SOURCE: Milestone Scientific, Inc.

Milestone Scientific, Inc.

April 07, 2016 14:03 ET

Milestone Scientific Reports Fourth Quarter and Year End 2015 Financial Results; Provides Update on Status of Clinical Trials for Epidural Instrument

LIVINGSTON, NJ--(Marketwired - April 07, 2016) - Milestone Scientific Inc. (NYSE MKT: MLSS), a medical R&D company that designs, patents, incubates and commercializes a growing portfolio of innovative injection technologies, today announced financial results for the fourth quarter and year ended December 31, 2015, and provided a business update including an update on its minority owned subsidiary which holds the exclusive rights to the epidural and intra-articular (IA) instruments ("Epidural & IA Subsidiary").

Leonard Osser, Chief Executive Officer of Milestone Scientific, stated, "Although our revenue declined compared to the same period last year, our revenue improved sequentially, and our gross profit increased compared to the same period last year. Moreover, we are making continued progress implementing a number of sales and marketing initiatives that will enable us to resume growth of our dental instruments in 2016. For the fourth quarter of 2015, we experienced a net loss of $1.4 million, or $0.07 per share, which reflects increased investment in sales and marketing for the dental instruments, as well as increased expenses related to the development of our medical instruments. Heading into the first quarter of 2016, we are now seeing the positive impact of these initiatives and anticipate improved revenue for the first quarter of 2016 and for the full year. I am also pleased to report that our global sales initiatives for the dental instrument are taking hold and we are seeing positive results heading into 2016, especially in China. We recently announced a purchase order for one thousand dental instruments and over seven thousand disposable handpieces from Milestone China, a joint venture distribution company between Milestone Scientific and a team of senior healthcare executives from China. The purchase order is valued at approximately $1.4 million, and will be recognized in the first quarter of 2016. Based on the feedback thus far, we expect these purchase orders will continue to increase in 2016."

Mr. Osser continued, "We have nearly completed the clinical trials of our epidural instrument, and have less than 40 patients remaining. Our trial was delayed due, in part, to the recent addition of two new sites in the U.S. at leading universities, which will broaden the scope of our clinical trials. The trials at these two sites are commencing this week and should be completed in May. We are also pleased to report that we have had abstracts on our epidural instrument accepted in some of the most prestigious academic journals in the U.S. and Europe. Upon completion of the clinical trials, we will conduct a statistical analysis, which should take no more than one week, at which time, we will submit the final data to the U.S. Food & Drug Administration (FDA). Feedback from distributors has been positive, however, in order to negotiate the most favorable terms, we are holding off on signing new distributors until the FDA approval is in place. We have also submitted the required information to the U.S. FDA for approval of the IA instrument, and are awaiting feedback, the timing of which is uncertain as this remains outside of our control. At the same time, we remain focused on launching new medical instruments, which we believe will open sizable new markets for the company."

Revenue for the year ended December 31, 2015 was $9.5 million versus $10.3 million for year ended December 31, 2014. The decrease in revenue of $(841,521) or 8% was due to a decrease in instruments and handpiece unit sales. In the domestic market, total revenue decreased by $(1.1) million. On the international front, total revenue increased by $308,000 to $5.9 million versus $5.6 million for the same period in 2014. Gross profit for the year ended December 31, 2015 was $6.4 million or 68% of revenue versus $6.7 million or 65% of revenue for the year ended December 31, 2014. Operating loss for the year ended December 31, 2015 was $(3,056,748) versus an operating loss of $790,196 for the same period last year. Net loss for the year ended December 31, 2015 was $(5,539,903), or $(0.26) per share, versus a loss of $(1,707,496), or $(0.08) per share, for the comparable period in 2014. Net loss for the year ended December 31, 2015 includes a Loss on Earnings from the Medical Joint Venture of $(2,019,211) compared to $(891,500) for the same period last year and a Loss of Earnings on Milestone China of $(418,432) compared to a loss of $(810,000) for the same period last year.

Conference Call

Milestone Scientific's executive management team will host a teleconference on Monday, April 11, 2016 at 8:00 AM Eastern Time to discuss the company's financial results. The conference call can be accessed via telephone by dialing toll free 888-710-4015 and entering the passcode 6792477 or on the company website at www.milestonescientific.com. For those unable to participate at that time, a replay of the call can be accessed by dialing 888-203-1112 and entering the pass code 6792477. The replay will be available for 90 days.

About Milestone Scientific Inc.

Milestone Scientific Inc. (MLSS) is a medical R&D company that designs, patents, incubates and commercializes a growing portfolio of innovative injection technologies. Milestone's computer-controlled systems make injections precise, efficient, and virtually painless. For more information please visit our website: www.milestonescientific.com.

Safe Harbor Statement
This press release contains forward-looking statements regarding the timing and financial impact of Milestone's ability to implement its business plan, expected revenues and future success. These statements involve a number of risks and uncertainties and are based on assumptions involving judgments with respect to future economic, competitive and market conditions and future business decisions, all of which are difficult or impossible to predict accurately and many of which are beyond Milestone's control. Some of the important factors that could cause actual results to differ materially from those indicated by the forward-looking statements are general economic conditions, failure to achieve expected revenue growth, changes in our operating expenses, adverse patent rulings, FDA or legal developments, competitive pressures, changes in customer and market requirements and standards, and the risk factors detailed from time to time in Milestone's periodic filings with the Securities and Exchange Commission, including without limitation, Milestone's Annual Report for the year ended December 31, 2014. The forward looking statements in this press release are based upon management's reasonable belief as of the date hereof. Milestone undertakes no obligation to revise or update publicly any forward-looking statements for any reason.

