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8-K - FORM 8-K - SANUWAVE Health, Inc.snwv20140807_8k.htm
EX-99 - EXHIBIT 99.2 - SANUWAVE Health, Inc.ex99-2.htm

 

Exhibit 99.1

FOR IMMEDIATE RELEASE

 

 

SANUWAVE HEALTH REPORTS SECOND QUARTER FINANCIAL RESULTS

AND PROVIDES A BUSINESS UPDATE

 

ALPHARETTA, GA, August 6, 2014 – SANUWAVE Health, Inc. (OTCQB: SNWV) today reported financial results for the three and six months ended June 30, 2014 and provided a business update. The Company will host a conference call on Thursday, August 7, 2014, at 11:00 a.m. Eastern Time.

 

Highlights of the second quarter and recent weeks include:

 

 

Achieved the minimum required 90 patients in the Phase III supplemental clinical trial using dermaPACE® for treating diabetic foot ulcers as reported on April 30, 2014. The 90 patients have now completed the 12 week efficacy assessment period which is an important milestone. The Company anticipates having the feedback from the independent Data Monitoring Committee regarding the initial efficacy analysis of these first 90 patients in September 2014.

 

 

Signed a strategic agreement with Premier Shockwave, Inc. to manage the Company's OssaTron® devices which are FDA approved for the treatment of multiple orthopedic conditions that have failed to respond to conservative treatment.

 

 

Received a patent issued by the U.S. Patent and Trademark Office related to the use of shock waves for stimulation of proliferation inside the body of donor stem cells. The proliferated donor stem cells are then harvested for further laboratory proliferation to create transplant cells. In another step, shock waves are used to pre-treat the targeted location for tissue regeneration, to stimulate blood vessel formation and thus increase survival rate for transplanted stem cells. Furthermore, the methods of this patent include the application of shock waves after stem cell transplantation in the recipient area to accelerate and enhance tissue reconstruction.

 

“We achieved a significant milestone for SANUWAVE in the second quarter with the 90th patient being enrolled in the dermaPACE clinical trial and now having completed the 12 week efficacy assessment period,” stated Kevin A. Richardson, II, Chairman of the board of directors. “We anticipate having the feedback from the Data Monitoring Committee regarding the first 90 patients in September and look forward to updating shareholders at that time. We have continued to enroll patients in the dermaPACE® clinical trial for treating diabetic foot ulcers and remain focused on completing the trial as soon as possible to address this $3 billion market opportunity in the United States.”

 

“In addition, our technology platform includes 38 issued and pending patents, and finding additional strategic partners, such as Premier Shockwave, to help us monetize and advance new uses for our technology covered by these patents into other verticals and applications, including stem cells, is very important for us to achieve our ultimate goal, which is to maximize shareholder value,” concluded Mr. Richardson.

 

 
 

 

 

Second Quarter Financial Results

Revenue for the three months ended June 30, 2014 was $238,115, compared to $160,617 for the same period in 2013, an increase of $77,498, or 48%. The increase in revenue for 2014 was due to higher sales of orthoPACE devices in 2014 in Asia/Pacific, as compared to the prior year, as well as higher sales of refurbished applicators in Europe.

 

Research and development expenses for the three months ended June 30, 2014 were $1,013,652, compared to $624,533 for the same period in 2013, an increase of $389,119, or 62%. Research and development expenses increased in 2014 as a result of the clinical study starting the more costly enrollment phase in June 2013.

 

General and administrative expenses for the three months ended June 30, 2014 were $694,402, as compared to $1,157,119 for the same period in 2013, a decrease of $462,717, or 40%. The decrease in general and administrative expenses is primarily due to reduced stock-based compensation expense for 2014 due to the forfeiture of non-vested stock options by a terminated employee in 2014.

 

Net loss for the three months ended June 30, 2014 was $1,693,650, or ($0.03) per basic and diluted share, compared to a net loss of $818,331, or ($0.04) per basic and diluted share, for the same period in 2013, an increase in the net loss of $875,319, or 107%. The increase in the net loss was primarily a result of the one-time non-cash gain of $2,328,000 in other income in 2013 for the embedded conversion feature of the Senior Secured Notes which were converted to equity in the third quarter of 2013, offset by accrued interest expense on the Senior Secured Notes.

 

Six Months Ended June 30, 2014 Financial Results

Revenue for the six months ended June 30, 2014 was $383,213, compared to $361,851 for the same period in 2013, an increase of $21,362, or 6%. The increase in revenue for 2014 was due to higher sales of device applicators as compared to the prior year.

 

Operating expenses for the six months ended June 30, 2014 were $3,936,073, compared to $3,141,618 for the same period in 2013, an increase of $794,455, or 25%. The increase in operating expenses is primarily a result of the clinical study starting the more costly enrollment phase in June 2013.

