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, 2022

 or

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

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 Orange425 Eagle Rock Avenue Livingston, New Jersey 07039Suite 403, Roseland, NJ 07068

(Address of principal executive offices)

 

(973) 535-2717

(Registrant’ss 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 Section12(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 filer☐ (Do not check if a smaller reporting company)

Smaller reporting company ☑

Emerging growth company ☐

 

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

 

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

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

Title of each class

Trading Symbol(s)

Name of Exchange on which registered

Common Stock

MLSS

NYSE American

 

As November 14, 2017,of  May 16, 2022, the registrant hadhas a total of 32,989,72468,432,335 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 IFINANCIAL INFORMATION

Item 1.

Unaudited Condensed Consolidated Financial Statements

4

Condensed Consolidated Balance Sheets September 30, 2017 (Unaudited)as of March 31, 2022 and December 31, 2016 (Audited)2021

4

Condensed Consolidated Statements of Operations for the three and nine months ended September 30, 2017March 31, 2022 and 2016 (Unaudited)2021

5

Condensed Consolidated StatementStatements of Changes in StockholdersStockholders’ Equity for the ninethree months ended September 30, 2017 (Unaudited)March 31, 2022 and 2021

6

Condensed Consolidated Statements of Cash Flows for the ninethree months ended September 30, 2017March 31, 2022 and 2016 (Unaudited)2021

78

Notes to Condensed Consolidated Financial Statements (Unaudited)

9

8

Item 2.

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

24

21

Item 3.

Quantitative and Qualitative Disclosures About Market Risk

28

26

Item 4.

Controls and Procedures

2628

PART IIOTHER INFORMATION

Item 1.

Legal Proceedings

28

27

Item 1A.

Risk Factors

29

27

Item 2.

Unregistered Sales of Equity Securities and Use of Proceeds

30

27

Item 3.

Defaults Upon Senior Securities

30

27

Item 4.

Mine Safety Disclosures

30

27

Item 5.

Other Information

30

27

Item 6.

Exhibits

31

28

Signatures

32

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. The forward-looking statements included herein are based on current expectations that involve numerous risks and uncertainties. Milestone Scientific’s plans and objectives are based, in part, on assumptions involving the continued expansion of its business. Assumptions relating to the foregoing involve judgments with respect to, among other things, future economic, competitive and market conditions and future business decisions, all of which are difficult or impossible to predict accurately and many of which are beyond the control of Milestone Scientific. Although Milestone Scientific believes that its assumptions underlying the forward-looking statements are reasonable, any of the assumptions could prove inaccurate. Considering the significant uncertainties inherent in the forward-looking statements included herein, our history of operating losses that are expected to continue during the ongoing COVID-19 pandemic, the early stage operations of and relative lack of acceptance of our medical products, relying exclusively on two third parties to manufacture our products, changes in our informal manufacturing arrangements made by the manufacturers of our products and disruptions at the manufacturing facilities of our manufacturers exposes us to risks that may harm our business, restrict our operations or require us to relinquish proprietary rights, if physicians do not accept or use our CompuFlo® Epidural Computer Controlled Anesthesia System our ability to generate revenue from sales will be materially impaired, exposure to the risks inherent in international sales and operations, including China, and developments by competitors may render our products or technologies obsolete or non-competitive, the inclusion of such information should not be regarded as a representation by Milestone Scientific or any other person that the objectives and plans of Milestone Scientific will be achieved. Prospective investors are cautioned that any forward-looking statements are not guarantees of future performance and are subject to risks and uncertainties and the actual results may differ materially from those included within the forward-looking statements as a result of various factors. Such forward-looking statements should, therefore, be considered in light of various important factors, including those set forth herein and others set forth from time to time in Milestone Scientific’s reports, including without limitations,limitation, Milestone Scientific's Annual Report on Form 10-K for the year ended December 31, 20162021 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 ®; CathCheckTM; the Milestone logo ®; SafetyWand®; STA Single Tooth Anesthesia System®Device®; and The Wand ®.

 


 PART I—FINANCIAL INFORMATION

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 

 See Notes to Condensed Consolidated Financial Statements

MILESTONE SCIENTIFIC AND SUBSIDIARIES

CONDENSED CONSOLIDATED BALANCE SHEETS

(UNAUDITED)

  

March 31, 2022

  

December 31, 2021

 

ASSETS

        

Current assets:

        

Cash and cash equivalents

 $13,254,775  $14,764,346 

Accounts receivable, net

  1,063,613   943,272 

Accounts receivable, related party net

  269,973   0 

Prepaid expenses and other current assets

  622,080   375,360 

Inventories, net

  1,799,908   1,541,513 

Advances on contracts

  1,217,253   1,309,260 

Total current assets

  18,227,602   18,933,751 

Furniture, fixtures and equipment, net

  20,325   23,713 

Intangibles, net

  264,192   277,619 

Right of use assets

  528,907   550,511 

Other assets

  24,150   24,150 

Total assets

 $19,065,176  $19,809,744 
         
         

LIABILITIES AND STOCKHOLDERS’ EQUITY

        

Current liabilities:

        

Accounts payable

 $1,012,093  $780,428 

Accounts payable, related party

  1,128,919   395,857 

Accrued expenses and other payables

  1,335,451   1,417,248 

Accrued expenses, related party

  257,815   414,241 

Current portion of finance lease liabilities

  8,743   8,545 

Current portion of operating lease liabilities

  83,585   81,001 

Total current liabilities

  3,826,606   3,097,320 

Non-current portion of finance lease liabilities

  17,801   20,062 

Non-current portion of operating lease liabilities

  454,857   476,980 

Total liabilities

 $4,299,264  $3,594,362 
         

Commitments

          
         

Stockholders’ equity

        
Common stock, par value $.001;authorized 100,000,000 shares; 68,153,336 shares issued at March 31, 2022 and December 31, 2021 and 68,120,003 shares outstanding as March 31, 2022 and December 31, 2021;  68,153   68,153 

Additional paid in capital

  125,385,315   124,915,560 

Accumulated deficit

  (109,605,997)  (107,704,274)

Treasury stock, at cost, 33,333 shares

  (911,516)  (911,516)

Total Milestone Scientific, Inc. stockholders' equity

  14,935,955   16,367,923 

Noncontrolling interest

  (170,043)  (152,541)

Total stockholders’ equity

  14,765,912   16,215,382 
         

Total liabilities and stockholders’ equity

 $19,065,176  $19,809,744 

The accompanying notes are an integral part of these unaudited condensed consolidated financial statements

 


MILESTONE SCIENTIFIC INC.

 

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS

 

(Unaudited)

 
                    
  

Three Months Ended September 30,

   

Nine Months Ended September 30,

 
  

2017

   

2016

   

2017

   

2016

 

Revenue

                   

Product sales, net

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

Cost of products sold

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

Gross profit

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

Selling, general and administrative expenses

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

Research and development expenses

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

Total operating expenses

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

Loss from operations

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

Other (expenses)

  (1,046)   (846)   (3,278)   (2,782)

Interest income

  3,582    -    6,495    - 

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

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

Provision for income tax

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

Loss before equity in net earnings of equity investments

  (1,417,546)

 

  (1,585,551)

 

  (3,507,039)

 

  (4,766,862)

Loss on earnings from China Joint Venture

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

Loss in equity investments

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

Net Loss

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

Net loss attributable to noncontrolling interests

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

Net loss attributable to Milestone Scientific Inc.

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

Net loss per share applicable to common stockholders

                   

Basic

 $(0.04)  $(0.06)  $(0.10)  $(0.16)

Diluted

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

Weighted average shares outstanding and to be issued

                   

Basic

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

Diluted

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

 See Notes to Condensed Consolidated Financial Statements

MILESTONE SCIENTIFIC AND SUBSIDIARIES

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS

(UNAUDITED)

 

  

For the three months ended 

March 31, 2022

  

For the three months ended 

March 31, 2021

 
         

Product sales, net

 $2,700,902  $2,924,707 

Cost of products sold

  1,018,476   1,122,413 

Gross profit

  1,682,426   1,802,294 
         

Selling, general and administrative expenses

  3,115,629   2,749,299 

Research and development expenses

  464,466   16,444 

Depreciation and amortization expense

  16,814   20,924 

Total operating expenses

  3,596,909   2,786,667 
         

Loss from operations

  (1,914,483)  (984,373)

Interest expense, net

  (4,742)  (2,535)

Loss before provision for income taxes and net of equity investments

  (1,919,225)  (986,908)

Provision for income taxes

  0   (250)

Loss before equity investment

  (1,919,225)  (987,158)

Deferred profit and divesture-equity investment (See Note 6)

  0   1,301 

Net loss

  (1,919,225)  (985,857)

Net loss attributable to noncontrolling interests

  (17,502)  (12,988)

Net loss attributable to Milestone Scientific Inc.

 $(1,901,723) $(972,869)
         

Net loss per share applicable to common stockholders—

        

Basic

  (0.03)  (0.01)

Diluted

  (0.03)  (0.01)
         

Weighted average shares outstanding and to be issued—

        

Basic

  69,013,001   66,578,435 

Diluted

  69,013,001   66,578,435 

          The accompanying notes are an integral part of these unaudited condensed consolidated financial statements

5

MILESTONE SCIENTIFIC AND SUBSIDIARIES

CONDENSED CONSOLIDATED STATEMENTS OF CHANGES IN STOCKHOLDERS' EQUITY

FOR THREE MONTHS ENDED MARCH 31, 2022 

(UNAUDITED)

  

Common Stock Share

  

Common Stock Amount

  

Additional Paid in Capital

  

Accumulated Deficit

  

Noncontrolling Interest

  

Treasury Stock

  

Total Stockholder Equity

 

Balance January 1, 2022

  68,153,336  $68,153  $124,915,560  $(107,704,274) $(152,541) $(911,516) $16,215,382 

Stock based compensation

  -   0   305,370   0   0   0   305,370 

Common stock to be issued to employees for bonuses

  -   0   164,385   0   0   0   164,385 

Net loss

  -   0   0   (1,901,723)  (17,502)  0   (1,919,225)

Balance March 31, 2022

  68,153,336  $68,153  $125,385,315  $(109,605,997) $(170,043) $(911,516) $14,765,912 

The accompanying notes are an integral part of these unaudited 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

                   

See Notes to Condensed Consolidated Financial StatementsCONDENSED CONSOLIDATED STATEMENTS OF CHANGES IN STOCKHOLDERS' EQUITY

FOR THREE MONTHS ENDED MARCH 31, 2021

(UNAUDITED)

  

Common Stock Share

  

Common Stock Amount

  

Additional Paid in Capital

  

Accumulated Deficit

  

Noncontrolling Interest

  

Treasury Stock

  Total Stockholder Equity 

Balance January 1, 2021

  64,171,435  $64,171  $117,934,696  $(100,885,957) $(94,426) $(911,516) $16,106,968 

Stock based compensation

  -   0   113,507   0   0   0   113,507 

Common stock issued to employee for compensation expensed in prior periods

  7,075   7   0   0   0   0   7 

Common stock to be issued for payment of consulting services expensed in prior periods

  40,010   40   0   0   0   0   40 

Common stock issued to board of directors for services expensed in prior periods

  18,879   18   0   0   0   0   18 

Common stock issued to employee for stock options exercised

  435,558   436   689,754   -   -   -   690,190 

Common stock to be issued to employees for bonuses

  -   0   100,000   0   0   0   100,000 

Common stock issued for warrants exercised

  1,918,925   1,919   3,010,297   0   0   0   3,012,216 

Net loss

  -   0   0   (972,869)  (12,988)  0   (985,857)

Balance March 31, 2021

  66,591,882  $66,591  $121,848,254  $(101,858,826) $(107,414) $(911,516) $19,037,089 

The accompanying notes are an integral part of these unaudited condensed consolidated financial statements

7

MILESTONE SCIENTIFIC AND SUBSIDIARIES

CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS

FOR THE THREE MONTHS ENDED

(UNAUDITED) 

  

 

March 31, 2022

  

March 31, 2021

 

Cash flows from operating activities:

        

