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 September 30, 2017March 31, 2018

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

                                                    

As November 14, 2017,of May 15, 2018, the registrant hadhas a total of 32,989,72433,468,197 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.

Financial Statements

 

 

 

 

Condensed Consolidated Balance Sheets September 30, 2017March 31, 2018 (Unaudited) and December 31, 20162017 (Audited)

 

4

 

 

Condensed ConsolidatedConsolidated Statements of Operations for the three and nine months ended September 30,March 31, 2018 and 2017 and 2016 (Unaudited)

 

5

 

 

Condensed Consolidated Statement of Changes in StockholdersStockholders’ Equity for the ninethree months ended September 30, 2017March 31, 2018 (Unaudited)

 

6

 

 

Condensed Consolidated Statements of Cash Flows for the ninethree months ended September 30,March 31, 2018 and March 31, 2017 and 2016 (Unaudited)

 

7

 

 

Notes to Condensed Consolidated Financial Statements (Unaudited)

 

8

Item 2.

 

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

 

21

Item 3.

 

Quantitative and Qualitative Disclosures About Market Risk

 

2625

Item 4.

 

Controls and Procedures

 

2625

 

PART IIII—OTHER INFORMATION

 

 

Item 1.

 

Legal Proceedings

 

2726

Item 1A.

 

Risk Factors

 

2726

Item 2.

 

Unregistered Sales of Equity Securities and Use of Proceeds

 

2726

Item 3.

 

Defaults Upon Senior Securities

 

2726

Item 4.

 

Mine Safety Disclosures

 

2726

Item 5.

 

Other Information

 

2726

Item 6.

 

Exhibits

 

2827

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 ofconsidering 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, 20162017 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 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 INC. AND SUBSIDIARIES

CONDENSED CONSOLIDATED BALANCE SHEETS

  

March 31, 2018

  

December 31, 2017

 

ASSETS

 

(Unaudited)

  

(Audited)

 

Current Assets:

        

Cash and cash equivalents

 $2,094,238  $2,636,956 

Accounts receivable, net

  833,836   1,535,513 

Accounts receivable from related party

  1,725,450   1,725,450 

Notes receivable from financing transaction, current

  500,000   500,000 

Prepaid expenses and other current assets

  494,717   436,410 

Deferred cost related party

  1,109,671   1,109,671 

Inventories, net

  3,265,058   3,379,209 

Advances on contracts

  984,408   697,192 

Total current assets

  11,007,378   12,020,401 

Furniture, fixtures & equipment, net

  115,502   141,760 

Patents, net

  2,552,382   2,789,748 

Notes receivable from financing transaction, noncurrent

  650,000   650,000 

Other assets

  26,878   26,878 

Total assets

 $14,352,140  $15,628,787 
         

LIABILITIES AND STOCKHOLDERS’ EQUITY

        

Current Liabilities:

        

Accounts payable

 $1,556,689  $977,623 

Accounts payable related party

  1,075,078   985,678 

Accrued expenses and other payables

  1,928,654   2,287,908 

Deferred profit, related party

  714,717   751,500 

Deferred revenue, related party

  1,725,450   1,725,450 

Total current liabilities

  7,000,588   6,728,159 

Deferred gain from financing transaction

  1,400,000   1,400,000 

Total liabilities

  8,400,588   8,128,159 
         

Commitments and Contingencies

        

 

Stockholders’ Equity

        

Series A convertible preferred stock, par value $.001, authorized 5,000,000 shares, and 7,000 shares issued and outstanding as of March 31, 2018 and December 31, 2017

  7   7 

Common stock, par value $.001; authorized 50,000,000 shares; 33,216,571 shares issued, 1,699,323 shares to be issued and 33,183,238 shares outstanding as of March 31, 2018; 33,191,571 shares issued, 1,401,247 shares to be issued and 33,158,238 shares outstanding as of December 31, 2017;

  34,915   34,593 

Additional paid-in capital

  87,115,071   86,689,084 

Accumulated deficit

  (80,442,262)  (78,568,284)

Treasury stock, at cost, 33,333 shares

  (911,516)  (911,516)

Total Milestone Scientific Inc. stockholders' equity

  5,796,215   7,243,884 

Noncontrolling interest

  155,337   256,744 

Total stockholders’ equity

  5,951,552   7,500,628 

Total liabilities and stockholders’ equity

 $14,352,140  $15,628,787 

                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 

MILESTONE SCIENTIFIC INC. AND SUBSIDIARIES

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS

(UNAUDITED)

  

For the Three Months Ended

 
         
  

March 31, 2018

  

March 31, 2017

 

Revenue

        

Product sales, net

 $1,805,605  $3,688,988 

Cost of products sold

  562,676   1,402,285 

Gross profit

  1,242,929   2,286,703 
         

Selling, general and administrative expenses

  3,018,780   2,707,620 

Research and development expenses

  225,817   105,015 

Total operating expenses

  3,244,597   2,812,635 

Loss from operations

  (2,001,668)  (525,932)

Other expenses

  (1,700)  (1,209)

Interest income

  2,664   758 

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

  (2,000,704)  (526,383)

Provision for income taxes

  (11,464)  (7,201)

Loss before equity in net losses of equity investments

  (2,012,168)  (533,584)

Loss on earnings from China Joint Venture

  36,783   (44,401)

Net loss

  (1,975,385)  (577,985)

Net loss attributable to noncontrolling interests

  (101,407)  (73,117)

Net loss attributable to Milestone Scientific Inc.

 $(1,873,978) $(504,868)
         

Net loss per share applicable to common stockholders—

        

Basic

 $(0.06) $(0.02)

Diluted

 $(0.06) $(0.02)
         

Weighted average shares outstanding and to be issued—

 

Basic

  34,766,014   32,004,548 

Diluted

  34,766,014   32,004,548 

                See Notesnotes 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 INC. AND SUBSIDIARIES

CONDENSED CONSOLIDATED STATEMENT OF CHANGES IN STOCKHOLDERS’ EQUITY

(UNAUDITED)

  

Preferred Stock Shares

 

Preferred Stock Amount

 

Common Stock Shares

 

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 employee for bonuses

     323,076 323 339,177 - - - 339,500

Net loss

 - -       (1,873,978)(101,407)- (1,975,385)

Balance, March 31, 2018

 7,000 $ 7 34,915,894 $ 34,915 $ 87,115,071 $ (80,442,262)$ 155,337 $ (911,516)$ 5,951,552

See Notesnotes to Condensed Consolidated Financial Statements


MILESTONE SCIENTIFIC INC. AND SUBSIDIARIES

CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS

(UNAUDITED)

 

 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

  

March 31, 2018

  

March 31, 2017

 

Cash flows from operating activities:

        

         Net loss

 $(1,975,385) $(577,985)

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

     

         Depreciation expense

  27,625   16,860 

         Amortization of patents

  237,366   17,682 

         Stock compensation

  86,809   116,718 
          Equity income on China joint venture  (36,783)   - 

Changes in operating assets and liabilities:

        

         Decrease (increase) in accounts receivable

  701,677   (824,182)

         Decrease in accounts receivable related party

  -   1,400,801 

         Decrease in inventories

  114,151   68,885 

         Increase to in advances on contracts

  (287,216)  (161,114)

         Increase in prepaid expenses and other current assets

  (58,307)  (207,613)

         Increase in other assets

  -   (9,523)

         Decrease in deferred cost, related party

  -   438,925 

         Increase (decrease) in accounts payable

  579,070   (452,157)

         Increase (decrease) in accounts payable related party

  89,400   (152,748)

         (Decrease) increase in accrued expenses and other payables

  (19,757)  96,841 

         (Decrease) in deferred revenue, related party

  -   (645,400)

Net cash used in operating activities

  (541,350)  (874,010)

Cash flows from investing activities:

        

         Purchase of property and equipment

  (1,368)  - 

Net cash used in investing activities

  (1,368)  - 

Cash flows from financing activities:

        

         Net proceeds on Public offering

  -   150,836 

         Proceeds from exercise of stock options

  -   62,500 

Net cash provided by financing activities

  -   213,336 

Net decrease in cash and cash equivalents

  (542,718)  (660,674)

