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Sunshine Heart Announces Corporate Updates And First Quarter 2013 Financial Results

Stocks in this article: SSH

Following the positive 12-month follow up data for the C-Pulse feasibility study announced at the 2012 Transcatheter Cardiovascular Therapeutics (TCT) conference, the Company expects to submit the trial manuscript titled, "Ambulatory Extra-Aortic Counterpulsation in Patients with Moderate to Advanced Chronic Heart Failure," to a major medical journal for publication.

Sunshine Heart is currently in discussions with physicians regarding the potential weaning of additional patients from the C-Pulse system, based upon significant improvements since the time of implant. To-date, two patients implanted in the Company's Feasibility study have been permanently weaned from the device. The Company expects to report on the status of these additional patients in the coming months, as appropriate.

On the research and development front, the Company has executed an agreement with Cirtec Medical Systems, a leader in advanced engineering and manufacturing capabilities specializing in minimally invasive surgical and delivery devices, on a development pathway for its fully implantable C-Pulse pump. The Company is targeting the completion of a chronic animal trial in late 4Q13 for the pump and intends to provide more information as progress is made.

The Company is also pleased to report that it is aware of early stage work being done by a U.S. center evaluating the use of C-Pulse as a technology for Fontan Mechanical Assistance for patients born with single ventricles. In addition, Sunshine Heart has been approached by a separate center that is interested in conducting pre-clinical studies to evaluate C-Pulse as a non-blood contacting right ventricular assist device. Information regarding progress of these potential therapeutic indications for C-Pulse will be provided as data becomes available.

On May 6, 2013, Sunshine Heart completed its requested delisting from the Australian stock exchange. The Company is now traded solely on the NASDAQ Capital Market under symbol "SSH."

SUNSHINE HEART, INC. Condensed Consolidated Statements of Operations and Comprehensive Loss (Unaudited) (In thousands, except per share amounts)
 
  Three months ended March 31,
  2013 2012
Net sales $-- $--
     
Operating expenses    
Selling, general and administrative 1,976 1,940
Research and development 2,426 2,166
Total operating expenses 4,402 4,106
Loss from operations (4,402) (4,106)
Interest income 3 25
Loss before income taxes (4,399) (4,081)
Income tax benefit -- --
Net loss $(4,399) $ (4,081)
     
Basic and diluted loss per share $ (0.47) $ (0.66)
     
Weighted average shares outstanding – basic and diluted 9,417 6,169
     
Comprehensive loss $ (4,407) $ (4,027)
 
Condensed Consolidated Balance Sheets (Dollars in thousands, except share amounts)  
 
  March 31, 2013 December 31, 2012
  (unaudited)  
     
Current assets    
Cash and cash equivalents $10,970 $14,224
Other current assets 504 333
Total current assets 11,474 14,557
Property, plant and equipment, net 448 479
TOTAL ASSETS $11,922 $ 15,036
     
Current liabilities    
Accounts payable $1,584 $1,156
Accrued salaries, wages, and other compensation 435 931
Total current liabilities 2,019 2,087
Total liabilities 2,019 2,087
     
Commitments and contingencies -- --
     
Stockholders' equity    
Preferred Stock as of March 31, 2013 and December 31, 2012, par value $0.0001; per share; authorized 40,000,000 shares -- --
Common stock as of March 31, 2013 and December 31, 2012, par value $0.0001  per share; authorized 100,000,000 shares: issued  and outstanding 9,509,867 and 9,282,724 shares, respectively 1 1
Additional paid‑in capital 92,378 91,017
Accumulated other comprehensive loss:    
Foreign currency translation adjustment 1,177 1,185
Accumulated deficit (83,653) (79,254)
Total stockholders' equity 9,903 12,949
TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY $11,922 $ 15,036
 
Condensed Consolidated Statements of Cash Flows (Unaudited) (in thousands)
 
  For the three months ended March 31,
  2013 2012
Net loss $ (4,399) $ (4,081)
Adjustments to reconcile net loss to cash flows used in operating activities:    
Depreciation and amortization 40 31
Loss on disposal of plant and equipment -- 63
Stock-based compensation expense 367 318
Amortization of warrants for service agreements 120 --
Changes in assets and liabilities    
Other current assets (171) (299)
Accounts payable and accrued expenses (71) (800)
Net cash used in operations (4,114) (4,768)
Cash flows used in investing activities:    
Purchases of property and equipment (9) (89)
Net cash used in investing activities (9) (89)
Cash flows provided by financing activities:    
Net proceeds from the sale of common stock 874 2,061
Net cash provided by financing activities 874 2,061
Effect of exchange rate changes in cash (5) 65
Net decrease in cash and cash equivalents (3,254) (2,731)
Cash and cash equivalents - beginning of period 14,224 6,563
CASH AND CASH EQUIVALENTS - END OF PERIOD $10,970 $ 3,832

About the C-Pulse ® Heart Assist System

The C-Pulse Heart Assist System, or C-Pulse System, an investigational device in the United States, Canada and countries that do not recognize the CE mark approval, utilizes the scientific principles of intra-aortic balloon counter-pulsation applied in an extra-aortic approach to assist the left ventricle by reducing the workload required to pump blood throughout the body, while increasing blood flow to the coronary arteries. Combined, these potential benefits may help sustain the patient's current condition or, in some cases, reverse the heart failure process, thereby potentially preventing the need for later-stage heart failure devices, such as left ventricular assist devices (LVADs), artificial hearts or transplants. It may also provide relief from the symptoms of Class III and ambulatory Class IV heart failure and improve quality of life and cardiac function. Based on the results from our feasibility trial, we also believe that some patients treated with our C-Pulse System will be able to stop using the device due to sustained improvement in their conditions as a result of the therapy.

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