Trinity Biotech plc and its subsidiaries (Trinity Biotech) operate as a commercial stage biotechnology company that focuses on diabetes management solutions and human diagnostics, including wearable biosensors.
The company develops, acquires, manufactures, and markets diagnostic systems, including both reagents and instrumentation, for the point-of-care and clinical laboratory segments of the diagnostic market. These products are used to detect autoimmune, infectious, and sexually transmitted...
Trinity Biotech plc and its subsidiaries (Trinity Biotech) operate as a commercial stage biotechnology company that focuses on diabetes management solutions and human diagnostics, including wearable biosensors.
The company develops, acquires, manufactures, and markets diagnostic systems, including both reagents and instrumentation, for the point-of-care and clinical laboratory segments of the diagnostic market. These products are used to detect autoimmune, infectious, and sexually transmitted diseases, diabetes and disorders of the liver and intestine. In January 2024, the company has entered the biosensor industry, with the acquisition of the biosensor assets of Waveform Technologies Inc. (‘Waveform’) and intends to develop a range of biosensor devices and related services, starting with a continuous glucose monitoring (‘CGM’) product.
Principal Markets
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.
Point-of-Care
Point-of-care refers to diagnostic tests which are carried out in the presence of the patient.
Uni-Gold HIV
The company believes that it 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 its HIV screening test, TrinScreen, which received World Health Organisation approval in February 2022. During December 2023, the company began commercial shipments of Trinscreen to Kenya as part of an initial purchase order it received for 2.5 million tests. An additional purchase order for 2.0 million tests was received from USAID during April 2024. Market opportunities for TrinScreen also exist in other territories, in emerging countries, and the company expects to receive and fulfil orders from other territories during 2024.
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 kits for the detection of 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 it serves include: Sexually transmitted diseases, including Syphilis and Herpes; Markers for Epstein Barr, Measles, Mumps, Toxoplasmosis, Cytomegalovirus, Rubella, Varicella and other viral pathogens; and SARS-CoV-2.
The company also develops, manufactures, and distributes products primarily in enzyme-linked immunosorbent assay (‘ELISA’) format. As a complement to its product range, it also offers third party automated processors to its customers. Many of the products in its infectious diseases’ product line are FDA cleared for sale in the United States and CE marked in Europe. Products are sold in approximately 100 countries in total, with the focus on the Americas, Europe, and Asia. The infectious disease products are sold through its sales and marketing organization to a variety of customers, including public health authorities, clinical, and reference laboratories directly in the U.S. and UK 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 boronate affinity technology to measure HbA1c which is a marker of a patient’s average blood sugar control over the last 100 to 120 days. It is a highly accurate biomarker available for the diagnosis of diabetes and is a strong indicator of a diabetic’s glycemic control. HbA1c is also used to identify those at risk of becoming diabetic; often referred to as impaired glucose tolerance. Additionally, HbA1c is used in the assessment of diabetes complications. The company manufactures its own HbA1c instrument, the Premier Hb9210, which was launched in Europe and obtained FDA approval in late 2011. In the U.S.A and Brazil, the company sells the Premier Hb9210 through its own direct sales organizations. In the rest of the world, it 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 EU). The Premier Resolution detects and identifies haemoglobinapothies. 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. In August 2023, the Premier Resolution was approved by the FDA allowing the instrument to be sold in the U.S. The Premier Resolution uses an internally designed column, as well as state of the art hardware and software.
Autoimmune Diseases
In 2013, the company acquired Immco Diagnostics (‘Immco’), an autoimmunity company known for novel assay development and high impact contributions to autoimmune disease diagnostic research. Immco develops, manufactures, and sells products in the following formats for diagnosis of autoimmune diseases, including Immunofluorescence Assay (‘IFA’), Enzyme-linked immunosorbent (‘ELISA’), Western Blot (‘WB’), and Line immunoassay (‘LIA’).
Many of Immco’s products are FDA cleared for sale in the U.S. and CE marked in Europe. The Immco product line addresses the lower throughput, specialty autoimmune segment. The principal autoimmune conditions in this segment are Rheumatoid Arthritis, Vasculitis, Lupus, Celiac and Crohn’s Disease, Ulcerative Colitis, Neuropathy, Hashimoto’s Disease, and Grave’s Disease.
The Immco products are sold through the company’s sales and marketing organization to clinical and reference laboratories directly in the U.S. and via distributors in other countries.
