Toronto, Ontario - March 17, 2006
Novadaq® Technologies Inc. (TSX: NDQ), a developer of medical imaging
systems for the operating room, today announced its financial results
for the fourth quarter and year ended December 31, 2005. In this press
release, unless otherwise indicated, all dollar amounts are expressed
in US dollars.
"We entered the public markets on June 10, 2005, with a vision to
commercialize disease specific diagnostic and therapeutic image guided
procedures, with the potential to improve clinical outcomes and the
cost of healthcare," said Arun Menawat, President and CEO of Novadaq
Technologies Inc. "Since that time we have met major milestones. The
fourth quarter of 2005 was the first full quarter in which SPY, our
cardiac surgery imaging product, was marketed commercially in the
United States, meeting our first key milestone. We now have 30 systems
installed in the United States. Clinical trials for the treatment of
wet AMD continued in Europe and North America, using our unique imaging
based device, the OPTTX System. Also, in February 2006 we signed an
exclusive license with the University of Rochester over a broad
portfolio of patents in the field of intra-operative fluorescence
guided imaging of nerves, and we have now begun development of a new
device, LUNATM, for the visualization of nerves and lymphatics to
potentially reduce negative outcomes including impotency, during
critical operations such as radical prostatectomy."
Selected Fiscal 2005 Financial Highlights and Operating Highlights
-
Received FDA clearance for SPY Intra-operative Imaging System
-
United States patent issued for SPY: Method and Apparatus For Performing Intra-Operative Angiography
-
Signed North American distribution agreement with the Sorin Group for SPY
-
Signed U.S. service agreement with Kodak for SPY
-
Established U.S. subsidiary to extend infrastructure and ensure support for SPY
-
Hired U.S. based clinical educators to support sales to the cardiac surgery market
-
Executed on clinical advancement for OPTTX, completing the product development of the first generation device
-
Cdn. $25 million initial public offering on June 10, 2005 (TSX: NDQ)
-
Strengthened intellectual property platform and filed 6 new patent applications in several areas including nerve mapping
Financial Results
Year Ended December 31, 2005 Compared to Year Ended December 31, 2004
Revenue from all sources in 2005 was $623,439, representing a decrease
of $523,835 from revenue in 2004 of $1,147,274. The overall decrease
includes a reduction in capital sale revenue of $808,864 offset by an
increase in procedure based revenue of $285,029. Approximately 92% of
procedure based revenue was generated from Company owned imaging
systems installed in the US, with the remainder representing sales of
consumable supplies to customers outside the US who have purchased
systems. The decrease in capital sale revenue reflects the sale of 2
imaging systems in 2005 versus 10 in 2004. The Company agreed to sell
an additional 6 imaging systems in Japan in the fourth quarter of 2005
and revenue will be recorded when the systems are shipped in 2006. In
addition, a decision was made to change the revenue model in Japan to a
blended capital sale/procedure based model. This change involved a
significant reduction in the capital sale price offset by a planned
increase in the price of consumable supplies.
The launch of SPY in the US, our key market is still in the early
stage. December 31, 2005 represented the end of the first full quarter
of commercial activities conducted by Sorin, our sales partner in the
US during which time over half of the annual procedure based revenue
for the year was recorded.
Gross profit as a percentage of sales decreased from 72.2% in 2004 to
55.9% in 2005 as a result of a shift in focus from capital device sales
to procedure based revenue. The gross profit percentage earned on
capital sales is higher than the percentage earned on procedural
revenue as the procedural gross profit is net of sales commissions, and
the cost of consumable supplies
Sales and marketing expenses increased to $1,248,551 in 2005 from
$247,892 in 2004. The increase in sales and marketing expenses was a
result of the commercial launch of the SPY System in the US in 2005,
and included an increase in employee costs (approximately $450,000); an
increase in travel costs (approximately $165,000) and an increase in
costs incurred for trade shows, surgical meetings, marketing materials
and advertising (approximately $318,000). Sales and Marketing expenses
are expected to continue to increase moderately during 2006 as the
Company continues to build its team of clinical educators and other
internal resources.
