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Novadaq@ Technologies Inc. (TSX:NDQ), a developer of real-time imaging
systems for use in the operating room, today announced financial
results for its fiscal year and fourth quarter ended December 31,
2011. Unless otherwise indicated, all dollar amounts in this press
release are expressed in United States (U.S.) dollars.
"Last year in collaboration with our partners, LifeCell and Intuitive
Surgical@, we advanced our goal of becoming a leader in providing
imaging technology for surgeons," said Dr. Arun Menawat, Novadaq's
President and CEO. "In the fourth quarter, we estimate that nearly 8%
of breast reconstruction surgeries performed in the U.S. involved the
use of SPY Imaging, effectively tripling penetration into our lead
application over the period of one year. Exiting 2011, more than 10%
of mid-to-large U.S. hospitals were users of Novadaq's imaging
systems."
"Looking ahead into 2012, we anticipate continued expansion of the SPY
Elite and FIREFLY installed bases, increased penetration in breast
reconstruction, and launches of new applications including colorectal
and vascular surgeries. Novadaq also continues to progress toward a
direct launch of our PINPOINT Endoscopic Fluorescence Imaging System
in the second half of 2012."
Fourth Quarter and YE2011 Corporate Highlights
-- The company's main performance metric in 2011 was "system shipments". In
the fourth quarter, Novadaq shipped 150 SPY and FIREFLY Systems. At
December 31, 2011, the number of U.S. hospitals with installed SPY and
FIREFLY Systems exceeded 300.
-- Approximately 175 SPY Systems are in use for breast reconstruction
surgery, our lead indication. During the fourth quarter, the average
annualized run rate for each of these systems was approximately 50
procedures.
-- 2,700 SPY procedure kits for open surgical applications were shipped to
hospitals during the fourth quarter, representing a 128% increase over
the same period in 2010, and a 21% sequential increase compared with Q3-
2011. In total, 7,838 SPY procedure kits were shipped to hospitals
during 2011, representing a 110% increase compared with 2010.
-- In November 2011, Novadaq signed exclusive multi-year sales and
marketing agreements with Kinetic Concepts, Inc. for the development and
commercialization of SPY technology for wound care applications. Novadaq
also expanded its agreements with LifeCell for commercialization of SPY
Elite into additional applications including vascular surgery.
-- The fourth quarter marked the first publication of articles describing
the use of SPY during tibial bypass surgery and treatment of battlefield
extremity injuries. This increases the number of SPY publications to 52,
including two textbook chapters, which recommend use of SPY in breast
reconstruction surgery.
-- Subsequent to year-end, Novadaq named MAQUET Cardiovascular as the
exclusive U.S. distributor of Novadaq's CO2 Heart Laser products.
Financial Highlights
-- Revenues in the fourth quarter totaled $5.0 million, a 119% increase
compared with $2.3 million in the same period in 2010.
-- Revenues for the 2011 fiscal year totaled $15.3 million, a 10% increase
compared with $13.9 million in 2010. Excluding a one-time milestone
payment of $3.9 million recognized in 2010, the year-over-year revenue
increase would have been 53%. SPY product sales to hospitals grew at a
substantially faster rate. During 2011, revenues reported by the Company
represented only Novadaq's share of end user sales, which were paid to
the Company by its partners. During the first 9 months of 2010, Novadaq
sold SPY products directly and, as such, Novadaq recognized all of the
revenues from sales to hospitals during that period.
-- Fourth quarter recurring revenues from our SPY and TMR businesses
totaled $2.4 million, representing growth of 67% compared with the same
period in 2010.
-- Operating burn (cash used in operating activities before changes in
working capital) was close to break-even at $0.03 million in the fourth
quarter. This compares with operating burn of $2.39 million for the same
period in 2010, and $0.45 million in Q3-2011. Working capital consumed
$1.45 million during the fourth quarter before the impact of a licensing
payment, and $2.15 million was invested, including $1.81 million to
build the SPY Elite installed base.
