FRANKLIN, Mass., Aug. 12, 2011 /PRNewswire/ -- PLC Systems Inc. (OTCBB: PLCSF), a company focused on innovative medical device technologies, today reported financial results for the three- and six month periods ended June 30, 2011. These results only include the company's RenalGuard® operations, since PLC completed the sale of its transmyocardial revascularization (TMR) business to Novadaq Corp. during the first quarter of 2011. Results from the TMR business are reflected in discontinued operations for all periods presented.
Second quarter 2011 total revenues were $398,000, compared to $249,000 in the second quarter of 2010, a marked improvement over the $57,000 reported in the first quarter this year. The net loss from continuing operations for the second quarter of 2011 was $541,000, or $0.02 per basic and diluted share, compared to a net loss from continuing operations of $869,000, or $0.03 per basic and diluted share, in the second quarter of 2010. During the first quarter of 2011, PLC announced that it had secured up to $6 million in convertible secured debt financing from an institutional investor, of which $4 million, less financing costs of $530,000, was received at the initial closing in February 2011.
Mark R. Tauscher, President and Chief Executive Officer of PLC Systems Inc., stated, "I am pleased to see that in the second quarter this year, as we anticipated, we were successful in reviving RenalGuard sales in the European Union to levels higher than we produced in any quarter last year. We believe we are now in a better position from which to add more distributors, expand market penetration and develop meaningful sales traction in the European market, and other countries where RenalGuard is already available. Thanks to our improved financial position and the positive scientific data produced in two separate Italian clinical trials, we fully intend to attack all opportunities with a new focused sales and marketing approach in order to increase use of RenalGuard and expand the number of healthcare institutions at which it is available."
He added, "At the same time, we have also completed most of the steps required to recommence the U.S. pivotal trial for RenalGuard in order to gain approval from the FDA to market and sell RenalGuard in the U.S. We look forward to announcing our first sites and first enrolled patients in this important trial in the coming months."
Financial UpdateAs of June 30, 2011, PLC reported $4,059,000 in cash and equivalents, an increase of $2,735,000 from the Company's cash position as of December 31, 2010. The increased cash position reflects the net proceeds from the sale of the TMR business and the secured convertible debt financing.
During the second quarter of 2011, PLC shipped 455 single-use RenalGuard disposable sets and 14 RenalGuard consoles internationally, compared to 180 RenalGuard single-use disposable sets and five consoles that shipped in the second quarter of 2010. As a result, RenalGuard revenues increased $102,000, or 58%, in the second quarter of 2011 as compared to the same period in 2010. OEM revenues increased $48,000, or 67%, in the second quarter of 2010, reflecting primarily the recognition of revenue related to transactions that were previously deferred. The OEM assets were sold in May 2010 and all transactions previously deferred have been recognized in full.
Sales, General and Administrative costs decreased to $667,000 in the second quarter of 2011, from $839,000 in the second quarter of 2010. This decrease reflects the impact of decreased compensation expenses in the current year period resulting from 2010 workforce reductions and the departure of the company's former Chief Financial Officer. Research & Development expenses increased to $373,000 in the second quarter of 2011, from $113,000 in the second quarter of 2010. This increase reflects the higher costs associated with preparations for the Company's U.S. clinical trial of RenalGuard.
Six Months ResultsFor the six months period in 2011, PLC reported revenues of $455,000, compared to $516,000 in the same period of 2010. Net loss from continuing operations for the first six months of 2011 was $5,560,000, or a loss of $0.18 per basic and diluted share, compared to a net loss from continuing operations of $2,088,000, or a loss of $0.07 per share, in the same period last year.
Recent EventsKaren Raus, Controller and Principal Financial Officer of PLC, is leaving the company effective today for a CFO position at another company. The company has launched a search for a new principal financial officer.
Effective August 15, 2011, PLC is moving to a new, smaller facility, in Milford, Massachusetts, recognizing its lower space requirements and saving significant costs over the long-term.
About PLC Systems Inc.PLC Systems Inc., headquartered in Franklin, Mass., is a medical device company focused on innovative technologies for the cardiac and vascular markets. PLC's newest product, RenalGuard, has been developed to help prevent the onset of Contrast-Induced Nephropathy (CIN) in at-risk patients undergoing certain imaging procedures. The Product is CE-marked and is being marketed in Europe and selected countries around the world. Two investigator-sponsored European studies have demonstrated RenalGuard's effectiveness at preventing CIN. RenalGuard is being studied in a pivotal trial in the U.S., as required for approval by FDA.
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 that we may not receive necessary regulatory approvals to market our RenalGuard product or that such approvals may be withdrawn, the current clinical trials in Italy and the planned future U.S. clinical trial for RenalGuard may not be completed in a timely fashion, if at all, or, if these clinical trials are completed, they may not produce clinically significant or meaningful results, 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 the "Forward Looking Statements" section of our Annual Report on Form 10-K for the year ended December 31, 2010, a copy of which is on file with the SEC.
PLC Systems, PLC Medical Systems, PLC, RenalGuard and RenalGuard System are trademarks of PLC Systems Inc.
Novadaq is a trademark of Novadaq Technologies, Inc.(Financial tables follow)PLC SYSTEMS INC.CONSOLIDATED STATEMENTS OF OPERATIONS(In thousands, except per share data)
(Unaudited)Three Months EndedJune 30,Six Months EndedJune 30,2011201020112010Revenues
516Cost of revenues
198264338696Gross profit (loss)
200(15)117(180)Operating expensesSelling, general and administrative
6678391,2601,640Research and development
373113446366Total operating expenses
1,0409521,7062,006Gain on the sale of assets
(40)(98)(40)(98)Loss from continuing operations
(800)(869)(1,549)(2,088)Other expense:Interest expense
(115)--(161)--Financing costs associated with convertible notes
----(530)--Change in fair value of warrant liabilities
372--(1,104)--Change in fair value of convertible notes
2--(2,216)--Total other expense
259--(4,011)--Net loss from continuing operations
(541)(869)(5,560)(2,088)Discontinued operations:Income from discontinued operations
--670531,328Gain on sale of discontinued operations
----1,179--Net income from discontinued operations
$ (541)$ (199)$(4,328)$ (760)Net loss per weighted average share, basic and diluted:From loss on continuing operations attributable
to common stockholders
$(0.02)$(0.03)$ (0.18)$(0.07)From income on discontinued operations
--0.020.000.04From gain on sale of discontinued operations
----0.04--Net loss attributable to common stockholders
per weighted average share, basic and diluted
$ (0.02)$ (0.01)$ (0.14)$(0.03)Weighted average shares outstanding:Basic and diluted
30,35130,35130,35130,351CONDENSED BALANCE SHEET(In thousands, except per share data)
2010Cash and cash equivalents$4,059$1,324Total current assets4,7443,102Total assets4,9523,315Total current liabilities3251,881Shareholders' equity (deficit)(2,784)1,434Contact:
Mary T. ConwayConway Communications508firstname.lastname@example.org
|SOURCE PLC Systems Inc.|
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