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, 2014

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.     x  Yes     ¨   No

Indicate by check mark whether the registrant has submitted electronically and posted on its corporate Website, if any, every Interactive Data File required to be submitted and posted pursuant to Rule 405 of Regulation S-T during the preceding 12 months (or for such shorter period that the registrant was required to submit and post such files).     x  Yes     ¨  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 13, 2014, the Issuer had a total of 21,266,533 shares of Common Stock, $.001 par value outstanding.

 

 

 

 

 

 


MILESTONE SCIENTIFIC INC

TABLE OF CONTENTS

PART I - FINANCIAL INFORMATION

 

Item 1.

 

Financial Statements

  

 

 

 

 

 

 

Condensed Balance Sheets

  

 

 

 

September 30, 2014 (Unaudited) and December 31, 2013 (Audited)

  

4

 

 

 

 

 

Condensed Statements of Operations

  

 

 

 

Three and Nine Months Ended September 30, 2014 and 2013 (Unaudited)

  

 5

 

 

 

 

 

Condensed Statement of Changes in Stockholders’ Equity

  

 

 

 

Nine Months Ended September 30, 2014 (Unaudited)

  

6

 

 

 

 

 

Condensed Statements of Cash Flows

  

 

 

 

Nine Months Ended September 30, 2014 and 2013 (Unaudited)

  

7

 

 

 

 

 

Notes to Condensed Financial Statements (Unaudited)

  

8

 

 

 

Item 2.

 

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

  

16

 

 

 

Item 3.

 

Quantitative and Qualitative Disclosures About Market Risk.

  

22

 

 

 

Item 4.

 

Controls and Procedures

  

23

 

 

 

 

 

PART II - OTHER INFORMATION

  

 

 

 

 

Item 1.

 

Legal Proceedings

  

24

 

 

 

Item 1A.

 

Risk Factors

  

24

 

 

 

Item 2.

 

Unregistered Sales of Equity Securities and Use of Proceeds

  

24

 

 

 

Item 3.

 

Defaults Upon Senior Securities

  

24

 

 

 

Item 4.

 

Mine Safety Disclosures

  

24

 

 

 

Item 5.

 

Other Information

  

24

 

 

 

Item 6.

 

Exhibits

  

25

 

 

SIGNATURES

  

26

 

 

 

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’s future plans of operations, business strategy, results of operations and financial condition. Milestone 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’s reports and registration statements filed with the Securities and Exchange Commission (the “Commission”). Milestone disclaims any intent or obligation to update such forward-looking statements.

 

 

 

3


MILESTONE SCIENTIFIC INC.

CONDENSED BALANCE SHEETS

 

September 30, 2014

 

 

December 31, 2014

 

 

(Unaudited)

 

 

 

 

 

ASSETS

 

 

 

 

 

 

 

Current Assets:

 

 

 

 

 

 

 

Cash and cash equivalents

$

781,497

 

 

$

1,147,198

 

Treasury bills

 

9,499,865

 

 

 

-

 

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

 

 

 

 

 

 

 

September 30, 2014  and $5,000 as of December 31, 2013

 

1,624,345

 

 

 

1,532,856

 

Inventories

 

2,241,466

 

 

 

1,321,652

 

Advances on contracts

 

1,092,528

 

 

 

727,478

 

Prepaid expenses and other current assets

 

370,933

 

 

 

150,451

 

     Total current assets

 

15,610,634

 

 

 

4,879,635

 

Advances on contracts

 

218,875

 

 

 

1,580,874

 

Investment in Milestone Medical Inc

 

619,574

 

 

 

924,115

 

Investment in Milestone Education LLC

 

31,627

 

 

 

42,082

 

Investment in Milestone China

 

165,229

 

 

 

-

 

Furniture, Fixtures & Equipment net of accumulated depreciation of $459,918

 

 

 

 

 

 

 

as of September 30, 2014 and $476,884 as of December 31, 2013

 

77,994

 

 

 

23,988

 

Patents, net of accumulated amortization of $557,280 as of September 30, 2014

 

 

 

 

 

 

 

and $498,502 as of December 31, 2013

 

532,957

 

 

 

591,735

 

Other assets

 

12,917

 

 

 

12,917

 

Total assets

$

17,269,807

 

 

$

8,055,346

 

 

 

 

 

 

 

 

 

LIABILITIES AND STOCKHOLDERS' EQUITY

 

 

 

 

 

 

 

Current Liabilities:

 

 

 

 

 

 

 

Accounts payable

$

1,340,889

 

 

$

2,020,368

 

Customer advances

 

49,441

 

 

 

-

 

Accrued expenses and other payables

 

610,327

 

 

 

515,133

 

    Total current liabilities

 

2,000,657

 

 

 

2,535,501

 

 

 

 

 

 

 

 

 

Commitments and Contingencies

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Stockholders' Equity

 

 

 

 

 

 

 

Series A Convertible Preferred Stock, par value $.001, authorized 5,000,000

 

 

 

 

 

 

 

shares, 7,000 and zero shares issued and outstanding, respectively

 

7

 

 

 

-

 

Common stock, par value $.001; authorized 50,000,000 shares; 21,251,533

 

 

 

 

 

 

 

shares issued 875,322 shares to be issued and 21,218,200 shares

 

 

 

 

 

 

 

outstanding as of September 30, 2014; 17,759,540 shares issued,

 

 

 

 

 

 

 

1,839,930 shares to be issued, and 17,726,207 shares outstanding

 

 

 

 

 

 

 

as of December 31, 2013

 

22,126

 

 

 

19,599

 

Additional paid-in capital

 

76,757,084

 

 

 

66,677,200

 

Accumulated deficit

 

(60,598,551

)

 

 

(60,265,438

)

Treasury stock, at cost, 33,333 shares

 

(911,516

)

 

 

(911,516

)

     Total stockholders' equity

 

15,269,150

 

 

 

5,519,845

 

Total liabilities and stockholders' equity

$

17,269,807

 

 

$

8,055,346

 

 

 See Notes to Condensed Financial Statements

 

 

 

4


MILESTONE SCIENTIFIC INC.

