10-QSB
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 10-QSB
Mark One
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þ |
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QUARTERLY REPORT UNDER SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the Quarterly Period Ended March 31, 2007
OR
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o |
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TRANSITION REPORT UNDER 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
or organization)
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(I.R.S. Employer
Identification No.) |
220 South Orange Avenue, Livingston, New Jersey 07039
(Address of principal executive office)
(Registrants telephone number, including area code)
Check whether the Issuer (1) has filed all reports required to be filed by Section 13 or
15(d) of the Exchange Act during the past 12 months (or for such shorter period that the registrant
was required to file such reports), and (2) has been subject to such filing requirements for the
past 90 days. Yes þ No o
Indicate by check mark whether the Registrant is a shell company (as defined in Rule 12b-2 of
the Exchange Act). Yes o No þ
As of May 15, 2007, the Issuer had a total of 11,703,267 shares of Common Stock, $.001 par value,
outstanding.
FORWARD LOOKING STATEMENTS
When used in this Quarterly Report on Form 10-QSB, 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 Scientific Inc.s (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 that 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.
2
MILESTONE SCIENTIFIC INC.
INDEX
3
MILESTONE SCIENTIFIC INC.
CONDENSED BALANCE SHEETS
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March 31, 2007 |
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(Unaudited) |
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December 31, 2006 |
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ASSETS |
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Current Assets: |
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Cash and cash equivalents |
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$ |
451,202 |
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$ |
1,160,116 |
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Accounts receivable , net of allowance for doubtful accounts of $21,441
in 2007 and $16,519 in 2006 |
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1,414,132 |
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346,619 |
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Royalty receivable |
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47,936 |
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|
60,107 |
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Inventories |
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1,224,412 |
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1,323,338 |
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Advances to contract manufacturer |
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1,096,935 |
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1,077,871 |
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Prepaid expenses |
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122,558 |
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97,073 |
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Total current assets |
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4,357,175 |
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4,065,124 |
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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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Equipment, net of accumulated depreciation of $427,767 as of March 31, 2007 and $402,914 as of December 31, 2006 |
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449,720 |
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459,259 |
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Patents, net of accumulated amortization of $47,651 as of March 31, 2007 and $41,939 as of December 31, 2006 |
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521,042 |
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526,753 |
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Other assets |
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13,206 |
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14,153 |
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Total assets |
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$ |
5,417,462 |
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$ |
5,141,608 |
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LIABILITIES AND STOCKHOLDERS EQUITY |
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Current Liabilities: |
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Accounts payable |
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$ |
1,462,020 |
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$ |
1,196,107 |
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Accrued expenses |
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449,137 |
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232,076 |
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Deferred compensation payable to officers |
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44,497 |
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Total current liabilities |
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1,955,654 |
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1,428,183 |
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Stockholders Equity |
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Common stock, par value $.001; authorized 50,000,000 shares; 11,707,637 shares issued, 337,036 shares to be
issued, and 11,674,304 shares outstanding |
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12,046 |
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12,031 |
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Additional paid-in capital |
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58,003,614 |
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57,720,129 |
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Accumulated deficit |
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(53,642,336 |
) |
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(53,107,219 |
) |
Treasury stock, at cost, 33,333 shares |
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(911,516 |
) |
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(911,516 |
) |
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Total stockholders equity |
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3,461,808 |
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3,713,425 |
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Total liabilities and stockholders equity |
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$ |
5,417,462 |
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$ |
5,141,608 |
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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 |
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March 31, 2007 |
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March 31, 2006 |
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Product sales, net |
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$ |
2,262,027 |
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$ |
1,560,919 |
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Royalty income |
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47,936 |
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136,837 |
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Total revenue |
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2,309,963 |
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1,697,756 |
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Cost of products sold |
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831,210 |
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751,162 |
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Royalty expense |
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5,752 |
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16,421 |
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Total cost of revenue |
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836,962 |
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767,583 |
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Gross profit |
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1,473,001 |
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930,173 |
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Selling, general and administrative expenses |
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1,836,888 |
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1,479,714 |
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Research and development expenses |
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178,566 |
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163,442 |
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Total operating expenses |
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2,015,454 |
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1,643,156 |
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Loss from operations |
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(542,453 |
) |
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(712,983 |
) |
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Interest income |
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7,336 |
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27,404 |
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Net loss applicable to common stockholders |
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$ |
(535,117 |
) |
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$ |
(685,579 |
) |
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Loss per share applicable to common stockholders basic and diluted |
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$ |
(0.05 |
) |
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$ |
(0.06 |
) |
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Weighted average shares outstanding and to be issued basic and
diluted |
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11,958,098 |
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|
11,741,578 |
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See Notes to Condensed Financial Statements
5
MILESTONE SCIENTIFIC INC.
