London, UK, 9 April 2013 – Lombard Medical Technologies PLC (AIM: LMT), the specialist medical technology company focused on innovative vascular products, today announces its results for the year ended 31 December 2012.
Operational highlights
• Demand, as measured by patients treated, for Aorfix™ increased 13% in main EU markets (UK, Germany, Italy and Spain) with 382 patients treated (2011: 338 patients)
-- Demand was not fully reflected in revenue as it was partly supplied from distributor stock
• Aorfix™ revenue of £2.3m in main EU markets (2011: £2.2m)
-- 32% growth in Germany reflecting expansion of direct sales team
• High angle clinical data from US PYTHAGORAS trial presented in June 2012
-- Strong data despite extremely challenging patient group with high neck angles
• Launch of Aorflex™ delivery system in April 2012
-- Encouraging clinician feedback
• Key hire – appointment of Ian Ardill to the Board as Chief Financial Officer in January 2012
Financial highlights
• Total commercial revenue (total revenue less revenue from the clinical trial) flat at £3.9m (2011: £3.9m) despite procedure growth of 13% in main EU markets
• Total revenue declined to £3.9m (2011: £4.0m) due to completion of US trial enrolment and loss of related revenues
• Operating loss decreased by 28% to £8.2m (2011: £11.4m)
• Cash and cash equivalents of £2.7m as at 31 December 2012 (31 December 2011: £7.5m)
• £3.0m raised from issue of convertible loan notes to Invesco Asset Management Limited (“Invesco”) in March 2012
• Share consolidation of 1 new ordinary share of 20p for every 200 existing ordinary shares of 0.1p in March 2012
• Six month extension of Long Stop Date of Second Tranche of the May 2011 Fundraising
• Participation of £2.8m by LSP Life Sciences Fund N.V., a specialist healthcare fund, in the Second Tranche of the May 2011 Fundraising
Post period events
• 14 February 2013 - US FDA approval of Aorfix™ for the endovascular repair of AAAs
-- Label indication for the treatment of patients with angulations at the neck of the aneurysm from 0 to 90 degrees
-- Aorfix™ the only endovascular stent graft licensed in the US for use in cases with neck angulations greater than 60 degrees (consistent with high-angle, 90 degree, label claim in Europe)
• US approval of Aorfix™ has triggered receipt of £14.1m gross funds from the Second Tranche of the May 2011 Fundraising
• Aorfix™ approval in Japan anticipated in 2014
-- US approval has triggered receipt of $2.5m from the $5.0m convertible loan facility granted by Medico’s Hirata Inc., the Company’s distribution partner in Japan
Simon Hubbert, Chief Executive of Lombard Medical, commented:
“2012 has been a key year for the Company, during which we worked to ensure the approval of Aorfix™ in the US. I am delighted our efforts have been rewarded and Aorfix™ is now approved by the FDA; the only endovascular stent graft licensed in the US for use in cases with neck angulations up to 90 degrees.
“We also made good progress across the rest of the business; reporting an increase in Aorfix™ cases in the main EU markets and sales growth of 32% in Germany. In addition, we launched our new Aorflex™ delivery device and our expanded size range of custom built stent graft devices will be available by mid-year.
“With the US approval of Aorfix™ in February, the stage is now set for significant future growth for the Company which we believe will also translate into significant shareholder value. We look forward to launching Aorfix™ in the US through our own direct sales force and are confident of capturing a meaningful share of the world’s single largest market for the treatment of AAAs.”
About Lombard Medical
Lombard Medical Technologies PLC (AIM: LMT), is a medical device company focused on device solutions for the $1.2 billion dollar per annum abdominal aortic aneurysm (AAA) repair market. AAAs are a balloon-like enlargement of the aorta which, if left untreated, may rupture and cause death. Approximately 4.5 million people are living with AAAs in the developed world and each year 600,000 new cases are diagnosed. The market for endovascular stent grafts for this application is expected to grow to $1.6 billion by 2015. The Company’s lead product, Aorfix™, is an endovascular stent graft which has been specifically designed to solve the problems that exist in treating complex tortuous anatomy which is often present in advanced AAA disease. Aorfix™ is currently being commercialised in the EU, and has been approved by the FDA in the US
The Company is headquartered in Oxfordshire, with operations in Ayrshire and Phoenix, USA.
Further background on the Company can be found at www.lombardmedical.com.
For further information:
Lombard Medical Technologies PLC Tel: 01235 750 800
Simon Hubbert, Chief Executive Officer
Ian Ardill, Chief Financial Officer
Canaccord Genuity Limited
Lucy Tilley/ Henry Fitzgerald O’Connor/
Tim Redfern/ Dr. Julian Feneley
Tel: 020 7523 8000
FTI Consulting
Simon Conway / Susan Stuart / Victoria Foster Mitchell Tel: 020 7831 3113
References
1. US Market for Peripheral Vascular Devices and Accessories, iData Research Inc., February 2012
2. Eurostar Study results (Frequency, predictive factors, and consequences of stent-graft kink following endovascular AAA repair. Fransen GA, Desgranges P, Laheij RJ, Harris PL, Becquemin JP; EUROSTAR Collaborators . Published in J Endovasc Ther. 2003 Oct;10(5):913-8.)
