SOURCE: Viveve Medical, Inc.

Viveve Medical, Inc. Logo

November 14, 2014 09:25 ET

Viveve Reports Third Quarter 2014 Financial Results

SUNNYVALE, CA--(Marketwired - November 14, 2014) - Viveve Medical, Inc. ("Viveve") (PINKSHEETS: VIVMF), the parent company to Viveve, Inc., a company focused on women's health, today reported financial results for the period ended September 30, 2014. These results are the first financial results reported for Viveve following the merger of Viveve, Inc. with PLC Systems, Inc.

"With the completion of our recent financing transactions we believe we are now in a position to successfully execute our strategic plans," said Patricia Scheller, Viveve's Chief Executive Officer. "Our focus has been and will continue to be driving commercialization through the attainment of necessary regulatory clearances, generating differentiating clinical data and increasing awareness about a condition that affects millions of women worldwide. We believe our treatment provides the first real hope in the effort to effectively address vaginal introital laxity."

Recent Business Highlights

  • Became publicly traded under the symbol VIVMF following the completion of the merger of Viveve, Inc. and PLC Systems, Inc.
  • Successfully raised $6 million in equity capital, including the conversion of $1.5 million in outstanding debt, to support additional clinical and global commercialization efforts
  • Secured a $5 million term loan (of which Viveve, Inc. has drawn $2.5 million) to fund working capital, as we begin to more aggressively pursue sales of the Viveve System
  • Preparing for the imminent launch of the VIVEVE I clinical trial in Europe and Canada

Financial Results

Research and development expenses for the three months ended September 30, 2014 totaled $572,134, compared to research and development expense of $177,203 for the three months ended September 30, 2013, an increase of $394,931, or approximately 223%. Spending on research and development increased in the third quarter of 2014 as we prepared for our OUS Clinical Trial and incurred costs associated with the trial's implementation. Research and development further increased due to additional engineering work related to certain product improvement efforts.

Selling, general and administrative expenses for the three months ended September 30, 2014 totaled $1,790,014, compared to $532,369 for the three months ended September 30, 2013, an increase of $1,257,645, or approximately 236%. The increase in general and administrative expenses was primarily attributable to additional professional services related expenses associated with our recent merger and to a lesser degree greater spending to build inventory and brand and market awareness.

Net loss for the three months ended September 30, 2014 was $2,504,159 or a loss of $0.52 per share, compared with a net loss of $871,893, or a loss of $0.23 per share, for the three months ended September 30, 2013.

Cash and cash equivalents were $1,976,980 as of September 30, 2014, an increase of $1,546,873 from $430,107 as of December 31, 2013.

About Viveve

Viveve, Inc., the operating subsidiary of Viveve Medical, Inc., is a women's health company passionately committed to advancing new solutions to improve women's overall well-being and quality of life. The company's lead product, the Viveve® System, is a non-surgical, non-ablative medical device that remodels collagen and restores tissue. The Viveve System treats the condition of vaginal laxity, which is the result of the over-stretching of tissue during childbirth that can result in a decrease in physical sensation and sexual satisfaction. Physician surveys indicate that vaginal laxity is the number one post-delivery physical change for women, being more prevalent than weight gain, urinary incontinence or stretch marks. The Viveve Treatment uses patented, reverse-thermal gradient radiofrequency technology to tighten the tissues of the vaginal introitus (opening) and requires only a 30-minute out-patient treatment in a physician's office. The Viveve System has received regulatory approval in Europe, Canada and Hong Kong and is available through physician import license in Japan. It is currently not available for sale in the U.S. For more information, please visit Viveve's website at www.viveve.com.

Safe Harbor Statement

All statements in this press release that are not based on historical fact are "forward-looking statements." While management has based any forward-looking statements included in this press release on its current expectations, the information on which such expectations were based may change. These forward-looking statements rely on a number of assumptions concerning future events and are subject to a number of risks, uncertainties and other factors, many of which are outside of our control, which could cause actual results to materially differ from such statements. Such risks, uncertainties, and other factors include, but are not limited to, the fluctuation of global economic conditions, the performance of management and our employees, our ability to obtain financing, competition, general economic conditions and other factors that are to be detailed in our periodic and current reports available for review at www.sec.gov. Furthermore, we operate in a highly competitive and rapidly changing environment where new and unanticipated risks may arise. Accordingly, investors should not place any reliance on forward-looking statements as a prediction of actual results. We disclaim any intention to, and undertake no obligation to, update or revise forward-looking statements to reflect events or circumstances that subsequently occur or of which we hereafter become aware.

Viveve is a registered trademark of Viveve, Inc.

 
VIVEVE MEDICAL, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
(unaudited)
     
  September 30, 2014 December 31, 2013
ASSETS    
Current assets:        
 Cash and cash equivalents $1,976,980  $430,107 
 Accounts receivable  3,750   - 
 Inventory  136,902   228,163 
 Prepaids and other current assets  188,006   308,183 
  Total current assets  2,305,638   966,453 
Property and equipment, net  191,663   127,524 
Other assets  652,045   43,783 
  Total assets $3,149,346  $1,137,760 
LIABILITIES AND STOCKHOLDERS' EQUITY (DEFICIT)        
Current liabilities:        
 Accounts payable $566,059  $967,315 
 Accrued liabilities  387,538   516,152 
 Note payable  1,471,799   1,463,244 
 Related party convertible bridge notes  -   4,875,000 
  Total current liabilities  2,425,396   7,821,711 
Preferred stock warrant liabilities  -   623,672 
  Total liabilities  2,425,396   8,445,383 
         
Stockholders' equity (deficit):        
 Series A convertible preferred stock  -   23,863 
 Series B convertible preferred stock  -   171,199 
 Preferred stock, no par value  -   - 
 Common stock, $0.001 par value  -   6,556 
 Common stock and paid-in capital, no par value  35,066,274   - 
 Additional paid-in capital  -   22,395,684 
 Accumulated deficit  (34,342,324)  (29,904,925)
  Total stockholders' equity (deficit)  723,950   (7,307,623)
  Total liabilities and stockholders' equity (deficit) $3,149,346  $1,137,760 
   
        
        
VIVEVE MEDICAL, INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(unaudited)
        
      
 Three Months Ended Nine Months Ended
 September 30, September 30,
 2014 2013 2014 2013
        
Revenue$17,180  $4,610  $64,475  $147,660 
Cost of revenue 14,724   1,493   40,075   110,528 
  Gross profit 2,456   3,117   24,400   37,132 
                
Operating expenses:               
Research and development 572,134   177,203   940,954   628,545 
Selling, general and administrative 1,790,014   532,369   3,085,580   2,517,791 
  Total operating expenses 2,362,148   709,572   4,026,534   3,146,336 
  Loss from operations (2,359,692)  (706,455)  (4,002,134)  (3,109,204)
Interest income 2   2   5   5 
Interest expense (152,296)  (156,727)  (486,582)  (334,380)
Other income (expense), net 7,827   (8,713)  51,312   11,230 
  Net loss$(2,504,159) $(871,893) $(4,437,399) $(3,432,349)
                
                
Net loss per share:               
  Basic and diluted$(0.52) $(0.23) $(1.08) $(0.92)
                
Weighted average shares used in               
computing net loss per common share               
  Basic and diluted 4,829,300   3,743,282   4,109,266   3,743,282 
                

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