e10vq
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 10-Q
(Mark One)
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þ |
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QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the quarterly period ended March 31, 2011
or
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o |
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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)
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Delaware
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13-3545623 |
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(State or other jurisdiction of incorporation or organization)
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(I.R.S. Employer Identification No.) |
220 South Orange Avenue, Livingston, New Jersey 07039
(Address of principal executive offices)
(973) 535-2717
(Registrants telephone number, including area code)
(Former name, former address and former fiscal year, if changed since last report)
Indicate by check mark whether the registrant (1) has filed all reports required to be filed
by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or
for such shorter period that the registrant was required to file such reports), and (2) has been
subject to such filing requirements for the past 90 days. þ Yes o 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 Yes o 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.
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Large accelerated filer o
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Accelerated filer o
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Non-accelerated filer o
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Smaller reporting company þ |
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(Do not check if a smaller reporting company)
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Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the
Exchange Act). o Yes þ No
As of May 9, 2011, the Issuer had a total of 15,041,172 shares of Common Stock, $.001 par value
outstanding.
MILESTONE SCIENTIFIC INC
INDEX
2
FORWARD-LOOKING STATEMENTS
When used in this Quarterly Report on Form 10-Q, the words may, will, should, expect,
believe, anticipate, continue, estimate, project, intend and similar expressions are
intended to identify forward-looking statements within the meaning of Section 27A of the Securities
Act of 1933, as amended and Section 21E of the Security Exchange Act of 1934, as amended (the
Exchange Act) regarding events, conditions and financial trends that may affect Milestones
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
Milestones reports and registration statements filed with the Securities and Exchange Commission
(the Commission). Milestone disclaims any intent or obligation to update such forward-looking
statements.
3
MILESTONE SCIENTIFIC INC.
CONDENSED BALANCE SHEETS
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March 31, 2011 |
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December 31, 2010 |
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(Unaudited) |
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ASSETS |
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Current Assets: |
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Cash and cash equivalents |
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$ |
155,263 |
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$ |
627,082 |
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Accounts receivable, net of allowance for doubtful accounts of $202,160 in 2011 and 2010 |
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1,380,195 |
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796,221 |
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Inventories |
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850,708 |
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986,947 |
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Advances to contract manufacturer, current |
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728,509 |
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730,491 |
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Prepaid expenses and other current assets |
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243,304 |
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247,465 |
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Total current assets |
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3,357,979 |
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3,388,206 |
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Accounts receivable-long term, net of allowance for doubtful accounts of $426,840 as of March 31, 2011
and $438,840 as of December 31, 2010 |
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273,160 |
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361,160 |
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Advances to contract manufacturer, non current |
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2,227,837 |
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1,713,794 |
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Investment in distributor, at cost |
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76,319 |
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76,319 |
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Furniture, Fixtures & Equipment net of accumulated depreciation of $431,769 as of March 31, 2011
and $426,482 as of December 31, 2010 |
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63,903 |
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66,936 |
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Patents, net of accumulated amortization of $316,239 as of March 31, 2011
and $294,934 as of December 31, 2010 |
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935,717 |
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944,858 |
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Other assets |
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41,081 |
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57,750 |
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Total assets |
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$ |
6,975,996 |
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$ |
6,609,023 |
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LIABILITIES AND STOCKHOLDERS EQUITY |
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Current Liabilities: |
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Accounts payable short term |
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$ |
2,885,994 |
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$ |
2,883,587 |
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Accrued expenses and other payable |
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649,771 |
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511,304 |
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Total current liabilities |
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3,535,765 |
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3,394,891 |
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Long-term Liabilities: |
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Accounts payable long term |
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710,162 |
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440,376 |
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Notes Payable-net of discount of $7,662 and $8,361, respectively |
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442,338 |
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441,639 |
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Total long-term liabilities |
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1,152,500 |
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882,015 |
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Commitments and Contingencies |
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Stockholders Equity |
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Common stock, par value $.001; authorized 50,000,000 shares; 15,030,459 shares issued
642,847 shares to be issued and 14,997,126 shares outstanding as of March 31, 2011;
14,915,959 shares issued, 637,013 shares to be issued, and 14,882,626 shares outstanding
as of December 31, 2010 |
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15,673 |
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15,552 |
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Additional paid-in capital |
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62,703,180 |
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62,606,043 |
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Accumulated deficit |
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(59,519,606 |
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(59,377,962 |
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Treasury stock, at cost, 33,333 shares |
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(911,516 |
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(911,516 |
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Total stockholders equity |
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2,287,731 |
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2,332,117 |
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Total liabilities and stockholders equity |
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$ |
6,975,996 |
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$ |
6,609,023 |
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See Notes to Condensed Financial Statements
4
MILESTONE SCIENTIFIC INC.
CONDENSED STATEMENTS OF OPERATIONS
(Unaudited)
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Three Months Ended March 31, |
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2011 |
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2010 |
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Product sales, net |
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$ |
2,425,988 |
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$ |
2,562,578 |
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Cost of products sold |
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879,588 |
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900,712 |
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Gross profit |
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1,546,400 |
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1,661,866 |
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Selling, general and administrative expenses |
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1,624,255 |
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1,541,702 |
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Research and development expenses |
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43,718 |
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88,464 |
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Total operating expenses |
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1,667,973 |
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1,630,166 |
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(Loss) income from operations |
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(121,573 |
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31,700 |
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Other (expense) income |
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Other income |
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61,916 |
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Interest expense |
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(19,386 |
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(9,343 |
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Amortization of debt issuance |
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(699 |
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(699 |
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Interest income |
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14 |
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348 |
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Total other (expenses) income |
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(20,071 |
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52,222 |
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Net (loss) income applicable to common stockholders |
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$ |
(141,644 |
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$ |
83,922 |
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Net (loss) income per share applicable to common stockholders - |
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Basic |
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$ |
(0.01 |
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$ |
0.01 |
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Diluted |
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$ |
(0.01 |
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$ |
0.01 |
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Weighted average shares outstanding and to be issued - |
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Basic |
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14,875,541 |
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13,875,278 |
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Diluted |
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14,875,541 |
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14,320,821 |
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See Notes to Condensed Financial Statements
5
MILESTONE SCIENTIFIC INC.
