Click here to close now.




















Welcome!

News Feed Item

PLC Systems Reports Fourth Quarter and Full Year 2013 Financial Results

RenalGuard(R) Sales Increase 18% for the Full Year to $1.3 Million

MILFORD, MA--(Marketwired - March 28, 2014) - PLC Systems Inc. (OTCQB: PLCSF), a medical device company focused on innovative technologies for the cardiac and vascular markets, today reported financial results for the three and twelve months ended December 31, 2013.

For the year 2013, PLC reported revenues of $1,274,000, compared with total revenues of $1,080,000 for 2012, an increase of 18%. In the fourth quarter of 2013, total revenues were $205,000, a reduction from the $485,000 in the fourth quarter of 2012, a period that included recognition of previously-deferred revenues of $251,000 related to the company's distributor in Italy and a large initial console stocking order to our distributor in Brazil. Fourth quarter 2013 revenues were comprised of $192,000 for single-use RenalGuard disposable sets and $13,000 for RenalGuard consoles shipped internationally, compared with $156,000 and $329,000, respectively, in the fourth quarter of 2012.

"2013 was an important year for our company and RenalGuard, even though sales during the fourth quarter fell somewhat when compared to the prior year period, which featured a large stocking order to Discomed, our distributor in Brazil. For the full year, we grew our RenalGuard franchise nicely, increasing revenues nearly 20%, and introducing more physicians to the benefits that RenalGuard can provide in helping address acute kidney injury in at-risk patients undergoing certain imaging procedures," commented Mark Tauscher, president and chief executive officer of PLC Systems. "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."

Mr. Tauscher added, "At the same time, we made progress in enrolling 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 the acute kidney injury (AKI) known as Contrast-Induced Nephropathy, or CIN. We currently expect to reach the key milestone of enrolling the level of patients required for the sample set re-estimation by the middle of this year."

He concluded, "In addition, we raised approximately $4.35 million in net proceeds during 2013 through the issuance of convertible notes, common stock and warrants, enabling us to move forward with both international distribution and our U.S. clinical trial program."

Highlights of 2013 include:

  • Initiation of a 60 patient clinical trial of RenalGuard's efficacy in reducing contrast induced AKI in Japan. This trial is required in order for RenalGuard to be distributed in Japan.
  • Initiating additional investigator-sponsored clinical trials of RenalGuard aimed at additional indications including one at the Tel Aviv Sourasky Medical Center in Israel by Dr. Yaron Arbel, the Director of the hospital's Cardio Vascular Research Center, evaluating the effectiveness of RenalGuard at preventing AKI in patients undergoing Transcatheter Aortic Valve Implantation (TAVI).
  • Showcasing RenalGuard in two live cases broadcast from Israel and France, respectively, at Transcatheter Cardiovascular Therapeutics (TCT) 2013, the largest worldwide meeting for interventional cardiologists.
  • Presentation at TCT 2013 of a survey by the Italian Society of Invasive Cardiology (GISE) demonstrating that RenalGuard is becoming the standard of care among Italian cardiologists in preventing CI-AKI.
  • Expanding the U.S. and international patent protection for RenalGuard to bolster the company's intellectual property portfolio, with a total of 12 patents now issued worldwide, and another 12 patent applications filed worldwide

Financial Results
Gross profit for the fourth quarter of 2013 was $112,000 or 55.0% of revenues, compared with $252,000 or 52.0% of revenues in the same quarter of the prior year. The decrease in gross profit was attributable to the decrease in sales volume. Selling, general and administrative expense was $734,000 in the fourth quarter of 2013, consistent with the same period in 2012, and the company recorded research and development expense of $457,000 during the fourth quarter of 2013, compared with $414,000 in the fourth quarter of 2012. The increase reflects the pace of enrolling patients into the RenalGuard U.S. pivotal trial, which began in January 2012. 

During the fourth quarter of 2013, the company recorded a gain on the changes in the fair value of convertible notes and warrants in the net amount of $5,101,000, as compared to $4,094,000 for the fourth quarter of 2012. As a result, net income for the fourth quarter of 2013 was $3,972,000, compared with net income for the fourth quarter of 2012 of $3,001,000.

For the year 2013, the company reported revenues of $1,274,000, compared with total revenues of $1,080,000 for 2011, an increase of 18%. Net income for 2013 was $3,499,000, or $0.05 per share ($0.03 per share on a diluted basis), which included net other income of $8,203,000, which was primarily attributable to the changes in fair value of the warrants and convertible notes, less extinguishment losses. This compares to a net loss for 2012 of $8,387,000, or $0.27 per share, which included net other expense of $4,262,000, which was primarily attributable to the changes in fair value of the warrants and convertible notes.

