SYS-CON MEDIA Authors: Pat Romanski, Elizabeth White, Yeshim Deniz, Glenn Rossman, Cynthia Dunlop

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.

@CloudExpo Stories
The Internet of Things will greatly expand the opportunities for data collection and new business models driven off of that data. In her session at Internet of @ThingsExpo, Esmeralda Swartz, CMO of MetraTech, will discuss how for this to be effective you not only need to have infrastructure and operational models capable of utilizing this new phenomenon, but increasingly service providers will need to convince a skeptical public to participate. Get ready to show them the money! Speaker Bio: ...
Compute virtualization has been transformational, yet security policy implementation and enforcement has lagged behind in agility and automation. There are a number of key considerations when implementing policy in private and hybrid clouds. In his session at 15th Cloud Expo, Holland Barry, VP of Technology at Catbird, will discuss the impact of this new paradigm and what organizations can do today to safely move to software-defined network and compute architectures, including: How normal ope...
Samsung VP Jacopo Lenzi, who headed the company's recent SmartThings acquisition under the auspices of Samsung's Open Innovaction Center (OIC), answered a few questions we had about the deal. This interview was in conjunction with our interview with SmartThings CEO Alex Hawkinson. IoT Journal: SmartThings was developed in an open, standards-agnostic platform, and will now be part of Samsung's Open Innovation Center. Can you elaborate on your commitment to keep the platform open? Jacopo Lenzi: S...
How do APIs and IoT relate? The answer is not as simple as merely adding an API on top of a dumb device, but rather about understanding the architectural patterns for implementing an IoT fabric. There are typically two or three trends: Exposing the device to a management framework Exposing that management framework to a business centric logic • Exposing that business layer and data to end users. This last trend is the IoT stack, which involves a new shift in the separation of what stuff hap...
SYS-CON Events announced today that SOA Software, an API management leader, will exhibit at SYS-CON's 15th International Cloud Expo®, which will take place on November 4–6, 2014, at the Santa Clara Convention Center in Santa Clara, CA. SOA Software is a leading provider of API Management and SOA Governance products that equip business to deliver APIs and SOA together to drive their company to meet its business strategy quickly and effectively. SOA Software’s technology helps businesses to accel...
SYS-CON Events announced today that Utimaco will exhibit at SYS-CON's 15th International Cloud Expo®, which will take place on November 4–6, 2014, at the Santa Clara Convention Center in Santa Clara, CA. Utimaco is a leading manufacturer of hardware based security solutions that provide the root of trust to keep cryptographic keys safe, secure critical digital infrastructures and protect high value data assets. Only Utimaco delivers a general-purpose hardware security module (HSM) as a customiz...
Almost everyone sees the potential of Internet of Things but how can businesses truly unlock that potential. The key will be in the ability to discover business insight in the midst of an ocean of Big Data generated from billions of embedded devices via Systems of Discover. Businesses will also need to ensure that they can sustain that insight by leveraging the cloud for global reach, scale and elasticity.
SYS-CON Events announced today that ElasticBox is holding a Hackathon at DevOps Summit, November 6 from 12 pm -4 pm at the Santa Clara Convention Center in Santa Clara, CA. You can enter as an individual or team of up to 10 developers. A New Star Is Born Every Month! All completed ElasticBoxes will then be sent to a judging panel - 12 winners will be featured on the ElasticBox website in 2015. All entrants will receive five full enterprise licenses for one year + ElasticBox headphones + Elasti...
Once the decision has been made to move part or all of a workload to the cloud, a methodology for selecting that workload needs to be established. How do you move to the cloud? What does the discovery, assessment and planning look like? What workloads make sense? Which cloud model makes sense for each workload? What are the considerations for how to select the right cloud model? And how does that fit in with the overall IT tranformation? In his session at 15th Cloud Expo, John Hatem, head of V...
Cloud services are the newest tool in the arsenal of IT products in the market today. These cloud services integrate process and tools. In order to use these products effectively, organizations must have a good understanding of themselves and their business requirements. In his session at 15th Cloud Expo, Brian Lewis, Principal Architect at Verizon Cloud, will outline key areas of organizational focus, and how to formalize an actionable plan when migrating applications and internal services to...