Net loss

 $(1,919,225) $(985,857)

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

        

Depreciation expense

  3,388   9,572 

Amortization of intangibles

  13,426   11,352 

Stock based compensation

  305,370   113,507 

Employees paid in stock

  164,385   115,000 

Non-cash operating lease expense

  (17,378)  1,883 

Deferred profit and divesture-equity investment (See Note 6)

  0   (1,301)

Changes in operating assets and liabilities:

        

(Increase) decrease in accounts receivable

  (120,341)  101,895 

(Increase) in accounts receivable, related party

  (269,973)  (267,300)

(Decrease) increase in inventories

  (258,395)  399,630 

Decrease (Increase) in advances on contracts

  92,007   (338,995)

(Increase) in prepaid expenses and other current assets

  (246,720)  (272,905)

Increase in accounts payable

  231,668   211,072 

Increase (decrease) in accounts payable, related party

  733,062   (200,778)

(Decrease) increase in accrued expenses

  (81,797)  339,518 

Decrease in accrued expenses, related party

  (156,427)  (204,107)

Decrease operating right of use lease liability

  19,442   0 
Net cash used in operating activities   $(1,507,508) $(967,814)
         

Cash flows from investing activities:

        

Purchase of furniture, fixtures, and equipment

  0   (5,916)

Net cash used in investing activities

 $0  $(5,916)
         

Cash flows from financing activities:

        

Proceeds from exercise of warrants

  0   3,012,216 

Payments finance lease obligations

  (2,063)  (1,883)

Common stock issued to employee for option exercised

  0   690,190 

Net cash (used in) provided by financing activities

 $(2,063) $3,700,523 
         

Net (decrease) increase in cash and cash equivalents

  (1,509,571)  2,726,793 

Cash and cash equivalents at beginning of period

  14,764,346   14,223,917 

Cash and cash equivalents at end of period

 $13,254,775  $16,950,710 

The accompanying notes are an integral part of these unaudited condensed consolidated financial statements 

 


 

 MILESTONE SCIENTIFIC INC. AND SUBSIDIARIES 

 CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS 

 (Unaudited) 

  

Nine Months Ended September 30,

  

2017

 

2016

Cash flows from operating activities:

    

Net loss

$

       (3,535,980)

$

       (5,321,628)

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

    

   Depreciation expense

 

               44,046

 

               69,345

   Amortization of patents

 

             187,209

 

               53,017

   Stock compensation

 

        530,966

 

         1,136,430

Loss China joint venture

 

               28,941

 

             545,950

Changes in operating assets and liabilities:

    

   (Increase) in accounts receivable

 

       (1,197,252)

 

           (759,385)

   Decrease in accounts receivable related party

 

         2,001,800

 

 - 

   Decrease in other receivable

 

               10,000

 

               58,140

   Decrease (increase) in inventories

 

             436,998

 

           (225,998)

   (Increase) to advances on contracts

 

           (291,342)

 

             (53,566)

   Increase  (Decrease) to prepaid expenses and other current assets

 

           (260,081)

 

               27,701

   (Increase) in other assets

 

               (9,523)

 

 - 

   (Decrease) increase in accounts payable

 

           (725,170)

 

             169,388

   (Decrease) in accounts payable related party

 

           (332,711)

 

 - 

   Increase in deferred profit, related party

 

             257,323

  

Increase in accrued expenses and other payables

 

         1,583,624

 

             181,324

   (Decrease) in deferred revenue

 

       (289,000)

 

 - 

         Net cash used in operating activities

 

       (1,560,152)

 

       (4,119,282)

Cash flows from investing activities:

    

   Purchase of intangible assets

 

             (39,520)

 

             (15,616)

   Purchase of property and equipment

 

               (4,749)

 

             (14,945)

Purchase of intangibles assets-Apad 

           (153,647)

 

                        -   

   Consolidation of variable interest entity

 

                        -   

 

               50,621

        Net cash (used in) provided by investing activities

 

           (197,916)

 

               20,060

Cash flows from financing activities:

    

Capital contribution from noncontrolling interest

 

                        -   

 

                 2,543

Proceeds from Private Placement Offering                                                -    2,225,000

   Proceed from financing transaction

 

             250,000

 

                        -   

   Proceeds from exercise of stock options

 

               62,500

 

    -    

   Net proceeds on Private Placement Offering

 

             150,836

 

                        -   

         Net cash provided by investing activities

 

             463,336

 

         2,227,543

Net decrease in cash and cash equivalents

 

       (1,294,732)

 

       (1,871,679)

Cash and cash equivalents at beginning of period

 

         3,602,229

 

         4,194,384

Cash and cash equivalents at end of period

$

         2,307,497

$

         2,322,705

     

Supplemental disclosure of cash flow information:

    

   Net assets acquired from variable entity

  $

               14,076

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

   Sale of Milestone China shares, financing transaction 

 $

         1,400,000

 

                        -   

   Shares issued to employees for bonus

 $

         259,841

$

             389,318

   Shares issued to consultants in lieu of cash payments

 $

             422,249

$

             366,299

See Notes to Condensed Consolidated Financial Statements


MILESTONE SCIENTIFIC, INC.

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

(UNAUDITED)

Note 1-NOTE 1 ORGANIZATION andAND BUSINESS

 

All references in this report to Milestone“Milestone Scientific,” “us,” “our,” “we,” “the Company”the “Company” or “Milestone” refer to Milestone Scientific Inc., and its consolidated subsidiaries, Wand Dental, Milestone Advanced Cosmetic,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®ompuDent®; CompuMed®CompuMed®; CompuFlo®CompuFlo®; DPS Dynamic Pressure Sensing Technology®technology®; Milestone Scientific ®; ®;CathCheckTM; the Milestone logo ®; SafetyWand®®; SafetyWand®; STA Single Tooth Anesthesia System®System®; and The Wand ®.®.

 

Milestone Scientific was incorporated in the State of Delaware in August 1989. Milestone Scientific has developed a proprietary, computer-controlled anesthetic delivery instrument, through the use ofdevice, using The Wand®Wand®, a single use disposable handpiece. The instrumentdevice is marketed in dentistry under the trademark CompuDent®CompuDent®, and STA Single Tooth Anesthesia System®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 instrumentsdevices are sold in the United States, Canada and in 4760 other countries. To date there have been noCertain medical instruments 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, Milestone Scientific received 510(k)510(k) marketing clearance from the U.S. Food and Drug Administration (FDA) on the CompuFlo® Epidural Computer Controlled Anesthesia System.

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

During 2016, Milestone Scientific filed for 510(k) marketing clearance with the FDA for both intra-articular and epidural injections with the CompuFlo® Computer Controlled Anesthesia System.  In June 2017, the FDA approved the CompuFlo® Epidural Computer Controlled Anesthesia System for epidural injections.  Milestone Scientific is(“Epidural”).We are in the process of introductory meetingsmeeting with medical facilities and device distributors within the United States, Middle East and foreign markets. Milestone Scientific’s immediate focus is on marketing its epidural instrument throughoutEurope. To date there have been seventeen medical devices sold in the United States and Europe.limited amounts sold internationally. Certain of our medical instruments have obtained European CE mark approval and can be marketed and sold in most European countries.

NOTE 2-LIQUIDITYAND UNCERTAINTIES

 

In December 2016, we received notification fromThe Company has evaluated whether there are conditions or events, considered in the FDAaggregate, that based uponraise substantial doubt about the 510(k) application submitted for intra- articular injections, we did not adequately documentCompany's ability to continue as a going concern within one year after the date that the device met unaudited condensed consolidated financial statements are issued. As of March 31, 2022, the equivalency standard required for 510(k) clearance. Following consultation with the FDA OfficeCompany had an accumulated deficit of Device Evaluation, we intend to provide additional data, which could include$109.6 million and has incurred a new Human Factor Validation study (HFV Study) in supportnet loss of a new 510(k) applicationapproximately $1.9 million for the device. An HFV Study demonstrates the ease of use of a product.

In December 2016, we completed an underwritten public offering of 2,000,000 shares of common stock and warrants 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 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 balance sheet, along with a deferral from financing transaction ($1,400,000). The carrying value of the forty (40%) percent investment at the transaction date was zero (see Note 5).

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

In July 2017, Milestone Scientific's Compensation Committee approved the issuance of 400,000 stock options to Gian Domenico Trombetta, 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 on the date of the 2018 Annual Stockholder meeting, subject to approval of a new or amended equity incentive plan at such meeting.)

Milestone Scientific has incurred operating losses and negative cash flows from operating activities in virtually 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 instruments and obtain regulatory approval for one of its medical instruments ( the June, 2017 FDA approval of the epidural instrument), as well as to aggressively market its dental instruments. 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 instruments and disposables business in the United States (following June 2017 FDA approval of its CompuFlo® Computer Controlled Anesthesia System ) and worldwide, and a reductions in operating expenses. period ended March 31, 2022. Management believes that Milestone Scientific, Inc. 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 instrument and eventually generate positive cash flow from the anticipated medical business.

 

NOTE - 2 SUMMARY OF ACCOUNTING POLICIES

1. BasisIn addition to its employees, the Company relies on (i) distributors, agents, and third-party logistics providers in connection with product sales and distribution and (ii) raw material and component suppliers in the U.S., Europe, and China. If the Company, or any of Consolidationthese entities encounter any disruptions to its or their respective operations or facilities, or if the Company or any of these third-party partners were to shut down for any reason, including by fire, natural disaster, such as a hurricane, tornado or severe storm, power outage, systems failure, labor dispute, pandemic or other public health crises, or other unforeseen disruption, then the Company or they may be prevented or delayed from effectively operating its or their business, respectively.

 

The accompanyingcoronavirus (COVID-19) adversely impacted the Company's operations, our distributors and suppliers in recent years. In spite of the reopening of dental offices, hospitals, and pain clinics throughout the country and the rest of the world, revenues for three months ended March 31, 2022 and 2021 were adversely affected in particular for the medical business. However, any business interruptions, resulting from COVID-19, or new strain could significantly disrupt our operations and could have a material adverse impact on our business in the future. 

In addition, it is uncertain as to what effect the continuing spread of COVID-19 will have on the commercialization efforts of our CompuFlo Epidural and CathCheck systems. Such future developments could have a material adverse effect on the Company financial results and its ability to conduct business as expected.

The Ukrainian-Russian conflict, sanctions imposed by the United States and other western democracies, and any expansion is likely to have unpredictable and wide-ranging effects on the domestic and global economy and financial markets, which could have an adverse effect on our business and results of operations. Already the conflict has caused market volatility, a sharp increase in certain commodity prices, such as wheat and oil, and an increasing number and frequency of cybersecurity threats. So far, we have experienced a decrease in international sales from Ukraine and halted all sales to Russia, a direct impact from the conflict. We will continue to monitor the situation carefully and, if necessary, take action to protect our business, operations and financial condition.  

9

NOTE 3 — SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES

1.Principles of Consolidation

The unaudited 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 10Q10-Q and Article 8 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 condensed consolidated 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 consolidated financial statements and notes thereto for the year ended December 31, 2016, 2021, included in Milestone Scientific's Annual Report on Form 10-K.10-K.

3.Use of Estimates

The preparation of the unaudited condensed consolidated financial statements in conformity with GAAP requires management to make estimates and assumptions in determining the reported amounts of assets and liabilities and disclosure of contingent 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, stock compensation expense, and valuation allowances on deferred tax assets. Actual results could differ from those estimates.

4.Revenue Recognition

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, 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 related and third parties.

Revenue from product sales is recognized upon transfer of control of a product to a customer, generally upon date of shipment. 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. 

10

Sales Returns

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

Financing and Payment

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

 

3. ReclassificationsDisaggregation of Revenue

 

Certain reclassifications have been made toThe Company operates in 2 operating segments: dental and medical. Therefore, results of the 2016 financial statements to conform toCompany operations are reported on a consolidated basis for purposes of segment reporting, consistent with internal management reporting. See Note 10 for revenues by geographical market, based on the consolidated 2017 financial statement presentation. These reclassifications had no effect on net loss or cash flows as previously reported. customer’s location, and product category for the three months ended March 31, 2022 and 2021.

