UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

FORM 10-Q

 

(Mark One)

x

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

For the quarterly period ended September 30, 2015

Or

¨

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

For the transition period from                      to                     

Commission File Number: 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)

 

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.    xYes     ¨   No

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

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, or a smaller reporting company. See the definitions of “large accelerated filer,” “accelerated filer” and “smaller reporting 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

 

x

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

As of November 12, 2015, the Issuer had a total of 21,478,248 shares of Common Stock, $.001 par value, outstanding.

 

 

 

 

 

 


MILESTONE SCIENTIFIC INC

TABLE OF CONTENTS

PART I—FINANCIAL INFORMATION

 

Item 1. Financial Statements

  

 

 

 

 

 

 

Condensed Consolidated Balance Sheets September 30, 2015 (Unaudited) and December 31, 2014 (Audited)

  

4

 

 

 

 

 

Condensed Consolidated Statements of Operations Three and Nine months Ended September 30, 2015 and 2014 (Unaudited)

  

5

 

 

 

 

 

Condensed Consolidated Statement of Changes in Stockholders’ Equity for the Nine months Ended September 30, 2015 (Unaudited)

  

6

 

 

 

 

 

Condensed Consolidated Statements of Cash Flows for the Nine months Ended September 30, 2015 and 2014 (Unaudited)

  

7

 

 

 

 

 

Notes to Condensed Consolidated Financial Statements (Unaudited)

  

8

 

 

 

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

  

15

 

 

 

Item 3. Quantitative and Qualitative Disclosures About Market Risk

  

19

 

 

 

Item 4.Controls and Procedures

  

19

 

 

 

 

 

PART II—OTHER INFORMATION

  

 

 

 

 

Item 1. Legal Proceedings

  

20

 

 

 

Item 1A. Risk Factors

  

20

 

 

 

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

  

20

 

 

 

Item 3. Defaults Upon Senior Securities

  

20

 

 

 

Item 4. Mine Safety Disclosures

  

20

 

 

 

Item 5. Other Information

  

20

 

 

 

Item 6. Exhibits

  

20

 

 

SIGNATURES

  

22

 

 

 

2


FORWARD-LOOKING STATEMENTS

When used in this Quarterly Report on Form 10-Q, the words “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 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 to the following trademarks: CompuDent®, CompuMed®, CompuFlo®, The Wand®, The Wand Plus®, The SafetyWand®Dynamic Pressure Sensing Technology®STA Single Tooth Anesthesia, (STA Instrument, instruments and handpieces), Ionic White® (light emitting diode), and Ionic White (whitening toothpaste).

3


 

MILESTONE SCIENTIFIC INC. AND SUBSIDIARIES

CONDENSED CONSOLIDATED BALANCE SHEETS

 

 

 

September 30, 2015

 

 

December 31, 2014

 

 

 

(Unaudited)

 

 

(Audited)

 

ASSETS

 

 

 

 

 

 

 

 

Current Assets:

 

 

 

 

 

 

 

 

Cash and cash equivalents

 

$

4,390,783

 

 

$

10,367,993

 

Accounts receivable, net of allowance for doubtful accounts of $5,000 as of

September 30, 2015 and December 31, 2014

 

 

2,349,347

 

 

 

1,541,478

 

Due from related party

 

 

85,959

 

 

 

 

Note receivable-Milestone Medical Inc

 

 

2,000,000

 

 

 

 

Inventories

 

 

2,804,906

 

 

 

2,497,099

 

Advances on contracts

 

 

1,211,926

 

 

 

721,197

 

Prepaid expenses and other current assets

 

 

428,570

 

 

 

454,566

 

Total current assets

 

 

13,271,491

 

 

 

15,582,333

 

Investment in Milestone Medical Inc

 

 

 

 

 

888,720

 

Investment in Milestone Education LLC

 

 

18,700

 

 

 

24,192

 

Investment in Milestone China

 

 

161,588

 

 

 

348,651

 

Furniture, fixtures & equipment net of accumulated depreciation of $437,024 as of

September 30, 2015 and $416,210 as of December 31, 2014

 

 

115,616

 

 

 

88,818

 

Patents, net of accumulated amortization of $628,953 as of September 30, 2015 and

   $576,960 as of December 31, 2014

 

 

480,021

 

 

 

530,029

 

Other assets

 

 

17,355

 

 

 

14,685

 

Total assets

 

$

14,064,771

 

 

$

17,477,428

 

LIABILITIES AND STOCKHOLDERS’ EQUITY

 

 

 

 

 

 

 

 

Current Liabilities:

 

 

 

 

 

 

 

 

Accounts payable

 

$

780,934

 

 

$

1,453,908

 

Accrued expenses and other payables

 

 

1,350,853

 

 

 

981,168

 

Total current liabilities

 

 

2,131,787

 

 

 

2,435,076

 

Commitments and Contingencies

 

 

 

 

 

 

 

 

Stockholders’ Equity

 

 

 

 

 

 

 

 

Series A convertible preferred stock, par value $.001, authorized 5,000,000 shares,

   7,000 shares issued and outstanding, respectively

 

 

7

 

 

 

7

 

Common stock, par value $.001; authorized 50,000,000 shares; 21,478,248 shares

   issued, 963,451 shares to be issued and 21,444,915 shares outstanding as of

   September 30, 2015; 21,404,494 shares issued, 974,953 shares to be issued and

   21,371,161 shares outstanding as of December 31, 2014

 

 

22,442

 

 

 

22,380

 

Additional paid-in capital

 

 

78,016,152

 

 

 

77,504,415

 

Accumulated deficit

 

 

(66,028,987

)

 

 

(61,967,462

)

Treasury stock, at cost, 33,333 shares

 

 

(911,516

)

 

 

(911,516

)

Total stockholders' equity

 

 

11,098,098

 

 

 

14,647,824

 

Noncontrolling interest

 

 

834,886

 

 

 

394,528

 

Total Equity

 

 

11,932,984

 

 

 

15,042,352

 

Total liabilities and stockholders’ equity

 

$

14,064,771

 

 

$

17,477,428

 

 

See Notes to Condensed Consolidated Financial Statements

 

 

