UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 


FORM 10-Q


(Mark One)

QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

 

For the quarterly periodquarter ended SeptemberJune 30, 20172019

Or

 or

TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

 

For the transition period from to

 

Commission File Number:file number 001-14053


MILESTONE SCIENTIFIC INC.Milestone Scientific Inc.

(Exact name of registrant as specified in its charter)


Delaware

13-3545623

(State or other jurisdiction of
incorporation Incorporation or organization)
organization

(I.R.S. Employer
Identification No.)

 

220 South Orange Avenue, Livingston, New JerseyNJ 07039

(Address of principal executive offices)

(973) 535-2717

(Registrant’sRegistrant’s telephone number, including area code)code: 973-535-2717

 

(Former name, former address and former fiscal year, if changed since last report)


Securities registered pursuant to Section 12(b) of the Act:

Title of each class

Name of each exchange on which registered

Common Stock, par value $.001 per share

NYSE MKT LLCAmerican

 

Securities registered pursuant to section 12(g) of the Act:                    NONE

 

Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days.   ☑ Yes    ☐   No

 

Indicate by check mark whether the registrant has submitted electronically and posted on its corporate Website, if any, every Interactive Data File required to be submitted and posted pursuant to Rule 405 of Regulation S-T during the preceding 12 months (or for such shorter period that the registrant was required to submit and post such files).  ☑ Yes   ☐ No

 

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, smaller reportingreporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.

Large accelerated filer ☐

Accelerated filer ☐ 

Non-accelerated filerfiler☐ (Do not check if a smaller reporting company)

Smaller reporting company ☑

Emerging growth company ☐

 

 

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.    ☐

 

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act).    ☐ Yes    ☑ No

Securities registered pursuant to Section 12(b) of the Act:

Title of each class

Trading Symbol(s)

Name of Exchange on which registered

Common Stock

MLSS

NYSE American

 

As Novemberof August 14, 2017,2019, the registrant hadhas a total of 32,989,72447,490,155 shares of Common Stock, $.001$0.001 par value outstanding.

DOCUMENTS INCORPORATED BY REFERENCE

None

 

 

MILESTONE SCIENTIFIC INC.

Form 10-Q 

TABLE OF CONTENTS

 

 

PART II—FINANCIAL INFORMATION

 

 

Item 1.

Unaudited Condensed Consolidated Financial Statements

 

 

 

Condensed Consolidated Balance Sheets Septemberas of June 30, 2017 (Unaudited)2019  and December 31, 2016 (Audited)2018

4

 

 

Condensed Consolidated

Statements of Operations for the three and ninesix months ended SeptemberJune 30, 20172019  and 2016 (Unaudited)2018

5

 

 

Condensed Consolidated Statement

Statements of Changes in StockholdersStockholders’ Equity for the ninethree and six months ended SeptemberJune 30, 2017 (Unaudited)2019 and 2018

6

 

 

Condensed Consolidated

Statements of Cash Flows for the ninesix months ended SeptemberJune 30, 20172019 and 2016 (Unaudited)2018

78

 

 

Notes to Condensed Consolidated Financial Statements (Unaudited)

9

 

8

Item 2.

Management’sManagement’s Discussion and Analysis of Financial Condition and Results of Operations

22

 

21

Item 3.

Quantitative and Qualitative Disclosures About Market Risk

26

Item 4.

Controls and Procedures

26

27

 

PART II—OTHER INFORMATION

 

 

Item 1. 4.

Controls and Procedures

27

 

PART II—OTHER INFORMATION

Item 1.

Legal Proceedings

27

 

27

Item 1A.

Risk Factors

27

 

27

Item 2.

Unregistered Sales of Equity Securities and Use of Proceeds

27

27

Item 3.

Defaults Upon Senior Securities

27

27

Item 4.

Mine Safety Disclosures

27

27

Item 5.

Other Information

27

27

Item 6.

Exhibits

 28

28

Signatures

29

 


 

FORWARD-LOOKING STATEMENTS

 

When used in this Quarterly Report on Form 10-Q, the words may”“may”, “will”, “should”, “expect”, “believe”, “anticipate”, “continue”, “estimate”, “project”, “intend” and similar expressions are intended to identify forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended and Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”) regarding events, conditions and financial trends that may affect Milestone Scientific’s future plans of operations, business strategy, results of operations and financial condition. Milestone Scientific wishes to ensure that such statements are accompanied by meaningful cautionary statements pursuant to the safe harbor established in the Private Securities Litigation Reform Act of 1995. Prospective investors are cautioned that any forward-looking statements are not guarantees of future performance and are subject to risks and uncertainties and the actual results may differ materially from those included within the forward-looking statements as a result of various factors. Such forward-looking statements should, therefore, be considered in light of various important factors, including those set forth herein and others set forth from time to time in Milestone Scientific’s reports, including without limitations, Milestone Scientific's Annual Report on Form 10-K for the year ended December 31, 20162018 filed with the Securities and Exchange Commission (the “SEC”). Milestone Scientific disclaims any intent or obligation to update such forward-looking statements.

 

Milestone Scientific is the owner of the following registered U.S. trademarks: CompuDent®; CompuMed®; CompuFlo®; DPS Dynamic Pressure Sensing Technology®technology®; Milestone Scientific ®; the Milestone logo ®; SafetyWand®; STA Single Tooth Anesthesia System®Device®; and The Wand ®.

 


PART I—FINANCIAL INFORMATIONPart I- Financial Information

Item 1. Financial Statements

MILESTONE SCIENTIFIC INC. AND SUBSIDIARIES

 

CONDENSED CONSOLIDATED BALANCE SHEETS

 
         
  

September 30, 2017

  

December 31, 2016

 
  

(Unaudited)

  

(Audited)

 

ASSETS

 

Current Assets:

        

Cash and cash equivalents

 $2,307,497  $3,602,229 

Accounts receivable, net of allowance for doubtful accounts of $10,000 as of September 30, 2017 and $5,000 as of December 31, 2016

  1,999,636   802,384 

Accounts receivable from related party

  712,800   2,714,600 

Other receivable

  -   10,000 

Notes receivable from financing transaction, short term

  500,000   - 

Inventories

  4,165,721   4,602,719 

Advances on contracts

  992,242   700,900 

Deferred Cost

  362,718   620,041 

Prepaid expenses and other current assets

  552,010   291,929 

Total current assets

  11,592,624   13,344,802 

Furniture, fixtures & equipment net of accumulated depreciation of $703,191 as of September 30, 2017 and $659,144 as of December 31, 2016

  119,729   159,026 

Patents, net of accumulated amortization of $904,295 as of September 30, 2017 and $717,086 as of December 31, 2016

  3,152,415   660,457 

Notes receivable from financing transaction long term

  650,000   - 

Other assets

  26,878   17,355 

Total assets

 $15,541,646  $14,181,640 
         

LIABILITIES AND STOCKHOLDERS’ EQUITY

 

Current Liabilities:

        

Accounts payable

 $616,036  $1,341,207 

Accounts payable related party

  902,341   1,235,052 

Accrued expenses and other payables

  2,162,786   1,436,262 

Deferred profit, related party

  659,931   630,990 

Deferred revenue

  712,800   1,001,800 

Total current liabilities

  5,053,894   5,645,311 
         

Deferral from financing transaction

  1,400,000   - 

Total liabilities

  6,453,894   5,645,311 
         

Commitments and Contingencies

        

Stockholders’ Equity

        

Series A convertible preferred stock, par value $.001, authorized 5,000,000 shares, 33,333 shares held in the treasury, and 7,000 shares issued and outstanding as September 30, 2017 and December 31, 2016

  7   7 

Common stock, par value $.001; authorized 50,000,000 shares;33,023,057 shares issued, 1,404,405 shares to be issued and 32,989,724 shares outstanding as of September 30, 2017; 30,457,224 shares issued, 1,270,481 shares to be issued and 30,423,891 shares outstanding as of December 31, 2016

  34,426   31,720 

Additional paid-in capital

  86,442,802   82,761,503 

Accumulated deficit

  (76,778,556)  (73,381,491)

Treasury stock, at cost, 33,333 shares

  (911,516)  (911,516)

Total stockholders' equity

  8,787,163   8,500,223 

Noncontrolling interest

  300,589   36,106 

Total Equity

  9,087,752   8,536,329 

Total liabilities and stockholders’ equity

 $15,541,646  $14,181,640 

MILESTONE SCIENTIFIC AND SUBSIDIARIES

CONDENSED CONSOLIDATED BALANCE SHEETS

(Unaudited)

 

 

 

June 30, 2019

  

December 31, 2018

 
ASSETS        

Current assets:

        

Cash and cash equivalents

 $2,337,593  $743,429 

Accounts receivable, net

  1,658,919   1,978,456 

Accounts receivable, related party, net

  -   100,000 

Prepaid expenses and other current assets

  406,563   414,541 

Deferred cost, related party

  -   50,000 

Inventories, net

  1,270,480   1,921,051 

Advances on contracts

  530,114   648,783 

Operating lease-right of use assets

  92,830   - 

Total current assets

  6,296,499   5,856,260 

Furniture, fixtures and equipment, net

  65,668   82,557 

Patents, net

  408,767   435,273 

Other assets

  17,355   26,878 

Total assets

 $6,788,289  $6,400,968 
         

LIABILITIES AND STOCKHOLDERS’ EQUITY

        
Current liabilities:        

Accounts payable

 $1,192,823  $1,205,396 

Accounts payable, related party

  1,283,367   1,663,849 

Accrued expenses and other payables

  1,464,846   1,481,715 

Accrued expenses, related party

  125,428   - 

Operating lease liabilities-current

  92,830   - 

Deferred profit, related party

  372,700   421,800 

Deferred revenue, related party

  -   100,000 

Derivative liability

  1,418,863   - 

Total current liabilities

  5,950,857   4,872,760 

Total liabilities

 $5,950,857  $4,872,760 
         

Commitments and contingencies

        
         

Stockholders’ equity

        

Series A convertible preferred stock, par value $.001, authorized 5,000,000 shares, 0 and 7,000 shares issued and outstanding as of June 30, 2019 and December 31, 2018.

 $-  $7 

Common stock, par value $.001; authorized 50,000,000 shares; 47,132,220 shares issued, 0 shares to be issued and 47,098,886 shares outstanding as of June 30, 2019 ; 33,859,034 shares issued, 2,470,565 shares to be issued and 33,825,701 shares outstanding as of December 31, 2018;

  47,132   36,330 

Additional paid in capital

  89,559,585   88,414,718 

Accumulated deficit

  (87,823,965)  (85,999,929)

Treasury stock, at cost, 33,333 shares

  (911,516)  (911,516)

Total Milestone Scientific Inc. stockholders' equity

  871,236   1,539,610 

Noncontrolling interest

  (33,804)  (11,402)

Total stockholders’ equity

 $837,432  $1,528,208 
         

Total liabilities and stockholders’ equity

 $6,788,289  $6,400,968 

See Notesnotes to Condensed Consolidated Financial Statements


MILESTONE SCIENTIFIC INC.

 

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS

 

(Unaudited)

 
                    
  

Three Months Ended September 30,

   

Nine Months Ended September 30,

 
  

2017

   

2016

   

2017

   

2016

 

Revenue

                   

Product sales, net

 $2,853,813   $3,186,596   $9,066,550   $8,973,726 

Cost of products sold

  1,044,540    1,517,561    3,320,411    3,675,552 

Gross profit

  1,809,273    1,669,035    5,746,139    5,298,174 
                    

Selling, general and administrative expenses

  3,205,996    2,933,950    8,996,092    9,226,062 

Research and development expenses

  16,884    303,268    241,964    756,045 

Total operating expenses

  3,222,880    3,237,218    9,238,056    9,982,107 

Loss from operations

  (1,413,607)   (1,568,183)   (3,491,917)   (4,683,933)

Other (expenses)

  (1,046)   (846)   (3,278)   (2,782)

Interest income

  3,582    -    6,495    - 

Loss before provision for income tax and equity in net earnings of equity investments

  (1,411,071)   (1,569,029)   (3,488,700)   (4,686,715)

Provision for income tax

  (6,475)   (16,522)   (18,339)   (80,147)

Loss before equity in net earnings of equity investments

  (1,417,546)

 

  (1,585,551)

 

  (3,507,039)

 

  (4,766,862)

Loss on earnings from China Joint Venture

  -    (253,451)   (28,941)   (554,766)

Loss in equity investments

  -    (253,451)   (28,941)   (554,766)

Net Loss

  (1,417,546)   (1,839,002)   (3,535,980)   (5,321,628)

Net loss attributable to noncontrolling interests

  (6,605)   (137,752)   (138,915)   (1,113,958)

Net loss attributable to Milestone Scientific Inc.

 $(1,410,941)  $(1,701,250)  $(3,397,065)  $(4,207,670)
                    

Net loss per share applicable to common stockholders

                   

Basic

 $(0.04)  $(0.06)  $(0.10)  $(0.16)

Diluted

 $(0.04)  $(0.06)  $(0.10)  $(0.16)
                    

Weighted average shares outstanding and to be issued

                   

Basic

  33,573,676    29,155,712    32,501,221    25,965,566 

Diluted

  33,573,676    29,155,712    32,501,221    25,965,566 

 See Notes to Condensed Consolidated Financial Statements


  

 MILESTONE SCIENTIFIC INC. AND SUBSIDIARIES 

 CONDENSED CONSOLIDATED STATEMENT OF CHANGES IN STOCKHOLDERS' EQUITY 

 (Unaudited) 

                   
  

Preferred Stock

 

Common Stock

          
  

Shares

 

Amount

 

Shares

 

Amount

 

 Additional
Paid-in
Capital 

 

 Accumulated
Deficit 

 

 Noncontrolling
interest 

 

 Treasury
Stock 

 

 Total 

Balance, January 1, 2017

 

           7,000

 

 $                   7

 

     31,727,705

 

 $          31,720

 

 $    82,761,503

 

 $  (73,381,491)

 

 $           36,106

 

 $    (911,516)

 

 $    8,536,329

Stock based compensation

 

 - 

 

 - 

     

             530,966

 

 - 

 

 - 

 

 - 

 

        530,966

Common stock to be issued to employee for compensation

     

             10,913

 

                     11

 

               14,989

 

 - 

 

 - 

 

 - 

 

             15,000

Common stock issued to employee for exercise of stock options

     

             83,333

 

                     83

 

               62,417

 

 - 

 

 - 

 

 - 

 

             62,500

Common stock issued for payment of consulting services

     

           245,373

 

                   260

 

             422,249

 

 - 

 

 - 

 

 - 

 

           422,509

Common stock to be issued to employee for bonuses

     

           158,082

 

                   151

 

             259,841

 

 - 

 

 - 

 

 - 

 

           259,992

Common stock issued for assets acquired

     1,646,358 

               1,646

 

          2,484,354

       

        2,486,000

Common Stock exchanged for MMD

     

           311,998

 

                   311

 

           (403,709)

 

 - 

 

              403,398

 

 - 

 

                      -   

Common stock issued to directors for bonuses

     

           120,000

 

                   120

 

             159,480

 

 - 

 

 - 

 

 - 

 

           159,600

Sale of Common Stock - Public Offering

     

           123,700

 

                   124

 

             150,712

 

 - 

 

 - 

 

 - 

 

           150,836

Net loss

 

 - 

 

 - 

     

 - 

 

        (3,397,065)

 

            (138,915)

 

 - 

 

      (3,535,980)

Balance, September 30, 2017

 

           7,000

 

 $                   7

 

     34,427,462

 

 $          34,426

 

 $ 86,442,802

 

 $  (76,778,656

 

 $         300,589

 

 $    (911,516)

 

 $ 9,087,752

                   

MILESTONE SCIENTIFIC AND SUBSIDIARIES

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS

(UNAUDITED)

  

For the three months ended

June 30, 2019

  

For the three months ended

June 30, 2018

  

For the six

months ended

June 30, 2019

  

For the six

months ended

June 30, 2018

 

Product sales, net

 $2,257,851  $2,428,498  $4,173,759  $4,234,103 

Cost of products sold

  752,183   1,021,573   1,370,876   1,584,250 

Gross profit

  1,505,668   1,406,925   2,802,883   2,649,853 
                 

Selling, general and administrative expenses

  2,517,970   2,821,837   4,627,023   5,840,601 

Research and development expenses

  95,529   9,775   101,875   235,592 

Total operating expenses

  2,613,499   2,831,612   4,728,898   6,076,193 

Loss from operations

  (1,107,831)  (1,424,687)  (1,926,015)  (3,426,340)
                 

Other expenses

  (2,563)  (1,756)  (4,825)  (3,457)

Interest income

  188   1,926   1,207   4,590 

Change in fair value of derivative liability

  12,462   -   52,722   - 

Loss before provision for income taxes and net losses of equity investments

  (1,097,744)  (1,424,517)  (1,876,911)  (3,425,207)

Provision for income taxes

  (14,163)  (4,075)  (18,627)  (15,538)

Loss before equity in net earnings (losses) of equity investments

  (1,111,907)  (1,428,592)  (1,895,538)  (3,440,745)

(income)loss from earnings from China Joint Venture

  (58,664)  (78,591)  (49,100)  (115,374)

Net loss

  (1,053,243)  (1,350,001)  (1,846,438)  (3,325,371)

Net loss attributable to noncontrolling interests

  11,959   6,994   22,402   108,657 

Net loss attributable to Milestone Scientific Inc.