 

4.

5.Variable InterestInterest 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 has completed the VIE analysis relating to Milestone China and Anhui Maishida Medical Technology, Co. Ltd. (“Anhui”).

 

Milestone Scientific has determined that due to the loss of equity investment in Anhui, the Company no longer has significant influence of Anhui and therefore Anhui is the primary beneficiary of Milestone Education as of January 2016. Accordingly, the assets and liabilities of Milestone Education are included in the accompanying condensed consolidated financial statements.

Becausenot a variable interest. Milestone Scientific had an increasinghas a 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

   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.

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

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

 

Milestone managementScientific 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 hasChina who have the power to direct the activities that most significantly impact the economic performance of Milestone China. Management has concluded that Milestone Scientific is not the primary beneficiary under ASC 810. Accordingly, Milestone China has not been consolidated into the financial statements of Milestone Scientific and continues to beis accounted for under the equity method. See Note 6.

 

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. As of March 31, 2022 and December 31, 2021. Milestone Scientific has approximately $12.4 million and $13.9 million, respectively, of investments with short term maturities classified as cash equivalents.  At times, such cash, may be more than the Federal Deposit Insurance Corporation insurance limit. 

 


11

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 ability or inability of its customers to make payments on amounts billed. A majority ofMost 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, 2022, and December 31, 2021, accounts receivable was recorded, net of allowance for doubtful accounts of $10,000.

 

7. Product Return and Warranty

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

8.Inventories

 

Inventories principally consist of finished goods and component parts stated at the lower of cost (first-in, first-out(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, defective, and obsolete inventory is recorded if required based on past and expected future sales, potential technological obsolescence, and product expiration requirements.

 

The valuation allowance creates a new cost basis for the inventory, and it is not subsequently marked up through a reduction in the valuation allowance based on any changes in the underlying facts and circumstances. When the valuation allowance is initially recorded, the increase to the allowance is recognized as an increase in cost of sales. The valuation allowance is only reduced if or when the underlying inventory is sold or destroyed, at which time cost of sales recognized would include the previous adjusted cost basis.

9.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 termlong-term assets on the condensed consolidated balance sheets.unaudited 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 provision for income tax line on the condensed consolidated statementsunaudited Condensed 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. Furniture, Fixture and Equipment  

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

11. 9.Intangible Assets - Patents and Developed Technology

 

Patents are recorded at cost to prepare and file the applicable documents with the USU.S. 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 willare recorded at acquisition cost and be amortized at the estimated average useful life oflife.  Patent defense costs, to the patent. These patentsextent applicable, are recorded at the acquisition cost and included legal fees.expensed as incurred.                      

 

12.

10.Impairment of Long-Lived Assets

 

Milestone Scientific reviews long-livedLong-lived assets with finite lives are tested for impairment whenever events or changes in circumstances (i.e. a triggering event) indicate that the carrying amounts amount of an asset may not be recoverable. The carrying valueCompany’s impairment review process is based upon an estimate of the assets is evaluated in relation to the operating performance and future undiscounted cash flowsflow. Factors the Company considers that could trigger an impairment review include the following:

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

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

significant negative industry or economic trends

significant technological changes, which would render the technology obsolete

Recoverability of the underlying assets. Milestone Scientific adjusts the net book value of an underlying asset if its fair value is determinedassets that will continue to be less than its net book value. There have been no impairment indicators or triggering events and therefore, no impairment reviews have been performedused in the period ending September 30, 2017.


13. Revenue RecognitionCompany's operations is measured by comparing the carrying value to the future net undiscounted cash flows expected to be generated by the asset or asset group. Future undiscounted cash flows include estimates of future revenues, driven by market growth rates, and estimated future costs.

 

12

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

14. Shipping and Handling Costs

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

15. 11.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.

12.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. UseAt March 31, 2022, and December 31, 2021, we had 0 uncertain tax positions that required recognition in the unaudited condensed consolidated financial statements. Milestone Scientific's policy is to recognize interest and penalties on unrecognized tax benefits in income tax expense in the unaudited condensed Consolidated Statements of EstimatesOperations. NaN interest and penalties are present for periods open. Tax returns for the 2018,2019 and 2020 years are subject to audit by federal and state jurisdictions.

 

The preparation of financial statements in conformity with GAAP requires management to make 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. 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 between market participants in the principal market at the measurement date (exit price). We are required to classify fair value measurements in one of the following categories:

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

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

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

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 particular 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

13.Basic and Diluted Net INCOME (Loss)Loss Per Common Share

 

Milestone Scientific presents "basic"“basic” earnings (loss) per common share applicable to common stockholders and, if applicable, "diluted"“diluted” earnings (loss) per common share applicable to common stockholders pursuant to the provisions of Statement of Financial Accounting Standards ASC Topic 260.260, “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.common shares of 69,013,001 and 66,578,435 for the three months ended March 31, 2022, and 2021 respectively. The calculation of diluted earnings per common share is similar tolike 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 debtwarrants were issued during the period. The Company also includes shares to be issued to employees in the calculation of basic earnings per share because the shares to be issued settle a compensation obligation in a fixed number of shares.

 

Since Milestone Scientific had net losses for in the three months and nine months ended September 30, 2017 March 31, 2022, and 2016,2021, the assumed effects of the exercise of potentially dilutive outstanding stock options, unissued restricted stock awards (“RSA”) and warrants, were not included in the calculation as their effect would have been anti-dilutive. Such outstanding options, RSA and warrants totaled 4,629,5577,543,252 and 1,885,010 at September 30, 20176,092,193 on March 31, 2022, and 2016,2021, respectively.

 

NOTE - 4 CONSOLIDATION OF VARIABLE INTEREST ENTITY

14.Fair Value of Financial Instruments

 

Milestone EducationFair value is the price that would be received to sell an asset or paid to transfer a 50% owned subsidiaryliability in an orderly transaction between market participants in the principal market at the measurement date (exit price). The Company required to classify fair value measurements in one of Milestone Scientific which began operations in 2013the following categories: 

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

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

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

Financial assets and liabilities are classified based on the lowest level of input that is significant to provide trainingthe fair value measurement. Our assessment of the significance of an input to the fair value measurement requires judgment and education to dentists throughoutmay affect the world. Milestone Scientific accounted for its investment in Milestone Education usingvaluation of the equity methodfair value of accounting through assets and liabilities and their placement within the fair value hierarchy levels. As of March 31, 2022, and December 31,  2015. Approximately 81% of2021 the revenue earned by Milestone Education is from services performed for Milestone Scientific as of September 30, 2017. AsCompany does not have any assets or liabilities that were measured at fair value on 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. recurring basis.

 

NOTE - 5 INVESTMENTS IN UNCONSOLIDATED SUBSIDIARIES

Advance Ocular Science SA15. Stock-Based Compensation 
 

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%accounts for stock-based compensation under ASC Topic 718, Share-Based Payment. ASC Topic 718 requires all share-based payments to employees, non-employees, directors, and officers, including grants 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 yetemployee stock options, 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 includedrecognized in the unaudited condensed consolidated financial statements at September 30, 2017of operations over the service period, as no further investment has been made by Milestone Scientific.an operating expense, based on the grant-date fair values.

13

 

Milestone China Ltd.

16.Recent Accounting Pronouncements

 

In June 2014, Milestone Scientific invested $1 millionJanuary 2020, FASB issued ASU 2020-01, “Investments—Equity Securities (Topic 321), Investments—Equity Method and Joint Ventures (Topic 323), and Derivatives and Hedging (Topic 815), which, generally, provides guidance for investments in Milestone China Ltd. (“Milestone China”) by contributing 772 STA Instruments to Milestone Chinaentities accounted 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 ChinaASU 2020-01 is effective for all entities with fiscal years beginning after December 15, 2021, including interim periods therein. The adoption 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, whichthis standard did not 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 presentedimpact 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.Company's condensed consolidated financial statement.

 

Milestone Scientific had $356,400In August 2020, FASB issued ASU 2020-06, “Debt—Debt with Conversion and $1,714,600Other Options (Subtopic 470-20) and Derivatives and Hedging—Contracts in Entity’s Own Equity (Subtopic 815-40): Accounting for Convertible Instruments and Contracts in an Entity’s Own Equity; which, generally, provides guidance for accounting regarding derivatives relating to entities common stock and earnings per share. ASU 2020-06 is effective for all entities with fiscal years beginning after December 15, 2021, including interim periods therein. The adoption 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 receivablethis standard did not have an impact on the condensedCompany's consolidated balance sheets. financial statement.

 

Milestone Scientific defersIn October 2021, FASB issued ASU 2021-08, Business Combinations (Topic 805), Accounting for Contract Assets and Contract Liabilities from Contracts with Customers, which provides guidance on accounting for contract assets and contract liabilities acquired in a business combination in accordance with Topic ASC 606, Revenue Recognition from Contracts with Customers (“ASC 606”). To achieve this, an acquirer may assess how the totalacquiree applied ASC 606 to determine what to record for the acquired revenue contracts. Generally, this should result in an acquirer recognizing and costs of goods sold when instrumentsmeasuring the acquired contract assets 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 actuallycontract liabilities consistent with how they were recognized and when Milestone China sellsmeasured in the acquired inventoryacquiree’s financial statements. The amendments of ASU 2021-08 are for fiscal years beginning after December 15, 2022, including interim periods. Early adoption is permitted, including adoption in an interim period. An entity that early adopts in an interim period should apply the amendments (1) retrospectively to third parties, an eliminationall business combinations for which the acquisition date occurs on or after the beginning of the intra-entity profit is required as offiscal year that includes 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 in the case of performance based options over theinterim period of the expected performance. For the threeearly application 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(2) prospectively 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.

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 estimatedall business combinations that occur on or after the date of grantinitial application. The Company will evaluate the impact of ASU 2021-08 on any future business combinations the Company may enter in the future.

In June 2016, the FASB issued ASU 2016-13,Measurement of Credit Losses on Financial Instruments (“ASU 2016-13”), which amends the guidance on measuring credit losses for certain financial assets measured at amortized cost, including trade receivables. The FASB has subsequently issued several updates to the standard, providing additional guidance on certain topics covered by the standard. This update requires entities to recognize an allowance for credit losses using a forward-looking expected loss impairment model, taking into consideration historical experience, current conditions, and supportable forecasts that impact collectability. In November 2019, the Black Scholes option-pricing model atFASB issued ASU 2019-10,Financial Instruments - Credit Losses (Topic, 326), Derivatives and hedging (Topic 815), and Leases (Topic 842): Effectivedates, which deferred the effective date of grant. In accordanceASU 2016-13 for the Company. As a result of ASU 2019-10, ASU 2016-13 is effective for all entities with fiscal years beginning after December 15, 2022, including interim periods. The adoption of this update is not expected to have a material impact on the provisions of FASB ASC 505, Milestone Scientific re-measures the value of the grant at each presentation date unless there is a significant disincentive for non-performance or until performance has been. For the three and nine months ended September 30, 2017, Milestone Scientific recognized income of $6,067 and $12,324, respectively related to non-employee options. For the three and nine months ended September 30, 2016, Milestone Scientific recognized expense of $2,807 and $8,421 respectively related to non-employee options.Company's condensed consolidated financial statements.

NOTE – 7 CONCENTRATION OF CREDIT RISK4 — INVENTORIES

 

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

  

March 31, 2022

  

December 31, 2021

 
         

Dental finished goods, net

 $632,003  $342,465 

Medical finished goods, net

  989,257   1,119,709 

Component parts and other materials

  178,648   79,339 

Total inventories

 $1,799,908  $1,541,513 

The Company maintains an allowance for doubtful accounts based on a historyslow moving Medical finished goods of past write-offs approximately $450,000 as of March 31, 2022 and collections and current credit conditions.

December 31, 2021.


NOTE – 85 — ADVANCES ON CONTRACTS

 

The advances on contracts represent funding of future STA inventoryinventory purchases, epidural instruments, and Epiduralepidural replacements parts. The balance of the advances Asas of September 30, 2017 March 31, 2022, and December 31, 2016 2021 is $992,242approximately $1.2 million and $700,900,$1.3 million, respectively. The advance is classified as current based on the estimated annual usage of the underlying inventory.  