4


MILESTONE SCIENTIFIC INC. AND SUBSIDIARIES

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS

(Unaudited)

 

 

 

Three Months Ended September 30,

 

 

Nine Months Ended September 30,

 

 

 

2015

 

 

2014

 

 

2015

 

 

2014

 

Product sales, net

 

$

2,459,958

 

 

$

2,535,098

 

 

$

6,996,921

 

 

$

7,662,864

 

Cost of products sold

 

 

794,285

 

 

 

829,546

 

 

 

2,298,162

 

 

 

2,624,950

 

Gross profit

 

 

1,665,673

 

 

 

1,705,552

 

 

 

4,698,759

 

 

 

5,037,914

 

Selling, general and administrative expenses

 

 

2,480,354

 

 

 

1,838,388

 

 

 

6,969,332

 

 

 

4,749,112

 

Research and development expenses

 

 

20,676

 

 

 

29,370

 

 

 

49,616

 

 

 

74,254

 

Total operating expenses

 

 

2,501,030

 

 

 

1,867,758

 

 

 

7,018,948

 

 

 

4,823,366

 

(Loss) income from operations

 

 

(835,357

)

 

 

(162,206

)

 

 

(2,320,189

)

 

 

214,548

 

      Other income (expenses)

 

 

(632

)

 

 

-

 

 

 

(632

)

 

 

-

 

Interest income (expense)

 

 

(411

)

 

 

755

 

 

 

(329

)

 

 

916

 

Loss on earnings from Milestone Medical Inc.

 

 

(590,612

)

 

 

(223,834

)

 

 

(1,566,711

)

 

 

(567,550

)

Income (loss) on earnings from Education Joint Venture

 

 

2,343

 

 

 

(2,633

)

 

 

(5,493

)

 

 

(10,455

)

Loss on earnings from China Joint Venture

 

 

(123,083

)

 

 

29,428

 

 

 

(187,062

)

 

 

29,428

 

Total other expenses, net

 

 

(712,395

)

 

 

(196,284

)

 

 

(1,760,227

)

 

 

(547,661

)

Loss before provision for income taxes

 

 

(1,547,752

)

 

 

(358,490

)

 

 

(4,080,416

)

 

 

(333,113

)

Provision for Income Tax

 

 

(27,105

)

 

 

 

 

 

(40,751

)

 

 

 

Net Loss

 

 

(1,574,857

)

 

 

(358,490

)

 

 

(4,121,167

)

 

 

(333,113

)

Net loss attributable to the noncontrolling interests

 

 

5,655

 

 

 

 

 

 

59,642

 

 

 

 

Net loss attributable to Milestone

   Scientific Inc.

 

$

(1,569,202

)

 

$

(358,490

)

 

$

(4,061,525

)

 

$

(333,113

)

Net loss per share applicable to common stockholders

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Basic

 

$

(0.07

)

 

$

(0.02

)

 

$

(0.19

)

 

$

(0

)

Diluted

 

$

(0.07

)

 

$

(0.02

)

 

$

(0.19

)

 

$

(0

)

Weighted average shares outstanding and to be issued—

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Basic

 

 

21,418,145

 

 

 

21,189,245

 

 

 

21,375,317

 

 

 

19,621,471

 

Diluted

 

 

21,418,145

 

 

 

21,189,245

 

 

 

21,375,317

 

 

 

19,621,471

 

 

See Notes to Condensed Consolidated Financial Statements

 

 

 

5


MILESTONE SCIENTIFIC INC. AND SUBSIDIARIES

CONDENSED CONSOLIDATED STATEMENT OF CHANGES IN STOCKHOLDERS’ EQUITY

NINE MONTHS ENDED SEPTEMBER 30, 2015

(Unaudited)

 

 

 

Preferred Stock

 

 

Common Stock

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Shares

 

 

Amount

 

 

Shares

 

 

Amount

 

 

Additional

Paid-in

Capital

 

 

Accumulated

Deficit

 

 

Noncontrolling

interest

 

 

Treasury

Stock

 

 

Total

 

Balance, January 1, 2015

 

 

7,000

 

 

$

7

 

 

 

22,379,447

 

 

$

22,380

 

 

$

77,504,415

 

 

$

(61,967,462

)

 

$

394,528

 

 

$

(911,516

)

 

$

15,042,352

 

Stock based compensation

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

334,049

 

 

 

 

 

 

 

 

 

 

 

 

334,049

 

Capital contribution from

   noncontrollling interest

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

500,000

 

 

 

 

 

 

500,000

 

Common stock to be issued to

   employee for bonuses

 

 

 

 

 

 

 

 

 

 

28,653

 

 

 

29

 

 

 

99,971

 

 

 

 

 

 

 

 

 

 

 

 

 

100,000

 

Common stock issued to

   employee for bonuses

 

 

 

 

 

 

 

 

 

 

7,407

 

 

 

7

 

 

 

19,993

 

 

 

 

 

 

 

 

 

 

 

 

 

20,000

 

Common stock issued for

   payment of consulting

   services

 

 

 

 

 

 

 

 

 

 

12,098

 

 

 

12

 

 

 

29,988

 

 

 

 

 

 

 

 

 

 

 

 

 

30,000

 

Common stock issued for

   payment of employee

  compensation

 

 

 

 

 

 

 

 

 

 

5,761

 

 

 

6

 

 

 

14,994

 

 

 

 

 

 

 

 

 

 

 

 

 

15,000

 

Exercise of stock options for

   consultants

 

 

 

 

 

 

 

 

 

 

8,333

 

 

 

8

 

 

 

12,742

 

 

 

 

 

 

 

 

 

 

 

 

 

12,750

 

Net loss

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(4,061,525

)

 

 

(59,642

)

 

 

 

 

 

(4,121,167

)

Balance, September 30, 2015

 

 

7,000

 

 

$

7

 

 

 

22,441,699

 

 

$

22,442

 

 

$

78,016,152

 

 

$

(66,028,987

)

 

$

834,886

 

 

$

(911,516

)

 

$

11,932,984

 

 

See Notes to Condensed Consolidated Financial Statements

 

 

 

6


MILESTONE SCIENTIFIC INC. AND SUBSIDIARIES

CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS (Unaudited)

 

 

 

Nine Months Ended September 30,

 

 

 

2015

 

 

2014

 

Cash flows from operating activities:

 

 

 

 

 

 

 

 

Net loss

 

$

(4,121,167

)

 

$

(333,113

)

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

 

 

 

 

 

 

 

 

Depreciation expense

 

 

20,815

 

 

 

12,124

 

Amortization of patents

 

 

51,994

 

 

 

58,778

 

Common stock and options for compensation, consulting and vendor services

 

 

499,049

 

 

 

324,279

 

Equity loss on Milestone Medical Inc.

