UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 10-Q
(Mark One)
   
þ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For the quarterly period endedJuneSeptember 30, 2009
or
   
o 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,45 Knightsbridge Road Piscataway, New Jersey 0703908854
(Address of principal executive offices)
(973) 535-2717
(Registrant’s telephone number, including area code)
(220 South Orange Avenue Livingston, New Jersey 07039
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.þ Yeso 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).o Yeso 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 filero Accelerated Filero Non-accelerated filero Smaller reporting companyþ
    (Do not check if a smaller reporting company)  
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act).o Yesþ No
As of August 5,November 10, 2009, the Issuer had a total of 13,417,57413,939,461 shares of Common Stock, $.001 par value outstanding.
 
 

 

 


 

MILESTONE SCIENTIFIC INC
INDEX
     
PART I — FINANCIAL INFORMATION
 
     
    
     
  4 
     
  5 
     
  6 
     
  7 
     
  8 
     
  15 16 
     
  22 24 
     
  22 24 
     
 
     
  23 25 
     
  23 25 
     
  23 25 
     
  24 26 
     
  24 26 
     
  24 26 
     
  25 27 
     
  26 28 
     
 Exhibit 31.1
 Exhibit 31.2
 Exhibit 32.1
 Exhibit 32.2

 

2


FORWARD-LOOKING STATEMENTS
When used in this Quarterly Report onForm 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 and Section 21E of 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


ITEM 1.
Financial Statements.
MILESTONE SCIENTIFIC INC.
CONDENSED BALANCE SHEETS
                
 June 30, 2009 December 31, 2008  September 30, 2009 December 31, 2008 
 (Unaudited)  (Unaudited)   
ASSETS  
Current Assets:  
Cash and cash equivalents $498,576 $743,665  $497,455 $743,665 
Accounts receivable, net of allowance for doubtful accounts of $5,000 in 2009 and 2008 797,620 925,742  500,880 925,742 
Stock Subscription Receivable 112,500  
Inventories 632,625 719,902  888,641 719,902 
Advances to contract manufacturer 124,950 250,110  148,960 250,110 
Prepaid expenses and other current assets 105,509 218,296  136,134 218,296 
          
Total current assets 2,159,280 2,857,715  2,284,570 2,857,715 
Advances to contract manufacturer 400,735 415,780  324,235 415,780 
Investment in distributor, at cost 76,319 76,319  76,319 76,319 
Furniture, Fixtures & Equipment net of accumulated depreciation of $373,570 as of June 30 ,2009 and $345,377 as of December 31, 2008 154,511 152,574 
Patents, net of accumulated amortization of $172,449 as of June 30, 2009 and $135,406 as of December 31, 2008 908,571 901,045 
Other assets 15,874 7,317 
Furniture, Fixtures & Equipment net of accumulated depreciation of $384,407 as of September 30, 2009 and $345,377 as of December 31, 2008 149,820 152,574 
Patents, net of accumulated amortization of $191,580 as of September 30, 2009 and $135,406 as of December 31, 2008 921,858 901,045 
Other assets-including advance payment for consulting services $127,772 in 2009 143,645 7,317 
          
Total assets $3,715,290 $4,410,750  $3,900,447 $4,410,750 
          
  
LIABILITIES AND STOCKHOLDERS’ EQUITY  
Current Liabilities:  
Accounts payable $1,008,710 $829,130  $880,869 $829,130 
Accrued expenses and other payable 461,108 495,897  539,645 495,897 
Line of credit-net of discount of $36,152 1,263,848  
Line of credit-net of discount of $28,976 1,271,024  
          
Total current liabilities 2,733,666 1,325,027  2,691,538 1,325,027 
          
  
Long-term Liabilities:  
Line of credit-net of discount of $52,530  1,247,470   1,247,470 
Notes Payable-net of discount of $12,555 and $11,927, respectively 437,445 438,073 
Notes Payable-net of discount of $11,856 and $11,927, respectively 438,144 438,073 
          
Total long-term liabilities 437,445 1,685,543  438,144 1,685,543 
          
  
Commitments and Contingencies  
Stockholders’ Equity  
Common stock, par value $.001; authorized 50,000,000 shares; 13,117,574 shares issued 550,093 shares to be issued and 13,084,241 shares outstanding as of June 30, 2009; 12,695,685 shares issued, 504,639 shares to be issued, and 12,662,352 shares outstanding as of December 31, 2008 13,667 13,200 
Common stock, par value $.001; authorized 50,000,000 shares; 13,928,832 shares issued 550,093 shares to be issued and 13,895,499 shares outstanding as of September 30, 2009; 12,695,685 shares issued, 504,639 shares to be issued, and 12,662,352 shares outstanding as of December 31, 2008 14,478 13,200 
Additional paid-in capital 59,893,580 59,531,865  60,492,626 59,531,865 
Accumulated deficit  (58,451,552)  (57,233,369)  (58,824,823)  (57,233,369)
Treasury stock, at cost, 33,333 shares  (911,516)  (911,516)  (911,516)  (911,516)
          
Total stockholders’ equity 544,179 1,400,180  770,765 1,400,180 
          
Total liabilities and stockholders’ equity $3,715,290 $4,410,750  $3,900,447 $4,410,750 
          
See Notes to Condensed Financial Statements (unaudited)

 

4


MILESTONE SCIENTIFIC INC.
CONDENSED STATEMENTS OF OPERATIONS
(Unaudited)
                                
 Three Months Ended June 30, Six Months Ended June 30,  Three Months Ended September 30, Nine Months Ended September 30, 
 2009 2008 2009 2008  2009 2008 2009 2008 
  
Product sales, net 2,036,902 1,540,883 $4,241,721 $2,928,873  $1,909,263 $1,813,103 $6,150,984 $4,741,976 
Royalty income  9,007  23,170   5,112  28,282 
                  
Total revenue 2,036,902 1,549,890 4,241,721 2,952,043  1,909,263 1,818,215 6,150,984 4,770,258 
                  
 
Cost of products sold 862,741 594,437 1,779,291 1,058,361  709,003 740,398 2,488,294 1,798,758 
         
Total cost of revenue 862,741 594,437 1,779,291 1,058,361 
         
          
Gross profit 1,174,161 955,453 2,462,430 1,893,682  1,200,260 1,077,817 3,662,690 2,971,500 
                  
  
Selling, general and administrative expenses 1,753,237 1,367,807 3,482,052 2,839,784  1,477,948 1,199,353 4,960,000 4,039,137 
Research and development expenses 32,347 36,000 99,969 84,319  57,972 35,181 157,941 119,500 
                  
Total operating expenses 1,785,584 1,403,807 3,582,021 2,924,103  1,535,920 1,234,534 5,117,941 4,158,637 
                  
  
Loss from operations  (611,423)  (448,354)  (1,119,591)  (1,030,421)  (335,660)  (156,717)  (1,455,251)  (1,187,137)
  
Interest expense  (37,986)  (18,668)  (85,389)  (49,592)  (30,230)  (23,863)  (115,619)  (73,455)
Interest-Amortization of debt issuance  (7,875)  (7,567)  (15,750)  (13,696)  (7,875)  (7,926)  (23,625)  (21,622)
Interest income 742 1,471 2,547 4,707  495 1,773 3,041 6,479 
                  
Net loss applicable to common stockholders  (656,542)  (473,118) $(1,218,183) $(1,089,002) $(373,270) $(186,733) $(1,591,454) $(1,275,735)
                  
  
Loss per share applicable to common stockholders – basic and diluted $(0.05) $(0.04) $(0.09) $(0.09)
Loss per share applicable to common stockholders — basic and diluted $(0.03) $(0.02) $(0.12) $(0.10)
                  
  
Weighted average shares outstanding and to be issued – basic and diluted 13,062,102 12,228,792 12,965,658 12,370,659 
Weighted average shares outstanding and to be issued — basic and diluted 13,486,513 12,709,260 13,139,276 12,631,311 
                  
See Notes to Condensed Financial Statements (unaudited)

 

5


MILESTONE SCIENTIFIC INC.
CONDENSED STATEMENTSTATEMENTS OF CHANGES IN STOCKHOLDERS’ EQUITY
SIXNINE MONTHS ENDED JUNESEPTEMBER 30, 2009
(Unaudited)
                                     
 Additional        Additional       
 Common Stock Paid-in Accumulated Treasury    Common Stock Paid-in Accumulated Treasury   
 Shares Amount Capital Deficit Stock Total  Shares Amount Capital Deficit Stock Total 
  
Balance, January 1, 2009 13,200,324 $13,200 $59,531,865 $(57,233,369) $(911,516) $1,400,180  13,200,324 $13,200 $59,531,865 $(57,233,369) $(911,516) $1,400,180 
Options issued to employees and consultants 108,357 108,357  129,214 129,214 
Common stock issued for payment of consulting services to settle accounts payable 137,297 137 65,863 66,000  502,660 503 481,997 482,500 
Common stock issued for payment of employee compensation 284,592 285 137,540 137,825  312,371 312 150,013 150,325 
Common stock issued in advance of services-Chairman 84,783 85  (85)  
Common stock to be issued for settlement of deferred compensation 45,454 45 24,955 25,000  45,454 45 24,955 25,000 
Sale of common stock 333,333 333 149,667 150,000 
Proceeds on the sale of stock option agreement 25,000 25,000  25,000 25,000 
Net loss  (1,218,183)  (1,218,183)  (1,591,454)  (1,591,454)
                          
Balance, June 30, 2009 13,667,667 $13,667 $59,893,580 $(58,451,552) $(911,516) $544,179 
Balance, September 30, 2009 14,478,925 $14,478 $60,492,626 $(58,824,823) $(911,516) $770,765 
                          
See Notes to Condensed Financial Statements (unaudited)

 

6


MILESTONE SCIENTIFIC INC.
CONDENSED STATEMENTS OF CASH FLOWS (Unaudited)
                