CONDENSED STATEMENTS OF CHANGES IN STOCKHOLDERS EQUITY
THREE MONTHS ENDED MARCH 31, 2011
(Unaudited)
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Additional |
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Common Stock |
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Paid-in |
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Accumulated |
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Treasury |
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Shares |
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Amount |
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Capital |
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Deficit |
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Stock |
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Total |
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Balance, January 1, 2011 |
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15,552,972 |
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$ |
15,552 |
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$ |
62,606,043 |
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$ |
(59,377,962 |
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$ |
(911,516 |
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$ |
2,332,117 |
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Options issued to employees and consultants |
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53,674 |
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53,674 |
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Options exercised |
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100,000 |
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100 |
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24,900 |
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25,000 |
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Common stock issued for payment of
consulting services to settle accounts payable |
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7,000 |
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7 |
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6,993 |
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7,000 |
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Common stock issued for payment of
employee compensation |
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7,500 |
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8 |
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7,492 |
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7,500 |
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Common stock to be issued for payment of
consulting services |
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5,834 |
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6 |
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4,078 |
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4,084 |
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Net loss |
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(141,644 |
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(141,644 |
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Balance, March 31, 2011 |
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15,673,306 |
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$ |
15,673 |
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$ |
62,703,180 |
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$ |
(59,519,606 |
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$ |
(911,516 |
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$ |
2,287,731 |
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See Notes to Condensed Financial Statements
6
MILESTONE SCIENTIFIC INC.
CONDENSED STATEMENTS OF CASH FLOWS
(Unaudited)
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THREE MONTHS ENDED MARCH 31, |
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2011 |
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2010 |
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Cash flows from operating activities: |
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Net (loss) income |
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$ |
(141,644 |
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$ |
83,922 |
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Adjustments to reconcile net (loss) income to net cash provided by operating activities: |
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Depreciation expense |
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5,287 |
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18,651 |
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Amortization of patents |
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21,305 |
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20,410 |
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Amortization of debt discount |
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699 |
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699 |
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Common stock and options issued for compensation, consulting
and vendor services |
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72,258 |
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124,718 |
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Loss on sale/disposal of equipment |
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Bad debt expense (Reversal) |
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(12,000 |
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Changes in operating assets and liabilities: |
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(Increase) Decrease in accounts receivable |
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(483,974 |
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132,524 |
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Decrease (Increase) in inventories |
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136,239 |
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(160,605 |
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(Increase) to advances to contract manufacturer |
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(512,061 |
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(595,978 |
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Decrease (Increase) to prepaid expenses and other current assets |
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4,161 |
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(168,259 |
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Decrease in other assets |
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16,669 |
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17,365 |
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Increase in accounts payable |
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272,193 |
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797,665 |
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Increase (Decrease) in accrued expenses |
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138,467 |
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(22,675 |
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Net cash (used in) provided by operating activities |
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(482,401 |
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248,437 |
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Cash flows from investing activities: |
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Purchases of property and equipment |
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(2,254 |
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(19,844 |
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Payment for patents rights |
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(12,164 |
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(39,695 |
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Net cash used in investing activities |
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(14,418 |
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(59,539 |
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Cash flows from financing activities: |
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Proceeds from exercise of stock options |
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25,000 |
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Net cash provided by financing activities |
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25,000 |
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NET (DECREASE) INCREASE IN CASH AND CASH EQUIVALENTS |
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(471,819 |
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188,898 |
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Cash and cash equivalents at beginning of period |
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627,082 |
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1,029,129 |
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Cash and cash equivalents at end of period |
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$ |
155,263 |
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$ |
1,218,027 |
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Supplemental disclosure of cash flow information: |
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Interest paid |
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$ |
23,000 |
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$ |
24,000 |
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See Notes to Condensed Financial Statements
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 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, 2010 included in Milestones Annual Report on
Form 10-K.
In the opinion of Milestone, the accompanying unaudited financial statements contain all
adjustments (consisting of normal recurring entries) necessary to fairly present Milestones
financial position as of March 31, 2011 and December 31, 2010 and the results of its operations for
the three months ended March 31, 2011 and 2010.
The results reported for the three months ended March 31, 2011 are not necessarily indicative of
the results of operations which may be expected for a full year.
The Company had a negative cash flow from operation at March 31, 2011 of $482,401 and positive cash
flows from operating activities of at March 31, 2010 of $248,437. At March 31, 2011, the Company
had cash and cash equivalents of $155,263 and a negative working capital of $177,786. The Company
borrowed $450,000 in 2008 from a shareholder, with a due date of January 2009. This additional
borrowing was refinanced at December 31, 2008 and the due date was extended to June 30, 2012. The
Company is continuing the pursuit of positive cash flows from operating activities through an
increase in revenue based upon managements assessment of present contracts and current
negotiations and reductions in operating expenses. The Company may require the need for a higher
level of marketing and sales efforts that at present it cannot fund. If the Company is unable to
continue 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 traditional capital can be raised on terms and conditions satisfactory to the
Company, if at all. If positive cash flow cannot continue to be achieved or 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 Companys operating results.
The Companys historical losses 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.
NOTE 1 SUMMARY OF ACCOUNTING POLICIES
Cash and Cash Equivalents
Milestone considers all highly liquid investments purchased with a maturity of three months or less
to be cash equivalents.
8
Accounts Receivable
The realization of Accounts Receivable current and long-term will have a significant impact on the
Company. Consequently, Milestone estimates losses resulting from the inability of its customers to
make payments for amounts billed. The collectability of outstanding amounts is continually
assessed.
Inventories
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.
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 and by limiting access to our facilities. There can be no assurance that our program of
patents, confidentiality agreements and restricted access to our facilities will be sufficient to
protect our proprietary technology.
Accounts Payable
Current and long term accounts payable represents amounts due to suppliers of the Company. Long
term accounts payable is based on an informal payment agreement with the supplier to assist in the
purchasing of instruments and handpieces, beyond one year from the balance sheet date.
Revenue Recognition
Revenue from product sales is recognized net of discounts and allowances to the domestic
distributor on the date of shipment of the goods, for essentially all shipments, since the terms
are FOB warehouse. The Company will recognize revenue on date of arrival where shipments are FOB
destination. Shipments to the international distributors are FOB the 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, Milestone 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. The only obligation after sale is the normal
commercial warranty against manufacturing defects if the alleged defective unit is returned within
the warranty 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 evaluation for impairment of
long-lived assets and valuation allowances on deferred tax assets. Actual results could differ from
those estimates.
9
Fair Value Measurements: We follow the provisions of ASC 820, Fair Value Measurements and
Disclosures related to financial assets and liabilities that are being measured and reported on a
fair value basis. Fair value is the price that would be received to sell an asset or paid to
transfer a liability in an orderly transaction between market participants in the
principal market at the measurement date (exit price). We are required to classify fair value
measurements in one of the following categories:
Level 1 inputs which are defined as quoted prices (unadjusted) in active markets for identical
assets or liabilities that the reporting entity has the ability to access at the measurement date.
Level 2 inputs which are defined as inputs other than quoted prices included within Level 1 that
are observable for the assets or liabilities, either directly or indirectly.
Level 3 inputs are defined as unobservable inputs for the assets or liabilities.
Financial assets and liabilities are classified based on the lowest level of input that is
significant to the fair value measurement. Our assessment of the significance of a particular input
to the fair value measurement requires judgment, and may effect the valuation of the fair value of
assets and liabilities and their placement within the fair value hierarchy levels.
The carrying amounts reported in the balance sheet for cash, accounts receivable, advances to
contract manufacturer, accounts payable and accrued expenses approximate fair value based on the
maturity of these instruments.