CONDENSED STATEMENT OF CHANGES IN STOCKHOLDERS EQUITY
THREE MONTHS ENDED MARCH 31, 2007
(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, 2007 |
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12,029,672 |
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$ |
12,031 |
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$ |
57,720,129 |
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$ |
(53,107,219 |
) |
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$ |
(911,516 |
) |
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$ |
3,713,425 |
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Common stock issued for exercised options |
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10,000 |
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|
10 |
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|
8,290 |
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|
|
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|
8,300 |
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Common stock and options issued for
payment of consulting services |
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240,438 |
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|
240,438 |
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Common stock and options issued for
payment of employee compensation |
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5,001 |
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5 |
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|
34,757 |
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|
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|
34,762 |
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Net loss |
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(535,117 |
) |
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(535,117 |
) |
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Balance, March 31, 2007 |
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|
12,044,673 |
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|
$ |
12,046 |
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|
$ |
58,003,614 |
|
|
$ |
(53,642,336 |
) |
|
$ |
(911,516 |
) |
|
$ |
3,461,808 |
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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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2007 |
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2006 |
|
Cash flows from operating activities: |
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Net loss |
|
$ |
(535,117 |
) |
|
$ |
(685,579 |
) |
Adjustments to reconcile net loss to net cash used in operating activities: |
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|
|
|
|
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Depreciation expense |
|
|
24,853 |
|
|
|
24,300 |
|
Amortization of patents |
|
|
5,712 |
|
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|
5,712 |
|
Common stock
issued for exercised options |
|
|
8,300 |
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|
|
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|
Common stock and options issued for compensation, consulting,
and vendor services |
|
|
275,201 |
|
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|
91,058 |
|
Other |
|
|
|
|
|
|
1,918 |
|
Bad debt expense |
|
|
5,688 |
|
|
|
7,743 |
|
Changes in operating assets and liabilities: |
|
|
|
|
|
|
|
|
Accounts receivable |
|
|
(1,073,202 |
) |
|
|
(158,651 |
) |
Royalty receivable |
|
|
12,171 |
|
|
|
48,864 |
|
Inventories |
|
|
98,926 |
|
|
|
25,656 |
|
Advances to contract manufacturer |
|
|
(19,064 |
) |
|
|
(143,857 |
) |
Prepaid expenses |
|
|
(25,485 |
) |
|
|
11,040 |
|
Other assets |
|
|
947 |
|
|
|
2,514 |
|
Accounts payable |
|
|
265,914 |
|
|
|
122,615 |
|
Accrued expenses |
|
|
217,059 |
|
|
|
158,270 |
|
Deferred compensation |
|
|
44,497 |
|
|
|
43,333 |
|
|
|
|
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Net cash used in operating activities |
|
|
(693,600 |
) |
|
|
(445,064 |
) |
|
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Cash flows from investing activities: |
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|
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|
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Purchases of
property and equipment |
|
|
(15,314 |
) |
|
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|
Payment for patent rights |
|
|
|
|
|
|
(2,805 |
) |
|
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Net cash used in investing activities |
|
|
(15,314 |
) |
|
|
(2,805 |
) |
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NET (DECREASE) IN CASH AND CASH EQUIVALENTS |
|
|
(708,914 |
) |
|
|
(447,869 |
) |
Cash and cash equivalents at beginning of period |
|
|
1,160,116 |
|
|
|
2,892,679 |
|
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Cash and cash equivalents at end of period |
|
$ |
451,202 |
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|
$ |
2,444,810 |
|
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|
See Notes to Condensed Financial Statements
7
MILESTONE SCIENTIFIC INC.
NOTES TO CONDENSED FINANCIAL STATEMENTS
(Unaudited)
Note 1 Summary of accounting policies
The unaudited financial statements of Milestone Scientific Inc. (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, 2006 included in Milestones
Annual Report on Form 10-KSB. The accounting policies used in preparing these unaudited
financial statements are the same as those described in the December 31, 2006 financial
statements.
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, 2007 and the results of its operations for the three
months ended March 31, 2007 and 2006.
The results reported for the three months ended March 31, 2007 are not necessarily
indicative of the results of operations which may be expected for a full year.
