UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 8-K
CURRENT REPORT
PURSUANT TO SECTION 13 OR 15(d) OF THE
SECURITIES EXCHANGE ACT OF 1934
Date of Report (Date of earliest event reported): April 5, 2013
PLC Systems Inc.
(Exact Name of Registrant as Specified in Charter)
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Yukon Territory, Canada |
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1-11388 |
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04-3153858 |
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(State or other Jurisdiction of Incorporation or Organization) |
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(Commission File Number) |
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(IRS Employer |
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PLC Systems, Inc. |
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01757 |
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(Address of principal executive offices) |
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(Zip Code) |
Registrant’s telephone number, including area code: 508-541-8800
(Former Name or Former Address, if Changed Since Last Report)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):
o Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
o Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
o Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
o Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
Item 2.02. Results of Operations and Financial Condition.
On March 28, 2013, PLC Systems Inc. announced its financial results for the year ended December 31, 2012. The full text of the press release issued in connection with the announcement is furnished as Exhibit 99.1 to this Current Report on Form 8-K.
The information in this Form 8-K (including Exhibit 99.1) shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in such a filing.
Item 9.01. Financial Statements and Exhibits.
(d) Exhibits
The following exhibit relating to Item 2.02 shall be deemed to be furnished, and not filed:
99.1 Press release issued by the Registrant on March 28, 2013.
SIGNATURE
Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
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PLC SYSTEMS, INC. | |
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Date: April 5, 2013 |
By: |
/s/ Gregory W. Mann |
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Gregory W. Mann, Chief Financial Officer |
Exhibit 99.1
Contacts:
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LHA |
PLC Systems Inc. |
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@LHA_IR_PR |
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PLC SYSTEMS 2012 FINANCIAL RESULTS FEATURE RENALGUARD SALES UP 157% FOR THE FOURTH QUARTER AND 96% FOR THE FULL YEAR
MILFORD, Mass. (March 28, 2013) — PLC Systems Inc. (OTCBB: PLCSF), a medical device company focused on innovative technologies for the cardiac and vascular markets, today reported financial results for the three and 12 months ended December 31, 2012.
Highlights of the fourth quarter of 2012 and recent weeks include:
· Revenues were $485,000 in the fourth quarter of 2012, compared with $189,000 in the fourth quarter of 2011, an increase of 157%
· Shipped first stocking orders to Brazil and made continued progress across Latin America to secure regulatory approvals for RenalGuard
· Continued to broaden awareness of Contrast-Induced Nephropathy (CIN) with presence at Transcatheter Cardiovascular Therapeutics (TCT) 2012, a key medical conference
· Raised $4.0 million in gross proceeds from an equity financing in February 2013
Management Commentary
“RenalGuard sales during the fourth quarter showed a marked improvement as we filled a large stocking order to Discomed, our distributor in Brazil,” commented Mark Tauscher, president and chief executive officer of PLC Systems. “We worked for more than a year to secure the necessary approvals from Brazilian regulatory authorities, and are making progress in our efforts to receive regulatory approvals across Latin America via our distributor Girlow USA.”
Mr. Tauscher added, “We continue to enroll patients into our pivotal trial to support a Premarket Approval filing for RenalGuard with the U.S. Food and Drug Administration to reduce the onset of CIN. We raised $4.0 million in gross proceeds in an equity offering during the first quarter of 2013. Of the estimated 7.0 million diagnostic and interventional imaging procedures performed worldwide each year that involve the use of contrast agents, we believe that 15% or approximately 1.0 million patients could be considered at-risk for CIN and thus benefit from RenalGuard.
“We are continuing work to expand the awareness of the serious damage to kidneys that may result from CIN. During the fourth quarter of 2012, we had a well-attended booth at an important medical conference, the Transcatheter Cardiovascular Therapeutics meeting in Miami. Although the meeting was held in the U.S., the majority of attendees were from countries where we have distribution, and we were particularly pleased with the efforts of Artech, our distributor in Italy, and ACIST, our distributor in
France and Germany. A panel discussion on the prevention of CIN using matched hydration served to highlight the need for prevention of this disease and the efficacy of RenalGuard. We look forward to attending EuroPCR, the annual meeting the European Association for Percutaneous Cardiovascular Interventions in May in Paris. RenalGuard will be well-represented there,” Mr. Tauscher concluded.