  (1,041,284)  (1,343,007)  (1,824,036)  (3,216,714)
                 

Net loss per share applicable to common stockholders—

                

Basic

 $(0.02) $(0.04) $(0.04) $(0.09)

Diluted

 $(0.02) $(0.04) $(0.04) $(0.09)
                 

Weighted average shares outstanding and to be issued—

                

Basic

  45,366,237   35,297,906   41,904,581   34,939,306 

Diluted

  45,366,237   35,297,906   41,904,581   34,939,306 

See Notesnotes to Condensed Consolidated Financial Statements

 


 

 MILESTONE SCIENTIFIC INC. AND SUBSIDIARIES 

 CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS 

 (Unaudited) 

  

Nine Months Ended September 30,

  

2017

 

2016

Cash flows from operating activities:

    

Net loss

$

       (3,535,980)

$

       (5,321,628)

Adjustments to reconcile net loss to net cash used in operating activities:

    

   Depreciation expense

 

               44,046

 

               69,345

   Amortization of patents

 

             187,209

 

               53,017

   Stock compensation

 

        530,966

 

         1,136,430

Loss China joint venture

 

               28,941

 

             545,950

Changes in operating assets and liabilities:

    

   (Increase) in accounts receivable

 

       (1,197,252)

 

           (759,385)

   Decrease in accounts receivable related party

 

         2,001,800

 

 - 

   Decrease in other receivable

 

               10,000

 

               58,140

   Decrease (increase) in inventories

 

             436,998

 

           (225,998)

   (Increase) to advances on contracts

 

           (291,342)

 

             (53,566)

   Increase  (Decrease) to prepaid expenses and other current assets

 

           (260,081)

 

               27,701

   (Increase) in other assets

 

               (9,523)

 

 - 

   (Decrease) increase in accounts payable

 

           (725,170)

 

             169,388

   (Decrease) in accounts payable related party

 

           (332,711)

 

 - 

   Increase in deferred profit, related party

 

             257,323

  

Increase in accrued expenses and other payables

 

         1,583,624

 

             181,324

   (Decrease) in deferred revenue

 

       (289,000)

 

 - 

         Net cash used in operating activities

 

       (1,560,152)

 

       (4,119,282)

Cash flows from investing activities:

    

   Purchase of intangible assets

 

             (39,520)

 

             (15,616)

   Purchase of property and equipment

 

               (4,749)

 

             (14,945)

Purchase of intangibles assets-Apad 

           (153,647)

 

                        -   

   Consolidation of variable interest entity

 

                        -   

 

               50,621

        Net cash (used in) provided by investing activities

 

           (197,916)

 

               20,060

Cash flows from financing activities:

    

Capital contribution from noncontrolling interest

 

                        -   

 

                 2,543

Proceeds from Private Placement Offering                                                -    2,225,000

   Proceed from financing transaction

 

             250,000

 

                        -   

   Proceeds from exercise of stock options

 

               62,500

 

    -    

   Net proceeds on Private Placement Offering

 

             150,836

 

                        -   

         Net cash provided by investing activities

 

             463,336

 

         2,227,543

Net decrease in cash and cash equivalents

 

       (1,294,732)

 

       (1,871,679)

Cash and cash equivalents at beginning of period

 

         3,602,229

 

         4,194,384

Cash and cash equivalents at end of period

$

         2,307,497

$

         2,322,705

     

Supplemental disclosure of cash flow information:

    

   Net assets acquired from variable entity

  $

               14,076

Shares issued to for assets acquired $2,484,354                         -   

   Sale of Milestone China shares, financing transaction 

 $

         1,400,000

 

                        -   

   Shares issued to employees for bonus

 $

         259,841

$

             389,318

   Shares issued to consultants in lieu of cash payments

 $

             422,249

$

             366,299

MILESTONE SCIENTIFIC INC. AND SUBSIDIARIES

CONDENSED CONSOLIDATED STATEMENTS OF CHANGES IN STOCKHOLDERS' EQUITY

FOR THE THREE AND SIX MONTHS ENDED JUNE 30, 2019 AND 2018

(UNAUDITED)

  

Preferred Stock Shares

  

Preferred Stock

  

Common Stock Share

  

Common Stock Amount

  

Additional Paid in Capital

  

Accumulated Deficit

  

Noncontrolling Interest

  

Treasury Stock

  

Total

 

Balance, January 1, 2019

  7,000  $7   36,329,600  $36,330  $88,414,718  $(85,999,929) $(11,402) $(911,516) $1,528,208 

Stock based compensation

  -   -   -   -   56,988   -   -   -   56,988 

Common stock to be issued to employees for bonuses

  -   -   175,715   175   61,325   -   -   -   61,500 

Common stock to be issued for payment of consulting services

  -   -   118,115   118   39,882   -   -   -   40,000 

Common stock to be issued to employee for compensation

  -   -   22,727   23   7,477   -   -   -   7,500 

Common stock to be issued to board of directors for services rendered

  -   -   20,588   21   6,979   -   -   -   7,000 

Common stock issued in public offering

  -   -   6,282,400   6,281   1,968,265   -   -   -   1,974,546 

Common stock issued in private offering

  -   -   714,286   714   249,286   -   -   -   250,000 

Reclassification of warrants and Shares to be issued to derivative liability (Note 8)

  -   -   -   -   (406,045)  -   -   -   (406,045)

Net loss

  -   -   -   -   -   (782,752)  (10,443)  -   (793,195)

Balance, March 31, 2019

  7,000  $7   43,663,431  $43,662  $90,398,875  $(86,782,681) $(21,845) $(911,516) $2,726,502 
Stock based compensation                  44,712   -   -   -   44,712 
Common stock to be issued for payment of consulting services          265,140   265   139,735   -   -   -   140,000 
Common stock to be issued to employee for compensation          41,667   42   14,958   -   -   -   15,000 
Common stock to be issued to board of directors for services rendered          82,442   82   29,918   -   -   -   30,000 
Conversion of Preferred Shares to Common Stock (Mandatory)  (7,000)  (7.00)  5,982,906   5,983   (5,976)  -   -   -   - 
Reclassification of warrants and Shares to be issued to derivative liability (Note 8)          (2,903,366)  (2,902)  (1,062,637)  -   -   -   (1,065,539)
Net loss  -   -   -   -   -   (1,041,284)  (11,959)  -   (1,053,243)
Balance, June 30, 2019  -  $-   47,132,220  $47,132  $89,559,585  $(87,823,965) $(33,804) $(911,516) $837,432 


  

Preferred Stock Shares

  

Preferred Stock

  

Common Stock Share

  

Common Stock Amount

  

Additional Paid in Capital

  

Accumulated Deficit

  

Noncontrolling Interest

  

Treasury Stock

  

Total

 

Balance, January 1, 2018

  7,000  $7   34,592,818  $34,593  $86,689,084  $(78,568,284) $256,744  $(911,516) $7,500,628 
Stock based compensation                 $86,809   -   -   -   86,809 
Common stock to be issued to employees for bonuses          323,076  $323  $339,177   -   -   -   339,500 
Common stock for Asset Acquisition                     $(1,873,707) $(101,663)      (1,975,370)
Net loss                                  - 
Balance, March 31, 2018  7,000  $7   34,915,894  $34,916  $87,115,070  $(80,441,991) $155,081  $(911,516) $5,951,567 

Stock based compensation

  -   -   -   -   84,092   -   -   -   84,092 

Common stock to be issued to employees for bonuses

  -   -   79,307   79   59,921   -   -   -   60,000 

Common stock to be issued for payment of consulting services

  -   -   296,046   294   249,455   -   -   -   249,749 

Common stock to be issued to employee for compensation

  -   -   37,267   37   37,463   -   -   -   37,500 

Common stock for Asset Acquisition

  -   -   244,959   245   286,357   -   -   -   286,602 

Net loss

  -   -   -   -   -   (1,343,007)  (6,994)  -   (1,350,001)

Balance, June 30, 2018

  7,000  $7   35,573,473  $35,571  $87,832,358  $(81,784,998) $148,087  $(911,516) $5,319,509 

See Notesnotes to Condensed Consolidated Financial Statements

 


 

MILESTONE SCIENTIFIC INC. AND SUBSIDIARIES

CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS

(UNAUDITED)

  

For the six

months ended

June 30, 2019

  

For the six

months ended

June 30, 2018

 

Cash flows from operating activities:

        

Net loss

 $(1,846,437) $(3,325,371)

Adjustments to reconcile net loss to net cash used in operating activities:

        

Depreciation expense

  24,993   40,762 

Amortization of patents

  26,506   469,356 

Stock compensation

  101,700   170,901 

Income from earnings on China joint venture

  (49,100)  (115,374)

Inventory reserve

  (2,061)  290,349 

Change in fair value of derivative liability

  (52,722)  - 
Amortization of right-of-use assets  79,109   - 

Changes in operating assets and liabilities:

        

Decrease (increase) in accounts receivable

  319,537   (304,632)

Decrease (increase) in accounts receivable, related party

  100,000   (1,092,540)

Decrease in other receivables

  9,523   - 

Decrease in inventories

  652,631   778,530 

Decrease (increase) in advances on contracts

  118,669   (164,590)

Decrease (increase) in prepaid expenses and other current assets

  7,978   (48,343)

(Decrease) increase in accounts payable

  (12,573)  511,632 

(Decrease) increase in accounts payable, related party

  (380,482)  243,360 

Increase (decrease) in deferred cost, related party

  50,000   (686,365)

Increase in accrued expenses

  284,128   623,014 

Increase in accrued expenses, related party

  125,428   - 

(Decrease) increase in deferred revenue, related party

  (99,997)  1,092,540 
Decrease in operating lease-right of use asset  (79,109)  - 

Net cash used in operating activities

  (622,279)  (1,516,771)

Cash flows from investing activities:

        

Purchase of intangible assets

  -   (4,531)
Purchase of property and equipment  (8,104)  - 

Net cash used in investing activities

  (8,104)  (4,531)

Cash flows from financing activities:

        

(Payments for) financing transaction

  -   (250,000)

Net proceeds from Public Placement Offering

  1,974,547   - 

Net proceeds from Private Placement Offering

  250,000   - 

Net cash provided by financing activities

  2,224,547   (250,000)

Net increase (decrease) in cash and cash equivalents

  1,594,164   (1,771,302)

Cash and cash equivalents at beginning of period

  743,429   2,636,956 

Cash and cash equivalents at end of period

 $2,337,593  $865,654 
         

Supplemental disclosure of cash flow information:

        

Shares issued to employee for bonuses

 $61,500  $399,500 

Shares issue to board of directors for services rendered

 $37,000  $- 

Shares issued to employees for compensation

 $22,500  $- 

Shares issued to consultants in lieu of cash payments

 $180,000  $249,749 

Common stock issued for asset acquisition

 $-  $286,602 

Sale of Milestone China share, financing transaction

 $-  $(1,400,000)

Initial recognition of operating lease-right of use assets

 $(166,292) $- 

Initial recognition of operating lease right to used liabilities

 $166,292  $- 

Derivative liability for shares over allotment

 $1,471,585  $- 

See notes to Condensed Consolidated Financial Statements


MILESTONE SCIENTIFIC INC.

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

(UNAUDITED)

 

Note 1-NOTE 1 — ORGANIZATION andAND BUSINESS

 

All references in this report to Milestone“Milestone Scientific,” “us,” “our,” “we,” “the Company”the “Company” or “Milestone” refer to Milestone Scientific Inc., and its consolidated subsidiaries, Wand Dental, Inc., Milestone Advanced Cosmetic Systems, Inc., Milestone Medical, Inc. and Milestone Education LLC (all described below), unless the context otherwise indicates. Milestone Scientific is the owner of the following registered U.S. trademarks: CompuDent®; CompuMed®; CompuFlo®; DPS Dynamic Pressure Sensing Technology®technology®; Milestone Scientific ®; the Milestone logo ®; SafetyWand®; STA Single Tooth Anesthesia System®; and The Wand ®.

 

Milestone Scientific was incorporated in the State of Delaware in August 1989. Milestone Scientific has developed a proprietary, computer-controlled anesthetic delivery instrument, through the use ofdevice, using The Wand®, a single use disposable handpiece. The instrumentdevice is marketed in dentistrythe dental market under the trademark CompuDent®, and STA Single Tooth Anesthesia System® and in medicinethe medical market under the trademark CompuMed®. CompuDent® is suitable for all dental procedures that require local anesthetic. CompuMed® has regulatory approval for epidural medical procedures, and is expected to be suitable, for many medical procedures regularly performed in Plastic Surgery, Hair Restoration Surgery, Podiatry, Colorectal Surgery, Dermatology, Orthopedicsplastic surgery, hair restoration surgery, podiatry, colorectal surgery, dermatology, orthopedics and a number ofmany other disciplines. The dental instrumentsdevices are sold in the United States, US territories, Canada and in 4760 other countries. To date there have been no medical instruments sold in the United States and limited amounts sold internationally, although certain medical instruments have obtained CE mark approval and can be marketed and sold in most European countries. In June 2017, Milestone Scientific received 510(k) marketing clearance from the U.S. Food and Drug Administration (FDA) on the CompuFlo® Epidural Computer Controlled Anesthesia System.

 

During 2015, our common stock was listed on the NYSE MKT under the ticker symbol “MLSS”.

During 2016, Milestone Scientific filed for 510(k) marketing clearance with the FDAU.S. Food and Drug Administration (FDA) for both intra-articular and epidural injections with the CompuFlo®CompuFlo® Computer Controlled Anesthesia System.  In June 2017, the FDA approved the CompuFlo® Epidural Computer Controlled Anesthesia System for epidural injections. Milestone Scientific is in the process of introductory meetings with medical device distributors within the United States and foreign markets. Milestone Scientific’s immediate focus is on marketing its epidural instrumentdevice throughout the United States and Europe. To date there have been five medical devices sold in the United States and limited amounts sold internationally, although certain medical devices have obtained CE mark approval and can be marketed and sold in most European countries.

 

In December 2016, we received notification from the FDA that based upon the 510(k) application-application submitted for intra- articular injections, we did not adequately document that the device met the equivalency standard required for 510(k) clearance.clearances. Following consultation with the FDAFDA’s Office of Device Evaluation, we intend to provide additional data, which could include a new Human Factor Validation study (HFV Study) in support offile a new 510(k) application for the device. An HFV Study demonstratesdevice in 2019, providing the ease of use of a product.Company secures additional funding.

 

In November 2018, Milestone Scientific received a letter from NYSE American LLC (the “Exchange”) stating that the Company was not in compliance with the continued listing standards as set forth in Section(s) 1003(a)(i), (ii), and (iii) of the NYSE American Company Guide (the “Company Guide”).On December 2016, we completed20, 2018, the Company submitted a plan of compliance (the “Plan”) to the Exchange addressing how it intends to regain compliance with Section(s) 1003(a)(i), (ii) and (iii) of the Company Guide by May 20, 2020. On January 24, 2019, the Company received a letter from the Exchange stating that the Company’s Plan has been accepted. The Company is still not in compliance with Section(s) 1003(a)(i), (ii) and (iii) of the Company Guide and its listing on the Exchange is being continued pursuant to an underwrittenextension granted by the Exchange.

In February 2019, Milestone Scientific consummated a public offering and a private placement of 2,000,000Common Stock. The public offering generated gross proceeds of approximately $2.0 million for the issuance of 5,715,000 shares of commoncommon stock and warrants to purchase up to 1,592,7751,428,750 shares of common stock. The warrants terms are 5 years and they are exercisable at $0.50. Subsequent to the public offering pricethe underwriter exercised its overallotment option and paid approximately $198,000 for each share567,400 additional shares of common and related warrant was $1.50. Theas well as 141,850 warrants.

Also, in February 2019, the Company generated gross proceeds from this offering werea private placement of approximately $3,000,000, before deducting underwriting discounts and commissions and other offering expenses.

In January 2017, the underwriter exercised a portion of its over-allotment option and purchased an additional 123,700$250,000 for 714,286 shares of common stock at the public offering priceand warrants to purchase 178,571 shares of $1.499 per share. The gross proceeds were approximately $186,000 before deducting underwriting discounts and commissions and other offering expenses.


In June 2017,common stock from  Bp4 S.p.A., a principal stockholder of Milestone Scientific, entered into an agreement forthat exercised its right to participate on a pro-rata basis on the salerecent public offering. Bp4’s CEO is a director of its interest in Milestone China (a forty (40%) percent interest) (the “Milestone China Shares”) to an unaffiliated United States domiciled purchaser and a 10-year option agreement to repurchase the Milestone China Shares. The purchase price for the Milestone China Shares was $1,400,000 of which $125,000 was paid in cash and $1,275,000 was paid by delivery of a non-interest bearing secured promissory note. The note is payable in quarterly installments of $125,000 and is secured by the Milestone China Shares until full repayment.  In addition, the purchaser is precluded from selling all or substantially all of its assets prior to repayment of the note. The 10-year option agreement provides Milestone Scientific an option to repurchase the Milestone China Shares at $1,400,000 within the first two years and at fair market value (as defined in such agreement) for the remainder of the 10-year term. The transaction has been accounted for as a secured financingalso Chief Executive Officer and Milestone Scientific will continue to account for its relationship with Milestone China under the equity method of accounting. A note receivable is presented on the Company’s balance sheet, along with a deferral from financing transaction ($1,400,000). The carrying value of the forty (40%) percent investment at the transaction date was zero (see Note 5).

On July 13, 2017, Milestone Scientific consummated a previously disclosed Asset Purchase Agreement (the “Agreement”) with APAD Octrooi B.V. and APAD B.V. (each, a “Seller” and collectively, the “Sellers”) pursuant to which Milestone Scientific acquired certain patent rights and other intellectual property rights related to the Sellers’ computer controlled injection instrument (the “Purchased Assets”) which has been accounted for as an asset acquisition. On the closing date, Milestone Scientific issued to the Sellers an aggregate of 1,646,358 shares of its common stock, valued at $2,486,000 which shares are subject to certain post-closing upward or downward adjustments not to exceed twenty-five percent of the initial shares as of the purchase date or 250,000 Euros, as defined in the Agreement. As of September 30, 2017, Milestone Scientific has recorded a $167,000 liability relating to the estimated additional shares that would have to be issued according this provision in the Agreement. Milestone Scientific paid approximately $153,000 in legal fees on behalf of the Seller as stipulated based on the terms of the Agreement. The patents and other intellectual property purchased in the amount of approximately $2,639,000 have been capitalized and will amortized over their five year estimated useful life and tested for impairment as a finite lived intangible asset.

In July 2017, Milestone Scientific's Compensation Committee approved the issuance of 400,000 stock options to Gian Domenico Trombetta, CEODirector of Wand Dental, a Directorwholly owned subsidiary of Milestone ScientificScientific. The warrants terms are 5 years and they are exercisable at $0.50.

NOTE 2- GOING CONCERN AND LIQUIDITY

The Company has evaluated whether there are conditions or events, considered in the aggregate, that raise substantial doubt about the Company's ability to continue as a director of Innovest S.p.A., an Italian investor (250,000 options at an exercise price of $2.55 per share were issued on July 7, 2017 and 150,000 options having an exercise price at the higher of $2.55 or the market price of the stock ongoing concern within one year after the date ofthat the 2018 Annual Stockholder meeting, subject to approval of a new or amended equity incentive plan at such meeting.)

condensed  consolidated financial statements are issued. Milestone Scientific has incurred operating losses and negative cash flows from operating activities in virtuallyvirtually each year since its inception. Milestone ScientificAt June 30, 2019 cash on hand was $2.3 million. Based on the expected cash needed for operating activities, the Company’s current cash and liquidity is actively pursuingnot sufficient to finance the  generation of revenue, positive operating income and net income. The capital raised in December 2016 and January 2017 provided Milestone Scientific with working capitalrequirements for at least the next 12 months from the filing date.  These factors raise substantial doubt regarding the Company’s ability to continue to develop its medical instruments and obtain regulatory approval for one of its medical instruments ( the June, 2017 FDA approval of the epidural instrument), as well as to aggressively market its dental instruments. a going concern.   


Milestone Scientific is actively pursuing the generation of positive cash flows from operating activities through an increase in revenue from its dental business worldwide, the generation of revenue from its medical instrumentsdevices and disposables business in the United States (following June 2017 FDA approval of its CompuFlo® Computer Controlled Anesthesia System ) and worldwide, and a reductionsreduction in operating expenses. Management believes that Milestone ScientificHowever, the Company’s continued operations will have sufficient cash reserves to meetdepend on its anticipated obligations over the next twelve month period following the date of this report. However, Milestone Scientific will likely  needability to raise additional capital priorthrough various potential sources until it achieves profitability, if ever. Management is actively pursuing financing or other strategic plans but can provide no assurances that such financing or other strategic plans will be available on acceptable terms, or at all.

These condensed  consolidated financial statements have been prepared with the assumption that the Company will continue as a going concern and will be able to realize its assets and discharge its liabilities in the expected generationnormal course of sustainable positive cash flow from operating activitiesbusiness and do not include any adjustments to reflect the possible future effects on the recover ability and classification of assets or the amounts and classification of liabilities that may also need to raise additional capital to effectively launch its approved medical instrument and eventually generate positive cash flowresult from the anticipated medical business.inability of the Company to continue as a going concern.  

 

NOTE - 2 3 — SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES

 

1.  BasisPrinciples of Consolidation

 

The accompanying condensed consolidated financial statements have been prepared in accordance with accounting principles generally acceptedaccepted in the United States ("GAAP") and include the accounts of Milestone Scientific and its wholly owned and majority owned subsidiaries, including, Wand Dental (wholly owned), Milestone Advanced Cosmetic (majority owned), Milestone Education (wholly owned) and Milestone Medical (majority owned). Milestone Education is a variable interest entity of which Milestone Scientific is the primary beneficiary and is consolidated into Milestone Scientific's financial statements. All significant, intra-entity transactions and balances have been eliminated in the consolidation.