CONDENSED STATEMENTS OF OPERATION

(Unaudited)

 

 

Three Months Ended

September 30,

 

 

Nine Months Ended

September 30,

 

 

2014

 

 

2013

 

 

2014

 

 

2013

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Product sales

$

2,535,098

 

 

$

2,444,195

 

 

$

7,662,864

 

 

$

7,211,973

 

Cost of products sold

 

829,546

 

 

 

677,792

 

 

 

2,624,950

 

 

 

2,233,944

 

Gross profit

 

1,705,552

 

 

 

1,766,403

 

 

 

5,037,914

 

 

 

4,978,029

 

Selling, general and administrative expenses

 

1,838,388

 

 

 

1,317,433

 

 

 

4,749,112

 

 

 

4,045,465

 

Research and development expenses

 

29,370

 

 

 

12,698

 

 

 

74,255

 

 

 

177,419

 

Total operating expenses

 

1,867,758

 

 

 

1,330,131

 

 

 

4,823,366

 

 

 

4,222,884

 

(Loss) Income from operations

 

(162,206

)

 

 

436,272

 

 

 

214,548

 

 

 

755,145

 

Other income (expenses)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Other income

 

-

 

 

 

-

 

 

 

-

 

 

 

17,543

 

Interest income (expense)

 

755

 

 

 

(5,550

)

 

 

916

 

 

 

(70,119

)

Loss from Medical Joint Venture

 

(223,834

)

 

 

(212,199

)

 

 

(567,550

)

 

 

(259,291

)

Loss from Education Joint Venture

 

(2,633

)

 

 

-

 

 

 

(10,455

)

 

 

-

 

Gain from China Joint Venture

 

29,428

 

 

 

-

 

 

 

29,428

 

 

 

-

 

Total other expenses, net

 

(196,284

)

 

 

(217,749

)

 

 

(547,661

)

 

 

(311,868

)

Net (loss) income applicable to common stockholders

$

(358,490

)

 

$

218,523

 

 

$

(333,113

)

 

$

443,277

 

Net (loss) income per share applicable to common stockholders -

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Basic

$

(0.02

)

 

$

0.01

 

 

$

(0.02

)

 

$

0.03

 

Diluted

$

(0.02

)

 

$

0.01

 

 

$

(0.02

)

 

$

0.03

 

Weighted average shares outstanding and to be issued -

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Basic

 

21,189,245

 

 

 

17,333,941

 

 

 

19,621,471

 

 

$

16,955,048

 

Diluted

 

21,189,245

 

 

 

17,716,964

 

 

 

19,621,471

 

 

$

17,322,388

 

 

See Notes to Condensed Financial Statements

 

 

 

5


MILESTONE SCIENTIFIC INC.

CONDENSED STATEMENT OF CHANGES IN STOCKHOLDERS’ EQUITY

NINE MONTHS ENDED SEPTEMBER 30, 2014

(Unaudited)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Preferred Stock

 

 

Common Stock

 

 

Additional

 

 

Accumulated

 

 

Treasury

 

 

 

 

 

 

Shares

 

 

Amount

 

 

Shares

 

 

Amount

 

 

Paid in Capital

 

 

Deficit

 

 

Stock

 

 

Total

 

Balance, January 1, 2014

 

-

 

 

$

-

 

 

 

19,599,470

 

 

$

19,599

 

 

$

66,677,200

 

 

$

(60,265,438

)

 

$

(911,516

)

 

$

5,519,845

 

Options to employees and consultants

 

 

 

 

 

 

 

 

 

-

 

 

 

-

 

 

 

119,630

 

 

 

-

 

 

 

-

 

 

$

119,630

 

Common stock to be issued to employee for bonuses

 

 

 

 

 

 

 

 

 

12,500

 

 

 

12

 

 

 

19,988

 

 

 

-

 

 

 

-

 

 

$

20,000

 

Common stock issued for directors compensation

 

 

 

 

 

 

 

 

 

30,000

 

 

 

30

 

 

 

55,170

 

 

 

-

 

 

 

-

 

 

$

55,200

 

Common stock issued for payment of consulting services

 

 

 

 

 

 

 

 

 

107,461

 

 

 

107

 

 

 

199,393

 

 

 

-

 

 

 

-

 

 

$

199,500

 

Common stock issued for payment of employee compensation

 

 

 

 

 

 

 

 

 

20,658

 

 

 

21

 

 

 

35,603

 

 

 

-

 

 

 

-

 

 

$

35,624

 

Exercise of stock options for employees and consultants

 

 

 

 

 

 

 

 

 

281,766

 

 

 

282

 

 

 

161,249

 

 

 

-

 

 

 

-

 

 

$

161,531

 

Exercise of stock options for directors

 

 

 

 

 

 

 

 

 

75,000

 

 

 

75

 

 

 

41,175

 

 

 

-

 

 

 

-

 

 

$

41,250

 

Sale of Common Stock - Innovest and Series A

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Convertible Preferred Shares

 

7,000

 

 

$

7

 

 

 

2,000,000

 

 

 

2,000

 

 

 

9,447,676

 

 

 

-

 

 

 

-

 

 

$

9,449,683

 

Net loss

 

 

 

 

 

 

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

(333,113

)

 

 

-

 

 

$

(333,113

)

Balance, September 30, 2014

 

7,000

 

 

$

7

 

 

 

22,126,855

 

 

$

22,126

 

 

$

76,757,084

 

 

$

(60,598,551

)

 

$

(911,516

)

 

$

15,269,150

 

 

See Notes to Condensed Financial Statements

 

 

 

6


MILESTONE SCIENTIFIC INC.

