MILESTONE SCIENTIFIC INC. - Quarter Report: 2008 March (Form 10-Q)
Table of Contents
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 10-Q
(Mark One)
þ | QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the quarterly period ended March 31, 2008
or
o | TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the transition period from to
Commission File Number: 001-14053
MILESTONE SCIENTIFIC INC.
(Exact name of registrant as specified in its charter)
Delaware | 13-3545623 | |
(State or other jurisdiction of incorporation or organization) | (I.R.S. Employer Identification No.) |
220 South Orange Avenue, Livingston, New Jersey 07039
(Address of principal executive offices)
(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 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. (Check one):
Large accelerated filer o | Accelerated filer o | Non-accelerated filer o | Smaller reporting company þ | |||
(Do not check if a smaller reporting company) |
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the
Exchange Act).
o Yes þ No
APPLICABLE ONLY TO ISSUERS INVOLVED IN BANKRUPTCY
PROCEEDINGS DURING THE PRECEDING FIVE YEARS:
PROCEEDINGS DURING THE PRECEDING FIVE YEARS:
Indicate by check mark whether the registrant has filed all documents and reports required to be
filed by Sections 12, 13 or 15(d) of the Securities Exchange Act of 1934 subsequent to the
distribution of securities under a plan confirmed by a court.
o Yes o No
SEC1296 (02-08) | Potential persons who are to respond to the collection of information contained in this form are not required to respond unless the form displays a currently valid OMB control number. |
As of May 15, 2008, the Issuer had a total of 12,202,186 shares of Common Stock, $.001 par value
outstanding.
MILESTONE SCIENTIFIC INC
INDEX
PART I FINANCIAL INFORMATION |
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PART II OTHER INFORMATION |
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CERTIFICATIONS |
||||||||
EX-31.1: CERTIFICATION | ||||||||
EX-31.2: CERTIFICATION | ||||||||
EX-32.1: CERTIFICATION | ||||||||
EX-32.2: CERTIFICATION |
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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 and Section 21E of 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 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.
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ITEM 1. FINANCIAL STATEMENTS
MILESTONE SCIENTIFIC INC.
CONDENSED BALANCE SHEETS
March 31, 2008 | December 31, 2007 | |||||||
(Unaudited) | ||||||||
ASSETS |
||||||||
Current Assets: |
||||||||
Cash and cash equivalents |
$ | 237,716 | $ | 745,003 | ||||
Accounts receivable , net of allowance for doubtful accounts of $5,000
in 2008 and 2007 |
344,348 | 346,347 | ||||||
Royalty receivable |
14,163 | 15,358 | ||||||
Inventories |
1,338,572 | 1,636,744 | ||||||
Advances to contract manufacturer |
1,193,551 | 1,192,584 | ||||||
Prepaid expenses |
204,717 | 169,727 | ||||||
Total current assets |
3,333,067 | 4,105,763 | ||||||
Investment in distributor, at cost |
76,319 | 76,319 | ||||||
Equipment, net of accumulated depreciation of $302,885 as of March 31, 2008
and $284,145 as of December 31, 2007 |
204,999 | 220,808 | ||||||
Patents, net of accumulated amortization of $90,441 of March 31, 2008
and $79,498 as of December 31, 2007 |
645,193 | 559,378 | ||||||
Other assets |
24,551 | 27,297 | ||||||
Total assets |
$ | 4,284,129 | $ | 4,989,565 | ||||
LIABILITIES AND STOCKHOLDERS EQUITY |
||||||||
Current Liabilities: |
||||||||
Accounts payable |
$ | 1,466,302 | $ | 1,855,835 | ||||
Accrued expenses |
285,300 | 201,103 | ||||||
Deferred compensation payable to officers |
30,376 | 15,833 | ||||||
Total current liabilities |
1,781,978 | 2,072,771 | ||||||
Long-term Liabilities: |
||||||||
Accounts payable-long term |
| $ | 443,847 | |||||
Line of credit-net of discount of $59,242 and $65,371, respectively |
940,758 | 934,629 | ||||||
Total long-term liabilities |
940,758 | 1,378,476 | ||||||
Commitments and Contingencies |
||||||||
Stockholders Equity |
||||||||
Common stock, par value $.001; authorized 50,000,000 shares; 12,119,143 shares issued
504,639 shares to be issued, and 12,085,810 shares outstanding in 2008; 11,787,572
shares issued, 421,306 shares to be issued, and 11,754,239 shares outstanding in 2007 |
12,625 | 12,210 | ||||||
Additional paid-in capital |
59,122,084 | 58,483,539 | ||||||
Accumulated deficit |
(56,661,800 | ) | (56,045,915 | ) | ||||
Treasury stock, at cost, 33,333 shares |
(911,516 | ) | (911,516 | ) | ||||
Total stockholders equity |
1,561,393 | 1,538,318 | ||||||
Total liabilities and stockholders equity |
$ | 4,284,129 | $ | 4,989,565 | ||||
See Notes to Condensed Financial Statements
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MILESTONE SCIENTIFIC INC.