2. Basis of Presentation

 

The unaudited condensed consolidated financial statements of Milestone Scientific have been prepared in accordance with accounting principles generally accepted in the United States of America (GAAP) for interim financial information with the instructions for Form 10Q and Article 8 of Regulation S-X. Accordingly, they do not include all of the information and footnotes required by GAAP for complete annual financial statements. In the opinion of management, the accompanying unaudited financial statements contain all adjustments (consisting of normal recurring entries) necessary to fairly present such interim results. Interim results are not necessarily indicative of the results of operations which may be expected for a full year or any subsequent period. These unaudited condensed consolidated financial statements should be read in conjunction with the financial statements and notes thereto for the year ended December 31, 2016,2018, included in Milestone Scientific's Annual Report on Form 10-K.

 

3.  Reclassifications

 

Certain reclassifications have been made to the 20162018 financial statements to conform to the condensed  consolidated 20172019 financial statement presentation. These reclassifications had no effect on net loss or cash flows as previously reported.

 

4. Variable Interest Entities

A variable interest entity ("VIE") is an entity that either (i) has insufficient equity to permit the entity to finance its activities without additional subordinated financial support or (ii) has equity investors who lack the characteristics of a controlling financial interest. A VIE is consolidated by its primary beneficiary. The primary beneficiary has both the power to direct the activities that most significantly impact the entity's economic performance and the obligation to absorb losses or the right to receive benefits from the entity that could potentially be significant to the VIE.

If Milestone Scientific determines that it has operating power and the obligation to absorb losses or receive benefits, Milestone Scientific consolidates the VIE as the primary beneficiary. Milestone Scientific’s involvement constitutes power that is most significant to the entity when it has unconstrained decision making ability over key operational functions within the entity.                  

Milestone Scientific is the primary beneficiary of Milestone Education as of January 2016. Accordingly, the assets and liabilities of Milestone Education are included in the accompanying condensed consolidated financial statements.

Because  Milestone Scientific had an increasing  variable interest in  Milestone China, it further considered the guidance in Accounting Standard Codification ("ASC") 810 as it relates to determining whether Milestone China is a VIE and, if so, identifying the primary beneficiary. As Milestone China’s equity at risk and voting rights were not proportional to their economic interest, Milestone China was determined to be a VIE. Milestone Scientific would be considered the primary beneficiary of the VIE if it has both of the following characteristics:

   Power Criterion: The power to direct the activities that most significantly impact the entity’s economic performance; and

   Losses/Benefits Criterion: The obligation to absorb losses that could potentially be significant or the right to receive benefits that could potentially be significant to the VIE.

Milestone management does not have the ability to control the activities that most significantly impact Milestone China's economics and, therefore, the power criterion has not been met. Management placed the most weight on the relationship and significance of activities of Milestone China to the majority shareholder/CEO of Milestone China.  As majority shareholder, majority holder of voting rights, and the active CEO, the 53% investor has the power to direct the activities that most significantly impact the economic performance of Milestone China. Management has concluded that Milestone Scientific is not the primary beneficiary under ASC 810. Accordingly, Milestone China has not been consolidated into the financial statements of Milestone Scientific and continues to be accounted for under the equity method.

5. Cash and Cash Equivalents

Milestone Scientific considers all highly liquid investments purchased with an original maturity of three months or less to be cash equivalents.


6. Accounts Receivable

Milestone Scientific sells a significant amount of its product on credit terms to its major distributors. Milestone Scientific estimates losses from the inability of its customers to make payments on amounts billed. A majority of credit sales are due within ninety days from invoicing. There have not been any significant credit losses incurred to date.

7. Product Return and Warranty

Milestone Scientific generally does not accept non-defective returns from its customers. Product returns under warranty are accepted, evaluated and repaired or replaced in accordance with the Warranty Policy. Returns not within the Warranty Policy are evaluated and the customer is charged for the repair.

8. Inventories

Inventories principally consist of finished goods and component parts stated at the lower of cost (first-in, first-out method) or market. Inventory quantities on hand are reviewed on a quarterly basis and a provision for excess and obsolete inventory is recorded if required based on past and expected future sales, potential technological obsolescence and product expiration requirements. 

9. Equity Method Investments

Investments in which Milestone Scientific has the ability to exercise significant influence, but do not control, are accounted for under the equity method of accounting and are included in the long term assets on the condensed consolidated balance sheets. Under this method of accounting, Milestone Scientific's share of the net earnings or losses of the investee is presented below the income tax line on the condensed consolidated statements of operations.

Milestone Scientific evaluates its equity method investments whenever events or changes in circumstance indicate that the carrying amounts of such investments may be impaired. If a decline in the value of an equity method investment is determined to be other than temporary, a loss is recorded in earnings in the current period.

10. Furniture, Fixture and Equipment  

Equipment is recorded at cost, less accumulated depreciation. Depreciation expense is computed using the straight-line method over the estimated useful lives of the assets, which range from five to seven years. The costs of maintenance and repairs are charged to operations as incurred.

11. Intangible Assets - Patents

Patents are recorded at cost to prepare and file the applicable documents with the US Patent Office, or internationally with the applicable governmental office in the respective country. The costs related to these patents are being amortized using the straight-line method over the estimated useful life of the patent. Patents acquired from another business entity will be amortized at the estimated average useful life of the patent. These patents are recorded at the acquisition cost and included legal fees.

12. Impairment of Long-Lived Assets

Milestone Scientific reviews long-lived assets for impairment whenever events or circumstances (i.e. a triggering event) indicate that the carrying amounts may not be recoverable. The carrying value of the assets is evaluated in relation to the operating performance and future undiscounted cash flows of the underlying assets. Milestone Scientific adjusts the net book value of an underlying asset if its fair value is determined to be less than its net book value. There have been no impairment indicators or triggering events and therefore, no impairment reviews have been performed in the period ending September 30, 2017.


13. Revenue Recognition

Revenue from product sales is recognized, net of discounts and allowances to domestic distributors, on the date of shipment for substantially all shipments, since the shipment terms are FOB warehouse. Milestone Scientific recognizes revenue on date of arrival of the goods at the customer's location, where shipments are FOB destination. In all cases the price to the buyer is fixed and the collectability is reasonably assured. Further, Milestone Scientific has no obligation on these sales for any post installation, set-up or maintenance, these being the responsibility of the buyer. Milestone Scientific's only obligation after sale is the normal commercial warranty against manufacturing defects if the alleged defective unit is returned within the warranty period. Instrument and hand pieces are not bundled but rather sold separately and, as such, there are no multiple element determinations in connection with the revenue recognition.

14. Shipping and Handling Costs

Milestone Scientific includes shipping and handling costs in cost of goods sold. These costs are paid by or billed to customers at the time of shipment for domestic shipments. International shipments are FOB warehouse, therefore no costs are incurred by Milestone Scientific.

15. Research and Development

Research and development costs, which consist principally of new product development costs payable to third parties, are expensed as incurred. Advance payments for the research are amortized to expense either as services are performed or over the relevant service period using the straight line method.

16. Income Taxes

Milestone Scientific accounts for income taxes pursuant to the asset and liability method which requires deferred income tax assets and liabilities to be computed for temporary differences between the financial statement and tax basis of assets and liabilities that will result in taxable or deductible amounts in the future based on enacted tax laws and rates applicable to the periods in which the differences are expected to affect taxable income. Valuation allowances are established when necessary to reduce deferred tax assets to the amount expected to be realized.

17.  Use of Estimates

 

The preparation of financial statements in conformity with GAAP requires management to makemake estimates and assumptions in determining the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and reported amounts of revenues and expenses during the reporting period. The most significant estimates relate to the allowance for doubtful accounts, inventory valuation, and cash flow assumptions regarding evaluations for impairment of long-lived assets and going concern considerations, and valuation allowances on deferred tax assets. Actual results could differ from those estimates.

5.  Revenue Recognition

Under ASC 606, the Company recognizes revenue when its customer obtains control of promised goods or services, in an amount that reflects the consideration which the Company expects to receive in exchange for those goods or services. To perform revenue recognition for arrangements within the scope of ASC 606, the Company performs the following five steps: 

i.

identification of the promised goods or services in the contract;

ii.

determination of whether the promised goods or services are performance obligations including whether they are distinct in the context of the contract;

iii.

measurement of the transaction price, including the constraint on variable consideration;

iv.

allocation of the transaction price to the performance obligations based on estimated selling prices; and

v.

recognition of revenue when (or as) the Company satisfies each performance obligation. A performance obligation is a promise in a contract to transfer a distinct good or service to the customer and is the unit of account in ASC 606.

The Company derives its revenues from the sale of its products, primarily dental instruments, handpieces, and other related products. The Company sells its products through a global distribution network that includes both exclusive and non-exclusive distribution agreements with related and third parties.


Revenue from product sales is recognized upon transfer of control of a product to a customer, generally upon date of shipment. For certain arrangements where the shipping terms are FOB destination, revenue is recognized upon delivery. The Company has no obligation on product sales for any installation, set-up or maintenance, these being the responsibility of the buyer. Milestone Scientific's only obligation after sale is the normal commercial warranty against manufacturing defects if the alleged defective unit is returned within the warranty period. 

Sales Returns

The Company records allowances for product returns as a reduction of revenue at the time product sales are recorded. Several factors are considered in determining whether an allowance for product returns is required, including the customers’ return rights and the Company’s historical experience with returns and the amount of product in the distribution channel not consumed by patients and subject to return. The Company relies on historical return rates to estimate returns. In the future, if any of these factors and/or the history of product returns change, adjustments to the allowance for product returns may be required.

Financing and Payment

Our payment terms differ by geography and customer, but payment is generally required within 90 days from the date of shipment or delivery.

Disaggregation of Revenue

We operate in two operating segments: dental and medical. Therefore, results of our operations are reported on a consolidated basis for purposes of segment reporting, consistent with internal management reporting. See Note 10 for revenues by geographical market  and operating results by segment for the three and six months ended June 30, 2019 and 2018. 

6.  Variable Interest Entities

A variable interest entity ("VIE") is an entity that either (i) has insufficient equity to permit the entity to finance its activities without additional subordinated financial support or (ii) has equity investors who lack the characteristics of a controlling financial interest. A VIE is consolidated by its primary beneficiary. The primary beneficiary has both the power to direct the activities that most significantly impact the entity's economic performance and the obligation to absorb losses or the right to receive benefits from the entity that could potentially be significant to the VIE. 

If Milestone Scientific determines that it has operating power and the obligation to absorb losses or receive benefits, Milestone Scientific consolidates the VIE as the primary beneficiary. Milestone Scientific’s involvement constitutes power that is most significant to the entity when it has unconstrained decision-making ability over key operational functions within the entity.        

Because Milestone Scientific has a variable interest in Milestone China, it considered the guidance in ASC 810, “Consolidation” as it relates to determining whether Milestone China is a VIE and, if so, identifying the primary beneficiary. Milestone Scientific would be considered the primary beneficiary of the VIE if it has both of the following characteristics:

Power Criterion: The power to direct the activities that most significantly impact the entity’s economic performance; and

Losses/Benefits Criterion: The obligation to absorb losses that could potentially be significant or the right to receive benefits that could potentially be significant to the VIE

Milestone Scientific does not have the ability to control the activities that most significantly impact Milestone China's economics and, therefore, the power criterion has not been met. Management placed the most weight on the relationship and significance of activities of Milestone China to the CEO and a group of significant shareholders, including the Milestone China CEO, of Milestone China which have the power to direct the activities that most significantly impact the economic performance of Milestone China. Management has concluded that Milestone Scientific is not the primary beneficiary under ASC 810. Accordingly, Milestone China has not been consolidated into the financial statements of Milestone Scientific and continues to be accounted for under the equity method. See Note 6.

7. Cash and Cash Equivalents

Milestone Scientific considers all highly liquid investments purchased with an original maturity of three months or less to be cash equivalents.

8. Accounts Receivable

Milestone Scientific sells a significant amount of its product on credit terms to its major distributors. Milestone Scientific estimates losses from the inability of its customers to make payments on amounts billed. Most credit sales are due within 90 days from invoicing. As of June 30, 2019 and December 31, 2018, accounts receivable (non- related party) was recorded, net of allowance for doubtful accounts of $10,000.


9. Product Return and Warranty

Milestone Scientific generally does not accept non-defective returns from its customers, except for certain customers that can return factory sealed purchases (inventory) that still remain in their locations at the time of termination of their Distributor Agreement. Product returns under warranty are accepted, evaluated and repaired or replaced in accordance with the Warranty Policy. Returns not within the Warranty Policy are evaluated and the customer is charged for the repair.

10.  Inventories

Inventories principally consist of finished goods and component parts stated at the lower of cost (first-in, first-out method) or net realizable value. Inventory quantities on hand are reviewed on a quarterly basis and a provision for excess, slow moving, defective, and obsolete inventory is recorded if required based on past and expected future sales, potential technological obsolescence and product expiration requirements. As of June 30, 2019 and December 31, 2018, inventory was recorded net of a valuation allowance for slow moving and defective inventory of approximately $754,000 and $763,000,  respectively. 

11.  Equity Method Investments

Investments in which Milestone Scientific can exercise significant influence, but do not control, are accounted for under the equity method of accounting and are included in the long-term assets on the condensed consolidated balance sheets. Under this method of accounting, Milestone Scientific's share of the net earnings or losses of the investee is presented below the income tax line on the Condensed  Consolidated Statements of Operations.

12.  Furniture, Fixture and Equipment  

Equipment is recorded at cost, less accumulated depreciation. Depreciation expense is computed using the straight-line method over the estimated useful lives of the assets, which range from two to seven years. The costs of maintenance and repairs are charged to operations as incurred. 

13.  Intangible Assets – Patents and Developed Technology

Patents are recorded at cost to prepare and file the applicable documents with the US Patent Office, or internationally with the applicable governmental office in the respective country. The costs related to these patents are being amortized using the straight--line method over the estimated useful life of the patent. Patents and other developed technology acquired from another business entity are amortized over the remaining estimated useful life of the patent. 

14.  Impairment of Long-Lived Assets

Long-lived assets with finite lives are tested for impairment whenever events or changes in circumstances indicate that the carrying amount of an asset may not be recoverable. The Company’s impairment review process is based upon an estimate of future undiscounted cash flow. Factors the Company considers that could trigger an impairment review include the following:

significant under performance relative to expected historical or projected future operating results;

significant changes in the manner of our use of the acquired assets or the strategy for our overall business;

significant negative industry or economic trends; and

significant technological changes, which would render the technology obsolete.

Recoverability of assets that will continue to be used in the Company's operations is measured by comparing the carrying value to the future net undiscounted cash flows expected to be generated by the asset or asset group. Future undiscounted cash flows include estimates of future revenues, driven by market growth rates, and estimated future costs.

15.  Research and Development

Research and development costs, which consist principally of new product development costs payable to third parties, are expensed as incurred. Advance payments for the research are amortized to expense either as services are performed or over the relevant service period using the straight-line method.

16.  Income Taxes

Milestone Scientific accounts for income taxes pursuant to the asset and liability method which requires deferred income tax assets and liabilities to be computed for temporary differences between the financial statement and tax basis of assets and liabilities that will result in taxable or deductible amounts in the future based on enacted tax laws and rates applicable to the periods in which the differences are expected to affect taxable income. Valuation allowances are established when necessary to reduce deferred tax assets to the amount expected to be realized.                


At June 30, 2019 and December 31, 2018, we had no uncertain tax positions that required recognition in the condensed consolidated financial statements. Milestone Scientific's policy is to recognize interest and penalties on unrecognized tax benefits in income tax expense in the condensed consolidated statements of operations. No interest and penalties are present for periods open. Tax returns for the 2015, 2016, and 2017 years are subject to audit by federal and state jurisdictions. 

17.  Basic and diluted net loss per common share

Basic earnings (loss) per common share is computed by dividing the net earnings (loss) for the period by the weighted average number of common shares outstanding during the period. In periods where there is net income, we apply the two-class method to calculate basic and diluted net income (loss) per share of common stock, as our Series A Convertible Preferred Stock is a participating security. The two-class method is an earnings allocation formula that treats a participating security as having rights to earnings that otherwise would have been available to common stockholders. In periods where there is a net loss, the two-class method of computing earnings per share does not apply as our Series A Convertible Preferred Stock does not  contractually participate in our losses. 

The Company did not include any portion of outstanding options,  warrants or convertible preferred stock in the calculation of diluted loss per common share because all such securities are anti-dilutive for all periods presented. The application of the two-class method of computing earnings per share under general accounting principles for participating securities is not applicable during these periods because those securities do not contractually participate in its losses.

Since Milestone Scientific had net losses for 2019 and 2018, the assumed effects of the exercise of potentially dilutive outstanding stock options, warrants and convertible preferred stock were not included in the calculation as their effect would have been anti-dilutive. Such outstanding options and warrants totaled 5,053,832 and 6,703,553 at June 30, 2019 and December 31, 2018,  respectively.

 

18.  Fair Value of Financial Instruments

 

Fair Value Measurements: Fair value is the price that would be received to sell an asset or paid to transfer a liability in an orderly transaction betweenbetween market participants in the principal market at the measurement date (exit price). We are required to classify fair value measurements in one of the following categories:

 

   Level 1 inputs which are defined as quoted prices (unadjusted) in active markets for identical assets or liabilities that the reporting entity has the ability to access at the measurement date.

    Level 2 inputs which are defined as inputs other than quoted prices included within Level 1 that are observable for the assets or liabilities, either directly or indirectly.

    Level 3 inputs are defined as unobservable inputs for the assets or liabilities.

Level 1 inputs which are defined as quoted prices (unadjusted) in active markets for identical assets or liabilities that the reporting entity can access at the measurement date.

Level 2 inputs which are defined as inputs other than quoted prices included within Level 1 that are observable for the assets or liabilities, either directly or indirectly.

Level 3 inputs are defined as unobservable inputs for the assets or liabilities.

 

Financial assets and liabilities are classified based on the lowest level of input that is significant to the fair value measurement. Our assessment of the significance of a particularan input to the fair value measurement requires judgment and may affect the valuation of the fair value of assets and liabilities and their placement within the fair value hierarchy levels.

The following table provides the carrying value and fair value of the Company’s financial assets or liabilities (see Note 8 ) measured at fair value on a recurring basis as of June 30, 2019.

  

Carrying
Value

  

Level 1

  

Level 2

  

Level 3

 
                 

Derivative Warrants

 $370,747   -   -  $370,747 

Shares to be issued-liability

  1,045,212   1,045,212   -   - 

Total June 30, 2019

 $1,415,959  $1,045,212  $-  $370,747 

The following additional disclosures relate to the changes in fair value of the Company’s Level 3 instruments during the six months ended June 30, 2019 :

  

June 30, 2019

 

Balance at beginning of year

 $- 

Warrants issued in connection with public offering (See Note 8)

  376,497 

Change in fair value of derivative liability

  (5,750)

Balance at end of period

 $370,747 


19. Derivative Liability

The Company does not use derivative instruments to hedge exposures to cash flow, market or foreign currency risks; however, the Company has certain financial instruments that qualify as derivatives and are classified as liabilities on the balance sheet. The Company evaluates all its financial instruments to determine if those instruments or any potential embedded components of those instruments qualify as derivatives that need to be separately accounted for in accordance with FASB ASC 815, “Derivatives and Hedging”.  Derivatives satisfying certain criteria are recorded at fair value at issuance and marked-to-market at each balance sheet date with the change in the fair value recorded as income or expense. In addition, upon the occurrence of an event that requires the derivative liability to be reclassified to equity, the derivative liability is revalued to fair value at that date.  

20.  Stock-Based Compensation

Share-based payments to employees, including grants of employee stock options, is recognized in the condensed consolidated statements of operations over the service period, as an operating expense, based on the grant-date fair values. 