Recent Accounting Pronouncements
Fair Value Measurements and Disclosures (Topic 820): Improving Disclosures about Fair Value
Measurements. Effective for interim and annual reporting periods beginning after December 15, 2009,
except for the disclosures about purchases, sales, issuances, and settlements in the roll forward
of activity in Level 3 fair value measurements. Those disclosures are effective for fiscal years
beginning after December 15, 2010, and for interim periods within those fiscal years. This
statement does not currently impact the financial statement of the company.
In the second quarter of 2010, the FASB issued Accounting Standards Updates (ASU) 2010-09, Fair
Value Measurements and Disclosures: Improving Disclosures about Fair Value Measurements (ASU
2010-06). ASU 2010-06 amends FASB ASC Topic 820, Fair Value Measurements and Disclosures, and
requires reporting entities to make new disclosures about recurring or nonrecurring fair-value
measurements. ASU 2010-06 also clarifies existing fair-value measurement disclosure guidance about
the level of disaggregation, inputs and valuation techniques. Except for the detailed Level 3
rollforward disclosures, we adopted the provisions of ASU 2010-06 in the first quarter of 2010.
This adoption did not affect our financial statements. We adopted the provisions of ASU 2010-06
related to the new Level 3 rollforward disclosures in the first quarter of 2011 and this adoption
did not materially affect our financial statements.
In the first quarter of 2010, the FASB issued ASU 2010-09, Subsequent Events: Amendments to Certain
Recognition and Disclosure Requirements (ASU 2010-09). ASU 2010-09 amends ASC 855, Subsequent
Events, so that SEC filers are no longer required to disclose the date through which subsequent
events have been evaluated in financial statements. We adopted the provisions of ASU 2010-09 in the
first quarter of 2010.
In December 2010, the FASB issued ASU No. 2010-28, Intangibles-Goodwill and Other (Topic 350) When
to Perform Step 2 of the Goodwill Impairment Test for Reporting Units with Zero or Negative
Carrying Amounts. This guidance clarifies application of Step 2 of the goodwill impairment test.
The guidance requires an entity to perform Step 2 if it is more likely than not that an impairment
exists. This accounting guidance is effective for fiscal years beginning after December 15, 2010.
This statement does not currently impact the financial statements of the Company.
In October 2009, the FASB issued ASU 2009-13, Revenue Recognition (Topic 605):
Multiple-Deliverable Revenue Arrangements a consensus of the FASB Emerging Issues Task Force,
which amends the criteria for when to evaluate individual delivered items in a multiple deliverable
arrangement and how to allocate consideration received. This ASU is effective for fiscal years
beginning on or after June 15, 2010, which is January 1, 2011 for the Company. This statement does
not currently impact the financial statement of the company.
10
NOTE 2 BASIC AND DILUTED NET INCOME (LOSS) PER COMMON SHARE
Milestone presents basic and fully diluted earnings (loss) per common share applicable to
common stockholders, and, if applicable, diluted earnings (loss) per common share applicable to
common stockholders pursuant to the provisions of FASB ASC Topic 260. Basic earnings (loss) per
common share is calculated by dividing net income or loss applicable to common stockholders by the
weighted average number of common shares outstanding and to be issued during each period. The
calculation of diluted earnings per common share is similar to that of basic earnings per common
share, except that the denominator is increased to include the number of additional common shares
that would have been outstanding if all potentially dilutive common shares, such as those issuable
upon the exercise of stock options and warrants were issued during the period.
NOTE 3 ACCOUNTS RECEIVABLE CURRENT AND LONG TERM
The Company sells a significant amount of its product on credit terms to its major distributors.
The Company estimates losses from the inability of its customers to make payments on amounts
billed. A majority of credit sales are due within ninety days from invoicing. In 2010, the Company
shipped a significant order to a major international distributor. At the time of the shipment,
regulatory approval to sell the product in the respective country was in process. Obtaining such
regulatory approval was not a condition of the purchase order and sale to the distributor. The
regulatory approval has been delayed and as such the customer has not paid the full amount of the
invoiced shipment. The Company is receiving periodic payments from the international distributor.
Based on the periodic payment plan prepared by the international distributor, the Company has
recorded a long term net accounts receivable of $273,160 as of March 31, 2011. The current portion
of this net accounts receivable is approximately $163,000. The Company reserved $624,000 of the
total accounts receivable from this distributor as March 31, 2011.
NOTE 4 STOCK OPTION PLANS
FASB ASC Topic 505, Share-Based Payment, 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.
A summary of option activity for employees under the plans as of March 31, 2011, and changes during
the three months ended, is presented below:
|
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|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted |
|
|
|
|
|
|
|
|
|
|
Weighted |
|
|
Average |
|
|
Aggregate |
|
|
|
Number |
|
|
Averaged |
|
|
Remaining |
|
|
Intrinsic |
|
|
|
of |
|
|
Exercise |
|
|
Contractual |
|
|
Options |
|
|
|
Options |
|
|
Price |
|
|
Life (Years) |
|
|
Value |
|
|
Outstanding, January 1, 2011 |
|
|
928,504 |
|
|
$ |
1.07 |
|
|
|
3.92 |
|
|
$ |
|
|
Granted |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Exercised |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Forfeited or expired |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Outstanding, March 31, 2011 |
|
|
928,504 |
|
|
|
1.07 |
|
|
|
3.68 |
|
|
|
36,666 |
|
Exercisable, March 31, 2011 |
|
|
473,397 |
|
|
|
0.95 |
|
|
|
2.49 |
|
|
|
36,415 |
|
Milestone recognizes compensation expense on a straight line basis over the requisite service
period. During the three months ended March 31, 2011, Milestone recognized a $50,897 of total
compensation cost. As of March 31, 2011, there was $242,242 of total unrecognized compensation
cost related to non-vested options which Milestone expects to recognize over a weighted average
period of 2.75 years. A six percent rate of forfeitures is assumed in the calculation of the
compensation cost for the period.
Expected volatilities are based on historical volatility of Milestones common stock over a period
commensurate with anticipated term. Milestone uses historical data to estimate option exercise and
employee termination within the valuation model.
11
A summary of option activity for non-employees under the plans as of March 31, 2011, and changes
during the three months ended, is presented below:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted |
|
|
|
|
|
|
|
|
|
|
Weighted |
|
|
Average |
|
|
Aggregate |
|
|
|
Number |
|
|
Averaged |
|
|
Remaining |
|
|
Intrinsic |
|
|
|
of |
|
|
Exercise |
|
|
Contractual |
|
|
Options |
|
|
|
Options |
|
|
Price |
|
|
Life (Years) |
|
|
Value |
|
|
Outstanding, January 1, 2011 |
|
|
534,999 |
|
|
|
1.85 |
|
|
|
1.51 |
|
|
|
|
|
Granted |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Exercised |
|
|
100,000 |
|
|
|
0.25 |
|
|
|
|
|
|
|
|
|
Forfeited or expired |
|
|
120,000 |
|
|
|
1.75 |
|
|
|
|
|
|
|
|
|
Outstanding, March 31, 2011 |
|
|
314,999 |
|
|
|
2.39 |
|
|
|
1.84 |
|
|
|
21,700 |
|
Exercisable, March 31, 2011 |
|
|
294,998 |
|
|
|
2.47 |
|
|
|
1.70 |
|
|
|
21,700 |
|
During the three months ended March 31, 2011, Milestone recognized $16,137 of expenses related to
non-employee options that vested during the year. The total unrecognized compensation cost related
to non-vested options was $8,002 as of March 31, 2011. A six percent rate of forfeitures is assumed
in the calculation of the compensation cost for the period.