CONDENSED STATEMENTS OF OPERATIONS
(Unaudited)
Three Months Ended March 31, | ||||||||
2008 | 2007 | |||||||
Product sales, net |
$ | 1,387,990 | $ | 2,262,027 | ||||
Royalty income |
14,163 | 47,936 | ||||||
Total revenue |
1,402,153 | 2,309,963 | ||||||
Cost of products sold |
463,924 | 831,210 | ||||||
Royalty expense |
| 5,752 | ||||||
Total cost of revenue |
463,924 | 836,962 | ||||||
Gross profit |
938,229 | 1,473,001 | ||||||
Selling, general and administrative expenses |
1,471,978 | 1,836,888 | ||||||
Research and development expenses |
48,319 | 178,566 | ||||||
Total operating expenses |
1,520,297 | 2,015,454 | ||||||
Loss from operations |
(582,068 | ) | (542,453 | ) | ||||
Interest expense |
(30,924 | ) | | |||||
Interest-Amortization of debt issuance |
(6,129 | ) | | |||||
Interest income |
3,236 | 7,336 | ||||||
Net loss applicable to common stockholders |
$ | (615,885 | ) | $ | (535,117 | ) | ||
Loss per share applicable to common stockholders -
basic and diluted |
$ | (0.05 | ) | $ | (0.05 | ) | ||
Weighted average shares outstanding and to be issued -
basic and diluted |
12,262,256 | 11,958,098 | ||||||
See Notes to Condensed Financial Statements
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MILESTONE SCIENTIFIC INC.
CONDENSED STATEMENT OF CHANGES IN STOCKHOLDERS EQUITY
THREE MONTHS ENDED MARCH 31, 2008
(Unaudited)
Additional | ||||||||||||||||||||||||
Common Stock | Paid-in | Accumulated | Treasury | |||||||||||||||||||||
Shares | Amount | Capital | Deficit | Stock | Total | |||||||||||||||||||
Balance, January 1, 2008 |
12,208,878 | $ | 12,210 | $ | 58,483,539 | $ | (56,045,915 | ) | $ | (911,516 | ) | $ | 1,538,318 | |||||||||||
Options issued to employees and consultants |
| | 34,281 | 34,281 | ||||||||||||||||||||
Common stock issued for payment of services |
156,448 | 157 | 262,591 | 262,748 | ||||||||||||||||||||
Common stock issued for payment of
consulting services |
165,780 | 166 | 225,933 | 226,099 | ||||||||||||||||||||
Common stock issued for payment of
employee compensation |
9,314 | 9 | 15,823 | 15,832 | ||||||||||||||||||||
Common stock to be issued for settlement of
deferred compensation |
83,333 | 83 | 99,917 | 100,000 | ||||||||||||||||||||
Net loss |
(615,885 | ) | (615,885 | ) | ||||||||||||||||||||
Balance, March 31, 2008 |
12,623,753 | $ | 12,625 | $ | 59,122,084 | $ | (56,661,800 | ) | $ | (911,516 | ) | $ | 1,561,393 | |||||||||||
See Notes to Condensed Financial Statements
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MILESTONE SCIENTIFIC INC.
CONDENSED STATEMENTS OF CASH FLOWS (Unaudited)
THREE MONTHS ENDED MARCH 31, | ||||||||
2008 | 2007 | |||||||
Cash flows from operating activities: |
||||||||
Net loss |
$ | (615,885 | ) | $ | (535,117 | ) | ||
Adjustments to reconcile net loss to net cash used in operating activities: |
||||||||
Depreciation expense |
18,740 | 24,853 | ||||||
Amortization of patents |
10,943 | 5,712 | ||||||
Amortization of debt discount |
6,129 | | ||||||
Common stock and options issued for compensation, consulting
and vendor services |
638,960 | 283,501 | ||||||
Bad debt expense |
| 5,688 | ||||||
Changes in operating assets and liabilities: |
||||||||
Decrease (increase) in accounts receivable |
1,999 | (1,073,202 | ) | |||||
Decrease in royalty receivable |
1,195 | 12,171 | ||||||
Decrease in inventories |
298,172 | 98,926 | ||||||
Increase to advances to contract manufacturer |
(967 | ) | (19,064 | ) | ||||
(Increase) to prepaid expenses and other current assets |
(34,990 | ) | (25,485 | ) | ||||
Decrease in other assets |
2,746 | 947 | ||||||
(Decrease) increase in accounts payable |
(833,380 | ) | 265,914 | |||||
Increase in accrued expenses |
84,197 | 217,059 | ||||||
Increase in deferred compensation |
14,543 | 44,497 | ||||||
Net cash used in operating activities |
(407,598 | ) | (693,600 | ) | ||||
Cash flows from investing activities: |
||||||||
Purchases of property and equipment |
(2,931 | ) | (15,314 | ) | ||||
Payment for patents rights |
(96,758 | ) | | |||||
Net cash used in investing activities |
(99,689 | ) | (15,314 | ) | ||||
NET DECREASE IN CASH AND CASH EQUIVALENTS |
(507,287 | ) | (708,914 | ) | ||||
Cash and cash equivalents at beginning of period |
745,003 | 1,160,116 | ||||||
Cash and cash equivalents at end of period |
$ | 237,716 | $ | 451,202 | ||||
Supplemental disclosure of cash flow information: |
||||||||
Interest expense paid in cash |
| | ||||||
Income taxes paid |
$ | 3,140 | |
See Notes to Condensed Financial Statements
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MILESTONE SCIENTIFIC INC.