Research and development expenses increased by $2,336,481 from
$1,277,386 in 2004 to $3,613,867 in 2005. The overall increase reflects
increases in employee and related office and travel costs for
additional engineering staff to support the OPTTX design efforts and to
support commercial manufacturing of SPY, and additional clinical staff
to plan and execute OPTTX trials (increase of approximately
$1,052,000).The increase also related to increased costs incurred to
design and build next generation OPTTX devices for use in clinical
trials (increase of approximately $685,000), an increase in patent
costs (approximately $340,000) and an increase in SPY product
development costs (approximately $79,000). Research and development
costs are expected to continue to increase during 2006 to support the
patient registry and product development initiatives for SPY and
clinical trials for OPTTX and LUNA.
General and administration expenses increased by $1,166,173 to
$2,894,494 in 2005 from $1,728,321 in 2004. This increase related to
increases in employee costs to support the commercial launch of SPY and
public company costs (increase of approximately $203,000), an increase
in stock based compensation of approximately $400,000 which
substantially related to the contractual vesting of options upon the
completion of the Company's initial public offering, insurance costs
related to public company D&O and product liability coverage
(increase of approximately $173,000), investor relations costs
(increase of approximately $170,000) and professional fees (increase of
approximately $101,000).
Depreciation expense decreased by $32,562 from 2004 to 2005 as certain
SPY imaging devices that were being used in research and development in
2004 were converted to revenue producing assets during 2005.
Amortization of these devices was included in depreciation expense in
2004 and cost of sales in 2005. Amortization increased by $22,063 from
2004 to 2005 as a result of license payments made in June 2005 which
are capitalized and amortized.
Interest income increased by $460,759 from 2004 to 2005 as a result of
the increase in cash and short term investment balances following
completion of the Company's initial public offering on June 10, 2005.
Net loss increased by approximately $4,102,000 as a result of a
reduction in gross profit of approximately $480,000, an increase in
sales and marketing costs of approximately $1,000,000, an increase in
research and development expenses of approximately $2,336,000, an
increase in general and administrative expenses of approximately
$1,166,000, offset partially by an increase in foreign exchange gain of
approximately $411,000 and increased interest income of approximately
$460,000.
As at December 31, 2005 the Company had cash, cash equivalents and
short-term investments of $22,774,263, an increase of $13,375,989 over
December 31, 2004. The increase in these balances was primarily the
result of the initial public offering completed on June 10, 2005 for
net proceeds of $17,850,019 offset by cash used in operations during
2005 YTD. Cash used in operating activities increased from $2,157,185
in 2004 to $4,287,270 in 2005.
As at December 31, 2005 there were a total of 18,006,689 common shares
(21,367,578 on a fully diluted basis) and no preferred shares
outstanding.
Quarter Ended December 31, 2005 Compared to Quarter Ended September 30, 2005
The fourth quarter of 2005 was the first full quarter of sales activity
by Sorin and procedure based revenue more than doubled from the third
quarter of 2005. Capital sale revenue was down from the third quarter
of 2005 as there were no SPY systems shipped in the fourth quarter.
Gross profit as a percentage of sales decreased from 65% in the third
quarter of 2005 to 34% because of the reduction in capital sales. The
gross profit percentage earned on capital sales is higher than the
percentage earned on procedural revenue as the procedural gross profit
is net of sales commissions in the range of 30% to 40% based on
pricing, and the cost of consumable supplies.
Sales and marketing and general administrative expenses increased from
the third to the fourth quarter of 2005 to support the increase in SPY
sales activity in the US. The increase in R&D expense related
primarily to increased engineering salary and other costs to support
OPTTX device development and increased patent costs incurred to develop
the Company's intellectual property portfolio.
Conference call
Novadaq will host a conference call on Monday, March 20, 2006 at 4:30
p.m. E.T. to discuss the financial results for the fourth quarter and
full year ended December 31, 2005. To access the conference call by
telephone, dial 416-644-3427 or 1-800-814-4890. Please connect
approximately ten minutes prior to the beginning of the call to ensure
participation. The conference call will be archived for replay until
March 27, 2006 at midnight. To access the archived conference call,
dial 416-640-1917 or 1-877-289-8525 and enter the reservation number
21180888 followed by the number sign.
