Trinity Biotech Announces Quarter 2 Financial Results and Acquisition of Immco Diagnostics Inc.

Note: The following is an excerpt from the complete press release issued by Trinity Biotech.

DUBLIN, IRELAND -- Trinity Biotech plc (NASDAQ:TRIB), a leading developer and manufacturer of diagnostic products for the point-of-care and clinical laboratory markets, today announced results for the quarter ended June 30, 2013 and the acquisition of Immco Diagnostics Inc. [Summit Partners invested in Immco Diagnostics in 2007]

Acquisition of Immco Diagnostics Inc.

Trinity Biotech is pleased to announce the acquisition of Immco Diagnostics Inc. (Immco) on July 26, 2013. Headquartered in Buffalo, New York, Immco is a diagnostic company specializing in the development, manufacture and sale of autoimmune test kits on a worldwide basis. This product line is complemented by specialized reference laboratory services in diagnostic immunology, pathology and immunogenetics, marketed to US-based reference laboratories and hospitals.

It is Trinity Biotech's intention to retain Immco's existing management team which, led by Mr. Bill Maggio, has a proven track record and expertise in growing a successful autoimmune business.

Currently, over 50 million Americans are affected by more than 80 different autoimmune diseases. Autoimmune diseases are now the second leading cause of chronic illness and the leading cause of death amongst women over 65. The autoimmune market is divided into two main segments, the first of which is the automated, high volume segment for standard analytes such as thyroid markers. This segment is dominated by the large diagnostic players such as Abbott, Roche and Beckman Coulter, is growing slowly and is one where Immco does not participate.

Instead, Immco's position is in the $250m, high growth (over 10% p.a.), lower throughput, speciality autoimmune segment, where the competition is limited to a small number of key players, principally Bio-Rad, Werfen-Inova and Phadia. The principal autoimmune conditions in this segement are Rheumatoid Arthritis, Vasculitis, Lupus, Celiac and Crohn's disease, Ulcerative Colitis, Neuropathy, Hashimoto's and Graves disease. Meanwhile, the two key technologies employed are Immunoflourescence (IFA) and Immunoassay (EIA). Immco offers a comprehensive range of more than 120 products across all the main autoimmune segments with its EIA product range running on the DSX/DS2 Instrument platform while the IFA products are capable of being read manually or on Immco's proprietary IFA reading system, iSight. In terms of range, breadth and technical performance, the Immco IFA range is best on the market, while the EIA range is of the highest quality and very competitive with the market leaders.

Immco currently sells its products through a network of distributors, mainly outside the USA. In Europe, Immco's main distribution partner is Menarini, a company with which Trinity already has deep distribution ties. The broadening of the relationship between Menarini and Trinity through the additional distribution of the Immco product is viewed very positively by all parties. To date Immco has had very low product sales in the USA due to a lack of FDA product approvals and sales force. However, over the past 24 months, Immco has been successful in harmonizing its complete IFA and EIA product ranges, virtually all of which have now been FDA 510K cleared. Through Trinity Biotech's existing US based sales force (which already sells approximately $2m of Trinity's own autoimmune products) and installed base of EIA instrumentation, Trinity expects to immediately launch Immco's products in the USA. Moreover, as the Immco autoimmune product range complements Trinity's existing infectious disease EIA range, we intend that our large range of installed DSX and DS2 instruments which currently run our infectious disease product line will now also run the entire Immco autoimmune EIA range. We believe that this in turn will help drive growth in both ranges of products due to the synergistic effect of a broader menu offering.

Immco is further driving expansion with the development of a number of new diagnostic kits, such as the ImmuLisa™ Enhanced Cardiolipin Antibody ELISAs recently cleared by the FDA, and there is a robust pipeline of novel assays in development. Meanwhile, the Immco reference laboratory is in the process of launching exclusive panels of tests for Sjögren's Syndrome and Chronic Rhinosinusitus, both of which are significantly underdiagnosed conditions with high incidence.

In summary, Trinity expects to grow Immco's revenues by

  • harnessing the breadth, quality and uniqueness of Immco's product range, in the context of only recently having obtained FDA approval;
  • leveraging Trinity's sales force and in particular, installed instrument base in the USA;
  • leveraging Trinity's international distributor network;
  • introducing new innovative autoimmune products which are now beginning to emerge from the development phase; and
  • exploiting the synergies that exist between Trinity's existing infectious diseases and Immco's autoimmune product ranges.

Comments
Ronan O'Caoimh, CEO, stated "'Firstly, we are pleased to have completed the acquisition of Immco which has a truly excellent and complete range of autoimmune products with, in our opinion, the best IFA range in the world and an ELISA range that matches the quality of the market leaders. In addition, it also has a very exciting and innovative product development pipeline. The autoimmune market is currently growing at a rate well above the overall diagnostics market and this product range fits very well with our existing infectious diseases product offering. Trinity already has a large installed base of DSX instruments which run our infectious diseases product range and it is expected that these instruments will now also run the Immco range of autoimmune products. Further synergies will be achieved by leveraging Trinity's existing US sales force and international distributor network. Due to these factors we expect the Immco product line to be a significant driver of growth for Trinity, both from a revenue and profitability point of view.

Litigation Reform Act of 1995. Investors are cautioned that such forward-looking statements involve risks and uncertainties including, but not limited to, the results of research and development efforts, the effect of regulation by the United States Food and Drug Administration and other agencies, the impact of competitive products, product development commercialisation and technological difficulties, and other risks detailed in the Company's periodic reports filed with the Securities and Exchange Commission.

Trinity Biotech 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. The products are used to detect infectious diseases and to quantify the level of Haemoglobin A1c and other chemistry parameters in serum, plasma and whole blood. Trinity Biotech sells direct in the United States, Germany, France and the U.K. and through a network of international distributors and strategic partners in over 75 countries worldwide. For further information please see the Company's website: www.trinitybiotech.com.

Source: Trinity Biotech

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