   
   
MILESTONE SCIENTIFIC AND SUBSIDIARIES  
CONSOLIDATED BALANCE SHEETS  
DECEMBER 31, 2015 and 2014  
   
    December 31, 2015     December 31, 2014  
ASSETS                
Current Assets:                
  Cash and cash equivalents   $ 4,194,384     $ 10,367,993  
  Accounts receivable, net of allowance for doubtful accounts of $5,000 as of December 31, 2015 and December 31, 2014     1,793,801       1,541,478  
  Other receivable     58,140       -  
  Inventories     4,258,094       2,497,099  
  Advances on contracts     1,215,128       721,197  
  Prepaid expenses and other current assets     304,604       454,566  
    Total current assets     11,824,151       15,582,333  
Investment in Milestone Medical Inc     -       888,720  
Investment in Milestone Education LLC     16,346       24,192  
Investment in Milestone China     -       348,651  
Furniture, fixtures & equipment net of accumulated depreciation of $566,477 as of December 31, 2015 and $416,210 as of December 31, 2014     235,935       88,818  
Patents, net of accumulated amortization of $646,388 as of December 31, 2015 and $576,960 as of December 31, 2014     715,540       530,029  
Other assets     17,355       14,685  
      Total assets   $ 12,809,327     $ 17,477,428  
LIABILITIES AND STOCKHOLDERS' EQUITY                
Current Liabilities:                
  Accounts payable   $ 2,088,268     $ 1,453,908  
  Accrued expenses and other payables     1,555,567       981,168  
    Total current liabilities     3,643,835       2,435,076  
Commitments and Contingencies                
Stockholders' Equity                
  Series A convertible preferred stock, par value $.001, authorized 5,000,000 shares, 7,000 shares issued and outstanding, respectively     7       7  
  Common stock, par value $.001; authorized 50,000,000 shares; 21,720,497 shares issued, 963,451 shares to be issued and 21,687,164 shares outstanding as of December 31, 2015; 21,404,494 shares issued, 974,953 shares to be issued and 21,371,161 shares outstanding as of December 31, 2014     22,685       22,380  
  Additional paid-in capital     78,632,383       77,504,415  
  Accumulated deficit     (67,434,984 )     (61,967,462 )
  Treasury stock, at cost, 33,333 shares     (911,516 )     (911,516 )
    Total Milestone Scientific Inc. stockholders' equity     10,308,575       14,647,824  
Noncontrolling interest     (1,143,083 )     394,528  
  Total Equity     9,165,492       15,042,352  
      Total liabilities and stockholders' equity   $ 12,809,327     $ 17,477,428  
                 
 
 
The following table includes assets to settle liabilities of the consolidated variable interest. These assets and liabilities are included in the consolidated balance sheet above.
Assets:      
  Cash and cash equivalents   $ 1,222
  Accounts receivable     45,075
  Inventories     885,961
  Advances on contracts     43,524
  Furniture, fixtures & equipment net of accumulated depreciation     119,007
Liabilities:      
  Accounts payable   $ 461,292
  Accrued expenses and other payables     354,361
       
   
   
MILESTONE SCIENTIFIC AND SUBSIDIARIES  
CONSOLIDATED STATEMENTS OF OPERATIONS  
YEARS ENDED DECEMBER 31, 2015 AND 2014  
   
    2015     2014  
Product sales, net   $ 9,491,569     $ 10,333,090  
Cost of products sold     3,048,260       3,630,765  
  Gross profit     6,443,309       6,702,325  
Selling, general and administrative expenses     9,399,201       7,404,258  
Research and development expenses     100,856       88,243  
Total operating expenses     9,500,057       7,492,501  
Loss from operations     (3,056,748 )     (790,176 )
  Other (expenses)     (5,347 )     -  
  Interest income     3,838       2,389  
    Total other expenses, net     (1,509 )     2,389  
      Loss before provision for income tax and equity in net earnings of equity investments     (3,058,257 )     (787,787 )
      Provision for income tax     (36,157 )     (9,509 )
      Loss before equity in net earnings of equity investments     (3,094,414 )     (797,296 )
        Loss on earnings from Milestone Medical Inc.     (2,019,211 )     (891,500 )
        Loss on earnings from Education Joint Venture     (7,846 )     (17,890 )
        Loss on earnings from China Joint Venture     (418,432 )     (810 )
        Net loss in equity investments     (2,445,489 )     (910,200 )
          Net Loss     (5,539,903 )     (1,707,496 )
          Net loss attributable to noncontrolling interests     72,381       5,472  
            Net loss attributable to Milestone Scientific Inc.   $ (5,467,522 )   $ (1,702,024 )
Net loss per share applicable to common stockholders-                
  Basic   $ (0.26 )   $ (0.08 )
  Diluted   $ (0.26 )   $ (0.08 )
Weighted average shares outstanding and to be issued-                
  Basic     21,429,993       20,063,513  
  Diluted     21,429,993       20,063,513  

Contact Information

  • Contact:
    David Waldman
    Klea Theoharis
    Crescendo Communications, LLC
    Email: mlss@crescendo-ir.com
    Tel: 212-671-1020