The Company has incurred
recurring operating losses and negative operating cash flows since its inception. At March 31, 2007, the Company had cash
and cash equivalents and working capital of $451,000 and $2,402,000, respectively. The Company is actively pursuing generation of positive cash flows from operating activities
through increases in revenues and reductions in operating expenses. The Company believes that its current resources will be sufficient to fund its planned operations at the
current level for at least through March 31, 2008.
Note 2 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.
Note 3 Royalty receivable
Royalty receivable represents the royalty due from United Systems Inc, the licensee of
Milestones proprietary consumer dental whitening product, which is sold under Milestones
distributors trademark of Ionic White.
Note 4 Inventories
Inventories principally consist of finished goods and component parts stated at the lower of
cost (first-in, first-out method) or market.
Note 5 Advances to contract manufacturer
Advances to contract manufacturer represent deposits to the Companys contract manufacturer
to fund future inventory purchases.
8
Note 6 Basic and diluted net loss per common share
Milestone presents basic earnings (loss) per common share and, if applicable, diluted
earnings per common share pursuant to the provisions of Statement of Financial Accounting
Standards No. 128, Earnings per Share (SFAS 128). Basic earnings (loss) per common
shares is calculated by dividing net income or loss applicable to common stock by the
weighted average number of common shares outstanding and to be issued during each period.
The calculation of diluted earnings per common share is similar to that of basic earnings
per common share, except that the denominator is increased to include the number of
additional common shares that would have been outstanding if all potentially dilutive common
shares, such as those issuable upon the exercise of stock options, warrants, and the
conversion of notes payable and preferred stock were issued during the period.
Since Milestone had net losses for the three months ended March 31, 2007 and 2006, the
assumed effects of the exercise of outstanding stock options and warrants and the conversion
of preferred stock into common stock were not included in the calculation as their effect
would have been anti-dilutive. Such outstanding options, warrants and preferred stock
totaled 3,644,920 and 3,605,085 at March 31, 2007 and 2006, respectively.
Note 7 Significant Customer
Milestone had one customer who
accounted for approximately 49% of its net sales for the
three months ended March 31, 2007 and 25.3% of its net sales for the prior year period. At
March 31, 2007, receivables from two customers accounted for
approximately 70% and 16% respectively of Milestones
total accounts receivable.
Note 8 Stock Option Plans
Milestone adopted SFAS No. 123R, Share-Based Payment, an Amendment of FASB Statement No.
123, under the modified-prospective transition method on January 1, 2006. SFAS No. 123R
requires all share-based payments to employees, including grants of employee stock options,
to be recognized in the income statements 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 123R, the Company 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, the Company accounted for its stock option plans using the intrinsic value method
of accounting prescribed by APB Opinion No. 25.
Employees: As of March 31, 2007, there were 137,667 outstanding options granted under the
Milestone 1997 Stock Option Plan and 235,000 outstanding options granted under the
Milestone 2004 Stock Option Plan. As a result of adopting Statement of Financial
Accounting Standards No.123 (revised 2004), Share-Based Payment, the Company recognized
$20,762 in share-based compensation expense and a corresponding increase in net loss for
the three months ended March 31, 2007. This share-based compensation expense had minimal
impact on the Companys basic and diluted earnings per share.
The fair value of each option granted was
estimated on the date of the grant using the
Black-Scholes option pricing model.
Expected volatilities are based on historical volatility of the companys common stock.
The company uses historical data to estimate option exercise and employee termination
within the valuation model. The expected term of the option granted is estimated based on
historical
9
behavior of employees and represents the period of time that options granted are expected to
be outstanding. A summary of option activity under the plan as of March 31, 2007, and
changes during the three months then ended is presented below:
|
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|
Weighted |
|
|
|
|
|
|
|
|
Weighted |
|
Average |
|
|
|
|
Number |
|
Average |
|
Remaining |
|
Aggregate |
|
|
of |
|
Exercise |
|
Contractual |
|
Intrinsic |
Options |
|
Options |
|
Price |
|
Life (Years) |
|
Value |
Outstanding, January 1, 2007 |
|
|
427,834 |
|
|
|
1.83 |
|
|
|
3.3 |
|
|
|
|
|
Granted |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Exercised |
|
|
(10,000 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
Forfeited or expired |
|
|
(45,167 |
) |
|
|
0.00 |
|
|
|
0.0 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Outstanding, March 31, 2007 |
|
|
372,667 |
|
|
|
1.83 |
|
|
|
3.29 |
|
|
|
516,652 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Exercisable, March 31, 2007 |
|
|
250,889 |
|
|
|
2.04 |
|
|
|
3.06 |
|
|
|
300,918 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
As of March 31, 2007, there was $59,546 of total unrecognized compensation cost related
to nonvested share-based compensation arrangements granted under the plan. That cost is
expected to be recognized over a weighted average period of two and a half years.