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NOTE 6 – INVESTMENT IN AND TRANSACTIONS WITH EQUITY INVESTEES

 

NOTE – 9 INCOME TAXESMilestone China Ltd.

Ownership

In June 2014, Milestone Scientific invested $1 million in Milestone China Ltd. (“Milestone China”), by contributing dental instruments to Milestone China for a 40% ownership interest. Milestone China owns approximately 75% of Milestone Beijing Medical Equipment Company, Ltd (“Milestone Beijing”). At the time, Milestone Beijing had primary responsibility for the sales, marketing, and distribution of the Company’s dental products in China. Milestone Scientific recorded its investment in Milestone China under the equity method of accounting. 

In first quarter of 2020, Milestone China and certain manufacturing/marketing affiliates entered into a reorganization agreement (the “Transaction”) pursuant to which Milestone China was to merge into an affiliated manufacturing company, Anhui Maishida Medical Technology, Co. Ltd. (“Anhui”), with Anhui as the surviving entity and to have complete responsibility for sales, marketing, and distribution for the Company’s dental products in China. After completion of the Transaction, Milestone Scientific was expected to have an approximate 28.4% direct ownership in Anhui. Due to the COVID-19 pandemic, the regulatory approval of the planned Transaction was delayed while applicable government offices were closed in China and Hong Kong. Until the completion of the transaction Milestone Scientific's 28.4% in Anhui was held by Milestone China.

On November 23, 2021, management of Milestone Scientific became aware that on October 8, 2021, without approval from Milestone Scientific, (i) Milestone China entered into an Equity Transfer Agreement whereby Milestone China’s 28.4% equity stake in Anhui was transferred to Lidong Zhang, the CEO of Milestone China and Anhui, in exchange for RMB 2,840 million (approximately $440,351) of which no amounts have been or are expected to be received, see below, and (ii) Anhui held a shareholders’ meeting at which the Equity Transfer Agreement was approved by the shareholders of Anhui, eliminating Milestone China’s equity interest in Anhui and Milestone Scientific’s indirect equity interest in Anhui. Based on a review of the minutes of the Anhui shareholders’ meeting, Milestone China was not listed as a shareholder in such  meeting due to the executed Equity Transfer Agreement between Lidong Zhang and Milestone China.

Though management believes that this conveyance by Milestone China to LiDong Zhang is outside of the laws of Hong Kong and/or China, as may be applicable, at this juncture Milestone Scientific has no ownership in Anhui and Milestone China has no assets or operations. After considering taking action to assert our rights in the matter, and based on the acknowledgement that such course of action is not without its procedural and substantive challenges in Hong Kong and/or China and, importantly, in view of Michelle Zhang dba Solee Science & Technology USA (“Solee”) (see below), a company located in New Jersey, who became the independent distributor, former agent, for Milestone China and its subsidiaries, and due to the good working relationship developing between Milestone Scientific and Solee and reduction of Milestone Scientific’s credit exposure to a Chinese entity, management is not pursuing any legal action at this time to recover our equity interest.

However, management has determined to pursue an investigation of whether the above-described consideration payable by LiDong Zhang to Milestone China was actually paid to Milestone China and, if so, its recovery. Nevertheless, at this time, Milestone Scientific has not received any consideration, does not know if any of such consideration promised to Milestone China for its interest in Anhui has been paid and, if paid, whether it can recover its share of such consideration. As a result, at this time, Milestone Scientific has not received any consideration and does not know if any of the consideration promised to Milestone China for its interest in Anhui has been paid and, if paid, unless circumstances change, Milestone Scientific does not expect it will receive any of the consideration received by Milestone China for its assets without pursuing legal action. As a result, Milestone Scientific has not recorded a gain or receivable related to the transfer of Anhui. As of March 31, 2022, and December 31, 2021 the investment in Milestone China was zero.

Related Party Transactions

Milestone China Distribution Agreement

Milestone China had been Milestone Scientific’s exclusive distributor in China. During 2017 and prior to the payment default during 2018, Milestone Scientific agreed to sell inventory to Milestone China and its agent. During 2018, Milestone Scientific entered into a payment arrangement with Milestone China to satisfy past due receivables from Milestone China and its agents which amounted to $2.8 million at the time of the payment arrangement. Milestone Scientific collected $950,000 under this arrangement, until Milestone China defaulted on the payment arrangements.

15

For three months ended March 31, 2022, Milestone Scientific shipped handpieces to Solee for the sale to Anhui and recognized revenue of $370,000, of which approximately $270,000 at March 31, 2022 was included in account receivable related party. For the three months ended March  31,2021, Milestone Scientific shipped instruments and handpieces to Solee for the sale to Anhui and recognized revenue of $506,400. As of December 31, 2021, the Company has approximately $89,000 of deposits from Solee for future shipment of goods included in accrued expenses on the accompanying consolidated balance sheet. As of March 31, 2022, the Company had no deposits from Solee for future shipment of goods included in accrued expenses on the accompanying consolidated balance sheet.  

Beginning in mid- November 2021, Milestone Scientific entered into discussions with Michelle Zhang dba Solee Science & Technology USA (“Solee”), a company located in New Jersey, to become Milestone Scientific’s independent distributor for China, the former agent, for Milestone China and its subsidiaries. On November 22, 2021, Wand Dental, Inc., a United States subsidiary of Milestone Scientific, entered into a Buy and Sell Agreement with Solee, pursuant to which Milestone Scientific granted Solee the right to sell Milestone Scientific’s STA instruments, associated handpieces, and spare parts in China to Anhui. As of  March 31, 2022 and December 31, 2021, there have been no shipment under the new agreement to Solee.

Gross Profit Deferral

 

Due to timing differences of when the inventory sold to Milestone Scientific's historyChina, Anhui or their agent is recognized and when Milestone China and Anhui sells the acquired inventory to third parties, an elimination of operating losses, a full valuation allowancesthe recorded profit is required as of the balance sheet date. In accordance with ASC 323Investment Equity Method and Joint Ventures, Milestone Scientific has deferred its ownership percentage of the gross profit associated with recognized revenue from sales to Milestone China, Solee as an agent, and Anhui until that product is sold to third parties.

The Company deferred profits on sales to Anhui and Milestone China due to its equity investment in the Companies, pursuant to ASC 323.Investments Equity Method and Joint Ventures. Due to the Equity Transfer Agreement discussed above, the Company no longer has any equity interest and/or significant influence in Anhui via Milestone China and, as such, all previously deferred profit of $407,000 has been providedrecognized in the accompanying statement of operations at the date of the Equity Transfer Agreement.

At Mach 31,2022, and December 31, 2021 the deferred profit was approximately $0, which is included in deferred profit, related party in the unaudited condensed consolidated balance sheets. For the three months ended March 31, 2022, and 2021, Milestone Scientific recorded income from gross profit deferral of  approximately $0 and $1,301, respectively, in relation to gross profit previously deferred on product sold to Milestone China, Anhui, and Solee recorded as deferred profit and divesture-equity investment on the accompanying  unaudited condensed consolidated statement of operations. 

NOTE 7 — PATENTS

  

March 31, 2022

     
  

Cost

  

Accumulated Amortization

  

Net

 

Patents-foundation intellectual property

 $1,377,863  $(1,113,671) $264,192 

Total

 $1,377,863  $(1,113,671) $264,192 

  

December 31, 2021

     
  

Cost

  

Accumulated Amortization

  

Net

 

Patents-foundation intellectual property

 $1,377,863  $(1,100,244) $277,619 

Total

 $1,377,863  $(1,100,244) $277,619 

Patents are amortized utilizing the straight-line method over estimated useful lives ranging from 3 to 20 years. Amortization expense was approximately $13,000 and $11,000 for allthe three months ended March 31, 2022, and March 31, 2021, respectively. The annual amortization expense expected to be recorded for existing intangibles assets for the years 2022 through 2026 and thereafter, is approximately $40,000, $52,000, $34,000, $28,000 and $110,000.

16

NOTE 8 STOCKHOLDERS EQUITY

Warrants

The following table summarizes information about shares issuable under warrants outstanding as of March 31, 2022:

  

Warrant shares outstanding

  

Weighted Average exercise price

  

Weighted Average remaining life

  

Intrinsic value

 
                 

Outstanding at January 1, 2022

  4,268,221   2.18   1.50  $1,187,546 

Issued

  0   0   -   - 

Exercised

  0   0   -   - 

Outstanding and exercisable at March 31, 2022

  4,268,221   2.18   1.25  $580,142 

Shares to Be Issued

As of March 31, 2022, and 2021, there were 2,000,127 and 2,264,127 shares respectively, to be issued whose issuance has been deferred to the employees of Milestone Scientific's deferred tax assets At September 30, 2017 Scientific, Inc. respectively.  

As of March 31, 2022, and December2021, there were 174,364 and 144,024 shares, respectively, to be issued to non-employees,  that will be issued for services rendered. The number of shares was fixed at the date of grant and were fully vested upon grant date.

The following table summarizes information about shares to be issued on March 31, 2016, no recognition was given2022, and 2021, respectively.

  

March 31, 2022

  

March 31, 2021

 
         

Shares-to-be-issued, outstanding January 1, 2022 and 2021, respectively

  2,066,343   2,440,878 

Granted in current period

  108,148   33,238 

Issued in current period

  0   (65,965)

Shares-to be issued outstanding March 31, 2022 and 2021, respectively

  2,174,491   2,408,151 

Stock Options Plans

The Milestone Scientific Inc. 2020 Equity Compensation Plan, as amended and restated (the "2020 Plan"), provides for awards of restricted common, stock restricted stock units, options to purchase and other awards, up to a maximum 4,000,000 shares of common stock and expires in June 2031. Options may be granted to employees, directors, and consultants of Milestone Scientific for the purchase of shares of common stock at a price not less than the fair market value of common stock on the date of grant. In general, options become exercisable over a three-year period from the grant date and expire five years after the date of grant.

On April 8, 2021, as part of its Succession Plan going into effect on April 23, 2021, the Company announced that Leonard Osser, the Interim Chief Executive Officer, would be accepting the role of Vice Chairman of the Board of Directors. As part of accepting this role, he would be granted options to purchase 2,000,000 shares of common stock, exercisable at the fair market value of the common stock on the date of grant, vesting over the five-year period after he steps down as Interim Chief Executive Officer of the Company or ten years from the date of grant, whichever shall end first. The options were issued pursuant to the utilization2020 Plan.

Milestone Scientific recognizes compensation expense over the requisite service period. For three months ended March 31, 2022 and 2021, Milestone Scientific recognized $305,370, and $113,507 of total employee compensation cost, respectively, recorded in general and administrative expenses on the statement of operations.

As of March 31, 2022 and 2021, there was $3,140,335 and $914,389 of total unrecognized compensation cost related to non- vested options, respectively. Milestone Scientific expects to recognize these costs over a weighted average period of 3.25 and 2.70 for the three months ended of March 31, 2022 and 2021, respectively. 

17

A summary of option activity for employees under the plans and changes during the three months ended March 31, 2022 is presented below:        

  

Number of Options

  

Weighted Averaged Exercise Price $

  

Weighted Average Remaining Contractual Life (Years)

  

Aggregate Intrinsic Options Value $

 

Options outstanding January 1, 2022

  2,843,693   2.39   7.69   49,246 

Granted during 2022

  216,296   1.52   2.98   - 

Exercised during 2022

  0   0   -   - 

Forfeited or expired during 2022

  0   0   -   - 

Options outstanding March 31, 2022

  3,059,989   2.37   7.36   0 

Exercisable, March 31, 2022

  594,914   1.98   3.80   0 

The Company used the following assumptions to calculate the fair value of the remaining net operating loss carryforwards instock option grants using the Black-Scholes option pricing model on the measurement date during three months ended March 31, 2022, risk free interest rate of 2.45%, Volatility of 89.76% (which is based on the Company’s historical over the expected term), expected term 3 years, dividend rate 0% and closing price of the Company’s common stock was $1.52.