-- Novadaq ended the fourth quarter with $9.6 million cash. The company
expects to receive up to $4 million in milestone payments from its
existing agreements during the next two years, and we have received an
asset-based loan offer from the Royal Bank of Canada, subject to various
approvals, to increase our debt facility limit to $5.5 million from $2.5
million.
Conference Call
Novadaq is pleased to invite all interested parties to participate in
a conference call today, February 16, at 8:30 a.m. Eastern Time during
which the results will be discussed.
Those wishing to access the live conference call by telephone should
dial 1-877-407-8031 (within Canada and the United States) or
1-201-689-8031 (international callers) several minutes prior to the
beginning of the call. A telephonic replay of the conference call will
be made available until midnight on March 16, 2012 and can be accessed
by dialing 1-877-660-6853 (within Canada and the United States) or
1-201-612-7415 (international callers) and entering the account number
286 and the conference identification number 388170 when prompted.
The call will be archived for 90 days on the Company's website at
http://www.novadaq.com(http://www.novadaq.com) under the "Events" tab
in the Investors section. In addition, a replay of the call will be
available for download to a portable audio player or computer, as an
MP3 or podcast file, at the same location on Novadaq's website.
About Novadaq Technologies Inc.
Novadaq primarily develops, manufactures and markets real-time
fluorescence imaging products that are designed for use by surgeons in
the operating room and other clinical settings where open, minimally
invasive or interventional surgical procedures are performed. The
Company's SPY@ Imaging core technology enables surgeons to visualize
blood flow in vessels, co-joined vessels and micro-vessels, and to
assess the quality of blood perfusion in tissue, without exposing the
patient to radiation. More than 50 peer-reviewed publications
demonstrate that the use of SPY Imaging during complex surgery leads
to fewer post-operative complications and lower hospital costs. The
SPY Imaging System is United States Food and Drug Administration
("FDA") 510(k) cleared for use during a variety of open surgical
applications. The endoscopic version of SPY, which will be marketed
under the brand name PINPOINT, combines the capabilities of SPY
Imaging with high definition ("HD") visible light visualization
offered by conventional endoscopes. The majority of Novadaq's current
revenues come from alliances formed with leading companies in relevant
markets where SPY technology has been demonstrated to improve clinical
outcomes in open, minimally invasive and robotic surgery applications.
Novadaq's first alliance that integrates SPY Imaging into the 3-D HD
imaging capabilities of the da Vinci@ Surgical Robotic System offered
by Intuitive Surgical@, Inc., received FDA 510(k) clearance in
February 2011. In September 2010, Novadaq entered into an exclusive
North American sales and marketing alliance with LifeCell
Corporation, for SPY in open plastic and reconstructive,
gastrointestinal and head and neck surgeries. In November 30, 2011,
Novadaq signed exclusive, multi-year sales and marketing agreements
with Kinetic Concepts, Inc., for wound care applications and extended
its agreement with LifeCell for the commercialization of the SPY
System into vascular surgery. The SPY Imaging System for cardiac
applications is marketed directly, whereas the CO2 Heart Laser for
TMR is distributed by MAQUET Cardiovascular. For more information,
please visit the Company's website at
http://www.novadaq.com(http://www.novadaq.com).
Forward-Looking Statements
Certain statements included in this press release may be considered
forward-looking. Such statements involve known and unknown risks,
uncertainties and other factors that may cause actual results,
performance or achievements to be materially different from those
implied by such statements, and therefore these statements should not
be read as guarantees of future performance or results. All
forward-looking statements are based on Novadaq's current beliefs as
well as assumptions made by and information currently available to
Novadaq and relate to, among other things, the Company's strategy,
strategic goals, research and development activities, research and
clinical testing outcomes, taxes, capital expenditures, future
operations, future financial position, future revenues/results,
projected costs, prospects and plans and objectives of management.
