Company Reports Fourth Quarter and 2006 Results; Provides Update on
RenalGuard(TM) Product Initiative FRANKLIN, Mass., March 21
/PRNewswire-FirstCall/ -- PLC Systems Inc. (AMEX:PLC), a company
focused on innovative cardiac and vascular medical device-based
technologies, today announced that it has reached definitive
agreement with Edwards Lifesciences LLC (NYSE:EW), which had been
its exclusive sales and marketing partner for TMR products and
services in the U.S., to assign this distribution agreement to
Novadaq Corp., a wholly-owned U.S. subsidiary of Novadaq
Technologies, Inc. (TSX: NDQ), a developer of medical imaging
systems for the operating room. Following that assignment, PLC and
Novadaq signed a new exclusive distribution agreement. "Today, we
are taking a major step for our TMR business by naming a new
partner in Novadaq," said Mark R. Tauscher, president and chief
executive officer of PLC Systems. "We, and Novadaq, see strong
synergistic opportunities for our TMR products used in real-time in
conjunction with Novadaq's SPY(R) Intra-operative Imaging System,
for which Novadaq recently built a direct US sales team that
targets the same end user as we do, the cardiac surgeon. We
appreciate the support of Edwards throughout the launch and
building of our TMR business, but recognize that its focus has now
moved in other directions, and we are pleased to find a new and
able partner in Novadaq to make this a seamless transition for our
growing customer base." For the exclusive United States
distribution rights, Novadaq will pay Edwards cash consideration in
the amount of $1 million at closing, an earn-out for the balance of
2007 which is estimated to be $3 million and a final payment of $3
million which is deferred under a one-year secured promissory note.
Novadaq will also purchase Edwards' inventory and certain property
used in its distribution of TMR at Edwards' net book value.
Subsequently, PLC has reached a new distribution agreement with
Novadaq enabling Novadaq to assume a similar role, effective
immediately, as PLC's exclusive distributor for its TMR products in
the U.S. Currently, Novadaq's U.S. sales force includes direct
sales people and clinical educators, all focused on the cardiac
surgery customer base, which parallels the customer contact for
TMR, and Novadaq intends to expand this team by hiring Edwards'
existing U.S. laser sales force. Mr. Tauscher added, "This has been
a pivotal year for PLC, with the announcement in mid-September of
our new product initiative, RenalGuard(TM), which we believe will
enable us to achieve greater long-term growth than we would by
focusing on TMR alone. The revenue stream from the TMR business
enables us to drive forward on RenalGuard's clinical program. We
remain very excited about the major market opportunity for
RenalGuard in preventing Contrast-Induced Nephropathy (CIN), a
serious side effect that can result in patient death and that
affects at risk patients, who constitute a meaningful portion of
the millions of people undergoing imaging procedures worldwide. We
continue to work aggressively with institutions to secure approval
of our protocol, and while we are encountering some institutional
research approval delays, just last week, we announced that the
first patients had been successfully treated at Cape Cod Hospital.
We continue working toward securing CE Mark approval for RenalGuard
therapy by the middle of 2007, followed by initial international
distribution starting in the second half of 2007. We are currently
targeting FDA approval and the launch of U.S. distribution by the
middle of 2009. We continue to see a potential market opportunity
for RenalGuard of some $500 million, and we are very excited about
our plan to pursue this market aggressively." Fourth Quarter and
Year Results The company also today reported financial results for
the three and twelve months ended December 31, 2006. Fourth quarter
2006 total revenues were $1,747,000 compared with $1,811,000 in the
fourth quarter of 2005. The net income for the fourth quarter of
2006 was $36,000, or $0.00 per diluted share, compared to a net
loss of $397,000, or a loss of $.0.01 per diluted share, in the
fourth quarter of 2005. Total revenues for 2006 were $7,146,000
compared to total revenues of $7,636,000 for 2005. Net income for
2006 was $1,319,000, or $0.04 per diluted share, compared to a net
loss of $1,268,000, or a loss of $0.04 per diluted share, for 2005.
2006's net income reflects a gain of $1,432,000 in the first
quarter of 2006 from the sale of the company's Optiwave disposable
manufacturing rights to Edwards. During the fourth quarter of 2006,
PLC shipped four new CO2 Heart Lasers (HL2) to U.S. hospitals
through Edwards. PLC ended 2006 with 156 HL2 CO2 Heart Lasers
located at heart centers throughout the U.S. Also during the fourth
quarter of 2006, a total of 509 disposable kits were shipped
worldwide by Edwards and PLC. Edwards delivered 466 of these kits
to U.S. hospitals and PLC shipped 43 disposable kits to
international customers. In comparison, a total of 555 disposable
kits were delivered worldwide during the fourth quarter of 2005.