 

Net loss for the six months ended June 30, 2014 was $4,257,604, or ($0.10) per basic and diluted share, compared to a net loss of $6,187,664, or ($0.29) per basic and diluted share, for the same period in 2013, a decrease in the net loss of $1,930,060, or 31%. The decrease in the net loss was primarily a result of the one-time non-cash loss of $1,409,000 in other income in 2013 for the embedded conversion feature of the Senior Secured Notes which were converted to equity in the third quarter of 2013, offset by increased expenses in 2014 for the dermaPACE clinical study.

 

On June 30, 2014, the Company had cash and cash equivalents of $6,153,055 compared with $182,315 as of December 31, 2013, an increase of $5,970,740. For the six months ended June 30, 2014 and 2013, net cash used by operating activities was $4,093,335 and $1,983,647, respectively, an increase of $2,109,688, or 106%. The increase was primarily due to the increased research and development expenses in 2014, as compared to 2013, of $809,279 for expenses associated with the dermaPACE clinical trial as a result of the clinical study starting the more costly enrollment phase in June 2013 and the reduction of accounts payable and accrued expenses in 2014 of $1,051,311. Net cash provided by financing activities for the six months ended June 30, 2014 and 2013 was $10,072,492 and $1,980,497, respectively, which in 2014 consisted of the net proceeds from the 2014 Private Placement of $8,562,500, the proceeds from the 18% Convertible Promissory Notes of $815,000 and the proceeds from sale of capital stock per the Subscription Agreement with a related party of $900,000 and in 2013 primarily consisted of the net proceeds from the subscriptions payable for Senior Secured Notes of $1,570,000.

 

 
 

 

 

Conference Call

The Company will host a conference call on Thursday, August 7, 2014, beginning at 11:00 AM ET to discuss the second quarter financial results and provide a business update.

 

Shareholders and other interested parties can participate in the conference call by dialing 877-407-9055 (U.S. and Canada) or 201-493-6743 (international).

 

A replay of the conference call will be available beginning two hours after its completion through August 14, 2014 by dialing 877-660-6853 (U.S. and Canada) or 201-612-7415 (international) and entering Conference ID 414704.

 

About SANUWAVE Health, Inc.

SANUWAVE Health, Inc. (www.sanuwave.com) is a shock wave technology company initially focused on the development and commercialization of patented noninvasive, biological response activating devices for the repair and regeneration of skin, musculoskeletal tissue and vascular structures. SANUWAVE’s portfolio of regenerative medicine products and product candidates activate biologic signaling and angiogenic responses, producing new vascularization and microcirculatory improvement, which helps restore the body’s normal healing processes and regeneration. SANUWAVE applies its patented PACE technology in wound healing, orthopedic/spine, plastic/cosmetic and cardiac conditions. Its lead product candidate for the global wound care market, dermaPACE®, is CE Marked throughout Europe and has device license approval for the treatment of the skin and subcutaneous soft tissue in Canada, Australia and New Zealand. In the U.S., dermaPACE is currently under the FDA’s Premarket Approval (PMA) review process for the treatment of diabetic foot ulcers. SANUWAVE researches, designs, manufactures, markets and services its products worldwide, and believes it has demonstrated that its technology is safe and effective in stimulating healing in chronic conditions of the foot (plantar fasciitis) and the elbow (lateral epicondylitis) through its U.S. Class III PMA approved OssaTron® device, as well as stimulating bone and chronic tendonitis regeneration in the musculoskeletal environment through the utilization of its OssaTron, Evotron® and orthoPACE® devices in Europe, Asia and Asia/Pacific. In addition, there are license/partnership opportunities for SANUWAVE’s shock wave technology for non-medical uses, including energy, water, food and industrial markets.

 

Forward-Looking Statements

This press release may contain “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, such as statements relating to financial results and plans for future business development activities, and are thus prospective. Forward-looking statements include all statements that are not statements of historical fact regarding intent, belief or current expectations of the Company, its directors or its officers. Investors are cautioned that any such forward-looking statements are not guarantees of future performance and involve risks and uncertainties, many of which are beyond the Company’s ability to control. Actual results may differ materially from those projected in the forward-looking statements. Among the key risks, assumptions and factors that may affect operating results, performance and financial condition are risks associated with the regulatory approval and marketing of the Company’s product candidates and products, unproven pre-clinical and clinical development activities, regulatory oversight, the Company’s ability to manage its capital resource issues, competition, and the other factors discussed in detail in the Company’s periodic filings with the Securities and Exchange Commission. The Company undertakes no obligation to update any forward-looking statement.

 

For additional information about the Company, visit www.sanuwave.com.

 

 
 

 

 

Contact:

 

DC Consulting, LLC

407-792-3333

investorinfo@dcconsultingllc.com

 

Investor Relations

RedChip Companies, Inc.

