UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549


FORM 10-Q


 

FORM 10-Q


(Mark One)

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

 

For the quarterly period ended September 30, 2016March 31, 2017

 

Oror

 

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: 001-14053


 

MILESTONE SCIENTIFIC INC.

(Exact name of registrant as specified in its charter)


 

Delaware

 

13-3545623

(State or other jurisdiction of
incorporation or organization)

 

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

 

220 South Orange Avenue, Livingston, New Jersey 07039

(Address of principal executive offices)

 

(973) 535-2717

(Registrant’s telephone number, including area code)

 

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


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

 

Title of each class

 

Name of each exchange on which registered

Common Stock, par value $.001 per share

 

NYSE MKT LLC

 

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 FileFile 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 thethe registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, or a smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer”filer,” “smaller reporting company,” and “smaller reporting“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    ☐  Yes    ☑  No

 

As November 9, 2016,May 15, 2017, the Issuerregistrant had a total of 28,054,67030,731,368 shares of Common Stock, and $.001 par value, outstanding.



 

 



MILESTONE SCIENTIFIC INCINC.

TABLE OF CONTENTS

 

PART I—FINANCIAL INFORMATION

 

Item 1.

Financial Statements

 

Condensed Consolidated Balance Sheets September 30, 2016March 31, 2017 (Unaudited) and December 31, 20152016 (Audited)

 

4

 

Condensed Consolidated Statements of Operations for the three and nine months ended September 30,March 31, 2017 and 2016 and 2015 (Unaudited)

 

5

 

Condensed Consolidated Statement of Changes in Stockholders’ Equity for the ninethree months ended September 30, 2016March 31, 2017 (Unaudited)

 

6

 

Condensed Consolidated Statements of Cash Flows for the ninethree months ended September 30,March 31, 2017 and March 31, 2016 and 2015(Unaudited)(Unaudited)

 

7

 

Notes to Condensed Consolidated Financial Statements (Unaudited)

 

8

Item 2.

 

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

 

1921

Item 3.

 

Item 3. Quantitative and Qualitative Disclosures About Market Risk

 

24

Item 4. Controls and Procedures

25

Item 4.

 

Controls and Procedures

 

25

PART II—OTHER INFORMATION

Item 1.

Legal Proceedings

 

Item 1. Legal Proceedings

26

Item 1A.

 

Risk Factors

 

Item 1A. Risk Factors

26

Item 2.

 

Item 2. Unregistered Sales of Equity Securities and Use of Proceeds

26

Item 3.

 

Item 3. Defaults Upon Senior Securities

 26

Item 4.

Mine Safety Disclosures

26

Item 5.

 

Other Information

 

Item 4. Mine Safety Disclosures

26

Item 6.

 

Exhibits

 

Item 5. Other Information

26

Item 6. Exhibits

27

Signatures

 

Signatures

28

 

 



 

FORWARD-LOOKING STATEMENTS

 

When used in this Quarterly Report on Form 10-Q, the words may”“may”, “will”, “should”, “expect”, “believe”, “anticipate”, “continue”, “estimate”, “project”, “intend” and similar expressions are intended to identify forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended and Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”) regarding events, conditions and financial trends that may affect Milestone Scientific’s future plans of operations, business strategy, results of operations and financial condition. Milestone Scientific wishes to ensure that such statements are accompanied by meaningful cautionary statements pursuant to the safe harbor established in the Private Securities Litigation Reform Act of 1995. Prospective investors are cautioned that any forward-looking statements are not guarantees of future performance and are subject to risks and uncertainties and the actual results may differ materially from those included within the forward-looking statements as a result of various factors. Such forward-looking statements should, therefore, be considered in light of various important factors, including those set forth herein and others set forth from time to time in Milestone Scientific’s reports, including without limitations, Milestone Scientific's Annual Report on Form 10-K  for the year ended December 31, 2016,and registration statements filed with the Securities and Exchange Commission (the “SEC”). Milestone Scientific disclaims any intent or obligation to update such forward-looking statements.

Milestone Scientific has rights tois the owner of the following registered U.S. trademarks: CompuDent®, CompuMed®, CompuFlo®, The Wand®, The Wand Plus®, The SafetyWand®CompuDent®; CompuMed®; CompuFlo®; DPS Dynamic Pressure Sensing Technology®, and Technology®; Milestone Scientific ®; the Milestone logo ®; SafetyWand®; STASingle Tooth Anesthesia (STA Instrument, instruments System®; and handpieces).The Wand ®.

 



PART I—FINANCIAL INFORMATION

Item 1. Financial Statements

MILESTONE SCIENTIFIC INC. AND SUBSIDIARIES

CONDENSED CONSOLIDATED BALANCE SHEETS

  

March 31, 2017

  

December 31, 2016

 
  

(Unaudited)

  

(Audited)

 

ASSETS

 
         

Current Assets:

        

Cash and cash equivalents

 $2,941,555  $3,602,229 

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

  1,626,566   802,384 

Accounts receivable from related party

  682,809   2,083,610 

Other receivable

  -   10,000 

Inventories

  4,533,834   4,602,719 

Advances on contracts

  862,014   700,900 

Deferred cost

  181,116   620,041 

Prepaid expenses and other current assets

  509,542   291,929 

Total current assets

  11,337,436   12,713,812 

Furniture, fixtures & equipment net of accumulated depreciation of $676,144 as of March 31, 2017 and $659,144 as of December 31, 2016

  142,166   159,026 

Patents, net of accumulated amortization of $734,768 as of March 31, 2017 and $717,086 as of December 31, 2016

  642,775   660,457 

Other assets

  26,878   17,355 

Total assets

 $12,149,255  $13,550,650 
         

LIABILITIES AND STOCKHOLDERS’ EQUITY

 

Current Liabilities:

        

Accounts payable

 $889,050  $1,341,207 
Accounts payable related party  1,082,304   1,235,052 

Accrued expenses and other payables

  1,294,353   1,436,262 

Deferred revenue

  356,400   1,001,800 

Total current liabilities

  3,622,107   5,014,321 
         

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 March 31, 2017 and December 31, 2016

  7   7 

Common stock, par value $.001; authorized 50,000,000 shares; 30,712,686 shares issued, 1,361,071 shares to be issued and 30,679,353 shares outstanding as of March 31, 2017; 30,457,224 shares issued, 1,270,481 shares to be issued and 30,423,891 shares outstanding as of December 31, 2016

  32,073   31,720 

Additional paid-in capital

  83,329,954   82,761,503 

Accumulated deficit

  (73,886,359)  (73,381,491)

Treasury stock, at cost, 33,333 shares

  (911,516)  (911,516)

Total Milestone Scientific Inc. stockholders' equity

  8,564,159   8,500,223 

Noncontrolling interest

  (37,011)  36,106 

Total Equity

  8,527,148   8,536,329 

Total liabilities and stockholders’ equity

 $12,149,255  $13,550,650 

See Notes to Condensed Consolidated Financial Statements


MILESTONE SCIENTIFIC INC.

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS

(Unaudited)

  

March 31, 2017

  

March 31, 2016

 

Revenue

        

Product sales, net

 $3,688,988  $3,569,374 

Cost of products sold

  1,402,285   1,368,190 

Gross profit

  2,286,703   2,201,184 

Selling, general and administrative expenses

  2,707,620   3,001,130 

Research and development expenses

  105,015   143,442 

Total operating expenses

  2,812,635   3,144,572 

Loss from operations

  (525,932)  (943,388)

Other (expenses)

  (1,209)  (1,237)

Interest income

  758   302 

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

  (526,383)  (944,323)
         

Provision for income tax

  (7,201)  (46,834)

Loss before equity in net earnings of equity investments

  (533,584)  (991,157)

Loss on earnings from China Joint Venture

  (44,401)  (269,726)

Loss in equity investments

  (44,401)  (269,726)

Net Loss

  (577,985)  (1,260,883)

Net loss attributable to noncontrolling interests

  (73,117)  (510,824)

Net loss attributable to Milestone Scientific Inc.

 $(504,868) $(750,059)
         

Net loss per share applicable to common stockholders

        

Basic

 $(0.02) $(0.03)

Diluted

 $(0.02) $(0.03)

Weighted average shares outstanding and to be issued

        

Basic

  32,004,548   22,609,349 

Diluted

  32,004,548   22,609,349 

See Notes to Condensed Consolidated Financial Statements


MILESTONE SCIENTIFIC INC. AND SUBSIDIARIES

CONDENSED CONSOLIDATED STATEMENT OF CHANGES IN STOCKHOLDERS' EQUITY

(Unaudited)

  

Preferred Stock

  

Common Stock

                     
  

Shares

  

Amount

  

Shares

  

Amount

  

Additional
Paid-in
Capital

  

Accumulated
Deficit

  

Noncontrolling
interest

  

Treasury
Stock

  

Total

 

Balance, January 1, 2017

  7,000  $7   31,727,705  $31,720  $82,761,503  $(73,381,491) $36,106  $(911,516) $8,536,329 

Stock based compensation

  -   -           116,718   -   -   -   116,718 

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

          24,271  $31   43,719   -   -   -   43,750 

Common stock to be issued to employee for bonuses

          114,748  $115   194,885   -   -   -   195,000 

Sale of Common Stock - Public Offering

          123,700  $124   150,712               150,836 

Net loss

  -   -           -   (504,868)  (73,117)  -   (577,985)

Balance, March 31, 2017

  7,000  $7   32,073,757  $32,073  $83,329,954  $(73,886,359) $(37,011) $(911,516) $8,527,148 

See Notes to Condensed Consolidated Financial Statements


  

MILESTONE SCIENTIFIC INC. AND SUBSIDIARIES

CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS

(Unaudited)

 

  

March 31, 2017

  

March 31, 2016

 

Cash flows from operating activities:

        

Net loss

 $(577,985) $(1,260,883)
Adjustments to reconcile net loss to net cash (used in) provided by operating activities:        

Depreciation expense

  16,860   22,786 

Amortization of patents

  17,682   17,538 

Stock based compensation

  116,718   444,505 

Equity earning on China joint venture

  -   164,837 

Changes in operating assets and liabilities:

        

Increase in accounts receivable

  (824,182)  (475,351)
       Decrease in related parties  1,400,801   - 

Decrease in other receivable

  10,000   - 

Decrease in inventories

  68,885   359,857 

Increase to advances on contracts

  (161,114)  (38,517)

Decrease in deferred cost

  438,925   - 

Increase to prepaid expenses and other current assets

  (217,613)  (200,732)

Increase in other assets

  (9,523)  - 

Decrease in accounts payable

  (452,157)  (237,853)
Decrease in accounts payable related party  (152,748)  - 

Increase in accrued expenses and other payables

  96,841   (185,313)

Decrease in deferred revenue

  (645,400)  - 

Net cash (used in) operating activities

  (874,010)  (1,389,126)

Cash flows from investing activities:

        

Investment in China Join Venture

  -   (164,837)

Purchases of intangible assets

  -   (14,442)

Purchases of property and equipment

  -   (4,822)

Consolidation of variable interest entity

  -   50,621 

Net cash used in investing activities

  -   (133,480)

Cash flows from financing activities:

        

Net proceeds on Public Offering

  150,836   - 
Proceeds from employee exercise of stock options  62,500   - 

Net cash provided by investing activities

  213,336   - 

Net (decrease) in cash and cash equivalents

  (660,674)  (1,522,606)

Cash and cash equivalents at beginning of year

  3,602,229   4,194,384 

Cash and cash equivalents at end of year

 $2,941,555  $2,671,778 
         

Supplemental disclosure of cash flow information:

        

Shares issued to employees for bonus

 $195,000  $- 

Shares issued to consultants in lieu of cash payment

 $43,750  $- 

Net assets acquired from variable interest entity

 $-  $20,472 

MILESTONE SCIENTIFIC INC. AND SUBSIDIARIES

CONDENSED CONSOLIDATED BALANCE SHEETS

NINE MONTHS ENDED SEPTEMBER 30, 2016

(Unaudited)  

  

September 30, 2016

 

December 31, 2015

 
  

(unaudited)

 

(audited)

 

ASSETS

       

Current Assets:

       

Cash and cash equivalents

 $2,322,705 $4,194,384 

Accounts receivable, net of allowance for doubtful accounts of $10,000 as of September 30, 2016 and $5,000 as of December 31, 2015

  2,553,186  1,863,582 

Other receivable

  -  58,140 

Inventories

  4,319,255  4,258,094 

Advances on contracts

  1,268,694  1,215,128 

Prepaid expenses and other current assets

  276,903  304,604 

Total current assets

  10,740,743  11,893,932 

Investment in Milestone Education LLC

  -  16,346 

Furniture, fixtures & equipment net of accumulated depreciation of $636,265 as of September 30, 2016 and $566,477 as of December 31, 2015