 

 

1,566,711

 

 

 

567,550

 

Equity loss on Education joint venture

 

 

5,493

 

 

 

10,455

 

Equity earning on China joint venture

 

 

187,062

 

 

 

(29,428

)

Changes in operating assets and liabilities:

 

 

 

 

 

 

 

 

Increase in accounts receivable

 

 

(807,869

)

 

 

(91,489

)

Increase in related party

 

 

(85,959

)

 

 

-

 

Increase in inventories

 

 

(307,807

)

 

 

(919,814

)

(Increase) decrease to advances on contracts

 

 

(490,729

)

 

 

996,949

 

(Increase) decrease to prepaid expenses and other current assets

 

 

25,996

 

 

 

(114,807

)

Increase in other assets

 

 

(2,670

)

 

 

 

Decrease in accounts payable

 

 

(672,974

)

 

 

(629,479

)

Increase in customer advances

 

 

 

 

 

49,441

 

Increase in accrued expenses and other payables

 

 

369,685

 

 

 

95,194

 

Net cash used in operating activities

 

 

(3,762,370

)

 

 

(3,360

)

Cash flows from investing activities:

 

 

 

 

 

 

 

 

Notes receivable to Milestone Medical Inc

 

 

(2,000,000

)

 

 

 

Advances to related parties

 

 

(677,991

)

 

 

(398,810

)

Addition to intangible assets

 

 

(1,986

)

 

 

-

 

Purchases of property and equipment

 

 

(47,613

)

 

 

(66,130

)

Net cash used in investing activities

 

 

(2,727,590

)

 

 

(464,940

)

Cash flows from financing activities:

 

 

 

 

 

 

 

 

Proceeds from exercise of stock options

 

 

12,750

 

 

 

202,781

 

Net proceeds on Private Placement Offering in May 2014

 

 

 

 

 

9,449,683

 

Repayment of related party loan

 

 

 

 

 

(50,000

)

Capital contribution from noncontrolling interest

 

 

500,000

 

 

 

 

Net cash provided by financing activities

 

 

512,750

 

 

 

9,602,464

 

NET INCREASE (DECREASE) IN CASH AND CASH EQUIVALENTS

 

 

(5,977,210

)

 

 

9,134,164

 

Cash and cash equivalents at beginning of period

 

 

10,367,993

 

 

 

1,147,198

 

Cash and cash equivalents at end of period

 

$

4,390,783

 

 

$

10,281,362

 

Supplemental disclosure of cash flow information:

 

 

 

 

 

 

 

 

Shares issued to directors for the exercise of stock options

 

$

 

 

$

41,250

 

Shares issued to directors for compensation

 

$

 

 

$

55,200

 

Shares to be issued to employees for bonuses

 

$

100,000

 

 

$

 

Shares issued to employees for exercise of stock options

 

$

 

 

$

104,615

 

Shares issued to employees in lieu of cash compensations

 

$

42,500

 

 

$

35,624

 

Shares issued to consultants for exercise of stock options

 

$

60,000

 

 

$

199,500

 

Net proceeds on Private Placement Offering

 

$

 

 

$

56,916

 

 

See Notes to Condensed Consolidated Financial Statements

 

 

7


MILESTONE SCIENTIFIC INC.

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

(UNAUDITED)

 

ORGANIZATION, BUSINESS AND BASIS OF PRESENTATION

Milestone Scientific Inc. and subsidiary (collectively “Milestone Scientific”, “our”, “us” or “we”) was incorporated in the state of Delaware in August 1989.

The unaudited consolidated financial statements of Milestone Scientific have been prepared in accordance with accounting principles generally accepted in the United States of America for interim financial information. Accordingly, they do not include all of the information and footnotes required by accounting principles generally accepted in the United States of America 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, 2014 included in Milestone Scientific’s Annual Report on Form 10-K.

On June 1, 2015, Milestone Scientific up-listed to the NYSE MKT under the ticker symbol MLSS.

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, 2015 and the results of its operations for the three and nine months then ended.

The results reported for the three and nine months ended September 30, 2015 are not necessarily indicative of the results of operations which may be expected for a full year.

 

Milestone Scientific has incurred significant operating losses since its inception except for 2013 and the first quarter of 2014. Milestone Scientific had negative cash flows from operating activities for the nine months ending September 30, 2015 of $3816,480 and a negative cash flow of $3,360 for the nine months ended September 30, 2014. At September 30, 2015, Milestone Scientific had cash and cash equivalents of $4,390,783 and a positive working capital of $11,139,704 as compared to working capital of $13,147,257 at December 31, 2014. The working capital decreased by $2,007,553 as compared to December 31, 2014. The change in working capital is primarily due to a decrease in cash and cash equivalents, increase in accounts receivable, note receivable, inventories, and advances on contract and a decrease in current liabilities. Milestone Scientific’s management continues to examine all areas of the business to manage its cash flow. 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 current negotiations and reductions in operating expenses.

 

As of September 30, 2015, Milestone Scientific believes that it has sufficient cash reserves, collections of accounts and notes receivable to meet all of its anticipated obligations for the next twelve months. Milestone Scientific will continue to manage its cash position while taking strategic steps to expand its business in the medical and dental, business sectors.

 

NOTE -1 SUMMARY OF ACCOUNTING POLICIES

Principles of Consolidation

The accompanying consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States (“GAAP”) and include the account of Milestone Scientific and its wholly owned subsidiary Wand Dental Inc. Additionally, the consolidated financial statements include the account of Milestone Scientific Advanced Cosmetic System, Inc. (“ACS”), a Delaware corporation that is seventy (70) percent owned by Milestone Scientific. The minority interest (thirty percent) in ACS is recorded in the equity section of the consolidated financial statements as noncontrolling interest. All significant intercompany transactions and balances have been eliminated in the consolidation.