NOTES TO FINANCIAL STATEMENTS
(UNAUDITED)
(UNAUDITED)
NOTE A ORGANIZATION, BUSINESS AND BASIS OF PRESENTATION
Milestone Scientific Inc. (Milestone) was incorporated in the State of Delaware in August 1989.
The unaudited financial statements of Milestone Scientific Inc. (the Company) 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, 2007 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, 2007 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, 2008 and December 31, 2007 and the results of its operations for
the three months ended March 31, 2008 and 2007.
The results reported for the three months ended March 31, 2008 are not necessarily indicative of
the results of operations which may be expected for a full year.
The Company has incurred operating losses and negative cash flows from operating activities since
its inception, including a net loss of $615,885 and $535,117 for the three months ended March 31,
2008 and 2007, respectively. At March 31, 2008, the Company had cash and cash equivalents and
working capital of $237,716 and $1,551,089, respectively. Additionally, as discussed in Note B-10,
on June 28, 2007, the Company secured a revolving line of credit in the aggregate amount of
$1,000,000 from a stockholder which line was fully borrowed at December 31, 2007. The Line of
Credit subsequent to March 31, 2008 was increased by $300,000 to $1,300,000. All terms and
conditions remain unchanged. The Company is actively pursuing the generation 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; however, the
Company does not now have sufficient cash reserves to meet all of its anticipated obligations for
the next twelve months. The Company anticipates the need for a higher level of marketing and sales
efforts that at present it cannot fund. If the Company is unable to generate positive cash flows
from its operating activities it will need to raise additional capital. There is no assurance that
the Company will be able to achieve positive operating cash flows or that traditional capital can
be raised on terms and conditions satisfactory to the Company, if at all. If additional capital is
required and it cannot be raised, then the Company would be forced to curtail its development
activities, reduce marketing expenses for existing dental products or adopt other cost saving
measures, any of which might negatively affect the 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
adjustments that might result from the outcome of this uncertainty.
On November 6, 2007 Milestone entered into a Collaboration Agreement (the Agreement) with a
global diversified healthcare company (the Collaborator) to conduct a feasibility study to
evaluate the potential application of Milestones proprietary CompuFlo Injection System for
injecting medicaments. The name of the company is not provided pursuant to the confidentiality
provisions in the Agreement. Under the terms of the Agreement, Milestone will provide, at no cost
to the Collaborator, a mutually agreed quantity of CompuFlo Injection Systems and training on
proper operation of the
systems for use in the feasibility study. All other costs and expenses associated with the
feasibility study will be the
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responsibility of the Collaborator. The Collaborator may terminate
the Agreement at any time upon at least ten (10) days prior written notice to Milestone, provided
that the Collaborator shall be responsible for any reasonable, non-cancelable costs and expenses
incurred by Milestone or its approved subcontractors prior to the date of termination. There can be
no assurance that the feasibility study will be successfully concluded or, if successfully
concluded, that it will lead to any further agreements with the Collaborator for their use of
Milestones technology or products.
NOTE B SUMMARY OF ACCOUNTING POLICIES
1. Cash and Cash Equivalents
Milestone considers all highly liquid investments purchased with a maturity of three months or less
to be cash equivalents.
2. Inventories
Inventories principally consist of finished goods and component parts stated at the lower of cost
(first-in, first-out method) or market.
3. 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
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.
4. Revenue Recognition
Revenue from product sales is recognized net of discounts and allowances to our domestic
distributor on the date of arrival of the goods at the customers location as shipments are FOB
destination. Shipments to our international distributors are FOB our warehouse and revenue is
therefore recognized on shipment. In both cases, the price to the buyer is fixed and the
collectability is reasonably assured. Further, we have no obligation on these sales for any post
sale installation, set-up or maintenance, these being the responsibility of the buyer. Customer
acceptance is considered made at delivery. Our only obligation after sale is the normal commercial
warranty against manufacturing defects if the alleged defective unit is returned within the
warranty period.
Royalty income is recognized as earned based on reports received from the licensee and related
royalty expense is accrued during the same period.
5. Basic and diluted net loss per common share
Milestone presents basic earnings (loss) per common share applicable to common stockholders and,
if applicable, diluted earnings (loss) per common share applicable to common stockholders
pursuant to the provisions of Statement of Financial Accounting Standards No. 128, Earnings per
Share (SFAS 128). 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, warrants, and
the conversion of preferred stock were issued during the period.
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Since Milestone had net losses for the three months ended March 31, 2008 and 2007, the assumed
effects of the exercise of outstanding stock options and warrants were not included in the
calculation as their effect would have been anti-dilutive. Such outstanding options and warrants
totaled 3,343,746 at March 31, 2008 and 3,644,920 at March 31, 2007.
6. 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.
7 Stock Option Plans
Effective January 1, 2006 Milestone adopted SFAS No. 123R, Share-Based Payment, an Amendment of
FASB Statement No. 123 (SFAS No. 123R), under the modified-prospective transition method whereby
prior periods will not be restated for comparability. SFAS No. 123R requires all share-based
payments to employees, including grants of employee stock options, to be recognized in the
statements of operations over the service period, as an operating expense, based on the grant-date
fair values. Pro-forma disclosure is no longer an alternative. As a result of adopting SFAS No.