  181,906  235,935 

Patents, net of accumulated amortization of $699,405 as of September 30, 2016 and $646,388 as of December 31, 2015

  678,139  715,540 

Other assets

  17,355  17,355 

Total assets

 $11,618,143 $12,879,108 

LIABILITIES AND STOCKHOLDERS’ EQUITY

       

Current Liabilities:

       

Accounts payable

 $2,273,585 $2,088,268 

Accrued expenses and other payables

  1,741,806  1,555,567 

Other liabilities

  381,113  69,781 

Total current liabilities

  4,396,504  3,713,616 

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, 2016 and December 31, 2015

  7  7 

Common stock, par value $.001; authorized 50,000,000 shares; 28,066,666 shares issued, 1,145,481shares to be issued and 28,033,333 shares outstanding as of September 30, 2016; 21,720,497 shares issued, 963,451 shares to be issued and 21,687,164 shares outstanding as of  December 31, 2015

  29,213  22,685 

Additional paid-in capital

  79,477,418  78,632,383 

Accumulated deficit

  (71,642,654)  (67,434,984)

Treasury stock, at cost, 33,333 shares

  (911,516)  (911,516)

Total Milestone Scientific Inc. stockholders' equity

  6,952,468  10,308,575 

Noncontrolling interest

  269,171  (1,143,083)

Total Equity

  7,221,639  9,165,492 

Total liabilities and stockholders’ equity

 $11,618,143 $12,879,108 

See Notes to Unaudited Condensed Consolidated Financial Statements

       

See Notes to Condensed Consolidated Financial Statements

 

 



MILESTONEMILESTONE SCIENTIFIC INC. AND SUBSIDIARIES

CONDENSED CONSOLIDATED STATEMENT OF OPERATIONS

NINE MONTHS ENDED SEPTEMBER 30, 2016

(Unaudited)

  

Three Months Ended September 30,

  

Nine Months Ended September 30,

 
  

2016

  

2015

  

2016

  

2015

 

Product sales, net

 $ 3,186,596  $ 2,459,958  $ 8,973,726  $ 6,996,921 

Cost of products sold

 1,517,561  794,285  3,675,552  2,298,162 

Gross profit

 1,669,035  1,665,673  5,298,174  4,698,759 

Selling, general and administrative expenses

 2,933,950  2,480,354  9,226,062  6,969,332 

Research and development expenses

 303,268  20,676  756,045  49,616 

Total operating expenses

 3,237,218  2,501,030  9,982,107  7,018,948 

Loss from operations

 (1,568,183) (835,357) (4,683,933) (2,320,189)

Interest expense

 (846) (1,043) (2,782) (961)

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

 (1,569,029) (836,400) (4,686,715) (2,321,150)

Provision for income tax

 (16,522) (27,105) (80,147) (40,751)

Loss before equity in net earnings of equity investments

 (1,585,551) (863,505) (4,766,862) (2,361,901)

Loss on earnings from Milestone Medical

 -  (590,612) -  (1,566,711)

Income (Loss) on earnings from Education Joint Venture

 -  2,343  -  (5,493)

Loss on earnings from China Joint Venture

 (253,451) (123,083) (554,766) (187,062)

Loss in equity investments

 (253,451) (711,352) (554,766) (1,759,266)

Net Loss

 (1,839,002) (1,574,857) (5,321,628) (4,121,167)

Net loss attributable to noncontrolling interests

 (137,752) (5,655) (1,113,958) (59,642)

Net loss attributable to Milestone Scientific Inc.

 $ (1,701,250) $ (1,569,202) $ (4,207,670) $ (4,061,525)

Net loss per share applicable to common stockholders

            

Basic

 $ (0.05) $ (0.07) $ (0.16) $ (0.19)

Diluted

 $ (0.05) $ (0.07) $ (0.16) $ (0.19)

Weighted average shares outstanding and to be issued

            

Basic

 29,155,712  21,418,145  25,965,566  21,375,317 

Diluted

 29,155,712  21,418,145  25,965,566  21,375,317 

See Notes to Unaudited Condensed Consolidated Financial Statements

            


MILESTONE SCIENTIFIC INC. AND SUBSIDIARIES

CONDENSED CONSOLIDATED STATEMENT OF CHANGES IN STOCKHOLDERS’ EQUITY

NINE MONTHS ENDED SEPTEMBER 30, 2016

(Unaudited)

  

Preferred Stock

 

Common Stock

           
  

Shares

 

Amount

 

Shares

 

Amount

 

Additional
Paid-in
Capital

 

Accumulated
Deficit

 

Noncontrolling
interest

 

Treasury
Stock

 

Total

 

Balance, January 1, 2016

 7,000 $ 7 22,683,948 $ 22,685 $ 78,632,383 $ (67,434,984)$ (1,143,083)$ (911,516)$ 9,165,492 
                    

Consolidation of Milestone Education

 - - - - - - 16,346 - 16,346 

Stock based compensation

 - - - - 357,934 - - - 357,934 

Common stock to be issued to employee for bonuses

 - - 182,030 182 389,318 - - - 389,500 

Common stock to be issued to employee for compensation

   10,709 11 22,489       22,500 

Common stock issued for payment of consulting
services

   196,218 196 366,299       366,495 

Common Stock exchanged for MMD

     5,035,042 5,035 (2,514,901)  2,509,866   - 

Sale of Common Stock - Private Placement

     1,104,200 1,104 2,223,896       2,225,000 

Net loss

 - - - - - (4,207,670)(1,113,958)- (5,321,628)

Balance, September 30, 2016

 7,000 $ 7 29,212,147 $ 29,213 $ 79,477,418 $ (71,642,654)$ 269,171 $ (911,516)$ 7,221,639 
                    

See Notes to Unaudited Condensed Consolidated Financial Statements

                 


MILESTONE SCIENTIFIC INC. AND SUBSIDIARIES

CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS

(Unaudited) 

  

For the Nine Month Ended September 30,

 
  

2016

  

2015

 

Cash flows from operating activities:

      

Net loss

 $ (5,321,628) $ (4,121,167)

Adjustments to reconcile net cash used in operating activities:

      

Depreciation expense

 69,345  20,815 

Amortization of patents

 53,017  51,994 

Common stock and options for compensation, consulting and vendor services

 1,136,430  499,049 

Equity loss on Milestone Medical

 -  1,566,711 

Equity loss on Education joint venture

 -  5,493 

Equity loss on China joint venture

 545,950  187,062 

Changes in operating assets and liabilities:

      

Increase in accounts receivable

 (759,385) (807,869)

Decrease (Increase) in other receivable

 58,140  (85,959)

Increase in inventories

 (225,998) (307,807)

Increase to advances on contracts

 (53,566) (490,729)

Increase to prepaid expenses and other current assets

 27,701  25,996 

Increase in other assets

 -  (2,670)

Increase (decrease) in accounts payable

 169,388  (672,974)

Increase in accrued expenses and other payables

 181,324  369,685 

Net cash used in operating activities

 (4,119,282) (3,762,370)

Cash flows from investing activities:

      

Notes receivable from Milestone Medical

 -  (2,000,000)

Due from related party

 -  (677,991)

Investment in Treasury Bills

 -  - 

Purchases of intangible assets

 (15,616) (1,986)

Purchases of property and equipment

 (14,945) (47,613)

Cash acquired from variable interest entity

 50,621  - 

Net cash provided by (used in) investing activities

 20,060  (2,727,590)

Cash flows from financing activities:

      

Capital contribution from noncontrolling interest

 2,543  - 

Proceeds from exercise of stock options

 -  12,750 

Net Proceeds on Private Placement Offering

 2,225,000  - 

Capital contribution from noncontrolling interest

 -  500,000 

Net cash provided by investing activities

 2,227,543  512,750 

Net decrease in cash and cash equivalents

 (1,871,679) (5,977,210)

Cash and cash equivalents at beginning of period

 4,194,384  10,367,993 

Cash and cash equivalents at end of period

 $ 2,322,705  $ 4,390,783 
       

Supplemental disclosure of cash flow information:

      

Net assets acquired from variable interest entity

 $ 14,076  $ - 

Shares issued to employees in lieu of cash compensations

 $ 22,489  $ 42,500 

Shares issued to employees for bonus

 $ 389,318  $ 100,000 

Shares issued to consultants in lieu of cash payment

 $ 366,299  $ 60,000 

See Notes to Unaudited Condensed Consolidated Financial Statements

      


MILESTONE SCIENTIFIC INC. AND SUBSIDIARIES

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

(UNAUDITED)

Note 1- ORGANIZATION, BUSINESS AND BASIS OF PRESENTATION

 

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

Milestone Scientific”, “our”, “us” or “we”)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 of The Wand®, a single use disposable handpiece. The instrument is marketed in dentistry under the trademark CompuDent®,and STA Single Tooth Anesthesia System® Wand Plus® and STA (Single Tooth Anesthesia) TMand in medicine under the trademark CompuMed®. CompuDent® CompuDent® is suitable for all dental procedures that require local anesthetic. CompuMed®is suitable for many medical procedures regularly performed in Plastic Surgery, Hair Restoration Surgery, Podiatry, Colorectal Surgery, Dermatology, Orthopedics and a number of other disciplines. The dental instruments are sold in the United States and in over 47 countries abroad. ThereTo date there have been no medical instruments sold in the United States and limited amounts sold internationally, as of the reporting date, although certain medical instruments have obtained CE mark approval and now can be marketed and sold in most European countries.   Milestone Scientific’sScientific's products are manufactured by a third-party contract manufacturer.

 

In July 2014, Milestone Scientific acquired all of the 750,000 outstanding shares of an inactive Florida corporation and changed its name to Wand Dental, Inc.During 2015, our common stock was listed on the NYSE MKT LLC (“Wand Dental”NYSE MKT”). In September 2014, that corporation was merged into a Delaware corporation, retaining under the same name and capitalization. On July 1, 2014, Wand Dental was capitalized with cash and received Milestone Scientific’s dental business and related dental assets including the exclusive license of Milestone Scientific’s, patents, trademarks, and technology for use in the dental marketplace. Wand Dental is consolidated into Milestone Scientific.

The unaudited consolidated financial statements of Milestone Scientific have been prepared in accordance with accounting principles generally accepted in the United States for interim financial informationticker symbol “MLSS”. Accordingly, they do not include all of the information and footnotes required by accounting principles generally accepted in the United States for complete financial statements. These unaudited consolidated financial statements should be read in conjunction with the financial statements and notes thereto for the year ended December 31, 2015 included in Milestone Scientific’s Annual Report on Form 10-K.

In the opinion of management, the accompanying unaudited financial statements contain all adjustments (consisting of normal recurring entries) necessary to fairly present Milestone Scientific’s financial position as of September 30, 2016 and the results of its operations for the three and nine months then ended.

The results of operations reported for the three and nine months ended September 30, 2016 are not necessarily indicative of the results of operations which may be expected for a full year.

 

In June 2016, a group of investors that participated in our May 2014 financing investedwe raised an additional $2.0 million of gross proceeds in Milestone Scientific through a private placement of one million restricted shares of our common stock, $.001 par value per share (“common stock”), at a price of $2.00 per share.

In the second quarter of 2016, Milestone Scientific initiated a share exchange program pursuant to which we would exchangeexchanged one share of common stock for every two outstanding shares of Milestone Medical (described below) common stock, a previously consolidated variable interest entity. As a result of September 30,the exchange program, at March 31, 2017, Milestone Scientific owned approximately 96% of Milestone Medical.

In July 2016, 5,035,042Milestone Scientific raised gross proceeds of $250,000 in a registered direct offering of 104,200 shares of common stock have been issued in exchange for 9,005,000 shares of Milestone Medical common stock.  As a result of these exchanges, at September 30, 2016 Milestone Scientific owns approximately 91% of Milestone Medical.$2.40 per share.

 

In July 2016,2016, Milestone Scientific filed for 510(K)510(k) marketing clearance with the USUnited States Food and Drug administration (FDA) for marketing clearance ofAdministration ("FDA") Milestone Medical's (described below) epidural anesthetic injections instrument. This clearance is necessary to begin commercialization of thisthese medical instrumentinstruments in the United States.

 

In JulyDecember 2016, we received notification from the FDA that based upon the 510(k) application submitted for Milestone Scientific's Compu-Flo Intra Articular Computer Controlled Injection System, did not adequately document that the device met the equivalency standard required for 510(k) clearance. Following consultation with the FDA Office of Device Evaluation, we intend to provide additional data, which could include a new Human Factor Validation study (HFV Study) in support of a new 510(k) application for the device. An HFV Study demonstrates the ease of use of a product. The cost to generate this incremental data is estimated to be approximately $100,000.