 SIX MONTHS ENDED JUNE 30,  Nine Months Ended September 30, 
 2009 2008  2009 2008 
Cash flows from operating activities:  
Net loss $(1,218,183) $(1,089,002) $(1,591,454) $(1,275,735)
Adjustments to reconcile net loss to net cash used in operating activities:  
Depreciation expense 28,193 37,214  39,030 54,367 
Amortization of patents 37,043 23,588  56,174 37,869 
Amortization of debt discount 15,750 13,696  23,625 21,622 
Common stock and options issued for compensation, consulting and vendor services 337,182 267,232  787,040 312,252 
Loss on sale/disposal of equipment  4,996   2,255 
Changes in operating assets and liabilities:  
Decrease (Increase) in accounts receivable 128,122  (217,739) 424,862  (397,416)
Decrease in royalty receivable  6,352   10,247 
Decrease in inventories 87,277 548,345 
(Increase) Decrease in inventories  (168,739) 791,447 
Decrease to advances to contract manufacturer 140,205 215,151  192,695 350,183 
Decrease to prepaid expenses and other current assets 112,787 76,878  82,162 126,042 
(Increase) Decrease in other assets  (8,557) 17,216   (136,329) 18,029 
Increase (Decrease) in accounts payable 179,580  (560,010) 89,239  (922,463)
(Decrease) Increase in accrued expenses  (34,790) 63,071 
Increase in deferred compensation  3,959 
Increase in accrued expenses 46,247 171,095 
(Decrease) Increase in deferred compensation  (2,500) 7,042 
          
Net cash used in operating activities  (195,391)  (589,053)  (157,948)  (693,164)
     
      
Cash flows from investing activities:  
Purchases of property and equipment  (30,130)  (4,296)  (36,276)  (5,738)
Proceeds on sale of equipment  7,749   7,750 
Payment for patents rights  (44,568)  (198,760)  (76,986)  (267,831)
          
Net cash used in investing activities  (74,698)  (195,307)  (113,262)  (265,819)
          
 
Cash flows from financing activities:  
Notes Payable-Short Term borrowing  200,000 
Line of credit borrowing 300,000   300,000 
Proceeds from sale of stock options 25,000   25,000  
          
Net cash provided by financing activities 25,000 300,000  25,000 500,000 
          
  
NET DECREASE IN CASH AND CASH EQUIVALENTS  (245,089)  (484,360)  (246,210)  (458,983)
Cash and cash equivalents at beginning of period 743,665 745,003  743,665 745,003 
          
Cash and cash equivalents at end of period $498,576 $260,643  $497,455 $286,020 
          
Supplemental disclosure of cash flow information:  
Interest paid in cash $ $3,000 
     
Income taxes paid $5,821 $3,140  $8,225 $ 
          
Stocks issued to employees in lieu of cash compensation $134,825 $15,832  $150,325 $92,544 
     
Shares issued to officer in advance of services $97,500 $ 
          
Warrants issued in connection with line of credit $ $21,575  $ $21,575 
          
Shares issued to settle accounts payable $66,000 $518,845  $482,500 $548,845 
          
See Notes to Condensed Financial Statements (unaudited)

 

7


MILESTONE SCIENTIFIC INC.
NOTES TO CONDENSED FINANCIAL STATEMENTS
(UNAUDITED)
ORGANIZATION, BUSINESS AND BASIS OF PRESENTATION
Milestone Scientific Inc. (“Milestone” or the “Company”) was incorporated in the State of Delaware in August 1989. The Company leased additional office space in June 2009 and moved its headquarters to 45 Knightsbridge Road in Piscataway, New Jersey.
The unaudited financial statements of Milestone 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 financial statements should be read in conjunction with the financial statements and notes thereto for the year ended December 31, 2008 included in Milestone’s Annual Report on Form 10-K. The accounting policies used in preparing these unaudited financial statements are the same as those described in the December 31, 2008 financial statements.
In the opinion of Milestone, the accompanying unaudited financial statements contain all adjustments (consisting of normal recurring entries) necessary to fairly present Milestone’s financial position as of JuneSeptember 30, 2009 and December 31, 2008 and the results of its operations for the sixthree and nine months ended JuneSeptember 30, 2009 and 2008.
The results reported for the three and sixnine months ended JuneSeptember 30, 2009 are not necessarily indicative of the results of operations which may be expected for a full year.
The Company has incurred operating losses and negative cash flows from operating activities since its inception, including a net loss of $1,218,183$1,591,454 and $1,089,002$1,275,735 for the sixnine months ended JuneSeptember 30, 2009 and 2008, respectively. At JuneSeptember 30, 2009, the Company had cash and cash equivalents of $498,576$497,455 and negative working capital of $574,386.$406,968. The working capital is negative by the inclusion in current liabilities as of JuneSeptember 30, 2009 of the $1,300,000 line of credit, due on June 30, 2010. As discussed in Note 5, the Company secured a revolving line of credit in the aggregate amount of $1.3 million from a stockholder, which line was fully borrowed at December 31, 2008. All borrowings and interest thereon must be repaid by June 30, 2010, and after the expiration date of the line, may be repaid by Milestone in cash or, or at its option, in shares of common stock. As mentioned above, this borrowing is classified as a current liability as of JuneSeptember 30, 2009. Additionally, the Company borrowed $450,000 in 2008 from the same shareholder, with aan original due date of January 2009. This additional borrowing was refinanced at December 31, 2008 and the due date was extended to June 30, 2012 (as discussed in Note 5). The Company, at JuneSeptember 30, 2009, expects to have sufficient cash reserves to meet all of its anticipated obligations through December 31, 2009. Additionally, the Company 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. If the Company is unable to generate positive cash flows from its operating activities, it will need to raise additional capital. There is no assurance that the Company will be able to achieve positive operating cash flows or that additional capital can be raised on terms and conditions satisfactory to the Company, if at all. If additional capital is required and it cannot be raised, then the Company would be forced to curtail its development activities, reduce marketing expenses for existing dental products or adopt other cost saving measures, any of which might negatively affect the Company’s operating results.
The Company’s recurring losses and negative operating cash flows raises substantial doubt about its ability to continue as a going concern. The accompanying financial statements do not include any adjustments that might result from the outcome of this uncertainty.

 

8


NOTE 1 — SUMMARY OF ACCOUNTING POLICIES
Cash and Cash Equivalents
Milestone considers all highly liquid investments purchased with an original maturity of three months or less to be cash equivalents.
Inventories
Inventories principally consist of finished goods and component parts stated at the lower of cost (first-in, first-out method) or market.
Patents
Patents are recorded at actual cost to prepare and file the applicable documents with the United States Patent Office, or internationally with the applicable governmental office in the respective country. Although certain patents have not yet been approved, the costs related to these patents are being amortized using the straight-line method over the estimated useful life of the patent. If the applicable patent application is ultimately rejected, the remaining unamortized balance will be expensed in the period in which the Company receives a notice of such rejection. Patent applications filed and patents obtained in foreign countries are subject to the laws and procedures that differ from those in the United States. Patent protection in foreign countries may be different from patent protection under United States laws and may not be favorable to the Company. The Company also attempts to protect our proprietary information through the use of confidentiality agreements limiting access to ourits facilities. There can be no assurance that ourits program of patents, confidentiality agreements and restricted access to ourits facilities will be sufficient to protect ourits proprietary technology.
Revenue Recognition
Revenue from product sales is recognized net of discounts and allowances to ourthe Company’s domestic distributors on the date of arrival of the goods at the customer’s location as shipments are FOB destination. Shipments to ourthe Company’s international distributors are FOB ourMilestone’s warehouse and revenue is therefore recognized on shipment. In both cases, the price to the buyer is fixed and the collectability is reasonably assured. Further, we havethe Company has no obligation on these sales for any post sale installation, set-up or maintenance, these being the responsibility of the buyer. Customer acceptance is considered made at delivery. OurThe Company’s only obligation after sale is the normal commercial warranty against manufacturing defects if the alleged defective unit is returned within the warranty period.
Royalty income was recognized as earned based on reports received from the licensee, and related royalty expense is accrued during the same period.
Use of Estimates
The preparation of financial statements in conformity with accounting principles generally accepted in the United States of America requires management to make estimates and assumptions in determining the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and reported amounts of revenues and expenses during the reporting period. The most significant estimates relate to the allowance for doubtful accounts, inventory valuation, cash flow assumptions regarding evaluations for impairment of long-lived assets and valuation allowances on deferred tax assets. Actual results could differ from those estimates.
Recent Accounting Pronouncements
In June 2009, the FASB issued SFAS No. 168 (“SFAS 168”), “Accounting Standards Codification ™ and the Hierarchy of Generally Accepted Accounting Principles”. The FASB Accounting Standards Codification™ (“Codification”) has become the source of authoritative accounting principles recognized by the FASB to be applied by nongovernmental entities in the preparation of financial statements in accordance with GAAP. All existing accounting standard documents are superseded by the Codification and any accounting literature not included in the Codification will not be authoritative. However, rules and interpretive releases of the Securities Exchange Commission (“SEC”) issued under the authority of federal securities laws will continue to be sources of authoritative GAAP for SEC registrants.

9


SFAS 168 is effective for interim and annual reporting periods ending after September 15, 2009. Therefore, beginning with our quarter ending September 30, 2009, all references made by it to GAAP in its consolidated financial statements now use the new Codification numbering system. The Codification does not change or alter existing GAAP and, therefore, it is not having an impact on the Company’s financial position, results of operations and cash flows.
FASB ASC Topic 350-30-65-2, formerly, Emerging IssuesIssue Task Force (“EITF”) Issue No.(EIFT) No 08-7 Accounting for Defensive Intangible Assets, issued in November 2007, provides accounting and reporting guidance when an intangible acquired though a business combination or an asset acquisition that an entity does not intend to use but does intend to prevent others from using, commonly called a defensive asset or a locked up asset, because while the asset is not being actively used, it is likely contributing to an increase in the value of the other assets owned by the entity. This issue is effective for intangible assets acquired on or after the beginning of the first annual period beginning on or after December 15, 2008. This Statement does not currently impact the financial statements of the Company.