Readers are cautioned not to place undue reliance on these
forward-looking statements, which speak only as of the date of this
press release. Due to risks and uncertainties, including the risks and
uncertainties identified by Novadaq in its public securities filings
actual events may differ materially from current expectations. Novadaq
disclaims any intention or obligation to update or revise any
forward-looking statements, whether as a result of new information,
future events or otherwise.
Note: LifeCell Corporation is a business unit and trademark of
Kinetic Concepts, Inc. Intuitive Surgical and da Vinci are registered
trademarks of Intuitive Surgical.
Novadaq Technologies Inc.
CONSOLIDATED STATEMENTS OF FINANCIAL POSITION
(expressed in U.S. dollars)
December December
31, 2011 31, 2010
----------------------------
ASSETS
Current assets
Cash and cash equivalents 9,633,608 5,597,407
Accounts receivable 2,018,782 1,434,964
Prepaid expenses and other 829,625 1,193,423
Inventories 1,755,729 778,984
Non-current assets
Available-for-sale financial instruments - -
Property and equipment 6,034,674 1,202,468
Prepaid expenses and other - 144,456
Deferred taxes 248,640 -
Other intangible assets 2,272,434 1,968,483
----------------------------
Total Assets 22,793,492 12,320,185
----------------------------
----------------------------
LIABILITIES AND SHAREHOLDERS' EQUITY
Current liabilities
Accounts payable 2,474,021 2,913,979
Provisions 41,300 19,520
Income taxes payable 11,973 24,066
Deferred revenue 396,859 549,865
Deferred license revenue 1,300,000 800,000
Deferred license and development revenue - -
Repayable government assistance 197,760 507,675
Non-current liabilities
Deferred tax liabilities 248,640 -
Convertible debentures 4,223,454 3,891,753
Deferred revenue 188,883 190,609
Deferred license revenue 4,591,666 2,933,333
Repayable government assistance 214,402 -
Shareholder warrants 8,278,105 1,276,464
----------------------------
Total Liabilities 22,167,063 13,107,264
----------------------------
Shareholders' Equity
Share capital 98,695,023 87,897,555
Contributed surplus 6,772,298 5,985,190
Equity component of convertible debentures 1,454,353 1,968,395
Deficit (106,295,245) (96,638,219)
----------------------------
Total Shareholders' Equity 626,429 (787,079)
----------------------------
Total Liabilities and Shareholders' Equity 22,793,492 12,320,185
----------------------------
----------------------------
Novadaq Technologies Inc.
CONSOLIDATED STATEMENTS OF LOSS AND COMPREHENSIVE LOSS
(expressed in U.S. dollars)
For the three months For the twelve months
ended ended
December December December December
31, 2011 31, 2010 31, 2011 31, 2010
--------------------------------------------------
Product sales 4,404,981 1,809,988 12,925,953 8,355,273
Royalty revenue 116,797 - 395,398 -
Milestone revenue 241,667 - - 3,958,737
Deferred partnership fee
revenue - 200,000 841,667 266,667
Service revenue 231,632 266,029 1,129,423 1,290,644
--------------------------------------------------
Total revenues 4,995,077 2,276,017 15,292,441 13,871,321
Cost of sales 2,072,642 1,249,878 6,634,206 5,534,087
--------------------------------------------------
Gross margin 2,922,435 1,026,139 8,658,235 8,337,234
--------------------------------------------------
Selling and distribution
costs 1,348,328 1,380,978 5,375,612 7,067,288
Research and development
expenses 1,185,349 1,563,379 4,610,694 4,915,669
Administrative expenses 1,194,632 1,119,148 4,550,971 4,070,693
Write-down of intangible
assets - - - 4,828,605
Write-down of equipment - - 314,213 -
Write-down of inventory (95) - 15,287 426,600
--------------------------------------------------
Total operating expenses 3,728,214 4,063,505 14,866,777 21,308,855
--------------------------------------------------
Loss from operations (805,779) (3,037,366) (6,208,542) (12,971,621)
Finance costs (169,895) (165,489) (679,069) (643,100)
Finance income 1,841 4,650 15,421 16,099
Warrants revaluation
adjustment (1,029,310) 51,763 (3,306,128) (463,697)
Gain (loss) on investment - - 25,000 (125,000)
--------------------------------------------------
Loss and comprehensive
loss for the period (2,003,143) (3,146,442) (10,153,328) (14,187,319)
--------------------------------------------------
--------------------------------------------------
Basic and diluted loss
and comprehensive loss
per share for the period (0.05) (0.11) (0.32) (0.52)
--------------------------------------------------
--------------------------------------------------
Novadaq Technologies Inc.