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, including 92,775 additional warrants pursuant to a partial exercise of the over-allotment option granted to the underwriters. The public offering price for each share and related warrant was $1.50. The warrants have a three-year term and an exercise price of $2.55 per share. The gross proceeds from this offering were approximately $3,000,000, before deducting underwriting discounts and commissions and other offering expenses.


In January 2017, in connection with Milestone Scientific raised $250,000public offering of shares in December 2016, the underwriter of the offering exercised a portion of its over-allotment option and purchased an additional capital from the sale of 104,200123,700 shares of common stock at $2.40the public offering price of $1.499 per share. The Company incurred placement agent fees equal to ten percent of the gross proceeds or $25,000, which are reflected as an offset against additional paid-in capital as of September 30, 2016. to Milestone Scientific from this exercise was approximately $186,000 before deducting underwriting discounts and commissions and other offering expenses.   

 

Milestone Scientific has incurred operating losses and negative cash flows from operating activities since its inception, except for 2013. Milestone Scientific is actively pursuing the generation of revenue, positive operating income and net income. The capital raised in May 2014December 2016 and June and July 2016 providedJanuary 2017, provide Milestone Scientific with the opportunity to continue to develop and commercialize additional medical instruments and aggressively market itsthe dental instruments throughout the world. Milestone Scientific is actively pursuing the generation of positive cash flows from operating activities through an increase in revenue based upon management’s assessment of present contracts and managementcurrent negotiations and reductions in operating expenses. Management believes itsthat Milestone Scientific will have sufficient cash on hand and remaining net current assets are sufficientreserves to meet its anticipated obligations over the next twelve months.months from the issuance date of this report.  However, Milestone Scientific may need to raise additional capital prior to management’smanagement's expected generation of sustainable positive cash flow from operating activities.     

 

NOTE -– 1 2 SUMMARY OF ACCOUNTING POLICIES

 

1.Principles Basis of Consolidation

 

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

2.Reclassifications

 

Certai2. n reclassifications have been made to the 2015 financial statements to conform to the consolidated 2016 financial statement presentation. These reclassifications had no effect on net loss or cash flows as previously reported.Basis of Presentation

 

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

3. Variable Interest EntitiesEntities

 

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

 


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

 

Milestone Scientific is the primary beneficiary of Milestone Medical throughas of December 31, 2015 (see Note 3)4) and Milestone Education as VIEs.of January 2016. Accordingly, the assets and liabilities of Milestone Medical and Milestone Education are included in the accompanying consolidatedcondensed consolidated financial statements. See Note 3 for further details regarding the treatment of the VIE.

 

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

 

 

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

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

 

Milestone management does not have the ability to control the activities that most significantly impact China’sMilestone China's economics and, therefore, the power criterion has not been met. Management placed the most weight on the relationship and significance of activities of Milestone China to the majority shareholder/CEO of Milestone China.  As majority shareholder, majority holder of voting rights, and the active CEO, the 53% investor has the power to direct the activities that most significantly impact the economic performance of Milestone China. Management has concludesconcluded that Milestone Scientific is not the primary beneficiary under ASC 810. Accordingly, Milestone China has not been consolidated into the financial statements of Milestone Scientific and continues to be accounted for under the equity method (see Note 4)5).

                  

4. 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.

 

5. Accounts Receivable

 

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

 

6. Product Return and Warranty

 

Milestone Scientific generally does not accept non-defective returns from its customers. ProductProduct 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.

7. Inventories

 

7.            Inventories

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

 


8. Equity Method Investments

 

Investments in which we haveMilestone Scientific has the ability to exercise significant influence, but do not control, are accounted for under the equity method of accounting and are included in the long term assets on the Condensed Consolidated Balance Sheets.condensed consolidated balance sheets. Under this method of accounting, ourMilestone Scientific's share of the net earnings or losses of the investee is presented below the income tax line on the Condensed Consolidated Statementscondensed consolidated statements of Operations. We evaluate ouroperations. Milestone Scientific evaluates its equity method investments whenever events or changes in circumstance indicate that the carrying amounts of such investments may be impaired. If a decline in the value of an equity method investment is determined to be other than temporary, a loss is recorded in earnings in the current period.

 

9. Furniture, Fixture and Equipment  

 

Equipment is recorded at cost, less accumulated depreciation. DepreciationDepreciation 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.

 

10.  Intangible Assets - Patents

 

Patents are recorded at cost to prepare and file the applicable documents with the United StatesUS Patent Office, or internationally with the applicable governmental office in the respective country. Although certain patents have not yet been approved, the costs related to these patents are being amortized using the straight-line method over the estimated useful life of the patent. If the applicable patent application is ultimately rejected, the remaining unamortized balance will be expensed in the period in which Milestone Scientific receives notice of such rejection.  Patent defense costs, to the extent applicable are expensed as incurred.  Patent applications filed and patents obtained in foreign countries are subject to the laws and procedures that differ from those in the United States. Patent protection in foreign countries may be different from patent protection under United States laws and may not be favorable to Milestone Scientific. Milestone Scientific also attempts to protect the proprietary information through the use of confidentiality agreements and by limiting access to its facilities. There can be no assurance that the program of patents, confidentiality agreements and restricted access to the facilities will be sufficient to protect the proprietary technology.

 

11. Impairment of Long-Lived Assets

 

Milestone Scientific reviews long-lived assets for impairment whenever events or circumstances (i.e. a triggering event) indicate that the carrying amounts may not be recoverable. The carrying value of the assets is evaluated in relation to the operating performance and future undiscounted cash flows of the underlying assets. Milestone Scientific adjusts the net book value of an underlying asset if its fair value is determined to be less than its net book value. There have been no impairment indicators or triggering events and therefore, no impairment reviews have been performed in the period ending September 30, 2016.March 31, 2017.

 

12. Revenue Recognition

 

Revenue from product sales is recognized, net of discountsdiscounts and allowances to domestic distributors, on the date of shipment for essentiallysubstantially all shipments, since the shipment terms are FOB warehouse. Milestone Scientific will recognizerecognizes revenue on date of arrival of the goods at the customer’scustomer's location, where shipments are FOB destination. Shipments to international distributors are FOB warehouse, therefore revenue is recognized on shipment of the goods. 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’sScientific'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.

 


13. Shipping and Handling Costs

 

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

 

14. Research and Development

 

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

 

15. Income Taxes

 

Milestone Scientific accounts for income taxes pursuant to the asset and liability method which requires deferred income tax assets and liabilities to be computed for temporary differences between the financial statement and tax basis of assets and liabilitiesliabilities 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.

16. Use of Estimates

           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.

 

16.17. 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.

18. Recent Accounting Pronouncements

 

In May 2014, the Financial Accounting Standards Board (“FASB”("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, with early adoption permitted only for reporting periods beginning after December 15, 2016. 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 August 2014, the FASB issued a new standard Accounting Standards Update (“ASU”) No.2014-15, “Presentation of Financial Statements – Going Concern” (Subtopic 205-40).The new standard is intended to increase the disclosure as it relates to management’s assessment of the abilities to continue as a going concern.  The standard will be effective for the annual period ending after December 15, 2016. Milestone Scientific will be adopting this standard with its annual reporting of December 31, 2016 to include enhanced disclosures as it relates to management’s considerations.

In November 2015, the FASB issuedissued 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 will 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“") 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, 20192018 and for interim periods within fiscal years beginning after December 15, 2020. 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 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. Milestone Scientific is inThe Company has adopted the process of determining what impact, if any,standard, effective January 1, 2017, and has determined the adoption of this ASUstandard will not have an impact on its financial position, results of operations and cash flows.reporting.

 

In March 2016, the FASB issued a new standard ASU No.2016-09, Compensation“Compensation – Stock Compensation” (Topic 718).: The new standard is intended, under FASB’s Simplification Initiative, to clarifyaddress certain reportingdiversity of application within previous guidance.  The new standard primarily addresses certain tax aspects relating toin connection with the stock based compensation relating primarily to forfeitures, tax impacts and cash flow presentation. Certain attributes will be treated prospectively, while others will require a retroactive application. Generally, the changesheld. It will be effective for fiscal years and interim periods, beginning after December 15, 2016. Milestone Scientific is inThe Company has adopted the process of determining what impact, if any,standard, effective January 1, 2017, and has determined the adoption of this ASU willstandard does not have an impact on its financial position, results of operations and cash flows.reporting.

 

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, 2019.2018. 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 of"Statement Cash Flows – Classification“Classification of Certain Cash Receipts and Cash Disbursements” (TopicDisbursements" 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.2016-16, "Income Taxes Intra-Entity Transfers of Assets Other Than Inventory" (Topic 740). The new standard provides guidance as to address the deferred tax treatment on certain intra-entity transfer of assets, other than inventory.  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 all entities for fiscal years and interim periods, beginning after December 15, 2016. 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 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 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.

 

We have evaluated all otherIn January 2017, the FASB issued a new standard ASU No.2017-04, “Intangibles Goodwill and unadopted ASUsOther – Simplifying the Test for Goodwill Impairment” (Topic 350). The new standard provides guidance as to simplify the testing and, believepotential, measurement of impairment of goodwill.  It will be effective for all entities for fiscal years and interim periods, beginning after December 15, 2020. Milestone Scientific is in the process of determining what impact, if any, the adoption of these standardsthis ASU will not have a material impact on its resultspresentation within the statement of operations, financial position, or cash flows of its common stock.flows.

 

NOTE -– 2 3 Basic and Diluted Net INCOME (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. Basic earnings (loss) per common share is calculated by dividing net income or loss applicable to common stockholders by the weighted average number of common shares outstanding and to be issued during each period. The calculation of diluted earnings per common share is similar to that of basic earnings per common share, except that the denominator is increased to include the number of additional common shares that would have been outstanding if all potentially dilutive common shares, such as those issuable upon the exercise of stock options, warrants, and the conversion of debt were issued during the period.

 

Since Milestone Scientific had net losses for 2016three months ended March 31, 2017 and 2015,2016, the assumed effects of the exercise of potentiallypotentially dilutive outstanding stock options of 1,885,010and warrants were not included in the calculation as their effect would have been anti-dilutive. Such outstanding options and warrants totaled 3,457,615 and 1,776,677 at March 31, 2017 and 2016, respectively.

           

NOTE - 4 – 3 CONSOLIDATION OF VARIABLE INTEREST ENTITY

 

Milestone Medical

 

            As of March 31, 2017, Milestone Medical is was approximately 91%96% owned by Milestone Scientific as of September 30, 2016.Scientific. Milestone Medical was established to develop and commercialize intra-articular and epidural drug delivery instruments, utilizing an exclusive royalty-free license to Milestone Scientific’sScientific's CompuFlo technology. The license was contributed by Milestone Scientific for ourits initial 50% ownership in Milestone Medical. Medical in September 2011. 

           

Since ourits initial investment in Milestone Medical, we haveMilestone Scientific had accounted for the investment in accordance with the equity method of accounting. However, during 2015, Milestone Scientific provided short term bridge financing to Milestone Medical in anticipation of the completion of a secondary stock offering in Poland. In December 2015, Milestone Medical suspended this capital raise efforts meriting re-consideration of the initial accounting for the investment as an equity method investment. In April 2016, Milestone Medical cancelled the uplisting of its shares to the Poland Warsaw Stock Exchange.  

        

As a result of the change in circumstances around the proposed offering in December 2015 by Milestone Medical, weMilestone Scientific reevaluated ourits relationship with Milestone Medical and Milestone Medical’sMedical's status as a VIE and determined that Milestone Medical doesdid not have sufficient capital at risk to support its activities without additional financial support from us.Milestone Scientific.  Since the factors giving rise to concluding that Milestone Medical is a VIE happened so closeproximate to the end of fiscal year 2015, the date for measuring the consolidation of Milestone Medical has beenwas deemed to be December 31, 2015.

 

In the second quarter of 2016, Milestone Scientific initiated a share exchange program pursuant to which weit would exchange one share of common stock for every two outstanding shares of Milestone Medical common stock. As there was no change in control, the acquisition of the non-controlling interest is reflected as an equity transaction with the carrying value of the non-controlling interest adjusted to reflect Milestone Scientific’sScientific's increased ownership interest in the subsidiary.  As of September 30, 2016, 5,035,042 shares of common stock have been issued in exchange for 9,005,000 shares of Milestone Medical common stock.  As a result of these exchanges, Milestone Scientific owns approximately 91%96% of Milestone Medical at September 30, 2016.

As a result of our increased ownership in Milestone Medical, we have determined that we continue to have control of Milestone Medical and have consolidated Milestone Medical in the accompanying condensed consolidated financial statements.March 31, 2017.