21.  Recent Accounting Pronouncements

 

On January 1, 2019, we adopted Accounting Standards Update No. 2016-02, Leases (Topic 842) (ASU 2016-02), by ASU 2018-11, which supersedes the lease accounting guidance under Topic 840, and generally requires lessees to recognize operating and financing lease liabilities and corresponding right-of-use (ROU) assets on the balance sheet and to provide enhanced disclosures surrounding the amount, timing and uncertainty of cash flows arising from leasing arrangements. We adopted the new guidance using the modified retrospective transition approach by applying the new standard to all leases existing at the date of initial application and not restating comparative periods. The most significant impact was the recognition of ROU assets and lease liabilities for operating leases. In May 2014,adopting the new standard, the Company elected to utilize the available package of practical expedients permitted under the transition guidance, which does not require the reassessment of the following: i) whether existing or expired arrangements are or contain a lease, ii) the lease classification of existing or expired leases, and iii) whether previous initial direct costs would qualify for capitalization under the new lease standard. As of the adoption date, the Company identified three operating lease arrangements in which it is a lessee. The adoption of this standard resulted in the recognition of operating lease liabilities and right-of-use assets of $166,292 in the Company’s condensed consolidated balance sheets. The adoption of the standard did not have a material effect on the Company’s statements of operations or statements of cash flows. For information regarding the impact of Topic 842 adoption, see Note 13 – Commitments.

On August 28, 2018, the Financial Accounting Standards Board ("FASB"(“FASB”) issued guidanceASU 2018-13, Fair Value Measurement: Disclosure Framework - Changes to the Disclosure Requirements for revenue recognition for contracts, supersedingFair Value Measurement (Topic 820), which changes the previous revenue recognitionfair value measurement disclosure requirements along with most existing industry-specific guidance. The guidance requires an entity to review contracts in five steps: 1) identify the contract, 2) identify performance obligations, 3) determine the transaction price, 4) allocate the transaction price, and 5) recognize revenue. The new standard will result in enhanced disclosuresof ASC 820. This ASU removes certain disclosure requirements regarding the nature, amount, timingamounts and uncertainty of revenue arising from contracts with customers. In August 2015, the FASB issued guidance approving a one-year deferral, making the standard effectivereasons for reporting periods beginning after December 15, 2017. The FASB continues to release guidance clarifying certain aspectstransfers between Level 1 and Level 2 of the revenue guidance. We do not believe that this new accounting pronouncement will have a material impact on our financial statements.

   In November 2015,fair value hierarchy and the FASB issued guidance simplifyingpolicy for timing of transfers between the balance sheet classificationlevels. This ASU also adds disclosure requirements regarding unrealized gains and losses included in Other Comprehensive Income for recurring Level 3 fair value measurements and the range and weighted average of deferred taxes. The new guidance requires that all deferred taxes be presented as noncurrent, rather than separated into current and noncurrent amounts. The guidanceunobservable inputs used in Level 3 fair value measurements. ASU 2018-13 is effective for reporting periods beginning after December 15, 2016 and early adoption is permitted. In addition, the adoption of guidance can be applied either prospectively or retrospectively to all periods presented. The Company has adopted this pronouncement as of January 1, 2017, and applied retrospectively, for its provision for income taxes disclosure. The adoption did not have an impact on the presentation of the balance sheet, as the Company assigns a full valuation allowance to its net deferred tax asset.

In February 2016, the FASB issued a new standard Accounting Standards Update ("ASU ") No.2016-02, "Leases"(Topic 842). The new standard is intended to increase transparency and comparability among organizations to recognize lease assets and liabilities on the balance sheet and disclose key information about leasing arrangements. It will be effective forentities with fiscal years beginning after December 15, 2018. Milestone Scientific is in the process of determining what impact, the adoption of this ASU will have on its financial position, results of operations and cash flows.

In March 2016, the FASB issued a new standard ASU No.2016-07, “Investments - Equity Method and Joint Ventures” (Topic 323): The new standard is intended to eliminate the requirement that when an investment qualifies for the use of the equity method as a result of an in increase in the level of ownership or degree of influence, results of operations and retained earnings retroactively on a step-by-step basis as if the equity method had been in effect all of the previous periods that the investment was held. It will be effective for all entities for fiscal years and2019, including interim periods beginning after December 15, 2016.therein. Early adoption is permitted for any eliminated or modified disclosures upon issuance of ASU 2018-13. The adoptionCompany is currently evaluating the impact of adopting this standard did not have a material impact on our financial statements.

In March 2016, the FASB issued a new standard ASU No.2016-07, “Investments - Equity Method and Joint Ventures” (Topic 323): The new standard is intended to eliminate the requirement that when an investment qualifies for the use of the equity method as a result of an in increase in the level of ownership or degree of influence, results of operations and retained earnings retroactively on a step-by-step basis as if the equity method had been in effect all of the previous periods that the investment was held. It will be effective for all entities for fiscal years and interim periods, beginning after December 15, 2016. The adoption of this standard did not have a material impact on our financial statements.standard.

 

In June 2016, the FASB issued a new standard ASU No.2016-13, Financial“Financial Instruments – Credit Losses” (Topic 326).: The new standard is intended to replace the incurred loss impairment methodology in current GAAP with a methodology that reflects expected credit losses and requires consideration of a broader range of reasonable and supportable information to inform credit loss estimates. It will be effective for all entities for fiscal years and interim periods, beginning after December 15, 2018. Milestone Scientific is in2019. We are currently evaluating the processimpact of determining what impact, if any, the adoption ofadopting this ASU will haveguidance on its financial position,our consolidated balance sheet, results of operationsoperation and cash flows.financial condition.

 

In August 2016,July 2017, the FASB issued a new standard ASU No.2016-15, "Statement Cash Flows “Classification of Certain Cash ReceiptsNo.2017-11, “Earnings Per Share” (Topic 260), “Distinguishing Liabilities from Equity” (Topic 480), “Derivatives and Cash Disbursements" Topic 230)Hedging” (Topic 815). The new standard provides guidance asrelating to the conformity of presentation ofequity-linked instruments that include certain cash receipts and disbursements.features. It will be effective for all entities for fiscal years and interim periods, beginning after December 15, 2017. Milestone Scientific is in the process of determining what impact, if any, the adoption of this ASU will have on its presentation within the statement of cash flows.

In October 2016, the FASB issued a new standard ASU No.2016-17, "Consolidation Interests Held through Related Parties That Are under Common Control"(Topic 810). The new standard provides guidance as to consideration of consolidation requirements of a primary beneficiary and variable interest entity that are part of related party group under common control. It will be effective for fiscal years and interim periods, beginning after December 15, 2016.2018. Milestone Scientific  has adopted thethis standard effectivein on January 1, 2017, which did not have an impact on its financial reporting.

In November 2016, the FASB issued a new standard ASU No.2016-18, “Statement of Cash Flows – Restricted Cash” (Topic 230).2019. The new standard provides guidance as to address the diversity of treatment of restricted cash on the statement of cash flows. It will be effective for all entities for fiscal years and interim periods, beginning after December 15, 2017 and


interim periods therein. Milestone Scientific does not expect the adoption of this ASU towill have a materialimmaterial effect on its presentation within the statement of cash flows.Cash Flows.

NOTE 4 — INVENTORIES

Inventories consist of the following:

 

June 30, 2019

  

December 31, 2018

 
         

Dental finished goods, net

 $1,035,167  $1,609,000 

Medical finished goods, net

  153,769   188,133 

Component parts and other materials

  81,544   123,918 

Total inventories

 $1,270,480  $1,921,051 

At June 30, 2019 and December 31, 2018, there is a reserve for slow moving medical finished goods of $452,120 and $454,183, respectively, and damaged or slow moving dental finished goods of $302,073 and $309,196, respectively. The reserve for the medical finished goods was primarily related to the delay in commercialization of the intra-articular medical instrument. 


NOTE 5 — ADVANCES ON CONTRACTS

 

In January 2017,The advances on contracts represent funding of future STA inventory purchases and epidural replacements parts. The balance of the FASB issued a new standard ASU No.2017-01, “Business Combinations” (Topic 805).advances as of June 30, 2019 and December 31, 2018 is approximately  $530,000 and $649,000 respectively. The new standard provides guidance to clarifyadvance is classified as current based on the definitionestimated annual usage of a ‘business’, and assist entities in evaluation whether a transaction should be accounted for as an acquisition/disposal of assets or a business. It will be effective for public entities for fiscal years and interim periods, beginning after December 15, 2017, with limited early application. Milestone Scientific is in the process of determining what impact, if any, the adoption of this ASU will have on its presentation within the statement of cash flows.underlying inventory.  

 

In May 2017, the FASB issued a new standard ASU No.2017-09, “CompensationNOTE 6 – Stock Compensation” (Topic 718). The new standard provides guidance and clarity for modification to equity based compensation programs. It will be effective for all entities for fiscal years and interim periods, beginning after December 15, 2017. Milestone Scientific is in the process of determining what impact, if any, the adoption of this ASU will have on its presentation within the statement of cash flows.

NOTE - 3 Basic and Diluted Net INCOME (Loss) Per Common ShareINVESTMENT IN AND TRANSACTIONS WITH UNCONSOLIDATED SUBSIDIARIES

 

Milestone Scientific presents "basic" earnings (loss) per common share applicable to common stockholders and, if applicable, "diluted" earnings (loss) per common share applicable to common stockholders pursuant to the provisions of Statement of Financial Accounting Standards ASC Topic 260. Basic earnings (loss) per common share is calculated by dividing net income or loss applicable to common stockholders by the weighted average number of common shares outstanding and to be issued during each period. The calculation of diluted earnings per common share is similar to that of basic earnings per common share, except that the denominator is increased to include the number of additional common shares that would have been outstanding if all potentially dilutive common shares, such as those issuable upon the exercise of stock options, warrants, and the conversion of debt were issued during the period.China Ltd.

           

Since Milestone Scientific had net losses for three months and nine months ended September 30, 2017 and 2016, the assumed effects of the exercise of potentially dilutive outstanding stock options and warrants were not included in the calculation as their effect would have been anti-dilutive. Such outstanding options and warrants totaled 4,629,557 and 1,885,010 at September 30, 2017 and 2016, respectively.

NOTE - 4 CONSOLIDATION OF VARIABLE INTEREST ENTITY

Milestone Education is a 50% owned subsidiary of Milestone Scientific which began operations in 2013 to provide training and education to dentists throughout the world. Milestone Scientific accounted for its investment in Milestone Education using the equity method of accounting through December 31, 2015. Approximately 81% of the revenue earned by Milestone Education is from services performed for Milestone Scientific as of September 30, 2017. As a result of this dependency and relationship, we determined that we had the power to direct the activities that most significantly impact Milestone Education's economic performance, and therefore is consolidated in our financial statements. 

NOTE - 5 INVESTMENTS IN UNCONSOLIDATED SUBSIDIARIES

Advance Ocular Science SA

Advanced Ocular Sciences SA ("Advanced Ocular") is a shell company attempting to develop an instrument to deliver injections into the eyes. As of September 30, 2017, Milestone Scientific owns 25% of this entity. During 2015, Milestone Scientific advanced $78,798 for marketing and strategy planning to Advanced Ocular and it, or its organizers, were obligated to repay this advance if a public offering of Advanced Ocular equity was approved and funded in Poland during 2016. However, a public offering has yet to be completed in Poland. As a result, Milestone Scientific wrote-off the $78,798 advanced to Advanced Ocular as of December 31, 2016. Advance Ocular was not included in the condensed consolidated financial statements at September 30, 2017 as no further investment has been made by Milestone Scientific.

Milestone China Ltd.Ownership

 

In June 2014, Milestone Scientific invested $1 million in Milestone China Ltd. (“Milestone China”) by contributing 772 STA Instruments to Milestone China for a 40% ownership interest. Milestone Scientific recorded this investment under the equity method of accounting. 

Related Party Transactions

Milestone China is Milestone Scientific’s exclusive distributor in China.  During 2017 and prior to the payment default during 2018, Milestone Scientific recorded a loss on its investment inagreed to sell inventory to Milestone China of $0 and $164,837, as of September 30, 2017 and 2016, respectively. Milestone Scientific's investment in Milestone China was $0 as of September 30, 2017 and December 31, 2016, respectively. Milestone Scientific incurred cumulative losses on its investment in Milestone China of $2,078,484 and $1,124,350 as of September 30, 2017 and December 31, 2016, respectively, which have been suspended.


  In June 2017,agent. During 2018 Milestone Scientific entered into an agreement for the sale of the Milestone China Shares to an unaffiliated United States domiciled purchaser and a 10-year option agreement to repurchase the Milestone China Shares. The purchase price for the Milestone China Shares was $1,400,000 of which $125,000 was paid in cash and $1,275,000 was paid by delivery of a non-interest bearing secured promissory note. The note is payable in quarterly installments of $125,000 until paid in full and is secured by the Milestone China Shares until full repayment.  In addition, pursuant to such note, the purchaser is precluded from selling all or substantially all of its assets prior to repayment of the note. The 10-year option agreement provides Milestone Scientific an option to repurchase the 40% equity interest at $1,400,000 within the first two years and at fair value (as defined in such agreement) for the remainder of the 10-year term. The transaction has been accounted for as a secured financing and Milestone Scientific will continue to account for its relationshippayment arrangement with Milestone China to satisfy past due receivables from Milestone China and it’s agents which amounted to $ 2.8 million  at the time of the payment arrangement. The payment terms required payments of $200,000 per month beginning in July 2018 through November 2018 and a balloon payment of approximately $1,425,000 during December 2018. Milestone Scientific collected $950,000 under the equity methodpayment arrangement which resulted in a deferred revenue and deferred cost balance of accounting. A note receivable is presented$1.8 million and $1.25 million, respectively. Due to the default on the Balance Sheet, along witharrangement  and Milestone China’s liquidity constraints, Milestone Scientific  halted  shipments to Milestone China and the Company has adjusted the accounts receivable related party and the deferred revenue related party based on the expected payment realization and recorded a deferral from financing transaction ($1,400,000). The carrying valuereserve against the related deferred cost of $1.25 million during the forty (40%) percent investment at the transaction date was zero.fourth quarter of 2018.

 

Milestone Scientific had $356,400 and $1,714,600 of related party sales of handpieces and instruments to Milestone China and Milestone China’s agent during the three and nine months ended September 30, 2017 respectively. Milestone Scientific had $1,977,862 and $3,203,466 of related party sales of handpieces and instruments to Milestone China during the three and nine months ended September 30, 2016, respectively. As of September 30, 2017 and December 31, 2016, Milestone Scientific recorded deferred revenues and deferred costsrecognized revenue associated with sales to Milestone China and it’s agents of $712,800$50,000 and $362,718,$100,000 for the three and $1,001,800six months ended June 30, 2019, respectively. For the three and $620,041, respectively.  As of Septembersix months ended June 30, 2017 and December 31, 2016, Milestone China’s agent owed $712,800 and $2,714,600, respectively, to2018, Milestone Scientific which is included in related party accounts receivable on the condensed consolidated balance sheets. 

Milestone Scientific defers the totalrecognized no revenue and costs of goods sold when instruments and handpieces are shippedassociated with sales to Milestone China and Milestone China’s agent due to market conditions and Milestone China liquidity concerns. it’s agents. 

Gross Profit Deferral

Due to timing differences of when the inventory sold to Milestone China is actually recognized and when Milestone China sells the acquired inventory to third parties, an elimination of the intra-entity profit is required as of the balance sheet date. In accordance with ASC 323 Equity Method and Joint Ventures, Milestone Scientific has deferred 40% of the gross profit associated with previously recognized revenue from sales to Milestone China until that has not beenproduct is  sold to third parties.

At SeptemberJune 30, 20172019 and December 31, 2016,2018 , the deferred profit was $659,931$372,200 and $630,990,$421,800, respectively, which is included in deferred profit, related party in the condensed consolidated balance sheets. For the ninethree and six months ended SeptemberJune 30, 2017 and 2016, the loss2019, Milestone Scientific recorded income on equity investment was $28,941of  $58,664 and $554,766,$49,100 respectively, which is included in the condensed consolidated statements of operation.for product sold by Milestone China to third parties. For the three and six months ended SeptemberJune 30, 2017 and 2016, the loss2018, Milestone Scientific recorded an income on equity investment of  $78,591 and $115,374 respectively, for product sold by Milestone China to third parties.

Equity Method Disclosures

As June 30,2019 and December 31, 2018, Milestone Scientific's investment in Milestone China was $0$0. As of June 30, 2019 and $253,451,December 31, 2018, Milestone Scientific’s share of cumulative losses of Milestone China were $4,223,449 and $3,380,388, respectively, which is included in the condensed consolidated statements of operation.have been suspended.

 

The following table includes summarized financial information (unaudited) of Milestone China:

 

September 30, 2017

 

December 31, 2016

 

Assets:

      

Current Assets

$7,127,064 $9,362,198 

Non-Current Assets

 2,981,574  2,467,547 

Total Assets:

 10,108,638  11,829,745 
       

Liabilities:

      

Current Liabilities

 10,449,791  9,900,611 

Stockholders' equity

 (341,153)  1,929,134 

Total liabilities and stockholders’ equity

$10,108,638 $11,829,745 

  

Three Months Ended September 30,

  

Nine Months Ended September 30,

 
  

2017

  

2016

  

2017

  

2016

 
                 

Net Sales

 $1,382,588  $329,617  $2,548,140  $658,939 

Cost of Goods Sold

  556,430   262,576   1,445,634   546,440 

Gross Profit

  826,158   (67,041)  1,102,506   112,499 

Other Expenses

  (1,886,180)  (1,160,834)  (3,487,845)  (1,673,731)

Net Losses

 $(1,060,022) $(1,093,793) $(2,385,339) $(1,561,232)
  

June 30, 2019

  

December 31, 2018

 

Assets:

 

(unaudited)

  

(unaudited)

 

Current assets

 $13,966,781  $10,587,648 

Non-current assets

  4,974,387   4,603,485 

Total assets:

 $18,941,168  $15,191,133 
         

Liabilities:

        

Current liabilities

 $23,276,964  $17,696,033 

Stockholders' deficit

  (4,335,796)  (2,504,900)

Total liabilities and stockholders’ deficit

 $18,941,168  $15,191,133 

 


 

  

For the three

months ended

June 30, 2019

  

For the three months ended

June 30, 2018

  

For the six

months ended

June 30, 2019

  

For the six

months ended

June 30, 2018

 
  

(unaudited)

  

(unaudited)

  

(unaudited)

  

(unaudited)

 

Net sales

 $1,149,474  $1,328,079  $1,753,802  $2,085,034 

Cost of goods sold

  324,300   650,840   559,400   1,098,452 

Gross profit

  825,174   677,239   1,194,402   986,582 

Other expenses

  (1,423,353)  (1,119,440)  (3,302,057)  (2,371,652)

Net loss

 $(598,179) $(442,201) $(2,107,655) $(1,385,070)

NOTE – 6 7 — PATENTSStock Option Plans

 

  

June 30, 2019

 
  

Cost

  

Impairment

  

Accumulated Amortization

  

Net

 

Patents-foundation intellectual property

 $1,377,863  $-  $(969,096) $408,767 

Total

 $1,377,863  $-  $(969,096) $408,767 

Milestone Scientific recognizes compensation

  

December 31, 2018

 
  

Cost

  

Impairment

  

Accumulated Amortization

  

Net

 

Patents-foundation intellectual property

 $1,377,863  $-  $(942,590) $435,273 

Epidural-Apad acquired patents

  2,639,647   (1,539,794)  (1,099,853)  - 

Total

 $4,017,510  $(1,539,794) $(2,042,443) $435,273 

Patents are amortized utilizing the straight-line method over estimated useful lives ranging from 3 to 20 years. Amortization expense on a straight line basis over the requisite service periodwas approximately  $13,000 and in the case of performance based options over the period of the expected performance. For$26,500 for the three and ninesix months ended SeptemberJune 30, 2017 Milestone Scientific recognized $299,1752019, respectively. Amortization expense was approximately $232,000 and $543,290 of total employee stock based compensation cost, respectively. For$469,000 for the three and ninesix months ended SeptemberJune 30, 2016,2018, respectively.