A summary of option activity for non-employees under the plans and changes during the three months ended March 31, 2022 presented below:        

  

Number of Options

  

Weighted Averaged Exercise Price $

  

Weighted Average Remaining Contractual Life (Years)

  

Aggregate Intrinsic Options Value $

 

Options outstanding January 1, 2022

  83,330   1.85   3.33   49,748 

Granted during 2022

  0   0   -   - 

Exercised during 2022

  0   0   -   - 

Options outstanding March 31, 2022

  83,330   1.85   3.08   22,585 

Exercisable, March 31, 2022

  63,883   1.68   2.85   22,582 

 For the three months ended March 31, 2022 and 2021, Milestone Scientific recognized approximately $4,978 and $10,329 expense related to non-employee options, respectively.

The information below summarizes the restricted stock award activity for year ended March 31, 2022.

  

Number of Shares

  

Weighted Average Grant-Date Fair Value per Award

 

Non-vested as January 1, 2022

  96,557   2.33 

Granted

  75,758   1.32 

Vested

  0     

Cancelled

  (41,499)    

Non-vested as March 31, 2022

  130,816   1.90 

As of March 31, 2022, there were 130,816 restricted shares granted and deferred under the terms of an employment agreements with the Territory Manager of Milestone Scientific. Such shares will be issued to each party upon completion of these periods.2 years of employment. For the three months ended March 31, 2022, the Company recognized stock compensation expense of approximately $22,000. As of March 31, 2022, the total unrecognized compensation expense was $169,792 related to unvested restricted stock awards, which the Company expects to recognize over an estimated weighted-average period of 1.46 years. 

18

NOTE 9 — INCOME TAXES

 

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

  

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 condensed consolidated financial statements.

NOTE10 SIGNIFICANT CONCENTRATIONS & GEOGRAPHICAL INFORMATION — SEGMENT AND GEOGRAPHIC DATA

 

Milestone Scientific’s consolidated dentalWe conduct our business through 2 reportable segments: Dental and Medical. These segments offer different products and services to different customer base. The Company provides general corporate services to its segments; however, these services are not considered when making operating decisions and assessing segment performance. These services are reported under “Corporate Services” below and these include costs associated with executive management, investor relations, patents, trademarks, licensing agreements, new instruments developments, financing activities and public company compliance.

The following tables present information about our reportable and operating segments:

  

Three months ended March 31,

 

Sales

        

Net Sales:

 

2022

  

2021

 

Dental

 $2,693,352  $2,853,657 

Medical

  7,550   71,050 

Total net sales

 $2,700,902  $2,924,707 

Operating Income (Loss):

 

2022

  

2021

 

Dental

 $354,240  $1,126,069 

Medical

  (1,236,091)  (895,781)

Corporate

  (1,032,632)  (1,214,661)

Total operating loss

 $(1,914,483) $(984,373)

Depreciation and Amortization:

 

2022

  

2021

 

Dental

 $893  $1,706 

Medical

  1,019   3,851 

Corporate

  14,902   15,367 

Total depreciation and amortization

 $16,814  $20,924 

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

 

2022

  

2021

 

Dental

 $352,797  $1,125,154 

Medical

  (1,237,540)  (897,051)

Corporate

  (1,034,482)  (1,215,011)

Total loss before taxes and equity in earnings of affiliate

 $(1,919,225) $(986,908)

Total Assets

 

March 31, 2022

  

December 31, 2021

 

Dental

 $5,750,344  $6,163,169 

Medical

  1,301,884   1,373,511 

Corporate

  12,012,948   12,273,064 

Total assets

 $19,065,176  $19,809,744 

19

The following table presents information about our operations by geographic area for three months ended March 31, 2022 and 2021.  Net sales by product and by geographical regiongeographic area are as follows:  Revenue frombased on the medical segment is not material asrespective locations of September 2017.our subsidiaries:

  

March 31, 2022

  

March 31, 2021

 

Domestic: US

 

Dental

  

Medical

  

Grand Total

  

Dental

  

Medical

  

Grand Total

 

Instruments

 $122,968  $0  $122,968  $176,016  $0  $176,016 

Handpieces

  795,859   7,550   803,409   794,984   8,150   803,134 

Accessories

  24,860   0   24,860   17,908   0   17,908 

Grand Total

 $943,687  $7,550  $951,237  $988,908  $8,150  $997,058 
                         

International: Rest of World

                        

Instruments

 $453,560  $0  $453,560  $383,255  $42,500  $425,755 

Handpieces

  923,952   0   923,952   954,534   20,400   974,934 

Accessories

  12,189   0   12,189   20,560   0   20,560 

Grand Total

 $1,389,701  $0  $1,389,701  $1,358,349  $62,900  $1,421,249 
                         

International: China

                        

Instruments

 $0  $0  $0  $150,000  $0  $150,000 

Handpieces

  359,964   0   359,964   356,400   0   356,400 

Accessories

  0   0   0   0   0   0 

Grand Total

 $359,964  $0  $359,964  $506,400  $0  $506,400 
                         

Total Product Sales

 $2,693,352  $7,550  $2,700,902  $2,853,657  $71,050  $2,924,707 

 

  

Three months Ended September 30,

 

Nine months Ended September 30,

  

2017

 

2016

 

2017

 

2016

DOMESTIC

                    

Instruments

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

Handpieces

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

Other

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

Total Domestic

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

INTERNATIONAL-Europe

                    

Instruments

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

Handpieces

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

Other

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

Total International -Europe

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

INTERNATIONAL-China

                    

Instruments

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

Handpieces

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

Other

  -    -    1,800    -  

Total International-China

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

Domestic

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

International -Europe

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

International -China

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

NOTE 11-- CONCENTRATIONS

 

Milestone Scientific has informal arrangements with a third party manufacturer-party U.S. manufacturers of the STA, CompuDent®CompuDent and CompuMed® instruments,CompuMed devices, pursuant to which they manufacture these products under specific purchase orders but without any long-term contract or minimum purchase commitment. In March 2016, Milestone 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 March 31, 2022 and December 31, 2016.2021.  The termination of the manufacturing relationship with any of these manufacturers could have a material adverse effect on Milestone Scientific’s ability to produce and sell its products. Although alternate sources of supply exist, and new manufacturing relationships could be established, Milestone Scientific would need to recover its existing tools or have new tools produced. Establishment of new manufacturing relationships could involve significant expense and delay. Any curtailment or interruption of the supply, because of termination of such a relationship, would have a material adverse effect on Milestone Scientific’s financial condition, business, and results of operations.  

 

For the three months ended September 30, 2017 , March 31, 2022, an aggregate of approximately 67%13%, 13%, and 31% of Milestone Scientific'sthe Company’s net product sales were to two customers/from three distributors, (one of which, Milestone China, is  a related party), 54%, and 13%, respectively. For the ninethree months ended September 30, 2017, March 31, 2021, an aggregate of approximately 72%29% of Milestone Scientific'sthe Company’s net product sales were to two customers/distributors (one of which, Milestone China, is a related party), 53%, and 19%,from one domestic distributor, 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 nineAdditionally, three months ended September 30, 2017. ForMarch 31, 2021 approximately 18% of the three months ended September 30, 2016, an aggregate of 61% of Milestone Scientific'sCompany’s net product sales wereare 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.China.

 

For the three months ended March 31, 2022, we had the four distributors that accounted for 12%, 18%, 20,% and 21% amount of accounts receivable, respectively.  As of December 31, 2021 we had three distributors that accounted for 13%, 28%, and 29% amount of accounts receivable, respectively.

NOTE – 11 Employment and Consulting Agreements12-- RELATED PARTY TRANSACTIONS

 

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 PARTIESUnited Systems

 

Milestone Scientific has a manufacturing agreement with United Systems (a(whose controlling shareholder, Tom Cheng, is a significant stockholder of Milestone)Milestone Scientific), the principal manufacturers of its handpieces, pursuant to which it manufactures products under specific purchase orders, but without minimum purchase commitments. Purchases from this manufacturer were $721,225approximately $1.2 million and $1,690,582$385,000 for the three and nine months ended September 30, 2017,March 31, 2022 and 2021, respectively. PurchasesAs of handpieces from this manufacturer were $967,003March  31,2022 and $2,088,229 for the three and nine months ended September 30, 2016, respectively. December 31, 2021, Milestone Scientific owed $902,341 and $984,286 to this manufacturer as of September 30, 2017approximately $1.1 million, 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,$548,000, respectively, to Milestone Scientific which is included in accounts payable, related party accounts receivableand accrued expense, related party on the unaudited condensed consolidated balance sheets. 

20

Milestone China

See Note 6 of the notes to the unaudited condensed consolidated financial statements.
 
Other

 

In August 2016, K. Tucker Andersen, a significant stockholder of Milestone Scientific, entered into a three-yearthree-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,March 31, 2022, and 2021, respectively.

In August 2016, K. Tucker Andersen, a significant stockholder of Milestone Scientific, entered into a three-year agreement with Milestone Scientific to provide financial and business strategic services. Expenses recognized on this agreement were $25,000 and $75,000 for each of the three and nine months ended September 30, 2016, respectively.March 31, 2022 and 2021.

 

In January 2017, Milestone Scientific entered intoThe Company engaged Mr. Trombetta as a 12 month agreement with Innovest S.p.A. consultant for a period of twelve months (beginning October 1, 2020, and ending September 30, 2021), to provide international business dental information and business contacts to the Company and provide consulting services (see Note 13).for new international business and dental segments. For the three months ended March 31, 2022 and 2021, the Company expensed $0 and $15,000, respectively, for services rendered by Mr. Trombetta. Mr. Trombetta received shares of the Company’s common stock. This agreement was terminated September 30, 2021. 

 

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 AffairsAffairs’ royalty fee was $122,606approximately $133,000 and $446,098$136,000 for the three and nine months ended September 30, 2017, respectively. The Director of Clinical Affairs’ royalty fee was $148,185 March 31, 2022 and $449,875 for the three and nine months ended September 30, 2016,2021, respectively. Additionally, Milestone Scientific expensed consulting fees to the Director of Clinical Affairs of  $68,751 and $206,253$39,000 for the three and nine months ended September 30, 2017, March 31, 2022 and 20162021, respectively. As of  March 31, 2022 and December 31, 2021, Milestone Scientific owed the Director Clinical Affairs for royalties of approximately $133,000 and $123,000, respectively, which is included in accounts payable, related party and accrued expense, related party, in the condensed consolidated balance sheet.

 

In January 2017, On March 2, 2021, Milestone Scientific entered into a 12 month agreementRoyalty Sharing Agreement with Innovest S.p.A.Leonard Osser, the Company’s then Interim Chief Executive Officer, pursuant to provide consulting services. This agreement will renewwhich Mr. Osser sold, transferred and assigned to the Company all of his rights in and to a certain patent application as to which he is a co-inventor with Dr. Hochman, and the Company agreed to pay to Mr. Osser, beginning May 9, 2027, half of the royalty (2.5%) on net sales that would otherwise be payable to Dr. Hochman and his wife under their Technology Sale Agreement with the Company, the Hochman's having agreed with the Company pursuant to an addendum to such Technology Sale Agreement dated February 25, 2021 to reduce from 5% to 2.5% the payments due to them on May 9, 2027 and thereafter, with respect to dental products.

Pursuant to a Succession Agreement dated April 6, 2021 between Mr. Osser and the Company: (i) the Employment Agreement dated as of July 10, 2017 between Mr. Osser and the Company, pursuant to which upon Mr. Osser stepping down as Interim Chief Executive Officer of the Company, the Company agreed to employ him as Managing Director, China Operations of the Company (the “China Operations Agreement”), and (ii) the Consulting Agreement dated as of July 10, 2017 (the “Consulting Agreement”) between the Company and U.S. Asian Consulting Group, LLC, a company of which Mr. Osser is a principal, the compensation under the China Operations Agreement was modified to reduce the overall compensation by $100,000 to $200,000, split equally between a cash amount and an amount in shares, and the compensation under the Consulting Agreement is increased by $100,000 to $200,000, equally split between a cash amount and an amount in shares, which shares were formerly payable under the China Operations Agreement.  Compensation under the China Operations Agreement and the Consulting Agreement are payable for successive 12 month terms unless terminated by Innovest S.p.A9.5 years from May 19, 2021.