123R, Milestone recognizes as compensation expense in its financial statements the unvested portion
of existing options granted prior to the effective date and the cost of stock options granted to
employees after the effective date based on the fair value of the stock options at grant date.
Prior to the adoption of SFAS No. 123R, Milestone accounted for its stock option plans using the
intrinsic value method of accounting prescribed by APB Opinion No. 25.
A summary of option activity for employees under the plans as of March 31, 2008, 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, 2008 |
391,334 | 1.86 | 2.54 | $ | 108,800 | |||||||||||
Granted |
33,333 | 1.15 | 4.86 | | ||||||||||||
Exercised |
| | | | ||||||||||||
Forfeited or expired |
(36,334 | ) | 1.20 | | | |||||||||||
Outstanding, March 31, 2008 |
388,333 | 1.86 | 3.01 | | ||||||||||||
Exercisable, March 31, 2008 |
293,111 | 2.00 | 2.61 | |
The weighted average grant date fair value of options granted to employees during the three months
ended March 31, 2008 was $1.15. The fair value of the options was estimated on the date of grant
using the Black-Scholes option pricing model with the following weighted average assumptions:
expected life three years, volatility of 285% and a risk free interest rate of 3.77%.
Milestone recognizes compensation expense on a straight line basis over the requisite service
period. During the three months ended March 31, 2008, Milestone recognized $20,729 of total
compensation cost related to options that vested during the period. As of March 31, 2008, there was
$47,897 of total unrecognized compensation cost related to non-vested options which Milestone
expects to recognize over a weighted average period of two and three quarter years.
As of March 31, 2008, the Fair Market Value of the Companys stock was less than the exercise price
of the options, therefore there is no aggregate intrinsic value calculated.
A summary of option activity for non-employees under the plans as of March 31, 2008 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, 2008 |
639,133 | 3.15 | 2.56 | $ | 20,667 | |||||||||||
Granted |
| | | | ||||||||||||
Exercised |
| | | | ||||||||||||
Forfeited or expired |
(11,666 | ) | | | | |||||||||||
Outstanding, March 31, 2008 |
627,467 | 3.14 | 2.36 | | ||||||||||||
Exercisable, March 31, 2008 |
502,467 | 3.48 | 1.99 | |
During the three months ended March 31, 2008, Milestone recognized $13,552 of expenses related to
non-employee options that vested during the year. The total unrecognized compensation cost related
to non-vested options was $100,137 as of March 31, 2008.
As of March 31, 2008, the Fair Market Value of the Companys stock was less than the exercised
price of the options, therefore, there was no aggregate intrinsic value calculated.
In accordance with the provisions of SFAS No.123R, all other issuances of common stock, stock
options or other equity instruments to non-employees as consideration for goods or services
received by Milestone are accounted for based on the fair value of the equity instruments issued
(unless the fair value of the consideration received can be more reliably measured). The fair value
of any options or similar equity instruments issued is estimated based on the Black-Scholes
option-pricing model, which meets the criteria set forth in SFAS No. 123, and the assumption that
all of the options or other equity instruments will ultimately vest. Such fair value is measured as
of an appropriate date pursuant to the guidance in the consensus of the Emerging Issues Task Force
(EITF) for EITF Issue No. 96-18 (generally, the earlier of the date the other party becomes
committed to provide goods or services or the date performance by the other party is complete) and
capitalized or expensed as if Milestone had paid cash for the goods or services.
Expected volatilities are based on historical volatility of Milestones common stock over a period
commensurate with expected term. Milestone uses historical data to estimate option exercise and
employee termination within the valuation model. The expected term of the options granted was
estimated using the simplified method as the average of the contractual term and vesting term of
the option.
8. 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 units of CompuDent. As part of this
agreement, Milestone has advanced approximately $1.2 million to the vendor for purchase of
materials at March 31, 2008. 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 at March 31, 2008.
Milestone closely monitors the extension of credit to its customers while maintaining allowances,
if necessary, for potential credit losses. On a periodic basis, Milestone evaluates its accounts
receivable and establishes an allowance for doubtful accounts, based on a history of past
write-offs and collections and current credit conditions. Management does not believe that
significant credit risk exists with respect to accounts receivable at March 31, 2008.
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9. Recent Accounting Pronouncements
In September 2006, the FASB issued SFAS No. 157, Fair Value Measurements. This new standard
defines fair value, establishes a framework for measuring fair value in generally accepted
accounting principles and expands disclosures about fair value measurements. This statement does
not require any new fair value measurements but provides guidance in determining fair value
measurements presently used in the preparation of financial statements. This new standard is
effective for financial statements issued for fiscal years beginning after November 15, 2007. This
Standard was adopted as of January 1, 2008 and did not have a significant impact on Milestones
results of operations or financial position.
