LONDON (Alliance News) - Epistem Holdings PLC widened losses as delays in the completed development of its Genedrive product effected out turn and expectations in the full-year ended June 30.
The biotechnology and medicine company posted revenues of GBP5.4 million, down from GBP5.6 million in the previous year. Pretax losses were GBP1.5 million, widened from GBP726,000 in the previous year as it made high levels of investment in its Genedrive and Novel Therapies programmes.
The company said that its key priority was to gain approval for its Genedrive treatment, which was due to be launched during the year but was delayed by technical and manufacturing issues. "The issues were mainly with the firmware and software in the unit," Chief Executive Officer Matthew Walls told Alliance News. "The more people who use the unit the more we're putting it through its paces, so as we've been testing and going through the validation we've found there are other firmware issues we need to get right."
"We're towards the end of that process, but we need to validate, verify it properly then we go back to our final stage clinical trials, and then we go to market," said Walls. The company hopes to finish this part of the process before the end of this year then position it to go into trial by the beginning of next year, ready for the market in the second-half of 2014.
Epistem failed to meet the milestones and time-scale it agreed with its partner Becton Dickinson, meaning its agreement with the company was terminated. Although Epistem is still in dialogue with Becton, and Walls says there's a good probability that they might make another agreement with the company. "They're one of several we're talking to at the moment," Walls said, "they remain interested in what we're doing."
The company is working with Xcleris to prepare Genedrive for launch in India, but it is looking to expand outside of that territory. "We'll be looking for another partner outside of India for Tuberculosis, and the other infectious diseases we handle," Walls said, "depending on the group we think are best positioned to exploit it."
"It's not our intention to build a company that has marketing and distribution in the field, we'll give that to the bigger diagnostic groups that can properly exploit that for us," Walls said.
Genedrive is a molecular diagnostic technology. The company says it is finalising the technical development and scale up of the technology read to begin its first application in the diagnosis of TB. The company now expects to launch the product to market in the second half of 2014, however it warned that it will require further investments in resources and infrastructure to support future partnerships.
Although the company widened its pretax loss, Walls thinks that the launch of Genedrive will help bring the company back to profit.
"Not this financial year, I suspect the following year is when we'll start to move back to profit, it's fair to align them to when the product goes to market," Walls said. "It's our first product, and inevitably its taken a bit of time to get where we are but its an exciting time."
Shares in Epistem were trading up 2.60 pence at 325.10 pence Tuesday afternoon.
By Hana Stewart-Smith; hanassmith@alliancenews.com; @HanaSSAllNews
Copyright 2013 Alliance News Limited. All Rights Reserved.