         Cash and cash equivalents at beginning of period

  2,636,956   3,602,229 

         Cash and cash equivalents at end of period

 $2,094,238  $2,941,555 
         

         Supplemental disclosure of cash flow information:

        

         Shares issued to employees for bonuses

 $339,500  $195,000 

         Shares issued to consultants in lieu of cash payments

 $-  $43,750 

See Notesnotes 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 Devices, 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®Device®; 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 dentistry under the trademark CompuDent®, and STA Single Tooth Anesthesia System®Device® and in medicine under the trademark CompuMed®. CompuDent® is suitable for all dental procedures that require local anesthetic. CompuMed® is 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, Canada and in 4753 other countries. To date there have been no medical instrumentsdevices sold in the United States and limited amounts sold internationally, although certain medical instrumentsdevices have obtained CE mark approval and can be marketed and sold in most European countries. In June 2017,

During 2016, Milestone Scientific received 510(k)filed for 510(k) marketing clearance fromwith 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 FDA for both intra-articular and epidural injections with the CompuFlo®CompuFlo® Computer Controlled Anesthesia System.System (the “CompuFlo Epidural 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.

 

In December 2016, we received notification from the FDA that based upon the 510(k) application510(k)-application submitted for intra- articular injections, we did not adequately document that the device met the equivalency standard required for 510(k) clearance.510(k) clearances. Following consultation with the FDA Office of Device Evaluation, we intend to provide additional data, which could includefile a new Human Factor Validation study (HFV Study) in support of a new 510(k)510(k) application for the device. An HFV Study demonstrates the ease of use of a product.device in 2018.

NOTE 2- LIQUIDITY AND UNCERTAINTIES

    

In December 2016, we completed an underwritten public offeringaccordance with Accounting Standard Codification (“ASC”) 205-40, “Presentation of 2,000,000 shares of common stock and warrantsFinancial Statements – Going Concern”, the Company has evaluated whether there are conditions or events, considered in the aggregate, that raise substantial doubt about the Company's ability to purchase up to 1,592,775 shares of common stock. The public offering price for each share and related warrant was $1.50. The gross proceeds from this offering were 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 shares of common stock at the public offering price 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, Milestone Scientific entered into an agreement for the sale 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 forcontinue as a secured financing 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 fivegoing concern within one 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, CEO of Wand Dental, a Director of Milestone Scientific and 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 onafter the date ofthat the 2018 Annual Stockholder meeting, subject to approval of a new or amended equity incentive plan at such meeting.)

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 Scientific is actively pursuing the generation of revenue, positive operating income and net income. The capital raised in December 2016 and January 2017 provided Milestone Scientific with working capital to continue to develop its medical instrumentsdevices and obtain regulatory approval for one of its medical instruments ( the June, 2017 FDA approval of the epidural instrument)CompuFlo® Epidural Computer Controlled Anesthesia System (the “CompuFlo Epidural System”), as well as 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, 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 ) Epidural System) and worldwide, and a reductionsreduction in operating expenses.

Management believes that Milestone Scientific will have sufficient cash reserves to meet its anticipated obligations over the next twelve month period following months from the filing date of this quarterly report. However, Milestone Scientific will likely need to raise additional capital prior to the expected generation of sustainable positive cash flow from operating activities and may also need to raise additional capital to effectively launch its approved medical instrumentEpidural Device and eventually generate positive cash flow from the anticipated medical business.

The Company is subject to several risks like those of development stage companies, including dependence on key individuals and products, the difficulties inherent in the development of a commercial market, the potential need to obtain additional capital necessary to fund the development of its products, and competition from larger companies and other medical device companies that develop similar or substitute products. The Company's sales performance, selling and marketing expenditures to develop sales performance, as well as the status of each of its new product development programs and the resulting operating income (loss), will significantly impact its cash requirements.  


NOTE 3 — SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES

 

NOTE - 2 SUMMARY OF ACCOUNTING POLICIES

1. Basis Principles 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) 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 810 of Regulation S-X.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, 2017, included in Milestone Scientific's Annual Report on Form 10-K.10-K.

 

3.  Reclassifications

 

Certain reclassifications have been made to the 20162017 financial statements to conform to the condensed consolidated 20172018 financial statement presentation. These reclassifications had no effect on net loss or cash flows as previously reported.

4. 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 and that includes both exclusive and non-exclusive distribution agreements with third parties.

Revenue from product sales are 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

We generally do not accept non-defective returns from our customers. Product returns under warranty are accepted, evaluated and repaired or replaced in accordance with the Company’s warranty policy. Returns not within the warranty policy are evaluated and the customer is charged for repair.

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 12 for revenues by geographical market, based on the customer’s location, and product category for the three months ended March 31, 2018 

 

4. Variable Interest5.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 controllingcontrolling 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 makingdecision-making ability over key operational functions within the entity.                  

 

Milestone Scientific isbecame the primary beneficiary of Milestone Education as of January 2016. 2017. 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") ASC 810, “Consolidation” 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

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.

 

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. ManagementManagement 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.method

 

5.6. 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.

 


6.7. 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 majorityMost of credit sales are due within ninetywithin 90 days from invoicing. There have not been any significant credit losses incurred to date. As of March 31, 2018 and December 31, 2017, accounts receivable was recorded, net of allowance for doubtful accounts of $10,000.

 

7. 8. Note Receivable

Milestone Scientific values note receivable at historic cost less amount paid against principle. Milestone Scientific estimates losses on the note-based payments and credit quality of the debtor. 

9.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.Company’s warranty policy. Returns not within the Warranty Policywarranty policy are evaluatedevaluated and the customer is charged for the repair.

 

8.10. Inventories

 

Inventories principally consist of finished goods and component parts stated at the lower of cost (first-in, first-out(first-in, first-out method) or market.net realizable value. Inventory quantities on hand are reviewed on a quarterly basis and a provision for excess, slow moving, and obsolete inventory is recorded if required based on past and expected future sales, potential technological obsolescence and product expiration requirements. As of March 31, 2018, and December 31, 2017, inventory was recorded net of allowance for slow moving inventory of approximately $220,000.

 

9.11. Equity Method Investments

 

Investments in whichwhich Milestone Scientific has the ability tocan exercise significant influence, but do not control, are accounted for under the equity method of accounting and are included in the long termnoncurrent assets on the condensed consolidated balance sheets.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 statementsCondensed Consolidated Statements of operations.

Operations. Milestone Scientific evaluates its equity method investments wheneverwhenever 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.

 

10.12. 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 fivetwo to seven years. years. The costs of maintenance and repairs are charged to operations as incurred.

 


11. 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 governmentalgovernmental 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 will be amortized at the estimated average useful life of the patent. These patents and developed technology are recorded at the acquisition cost and included legal fees.cost. 

 

12.Patent defense costs, to the extent applicable, are expensed as incurred.  Patent applications filed, and patents obtained in foreign countries are subject to the laws and procedures that differ from those in the United States. Patent protection in foreign countries may be different from patent protection under United States laws and may not be favorable to Milestone Scientific. Milestone Scientific also attempts to protect the proprietary information using confidentiality agreements and by limiting access to its facilities. There can be no assurance that the program of patents, confidentiality agreements and restricted access to the facilities will be sufficient to protect the proprietary technology.              

14. Impairment of Long-Lived Assets

 

As of March 31, 2018, Milestone Scientific reviewshas reviewed long-lived assets for impairment whenever events or circumstances (i.e. a triggering event) indicate that the carrying amounts may not be recoverable.any impairments. The carrying value of the assets is evaluated in relation to the operating performance and future undiscounted cash flows of the underlying assets.assets when an impairment indicator or triggering event occurs. 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, there were no impairment reviews have been performed in the period ending September 30,impairments as of March 31, 2018 and December 31, 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.

14.15. Shipping and Handling Costs

 

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

 

15.16. 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 linestraight-line method.

  

16.17. 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 temporarytemporary 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.