CONSOLIDATED STATEMENTS OF CASH FLOWS
(expressed in U.S. dollars)
For the three months For the twelve months
ended ended
December December December December
31, 2011 31, 2010 31, 2011 31, 2010
-------------------------------------------------
OPERATING ACTIVITIES
Loss for the period (2,003,153) (3,146,442) (10,153,328) (14,187,319)
Items not affecting cash
Depreciation and
impairment of property
and equipment 331,761 199,307 1,050,929 884,869
Amortization and
impairment of
intangible assets 294,752 330,055 1,119,691 881,672
Impairment of investment - - - 125,000
Redemption of investment - - (25,000) -
Stock option
compensation 212,315 183,482 876,767 786,578
Finance costs, including
imputed interest on
convertible debentures 100,875 94,404 398,448 364,053
Write-down of intangible
assets - - - 4,828,605
Write-down of equipment - - 314,213 -
Write-down of inventory (95) - 15,287 426,600
Warrants revaluation
adjustment 1,029,310 (51,763) 3,306,128 463,697
-------------------------------------------------
(34,235) (2,390,957) (3,096,865) (5,426,245)
-------------------------------------------------
Changes in working capital
Increase in deferred
revenue 2,679,368 834,092 2,003,601 340,993
Increase in accounts
receivable (85,114) 221,259 (583,818) (36,371)
Increase in inventories (80,005) (216,284) (992,032) (188,315)
Decrease in accounts
payable (1,222,116) (165,354) (588,099) (113,761)
Decrease (increase) in
prepaid expenses and
other 261,516 (1,230,548) 259,614 1,038,973
-------------------------------------------------
Net change in non-cash
working capital balances
related to operations 1,553,649 (556,835) 99,266 1,041,519
-------------------------------------------------
Cash used in operating
activities 1,519,414 (2,947,792) (2,997,599) (4,384,726)
-------------------------------------------------
INVESTING ACTIVITIES
Purchase of property and
equipment (2,145,876) (194,848) (6,197,348) (324,784)
Purchase of TMR business - - (1,000,000) -
Redemptions of long-term
investment - - 25,000 25,000
-------------------------------------------------
Cash used in investing
activities (2,145,876) (194,848) (7,172,348) (299,784)
-------------------------------------------------
FINANCING ACTIVITIES
Issuance of common
shares and warrants - - 15,273,401 8,121,337
Transaction costs of
common shares and
warrants - - (998,207) (511,180)
Options exercised 2,500 4,880 42,664 39,964
National Research
Council loan repayments (73,765) - (95,513) -
-------------------------------------------------
Cash provided by financing
activities (71,265) 4,880 14,222,345 7,650,121
-------------------------------------------------
Net increase in cash and
cash equivalents (697,727) (3,137,760) 4,052,398 2,965,611
Net foreign exchange
difference 27,587 64,580 (16,197) 106,838
Cash and cash equivalents
at January 1 10,303,748 8,670,587 5,597,407 2,524,958
-------------------------------------------------
Cash and cash equivalents
at December 31 9,633,608 5,597,407 9,633,608 5,597,407
-------------------------------------------------
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