Half Yearly Report
Operational highlights
· US FDA approval of Aorfix™ for the endovascular repair of AAAs (Abdominal Aortic Aneurysms)
o Only endovascular stent graft approved in US for use in cases with neck angulations up to 90 degrees
o Unique 0-90 degree label indication enabling treatment of broadest range of AAA anatomies
o Compelling case for use over competing products supported by extensive body of clinical evidence
o One of only nine PMAs (pre-market approvals) granted by the FDA in H1 2013
· Aorflex™ next generation delivery system approved by the FDA in June for commercial use in the US
· Aorfix US commercial launch underway, formal launch event at VEITH Symposium, November 2013
o Initial commercial cases successfully completed
o Direct sales team of 20 people recruited and product training completed
o Physician training programme commenced
· Approval for Aorfix in Japan on track, approval anticipated in H1 2014
Financial highlights
· Total revenue increased 2%, in line with expectations, to £2.0m (H1 2012: £2.0m)
· Aorfix commercial revenue increased 8% to £1.7m (H1 2012: £1.6m)
o Revenue increased 6% in the four main EU markets (UK, Germany, Italy and Spain) to £1.1m (H1 2012: £1.0m)
o Revenue in Germany increased by 47% offsetting the effect of continued EVAR centre consolidation in the UK
o Revenue outside the main EU markets increased 9% to £0.6m (H1 2012: £0.5m)
· Significant increase in demand for Aorfix in Germany and Spain offsetting decline in demand for Aorfix in UK which is expected to stabilise in H2 2013
o Combined demand for Aorfix over the four main EU markets steady with 194 patients treated (H1 2012: 195)
· Operating loss increased by 11% to £4.8m (H1 2012: £4.4m)
· Loss after taxation increased by 14% to £4.9m (H1 2012: £4.4m)
· Financing
o Aorfix US approval triggered receipt £13.5m (net of expenses) of the c.£14.1m Second Tranche of the two tranche April 2011 fundraising as well as the Company's ability to draw down $2.5m from the $5.0m loan facility granted by its exclusive Japanese distribution partner, Medico's Hirata Inc.
o £20.9m (net of expenses) raised from a placing, subscription and offer of shares in June
o £3.0m Convertible Loan Notes issued to Invesco in 2012 were converted into new Ordinary Shares
· Strong cash position - £34.3m as at 30 June 2013 (30 June 2012: £5.2m)
Post period events
· Appointment of Raymond W. Cohen as Non-executive Chairman in July