During 2018, the Company determined  that the APAD Patents purchased in 2017 will not be further developed or commercialized before their estimated useful life expires.  As such, management determined that these assets were impaired and a charge of approximately $1.5 million was recorded.  

NOTE 8— STOCKHOLDERS’ EQUITY

PUBLIC OFFERING AND PRIVATE PLACEMENT

In February 2019, Milestone Scientific recognized $81,678consummated a public offering and $107,205a private placement of total employeeCommon Stock. The public offering generated gross proceeds of approximately $2.0 million for the issuance of 5,715,000 shares of common stock based compensation cost, respectively. Asand warrants to purchase 1,428,750 shares of September 30, 2017 and 2016, there was $1,389,525 and $580,331 of total unrecognized compensation cost related to nonvested options, respectively, which Milestone Scientific expects to recognize these cost over a weighted average period of 2.5common stock. The warrants’ term is 5 years and 2.49 years asthey are exercisable at $0.50. Subsequent to the public offering the underwriter exercised its overallotment option and paid approximately $198,000 for  567,400 additional shares of September 30, 2017common stock and 2016, respectively.141,850 warrants.

 

Also, in February 2019, the Company generated gross proceeds from a private placement of approximately $250,000 for 714,286 shares of common stock and warrants to purchase 178,571 shares of common stock from  Bp4 S.p.A., a principal stockholder of Milestone Scientific, that exercised its right to participate on a pro-rata basis on the recent public offering. Bp4’s CEO is a director of Milestone Scientific and also Chief Executive Officer and Director of Wand Dental, a wholly owned subsidiary of Milestone Scientific. The warrants’ terms are 5 years and they are exercisable at $0.50

WARRANTS

The following table summarizes information about shares issuable under warrants outstanding at June 30, 2019 :

  

Warrant shares outstanding

  

Weighted Average exercise price

  

Weighted Average remaining life

  

Intrinsic value

 

Outstanding at January 1, 2019

  1,592,775  $2.55  $0.48   - 

Issued

  1,749,171  $0.50  $4.60   - 

Exercised

  -   -   -   - 

Expired or cancelled

  -   -   -   - 
Outstanding and exercisable at June 30, 2019  3,341,946  $1.48  $2.60   - 


PREFERRED STOCK

In May 2014, Milestone completed a private placement, which raised gross proceeds of $10 million, from the sale of $3 million of Milestone Scientific common stock (two million shares at $1.50 per share) and $7 million of our Series A summaryConvertible Preferred Stock ("preferred stock") (7,000 shares at $1,000 per share).  These shares are convertible, at the option of option activitythe holder, into the number of shares of common stock equal to the stated value divided by $2.545, subject to anti-dilution adjustments, at any time before May 14, 2019. These shares are mandatory convertible on May 14, 2019, into the number of shares of common stock equal to the stated value divided by $2.545 per share or $1.50 per share if the common stock does not trade at $3.15 for period of time, as defined by the agreements, both subject to anti-dilution adjustment.

The conversion ratio and anti-dilution adjustment becomes effective if a triggering event occurs such as; issuance of stock dividends or distributions, subdivisions, splits, issuance of stock purchase rights, debt and distributions, cash dividends or distributions, self-tender offers and exchange offers, rights plans and issuance below the conversion price, as defined in the Investment Agreement. Generally, each share of preferred stock entitles the holder to vote together with the holders of Milestone Scientific common stock, as a single class, on all matters submitted for the approval of the holders of Milestone Scientific common stock and has the number of votes equal to the number of shares of our common stock into which they are then convertible.  In addition, preferred stock is also entitled to share, pari passu, in any cash dividends declared on Milestone Scientific common stock on as converted basis.

On May 14, 2019, the mandatory conversion date, the Preferred Stock was converted at a rate of $1.17 per common share resulting in the issuances of 5,982,906 shares of common stock.

SHARES TO BE ISSUED

As of June 30, 2019  2,185,910 shares to be issued  to employees were classified as liability until there are sufficient number of authorized shares of common stock to cover the issuance of the shares.   As of December 31, 2018, there were   1,908,813 shares, whose issuance has been deferred under the plansterms of an employment agreements with the Chief Executive Officer, Chief Financial Officer and changes duringother employees of Milestone Scientific. Such shares will be issued to each party upon termination of their employment. As of June 30, 2019, 717,456 shares to be issued to non-employees were classified as liability until there are sufficient number of authorized shares of common stock to cover the nine month ended September 30, 2017, is presented below: issuance of the shares. As of December 31, 2018, there were 561,752 shares, respectively, that will be issued to non-employees for services rendered. The number of shares was fixed at the date of grant and were fully vested upon grant date.

 

 

Number of

Options

 

Weighted

Averaged

Exercise  Price $

 

Weighted Average

Remaining

Contractual Life

(Years)

 

Aggregate Intrinsic

Options Value $

 

Options outstanding January 1, 2017

1,511,995 1.74 2.97 - 

Granted

1,383,121 2.04 4.26   

Exercised during 2017

(83,333) 0.75     

Forfeited or expired

        

Options outstanding September 30, 2017

2,811,783 1.98 3.31   

Exercisable, September 30, 2017

1,380,958 1.98 2.22   

SHARES AND WARRANTS IN EXCESS OF AUTHORIZED SHARES

 

A summaryAs a result of option activity for non-employees under the plansshares and warrants issued in the public and private offerings as well as other issuances of common stock during 2019, the Company does not have a sufficient number of authorized shares of common stock to cover the exercise and issue of approximately 4,850,000 outstanding equity instruments. Therefore, the warrants issued in the public and private placements during 2019 and 2016 are classified as liabilities and will continue to be liability-classified until there are sufficient number of authorized shares of common stock to cover the shares issuable upon exercise of the warrants. As long as the warrants are liability-classified, they will continue to be re-measured each reporting period, with any increase or decrease in value recorded as a loss or gain in the condensed consolidated statement of September 30, 2017 and changes during the six month ended isoperations. 

  

Number of

Options

  

Weighted

Averaged

Exercise

Price $

  

Weighted

Average

Remaining

Contractual

Life (Years)

  

Aggregate

Intrinsic

Options

Value $

 

Options outstanding January 1, 2017

  224,999   2.52   5.32   - 

Granted

  -             

Exercised during 2017

  -             

Forfeited or expired

  -             

Options outstanding September 30, 2017

  224,999   2.52   4.57   - 

Exercisable, September 30, 2017

  12,960   2.33   3.68   - 

 

The fair value of the non-employee options was estimated onwarrants is determined using a Black-Scholes option pricing model.  The following assumptions were used to value the date of grantwarrants at the reclassification to liability date:

  

2016 Warrants

  

2019 Warrants

 

Expected Term

 0.4 years  

5 years

 

Volatility

  100%  85%

Dividend yield

  0.00%  0.00%

Exercise Price

 $2.55  $0.50 

Risk-free interest rate

  2.09%  2.50%

Weighted average fair value of warrants granted

  -  $0.22 

Number of shares underlying warrants granted

  201,044   1,749,171 

As these warrants are liability-classified, they were revalued at June 30, 2019 using the Black Scholes option-pricing model at the date of grant. In accordance with the provisions of FASB ASC 505, Milestone Scientific re-measures the value of the grant at each presentation date unless there is a significant disincentive for non-performance or until performance has been. following assumptions:

  

2016 Warrants

  

2019 Warrants

 

Expected Term

 

0.4 years

  

4.6 years

 

Volatility

  100%  84%

Dividend yield

  0.00%  0.00%

Exercise Price

 $2.55  $0.50 

Risk-free interest rate

  2.09%  1.76%

Weighted average fair value of warrants granted

 $-  $0.21 

For the three and ninesix months ended SeptemberJune 30, 2017, Milestone Scientific recognized income of $6,0672019 the gain(loss) on the liability classified warrants was approximately ($34,000) and $12,324, respectively related to non-employee options. For the three and nine months ended September 30, 2016, Milestone Scientific recognized expense of $2,807 and $8,421 respectively related to non-employee options.

NOTE – 7 CONCENTRATION OF CREDIT RISK

Milestone Scientific's consolidated financial instruments that are exposed to concentrations of credit risk consist primarily of cash, trade accounts receivable, and advances on contracts. Milestone Scientific places its cash and cash equivalents with large financial institutions. At times, such investments may be in excess of the Federal Deposit Insurance Corporation insurance limit. Milestone Scientific has not experienced any losses in such accounts and believes it is not exposed to any significant credit risks. Financial instruments which potentially subject Milestone Scientific to credit risk consist principally of trade accounts receivable, as Milestone Scientific does not require collateral or other security to support customer receivables, and advances on contracts. Milestone Scientific closely monitors the extension of credit to its customers while maintaining allowances, if necessary, for potential credit losses. On a periodic basis, Milestone Scientific evaluates its accounts receivable and establishes an allowance for doubtful accounts, based on a history of past write-offs and collections and current credit conditions.$6,000, respectively.

 

  


NOTE – 8 ADVANCES ON CONTRACTSAdditionally, approximately 2,900,000 of shares to be issued  are classified as liabilities until there are sufficient number of authorized shares of common stock to cover the issuance of such shares. These shares were valued at the trading price of a share of the Company’s common stock ( $0.36 as of June 30, 2019 ) and they will continue to be re-measured each reporting period, with any increase or decrease in value recorded as a loss or gain in the condensed consolidated statement of operations. For the three and six months ended June 30, 2019 the gain(loss) on the liability classified shares to be issued was approximately $47,000, respectively.  The Company plans to seek shareholder approval to increase the number of authorized shares of Common Stock at the next Shareholder’s meeting.

 

The advances on contracts represent funding of future STA inventory purchases and Epidural replacements parts. The balance of the advances As of September 30, 2017 and December 31, 2016 is $992,242 and $700,900, respectively. The advance is classified as current based on the estimated annual usage of the underlying inventory.   

NOTE 9 — INCOME TAXES

 

Due to Milestone Scientific's history of operating losses, a full valuation allowances hashave been provided for all of Milestone Scientific's deferred tax assets At Septemberat June 30, 20172019 and December 31, 2016, no recognition was given to the utilization of the remaining net operating loss carryforwards in each of these periods.2018.

 

The utilization of Milestone Scientific's net operating losses may be subject to a substantial limitation due to the "change of ownership provisions"provisions" under Section 382 of the Internal Revenue Code and similar state provisions. Such limitation may result in the expiration of the net operating loss carry forwards before their utilization. Milestone Scientific has established a 100% valuation allowance for all of its deferred tax assets due to uncertainty as to their future realization.

NOTE 10 — SEGMENT AND GEOGRAPHIC DATA

        

As of September 30, 2017We conduct our business through two reportable segments:  dental and December 31, 2016, state tax liability was approximately $18,339medical. These segments offer different products and $63,000, respectively. Such expense was recognized in the accompanying condensed consolidated financial statements.services to different customer base. The following tables present information about our reportable and operating segments:

 

  

Three months ended June 30

  

Six months ended June 30

 

Sales

                

Net Sales:

 

2019

  

2018

  

2019

  

2018

 

Dental

 $2,242,751  $2,388,898  $4,158,259  $4,158,003 

Medical

  15,100   39,600   15,500   76,100 

Total net sales

 $2,257,851  $2,428,498  $4,173,759  $4,234,103 
                 

Operating Income (Loss):

 

2019

  

2018

  

2019

  

2018

 

Dental

 $629,474  $723,084  $1,121,440  $1,080,249 

Medical

  (664,658)  (846,164)  (1,156,341)  (1,554,546)

Corporate

  (1,072,647)  (1,301,607)  (1,891,114)  (2,952,043)

Total operating loss

 $(1,107,831) $(1,424,687) $(1,926,015) $(3,426,340)
                 

Depreciation and Amortization:

 

2019

  

2018

  

2019

  

2018

 

Dental

 $3,950  $4,103  $7,886  $8,244 

Medical

  5,999   2,478   12,170   19,355 

Corporate

  15,507   238,546   31,445   482,519 

Total depreciation and amortization

 $25,456  $245,127  $51,501  $510,118 
                 

Income (loss) before taxes and equity in earnings of affiliates:

 

2019

  

2018

  

2019

  

2018

 

Dental

 $627,051  $725,007  $1,120,035  $1,084,829 

Medical

  (664,007)  (846,737)  (1,156,393)  (1,555,691)

Corporate

  (1,060,788)  (1,302,787)  (1,840,553)  (2,954,345)

Total loss before taxes and equity in earnings of affiliate

 $(1,097,744) $(1,424,517) $(1,876,911) $(3,425,207)

NOTE – 10 SIGNIFICANT CONCENTRATIONS & GEOGRAPHICAL INFORMATION

Total Assets:

 

June 30, 2019

  

December 31, 2018

 

Dental

 $5,409,961  $5,169,944 

Medical

  276,787   328,208 

Corporate

  1,101,541   902,816 

Total assets

 $6,788,289  $6,400,968 


The following table presents information about our operations by geographic area for the three and six months June 30, 2019 and 2018. Net sales by geographic area are based on the respective locations of our subsidiaries:   

 

Milestone Scientific’s consolidated dental sales by product and by geographical region are as follows:  Revenue from the medical segment is not material as of September 2017.

  

Three months ended June 30,

  

Six months ended June 30,

 

Domestic-US & Canada

 

2019

  

2018

  

2019

  

2018

 

Devices

 $146,289  $11,505  $270,285  $132,553 

Handpieces

  1,030,391   1,158,975   1,819,544   1,927,506 

Other

  32,463   22,377   49,279   51,228 

Total Domestic US & Canada

 $1,209,143  $1,192,857  $2,139,108  $2,111,287 

International ROW

                

Devices

 $339,570  $367,450  $624,915  $652,518 

Handpieces

  631,129   839,194   1,262,839   1,418,021 

Other

  28,009   28,997   46,897   52,277 

Total International-ROW

 $998,708  $1,235,641  $1,934,651  $2,122,816 

International-China

                

Devices

 $-  $-  $-  $- 

Handpieces

  50,000   -   100,000   - 

Other

  -   -   -   - 

Total International

 $50,000  $-  $100,000  $- 

Domestic. International Analysis

                

Domestic-US & Canada

 $1,209,143  $1,192,857  $2,139,108  $2,111,287 

International -ROW

  998,708   1,235,641   1,934,651   2,122,816 

International -China

  50,000   -   100,000   - 

Total Product Sales

 $2,257,851  $2,428,498  $4,173,759  $4,234,103 

 

  

Three months Ended September 30,

 

Nine months Ended September 30,

  

2017

 

2016

 

2017

 

2016

DOMESTIC

                    

Instruments

 $452,232   $-   $857,525   $852,149  

Handpieces

  893,496    106,908    3,230,567    1,860,593  

Other

  12,338    12,508    53,037    46,634  

Total Domestic

 $1,358,066   $119,416   $4,141,129   $2,759,376  

INTERNATIONAL-Europe

                    

Instruments

 $340,575   $1,416,030   $1,053,050   $1,974,280  

Handpieces

  765,821    713,766    2,068,007    1,845,424  

Other

  32,951    87,984    89,764    188,046  

Total International -Europe

 $1,139,347   $2,217,780   $3,210,821   $4,007,750  

INTERNATIONAL-China

                    

Instruments

 $-   $493,000   $1,000,000   $1,493,800  

Handpieces

  356,400    356,400    712,800    712,800  

Other

  -    -    1,800    -  

Total International-China

 $356,400   $849,400   $1,714,600   $2,206,600  
                     

Domestic

 $1,358,066   $119,416   $4,141,129   $2,759,376  

International -Europe

  1,139,347    2,217,780    3,210,821    4,007,750  

International -China

  356,400    849,400    1,714,600    2,206,600  
  $2,853,813   $3,186,596   $9,066,550   $8,973,726  

NOTE 11 – CONCENTRATIONS

 

Milestone Scientific has informal arrangements with a third party manufacturerthird-party manufacturers of the STA, CompuDent®CompuDent ,CompuMed devices and CompuMed®handpieces, pursuant to which they manufacture these products under specific purchase orders but without any long-term contract or minimum purchase commitment. Consequently, advances on contracts have been classified as current at June 30, 2019   and December 31, 2018. The termination of the manufacturing relationship with any of these manufacturers could have a material adverse effect on Milestone Scientific’s ability to produce and sell its products. Although alternate sources of supply exist, and new manufacturing relationships could be established, Milestone Scientific would need to recover its existing tools or have new tools produced. Establishment of new manufacturing relationships could involve significant expense and delay. Any curtailment or interruption of the supply, because of termination of such a relationship, would have a material adverse effect on Milestone Scientific’s financial condition, business and results of operations.              

For the three and six months ended June 30, 2019 an aggregate of approximately 52%  and 50%, respectively, of Wand Dental’s net product sales were to one customer/distributor. For the three and six months ended June 30, 2018 an aggregate of approximately 44%  and 43%, respectively, of Wand Dental’s net product sales were to one customer/distributor. Accounts receivable for two customer/distributor amounted to approximately $2,850,461 or 82%, or 52% and 30% of Milestone Scientific's gross accounts receivable as of June 30, 2019.  Accounts receivable, including related party accounts receivable, for the major customer/distributor (i.e., Milestone China, a related party), amounted to approximately $2,555,000, or 78% of Milestone Scientific's accounts receivable, as of December 31, 2018. As of  June 30, 2019 ,  Milestone China owed $1,817,990 to Milestone Scientific. Due to the delinquent nature of the scheduled payments and Milestone China’s further liquidity constraints, Milestone Scientific reduced accounts receivable, related party and deferred revenue, related party by $1,817,990 in 2018, this allowance remains recorded as of June 30, 2019 . Additionally, Milestone Scientific has a reserve of $1,250,928 at June 30, 2019 and December 31, 2018, against the associated deferred cost, related party which was recorded in 2018.  

NOTE 12 -- RELATED PARTY TRANSACTIONS

United Systems

Milestone Scientific has a manufacturing agreement with United Systems (whose controlling shareholder, Tom Cheng, is a significant stockholder of Milestone Scientific), the principal manufacturers of its handpieces, pursuant to which it manufactures products under specific purchase orders, but without minimum purchase commitments. Purchases from this manufacturer were approximately $167,000 and $505,600 for the three and six months ended June 30, 2019, respectively.  Purchases from this this manufacturer were approximately $222,000 and $574,000 for the three and six months ended June 30, 2018 respectively. As June 30, 2019 and December 31,2018, Milestone Scientific owed this manufacturer approximately $1.0 million, which is included in accounts payable, related party on the condensed consolidated balance sheets. In February 2019, Milestone Scientific board of directors granted United Systems (controlling shareholder, Tom Cheng) 285,714 shares of stock at $0.35 or $100,000 for consulting services. These shares were included in shares to be issued as of  June 30, 2019.


During  2018 Milestone Scientific through its wholly owned subsidiary, Wand Dental, entered into an agreement with United Systems. The agreement was a Royalty Agreement for handpieces sold to Milestone China by United Systems. United Systems will pay Wand Dental a royalty equal to the net profit that Wand Dental would have received if the handpieces were sold directly to Milestone China or its Agent. As of June 30, 2019 and  December 31, 2018, Wand Dental had deferred royalty income of $342,540 that will be recognized at the earlier of when payment of the royalties is received from United Systems or when collectability is deemed to be assured and is included in accounts receivable, related party and deferred revenue, related party on the condensed  consolidated balance sheets.  