Cash and cash equivalents were $769,000 as of December 31, 2013, an increase of $511,000 from $258,000 as of December 31, 2012.

Based upon the current financial condition of the Company and the expectation of continued quarterly losses from operations during 2014, management is currently investigating ways to raise additional capital that can be completed in the next several weeks. The Company believes that its existing resources, based on its currently projected financial results, are sufficient to fund operations through April 2014.

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, 2013, 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.

                                                                            
                              PLC SYSTEMS INC.                              
                   CONSOLIDATED STATEMENTS OF OPERATIONS                    
                   (In thousands, except per share data)                    
                                                                            
                                     Three Months Ended      Year Ended     
                                        December 31,        December 31,    
                                     ------------------  ------------------ 
                                       2013      2012      2013      2012   
                                     --------  --------  --------  -------- 
                                                                            
Revenues                             $    205  $    485  $  1,274  $  1,080 
Cost of revenues                           93       233       531       541 
                                     --------  --------  --------  -------- 
Gross profit                              112       252       743       539 
                                     --------  --------  --------  -------- 
                                                                            
Operating expenses:                                                         
  Selling, general and                                                      
   administrative                         734       734     3,329     2,633 
  Research and development                457       414     2,118     2,031 
                                     --------  --------  --------  -------- 
    Total operating expenses            1,191     1,148     5,447     4,664 
                                     --------  --------  --------  -------- 
Loss from operations                   (1,079)     (896)   (4,704)   (4,125)
Other income (expense):                                                     
  Interest expense                        (73)     (186)     (337)     (555)
  Foreign currency transaction gains        8        --        17        14 
  Financing costs associated with                                           
   convertible notes                       --        --        --       (80)
  Change in fair value of warrant                                           
   and options liabilities              3,772     1,900     6,964    (1,617)
  Change in fair value of                                                   
   convertible notes                    1,329     2,194     4,814    (2,024)
  Loss from the extinguishment of                                           
   convertible notes                       --        --    (3,274)       -- 
  Other income                             15       (11)       19        -- 
                                     --------  --------  --------  -------- 
    Total other income (expense)        5,051     3,896     8,203    (4,262)
                                     --------  --------  --------  -------- 
Net income (loss)                    $  3,972  $  3,001  $  3,499  $ (8,387)
                                     ========  ========  ========  ======== 
Net income (loss) per weighted                                              
 average share, basic:               $   0.03  $   0.09  $   0.05  $  (0.27)
Net income (loss) per weighted                                              
 average share, diluted:             $   0.02  $   0.09  $   0.03        -- 
Weighted average shares outstanding:                                        
  Basic                               125,000    32,434    77,061    31,139 
  Diluted                             160,667    32,434   112,728        -- 
                                                                            
                                                                            
                          CONDENSED BALANCE SHEET                           
                                                                            
                                                 December 31,  December 31, 
                                                     2013          2012     
                                                 ------------  ------------ 
Cash and cash equivalents                        $        769  $        258 
Total current assets                                    1,517         1,020 
Total assets                                            1,558         1,091 
Total current liabilities                                 983         1,140 
Total liabilities                                       8,200        13,038 
Shareholders' equity (deficit)                         (6,642)      (11,947)
                                                                            

More Stories By Marketwired .

Copyright © 2009 Marketwired. All rights reserved. All the news releases provided by Marketwired are copyrighted. Any forms of copying other than an individual user's personal reference without express written permission is prohibited. Further distribution of these materials is strictly forbidden, including but not limited to, posting, emailing, faxing, archiving in a public database, redistributing via a computer network or in a printed form.