 

Milestone Education LLC

Milestone Education is a 50% owned subsidiary of Milestone Scientific which began operations in 2013 to provide training and education to dentists throughout the world. Milestone Scientific accounted forfor its investment in Milestone Education using the equity method of accounting through December 31, 2015. Approximately 83%82% of the revenue earned by Milestone Education is from services performed for Milestone Scientific.Scientific as of March 31, 2017. As a result of this relationship, we determined that we havehad the power to direct the activities that most significantly impact Milestone Education’sEducation's economic performance, and that it iswas  a VIE and shouldwould  be consolidated in the financialsfinancial statements  of Milestone Scientific.Scientific effective January 2016.


NOTE - 5 INVESTMENT IN UNCONSOLIDATED SUBSIDIARIES

 

The financial information in the table below summarizes the combined results of operations of Milestone Scientific and its subsidiaries, including Milestone Medical and Milestone Education, on a pro forma basis as though the companies had been combined as of the beginning of the earliest period presented. The pro forma financial information is presented for informational purposes only and is not indicative of the result of operations that would have been achieved if the consolidation had taken place at the beginning of the period presented.

The financial statements of Milestone Education have been consolidated in the accompanying condensed consolidated financial statements.

The financial information in the table below summarizes the combined results of operations of Milestone Scientific and its subsidiaries, including Milestone Medical and Milestone Education, on a pro forma basis as though the companies had been combined as of the beginning of the earliest period presented. The pro forma financial information is presented for informational purposes only and is not indicative of the result of operations that would have been achieved if the consolidation had taken place at the beginning of the period presented.

  

Three Months Ended September 30, 2015

Pro Forma

  

Nine Months Ended September 30, 2015

Pro Forma

 
       

Total revenue

 $ 2,509,096  $ 7,099,164 

Cost of products sold

 805,429  2,312,980 

Gross Profit

 1,703,667  4,786,184 

Selling, general and administrative expenses

 3,481,703  9,609,318 

Research and development expenses

 217,138  621,870 

Operating expenses

 3,698,841  10,231,188 

Loss from operations

 (1,995,174) (5,445,004)

Interest expense

 (18,237) (21,655)

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

 (2,013,411) (5,466,659)

Provision for Income Tax

 (27,105) (40,751)

Loss before equity in net earnings of equity investments

 (2,040,516) (5,507,410)

Loss on earnings from China Joint Venture

 (123,083) (187,063)

Loss in equity investments

 (123,083) (187,063)

Net loss

 (2,163,599) (5,694,473)

Less: Net loss attributable to the noncontrolling interests

 (594,397) (1,632,948)

Net loss attributable to Milestone Scientific Inc.

 $ (1,569,202) $ (4,061,525)

NOTE – 4 INVESTMENT IN UNCONSOLIDATED SUBSIDIARIES

Advance Ocular Science SA

 

Advanced Ocular Sciences SA (“("Advanced Ocular”Ocular") is an entity organized to develop an instrument that delivers injections into the eyes. Advanced Ocular is a shell company as of September 30, 2016.March 31, 2017, Milestone Scientific owns 25% of this entity. As of the balance sheet date, no equity has been contributed to Advanced Ocular by Milestone Scientific. During 2015, Milestone Scientific advanced $78,798 for marketing and strategy planning to Advanced Ocular and they, or their organizers, are obligated to repay this advance once a public offering of Advanced Ocular equity is approved and funded in Poland during 2016. No public offering was completed in Poland as of September 30, 2016.March 31, 2017.

    As such, Milestone Scientific has written-off the $78,798 advanced to Advanced Ocular as of September 30,December 31, 2016. Advance Ocular was not included in the condensed consolidated financial statements at September 30, 2016March 31, 2017 as no investment has been made by Milestone Scientific. The suspended losses approximated $19,700 at September 30, 2016. 

 

Milestone China Ltd.

           

In June 2014, Milestone Scientific invested $1 million through the contribution of 772 STA instruments (at a distributor price of approximately $1,296 per instrument) for a forty percent (40%) ownership in Milestone China Ltd. (“Milestone China”).  In 2014, the instruments were shipped and were recorded as an investment in Milestone China at the cost of the inventory contributed. In January 2016, Milestone Scientific contributed 308 by contributing 772 STA instruments with a retail value of approximately $400,000 ($1,296 per instrument)Instruments to Milestone China which increased Milestone Scientific’s investment by approximately $165,000 which represents the cost of the instruments. This did not increase Milestone Scientific’s percentage offor a 40% ownership since the contribution was proportionate to contributions from other shareholders.

interest. Milestone Scientific recorded this investment under the equity method of accounting. Milestone Scientific recorded a loss on its investment in Milestone China of $253,451$0 and $554,766 for the three$164,837, as of March 31, 2017 and nine months ended September 30, 2016, respectively, and $123,083 and $187,062 for the three and nine months ended September 30, 2015, respectively. Milestone Scientific’sScientific' investment in Milestone China was $0 as of September 30, 2016March 31, 2017 and December 31, 2015. 2016, respectively. Milestone Scientific had suspendedincurred losses on its investment in Milestone China of $405,205,$1,528,376 and $1,124,350 as of September 30, 2016.March 31, 2017 and December 31, 2016, respectively, which have been suspended.

           

Milestone Scientific sold $3,203,466 in instrumentshad $356,400 and $1,000,000 of related party sales of handpieces and instruments during the ninethree months ended September 30,March 31, 2017 and 2016, respectively, to Milestone China. As of March 31, 2017 and December 31, 2016 Milestone Scientific recorded deferred revenues and deferred costs associates with sales to Milestone China of $356,400 and $181,116, and $1,001,800 and $620,041, respectively.  As of March 31, 2017 and December 31, 2016 Milestone China owes $1,850,200$1,358,200 and $2,714,600, respectively, to Milestone Scientific for handpieces and STA instruments and handpieces shipped in 2016, which is included in accounts receivable at September 30, 2016.Accounts Receivable from related party on the condensed consolidated balance sheets.  Milestone China payment terms are ninety dayspaid $1,001,800 in April 2017 to satisfy the outstanding instruments sales from receipt of goods.2016 and therefore $1,001,800 has been recorded in revenue related to 2016 sales for the three months ended March 31, 2017.  

           

Milestone Scientific recognizes the total revenue and costs of goods sold at the time the shipment of instruments and handpieces to Milestone China.China are paid. However, due to timing differencesdifferences of when the inventory is sold to Milestone China and when Milestone China sells the acquired inventory to third parties, elimination of the intra-entity profit is required as of the balance sheet date. In accordance with ASC 323 Equity Method and Joint Ventures, Milestone Scientific has deferred the gross profit associated with inventory shipped to Milestone China that has not been sold to third parties. The deferred profit of $381,113 is$675,391 and $630,990, as of March 31, 2017 and December 31, 2016, respectively was included within accounts receivable from related party in the condensed consolidated balance sheets. The profit deferred was $44,401 and $104,889 as of March 31, 2017 and 2016, respectively, and was included within loss on earnings from Milestone China withinJoint Venture on the Condensed Consolidated Statementscondensed consolidated statements of Operations and presented in other liabilities in the Condensed Consolidated Balance Sheets.operations.   

 

The following table includes summarized financial information for Milestone China the unconsolidated subsidiary:of Milestone China:

  

March 31, 2017

  

December 31, 2016

 
    (Unaudited)   (Unaudited) 

Assets:

        

Current Assets

 $10,110,398  $9,362,198 

Non-Current Assets

  2,743,178   2,467,547 

Total Assets:

  12,853,375   11,829,745 
         

Liabilities:

        

Current Liabilities

  11,884,862   9,900,611 

Stockholders' equity

  968,714   1,929,134 

Total liabilities and stockholders’ equity

 $12,853,575  $11,829,745 
         
  

March 31, 2017

  

March 31, 2016

 

Net Sales

 $427,400  $272,220 

Cost of Goods Sold

  479,411   209,400 

Gross Profit

  (52,011)  62,820 

Other Expenses

  (958,055)  (379,773)

Net Losses

 $(1,010,066) $(316,953)

 

  

September 30, 2016

  

December 31, 2015

 
  

(unaudited)

  

(unaudited)

 

Assets:

      

Current Assets

 $ 6,523,902  $ 772,999 
       

Non-Current Assets

 1,745,764  903,766 
       

Total Assets:

 $ 8,269,666  $ 1,676,765 
       

Liabilities

      

Current Liabilities

 4,406,577  580,613 
       

Stockholders' equity

 3,863,089  1,096,152 
       

Total liabilities and stockholders’ equity

 $ 8,269,666  $ 1,676,765 

 

  

Three Months Ended September 30,

  

Nine Months Ended September 30,

 
  

2016

  

2015

  

2016

  

2015

 
  

(unaudited)

  

(unaudited)

  

(unaudited)

  

(unaudited)

 
             

Net Sales

 $ 329,617  $1,193,234  $ 2,645,119  $ 2,226,434 

Cost of Good Sold

 444,255  1,161,983  2,529,374  1,830,272 

Gross Profit

 (114,638) 31,251  115,745  396,162 

Other Expenses

 (305,742) (338,963) (1,002,484) (863,819)

Net Loss

 $ (420,380) $ (307,712) $ (886,739) $ (467,697)

NOTE 5 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 the period of the expected performance. For the three months ended September 30,March 31, 2017 and 2016 and 2015,respectively, Milestone Scientific recognized $81,678$133,810 and $107,205$134,405 of total employee compensation cost, respectively. For the nine months ended September 30, 2016 and 2015, Milestone Scientific recognized $357,934 and $334,049 of total employeestock based compensation cost, respectively. As of September 30,March 31, 2017 and 2016, and 2015, there was $580,331$734,114 and $881,765 respectively,$1,026,024 of total unrecognized compensation cost related to non-vested options.nonvested options, respectively, which Milestone Scientific expects to recognize these cost over a weighted average period of 2.492.7 years and 3.592.99 years as of September 30,March 31, 2017 and 2016, and 2015, respectively.

 

 In March 2016, the FASB issued ASU No. 2016-09, Stock Compensation (Topic 718), which includes provisions intended to simplify various aspects related to how share-based payments are accounted for and presented in the financial statements. The standard is effective for annual periods beginning after December 15, 2016. During the first quarter 2017, the Company adopted this ASU. The key effects of the adoption on the Company's financial statements include that the Company will now recognize windfall tax benefits as deferred tax assets instead of tracking the windfall pool and recording such benefits in equity. Additionally, the Company has elected to recognize forfeitures by estimating them at the time of grant. This adoption of this pronouncement had no material effects on Milestone Scientific's financial statements. 

A summary of option activityactivity for employees under the plans and changes during the nine monthsthree month ended September 30, 2016,March 31, 2017, is presented below:

 

  

Number of Options

 

Weighted

Averaged Exercised Price

 

Weighted Average Remaining Contractual Life (Years)

 

Aggregate Intrinsic Options Value $

Outstanding January 1, 2016

 1,419,436  $ 1.56 2.78 $1,220,338
         

Granted

 348,908 1.72 4.35 376,821
         

Forfeited or Expired

 (100,000)2.50   -
         

Exercised

 - - - -
         

Outstanding September 30, 2016

 1,668,344 $1.54 2.44 $1,147,015
         

Exercisable September 30, 2016

 1,170,718 $1.36 1.95 $999,904
  

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   5,469 

Granted

  211,179   1.64   4.78     

Exercised during 2017

  (83,333)  .75         

Forfeited or expired

                

Options outstanding March 31, 2017

  1,639,841   1.87   3.14     

Exercisable, March 31, 2017

  1,118,096   1.84   2.70     

 

A summary of option activity for non-employees under the plans as of March 31, 2017 and 2016, and changes during the nine monthsyear ended September 30, 2016, is presented below:

 

  

Number of Options

 

Weighted

Averaged Exercised Price

 

Weighted Average Remaining Contractual Life (Years)

 

Aggregate Intrinsic Options Value $

Outstanding January 1, 2016

 8,333 $2.70 4.83 $-
         

Granted

 208,333 2.55 0.00 -
         

Forfeited or Expired

 - 0.00 0.00 -
         

Exercised

 - - - -
         

Outstanding September 30, 2016

 216,666 $2.55 5.58 $-
         

Exercisable September 30, 2016

 555 $2.52 4.51 $-
  

Number of

Options

  

Weighted

Averaged

Exercise

Price $

  

Weighted

Average

Remaining Contractual

Life (Years)

  

Aggregate

Intrinsic

Options

Value $

 

Options outstanding January 1, 2017

  224,999   2.53   5.32   - 

Granted

  -             

Exercised during 2017

  -             

Forfeited or expired

  -             

Options outstanding March 31, 2017

  224,999   2.53   5.12   - 

Exercisable, March 31, 2017

  10,183   2.33   5.07   - 

 


The fair value of the non-employee options was estimated on the date of grant using the Black Scholes option-pricing model at the date of grant. In accordance with the provisions of FASB ASC 505, Milestone Scientific will re-measure the value of the grant at each presentation date unless there is a significant disincentive for non-performance or until performance is completed.has been. For the three and nine months ended September 30,March 31, 2017, and 2016 Milestone Scientific recognized $2,807income of $17,092 and $8,421 expenseexpensed $1,175, respectively related to non-employee options. During the three and nine months ended September 30, 2015, Milestone Scientific had no expense related to non-employee options. As of September 30, 2016, there was a total of $359,485 unrecognized compensation cost related to non-vested options which the company expects to recognize over a weighted average period of 5.5 years.