Mike Bowdoin, Vice President

800-733-2447, ext. 110

mike@redchip.com

 

 



  

(FINANCIAL TABLES FOLLOW)

 

 
 

 

 

SANUWAVE HEALTH, INC. AND SUBSIDIARIES

CONDENSED CONSOLIDATED BALANCE SHEETS

(UNAUDITED)

 

     

June 30,

   

December 31,

 
     

2014

   

2013

 

ASSETS

 

CURRENT ASSETS

                 

Cash and cash equivalents

  $ 6,153,055     $ 182,315  

Accounts receivable - trade, net of allowance for doubtful accounts of $43,433 in 2014 and $43,282 in 2013

    59,721       139,736  

Inventory

    250,605       246,006  

Prepaid expenses

    126,364       75,020  

TOTAL CURRENT ASSETS

    6,589,745       643,077  
                   

PROPERTY AND EQUIPMENT, at cost, less accumulated depreciation

    7,218       13,267  
                   

OTHER ASSETS

    11,440       11,444  
                   

INTANGIBLE ASSETS, at cost, less accumulated amortization

    766,891       920,269  

TOTAL ASSETS

  $ 7,375,294     $ 1,588,057  
                   

LIABILITIES

 

CURRENT LIABILITIES

                 

Accounts payable

  $ 399,126     $ 935,028  

Accrued expenses

    348,163       863,572  

Accrued employee compensation

    125,380       140,102  

Convertible promissory note

    -       147,775  

Promissory notes

    -       89,038  

Interest payable, related parties

    80,968       163,729  

Capital lease payable

    1,343       3,951  

TOTAL CURRENT LIABILITIES

    954,980       2,343,195  
                   

NON-CURRENT LIABILITIES

                 

Notes payable, related parties

    5,372,743       5,372,743  

TOTAL LIABILITIES

    6,327,723       7,715,938  
                   

COMMITMENTS AND CONTINGENCIES

    -       -  
                   

STOCKHOLDERS' EQUITY (DEFICIT)

 

PREFERRED STOCK, SERIES A CONVERTIBLE, par value $0.001, 6,175 shares authorized; 6,175 shares issued and outstanding

    6       -  
                   

PREFERRED STOCK - UNDESIGNATED, par value $0.001, 4,993,825 shares authorized; no shares issued and outstanding

    -       -  
                   

COMMON STOCK, par value $0.001, 150,000,000 shares authorized; 50,706,519 and 37,984,182 issued and outstanding in 2014 and 2013, respectively

    50,707       37,984  
                   

ADDITIONAL PAID-IN CAPITAL

    87,462,798       76,037,490  
                   

ACCUMULATED OTHER COMPREHENSIVE INCOME

    1,707       6,688  
                   

ACCUMULATED DEFICIT

    (86,467,647 )     (82,210,043 )

TOTAL STOCKHOLDERS' EQUITY (DEFICIT)

    1,047,571       (6,127,881 )

TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY (DEFICIT)

  $ 7,375,294     $ 1,588,057  

 

 
 

 

 

SANUWAVE HEALTH, INC. AND SUBSIDIARIES

CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS

(UNAUDITED)

 

       

Three Months Ended

   

Three Months Ended

   

Six Months Ended

   

Six Months Ended

 
       

June 30,

   

June 30,

   

June 30,

   

June 30,

 
       

2014

   

2013

   

2014

   

2013

 
                                     

REVENUE

  $ 238,115     $ 160,617     $ 383,213     $ 361,851  
                                     

COST OF REVENUE

    63,399       23,783       81,736       79,594  
                                     
   

GROSS PROFIT

    174,716       136,834       301,477       282,257  
                                     

OPERATING EXPENSES

                               
 

Research and development

    1,013,652       624,533       1,778,497       969,218  
 

General and administrative

    694,402       1,157,119       1,994,713       2,009,040  
 

Depreciation

    4,770       4,991       9,485       9,982  
 

Amortization

    76,689       76,689       153,378       153,378  
   

TOTAL OPERATING EXPENSES

    1,789,513       1,863,332       3,936,073       3,141,618  
                                     
   

OPERATING LOSS

    (1,614,797 )     (1,726,498 )     (3,634,596 )     (2,859,361 )
                                     

OTHER INCOME (EXPENSE)

                               
 

Gain (loss) on embedded conversion feature of Senior Secured Notes

    -       2,328,000       -       (1,409,000 )
 

Interest expense, net

    (77,838 )     (1,416,140 )     (620,130 )     (1,925,030 )
 

Gain on sale of fixed assets

    -       -       -       7,500  
 

Loss on foreign currency exchange

    (1,015 )     (3,693 )     (2,878 )     (1,773 )
   

TOTAL OTHER INCOME (EXPENSE)