Latest Stories
ElasticBox, the agile application delivery manager, announced freely available public boxes for the DevOps community. ElasticBox works with enterprises to help them deploy any application to any cloud. Public boxes are curated reference boxes that represent some of the most popular applications and tools for orchestrating deployments at scale. Boxes are an adaptive way to represent reusable infrastructure as components of code. Boxes contain scripts, variables, and metadata to automate proces...
Contrary to mainstream media attention, the multiple possibilities of how consumer IoT will transform our everyday lives aren’t the only angle of this headline-gaining trend. There’s a huge opportunity for “industrial IoT” and “Smart Cities” to impact the world in the same capacity – especially during critical situations. For example, a community water dam that needs to release water can leverage embedded critical communications logic to alert the appropriate individuals, on the right device, as...
To assist customers with legacy Windows Server 2003 that is no longer supported by Microsoft, Racemi has introduced fixed price packages for upgrading and migrating Windows Server 2003 servers to either Windows 2008 R2 or Windows 2012 R2 and the choice of Amazon Web Services (AWS) or SoftLayer cloud. "We're extending a lifeline by upgrading the legacy servers to more modern Windows Server platforms while taking advantage of cloud computing," said James Strayer, vice president of product managem...
To support developers and operations professionals in their push to implement DevOps principles for their infrastructure environments, ProfitBricks, a provider of cloud infrastructure, is adding support for DevOps tools Ansible and Chef. Ansible is a platform for configuring and managing data center infrastructure that combines multi-node software deployment, ad hoc task execution, and configuration management, and is used by DevOps professionals as they use its playbooks functionality to autom...
Manufacturing connected IoT versions of traditional products requires more than multiple deep technology skills. It also requires a shift in mindset, to realize that connected, sensor-enabled “things” act more like services than what we usually think of as products. In his session at @ThingsExpo, David Friedman, CEO and co-founder of Ayla Networks, will discuss how when sensors start generating detailed real-world data about products and how they’re being used, smart manufacturers can use the ...
Skeuomorphism usually means retaining existing design cues in something new that doesn’t actually need them. However, the concept of skeuomorphism can be thought of as relating more broadly to applying existing patterns to new technologies that, in fact, cry out for new approaches. In his session at DevOps Summit, Gordon Haff, Senior Cloud Strategy Marketing and Evangelism Manager at Red Hat, discussed why containers should be paired with new architectural practices such as microservices rathe...
SYS-CON Events announced today that HPM Networks will exhibit at the 17th International Cloud Expo®, which will take place on November 3–5, 2015, at the Santa Clara Convention Center in Santa Clara, CA. For 20 years, HPM Networks has been integrating technology solutions that solve complex business challenges. HPM Networks has designed solutions for both SMB and enterprise customers throughout the San Francisco Bay Area.
Puppet Labs has announced the next major update to its flagship product: Puppet Enterprise 2015.2. This release includes new features providing DevOps teams with clarity, simplicity and additional management capabilities, including an all-new user interface, an interactive graph for visualizing infrastructure code, a new unified agent and broader infrastructure support.
SYS-CON Events announced today that Pythian, a global IT services company specializing in helping companies leverage disruptive technologies to optimize revenue-generating systems, has been named “Bronze Sponsor” of SYS-CON's 17th Cloud Expo, which will take place on November 3–5, 2015, at the Santa Clara Convention Center in Santa Clara, CA. Founded in 1997, Pythian is a global IT services company that helps companies compete by adopting disruptive technologies such as cloud, Big Data, advance...
All major researchers estimate there will be tens of billions devices - computers, smartphones, tablets, and sensors - connected to the Internet by 2020. This number will continue to grow at a rapid pace for the next several decades. With major technology companies and startups seriously embracing IoT strategies, now is the perfect time to attend @ThingsExpo, November 3-5, 2015, at the Santa Clara Convention Center in Santa Clara, CA. Learn what is going on, contribute to the discussions, and e...
SYS-CON Events announced today that G2G3 will exhibit at SYS-CON's @DevOpsSummit Silicon Valley, which will take place on November 3–5, 2015, at the Santa Clara Convention Center in Santa Clara, CA. Based on a collective appreciation for user experience, design, and technology, G2G3 is uniquely qualified and motivated to redefine how organizations and people engage in an increasingly digital world.
In their Live Hack” presentation at 17th Cloud Expo, Stephen Coty and Paul Fletcher, Chief Security Evangelists at Alert Logic, will provide the audience with a chance to see a live demonstration of the common tools cyber attackers use to attack cloud and traditional IT systems. This “Live Hack” uses open source attack tools that are free and available for download by anybody. Attendees will learn where to find and how to operate these tools for the purpose of testing their own IT infrastructu...
DevOps Summit, taking place Nov 3-5, 2015, at the Santa Clara Convention Center in Santa Clara, CA, is co-located with 17th Cloud Expo and will feature technical sessions from a rock star conference faculty and the leading industry players in the world. The widespread success of cloud computing is driving the DevOps revolution in enterprise IT. Now as never before, development teams must communicate and collaborate in a dynamic, 24/7/365 environment. There is no time to wait for long development...
Too often with compelling new technologies market participants become overly enamored with that attractiveness of the technology and neglect underlying business drivers. This tendency, what some call the “newest shiny object syndrome,” is understandable given that virtually all of us are heavily engaged in technology. But it is also mistaken. Without concrete business cases driving its deployment, IoT, like many other technologies before it, will fade into obscurity.
Whether you like it or not, DevOps is on track for a remarkable alliance with security. The SEC didn’t approve the merger. And your boss hasn’t heard anything about it. Yet, this unruly triumvirate will soon dominate and deliver DevSecOps faster, cheaper, better, and on an unprecedented scale. In his session at DevOps Summit, Frank Bunger, VP of Customer Success at ScriptRock, will discuss how this cathartic moment will propel the DevOps movement from such stuff as dreams are made on to a prac...