The diagnostic product line is complemented by Immco’s New York State Department of Health licensed reference laboratory offering specialized services in diagnostic immunology, pathology, and immunogenetics, and is marketed to U.S.-based reference laboratories and hospitals.
In addition, Immco markets a panel of proprietary early markers for Sjögrens disease often referred to as ‘dry eye disorder’.
Clinical Chemistry
The specialty clinical chemistry business of the company includes reagent products, such as ACE, bile acids, 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 many disease states from liver and kidney disease to G6PDH deficiency which is an indicator of haemolytic anaemia.
Blood Bank Screening
The company manufactures enzyme-linked immunosorbent assays, for the detection of syphilis and malaria. These products are sold through distributors and are manufactured under original equipment manufacturer agreements for other third-party diagnostic companies.
Continuous Glucose Monitoring
In January 2024, the company acquired the biosensor and CGM assets of privately held Waveform Technologies, Inc. (‘Waveform’). Waveform, a developer of novel and proprietary new technologies for diabetes care, received a CE Mark for its Cascade CGM in 2019, which has since been commercially available in Europe. The primary use of the device is to continuously monitor glucose in the human body. The Cascade CGM device and any subsequently developed sensor would be subject to regulatory oversight from the FDA and country specific regulatory authorities and would be subject to the risks. Glucose in the blood diffuses from capillaries into the liquid between cells known as interstitial fluid. The Waveform CGM device is an electrochemical biosensor which detects the concentration of glucose in interstitial fluid by means of an enzyme immobilised at the surface of a sensor wire inserted into the skin. The action of the enzyme results in the generation of electrical that is relayed to an attached transmitter where it is converted by a firmware algorithm into a blood glucose concentration. The transmitter then sends this blood glucose measurement to a smartphone or other device where the time within healthy range is tracked, and the user alerted to risks of hypo- or hyperglycaemic episodes.
The Waveform CGM technology contains innovative and proprietary aspects with what it believes are important benefits. Significantly, the special composition of the sensor wire and the unique formulation of its protective outer membrane contribute to the ability to achieve needle-free insertion. Needle free insertion has numerous benefits, including a reuseable applicator as no needle needs to be safely disposed. This, combined with a reusable transmitter which is also a feature of the acquired CGM technology, allows for two clear benefits. Firstly, it allows for a lower cost of production of the redesigned CGM product compared to the principal CGM market players and secondly, it reduces the biological waste concerns associated with the marketed single-use disposable systems.
The CGM technology acquired from Waveform was developed over many years and Waveform has granted a perpetual, worldwide, non-exclusive license to DexCom, Inc. and its affiliates, for some of the patents acquired the company and it retains the right to use and exploit.
Principal Development Projects
Haemoglobin Development
Premier Hb9210 Instrument for Haemoglobin A1c Testing
A product development plan focuses on improvements in the company’s flagship Premier 9210 instrument is ongoing. The package of changes aims to expand the target market, reduce instrument downtime and service cost, and significantly expand operating margins.
The company’s program to develop an improved, backward compatible column Diabetes HbA1c column system is complete. The results of this development program have exceeded expectations, with its new column system delivering up to four times the number of injections compared to the existing product. The company is executing on the commercial launch of these new products.
Premier Resolution Instrument for Haemoglobin Variant Testing
The company developed the Premier Resolution instrument which is utilized for haemoglobin variant testing. The instrument achieved 510(k) approval from the FDA in August 2023. The instrument has been sold in certain international markets outside of the U.S. for many years. Premier Resolution continues to be enhanced with unique features, such as lot specific gradients, an optimized internally designed column with extended column life, and a rapidly expanding on-board variant library.
Point-of-care Development
A combination HIV/Syphilis point-of-care rapid test is also being developed using its existing lateral flow format, the company expects this project to restart in 2024.
Continuous Glucose Monitoring Development
In January 2024, the company acquired the biosensor and CGM assets of Waveform. It is the company’s intention to further develop these assets with its research and development activities including optimizing sensor design and manufacture, reanalyzing user data from Waveform’s clinical trial data sets, software improvements including algorithm and app development, and performing new pre-pivotal and pivotal clinical trials.
In tandem with the acquisition of the Waveform CGM assets, the company also hired several of the key research and development personal that previously worked on developing the Waveform CGM. Additionally, the company has engaged an internationally recognized and reputable technical development consulting house to work on some key development activities. The company plans to further augment the CGM development function with further hires in the coming months.