9


EITF Issue No. 07-1,FASB ASC Topic 808-10-05, Accounting for Collaborative Agreements, issued in November 2007, defines a Collaborative Arrangement and establishes the reporting requirements for transactions between participants in a collaborative arrangement and between participants in an arrangement with third parties. This issue shall be effective beginning after December 15, 2008 and interim periods within those fiscal years. This Statement does not currently impact the financial statements of the Company.
In December 2007, the Financial Accounting Standards Board (FASB) issued SFAS No.141 (revised),FASB ASC Topic 805-10-65-1,Summary No. 141 (revised 2007)”. SFAS No.141 (revised) provides for improving the relevance, representational faithfulness, and comparability of the information that an entity provides in its financial reports about a business combination and its effects. SFAS No.141 (revised) applies prospectively to business combinations for which the acquisition date is on or after December 15, 2008. This statement does not currently impact the financial statements of the Company.
In December 2007, the FASB issued SFAS No.160,ASC Topic 810,Non-controlling InterestNon controlling Interests in Consolidated Financial Statements- andan amendment of ARB No. 51”.SFAS No.160 establishes accounting and reporting standards for non-controlling interests, sometimes called minority interests for the portion of equity in a subsidiary not attributable, directly or indirectly, to a parent. SFAS No.160 is effective for fiscal years, and interim periods within those fiscal years, beginning after December 15, 2008. This statement does not currently impact the financial statements of the Company.
In March 2008, the FASB issued SFAS No. 161,ASC Topic 815-10-20, “Disclosure about Derivative Instruments and Hedging Activities an amendment of FASB No. 133”. This Statement requires enhanced disclosure about an entity’s derivative and hedging activities. The effective date for this Statement is for financial statements issued for fiscal yearyears and interim periods beginning after November 15, 2008. This Statement does not currently impact the financial statements of the Company.
In May 2008, the FASB issued FSP Accounting Principles Board (APB) Opinion 14-1, “Accounting for Convertible Debt Instruments That May Be Settled in Cash upon Conversion (Including Partial Cash Settlement)” (FSP APB 14-1)(FASB ASC 470-20-65-3) which applies to all convertible debt instruments that have a net settlement feature; which means that such convertible debt instruments, by their terms, may be settled either wholly or partially in cash upon conversion. FSP APB 14-1FASB ASC 470-20-65-3 requires issuers of convertible debt instruments that may be settled wholly or partially in cash upon conversion to separately account for the liability and equity components in a manner reflective of the issuer’s nonconvertible debt borrowing rate. Previous guidance provided for accounting for this type of convertible debt instrument entirely as debt. FSP APB 14-1FASB ASC 470-20-65-3 is effective for financial statements issued for fiscal years beginning after December 15, 2008 and interim periods within those fiscal years. This statement does not currently impact the financial statements of the Company.
In May 2008, the FASB issued SFAS No. 163,ASC Topic 944, “Accounting for Financial Guarantee Insurance Contracts - - an interpretation of FASB No.60”Contracts”. The Statement requires that an insurance enterprise recognize a claim liability prior to an event of default, when thethere is evidence that credit deterioration has occurred in an insured financial obligation. This Statement is effective for fiscal years beginning after December 15, 2008, and interim periods within the fiscal year. This Statement does not currently impact the financial statements of the Company.

10


In May 2009, the
FASB issued SFAS No. 165,ASC Topic 855, “Subsequent Events” — (SFAS No. 165) a statement that requires disclosure of events that occur after the balance sheet date, but before the financial statements are issued. The effective date of this statement is for interim or annual financial periods after June 15, 2009. This Statement does impact and is adopted byIn accordance with the ASC, the Company as ofreviewed the effective date ofevents for inclusion in the statement.financial statements through the filing date.
The FASB issued Statement No.166,ASC Topic 860Accounting“Accounting for Transfers of Financial Assets (SFAS 166) — an amendment of FASB No. 140140” was issued in June 2009. The purpose of this statementStatement was to address practices that developed subsequent to the issuance of SFAS No. 140, that were not consistent with the intent or key requirements of that statement.Statement. This statementStatement must be applied as of the beginning of each entity’s first annual reporting period that begins after November 15, 2009. This Statement does not currently impact the financial statements of the Company.
Statement No.167 — Amendment to FASB Interpretation No.46(R) was issued in June 2009 by the Financial Accounting Standards Board. The purpose is to improve financial reporting by enterprises involved with variable interest entities. The statementStatement is effective as of the beginning of each reporting entity’s first annual reporting period that begins after November 15, 2009. This Statement does not currently impact the financial statements of the Company.

10


Reclassifications
Certain reclassifications have been made to the 2008 balances to conform to the presentation used in 2009. These reclassificationreclassifications had no effect on operating results previously reported.
NOTE — 2 BASIC AND DILUTED NET LOSS PER COMMON SHARE
Milestone presents “basic” earnings (loss) per common share applicable to common stockholders and, if applicable, “diluted” earnings (loss) per common share applicable to common stockholders pursuant to the provisions of Statement of Financial Accounting Standards No. 128, “Earnings per Share” (SFAS 128).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.
Since Milestone had net losses for the three and sixnine months ended JuneSeptember 30, 2009 and 2008, the assumed effects of the exercise of outstanding stock options and warrants were not included in the calculation as their effect would have been anti-dilutive. Such outstanding options and warrants totaled 1,295,3311,316,997 at JuneSeptember 30, 2009 and 3,535,4123,537,079 at JuneSeptember 30, 2008. The major reduction in the total outstanding options and warrants is due to the expiration of 2,182,946 of2,227,946 warrants in the first and second quarter of 2009. Outstanding warrants totaled 175,000 at JuneSeptember 30, 2009 and 2,357,946 at September 30, 2008.
Additionally, the Company has an existing Line of Credit and related accrued interest that is convertible into 5,594,613 share of common stock at its option by June 30, 2008.2010.
NOTE — 3 STOCK OPTION PLANS
Effective January 1, 2006, Milestone adopted SFAS No. 123R,FASB ASC Topic 505,Share-Based PaymentPayment”, an Amendment of FASB Statement No. 123” (SFAS No. 123R), under the modified-prospective transition method whereby prior periods will not be restated for comparability. SFAS No. 123RTopic 505 requires all share-based payments to employees, including grants of employee stock options, to be recognized in the statements of operations over the service period, as an operating expense, based on the grant-date fair values. Pro-forma disclosure is no longer an alternative. As a result of adopting SFAS No. 123R, Milestone recognizes as compensation expense in its financial statements the unvested portion of existing options granted prior to the effective date and the cost of stock options granted to employees after the effective date based on the fair value of the stock options at grant date. Prior to the adoption of SFAS No. 123R, Milestone accounted for its stock option plans using the intrinsic value method of accounting prescribed by APB Opinion No. 25.

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A summary of option activity for employees under the stock option plans as of JuneSeptember 30, 2009, and changes during the sixnine months ended is presented below:
                                
 Weighted    Weighted   
 Weighted Average Aggregate  Weighted Average Aggregate 
 Number Averaged Remaining Intrinsic  Number Averaged Remaining Intrinsic 
 of Exercise Contractual Options  of Exercise Contractual Options 
 Options Price Life (Years) Value  Options Price Life (Years) Value 
  
Outstanding, January 1, 2009 570,832 $1.51 3.01 $75  570,832 $1.51 3.01 $75 
Granted 403,056 0.55 4.74   528,056 0.62 4.59 194,122 
Exercised          
Forfeited or expired  (263,556) 4.40     (371,890) 0.88   
Outstanding, June 30, 2009 710,332 1.09 3.27 26,292 
Exercisable, June 30, 2009 442,248 0.64 2.63 1,389 
Outstanding, September 30, 2009 726,998 1.19 3.16 106,766 
Exercisable, September 30, 2009 464,330 1.40 2.37 45,433 
The weighted average grant date fair value of options granted to employees during the sixnine months ended JuneSeptember 30, 2009 was $0.46.$0.69. The fair value of the options was estimated on the date of grant using the Black-Scholes option pricing model with the following weighted average assumptions: expected life of five years, volatility of 301%227% and a risk free interest rate of 1.20%1.580%. A six percent rate of forfeitures is assumed in the calculation of the compensation costs for the period.
Milestone recognizes compensation expense on a straight line basis over the requisite service period. During the sixnine and three months ended JuneSeptember 30, 2009,2009. Milestone recognized $46,222$54,244 and $8,022, respectively, of total compensation cost related to options that vested during the period. As of JuneSeptember 30, 2009, there was $99,819$180,006 of total unrecognized compensation cost related to non-vested options which Milestone expects to recognize over a weighted average period of three and one quarter years.

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The 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. The expected term of the options granted was estimated using the simplified method as the average of the contractual term and vesting term of the option.
A summary of option activity for non-employees under the stock option plans as of JuneSeptember 30, 2009, and changes during the sixnine months ended is presented below:
                                
 Weighted    Weighted   
 Weighted Average Aggregate  Weighted Average Aggregate 
 Number Averaged Remaining Intrinsic  Number Averaged Remaining Intrinsic 
 of Exercise Contractual Options  of Exercise Contractual Options 
 Options Price Life (Years) Value  Options Price Life (Years) Value 
  
Outstanding, January 1, 2009 627,467 3.14 1.61   627,467 $3.14 1.61 $ 
Granted 135,000 0.25 3.30 35,250  140,000 0.32 2.91 35,250 
Exercised          
Forfeited or expired  (352,468) 3.44     (352,468) 3.45   
Outstanding, June 30, 2009 409,999 1.94 2.98 35,250 
Exercisable, June 30, 2009 347,499 1.89 3.05 35,250 
Outstanding, September 30, 2009 414,999 1.93 2.69 87,900 
Exercisable, September 30, 2009 347,499 1.97 2.80 87,900 
During the sixthree and nine months ended JuneSeptember 30, 2009, Milestone recognized $62,136$12,835 and $74,970, respectively, of expenses related to non-employee options that vested during the period. The total unrecognized compensation cost related to non-vested options was $32,382$22,428 as of JuneSeptember 30, 2009.
In accordance with the provisions of SFAS No.123R,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, which meets the criteria set forth in SFAS No. 123R, 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, in the consensus of the EITF for EITF Issue No. 96-18 (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.

12


NOTE — 4 CONCENTRATION OF CREDIT RISK
Milestone’s financial instruments that are exposed to concentrations of credit risk consist primarily of cash, trade accounts receivable, and advances to contract manufacturers. Milestone 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 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 to a contract manufacturer. Milestone entered into a purchase agreement in 2004 with a vendor to supply Milestone with 5,000 units ofCompuDent. As part of this agreement, Milestone has a remaining advance of approximately $525,685$473,195 with the vendor for purchase of materials at JuneSeptember 30, 2009. The advance will be credited to Milestonereduced as the goods are delivered. Milestone does not believe that significant credit risk exists with respect to this advance to the contract manufacturer at JuneSeptember 30, 2009.
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 does not believe that significant credit risk exists with respect to accounts receivable at JuneSeptember 30, 2009.