 

17.18. Basic and diluted net loss per common share

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 ASC 260, “Earnings per Share”. 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 like 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.

Since Milestone Scientific had net losses for 2018 and 2017, 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 3,510,335 and 3,710,335 at March 31, 2018 and December 31, 2017, respectively.


19. 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.

 

18.20. 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 tocan 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.


19. Recent Accounting Pronouncements

In May 2014, the Financial Accounting Standards Board ("FASB") issued guidance for revenue recognition for contracts, superseding the previous revenue recognition 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 disclosures regarding the nature, amount, timing and uncertainty of revenue arising from contracts with customers. In August 2015, the FASB issued guidance approving a one-year deferral, making the standard effective for reporting periods beginning after December 15, 2017. The FASB continues to release guidance clarifying certain aspects 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, the FASB issued guidance simplifying the balance sheet classification of deferred taxes. The new guidance requires that all deferred taxes be presented as noncurrent, rather than separated into current and noncurrent amounts. The guidance 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 for 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 and interim periods, beginning after December 15, 2016. The adoption of 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.

In June 2016, the FASB issued a new standard ASU No.2016-13, “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 in the process of determining what impact, if any, the adoption of this ASU will have on its financial position, results of operations and cash flows.

 In August 2016, the FASB issued a new standard ASU No.2016-15, "Statement Cash Flows “Classification of Certain Cash Receipts and Cash Disbursements" Topic 230). The new standard provides guidance as to the conformity of presentation of certain cash receipts and disbursements. 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. Milestone Scientific has adopted the standard, effective 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). 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 to have a material effect on its presentation within the statement of cash flows.

In January 2017, the FASB issued a new standard ASU No.2017-01, “Business Combinations” (Topic 805). The new standard provides guidance to clarify the definition 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.

In May 2017, the FASB issued a new standard ASU No.2017-09, “Compensation – 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 21. Stock-Based CompensationBasic and Diluted Net INCOME (Loss) Per Common Share

 

Milestone Scientific presents "basic" earnings (loss) per common share applicableaccounts for stock-based compensation under ASC 718, “Compensation – Stock Compensation”. ASC 718 requires all share-based payments to common stockholders and, if applicable, "diluted" earnings (loss) per common share applicable to common stockholders pursuant to the provisionsemployees, including grants 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 andemployee stock options, 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, suchrecognized as those issuable upon the exercise of stock options, warrants, and the conversion of debt were issued during the period.

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.

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. Milestone Scientific recorded a loss on its investment 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 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, 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 relationship with Milestone China under the equity method of accounting. A note receivable is presented on the 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.

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. 

Milestone Scientific defers the total revenue and costs of goods sold when instruments and handpieces are shipped to Milestone China and Milestone China’s agent due to market conditions and Milestone China liquidity concerns. 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 recognized revenue from Milestone China that has not been sold to third parties. At September 30, 2017 and December 31, 2016, the deferred profit was $659,931 and $630,990, respectively, which is included in the condensed consolidated balance sheets. For the nine months ended September 30, 2017 and 2016, the loss on equity investment was $28,941 and $554,766, respectively, which is included in the condensed consolidated statements of operation. For the three months ended September 30, 2017 and 2016, the loss on equity investment was $0 and $253,451, respectively, which is included in the condensed consolidated statements of operation.

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)


NOTE – 6 Stock Option Plans

Milestone Scientific recognizes compensation expense on a straight line basis over the requisite service period and inas an operating expense, based on the case of performance based options over the period of the expected performance. For the three and nine months ended September 30, 2017 Milestone Scientific recognized $299,175 and $543,290 of total employee stock based compensation cost, respectively. For the three and nine months ended September 30, 2016, Milestone Scientific recognized $81,678 and $107,205 of total employee stock based compensation cost, respectively. As 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 2.5 years and 2.49 years as of September 30, 2017 and 2016, respectively.grant-date fair values.

A summary of option activity for employees under the plans and changes during the nine month ended September 30, 2017, is presented below:

 

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   

A summary of option activity for non-employees under the plans As of September 30, 2017 and changes during the six month ended is

  

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 on the date of grant using the Black Scholes option-pricing model at the date of grant.model. In accordance with the provisions of FASB ASC 505, Milestone Scientific re-measureswill re-measure the value of the grant at each presentation date unless there is a significant disincentive for non-performance or until performance has been.been rendered. For the three months March 31, 2018 and nine months ended September 30, 2017, Milestone Scientific recognized incomeapproximately $4,000 of $6,067expense, and $12,324, respectively17,100 of income 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.options, respectively.

 

NOTE – 7 CONCENTRATION OF CREDIT RISK22. Recent Accounting Pronouncements

 

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 equivalentsIn May 2014, the FASB issued Accounting Standards Update (“ASU”) No. 2014-09, “Revenue from Contracts with large financial institutions. At times, such investments may beCustomers (Topic 606)” (ASC 606). The standard, including subsequently issued amendments, replaces most existing revenue recognition guidance in excessU.S. GAAP. The key focus of the Federal Deposit Insurance Corporation insurance limit. Milestone Scientific has not experienced any lossesnew standard is that an entity should recognize revenue to depict the transfer of promised goods or services to customers in such accounts and believes it is not exposedan amount that reflects the consideration to any significant credit risks. Financial instruments which potentially subject Milestone Scientificthe entity expects to credit risk consist principallybe entitled in exchange for those goods or services. We adopted this new standard as 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 monitorsJanuary 1, 2018 by using 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.modified-retrospective method.

 

In connection with the adoption, we performed a review of our existing revenue arrangements as of January 1, 2018 following the five-step model outlined in ASC 606.

Based on our analysis, there were no changes identified that impacted the amount or timing of revenues recognized under the new guidance as compared to the previous guidance. Additionally, our analysis indicated that there were no changes to how costs to obtain and fulfill our customer contracts would be recognized under the new guidance as compared to the previous guidance.

In February 2016, the FASB issued ASU No. 2016-02, “Leases (Topic 842)”. This ASU requires lessees to recognize a right of use asset and lease liability on the balance sheet for all leases, with the exception of short-term leases. The Company will adopt this standard on January 1, 2019. We are currently evaluating the impact of adopting this guidance on our consolidated balance sheets, results of operations and financial condition.


NOTE – 8 ADVANCES ON CONTRACTSIn August 2016, the FASB issued ASU No. 2016-15, "Statement Cash Flows “Classification of Certain Cash Receipts and Cash Payments" (Topic 230). The new standard provides guidance as to the conformity of presentation of certain cash receipts and disbursements. The Company adopted this standard during the quarter ended March 31, 2018 and there was no material impact on the Company’s consolidated statements of cash flows.  

 

In May 2017, the FASB issued ASU No. 2017-09, “Compensation – Stock Compensation” (Topic 718). The advances on contracts represent funding of future STA inventory purchasesnew standard provides guidance and Epidural replacements parts.clarity for modification to equity-based compensation programs. The balance ofCompany adopted this standard during the advances As of September 30, 2017quarter ended March 31, 2018 and December 31, 2016 is $992,242 and $700,900, respectively. The advance is classified as current basedthere was no material impact 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 has been provided for all of Milestone Scientific's deferred tax assets At September 30, 2017 and December 31, 2016, no recognition was given to the utilization of the remaining net operating loss carryforwards in each of these periods.

The utilization of Milestone Scientific's net operating losses may be subject to a substantial limitation due to the "change of ownership 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.

As of September 30, 2017 and December 31, 2016, state tax liability was approximately $18,339 and $63,000, respectively. Such expense was recognized in the accompanying condensedCompany’s consolidated financial statements.

 

NOTE In February 2018, the FASB issued ASU No. 2018-02, “Income Statement 10 SIGNIFICANT CONCENTRATIONS & GEOGRAPHICAL INFORMATIONReporting Comprehensive Income (Topic 220)”, which amends the previous guidance to allow for certain tax effects “stranded” in accumulated other comprehensive income, which are impacted by the Tax Cuts and Jobs Act (the “Act”), to be reclassified from accumulated other comprehensive income into retained earnings. This amendment pertains only to those items impacted by the new tax law and will not apply to any future tax effects stranded in accumulated other comprehensive income. This standard is effective for fiscal years beginning after December 15, 2018 and allows for early adoption. The Company does not anticipate that the adoption of this standard will have a material impact on the Company’s consolidated balance sheet.