In March of 2010, the Company entered an agreement with a public relations firm to supply services
to the Company over a three year (cancelable) agreement. The first year of the agreement required
120,000 options to be provided with immediate exercisability. The Black Scholes calculation of
approximately $80,000 was recorded as an asset and an addition to additional paid in capital. The
entire $80,000 was amortized to expense over the twelve month period. The Company canceled the
agreement in September 2010 and the options expired in March 2011.
In accordance with the provisions of FASB ASC 505-50-15, all other issuances of common stock, stock
options or other equity instruments to non-employees as consideration for goods or services
received by Milestone are accounted for based on the fair value of the equity instruments issued
(unless the fair value of the consideration received can be more reliably measured). The fair value
of any options or similar equity instruments issued is estimated based on the Black-Scholes
option-pricing model, and the assumption that all of the options or other equity instruments will
ultimately vest. Such fair value is measured as of an appropriate date pursuant to the guidance,
(generally, the earlier of the date the other party becomes committed to provide goods or services
or the date of performance by the other party is complete) and capitalized or expensed as if
Milestone had paid cash for the goods or services.
NOTE 5 CONCENTRATION OF CREDIT RISK
Milestones financial instruments that are exposed to concentrations of credit risk consist
primarily of cash and trade accounts receivable, and advances to contract manufacturer. 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 contract manufacturer. Milestone entered into a purchase
agreement with a vendor to supply Milestone with 5,000 instruments of CompuDent and 12,000 STA
Instruments. As part of these agreements, Milestone has advanced approximately $2,956,346 and
$2,444,285 to the vendor for purchase of materials at March 31, 2011 and December 31, 2010,
respectively. The advance will be credited to Milestone as the goods are delivered. Milestone does
not believe that significant credit risk exists with respect to this advance to the contract
manufacturer.
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 has provided a reserve that it
believes is sufficient record accounts receivable at net realizable value as of March 31, 2011 and
December 31, 2010.
12
NOTE 6 ADVANCES TO CONTRACT MANUFACTURER
The net advances to contract manufacturer represent funding of future STA, CompuDent and Wand Plus
inventory purchases. The balance of the net advances as of March 31, 2011 and December 31, 2010 is
$2,956,346 and $2,444,285, respectively. The portion of this advance expected to be utilized in the
next twelve months is classified as current asset, with the remainder classified as non-current
asset. The Company has an outstanding accounts payable of $1,420,324 and $1,521,000 at March 31,
2011 and December 31, 2010, respectively to the contract manufacture specifically related to the
advances. The Company is making monthly payments to the contract manufacturer.
NOTE 7 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. The $1.3 million Line of Credit was converted into shares of Milestones common stock in
December 2009 at a conversion rate of $1.58 per share. A total of 822,785 shares were issued and
the debt liquidated at that date. Interest on the Line of Credit of aggregated $66,245 was accrued
as of March 31, 2011. This interest will be paid in equal quarterly payments of $23,000 in 2011.
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 twelve percent interest rate, interest compounded quarterly, with interest and principal
due at the maturity. Further, the note has warrants 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 March 31, 2011, the discount was $7,662.
Interest expense on this Line of Credit for the three months ended March 31, 2011 and 2010 is
$19,386 and $9,343, respectively. Accrued interest related to the line of credit was $210,443 and
$214,824 at March 31, 2011 and December 31, 2010, respectively. The charge for amortization of Debt
Discount related to this Line of Credit is $699 and $699 for the three months ended March 31, 2011
and March 31, 2010, respectively.
NOTE 8 STOCK ISSUANCE
During the three months ended March 31, 2011, the Company issued 7,000 shares of common stock
valued at $7,000 to two parties owed in connection with consulting expenses. Additionally, 7,500
shares of common stock valued at $7,500 were issued for payment of employee compensation. 100,000
shares were issued upon exercise of stock options for $25,000 ($0.25 per share).
NOTE 9 SIGNIFICANT CUSTOMERS
Milestone had net product sales to three customers (distributors) which in the aggregate accounted
for approximately 43% and 63% of revenue for three months ended March 31, 2011 and 2010,
respectively. Milestone had sales to one of these major customers (a worldwide distributor of
Milestones products based in China) of $494,108 (19%) for the three months ended March 31, 2010.
Accounts receivable from these three customers amounted to $1,000,141 and $533,191 representing 60%
and 44% of gross accounts receivable as of March 31, 2011 and December 31, 2010, respectively.
13
Milestones sales by product and by geographical region are as follows:
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended March 31, |
|
|
|
2011 |
|
|
2010 |
|
Instruments |
|
$ |
810,998 |
|
|
$ |
599,888 |
|
Handpieces |
|
|
1,580,325 |
|
|
|
1,936,303 |
|
Other |
|
|
34,665 |
|
|
|
26,387 |
|
|
|
|
|
|
|
|
|
|
$ |
2,425,988 |
|
|
$ |
2,562,578 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
United States |
|
$ |
1,312,566 |
|
|
$ |
1,204,972 |
|
Canada |
|
|
153,124 |
|
|
|
182,270 |
|
Other Foreign |
|
|
960,298 |
|
|
|
1,175,336 |
|
|
|
|
|
|
|
|
|
|
$ |
2,425,988 |
|
|
$ |
2,562,578 |
|
|
|
|
|
|
|
|
NOTE 10 COMMITMENTS AND OTHER
Contract Manufacturing Arrangement
Milestone has informal arrangements for the manufacture of its products. CompuDent, STA and
CompuMed instruments are manufactured for Milestone by Tricor Systems, Inc. pursuant to specific
purchase orders. The Wand disposable handpiece without a needle is manufactured for Milestone in
Mexico pursuant to scheduled production requirements. The Wand handpiece (with and without needles)
is 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 Milestones 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.
In January 2010, the Company issued a purchase order to Tricor Instruments for the purchase of
12,000 Wand/STA Instruments to be delivered over the next three years. The purchase order is for
$5,261,640. The Company will be required to make periodic payments over the next eighteen months to
purchase the parts necessary to complete this production. As of March 31, 2011, the Companys
production and sales of instruments for this commitment has been delayed. Consequently, advances to
contractor and accounts payable has been classified as current and long term at March 31, 2011.