A live audio webcast of the conference call will be available at
www.novadaq.com. Please connect at least ten minutes prior to the
conference call to ensure adequate time for any software download that
may be required to join the webcast. The webcast will be archived at
the above website for 90 days.
About Novadaq Technologies
Novadaq® Technologies Inc. (TSX: NDQ) develops and commercializes
medical devices based on its proprietary imaging platform for the
diagnosis and treatment of human vascular, ophthalmic, and neurologic
diseases and conditions. Novadaq's SPY® Intra-operative Imaging System,
commercially available worldwide, enables cardiac surgeons to visually
assess coronary vasculature and bypass graft functionality during the
course of open-heart bypass surgery. Novadaq's ophthalmic product, the
OPTTX® System, is aimed at the diagnosis, evaluation and treatment of
wet Age-related Macular Degeneration (AMD) by using the same core
imaging technology that is used in the SPY System. The OPTTX System is
currently being evaluated in clinical trials. Novadaq's product for
nerve visualization in prostate surgery, LUNA™ is designed to enable
surgeons to visualize nerve bundles during the course of radical
prostatectomy in order to reduce negative outcomes including impotency.
For more information, please visit the company's website at www.novadaq.com.
This press release contains certain information that may constitute
forward-looking information within the meaning of securities laws. In
some cases, forward-looking information can be identified by the use of
terms such as “may”, “will”, “should”, “expect”, “plan”, “anticipate”,
“believe”, “intend”, “estimate”, “predict”, “potential”, “continue” or
other similar expressions concerning matters that are not historical
facts. Forward-looking information may relate to management’s future
outlook and anticipated events or results, and may include statements
or information regarding the future financial position, business
strategy and strategic goals, research and development activities,
projected costs and capital expenditures, financial results, research
and clinical testing outcomes, taxes and plans and objectives of or
involving Novadaq. Particularly, information regarding future sales and
marketing activities and research and development activities, as well
as the Company’s plans for each of the SPY System and the OPTTX System,
and the potential for development of an application for the Company’s
imaging device in image guided conventional and minimally invasive
nerve-sparing radical prostatectomy (LUNA™), is forward-looking
information.
Forward-looking information is based on certain factors and assumptions
regarding, among other thinks, market acceptance and the rate of market
penetration of Novadaq’s SPY System, the clinical results of the use of
the SPY System, the results from clinical tests of the OPTTX System,
and potential opportunities in the AMD treatment market and in image
guided conventional and minimally invasive urological applications
including nerve-sparing radical prostatectomy. While the Company
considers these assumptions to be reasonable based on information
currently available to it, they may prove to be incorrect.
Forward looking-information is subject to certain factors, including
risks and uncertainties that could cause actual results to differ
materially from what we currently expect. These factors include risks
relating to the transition from research and development activities to
commercial activities, market acceptance and adoption of the SPY
System, dependence on key suppliers for components of the SPY System
and the OPTTX System, regulatory and clinical risks, risks relating to
the protection of intellectual property, risks inherent in the conduct
of research and development activities, including the risk of
unfavorable or inconclusive clinical trial outcomes, potential product
liability, competition and the risks posed by potential technological
advances, and risks relating to fluctuations in the exchange rate
between the US dollar and the Canadian dollar.
You should not place undue importance on forward-looking information
and should not rely upon this information as of any other date. While
Novadaq may elect to, Novadaq is under no obligation and does not
undertake to update this information at any particular time.
For additional information:
Arun Menawat, PhD, MBA
President & CEO
Novadaq Technologies Inc.
Phone: 905-629-3822 x 202
amenawat@novadaq.com
Investor Relations:
Michael Moore
The Equicom Group
Phone: 416-815-0700 x 241
mmoore@equicomgroup.com
03.17.06-ndq-q4-06
For complete financial statements please go to
www.sedar.com