 

In accordance with the provisions of FASB ASC 505-50-15, all other issuances of common stock, stock options or other equity instruments to non-employees as consideration for goods or services received by Milestone Scientific are accounted for based on the fair value of the equity instruments issued (unless the fair value of the consideration received can be more reliably measured). The fair value is measured as of an appropriate date pursuant to the guidance, (generally, the earlier of the date the other party becomes committed to provide goods or services or the date of performance by the other party is complete) and re-measured at each reporting period whether capitalized or expensed as if Milestone Scientific had paid cash for the goods or services.

NOTE 67 CONCENTRATION OF CREDIT RISK

 

Milestone ScientificScientific'’ss consolidated financial instruments that are exposed to concentrations of credit risk consist primarily of cash, trade accounts receivable, and advances on contracts. Milestone Scientific places its cash and cash equivalents with large financial institutions. At times, such investments may be in excess of the Federal Deposit Insurance Corporation insurance limit. Milestone Scientific has not experienced any losses in such accounts and believes it is not exposed to any significant credit risks. Financial instruments which potentially subject Milestone Scientific to credit risk consist principally of trade accounts receivable, as Milestone Scientific does not require collateral or other security to support customer receivables, and advances on contracts.  

 

Milestone Scientific closely monitors the extension of credit to its customers while maintainingmaintaining allowances, if necessary, for potential credit losses. On a periodic basis, Milestone Scientific evaluates its accounts receivable and establishes an allowance for doubtful accounts, based on a history of past write-offs and collections and current credit conditions. Management has provided a reserve that it believes is sufficient to record accounts receivable at net realizable value as of September 30, 2016March 31, 2017, and December 31, 2015,2016, respectively.

 

NOTE 78 ADVANCES ON CONTRACTS

 

The advances on contracts represent funding of future STA inventory purchases. The balance of the advances as of March 31, 2017, and December 31, 2016, is $862,014 and $700,900, respectively. The advance is classified as current based on the estimated annual usage of the underlying inventory.   

NOTE – 9 INCOME TAXES

Due to Milestone Scientific's history of operating losses, a full valuation allowances has been provided for all of Milestone Scientific's deferred tax assets at March 31, 2017 and December 31, 2016, no recognition was given to the utilization of the remaining net operating loss carryforwards in each of these periods.

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

           For the three month ended March 31, 2017 and December 31, 2016, state tax liability was approximately $7,201 and $47,000, respectively. Such expense was recognized in the accompanying condensed consolidated financial statements.


NOTE – 10 SIGNIFICANT CUSTOMERS & GEOGRAPHICAL INFORMATION

Milestone Scientific’s consolidated dental sales by product and by geographical region are as follows:

  

Three months Ended March 31

 
  

2017

  

2016

 

DOMESTIC

                

Instruments

 $185,645   10.8% $661,645   39.3%

Handpieces

  1,510,486   88.1%  988,143   58.7%

Other

  18,941   1.1%  34,379   2.0%

Total Domestic

 $1,715,071   100.0% $1,684,167   100.0%

INTERNATIONAL

                

Instruments

 $1,358,670   68.8% $1,268,156   67.3%

Handpieces

  583,349   29.6%  584,708   31.0%

Other

  31,898   1.6%  32,342   1.7%

Total International

 $1,973,917   100.0% $1,885,206   100.0%

DOMESTIC/INTERNATIONAL ANALYSIS

                

Domestic

 $1,715,071   46.5% $1,684,167   47.2%

International

 $1,973,917   53.5% $1,885,206   52.8%

Total Product Sales

 $3,688,988   100.0% $3,569,373   100.0%

Milestone Scientific has informal arrangementsarrangements with the manufacturer of the STA, CompuDent® and CompuMed® instruments, one of the principal manufacturers for those instruments pursuant to which they manufacture these products under specific purchase orders but without any long-term contract or minimum purchase commitment. In March 2016, Milestone Scientific has openentered into a purchase orders withcommitment for delivery of 3,000 instruments. There are 700 instruments remaining on this purchase order as of March 31, 2017. An advance an aggregate of $299,180 was remaining at March 31, 2017. In January 2017, Milestone Scientific entered into a contract manufacturer to manufacture STA instruments.  The contract manufacturer bills Wand Dental aspurchase commitment for the work progresses and it is Wand Dental’s policy to record these payments as advances on contracts. These advances are reclassified into inventory whendelivery of 2,000 instruments beginning in the contract manufacturer ships the product and title passes to Wand Dental. The4th quarter of 2017. An advance of $514,748 was recorded at March 31, 2017.Consequently, advances on contracts represent funding of future STA inventory purchases. The balance of the advanceshave been classified as of September 30, 2016current at March 31, 2017 and December 31, 2015, is $1,268,6942016.

For the three months ended March 31, 2017, an aggregate of approximately 79% of Milestone Scientific's net product sales were to two customers/ distributors (one of which was a related party), 52% and $1,215,12827%, respectively. The advance is classified as current based onAccounts receivable for the estimated annual usagetwo major customers/distributors amounted to an aggregate of approximately $2,481,055, or 83% of Milestone Scientific's accounts receivable for three months ended March 31, 2017. For the underlying inventory.   three months March 31, 2016, an aggregate of approximately 82% of Milestone Scientific's net product sales were to three customers/distributors (one of which was a related party), 35%, 26% and 21%, respectively. Accounts receivable for the two major customers /distributors amounted to approximately $2,994,686, or 85% of gross accounts receivable, for the year ended December 31, 2016.

 

NOTE 8 INCOME TAXES11

For the nine months ended September 30, 2016 and 2015, state tax credit $29,300 and liability was $40,751, respectively. Due to Milestone Scientific’s history of past operating losses, which required a full valuation allowances for all of Milestone Scientific’s deferred tax assets at September 30, 2016 and 2015, no recognition was given to the utilization of the remaining Federal net operating loss carryforwards.  RELATED PARTIES

NOTE – 9 CONCENTRATIONS & GEOGRAPHICAL INFORMATION

 

Milestone Scientific has a manufacturing agreement with one of theits principal manufacturers which is a related party, of its handpieces, which is a related party, pursuant to which they manufactureit manufactures products under specific purchase orders, but without minimum purchase commitments. A five percent shareholderPurchases of Milestone Scientific is also a shareholder of this vendor. Purchaseshandpieces from this supplier manufacturer were $2,088,229$452,352 and $1,801,449$636,059 during ninethe three months ended September 30,March 31, 2017 and 2016, and 2015, respectively. Milestone Scientific Inc owed $984,286$1,082,304 and $716,520$1,235,052 to this supplier manufacturer as of September 30, 2016March 31, 2017 and December 31, 2015,2016, respectively.

 

For the nine months ended September 30, 2016 and 2015 (i) two customers (distributors), one of which is a related party, accounted for approximately 70% (62% and 8%), and approximately 33% (15% and 18%), of Milestone Scientific’s net product sales, respectively; and (ii) two customers accounted for approximately $1,995,000 ($1,850,000 and $145,000) representing approximately 78% (72% and 6%), and three customers accounted for approximately $1,572,000 ($1,089,000, $306,000 and $177,000) representing 69% (47%, 13% and 9%), of accounts receivable, respectively.

Milestone Scientific’s sales by product category and by geographical region are as follows: 

  

Three Months Ended September 30,

 

Nine Months Ended September 30,

  

2016

 

2015

 

2016

 

2015

DOMESTIC

            

Instruments

 $- $9,555 $852,149 $611,845

Handpieces

  106,908  672,425  1,860,593  1,777,548

Other

  12,508  18,899  46,634  20,661

Total Domestic

 $119,416 $700,879 $2,759,376 $2,410,054

INTERNATIONAL

            

Instruments

 $1,909,030 $891,657 $3,468,080 $1,705,703

Handpieces

  1,070,166  861,512  2,558,224  2,833,043

Other

  87,984  5,910  188,046  48,121

Total International

 $3,067,180 $1,759,079 $6,214,350 $4,586,867

Total Product Sales

 $3,186,596 $2,459,958 $8,973,726 $6,996,921

NOTE – 10 PENSION PLANS

         

Milestone Scientific has a Defined Contribution Plan that allows eligible employeeshad $356,400 and $1,000,000 of related party sales of handpieces and instruments during the three months ended March 31, 2017 and 2016, respectively, to contribute partMilestone China. As of their salary through payroll deductions.March 31, 2017 and December 31, 2016 Milestone Scientific does not contributerecorded deferred revenues and cost associates with sales to this plan, but does payMilestone China of $356,400 and $181,116, and $1,001,800 and $620,041, respectively.  As of March 31, 2017 and December 31, 2016 Milestone China owes $1,358,200 and $2,714,600, respectively, to Milestone Scientific for handpieces and STA instruments which is included in Accounts Receivable from related party on the administrativecondensed consolidated balance sheets.  Milestone China paid $1,001,800 in April 2017 to satisfy the outstanding instruments sales from 2016 and therefore $1,001,800 has been recorded in revenue related to 2016 sales for the three months ended March 31, 2017.  


            Milestone Scientific recognizes the total revenue and costs of goods sold at the plan, whichtime the shipment of instruments and handpieces to Milestone China are paid. However, due to timing differences of when the inventory is sold to Milestone China and when Milestone China sells the acquired inventory to third parties, elimination of the intra-entity profit is required as of the balance sheet date. In accordance with ASC 323 Equity Method and Joint Ventures, Milestone Scientific has deferred the gross profit associated with inventory shipped to Milestone China that has not been sold to third parties. The deferred profit of $675,391 and $630,990, as of March 31, 2017 and December 31, 2016, respectively was included within accounts receivable from related party in the condensed consolidated balance sheets. The profit deferred was $44,401 and $104,889 as of March 31, 2017 and 2016, respectively, and was included within loss on earnings from China Joint Venture on the condensed consolidated statements of operations.   

          In August 2013, a stockholder of Milestone Scientific entered a three-year agreement with Milestone Scientific to provide financial and business strategic services. Expenses recognized on this agreement were not significant.$25,000 and $35,000 for the three months ended March 31, 2017 and 2016, respectively. 

 

NOTE 1112 COMMITMENTS AND OTHER

 

(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 atand provides for a monthly costlease payment of $12,522. Additionally, Milestone Scientific has other smaller insignificant leases ending through 2017. A 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,March 31, 2017 and 2016, rent expense amounted to $25,031$34,993, and $95,019, respectively. For the three and nine months ended September 30, 2015, rent expense amounted to $18,941 and $56,693,$35,232 respectively.

 

(2) Contract Manufacturing Arrangement

 

Milestone Scientific has informal arrangements for the manufacture of its product, The STA (single tooth anesthesia)Single Tooth Anesthesia System® instrument is manufactured for Milestone Scientific by Tricor Systems, Inc. pursuant to specific purchase orders. The STA and the Wand® Handpiece with Needle is supplied to Milestone Scientific by a contractor in the United States, which arranges for its manufacture with two factories in China.

 

The termination of the manufacturing relationship with any of the above manufacturers could have a material adverse effect on Milestone Scientific’sScientific’s ability to produce and sell its products. Although alternate sources of supply exist and new manufacturing relationships could be established, Milestone Scientific would need to recover its existing tools or have new tools produced. Establishment of new manufacturing relationships could involve significant expense and delay. Any curtailment or interruption of the supply, whether or not as a result of termination of such a relationship, would adversely affecthave a material adverse effect on Milestone Scientific.Scientific’s financial condition, business and results of operations.

 

(3) Other Commitments and Subsequent Events

 

Other Commitments

The Chief Executive Officer’sMilestone Scientific's employment agreement with Milestone Scientificits Chief Executive Officer provides 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. ForMilestone Scientific expensed approximately $51,000 for the three and nine months ended September 30,March 31, 2017 and 2016, approximately $50,777 and $152,000 was chargedrespectively to expense, respectively.  For the three and nine months ended September 30, 2015, approximately $50,778 and $152,000 was charged to expense, respectively.fund this obligation.  

 

The technology underlying the SafetyWandSafetyWand® and CompuFlo®, and an improvement to the controls for CompuDent® were developed by the Director of Clinical Affairs and assigned to us.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. The Director of Clinical Affairs was granted, pursuant to the agreement, an option to purchase, at fair market value on the date of the grant 8,333 shares of common stock upon the issuance of each additional patent relating to these technologies. If products produced by third parties use any of these technologies (under license from us) then the Director of Clinical Affairs will receive the corresponding percentage of the consideration received by Milestone Scientific for such sale or license.


