SINGAPORE, May 26 /Xinhua-PRNewswire-FirstCall/ -- Biosensors International Group, Ltd. ("Biosensors" or the "Company", Bloomberg: BIG SP) today reported its fourth fiscal quarter ("4Q FY06") and fiscal year ended March 31, 2006 financial results with total product revenue increasing by 35% to US$7.7 million in 4Q FY06 from US$5.7 million in the prior year's corresponding quarter, and an increase of 37% to US$28.6 million in the twelve months ending March 31, 2006 from US$20.9 million in the prior fiscal year. The increase in revenue is primarily attributable to growth in the sales of its drug-eluting stents ("DES"). Revenue from DES was US$3.2 million in 4Q FY06 compared with US$0.6 million in the prior year's corresponding quarter, and for the fiscal year, revenue from DES was US$9.0 million compared with US$1.2 million in prior fiscal year.
Mr. Yoh-Chie Lu, Chairman and CEO said, "The introduction of Axxion(TM) DES has given us the opportunity to strengthen our skills in supplying DES, including establishing of dedicated distribution networks for DES sales. While Axxion(TM) has contributed revenue in the quarters following its CE Mark approval in July last year, we remain focused on the launch of BioMatrix(TM) which will be the key revenue driver for the Company going forward. As such, this year, we have continued our investments to support BioMatrix(TM), including increasing clinical activities and strengthening our sales & marketing infrastructure. With Axxion(TM), we have been able to put to practice the management of DES logistics and this will help in expediting the eventual launch of BioMatrix(TM).
Licensing revenue was US$0.2 million in 4Q FY06, compared to US$25.0 million in the prior year's corresponding quarter, and US$9.3 million for FY06 compared to US$50.1 million in the prior fiscal year. This is consistent with management's expectations as licensing revenue is non-recurring in nature and milestone payments have already been recognized in prior periods.
R&D expenses which include new product research & development, clinical trials, patent registration and costs associated with regulatory approvals were US$6.9 million in 4Q FY06 compared to US$4.0 million in the prior year's corresponding quarter. For the fiscal year, this was US$19.2 million compared to US$9.6 million in prior fiscal year. The increase of US$9.6 million for the full year was primarily due to increased investments in clinical trials.
Sales and marketing expenses were US$2.9 million in 4Q FY06 compared to US$1.5 million in the prior year's corresponding quarter and were US$9.4 million in this fiscal year compared to US$5.5 million in last fiscal year. General and administrative expenses were US$3.4 million in 4Q FY06 compared to US$3.0 million in the prior year's corresponding quarter and totaled US$13.4 million in the full year compared to US$10.8 million in last fiscal year. The increased expenses are within management's expectation as we strengthen our sales & marketing infrastructure and incur additional G&A expenses related to operating as a public company.
The Group reported a net loss of US$9.7 million or US$0.01 loss per basic and diluted share in 4Q FY06 compared to a net profit of US$12.9 million or US$0.02 earnings per basic and diluted share for the prior year's corresponding period. For the fiscal year, the Group reported a net loss of US$22.5 million or US$0.03 loss per basic and diluted share compared to a net profit of US$20.0 million or US$0.03 earnings per basic and diluted share for in the prior year.
R&D and Intellectual Property Update
During the fiscal year under review, the Company made significant progress on BioMatrix(TM), its proprietary DES with biodegradable polymer and the Company's Biolimus A9(TM) drug. Mr. Lu commented, "Leading cardiologists have highlighted that there are escalating concerns over long-term complications associated with durable polymer-coated stents. Biosensors' biodegradable polymer technology offers alternative solutions to clinicians and should be attractive since it breaks down into water and carbon dioxide after the drug is eluted."
During the fiscal year under review, Biosensors also reported that it has been granted a patent from the U.S. Patent and Trademark Office covering the use of anti-restenotic, immuno-suppressive drugs in combination with a biodegradable drug-release polymer coating on a stent. Mr. John Shulze, Chief Technology Officer said, "We are pleased that we are addressing today's safety concerns and have invested in activities associated with the biodegradable technology and intellectual property protection related to this technology. We will continue our investments in clinical studies associated with BioMatrix(TM) as well as R&D for additional new products."
Ms. Chato Abad, Chief Financial Officer said: "In our industry, we need to aggressively invest in R&D activities including clinical studies and intellectual property rights to be able to introduce new and differentiated products and defend our IP when needed. One of our trials involving BioMatrix(TM), for instance, attracted strong interest from leading cardiologists which led to the decision to expand the trial to include more patients at more sites. We believe that such investments should yield positive results for the company in the long term. Similarly, it is also important for us to build and continuously enhance our internal infrastructure including the scale-up of our manufacturing and operations to ensure supply of high quality products. All these activities are in line with our internal plans and expectations."
Other Significant Updates
This year, Biosensors was successful in defending against an action for a preliminary injunction brought by Boston Scientific Corporation and Angiotech Pharmaceuticals Inc. for alleged infringement of a patent held by them. The Netherlands court denied the request for the injunction ruling that in their preliminary opinion the Axxion(TM) stent did not infringe on the Angiotech EP'376 patent. As a result, Biosensors is able to continue to market its Axxion(TM) stent.
Mr. Lu added: "This year was instrumental in establishing important groundwork for our road map for the future. We will continue to make plans to enhance our core strengths; I am confident that we are on track with our development plans and I look forward to achieving our milestones going forward."
Media Contact
Biosensors International Group
Ms Tina Lim, Executive, Corporate Communications
Tel: (65) 6213 5712
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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 two separate drug-eluting stent programs, BioMatrix(TM) and Axxion(TM), 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.