Non-Employees: As of March 31, 2007, there were 347,666 outstanding options granted under
the Milestone 1997 Stock Option Plan and 291,667 outstanding options granted under the
Milestone 2004 Stock Option Plan. The Company recognized
$227,938 in share-based compensation expense in net loss for
the three months ended March 31, 2007. This share-based compensation expense had minimal
impact on the Companys basic and diluted earnings per share.
The weighted average grant date fair
value of options to nonemployees during the period ended March 31, 2007 was $2.46.
The fair value of each option granted is estimated on the date of the grant using the
Black-Scholes option pricing model with the following assumptions used for the grants in the
three months ended March 31, 2007: dividend yield of 0%; expected volatility of 90.%; risk
free interest rate of 4.52%; and expected lives of 2.5 years.
Expected volatilities are based on historical volatility of the companys common stock.
The company uses historical data to estimate option exercise and nonemployee termination
within the valuation model. The expected term of the option granted is estimated based on
historical behavior of nonemployees and represents the period of time that options granted are
expected to be outstanding. A summary of option activity under the plan as of March 31,
2007, and changes during the three months then ended is presented below:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted |
|
|
|
|
|
|
|
|
|
|
Weighted |
|
|
Average |
|
|
|
|
|
|
|
|
|
|
average |
|
|
Remaining |
|
|
Aggregate |
|
|
|
Number of |
|
|
exercise |
|
|
Contractual |
|
|
Intrinsic |
|
|
|
Options |
|
|
price of options |
|
|
Life (Years) |
|
|
Value |
|
Outstanding, January 1, 2007 |
|
|
522,466 |
|
|
$ |
3.51 |
|
|
|
0 |
|
|
|
|
|
Granted |
|
|
125,000 |
|
|
|
1.75 |
|
|
|
|
|
|
|
|
|
Exercised |
|
|
0 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Forfeited or expired |
|
|
(8,333 |
) |
|
|
4.92 |
|
|
|
0 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Outstanding, March 31, 2007 |
|
|
639,133 |
|
|
|
3.15 |
|
|
|
3.17 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Exercisable, March 31, 2007 |
|
|
352,577 |
|
|
|
3.47 |
|
|
|
3.17 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
10
As of March 31, 2007, there was $140,134 of total unrecognized compensation cost
related to nonvested share-based compensation arrangements granted under the plan. That
cost is expected to be recognized over a weighted average period of two years.
Note 9 Agreements to Issue Common Stock and Stock Options
Under an agreement, the Companys marketing associate for a consumer tooth whitening product
agreed to purchase at $3.00 per share 500,000 shares of Milestone common stock in quarterly
installments of 125,000 shares within 10 days after the end of each of the four fiscal
quarters commencing July 1, 2005. Milestone is not required to sell these shares unless the
associate has purchased at least 625,000 starter kits in the first quarter, at least
1,250,000 starter kits in the first two quarters and at least 1,875,000 starter kits in the
first three quarters. Further, at Milestones option, all shares previously purchased must
be returned to Milestone and all monies paid to Milestone returned to the associate if it
has not purchased an aggregate of at least 3,000,000 starter kits for the twelve-month
period ending June 30,2006.
This agreement has been repeatedly extended for the associates commitment to purchase
common stock. As of March 31, 2007, no shares have been sold
under this agreement, as the associate did not purchase the minimum
amount of starter kits.
Note 10- Recent Accounting pronouncements
In June 2006, the Financial Accounting Standards Board (FASB) issued FASB
Interpretation No. 48, Accounting for Uncertainty in Income Taxes, an interpretation of FASB
Statement No. 109 (FIN 48). FIN 48 clarifies the accounting for uncertainties in income
taxes recognized in a companys financial statements in accordance with Statement 109 and
prescribes a recognition threshold and measurement attributable for financial disclosure of
tax positions taken or expected to be taken on a tax return. Additionally, FIN 48 provides
guidance on derecognition, classification, interest and penalties, accounting in interim
periods, disclosure and transition. We adopted the provisions of FIN 48 as of January 1,
2007. The adoption of FIN 48 did not impact our financial position, results of operations or
cash flows for the three months ended March 31, 2007.