The Director of Clinical Affairs’ royalty fee was $148,185$131,908 and $449,875 during$190,626 for the three and nine months ended September 30,March 31, 2017 and 2016, respectively and $117,320 and $313,751, during the three and nine months ended September 30, 2015, respectively. Additionally, Milestone Scientific expensed consulting fees to the Director of Clinical Affairs of $68,751 and $206,253 for the three and nine months ended September 30, 2016. Additionally, Milestone Scientific expensed consulting fees to the Director of Clinical Affairs of $39,300March 31, 2017 and $117,900 for the three and nine months ended September 30, 2015,2016, respectively.

 

Beginning January 1, 2016, Subsequent Events

Milestone Scientific entered into a non-exclusive distribution agreement with Henry Schein. In June 2016 Milestone Scientific established a new exclusive distribution arrangement for its dental products for the United Stateshas evaluated all subsequent events and Canada with Henry Schein Inc. (“Henry Schein”), a global leader of distributionhas determined that there are no events to recognize or disclose in the dental supplies. Under the new arrangement Milestone Scientific will, for the first time, have a dedicated independent sales force visiting dentists.

these financial statements.

 



ITEM 2.

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

 

The following discussions of our financial condition and results of operations should be read in conjunction with the financial statements and the notes to those statements includedincluded elsewhere in this Form 10-Q. Certain statements in this discussion and elsewhere in this report constitute forward-looking statements, within the meaning of section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), that involve risks and uncertainties. Our actual results may differ materially from those anticipated in these forward-looking statements.

 

OVERVIEW

 

Milestone Scientific Inc. (“Milestone Scientific”, “our”, “us” or “we”)Our common stock was officially listed on the NYSE MKT on June 1, 2015 and trades under the symbol “MLSS”. We have developed a proprietary, computer-controlled anesthetic delivery instrument, through the use of The Wand®, a single use disposable handpiece. The instrument is its trading symbol. Wemarketed in dentistry under the trademark CompuDent®, and STA Single Tooth Anesthesia System® and in medicine under the trademark CompuMed®. CompuDent® is suitable for all dental procedures that require local anesthetic. CompuMed® is suitable for many medical procedures regularly performed in plastic surgery, hair restoration surgery, podiatry, colorectal surgery, dermatology, orthopedics and a number of other disciplines. The dental instruments are sold in the United States and in over 47 countries abroad. There have been no medical instruments sold in the United States and limited amounts sold internationally as of the reporting date, although certain medical instruments have obtained CE mark approval and now can be marketed and sold in most European countries. Milestone Scientific’s products are manufactured by a medical research and development company that designs and patents innovative injection technology.  Our computer-controlled injection systems make injections precise, efficient and virtually painless.     third-party contract manufacturer.

 

In 2016,2017, Milestone Scientific remainsremained focused on advancing efforts to achieve our twothree primary objectives; those being:

Enhancing our global reach by partnering with distribution companies in the medical sector and

 

Obtaining the 510(k) marketing clearance with the United States Food and Drug Administration ("FDA") for the epidural and intra articular instruments.

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 Instrument (STA Instrument)

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

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

 

Our Injection TechnologySTA Instrument Growth

 

Since our inception we have engagedits market introduction in pioneering proprietary, innovative, computer-controlled injection technologiesearly 2007, the STA Instrument and solutions for the medical and dental markets. We have focused our energy and resources on redefining the worldwide standard of care for injection techniques by making the experience more comfortable for the patient and by reducing the anxiety and stress of administering injections for the healthcare provider.

We believe that we and our technology are widely recognized by key opinion leaders (i.e. academics and practicing dentists whose opinions are widely respected), industry experts and medical and dental practitioners as a leader in the emerging, high growth, computer-controlled injection industry; and we remain intent on expanding the use and application of our proprietary, patented technologies to achieve greater operational efficiencies, enhanced patient safety and therapeutic adherence, and improved quality of care within a broad range of medical disciplines.

We have developed and commercialized of proprietary, innovative, computer controlled injection instruments and related disposable, single-use handpieces for the medical and dental markets. We believe our dental instruments have set a new standard of care for dental injections. As of September 30, 2016, the Company has not yet obtained U.S. Food and Drug Administration (“FDA”) regulatory clearance for our new epidural anesthetic injections and intra-articular injections instruments However, as of September 2014, the company did receive European Union (CE) clearance to market the instruments in the European Market. Our technology is proven and well established and our dental instrumentsprior C-CLAD products have been used to administer millions of injections worldwide. Each of our instrumentsdeliver over 66 million safe, effective and comfortable injections. The instrument has a related single use disposable leading to a continuing revenue stream following sale of the instrument.

CompuDent® and the Wand®

Our first commercial product, the CompuDent®, and its associated disposable Wand® handpiece for the dental market is intended to allow the dentist to provide painless injections for virtually all dental procedures, including routine cleanings and fillings, as well as more sophisticated implants, root canals and crowns. New injections made possible by the CompuDent® eliminate collateral numbness of the tongue, lips and facial muscles and often hasten the onset of anesthesia by eliminating the need for preliminary mandibular blocks. The pencil grip used with the Wand® handpieces provides the practitioner with unprecedented tactile sense and accurate control and allows bi-directional rotation eliminating needle deflection, resulting in a greater success rate. Since the Wand® handpiece does not look like a typical syringe it also reduces patient anxiety and offers the possibility of curing dental phobia of which 40 million Americans suffer (see the Colgate Oral Care website). The CompuDent®instrument is considered one of the major advances in dentistry in the 20th Century and has been favorably evaluated in more than 50 peer reviewed or independentnumerous peer-reviewed, published clinical research reports, which we have reviewed.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.

 

CompuFloGlobal Distribution Network®

 

Our next significant intellectual property advancement was the development of our proprietary patented CompuFlo®technology for the precise delivery of anesthetics and other medicaments into various tissues and bodily cavities. The CompuFlo® technology has been U.S. Food and Drug Administration (“FDA”) approved and allows the practitioner to precisely regulate and control the flow rate of the injectable material while receiving visual and audible in-tissue pressure feedback, allowing the practitioner to determine the tissue into which the injectable material is being delivered. The CompuFlo®technology encompasses the painless delivery benefits of the CompuDent® while allowing the practitioner to know which tissues have been penetrated and to inject medicaments precisely into the desired location. With CompuFlo®, the injection of chemotherapeutics and other toxic substances outside the targeted area can be avoided. The instruments developed using the CompuFlo® also provide a digital record of the time and amount of anesthetic or medicament injected.

Our first system utilizing the CompuFlo®technology was our STA® instrument and related handpiece for the dental market. The STA® instrument and handpiece continue to provide all of the benefits of the CompuDent® system while better facilitating single tooth anesthesia (now generally performed with a high pressure spring loaded gun-like instrument) by allowing the practitioner to monitor and precisely control pressure, rate and volume. Instruments using the CompuFlo® technology can be used to inject a wide variety of liquid medicaments as well as anesthetics. We believe CompuFlo®avoids the negative side effects from the use of traditional hypodermic drug delivery injection instruments, which are well documented in dental and medical literature and include risk of death, transient or permanent paralysis, pain, tissue damage and post-operative complications. Pain and tissue damage often result from uncontrolled flow rates and pressure created during the administration of drug solutions into human tissue. While several technologies have been capable of controlling flow rate, we believe the ability to accurately and precisely control pressure has been unobtainable until the development of CompuFlo®.

The next systems utilizing the CompuFlo® technology were instruments for administering epidural injections and related disposable and an instrument for administering hyaluronic acid and other medicaments into both major and minor joints for the alleviation of pain associated with arthritis and other deleterious joint conditions.

Our epidural injection instrument using CompuFlo®pressure sensing technology provides an objective tool that we believe consistently and accurately identifies the epidural space by detecting the difference in pressure between the ligamentum flavum and the extraligamentary tissue. In studies utilizing the CompuFlo®technology the epidural space has been correctly identified 100% of the time. Knowing the precise location of a needle during an epidural injection procedure provides a measure of safety not presently available to doctors using conventional syringes, in the absence of fluoroscopy, who identify the epidural space by relying on the subjective perception of loss of resistance to saline.

Precisely controlling in-tissue pressure increases patient safety by reducing the risk of tissue damage and post-treatment pain related to excessive pressure that may occur during certain injections. Identification of the tissue, in which the needle tip is imbedded, is believed to be highly important in epidural injections, intra-articular injections and numerous organ, subcutaneous and intramuscular injections.

Our intra-articular injection instrument we believed to be particularly efficacious for arthritis patients who are obliged to endure multiple painful injections annually for a lifetime. Often these injections are not efficacious because the doctor using a syringe fails to locate the intra-articular space or does not inject the appropriate volume of hyaluronic acid or other medicament into that space. The CompuFlo®technology has been successful in administering hyaluronic acid and other medicaments into the intra-articular space in both small and large joints using its computer-controlled pressure sensing capabilities in an independent animal study.

Both the epidural and intra-articular instruments have obtained CE mark approval and may now be marketed and sold in most European countries and many other countries accepting CE approved instruments. In the United States we have completed required testing for the epidural instrument for birthing and pain management and have submitted the favorable results of these tests to the FDA. We expect to receive FDA approval of our epidural instrument by the end of the first quarter 2017 and of our intra-articular instrument in the same time frame. Given the fact that the speed of approval depends on the FDA it is impossible for any company to correctly predict the timely. The development of an international marketing network of independent distributors awaits the receipt of FDA approval, although a limited number of European and near-east distributors have already been appointed.

At earlier stages of development are our products using our CompuFlo® technology for less painful injections into the eye and for the subcutaneous injection of fillers and other substances in the dermatology market. In the self-injectable market there are a number of injectable drugs routinely self-administered in a home or office setting using spring loaded automatic injection devices by people who suffer from long term chronic conditions such as Multiple Sclerosis, Rheumatoid Arthritis, and other diseases of the auto immune system. We believe the CompuFlo®technology, using pressure sensing capabilities, can serve as a painless subcutaneous injection method for these self-administered drugs. A significant reduction in pain during delivery should have a positive impact on compliance, which is a major consideration when physicians are treating patients. In addition, the ability to record the injection will allow for significantly enhanced monitoring of the patient.

Distribution and Marketing ArrangementsCanadian Market

 

Beginning January 1, 2016, Milestone Scientific entered into a non-exclusive distribution agreement with Henry Schein, Inc. (“Henry Schein”). In June 2016, we established newthat agreement was replaced with an exclusive distribution arrangementsarrangement for our dental products for the United States and Canada with Henry Schein. Under these arrangementsthis arrangement we, will, for the first time, have a semi-dedicated independent sales force visiting dentists. We believe that these arrangementsthis arrangement will be more effective than previous arrangements relying on appearances at dental shows and catalog sales.

To date, Henry Schein has endeavored to accomplish the goals set forth in the exclusive distribution agreement for The Wand® STA instrument and handpieces, including training of its exclusive products sales specialists. Specifically, 25 exclusive product sales specialists have now been fully trained as experts in the features, advantages and benefits of The Wand® STA instrument and handpieces and all 25 are currently in the field selling the instrument. Henry Schein also plans to train an additional two to three dedicated customer service representatives to support dentists across North America through its exclusive product sales customer call center.  


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

 

International Market

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

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

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

In June 2014, Milestone Scientific invested $1 million in Milestone China Ltd. (“Milestone China”) by contributing 772 STA Instruments to Milestone China for a 40% ownership interest. Milestone Scientific recorded this investment under the equity method of accounting. Since September 2014, we have an established exclusive distribution arrangement with Milestone China for the distribution of the STA Instrument in China, which has led to the placement of our dental instruments in clinics serving major cities in China. Milestone China purchases STA Instruments from us for cash as required. We believe that Milestone China will make a positive impact on the dental and future medical business opportunities in China and other parts of Asia.

In China, where the dental market lags behind other health care services and has largely been neglected in the past,past, a CS Market Research report indicates that 50% of adults and 70% of children out of China’s estimated 1.3 billion plus population have tooth decay problems and over 90% have periodontal disease. See(See Shuyu Sun & Seth Pierrepont, Pierrepont. The Dental Equipment Market Over in ChinaCS Market Research (Sept. 20, 2005) and Opportunities Abound for Dental Care in China, CHINA BRIEFING (February 27, 2015)). With increasing affluence and increasing attention towards personal care, the provision of dental services has been growing rapidly. We have established exclusive distribution arrangements with Milestone China, Ltd, a 40% owned affiliate, which has placed our dental instruments in clinics serving major cities in China. We expect this initial limited distribution of instruments will lead to both increased sales of dental instruments and our single-use handpieces.

