Biosensors Reports Increases in Product Revenue for Fiscal '07 Second Quarter and First Half

Nov 09, 2006, 00:00 ET from Biosensors International Group, Ltd.

    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
     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
     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
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     Tel:   (65) 6213 5712
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     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.