Also, during the year ended December 31, 2018, a Distribution Agreement was  executed between Wand Dental and United Systems.  Under the Distribution Agreement United Systems purchased 1,000 STA instruments in June 2018, for delivery to Milestone China. Due to the related party nature and collectability concerns Wand Dental has deferred the sale. During 2018, Milestone Scientific had recorded deferred revenues and deferred costs associated with the sale to United Systems of $750,000 and $686,365, respectively. Milestone Scientific entered into a payment arrangement with Milestone China to satisfy past due receivables from Milestone China and it’s agents which amounted to $ 2.8 million at the time of the payment arrangement. The payment terms required payments of $200,000 per month beginning in July 2018 through November 2018 and a balloon payment of approximately $1,425,000 during December 2018. Due to the default on the arrangement  and Milestone China’s liquidity constraints, Milestone Scientific halted shipments to Milestone China. The Company has adjusted the accounts receivable related party and the deferred revenue related party based on the expected payment realization and recorded a reserve against the related deferred cost of $1.25 million which includes the sales  to United Systems. The amounts due from Untied Systems described above are included in the adjustments and reserves for Milestone China. See Note 6.

Milestone China

Milestone Scientific owns a 40% interest in Milestone China. See Note 6.

Other

In August 2016, K. Tucker Andersen, a significant stockholder of Milestone Scientific, entered into a three-year agreement with Milestone Scientific to provide financial and business strategic services. Expenses recognized on this agreement were $25,000 and $50,000 for the three and six months ended June 30, 2019 and 2018, respectively.

In January 2017, Milestone Scientific entered into a twelve-month agreement with Innovest S.p.A., a significant stockholder of Milestone Scientific, to provide consulting services. This agreement will renew for successive twelve-month terms unless terminated by Innovest S.p.A or Milestone Scientific. Expenses recognized on this agreement were $20,000  and $40,000 for the three and six months ended June 30, 2019 and 2018, respectively.

The Director of Clinical Affairs’ royalty fee was approximately $108,000 and $199,000 for the three and six months ended June 30, 2019,  respectively. The Director of Clinical Affairs’ royalty fee was approximately $116,956 and 202,481  for the three and six months ended June 30, 2018,  respectively. Additionally, Milestone Scientific expensed consulting fees to the Director of Clinical Affairs of $39,000 and $78,000 for the three and six months ended June 30, 2019 respectively. Milestone Scientific expensed consulting fees to the Director of Clinical Affairs of $39,000 and $107,751 for the three and six months ended June 30, 2018 respectively. As of June 30, 2019 and December 31, 2018, Milestone Scientific owed the Director Clinical Affairs for royalties of approximately $410,000 and $364,000, respectively, which is included in accounts payable, related party and accrued expense, related party. 

NOTE 13 — COMMITMENTS

(1) Contract Manufacturing Agreement 

Milestone Scientific has informal arrangements with third-party manufacturers of the STA, CompuDent® and CompuMed® devices, pursuant to which they manufacture these products under specific purchase orders but without any long-term contract or minimum purchase commitment. In March 2016, Milestone ScientificJanuary 2018, Wand Dental entered into a purchase commitment for delivery of 3,000 instruments, as of September 30, 2017 all instruments have been received. In January 2017, Milestone Scientific entered into anew purchase commitment for the delivery of 2,000 instruments1,000 devices beginning in 2019. As of June 30, 2019 we have an open purchase order of $819,725 for 1,000 instruments and have advanced $482,680 as of June 30, 2019 against these purchase commitment

(2)  Leases

Operating Leases

In June 2015, the 4th quarterCompany amended its original office lease of approximately 6,851 square feet for its headquarters in Livingston, New Jersey. Under the amendment, the Company leased an additional 774 square feet of rentable area of the building and extended the term of the lease through January 31, 2020 at a monthly cost of $12,522. The Company has an option to further extend the term of the lease, however, this option was not included in the determination of the lease’s right-of-use asset or lease liability. Per the terms of the lease agreement, the Company does not have a residual value guarantee. The Company will also be required to pay its proportionate share of certain operating costs and property taxes applicable to the leased premises in excess of new base year amounts. These costs are considered to be variable lease payments and are not included in the determination of the lease’s right-of-use asset or lease liability.

The Company identified and assessed the following significant assumptions in recognizing its right-of-use assets and corresponding lease liabilities:

As the Company’s leases do not provide an implicit rate, the Company estimated the incremental borrowing rate in calculating the present value of the lease payments. The Company has utilized its incremental borrowing rate based on the long-term borrowing costs of comparable companies in the Medical Device industry.

Since the Company elected to account for each lease component and its associated non-lease components as a single combined lease component, all contract consideration was allocated to the combined lease component.

The expected lease terms include noncancelable lease periods. Renewal option periods are not included in the determination of the lease terms as they were not reasonably certain to be exercised.


 

The components of 2017. An advancelease expense as of $948,094 was recorded at SeptemberJune 30, 2017. At September2019 were as follows:

         

Lease cost

 

Three Months Ended June 30, 2019

  

Six Months Ended June 30, 2019

 

Operating lease cost

 $39,554  $79,109 

Total lease cost

 $39,554  $79,109 

Other information

        

Cash paid for amounts included in the measurement of lease liabilities:

        

Operating cash flows from operating leases

     $79,109 

Right-of-use assets obtained in exchange for new operating lease liabilities

      - 

Weighted-average remaining lease term - operating leases

 

 

  

.06 years

 

Weighted-average discount rate - operating leases

      9.2%

Maturities of lease liabilities due under these lease agreements as of June 30, 2017, Milestone Scientific’s purchase commitment2019 are as follows:

2019 (excluding the 6 months ended June 30, 2019 )

 

Operating Leases

 

2020

 $79,109 

2021

  15,976 

2022

  - 

2023

  - 

Thereafter

  - 

Total lease payments

 $95,085 

Less: interest

 $(2,255)

Total operating lease liabilities as of June 30, 2019

 $92,830 

The Company adopted ASU 2016-02 on January 1, 2019 as noted above, and as required, the following disclosure is provided for this purchase order was $431,619. Consequently, advances on contracts have been classifiedperiods prior to adoption. Future annual minimum lease payments and operating lease commitments as current at September 30, 2017 andof December 31, 2016.

For the three months ended September 30, 2017 , an aggregate of approximately 67% of Milestone Scientific's net product sales2018 were to two customers/ distributors (one of which, Milestone China, is  a related party), 54%, and 13%, respectively. For the nine months ended September 30, 2017, an aggregate of approximately 72% of Milestone Scientific's net product sales were to two customers/distributors (one of which, Milestone China, is a related party), 53%, and 19%, respectively. Accounts receivable for the major customer/distributors amounted to an aggregate of approximately $1,403,148, or 70% of Milestone Scientific's accounts receivable for nine months ended September 30, 2017. For the three months ended September 30, 2016, an aggregate of 61% of Milestone Scientific's net product sales were to two customers/distributors (one of which ,Milestone China, is a related party), 44%,  and 17%, respectively. For the nine months ended September 30, 2016, an aggregate of approximately 70% of Milestone Scientific's net product sales were to two customers/distributors (one of which, Milestone China, is a related party), 62%, and 8%, respectively.

NOTE – 11 Employment and Consulting Agreements

In July 2017, Milestone Scientific entered into a three-year employment agreement with Daniel Goldberger to serve as President and Chief Executive Officer of Milestone Scientific. Under the agreement, Mr. Goldberger would receive base compensation of $300,000 per annum and may additionally earn annual bonuses of up to an aggregate of $400,000, payable one half in cash and one half in Milestone Scientific common stock (“Bonus Shares”) contingent upon achieving performance benchmarks periodically set for each year by the compensation committee of the Board. In addition to any such shares of common stock, Mr. Goldberger was entitled to receive stock options (“Bonus Options”) to acquire twice the number of any Bonus Shares earned, pursuant to a non-qualified stock option grant agreement under Milestone Scientific’s then existing equity compensation plan. The Bonus Options had a five-year term and were to vest in equal annual installments on each of the first, second and third anniversary of the grant date, subject to continued employment on such vesting date and accelerated vesting upon the occurrence of certain events. The exercise price of the Bonus Options was based on the fair market value of per share of common stock on the date of grant.

In July 2017, Milestone Scientific granted to Mr. Goldberger non-qualified stock options to purchase 921,942 shares of common stock at an exercise price of $2.00 per share. Those options had a five-year term and were to vest in equal annual installments on each of the first, second and third anniversaries of the grant date, subject to his continued employment on the vesting date and accelerated vesting upon the occurrence of certain events.

On October 5, 2017, Milestone Scientific Inc. announced that Daniel Goldberger had resigned as President and Chief Executive Officer effective October 2, 2017, upon which the previously described stock options granted to him in July 2017 terminated prior to vesting (see Note 14).

In July 2017, Milestone Scientific entered into a ten-year new employment agreement with Leonard Osser, who previously served as the Company’s President and Chief Executive Officer, to serve as Managing Director – China Operations. This new agreement provides for annual compensation of $300,000 consisting of $100,000 in cash and $200,000 in the Company’s common stock valued at the average closing price of the Company’s common stock on the NYSE or such other market or exchange on which its shares are then traded during the first fifteen (15) trading days of the last full calendar month of each year during the term of this agreement. This agreement supersedes all prior employment agreements between Mr. Osser and Milestone Scientific. If the Company terminates Mr. Osser’s employment “Without Cause,” other than due to his death or disability, or if Mr. Osser terminates his employment for “Good Reason” (both as defined in the agreement), Mr. Osser is entitled to be paid in one lump sum payment as soon as practicable following such termination: an amount equal to the aggregate present value (as determined in accordance with Section 280G(d)(4) of the Code) of all compensation pursuant to this agreement from the effective date of termination hereunder through the remainder of the Employment Term.

In July 2017, Mr. Osser also resigned from his positions of Chairman of the Board, Chief Executive Office and President of Milestone Medical. Upon his resignation, Milestone Medical entered in a consulting agreement with U.S. Asian Consulting Group LLC, an entity controlled by Mr. Osser, pursuant to which he will provide specific services to Milestone Medical for a ten- year term. Pursuant to the consulting agreement, U.S. Asian Consulting Group, LLC, is entitled to receive $100,000 per year for Mr. Osser's services.follows:

 


  

Total

  

Less than 1 Year

  

1-3 Years

  

3-5 Years

 

Operating Lease Obligations

 $175,557  $159,138  $16,419  $- 

NOTE – 12 RELATED PARTIES

 

Milestone Scientific has a manufacturing agreement with United Systems (a significant stockholder of Milestone), the principal manufacturers of its handpieces, pursuant to which it manufactures products under specific purchase orders, but without minimum purchase commitments. Purchases from this manufacturer were $721,225 and $1,690,582 for the three and nine months ended September 30, 2017, respectively. Purchases of handpieces from this manufacturer were $967,003 and $2,088,229 for the three and nine months ended September 30, 2016, respectively. Milestone Scientific owed $902,341 and $984,286 to this manufacturer as of September 30, 2017 and December 31, 2016, respectively.

Milestone Scientific had $356,400 and $1,714,600 of related party sales of handpieces and instruments to Milestone China and Milestone China’s agent during the three and nine months ended September 30, 2017 respectively. Milestone Scientific had $1,977,862 and $3,203,466 of related party sales of handpieces and instruments to Milestone China during the three and nine months ended September 30, 2016, respectively. As of September 30, 2017 and December 31, 2016, Milestone Scientific recorded deferred revenues and deferred costs associated with sales to Milestone China of $712,800 and $362,718, and $1,001,800 and $620,041, respectively.  As of September 30, 2017 and December 31, 2016, Milestone China’s agent owed $712,800 and $2,714,600, respectively, to Milestone Scientific which is included in related party accounts receivable on the condensed consolidated balance sheets. 

In August 2016, a stockholder of Milestone Scientific entered a three-year agreement with Milestone Scientific to provide financial and business strategic services. Expenses recognized on this agreement were $25,000 and $75,000 for the three and nine months ended September 30, 2017, respectively. Expenses recognized on this agreement were $25,000 and $75,000 for the three and nine months ended September 30, 2016, respectively.

In January 2017, Milestone Scientific entered into a 12 month agreement with Innovest S.p.A. to provide consulting services (see Note 13).

NOTE – 13 COMMITMENTS AND CONTINGENCIES

(1) Lease(3)  Other Commitments

 

The headquarters for Milestone Scientific is located at 220 South Orange Ave, Livingston, New Jersey. Milestone Scientific leases approximately 7,625 square feet of office space. The lease term expires January 31, 2020 and provides for a monthly lease payment of $12,522. Additionally, Milestone Scientific has other smaller insignificant leases ending through 2017. Further, a third party distribution and logistics center in Pennsylvania handles shipping and order fulfillment on a month-to-month basis. For the three and nine months ended September 30, 2017, rent expense amounted to $36,658 and $106,828 respectively. For the three and nine months ended September 30, 2016 rent expense amounted to $25,031 and $95,019, respectively.

(2) Other Commitments

Milestone Scientific's employment agreement (the “2009 Agreement”) with Leonard Osser, its former Chief Executive Officer, provided for payments of $203,111 per year for five years to the executive or as he directs such payments, to a third party, to fund his acquisition of, or contribution to, an annuity, pension, or deferred distribution plan; or for an investment for the benefit of the executive and his family. Milestone Scientific expensed approximately $51,000 and $152,000 for the three and nine months ended September 30, 2017, and 2016 respectively to fund this obligation. In July 2017, Milestone Scientific entered into a new employment agreement with Mr. Osser, which superseded the 2009 Agreement pursuant to which he stepped down from his position as Chief Executive Officer and became Managing Director – China Operations (see Note 11).  Pursuant to the new agreement, Milestone Scientific agreed to fund the last installment of $203,111 in January 2018 as provided for in the 2009 Agreement. 

The technology underlying the SafetyWand®Safety Wand® and CompuFlo®CompuFlo®, and an improvement to the controls for CompuDent®CompuDent® were developed by the Director of Clinical Affairs and assigned to Milestone Scientific. Milestone Scientific purchased this technology pursuant to an agreement dated January 1, 2005. The Director of Clinical Affairs will receive additional payments of 2.5% of the total sales of products using certain of these technologies, and 5% of the total sales of products using certain other of the technologies until the expiration of the last patent. The Director of Clinical Affairs was granted, pursuant to the agreement, an option to purchase, at fair market value on the date of the grant 8,333 shares of common stock upon the issuance of each additional patent relating tocovering these technologies. If products produced by third parties use any of these technologies (under license from us) then the Director of Clinical Affairs will receive the corresponding percentage of the consideration received by Milestone Scientific for such sale or license. See Note-12- other.  


The Director of Clinical Affairs’ royalty fee was $122,606 and $446,098 for the three and nine months ended September 30, 2017, respectively. The Director of Clinical Affairs’ royalty fee was $148,185 and $449,875 for the three and nine months ended September 30, 2016, respectively. Additionally, Milestone Scientific expensed consulting fees to the Director of Clinical Affairs of $68,751 and $206,253 for the three and nine months ended September 30, 2017, and 2016 respectively.NOTE 14— SUBSEQUENT EVENTS

 

In January 2017,July 2019, Milestone Scientific entered intoBoard of Directors approved the issuance of 200,000 Restricted Common Shares to a 12 month agreement with Innovest S.p.A.third party advisor to provide consulting services. This agreement will renewstrategic planning and an opportunity for successive 12 month terms unless terminated by Innovest S.p.A or Milestone Scientific. Expenses recognized on this agreement were $20,000 and $60,000maximizing  shareholder value for the three and nine months ended September 30, 2017, respectively.

On October 2, 2017, Milestone Scientific accepted the resignation of the then CEO, Daniel Goldberger. Subsequent to that date, Mr. Goldberger through his attorney advised Milestone Scientific’s attorneys, that Mr. Goldberger was entitled, based on the circumstances he asserted with respect to his resignation after acceptance of such resignation, to his basic salary ($300,000) for one year and certain other benefits (health and disability insurance for one year ($30,000 estimated) and a car allowance of $1,200 per month), in accordance with his employment contract dated July 10, 2017.  Under the circumstances asserted by Mr. Goldberger, he would also be entitled to the immediate vesting of options under the Milestone Scientific’s Stock Option Plan agreed to be granted to him pursuant to his employment agreement, exercisable for ninety days after his resignation, for 921,942 shares of Milestone Scientific at a price of $2.00 per share, which exercise price is in excess of the market price of Milestone Scientific’s shares on the date hereof.  Milestone Scientific believes that the assertion of Mr. Goldberger is not in accordance with the facts or the requirements of his employment contract, and Milestone Scientific intends to vigorously contest his assertion.

NOTE 14- Subsequent Events

On October 5, 2017, Milestone Scientific announced that Daniel Goldberger had resigned as President and Chief Executive Officer effective October 2, 2017.

On October 5, 2017, Milestone Scientific also announced the appointment of Leslie Bernhard, the Company’s current Chairman of the Board, as the Company’s Interim Chief Executive Officer, to serve in such role until the appointment of a new Chief Executive Officer.company. 

 

In connection with her appointment to serve asJuly 2019, Milestone Scientific hired an Investor Relations Consultant for a term of 18 months. Compensation under the Company’s Interim Chief Executive Officer, Ms. Bernhardagreement will be paid an annual salary of $200,000 and receive a one-time bonus of 100,000 shares of the Company’s Common Stock. In addition, at the completion of her service as Interim Chief Executive Officer, Ms. Bernhard shall be entitled to receive a cash bonus in an amount to be determined by the Board of Directors at that time.

150,000 restricted shares. 

 


ITEM 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations.Operations

 

The following discussions of ourthe financial condition and results of operations should be read in conjunction with the financial statements and the notes to those statements included elsewhere in this Form 10-Q.annual report. Certain statements in this discussion and elsewhereelsewhere in this report constitute forward-looking statements, within the meaning of section 21E of the Securities Exchange Act, of 1934, as amended (the “Exchange Act”), that involve risks and uncertainties. OurThe actual results may differ materially from those anticipated in these forward-looking statements. See "Risk Factors"  in  Form 10-K at December 31, 2018.

 

OVERVIEW

 

Our common stock was listed on the NYSE MKTAmerican on June 1, 2015 and trades under the symbol “MLSS”. We have developed a proprietary, computer-controlled anesthetic delivery instrument, through the use ofusing The Wand®Wand, a single use disposable handpiece. The instrument is marketed in dentistrydental sector under the trademark CompuDent®, and STA Single Tooth Anesthesia System®System and in medicinemedical sector under the trademark CompuMed®. CompuDent®CompuMed. CompuDent is suitable for all dental procedures that require local anesthetic. CompuMed®CompuMed is suitable for many medical procedures regularly performed in plastic surgery, hair restoration surgery, podiatry, colorectal surgery, dermatology, orthopedics and a number ofseveral other disciplines. The dental instruments are sold in the United States, US territories, Canada, and in over 4760 other countries abroad. In June 2017, the FDA approved our 510(k) application for marketing clearance in the United States of our CompuFlo Epidural Computer Controlled Anesthesia System.  We are in the process of introductory meetings with medical device distributors within the United States and Europe. There have been nofive medical instruments sold in the United States to date and limited amounts sold internationally as of the reporting date. Certain of our medical instruments have obtained European CE mark approval and can be marketed and sold in most European countries. In June 2017, the FDA approved our 510(k) application for marketing clearance in the United States of our CompuFlo® Epidural Computer Controlled Anesthesia System.  We are in the process of introductory meetings with medical device distributors within the United States and foreign markets. 