In
February 2007, the Financial Accounting Standards Board issued FASB
No. 159, The Fair Value Option for Financial Assets and Financial Liabilities Including an Amendment of FASB
Statement No. 115, which permits companies to measure many financial
instruments and certain other assets and liabilities at fair value on
an instrument-by-instrument basis (the fair value option). FASB 159
is effective for us on January 1, 2008. We are currently evaluating
the possible impact of adopting FASB No. 159 on our consolidated
financial statements.
In September 2006, the Financial Accounting Standards Board issued FASB 157, Fair Value Measurements. FASB 157 defines fair value, establishes a framework for measuring
fair value in generally accepted accounting principles and expands disclosures about fair value measurements. FASB 157
is effective for fiscal years beginning after November 15, 2007 and interim
periods within those fiscal years. The Company does not expect adoption of FASB No. 157 to have material effect on its results of operations or financial position.
ITEM 2. Managements Discussion and Analysis or Plan of Operation.
OVERVIEW
The following discussion 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-QSB. This discussion may contain forward-looking statements that involve risks and
uncertainties. Our actual results may differ materially from those anticipated in these
forward-looking statements as a result of certain factors, such as those set forth in our Form
10-KSB for the year ended December 31, 2006.
During the first quarter of 2007, the Company made considerable progress in advancing its
refined business strategy primarily focused on the development, commercialization and global
marketing and distribution of innovative painless injection products based on its patented core
technology, CompuFlo. Particular emphasis has been concentrated on bringing our patented and
novel Single Tooth Anesthesia (STA) delivery system to market, which incorporates the pressure
force feedback elements of the CompuFlo technology, allowing dental practitioners to accurately
administer injections into the periodontal ligament space, thus effectively anesthetizing a single
tooth.
11
In
2007, Milestone finalized an Exclusive Distribution and Supply
Agreement with Henry Schein, Inc., one of the worlds largest medical and dental distribution
companies, to become the exclusive distributor of the STA and CompuDent systems (and related
ancillary products) in both North America and Canada. We also granted Henry Schein first right of
refusal on distribution rights of the same products in the international marketplace, excluding
Poland, Norway, Sweden, Denmark and South Africa, where we have already identified alternative
sales and distribution partners.
In February 2007, the STA was formally unveiled to market at the 142nd Chicago Dental Society
Midwinter Meeting, one of the largest dental trade events held each year in the U.S. In late
March, we began fulfilling purchase orders from Henry Schein for the STA, with revenue recognition
occurring upon shipment. This resulted in a material improvement in our domestic sales during the
first quarter of this year, due to the impact of $632,309 in sales of STA systems and $20,545 in
sales of STA disposable handpieces.
The initial controlled soft introduction of our STA delivery system in the U.S. and Canada was
designed to develop grass-roots support in the field prior to our full scale launch of the STA
system scheduled to occur in the fourth quarter of this year or during the first quarter of 2008.
The initial shipments of the STA delivery system to Henry Scheins customers should help to
generate opportunities to promote much more rapid market adoption of the product by dental
professionals. Further, early adopters of the STA System should prove to be valuable sources of
insight and information regarding the powerful functionality and user benefits of the system,
helping us to build a meaningful library of product testimonials and a solid base of professional
references that will support and promote Henry Scheins sales and marketing efforts over time.
Despite a reduced focus on supporting formal sales and marketing initiatives associated with
our legacy dental injection system, CompuDent, domestic sales of the legacy product modestly
improved in the first quarter of 2007, increasing to $287,227 compared to $221,794 in the first
quarter of 2006. Moreover, domestic sales of our disposable handpieces used in conjunction with
CompuDent increased to $911,971 from $741,654 on a comparable first quarter over first quarter
basis for 2007 and 2006, respectively.
International sales, overall, were down in the first quarter of this year due largely to our
foreign distributors anticipation of the commercial availability of our STA system, which
circumvented pro-active marketing of the CompuDent system primarily in the European markets. We
are currently advancing through the regulatory process of obtaining a CE Mark for the STA system,
which will permit sales and marketing of the system in European Union (EU) countries. Once
received, we will support a formal international market launch of the product at that time, which
we anticipate will occur later this year. Although CompuDent system sales decreased, international
sales of disposable handpieces to current users of the CompuDent system grew 22%, rising to
$291,961 in the first three months of this year from $239,146 in the comparable period in the
previous year.
