Biosensors Reports Increases in Product Revenue for Fiscal '07 Second Quarter and First Half
SINGAPORE, Nov. 9 /Xinhua-PRNewswire-FirstCall/ -- Biosensors International Group, Ltd. ("Biosensors" or the "Company", Bloomberg: BIG SP) today reported its second fiscal quarter ("2Q FY07") and fiscal half year ended September 30, 2006 ("1H FY07") financial results. Total product revenue increased by 16 percent to US$8.2 million in 2Q FY07 from US$7.0 million in the prior corresponding quarter, and increased by 25 percent to US$16.1 million for the half year ending September 30, 2006 from US$12.9 million in the prior fiscal half year. The increases are primarily due to growth in sales of its Axxion(TM) drug-eluting stent. Revenue from drug-eluting stents was US$3.0 million in the quarter compared with US$1.9 million in the prior year's corresponding quarter, an increase of 58%. For the fiscal half year, revenue from drug-eluting stents increased by 161% to US$6.2 million compared to US$2.4 million in the prior fiscal half year. "Biosensors' drug-eluting stent technology, particularly our biodegradable polymer technology, continued to be highlighted at this year's Transcatheter Cardiovascular Therapeutics ("TCT") symposium, held in Washington D.C. last week," said Mr. Yoh-Chie Lu, Chairman and CEO of Biosensors. "During the symposium, safety concerns associated with first generation drug-eluting stents with non-biodegradable polymer carriers continued to be an active topic of discussion among leading cardiologists. In the opinion of some cardiologists, the use of a biodegradable polymer may provide a viable alternative to treat coronary artery disease in the face of such safety concerns," he added. At TCT this year, Terumo Corporation, a licensee of Biosensors' drug- eluting stent technology, presented positive clinical results from its nine- month Phase 1- NOBORI 1 trial. In this trial 120 patients were randomized into two groups; one receiving the TAXUS stent from Boston Scientific Corp. and the other, the Terumo NOBORI stent utilizing Biosensors proprietary Biolimus A9(R) drug and biodegradable polymer. The trial's objective was to show "non-inferior" clinical outcomes for the NOBORI stent, compared to the already-approved TAXUS stent. The trial achieved its primary endpoints and data on critical parameters such as late loss, major adverse cardiac event rates, target lesion revascularization, and target vessel revascularization were summarized in an October 25 press release and demonstrated that NOBORI was highly effective when compared against TAXUS. At TCT, Biosensors also revealed for the first time its latest drug- eluting stent technology with the first-in-man implantation of its BioMatrix(R) Freedom(TM) polymer-free, drug-eluting stent. Mr. Lu commented: "While companies are now focusing on catching up on biodegradable polymer technology, we have implanted the first surface-modified drug-eluting stent which we believe will be the next advance in stent technology. This proprietary technology does not involve polymeric drug carriers. We are happy to continue to develop new products that can offer improved patient care. For this reason, we need to continue to invest in our clinical and research efforts and stay ahead of our competition." Biosensors is currently awaiting CE Mark regulatory approval for its BioMatrix drug-eluting stent to begin commercialization in the European Union and Asia. For the quarter under review, licensing revenue was US$100,000 compared to US$31,000 in the prior year's corresponding quarter, and US$225,000 for 1HFY07 compared to US$9.1 million in the prior fiscal half year. The US$9.1 million included non-recurring milestone payments from one of its licensees. Research and Development ("R&D") expenses which include costs for new product development and testing, clinical trials, patent registration and regulatory approvals were US$5.3 million in 2Q FY07 compared to US$4.1 million in the prior year's corresponding quarter. For the current fiscal half year, R&D expenses were US$10.4 million compared to US$7.1 million in the prior fiscal half year. The increases in R&D expenses in both periods were due to increased clinical trials and regulatory expenses. Sales and marketing expenses were US$3.3 million in 2Q FY07 compared to US$2.5 million in the prior year's corresponding quarter, and were US$5.8 million in this fiscal half year compared to US$4.6 million in last fiscal half year. The increases were due mainly to expenses incurred for participation in trade shows and brand building activities, as well as higher payroll and related expenses associated with the ongoing build up of the Group's sales and marketing support functions. General and administrative expenses were US$4.5 million in 2Q FY07 compared to US$3.6 million in the prior year's corresponding quarter, and totaled US$8.4 million in the fiscal half year compared to US$6.8 million in last fiscal half year. The increase was primarily