SANUWAVE Reports Second Quarter Financial Results And Provides A Business Update

ALPHARETTA, Ga., Aug. 11, 2015 (GLOBE NEWSWIRE) -- SANUWAVE Health, Inc. (OTCQB:SNWV), today reported financial results for the three and six months ended June 30, 2015 and provided a business update. The Company will host a conference call tomorrow, Wednesday, August 12, 2015, at 10:00 a.m. Eastern Time.

Highlights of the second quarter and recent weeks:

• Update on Path to FDA PMA Submission: Together with our regulatory advisors, Musculoskeletal Clinical Regulatory Advisors, LLC (MCRA), the Company had an in-person meeting with the U.S. Food and Drug Administration (FDA) in June 2015 in which it was determined that the best path to success would be for the Company to retain the original analysis plan for the Company's Phase III supplemental clinical trial utilizing the dermaPACE^® for treating diabetic foot ulcers.
   
• Renegotiated Debt: SANUWAVE signed an amendment with HealthTronics, Inc. to extend the due date of its two promissory notes from August 1, 2015 to January 31, 2017. In connection with the amendment, the Company entered into a security agreement with HealthTronics, Inc. to provide a first security interest in the assets of the Company.
   
• Positive Results of SANUWAVE Technology on Biofilms: SANUWAVE presented at the Center for Biofilm Engineering's 2015 Biofilm Science and Technology Meeting held at Montana State University on July 13-16, 2015. The Company's presentation showed the effectiveness of its shock wave technology for the removal of biofilms from surfaces using only the mechanical stresses produced by the shock waves and therefore, reducing or eliminating the need to use chemicals, enzymes or antibiotics to destroy and remove biofilms.
   
• Utility Patent using Shock Waves in Oil Industry: The Company received U.S. patent entitled "Apparatuses and Methods for Generating Shock Waves for Use in the Energy Industry" (patent number 9,057,232) relating to the use of shock waves, generated with laser systems, for hydraulic fracturing of rock formations, which can be employed in both secondary and tertiary oil recovery. 
   
• Continued Research into New Applications: Continued testing of the Company's patented shock wave technology in collaboration with the following:
  
  
  • Blood sterilization at the University of Georgia.
  • Bacterial biofilm disruption at Montana State University.

• Increased Authorized Shares of Capital Stock: A proposal to amend the Company's Articles of Incorporation to increase the number of authorized shares of capital stock from 155 million to 355 million was approved by an overwhelming majority of the current shareholders. 

"We have had a very busy second quarter, achieving many of the milestones we established on our last conference call," stated Kevin A. Richardson, II, Chairman of the board of SANUWAVE.   "We extended the due date of our debt with HealthTronics, which will allow us the flexibility to complete our PMA submission.  Our shareholders overwhelming approved an increase in authorized shares, which will allow us to raise adequate capital to move forward as a company. At the same time we are well aware of making sure we minimize dilution to our faithful shareholders.  We also had an extremely positive meeting with the FDA in June and now feel confident that when our top line data is revealed, in early September, we will be in a position to successfully submit our PMA to the FDA.  In addition, we expanded our patent portfolio and have seen a strong level of inbound interest in commercializing our patent portfolio." 

"As we look at the remainder of 2015 we have three milestones which need to be met: 1) reveal top line data from the study, 2) begin submission of the PMA to the FDA, and 3) raise capital or complete a joint venture, partnership or sale of the wound product to complete the FDA trial successfully and begin commercialization of the product in 2016.  We are also working on a number of other non-medical initiatives, which we will keep shareholders abreast of as they occur," concluded Mr. Richardson.

Second Quarter Financial Results

Revenues for the three months ended June 30, 2015 were $239,983, compared to $238,115 for the same period in 2014, an increase of $1,868, or 1%. The increase in revenues for 2015 was due to higher sales of orthoPACE devices.

Research and development expenses for the three months ended June 30, 2015 were $456,789, compared to $1,013,652 for the same period in 2014, a decrease of $556,863, or 55%. Research and development costs decreased in 2015 as a result of lower payments to third party clinical sites participating in the dermaPACE clinical study as there were fewer active patients in the clinical study as compared to the prior period.

General and administrative expenses for the three months ended June 30, 2015 were $636,570, as compared to $694,402 for the same period in 2014, a decrease of $57,832, or 8%. General and administrative expenses in 2014 included consulting costs related to the capital raises completed in March 2014. The lower consulting costs were partially offset by higher legal fees in 2015 related to patent filings.

Net loss for the three months ended June 30, 2015 was $1,521,533, or ($0.02) per share, compared to a net loss of $1,693,650, or ($0.03) per share, for the same period in 2014, a decrease in the net loss of $172,117, or 10%. The decrease in the net loss was primarily a result of reduced operating expenses in 2015 discussed above offset by the loss on the warrant valuation adjustment.

Six Months Ended June 30, 2015 Financial Results

Revenues for the six months ended June 30, 2015 were $450,435, compared to $383,213 for the same period in 2014, an increase of $67,222, or 18%. The increase in revenues for 2015 was due to higher sales of orthoPACE devices in Europe.

Research and development expenses for the six months ended June 30, 2015 were $1,091,412, compared to $1,778,497 for the same period in 2014, a decrease of $687,085, or 39%. Research and development costs decreased in 2015 as a result of lower payments to third party clinical sites participating in the dermaPACE clinical study as there were fewer active patients in the clinical study as compared to the prior period.

General and administrative expenses for the six months ended June 30, 2015 were $1,202,862, as compared to $1,994,713 for the same period in 2014, a decrease of $791,851, or 40%. General and administrative expenses in 2014 included consulting costs related to the capital raises completed in March 2014. The lower consulting costs were partially offset by higher legal fees in 2015 related to patent filings.

Net loss for the six months ended June 30, 2015 was $2,680,648, or ($0.04) per share, compared to a net loss of $4,257,604, or ($0.10) per share, for the same period in 2014, a decrease in the net loss of $1,576,956, or 37%. The decrease in the net loss was primarily a result of reduced operating expenses in 2015 discussed above.