 

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 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  

Milestone Scientific has informal arrangements with a third party manufacturer of the STA, CompuDent® and CompuMed® instruments, 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 Scientific 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 a purchase commitment for the delivery of 2,000 instruments beginning in the 4th quarter


of 2017. An advance of $948,094 was recorded at September 30, 2017. At September 30, 2017, Milestone Scientific’s purchase commitment for this purchase order was $431,619. Consequently, advances on contracts have been classified as current at September 30, 2017 and December 31, 2016.

For the three months ended September 30, 2017 , an aggregate of approximately 67% of Milestone Scientific's net product sales 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 Agreements4 — NOTES RECEIVABLE

 

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.


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 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® and CompuFlo®, and an improvement to the controls for 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 to 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.  


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.

In January 2017, Milestone Scientific entered into a 12 month agreement with Innovest S.p.A. to provide consulting services. This agreement will renew for successive 12 month terms unless terminated by Innovest S.p.A or Milestone Scientific. Expenses recognized on this agreement were $20,000 and $60,000 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.

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

The following discussions of our 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. Certain statements in this discussion and elsewhere 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. Our actual results may differ materially from those anticipated in these forward-looking statements.

OVERVIEW

Our common stock was listed on the NYSE MKT on June 1, 2015 and trades under the symbol “MLSS”. We have developed a proprietary, computer-controlled anesthetic delivery instrument, through the use of The Wand®, a single use disposable handpiece. The instrument is marketed in dentistry under the trademark CompuDent®, and STA Single Tooth Anesthesia System® and in medicine under the trademark CompuMed®. CompuDent® is suitable for all dental procedures that require local anesthetic. CompuMed® is suitable for many medical procedures regularly performed in plastic surgery, hair restoration surgery, podiatry, colorectal surgery, dermatology, orthopedics and a number of other disciplines. The dental instruments are sold in the United States and in over 47 countries abroad. There have been no medical instruments sold in the United States 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, we remained focused on advancing efforts to achieve our four primary objectives; 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;

Enhancing our global reach by partnering with distribution companies in the medical sector; 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).

STA Instrument Growth

Since its market introduction in early 2007, the 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 entered 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 Wand® STA instrument and handpieces, including training of its exclusive products sales specialists. Specifically, 25 exclusive product sales specialists have now been fully trained as experts in the features, advantages and benefits of The Wand® STA instrument and handpieces and all 25 are currently in the field selling the instrument.

Henry Schein also plans to train an additional two to three dedicated customer service representatives 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 STA Instrument to select dental suppliers in various international regions in Asia, Africa, South America and Europe. They include Istrodent (Pty) Ltd. in South Africa 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.

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.

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. Milestone Scientific recorded a loss on its investment 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.

In June 2017, Milestone Scientific entered into an agreement for the sale of its forty percent (40%) interest in Milestone China (a forty (40%) percent interest) (the(the “Milestone China Shares”) to an unaffiliated United States domiciled purchaser and a 10-year10-year option agreement to repurchase the Milestone China Shares. The purchase price for the Milestone China Shares was $1,400,000$1,400,000 of which $125,000$125,000 was paid in cash and $1,275,000$1,275,000 was paid by delivery of a non-interest bearing secured promissory note. The note iswas payable in quarterly installments of $125,000 until paid in full$125,000 and iswas secured by the Milestone China Shares until full repayment.  In addition, pursuant to such note, the purchaser iswas precluded from selling all or substantially all of its assets prior to repayment of the note. The 10-year10-year option agreement provides Milestone Scientific an option to repurchase the Milestone China Shares at $1,400,000$1,400,000 within the firsttwo years and at fair market value (as defined in such agreement) for the remainder of the 10-year10-year term.

The transaction has been accounted for as a secured financing 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 condensed consolidated balance sheet, along with a deferral from financing transaction ($1,400,000)($1,400,000). The carrying value of the forty (40% (40%) percent investment at the transaction date was zero.

As of March 2, 2018, the promissory note was in default. In April 2018, Milestone Scientific entered into a Release, Assignment and Termination Agreement with the issuer of the promissory note, pursuant to which, Milestone Scientific repaid the $250,000 payment made by the issuer and the issuer returned the 1.4 million shares of Milestone China’s common stock to Milestone Scientific and cancelled the promissory note (see Note 16).    

NOTE 5 — INVENTORIES

Inventories at March 31, 2018 and December 31, 2017 consist of the following:

  

March 31, 2018

  

December 31, 2017

 
         

Dental finished goods

 $2,786,334  $2,846,272 

Medical finished goods, net

  453,454   475,285 

Component parts and other materials

  25,270   57,652 

Total

 $3,265,058  $3,379,209 

As of March 31, 2018, and December 31, 2017, inventory was recorded net of allowance for slow moving inventory of approximately $220,000.

NOTE 6 — ADVANCES ON CONTRACTS

The advances on contracts represent funding of future STA inventory purchases and Epidural replacements parts. The balance of the advances as of March 31, 2018 and December 31, 2017 was $984,408 and $697,192 respectively. The advance is classified as current based on the estimated annual usage of the underlying inventory.    


NOTE 7 – 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. As of March 31, 2018, and 2017, approximately 72% and 82% of the revenue earned by Milestone Education is from services performed for Milestone Scientific, respectively. Because 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 Milestone Education is consolidated in our financial statements. 

 NOTE 8 – INVESTMENT IN UNCONSOLIDATED AFFILIATE

Milestone China Ltd.

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. For the three months ended March 31, 2018, and 2017, Milestone Scientific recorded a loss on its investment in Milestone China of $0 and $44,401, respectively, inclusive of the intra-entity deferral of profit. As of  March 31, 2018 and December 31, 2017, Milestone Scientific's investment in Milestone China was $0. As of March 31, 2018, and December 31, 2017, Milestone Scientific’s share of cumulative losses of Milestone china were $3,524,617 and $3,147,470, respectively, which have been suspended.

As of March 2, 2018, the Note Receivable identified on the Balance Sheet was in default. If Milestone Scientific exercises its rights as a secured party it may be obligated to return to the purchaser up to the $250,000 received for the Milestone China Shares as surplus. At March 31, 2018, Milestone Scientific did not receive a response from the purchaser of the Milestone China Shares and did not recorded any financial benefit from the sale of Milestone China Shares to date. Refer to Note 4 for subsequent actions.

Milestone Scientific had no related party sales of handpieces and devices to Milestone China and Milestone China’s agent for three months ended March 31, 2018. Milestone Scientific had $1,001,800 of related party sales of handpieces and devices to Milestone China for the three months ended March 31, 2017. Milestone Scientific defers the total revenue and costs of goods sold when devices and handpieces are shipped to Milestone China and Milestone China’s agent due to market conditions and Milestone China liquidity concerns until a payment is received.

Due to timing differences of when the inventory sold to Milestone China is 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, “Investments – Equity Method and Joint Ventures”, Milestone Scientific has deferred 40% of the gross profit associated with recognized revenue from Milestone China that has not been sold to third parties. At March 31, 2018 and December 31, 2017, the deferred profit was $714,717 and $751,500, respectively, which is included in deferred profit, related party in the, condensed consolidated balance sheets.