  

Competition

Milestone Scientific faces intense competition from many companies in the medical and dental device industry, possessing substantially greater financial, marketing, personnel, and other resources. In dentistry the main competition is the syringe, a product that has been in use and virtually unchanged for more than 150 years. For epidurals, we face competition from the established method of providing epidurals with the use of two medical practitioners, one to insert and place the needle and the other to inject the anesthesia and potentially from a computer controlled injection instrument that claims to be able to reliably identify the epidural space but has had limited success in the marketplace.


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 each product category:

 

 

Three Months Ended September 30,

  

Nine Months Ended September 30,

  

Three months Ended March 31

 
 

2016

  

2015

  

2016

  

2015

  

2017

  

2016

 

DOMESTIC

                                                

Instruments

 $-     $9,555   1.4% $852,149   30.9% $611,845   25.4% $185,645   10.8% $661,645   39.3%

Handpieces

  106,908   89.5%  672,425   95.9%  1,860,593   67.4%  1,777,548   73.8%  1,510,486   88.1%  988,143   58.7%

Other

  12,508   10.5%  18,899   2.7%  46,634   1.7%  20,661   0.9%  18,941   1.1%  34,379   2.0%

Total Domestic

 $119,416   100.0% $700,879   100.0% $2,759,376   100.0% $2,410,054   100.0% $1,715,071   100.0% $1,684,167   100.0%

INTERNATIONAL

                                                

Instruments

 $1,909,030   62.2% $891,657   50.7% $3,468,080   55.8% $1,705,703   37.2% $1,358,670   68.8% $1,268,156   67.3%

Handpieces

  1,070,166   34.9%  861,512   49.0%  2,558,224   41.2%  2,833,043   61.8%  583,349   29.6%  584,708   31.0%

Other

  87,984   2.9%  5,910   0.3%  188,046   3.0%  48,121   1.0%  31,898   1.6%  32,342   1.7%

Total International

 $3,067,180   100.0% $1,759,079   100.0% $6,214,350   100.0% $4,586,867   100.0% $1,973,917   100.0% $1,885,206   100.0%

DOMESTIC/INTERNATIONAL ANALYSIS

DOMESTIC/INTERNATIONAL ANALYSIS

                                             

Domestic

 $119,416   3.7% $700,879   28.5% $2,759,376   30.7% $2,410,054   34.4% $1,715,071   46.5% $1,684,167   47.2%

International

  3,067,180   96.3%  1,759,079   71.5%  6,214,350   69.3%  4,586,867   65.6% $1,973,917   53.5% $1,885,206   52.8%

Total Product Sales

 $3,186,596   100.0% $2,459,958   100.0% $8,973,726   100.0% $6,996,921   100.0% $3,688,988   100.0% $3,569,373   100.0%

 

Milestone Scientific earned gross profit of approximately $1.7 million and $5.3 million62% in each of the three and nine months ended September 30, 2016. Milestone Scientific earned gross profit of approximately $1.7 millionMarch 31, 2017 and $4.7 million in the three and nine months ended September 30, 2015.2016, respectively. However, the revenues and related gross profits have not been sufficient to support overhead, new product introduction and research and development expenses. Although Milestone Scientific anticipates expending funds for research and development in 2016,2017, these amounts will vary based on the operating results for each quarter.

In 2017, Milestone Scientific has incurred annual operating lossesplans to support increased sales and negative cash flows from operating activities since its inception, except for 2013. At September 30, 2016,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 has sufficient cash reserveswill continue the utilization of independent hygienists for training individual practitioners and group practices domestically, refined and directed advertising to meet all of its anticipated obligations for at least the next twelve months, including a limited amount of financing for the operation of Milestone Medical until additional financing is consummated in late 2016dental professionals, continue to develop Key Opinion Leaders (KOL) and 2017. Milestone Scientific is actively pursuing the continued generation of positive cash flows from operating activities through increase in revenue, assessment of current contractssupport and current negotiations.broaden our global distribution network.

 

At December 31, 2015, Milestone Scientific determined that Milestone Medical was a variable interest entity (VIE), as such Milestone Medical was consolidated with Milestone Scientific. Previous to this determination Milestone Medical was accounted for under the equity method and the results of their operation were shown as a separate line on the Statement of Operation for periods prior to December 31, 2015.  Accordingly, in comparison with 2016 consolidated financial statements certain amounts may a not appear to be comparable to the corresponding results in 2015.

Results of Operations

 

The following table sets forth for the consolidated results of operations for the three and nine months ended September 30,March 31, 2017 and 2016, compared to 2015respectively, as a percentage of revenues. The trends suggested by this table may not be indicative of future operating results:

 

 

Three Months Ended September 30,

  

Nine Months Ended September 30,

  

Year Ended March 31,

 
 

2016

  

2015

  

2016

  

2015

  

2017

  

2016

 

Revenue

                

Product sales, net

 $ 3,186,596  100% $ 2,459,958  100% $ 8,973,726  100% $ 6,996,921  100
%
 $3,688,988   100% $3,569,374   100%

Cost of products sold

 1,517,561  48% 794,285  32% 3,675,552  41% 2,298,162  33%  1,402,285   38%  1,368,190   38%

Gross profit

 1,669,035  52% 1,665,673  68% 5,298,174  59% 4,698,759  67%  2,286,703   62%  2,201,184   62%

Selling, general and administrative expenses

 2,933,950  91% 2,480,354  99% 9,226,062  92% 6,969,332  99%  2,707,620   73%  3,001,130   84%

Research and development expenses

 303,268  9% 20,676  1% 756,045  8% 49,616  1%  105,015   3%  143,442   4%

Total operating expenses

 3,237,218  100% 2,501,030  100% 9,982,107  100% 7,018,948  100%  2,812,635   76%  3,144,572   88%

Loss from operations

 (1,568,183) (49)% (835,357) (34)% (4,658,933) (52)% (2,320,189) (33)%  (525,932)  (14)%  (943,388)  (26)%

Other (expenses)

  (1,209)  (0)%  (1,237)  (0)%

Interest expense

 (846) (0)% (1,043) (0)% (2,782) (0)% (961) (0)%  758   0%  302   0%

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

 (1,569,029) (49)% (836,400) (34)% (4,686,715) (52)% (2,321,150) (33)%  (526,383)  (14)%  (944,323)  (26)%

Provision for income tax

 (16,522) (1)% (27,105) 3% (80,147) (2)% (40,751) 2%  (7,201)  (0)%  (46,834)  (1)%

Loss before equity in net earnings of equity investments

 (1,,581,551) (46)% (863,505) (35)% (4,766,862) (53)% (2,361,901) (34)%  (533,584)  (14)%  (991,157)  (28)%

Loss on earnings from Milestone Medical

 -  0% (590,612) (24)% -  0% (1,566,711) (22)%

Income (Loss) on earnings from Education Joint Venture

 -  0% 2,343  0% -  0% (5,493) (0)%

Loss on earnings from China Joint Venture

 (253,451) 16% (123,083) 15% (554,766) 12% (187,062) 8%  (44,401)  (1)%  (269,726)  (8)%

Loss in equity investments

 (253,451) (8)% (711,352) (29)% (554,766) (6)% (1,759,266) (25)%  (44,401)  (1)%  (269,726)  (8)%

Net Loss

 (1,839,002) (58)% (1,574,857) (64)% (5,321,628) (59)% (4,121,167) (59)%  (577,985)  (16)%  (1,260,883)  (35)%

Net loss attributable to noncontrolling interests

 (137,752) (4)% (5,655) (0)% (1,113,958) (12)% (59,642) (1)%  (73,117)  (2)%  (510,824)  (14)%

Net loss attributable to Milestone Scientific Inc.

 $ (1,701,250) (53)% $ (1,569,202) (64)% $ (4,207,670) (47)% $ (4,061,525) (58)% $(504,868)  (14)% $(750,059)  (21)%

 


The three monthsThree Months ended September 30, 2016March 31, 2017 compared to the three monthsThree Months ended September 30, 2015March 31, 2016

 

The following paragraphs will describe the 2016 results of 2017 compared to 2015.2016.

 

Total revenues for the three months ended September 30,March 31, 2017 and 2016, and 2015principally dental revenues, were approximately $3.2$3.7 million and $2.5$3.6 million, respectively. The total revenue increased by approximately $727,000 or 28%,3% which was principally related to the increase in instrument and handpieceshandpiece sales to China. Domestic sales in the United States decreased by approximately $582,000 in 2016. In the third quarter of 2016 Henry Schein did not purchase instruments and handpieces as they continued to introduce our instrument to the market and sell down their current inventory. International Instruments sales increased by approximately $1 million$31,000 in 2017. International sales in 2017 increased by approximately $89,000 over the same period in 20152016 principally due to a shipment of STA instruments and handpiece to Milestone China. Handpieces sales increased by approximately $209,000 compared toHowever, we believe that the comparable period in 2015. International sales increased in total by approximately $1.3 million. In the USA, Milestone Scientific did not renew its non-exclusive distribution and marketing agreement with Aseptico Inc. after March 2016.  Instead, Milestone Scientific chose to continue our distribution and marketing effort in the USA and Canada pursuant to the non-exclusive distribution agreement with Henry Schein.  In June 2016 Milestone Scientific entered into an exclusive distribution agreement with Henry Schein pursuant to which Henry Schein agreed to have a dedicated independent sales force to market our dental products in the USA and Canada. We believe that this agreement with Henry Schein will lead to increased domestic sales in 2017 as the product and sales force training has been substantially completed as of STA instruments and handpieces in the fourth quarter of 2016 and intoMarch 31, 2017.

 

The gross margin in 2016 decreased to 52% versus 68% in 2015. This decrease in gross profit margin is due to a special price reduction given to a distributor in a key international market for instruments in an effort to stimulate growth in the 2016 sales volume.  This distributor is a related party of the Company. Although the gross margin percentage decreased 16%, gross profit dollars in 2016 was approximately the same as 2015, or approximately $1.7 million.

Selling, general and administrative expenses for the three months ended September 30, 2016March 31, 2017 were approximately $2.9$2.7 million versus $2.5$3.0 million in 2015. This net increasethe 2016 period. The decrease of approximately $428,000$293,000 is predominantly due to the consolidation of Milestone Medical commencing on December 31, 2015. In 2015, Milestone Medical was accounted for under the equity method, as such their line item expenses were recorded as a one line entry in the Statement of Operations as a Loss on Earnings from Milestone Medical of approximately $591,000. The total operating expense for Milestone Scientific for the quarter ending September 30, 2016 and 2015 was $3.1 million and $2.8 million, respectively, after giving effect to proforma consolidation of Milestone Medical in 2015, which resulted in a net increase of $300,000.

On a consolidated basis, giving effect to the consolidation of Milestone Medical, Milestone Education, LLC (“Milestone Education”), Milestone Advanced Cosmetic Systems, Inc. (“Milestone Cosmetic”) and Wand Dental, Inc. (“Wand Dental”), each a subsidiary of Milestone Scientific, selling, general and administrative expenses net increased by approximately $300,000 for the three months ended September 30, 2016 as compared to the same prior year period. The increasereduction in selling, general and administrative expenses include a decreaseresulting from the completion of $100,000the clinical studies relating to Milestone Medical's epidural and intra articular instruments in salaries and other compensation expense for the three months ended September 30, 2016 as compared to the same prior year period due to a temporary decrease in personnel.  Salary expense is expected to increase in future quarters as we fill existing open positions to grow our business.  The hiring of a replacement Senior Brand Manager, and an increase in our Clinical Hygienist staff to train our current and new customers is anticipated in the future. 2016.

 

            Research and development expenses for the three monthmonths ended September 30,March 31, 2017 and 2016 were approximately $105,000 and 2015 were $300,000 and $20,000,$143,000, respectively. The increasedecrease is due to researchthe phasing out of additional development cost associated with epidural and development projects within Advanced Cosmetic Systems, Inc that relates to the Botox instrument.intraarticular instruments.

 

The loss from operations for the three months ended September 30,March 31, 2017 and 2016 and 2015 was approximately $1.6 million$526,000 and $835,000,$943,000, respectively, an increasea decrease of approximately $732,000. The increase in loss from operations in 2016$417,000. This decrease is primarily attributable to the resultcompletion of the consolidationclinical studies relating to Milestone MedicalMedical's epidural and intra articular instruments in 2016.

 

The loss on earnings from the China Joint Venture was approximately $253,000$40,000 and $123,000$270,000 for the three months ended September 30,March 31, 2017 and 2016, and 2015, respectively, an increasea decrease of approximately $130,000. The increase in loss on earning from the China Joint Venture is primarily due to the China Joint Venture being in its initial operating and expansion cycle in China.  As such, we expect the China Joint Venture to continue to have losses in 2016.$230,000.