In February 2007, the Financial Accounting Standards Board (FASB) issued SFAS No.159, The Fair
Value Option for Financial Assets and Financial Liabilities Including an amendment of FASB
Statement No. 115. SFAS No.159 permits entities to choose to measure many financial instruments
and certain other items at fair value. The objective is to improve financial reporting by providing
entities with the opportunity to mitigate volatility in reported earnings caused by measuring
related assets and liabilities differently without having to apply complex hedge accounting
provisions. SFAS No.159 is effective as of the first fiscal year that begins after November 15,
2007. This Standard was adopted as of January 1, 2008, and did not have any impact on Milestones
results of operations or financial position.
In December 2007, the Financial Accounting Standards Board (FASB) issued SFAS No.141 (revised),
Summary No. 141 (revised 2007). SFAS No.141 (revised) provides for improving the relevance,
representational faithfulness, and comparability of the information that an entity provides in its
financial reports about a business combination and its effects. SFAS No.141 (revised) applies
prospectively to business combinations for which the acquisition date is on or after December 15,
2008. Milestone is considering the impact of this Statement on its financial statements.
In December 2007, the Financial Accounting Standards Board (FASB) issued SFAS No.160,
Non-controlling Interest in Consolidated Financial Statements- and amendment of ARB No. 51.
SFAS No.160 establishes accounting and reporting standards for non-controlling interests, sometimes
called minority interests, the portion of equity in a subsidiary not attributable, directly or
indirectly, to a parent. SFAS No.160 is effective for fiscal years, and interim periods within
those fiscal years, beginning after December 15, 2008. Milestone will consider the impact of this
Statement in 2009.
10. Line of credit
On June 28, 2007 the Company secured a $1 million line of credit from a stockholder. Borrowings
bear interest at 6% per annum, with one years interest at 1% payable in advance on each draw.
Borrowings and subsequent repayments may be made from time to time, in increments of $100,000,
until the expiration date for borrowing under the line of credit on December 31, 2008. All
borrowings and interest thereon must be repaid by June 30, 2010, and after the expiration date of
the line, may be repaid by Milestone in cash or, at its option, in shares of common stock valued at
the lower of $2.00 per share or 80% of the average closing price of its shares during the 20 days
ending with December 31, 2008. After December 31, 2008, and before June 30, 2010 the lender may
convert all or any part of the then outstanding balance and interest thereon into shares of Common
Stock at $4.00 per share. Three year warrants exercisable at $5.00 per share, in an amount
determined by dividing 50% of the amount borrowed by $5.00 will be issued on each drawdown. There
is no facility fee on the line. The warrants have been valued as of each draw down using the
Black-Scholes model and are reflected as a discount against the debt incurred under this line of
credit. At March 31, 2008 the remaining balance of Debt Discount was $59,242. The full amount of
the line of credit, $1 million, has been drawn at December 31, 2007. Interest expense on this Line
of Credit for the three months ended March 31, 2008 is $30,923. Additionally, the charge for
amortization of Debt Discount related to this Line of Credit is $6,129.
Subsequent to March 31, 2008, the above line of credit was increased by $300,000 to $1,300,000. All
term and conditions remain unchanged.
11. Significant customers
During the three months ended March 31, 2008 and 2007, Milestone had two customers (distributors)
who in the aggregate accounted for approximately 93% and 59% respectively, of its net product sales
for the three months ended March 31, 2008 and 2007. Milestone had sales to one customer (a
worldwide distributor of Milestones products based in South Africa) of approximately $255,311.
This represented 18% of the total net product sales for the three months ended March 31, 2008.
Accounts receivable from these two customers amounted to approximately $336,905 and $1,290,714
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representing 98% and 91% of gross accounts receivable for the three months ended March 31, 2008 and
2007, respectively.
Milestones sales by product and by geographical region are as follows:
Three Months Ended March 31, | ||||||||
2008 | 2007 | |||||||
CompuDent |
$ | 134,189 | $ | 338,307 | ||||
STA Units |
85,016 | 632,309 | ||||||
Handpieces |
1,141,750 | 1,203,932 | ||||||
STA Handpieces |
34,641 | 20,545 | ||||||
Other |
(7,606 | ) | 66,934 | |||||
$ | 1,387,990 | $ | 2,262,027 | |||||
United States |
$ | 897,715 | $ | 1,904,344 | ||||
Canada |
160,322 | 148,978 | ||||||
Other Foreign |
329,953 | 208,705 | ||||||
$ | 1,387,990 | $ | 2,262,027 | |||||
In January 2007, Milestone finalized an Exclusive Distribution and Supply Agreement with Henry
Schein, Inc. Henry Schein, Inc. will serve as the exclusive distributor of STA and CompuDent
systems (and ancillary products) in both North America and Canada, for a one year period. The
exclusive period has expired and the Company is considering alternative marketing and distribution
strategies that we believe will help us to accelerate and drive sales momentum.
The Company has informal arrangements with the manufacturer of our STA, CompuDent and CompuMed
units, one of the principal manufacturers of our handpieces and for those units pursuant to which
they manufacture these products under specific purchase orders but without any long-term contract
or minimum purchase commitment. The Company has a manufacturing agreement with one of the principal
manufacturers of our handpieces pursuant to which they manufacture products under specific purchase
orders but without minimum purchase commitments. The Company has established an alternate source of
supply for our handpieces in China and other alternate sources of supply exist.