 

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

  

March 31, 2018

  

December 31, 2017

 

Assets:

        

Current assets

 $10,678,999  $13,127,422 

Non-current assets

  3,381,262   3,213,520 

Total assets:

 $14,060,261  $16,340,942 
         

Liabilities:

        

Current liabilities

  12,414,362   18,468,937 

Stockholders' equity

  1,645,899   (2,127,995)

Total liabilities and stockholders’ equity

 $14,060,261  $16,340,942 
         
  

March 31, 2018

  

March 31, 2017

 

Net sales

 $756,956  $427,400 

Cost of goods sold

  (447,611)  (479,411)

Gross Profit

  309,345   (52,011)

Other Expenses

  (1,252,213)  (958,055)

Net Losses

 $(942,868) $(1,010,066)


 NOTE 9 — PATENTS

Patents at March 31, 2018 and December 31, 2017 are comprised of the Milestone China Shares allowsfollowing:

 

2018

 

2017

 
 

Cost

 

Accumulated Amortization

 

Net

 

Cost

 

Accumulated Amortization

  

Net

 

Patents-foundation intellectual property

$1,377,863 $(805,216)$572,647 $1,377,863 $(787,821) $590,042 

Epidural-Apad acquired patents

 2,639,647  (659,912) 1,979,735  2,639,647  (439,941)  2,199,706 

Total

$4,017,510 $(1,465,128)$2,552,382 $4,017,510 $(1,227,762) $2,789,748 

Patents are amortized utilizing the straight-line method over estimated useful lives ranging from 3 to 20 years, with a weighted average amortization period of approximately 5 years.

On July 13, 2017, Milestone Scientific consummated a Asset Purchase Agreement (the “Agreement”) with APAD Octrooi B.V. and APAD B.V. (each, a “Seller” and collectively, the “Sellers”) pursuant to continuewhich Milestone Scientific acquired certain patent rights and other intellectual property rights related to expandthe Sellers’ computer-controlled injection instrument (the “Purchased Assets”) and 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 approximately $2,486,000 for the Purchased Assets 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 China market by supplyingagreement. As of March 31, 2018, and December 31, 2017, Milestone ChinaScientific has recorded a liability of $295,000 relating to the estimated additional shares that would have to be issued according this provision in the Agreement. The asset purchase price of approximately $2,639,000, net of expenses has been capitalized and will amortized over their three-year estimated useful life.

Amortization expense was $237,366 and $17,682 for the three months ended March 31, 2018 and 2017, respectively. The annual amortization expense expected to be recorded for existing intangibles assets for the next five years from the balance sheet date of March 31, 2018 are as follows: $927,000, $920,000, $259,000, $39,000 and $39,000, respectively.

NOTE 10 — STOCKHOLDERS’ EQUITY

Shares to be Issued

As of March 31, 2018, and December 31, 2017, there were 1,699,323 and 1,401,247 shares of common stock, respectively, whose issuance has been deferred under the terms of an employment agreements with the STA Single Tooth Anesthesia System®Chief Executive Officer, Chief Financial Officer and related hand pieces, while eliminatingother employees of Milestone Scientific. Such shares will be issued to each such person upon termination of their employment. The number of shares was fixed at the burden ondate of grant and were fully vested upon grant date.

Shares Reserved for Future Issuance

As of March 31, 2018, and December 31, 2017 there were 5,209,658 and 5,111,582 shares reserved for future issuance and 3,510,335, and 3,710,335 shares underlying other stock options and warrants outstanding, respectively. At March 31, 2018 and December 31, 2017, there were 1,699,323 shares and 1,401,247 shares, respectively, reserved for issuance in settlement of deferred compensation to officers of 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.

Scientific.

 


NOTE 11 — INCOME TAXES

Due to Milestone Scientific's history of operating losses, a full valuation allowances have been provided for all of Milestone Scientific's deferred tax assets. As of March 31, 2018, and December 31, 2017, no recognition was given to the utilization of the remaining net operating loss carryforwards in each of these periods.

The utilization of Milestone Scientific's net operating losses may be subject to a substantial limitation due to the "change of ownership 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 its deferred tax assets due to uncertainty as to their future realization.  

Accounting for uncertainties in income taxes prescribes a recognition threshold and measurement attribute for the financial statement recognition and measurement of a tax position taken or expected to be taken in a tax return, and provides guidance on derecognition, classification, interest and penalties, disclosure and transition. At March 31, 2018, and December 31, 2017, we had no uncertain tax positions that required recognition in the consolidated financial statements. Milestone Scientific's policy is to recognize interest and penalties on unrecognized tax benefits in income tax expense in the Statements of Operations.

No interest and penalties are present for periods open. Tax returns for the 2014,2015, 2016 and 2017 years are subject to audit by federal and state jurisdictions.

NOTE 12 — SEGMENT AND GEOGRAPHIC DATA

We conduct our business through two reportable segments dental and medical.  These segments offer different products to different customer base. The following tables present information about our reportable and operating segments:

Sales

Three months ended March 31,

 

Net Sales:

2018

 

2017

 

Dental

$1,769,105 $3,688,988 

Medical

 36,500  - 

Total

$1,805,605 $3,688,988 
       

Operating (Loss):

2018

 

2017

 

Dental

$357,165 $1,275,631 

Medical

 (708,382) (624,326)

Corporate

 (1,650,451) (1,177,237)

Total

$(2,001,668)$(525,932)
       

Depreciation and Amortization:

2018

 

2017

 

Dental

$4,141 $4,468 

Medical

 16,877  9,360 

Corporate

 243,973  20,714 

Total

$264,991 $34,542 
       

Loss before taxes and equity in losses of affiliates:

2018

 

2017

 

Dental

$359,822 $1,276,099 

Medical

 (708,954) (624,796)

Corporate

 (1,651,572) (1,177,686)

Total

$(2,000,704)$(526,383)
       

Total Assets:

March 31, 2018

 

December 31, 2017

 

Dental

$9,302,960 $10,255,144 

Medical

 667,770  655,513 

Corporate

 4,381,410  4,718,130 
 $14,352,140 $15,628,787 

The following table presents information about our operations by geographic area as March 31, 2018 and 2017.  Net sales by geographic area are based on the respective locations of our subsidiaries

Domestic-US & Canada

 

March 31, 2018

 

March 31, 2017

Devices

 $121,048   $185,645  

Handpieces

  768,531    1,510,486  

Other

  28,851    18,941  

Total Domestic US & Canada

 $918,430   $1,715,072  

International ROW

          

Devices

 $279,468   $358,670  

Handpieces

  582,827    583,349  

Other

  24,880    30,097  

Total International-ROW

 $887,175   $972,116  

International-China

          

Devices

 $-   $1,000,000  

Handpieces

  -    -  

Other

  -    1,800  

Total International

 $-   $1,001,800  

Domestic. International Analysis

          

Domestic-US & Canada

 $918,430   $1,715,072  

International -ROW

  887,175    972,116  

International -China

  -    1,001,800  

Total Product Sales

 $1,805,605   $3,688,988  

NOTE 13 -- CONCENTRATION

Milestone Scientific has informal arrangements with a third-party manufacturer 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 January 2017, Milestone Scientific entered into a purchase commitment for the delivery of 2,000 instruments beginning in the 4th quarter of 2017. At March 31, 2018, Milestone Scientific’s purchase commitment for this purchase order was $186,965. In January 2018, Wand Dental entered into a new purchase commitment for the delivery of 2,000 devices beginning in the third quarter of 2018, Milestone Scientific’s purchase commitment for this purchase order was $1,397,440. An advance of $ 984,408 and $697,192 was recorded at March 31, 2018 and December 31, 2017, respectively. Consequently, advances on contracts have been classified as current at March 31, 2018 and December 31, 2017.  The termination of the manufacturing relationship with any of the above manufacturer 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, whether 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 months ended March 31, 2018, an aggregate of approximately 54% of Milestone Scientific's net product sales were to one customer/distributor. For the three months ended March 31, 2017, an aggregate of approximately 79% of Milestone Scientific's net product sales were to two customer/distributors (one of which, Milestone China, is a related party), 52%, and 27%, respectively. Accounts receivable for the major customer/distributors amounted to an aggregate of approximately $1,923,950, or 76% of Milestone Scientific's accounts receivable, as of March 31, 2018. Accounts receivable for the major customer/distributors amounted to an aggregate of approximately $2,555,476, or 78% of Milestone Scientific's accounts receivable, as of December 31, 2017.

 NOTE 14 -- RELATED PARTY TRANSACTIONS

Milestone Scientific has a manufacturing agreement with United Systems (whose controlling shareholder, Tom Cheng, is 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 $351,280 and $452,352 for the three months ended March 31, 2018 and 2017, respectively. As of March 31, 2018, and December 31, 2017, Milestone Scientific owed $1,075,078 and $985,678 this manufacturer, respectively.