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NOTE — 5 LINE OF CREDIT AND NOTE PAYABLE
On June 28, 2007, the Company secured a $1 million line of credit from a stockholder. This borrowing was amended to $1,300,000 as of September 30, 2008 under the same terms and conditions as the original. Borrowings bear interest at 6% per annum, with one year’s interest at 1% payable in advance on each draw. Monies may be drawn by Milestone under the line in multiples of $100,000 upon five days written notice to the stockholder from either Milestone’s Chief Executive Officer or Chief Financial Officer. Monies under the line in excess of $1,000,000 may be drawn in multiples of $25,000. Borrowings may be prepaid at any time in multiples of $100,000, without penalty. All borrowings and interest thereon must be repaid by June 30, 2010, and after the expiration date of the line, may be repaid by Milestone in cash or, at its option, in shares of common stock valued at the lower of $2.00 per share or 80% of the average closing price of its shares during the 20 trading days ending with December 31, 2008. At December 31, 2008, the conversion price at 80% of the average closing price of the Company’s common stock was $0.26 per share. After December 31, 2008, and before June 30, 2010 the lender may convert all or any part of the then outstanding balance and interest thereon into shares of Common Stockcommon stock at $4.00 per share. Three year warrants exercisable at $5.00 per share, in an amount determined by dividing 50% of the amount borrowed by $5.00 will be issued on each drawdown. There is no facility fee on the line. The warrants have been valued as of each draw down using the Black-Scholes model and are reflected as a discount against the debt incurred under this line of credit. At JuneSeptember 30, 2009, the remaining balance of Debt Discount was $36,152.$28,976. The full amount of the line of credit and amendment, $1.3 million, had been drawn at September 30, 2009 and December 31, 2008. As of JuneSeptember 30, 2009, this line of credit is classified as a current liability on the Condensed Balance Sheet. The Company borrowed an additional $450,000 from the same shareholder in 2008. The borrowing was originally on short term loan with a maturity date of January 19, 2009. In December 2008, this borrowing was refinanced with the shareholder with a due date of June 30, 2012. The borrowing includes a 12 percent interest rate, interest compounded quarterly, with interest and principle due at the maturity. Further, the note has warrants attached, exercisable for five years at the price of $0.32 per share for 45,000 shares of stock. The warrants were valued using the Black-Scholes model and are reflected as a discount against the debt. At JuneSeptember 30, 2009, the discount was $12,555.$11,856.
Interest expense on this line of credit and note payable for the sixthree and nine months ended JuneSeptember 30, 2009 and 2008 is $85,389was $30,230 and $49,592,$115,619, respectively, and $23,863 and $73,455, respectively. Accrued interest related to this line of credit and note payable was $179,056$207,868 at JuneSeptember 30, 2009. The charge for amortization of debt discount related to this line of credit and note payable is $15,750was $23,625 and $13,696$21,622 for the sixnine months ended JuneSeptember 30, 2009 and 2008, respectively.

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NOTE — 6 STOCK ISSUANCE
During the sixnine months ended JuneSeptember 30, 2009, the Company issued 137,297502,660 shares of common stock valued at $66,000 in connection with public relations and consulting expenses.$482,500 to pay off outstanding accounts payable at December 31, 2008. Additionally, 284,592397,154 shares of common stock valued at $137,825$247,825 were issued for payment of employee compensation and 333,333 shares were sold for $150,000, which is recorded as stock subscription receivable. The stock subscription receivable is reduced by offsetting inventory purchased in the third and fourth quarter of 2009. The 45,454 shares of common stock valued at $25,000 are to be issued in settlement of deferred compensation.
Included in the amount above are shares issued to the Company’s Chairman of the Board of Directors (84,783 shares) at a value of $97,500 in advance of services performed per her employment agreement. Additionally, a consultant to the Company was issued 173,913 shares valued at $200,000 in advance of the performance of his services over a three year period. Of this $200,000, $66,672 is included in the prepaid expenses as current assets and $127,772 is included in other non-current assets on the condensed Balance Sheet. Such amounts will be amortized to expense over the contract period.
NOTE — 7 SIGNIFICANT CUSTOMERS
Milestone had net product sales to twomajor customers (distributors) which in the aggregate accounted for approximately 65%72% and 92%77% of revenue for the sixnine months ended JuneSeptember 30, 2009 and 2008, respectively. Milestone had sales to one customer (a worldwide distributor of Milestone’s products based in South Africa) of $813,526$813,570 or 19%13% for the sixnine months ended JuneSeptember 30, 2009. Accounts receivable from these twomajor customers amounted to $476,826$174,311 and $481,560$642,584 representing 60%35% and 85%87% of gross accounts receivable as of JuneSeptember 30, 2009 and JuneSeptember 30, 2008, respectively.

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Milestone’s sales by product and by geographical region are as follows:
                
 Three Months Ended June 30,  Three Months Ended September 30, 
 2009 2008  2009 2008 
Instruments
 $815,905 $128,475  $511,531 $498,879 
Handpieces $1,200,369 $1,394,124  $1,373,255 $1,297,654 
Other $20,628 $18,284  $24,477 $16,570 
          
 $2,036,902 $1,540,883  $1,909,263 $1,813,103 
          
  
United States $1,408,336 $989,303  $1,151,475 $1,322,665 
Canada $151,171 $157,185  $148,916 $111,570 
Other Foreign $477,395 $394,395  $608,872 $378,868 
          
 $2,036,902 $1,540,883  $1,909,263 $1,813,103 
          
                
 Six Months Ended June 30,  Nine Months Ended September 30, 
 2009 2008  2009 2008 
Instruments
 $1,602,122 $347,679  $2,113,653 $846,558 
Handpieces $2,595,581 $2,543,069  $3,968,836 $3,840,723 
Other $44,018 $38,125  $68,495 $54,695 
          
 $4,241,721 $2,928,873  $6,150,984 $4,741,976 
          
  
United States $2,886,831 $1,887,018  $4,038,306 $3,209,683 
Canada $292,450 $317,507  $441,366 $429,077 
Other Foreign $1,062,440 $724,348  $1,671,312 $1,103,216 
          
 $4,241,721 $2,928,873  $6,150,984 $4,741,976 
          
In January 2007, Milestone finalized an Exclusive Distribution and Supply Agreement with Henry Schein, Inc. Henry Schein, Inc. served as the exclusive distributor ofSTAandCompuDentsystems (and ancillary products) in both North America and Canada, for a one year period. In June 2008, Milestone implemented a change to its domestic distribution strategy and signed Henry Schein, Inc. as a non-exclusive distributor ofSTAandCompuDentsystems (and ancillary products) in the United States and Canada.North America. That same month, the Company also signed Patterson Dental Supply as an additional non-exclusive partner to promote sales of ourthe Company’s products in the United States and Canada.North America. Early in the third quarter of 2008, the Company added four more non-exclusive distributors to ourits domestic sales network, including Benco Dental, Burkhard Dental, Goetze Dental and Atlanta Dental. Milestone continued to expand its domestic distribution network during the first sixnine months of 2009, welcoming Darby Dental Supply, Dental Health Products, Nashville Dental and Parkway Dental.
Milestone has also focused on expanding its global distribution network, granting exclusive rights to market, distribute and sell its products in certain key geographic markets around the world. In June 2008, the Company named Istrodent Pty Ltd AB as exclusive distributor of theSTA System(and ancillary products) in South Africa, and Unident AB as its exclusive distributor in Denmark, Sweden, Norway and Iceland. In April 2009, Milestone awarded exclusive distribution and marketing rights to China National Medicines Corporation, d/b/a Sinopharm, for theSTA System(and ancillary products).

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As of July 1, 2009, Milestone established a direct path to its international distributors’ networks. Effectively, Milestone will sell directly to existing and new international distributors, rather than through its previous worldwide distributor in South Africa. As part of the change, Milestone agreed to pay a commission to the previous distributor, based on actual international sales, over the next nine years. The commission is structured at two levels: Level One is based on historical sales volume, and Level Two is determined for incremental sales volume over the Level One plateau. The Company has informal arrangements withevaluated this event in September 2009 and continues to monitor the manufacturer of ourSTA,CompuDentandCompuMed units, one ofagreement through the principal manufacturers of our handpieces anddate that the financial statements are issued. The commission to the previous distributor was $117,790 for those units pursuant to which they manufacture these products under specific purchase orders but without any long-term contract or minimum purchase commitment. The Company has established an alternate source of supply for our handpieces in China and other alternate sources of supply exist.the quarter ending September 30, 2009.
NOTE — 8 COMMITMENTS AND OTHER
Contract Manufacturing Arrangement
Milestone has informal arrangements for the manufacture of its products.CompuDent, STAandCompuMedunits are manufactured for Milestone by Tricor Systems, Inc. pursuant to specific purchase orders.The Wanddisposable handpiecehand piece without a needle is manufactured for Milestone in Mexico pursuant to scheduled production requirements.The WandandSTAhandpieceshand pieces (with and without needles) isare supplied to Milestone by a product broker that arranges for its manufacture by manufacturers 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.
NOTE — 9 SUBSEQUENT EVENTS
AsSubsequent to the end of July 1,the third quarter, Milestone received a blanket purchase order from Sinopharm for 12,000STA Systems, deliverable of the next 36 months.
The Company, subsequent to September 30, 2009, Milestone establishedagreed to offer a direct pathbonus program to its international distributors’ network. Effectively, MilestoneChief Executive Officer that will sell directlyallow for an issuance of up to existing and new international distributors, rather than through its previous worldwide distributor$300,000 in South Africa. As partrestricted stock and/or stock options upon the achievement of specified revenues generated from the business with Sinopharm over a four year period. Such compensation will be recorded under this plan annually, upon successful achievement of the change, Milestone agreed to pay a commission tobonus program revenue targets as included in the previous distributor, based on actual international sales, over the next six years. The commission is structured at two levels: Level One is based on historical sales volume and Level Two is determined for incremental sales volume over the Level One plateau. The company evaluated this event in June 2009 and continues to monitor the agreement through the date that the financial statements are issued.agreement.

