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
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
Biosensors International Group
Ms Tina Lim, Executive, Corporate Communications
Tel: (65) 6213 5712
Allen & Caron Inc.
Mr. Matt Clawson
Executive Vice President, Investor Relations
Tel: (1) 949 474 4300
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 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.
SOURCE Biosensors International Group, Ltd.