Milestone Scientific had no related party sales of handpieces and devices to Milestone China and Milestone China’s agent for three months ended March 31, 2018. Milestone Scientific had $1,001,800 of related party sales of handpieces and devices to Milestone China for the three months ended March 31, 2017. Milestone Scientific defers the total revenue and costs of goods sold when devices and handpieces are shipped to Milestone China and Milestone China’s agent due to market conditions and Milestone China liquidity concerns until a payment is received.

In August 2016, K. Tucker Andersen, a significant 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 $50,000 for the three months ended March 31, 2018 and 2017.

In January 2017, Milestone Scientific entered into a 12-month agreement with Innovest S.p.A. to provide consulting services. This agreement will renew for successive 12-month terms unless terminated by Innovest S.p.A or Milestone Scientific. Expenses recognized on this agreement were $20,000 for the three months ended March 31, 2018 and 2017.

NOTE 15 — COMMITMENTS 

(1)  Contract Manufacturing Agreement

Milestone Scientific has informal arrangements with a third-party manufacturer 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 January 2017, Milestone Scientific entered into a purchase commitment for the delivery of 2,000 instruments beginning in the 4th quarter of 2017. At March 31, 2018, Milestone Scientific’s purchase commitment for this purchase order was $186,965. In January 2018 Wand Dental entered into a purchase commitment for the delivery of 2,000 instruments beginning in the 3rd quarter of 2018, Milestone Scientific’s purchase commitment for this purchase order was $1,397,440. An advance of $ 984,408 and $697,192 was recorded at March 31, 2018 and December 31, 2017, respectively.

(2)  Other Commitments

In February 2018, Milestone Scientific and Daniel Goldberger, the Company’s former President and Chief Executive Officer, who resigned effective October 2, 2017, signed a Settlement and Release Agreement with respect to Mr. Goldberger’s leaving the Company. The gross settlement was $175,000, and $80,555 was paid in March 2018. The remainder of the settlement will be paid over a nine-month period beginning in March 2018.

The technology underlying the Safety Wand® and CompuFlo®, and an improvement to the controls for 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 covering these technologies. 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 to 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. 

The Director of Clinical Affairs’ royalty fee was $85,769 and $131,908 for three months ended March 31, 2018 and 2017, respectively. Additionally, Milestone Scientific expensed consulting fees to the Director of Clinical Affairs of $68,751 for three months ended March 31, 2018 and 2017, respectively. 

In January 2017, Milestone Scientific entered into a 12-month agreement with Innovest S.p.A. to provide consulting services. This agreement will renew for successive 12-month terms unless terminated by Innovest S.p.A or Milestone Scientific. Expenses recognized on this agreement were $20,000 for three months ended March 31, 2018 and 2017.


NOTE 16 — SUBSEQUENT EVENTS

In April 2018, Milestone Scientific entered into a Release, Assignment and Termination Agreement (the “Termination Agreement”) with the issuer of the promissory note, pursuant to which, Milestone Scientific repaid the $250,000 payment made by the issuer and the issuer returned the 1.4 million shares of Milestone China’s common stock to Milestone Scientific and cancelled the Note. As a result of the Termination Agreement and related repayment made by Milestone Scientific, the Company derecognized the outstanding note receivable balance of $1,150,000 and the related deferred gain on financing transaction of $1,400,000, and no gain or loss was recognized on the transaction. See Note 4.

In May 2018, the Company entered a twelve-month Consulting Agreement to provide corporate finance advice, assisting the Company to establish corporate financing goals, and creating public awareness in European markets. The Company shall grant to the Consultant, upon fulfilment of Condition Precedent, an option to buy from the Company 500,000 shares of newly issued common stock at the price of $1.00; such option being exercisable any time up to the 1st anniversary year of this Agreement. The Condition Precedent is the purchase of at least 400,000 shares of the Company's common stock from the secondary market within 30 days of signing the Consulting Agreement. If the Consultant purchases up to additional 400,000 shares of the Company common stock in the secondary market in the period between 30 to 60 days from the date hereof, the option will increase up to an additional 500,000 shares of newly issued common stock at a price of 1.00, the proportion shall be on a 4 to 5 ratio (e.g., 400,000 shares purchased equals 500,000 shares option).


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

The following discussions of the 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 annual report. Certain statements in this discussion and elsewhere in this report constitute forward-looking statements, within the meaning of section 21E of the Exchange Act, that involve risks and uncertainties. The actual results may differ materially from those anticipated in these forward-looking statements.

OVERVIEW

Milestone Scientific is a biomedical technology research and development company that patents, designs, develops and commercializes innovative diagnostic and therapeutic injection technologies and devices for medical, dental, cosmetic and veterinary applications. Since our inception, we have engaged in pioneering proprietary, innovative, computer-controlled injection technologies and solutions for the medical and dental markets. We have focused our resources on redefining the worldwide standard of care for injection techniques by making the experience more comfortable for the patient by reducing the anxiety and stress of receiving injections from the healthcare provider. Our computer-controlled injection systems make injections precise, efficient and virtually painless. Milestone’s proprietary DPS Dynamic Pressure Sensing technology is our technology platform that advances the development of next-generation devices, regulating flow rate and monitoring pressure from the tip of the needle, through platform extensions for local anesthesia for subcutaneous drug delivery, with specific applications for cosmetic botulinum toxin injections, epidural space identification in regional anesthesia procedures and intra-articular joint injections. 

Milestone Scientific remains focused on advancing efforts to achieve the following five primary objectives: 

●         Establishing Milestone’s DPS Dynamic Pressure Sensing technology platform as the standard-of-care in painless and precise drug delivery, providing for the first time objective

           visual and audible in-tissue pressure feedback, and continuing to expand platform applications;

●         Following obtaining successful FDA clearance of our first medical device in June 2017, Milestone Scientific is transitioning from a research and development organization to

           a commercially focused medical device company;

●         Commercializing our CompuFlo Epidural System, a transformative device for epidural anesthesia procedures;

●         Expanding the global footprint of our CompuFlo Epidural System by partnering with distribution companies worldwide; and

●         Continuing the commercial launch and gain regulatory approval of our proprietary cosmetic injection device for delivery of botulinum toxin (such as Botox® and Dysport®).

Distribution and Marketing Arrangements

Our dental devices are sold in the United States, Canada, and in over 53 countries abroad. In June 2017, we received FDA regulatory clearance to sell our first medical device, the CompuFlo Epidural System in the United States. Since receiving FDA clearance in 2017 our epidural devices have had minimal sales in the United States and Europe. 

Dental Market

In the spring of 2009, Milestone Scientific signed a distribution and marketing agreement with China National Medicines Corporation, dba Sinopharm. In early October 2012, the State Food and Drug Administration (“CFDA”) of the People’s Republic of China approved the Wand STA System. However, the CFDA’s approval of the Wand STA handpieces was not received until May 2014 and the distribution of these handpieces in China began in the fourth quarter of 2014. The distribution and marketing agreement with Sinopharm was terminated in September 2014. Proximate to that time, we entered into a new agreement with Milestone China to be our distributor for the Wand STA System and handpieces in China.

In November 2012, Milestone Scientific signed an exclusive distributor and marketing agreement with a well-known U.S. domestic manufacturer and distributor, for the sale and distribution of the Wand STA System and handpieces in the United States and Canada. The marketing initiative included participation in United States and Canadian dental shows, as well as pediatric dental shows; an active advertising initiative targeting major dental publications; and direct mailing campaigns to over 150,000 dentists across the United States and Canada. This exclusive distributor and marketing agreement was converted to a non-exclusive agreement as of December 31, 2016.