 

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ITEM 2. Management’s Discussion and Analysis and Plan of Operation.
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 Exchange Act, that involve risks and uncertainties. Our actual results may differ materially from those anticipated in these forward-looking statements. See “Risk Factors” on Part II. ITEM 1A of this Form 10-Q.
OVERVIEW
During the secondthird quarter of 2009, Milestonewe remained focused on advancing efforts to achieve itsour 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, theSTA Single Tooth Anesthesia System(STA System); and
  
Identifying and pursing strategic collaborations with third parties to jointly develop new products utilizing our patentedCompuFlopressure force technology for novel new medical applications.
STA System Awards — Industry Recognition
Since its market introduction in the spring of 2007, theSTA Systemhas received rave reviews and awards from the dental industry. In July 2007, noted industry publicationDentistry Today featured theSTA Systemas one of the “Top 100 Products in 2007,” helping to promote much broader recognition of the instrument and validating theSTA System’s value proposition for dentists and patients alike. In April 2008,Medical Device & Diagnostic Industrymagazine distinguished theSTA Systemas a 2008 Medical Design Excellence Award winner in the “Dental Instruments, Equipment and Supplies” product category. Of the 33 products to receive this coveted award, theSTA Systemwas one of only two winning products that serve dental practitioners.
In December 2008, theSTA Systemwas again recognized as one of the dental industry’s best technological innovations, winning a “Townie Choice Award” fromDentaltown Magazinein the category “Anesthetics: Technique System”. This marked the second consecutive year that Milestone won a “Townie Choice Award”; in 2007, the Companywe won the same award for itsourCompuDent/The Wand.Also in December 2008, Milestone’s ourSTA Systemwas named as aDental Products Report“Top 100 2008 Product of Distinction.Distinction”. Each year,DPRspotlights the year’s Top 100 products. Of these 100 products, 50 are the ones most often inquired about byDPR’s readers via an online and Product Information Card reader service program. The other 50 represent “New Classics,” which recognize both old and newer products and categories chosen byDPR’seditorial staff for their “perceived impact on driving innovation or helping to establish a new, higher standard of care for patients.” TheSTA Systemwas recognized as a “New Classic” in the Technology category.
Second Annual Symposium on C-CLAD
In addition to winning noted acclaim among leading dental publications, our award winningSTA Systemhas also been gaining the support of many of the world’s leading dental practitioners and key opinion leaders. In February 2008, we hosted the First International C-CLAD Symposium in New Orleans, welcoming a distinguished panel of dental experts who gathered to discuss advancements in the scientific and clinical practice communities toward the common goal of advancing the science, knowledge and art of C-CLAD in dentistry. The forum yielded a number of exciting ideas on how Milestonewe can integrate theSTA Systemnot only into dental school curricula, but also extend messaging regarding its many unique benefits to the dental community and patients alike.

 

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On May 1-3,1 through 3, 2009, Milestonewe hosted the 2ndSecond International Annual Symposium on C-CLAD in Amelia Island, Florida. Stanley Malamed, DDS, Professor of Anesthesia & Medicine at the University of Southern California, School of Dentistry, again served as Chairman of the invitational event. With attendance triple that of 2008, this year’s Symposium covered a broad range of C-CLAD-related topics including:
The History of C-CLAD
Treating with Connection
Heart Rate Study
  
STACompassionate Care in the 21st Century
Injection Advances and Challenges
Physiologic and Clinical Characteristics of PDL Anesthesia Delivered by a High Pressure HandpieceHand piece and a Computerized Device
  
TheSTAfor Tots and Teens
Computerized Local Anesthesia in Dentistry: A Review
Today’s Technology
Managing a Successful Dental Practice: Why People Keep Coming Back
  
STA— The Dental School’s Perspective
Futuristic Vistas: The Dentist/Hygienist Partnership
In October 2009, Milestone expectsWe expect to publish and broadly distribute more than 100,000 copies of a comprehensive monograph reflecting the topics discussed at the Symposium and a consensus on the attendees’ attitudes, ideas and suggestions relating to promoting global industry adoption of C-CLAD technologies as the new standard of care for administering dental injections.
STA System Growth
Since its market introduction in early 2007, theSTA System,a prior computerized controlled local anesthesia delivery product,has been used to deliver tens of millions of 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 theSTA Systemis proving to be a valuable and beneficial instrument that is positively impacting the practice of dentistry worldwide. The utility and value of theSTA Systemis perhaps best summarized by Dr. Joe Blaes, who wrote in the December 2008 edition ofDental Economics, “I tried theSTA Systemand my patients absolutely love it. This is a no brainer — go get one ASAP!”
Global Distribution Network
TheSTA Systemand related handpieceshand pieces are marketed to the dental industry in the United States and Canada by many of the nation’s leading dental supply companies, including Henry Schein, Inc., Patterson Dental Supply, Benco Dental, Burkhart Dental, Goetze Dental, Atlanta Dental, Darby Dental Supply, Dental Health Products, Nashville Dental and Parkway Dental.
Collectively, our domestic network has more than 2,500 independent sales representatives trained to sell theSTA Systemand related handpieceshand pieces to dentists throughout the United States and Canada.North America.
On the global front, we also have granted exclusive marketing and distribution rights for theSTA Systemto select dental suppliers in various international regions.regions in Asia, Africa and Europe. They include Istrodent in South Africa and Unident in the Scandinavian countries of Denmark, Sweden, Norway and Iceland.
In MayApril 2009, the Companywe signed an Exclusive Distribution and Marketing Agreement with China National Medicines Corporation, d/b/a Sinopharm, which is China’s largest domestic manufacturer, distributor and marketer of pharmaceuticals and importer of medical devices and the country’s largest domestic distributor of dental anesthetic carpules to the Chinese dental industry.
Shortly before the end of the second quarter, Milestonewe announced that it waswe were refining itsour international marketing strategy to gain greater access to and penetration of the international dental markets for theSTA System, CompuDentand related disposable hand pieces. The new sales strategy provides for increasing hands-on oversight and support of Milestone’sour existing international distribution network, while also attracting new distributors throughout Europe, Asia and South America. To assist in this endeavor, Milestone named Shaul Koren, founder and CEO of Istrodent Pty Ltd AB and one of Milestone’sour strongest marketing allies outside of the U.S., as itsour new international sales director.International Sales Director. In collaboration with senior management, Mr. Koren will help manage product sales for the Companyus in all non-domestic markets worldwide.outside of North America.

 

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As a result of growing market awareness and appreciation of theSTA System, coupled with our active worldwide marketing efforts, sales of the instrument (and related handpieces)hand pieces) yielded four consecutive quarters of growth in 2008. In the first sixnine months of this year, we saw no indication that this trend is slowing or reversing. Sales of theSTA Systemand related handpiecesrecurring sales from disposable hand pieces helped increase total revenues by $1,496,058$1,380,726 during the sixnine months ended JuneSeptember 30, 2009, when compared to the same sixnine month period in the prior year.
Segmented Sales Performance
The following table shows a breakdown of our product sales (net), domestically and internationally, by product category, and the percentage of product sales (net) by each product category:
                                
 Three Months Ended June 30,  Three Months Ended September 30, 
 2009 2008  2009 2008 
DOMESTIC
  
Instruments
 $527,725  37.5% $(27,003)  -2.8% $263,451  22.9% $365,887  27.6%
Handpieces 861,991  61.2% 1,000,737  101.2% 865,508  75.1% 942,613  71.3%
Other 18,620  1.3% 15,569  1.6% 22,516  2.0% 14,165  1.1%
                  
Total Domestic $1,408,336  100.0% $989,303  100.0% $1,151,475  100.0% $1,322,665  100.0%
                  
INTERNATIONAL
  
Instruments
 $288,180  45.8% $155,478  28.2% $248,080  32.7% $132,992  27.1%
Handpieces 338,378  53.8% 393,387  71.3% 507,747  67.0% 355,041  72.4%
Other 2,008  0.4% 2,715  0.5% 1,961  0.3% 2,405  0.5%
                  
Total International $628,566  100.0% $551,580  100.0% $757,788  100.0% $490,438  100.0%
                  
  
DOMESTIC/INTERNATIONAL ANALYSISDOMESTIC/INTERNATIONAL ANALYSIS  
Domestic $1,408,336  69.1% $989,303  64.2% $1,151,475  60.3% $1,322,665  73.0%
International 628,566  30.9% 551,580  35.8% 757,788  39.7% 490,438  27.0%
                  
Total Product Sales $2,036,902  100.0% $1,540,883  100.0% $1,909,263  100.0% $1,813,103  100.0%
                  
                                
 Six Months Ended June 30,  Nine Months Ended September 30, 
 2009 2008  2009 2008 
DOMESTIC
  
Instruments
 $1,054,138  36.5% $54,141  2.9% $1,317,589  32.6% $420,028  13.0%
Handpieces 1,793,801  62.1% 1,800,417  95.4% 2,659,310  65.8% 2,743,031  85.5%
Other 38,892  1.4% 32,460  1.7% 61,407  1.6% 46,625  1.5%
                  
Total Domestic $2,886,831  100.0% $1,887,018  100.0% $4,038,306  100.0% $3,209,684  100.0%
                  
INTERNATIONAL
  
Instruments
 $547,984  40.4% $293,538  28.2% $796,064  37.7% $426,530  27.8%
Handpieces 801,780  59.2% 742,652  71.3% 1,309,526  62.0% 1,097,692  71.7%
Other 5,126  0.4% 5,665  0.5% 7,088  0.3% 8,070  0.5%
                  
Total International $1,354,890  100.0% $1,041,855  100.0% $2,112,678  100.0% $1,532,292  100.0%
                  
  
DOMESTIC/INTERNATIONAL ANALYSISDOMESTIC/INTERNATIONAL ANALYSIS  
Domestic $2,886,831  68.1% $1,887,018  64.4% $4,038,306  65.7% $3,209,684  67.7%
International 1,354,890  31.9% 1,041,855  35.6% 2,112,678  34.3% 1,532,292  32.3%
                  
