NURTURING D Y N A M I C G R O W T H Annual Report 2010/11 CONTENTS 01 Mission, Corporate Pro(cid:191) le 02 Milestones 04 Chairman’s Message 06 Co-CEOs’ Statements 08 Operations Review 12 Financial Review 16 Board of Directors 19 Management Team 20 Corporate Structure 22 Corporate Governance Report 30 Directors’ Interests in Shares and Share Options 32 Share Options and Share Plans 36 Financial Statements 113 Shareholding Statistics 115 Warrantholding Statistics 116 Notice of Annual General Meeting 120 Corporate Information 121 Corporate Directory BIOSENSORS INTERNATIONAL GROUP, LTD. MISSION Through our high quality medical devices, we impact the lives we touch, and are committed to continue investing in and developing pioneering medical technology, pharmacological research, and engineering new medical devices that will further bene(cid:191) t our patients. This will create the best possible patient outcomes, and provide value to our stakeholders including physicians, shareholders and employees. CORPORATE PROFILE Biosensors International Group Ltd. develops, manufactures and commercializes innovative medical devices used in interventional cardiology and critical care procedures. With the increasing use of the BioMatrix™ family of drug-eluting stents, we are rapidly emerging as a global leader in drug-eluting stents, an evolving therapy that is rapidly gaining market share from traditional cardiovascular therapies. ANNUAL REPORT 2010/11 01 MILESTONES FY 2010 May 2010 June 2010 July 2010 Launched Acquired assets Mr. Jeffrey B. Jump BioMatrix Flex™ of CardioMind appointed as CEO FY 2011 02 BIOSENSORS INTERNATIONAL GROUP, LTD. Nov 2010 Dr. Jack Wang appointed as Co-CEO Sep 2010 3-year results from Nov 2010 LEADERS suggest Hony Capital took improved safety and strategic stake effi cacy of BioMatrix and joined Flex™ over Cypher® Board of Directors Select™ Sep 2010 Oct 2010 Received CE Mark for Acquired assets long-length versions of of Devax BioMatrix FlexTM Mar 2011 Share placement to Company achieved strategic investors Atlantis sales and profi tability Investment Management targets for FY11 (Hong Kong) and Ever Union Capital ANNUAL REPORT 2010/11 03 CHAIRMAN’S MESSAGE DEAR SHAREHOLDERS, FY 2011 (“FY11”) was another good year for Biosensors. Our total revenue and net pro(cid:191) t both grew 35% over FY 2010 (“FY10”). The major contributor to such growth came from our BioMatrix™ drug-eluting stents (“DES”). Our technology continues to be validated both clinically and commercially. As we demonstrate the safety and ef(cid:191) cacy of BioMatrix, we continue to penetrate the DES market globally. As the DES market continues to grow, the foundations we have built over the past years will allow us to meet the challenges and grab the opportunities in the future. Biosensors is prepared for very exciting times ahead. During FY11, we enhanced our shareholder pro(cid:191) le with the entrance of Hony Capital. In October 2010, Hony Capital made a signi(cid:191) cant investment in Biosensors. Hony – a leading global investment (cid:191) rm – will prove to be an excellent partner to add value to Biosensors’ future. Additionally, we successfully completed a private placement in March 2011. As a result, we added two strategic shareholders, Atlantis Investment Management (Hong Kong) and Ever Union Capital, to our investor group. This strengthened our balance sheet to support our expansion plans. Hony’s established reputation as a private equity (cid:191) rm in Asia and its extensive knowledge of the healthcare industry, together with the investment expertise and experience of 04 BIOSENSORS INTERNATIONAL GROUP, LTD. both Atlantis Investment Management (Hong Kong) and Ever I would like to thank each of you for your support and Union Capital, bring immense strategic value to our company. con(cid:191) dence over the years that have brought Biosensors to where we are today. As we move forward, with a strong new FY11 was also a year we strengthened our executive base of investors and a strengthened management team, management team. We appointed Dr. Jack Wang and Mr. I hope we can continue to count on your support over the Jeffrey B. Jump as co-chief executive of(cid:191) cers. Both have years ahead. I would also like to offer my sincere thanks to the extensive medical device experience and have been working entire Biosensors team, whose collective efforts have helped for Biosensors for a long time. They are the (cid:191) rst internally- turn our vision into reality. promoted CEOs. Hence I am sure they will preserve and protect the culture of Biosensors. They have also made valuable contributions to the success of Biosensors over the years. To complete the team, Mr. Ronald H. Ede joined us at the beginning of (cid:191) scal year 2012 as our chief (cid:191) nancial of(cid:191) cer. A veteran (cid:191) nancial manager with many years of healthcare industry experience, Ronnie will support our business strategies through his (cid:191) nancial, corporate management and M&A experience. With the new team in place, we look forward to Biosensors being led to greater heights. Meanwhile I will continue to work closely with our board members and executive management team to develop strategic initiatives. We will continue to look not only at internal growth drivers such as new markets and products, but also at external development opportunities. Our business fundamentals remain excellent – and, have in fact improved, thanks to our own internal development and to the continued strong demand for medical devices in all the Sincerely, markets we serve. We remain committed to our long-term objective of becoming Asia’s leading DES company. We now Yoh-Chie LU have a strong platform from which to realize this goal. Chairman ANNUAL REPORT 2010/11 05 CO-CEOS’ STATEMENTS DEAR SHAREHOLDERS, At the beginning of FY11, we provided guidance for increased pro(cid:191) tability over FY10. Toward this end, we closed our U.S. administrative operations as part of our continued efforts to reduce costs and simplify