Beginning January 1, 2016, Milestone Scientific entered into a non-exclusive distribution agreement with Henry Schein. In June 2016, that agreement was replaced by a new agreement with Henry Schein providing for an exclusive distribution arrangement for our dental products in the United States and Canada by a newly formed marketing and sales group at Henry Schein. Under this arrangement, we have a semi-dedicated independent sales force visiting dentists. Henry Schein’s exclusive products sales specialist team, which is comprised of 25 sales representatives and supported by over 1,000 field service representatives, will exclusively market and distribute the Wand STA System and handpieces, together with a select group of other devices in the United States and Canada.

Our agreement with Henry Schein has minimum purchase orders to maintain exclusivity in the third through tenth years. We believe that this exclusive arrangement will be more effective than previous arrangements relying on Wand Dental's appearances at dental shows and catalog sales.  

Medical Market

Having received FDA clearance to sell the CompuFlo Epidural System in June 2017, we are in discussions with a small number of regional and national distributors. Our immediate focus is on marketing our epidural device throughout Europe.

In 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.

We have entered into a limited number of distributor arrangements in Europe and the Middle East for our CompuFlo Epidural Computer Controlled Anesthesia System. Our distribution strategy is initially aimed at having KOLs use and accept the device and initiate their own studies.

The following table shows a breakdown of Milestone Scientific’sScientific’s product sales (net), domestically and internationally, by product category, and the percentage of product sales (net) by eachbusiness segment product category:

        

  

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 March 31,

    

2018

 

2017

    

Reportable Segments

 

Reportable Segments

    

Dental

 

Medical

 

Total

 

Dental

 

Medical

 

Total

               

Domestic US / Canada:

            
 

Device

 

$       121,048

 

              $                 -   

 

$        121,048

 

$       185,645

 

$               -   

 

   $    185,645

 

Handpieces

 

       768,531

 

              -   

 

       768,531

 

    1,510,486

 

               -   

 

    1,510,486

 

Other

  

        28,851

 

              -   

 

        28,851

 

        18,941

 

               -   

 

        18,941

 

Total Domestic US / Canada

 

       918,430

 

              -   

 

       918,430

 

    1,715,072

 

               -   

 

    1,715,072

               

International Rest of the World:

            
 Device 246,968 

        32,500

 

      279,468

 

       358,670

 

               -   

 

       358,670

 

Handpieces

 

578,827

 

          4,000

 

     582,827

 

       583,349

 

               -   

 

       583,349

 

Other

  

        24,880

 

              -   

 

        24,880

 

        30,097

 

               -   

 

        30,097

 

Total International Rest of the World

 

       850,675

 

        36,500

 

       887,175

 

       972,116

 

               -   

 

       972,116

               

International China:

            
 Device 

               -   

 

              -   

 

               -   

 

    1,000,000

 

               -   

 

    1,000,000

 

Handpieces

 

               -   

 

              -   

 

               -   

 

          1,800

 

               -   

 

          1,800

 

Other

  

               -   

 

              -   

 

               -   

 

               -   

 

               -   

 

               -   

 

Total International China

 

               -   

 

              -   

 

               -   

 

    1,001,800

 

               -   

 

    1,001,800

               
 

Total Product Sales

 

$    1,769,105

 

$        36,500

 

$    1,805,605

 

 $   3,688,988

 

$               -   

 

$    3,688,988

 


Milestone Scientific plans to support increased sales and marketing activity through our current distributors and through newly appointed distributors of the Wand STA instrumentsdevices 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,CompuFlo Epidural System, Milestone Scientific is initiating marketing and sales efforts in the US to establish medical sector distributors for the sale of this instrumentdevice.


Current Product Platform

See Item 1. Description of Business.

Results of Operations

 

The following table sets forth for the consolidated results of operations for the three and nine months ended September 30,March 31, 2018 compared to 2017 respectively, as a percentage of revenues. 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)%

  

Three Months Ended

 

Operating results:

 

March 31, 2018

  

March 31, 2017

 

Net Sales

 $1,805,605  100% $3,688,988  100%

Cost of Sales

  562,676  31%  1,402,285  38%

Gross Profit

  1,242,929  69%  2,286,703  62%

Operating expenses:

              

Selling, general, and administrative

  3,018,783  167%  2,707,620  73%

Research & development

  225,817  13%  105,015  3%

Operating Loss

 $(2,001,668) -111% $(525,932) -14%

Other Expenses, net

  26,283  1%  (52,053) -1%

Net Loss

  (1,975,385) -109%  (577,985) -16%

Net loss profit attributable to noncontrolling interest

  (101,407) -6%  (73,117) 2%

Net loss attributable to Milestone Scientific Inc.

 $(1,873,978) -104% $(504,868) -14%

  

Three Months Ended

 
  

March 31, 2018

  

March 31, 2017

 

Cash flow:

      

Net cash used in operating activities

$

  (541,350

)$(874,010)

Net cash used in investing activities

$(1,368)$- 

Net cash provided by financing activities

$ - $ 213,336 

 

Milestone Scientific earned gross profit of approximately $1.8 million and $5.7 million in the three and nine monthsThree Months ended September 30, 2017. Milestone Scientific earned gross profit of approximately $1.7 million and $5.3 million in the three and nine monthsMarch 31, 2018 compared to Three Months ended September 30, 2016. However, the revenues and related gross profits have not been sufficient to support overhead, new product introduction and research and development expenses.March 31, 2017

 

The Three Months Ended September 30,Net sales for three months ended March 31, 2018 and 2017 compared to the Three Months Ended September 30, 2016were as follows:

 

  

2018

  

2017

  

Increase

(Decrease) $

  

%

 

Dental

 $1,769,105  $3,688,988  $(1,919,883) -52.04%

Medical

  36,500   -   36,500  100.00%

Total

 $1,805,605  $3,688,988  $(1,883,383) -51.05%

Total revenues

Consolidated revenue for the three months ended September 30,March 31, 2018 and 2017 and 2016 were approximately $2.9$1.8 million and $3.2$3.7 million, respectively. Total revenues decreased by approximately 10% which was principally related to the decrease in international sales of approximately $1.6 million, offset by the increase in domestic sales 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 Dental 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 in the USA by expanding our “KOL” (Key Opinion Leaders) coverage and specific hands on continuing education course throughout the USA.


Gross margin for the three months ended September 30,March 31, 2018 and 2017 was 63%, which increased from 52% for the three months ended September 30, 2016. The increase in gross profit relates to the increase in US sales in 2017were approximately $1.8 million and $3.7 million, respectively. Dental revenue decreased by approximately $1.9 million, which is was offset by special pricingprincipally related to a decrease in China to facilitate an increase in market share.

Selling, general and administrative expenses for the three months ended September 30, 2017 and 2016 were approximately $3.2 million versus $2.9 million, respectively. The increase of approximately $272,000 predominantly due to the additional  selling, general and administrative expenses is resulting from the completion of the clinical studies relatingsales to Milestone Medical's epidural instruments in 2016China (approximately $1.0 million) and Milestone Scientific initiating marketing and sales efforts in the U.S. to establish the medical sector. 

Research and development for the three months ended September 30, 2017 and 2016 were approximately $17,000 verse $303,000, respectively. The decrease of approximately $286,000 is predominantly due to the completion of the clinical studies relating to Milestone Medical's epidural instruments in 2016.

The loss from operations for the three months ended September 30, 2017 and 2016 was approximately $1.4 million,  verse $1.6 million respectively, a decrease of approximately $155,000. This decrease is primarily attributable to the completion of the clinical studies relating to Milestone Medical's epidural$900,000 in USA 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 in the United StatesCanada 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 asales. The 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 believeform 2017 and modifications to their business strategy to better serve the China dental market. The USA and Canadian revenue is lower in the first quarter of 2018, as Henry Schein purchased additional inventories in the fourth quarter of 2017, to avoid a price increase effective in the first quarter of 2018.  Medical revenue for the three months ended March 31, 2018 and 2017 were $36,500 and $0, respectively.


On June 12, 2017 the Company announced that the June 2016 exclusive distribution agreementCompuFlo Epidural System received 510(k) marketing clearances from the U.S. Food and Drug Administration (FDA). Milestone is in the process of attending medical device trade shows and attending introductory meetings with Henry Schein will continue to increase domestic sales in 2017 asmedical device distributors within the productUnited States and sales force training has been substantially completed as of September 30, 2017.European markets. The Company’s focus is on marketing its CompuFlo Epidural System throughout Europe.