Total Product Sales $4,241,721  100.0% $2,928,873  100.0% $6,150,984  100.0% $4,741,976  100.0%
                  
The Company earnedWe achieved gross profitsprofit margin of 58%63% and 60% for the three and sixnine months ended JuneSeptember 30, 2009, respectively. However, our revenues and related gross profits have not been sufficient to support our overhead, new product introduction and research and development expenses. Although the Company anticipateswe anticipate expending funds for research and development in 2009, these amounts will vary based on the operating results for each quarter. The Company hasWe have incurred operating losses and negative cash flows from operating activities since its inception. The Company is actively pursuing the generation of positive cash flows from operating activities through increaseincreases in revenue, assessment of current contracts and current negotiations and reductionreductions in operating expenses. The Company, at JuneAt September 30, 2009, expectswe expect to have sufficient cash reserves to meet all of itsour anticipated obligations through December 31, 2009.
New Product Development and Commercialization Utilizing CompuFlo Technology
Over the last decade, the drug delivery industry has evolved to become a key area in the development of value-added pharmaceutical products. According to market research firm Business Insights, “The global market grew from $15 billion to $40 billion during 2000-20062000–2006 as companies increasingly turned to drug delivery technologies as a means of expanding product lifecycles, enhancing drug efficacy and maximizing revenues.” Moreover, industry analysts agree that as patients live longer and are diagnosed with chronic and often debilitating ailments, the result will be a dramatic increase in self-administration of drug therapies in non-traditional settings for a number of conditions. This trend is creating an increased interest in routes of administration that are patient-friendly and cost-effective. It appears that pharma company decision makers are realizing that new drug product success no longer only depends on the medication itself, but also on achieving a patient-friendly form of application.delivery.

 

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In keeping with our stated goal for leveraging Milestone’sour patentedCompuFlotechnology in new medical applications, Milestone’sour management team has also continued to identify and pursue opportunities to form strategic collaborations in the areas of self-administered drug delivery, injections for osteoarthritis pain management and epidurals. The response to Milestone’sour proprietary technology with whom Milestone haswe have engaged in meaningful teaming discussions has continued to be encouraging. Throughout 2008, the Companywe have met with healthcare companies who expressed interest in potential applications of theCompuFlotechnology. As Milestone progresseswe progress through 2009, the Company will maintainmaintains its pursuit ofCompuFlo-based product development prospects that are deemed the most promising and commercially viable, and offer the greatest potential for allowing Milestoneus to fully realize the product development and commercialization opportunities.
Executive Management Change
On March 27, 2009, we accepted the resignation of our Chief Executive Officer, who chose to leave Milestone to pursue a new career opportunity. Our Chairman of the Board, hasLeonard Osser, temporarily assumed the post of Interim Chief Executive Officer and will remain as such until a suitable replacement has been identified and appointed byOfficer. However, on September 1, 2009, Leslie Bernhard, an independent member of our Board of Directors.Directors, was named Chairman, succeeding Mr. Osser who had led the Company as its Chairman since 1991. Mr. Osser now serves as our Chief Executive Officer.
Technology Rights
The technology underlying ourSafetyWandandCompuFlotechnology and an improvement to the controls forCompuDentwere developed by our Director of Clinical Affairs and assigned to us. We purchased this technology pursuant to an agreement dated January 1, 2005 for 43,424 shares of restricted common stock and $145,000 in cash, paid on April 1, 2005. In addition, our Director of Clinical Affairs will receive additional contingent payments of 2.5% of our total sales ofCompuDentand Wand Plus units using some of these technologies, and 5% of our total sales ofSTA units and handpieceshand pieces using some of our other technologies. If products produced by third parties use any of these technologies, under a license from Milestone, then he will also receive the corresponding percentage of the consideration received by us for such sale or license.
Intellectual Property
In August 2009, we were issued a Notice of Allowance by the U.S. Patent and Trademark Office for its U.S. patent application directed to the use of its disposable hand piece for fluid administration. Our award-winning hand piece is an instrument currently utilized in conjunction with the Company’sSTA,CompuDentandCompuMedsystems.
Subsequent to the end of the third quarter of 2009, the U.S. Patent and Trademark Office issued a Notice of Allowance for our U.S. patent application, titled “Computer Controlled Drug Delivery System with Dynamic Pressure Sensing.” This intellectual property represents one of the key technological components of our product development strategy relating to the development of advanced computer-controlled injection products for specific applications in the medical industry — most notably intra-articular injections and epidurals.
To date, we have been awarded a total of 23 U.S. utility and design patents relating to our Computer-Controlled Local Anesthesia Delivery (C-CLAD) technologies.
Summary of Significant Accounting Policies, Judgments and Estimates
Our discussion and analysis of our financial condition and results of operations are based upon our financial statements, which have been prepared in accordance with accounting principles generally accepted in the United States of America. The preparation of these financial statements requires us to make estimates and judgments that affect the reported amounts of assets, liabilities, revenues and expenses, and related disclosure of contingent assets and liabilities. On an on-going basis, we evaluate our estimates, including those related to accounts receivable, inventories, stock-based compensation, and contingencies. We base our estimates on historical experience and on various other assumptions that are believed to be reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities that are not readily apparent from other sources. Actual results may differ from those estimates under different assumptions or conditions.

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Accounts Receivable
The realization of Accounts Receivable will have a significant impact on the Company. Consequently, Milestone estimateswe estimate losses resulting from the inability of its customers to make payments for amounts billed. The collectability of outstanding amounts is continually assessed.
Inventories
Inventory costing, obsolescence and physical control are significantly important 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.
Impairment of Long-Lived Assets
The long livedlong-lived assets, of the Company, principally patents and trademarks, are the base features of the business. We review 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.

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Revenue Recognition
Revenue from product sales is recognized net of discounts and allowances to our domestic distributors on the date of arrival of the goods at the customer’s location as shipments are FOB destination. Shipments to our international distributor are FOB our warehouse and revenue is therefore recognized on shipment. In both cases the price to the buyer is fixed and the collectability is reasonably assured. Further, we have no obligation on these sales for any post installation, set-up or maintenance, these being the responsibility of the buyer. Customer acceptance is considered made at delivery. Our only obligation after sale is the normal commercial warranty against manufacturing defects if the alleged defective unit is returned within the warranty period.
Results of Operations
The consolidated results of operations for the sixthree and nine months ended JuneSeptember 30, 2009 compared to the same sixthree and nine month period in 2008 reflect our focus and development on theSTA System, as well as the Companyour continuing efforts on identifying collaborative partners for new product development utilizing ourCompuFlotechnology.
The following table sets forth for the periods presented statement of operations data as a percentage of revenues. The trends suggested by this table may not be indicative of future operating results.
                                                 
 Three Months Ended June 30, Six Months Ended June 30,  Three Months Ended September 30, Nine Months Ended September 30, 
 2009 2008 2009 2008  2009 2008 2009 2008 
Products sales, net $2,036,902  100% $1,540,883  99% $4,241,721  100% $2,928,873  99% $1,909,263  100% $1,813,103  100% $6,150,984  100% $4,741,976  99%
Royalty income   0% 9,007  1%   0% 23,170  1%   0% 5,112  0%   0% 28,282  1%
                                  
Total revenue 2,036,902  100% 1,549,890  100% 4,241,721  100% 2,952,043  100% 1,909,263  100% 1,818,215  100% 6,150,984  100% 4,770,258  100%
                                  
Cost of products sold 862,741  42% 594,437  38% 1,779,291  42% 1,058,361  36% 709,003  37% 740,398  41% 2,488,294  40% 1,798,758  38%
                                  
Gross Profit 1,174,161  58% 955,453  62% 2,462,430  58% 1,893,682  64% 1,200,260  63% 1,077,817  59% 3,662,690  60% 2,971,500  62%
                                  
Selling, general and administrative expenses 1,753,237  86% 1,367,807  88% 3,482,052  82% 2,839,784  96% 1,477,948  77% 1,199,353  66% 4,960,000  81% 4,039,137  85%
Research and development expenses 32,347  2% 36,000  3% 99,969  2% 84,319  3% 57,972  3% 35,181  2% 157,941  3% 119,500  3%
                                  
Total operating expenses 1,785,584  88% 1,403,807  91% 3,582,021  84% 2,924,103  99% 1,535,920  80% 1,234,534  68% 5,117,941  83% 4,158,637  88%
                                  
Loss from operations  (611,423)  -30%  (448,354)  -29%  (1,119,591)  -26%  (1,030,421)  -35%  (335,660)  -18%  (156,717)  -9%  (1,455,251)  -24%  (1,187,137)  -25%
Other income — interest & expense  (45,119)  -2%  (24,764)  -2%  (98,592)  -2%  (58,581)  -2%  (37,610)  -2%  (30,016)  -2%  (136,203)  -2%  (88,598)  -2%
                                  
Net loss $(656,542)  -32% $(473,118)  -31% $(1,218,183)  -29% $(1,089,002)  -37% $(373,270)  -20% $(186,733)  -11% $(1,591,454)  -26% $(1,275,735)  -27%
                                  

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Three months ended JuneSeptember 30, 2009 compared to three months ended JuneSeptember 30, 2008
Total revenues for the three months ended JuneSeptember 30, 2009 and 2008 were $2,036,902$1,909,263 and $1,549,890,$1,818,215, respectively. The total increase in product sales of $496,019,$96,160, or 32%5%, in 2009 over 2008 is primarily the result of the continuedSTAproduct sales growth. DomesticSTAunit sales increased $569,457decreased $75,333 in 2009 over 2008. This notable increase is due todecrease represented a slower sell through of the change in our distributor business model, initiated inSTA Systemduring the second quartersummer of 2008. The exclusive distributor arrangement was terminated in the second quarter of 2008 and a non exclusive arrangement was implemented with several national and regional distributors.this year. In the domestic market, handpiecehand piece sales were lower, decreasing by $138,746$77,105 or 14%8.2%. On the international front, unit sales increased in the secondthird quarter of 2009 over 2008 by $132,702,$115,088, or 85%87%, principally due to increased market penetration for theSTA System. Internationally, handpieces decreasedhand pieces increased by $55,009,$152,706, or 14%43% due to a loweran increased demand. Our international business is an area of growth potential for us.
Cost of products sold for the three months ended JuneSeptember 30, 2009 and 2008 were $862,741$709,003 and $594,437,$740,398 respectively. The $268,304,$31,395, or 45%4%, increasedecrease is primarily attributable to an increasea change in sales volume and a write-down of returned legacy defective merchandise of $36,066 in 2009.mix.
For the three months ended JuneSeptember 30, 2009, Milestonewe generated a gross profit of $1,174,161,$1,200,260, or 58%63%, as compared to a gross profit of $955,453,$1,077,817, or 62%59%, for the three months ended JuneSeptember 30, 2008. The decrease in gross profit percentage is due to product mix and the $36,066 write-down of returned legacy defective merchandise. The total increase in gross profit dollars of $218,708$122,443 is due to an increase in sales volume.dollar volume attributable to a change in our international sales process. Effective July 1, 2009, we began selling our products directly to international distributors. As a result of this change, we recorded a higher selling price of the product to our international distributor and pay a commission to our former master international distributor based on our agreement. This commission for the quarter is $117,790 and is included in Selling, General and Administrative Expenses in the third quarter.