ACS was organized in July 2014 by Milestone China (defined below) which is 40% owned by Milestone Scientific. ACS is owned fifty percent by Milestone China and fifty percent by Milestone Scientific. Milestone China has provided $900,000 of cash and Milestone Scientific provided a royalty-free license to utilize its technology to develop a Botox instrument. Milestone Scientific will also provide the resources to design and commercialize the instrument at cost. Through attribution Milestone Scientific owns seventy percent of ACS.

Milestone Scientific Inc. Poland SP z.o.o. an inactive Polish company was formed in 2014. Milestone Scientific Inc. owns seventy-five percent of Milestone Scientific Inc. Poland SP z.o.o.  

8


Accounts Receivable

The realization of accounts receivable will have a significant impact on Milestone Scientific. The criteria used by management to evaluate the adequacy of the allowance for doubtful accounts included, among others, credit worthiness of the customer, current trends, prior payment performance, the age of the receivables and Milestone Scientific’s overall historical experience.

Inventories

Inventory costing, obsolescence and physical control are significant to the on-going operation of the business. Inventories principally consist of finished goods and component parts stated at the lower of cost (first-in, first-out method) or market. Inventory quantities on hand are reviewed on a quarterly basis and a provision for excess and obsolete inventory is recorded if required based on past and expected future sales.

Investment in Milestone Medical

In March 2011, Milestone Scientific entered into a joint venture (the “Medical Joint Venture”) with Beijing 3H Scientific Technology Co., Ltd. (“Beijing 3H”), a People’s Republic of China (“PRC”) Company. Milestone Scientific contributed an exclusive worldwide royalty-free license for the development and commercialization of intra-articular and epidural drug delivery instruments, utilizing its patented CompuFlo technology to the Medical Joint Venture, and a group of individual investors including the controlling shareholders of Beijing 3H and a large shareholder of Milestone Scientific, who contributed $1.5 million. Milestone Scientific, with the consent of the investors, organized a domestic research and development joint venture corporation, now known as Milestone Medical Inc. (“formally Medical Joint Venture”). In the fourth quarter of 2014, the joint venture agreement with Beijing 3H was terminated. However, Milestone Medical has continued to implement its business plan. As of September 30, 2015, Milestone Scientific owned 49.98% of the Milestone Medical and has recorded the investment using the equity method of accounting.

Investment in Milestone China

In July 2014, Milestone Scientific agreed to invest $1.0 million through the contribution of 772 STA instruments for a 40% ownership in Milestone China Ltd., a Hong Kong based medical and dental distribution company (“Milestone China”). In 2014, 772 STA instruments were shipped and recorded at Milestone Scientific’s cost in the investment account for Milestone China on the Balance Sheet. Milestone China will purchase STA instruments and handpieces on credit terms as required. Milestone China began operations in July 2014.

Impairment of Long-Lived Assets

The long lived assets of Milestone Scientific, principally patents and trademarks are the base features of the business. Milestone Scientific reviews long-lived assets for impairment whenever circumstances and situations change such that there is an indication that the carrying amounts may not be recoverable. The carrying value of the asset is evaluated in relation to the operating performance and future undiscounted cash flows of the underlying assets.

Revenue Recognition

Revenue from product sales is recognized net of discounts and allowances to domestic distributors on the date of shipment for essentially all shipments, since the shipment terms are FOB warehouse. Milestone Scientific will recognize revenue on date of arrival of the goods at the customer’s location, where shipments are FOB destination. Shipments to international distributors are FOB warehouse, therefore revenue is recognized on shipment of the goods. Milestone China is an exception, where only 60% of revenue is recognized on shipment, and the remaining balance is deferred until the goods have been sold to a third party by Milestone China. In all cases the price to the buyer is fixed and the collectability is reasonably assured. Further, Milestone Scientific has no obligation on these sales for any post installation, set-up or maintenance, these being the responsibility of the buyer. Milestone Scientific’s only obligation after sale is the normal commercial warranty against manufacturing defects if the alleged defective unit is returned within the warranty period.

Recent Accounting Pronouncements

 

In July 2015, the FASB issued ASU No. 2015-11, Inventory (Topic 330): Simplifying the Measurement of Inventory. The new standard applies only to inventory for which cost is determined by methods other than last-in, first-out and the retail inventory method, which includes inventory that is measured using first-in, first-out or average cost. Inventory within the scope of this standard is required to be measured at the lower of cost and net realizable value. Net realizable value is the estimated selling prices in the ordinary course of business, less reasonably predictable costs of completion, disposal, and transportation. The new standard will be effective on

9


January 1, 2017. The adoption of this standard is not expected to have an impact on our financial position or results of operations.

 

In September 2015, the FASB issued ASU No. 2015-16, Business Combinations (Topic 805): Simplifying the Accounting for Measurement-Period Adjustments. The new standard requires that an acquirer recognize adjustments to provisional amounts that are identified during the measurement period in the reporting period in which the adjustment amounts are determined and sets forth new disclosure requirements related to the adjustments. The new standard will be effective for us on January 1, 2016. The adoption of this standard is not expected to have an impact on our financial position or results of operations.

 

NOTE – 2 Basic and Diluted Net INCOME (Loss) Per Common Share

 

Milestone Scientific presents “basic” and “fully diluted” earnings (loss) per common share applicable to common stockholders, and, if applicable, “diluted” earnings (loss) per common share applicable to common stockholders pursuant to the provisions of FASB 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 and warrants were issued during the period. (Fully diluted shares are only calculated if there is a net income.)

 

For the three and nine months ending September 30, 2015 and 2014, Milestone Scientific calculated basic and fully diluted earnings per common share as described in the previous paragraph.

  

NOTE – 3 ACCOUNTS RECEIVABLE

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

 

NOTE – 4 INVESTMENT IN UNCONSOLIDATED SUBSIDIARIES

Milestone Medical Inc

Milestone Medical had a zero net book value at September 30, 2015. In July 2013, Milestone Scientific entered a strategic partnership with the largest provider of specialty sales and distribution solutions for healthcare in the United States. This agreement was terminated in the second quarter of 2015.