12. Commitments and Other
Contract Manufacturing Arrangement
Milestone has informal arrangements for the manufacture of its products. CompuDent and CompuMed
units are manufactured for Milestone by Tricor Systems, Inc. pursuant to specific purchase orders.
The Wand disposable handpiece is manufactured for Milestone in Mexico pursuant to scheduled
production requirements. The Wand Handpiece with Needle is supplied to Milestone by the licensee of
Milestones proprietary consumer dental whitening product, which 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.
Other Commitments
Milestone acquired the technology underlying our CoolBlue Professional Whitening and Ionic White
Consumer Whitening Products. Under the terms of a licensing agreement with a third party
manufacturer, we will receive licensing
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fees resulting from the sales of the consumer whitening
product. Through December 31, 2006, Milestone paid royalties in connection with the tooth whitening
products to a purported holder of patent rights therein. Late in 2006 Milestone received a copy of
a patent office filing which appeared to show that the purported owner had relinquished rights to
the patent on which royalties had been paid. It is possible that, never-the-less, the purported
owner may claim continuing rights to receive royalties or that others may claim that payments are
owed in connection with Milestones prior sales.
Milestone has continued to accrue royalties due but has ceased making cash payments. In 2007,
Milestone stopped the sale of this product in the United States and has written off the cost of
patents relating to this product.
On August 24, 2007 Milestone commenced a Declaratory Judgment Action against Milton Hodosh, DMD in
the United States District Court for the District of New Jersey seeking a determination by that
Court that neither its Single Tooth Anesthesia (STA) System nor its CompuDent system infringed
claims set forth in United States Patent No. 6159161 by Dr. Hodosh on July 8, 1998 and issued by
the United States Patent Office on December 12, 2000. Milestones basic patents covering these
systems were issued by the United States Patent Office in January 1993. Subsequent to the
commencement of Milestones action for Declaratory Judgment, Dr. Hodosh commenced a patent
infringement suit in the United States District Court for the Southern District of New York.
Milestone has received opinions from patent counsel, not involved in the litigation, to the effect
that neither the STA System nor the CompuDent systems infringe any of the claims of Dr. Hodoshs
patents. Milestone believes that it has meritorious defenses to Dr. Hodoshs action and it intends
to vigorously defend this law suit. The case is currently in the discovery phase.
Subsequent Events
Subsequent to March 31, 2008, the line of credit from a stockholder was increased by $300,000 to
$1,300,000. All terms and conditions remain unchanged.
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ITEM 2. Managements Discussion and Analysis and Plan of Operation.
The following discussions of our financial condition and results of operations should be read
in conjunction with the financial statements and the notes to those statements included elsewhere
in this Form 10-Q. Certain statements in this discussion and elsewhere in this report constitute
forward-looking statements, within the meaning of section 21E of the Exchange Act, that involve
risks and uncertainties. Our actual results may differ materially from those anticipated in these
forward-looking statements. See Risk Factors on Part II. ITEM 1A of this Form 10-Q.
OVERVIEW
During the first quarter of 2008, we continued to focus our efforts on executing a long-term growth
strategy that is specifically designed to:
| optimize our tactical approach to product sales and marketing in order to increase penetration of the global dental and medical markets with our proprietary, patented Computer-Controlled Local Anesthesia Delivery (CCLAD) solutions; and | ||
| identify and pursue strategic collaborations with third parties to jointly develop new products utilizing our CompuFlo pressure force technology for novel, new dental and medical applications. |
In order to achieve the goals and objectives of the Company, it is essential that we have the
best people possible. In September of 2007 Robert (Bob) Presutti joined Milestone as the Vice
President of Sales and Marketing. Bob has assembled a sales and marketing team that is having a
positive impact on optimizing our sales and marketing strategies, and is developing innovative
tactics and action plans to achieve those strategies. In January of 2008, Joseph DAgostino
joined Milestone as the Acting Chief Financial Officer. Joseph has skills, talents and experience
that is necessary to help Milestone grow and develop in all areas of operations. He, too, has had a
very positive impact on our business.
In February 2007, the STA System 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.
Following considerable media attention in the national, business and trade press, STA product
shipments commenced in late March 2007.
Unfortunately, the anticipated sales ramp-up for the instrument did not meet our initial
expectations. Consequently, Milestone conducted a comprehensive market research study to closely
evaluate product perception and pricing, and to reassess our product messaging and tactical
approach to the dental community. The study involved surveying early STA System adopters,
prospective customers and industry thought leaders.
What we learned from our market research is that we have not properly communicated to the
dental community that the STA System can be used for ALL injections, not only the Single Tooth
Anesthesia, or periodontal intraligamentary (PDL), injection. As a result, the instruments value
proposition was not being optimized. Our research also confirmed that when giving injections using
hypodermic syringes to patients, many, if not most, dentists experience a similar level of fear,
stress and discomfort as the patient undergoing the actual treatment. However, according to Marty
Jablow, DMD, a dental practitioner in Woodbridge, New Jersey, The STA System allows me to begin
every injection technique with significantly less stress for me and the patient.