Other Events
In December 2009, Milestone announced that it signed an Agreement of Intent with China National
Medicines Corporation, Ltd. and Yichang Humanwell Pharmaceutical Co. Ltd., both incorporated in the
Peoples Republic of China (PRC), to develop intra-articular and epidural drug delivery instruments
utilizing Milestones patented CompuFlo technology. Milestone and its two PRC joint venture
partners agreed to establish a joint venture entity for this purpose in 2010. The required initial
funding for the new entity, estimated by the parties at $1.4 million, was to have been provided by
the two PRC companies, although Milestone would determine the proposed uses of their contribution.
As of March 31, 2011 the joint venture entity, has not been established nor has funding been
received.
14
In March 2011, Milestone entered into a new agreement with a PRC entity to establish a joint
venture entity in the PRC to develop intra-articular and epidural drug delivery instruments
utilizing Milestones patented CompuFlo technology. The PRC entity agreed to contribute up to $1.5
million to this joint venture entity, based on progress reports from Milestone and subject to
refund if the instruments are not developed because of technological problems within 30 months
of
the inception date. The initial $500,000 capital contribution was to have been made at inception.
The PRC joint venture entity has not been established. Therefore, to move the process forward,
Milestone organized a domestic research and development corporation to which its joint venture
partner made an initial capital contribution of $250,000, $105,000 of which was disbursed to
Milestone in March 2011 as reimbursement for previously incurred research and development costs
expensed by Milestone in prior years. Such amount ($105,000) is included in accrued expenses and
other payable at March 31, 2011 until the PRC joint venture entity is established and the required
initial funding by the other party is completed. The domestic corporation will be owned fifty
percent by Milestone and fifty percent by the other party. Milestone will account for its
investment in the joint venture using the equity method of accounting after an agreement is signed
by both parties and the required initial funding by the other party is completed. The Company
expects the finalization of this agreement to be accomplished in 2011. The newly formed corporation
has net assets of approximately $145,000 of cash as of March 31, 2011. Milestone believes that this
new joint venture represents a significant step forward in Milestones efforts to have its
innovative computer-controlled drug delivery technology adapted for medical usage.
15
ITEM 2. Managements 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.
OVERVIEW
In 2011, Milestone remains focused on advancing efforts to achieve our two primary objectives;
those being:
|
|
|
Optimizing our tactical approach to product sales and marketing in
order to materially increase penetration of the global dental and
medical markets with our proprietary, patented Computer-Controlled
Local Anesthesia Delivery (C-CLAD) solution, the STA Single Tooth
Anesthesia Instrument (STA Instrument); and |
|
|
|
|
Identifying and pursing strategic collaborations with third parties to
jointly develop new products utilizing our patented CompuFlo pressure
force technology for novel new medical applications. |
STA Instrument Awards Industry Recognition
Since its market introduction in the spring of 2007, the STA Instrument has received favorable
reviews and awards from the dental industry. In July 2007, noted industry publication Dentistry
Today featured the STA Instrument as one of the Top 100 Products in 2007, helping to promote much
broader recognition of the instrument and validating the STA Instruments value proposition for
dentists and patients alike. In April 2008, Medical Device & Diagnostic Industry magazine
distinguished the STA Instrument as 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, the STA Instrument was one of only two winning products that serve dental practitioners.
In December 2008, the STA Instrument was again recognized as one of the dental industrys best
technological innovations, winning a Townie Choice Award from Dentaltown Magazine in the category
Anesthetics: Technique Instrument. This marked the second consecutive year that Milestone won a
Townie Choice Award; in 2007, we won the same award for our CompuDent/The Wand. Also in December
2008, our Wand/STA Instrument was named as a Dental Products Report Top 100 2008 Product of
Distinction. Each year, DPR spotlights the years Top 100 products. Of these 100 products, 50 are
the ones most often inquired about by DPRs 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 by DPRs editorial staff for their perceived impact on driving
innovation or helping to establish a new, higher standard of care for patients. The STA Instrument
was recognized as a New Classic in the Technology category.
In July 2010, the STA Instrument was recognized as one of Dentistry Todays, Top 100
Products, for the third consecutive year. This honor is significant because it is unprecedented in
Milestones history and serves to support our objective of establishing our instrument as the new
global standard of care for painless dental injections.
Second Annual Symposium on C-CLAD
On May 1 through 3, 2009, we hosted the Second 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, the Second Symposium covered a broad range of C-CLAD related
topics including:
|
|
|
The History of C-CLAD |
|
|
|
|
Treating with Connection |
|
|
|
|
Heart Rate Study |
16
|
|
|
|
STA Compassionate Care in the 21st Century |
|
|
|
|
Injection Advances and Challenges |
|
|
|
|
Physiologic and Clinical Characteristics of PDL Anesthesia Delivered
by a High Pressure Hand piece and a Computerized Device |
|
|
|
|
The STA for Tots and Teens |
|
|
|
|
Computerized Local Anesthesia in Dentistry: A Review |
|
|
|
|
Todays Technology |
|
|
|
|
Managing a Successful Dental Practice: Why People Keep Coming Back |
|
|
|
|
STA The Dental Schools Perspective |
|
|
|
|
Futuristic Vistas: The Dentist/Hygienist Partnership |
In 2010, the company published and broadly distributed 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, the STA 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 the STA System is proving to be a valuable and beneficial instrument
that is positively impacting the practice of dentistry worldwide. The utility and value of the STA
System is perhaps best summarized by Dr. Joe Blaes, who wrote in the December 2008 edition of
Dental Economics, I tried the STA System and my patients absolutely love it. This is a no brainer
go get one ASAP!
Global Distribution Network
North America Market
The STA Instrument and related hand pieces are marketed to the dental industry in the United
States and Canada by many of the nations leading dental supply companies, including Henry Schein,
Inc., Patterson Dental Supply, Atlanta Dental, Benco Dental, Burkhart Dental, Cedar Dental, Darby
Dental Supply, Dental Health Products, Goetze Dental, Iowa Dental, Nashville Dental, Newark Dental
and Parkway Dental. In Canada, our independent distributors include Dental 2000, Mediclub, and
Specialty Dental.
In the third quarter of 2010, the company added a Domestic Sales Director to refocus our
attention on the USA and Canadian markets. The mission of the Domestic Sales Director is to grow
our business through marketing our STA Instrument to Dental Group Practices, as well as individual
dental practitioners. Through direct marketing to the Dental Group Practices and utilizing a group
of independent hygienists, the instrument and handpiece sales should increase substantially in the
future. The Company closed its first Group Dental Practice in January 2011, Towncare Dental.
International Market
On the global front, we also have granted exclusive marketing and distribution rights for the
Wand/STA Instrument to select dental suppliers in various international regions in Asia, Africa,
South America and Europe. They include Istrodent in South Africa and Unident in the Scandinavian
countries of Denmark, Sweden, Norway and Iceland.