 

In 2017,November 2018, Milestone Scientific received a letter from NYSE American LLC (the “Exchange”) stating that the Company was not in compliance with the continued listing standards as set forth in Section(s) 1003(a)(i), (ii), and (iii) of the NYSE American Company Guide (the “Company Guide”).On December 20, 2018, the Company submitted a plan of compliance (the “Plan”) to the Exchange addressing how it intends to regain compliance with Section(s) 1003(a)(i), (ii) and (iii) of the Company Guide by May 20, 2020.

On January 24, 2019, the Company received a letter from the Exchange stating that the Company’s Plan has been accepted by the Exchange. The Company is still not in compliance with Section(s) 1003(a)(i), (ii) and (iii) of the Company Guide and its listing on the Exchange is being continued pursuant to an extension granted by the Exchange. If the Company is not in compliance with the continued listing standards by May 20, 2020, or if the Company does not make progress consistent with the Plan, the Exchange will initiate delisting procedures as appropriate. The Company may appeal a staff delisting determination in accordance with Section 10 and Part 12 of the Company Guide.

In 2019, we remainedremain focused on advancing efforts to achieve our fourthree primary objectives;objectives in our medical sector, those being:

 ●       Obtaining the 510(k) marketing clearance with the FDA for the intra articular instruments

 

 

Identify distributors in the United States for the Epidural instruments, now that FDA clearance has been received;

Worldwide distribution of the CompuFlo Epidural Computer Controlled Anesthesia System; and

 

Enhancing our global reach by partnering with distribution companies inComplete the medical sector;Cosmetic device and

Optimizing our tactical approach to product sales and marketing in order to materially increase penetration of the global dental and medical markets with our proprietary, patented Computer-Controlled Local Anesthesia Delivery (C-CLAD) solution, the STA Single Tooth Anesthesia System® Instrument (STA Instrument) obtain European Regulatory Approve (CE market clearance).

 

Wand STA Instrument GrowthDental Market

 

Since its market introduction in early 2007, the Wand/STA Instrument and prior C-CLAD products have been used to deliver over 66 million safe, effective and comfortable injections. The instrument has also been favorably evaluated in numerous peer-reviewed, published clinical studies and associated articles. Moreover, there appears to be a growing consensus among users that the STA Instrument is proving to be a valuable and beneficial instrument that is positively impacting the practice of dentistry worldwide.

Global Distribution Network

United States and Canadian Market

 

Beginning January 1, 2016, Milestone Scientific enteredentered into a non-exclusive distribution agreement with Henry Schein, Inc. (“Henry Schein”). In June 2016, that agreement was replaced with an exclusive distribution arrangement for our dental products for the United States and Canada with Henry Schein. Under this arrangement we have a semi-dedicated independent sales force visiting dentists. We believe that this arrangement will be more effective than previous arrangements which primarily relied upon appearances at dental shows and catalog sales.

 

To date, Henry Schein has endeavored to accomplish the goals set forth in the exclusive distribution agreement for The WandWand/® STA instrument and handpieces, including training of its exclusive products salessale’s specialists. Specifically, up to 25 exclusive product sales specialists have now been fully trained as experts in the features, advantages and benefits of The WandWand/® STA instrument and handpieces and all 25 are currently in the field selling the instrument.

   

Henry Schein also plans to increase the number of exclusive product specialist in 2019 and to train  an additional two to three dedicated customer service representativesrepresentative to support dentists across North America through its exclusive product sales customer call center, as business volume increases.  


Henry Schein’s exclusive products sales specialist team, which is comprised of 25 products sales specialists and supported by over 1,000 field service representatives, will exclusively market and distribute The Wand® STA instrument and handpieces, together with a select group of other devices in the United States and Canada. Our agreement with Henry Schein has minimum purchase order requirements to maintain exclusivity in the third through tenth year of the term of the agreement. 

International Market

 

On the global front, we have granted exclusive marketing and distribution rights for the Wand/STA Instrument to select dental suppliers in various international regions in Asia, Africa, South America and Europe. They include Istrodent (Pty) Ltd.FM Produkty Dla Stomatologii in South AfricaPoland and Unident AB in the Scandinavian countries of Denmark, Sweden, Norway and Iceland.


In October 2012, the State Food and Drug Administration (CFDA) of the People’s Republic of China approved our STA Single Tooth Anesthesia System® (STA System). In May 2014, the CFDA also approved the STA handpieces for sale in China.Medical Market

 

In September 2014, Milestone Medical received CE clearance to distribute their epidural and intra-articular instruments in the European Community (EU). Milestone Medical signed a distribution agreement in March 2015 with a medical distributor in Poland for the distribution of the epidural instrument. This distribution agreement was terminated in late 2016 due to the distributor’s inadequate performance under the distribution agreement. Milestone Medical is continuing to pursue distributors for the instrument in the EU community.

During 2016, Milestone Scientific filed for 510(k) marketing clearance with the U.S. Food and Drug Administration (FDA) for both intra-articular and epidural injections with the CompuFlo Epidural System.  In June 2017, the FDA approved the CompuFlo Epidural System for epidural injections. Milestone Scientific is in the process of meeting with medical device distributors within the United States and foreign markets. Milestone Scientific’s immediate focus is on marketing its epidural device throughout the United States and Europe.

 

In December 2016, we received notification from the FDA that based upon the 510(k)-application submitted for intra- articular injections, we did not adequately document that the device met the equivalency standard required for 510(k) clearances. Following consultation with the FDA’s Office of Device Evaluation, we filed a new 510(k) application for the device in June 2014,2018. In August 2018, the FDA provided Milestone Scientific invested $1 millionwith a  list of questions on the intra-articular 510(k) application filed in Milestone China Ltd. (“Milestone China”) by contributing 772 STA InstrumentsJune 2018. Due to Milestone China for a 40% ownership interest.the delay in responding to FDA questions Milestone Scientific recorded this investment under the equity method of accounting. Milestone Scientific recordedwill be required file a loss on its investmentnew 510(K) application, which we intend to do in Milestone China of $0 and $164,837, as of September 30, 2017 and 2016, respectively. Milestone Scientific's investment in Milestone China was $0 as of September 30, 2017 and December 31, 2016, respectively. Milestone Scientific incurred cumulative losses beyond its investment in Milestone China of $1,606,913 and $1,124,350 as of September 30, 2017 and December 31, 2016, respectively, which have been suspended.2019, subject to available funding.

 

In June 2017,February and March 2018, Milestone Scientific hired an Executive VP of Global Sales and Marketing and a Vice President of US Sales to fill a significant gap in our commercialization efforts of the CompuFlo Epidural System. In October 2018, Milestone Medical signed a Distributor Agreement in the U.S. This agreement provides that this Distributor will purchase and hold an inventory of the CompuFlo Epidural System and disposables for sale. At this time there have been no minimum purchase established with the Distributor. This Distributor purchased five CompuFlo Epidural Systems and disposables after executing the Agreement.

In April 2019, Milestone Scientific entered into an agreementAgreement with American 3B Scientific, a leading supplier of didactic material for education, for the development and sale of its interest in Milestone China (a forty (40%) percent interest) (the “Milestone China Shares”) to an unaffiliated United States domiciled purchasera CompuFlo® Epidural Training Instrument. This instructional instrument utilizes the pressure sensing technology and a 10-year option agreement to repurchase the Milestone China Shares. The purchase price for the Milestone China Shares was $1,400,000 of which $125,000 was paid in cash and $1,275,000 was paid by delivery of a non-interest bearing secured promissory note. The note is payable in quarterly installments of $125,000 until paid in full and is secured by the Milestone China Shares until full repayment.  In addition, pursuant to such note, the purchaser is precluded from selling all or substantially all of its assets prior to repayment of the note. The 10-year option agreement provides Milestone Scientific an option to repurchase the Milestone China Shares at $1,400,000 within the first two years and at fair market value (as defined in such agreement) for the remainder of the 10-year term. The transaction has been accounted forwill be utilized as a secured financingtraining instrument to improve epidural placement success. The first sale of this new medical instrument occurred in May 2019, for three instruments and Milestone Scientific will continue to account for its relationship with Milestone China under the equity method of accounting. A note receivable is presented on the Company’s balance sheet, along with a deferral from financing transaction ($1,400,000). The carrying value of the forty (40%) percent investment at the transaction date was zero.three disposable kits.

 

The saleWe have entered into a limited number of distributor arrangements in Europe and the Milestone China Shares allows Milestone Scientific to continue to expand inMiddle East for our CompuFlo Epidural System. Our distribution strategy is initially aimed at having KOL's use and accept the China market by supplying Milestone China with the STA Single Tooth Anesthesia System®device and related hand pieces, while eliminating the burden on Milestone Scientific's management as a 40% minority owner.  Milestone Scientific believes that the sale will provide Milestone China with a new partner that may accelerate its penetration of the China market.initiates their own studies.

 


The following table shows a breakdown of Milestone Scientific’sScientific’s product sales (net), domestically and internationally, by product category for the period ending June 30, 2019 and the percentage of product sales (net) by each product category:2018:  

 

  

Three months Ended September 30,

  

Nine months Ended September 30,

 
  

2017

  

2016

  

2017

 

2016

 

DOMESTIC

                        

Instruments

 $452,232 33.3% $-   $857,525 20.7%$852,149  30.9%

Handpieces

  893,496 65.8%  106,908 89.5%  3,230,567 78% 1,860,593  67.4%

Other

  12,338 0.9%  12,508 10.5%  53,037 1.3% 46,634  1.7%

Total Domestic

 $1,358,066 100.0% $119,416 100.0% $4,141,129 100.0%$2,759,376  100.0%

INTERNATIONAL-Europe

                        

Instruments

 $340,575 29.9% $1,416,030 63.8% $1,053,050 32.8%$1,974,280  49.3%

Handpieces

  765,821 67.2%  713,766 32.2%  2,068,007 64.4% 1,845,424  46.0%

Other

  32,951 2.9%  87,984 4.0%  89,764 2.8% 188,046  4.7%

Total International -Europe

 $1,139,347 100.0% $2,217,780 100.0% $3,210,821 100.0%$4,007,750  100.0%

INTERNATIONAL-China

                        

Instruments

 $-   $493,000 58.0% $1,000,000 58.3%$1,493,800  67.7%

Handpieces

  356,400 100.0%  356,400 42.0%  712,800 41.6% 712,800  32.3%

Other

  -    -    1,800 0.1% -   

Total International-China

 $356,400 100.0% $849,400 100.0% $1,714,600 100.0%$2,206,600  100.0%
                         

Domestic

 $1,358,066 47.6% $119,416 3.7% $4,141,129 45.7%$2,759,376  30.7%

International-Europe

  1,139,347 39.9%  2,217,780 69.6%  3,210,821 35.4% 4,007,750  44.7%

International-China

  356,400 12.5%  849,400 26.7%  1,714,600 18.9% 2,206,600  24.6%

Total Product Sales

 $2,853,813 100.0% $3,186,596 100.0% $9,066,550 100.0%$8,973,726  100.0%
  

Three months ended June 30,

  

Six months ended June 30,

 

Domestic-US & Canada

 

2019

  

2018

  

2019

  

2018

 

Devices

 $146,289  $11,505  $270,285  $132,553 

Handpieces

  1,030,391   1,158,975   1,819,544   1,927,506 

Other

  32,463   22,377   49,279   51,228 

Total Domestic US & Canada

 $1,209,143  $1,192,857  $2,139,108  $2,111,287 

International ROW

                

Devices

 $339,570  $367,450  $624,915  $652,518 

Handpieces

  631,129   839,194   1,262,839   1,418,021 

Other

  28,009   28,997   46,897   52,277 

Total International-ROW

 $998,708  $1,235,641  $1,934,651  $2,122,816 

International-China

                

Devices

 $-  $-  $-  $- 

Handpieces

  50,000   -   100,000   - 

Other

  -   -   -   - 

Total International

 $50,000  $-  $100,000  $- 
                 

Total Product Sales

 $2,257,851  $2,428,498  $4,173,759  $4,234,103 

 

Milestone Scientific plans to support increased sales and marketing activity through our current distributors and through newly appointed distributors of the STA instruments and handpieces in the international market. In the United States and Canada, Milestone Scientific will continue the utilization of independent hygienists for training individual practitioners and group practices domestically, refined and directed advertising to dental professionals, continue to develop Key Opinion Leaders (KOL) and support and broaden our global distribution network. Additionally with the recent FDA marketing clearance for the epidural instrument, Milestone Scientific is initiating marketing and sales efforts in the US to establish medical sector distributors for the sale of this instrument


Results of Operations

 

The following table sets forth for the consolidated results of operations for the three and ninesix months ended SeptemberJune 30, 2017, respectively, as a percentage of revenues.2019 compared to 2018. The trends suggested by this table may not be indicative of future operating results:   results:  

   

Three months Ended September 30,

 

Nine months Ended September 30,

   

2017

 

2016

 

2017

 

2016

Revenue

                
 

Product sales, net

 

 $     2,853,813

 

100%

 

 $    3,186,596

 

100%

 

 $     9,066,550

 

100%

 

 $    8,973,726

 

100%

 

Cost of products sold

 

        1,044,540

 

37%

 

        1,517,561

 

48%

 

 $     3,320,411

 

37%

 

        3,675,552

 

41%

Gross profit

 

        1,809,273

 

63%

 

        1,669,035

 

52%

 

        5,746,139

 

63%

 

        5,298,174

 

59%

 

Selling, general and administrative expenses

 

        3,205,996

 

112%

 

        2,933,950

 

92%

 

        8,996,092

 

99%

 

        9,226,062

 

103%

 

Research and development expenses

 

              16,884

 

1%

 

           303,268

 

10%

 

           241,964

 

3%

 

           756,045

 

8%

Total operating expenses

 

        3,222,880

 

113%

 

        3,237,218

 

102%

 

        9,238,056

 

102%

 

        9,982,107

 

111%

Loss from operations

 

      (1,413,607)

 

(50)%

 

      (1,568,183)

 

(49)%

 

      (3,491,917)

 

(39)%

 

      (4,683,933)

 

(52)%

 

Other (expenses)

 

              (1,046)

 

(0)%

 

                 (846)

 

(0)%

 

              (3,278)

 

(0)%

 

             (2,782)

 

(0)%

 

Interest expense

 

                3,582

 

0%

 

                      -   

 

0%

 

                6,495

 

0%

 

                      -   

 

0%

Loss before provision for income tax and equity in net earnings of equity investments

      (1,411,071)

 

(49)%

 

      (1,569,029)

 

(49)%

 

      (3,488,700)

 

(38)%

 

      (4,686,715)

 

(52)%

 

Provision for income tax

 

              (6,475)

 

(0)%

 

           (16,522)

 

(1)%

 

            (18,339)

 

(0)%

 

           (80,147)

 

(1)%

Loss before equity in net earnings of equity investments

 

      (1,417,546)

 

(50)%

 

      (1,585,551)

 

(50)%

 

      (3,507,039)

 

(39)%

 

      (4,766,862)

 

(53)%

 

Loss on earnings from China Joint Venture

 

                      -   

 

0%

 

         (253,451)

 

(8)%

 

            (28,941)

 

(0)%

 

         (554,766)

 

(6)%

Loss in equity investments

 

                      -   

 

0%

 

         (253,451)

 

(8)%

 

            (28,941)

 

(0)%

 

         (554,766)

 

(6)%

Net Loss

 

      (1,417,546)

 

(50)%

 

      (1,839,002)

 

(58)%

 

      (3,535,980)

 

(39)%

 

      (5,321,628)

 

(59)%

 

Net loss attributable to noncontrolling interests

 

              (6,605)

 

(0)%

 

         (137,752)

 

(4)%

 

         (138,915)

 

(2)%

 

      (1,113,958)

 

(12)%

Net loss attributable to Milestone Scientific Inc.

 

 $   (1,410,941)

 

(49)%

 

 $  (1,701,250)

 

(53)%

 

 $   (3,397,065)

 

(37)%

 

 $  (4,207,670)

 

(47)%

  

For three months ended June 30,

  

For six months ended June 30,

 
  

2019

  

2018

  

2019

  

2018

 

Operating results:

                

Product sales, net

 $2,257,851  $2,428,498  $4,173,759  $4,234,103 

Cost of products sold

  752,183   1,021,573   1,370,876   1,584,250 

Gross profit

  1,505,668   1,406,925   2,802,883   2,649,853 
                 

Operating expenses:

                

Selling, general and administrative expenses

  2,517,970   2,821,837   4,627,023   5,840,601 

Research and development expenses

  95,529   9,775   101,875   235,592 

Loss from operations

  (1,107,831)  (1,424,687)  (1,926,015)  (3,426,340)

Other income, and loss on earning net

  54,588   74,686   79,577   100,969 

Net loss

  (1,053,243)  (1,350,001)  (1,846,438)  (3,325,371)

Net loss attributable to noncontrolling interests

  11,959   6,994   22,402   108,657 

Net loss attributable to Milestone Scientific Inc.

 $(1,041,284) $(1,343,007) $(1,824,036) $(3,216,714)

Cash flow:

 

June 30, 2019

  

June 30, 2018

 

Net cash used in operating activities

 $(622,279) $(1,516,771)

Net cash used in investing activities

  (8,104)  (4,531)

Net cash provided by financing activities

  2,224,547   (250,000)

 

Milestone Scientific earned gross profit of approximately $1.8 million and $5.7 million inFor the three and ninethree months ended SeptemberJune 30, 2017. Milestone Scientific earned gross profit of approximately $1.7 million and $5.3 million in the2019 compared to three and nine monthsmonths ended SeptemberJune 30, 2016. However, the revenues and related gross profits have not been sufficient to support overhead, new product introduction and research and development expenses.2018

 

The Three Months Ended September 30, 2017 compared to the Three Months Ended September 30, 2016Net sales for 2019 and 2018 were as follows:

  

2019

  

2018

  

Increase

Decrease

  

%

 

Dental

 $2,242,751  $2,388,898  $(146,147)  (6.12)%

Medical

  15,100   39,600   (24,500)  (61.87)%

Total sales, net

 $2,257,851  $2,428,498  $(170,647)  (7.03)%

 

Total revenuesConsolidated revenue for the three months ended SeptemberJune 30, 20172019 and 20162018, were approximately $2.9$2.3 million and $3.2$2.4 million, respectively. Total revenues decreased by approximately 10% which was principally related to the The decrease in international sales of approximately $1.6 million, offset by the increase$171,000 is primarily due to non-recurring order for handpieces and devices in domestic sales2018 from a Distributor in Mexico of approximately $1.2 million in 2017. International sales in 2017 decreased due to a reduction in shipments of handpieces and instruments to Milestone China. The decrease in Milestone China revenue is due to Milestone China working through its current inventories and adjusting its business model.  This trend of reduced revenue for shipments of Milestone China is not expected to continue in 2018. However, we believe that the June 2016 exclusive distribution agreement with Henry Schein will continue to lead to increased domestic sales in 2017 as the product and sales force training has been substantially completed as of September 30, 2017. Additionally, the Company has increased its exposure to the general dentist population$400,000. We are in the USA by expanding our “KOL” (Key Opinion Leaders) coverageprocess of attending medical device trade shows and specific hands on continuing education course throughoutattending introductory meetings with medical device distributors within the USA.United States and European markets.


Gross Profit for 2019 and 2018 were as follows: 

  

2019

  

2018

  

Increase

Decrease

  

%

 

Dental

 $1,499,329  $1,613,059  $(113,730)  (7.05)%

Medical

  6,339   (206,134)  212,473   (103.08)%

Total gross profit

 $1,505,668  $1,406,925  $98,743   7.02%

Consolidated gross margin for the three months ended SeptemberJune 30, 20172019 and 2018, was 63% approximately 67% and 58%, which increased from 52%respectively. The consolidated gross margin for the three months ended SeptemberJune 30, 2016. The increase in gross profit relates2019 did not require inventory write downs or reserve of $290,000 as compared to the increase in US sales in 2017 which is was offset by special pricing in China to facilitate an increase in market share.three months ended June 30,2018.

