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-
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,"
"anticipate," "believe," "project" or "continue" or the negative thereof
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.
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SOURCE Biosensors International Group, Ltd.