In late November 2007, we implemented a refined messaging platform that is helping us position
the products and its utility by dental practitioners. Further, with the addition of a new Director
of Marketing, Scott Mahnken, who joined the marketing team in February of this year, Milestone has
been implementing specific action plans to get its clarified message out to the market.
Additionally, we have made pricing adjustments to the STA System that align with the perceived
market value. At the Chicago Dental Societys 143rd Midwinter Meeting, held in late
February 2008, traffic through both Milestones and Henry Scheins exhibit areas remained highly
fluid and resulted in a significant number of STA Systems being sold to attendees over the three
day event, contributing to record STA System purchases by dentists during the month of February
2008.
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To perpetuate our progress and instigate further discussion and analysis of our marketing
strategies on a going forward basis, we hosted the First International Computer-Controlled Local
Anesthetic Delivery (CCLAD) Summit in New Orleans in early February 2008. The Summit welcomed a
distinguished panel of dental experts who gathered to discuss advancements in the scientific and
clinical practice communities toward the common goal of advancing the science, knowledge and
clinical utility of CCLAD in dentistry. This highly productive and interactive forum yielded a
number of compelling suggestions and recommendations from the panel on the clinical value and
practical utility of the STA System to the dental community.
The management teams at Milestone and our primary distributor in the U.S. and Canada,
recognize that we have not had the appropriate sales focus, or the market attention to drive a
successful new domestic product launch. Nonetheless, the STA System has performed extremely well in
the field. Based on our new customer surveying, those dentists who have acquired and now use the
instrument, are both impressed and satisfied with its performance and user benefits. Consequently,
we are engaged in alternative marketing and distribution strategies that we believe will help us
accelerate and drive the sales momentum in 2008
The STA System continues to be recognized by leading industry publications as one of the best
dental innovations. In April 2008, the Medical Device & Diagnostic Industry (MD&DI) magazine
distinguished the STA System as a winner of the 2008 Medical Design Excellence Award (MDEA) in the
dental instruments, equipment and supplies product category. Of the 33 products to receive an
MDEA this year, Milestones STA System was one of only two winning products that serve dental
practitioners. In July 2007, noted industry publication Dentistry Today featured the STA System as
one of the Top 100 Products in 2007.
In June of 2007, Milestone was granted a CE Mark approval of the STA System, which in turn
triggered our preparation for introducing the instrument to dental professionals in European Union
countries and other countries around the world that recognize the CE Mark approval process. In
collaboration with our international distribution partners, we anticipate formally launching the
sales and marketing of the STA System in South Africa in May 2008 and in selected European
countries beginning in the summer of 2008.
Following clearance of the 510(k) Pre-market Notification for the sale and marketing of our
patented CompuFlo technology, which we received from the U.S. Food and Drug Administration in July
2006, Milestone commissioned an in-depth, independent market study. Together, they provide clients
in the life science industries with single-source access to a full range of marketing services,
from analysis through complete strategic implementation. Tasked with identifying practical industry
applications using our CompuFlo technology platform. The study concluded that applications for
CompuFlo exceeded 700, including both medical and extra-medical uses.
In March 2007, Milestone signed a collaborative agreement with an Atlanta-based company
developing and commercializing advanced medical instrument technology for the minimally-invasive
treatment of cartilage damage and osteoarthritis. At that time, the companies agreed to
collaborate, at our collaborators expense, on the development of a specialized injection system
using Milestones CompuFlo technology to painlessly inject the collaborators proprietary products
in the intra-articular joint space. Animal studies performed under the Collaboration Agreement
demonstrated to our collaborators satisfaction that the prototype could meet its predetermined
performance benchmarks, leading us to commence negotiations for the development of a commercial
product and for a Distribution Agreement between our companies. However, we did not prove
successful in reaching an agreement and consequently, in September 2007, it was decided to
terminate negotiations.
In November 2007, we entered into a collaborative agreement with a globally diversified
healthcare company to conduct a feasibility study evaluating the potential application of our
CompuFlo technology for injecting certain medicaments produced by this company. We have completed
the initial study and are now hoping to leverage its findings to progress strategic discussions and
explore product development opportunities with the company.
Our focus in 2008 has and will continue to be largely centered on increasing sales of the STA
System, both domestically and internationally, as well as supporting sales of our legacy CCLAD
system, CompuDent and driving recurring orders of the disposable hand pieces used in conjunction
with both instruments. The challenge going forward will be leveraging creative and tactical
advertising and proactive marketing strategies to spread the right message about the STA System
to each and every dentist.
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As we continue to advance through 2008, Milestone will persist in identifying and pursuing
opportunities for only those applications for CompuFlo that have been deemed by management as the
most promising and viable and have the greatest potential for near term strategic alliances and
revenue contribution, with specific emphasis on new medical applications for the home market for
self administrated drugs, injections for osteoarthritis and epidurals.