CONDENSED STATEMENTS OF CASH FLOWS (Unaudited)

 

NINE MONTHS ENDED SEPTEMBER 30,

 

 

2014

 

 

2013

 

Cash flows from operating activities:

 

 

 

 

 

 

 

Net (loss) income

$

(333,113

)

 

$

443,277

 

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

 

 

 

 

 

 

 

Depreciation expense

 

12,124

 

 

 

13,114

 

Amortization of patents

 

58,778

 

 

 

58,360

 

Common stock and options issued for compensation, consulting and vendor services

 

324,279

 

 

 

512,846

 

Bad debt reversal

 

-

 

 

 

(295,488

)

Loss on Medical Joint Venture

 

567,550

 

 

 

259,291

 

Loss on Education Venture

 

10,455

 

 

 

-

 

Gain on China Venture

 

(29,428

)

 

 

-

 

Changes in operating assets and liabilities:

 

 

 

 

 

 

 

(Increase) in accounts receivable

 

(91,489

)

 

 

(309,424

)

(Increase) in inventories

 

(919,814

)

 

 

(235,998

)

Decrease to advances on contracts

 

996,949

 

 

 

273,885

 

(Increase) decrease to prepaid expenses and other current assets

 

(114,807

)

 

 

137,117

 

(Increase) in other assets

 

-

 

 

 

(5,600

)

(Decrease) in accounts payable

 

(629,479

)

 

 

(530,190

)

Increase in customer advances

 

49,441

 

 

 

-

 

Increase in accrued expenses

 

95,194

 

 

 

120,889

 

Net cash (used in) provided by operating activities

 

(3,360

)

 

 

442,079

 

Cash flows from investing activities:

 

 

 

 

 

 

 

Investment in Medical Joint Venture

 

(263,009

)

 

 

(259,291

)

Investment in Education Joint Venture

 

-

 

 

 

(50,000

)

Investment in China Joint Venture

 

(135,801

)

 

 

-

 

Investment in Treasury Bills

 

(9,499,865

)

 

 

-

 

Purchases of property and equipment

 

(66,130

)

 

 

(3,111

)

Payments for patent rights

 

-

 

 

 

(17,690

)

Net cash used in investing activities

 

(9,964,805

)

 

 

(330,092

)

Cash flows from financing activities:

 

 

 

 

 

 

 

Proceeds from exercise of stock options

 

202,781

 

 

 

29,600

 

Proceeds from the sale of common stock

 

-

 

 

 

50,000

 

Net proceeds on Private Placement Offering

 

9,449,683

 

 

 

-

 

Proceeds from related party loan

 

-

 

 

 

50,000

 

Repayment from related party loan

 

(50,000

)

 

 

(5,000

)

Net cash provided by financing activities

 

9,602,464

 

 

 

124,600

 

NET (DECREASE) INCREASE IN CASH AND CASH EQUIVALENTS

 

(365,701

)

 

 

236,587

 

Cash and cash equivalents at beginning of period

 

1,147,198

 

 

 

165,249

 

Cash and cash equivalents at end of period

$

781,497

 

 

$

401,836

 

Supplemental disclosure of non cash investing and financing activities:

 

 

 

 

 

 

 

Shares issued to directors for the exercise of stock options

$

41,250

 

 

$

29,600

 

Shares issued to directors for compensation

$

55,200

 

 

$

45,000

 

Shares issued for conversion of notes payable and accrued interest

$

-

 

 

$

860,081

 

Shares issued to employees for exercise of stock options

$

104,615

 

 

$

-

 

Shares issued to employees in lieu of cash compensation

$

35,624

 

 

$

35,625

 

Shares issued to consultants for services

$

199,500

 

 

$

317,500

 

Shares issued to consultants for exercise of stock options

$

56,916

 

 

$

-

 

 

See Notes to Condensed Financial Statements

 

 

7


MILESTONE SCIENTIFIC INC.

NOTES TO CONDENSED FINANCIAL STATEMENTS

(UNAUDITED)

September 30, 2014

ORGANIZATION, BUSINESS AND BASIS OF PRESENTATION

 

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

The unaudited financial statements of Milestone have been prepared in accordance with accounting principles generally accepted in the United States of America (“GAAP”) for interim financial information. Accordingly, they do not include all of the information and footnotes required by GAAP for complete financial statements.

These unaudited financial statements should be read in conjunction with the financial statements and notes thereto for the year ended December 31, 2013 included in Milestone'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’s financial position as of September 30, 2014 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, 2014 are not necessarily indicative of the results of operations which may be expected for a full year.