Prior to the fourth quarter of 2014 Milestone Scientific had distribution responsibility in the U.S. and Canada, and Beijing 3H was responsible for distribution in Macao, Hong Kong and other regions of Asia. In the fourth quarter of 2014, the joint venture agreement with Beijing 3H was terminated and Milestone Medical contracted with Milestone China to become its new distributor in Asia for both the epidural and intra-articular instruments. In the fourth quarter of 2014, Milestone Scientific Inc. purchased an additional 995,000 shares of Milestone Medical from another shareholder for $447,750 ($0.45 per share), which increased its percentage of ownership to 49.98% of Milestone Medical

Milestone Scientific recorded a loss on its investment in Milestone Medical of $590,612 and $1,566,711 for the three and nine months ended September 30, 2015 and $223,834 and $567,550 for the three and nine months ended September 30, 2014, respectively. For the nine month September 30, 2015 Milestone Scientific offset advances to Milestone Medical by $537,923 which is the excess loss of the Company’s investment in Milestone Medical. Milestone Scientific has accounted for its investment in Milestone Medical using the equity method of accounting. The losses described represent the applicable losses reported by Milestone Medical during the three and nine months ended September 30, 2015 and 2014, respectively. Milestone Scientific utilizes the equity method of accounting to recognize its financial results of the Medical Joint Venture.

 

Milestone Scientific did not have any legal expense related to seeking U.S. Food and Drug Administration (“FDA”) marketing clearance for the epidural and intra-articular instruments under section 510k for the three and nine months ended September 30, 2015. Milestone Scientific expensed $44,415 and $175,868 on behalf of Milestone Medical for the three and nine months ended September 30, 2014, respectively, for legal expenses related to seeking FDA marketing clearance for the epidural and intra-articular instruments under section 510K. As part of the joint venture agreement, Milestone Scientific agreed to pay all the legal fees related to the FDA clearance process.

Milestone Scientific had an investment in Milestone Medical of zero as September 30, 2015 and $888,720 as of December 31, 2014.

Milestone Education LLC.

10


 

The Education Joint Venture has been providing training and education to our dentists throughout the world. Milestone Scientific accounted for its investment in the Education Joint Venture using the equity method of accounting. The Education Joint Venture earned a profit of $4,686 and incurred a loss of $10,986 for the three and nine months ended September 30, 2015, respectively. The Education Joint Venture incurred a loss of $5,266 and $20,910 for the three and nine months ended September 30, 2014, respectively. Fifty percent of these losses were recorded in the condensed consolidated statements of operations for the three and nine months ended September 30, 2015 and 2014.

Milestone China Inc

In September 2014, Milestone Scientific agreed to invest $1. Million through the contribution of 772 STA instruments (at a distributor price of approximately $1,295 per instrument) for a forty percent ownership in Milestone China. The instruments were shipped to the distributors over a period of two years. Milestone China will purchase additional STA handpieces as required. In 2014, 772 STA instruments were shipped and are recorded at Milestone Scientific’s cost in the investment account for Milestone China on the Balance Sheet. Milestone China did not begin operations until July 2014. Milestone Scientific recognized a loss of $123,083 and $187,062 from Milestone China, for the three and nine months and ended September 30, 2015. These amounts represents 40% of the loss and profit of Milestone China for each period respectively. Milestone Scientific’s investment in Milestone China is $161,588 and $348,651 as of September 30, 2015 and December 31, 2014, respectively. Milestone Scientific shipped $938,304 of instruments and $138,600 of handpieces in the nine months ended September 30, 2015. Milestone Scientific recognized 60% of the revenue on shipments of instruments and handpieces. The remaining 40% of revenue is recognized at the time the goods are sold to a third party. At September 30, 2015 there was no deferred revenue, all instruments and handpieces were sold to a third party.

 

NOTE – 5 Stock Option Plans

A summary of option activity for employees under the plans and changes during the nine months ended September 30, 2015, is presented below:

 

 

 

 

 

 

 

 

 

 

Weighted

 

 

 

 

 

 

 

 

 

 

 

Weighted

 

 

Average

 

 

Aggregate

 

 

 

Number

 

 

Averaged

 

 

Remaining

 

 

Intrinsic

 

 

 

of

 

 

Exercise

 

 

Contractual

 

 

Options

 

 

 

Options

 

 

Price $

 

 

Life (Years)

 

 

Value $

 

Outstanding, January 1, 2015

 

 

1,472,130

 

 

 

1.33

 

 

 

3.23

 

 

 

1,430,231

 

Granted

 

 

157,306

 

 

 

3.01

 

 

 

4.48

 

 

 

57,000

 

Exercised

 

 

 

 

 

 

 

 

 

 

 

 

Forfeited or expired

 

 

 

 

 

 

 

 

 

 

 

 

Outstanding, September 30, 2015

 

 

1,629,436

 

 

 

1.49

 

 

 

2.50

 

 

 

2,620,771

 

Exercisable,  September 30, 2015

 

 

1,077,520

 

 

 

1.14

 

 

 

1.95

 

 

 

2,093,571

 

 

Milestone Scientific recognizes stock compensation expense on a straight line basis over the requisite service period. During the three months ended September 30, 2015, and 2014 Milestone Scientific recognized $107,205 and $39,877 of total stock compensation cost. During the nine months ended September 30, 2015 and 2014, Milestone Scientific recognized $334,049 and $119,630 of total stock compensation cost. As of September 30, 2015 and September 30, 2014, there was $881,765 and $272,946, respectively, of total unrecognized compensation cost related to non-vested options which Milestone Scientific expects to recognize over a weighted average period of 3.59 years and 2.0 years at September 30, 2015 and 2014, respectively. A 6%  rate of forfeitures is assumed in the calculation of the compensation cost for the period in 2015 and 2014.

Expected volatilities are based on historical volatility of Milestone Scientific’s common stock over a period commensurate with the anticipated term. Milestone Scientific uses historical data to estimate option exercise and employee termination within the valuation model.