SAP is delivering break-through innovation combined with fantastic user experience powered by the market-leading in-memory technology, SAP HANA. In his General Session at 15th Cloud Expo, Thorsten Leiduck, VP ISVs & Digital Commerce, SAP, will discuss how SAP and partners provide cloud and hybrid cloud solutions as well as real-time Big Data offerings that help companies of all sizes and industries run better. SAP launched an application challenge to award the most innovative SAP HANA and SAP ...
Ixia develops amazing products so its customers can connect the world. Ixia helps its customers provide an always-on user experience through fast, secure delivery of dynamic connected technologies and services. Through actionable insights that accelerate and secure application and service delivery, Ixia's customers benefit from faster time to market, optimized application performance and higher-quality deployments.
SYS-CON Events announced today that Calm.io has been named “Bronze Sponsor” of DevOps Summit Silicon Valley, which will take place on November 4–6, 2014, at the Santa Clara Convention Center in Santa Clara, CA. Calm.io is a cloud orchestration platform for AWS, vCenter, OpenStack, or bare metal, that runs your CL tools puppet, Chef, shell, git, Jenkins, nagios, and will soon support New Relic and Docker. It can run hosted, or on premise and provides VM automation / expiry, self-service portals,...
In her General Session at 15th Cloud Expo, Anne Plese, Senior Consultant, Cloud Product Marketing, at Verizon Enterprise, will focus on finding the right mix of renting vs. buying Oracle capacity to scale to meet business demands, and offer validated Oracle database TCO models for Oracle development and testing environments. Anne Plese is a marketing and technology enthusiast/realist with over 19+ years in high tech. At Verizon Enterprise, she focuses on driving growth for the Verizon Cloud pla...
SYS-CON Events announced today that Aria Systems, the recurring revenue expert, has been named "Bronze Sponsor" of SYS-CON's 15th International Cloud Expo®, which will take place on November 4-6, 2014, at the Santa Clara Convention Center in Santa Clara, CA. Aria Systems helps leading businesses connect their customers with the products and services they love. Industry leaders like Pitney Bowes, Experian, AAA NCNU, VMware, HootSuite and many others choose Aria to power their recurring revenue bu...
The Internet of Things (IoT) is going to require a new way of thinking and of developing software for speed, security and innovation. This requires IT leaders to balance business as usual while anticipating for the next market and technology trends. Cloud provides the right IT asset portfolio to help today’s IT leaders manage the old and prepare for the new. Today the cloud conversation is evolving from private and public to hybrid. This session will provide use cases and insights to reinforce t...
As Platform as a Service (PaaS) matures as a category, developers should have the ability to use the programming language of their choice to build applications and have access to a wide array of services. Bluemix is IBM's open cloud development platform that enables users to easily build cloud-based, creative mobile and web applications without having to spend large amounts of time and resources on configuring infrastructure and multiple software licenses. In this track, you will learn about the...
Blue Box has closed a $10 million Series B financing. The round was led by a strategic investor and included participation from prior investors including Voyager Capital and Founders Collective, as well as the Blue Box executive team. This round follows a $4.3 million Series A closed in December of 2012 and led by Voyager Capital. In May of this year, the company announced general availability of its private cloud as a service offering, Blue Box Cloud. Since that release, the company has dem...
SYS-CON Events announced today that Verizon has been named "Gold Sponsor" of SYS-CON's 15th International Cloud Expo®, which will take place on November 4-6, 2014, at the Santa Clara Convention Center in Santa Clara, CA. Verizon Enterprise Solutions creates global connections that generate growth, drive business innovation and move society forward. With industry-specific solutions and a full range of global wholesale offerings provided over the company's secure mobility, cloud, strategic network...
SimpleECM is the only platform to offer a powerful combination of enterprise content management (ECM) services, capture solutions, and third-party business services providing simplified integrations and workflow development for solution providers. SimpleECM is opening the market to businesses of all sizes by reinventing the delivery of ECM services. Our APIs make the development of ECM services simple with the use of familiar technologies for a frictionless integration directly into web applicat...