Conference Call PLC Systems will be hosting a conference call
today, March 21, at 4:00 p.m. Eastern Time to discuss these
matters. The call may be joined by dialing (866) 202-0886, or
internationally, (617) 213-8841, at least five minutes prior to the
start of the call. The passcode is: 59124812. A live webcast of the
call will be accessible at the investor relations section of the
Company's website at http://www.plcmed.com/. An archived webcast of
the conference call will be available beginning one hour after the
completion of the call in the same location. A replay of the call
can also be accessed telephonically by dialing 888-286-8010, or
internationally 617-801-6888, using passcode 19634817, from 6 pm on
March 21, 2007 through midnight March 28, 2007. About PLC Systems
Inc. PLC Systems Inc. (AMEX:PLC) is a medical technology company
specializing in innovative technologies for the cardiac and
vascular markets. Headquartered in Franklin, Mass., PLC pioneered
the CO2 Heart Laser System, which cardiac surgeons use to perform
CO2 transmyocardial revascularization (TMR) to alleviate symptoms
of severe angina. CO2 TMR offers a treatment option for angina
patients who suffer from severe coronary artery disease. The CO2
Heart Laser is the world's first TMR angina relief device approved
by both the U.S. Food and Drug Administration and Japanese Ministry
of Health, Labor and Welfare. In addition, the company recently
initiated clinical studies for its RenalGuard(TM) Therapy and
RenalGuard(TM) System. Renal Guard Therapy is a fully-automated,
matched fluid replacement system intended for interventional
cardiology and radiology patients undergoing diagnostic and
therapeutic imaging procedures where contrast agents are
administered. Additional company information can be found at
http://www.plcmed.com/. This press release contains
"forward-looking" statements. For this purpose, any statements
contained in this press release that relate to prospective events
or developments are deemed to be forward-looking statements. Words
such as "believes," "anticipates," "plans," "expects," "will" and
similar expressions are intended to identify forward-looking
statements. Our statements of our objectives are also
forward-looking statements. While we may elect to update
forward-looking statements in the future, we specifically disclaim
any obligation to do so, even if our estimates change, and you
should not rely on these forward-looking statements as representing
our views as of any date subsequent to the date of this press
release. Actual results could differ materially from those
indicated by such forward-looking statements as a result of a
variety of important factors, including Novadaq may be unsuccessful
in selling our products, the transition period following Novadaq's
new role as our exclusive US distributor may adversely affect our
revenues, we and Novadaq may be unable to convince health care
professionals and third party payers of the medical and economic
benefits of performing TMR, there can be no assurance that all
payers will reimburse health care providers who perform TMR
procedures or that reimbursement, if provided, will be adequate, we
may not receive necessary regulatory approvals to market our
RenalGuard product, the clinical trials for that product may not be
successful, the RenalGuard product may not be commercially
accepted, operational changes, competitive developments may affect
the market for our products, regulatory approval requirements may
affect the market for our products, and additional risk factors
described in our Report on Form 10-K for the year ended December
31, 2005, and our other SEC reports. PLC Systems, PLC Medical
Systems, PLC and CO2 Heart Laser and RenalGuard are trademarks of
PLC Systems Inc. Edwards Lifesciences is a trademark of Edwards
Lifesciences Corporation. Novadaq and SPY are trademarks of Novadaq
Technologies, Inc. Contact: Mary T. Conway Conway Communications
617-244-9682 PLC SYSTEMS INC. CONSOLIDATED STATEMENTS OF OPERATIONS
(In thousands, except per share data) Three Months Ended Year Ended
December 31, December 31, 2006 2005 2006 2005 Revenues: Product
sales -- Edwards $1,201 $1,278 $4,918 $5,476 Product sales -- other
199 159 744 621 Service fees -- Edwards 320 327 1,354 1,311 Service
fees -- other 27 47 130 228 Total revenues 1,747 1,811 7,146 7,636
Cost of revenues: Product sales -- Edwards 472 485 1,644 2,064
Product sales -- other 72 48 387 252 Service fees -- Edwards 145
142 550 577 Service fees -- other 40 58 151 173 Total cost of
revenues 729 733 2,732 3,066 Gross profit 1,018 1,078 4,414 4,570
Operating expenses: Selling, general and administrative 544 820
3,014 3,336 Research and development 539 720 1,924 2,750 Total
operating expenses 1,083 1,540 4,938 6,086 Gain on the sale of
manufacturing rights -- -- 1,432 -- Income (loss) from operations
(65) (462) 908 (1,516) Other income, net 126 65 436 248 Income
(loss) before income taxes 61 (397) 1,344 (1,268) Provision for
income taxes 25 -- 25 -- Net income (loss) $36 $(397) $1,319
$(1,268) Basic and diluted income (loss) per share $0.00 $(0.01)
$0.04 $(0.04) Average shares outstanding: Basic 30,268 30,079
30,170 30,074 Diluted 30,723 30,079 30,572 30,074 CONDENSED BALANCE
SHEET December 31, December 31, 2006 2005 Cash and short-term
investments $10,034 $9,460 Total current assets 12,802 12,008 Total
assets 13,176 12,467 Total current liabilities 2,953 3,044
Shareholders' equity 7,129 5,543 DATASOURCE: PLC Systems CONTACT:
Mary T. Conway of Conway Communications, +1-617-244-9682, Web site:
http://www.plcmed.com/
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