Milestone has incurred significant operating losses from its inception, through December 31, 2012. For the year ended December 31, 2013, Milestone had net income of $1,464,930. For the nine months ended September 30, 2014, Milestone had a net loss of $333,113. Milestone had negative cash flows from operations for the nine months ended September 30, 2014 of $3,360 and positive cash flows from operating activities for the nine months ending September 30, 2013 of $442,079. At September 30, 2014, Milestone had cash and cash equivalents including Treasury Bills of $10,281,362 and a positive working capital of $13,609,977. The working capital increased by $11,265,843 as compared to December 31, 2013 working capital of $2,344,134. The positive change in working capital is due to Milestone’s capital raise of $10 million in May 2014 (net proceeds, $9,449,683), offset by a loss for the nine month period.  Milestone 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, 2014, Milestone has sufficient cash reserves to meet all of its anticipated obligations for the next twelve months.  

 

NOTE 1 – SUMMARY OF ACCOUNTING POLICIES

Recent Accounting Pronouncements

 

Compensation-Stock Compensation: In June 2014, the Financial Accounting Standards Board ("FASB") issued Accounting Standards Update ("ASU") No. 2014-12, "Accounting for Share-Based Payments When the Terms of an Award Provide That a Performance Target Could Be Achieved after the Requisite Service Period," (Topic 718) ("ASU 2014-12"). The accounting standard update clarifies the accounting guidance on how to account for share-based payment awards that require a specific performance target to be achieved in order for employees to become eligible to vest in the awards. ASU 2014-12 requires that a performance target that affects vesting and that could be achieved after the requisite service period be treated as a performance condition. As such, the performance target should not be reflected in estimating the grant-date fair value of the award. Compensation costs should be recognized in the period in which it becomes probable that the performance target will be achieved and should represent the compensation cost attributable to the period(s) for which the requisite service has been rendered. ASU 2014-12 is effective for annual periods and interim periods beginning after December 15, 2015 and early adoption is permitted. This amendment may be applied (a) prospectively to all awards granted or modified after the effective date or (b) retrospectively to all awards with performance targets that are outstanding as of the beginning of the earliest annual period presented in the financial

8


statements and to all new or modified awards thereafter. We are currently in the process of evaluating the impact of adopting this pronouncement.

 

In August 2014, the FASB issued guidance requiring management to evaluate on a regular basis whether any conditions or events have arisen that could raise substantial doubt about the entity's ability to continue as a going concern. The guidance 1) provides a definition for the term "substantial doubt," 2) requires an evaluation every reporting period, interim periods included, 3) provides principles for considering the mitigating effect of management's plans to alleviate the substantial doubt, 4) requires certain disclosures if the substantial doubt is alleviated as a result of management's plans, 5) requires an express statement, as well as other disclosures, if the substantial doubt is not alleviated, and 6) requires an assessment period of one year from the date the financial statements are issued. The standard is effective for our reporting year beginning January 1, 2017 and early adoption is permitted. We do not expect the adoption of this guidance to have a material impact on our financial statements.

 

 

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

 

Milestone presents “basic” and “fully diluted” income (loss) per common share applicable to common stockholders, and, if applicable, “diluted” income (loss) per common share applicable to common stockholders pursuant to the provisions of FASB ASC Topic 260. Basic income (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 income 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 and conversion of convertible preferred stock, were issued during the period.

 

For the three and nine months ended September 30, 2013, Milestone calculated basic and fully diluted earnings per common share as described in previous paragraph. Since Milestone had losses for the three and nine months ended September 30, 2014, the assumed effect on outstanding stock options and the conversion of the preferred shares (Note 13) were not included in the calculation as then effect would have been antidilutive.

  

 

NOTE – 3 ACCOUNTS RECEIVABLE

Milestone sells a significant amount of its product on credit terms to its major distributors. Milestone estimates losses from the inability of its customers to make payments on amounts billed. A majority of credit sales are due within sixty days from invoicing.    

 

NOTE – 4 TREASURY BILLS

 

The fair values of Milestone marketable securities are determined in accordance with GAAP, with fair value being defined as the amount that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants.  As such, fair value is a market-based measurement that should be determined based on assumptions that market participants would use in pricing an asset or liability. As a basis for considering such assumptions, the Company utilizes the three-tier value hierarchy, as prescribed by GAAP, which prioritizes the inputs used in measuring fair value, as follows:

 

·

Level 1 - inputs to the valuation methodology are quoted prices (unadjusted) for identical assets or liabilities in active markets.

 

·

Level 2 - inputs to the valuation methodology include quoted prices for similar assets and liabilities in active markets, and inputs that are observable for the asset or liability, either directly or indirectly, for substantially the full term of the financial instrument.

 

·

Level 3 - inputs to the valuation methodology are unobservable and significant to the fair value measurement.