Milestone will continue to reinforce and support its growing international sales and
distribution channels. By doing so, we hope to materially expand our global market penetration of
the professional medical and dental industries and drive broad brand awareness and appreciation for
both our legacy and newly commercialized painless injection solutions.
In the first quarter of 2007, we signed a Collaboration Agreement with Carticept Medical,
Inc., an Atlanta-based company developing and commercializing advanced medical device technology
for the minimally-invasive treatment of cartilage damage and osteoarthritis. Milestone and
Carticept have agreed to collaborate, at Carticepts cost, on the development of a specialized
Injection System for the treatment of arthritic joints. The Injection System will use our patented
CompuFlo technology to painlessly inject Carticepts proprietary products into the intra-articular
joint space. Once Carticept is satisfied that the prototype meets predetermined performance
benchmarks, then Carticept and Milestone
12
will develop a professional version of the System suitable for commercialization and
distribution to the professional medical markets.
The Carticept agreement represented a significant step forward in our efforts to pursue
strategic partnerships and revenue sharing collaborations with established industry leaders who
share our interest in leveraging CompuFlo to develop new, cutting edge solutions capable of
addressing many of the more than 700 market applications identified in the independent research
study we commissioned in 2006. As we progress through 2007, we will continue to work towards
identifying other strategic opportunities for joint development projects using CompuFlo as the
impetus for new product development.
Selling, general and administrative expenses for the first quarter increased, reflecting
spending associated with the soft domestic market launch of the STA, which included expenses
associated to advertising, trade show and sales training and support. The rise in selling,
general and administrative expenses was also attributable to a non-cash
charge of $248,700 associated with the accounting for share based compensation expense.
The total increase was offset by
our continued attention on strict cost containment in our general operating activities. Related
research and development expenses for STA and CompuFlo totaled $178,566 for the first quarter
period of 2007. While this total represented 10% of the total operating expenses, the continued
investment in these development and commercialization programs is crucial for our Companys future
success.
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, |
|
|
|
2007 |
|
|
2006 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
DOMESTIC |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
CompuDent |
|
$ |
287,227 |
|
|
|
15.1 |
% |
|
$ |
221,794 |
|
|
|
21.4 |
% |
STA units |
|
|
632,309 |
|
|
|
33.2 |
% |
|
|
|
|
|
|
0.0 |
% |
Handpieces |
|
|
911,971 |
|
|
|
47.9 |
% |
|
|
741,654 |
|
|
|
71.6 |
% |
STA handpieces |
|
|
20,545 |
|
|
|
1.1 |
% |
|
|
0 |
|
|
|
0.0 |
% |
Other |
|
|
52,293 |
|
|
|
2.7 |
% |
|
|
72,547 |
|
|
|
7.0 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
Total Domestic |
|
$ |
1,904,344 |
|
|
|
100.0 |
% |
|
$ |
1,035,995 |
|
|
|
100.0 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
INTERNATIONAL |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
CompuDent |
|
$ |
51,080 |
|
|
|
14.3 |
% |
|
$ |
231,908 |
|
|
|
44.2 |
% |
Handpieces |
|
|
291,961 |
|
|
|
81.6 |
% |
|
|
239,146 |
|
|
|
45.5 |
% |
Other |
|
|
14,642 |
|
|
|
4.1 |
% |
|
|
53,870 |
|
|
|
10.3 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
Total International |
|
$ |
357,683 |
|
|
|
100.0 |
% |
|
$ |
524,924 |
|
|
|
100.0 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
DOMESTIC/INTERNATIONAL ANALYSIS |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Domestic |
|
$ |
1,904,344 |
|
|
|
84.2 |
% |
|
$ |
1,035,995 |
|
|
|
66.4 |
% |
International |
|
|
357,683 |
|
|
|
15.8 |
% |
|
|
524,924 |
|
|
|
33.6 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
Total Product Sales |
|
$ |
2,262,027 |
|
|
|
100.0 |
% |
|
$ |
1,560,919 |
|
|
|
100.0 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
Summary of Significant Accounting Policies
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.
Results of Operations
The results of operations for the three months ended March 31, 2007 reflect a stable growth of
our user base, well controlled expenditures necessary to expand our market, and significant
investment in
13
new product development. The net loss for the
three months ended March 31, 2007 represents a
22% improvement from the same period in 2006.
