained FDA approval in 2011. In Europe, the company distributes Premier Hb9210 through its partner Menarini Diagnostics. In the USA and Brazil, it sells the Premier Hb9210 through its direct sales organizations. In the rest of the world, the company sells the Premier Hb9210 through a network of distributors.

The company also sells products for hemoglobin variants, through the Premier Resolution (CE cleared - meaning it can be sold in the European Union (EU)). The Premier Resolution detects and identifies haemoglobinapothies. These are genetic defects that result in abnormal structure of the haemoglobin molecule. Haemoglobinapathies include sickle-cell diseases, alpha and beta thalassemia, which are amongst the most common genetic disorders in the world.

The company has launched the Premier Resolution, its next generation Haemoglobinapothy Analyzer in Europe and the Middle East after undergoing rigorous and successful field trials. The company expects to submit the Premier Resolution to the FDA for approval in 2022. The submission has been significantly delayed due to the Covid-19 pandemic. The Premier Resolution uses an internally designed column, as well as hardware and software.

The point-of-care segment of the HbA1c market is addressed by the Tri-stat system. The Tri-stat offers rapid, precise analysis. Using boronate affinity technology and a two phase optical system, the instrument can process three samples simultaneously with the three results available in approximately 10 minutes. In 2018, a new, second generation Tri-stat analyzer was launched in international markets outside of the U.S. In 2020, an enhanced version of the Tri-stat analyzer was launched, which includes a dual detector for improved performance.

Autoimmune Diseases

The company owns Immco Diagnostics Inc. (Immco), an autoimmunity company known for assay development and impactful contributions to autoimmune disease diagnostic research. It develops, manufactures and distributes products in various formats for diagnosis of autoimmune diseases, such as immunofluorescence assay (IFA), Enzyme-linked immunosorbent (ELISA), Western Blot (WB), and line immunoassay (LIA). The Immco products are a fit for the instrument platforms that the company markets its infectious diseases products. Additionally, it sells a line of IFA processors. The majority of Immco's products are FDA cleared for sale in the U.S. and CE marked in Europe.

The Immco product line addresses the high growth, lower throughput, specialty autoimmune segment, where competition is limited. In addition, Immco markets a panel of proprietary early markers for Sjogrens disease often referred to as 'dry eye disorder'. The Immco products are sold through the company's sales and marketing organization to clinical and reference laboratories directly in the U.S.A. and through distributors in other countries. The diagnostic product line is complemented by Immco's New York state licensed reference laboratory offering specialized services in diagnostic immunology, pathology and immunogenetics, and is marketed to U.S.-based reference laboratories and hospitals.

Clinical Chemistry

The specialty clinical chemistry business of the company includes reagent products, such as ACE, bile acids, lactate, oxalate and glucose-6-phosphate dehydrogenase (G6PDH) that are clearly differentiated in the marketplace. These products are suitable for both manual and automated testing and have proven performance in the diagnosis of various disease states from liver and kidney disease to G6PDH deficiency, which is an indicator of haemolytic anaemia.

Blood Bank Screening

The company manufactures ELISA, for the detection of syphilis and malaria. These products are sold through distributors and are manufactured under original equipment manufacturer agreements for other major third party diagnostic companies. The business is not operating in the United States.

Research and Products under Development

The company has research and development groups focusing separately on hemoglobin, infectious diseases and autoimmune products. During 2022, these groups were located in Ireland and the USA and largely mirror the production capability at each production site. In addition to in-house activities, it sub-contracts some research and development from time to time to independent researchers based in the U.S.A. and Europe.

Sales and Marketing

The company sells its product through its own direct sales force in the United States. Its sales team in the United States engages in marketing and selling its range of POC, infectious diseases, haemoglobins, autoimmune and clinical chemistry products. Meanwhile the direct sales force in Brazil sells the company's haemogloblins product range.

Through its international sales and marketing organization, which is located in Ireland, the company sells its clinical chemistry product range directly to hospitals and laboratories in Germany and France; infectious diseases and clinical chemistry product ranges directly to hospitals and laboratories in the U.K.; and various product lines through independent distributors and strategic partners in a further 100 countries.

Suppliers

The company's distributor of raw materials for the life sciences industry, Benen Trading Ltd (trading as Fitzgerald Industries), is based in Bray, Ireland and Acton, Massachusetts.

Research and Development (R&D)

The company's R&D expenditures were U.S.$707,000 in 2022.

Government Regulation

All of the company's products sold in the United States are medical devices subject to the Federal Food, Drug, and Cosmetic Act (FDCA), as implemented and enforced by the FDA.

The primary regulatory bodies, which require clinical testing are the FDA in the United States, the Health Product Regulatory Authority (as the authority over the company in Europe) and Health Canada. The company's products sold in the United States are medical devices subject to the FDCA, as implemented and enforced by the FDA. To renew the company's Clinical Laboratory Improvement Amendments of 1988 (CLIA) certificate, the company is subject to survey and inspection every two years to assess compliance with program standards.

Under the federal Health Insurance Portability and Accountability Act of 1996, as amended by the Health Information Technology for Economic and Clinical Health Act, or collectively, HIPAA, the U.S. Department of Health and Human Services (HHS), has issued regulations to protect the privacy and security of individually identifiable health information, also known as protected health information (PHI), held, used or disclosed by health care providers, such as the company's reference laboratory, and other covered entities.

Competition

The company's main competitors (and their principal products with which it competes) include: Premier (First response), Chembio (Stat-Pak, DPP HIV-Syphilis), Abbott (Determine, SD BioLine, Abon, Acon, Afinion, Architect), SD Biosensor, Wondf, Bejing Wanta, Roche TinaQuant 3, Bio_Rad (Variant 2 Turbo, D 100, BioPlex 2200) Tosoh ( G8 & G11) Arkray 8180, Siemens DCA, Sebia Capyllaris 2&3, Bio-Rad Variant 2, Sebia Capyllaris 2, Euroimmun, Aesku, Werfen, Copan, Becton Dickenson, Pointe Scientific and DiaSorin Liaison.

History

Trinity Biotech plc was founded in 1992. The company was incorporated as a public limited company registered in Ireland in 1992.