In April 2009, we signed an Exclusive Distribution and Marketing Agreement with China National
Medicines Corporation, d/b/a Sinopharm, which is Chinas largest domestic manufacturer, distributor
and marketer of pharmaceuticals and importer of medical devices and the countrys largest domestic
distributor of dental anesthetic carpules to the Chinese dental industry. Prior to the end of
2009, China National Medicines issued Milestone a blanket purchase order for 12,000 STA Instruments
to be delivered over 36 months, thereby marking the Companys initial penetration into Chinas
emerging dental market.
17
As of March 30, 2011, China National Medicine has not received the appropriate registration
approval from the regulatory body in China, therefore, shipment of Wand/STA Instruments and
handpieces have been suspended pending the approval to sell and distribute these products in China.
It is expected that the approval by the appropriate Chinese regulatory body will be received in
2011.
According to a report published by the U.S. Department of Commerce, titled Chinas Emerging
Markets: Opportunities in the Dental and Dental Lab Industry, Chinas dental market lags behind
other healthcare services and has largely been neglected in the past. In fact, CS Market Research
reports that of Chinas 1.3 billion plus population, 50% of the adults and 70% of the children are
estimated to have decayed tooth problems, and over 90% have periodontal disease. However, with
increasing affluence of the Chinese population, as well as increasing attention towards personal
care, demand for dental services has been growing. Market research firm Freedonia agrees, noting
that demand for dental products in China is expected to climb to 21.5 billion RMB (US$3.15 billion)
by 2012, due primarily to escalating personal income levels and government programs promoting
awareness of the benefits of good oral care.
Shortly before the end of the second quarter 2009, we announced that we were refining our
international marketing strategy to gain greater access to and penetration of the international
dental markets for the Wand/STA Instrument, CompuDent and related disposable hand pieces. The new
sales strategy provides for increasing hands-on oversight and support of our existing international
distribution network, while also attracting new distributors throughout Europe, Asia and South
America. To assist in this endeavor, Milestone added in the spring of 2010 an International Sales
Director to focus on growth of our products outside the USA and Canada. The new addition to the
companys staff has proven to be a positive improvement to our sales and marketing effort outside
the USA and Canada.
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 March 31, |
|
|
|
2011 |
|
|
2010 |
|
DOMESTIC |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Instruments |
|
$ |
355,972 |
|
|
|
27.1 |
% |
|
$ |
251,597 |
|
|
|
20.9 |
% |
Handpieces |
|
|
936,049 |
|
|
|
71.3 |
% |
|
|
929,984 |
|
|
|
77.2 |
% |
Other |
|
|
20,545 |
|
|
|
1.6 |
% |
|
|
23,391 |
|
|
|
1.9 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
Total Domestic |
|
$ |
1,312,566 |
|
|
|
100.0 |
% |
|
$ |
1,204,972 |
|
|
|
100.0 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
INTERNATIONAL |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Instruments |
|
$ |
455,026 |
|
|
|
40.9 |
% |
|
$ |
348,291 |
|
|
|
25.7 |
% |
Handpieces |
|
|
644,276 |
|
|
|
57.9 |
% |
|
|
1,006,319 |
|
|
|
74.1 |
% |
Other |
|
|
14,120 |
|
|
|
1.2 |
% |
|
|
2,996 |
|
|
|
0.2 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
Total International |
|
$ |
1,113,422 |
|
|
|
100.0 |
% |
|
$ |
1,357,606 |
|
|
|
100.0 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
DOMESTIC/INTERNATIONAL ANALYSIS |
|
|
|
|
|
|
|
|
|
|
|
|
Domestic |
|
$ |
1,312,566 |
|
|
|
54.1 |
% |
|
$ |
1,204,972 |
|
|
|
47.0 |
% |
International |
|
|
1,113,422 |
|
|
|
45.9 |
% |
|
|
1,357,606 |
|
|
|
53.0 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
Total Product Sales |
|
$ |
2,425,988 |
|
|
|
100.0 |
% |
|
$ |
2,562,578 |
|
|
|
100.0 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
The Company earned gross profits of 64% and 65% for the three months ended March 31, 2011 and
2010, 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 anticipates
expending funds for research and development in 2011, these amounts will vary based on the
operating results for each quarter. The Company has incurred operating losses since its inception.
The Company is actively pursuing the generation of sustainable positive cash flows from operating
activities through increases in revenue, to be derived from a change in the business model in U.S.
and Canada. This change in business model incorporates a team of local dental hygienists training
and educating the respective dentist in their territories. The business model replaces the
Companys sale force and third party manufactures reps business model.
18
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 20002006 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 depends only on the
medication itself, but also on achieving a patient-friendly form of delivery.
Central to Milestones robust IP portfolio, currently comprised of 24 issued patents, is its
FDA-approved CompuFlo®
system for the precise delivery and aspiration of all
medicaments. Milestones patented CompuFlo®
system and DPS Dynamic Pressure Sensing®
technology are revolutionary technologies that are relevant for the entire category of subcutaneous
drug delivery injections and fluid aspiration enabling healthcare practitioners to achieve
multiple unique benefits that cannot currently be accomplished with existing technologies.
The negative side effects possible when using the manual hypodermic syringe are well
documented in the medical and dental literature, and include tissue damage, transient or permanent
paralysis, subjective pain response, post-operative complications, and the risk of medical
emergencies, which in certain circumstances can result in a patient fatality. Patient pain and
tissue damage are a direct physical result of a clinicians inability to accurately control a wide
range of variables when using the manual syringe.
In contrast, the technical advantages of the CompuFlo® system with DPS Dynamic Pressure
Sensing® technology are numerous and dramatic. They include precise controlling and monitoring of
all critical variables during drug delivery, including:
|
|
|
a true painless experience for all injections |
|
|
|
|
eliminates disruptive injection behavior |
|
|
|
|
site specific targeting |
|
|
|
|
controlled needle exit-pressure |
|
|
|
|
precise flow rate and drug volumes |
|
|
|
|
patient treatment documentation |
|
|
|
|
superior ergonomics |
|
|
|
|
elimination of needle deflection (causing missed injections, lost time and anxiety ) |
|
|
|
|
advanced tactile needle control |
|
|
|
|
precision fluid metering |
The use of Milestones technology also enables the clinician to receive real-time continuous
feedback relating to the local tissue conditions during the injection process. This real-time
feedback enables the accurate differentiation and identification of specific tissues types and
anatomical locations, making subcutaneous drug delivery safer, easier and more effective, thereby
fundamentally transforming what formerly was an art into a science.
Recognized as a world leader in advanced computer-controlled injection technologies, Milestone
has spent over a decade developing and perfecting its portfolio of technologies that eliminate pain
and enable unequaled precision that can be applied to a wide array of subcutaneous injections routinely used in the practice of Medicine
and Dentistry. Moreover, none of Milestones C-CLAD injection products look like a syringe or feel
like a syringe, and they perform far better than the antiquated manual syringe, resulting in a much
enhanced experience for the patient, the practitioner and the business of dentistry.