A summary of option activity for non-employees under the plans and changes during the nine months ended September 30, 2015, is presented below:

 

11


 

 

 

 

 

 

 

 

 

 

Weighted

 

 

 

 

 

 

 

 

 

 

 

Weighted

 

 

Average

 

 

Aggregate

 

 

 

Number

 

 

Averaged

 

 

Remaining

 

 

Intrinsic

 

 

 

of

 

 

Exercise

 

 

Contractual

 

 

Options

 

 

 

Options

 

 

Price $

 

 

Life (Years)

 

 

Value $

 

Outstanding, January 1, 2015

 

 

16,666

 

 

 

1.27

 

 

 

0.62

 

 

 

17,166

 

Granted

 

 

 

 

 

 

 

 

 

 

 

 

Expired

 

 

 

 

 

 

 

 

 

 

 

 

Exercised

 

 

8,333

 

 

 

1.53

 

 

 

 

 

 

 

Outstanding, September 30, 2015

 

 

8,333

 

 

 

1.01

 

 

 

0.19

 

 

 

17,166

 

Exercisable, September 30, 2015

 

 

8,333

 

 

 

1.01

 

 

 

0.19

 

 

 

17,166

 

 

During the nine months ended September 30, 2015 and September 30, 2014, Milestone Scientific had no expenses related to non-employee options that vested during the period. There was no unrecognized compensation cost related to non-vested options as of September 30, 2015. A six percent rate of forfeitures is assumed in the calculation of the compensation cost for the period.

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 of any options or similar equity instruments issued is estimated based on the Black-Scholes option-pricing model and the assumption that all of the options or other equity instruments will ultimately vest. Such 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 capitalized or expensed as if Milestone Scientific had paid cash for the goods or services.

 

NOTE – 6 CONCENTRATION OF CREDIT RISK

 

Milestone Scientific’s consolidated financial instruments that are exposed to concentrations of credit risk consist primarily of cash, trade accounts receivable, and advances on contracts. Milestone Scientific places its cash and cash equivalents with large financial institutions. At times, such investments may be in excess of the Federal Deposit Insurance Corporation insurance limit. Milestone Scientific has not experienced any losses in such accounts and believes it is not exposed to any significant credit risks. Financial instruments which potentially subject Milestone Scientific to credit risk consist principally of trade accounts receivable, as Milestone Scientific does not require collateral or other security to support customer receivables, and advances on contracts. Milestone Scientific entered into a purchase agreement with a vendor to supply Milestone Scientific with 12,000 STA Instruments and this commitment was completed in September 2015. Milestone Scientific does not believe that significant credit risk exists with respect to this advance to the contract manufacturer.

 

Milestone Scientific closely monitors the extension of credit to its customers while maintaining allowances, if necessary, for potential credit losses. On a periodic basis, Milestone Scientific evaluates its accounts receivable and establishes an allowance for doubtful accounts, based on a history of past write-offs and collections and current credit conditions. Management has provided a reserve that it believes is sufficient to record accounts receivable at net realizable value as of September 30, 2015 and December 31, 2014.

 

NOTE – 7 ADVANCES ON CONTRACTS

 

The advances on contracts represent funding of future STA inventory purchases. The balance of the advances as of September 30, 2015 and December 31, 2014 is $1,211,926 and $721,197, respectively. The advance is classified as current based on the estimated annual usage of the underlying inventory.

 

NOTE – 8 INCOME TAXES

 

For the three and nine months ending September 30, 2015, state tax liability was approximately $27,000 and $41,000. Such expense was recognized in the accompanying consolidated financial statements as of September 30, 2015. 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, 2015 and 2014, no recognition was given to the utilization of the remaining Federal net operating loss carryforwards.   

 

NOTE – 9 COMMON STOCK ISSUANCES

As of September 30, 2015 Milestone Scientific issued 40,155 shares to a former employee based on a deferred compensation agreement. In addition Milestone Scientific Inc. issued 13,168shares of common stock valued at $35,000 for the payment of employee compensation and 12,098 share of common stock valued at $30,000was issued for payment of services. Milestone Scientific Inc. also issued 8,333 shares of common stock on the exercise of certain stock options valued at $12,750.  

12


 

 

NOTE – 10 PREFERRED STOCK ISSUANCE

In May 2014, Milestone Scientific completed a $10 million private placement pursuant,  which raised $3 million, from the sales of 2 million shares of common stock at $1.50 per share, and $7 million from the sale of 7,000 shares of Series A Convertible Preferred Stock (the “Series A Stock”), with a stated value of $1,000 per share. The Series A Stock votes together with the Common Stock on a converted basis and as a single class. However, those shares have class voting rights as to amendments to the Certificate of Incorporation adversely affecting the Series A Stock and increasing in the number of authorized shares of Series A Stock. Issuances of additional shares of Series A Stock, and increases in the size of the board, prior to the time for the holders of the Series A Stock, no longer have a right to nominate a designee for election to the board or issuance of “senior stock” or “parity stock.” The Series A Stock is entitled to a liquidation preference in an amount equal to the greater of 100% of its $1,000 per share stated value plus an amount equal to any then accrued and unpaid dividends, or the amount the Series A Stock would receive if all the outstanding shares of Series A Stock had been converted into common stock at $2.545 per share, subject to adjustment in accordance with the terms and provisions of the Certificate of Incorporation (the “base conversion price”). The Series A Stock is convertible into common stock at the base conversion price at the option of the holder or mandatorily convertible into common stock on May 13, 2019, at the base conversion price provided that certain “threshold” prices have been achieved during the 360 calendar day period prior to such date. If those threshold prices have not been achieved, the Series A Stock will convert at $1.50 per share on May 13, 2019.    

 

NOTE – 11 RELATED PARTY

Milestone Scientific has a manufacturing agreement with a related party. The related party manufactures products under specific purchase orders but without minimum purchase commitments. Milestone Scientific purchased $447,817 and $325,628 from the supplier for the three months ended September 30, 2015 and 2014, respectively. Milestone Scientific purchased $1,801,449 and $2,069,546 from the supplier for the nine months ended September 30, 2015 and 2014, respectively. Milestone Scientific owed $427,231 and $502,167 to this supplier as of September 30, 2015 and December 31, 2014, respectively.