Sales and Marketing
The company sells its products through its own direct sales force in the U.S. The company’s sales team in the U.S. is responsible for marketing and selling its range of point-of-care, 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 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 all product lines through independent distributors and strategic partners in a further approximately 100 countries.
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, and FreeStyle Libre), SD Biosensor (Standard Q), Bejing Wantai Biological Pharmacy (Wantai), Roche (Cobas and TinaQuant 3), Bio-Rad (Variant 2, Variant 2 Turbo, D 100, and BioPlex 2200) Tosoh ( G8 and G11), Arkray 8180, Siemens DCA, Sebia (Capyllaris 2 and Capyllaris 3), Shanghai Kehua Bio-Engineering (KHB), Euroimmun, Guangzhou Wondfo Biotech Co., Ltd (Wondfo), Aesku, Werfen, Copan, Becton Dickenson, Pointe Scientific, Dexcom (G6, G7, Dexcom One, and Stelo) and DiaSorin Liaison.
The company also has competition with several large companies, such as Abbott Diagnostics, DexCom Inc., Diasorin Inc., Johnson & Johnson, Roche Diagnostics, Siemens (from the combined acquisitions of Bayer, Dade-Behring and DPC), and Thermo Fisher.
Patents
As part of the Waveform asset acquisition, the company acquired a CGM patent portfolio that includes numerous issued and pending patent applications in the U.S. and other parts of the world.
Licenses
The company has entered a number of licensing arrangements including the following:
Immco entered into a licence agreement on January 19, 2012, and subsequently an amended licence agreement on June 14, 2018. The licence pertains to any product or service relating to identifying indicators of Sjogren’s disease. The agreement is effective through January 21, 2036, and is worldwide in scope. Royalties are payable based on agreement in place.
On December 19, 1999, the company obtained a non-exclusive commercial licence from the National Institutes of Health (‘NIH’) in the United States for NIH patents relating to the general method of producing HIV-1 in cell culture and methods of serological detection of antibodies to HIV-1.
The company acquired CGM technology from Waveform in January 2024. This technology has been developed over many years and Waveform has granted a perpetual, worldwide, non-exclusive license to DexCom, Inc. and its affiliates, for some of the patents acquired by the company and retain the right to use and exploit.
In connection with the acquisition, the company entered into a transition agreement with Bayer Healthcare LLC (‘Bayer’). As a portion of the acquired intellectual property was developed originally by Bayer, the transition agreement provides that the company pays Bayer a royalty on net sales of the CGM products.
Research and Development
The company's research and development expenses were US$4.4 million for the year ended December 31, 2023.
Regulations
Many of the company’s products that are sold in the United States are medical devices subject to the Federal Food, Drug, and Cosmetic Act (‘FDCA’), as implemented and enforced by the U.S. Food and Drug Administration (‘FDA’) Certain products sold in the United States require FDA clearance to market under Section 510(k) of the FDCA. Other products sold in the United States require premarket approval (‘PMA’) to market.
The company is required to have Institutional Review Board (IRB) approval prior to and during its clinical trials and must obtain informed consent from study participants. The company supplies clinical laboratories with raw materials, such as reagent products, that may be used by clinical laboratories in clinical laboratory tests, which are regulated under Clinical Laboratory Improvement Amendments of 1988 (CLIA), as well as by applicable state laws. The U.S. Foreign Corrupt Practices Act (‘FCPA’), to which the company is subject, prohibits corporations and individuals from engaging in bribery and corruption when dealing with foreign government officials and foreign political parties.
The company is also subject to the FCPA’s accounting provisions, which require it to keep accurate books and records and to maintain a system of internal accounting controls sufficient to assure management’s control, authority, and responsibility over its assets. The laws to which the company is subject because of its international sales also include the U.K. Bribery Act (the ‘Bribery Act’), which proscribes giving and receiving bribes in the public and private sectors, bribing a foreign public official, and failing to have adequate procedures to prevent employees and other agents from giving bribes.
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 its reference laboratory, and other covered entities. The company also remain subject to federal and state privacy-related laws that may be more restrictive or contain different requirements than the privacy regulations issued under HIPAA.
The International Organization for Standardization (ISO) 13485 certification indicates that its quality system complies with standards applicable to activities ranging from initial product design and development through production and distribution. In the U.S., the company is subject to the Toxic Substances Act (TSCA) and Pollution Prevention Act (PCA) under the auspices of the Environmental Protection Agency (EPA). The company’s facility in Bray, Ireland is certified to ISO 14001.
History
Trinity Biotech plc was founded in1992. The company was incorporated in Ireland in 1992.
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