 

Gross marginProfit for three months ended March 31, 2018 and 2017 were as follows:

  

2018

  

2017

  

Increase (Decrease) $

  

%

 

Dental

 $1,218,026  $2,286,703  $(1,068,677)  -46.73%

Medical

  24,903   -   24,903   100.00%

Total

 $1,242,929  $2,286,703  $(1,043,774)  -45.65%

Consolidated gross profit for the ninethree months ended September 30,March 31, 2018 and 2017 was 63%were approximately 69% and 62%, which increased from 59% for the nine months ended September 30, 2016.respectively. The increaseimprovement in gross profit relatespercentage for the three months ended March 31, 2018 is due to the increasedecrease in US sales to Milestone China which sales have a reduced gross profit margin as Milestone China is expanding its market penetration. The gross profit dollars decreased by approximately $1.0 million due to lower revenues in which was offset by special pricing in China to facilitate an increase in market share.the first quarter 2018.

 

Selling, general and administrative expenses for the ninethree months ended September 30,March 31, 2018 and 2017 were as follows: 

  

2018

  

2017

  

Increase (Decrease) $

  

%

 

Dental

 $860,861  $1,008,071  $(147,210) -14.60%

Medical

  678,052   589,483   88,569  15.02%

Corporate

  1,479,867   1,110,066   369,801  33.31%

Total

 $3,018,780  $2,707,620  $311,160  11.49%

Consolidated selling, general and 2016administrative expenses for the three months ended March 31, 2018 and 2017 were approximately $9$3 million versus $9.2$2.7 million,, respectively. The decreaseincrease of approximately $230,000$311,000 is predominantly due to the reductionincrease in Corporate expenses. Milestone Scientific Corporate SG&A expenses resulting fromincreased by approximately $370,000 essentially all the completionincrease represents (approx. $220,000) amortization of the clinical studies relating to Milestone Medical's epidural and intra articular instrumentspatents acquired in 2016.the APAD purchase in 2017. 

 

Research and Development for three months ended March 31, 2018 and 2017 were as follows:

  

2018

  

2017

  

Increase (Decrease) $

  

%

 

Dental

 $-  $3,000  $(3,000) -100.00%

Medical

  55,233   34,844   20,389  58.52%

Corporate

  170,584   67,171   103,413  153.95%

Total Sales

 $225,817  $105,015  $120,802  115.03%

Consolidated research and development expenses for the ninethree months ended September 30,March 31, 2018 and 2017 and 2016 were approximately $242,000$226,000 and $756,000,$105,000, respectively. The decreaseincrease is due to reduction inthe development cost associated with epiduralof the cosmetic injection device.

Profit (Loss) from Operations for three months ended March 31, 2018 and intra articular instruments.2017 were as follows:

  

2018

  

2017

  

Increase (Decrease) $

  

%

 

Dental

 $357,165  $1,275,631  $(918,466) -71.94%

Medical

  (708,382)  (624,326)  (84,056) 13.46%

Corporate

  (1,650,451)  (1,177,237)  (473,214) 40.26%

Total

 $(2,001,668) $(525,932) $(1,475,736) 280.60%

 

The loss from operations for the ninethree months ended September 30,March 31, 2018 and 2017 and 2016 was approximately $3.5million$2 million and $4.7 million,$526,000, respectively, a decreasean increase of approximately $1.2$1.5 million. This decreaseincrease is primarily attributableattribute to the completionreduction in net sales of $1.8 million, and an increase in selling, general and administrative of $311,000 as explained above, represents the clinical studies and reduced research and development expenses relating to our epidural and intra articular instruments in 2017 and gross profit.increase loss of operations for the first quarter 2018.

 


Liquidity and Capital Resources

 

At September 30, 2017,March 31, 2018, Milestone Scientific had cash and cash equivalents of approximately $2.3$2.1 million, total current assets of approximately $11.6$11.0 million and working capital of approximately $6.5$4 million. We believe that our cash on hand, accounts receivablereceivable and the anticipated revenues from the dental business will be sufficient to fund our business operations for at least the next 12 months from the filing date of this Form 10-Q.

 

Milestone Scientific continues to take positive steps to maintain adequate inventory levels and advances on contracts to maintain available inventory to meet our domestic and international sales requirements. For the ninethree months ended September 30,March 31, 2018 and 2017, and 2016, our netwe had cash flows 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.$541,000 and $874,000, respectively.

 


Milestone Scientific has incurred annual operating losses and negative cash flows from operating activities since its inception. The capital raised in December 2016 and January 2017 provided Milestone ScientificScientific with working capital to continue to develop its medical instrumentsdevices and obtain FDA regulatory approval for oneclearance of its medical instruments (the June 2017 FDA approval of the epidural instrument),CompuFlo Epidural System, as well as 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 CompuFlo Epidural System has obtained FDA clearance in the United States (June 2017), the Company’s development costs should be lower in 2018. The FDA clearance will provide the Company with the opportunity to establish distribution in the USA. At the same time, the Company is looking to establish additional financing opportunities to help with the commercialization of the Epidural device. The intra-articular device will have sufficient cash and liquidity to meet its anticipated obligations overbegin the next twelve-month period following510K application process in the datesecond quarter of this report.   year. Most of the cost associated with this application will be internal personnel cost and some low level third party review expense.

 

Milestone Scientific believes that the FDA clearance of its 510(k) application with respect to the CompuFlo® Epidural Computer Controlled AnesthesiaSystem will provide Milestone Scientific with the opportunity to enter the US medical device market and generate revenues in the future. Milestone Scientific believes that it has sufficient inventory of the epidural instrumentsdevices to satisfy the near termnear-term marketing opportunities.

In 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.

Milestone Scientific believes that the June 2016 exclusive distribution agreement with Henry Schein will continue to improve its domestic revenues in 2018. The dental agreement has provided a substantial increase in US and Canada dental revenue in 2017 (approximately $2 million). To further reduce Milestone Scientific's expenditures, Milestone Medical is carefully managing expenses related to obtaining FDA clearance for the intra-articular devices.

 

Our condensed consolidated balance sheets included in this Quarterly Report reflects a decrease of approximately $1.8$1.0 million in current assets from December 31, 20162017 to September 30, 2017.March 31, 2018. This decrease in current assetsassets was primarily due to a reduction in cash, accounts receivable, from related parties, deferred cost, other receivables and inventory of approximately $4 million.$1,358,000. This was offset by an increaseincreases in accounts receivable,prepaid expenses and advances on contracts note receivable and prepaid expenses and other current assets of an aggregate of approximately $2.2 million.$345,000.

 

CurrentIn this Quarterly Report our consolidated balance sheets included an increase in current liabilities decrease by of approximately $591,000$364,000 from approximately $5.6$7.0 million to approximately $5.1$6.7 million. The decreaseincrease is primarily due to a decreasean increase in accounts payable of approximately $725,000,$579,000, accounts payable related party of approximately $333,000,$89,400, deferred revenueprofit related party of approximately $289,000 offset by an increase in deferred profit China of approximately $29,000,55,000 and an increasea decrease in accrued expenses of approximately $727,000.$359,000. 

 

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 September 30, 2017March 31, 2018 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, 2017March 31, 2018 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

 

Recent Sales of Unregistered SecuritiesNone.

In the quarter ended September 30, 2017, Milestone Scientific issued a total of 352,015 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 consideration for certain patent rights and other intellectual property rights related to the Sellers’ computer controlled injection instrument.

The foregoing shares were issued in reliance upon the exemptions from the registration requirements of the Securities Act of 1933, as amended (the "Act"), pursuant to Sections 4(a)(2), Section 4(a)(5) and/or Regulation D promulgated thereunder. A legend restricting resale, transfer, or other disposition of these shares other than in compliance with the Act was imprinted on the stock certificates evidencing such shares.

 

ITEMItem 3. 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

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: May 15, 2018

 

 

Date: November 14, 2017

 

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