 

9


Milestone invests excess cash in Treasury Bills with varying maturities, which are classified as available-for-sale securities and are re-measured to fair value on a recurring basis and are valued using Level 1 inputs, which are quoted prices (unadjusted) for identical assets in active markets:

 

September 30, 2014

 

Cost

 

 

Fair Value

 

 

Unrealized Gain (Loss)

 

Available for sale:

 

 

 

 

 

 

 

 

 

 

 

 

Treasury Bills

 

$

9,498,680

 

 

$

9,499,865

 

 

$

1,185

 

 

 

 

 

NOTE – 5 INVESTMENT IN JOINT VENTURES

 

In March 2011, Milestone entered into an agreement with a People’s Republic of China ("PRC") entity Beijing 3H Scientific Technology Co., Ltd  (Beijing 3H), to establish a medical joint venture entity in the PRC to develop intra-articular and epidural drug delivery instruments utilizing Milestone’s patented CompuFlo technology. Beijing 3H  agreed to contribute up to $1.5 million to this medical joint venture entity, based on progress reports from Milestone and subject to refund if the instruments are not developed because of technological problems within 30 months of the inception date. Milestone evaluates the technological feasibility of the products to be developed using the CompuFlo technology periodically and at every reporting date to establish if circumstances indicate that the technology continues to be feasible. Based on the available evidence Milestone concluded that the contingency associated with the return of capital to Beijing 3H no longer existed as of December 31, 2013, since the instruments have advanced beyond the development stage and accordingly no amounts have been accrued in the accompanying financial statements relating to this contingency. Milestone, with the consent of Beijing 3H, organized a domestic research and development corporation now knows as Milestone Medical Inc. (“Milestone Medical”) to which the principal shareholders of Beijing 3H and other shareholders completed a capital contribution of $1,500,000 and Milestone contributed an exclusive worldwide royalty-free license to use CompuFlo technology. Milestone Medical was initially owned fifty percent by shareholders of Beijing 3H and fifty percent by Milestone. Milestone Medical had a remaining net book value of approximately $245,000 at September 30, 2014.  Milestone has accounted for its investment in Milestone Medical using the equity method of accounting. Further, Milestone was authorized by the Milestone Medical to manage and oversee the development of the epidural and intra-articular instruments. In connection with this authorization, Milestone also entered into an agreement with a significant vendor to develop these two instruments.

 

Milestone has distribution responsibility in the U.S. and Canada. Beijing 3H will distribute in Macao, Hong Kong and other regions of Asia. Milestone Medical will distribute the epidural instruments in the PRC. In the rest of the world, responsibilities are shared by Milestone and Beijing 3H.

 

In July 2013, Milestone entered a strategic partnership with the largest provider of specialty sales and distribution solutions for healthcare in the United States. During the three year strategic partnership, the distributor will hold the exclusive rights to market, resell, label and distribute Milestone’s CompuFlo injection technology for use in epidural applications for childbirth and other pain management needs in hospitals in the U.S.

 

In the fourth quarter of 2013, Milestone Medical issued 2 million shares of its common stock in a private placement offering at $1.50 per share ($3.0 million) in Poland. As a result of this sale, Milestone Medical received net proceeds of $2,363,000.  The effect of this sale of new shares was to reduce Milestone’s ownership percentage from 50% to 45.5% (post transaction). Consistent with the equity method of account, the ownership percentage is treated as if the decreased percentage of ownership was the result of the sale of these shares. As a result, Milestone recorded in the fourth quarter of 2013, a $1,363,650 gain on dilutive effect of the sale of equity in Milestone Medical.

 

Milestone recorded a loss on its investment in Milestone Medical of $223,834 and $567,550 for the three and nine months ended September 30, 2014, respectively. The losses described represent 45.5% of the applicable losses reported by the Medical Joint Venture during the three and nine months ended September 30, 2014. Milestone recorded a loss on its investment in Milestone Medical  of $212,199 and $259,291 for the three and nine months ended September 30, 2013, respectively. The losses described represent 50% of the applicable losses reported by the Milestone Medical during the

10


three and nine months ended September 30, 2013.  Milestone utilizes the equity method of accounting to recognize its financial results of the joint venture.

 

Milestone expensed $44,415 and $175,868 on behalf of the Milestone Medical for the three and nine months ended September 30, 2014, respectively, for legal expenses related to seeking U.S. Food and Drug Administration marketing clearance for the epidural and intra-articular devices under section 510k. As part of the joint venture agreement, Milestone is to pay all fees related to the FDA clearance process.

 

Milestone had an investment in the Milestone Medical of $619,574 as of September 30, 2014 and there are no remaining suspended losses.

 

The Milestone Medical’s net loss for the three and nine months ended September 30, 2014 are $492,441 and $1,248,625, respectively.

 

On July 1, 2013, Milestone and Milestone Medical signed an agreement for the reimbursement of specific expenses incurred by Milestone specifically for the benefit of Milestone Medical. The expenses related to the agreement that have not been paid are $117,551 as of September 30, 2014 and are included in accounts receivable, net. This includes $168,500 and $300,930, which are the charges for the three and nine months ended September 30, 2014, respectively. The charges for the three and nine months ended September 30, 2013 were $132,787 and $141,834, respectively.

 

In the first quarter of 2013, the CEO of Milestone loaned Milestone $50,000 for use in capitalizing a fifty percent equity portion in the joint venture with Milestone Education LLC (the “Education Joint Venture”). This balance is included in the accrued expenses and other payables on the condensed balance sheet at December 31, 2013. This loan bore no interest and was paid off in April 2014.

 

The Education Joint Venture is expected to provide training and education to our dentists throughout the world. Milestone accounted for its investment in the Education Joint Venture using the equity method of accounting. Milestone Education LLC began operations in 2013. The Education Joint Venture incurred a loss of $2,663 and $10,455 for the three and nine months ended September 30, 2014, respectively. Fifty percent of these losses were recorded in the condensed statement of operations for the three and nine months ended September 30, 2014.