The Company recorded expense of $50,000 and $0 related to the Managing Director, China Operations for three months ended March 31, 2022 and 2021, respectively. The Company recorded expense of $50,000 and $0 related to the US Asian Consulting Group, LLC for three months ended March 31, 2022 and 2021, respectively.   

NOTE 13 — COMMITMENTS

(1) Contract Manufacturing Agreement

Milestone Scientific has informal arrangements with third-party manufacturers of the STA, CompuDent® and CompuMed® devices, pursuant to which they manufacture these products under specific purchase orders but without any long-term contract or Milestone Scientific. Expenses recognized on this agreement were $20,000 and $60,000minimum purchase commitment. The Company entered a new purchase commitment for the threedelivery of 3,300 STA CompuDent® instruments. As of March 31, 2022, the purchase order commitment was approximately $2.5 million and nine months ended September 30, 2017, respectively.advances of approximately $1.1 million are reported in advances on contracts in the consolidated balance sheet. As of December 31, 2021, the purchase order commitment was approximately $2.6 million and advances of approximately $1.3 million are reported in advances on contracts in the consolidated balance sheet.

 

21

On October 2, 2017, Milestone Scientific accepted As of March 31, 2022 and December 31, 2021 the resignationcompany also has advances on an open purchase order for long lead items for a future purchase order for the manufacturing of Epidural instrument of approximately $34,000, respectively. The balance 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,advances as of March 31, 2022, and December 31, 2021 is approximately $1.2 million and $1.3 million respectively. The advance is classified as current based on the circumstances he asserted with respectestimated annual usage of the underlying inventory.

(2)Leases

Operating Leases

In August 2019, the Company made the decision to his resignation after acceptancenot renew its existing office lease for its corporate headquarters located in Livingston, New Jersey and instead signed a new seven (7) year lease in a new facility located in Roseland, New Jersey (the “Roseland Facility”), which commenced of such resignation, to his basic salary ($300,000) for oneJanuary 8, 2020. Under the Roseland Facility lease, rent payments commence on April 1, 2020, and the monthly lease payments escalate annually on January 1 of each year, and range from $9,275 to $10,898 per month over the lease term. The Company is also required to pay a fixed electric charge equal to $2.00 per square foot which is  paid in equal monthly installments over the lease term or $11,130 annually. These fixed monthly payments have been included in the measurement of the operating lease liability and related operating lease right-of-use asset as the Company has elected the practical expedient to not separate lease and non-lease components for all leases. The Company is also required to pay its proportionate share of certain other benefits (healthoperating costs 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 entitledproperty taxes applicable 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, exercisableleased premises more than new base year amounts, which are accounted 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.as variable lease expenses. 

 

NOTE 14- Subsequent Events

On October 5, 2017, Milestone Scientific announced that Daniel Goldberger had resignedAs of March 31, 2022, total operating lease and finance right-of-use assets were $528,907 and total operating lease and finance liabilities were $538,441, of which $83,585 and $454,857 were classified as Presidentcurrent and Chief Executive Officer effective October 2, 2017.non-current, respectively. As of March 31, 2022, total finance lease liabilities were $26,544 of which $8,743 and $17,801 were classified as current and non-current, respectively. As of December 31, 2021, total operating lease and finance right-of-use assets were $550,511 and total operating lease and finance liabilities were $577,981, of which $81,001 and $476,980 were classified as current and non-current, respectively. As of December 31, 2021, total finance lease liabilities were $28,607, of which $8,545 and $20,062 were classified as current and non-current, respectively. 

 

The components of lease expense were as follows:

  

Three Months ended

March 31, 2022

  

Three Months ended

March 31, 2021

 

Cash paid for operating lease liabilities

  31,882   31,303 

Cash paid for finance lease liabilities

  2,685   2,685 

Right-of-use assets obtained in exchange for new operating lease liabilities (1)

  663,009   0 

Property and equipment obtained in exchange for new finance lease liabilities

  43,242   0 
         

Weighted Average Remaining Lease Term

        

Finance leases (years)

 

2.8 years

   3.8 

Operating leases (years)

 

5 years

   6 

(3Other Commitments

On October 5, 2017, March 2, 2021, Milestone Scientific also announced the appointment of Leslie Bernhard, the Company’s current Chairman of the Board, asentered into a Royalty Sharing Agreement with Leonard Osser, the Company’s Interim Chief Executive Officer, pursuant to servewhich Mr. Osser sold, transferred and assigned to the Company all of his rights in and to a certain patent application as to which he is a co-inventor with Mr. Hochman, and the Company agreed to pay to Mr. Osser, beginning May 9, 2027, half of the royalty (2.5%) on net sales that would otherwise be payable to Mr. Hochman and his wife under the Technology Sale Agreement referred to above, the Hochman's having agreed with the Company pursuant to an addendum to such role untilTechnology Sale Agreement dated February 25, 2021 to reduce from 5% to 2.5% the appointment of a new Chief Executive Officer.payments due to them on May 9, 2027 and thereafter, with respect to dental products.

22

NOTE14 SUBSEQUENT EVENTS

 

In connectionSubsequent to March 31, 2022, due to information identified during the Corrective Action Preventative Action (CAPA) investigation of the Epidural Disposable Kit, Part # 6100-01, lot HC 51 the scope of the voluntary market withdrawal needed to be expanded to include Part # 6100-03, lot HC 50. A new non-conformance was initiated and Lot HC 50 was added to the scope of the CAPA initiated above. The investigation via the CAPA identified that there is an issue with her appointmentthe id adaptors used in both lots HC 51 and HC 50. However, the health hazard evaluation shows that there is no risk to serve as the Company’s Interim Chief Executive Officer, Ms. Bernhardpatient or the user, thus management has determined there are no potential impacts to patients or users. Lots HC 51 and HC 50 are worth approximately $22,000 and $10,000 respectively. Management has not yet determined what the final disposition of the affected inventory will be paid an annual salary of $200,000 and receive a one-time bonus of 100,000 sharesafter the market withdrawal is completed.

Subsequent to March 31, 2022, the Company was notified that some of the Company’s Common Stock. In addition, atWand STA handpieces, reference # STA—5050-2725, lot B210113 were packaged incorrectly. The Company initiated a Corrective Action Preventative Action (CAPA) investigation to determine the completionroot cause and implement corrective actions. The Health Hazard Evaluation (HHE) was completed and showed that there is no risk to the patient or the user due to this discrepancy, thus management has determined there are no potential impacts to patients or users. However, to provide the highest quality products to the market, Milestone Scientific decided to initiate a voluntary market withdrawal on May 13, 2022. Lot B210113 is worth approximately $25,000. Management has not yet determined what the final disposition of her service as Interim Chief Executive Officer, Ms. Bernhard shallthe affected inventory will be entitled to receive a cash bonus in an amount to be determined byafter the Board of Directors at that time.market withdrawal is completed.

 

 


23

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

 

The following discussions of ourthe financial condition and results of operations should be read in conjunction with the financial statements and the notes to those statements included elsewherecontained in this report and in connection with management's discussion and analysis and the audited consolidated financial statements and notes thereto included in our Annual Report on Form 10-Q.10-K for the year ended December 31, 2021, which was filed with the Securities and Exchange Commission, or SEC on March 31, 2022. Certain statements in this discussion and elsewhereelsewhere in this report constitute forward-looking statements, within the meaning of section 21E of the Securities Exchange Act, of 1934, as amended (the “Exchange Act”), that involve risks and uncertainties. OurThe actual results may differ materially from those anticipated in these forward-looking statements.

 

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 and cosmetic use. Since our inception, we have engaged in pioneering proprietary, innovative, computer-controlled injection technologies, and solutions for the medical and dental markets. We believe our technologies are proven and well established. Our common stock was initially listed on the NYSE MKTAmerican on June 1, 2015 and trades under the symbol “MLSS”.

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 devices make injections precise, efficient, and virtually painless.

Milestone Scientific has developed a proprietary, computer-controlled anesthetic delivery instrument, through the use of device, using The Wand®, a single use disposable handpiece. The instrumentdevice is marketed in dentistry under the trademark CompuDent®CompuDent®, and STA Single Tooth Anesthesia System®System® and in medicine under the trademark CompuMed®. CompuDent® is suitable for all dental procedures that require local anesthetic. Our proprietary CompuMed®DPS Dynamic Pressure Sensing technology® is suitable for many medical procedures regularly performed in plastic surgery, hair restoration surgery, podiatry, colorectal surgery, dermatology, orthopedicsour technology platform that advances the development of next-generation devices. It regulates flow rate and a number of other disciplines. The dental instruments are sold inmonitoring pressure from 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 astip of the reporting date. Certain of ourneedle, through platform extensions for local anesthesia for subcutaneous drug delivery, used in various dental and medical instruments have obtained European CE mark approvalinjections. It has specific medical applications for cosmetic botulinum toxin injections, epidural space identification in regional anesthesia procedures 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. intra-articular joint injections.

 

In 2017, we remainedMilestone Scientific remains focused on advancing efforts to achieve our fourthe following three primary objectives; those being: 

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

 

Identify distributorsEstablishing Milestone’s DPS Dynamic Pressure Sensing technology platform as the standard-of-care in the United Statespainless and precise drug delivery, providing for the Epidural instruments, now that FDA clearance has been received;first time, objective visual and audible in-tissue pressure feedback, and continuing to expand platform applications;

 

EnhancingFollowing obtaining successful FDA clearance of our first medical device, Milestone Scientific is transitioning from a research and development organization to a commercially focused medical device company; and

Expanding our global reachfootprint of our CompuFlo Epidural and CathCheck System by utilizing a direct field sales force and 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).worldwide.

 

Because of combining the ability to regulate the flow rate and monitor pressure at the tip of the needle, Milestone Scientific developed the industry’s first solution for painlessly administering an intra-ligamentary injection, i.e., “single-tooth anesthesia” which could be used as the only injection necessary for achieving dental anesthesia, foregoing the need to administer traditional injections such as a nerve branch block. In addition to single-tooth anesthesia,the STA Instrument GrowthSystem can effectively perform all the traditional injections that dentists routinely give but can provide them virtually pain free and with numerous clinical advantages. This device, which also utilizes a disposable handpiece, is currently marketed by Milestone Scientific as the WandSTA® System. 

Milestone Scientific believes its dental devices have set a new standard of care for dental injections. Our dental devices have been used to administer tens of millions of injections worldwide. Each of our devices has a related single use disposable handpiece, leading to a continuing revenue stream following sale of the device. At present, we sell disposable handpieces unique to our legacy product (the Wand and CompuDent) to users who have not upgraded to our current dental product, the WandSTA System. 

Building on the success of our proprietary, core technology platform for dental injections, and desiring to pursue other growth opportunities, we have recently begun to expand the uses and applications of our proprietary, patented technologies to achieve greater operational efficiencies, enhanced patient safety and therapeutic adherence, patient satisfaction, and improved quality of care across a broad range of medical specialties. In June 2017, we received FDA regulatory clearance to sell the CompuFlo Epidural Computer Controlled Anesthesia System in the United States for certain medical applications. We intend to continue to expand the uses and applications of our DPS Dynamic Pressure Sensing technology.

24

We believe that we and our technology solutions are widely recognized by key opinion leaders (i.e., academics, anesthesiologists and practicing dentists whose opinions are widely respected), industry experts and medical and dental practitioners as a leader in the emerging, computer-controlled injection industry.

Wand STA Dental Market

 

Since its market introduction in early 2007, the WandSTA InstrumentSystem and prior C-CLAD productsdevices have been used to deliver over 66 80 million safe, effective, and comfortable injections. The instrument has also been favorably evaluated in numerous peer-reviewed, published clinical studies and associated articles. Moreover, there appears to be a growing consensus among users that the STA Instrument is proving to be a valuable and beneficial instrument that is positively impacting the practice of dentistry worldwide.