19
Based on an independent 2006 study, the number of potential applications for the CompuFlo®
technology stands at more than 700. Due to the sizable number of product development opportunities
within the medical arena for the technology, Milestone created an internal review committee to
assess and analyze the opportunities in a variety of medical sectors. Consequently, the Company
has elected to focus on those medical uses of the CompuFlo® system which have shown to be most
promising for obtaining a return on investment while simultaneously representing new product
introductions that will have the greatest impact on patients and the medical profession. Areas of
initial interest include developing CompuFlo®-based injection/aspiration systems for use in
Epidurals, Intra-Articular Injections, Self-Administered Injections, Neurosurgery, Ophthalmic
surgery and Derma Filler/Cosmetic surgery.
It should be noted that the CompuFlo® system is embedded in an FDA-approved prototype. This
technology is currently commercially available in the STA Single Tooth Anesthesia System®, which is
being sold worldwide in the dental market. Over 40 million patient injections have been given with
Milestones technologies to date.
Milestones technological innovations have been tried and proven by healthcare providers with
over 50 publications validating the efficacy and safety in a variety of medical and dental
injection applications. It is anticipated that future devices that are developed utilizing the
CompuFlo® system will only require a basic 510K approval from the FDA, thus minimizing development
cost and time to market.
Intellectual Property
In August 2009, we were issued a Notice of Allowance by the U.S. Patent and Trademark Office
for its a patent application directed for the use of our disposable hand piece for fluid
administration. Our award-winning handpiece is an instrument currently utilized in conjunction
with the Companys STA Single Tooth Anesthesia System®, the CompuDent® instrument and the CompuMed®
instrument.
In September 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.
During the second quarter of 2010, Milestone was issued a Notice of Allowance by the U.S.
Patent and Trademark Office for its U.S. patent application, titled Self-Administration Injection
System. Milestones innovative computer-controlled drug delivery platform has been designed to
reduce the anxiety and pain of self-administration of medications for the rapidly expanding
home-use market. The computer-controlled self-administration system provides a less threatening,
virtually painless means for patients to safely self-administer a variety of injections.
To date, we have been awarded and presently hold 20 U.S. utility and design patents relating
to our 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.
20
Accounts Receivable
The realization of Accounts Receivable current and long-term will have a significant impact on
the Company. Consequently, Milestone estimates 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 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.
Accounts Payable
Current and long term accounts payable represents amounts due to suppliers of the Company.
Long term accounts payable is based on an informal financing agreement with the supplier to assist
in the purchasing of instruments and handpieces, beyond one year from the balance sheet date.
Revenue Recognition
Revenue from product sales is recognized net of discounts and allowances to domestic
distributor on the date of shipment for essentially all shipments, since the shipment terms are FOB
warehouse. The company will recognize revenue on date of arrival of the goods at the customers
location where shipments are FOB destination. Shipments to international distributors are FOB the
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, the Company has 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. Milestones 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 three months ended March 31, 2011 compared to
the same three month period in 2010 reflect our focus and development on the Wand/STA Instruments,
as well as continuing efforts on identifying collaborative partners for new product development
utilizing our CompuFlo technology.
21
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 March 31 |
|
|
|
2011 |
|
|
2010 |
|
|
Products sales, net |
|
$ |
2,425,988 |
|
|
|
100 |
% |
|
$ |
2,562,578 |
|
|
|
100 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
Total revenue |
|
|
2,425,988 |
|
|
|
100 |
% |
|
|
2,562,578 |
|
|
|
100 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost of products sold |
|
|
879,588 |
|
|
|
36 |
% |
|
|
900,712 |
|
|
|
35 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
Gross Profit |
|
|
1,546,400 |
|
|
|
64 |
% |
|
|
1,661,866 |
|
|
|
65 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
Selling, general and
administrative expenses |
|
|
1,624,255 |
|
|
|
67 |
% |
|
|
1,541,702 |
|
|
|
60 |
% |
Research and development expenses |
|
|
43,718 |
|
|
|
2 |
% |
|
|
88,464 |
|
|
|
3 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
Total operating expenses |
|
|
1,667,973 |
|
|
|
69 |
% |
|
|
1,630,166 |
|
|
|
63 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
(Loss) income from operations |
|
|
(121,573 |
) |
|
|
-5 |
% |
|
|
31,700 |
|
|
|
1 |
% |
Total other (expenses) income |
|
|
(20,071 |
) |
|
|
-1 |
% |
|
|
52,222 |
|
|
|
2 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
Net (loss) income |
|
$ |
(141,644 |
) |
|
|
-6 |
% |
|
$ |
83,922 |
|
|
|
3 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
Three months ended March 31, 2011 compared to three months ended March 31, 2010
Total revenues for the three months ended March 31, 2011 and 2010 were $2,425,988 and
$2,562,578, respectively. The total decrease in product sales of $136,590 or 5.3%, in 2011 over
2010 is primarily the result of decreased international handpiece revenues. Domestic STA
instruments sales increased $118,025, in 2011 over 2010. This increase was due to an increased
demand at the distributor level in the domestic market. In the domestic market, total handpiece
sales increased by $6,065 or, (1%). On the international front, instruments sales increased in the
first quarter of 2011 over 2010 by $106,736 or 30.6% principally due to increased market
penetration for the Wand/STA Instruments. Internationally, handpieces decreased by $362,043, 36%
due to a decrease in STA handpieces sales to China. China handpiece sales in the first quarter of
2010 were $494,208.
Cost of products sold for the three months ended March 31, 2011 and 2010 were $879,588 and
$900,712, respectively.
For the three months ended March 31, 2011, Milestone generated a gross profit of $1,546,400,
or 64%, as compared to a gross profit of $1,661,866, or 65%, for the three months ended March 31,
2010. The total decrease in gross profit dollars of $115,466 is due to a decrease in international
handpiece sales and a small reduction in gross profit percentage.
Selling, general and administrative expenses for the three months ended March 31, 2011 and
2010 were $1,624,255 and $1,541,702, respectively. This relatively flat change of $82,553, or 5.4%,
is described in the following sections of this report. Although the Company continues to focus on
controlling expenses, there are a few areas that required additional capital investment in the
first quarter of 2011. The first quarter of 2011 noted several increases to continue on our planned
business model change to the education hygienist program. First, trade show and related expenses
(travel, fees and staffing) increased by $74,000 as the Company targeted this venue as a more cost
effective method to present our Wand/STA Instrument to a wide array of potential customers. Sales
expenses also increased during the first quarter of 2011 principally in travel costs as the
Companys two new sales director focus on opening new markets and expanding our distributor sales.