 

In June 2014, Milestone agreed to invest $1.0 million through the contribution of 772 STA instruments (at a distributor price of approximately $1,295 per instrument) for a forty percent ownership in a Hong Kong based medical and dental distribution company, (“Milestone China”). The instruments will be shipped to the distributors over a period of two years. Milestone China will purchase STA handpieces on a cash basis as required. 300 STA instruments were shipped in July 2014 and are recorded at Milestone’s cost in the investment account for Milestone China on the Balance Sheet in the third quarter of 2014. Milestone China did not begin operations until July 2014. The Milestone China Joint Venture incurred a gain of $29,428, which is forty (40) percent of the $73,570 net income, for the three and nine months ended September 30, 2014, respectively. Forty percent of these gains were recorded in the condensed statement of operations for the three and nine months ended September 30, 2014. Accordingly, the investment was recorded as $165,229 as of September 30, 2014.

 

NOTE – 6 Stock Option Plans

A summary of option activity for employees under the plans and changes during the nine months ended September 30, 2014, is presented below:

 

 

 

 

 

 

 

 

 

 

 

 

Weighted

 

 

 

 

 

 

 

 

 

 

 

Weighted

 

 

Average

 

 

Aggregate

 

 

 

Number

 

 

Averaged

 

 

Remaining

 

 

Intrinsic

 

 

 

of

 

 

Exercise

 

 

Contractual

 

 

Options

 

 

 

Options

 

 

Price $

 

 

Life (Years)

 

 

Value $

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Outstanding, January 1, 2014

 

 

1,484,499

 

 

 

1.03

 

 

 

2.88

 

 

 

996,554

 

Granted

 

 

6,024

 

 

 

1.65

 

 

 

4.75

 

 

 

-

 

Exercised

 

 

205,100

 

 

 

0.71

 

 

 

-

 

 

 

-

 

11


Forfeited or expired

 

 

48,900

 

 

 

1.15

 

 

 

-

 

 

 

-

 

Outstanding, September 30, 2014

 

 

1,236,523

 

 

 

1.08

 

 

 

2.59

 

 

 

1,049,867

 

Exercisable, September 30, 2014

 

 

885,232

 

 

 

1.01

 

 

 

1.58

 

 

 

811,956

 

 

Milestone recognizes stock compensation expense on a straight line basis over the requisite service period. For the three months ended September 30, 2014, Milestone recognized $39,877 of total stock compensation cost. During the nine months ended September 30, 2014, Milestone recognized $119,630 of total compensation. As of September 30, 2014, there was $272,946 of total unrecognized compensation cost related to non-vested options which Milestone expects to recognize over a weighted average period of 2.0 years. A six percent rate of forfeitures is assumed in the calculation of the compensation cost for the period.

Expected volatilities are based on historical volatility of Milestone’s common stock over a period commensurate with the anticipated term. Milestone 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, 2014, is presented below:

 

 

 

 

 

 

 

 

 

 

 

Weighted

 

 

 

 

 

 

 

 

 

 

 

Weighted

 

 

Average

 

 

Aggregate

 

 

 

Number

 

 

Averaged

 

 

Remaining

 

 

Intrinsic

 

 

 

of

 

 

Exercise

 

 

Contractual

 

 

Options

 

 

 

Options

 

 

Price $

 

 

Life (Years)

 

 

Value $

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Outstanding, January 1, 2014

 

 

173,332

 

 

 

0.48

 

 

 

0.59

 

 

 

210,833

 

Granted

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

Exercised

 

 

151,666

 

 

 

0.38

 

 

 

-

 

 

 

-

 

Forfeited or expired

 

 

5,000

 

 

 

1.15

 

 

 

-

 

 

 

-

 

Outstanding, September 30, 2014

 

 

16,666

 

 

 

1.27

 

 

 

0.87

 

 

 

11,000

 

Exercisable, September 30, 2014

 

 

16,666

 

 

 

1.27

 

 

 

0.87

 

 

 

11,000

 

 

During the six months ended September 30, 2014, Milestone 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, 2014.   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 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 had paid cash for the goods or services.

 

NOTE – 7 CONCENTRATION OF CREDIT RISK

Milestone’s financial instruments that are exposed to concentrations of credit risk consist primarily of cash and trade accounts receivable and treasury bills, and advances on contracts. Milestone places its cash and cash equivalents with large financial institutions and in treasury bills. At times, such investments may be in excess of the Federal Deposit Insurance Corporation insurance limit. Milestone 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 to credit risk consist principally of trade accounts receivable, as Milestone does not require collateral or other security to support customer receivables, and advances on contracts. Milestone entered into a purchase agreement with a vendor to supply Milestone with 12,000 STA Instruments (3,420 instruments are remaining on the purchase order as of September 30, 2014). As part of these agreements, Milestone has advanced approximately $1,311,000 and $2,308,000 to the vendor for purchase of materials at September 30, 2014 and December 31, 2013, respectively. The advance will be credited to Milestone as the goods are delivered. Milestone does not believe that significant credit risk exists with respect to this advance to the contract manufacturer.

12


Milestone closely monitors the extension of credit to its customers while maintaining allowances, if necessary, for potential credit losses. On a periodic basis, Milestone 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 believes that the reserve is sufficient to record accounts receivable at net realizable value as of September 30, 2014 and December 31, 2013.

Milestone purchased Treasury Bills with varying maturity dates periodically with excess cash.

 

NOTE – 8 ADVANCES ON CONTRACTS

The net advances on contracts represent funding of future STA inventory purchases. The balance of the net advances as of September 30, 2014 and December 31, 2013 is $1311,403 and $2,308,352, respectively. The portion of the advance that is expected to be utilized in the next twelve months is classified as current asset, with the remainder classified as non-current asset.