 

Selling, general and administrative expenses for 2019 and 2018 were as follows: 

  

2019

  

2018

  

Increase

Decrease

  

%

 

Dental

 $870,548  $957,464  $(86,916)  (9.08)%

Medical

  574,772   630,254   (55,482)  (8.80)%

Corporate

  1,072,650   1,234,119   (161,469)  (13.08)%

Total selling, general and administrative expenses

 $2,517,970  $2,821,837  $(303,867)  (10.77)%


Consolidated selling, general and administrative expenses for the three months ended SeptemberJune 30, 20172019 and 20162018, were approximately $3.2$2.5 million versus $2.9and $2.8 million, respectively.respectively. The increasedecrease of approximately $272,000 predominantly$300,000 is categorized in several areas. Salaries, bonus, and recruiting fees decreased by approximately $434,000 due to the additional  selling, general and administrative expensesreduction of bonuses in 2019. Executive pension expense decreased by approximately $50,000 in the second quarter of 2019 as the Company’s funding commitment was finalized in 2018.Employee recruiting expense increased by approximately $70,000 as the Company is resulting fromsearching for specific commercial personnel.  Patent amortization decreased by approximately $218,000 in 2019 compared to 2018 due to the completionimpairment of the clinical studies relating to Milestone Medical's epidural instruments in 2016 and Milestone Scientific initiating marketing and sales effortsAPAD patent in the U.S.third quarter of 2018. Intellectual regulatory quality control increased by approximately $92,000 as the Company prepares for changes in the European regulatory registration requirements Professional legal and accounting fees increased by approximately $143,000, related to establish thea foreign operations, and additional consulting agreement with a third party. Additionally, marketing expense increased by approximately $53,000 to support dental and medical sector. revenues.

 

Research and Development for 2019 and 2018 were as follows: 

  

2019

  

2018

  

Increase Decrease

  

%

 
Dental $-  $-  $-   0.00%

Medical

  95,529   9,775   85,754   877.28%
Corporate  -   -   -   0.00%

Total research and development

 $95,529  $9,775  $85,754   877.28%

Consolidated research and development expenses for the three months ended SeptemberJune 30, 20172019 and 20162018, were approximately $17,000 verse $303,000,$96,000 and $10,000, respectively. The decrease of approximately $286,000increase is predominantly due to the completion of the clinical studies relatingan instrument modification to Milestone Medical's epiduralcertain Epidural instruments in 2016.the development of an Epidural training instrument. The Epidural training instrument is not approved for use on humans or in a clinical setting. 

Profit (Loss) from Operations for 2019 and 2018 were as follows: 

  

2019

  

2018

  

Increase

Decrease

  

%

 

Dental

 $629,474  $723,084  $(93,610)  (12.95)%

Medical

  (664,658)  (846,164)  181,506   (21.45)%

Corporate

  (1,072,647)  (1,301,607)  228,960   (17.59)%

Total loss from operations

 $(1,107,831) $(1,424,687) $316,856   (22.244)%

 

The loss from operations was approximately $1 million and $1.4 million for the three months ending June 30, 2019 and  2018 respectively. The decrease in loss quarter over quarter is due to an increase of gross profit of approximately $100,000, a reduction in general administrative expense of approximately $300,00 and increase in research and development expense of approximately $100,000.

For the six months ended SeptemberJune 30, 20172019 compared to six months ended June 30, 2018

Net sales for 2019 and 20162018 were as follows:

  

2019

  

2018

  

Increase

Decrease

  

%

 

Dental

 $4,158,259  $4,158,003  $256   0.01%

Medical

  15,500   76,100   (60,600)  (79.63)%

Total sales, net

 $4,173,759  $4,234,103  $(60,344)  (1.43)%

Consolidated revenue for the six months ended June 30, 2019 and 2018 was approximately $1.4 million,  verse $1.64.2 million, respectively,respectively. The dental revenue for the six months ended June 30, 2018 included a decreasenon-recurring order for handpieces and devices in 2018 from a Distributor in Mexico of approximately $155,000. This decrease is primarily attributable to$400,000.  We are in the completionprocess of the clinical studies relating to Milestone Medical's epiduralattending medical device trade shows and intra articular instruments in 2016.

Nine months ended September 30, 2017 compared to Nine Months Ended September 30, 2016

Total revenues for the nine months ended September 30, 2017 and 2016, was from dental revenues, were approximately $9.1 million and $9.0 million, respectively. Total revenues increased by approximately 1% which was principally related to increased handpiece sales inattending introductory meetings with medical device distributors within the United States domestic sales by approximately $1.7 million in 2017 to 2016. International sales in 2017 decreased by approximately $1.6 million over the same period in 2016 due to a reduction in shipments to Milestone China. The reductions in shipments to Milestone China is due to Milestone China working through inventory purchases from late 2016. However, we believe that the June 2016 exclusive distribution agreement with Henry Schein will continue to increase domestic sales in 2017 as the product and sales force training has been substantially completed as of September 30, 2017.European markets.

 

Gross Profit for 2019 and 2018 were as follows: 

  

2019

  

2018

  

Increase

Decrease

  

%

 

Dental

 $2,796,171  $2,831,085  $(34,914)  (1.23)%

Medical

  6,712   (181,232)  187,944   (103.70)%

Total gross profit

 $2,802,883  $2,649,853  $153,030   5.78%

Consolidated gross margin for the ninesix months ended SeptemberJune 30, 20172019 and 2018, was approximately 67% and 63%, which increased from 59% for the nine months ended September 30, 2016.  The increase in gross profit relates to the increase in US sales in which was offset by special pricing in China to facilitate an increase in market share.respectively


 

Selling, general and administrative expenses for 2019 and 2018 were as follows: 

  

2019

  

2018

  

Increase

Decrease

  

%

 

Dental

 $1,674,731  $1,818,325  $(143,594)  (7.90)%

Medical

  1,061,178   1,308,306   (247,128)  (18.89)%

Corporate

  1,891,114   2,713,970   (822,856)  (30.32)%

Total selling, general and administrative expenses

 $4,627,023  $5,840,601  $(1,213,578)  (20.78)%

Consolidated selling, general and administrative expenses for the ninesix months ended SeptemberJune 30, 20172019 and 20162018, were approximately $9$4.6 million versus $9.2and $5.8 million,, respectively. The decrease of approximately $230,000$1.2 million is predominantlycategorized in several areas. Bonuses decreased by $620,000 based on management decision to curtail bonuses awards for the remainder of 2019. Also the Executive Pension expense decreased by $101,000 as the Company’s funding commitment was finalized in 2018. International consulting decreased by approximately $77,000 as management decided to reduce these services in 2019. Stock based compensation decreased by $65,000 as management did not provide stock options in 2018 to the executive team. Amortization expense for patents decreased by $442,000 due to the reduction in expenses resulting from the completionimpairment of the clinical studiesApad patents in 2018. Professional fees decreased by$188,000 relating to Milestone Medical's epidurallegal and intra articular instrumentsaccounting projects that ended in 2016.2018. Marketing expenses increased by $52,000 in the area of promotions and trials. Due to the quality control regulatory changes in the European community we incurred an increase in cost of approximately $116,000 for the six months ended June 30, 2019.

Research and Development for 2019 and 2018 were as follows: 

  

2019

  

2018

  

Increase

Decrease

  

%

 
Dental $-  $-  $-   0.00%

Medical

  101,875   65,008   36,867   56.71%

Corporate

  -   170,584   (170,584)  (100.00)%

Total research and development

 $101,875  $235,592  $(133,717)  (56.76)%

 

Research and development expenses for the ninesix months ended SeptemberJune 30, 20172019 and 20162018, were approximately $242,000$101,000 and $756,000,$236,000, respectively. The decrease is due management discretion and curtailment in the development of several new projects that were being worked on during 2018. Management decided make modification to reduction insome  Epidural instruments for the development cost associated withof an Epidural trainer instruments. CompuFlo® Epidural Trainer (CompuFlo Trainer), an instructional instrument that uses pressure sensing technology to improve epidural placement success. The CompuFlo Epidural Trainer is for training purposes only and intra articular instruments.not intended for clinical use.

Profit (Loss) from Operations for 2019 and 2018 were as follows:

  

2019

  

2018

  

Increase

Decrease

  

%

 

Dental

 $1,121,440  $1,080,249  $41,191   3.81%

Medical

  (1,156,341)  (1,554,546)  398,205   (25.62)%

Corporate

  (1,891,114)  (2,952,043)  1,060,929   (35.94)%

Total loss from operations

 $(1,926,015) $(3,426,340) $1,500,325   (43.79)%

 

The loss from operations was approximately $1.9 million and $3.4 million for the ninesix months ended SeptemberJune 30, 20172019 and  2016 was2018 respectively. The decrease in the loss of approximately $3.5million and $4.7$1.5 million respectively,relates to an increase in gross profit of approximately $150,000, a decreasereduction in administrative expenses of  approximately $1.2 million. This decrease is primarily attributable to the completion of the clinical studiesmillion and reducedreduction in research and development expenses relating to our epidural and intra articular instruments in 2017of approximately $135,000.The dental segment is still the primary revenue and gross profit.profit generator for the Company. The dental segment continues to generate revenue on a steady basis in the United States and Rest of the World and manage expenses during the process. Costs in the medical segment are beginning to increase as personnel are expanded in the U.S. to focus on our domestic Epidural device business.

 

Liquidity and Capital Resources

 

At SeptemberJune 30, 2017,2019 Milestone Scientific had cash and cash equivalents of approximately $2.3 million total current assets of approximately $11.6 million and working capital of approximately $6.5 million. We believe$345,000 versus working capital of $1 million at December 31, 2018.  For the six months ended June 30, 2019, we had negative cash flows from operating activities of approximately $620,000. Based on current and expected cash to be used in operating activities substantial doubt exists about the Company’s  ability to continue as a going concern for at least the next twelve months from the financial reporting date.

Management believes that ourthe current cash on hand, accounts receivableflow and the anticipated revenuessupport from the dental business will not be sufficientable to fund our business operationsmitigate  the expected selling expenditures for at leastthe Epidural  medical device commercialization, as well as other operating expenditures and  new product development programs,  over the next 12twelve months from the filing datefinancial reporting date.  Without additional funding  a delay, scale back or elimination of this Form 10-Q.

 Milestone Scientific continues to take positive steps to maintain adequate inventory levels and advancessome or all of the Company’s medical commercial strategy or development programs could be required, all of which could have a material adverse impact on contracts to maintain available inventory to meet our domestic and international sales requirements. For the nine months ended September 30, 2017 and 2016, our net cash used in operating activities was approximately $1.6 million and $4.1 million, respectively, which represents a decrease of approximately $2.5 million year over year.Company.

 


Milestone Scientific has incurred annual operating losses and negative cash flows from operating activities since its inception. The capital raised in  December 2016February 2019 (a capital raise in a public and January 2017private offering) provided Milestone ScientificScientific with working capital to continue to develop its medical instruments and obtain regulatory approval for one of its medical instruments (the June 2017 FDA approvalmarketing of the epidural instrument), as well asCompuFlo Epidural instrument and to aggressively  market its dental instruments.devices. Milestone Scientific is actively pursuing the generation of positive cash flows from operating activities through an increase in revenue from its dental business worldwide, and a reductionsreduction in operating expenses. Management believes

Now that the Company will have sufficient cash and liquidity to meet its anticipated obligations over the next twelve-month period following the date of this report.   

Milestone Scientific believes that theCompuFlo Epidural System has obtained FDA clearance of its 510(k) application with respectin the United States (June 2017), the development costs were reduced in 2019 but the selling costs are expected to continue to increase. The FDA clearance has provided the CompuFlo® Epidural Computer Controlled Anesthesia will provide Milestone Scientific Company with the opportunity to enter the US medical device market and generate revenuesestablish distribution in the future. Milestone Scientific believes that it has sufficient inventory ofUSA. At the epidural instrumentssame time, the Company is looking to satisfyestablish additional financing  to support  the near term marketing opportunities.Epidural device commercialization process. The intra-articular device is anticipated to restart the 510K application process later this year, if funding is available.

 

Our condensed consolidated balance sheets included in this Report reflects a decrease of approximately $1.8 million in current assets from December 31, 2016 to September 30, 2017. This decrease in current assets was primarily due to a reduction in cash, accounts receivable from related parties, deferred cost, other receivables and inventory of approximately $4 million. This was offset by an increase in accounts receivable, advances on contracts, note receivable and prepaid expenses and other current assets of an aggregate of approximately $2.2 million.

Current liabilities decrease by approximately $591,000 from approximately $5.6 million to approximately $5.1 million. The decrease is primarily due to a decrease in accounts payable of approximately $725,000, accounts payable related party of approximately $333,000, deferred revenue of approximately $289,000 offset by an increase in deferred profit China of approximately $29,000, and an increase in accrued expenses of approximately $727,000.

Subsequent Events

 On October 5, 2017, Milestone Scientific announced that Daniel Goldberger had resigned as President and Chief Executive Officer effective October 2, 2017.

 On October 5, 2017, Milestone Scientific also announced the appointment of Leslie Bernhard, the Company’s current Chairman of the Board, as the Company’s Interim Chief Executive Officer, to serve in such role until the appointment of a new Chief Executive Officer.

In connection with her appointment to serve as the Company’s Interim Chief Executive Officer, Ms. Bernhard will be paid an annual salary of $200,000 and receive a one-time bonus of 100,000 shares of the Company’s Common Stock.  In addition, at the completion of her service as Interim Chief Executive Officer, Ms. Bernhard shall be entitled to receive a cash bonus in an amount to be determined by the Board of Directors at that time.

Item 3. Quantitative and Qualitative Disclosures about Market Risk

        

Milestone Scientific is a smaller“smaller reporting company” as defined by Regulation S-K and, as such, is not required to provide the information required by this item.

  

Item 4. Controls and Procedures

��

Milestone Scientific’sScientific’s Interim Chief Executive Officer and Chief Financial Officer have evaluated the effectiveness of the design and operation of Milestone Scientific’s disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) as of the end of the period covered by this report. Based upon that evaluation, Milestone Scientific’s Interim Chief Executive Officer and Chief Financial Officer have concluded that the disclosure controls and procedures as of SeptemberJune 30, 20172019 are effective to ensure that information required to be disclosed in the reports Milestone Scientific files or submits under the Exchange Act is recorded, processed, summarized and reported within the time periods specified in the SEC’s rules and forms and that such information is accumulated and communicated to Milestone Scientific's management, including the Interim Chief Executive Officer and Chief Financial Officer, as appropriate, to allow timely decisions regarding required disclosure.

There werehave been no changes in Milestone Scientific’s internal control over financial reporting identified in connection with the evaluation that occurred during Milestone Scientific’s last fiscal quarter ended September 30, 2017 that have materially affected, or that are reasonably likely to materially affect, Milestone Scientific’s internal controls over financial reporting.

 


PART II – OTHER INFORMATION

 

ITEMItem 1.        LEGAL PROCEEDINGS Legal Proceedings

           

None.Milestone Scientific is not involved in any material litigation.

 

ITEMItem 1A.    RISK FACTORS Risk Factors

 

As a smaller reporting company, we are not required to provide the information required by this Item.

 

ITEMItem 2. UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS

RecentUnregistered Sales of UnregisteredEquity Securities and use of proceeds

 

In February 2019, our board of directors granted United Systems (whose controlling shareholder, Tom Cheng, is a significant shareholder of the quarter ended September 30, 2017, Milestone Scientific issued a total of 352,015Company) 285,714 shares of its common stock as follows:

120,000 shares to the Board of Directors with a total value of $159,480;

10,913 shares to an employee for compensation with a total value of $15,000; and

an aggregate of 221,102 shares to consultants for services rendered with a total value of $378,530.

In addition, as of July 13, 2017, pursuant to the Asset Purchase Agreement with APAD Octrooi B.V. and APAD B.V. (collectively, the “Sellers”), Milestone Scientific issued an aggregate of 1,646,358 shares of its common stock to the Sellers in considerationat $0.35 or $100,000 for certain patent rights and other intellectual property rights related to the Sellers’ computer controlled injection instrument.consulting services. 

 

The foregoing sharesThese securities were issued in reliance upon the exemptionsexemption from the registration requirementsafforded by Section 4(a)(2) of the Securities Act ofof 1933, as amended (the "Act"“Act”), pursuant to Sections 4(a)(2), Section 4(a)(5) and/. These securities may not be offered or Regulation D promulgated thereunder. A legend restricting resale, transfer,sold in the United States absent registration under or other disposition of these shares other than in compliance withexemption from the Act was imprinted on the stock certificates evidencing such shares.and any applicable state securities laws.

  

ITEMItem 3. DEFAULT UPON SENIOR SECURITIES Default upon Senior Securities

 

None.Milestone Scientific is not involved in any material litigation.

 

ITEMItem 4. MINE SAFETY DISCLOSURESMine Safety Disclosure

 

Not applicable.

 

ITEMItem 5. OTHER INFORMATIONOther Information

           

None.None

 


Item 6. Exhibits and Financial Statement Schedules

ITEM 6.Exhibit No

EXHIBITS

 

Description

10.5

New Employment Agreement between Milestone Scientific Inc. and Leonard Osser dated as of July 10, 2017. (1)

10.6

Employment Agreement between Milestone Scientific Inc. and Daniel Goldberger dated as of July 10, 2017. (1)

10.7

Covenant Agreement between Milestone Scientific Inc. and Daniel Goldberger dated and effective as of July 10, 2017. (1)

10.8

Consultant Agreement between Milestone Medical Inc. and U.S. Asian Consulting Group, LLC dated as of July 10, 2017*

 

31.1

Chief

Rule 13a-14(a) Certification-Chief Executive Officer Certification pursuant to section 302 of the Sarbanes-Oxley Act of 2002.*Officer*

31.2

Chief Operating Officer Certification pursuant to section 302 of the Sarbanes-Oxley Act of 2002.*

Rule 13a-14(a) Certification-Chief Financial Officer*

32.1

Chief

Section 1350 Certifications-Chief Executive Officer Certification pursuant to section 906 of the Sarbanes-Oxley Act of 2002.Officer***

32.2

Chief Operating Officer Certification pursuant to section 906 of the Sarbanes-Oxley Act of 2002.

Section 1350 Certifications-Chief Financial Officer***

101.INS

 

     101.INS

XBRL Instance Document.*Document*

101.SCH

XBRL Taxonomy Extension Schema Document.*Document*

101.CAL101.CAL

XBRL Taxonomy Extension Calculation Linkbase Document.*Document*

101.LAB

XBRL Taxonomy Extension Label Linkbase Document.*Document*

101.PRE

XBRL Taxonomy Extension Presentation Linkbase Document.*Document*

101.DEF

XBRL Taxonomy Extension Definition Linkbase Document.*Document*

*

Filed herewith.

**

Furnished, not filed, in accordance with Item

*     Filed herewith.

**   Furnished herewith and not filed, in accordance with item 601(32)(ii) of Regulation S-K.

(1)

Incorporated herein by reference to the Current Report on Form 8-K filed with the Securities and Commission on July 11, 2017.

 


 

SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.

 

 

MILESTONE SCIENTIFIC INC.

 

 

 

/s/ Leslie BernhardLeonard Osser

 

Leslie Bernhard

Leonard Osser

 

Interim Chief Executive Officer

 

(Principal Executive Officer)

 

 

 

/s/ Joseph D’AgostinoD’Agostino

 

Joseph D’AgostinoD’Agostino

 

Chief Operating Officer

 

Chief Financial Officer

 

(Principal Financial and Accounting Officer)

Date: August 14, 2019

 

 

Date: November 14, 2017

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