Biosensors Announces Record Product Revenue For Fiscal Second Quarter, First Half Results
Drug-Eluting Stent Commercialized in Europe Following July Receipt of
CE Mark Regulatory Approval
SINGAPORE, Nov. 11 /Xinhua-PRNewswire-FirstCall/ -- Biosensors International Group, Ltd. ("Biosensors" or "the Company", Bloomberg: BIG SP), a developer, manufacturer and marketer of innovative medical devices for interventional cardiology and critical care procedures, today announced that strong results from the commercial launch in Europe of its first drug-eluting stent (DES) drove a significant increase in DES sales in the 2006 fiscal second quarter ended September 30, 2005 (Q2 FY 06) over the corresponding period in FY05. In addition, the Company reported that its planned acceleration of research and development programs progressed well during the period and that R&D expenditures, paired with additional planned investments in R&D, will lead to timely initiation of important clinical trials for the Company's DES products in the coming periods. Biosensors' Chairman and CEO Yoh-Chie Lu said that this quarter had record product revenues, boosted by increased DES sales. The Company has also experienced six months of solid progress following its IPO in May. Mr. Lu added, "Since the IPO we have received CE Mark regulatory approval for our first DES product, strengthened our distribution network by enrolling key distributors in the major European markets, secured an important US patent that establishes a proprietary platform for our bioresorbable polymer technology and reported positive 12-month STEALTH clinical trial results for our BioMatrix(TM) DES system." Revenues from all product sales for Q2 FY 06 were US$7.0 million, a 44 percent increase over the US$4.9 million in product sales for same quarter in FY 05. This strong growth in revenue is attributable to a ramp up in sales of the Company's DES product line in the last two months of the quarter, following a successful product launch in targeted European and Asian countries after the Company received the CE Mark for its first DES in July this year. The Company's DES product line contributed sales of US$1.9 million in Q2 FY 06, up from US$251,000 in Q2 FY 05 and from US$457,000 in Q1 FY 06. The Company has signed up more than 50 distributors with more than half already fully trained and actively selling the product line. The Company will continue to expand its distribution network in preparation for its launch of BioMatrix(TM) which will be the Company's flagship DES program. Sales of traditional interventional cardiology products, including bare metal stents and delivery catheters, also grew from US$2.1 million in Q2 FY 05 to US$2.5 million in Q2 FY 06. Sales of critical care products, including blood pressure transducers and thermodilution catheters were US$2.7 million in Q2 FY 06 compared to US$2.6 million in Q2 FY 05. Mr. Lu said, "Sales of our DES product line, following their launch in Europe, have exceeded our internal projections and have given us a great deal of confidence in our strategy for this line of products. Although it is too early to draw long-term conclusions on our ultimate success in these markets, our distribution partners in locations across Europe and Asia are reporting early success and a receptive environment for the product line. Our strategy is to penetrate the DES market with Axxion(TM) and build as much market share as possible to pave the way for our launch of BioMatrix(TM), which we believe has technological advantages that can contribute continued market share growth. Based on this strategy, we anticipate that Axxion(TM) will be the primary engine for revenue growth until we receive CE Mark approval for the BioMatrix(TM) product line." The Company has submitted its flagship BioMatrix(TM) DES system for CE Mark regulatory approval and expects to receive approval in the first half of calendar year 2006. It received CE Mark approval for the Axxion(TM) DES system in July 2005. For Q2 FY 06, the Company reported a net loss of US$6.0 million, or 0.69 US cent loss per basic and diluted share, compared to a net loss of US$3.5 million, or 0.52 US cent loss per basic and diluted share, for Q2 FY 05. The reported loss was principally due to increased investments in R&D, expenses for sales and marketing efforts relating to the launch of the DES product line in Europe, as well as continued planned spending in preparation for clinical trials related principally to the BioMatrix(TM) line. These expenses were all in line with internal estimates. Mr. Lu further commented on the increase in R&D investment, saying, "We believe that our bioresorbable polymer technology is a viable solution to the safety issues that are facing the DES market today. This is an excellent position to be in, but there is much to be done. We are investing in the short-term to perform the necessary clinical trials and build an infrastructure so that the potential long-term rewards can be far greater than if we did not make these investments and merely managed the company for near- term profitability." Mr. Lu continued, "Information we have received from customers around the world, recently confirmed by several presentations at the Transcatheter Cardiovscular Therapeutics (TCT) conference in Washington DC, indicates that the DES market is clearly moving in a direction that focuses on patient safety, with concerns expressed relating to stents coated with durable polymer. Many cardiologists are keen to have a DES that reverts to a bare metal stent after the drug is fully eluted. Our technology, intellectual property and competitive position give us some distinct advantages in this area. In order to gain a fair share of this US$6 billion market, we need to aggressively collect clinical data at respected institutions around the world. We have set out to do just that." Licensing revenue for the quarter was negligible as most milestone payments from licensing agreements were received in prior periods. Revenues from product sales for the first half of fiscal year 2006 ended September 30, 2005 (1H FY 06) were US$12.9 million, a 30 percent increase over the US$9.9 million for the same period in FY 05. DES products contributed sales of US$2.4 million in 1H FY 06, up from US$266,000 in 1H FY 05. Sales revenue for traditional interventional cardiology products grew from US$4.5 million in 1H FY 05 to US$5.3 million in the FY 06 first half. Critical care products contributed US$5.3 million in the FY 06 first half compared to US$5.1 million for the same period in FY05. For 1H FY 06, the Company reported a net loss of US$5.3 million, or 0.63 US cent loss per basic and diluted share, compared to a net profit after taxation of US$11.3 million, or 1.68 US cent earnings per basic share and 1.45 US cent earnings per diluted share, for the prior year period in which the Company collected more than US$25 million in non-recurring licensing revenue. The balance sheet remained healthy at September 30, 2005 as cash and cash equivalents totaled US$86.8 million, and equity attributable to shareholders totaled US$101.1 million. 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 bioresorbable 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. Media Contact Information Biosensors International Group Ms Tina Lim, Executive, Corporate Communications Tel: +65-6213-5712 Email: email@example.com For investor related enquiries, please write to firstname.lastname@example.org WeR1 Consultants Pte Ltd Mona Leong Senior Consultant Tel: +65-6737 4844 / Hp: +65-9187-4449 Email: email@example.com Allen & Caron Inc. Matt Clawson Executive Vice President, Investor Relations Tel: +1-949-474-4300 Email: firstname.lastname@example.org
SOURCE Biosensors International Group, Ltd.
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