 

NOTE – 9 CUSTOMER ADVANCES

As of September 30, 2014, several customers paid in advance for future shipments of merchandise. These advanced payments will be reduced as shipments are made in 2014.

 

NOTE – 10 NOTE PAYABLE

Milestone borrowed $450,000 from a shareholder in 2008. The loan was originally a short term loan with a maturity date of January 19, 2009. In December 2008, May 30, 2012 and March 29, 2013, this loan was extended and the due date was last fixed at January 5, 2015. The loan accrues interest at 12% per annum, compounded quarterly. The loan and its related interest was converted into 614,344 shares of common stock on August 8, 2013.

Interest expense related to the note payable for the three and nine months ended September 30, 2013 was $4,879 and $53,518 dollars, respectively. This did not occur in 2014. Accrued interest payable related to the note payable was zero at September 30, 2013 and this did not occur 2014. Milestone had also secured a line of credit, from this shareholder, for $1.3 million which was converted into equity in 2009. However, the accrued interest remaining on the line of credit was not converted and the remaining balance at September 30, 2013 was zero.

Additionally, Milestone has an agreement with the manufacturer of the CompuDent and STA instruments to accrue interest on their outstanding accounts payable balance. For the quarter ending September 30, 2013, Milestone had zero interest expense under this agreement.

 

 

NOTE – 11 INCOME TAXES

Milestone’s expected federal and state income tax and benefit computed at the statutory rate (40%) on the pre-tax income for the nine months ended September 30, 2014 and 2013 amounted to a benefit of $263,000 and $2,000, respectively. Such benefit was recognized in the accompanying financial statements as of September 30, 2014 with recognition of a net operating loss carryforward. Due to Milestone’s history of past operating losses, which required a full valuation allowances for all of Milestone’s deferred tax assets at September 30, 2014 and 2013, no recognition was given to the utilization of the remaining net operating loss carryforwards.

 

NOTE – 12 COMMON STOCK ISSUANCES

During the nine months ended September 30, 2014, Milestone issued 20,658 shares of common stock valued at $35,624 for payment of employee compensation. In addition, 281,766 shares of common stock were issued on the exercised of certain stock options valued at $161,531 during the nine months ended September 30, 2014. Milestone also issued 75,000 shares of common stock on the exercised of certain stock options at a price of $1.84, valued at $41,250 to the Board of Directors for the nine months ended September 30, 2014 and 107,461 shares of common stock were issued, valued at $199,500, for payment of consulting services. In the nine months ended September 30, 2014, Milestone issued 30,000 shares of common stock to the Board of Directors, valued at $55,200 for their compensation.  

13


In the May 2014 Private Placement, Milestone issued 2 million shares of common stock for $3 million ($1.50 per share) in a capital raise with gross proceeds totaling $10 million. Convertible Preferred Stock was also issued in that capital raise. – (See Note 13, below.)

 

NOTE – 13 PREFERRED STOCK ISSUANCE

 

In the May 2014 Private Placement, Milestone issued 7,000 shares of Series A Convertible Preferred Stock (the “Series A Stock”), with a stated value of $1,000 per share which raised $7 million. The Series A Stock votes together with the Common Stock on an as converted basis and as a single class, except that such shares have class voting rights as to amendments to the Certificate of Incorporation adversely affecting the Series A Stock, increases in the number of authorized shares in that Series, issuance of additional shares of Series A Stock, increases in the size of the board prior to the time 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 also entitled to a liquidation preference equal to the greater of 100% of its $1,000 per share stated value or the amount the Series A Stock would receive on conversion into common stock and is convertible into common stock at $2.545 per share at the option of the holder or mandatorily convertible at this price on May 14, 2019, unless certain “threshold” prices have not been achieved prior to that date.

 

NOTE – 14 RELATED PARTY

A large shareholder of Milestone is also the principal shareholder of a major supplier of handpieces to Milestone. In addition, he is an investor in the PRC entity, Beijing 3H, which entered into a medical joint venture agreement with Milestone. Milestone purchased $2,069,546 and $2,146,096 from the supplier for the nine months ended September 30, 2014 and 2013, respectively. Milestone owed $502,167 and $1,024,653 to this supplier as of September 30, 2014 and December 31, 2013, respectively.

In the first quarter of 2013, the CEO of Milestone loaned the Company $50,000 for use in capitalizing a fifty percent equity portion in the Education Joint Venture. The loan bore no interest and was paid off in April 2014.

 

NOTE – 15 SIGNIFICANT CUSTOMERS & GEOGRAPHICAL INFORMATION

For the three months ended September 30, 2014, Milestone had two customers (distributors) that had approximately 45% of its net product sales and three customers (distributors) that had approximately 57% of its net product sales for three months ended September 30, 2013. Milestone had two customers (distributors) for the nine months ended September 30, 2014 that had approximately 44% of its net product sales and four customers (distributors) that had approximately 52% of its net product sales for nine months ended September 30, 2013, respectively. Milestone had accounts receivable for two customers that amounted to $996,476 representing 61% of gross accounts receivable as of September 30, 2014 and accounts receivable for three customers that amounted to $732,762 representing 48% of gross accounts receivable as of December 31, 2013, respectively.