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Selling, general and administrative expenses for the three months ended JuneSeptember 30, 2009 and 2008 were $1,753,237$1,477,948 and $1,367,807,$1,199,353, respectively. The $385,430,$278,595, or 28%23%, net increase is described in the following sections of this paragraph. Although the Company continueswe continue to reducefocus on reducing expenses, the 2009 secondthird quarter increase was due to higher expenses relating to promoting continued sales growth.growth and increased consulting expenses. Personnel and related expenses remained relatively unchanged. Marketing ($133,053) and sales ($195,430) expenses increased by $64,695, principally due to bonuses and higher payroll taxes and medical costs. Marketing ($266,790) and sales ($46,793) expenses increased by $313,583 principally due to increased marketing consulting fees related to hosting the 2nd Annual C-CLAD Symposium (approximately $171,000), attendance at trade shows and various sales promotions. Sales and trade show expenses increased by $80,847,$18,798, as the Company increased field sales personnel and increasedwe increase participation and presence at trade shows. Additionally, fieldinternational sales personnel andcommission increased by $117,790 due to a change in our international sales agreement with our former master international distributor, while our third party sales representative commissions increased by $60,862decreased based on increaseddecreased domestic sales of theSTA Systemsand related handpieces.. Other variable sales expenses for theSTA Systemand handpieceshand pieces increased in the secondthird quarter of 2009 due to higher royalty payments ($45,534)75,058). On the positive side of the ledger, professional accounting services decreased by $7,221$20,715 in the secondthird quarter of 2009 over the same period in 2008, due to completion of the Sarbanes Oxley initiative and lower audit fees. There2008. However, there was a decreasesignificant increase in consulting services of $36,125, a $19,487 savings$201,284 in annual proxy costs (electronic filing, Notice and Access System), a decreasethe third quarter of 2009, paid in insurance expense of $13,410 and a reductionstock, to professionals that have assisted in warehouse expense of $12,056.our continuous growth.
Research and development expenses for the three months ended JuneSeptember 30, 2009 and 2008 were $32,347$57,972 and $36,000,$35,181, respectively. This increase is due to expenses related to new prototype equipment in the medical field.
The loss from operations for the three months ended JuneSeptember 30, 2009 and 2008 was $611,423$335,660 and $448,354,$156,717, respectively. The $163,069, or 36%,$178,943 increase in loss from operations is explained above.
Interest income of $742 was earned for the three months ended June 30, 2009 compared with $1,471 for the same period in 2008. Interest income declined due to lower interest rates.
Interest expense was $37,986$30,230 and amortization of debt issuance was $7,875 relating to the line of credit and long term note payable was $7,875 for the secondthird quarter of 2009 compared to interest expense of $18,668$23,863 and amortization of debt issuance expense of $7,567$7,926 for the same quarter in 2008. The increase in interest expense $19,318of $6,367 is due to the $450,000 long term note, initiated in the fourth quarter of 2008 (as discussed in Note 5).
For the reasons explained above, net loss for the three months ended JuneSeptember 30, 2009 was $656,542$373,270 as compared to a net loss of $473,118$186,733 for the three months ended JuneSeptember 30, 2008. The $183,424, or 39%,$186,537 increase in net loss is primarily a result of the increase in sales and gross margin dollars, offset by one time increases in market consultingand sales costs and a decreasean increase in consulting and other selling, general and administrative expenses.

21


SixNine months ended JuneSeptember 30, 2009 compared to the sixnine months ended JuneSeptember 30, 2008
Total revenues for the sixnine months ended JuneSeptember 30, 2009 and 2008 were $4,241,721$6,150,984 and $2,952,043,$4,770,258, respectively. Total revenues increased by $1,289,678$1,380,726 or 44%29%. Contributing to this increase wasSTAunit sales of $1,257,068$1,268,728 and an increase inSTAhandpiecehand piece sales of $274,876.$434,451.CompuDentunit sales remained relatively unchanged andCompuDenthandpiecehand piece sales decreased by $249,809. Additionally, international$333,782. The breakdown of the change is as follows. International revenue increased $313,036,$580,386, or 30%38%, as compared to the 2008 period. Domestic product revenue increased $999,812by $828,622 in 2009, or 53%26%, as a result of a change in our distribution business model to a non-exclusive distributor base. This change was initiated in the second quarter of 2008. Domestic disposable handpiecehand piece sales decreased $6,617$83,721 and international disposable handpiecehand piece sales increased $59,129$211,834 or 8%19%. International unit sales increased by $369,534 or 87% for the nine months ending September 30, 2009 as compared to the same period in 2008. Our international business continues to be a substantial growth area for us.
Gross profit for the sixnine months ended JuneSeptember 30, 2009 and 2008 was $2,462,430,$3,662,690, or 58%60%, (net of a write-down of returned defective merchandise of $36,066) and $1,893,682,$2,971,500 or 64%62%, respectively. Gross profit dollars in the first six months of 2009 increased by $568,748$691,190 due to an increase in sales volume in 2009 over 2008. The gross profit percentage decrease was due principally to the change in product mix with a substantially larger proportion ofSTAunit sales and the write down of legacy returned defective merchandise in the sixnine months of 2009 over the same period in 2008. A portion of the increase in gross profit dollars ($117,790) is due to an increase in sales volume attributable to a change in how we record international sales. Effective July 1, 2009, the Company began selling our products directly to international distributors. As a result of this change, the Company records a higher selling price of the product to our international distributor and pays a commission to our former master international distributor based on our agreement. This commission is included in Selling, General and Administrative Expenses.

20


Selling, general and administrative expenses for the sixnine months ended JuneSeptember 30, 2009 and 2008 were $3,482,052$4,960,000 and $2,839,784,$4,039,137, respectively. The increase of $642,268,$920,863, or 22.6%23%, is primarily attributable to an increase in several expense categories. Sales and marketing expense increased by $392,653$614,654 for the period ending JuneSeptember 30, 2009. This increase was due to media and production spending of media of $74,435;$145,281; trade shows and travel expense of $141,164;$162,977; and cost relating to the C-CLAD Symposium, Key Opinion Leaders and sales promotions of $160,412,$187,560, offset by savings in employee relocation $33,602.of $23,869 and printing cost of $46,102. Commission expense increased by $108,181, representing $51,243 for Milestone field sales representatives and $56,938$49,703 for third party sales representatives due to sales volume increases.increases and by $117,790 for international sales commissions (effective July 1, 2009). General and administrative expenses increased a net of $233,549.$306,209. Expense increases in this category were wagesconsulting expenses of $24,635,$108,103 paid in stock based compensationto professionals that have assisted in the growth of $21,544,the Company, patent annuity expenses of $39,970, royalties of $80,502$155,560 (based on increasedSTAunit and hand piece sales), a business consultant study of $150,000, and an international business consultantsconsultant of $39,068. On a positive note, the Companywe reduced expenses for accounting costs by $99,640$97,397 (audit, review and Sarbanes Oxley)Sarbanes-Oxley), $19,696 reduction in proxy costs by $23,516 (electronic filing, Notice and Access System), reduced warehousing fees ($15,704)by $21,206 and reduced insurance costs ($25,527).by $29,531.
Research and development expenses for the sixnine months ended JuneSeptember 30, 2009 and 2008 were $99,969$157,941 and $84,319,$119,500, respectively.
Interest incomeexpense totaled $115,619 as of $2,547 was earned for the six months ended JuneSeptember 30, 2009, compared to $4,707 for the same period in 2008. The decreasean increase of $2,160,$42,164, or 45.9%, is the result of lower interest rates.
Interest expense of $85,389 as of June 30, 2009 increased $35,798, or 72.2%57%, over the same period in 2008. The increase in this expense is due to the $450,000 long term note that was initiated in the fourth quarter of 2008. Amortization of debt issuance costs of $15,750$23,625 is related to the long term debt outstanding as of JuneSeptember 30, 2009 (as discussed in Note 5).
For the reasons explained above, net loss for the sixnine months ended JuneSeptember 30, 2009 of $1,591,454 increased by $129,181,$315,719 or 11.9%25%, over the net loss for the sixnine month period ended JuneSeptember 30, 2008.
Working capital as of JuneSeptember 30, 2009 is negative $574,386.$406,968. Current assets declined by $698,435$573,145 in all current asset categories (principally in cash, accounts receivable and advances to a contract manufacturer) from December 31, 2008. Current liabilities increased by $1,408,639,$1,366,511, principally due to the classification of the $1.3 million line of credit, due June 30, 2010, as a current liability at JuneSeptember 30, 2009. The line of credit was classified as a Long-term Liabilitylong-term liability as of December 31, 2008. All borrowings and interest thereon must be repaid by June 30, 2010, and after the expiration date of the line, may be repaid by Milestoneus in cash or, at its option, in shares of common stock (as discussed in Note 5). Other increases in current liabilities are accounts payable for inventory purchases and a consultant business project. The Company isWe are making every effort to maintain a viable lower level of inventory and to keep control of operating costs.