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 |
|
|
|
2007 |
|
|
2006 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Products sales, net |
|
$ |
2,262,027 |
|
|
|
98 |
% |
|
$ |
1,560,919 |
|
|
|
92 |
% |
Royalty income |
|
|
47,936 |
|
|
|
2 |
% |
|
|
136,837 |
|
|
|
8 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
Total revenue |
|
|
2,309,963 |
|
|
|
100 |
% |
|
$ |
1,697,756 |
|
|
|
100 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost of products sold |
|
|
831,210 |
|
|
|
36 |
% |
|
|
751,162 |
|
|
|
44 |
% |
Royalty expense |
|
|
5,752 |
|
|
|
|
|
|
|
16,421 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total cost of revenue |
|
|
836,962 |
|
|
|
36 |
% |
|
|
767,583 |
|
|
|
45 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
Gross Profit |
|
|
1,473,001 |
|
|
|
64 |
% |
|
|
930,173 |
|
|
|
55 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
Selling, general and
administrative expenses |
|
|
1,836,888 |
|
|
|
79 |
% |
|
|
1,479,714 |
|
|
|
87 |
% |
Research and
development expenses |
|
|
178,566 |
|
|
|
8 |
% |
|
|
163,442 |
|
|
|
10 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
Total operating expenses |
|
|
2,015,454 |
|
|
|
87 |
% |
|
|
1,643,156 |
|
|
|
97 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss from operations |
|
|
(542,453 |
) |
|
|
-23 |
% |
|
|
(712,983 |
) |
|
|
-42 |
% |
Other income interest |
|
|
7,336 |
|
|
|
0 |
% |
|
|
27,404 |
|
|
|
2 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss |
|
$ |
(535,117 |
) |
|
|
-23 |
% |
|
$ |
(685,579 |
) |
|
|
-40 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months ended March 31, 2007 compared to three months ended March 31, 2006
Total revenues for the three months ended March 31, 2007 and 2006 were $2,309,963 (product
sales of $2,262,027 and royalty income of $47,936) and $1,697,756, respectively. The $701,108 or
44.9% increase in net product sales is primarily related to STA unit and handpiece sales of
$652,854 which did not exist in this same period last year. STA unit and handpiece sales are
entirely domestic thru the first quarter. Domestic revenue from CompuDent units increased $65,433
or 29.5%, while international revenue declined $180,828 or 78% from year earlier levels. Disposable
handpiece sales increased $170,317 or 23.0% domestically while international sales increased
$52,815 or 22.1% reflecting the continuing increase in the expanding base of CompuDent units in
service. The amount of $47,936 or 2% of total revenue is royalty income from granting United
Systems Inc. a license to manufacture, market, and sublicense the Ionic White to the consumer
market. Royalty income (net of royalty expenses) declined $78,232 or 65.0% reflecting retail
competition in this increasingly highly competitive market.
Cost of products sold for the three months ended March 31, 2007 and 2006 were $831,210 and
$751,162, respectively. The $80,048 or 10.6% increase is primarily attributable to the additional
cost of goods sold for the higher revenues previously discussed. Royalty expense related to the
royalty income from the sales of the Ionic White tooth whitening system was $5,752 for
the three months ended March 31, 2007, a decrease from last year of $10,669 or 65.% as a result of
lower royalties due to the market conditions described above. For the three months ended March
31, 2007, Milestone generated a gross profit of $1,473,001 or 64% as compared to a gross profit of
$930,173 or 55% for the same period in 2006. Excluding the net royalty income (net of royalty
expense) of $42,184 which has a gross profit of 88%, gross profit of products sales was $1,430,817
or 63% in 2006, representing a 21% increase in gross profit over the same period in 2006.
14
Selling, general and administrative expenses for the three months ended March 31, 2007 and 2006 were $1,836,888 and $1,479,714, respectively.
The $157,174 or 10.6% increase is attributable primarily to a
non-cash charge of $248,700 associated with the accounting for share based compensation expense, as well as costs associated to the soft domestic market launch of the STA delivery system, including costs related to advertising, trade show participation and sales training
and support.
Research and development expenses for the three months ended March 31, 2007 and 2006 were
$178,566 and $163,442, respectively. These costs are primarily associated with the development of
Milestones Single Tooth Anesthetic (STA) delivery system and continuing efforts on the CompuFlo
technology.
Loss
from operations for the three months ended March 31, 2007 and 2006 was $542,453 and
$712,983, respectively. The $170,530 or 24% decrease in loss from operations is the primarily the
result of increased revenue at higher gross profit %s.