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

 

 

Three Months Ended September 30,

 

 

 

Nine  Months Ended September 30,

 

 

2014

 

 

2013

 

 

 

2014

 

 

2013

 

Instruments

$

413,914

 

 

$

491,179

 

 

Instruments

$

1,938,293

 

 

$

1,760,079

 

Handpieces

 

2,090,580

 

 

 

1,927,391

 

 

Handpieces

 

5,608,776

 

 

 

5,328,751

 

Other

 

30,604

 

 

 

25,625

 

 

Other

 

115,795

 

 

 

123,143

 

 

$

2,535,098

 

 

$

2,444,195

 

 

 

$

7,662,864

 

 

$

7,211,973

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

United States

$

1,039,153

 

 

$

1,526,608

 

 

United States

$

3,434,171

 

 

$

3,907,560

 

Canada

 

30,548

 

 

 

119,594

 

 

Canada

 

100,321

 

 

 

241,937

 

Other Foreign

 

1,465,397

 

 

 

797,993

 

 

Other Foreign

 

4,128,372

 

 

 

3,062,476

 

 

$

2,535,098

 

 

$

2,444,195

 

 

 

$

7,662,864

 

 

$

7,211,973

 

14


 

NOTE – 16 PENSION PLANS

Milestone has a defined contribution plan that allows eligible employees to contribute part of their salary through payroll deductions. Milestone 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’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, 2014, respectively, $50,778 and $118,481 was charged to expenses for this commitment. The first installment payment of $203,111 for this pension was paid in July 2014.

NOTE – 17 COMMITMENTS AND OTHER

Milestone has informal arrangements for the manufacture of its products. STA, single tooth anesthesia, CompuDent and CompuMed instruments are manufactured for Milestone by Tricor Systems, Inc. pursuant to specific purchase orders. The STA and The Wand Handpiece with Needle are supplied to Milestone 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’s ability to produce and sell its products. Although alternate sources of supply exist and new manufacturing relationships could be established, Milestone 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.

A portion of the technology underlying the SafetyWand and CompuFlo, and an improvement to the CompuDent were developed by the Director of Clinical Affairs and assigned to us. Milestone 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 for such sale or license. For the three months ended September 30, 2014 and 2013, Milestone expensed the Director’s royalty fee of $89,600 and $77,886, respectively. Milestone expensed the Director’s royalty fees of $291,714 and $256,127 for the nine months ended September 30, 2014 and 2013, respectively. Additionally, for the three months ended September 30, 2014 and 2013, Milestone expensed consulting fees to the Director of $14,690 and $12,350, respectively. Milestone expensed consulting fees to the Director of $39,390 and $90,350, for the nine months ended September 30, 2014 and 2013, respectively.

In January 2010, Milestone 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. As of September 30, 2014, there are 3,420 STA instruments remaining on the purchase order. Milestone expects to receive these instruments by December 31, 2014. The advances on contracts have been classified as current and long term at September 30, 2014.

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

 

Beginning October 1, 2014, Milestone Scientific Inc acquired 100 percent of an inactive, previously established company and merged the Milestone dental business into this company. As part of this merger, Milestone now owns 100 percent of this new subsidiary Wand Dental Inc.  The subsidiary, Wand Dental Inc, has an exclusive distributor and licensing agreement for Milestone dental instruments and handpieces for the worldwide. All current Milestone distributors will be assigned to Wand Dental Inc.

 

 

 

15


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

 

In 2014, Milestone remains focused on advancing efforts to achieve our two primary objectives; those being:

 

 

 

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, including the STA Single Tooth Anesthesia Instrument (STA Instrument); and

 

 

 

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

 

 

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 52 million 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 November 2012, Milestone 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’s Single Tooth Anesthesia System® (STA System). In May 2014, the SFDA granted registration approval of the STA handpieces in China.

 

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 hand pieces. 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 added in the spring of 2010 an International Sales Director to focus on the growth of our products outside the USA and Canada.

 

In March 2011, we entered into a definitive joint venture agreement with Beijing 3H (Heart-Help-Health) Scientific Technology Co., Ltd. (Beijing 3H) for the development, commercialization, manufacture and marketing of epidural and intra-articular injection medical instruments. Milestone holds a 45.5% interest in the joint venture and shareholders of Beijing 3H and others have a 45.5% interest (the “Medical Joint Venture”). The Beijing 3H shareholders include a large shareholder in Milestone who is also the principal of a supplier to Milestone.

 

16


In late June 2014, Milestone agreed to invest $1 million for a 40% ownership in a Hong Kong organized medical and dental distribution company (“Milestone China”). Milestone’s contribution to this entity will be 772 instruments and handpieces will be purchased for cash as required. The new entity will provide positive impact on dental and future medical business in China and other parts of Asia. Milestone China did not begin operations until July 2014 and the first shipment of 300 STA instruments occurred in July 2014. Milestone records this investment under the equity method of accounting.

Segmented Sales Performance

The following table shows a breakdown of Milestone’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,

 

 

 

2014

 

 

2013

 

DOMESTIC

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Instruments

 

$

178,623

 

 

 

17.2

%

 

$

251,104

 

 

 

16

%

Handpieces

 

 

846,420

 

 

 

81.5

%

 

 

1,248,636

 

 

 

82

%

Other

 

 

14,110

 

 

 

1.3

%

 

 

26,868

 

 

 

2

%

Total Domestic

 

$

1,039,153

 

 

 

100.0

%

 

$

1,526,608

 

 

 

100

%

INTERNATIONAL

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Instruments

 

$

235,291

 

 

 

15.7

%

 

$

240,075

 

 

 

26

%

Handpieces

 

 

1,244,160

 

 

 

83.2

%

 

 

678,755

 

 

 

74

%

Other

 

 

16,494