Preliminary Results for the Year ended 31 December 2009
London, UK, 16 April 2010 – Lombard Medical Technologies PLC (“Lombard Medical”, or “the Company”), a medical device company focused on device solutions for the $1 billion dollar abdominal aortic aneurysm repair market, today announces its results for the year ended 31 December 2009.
Operating Highlights
Aorfix™ US trial and PMA submission
• 175 patients now enrolled into the US trial including more than 120 with high neck angles
• Three out of six FDA PMA modules submitted; two approved by the FDA in 2009
Aorfix™ European Commercialisation
• Commercial sales of Aorfix™ increased 49% to £1.7 million, with sales in Germany, Italy, Spain up 85%
• 1,000th Aorfix™ implanted in October 2009
• Aorfix™ received extended label claim in Europe as only approved product for treating high-angle tortuous anatomy
Business Reorganisation
• Strategic decision to focus resources on Aorfix™ successfully implemented during Q1 2009
• Sharp reduction in costs, headcount reduced by 50% from 2008 peak
• Further strategic review by new CEO John Rush to devote resources to European sales and marketing and FDA approval
• Polymer Coatings Division sold for £1.0 million, November 2009
Financial Highlights
• Revenues up 25% to £2.4 million (2008: £1.9 million)
• Operating expenses down 30% to £8.7 million (2008: £12.4 million)
• Net cash outflow from operating activities reduced by 37% to £6.7 million (2008: £10.5 million)
• Total loss for the year decreased by 37% to £6.2 million (2008: £9.9 million)
• Funds put in place to finance business plan - £6.4 million (£5.95 million net of expenses) successfully raised in January 2009 and £13.3 million (£12.1 million net of expenses) in February 2010
John Rush, Chief Executive of Lombard Medical, commented:
“2009 was a transformational year for Lombard Medical; during which we significantly reduced costs, refined our strategy and restructured the Company, placing us in a stronger position to capitalize on the large and growing commercial opportunity for our lead product, Aorfix™. The US trial has made good progress, with 175 patients now enrolled and we are on track to meet the remaining submission requirements. In Europe, where Aorfix™ is the only product approved for treating high- angle-neck aneurysms up to and including 90 degrees, we saw sales growth of almost 50%, led by strong performances in key markets including Germany, Italy and Russia. We are confident that by increasing our specialist sales force in Europe we can continue to capitalise on Aorfix’s™ unique label claim. The additional £13.3 million raised in January will enable us to execute our strategy and realise the full potential of Aorfix™.”
Lombard Medical Technologies PLC
Simon Neathercoat, Non-executive Chairman
John Rush, Chief Executive Officer
Tim Hall, Finance Director
Tel: 01235 750 800
Evolution Securities Limited
Barry Saint
Tim Redfern
Esther Lee
Tel : 020 7071 4300
Financial Dynamics
Jonathan Birt
Susan Quigley
Tel : 020 7831 3113
Notes to editors
About Lombard Medical
Lombard Medical Technologies PLC is a medical devices group developing stent grafts and other medical products for use in the treatment of vascular disease. The Company’s lead product, Aorfix™, is an endovascular stent graft for the treatment of abdominal aortic aneurysms (AAAs), a balloon-like enlargement of the aorta which, if untreated, may rupture and cause death. Approximately 4.5 million people are living with AAA in the developed world and each year 600,000 new cases are diagnosed. The market for endovascular stent grafts for the treatment of AAA is currently worth approximately $900 million and is expected to grow to around $1.6 billion by 2015. Aorfix™ is currently being commercialised in the EU, with a pivotal clinical trial ongoing in the USA.
The Company is headquartered in Oxfordshire, with operations in Ayrshire and Boston, USA.
Further background on the Company can be found at www.lombardmedical.com.