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
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."
Biosensors International Group
Ms Tina Lim, Executive, Corporate Communications
Tel: (65) 6213 5712
Media Relations / Investor Relations Firm
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 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
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.