On July 1, 2013, Milestone Scientific and Milestone Medical signed an agreement for the reimbursement of specific expenses incurred by Milestone Scientific specifically for the benefit of Milestone Medical. At September 30, 2015, the expenses due from Milestone Medical are $623,881, which were offset by $537,923 which is the excess loss of the company investment in Milestone Medical.

In December 2014, Milestone Scientific entered into a bridge financing to Milestone Medical while waiting approval of the capital raise, Milestone Scientific (49.98% owners) entered into a line of credit agreement allows Milestone Medical to borrow up to $2 million from Milestone Scientific through January 2016, if needed, to assist in paying for the capital raise. The loan provides for interest at a rate of 3.25% per annual, the prime rate at the inception of the line of credit. The agreement terminates at April 15, 2016. In September 2015 Milestone Scientific increased the line of credit to $2.5 million at the request of Milestone Medical Inc., due to the delay in obtaining regulatory approval to proceed with the additional capital raise. All other contractual conditions of the line of credit remain unchanged. $2,000,000 was borrowed by Milestone Medical as of September 30, 2015 and is recognized as notes receivable on the condensed consolidated balance sheet.

A wholly-owned subsidiary (Wand Dental) of Milestone Scientific shipped approximately $938,304 of instruments and $150,600 of handpieces in the nine months ended September 30, 2015 to Milestone China. Milestone China owes $1,088,904 Wand Dental for handpieces and instruments shipped in 2015. The receivable is included within the accounts receivable balance within the balance sheet.

 

NOTE – 12 SIGNIFICANT CUSTOMERS & GEOGRAPHICAL INFORMATION

Milestone Scientific had two customers (distributors) for the three months ended September 30, 2015, that had approximately 33% (15% and 18 %), of its net product sales and two customers (distributors) that had approximately 47% (21% and 26 %), of its net product sales for three months ended September 30, 2014. Milestone Scientific had two customers (distributors) for the nine months ended September 30, 2015 that had approximately 40% (22%, and 18 %) of the net product sales and two customers (distributors) that had approximately 46% (21% and 25 %) of its net product sales for the nine months ended September 30, 2014.

Milestone Scientific had accounts receivable for three major customers that amounted to $1,571,782 ($1,088,904, $306,221 and $176,657) representing 69% (47%, 13% and 9%) of accounts receivable as of September 30, 2015, and accounts receivable for two major customers of $1,099,804, or 69% as of December 31, 2014, respectively.

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

 

13


 

 

Three Months Ended September 30,

 

 

 

 

Nine Months Ended September 30,

 

 

 

2015

 

 

2014

 

 

 

 

2015

 

 

2014

 

Instruments

 

$

901,213

 

 

$

413,914

 

 

Instruments

 

$

2,317,547

 

 

$

1,938,293

 

Handpieces

 

 

1,533,936

 

 

 

2,090,580

 

 

Handpieces

 

 

4,610,592

 

 

 

5,608,776

 

Other

 

 

24,809

 

 

 

30,604

 

 

Other

 

 

68,782

 

 

 

115,795

 

 

 

$

2,459,958

 

 

$

2,535,098

 

 

 

 

$

6,996,921

 

 

$

7,662,864

 

United States

 

$

700,879

 

 

$

1,039,153

 

 

United States

 

$

2,410,054

 

 

$

3,434,171

 

Canada

 

 

145,808

 

 

 

30,548

 

 

Canada

 

 

189,164

 

 

 

100,321

 

Other Foreign

 

 

1,613,271

 

 

 

1,465,397

 

 

Other Foreign

 

 

4,397,703

 

 

 

4,128,372

 

 

 

$

2,459,958

 

 

$

2,535,098

 

 

 

 

$

6,996,921

 

 

$

7,662,864

 

 

 

NOTE – 13 PENSION PLANS

Milestone Scientific have a defined contribution plan that allows eligible employees to contribute part of their salary through payroll deductions. Milestone Scientific does not contribute to this plan but does pay the administrative costs of the plan, which are not significant.

In March 2014, the Board of Directors approved the Compensation Committee’s request to amend the Chief Executive Officer of Milestone Scientific’s employment agreement to provide benefits to make 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 Executive and his family. For the three and nine months ended September 30, 2015, approximately $51,000 and $102,000, was expensed.     

 

NOTE – 14 COMMITMENTS AND OTHER

Milestone Scientific has informal arrangements for the manufacture of its products. STA, single tooth anesthesia, and CompuDent instruments are 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’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 affect Milestone Scientific.

 

The technology underlying the SafetyWand and CompuFlo, and an improvement to the controls for CompuDent were developed by the Director of Clinical Affairs and assigned to us. Milestone Scientific purchased this technology pursuant to an agreement dated January 1, 2005. The Director 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. In addition, the Director is granted, pursuant to the agreement, an option to purchase, at fair market value on the date of the grant, 8,333 shares of the 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 will receive the corresponding percentage of the consideration received by Milestone Scientific for such sale or license. Milestone Scientific expensed the Director’s royalty fees of $117,320 and $89,600 for the three months ended September 30, 2015 and 2014, respectively. Milestone Scientific expensed the Director’s royalty fee of $313,751 and $291,714 for the nine months ended September 30, 2015 and 2014, respectively. Additionally, Milestone Scientific expensed consulting fees to the Director of zero and $39,390 for the nine months ended September30, 2015 and 2014, respectively.

 

In January 2010, Milestone Scientific issued a purchase order to Tricor Systems Inc for the purchase of 12,000 STA Instruments to be delivered over the next three years. The purchase order is for $5,261,640. Wand Dental Inc, a wholly-owned subsidiary of Milestone Scientific was assigned this commitment on October 1, 2014. As of September 30, 2015, this commitment was completed. In the second quarter of 2015, Wand Dental Inc entered into a new purchase commitment for 3,000 STA instruments, ($1,785,750) for the delivery of these instruments beginning October 2015 and into 2016. The balance of the advances as of September 30, 2015 and December 31, 2014 is $1,211,926 and $721,197, respectively.

