Trinity Biotech reports higher revenues, halts drug trial

Revenues at Irish medical diagnostic firm Trinity Biotech rose by 12.6 per cent in the third quarter to $27.2 million (€21.5 million), compared to $24.1 million (€19 million) for the same period a year earlier.

The company, which is based in Bray, Co Wicklow, and quoted on the Nasdaq exchange, also said it was to temporarily suspend FDA trials for its Meritas Troponin test.

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.

Profit before tax was $4.6 million, compared to $5 million a year earlier while operating profit meanwhile decreased from $4.8 million to $4.6 million.

Earnings before interest, tax, depreciation, amortisation and share option expense for the quarter was $6.2 million, Trinity said.

The company reported that point-of-care revenues rose by 2.8 per cent to $5.4 million when compared to the same quarter in 2013, largely on the back of growth in HIV-related drugs in the US.

Clinical laboratory revenues were up by 15.4 per cent from $18.8 million to $21.7 million. This was attributed to continued growth in the group’s Premier diabetes product and the impact from recent acquisitions.

Gross profit amounted to $13 million representing a gross margin of 47.9 per cent, which is lower than the 49.7 per cent achieved for the same quarter a year earlier.

Research and Development expenses increased to $1.1 million from $0.9 million when compared to the equivalent quarter last year.

Trinity also announced that was temporarily suspending enrolment into its Troponin clinical trials after it became aware of increased scatter (higher CV’s) in whole blood data.

The failure has now been positively identified as being attributable to a format change in a chemical raw material purchased from a third party supplier. This change caused instability in the product’s performance, which only became apparent over a period of time, the group said.

All clinical trial sites which have received batches of the product manufactured have been discontinued, while any clinical data generated using the impacted batches is to be excluded from the trial.

“While we are disappointed at the temporary suspension of our Troponin trials, the positive is that we caught the problem early, identified the source of the problem and fixed it. The trials will recommence in mid-February and we will submit to the FDA in August 2015,” said Trinity Biotech’s chief executive Ronan O’Caoimh.