Global Distribution Network

United States and Canadian Market

 

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

To date, Henry Schein has endeavored to accomplish the goals set forth inIn December 2020, 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.

arrangement with 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, togetherwas replaced with a select group of other devicesnon-exclusive distribution arrangement, for distribution in the United States and Canada. Our agreement

In January 2021, the Company began a process of signing non-exclusive dental distribution arrangements with Henry Schein has minimum purchase order requirements to maintain exclusivitydental distributors in specific geographical locations in the third through tenth yearUnited States and Canada. To date there are twelve new non-exclusive dental distributors engaged in the United States and Canada. The goal is to add not only additional non-exclusive distributors in the United States, but as well as exploring  other co-operation opportunities with Dental Service Organization, education institutions, dental schools and entities in specific dental market segments. To date there are two of such channel partners in the term of the agreement. United States.

 

International MarketThe goal of changing our marketing plan from a sole exclusive distributor in the USA and Canada, to a  large number of non-exclusive distributors is to increase placement of our Wand STA  System and thus the expansion of our dental disposables.

 

On the global front, we have granted exclusive marketing and distribution rights for the Wand STA InstrumentSystem  to select dental suppliers in various international regions in Asia, Africa, South America, and Europe. They include Istrodent (Pty) Ltd.FM Produkty Dla Stomatologii in South AfricaPoland and Unident AB in the Scandinavian countries of Denmark, Sweden, Norway, and Iceland. Additionally, the Company is in the process of evaluating current international distributors and adding new distributors, globally as required based on the economics of the region.

 

In October 2012,The Ukrainian-Russian conflict, sanctions imposed by the StateUnited States and other western democracies, and any expansion is likely to have unpredictable and wide-ranging effects on the domestic and global economy and financial markets, which could have an adverse effect on our business and results of operations. Already the conflict has caused market volatility, a sharp increase in certain commodity prices, such as wheat and oil, and an increasing number and frequency of cybersecurity threats. So far, we have experienced a decrease in international sales from Ukraine and halted all sales to Russia, a direct impact from the conflict. We will continue to monitor the situation carefully and, if necessary, take action to protect our business, operations and financial condition.  

Medical Market

During 2016, Milestone Scientific filed for 510(k) marketing clearance with the U.S. Food and Drug Administration (CFDA)(FDA) for both intra-articular and epidural injections with the CompuFlo Epidural System.  In June 2017, the FDA approved the CompuFlo Epidural System for epidural injections. During the end of the People’s Republicsecond quarter 2021, Milestone Scientific invested in sales force expansion, thus building up a stronger direct sales force aiming at increasing the adoption and penetration of China approved our STA Single Tooth Anesthesia System® (STA System). In May 2014,its technology. At the CFDA also approvedbeginning of the STA handpiecesyear Milestone Scientific had three sales managers  and by July 31, 2021 had established a direct sales force consisting of eleven full time employees covering the US North and Southeast regions along with California. Milestone Scientific continues to partner with distributors for sale in China.the international markets

 

In September 2014, Milestone MedicalDecember 2016, we received CE clearancenotification from the FDA that based upon the 510(k)-application submitted for intra-articular injections, we did not adequately document that the device met the equivalency standard required for 510(k) clearances. Following consultation with the FDA Office of Device Evaluation, we intended to distribute their epidural and intra-articular instruments in the European Community (EU). Milestone Medical signedfile a distribution agreement in March 2015 with a medical distributor in Polandnew 510(k) application for the distribution of the epidural instrument. This distribution agreement was terminateddevice in late 20162019. However, due to the distributor’s inadequate performance under the distribution agreement. Milestone Medical is continuingfinancing constraints, a new 510(k) application was not filed in 2019. The Company has decided not to pursue distributorsproceed with securing FDA approval for the intra-articular instrument inat the EU community.present time.

 

In June 2014,April 2020, Milestone Scientific, invested $1 millionannounced that it has validated and integrated the new CathCheck™ feature into the CompuFlo® Epidural System. Using CathCheck, physicians and nurses can now monitor the placement of a catheter to determine the presence or absence of a pulsatile waveform (heartbeat), providing new information that can be used to determine if the catheter is in Milestone China Ltd. (“Milestone China”)place or has become dislodged from the epidural space. This can be performed within seconds by contributing 772 STA Instruments to Milestone China for a 40% ownership interest. Milestone Scientific recorded this investment undermeasuring 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.pulsatile waveform within the epidural space.

 

In June 2017, Milestone Scientific entered intoMarch 2022, the Company was notified by a territory manager, that Epidural Disposable Kit, Part # 6100-01, lot HC 51 potentially had an agreementissue. The Company opened an investigation and decided to initiate a voluntary market withdrawal for the sale of its interest in Milestone China (a forty (40%) percent interest) (the “Milestone China Shares”)Epidural Disposable Kit, Part # 6100-01, lot HC 51. Management has determined that there are no potential impacts 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 allpatients or substantially all of its assets prior to repayment of the note. The 10-year option agreement provides Milestone Scientific an option to repurchase the Milestone China Shares at $1,400,000 within the first two years and at fair market value (as defined in such agreement) for the remainder of the 10-year term. The transaction has been accounted for as a secured 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.

The sale of the Milestone China Shares allows Milestone Scientific to continue to expand in the China market by supplying Milestone China with the STA Single Tooth Anesthesia System® and related hand pieces, while eliminating the burden on Milestone Scientific's management as a 40% minority owner.  Milestone Scientific believes that the sale will provide Milestone China with a new partner that may accelerate its penetration of the China market.

users.

 


25

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%
  

March 31, 2022

  

March 31, 2021

 

Domestic: US

 

Dental

  

Medical

  

Grand Total

  

Dental

  

Medical

  

Grand Total

 

Instruments

 $122,968  $-  $122,968  $176,016  $-  $176,016 

Handpieces

  795,859   7,550   803,409   794,984   8,150   803,134 

Accessories

  24,860   -   24,860   17,908       17,908 

Grand Total

 $943,687  $7,550  $951,237  $988,908  $8,150  $997,058 
                         

International: Rest of World

                        

Instruments

 $453,560  $-  $453,560  $383,255  $42,500  $425,755 

Handpieces

  923,952   -   923,952   954,534   20,400   974,934 

Accessories

  12,189   -   12,189   20,560       20,560 

Grand Total

 $1,389,701  $-  $1,389,701  $1,358,349  $62,900  $1,421,249 
                         

International: China

                        

Instruments

 $-  $-  $-  $150,000  $-  $150,000 

Handpieces

  359,964   -   359,964   356,400   -   356,400 

Accessories

  -   -   -   -   -   - 

Grand Total

 $359,964  $-  $359,964  $506,400  $-  $506,400 
                         

Total Product Sales

 $2,693,352  $7,550  $2,700,902  $2,853,657  $71,050  $2,924,707 

 

Milestone Scientific plans to support increased salesCurrent Product Platform

See Note 1, “Organization and marketing activity through our current distributors and through newly appointed distributors of the STA instruments and handpieces in the international market. In the United States and Canada, Milestone Scientific will continue the utilization of independent hygienists for training individual practitioners and group practices domestically, refined and directed advertising to dental professionals, continue to develop Key Opinion Leaders (KOL) and support and broaden our global distribution network. Additionally with the recent FDA marketing clearance for the epidural instrument, Milestone Scientific is initiating marketing and sales efforts in the US to establish medical sector distributors for the sale of this instrumentBusiness”.


Results of Operations

 

The following table sets forth for the consolidated results of operations for the three and nine months ended September 30, 2017, respectively, as a percentage of revenues.March 31, 2022 and 2021, respectively. 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)%

         
  

March 31, 2022

  

March 31, 2021

 

Operating results:

        

Product sales, net

 $2,700,902  $2,924,707 

Cost of products sold

  1,018,476   1,122,413 

Gross profit

  1,682,426   1,802,294 
         

Operating expenses:

        

Selling, general and administrative expenses

  3,115,629   2,749,299 

Research and development expenses

  464,466   16,444 

Depreciation and amortization expense

  16,814   20,924 

Total operating expenses

  3,596,909   2,786,667 

Loss from operations

  (1,914,483)  (984,373)

Other income, and interest expense net

  (4,742)  (1,484)

Net loss

  (1,919,225)  (985,857)

Net loss attributable to noncontrolling interests

  (17,502)  (12,988)

Net loss attributable to Milestone Scientific Inc.

  (1,901,723)  (972,869)

26

Cash flow:

 

March 31, 2022

  

March 31, 2021

 

Net cash used in operating activities

 $(1,507,508) $(967,814)

Net cash used in investing activities

  -   (5,916)

Net cash (used in) provided by financing activities

  (2,063)  3,700,523 

 

Milestone Scientific earned gross profit of approximately $1.8 million and $5.7 million in the three and nineThree months ended September 30, 2017. Milestone Scientific earned gross profit of approximately $1.7 million and $5.3 million in theMarch 31, 2022 compared three and nine monthsmonths 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, 2021

 

The Three Months Ended September 30, 2017 compared to the Three Months Ended September 30, 2016Net sales for 2022and 2021were as follows:

 

  

2022

  

2021

  

Change

 

Dental

 $2,693,352  $2,853,657  $(160,305)

Medical

  7,550   71,050  $(63,500)

Total sales, net

 $2,700,902  $2,924,707  $(223,805)

Total revenues

Consolidated revenue for the three months ended, September 30, 2017March 31, 2022, and 20162021 were approximately $2.7 million  and $2.9 million, and $3.2 million, respectively. Total revenues Dental revenue 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 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$160,000 for the three months ending March 31, 2022 as compared to the three months ended September 30, 2017 was 63%, which increased from 52%March 31, 2021. Medical revenue decreased approximately $63,000 for the three months ended September 30, 2016.ending March 31, 2022 as compared to the three months ending March 31, 2021. The increasepandemic had a significant impact on the labor and delivery departments within hospitals, much more so than other departments. This was due to the fact that many pregnant women have opted out of the vaccine, resulting in stricter restrictions than other departments.  As a result, our sales team was unable to enter the operatories, which limited our ability to demo and trial the instruments and thus influenced the obtained sales results of the three months ending March 2022.

Gross Profit for 2022and 2021 were as follows:

  

2022

  

2021

  

Change

 

Dental

 $1,677,661  $1,759,682  $(82,021)

Medical

  4,765   42,612  $(37,847)

Total gross profit

 $1,682,426  $1,802,294  $(119,868)

Consolidated gross profit relates tofor each of the increase in US sales in 2017 which isthree months ended March 31, 2022 and 2021 was offset by special pricing in China to facilitate an increase in market share.approximately 62%.  

 

Selling, general and administrative expenses 2022and 2021 were as follows:

  

2022

  

2021

  

Change

 

Dental

 $866,012  $631,882  $234,130 

Medical

  1,231,886   918,098   313,788 

Corporate

  

1,017,731

   1,199,319   (181,588)

Total selling, general and administrative expenses

 $3,115,629  $2,749,299  $366,330 

Consolidated selling, general and administrative expenses for the  three months ended September 30, 2017March 31, 2022 and 20162021, were approximately $3.2$3.1 million, versus $2.9and $2.7 million respectively.respectively. The increase of approximately $272,000 predominantly due$366,000 is categorized in several areas. Employee salaries, and benefits expenses increased approximately $312,000 during the three months ended March 31, 2022, as the Company hired additional employees to work on the additionalcommercialization of the CompuFlo® Epidural System. During the three months ended March 31, 2022, employee travel and other selling, general and administrative expenses is resulting fromincreased approximately $145,000 due to the completionre-opening of dental, and medical offices throughout the country, and the rest of the clinical studies relating to Milestone Medical's epidural instruments in 2016world. The Company's marketing, professional fees, and Milestone Scientific initiating marketing and sales efforts in the U.S. to establish the medical sector. warehousing expenses decreased approximately $91,000 for three months ended March 31, 2022.

