Pre-Close Trading and Strategic Update
Trading Update
Aorfix™ commercial revenue grew 25% to £3.9m with revenue from the main EU markets growing 9%. Revenue from the Rest of World ("ROW") markets grew 28% and the US contributed to fourth quarter Aorfix commercial revenue growth of 38% following formal launch in November. In Europe, the Company experienced strong demand and revenue growth in Germany and Spain. Following consolidation of EVAR centers in the UK, which negatively impacted UK revenue in the first half of 2013, second half 2013 Aorfix revenue in the UK recovered and was flat compared to the same period the previous year. Total Company revenue grew by 14% to £4.5m, reflecting a decline in revenue of the recently divested OEM business in Scotland which fell by 27% compared to last year. As previously announced, this business was divested on 20 December 2013.
Aorfix was approved by the United States Food and Drug Administration ("US FDA") in February 2013 with a unique label indication for the treatment of patients with angulations at the neck of the aneurysm up to and including 90 degrees. The product was formally launched in the US, the largest EVAR market, at the 40th Annual VEITH Symposium, in New York in November. While Aorfix is still in the initial phase of the US launch, the product rollout is progressing well, with the number of US physicians trained to use the device standing at 244 at the year end. As previously disclosed, the Company's 20-person sales team is targeting around 300 high volume EVAR centers that perform more than half of the EVAR procedures in the US.
In Japan, the Company now anticipates regulatory approval for Aorfix during 2014. Our exclusive Japanese marketing partner, Medico's Hirata, remains in dialogue with the Pharmaceuticals and Medical Devices Agency (PMDA) to achieve this. Medico's Hirata is a leading supplier of medical device products in Japan, with the sales infrastructure to realize the potential of Aorfix in this growing market, which in 2013 was estimated to account for approximately $140m or 10% of the global EVAR market.
As previously announced, the Company is expanding its manufacturing facility in Didcot, Oxfordshire, to support increasing global demand for Aorfix. The expansion, which involves the construction of a new cleanroom and materials handling space, will add around 10,000 sq. ft. to the existing facility. The expansion project is expected to be completed by the end of the first quarter of 2014.
The global AAA market for EVAR devices is estimated to be approximately $1.4bn. The US market is estimated to be worth around half of the global market and is expected to grow at a compound annual growth rate in excess of 7% over the next 5 years, driven largely by the growth of the ageing population and patient screening programs. In addition, introduction of new technologies such as Aorfix, which allow more patients to received endovascular treatment of AAA disease, could potentially further expand the market.
The Company closed 2013 with cash of £24.8m and debt of £1.5m on its balance sheet.
NASDAQ IPO
As announced today in a separate press release, the Company intends to submit a registration statement to the US Securities and Exchange Commission ("SEC") relating to a proposed US initial public offering of ordinary shares and a listing on NASDAQ ("NASDAQ IPO").
To facilitate the NASDAQ IPO, a new Cayman Islands holding company will be created and existing shares in Lombard Medical will be exchanged for new shares in that holding company ("Share Exchange")
Commencement of the initial public offering is conditional upon completion of the SEC review process with respect to the registration statement and is subject to market conditions and other considerations. In connection with the NASDAQ IPO, Lombard Medical will also delist its ordinary shares from AIM, a market of the London Stock Exchange.
In the Share Exchange, existing shareholders will receive shares in the new Cayman Islands holding company in exchange for the shares they hold in Lombard Medical. These new shares will not be admitted to trading on AIM. Shareholders will need to consider their ability to hold and trade NASDAQ listed shares following the Share Exchange and the AIM delisting. Full details of the proposals will be set out in a circular to shareholders in due course.
Lombard Medical intends to use proceeds from the NASDAQ IPO to accelerate its commercialization strategy for Aorfix in the US with a particular focus on continuing to expand its direct sales force to accelerate penetration of the US AAA market. The Company will also continue to invest in developing new products to treat complex vascular disease, including a stent graft to treat aneurysms in the thoracic aorta.
This press release does not constitute an offer of any securities for sale.
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