As previously reported, PLC Systems has established a number of goals for 2013, including:
· Initiating additional sites for the U.S. clinical trial and making significant progress in patient enrollment, with sample size re-estimation planned after 163 patients
· Achieving further market penetration of RenalGuard in geographies where it is currently available for sale
· Engaging additional distributors in key territories worldwide; the distributor in Latin America engaged in 2012 is awaiting product registration in 17 countries during 2013
· Undertaking additional investigator-sponsored clinical trials of RenalGuard in new territories aimed at additional indications
· Expanding the U.S. and international patent protection for RenalGuard to bolster the company’s intellectual property portfolio
· Obtaining a positive response from Japan’s Department of Health to an investigator-submitted clinical trial proposal, followed by the launch of a full clinical trial in that critical market
· Raising additional funds to support these initiatives
Financial Results
These results include only the company’s RenalGuard® operations as 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 as discontinued operations in the financial results for the 12 months ended December 31, 2011.
PLC Systems reported revenues for the fourth quarter of 2012 of $485,000, up 157% over revenues for the fourth quarter of 2011 of $189,000 due to higher volume of RenalGuard consoles sold to distributors, including a new distributor in Brazil. During the fourth quarter of 2012, PLC recognized revenues of $156,000 for single-use RenalGuard disposable sets and $329,000 for RenalGuard consoles shipped internationally, compared with $123,000 and $66,000, respectively, in the fourth quarter of 2011.
Gross profit was $252,000 or 52.0% of revenues during the fourth quarter of 2012, compared with $119,000 or 63.0% of revenues a year ago. The increase in gross profit was attributable to higher sales while the decline in gross margin percentage is due to the mix of consoles and single-use-sets sold.
Selling, general and administrative expense was $734,000, up 23% from $596,000 in the prior-year fourth quarter, largely due to an increase in stock-based compensation expense.
The company recorded research and development expense of $414,000 during the fourth quarter of 2012, compared with $453,000 in the fourth quarter of 2011. The slight decline is associated with the pace of enrolling patients into the RenalGuard U.S. pivotal trial, which began in January 2012. The company expects research and development expense to increase significantly as enrollment continues.
The company recorded a loss from continuing operations for the fourth quarter of 2012 of $896,000. During the fourth quarter of 2012, the company recorded a gain on the changes in the fair value of convertible notes and warrants in the amount of $4,100,000. Net income for the fourth quarter of 2012
was $3,001,000, or $0.09 per diluted share, compared with a net loss from continuing operations for the fourth quarter of 2011 of $1,028,000 or $0.03 per share.
For the year ended December 31, 2012, PLC reported revenues, all of which were from RenalGuard, of $1,080,000, compared with total revenues of $671,000 for 2011, an increase of 61%. RenalGuard revenues increased 96% over $551,000 in 2011. Total revenue for 2011 included $120,000 of OEM related sales. The net loss from continuing operations for 2012 was $8,387,000 or $0.27 per share, of which $3,641,000 was attributable to the change in fair value of the investor warrants and convertible notes issued during 2011 and 2012. This compares with a net loss from continuing operations for 2011 of $6,498,000, or $0.21 per share. Cash and cash equivalents were $258,000 as of December 31, 2012, compared with $2,585,000 as of December 31, 2011. The company expects that it will need to raise additional capital during 2013 based on current and anticipated revenue projections from foreign sales of RenalGuard, and the anticipated costs of the U.S. clinical trial.
About PLC Systems Inc.
PLC Medical Systems, Inc., the operating subsidiary of PLC Systems Inc., is a medical device company focused on innovative technologies for the cardiac and vascular markets. PLC’s lead product, RenalGuard®, significantly reduces the onset of CIN in at-risk patients undergoing certain cardiac and vascular imaging procedures. CIN is a form of acute kidney injury resulting from toxic contrast agents that occurs in 10% to 20% of at-risk patients. RenalGuard is CE-marked and is being sold in Europe and certain countries around the world via a network of distributors. Two investigator-sponsored studies in Europe have demonstrated RenalGuard’s effectiveness at preventing CIN. The CIN-RG RenalGuard pivotal study is underway in the U.S. to support a planned Premarket Approval filing with the U.S. Food and Drug Administration.