22


Liquidity and Capital Resources
As of JuneSeptember 30, 2009, we had cash and cash equivalents of $498,576$497,455 and working capital of negative $574,386.$406,968 The negative working capital is due to the classification of the $1.3 million line of credit as a Current Liabilitycurrent liability as of JuneSeptember 30, 2009. All borrowings and interest thereon must be repaid by June 30, 2010, and after the expiration date of the line, may be repaid by Milestoneus in cash or, at its option, in shares of common stock (as discussed in Note 5). MilestoneWe incurred net losses of $1,218,183$1,591,454 and $1,089,002$1,275,735 and negative cash flows from operating activities of $195,391$157,948 and $589,053$693,164 for the sixnine months ended JuneSeptember 30, 2009 and 2008, respectively.
Our working capital at September 30, 2009 was a negative $406,968 compared to a positive working capital of $1,532,688 as of December 31, 2008. The significant reduction in working capital as of September 30, 2009 is due to the classification of the $1.3 million line of credit classified as a current liability at September 30, 2009 as compared to a classification as a long term liability at December 31, 2008. All borrowings and interest thereon must be repaid by June 30, 2010 and may be repaid by us in cash or at our option in shares of common stock. Current assets decreased by $573,145, principally due to a decrease in cash by $246,210 and accounts receivable by $424,862. Inventory and stock subscription receivable increased by $281,239. Current liabilities increased by $1,366,511, principally due to the classification of the line of credit. We continue to strive to maintain a reasonable level of inventory and to keep control of operating cost.
Additionally, as of September 30, 2009, we had cash and cash equivalents of $497,455 as compared to $498,576 as of June 30, 2009, a decrease of $1,121. Our working capital on June 30, 2009 as compared to September 30, 2009 improved by $167,418. This continued effort is well under way to provide a cash flow neutral position in the future.
For the sixnine months ended JuneSeptember 30, 2009, our net cash used in operating activities was $195,391.$157,948. This was attributable primarily to a net loss of $1,218,183$1,591,454 adjusted for noncash items of $418,168,$905,869, which was comprised principally of common stock and options issued for compensation and consulting services and changes in operating assets and liabilities of $604,625.$527,637.
For the sixnine months ended JuneSeptember 30, 2009, Milestonewe used $74,698$113,262 in investing activities. This was primarily attributable to $44,568$76,986 of legal fees related to new patent applications. The Company hadWe have capital expenditures of $30,130,$36,276, primarily for the purchase of trade show booths for the purpose of showcasing theSTA System.

21

For the nine months ended September 30, 2009, we received $25,000 in financing activities.


The Company hasWe have incurred operating losses and negative cash flows from operating activities since its inception. The Company isWe are 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. The Company, at JuneSeptember 30, 2009, expects to have sufficient cash reserves to meet all of its anticipated obligations through December 31, 2009. If the Company iswe are unable to generate positive cash flows from its operating activities it will need to raise additional capital. There is no assurance that the Companywe will be able to achieve positive operating cash flows or that traditional capital can be raised on terms and conditions satisfactory to the Company. If additional capital is required and cannot be raised, then the Companywe would be forced to curtail its development activities, reduce marketing expenses for existing dental products or adopt other cost saving measures, any of which might negatively affect the Company’sour operating results.
The Company’sOur recurring losses and negative operating cash flows raisesraised substantial doubt about its ability to continue as a going concern. The accompanying financial statements do not include any adjustment that might result from the outcome of this uncertainty.

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Item 3. Quantitative and Qualitative Disclosures about Market Risk
ITEM 3.
Quantitative and Qualitative Disclosures about Market Risk.
As a smaller reporting company, we are not required to provide the information required by this item.
Item 4T. Controls and Procedures
ITEM 4T.
Controls and Procedures.
The Company’sOur management, including the Interim Chief Executive Officer and Chief Financial Officer, have evaluated the effectiveness of the design and operation of the Company’s disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) as of the end of the period covered by this report. Based upon that evaluation, the Company’s Interim Chief Executive Officer and Chief Financial Officer have concluded that the disclosure controls and procedures as of JuneSeptember 30, 2009 are effective to ensure that information required to be disclosed in the reports the Company fileswe filed or submits under the Exchange Act is recorded, processed, summarized and reported within the time periods specified in the SEC’s rules and forms and that such information is accumulated and communicated to the Company’sour management, including the Interim Chief Executive Officer and Chief Financial Officer, to allow timely decisions regarding disclosure.
There were no changes in the Company’sour internal control over financial reporting identified in connection with the evaluation that occurred during the Company’sour last fiscal quarter that have materially affected, or that are reasonably likely to materially affect, the Company’sour internal controls over financial reporting.

 

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PART II — OTHER INFORMATION
ITEM 1.
ITEM 1. LEGAL PROCEEDINGS
NONE
ITEM 1A.
ITEM 1A. RISK FACTORS
The following factors may affect the growth and profitability of Milestone and should be considered by any prospective purchaser or current holder of Milestone’sour securities:
We have no history of profitable operations. Continuing losses could exhaust our capital resources and force us to discontinue operations.
For the sixnine months ended JuneSeptember 30, 2009 and 2008 our revenues were approximately $4.2$6.2 million and $3.0$4.8 million, respectively. In addition, we have had losses for each year since the commencement of operations, including net losses of approximately $1.2$1.7 million and $1.1$1.3 million for the sixnine months ended JuneSeptember 30, 2009 and 2008, respectively. At JuneSeptember 30, 2009, we had an accumulated deficit of approximately $58.5$58.9 million. At JuneSeptember 30, 2009, the Companywe had cash and cash equivalents $498,576$497,455 and working capital of a negative $574,386.$406,968. Additionally, the Companywe secured a line of credit in the aggregate amount of $1.3 million from a stockholder. This line of credit of $1.3 million is classified as a current liability as of JuneSeptember 30, 2009. All borrowings and interest thereon must be repaid by June 30, 2010, and after the expiration date of the line, may be repaid by Milestoneus in cash or, at its option, in shares of common stock (as discussed in Note 5). Additionally, the Company borrowed $450,000 in 2008 from the same shareholder, with aan original due date of January 2009. This additional borrowing was refinanced at December 31, 2008 and the due date was extended to June 30, 2012, as discussed in Note 5. The Company, at JuneAt September 30, 2009, expectswe expect to have sufficient cash reserves to meet all of its anticipated obligations through December 31, 2009. Additionally, the Company iswe are actively pursuing the generation of positive cash flows from operating activities through increases in revenues based upon management’s assessment of present contracts and current negotiations and reductions in operating expenses. If the Company iswe are unable to generate positive cash flows from its operating activities it will need to raise additional capital. There is no assurance that the Companywe will be able to achieve positive operating cash flows or that additional capital can be raised on the terms and conditions satisfactory to the Companyus if at all. If additional capital is required and it cannot be raised, then the Companywe would be forced to curtail its development activities, reduce marketing expenses for existing dental products or adopt other cost savings measures, any of which might negatively affect the Company’sour operating results.
The Company’sOur recurring losses and negative operating cash flows raise substantial doubt about its ability to continue as a going concern.
There are no other changes to our risk factors from those disclosed in our Annual Report on Form 10-K for the year ended December 31, 2008.
ITEM 2.
ITEM 2. UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS
Recent Sales of Unregistered Securities
In the quarter ended JuneSeptember 30, 2009, Milestonewe issued a total of 77,697811,258 shares valued at $30,500$676,500 as follows:
                
 Shares Amount  Shares $ 
Shares issued for employee compensation 46,447 $18,000  112,562 $110,000 
Shares issued for services 31,250 12,500  365,363 416,500 
Shares sold 333,333 150,000 
          
 77,697 $30,500  811,258 $676,500 
          

 

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ITEM 3. DEFAULT UPON SENIOR SECURTIES
NONE
ITEM 4. SUBMISSION OF MATTERS TO A VOTE OF SECURITY HOLDERS
The Annual Meeting of Stockholders was held on June 4, 2009, pursuant to official notice, in New York, New York. The matters for consideration were:
1. Election of five (5) Directors; and
2.Ratification of the appointment of Holtz Rubenstein Reminick LLP as Milestone’s independent auditors for the current fiscal year.
DEFAULT UPON SENIOR SECURITIES
 (1)NONE
ITEM 4. Election of Board of Directors
SUBMISSION OF MATTERS TO A VOTE OF SECURITY HOLDERS
                 
Member Period to Serve  Votes in Favor  Votes Withheld  Abstain 
Leonard Osser One Year  10,784,981   332,889   0 
Leslie Bernhard One Year  11,055,189   62,681   0 
Jeffrey Fuller One Year  10,774,959   342,911   0 
Leonard M. Schiller One Year  11,053,542   64,328   0 
Pablo F. Serna C. One Year  11,063,017   54,853   0 
 (2)Ratification of Holtz Rubenstein Reminick LLP as independent auditors of Milestone Scientific Inc for the current fiscal yearNONE
         
Votes in Favor Votes Against  Abstain 
10,955,873  39,387   64,244 
ITEM 5.
ITEM 5. OTHER INFORMATION
NONE

 

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ITEM 6.
ITEM 6. EXHIBITS
The following exhibits are filed herewith:
     
 31.1  Chief Executive Officer Certification pursuant to section 302 of the Sarbanes-Oxley Act of 2002.
     
 31.2  Chief Financial Officer Certification pursuant to section 302 of the Sarbanes-Oxley Act of 2002.
     
 32.1  Chief Executive Officer Certification pursuant to section 906 of the Sarbanes-Oxley Act of 2002.
     
 32.2  Chief Financial Officer Certification pursuant to section 906 of the Sarbanes-Oxley Act of 2002.

 

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SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.
     
 MILESTONE SCIENTIFIC INC.
 
 
 /s/ Leonard Osser   
 Leonard Osser  
 Interim Chief Executive Officer  
   
 /s/ Joseph D’Agostino   
 Joseph D’Agostino  
 Chief Financial Officer  
Date: August 7,November 12, 2009

 

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EXHIBIT INDEX
31.1Chief Executive Officer Certification pursuant to section 302 of the Sarbanes-Oxley Act of 2002.
31.2Chief Financial Officer Certification pursuant to section 302 of the Sarbanes-Oxley Act of 2002.
32.1Chief Executive Officer Certification pursuant to section 906 of the Sarbanes-Oxley Act of 2002.
32.2Chief Financial Officer Certification pursuant to section 906 of the Sarbanes-Oxley Act of 2002.

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