 

Nine months ended September 30, 2016 compared to Nine months ended September 30, 2015

            Total revenues for the nine months ended September 30, 2016 and 2015 were approximately $8.9 and $7.0 million, respectively. The total dental revenue increased by approximately $2 million or 28% which was primarily related to the increase in instrument sales worldwide. Domestic sales in the United States increased by approximately $349,000 in 2016. This increase in revenue relates to sales of both STA instruments and handpieces. It is important to note that in the first half of 2016 Henry Schein a global leader in the distribution of medical, and dental supplies continued to purchased instruments and handpieces as a non-exclusive distributor in United States and Canada. In the third quarter Henry Schein continued to sell through their previously purchased dental inventory and increase their marketing base for the instruments and handpieces. International Instruments sales increased approximately $1.7 million over the same period in 2015 due to a shipment of STA instruments to China. Sales of handpieces decreased by $274,000 over the same period in 2015 as our distributor sells though their previously purchase handpieces. In the USA, Milestone Scientific did not renew its non-exclusive distribution and marketing agreement with Aseptico Inc. after March 2016.  Instead, Milestone Scientific chose to continue our distribution and marketing effort in the USA and Canada pursuant to the non-exclusive distribution agreement with Henry Schein.  In June 2016, Milestone Scientific entered into an exclusive distribution agreement with Henry Schein pursuant to which Henry Schein agreed to have a dedicated independent sales force to market our dental products in the USA and Canada. We believe that this agreement with Henry Schein will lead to increased domestic sales of STA instruments and handpieces in the fourth quarter of 2016 and into 2017.

The gross margin in 2016 decreased to 59% versus 67% in 2015. This decrease in gross profit margin is due to a special price reduction given to a distributor in a key international market for instruments in an effort to stimulate growth in the 2016 sales volume. This distributor is a related party of the Company.  Although the gross margin percentage decreased 8%, gross profit dollars in 2016 increased to approximately $5.3 million from approximately $4.7 million in 2015 or, by approximately $600,000 over the same prior year period.

Selling, general and administrative expenses for the nine months ended September 30, 2016 were approximately $9.2 million versus $7.0 million in 2015. This increase of approximately $2.2 million is predominantly due to the consolidation of Milestone Medical in the first half of 2016. In 2015, Milestone Medical was accounted for under the equity method, as such their line item expenses were recorded as a one line entry in the Statement of Operations as a Loss on Earnings from Milestone Medical. The total operating expense for Milestone Medical for the nine months ending September 30, 2016 and 2015 was $2.6 million and $3.1 million, respectively. The major reduction in the total operating expense for Milestone Medical was a reduction in Salary and Research and Development Expense of approximately $485,000.

On a consolidated basis, giving effect to the consolidation of Milestone Medical, Milestone Education, LLC (“Milestone Education”), Milestone Advanced Cosmetic Systems, Inc. (“Milestone Cosmetic”) and Wand Dental, Inc. (“Wand Dental”),  selling, general and administrative expenses increased by approximately $2.2 million  for the nine month  ended September 30, 2016.  This increase is related to marketing, consulting, administrative expense, and clinical studies compared to the same prior year period. However, in the remainder of 2016 Milestone Scientific expects that it will increase personnel which it believes is required to grow our business including hiring a replacement Senior Brand Manager, and an increase in our Clinical Hygienist staff to train our current and new customers.

Research and development expenses for the nine months ended September 30, 2016 and 2015 were approximately, $756,000 and $49,000, respectively. The increase is due to research and development projects within Advanced Cosmetic Systems, Inc that relates to the Botox instrument.

The loss from operations for the nine months ended September 30, 2016 and 2015 was approximately $4.7 million and $2.3 million, respectively, an increase of approximately, $2.4 million. The increase in loss from operations in 2016 is primarily the result of the consolidation Milestone Medical in 2016.

The loss on earnings from the China Joint Venture was approximately $554,000 and $187,000 for the nine months ended September 30, 2016 and 2015, respectively, an increase of approximately $367,000. The increase in loss on earning from the China Joint Venture is primarily due to the China Joint Venture being in its initial operating and expansion cycle in China.  As such, we expect the China Joint Venture to continue to have losses in 2016.

For the reasons explained above, and after factoring in the positive effects of net loss attributable to non-controlling interest, the net loss for the nine months ended September 30, 2016 was $5.3 million as compared to the net loss for the nine months ended September 30, 2015 of $4.1 million.

Liquidity and Capital ResourcesResources

 

At September 30, 2016,March 31, 2017, Milestone Scientific had cash and cash equivalents of approximately $2.3$2.9 million, total current assets of approximately $10.7$11.3 million and working capital of approximately $6.3$7.7 million.  We believe that our cash on hand, accounts receivable and the anticipated revenues from the dental business will be sufficient to operatefund our ongoing business operations for at least the next 12 months.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 maintainmaintain available inventory to meet our domestic and international sales requirements. Cash flows fromFor the three months ended March 31, 2017 and 2016, our net cash used in operating activities for the nine months ended September 30, 2016 and 2015 werewas approximately a negative $4.1$0.9 million and $3.7$1.4 million, respectively.respectively, which represents a decrease of approximately $0.5 million year over year.

 

Milestone            Milestone Scientific has incurred annual operating losses and negative cash flows from operating activities since its inception, except for the year ended December 31, 2013. Milestone Scientific is actively pursuing the generation of positive cash flows from operating activities through increases in revenues based upon management’smanagement's assessment of present contracts, and current negotiations and reductions in operating expenses. The consolidation of Milestone Medical in December 2015 and the lack of capital raising activities by Milestone Medical created a unique situation for Milestone Scientific. Milestone Scientific is not obligated to continue its financial support of Milestone Medical, but FDA clearance for Milestone Medical’s 510K FDA clearance is expected in 2017. Milestone Scientific expectsbelieves that clearance to commercialize theits epidural and intra articularintra-articular instruments in 2017 will improve theour capital raising opportunities and financial condition ofcondition.  Although there can be no assurances on the Company.

Milestone Scientifictiming and ultimate outcome, management believes that the new exclusive distribution agreement with Henry Schein, the world’s largest supplier of medical, dental and veterinary supplies and devices, will improve our dental revenues in the upcoming 12 months. To further reduce Milestone Scientific’s expenditures, Milestone Medical expenses related to FDA clearance for Milestone Medical's 510(k) epidural application may occur by the epiduralend of the second quarter of 2017.

            Our condensed consolidated balance sheets included in this report reflects a decrease of approximately $1.4 million in current assets from December 31, 2016 to March 31, 2017. This decrease in current assets was primarily due to a reduction in cash, accounts receivable from related party, deferred cost, other receivables and intra-articular instruments can be controlled as required to meet Milestone Scientific’s budget. By limiting the FDA relatedinventory of approximately $2,578,000. Offset by an increase in accounts receivable, advances on contracts, and prepaid expenses and increasing the dental instrumentother current assets of an aggregate of approximately $1,203,000.


Current liabilities decreased by approximately $1.4 million, from approximately $5.0 million to approximately $3.6 million. The decrease is primarily due to a decrease in accounts payable of $452,000, accounts payable related party of $153,000, accrued expenses of $141,000 and deferred revenue through the new distribution agreement and performing a detailed cash flow projection of the consolidated company and its subsidiaries, management believes that Milestone Scientific will have sufficient cash reserves to meet all of its anticipated obligations over the next twelve months.$645,000.

 

Item 3.     Quantitative and Qualitative Disclosures about Market Risk

 

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

 

Item

Item 4.     Controls and Procedures

Controls and Procedures

 

Milestone Scientific’s management, including theScientific’s Chief Executive Officer and Chief Financial Officer have evaluated the effectiveness of the design and operation of Milestone Scientific’s disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) as of the end of the period covered by this report (the “Evaluation Date”).report. Based upon that evaluation, Milestone Scientific’s Chief Executive Officer and Chief Financial Officer have concluded that the disclosure controls and procedures as of the Evaluation DateMarch 31, 2017 are effective to ensure that information required to be disclosed in the reports Milestone Scientific files or submits under the Exchange Act is recorded, processed, summarized and reported within the time periods specified in the SEC’s rules and forms andan that such information is accumulated and communicated to Milestone Scientific’sScientific's management, including the Chief Executive Officer and Chief Financial Officer, as appropriate to allow timely decisions regarding required disclosure.

 

There were no changes in Milestone Scientific’s internal control over financial reporting identified in connection with the evaluation that occurred during Milestone Scientific’s last fiscal quarter ended September 30, 2016March 31, 2017 that have materially affected, or that are reasonably likely to materially affect, Milestone Scientific’s internal controls over financial reporting.  

. 



PARTPART II – OTHER INFORMATION

 

ITEMITEM 1.

LEGAL PROCEEDINGS

 

None.

 

ITEMITEM 1A.

RISK FACTORS

 

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

 

ITEMITEM 2.

UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS

 

Recent Sales of Unregistered Securities

In September 2016, wethe quarter ended March 31, 2017, Milestone Scientific issued 10,709a total of 167,081 shares of its common stock as compensationfollows:

        83,333 shares upon the exercise of an outstanding stock option at an exercise price of $0.75 per share;

        9,158 shares to an employee.  The fair marketemployee for a bonus with a total value of $25,000; and

        an aggregate of 39,271 shares to six consultants for services rendered with a total value of $58,748.

The foregoing shares were issued in reliance upon the shares was $22,500 The issuance was exemptexemptions from the registration requirements of the Securities Act of 1933, as amended (the "Act"), pursuant to Sections 4(a)(2) andand/or 4(a)(5) of the Act and athereunder. A legend restricting the resale, transfer, or other disposition of such shares other than in compliance with the Act was imprinted on the stock certificate evidencing such shares.

            In August 2016, we issued 101,190 shares of common stock to an accredited investor for consulting services.  The fair market value of the shares was $141,666. The issuance was exempt from the registration requirements of the Act pursuant to Sections 4(a)(2) and 4(a)(5) of the Act and a legend restricting the resale, transfer, or other disposition of such shares other than in compliance with the Act was imprinted on the stock certificate evidencing such shares.

In July 2016, we issued an aggregate of 20,028 shares of common stock to four accredited investors for consulting services.  The fair market value of the shares was $56,078. The issuance was exempt from the registration requirements of the Act pursuant to Sections 4(a)(2) and 4(a)(5) of the Act and a legend restricting the resale, transfer, or other disposition of such shares other than in compliance with the Act was imprinted on the stock certificate evidencing such shares.

In the second quarter of 2016, Milestone Scientific initiated a share exchange program pursuant to which we would exchange one share of common stock for every two outstanding shares of Milestone Medical common stock. As there was no change in control, the acquisition of the non-controlling interest is reflected as an equity transaction with the carrying value of the non-controlling interest adjusted to reflect Milestone Scientific’s increased ownership interest in the subsidiary.  As of September 30, 2016, 5,035,042 shares of common stock have been issued in exchange for 9,005,000 shares of Milestone Medical common stock.  As a result of these exchanges, Milestone Scientific owns approximately 91% of Milestone Medical at September 30, 2016. As a result of these exchanges, Milestone Scientific owns approximately 91% of Milestone Medical at September 30, 2016. The issuances were exempt from the registration requirements of the Act pursuant to Sections 4(a)(2) and 4(a)(5) of the Act and a legend restricting the resale, transfer, or other disposition of such shares other than in compliance with the Act was imprinted on the stock certificates evidencing such shares.

 

ITEMITEM 3.

DEFAULT UPON SENIOR SECURITIES

 

None.

 

ITEMITEM 4.

MINE SAFETY DISCLOSURES

 

Not applicable.

 

ITEMITEM 5.

OTHER INFORMATION

 

None.

   



ITEM 6.

EXHIBITS

Exhibit No.

DescriptionEXHIBITS

31.1

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

31.2

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

32.1

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

32.2

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

32.2

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

101.INS

XBRL Instance Document.*

101.SCH

XBRL Taxonomy Extension Schema Document.*

101.CAL

XBRL Taxonomy Extension Calculation Linkbase Document.*

101.LAB

XBRL Taxonomy Extension Label LinkbaseLinkbase Document.*

101.PRE

XBRL Taxonomy Extension Presentation Linkbase Document.*

101.DEF

XBRL Taxonomy Extension Definition Linkbase Document.*


*

Filed herewith.

**

Furnished, not filed, in accordance with Item 601(32)(ii) of Regulation S-K.

 


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 INCINC.

/s/ Leonard Osser

Leonard Osser

Chief Executive Officer
(Principal Executive Officer)
  
 

/s/ Leonard Osser

 

Leonard Osser

Chief Executive Officer

(Principal Executive Officer)

/s/ Joseph D’Agostino

 

Joseph D’Agostino

 

Chief Operating Officer

 

Chief Financial Officer

(Principal Financial Officer)

Date: May 15, 2017

 

 

28

Date: November 9, 2016