Results for the year ended 31 December 2013
Operational highlights
· US FDA approval of Aorfix™ for the endovascular repair of AAAs in February 2013
o Only endovascular stent graft approved by the US for use in cases with neck angulation up to 90 degrees
· US FDA approval of Aorflex™, the next generation delivery system for Aorfix in June 2013
· Official US launch of Aorfix together with Aorflex at the VEITH Symposium in New York in November 2013
· Following US Aorfix approval, recruited and trained a US direct sales force of 20 individuals, including two regional managers
· Trained 244 physicians in the US to use Aorfix between July and December 2013
· Appointment of Raymond W. Cohen as Non-Executive Chairman in July 2013
Financial highlights
· Total revenue increased by 13% to $7.0m (2012: $6.2m)
· Aorfix commercial revenue increased 23% to $6.1m (2012: $5.0m)
o Aorfix revenue in main EU markets increased 8% to $3.9m (2012: $3.6m)
o Aorfix revenue in the US was $0.5m following launch in H2 2013
· Operating loss increased to $20.0m (2012: $13.1m) due to increases in sales and marketing headcount and activity in the US
· Cash and cash equivalents of $40.9m as at December 31, 2013 (December 31, 2012: $4.5m), increased primarily through the receipt of $53.2m (£34.4m) from equity fundraisings
· Financing:
o US approval of Aorfix in February 2013, which triggered receipt of the $20.4m (net of expenses) second tranche of the two tranche April 2011 fundraising
o US approval of Aorfix triggered Company's ability to draw down $2.5m from the $5.0m loan facility granted by our exclusive Japanese distribution partner, Medico's Hirata Inc.
o Raised an additional $32.8m (net of expenses) in June 2013 through a placing, subscription and offer for new shares
Post period events
· Live case demonstration using Aorfix at
o 2014 Leipzig Interventional Course (LINC) in Germany
o iCON 2014, a meeting of the International Society of Endovascular Specialists in Phoenix, Arizona
· Approval for Aorfix in Japan continues to be anticipated in 2014
This press release does not constitute an offer of any securities for sale. As a result of regulations applying to the Company after the filing of a Form F-1 Registration Statement with the US Securities and Exchange Commission on 10 March 2014, this press release does not include comments on Outlook or by our Chief Executive Officer.
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