 

Research and Developmentfor 2022and 2021 were as follows:

  

2022

  

2021

  

Change

 

Dental

 $456,516  $-  $456,516 

Medical

  7,950   16,444   (8,494)

Corporate

  -   -   - 

Total research and development

 $464,466  $16,444  $448,022 

27

Consolidated research and development expenses for the three months ended, September 30, 2017March 31, 2022 and 20162021, were approximately $17,000 verse $303,000,$464,000 and $16,000, respectively. The decreaseincrease of approximately $286,000approximately $448,000 is predominantly duerelated to the completion ofCompany exploring possible enhancements to the clinical studies relating to Milestone Medical's epidural instruments in 2016.STA Single Tooth Anesthesia System product line .

Profit (Loss) from Operationsfor 2022and 2021were as follows:

  

2022

  

2021

  

Change

 

Dental

 $354,240  $1,126,069  $(771,829)

Medical

  (1,236,091)  (895,781)  (340,310)

Corporate

  (1,032,632)  (1,214,661)  182,029 

Total loss from operations

 $(1,914,483) $(984,373) $(930,110)

 

The loss from operations was approximately $1.9 million and $1 million for the three months ended September 30, 2017ending March 31, 2022 and 2016 was approximately $1.4 million,  verse $1.6 million respectively, a decrease of approximately $155,000. This decrease2021, respectively. The increase is primarily attributable to the completion of the clinical studies relating to Milestone Medical's epidural 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 salesdecrease in revenue and gross profit, the United States domestic sales by approximately $1.7 million in 2017 to 2016. International sales in 2017 decreased by approximately $1.6 million over the same period in 2016Company incurred additional freight cost due to a reduction in shipments to Milestoneimporting delays from China. The reductions in shipments to Milestone China is due to Milestone China working through inventory purchases from late 2016. However, we believe that the June 2016 exclusive distribution agreement with Henry Schein will continue to increase domestic sales in 2017 as the product and, sales force training has been substantially completed as of September 30, 2017.

Gross margin for the nine months ended September 30, 2017 was 63%, which increased from 59% for the nine months ended September 30, 2016.  The increase in gross profit relates to the increase in US sales in which was offset by special pricing in China to facilitate an  increase in market share.

Selling,selling, general and administrative expenses for the nine months ended September 30, 2017 and 2016 were approximately $9 million versus $9.2 million, respectively. The decrease of approximately $230,000 is predominantly due to the reduction in expenses resulting from the completion of the clinical studies relating to Milestone Medical's epidural and intra articular instruments in 2016.

Research and development expenses for the nine months ended September 30, 2017 and 2016 were approximately $242,000 and $756,000, respectively. The decrease is due to reduction in development cost associated with epidural and intra articular instruments.

The loss from operations for the nine months ended September 30, 2017 and 2016 was approximately $3.5million and $4.7 million, respectively, a decrease of approximately $1.2 million. This decrease is primarily attributable to the completion of the clinical studies and reduced research and development expenses relating to our epidural and intra articular instruments in 2017 and gross profit.as discussed above.  

 

Liquidity and Capital Resources

 

At September 30, 2017,On March 31, 2022, Milestone Scientific had cash and cash equivalents of approximately $2.3 million, total current assets of approximately $11.6$13.3 million and working capital of approximately $6.5 million. We believe that our cash$14.4 million versus working capital of $15.8 million on hand, accounts receivable 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.December 31, 2021. For the ninethree months ended September 30, 2017March 31, 2022 and 2016, our net2021, we had cash flows used in operating activities wasof approximately $1.6$1.5 million and $4.1$1 million, respectively, which represents a decrease of approximately $2.5 million year over year.respectively. We believe our current cash on hand is sufficient to fund operations through 12 months from filing the unaudited condensed consolidated financial statements.

 


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 Scientific with working capital to continue to develop its medical instruments and obtain regulatory approval for one of its medical instruments (the June 2017 FDA approval of the epidural instrument), as well as to aggressively market its dental instruments. 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 devices and a reductionsdisposables business in operating expenses. Management believesthe United States and worldwide, as well as considering other strategic plans or transactions. 

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

Milestone Scientific believes that theCompuFlo Epidural System has obtained FDA clearance of its 510(k) application with respectin the United States (June 2017), the development costs were reduced in 2020, but the selling costs are expected to continue to increase. The FDA clearance has provided the CompuFlo® Epidural Computer Controlled Anesthesia will provide Milestone Scientific Company with the opportunity to enter the US medical device market and generate revenuesestablish distribution in the future. Milestone Scientific believes that it has sufficient inventory of the epidural instruments to satisfy the near term marketing opportunities.U.S. 

 

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

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

Subsequent Events

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

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

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

Item 3. Quantitative and Qualitative Disclosures about Market Risk

 

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

 

Item 4. Controls and Procedures

 

Milestone Scientific’s InterimScientific’s Chief Executive Officer and Chief Financial Officer havehas 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 havehas concluded that theour disclosure controls and procedures were not effective as of September 30, 2017 are effectiveMarch 31, 2022 due to ensure that information required to bea previously disclosed material weakness 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 were no changes in Milestone Scientific’sour internal control over financial reporting, identifiedas described in connection withour Annual Report on Form 10-K for the evaluation that occurred during Milestone Scientific’s last fiscal year ended December 31, 2021.

During the quarter ended September 30, 2017 that have materially affected, or that are reasonably likely to materially affect, March 31, 2022, the Company was in the process of remediating the identified material weakness.

PART II OTHER INFORMATION

Item1. Legal Proceedings

Milestone Scientific’s internal controls over financial reporting.  Scientific is not involved in any material litigation.

 


PART II – OTHER INFORMATION

ITEM 1.        LEGAL PROCEEDINGS

None.

Item 1A. Risk Factors

 

ITEM 1A.    RISK FACTORSThe COVID-19 pandemic has and may continue to adversely affect the Companys business. Additional factors could exacerbate such negative consequences and/or cause other materially adverse effects.

 

The COVID-19 pandemic did materially adversely affect the Company’s financial results and business operations in the Company’s three months ended March 31, 2022, while economic and health conditions in the United States and across most of the globe have continued to change rapidly due to the Omicron variant since the end of 2021. In the short-term, demand for the Company’s dental products is showing an increase in sell through activity to dental offices. However the change in demand may or may not continue and/or demand may or may not increase from historical levels depending on the duration and severity of the COVID-19 pandemic, the effectiveness of the ongoing vaccination process, the length of time it takes for normal economic and operating conditions to resume, additional governmental actions that may be taken and/or extensions of time for restrictions that have been imposed to date, and numerous other uncertainties. Such events may result in business and manufacturing disruption, inventory shortages, delivery delays, and reduced sales and operations, any of which could materially affect our business, financial condition, and results of operations.

The ability of the Companys employees to work may be significantly impacted by the Coronavirus.

The Company’s employees are being affected by the COVID-19 pandemic. From time to time, we have had employees working in the office, depending the local positivity rate of COVID-19. As a smaller reporting company, weresult of the Omicron variant, beginning in December 2021,  most of our office and management personnel were working remotely. As of March 15, 2022 the employees returned in full to the office. The health of the Company’s workforce is of primary concern and the Company may need to enact further precautionary measures to help minimize the risk of our employees being exposed to the coronavirus. Further, our management team is focused on mitigating the adverse effects of the COVID-19 pandemic, which has required and will continue to require a large investment of time and resources across the entire Company, thereby diverting their attention from other priorities that existed prior to the outbreak of the pandemic. If these conditions worsen, or last for an extended period of time, the Company’s ability to manage its business may be impaired, and operational risks, cybersecurity risks and other risks facing the Company even prior to the pandemic may be elevated.

The COVID-19 pandemic is affecting the Company’s customers, suppliers, vendors, and other business partners, but the Company is not able to assess the full extent of the current impact nor predict the ultimate consequences that will result therefrom.  

The full effects of the COVID-19 pandemic are highly uncertain and cannot be predicted.

The COVID-19 pandemic affected the Company’s operations during the three months ended March 31, 2022 and may continue to do so for an indeterminable period thereafter. All of these factors may have far reaching impacts on the Company’s business, operations, and financial results and conditions, directly and indirectly, including without limitation impacts on the health of the Company’s management and employees, manufacturing, distribution, marketing, sales operations, customer, and consumer behaviors, and on the overall economy. The scope and nature of these impacts, most of which are beyond the Company’s control, continue to evolve and the outcomes are uncertain.

Due to the above circumstances and as described generally in this Form 10-Q, the Company’s results of operations for the three-month period ended March 31, 2022 are not requirednecessarily indicative of the results to providebe expected for the full fiscal year. Management cannot predict the continued impact of the COVID-19 pandemic on the Company’s sales channels, supply chain, manufacturing, and distribution nor to economic conditions generally, including the effects on consumer spending. The ultimate extent of the effects of the COVID-19 pandemic on the Company is highly uncertain and will depend on future developments, and such effects could exist for an extended period of time even after the pandemic might end.

Our business and operations would suffer in the event of cybersecurity or other system failures.

Despite the implementation of security measures, our internal computer systems and those of any third parties with which we partner are vulnerable to damage from computer viruses, unauthorized access, natural disasters, terrorism, war and telecommunication and electrical failures. While we have not experienced any cybersecurity or system failure, accident or breach to date, if an event were to occur, it could result in a material disruption of our operations, substantial costs to rectify or correct the failure, if possible, and potentially violation of HIPAA and other privacy laws applicable to our operations. If any disruption or security breach resulted in a loss of or damage to our data or applications or inappropriate disclosure of confidential or protected information, required by this Item.we could incur liability, further development of our products could be delayed, and our operations could be disrupted, any of which could severely harm our business and financial condition.

Issues with product quality could have a material adverse effect upon our business, subject us to regulatory actions and cause a loss of customer confidence in us or our products.

In general, our success depends upon the quality of our products.  Quality management plays an essential role in meeting customer requirements, preventing defects, improving our products and services, and assuring the safety and efficacy of our products.  Our future success depends on our ability to maintain and continuously improve our quality management program.  A quality or safety issue may result in adverse inspection reports, warning letters, product recalls or seizures, monetary sanctions, injunctions to halt manufacture and distribution of products, civil or criminal sanctions, costly litigation, refusal of a government to grant approvals and licenses, restrictions on operations or withdrawal of existing approvals and licenses.  An inability to address a quality or safety issue in an effective and timely manner may also cause negative publicity, a loss of customer confidence in us or our current or future products, which may result in the loss of sales and difficulty in successfully launching new products.

29

 

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

RecentUnregistered Sales of UnregisteredEquity Securities

In the quarter ended September 30, 2017, Milestone Scientific issued a total and use 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.

proceedsIn 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.

ITEM 3.     DEFAULT UPON SENIOR SECURITIES 

None.

ITEM 4.        MINE SAFETY DISCLOSURES

 

Not applicable.

 

ITEM 5.     OTHER INFORMATIONItem3. Default upon Senior Securities

 

None.Not applicable.

Item4. Mine Safety Disclosure

Not applicable.

Item5. Other Information

Not applicable.

 


Item 6. Exhibits and Financial Statement Schedules

ITEM 6.Exhibit No

EXHIBITSDescription

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

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

31.2

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

32.1

ChiefSection 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.**

101.INS

Inline XBRL Instance Document.*Document*

101.SCH

Inline XBRL Taxonomy Extension Schema Document.*Document*

101.CAL101.CAL

Inline XBRL Taxonomy Extension Calculation Linkbase Document.*Document*

101.LAB

Inline XBRL Taxonomy Extension Label Linkbase Document.*Document*

101.PRE

Inline XBRL Taxonomy Extension Presentation Linkbase Document.*Document*

101.DEF

Inline XBRL Taxonomy Extension Definition Linkbase Document.*Document*

104Cover Page Interactive Data File (formatted as Inline XBRL and contained in Exhibit 101)


*

Filed herewith.

**

Furnished herewith and not filed, in accordance with Itemitem 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 BernhardArjan Haverhals

Arjan Haverhals

Chief Executive Officer 

Principal Financial Officer

Date: May 16, 2022

Leslie Bernhard

Interim Chief Executive Officer

(Principal Executive Officer)

/s/ Joseph D’Agostino

Joseph D’Agostino

Chief Operating Officer

Chief Financial Officer

(Principal Financial Officer)

 

Date: November 14, 2017

29

32