Interest income of $7,336 was earned in the three months ended March 31, 2007 compared to
$27,404 earned for the same period in 2006. The decrease of $20,068 or 73% in interest income is
the result of a decreased average cash balance.
For the reasons explained above, net loss for the three months ended March 31, 2007 was
$535,117 as compared to a net loss of $685,579 for the same period in
2006. The $150,462 or 22.0%
decrease in net loss is primarily a result of the increased total revenue and the increased gross
profit % partially offset by the increased operating expenses.
Cash flow results
As of March 31, 2007, Milestone had cash and cash equivalents of $451,202 and working capital
of $2,401,521.
For the three months ended March 31, 2007, Milestones net cash used in operating activities
was $693,600. This was attributable primarily to a net loss of $535,117 adjusted for noncash items
of $64,002 (of which $24,853 was depreciation expense; $5,712 was
amortization of patents; $283,501
was stock and options issued for compensation, consulting, and vendor services; $5,688 was bad debt expense); a $1,073,202 increase in accounts receivable; a $12,171
decrease in royalty receivable; a $98,926 decrease in inventories; a $19,064 increase in advances
to contract manufacturer; a $25,485 increase in prepaid expenses; a $947 decrease in other assets;
a $482,973 increase in accounts payable and accrued expenses; and, a $44,497 increase in deferred
compensation.
Management believes that existing financial resources coupled with expected cash flow from
operations are sufficient to meet Milestones capital needs for at least the next 12 months.
However, if Milestone determines that it is in its best interests to increase funding for the
development of various proposed medical products from its own resources, rather than relying on the
advancement of development funds by existing or potential development partners, if development
partners willing to fund certain development activities cannot be found or if cash flow from
operations is less than now expected, Milestone may need to raise additional capital. No
assurances can be given that additional capital, if required, can be raised on terms and conditions
satisfactory to Milestone. If additional capital is required and it cannot be raised, then
Milestone could be forced to curtail medical product development activities, cut marketing expenses
for existing dental products or adopt other cost saving measures, any of which might negatively
affect long-term growth prospects.
Liquidity and Capital Resources
15
Milestone
incurred net losses of approximately $535,000 and $686,000 and negative cash flows
from operating activities of approximately $694,000 and $445,000 during the three months
ended March 31, 2007 and 2006, respectively.
ITEM 3. CONTROLS AND PROCEDURES
|
a) |
|
Evaluation of Disclosure Controls and Procedures. Milestones management, with the
participation of the Chief Executive Officer and the Chief Financial Officer, carried out
an evaluation of the effectiveness of Milestones disclosure controls and procedures (as
defined in the Securities Exchange Act, Rule 13a-15(e) and 15d-15(e). Based upon that
evaluation, the Chief Executive Officer and Chief Financial Officer concluded that
Milestones disclosure controls and procedures were effective, as of the date of their
evaluation, for purposes of recording, processing, summarizing and timely reporting
material information required to be disclosed in reports filed by Milestone under the
Securities Exchange Act of 1934. |
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b) |
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Changes in Internal Control over Financial Reporting. There were no changes in our
internal controls over financial reporting that occurred during the period covered by this
report that have materially affected, or are reasonably likely to materially affect,
Milestones internal control over fiscal reporting. |
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PART II
ITEM 2. UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS
Recent Sales of Unregistered Securities
In the quarter ended March 31, 2007, Milestone issued total 15001 shares valued at $22,300.
ITEM 6. EXHIBITS
The following exhibits are filed herewith:
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31.1 |
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Chief Executive Officer Certification pursuant to section 302 of the
Sarbanes-Oxley Act of 2002. |
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31.2 |
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Chief Financial Officer Certification pursuant to section 302 of the
Sarbanes-Oxley Act of 2002. |
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32.1 |
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Chief Executive Officer Certification pursuant to section 906 of the
Sarbanes-Oxley Act of 2002. |
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32.2 |
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Chief Financial Officer Certification pursuant to section 906 of the
Sarbanes-Oxley Act of 2002. |
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SIGNATURES
In accordance with the requirements of the Exchange Act, the registrant caused this
report to be signed on its behalf by the undersigned, thereunto duly authorized.
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MILESTONE SCIENTIFIC INC.
Registrant
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/s/Leonard Osser
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Leonard Osser |
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Chairman and Chief Executive Officer |
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/s/David Cohn
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David Cohn |
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Chief Financial Officer |
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Dated: May 16, 2007
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