 

In August 2013, a shareholder of Milestone Scientific entered a three year agreement with Milestone Scientific to provide financial and business strategic services. The fee for these services are $100,000 annually.

 

Subsequent Events

14


Milestone Scientific has evaluated subsequent events and has determined that there are no other events to be disclosed.

 

 

ITEM 2.

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

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

OVERVIEW

Milestone Scientific was officially listed on the NYSE MKT on June 1, 2015.

In 2015, Milestone Scientific remains focused on advancing efforts to achieve our two primary objectives; those being:

 

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 Instrument (STA Instrument)

STA Instrument Growth

Since its market introduction in early 2007, the STA Instrument and a prior computerized controlled local anesthesia delivery product have been used to deliver over 60 million safe, effective and comfortable injections. The instrument has also been favorably evaluated in numerous peer-reviewed, published clinical studies and associated articles. Moreover, there appears to be a growing consensus among users that the STA Instrument is proving to be a valuable and beneficial instrument that is positively impacting the practice of dentistry worldwide.

Global Distribution Network

United States and Canadian Market

In September 2015, Milestone Scientific received official notification that a consortium led by, Milestone Scientific Inc. Poland, SP z.o.o. had been an awarded a $4.2 million grant from The Natural Centre for Research and development in Poland of which Milestone Scientific’s subsidiary will receive approximately $1.5 million in funding.

In August 2013, Milestone Scientific entered an exclusive distributor agreement (beginning October 1, 2013), with Henry Schein, for the sale and distribution of the CompuDent handpieces in the United States and Canada.

In July 2013, Milestone Scientific entered a strategic partnership with the largest provider of specialty sales and distribution solutions for healthcare. Pursuant to the strategic partnership, the distributor will hold, for a period of three years with the FDA market, the exclusive rights to market, resell, label and distribute Milestone Scientific’s CompuFlo injection technology for use in epidural applications for childbirth and other pain management needs in the U.S. hospital sector. This partnership was terminated in June 2015, due to delays in receiving FDA clearance on the instrument at that time.

In November 2012, Milestone Scientific entered an exclusive distribution and marketing agreement with a well-known U.S. domestic manufacturer and distributor, for the sale and distribution of the STA instruments and handpieces in United States and Canada.

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 in South Africa and Unident in the Scandinavian countries of Denmark, Sweden, Norway and Iceland.

In early October 2012, the State Food and Drug Administration (SFDA) of the People’s Republic of China approved Milestone Scientific’s Single Tooth Anesthesia System® (STA System). In May 2014, the CFDA, (previously the SFDA), granted registration approval of the STA handpieces in China.

15


Shortly before the end of the second quarter 2009, we announced that we were refining our international marketing strategy to gain greater access to and penetration of the international dental markets for the STA Instrument, CompuDent and related disposable handpieces. The new sales strategy provides for increasing hands-on oversight and support of our existing international distribution network, while also attracting new distributors throughout Europe, Asia and South America. To assist in this endeavor, Milestone Scientific added in the spring of 2010 an International Sales Director to focus on the growth of our products outside the USA and Canada. The position was eliminated in 2014 and subsidized with a consultant in Central and South America, while our new CEO of Wand Dental has focused his efforts in developing distributors in Europe and South America.

In March 2011, Milestone Scientific entered into a joint venture (the “Medical Joint Venture”) with Beijing 3H Scientific Technology Co., Ltd. (“Beijing 3H”), a People’s Republic of China (“PRC”) Company. Milestone Scientific contributed an exclusive worldwide royalty-free license for the development and commercialization of intra-articular and epidural drug delivery instruments, utilizing its patented CompuFlo technology to the Medical Joint Venture. A group of individual investors including the controlling shareholders of Beijing 3H and a large shareholder of Milestone Scientific contributed $1.5 million. Milestone Scientific, with the consent of the investors, organized a domestic research and development joint venture corporation, now known as Milestone Medical Inc. (“Milestone Medical”). In the fourth quarter of 2014, the joint venture agreement with Beijing 3H was terminated. However, Milestone Medical has continued to implement its business plan. As of September 30, 2015, Milestone Scientific owned 49.98% of Milestone Medical and has recorded the investment using the equity method of accounting.

Subsequent to the termination of the distribution agreement with Beijing 3H, Milestone Medical contracted with Milestone China to become the new distributor in Asia for both the epidural and intra-articular instruments while Milestone Scientific continues to have distribution responsibility in the U.S. and Canada. Milestone Scientific owns forty percent of Milestone China. As of September 30, 2015, Milestone Medical’s development of the two medical instruments is ongoing and nearing the completion. In September 2014, Milestone Medical received CE certification to distribute their instruments in European Community (EU). Milestone Scientific is actively pursuing medical distributors for the instrument in the EU community. In March 2015, Milestone Medical signed a distribution agreement with a Polish Medical distributor for the distribution of the epidural instrument. Shipment of instruments and disposables began in September 2015. In September 2015, Milestone Medical signed a distribution agreement with an Italian distributor for distribution of the epidural instrument in Italy. During the third quarter of 2015, the company shipped its first instruments to the Italian distributor.

Segmented Sales Performance

The following table shows a breakdown of Milestone Scientific’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,

 

 

 

2015

 

 

2014

 

 

 

 

2015

 

 

2014

 

DOMESTIC

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

DOMESTIC

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Instruments

 

$

9,555

 

 

 

1.0

%

 

$

178,623

 

 

 

17.2

%

 

Instruments

 

$

611,845

 

 

 

25.4

%

 

$

687,501

 

 

 

20.0

%

Handpieces

 

 

672,425

 

 

 

96.0

%

 

 

846,420

 

 

 

81.5

%

 

Handpieces

 

 

1,777,548

 

 

 

73.7

%

 

 

2,685,360

 

 

 

78.2

%

Other

 

 

18,898

 

 

 

3.0

%

 

 

14,110

 

 

 

1.3

%

 

Other

 

 

20,661

 

 

 

0.9

%

 

 

61,310

 

 

 

1.8

%

Total Domestic

 

 

700,878

 

 

 

100.0

%

 

 

1,039,153

 

 

 

100.0

%