-----BEGIN PRIVACY-ENHANCED MESSAGE----- Proc-Type: 2001,MIC-CLEAR Originator-Name: webmaster@www.sec.gov Originator-Key-Asymmetric: MFgwCgYEVQgBAQICAf8DSgAwRwJAW2sNKK9AVtBzYZmr6aGjlWyK3XmZv3dTINen TWSM7vrzLADbmYQaionwg5sDW3P6oaM5D3tdezXMm7z1T+B+twIDAQAB MIC-Info: RSA-MD5,RSA, UtLHA1wb2/Tl6cbvyx4U7D4dBFvroM/CFs3djUmzJk9CgHPS08ymxEKSjRmtdymX fkCgfKp5XofqJG+MgmB3kw== 0001104659-09-048425.txt : 20090810 0001104659-09-048425.hdr.sgml : 20090810 20090810095807 ACCESSION NUMBER: 0001104659-09-048425 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 2 CONFORMED PERIOD OF REPORT: 20090810 ITEM INFORMATION: Results of Operations and Financial Condition ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20090810 DATE AS OF CHANGE: 20090810 FILER: COMPANY DATA: COMPANY CONFORMED NAME: PLC SYSTEMS INC CENTRAL INDEX KEY: 0000879682 STANDARD INDUSTRIAL CLASSIFICATION: ELECTROMEDICAL & ELECTROTHERAPEUTIC APPARATUS [3845] IRS NUMBER: 043153858 FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 001-11388 FILM NUMBER: 09997734 BUSINESS ADDRESS: STREET 1: 10 FORGE PK CITY: FRANKLIN STATE: MA ZIP: 02038 BUSINESS PHONE: 5085418800 MAIL ADDRESS: STREET 1: 10 FORGE PARK CITY: FRANKLIN STATE: MA ZIP: 02038 8-K 1 a09-21194_18k.htm 8-K

 

 

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): August 10, 2009

 

PLC Systems Inc.

(Exact Name of Registrant as Specified in Charter)

 

Yukon Territory, Canada

 

1-11388

 

04-3153858

(State or Other Jurisdiction of Incorporation)

 

(Commission File Number)

 

(IRS Employer
Identification No.)

 

 

 

 

 

10 Forge Park, Franklin, Massachusetts

 

02038

(Address of Principal Executive Offices)

 

(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 August 10, 2009, PLC Systems Inc. announced its financial results for the quarter ended June 30, 2009.  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 August 10, 2009

 

2



 

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.

 

 

 

PLC SYSTEMS INC.

 

 

 

 

Date: August 10, 2009

By:

/s/ James G. Thomasch

 

 

James G. Thomasch, Senior Vice President,
Finance and Administration and Chief Financial Officer

 

3



 

EXHIBIT INDEX

 

Exhibit No.

 

Description

 

 

 

99.1

 

Press release issued by the Registrant on August 10, 2009

 

4


EX-99.1 2 a09-21194_1ex99d1.htm EX-99.1

Exhibit 99.1

 

FOR IMMEDIATE RELEASE

 

Contact: Mary T. Conway

 

 

Conway Communications

 

 

617-244-9682

 

 

mtconway@att.net

 

PLC SYSTEMS REPORTS SECOND QUARTER 2009 RESULTS;

ANNOUNCES TIMING FOR RELEASE OF PRELIMINARY DATA FROM

ITALIAN STUDY OF RENALGUARD

 

FRANKLIN, Mass., August 10, 2009 — PLC Systems Inc. (OTCBB: PLCSF), a company focused on innovative cardiac and vascular medical device-based technologies, today reported financial results for the three and six month periods ended June 30, 2009.

 

Second quarter 2009 total revenues were $1,220,000, down from $1,310,000 in the second quarter of 2008. International revenues in the second quarter of 2009 were more than 30% of this total, up substantially from the prior year, primarily reflecting progress in sales of the RenalGuard System™ in the European Union. The net loss for the second quarter of 2009 was $307,000, or $0.01 per diluted share, compared to a net loss of $671,000, or $0.02 per diluted share, in the second quarter of 2008.

 

Mark R. Tauscher, president and chief executive officer of PLC Systems Inc., stated,  “This is a very exciting time for PLC and our RenalGuard technology, since we now know when the first preliminary data from the CCM-University of Milan clinical trial will be released publicly.  We are focused on leveraging the medical community’s interest in this data at a series of key conferences in the next few months, providing us the opportunity to educate end-users and potential partners about our technology.

 

“This critical data will be presented first at ESC, a conference of European cardiologists, in Spain in late August. It will also be presented in the U.S. in late September at TCT, attended by U.S. interventional cardiologists. Lastly, RenalGuard and this study data will be in the forefront at the Italian Society of Interventional Cardiologists meeting in October. Thus, our participation in these important events in a short time period will enable us to share the first data on RenalGuard’s efficacy with the most influential clinicians in the market space.  As we have stated previously, we believe that positive data from the Italian clinical study will drive additional distributor agreements, generate stronger sales and, we hope, enable us to successfully raise additional funds to commence and complete our U.S. clinical study of RenalGuard.”