    (78,853 )     908,167       (623,008 )     (3,328,303 )
                                     
   

LOSS BEFORE INCOME TAXES

    (1,693,650 )     (818,331 )     (4,257,604 )     (6,187,664 )
                                     

INCOME TAX EXPENSE

    -       -       -       -  
                                     
   

NET LOSS

    (1,693,650 )     (818,331 )     (4,257,604 )     (6,187,664 )
                                     

OTHER COMPREHENSIVE INCOME (LOSS)

                               
 

Foreign currency translation adjustments

    (3,549 )     2,950       (4,981 )     (3,975 )
   

TOTAL COMPREHENSIVE LOSS

  $ (1,697,199 )   $ (815,381 )   $ (4,262,585 )   $ (6,191,639 )
                                     

LOSS PER SHARE:

                               
 

Net loss - basic and diluted

  $ (0.03 )   $ (0.04 )   $ (0.10 )   $ (0.29 )
                                     
 

Weighted average shares outstanding - basic and diluted

    48,423,293       21,757,310       44,035,108       21,517,719  

 

 
 

 

 

 

SANUWAVE HEALTH, INC. AND SUBSIDIARIES

 

CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS

 

(UNAUDITED)

 

     

Six Months Ended

   

Six Months Ended

 
     

June 30,

   

June 30,

 
     

2014

   

2013

 
                   

CASH FLOWS FROM OPERATING ACTIVITIES

               

Net loss

  $ (4,257,604 )   $ (6,187,664 )

Adjustments to reconcile net loss to net cash used by operating activities

               
 

Amortization

    153,378       153,378  
 

Depreciation

    9,485       9,982  
 

Change in allowance for doubtful accounts

    151       1,730  
 

Stock-based compensation - employees, directors and advisors

    57,755       507,395  
 

Stock issued for consulting services

    743,150       343,880  
 

Accrued interest on 18% Convertible Promissory Notes

    7,168       -  
 

Accretion of interest on warrants issued concurrent with a convertible promissory note

    339,864       -  
 

Loss on embedded conversion feature of Senior Secured Notes

    -       1,409,000  
 

Accretion of interest and accrued interest on Senior Secured Notes

    -       1,757,330  
 

Gain on sale of property and equipment

    -       (7,500 )
 

Changes in assets - (increase)/decrease

               
 

Accounts receivable - trade

    79,864       9,395  
 

Inventory

    (4,599 )     37,511  
 

Prepaid expenses

    (51,344 )     18,896  
 

Other

    4       110  
 

Changes in liabilities - increase/(decrease)

               
 

Accounts payable

    (535,902 )     104,603  
 

Accrued expenses

    (515,409 )     (12,800 )
 

Accrued employee compensation

    (14,722 )     (133,685 )
 

Promissory notes - accrued interest

    (21,813 )     5,688  
 

Interest payable, related parties

    (82,761 )     (896 )
 

NET CASH USED BY OPERATING ACTIVITIES

    (4,093,335 )     (1,983,647 )
                   

CASH FLOWS FROM INVESTING ACTIVITIES

               
 

Sale of property and equipment

    -       7,500  
 

Purchase of property and equipment

    (3,436 )     -  
 

NET CASH PROVIDED (USED) BY INVESTING ACTIVITIES

    (3,436 )     7,500  
                   

CASH FLOWS FROM FINANCING ACTIVITIES

               
 

Proceeds from 2014 Private Placement, net

    8,562,500       -  
 

Proceeds from sale of capital stock - subscription agreement

    900,000       75,000  
 

Proceeds from 18% Convertible Promissory Notes

    815,000       -  
 

Proceeds from convertible promissory notes, net

    325,000       -  
 

Proceeds from employee stock option exercise

    12,600       37,917  
 

Proceeds from subscriptions payable for Senior Secured Notes

    -       1,570,000  
 

Proceeds from promissory notes

    -       300,000  
 

Payments of principal on convertible promissory notes

    (450,000 )     -  
 

Payments of principal on promissory notes

    (90,000 )     -  
 

Payments of principal on capital lease

    (2,608 )     (2,420 )
 

NET CASH PROVIDED BY FINANCING ACTIVITIES

    10,072,492       1,980,497  
                   

EFFECT OF EXCHANGE RATES ON CASH

    (4,981 )     (3,975 )
                   
 

NET INCREASE IN CASH AND CASH EQUIVALENTS

    5,970,740       375  
                   

CASH AND CASH EQUIVALENTS, BEGINNING OF PERIOD

    182,315       70,325  
 

CASH AND CASH EQUIVALENTS, END OF PERIOD

  $ 6,153,055     $ 70,700  
                   

SUPPLEMENTAL INFORMATION

               
 

Cash paid for interest, related parties

  $ 244,836     $ 161,936  

 

  

*****