Additional company information can be found at 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 that we may not receive necessary regulatory approvals to market our RenalGuard product or that such approvals may be withdrawn, the U.S. clinical trial for RenalGuard may not be completed in a timely fashion, if at all, or, if this clinical trial is completed, it may not produce clinically significant or meaningful results, the RenalGuard product may not be commercially accepted, operational changes, the need for additional financing, 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, 2012, 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.
(Tables to follow)
PLC SYSTEMS INC.
CONSOLIDATED STATEMENTS OF OPERATIONS
(In thousands, except per share data)
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Three Months Ended |
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Year Ended |
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2012 |
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2011 |
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2012 |
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2011 |
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Revenues |
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$ |
485 |
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$ |
189 |
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$ |
1,080 |
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$ |
671 |
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Cost of revenues |
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233 |
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70 |
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541 |
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426 |
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Gross profit |
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252 |
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119 |
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539 |
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245 |
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Operating expenses |
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Selling, general and administrative |
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734 |
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596 |
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2,633 |
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2,445 |
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Research and development |
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414 |
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453 |
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2,031 |
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1,212 |
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Total operating expenses |
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1,148 |
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1,049 |
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4,664 |
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3,657 |
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Gain on the sale of assets |
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— |
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— |
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— |
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(40 |
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Loss from continuing operations |
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(896 |
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(930 |
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(4,125 |
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(3,372 |
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Other income expense: |
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Interest expense |
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(186 |
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(117 |
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(555 |
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(396 |
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Other income (expense) |
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(11 |
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9 |
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14 |
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10 |
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Financing costs associated with convertible notes |
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— |
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— |
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(80 |
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(530 |
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Change in fair value of warrant liabilities |
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1,900 |
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64 |
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(1,617 |
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(808 |
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Change in fair value of convertible notes |
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2,194 |
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(54 |
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(2,024 |
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(1,894 |
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Total other income (expense) |
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3,896 |
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98 |
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(4,262 |
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(3,618 |
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Net income (loss) from continuing operations before income taxes |
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3,001 |
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(1,028 |
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(8,387 |
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(6,990 |
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Benefit for income taxes from continuing operations |
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— |
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492 |
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Net loss from continuing operations, net of income taxes |
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— |
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— |
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(8,387 |
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(6,498 |
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Discontinued operations: |
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Income from discontinued operations, net of income taxes |
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— |
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— |
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— |
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53 |
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Gain on sale of discontinued operations, net of income taxes |
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— |
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— |
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— |
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687 |
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Net income from discontinued operations |
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— |
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— |
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— |
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740 |
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Net income (loss) |
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$ |
3,001 |
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$ |
(1,028 |
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$ |
(8,387 |
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$ |
(5,758 |
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Net income (loss) per weighted average share, basic and diluted: |
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From income (loss) on continuing operations attributable to common stockholders |
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$ |
0.09 |
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$ |
(0.03 |
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$ |
(0.27 |
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$ |
(0.21 |
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From income on discontinued operations |
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0.00 |
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0.00 |
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0.00 |
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0.00 |
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From gain on sale of discontinued operations |
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0.00 |
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0.00 |
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0.00 |
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0.02 |
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Net income (loss) attributable to common stockholders per weighted average share, basic and diluted |
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$ |
0.09 |
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$ |
(0.03 |
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$ |
(0.27 |
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$ |
(0.19 |
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Weighted average shares outstanding: |
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Basic and diluted |
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32,434 |
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30,351 |
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31,139 |
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30,351 |
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CONDENSED BALANCE SHEET
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December 31, |
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December 31, |
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Cash and cash equivalents |
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$ |
258 |
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$ |
2,585 |
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Total current assets |
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1,020 |
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3,509 |
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Total assets |
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1,091 |
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3,549 |
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Total current liabilities |
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1,140 |
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710 |
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Shareholders’ equity (deficit) |
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(11,947 |
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(4,088 |
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