 

Mr. Tauscher added, “We are now seeing that RenalGuard is beginning to gain traction in the European Union, with the addition of our second distributor in Spain and a third one in Bangladesh and the continued sales ramp in Italy, where we began our launch last year. Further, we are very pleased that yet another well-known cardiologist, Dr. Carlo Briguori, has commenced his own clinical study of RenalGuard’s efficacy at the Clinico Medeterranea in Naples, Italy. Thus, we are very fortunate that all of these highly-visible events are occurring within a short time period.”

 

During the second quarter of 2009, 240 disposable TMR kits were shipped, consisting of 218 kits shipped to hospitals in the U.S. by Novadaq and 22 kits shipped internationally by PLC. In comparison, a total of 382 disposable TMR kits were shipped worldwide during the second quarter of 2008.

 



 

PLC did not record any international or domestic laser sales during the second quarter of 2009. In the same quarter of 2008, PLC shipped six CO2 Heart Lasers (HL2) to U.S. hospitals, comprised of two new systems and four redeployments, through Novadaq Technologies, PLC’s U.S. marketing and distribution partner for its TMR products. PLC ended the second quarter of 2009 with 169 HL2 CO2 Heart Lasers located at heart centers throughout the U.S.

 

PLC shipped 380 single use sets associated with its RenalGuard System internationally during the second quarter of 2009, along with 16 consoles, associated with its launch of RenalGuard in Italy, Spain and now Bangladesh. In contrast, there were no shipments of RenalGuard sets or consoles in the second quarter of 2008.

 

Six Months Results

 

For the first half of 2009, total revenues were $2,787,000, up 12% from $2,478,000 in the same period of 2008. The net loss for the first six months of 2009 was $665,000, or $0.02 per share, compared to a net loss of $1,433,000, or $0.05 per share, in the first half of 2008.

 

Conference Call

 

PLC Systems will host a conference call today, August 10, 2009, at 11:00 a.m. ET to discuss these matters. The call may be joined by dialing (866) 788-0547, or internationally, (857) 350-1685, at least ten minutes prior to the start of the call. The passcode is 17069907. A live webcast of the call will be accessible at the investor relations section of the Company’s website at 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.

 

About PLC Systems Inc.

 

PLC Systems Inc. is a medical technology company specializing in innovative technologies for the cardiac and vascular markets. Headquartered in Franklin, Massachusetts, PLC pioneered the CO2 Heart Laser System, which cardiac surgeons use to perform CO2 transmyocardial revascularization (TMR) to alleviate symptoms of severe angina.  PLC’s newest product, RenalGuard, is approved for sale in the EU as a general fluid balancing device. 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, we may be unable to raise sufficient funds in the future to implement our business plan and/or commence our planned U.S. clinical trial for RenalGuard, 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, 2008, and our other SEC reports.

 

PLC Systems, PLC Medical Systems, PLC, CO2 Heart Laser, 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)

 

 

 

Three Months Ended
June 30,

 

Six Months Ended
June 30,

 

 

 

2009

 

2008

 

2009

 

2008

 

Revenues:

 

 

 

 

 

 

 

 

 

Product sales

 

$

 864

 

$

1,032

 

$

2,123

 

$

1 ,838

 

Service fees

 

356

 

278

 

664

 

640

 

Total revenues

 

1,220

 

1,310

 

2,787

 

2,478

 

 

 

 

 

 

 

 

 

 

 

Cost of revenues:

 

 

 

 

 

 

 

 

 

Product sales

 

337

 

423

 

748

 

643

 

Service fees

 

126

 

150

 

327

 

335

 

Total cost of revenues

 

463

 

573

 

1,075

 

978

 

 

 

 

 

 

 

 

 

 

 

Gross profit

 

757

 

737

 

1,712

 

1,500

 

 

 

 

 

 

 

 

 

 

 

Operating expenses:

 

 

 

 

 

 

 

 

 

Selling, general and administrative

 

880

 

831

 

1,965

 

1,801

 

Research and development

 

185

 

602

 

414

 

1,210

 

Total operating expenses

 

1,065

 

1,433

 

2,379

 

3,011

 

 

 

 

 

 

 

 

 

 

 

Loss from operations

 

(308

)

(696

)

(667

)

(1,511

)

Other income, net

 

1

 

25

 

2

 

78

 

Net loss

 

$

(307

)

$

 (671

)

$

 (665

)

$

(1,433

)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Basic and diluted loss per share

 

$

(0.01

)

$

(0.02

)

$

(0.02

)

$

 (0.05

)

Weighted average shares outstanding:

 

 

 

 

 

 

 

 

 

Basic and diluted

 

30,351

 

30,330

 

30,351

 

30,330

 

 

CONDENSED BALANCE SHEET

 

 

 

June 30,
2009

 

December 31,
2008

 

Cash and cash equivalents

 

$

3,550

 

$

5,026

 

Total current assets

 

5,999

 

7,562

 

Total assets

 

6,298

 

7,913

 

Total current liabilities

 

2,790

 

3,364

 

Shareholders’ equity

 

2,601

 

3,191

 

 

# # #

 


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