Salaries increased by $45,000 in this quarter over the comparable quarter in the prior year,
principally due the increased compensation of the two new sales directors (Domestic and
International). Legal fees increased by $30,000 in the aggregate for routine litigation and patent
annuities. Other expenses for the quarter decreased by approximately $66,000, as compared to the
same period in 2010. The principal areas of decrease were; $12,000 reduction on the reserve for bad
debts, as the Company reversed a portion of the bad debt reserve based on payments made by a
Chinese distributor in the first quarter of 2011. The international commission decreased by $70,000
as the contractual threshold for commission rate was achieved in January 2011.
22
Research and development expenses for the three months ended March 31, 2011 and 2010 were
$43,718 and $88,464, respectively.
The loss from operation for three months ended March 31, 2011 was $121,573 and the net income
from operations for the three months ended March 31, 2010 was $31,700, respectively. The $153,273,
or 483.5%, decrease is explained above.
Interest expense of $19,386 and amortization of debt issuance was $699 relating to the
conversion of the $1.3 million line of credit into common stock in December 2009 was charged for
the three months ended March 31, 2011, compared to $9,343 and $699, respectively, for the same
period in 2010.
Other Income includes $61,916 in 2010. This represents the balance of the sale of tax credits
for 2009, under the New Jersey Technology Business Tax Certificate Program.
For the reasons explained above, net loss for the three months ended March 31, 2011 was
$141,644 as compared to a net income of $83,922 for the three months ended March 31, 2010. The
$225,566, or 268.8%, decrease in net profit is primarily a result of a decrease in gross margin
dollars of $115,466 offset by an increase in selling, general and administrative expenses of
$82,553; a significant reduction in research and development expense of $44,745 and a reduction of
$61,916 (2010 sale of tax credit) in other income.
23
Liquidity and Capital Resources
As of March 31, 2011, the Company had cash and cash equivalents of $155,263 and a negative
working capital of $177,786. Milestone had a net loss of $141,644 and a net income of $83,922 for
the three months ended March 31, 2011 and 2010, respectively. The significant decrease in working
capital of $171,101 in 2011 was caused by a delay in obtaining regulatory approval to sell our
instruments and handpieces in China. Based on the initial purchase order from our distributor in
China in 2009, the Company ramped up purchasing of parts in anticipation of significant sales in
2010 and future years. As a result of the delay in shipping, the advances to contract manufacturer
has increased significantly, (current and long term), in 2011 as compared to 2010. Additionally,
the accounts payable due to suppliers has also increased and is classified as current and long
term. And finally, the accounts receivable from the China distributor has been classified between
current and long term net of a reserve of doubtful accounts of $624,000.
As a result of this delay on shipments to China, the decrease in working capital at March 31,
2011, of $171,101, consists of a net current asset decrease of $30,227. The significant current
asset changes are; current accounts receivable increased by $583,974, cash decreased by $471,819,
utilized in operations and to pay for parts required for the China production and inventory
decreased by $136,239. Current liabilities increased by $140,874.
The Company has also incurred increases in non current advances to contract manufacturer of
$514,043 and an increase in non current accounts payable of $269,786 as a result of the delay in
shipping instruments and handpieces to our distributor in China. The Company continues to take
positive steps to maintain adequate inventory levels and advances to contract manufacturers to
maintain available inventory to meet our domestic and international sales requirements. Cash flows
from operating activities for the three months ended March 31, 2011 was a negative $482,401 and for
the three months ended March 31, 2010 was a positive $248,437.
For the three months ended March 31, 2011, our net cash used in operating activities was
$482,401. This was attributable primarily to a net loss of $141,644 adjusted for noncash items of
$87,549 principally common stock and options issued for compensation, consulting and vendor
services and offset by changes in operating assets and liabilities of $428,306.
For the three months ended March 31, 2011, $14,418 was used in investing activities. This was
primarily attributable to $12,164 of legal fees related to new patent application. Capital
expenditures of $2,254 were primarily for the leasehold improvement.
For the three months ended March 31, 2011, $25,000 was provided by financing activities. This
was primarily attributable to the exercising of stock options.
The Company has incurred operating losses and negative cash flows from operating activities
since its inception, except for 2009. The Company did not achieve positive cash flow in 2010. The
Company is actively pursuing the generation of positive cash flows from operating activities
through increases in revenues based upon managements assessment of present contracts and current
negotiations and reductions in operating expenses. As of December 31, 2010, the Company believes
that it does not have sufficient cash reserves to meet all of its anticipated obligations for the
next twelve months. However, if the Company requires a need for a higher level of marketing and
sales effort, or if the Company is unable to continue generating 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 continue to achieve positive operating cash flows or that additional
capital can be raised on the 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 savings measures, any of which might negatively affect the Companys operating results.
The Companys 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 adjustment that might result from the outcome of this uncertainty.
24
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 4. Controls and Procedures
The Companys management, including the Chief Executive Officer and Chief Financial Officer,
have evaluated the effectiveness of the design and operation of the Companys 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 Companys Chief Executive Officer
and Chief Financial Officer have concluded that the disclosure controls and procedures as of March
31, 2011 are effective to ensure that information required to be disclosed in the reports the
Company files or submits under the Exchange Act is recorded, processed, summarized and reported
within the time periods specified in the SECs rules and forms and that such information is
accumulated and communicated to the Companys management, including the Chief Executive Officer and
Chief Financial Officer, to allow timely decisions regarding disclosure.
There were no changes in the Companys internal control over financial reporting identified in
connection with the evaluation that occurred during the Companys last fiscal quarter ended March
31, 2011 that have materially affected, or that are reasonably likely to materially affect, the
Companys internal controls over financial reporting.
25
PART II OTHER INFORMATION
ITEM 1. LEGAL PROCEEDINGS
None.
ITEM 1A. RISK FACTORS
As a smaller reporting company we are not required to provide the information required by this
Item.
ITEM 2. UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS
Recent Sales of Unregistered Securities
In the quarter ended March 31, 2011, Milestone issued total 120,334 shares valued at $43,584
as follows:
|
|
|
|
|
|
|
|
|
|
|
Shares |
|
|
$ |
|
Shares issued for Employee Compensation |
|
|
7,500 |
|
|
$ |
7,500 |
|
Shares issued for services |
|
|
12,834 |
|
|
|
11,084 |
|
Options exercised |
|
|
100,000 |
|
|
|
25,000 |
|
|
|
|
|
|
|
|
|
|
|
120,334 |
|
|
$ |
43,584 |
|
These issuances were exempt from registration pursuant to Section 4(2) of the Securities Act
of 1933, as amended (the Act) and a legend restricting the sale, transfer, or other disposition
of these shares other than in compliance with the Act was imprinted on stock certificates
evidencing the shares.
ITEM 3. DEFAULT UPON SENIOR SECURTIES
None.
ITEM 4. (Removed and Reserved)
None.
ITEM 5. OTHER INFORMATION
None.
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. |
26
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 |
|
|
Chief Executive Officer |
|
|
|
|
|
/s/ Joseph DAgostino
|
|
|
Joseph DAgostino |
|
|
Chief Financial Officer |
|
Date: May 9, 2011
27