our operating structure. Our various cost-reduction measures have positively impacted our bottom line: operating pro(cid:191) ts grew signi(cid:191) cantly, while we successfully scaled up production output to meet increasing demand without compromising our stringent quality standards. We would like to commend our Biosensors colleagues for these achievements. With the consolidation of our manufacturing and R&D activities in Singapore, we expect our new operating structure to accelerate the entry of new products into the market and to help strengthen our presence in Asia. We are committed to investing in R&D – crucial to supporting innovation and growth in our industry – in whichever locations that can strategically improve our overall R&D capability. We have built a strong balance sheet to support this goal. We are equally pleased to report that our joint-venture in China, JW Medical Systems (“JWMS”), has achieved strong operating performance and record growth in FY11, making an important contribution to our own double-digit growth in net pro(cid:191) t over FY10. We are committed to our long term vision of becoming Asia’s premier medical technology company. Jeff and I are working closely together with the intention of achieving this goal. We would like to thank all our shareholders for their continued trust in and support of Biosensors. Sincerely Jack Wang Co-CEO 06 BIOSENSORS INTERNATIONAL GROUP, LTD. DEAR SHAREHOLDERS, At the beginning of FY11, we provided guidance for product revenues ranging from US$135 million to US$145 million. We are pleased to report that we have met our revenue target with yet another record year, driven largely by sales of our BioMatrix™ family of DES, which grew 59% over FY10 – a remarkable achievement given that we did not obtain any major new regulatory approvals during the (cid:191) scal year. We bene(cid:191) ted from positive growth across all our global markets throughout FY11 and strong sales and marketing execution. We are also pleased to report the positive contribution of licensing revenue from our partners. Our market success is attributable to robust technology and the growing body of clinical-based evidence for the BioMatrix family of DES. We continue to enhance our global clinical program, comprising LEADERS, Global LEADERS, and over 40 clinical studies and registry programs around the world. Our expanding product portfolio provides a comprehensive suite of products to address the diverse needs of interventional cardiologists globally. In addition to our BioMatrix workhorse family of stents, we will be adding Axxess™ – the world’s (cid:191) rst limus-coated DES dedicated to treating bifurcation lesions. Going forward, Jack and I will continue to work closely together as we grow our top-line across Asia and Europe, as well as to focus our efforts on emerging markets, including China, India and Brazil. We would like to thank all our shareholders for their continued support, as we look forward to another exciting year ahead. Sincerely Jeffrey B. Jump Co-CEO ANNUAL REPORT 2010/11 07 OPERATIONS REVIEW SALES & MARKETING 15%-20% of all patients undergoing percutaneous coronary We continue to report strong sales growth for our BioMatrix™ family interventions (PCI). We plan to launch Axxess in our major global of DES. FY11 sales grew 59% over FY10 due to increased sales markets during Q3 FY12. in existing markets, continued expansion in a few new geographic areas and the successful launch of BioMatrix Flex™ – our second- The assets of both CardioMind and Devax represent the start of generation DES system which received CE Mark approval in a new phase in the Company’s development, which we intend to Q4 FY10. continue with further strategic acquisitions in the future. BioMatrix Flex offers the unique combination of Biolimus A9™ (BA9™), an anti-restenotic drug developed and patented MANUFACTURING AND QUALITY ASSURANCE by Biosensors speci(cid:191) cally for use with DES, combined with Overall product gross margins continued to improve in FY11, biodegradable polymer abluminally coated onto an advanced, increasing to 75% from 70% in FY10. Growing DES sales with highly (cid:192) exible stent platform designed for enhanced deliverability. continuous re(cid:191) nements in our manufacturing processes helped drive the margin growth. Our team continues to perform well across all areas and sales channels. Our sales growth has resulted from increased penetration We remain committed to providing world-class products designed of existing markets; we did not receive any major new regulatory to enhance patients’ lives, and to continuous improvement in approvals during FY11. We anticipate our market penetration will meeting our customers’ expectations. This commitment is based continue to increase as we move deeper into existing markets and on maintaining both an effective quality management system and establish direct sales operations in key markets, such as Germany. a trained and competent organization, as well as complying with required standards and regulations. In FY11, we acquired two specialty DES products: Sparrow® from CardioMind and Axxess™ from Devax. The Sparrow stent system In August 2010, our Singapore manufacturing and operations hub gives Biosensors access to technology with potential for use in received the inaugural Growth Award in 2010’s Manufacturing small vessels throughout the body, including coronary, peripheral Excellence Award (“MAXA”), Singapore’s highest honor for and neurological applications. Axxess is the (cid:191) rst CE Mark-approved companies with manufacturing excellence. The MAXA Growth limus-eluting stent designed speci(cid:191) cally to treat bifurcation Award is awarded to fast-growing manufacturing companies lesions – the complex type of coronary artery disease that forms that demonstrate manufacturing excellence, innovation and at the intersection of two vessels – which occur in approximately sustainability. 08 BIOSENSORS INTERNATIONAL GROUP, LTD.
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