due to higher office expenses including the amortization of a new Enterprise Resource Planning (ERP) software, and other professional services. For 2Q FY07, the Group reported a net loss of US$9.2 million, or 1.01 US cents loss per basic and diluted share compared to a net loss of US$6.0 million, or 0.69 US cent loss per basic and diluted share in 2Q FY06. The net loss for first half FY07 was US$15.9 million, or 1.75 US cent loss per basic and diluted share compared to a net loss of US$5.3 million, or 0.63 US cent loss per basic and diluted share in first half FY06. Mr. Kee Lock Chua, President of Biosensors commented: "In our industry, we need to be ahead of the technology roadmap. While we are awaiting the CE-Mark approval for our flagship BioMatrix stent, we need to continue our investments to enhance our technology and infrastructure. That has been the hallmark of Biosensors and has enabled us to be ahead of our competitors in biodegradable polymer and now polymer-free stent technology. Our operating expenses are planned to rise in line with our investments into the LEADERS and STEALTH II clinical trials as well as the buildup of our sales and marketing infrastructure. These are necessary expenditures which will form the foundation for the Company's future growth." Other Significant Updates In October this year, Biosensors received regulatory approval from the Japanese Ministry of Health, Labor and Welfare for its bare metal S-Stent(TM), permitting commercialization in the large Japanese market. "In the face of safety concerns with non-biodegradable polymer drug carriers, bare metal stents remain a viable option for cardiologists particularly with our S-Stent having one of the lowest restenosis rates," Mr. Chua said. Biosensors also recently announced that it has signed a Letter of Intent to acquire up to 20 percent of JW Medical Systems Limited which is based in the City of Weihai, Province of Shandong, China. JW Medical launched distribution of its Excel drug-eluting stent in China in January 2006 and has about a 20 percent share of the Chinese market. Mr. Chua said, "We are constantly expanding our distribution network around the world. Collaborations such as the one with JW Medical will enable us to leverage on an established distribution network and give us immediate access to the fast-growing Chinese market. We will also receive royalty income through our licensing arrangement with JW Medical. The China market is large and we need to be able to tap into the various networks to widen our market outreach." Media Contact Biosensors International Group Ms Tina Lim, Executive, Corporate Communications Tel: (65) 6213 5712 Email: firstname.lastname@example.org Media Relations / Investor Relations Firm United States Allen & Caron Inc. Mr. Matt Clawson Executive Vice President, Investor Relations Tel: (1) 949 474 4300 Email: email@example.com About Biosensors International Group, Ltd. Biosensors develops, manufactures and markets innovative medical devices used in interventional cardiology and critical care procedures. Biosensors is well-positioned to emerge as a leader in drug-eluting stents, an evolving therapy that is rapidly gaining market share from traditional therapies such as bare-metal stenting and open-heart surgery. Biosensors has internally developed technology to address each component of a drug-eluting stent system, including a stent, a stent delivery catheter, a biodegradable polymer and a proprietary anti-restenotic drug. It is pursuing three separate drug-eluting stent programs, BioMatrix(R), Axxion(TM), and BioMatrix(R) Freedom(TM), a polymer-free drug-eluting stent, and has licensed aspects of its drug-eluting stent technology to four companies. Forward Looking Statements Certain statements herein include forward-looking statements within the meaning of the U.S. Private Securities Litigation Reform Act of 1995. Forward- looking statements generally can be identified by the use of forward-looking terminology, such as "may," "will," "expect," "intend," "estimate," "anticipate," "believe," "project" or "continue" or the negative thereof or other similar words. All forward-looking statements involve risks and uncertainties, including, but not limited to, customer acceptance and market share gains, competition from companies that have greater financial resources; introduction of new products into the marketplace by competitors; successful product development; dependence on significant customers; the ability to recruit and retain quality employees as Biosensors grows; and economic and political conditions globally. Actual results may differ materially from those discussed in, or implied by, the forward-looking statements. The forward- looking statements speak only as of the date of this release and Biosensors assumes no duty to update them to reflect new, changing or unanticipated events or circumstances.
SOURCE Biosensors International Group, Ltd.
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