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, | ||||||||||||||||
2008 | 2007 | |||||||||||||||
DOMESTIC |
||||||||||||||||
CompuDent |
$ | 65,570 | 7.3 | % | $ | 287,227 | 15.1 | % | ||||||||
STA units |
15,574 | 1.7 | % | 632,309 | 0.0 | % | ||||||||||
Handpieces |
793,818 | 88.4 | % | 911,971 | 82.2 | % | ||||||||||
STA handpieces |
31,091 | 3.5 | % | 20,545 | 0.0 | % | ||||||||||
Other |
(8,338 | ) | -0.9 | % | 52,292 | 2.7 | % | |||||||||
Total Domestic |
$ | 897,715 | 100.0 | % | $ | 1,904,344 | 100.0 | % | ||||||||
INTERNATIONAL |
||||||||||||||||
CompuDent |
$ | 68,619 | 14.0 | % | $ | 51,080 | 14.3 | % | ||||||||
STA units |
69,442 | 14.2 | % | | 0.0 | % | ||||||||||
Handpieces |
347,932 | 71.0 | % | 291,961 | 81.6 | % | ||||||||||
STA handpieces |
3,550 | 0.7 | % | 0 | 0.0 | % | ||||||||||
Other |
732 | 0.1 | % | 14,642 | 4.1 | % | ||||||||||
Total International |
$ | 490,275 | 100.0 | % | $ | 357,683 | 100.0 | % | ||||||||
DOMESTIC/INTERNATIONAL ANALYSIS |
||||||||||||||||
Domestic |
$ | 897,715 | 64.7 | % | $ | 1,904,344 | 84.2 | % | ||||||||
International |
490,275 | 35.3 | % | 357,683 | 15.8 | % | ||||||||||
Total Product Sales |
$ | 1,387,990 | 100.0 | % | $ | 2,262,027 | 100.0 | % | ||||||||
The Company earned gross profits of 67% and 64% in for the three months ended March 31, 2008
and 2007, 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 2008, these amounts will vary
based on the operating results for each quarter. The Company has incurred operating losses and
negative cash flows from operating activities since its inception. The Company is actively pursuing
the generation of positive cash flows from operating activities through increase in revenue,
assessment of current contracts and current negotiations and reduction in operating expenses;
however the Company does not have sufficient cash reserves to meet all of its anticipated
obligations for the next twelve months.
Technology Rights
The technology underlying our SafetyWand and CompuFlo technology and an improvement to the
controls for CompuDent were developed by our Director of Clinical Affairs and assigned to us. We
purchased this technology pursuant to an agreement dated January 1, 2005, for 43,424 shares of
restricted common stock and $145,000 in cash, paid on April 1, 2005. In addition, our Director of
Clinical Affairs will receive additional deferred contingent payments of 2.5% of our total sales of
products using some of these technologies, and 5% of our total sales of products using some of our
other technologies. If products produced by third parties use any of these technologies, under a
license from Milestone, then he will also receive the corresponding percentage of the consideration
received by us for such sale or license.
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 U.S.. 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,
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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. See NOTE B. ITEM 1.
FINANCIAL STATEMENTS
Accounts Receivable
The realization of Accounts Receivable 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 is 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.
Revenue Recognition
Revenue from product sales is recognized net of discounts and allowances to our domestic
distributor on the date of arrival of the goods at the customers location as shipments are FOB
destination. Shipments to our international distributor are FOB our warehouse and revenue is
therefore recognized on shipment. In both cases the price to the buyer is fixed and the
collectability is reasonably assured. Further, we have no obligation on these sales for any post
installation, set-up or maintenance, these being the responsibility of the buyer. Customer
acceptance is considered made at delivery. Our only obligation after sale is the normal commercial
warranty against manufacturing defects if the alleged defective unit is returned within the
warranty period.
Royalty income is recognized as earned based on reports received from the licensee and related
royalty expense is accrued during the same period.
Use of Estimates
The preparation of financial statements in conformity with accounting principles generally
accepted in the United States of America requires management to make estimates and assumptions in
determining the reported amounts of assets and liabilities and disclosure of contingent assets and
liabilities at the date of the financial statements and reported amounts of revenues and expenses
during the reporting period. The most significant estimates relate to the allowance for doubtful
accounts, inventory valuation, cash flow assumptions regarding evaluations for impairment of
long-lived assets and valuation allowances on deferred tax assets. Actual results could differ from
those estimates.
Results of Operations
The consolidated results of operations for the three months ended March 31, 2008 compared to
the same three month period in 2007 reflect our focus and development into the STA System delivery
system, as well continuing efforts on the CompuFlo technology.
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.
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Three Months Ended March 31 | ||||||||||||||||
2008 | 2007 | |||||||||||||||
Products sales, net |
$ | 1,387,990 | 99 | % | $ | 2,262,027 | 98 | % | ||||||||
Royalty income |
14,163 | 1 | % | 47,936 | 2 | % | ||||||||||
Total revenue |
1,402,153 | 100 | % | $ | 2,309,963 | 100 | % | |||||||||
Cost of products sold |
463,924 | 33 | % | 831,210 | 36 | % | ||||||||||
Royalty expense |
| | 5,752 | 0 | % | |||||||||||
Total cost of revenue |
463,924 | 33 | % | 836,962 | 36 | % | ||||||||||
Gross Profit |
938,229 | 67 | % | 1,473,001 | 64 | % | ||||||||||
Selling, general and
administrative expenses |
1,471,978 | 105 | % | 1,836,888 | 79 | % | ||||||||||
Research and
development expenses |
48,319 | 3 | % | 178,566 | 8 | % | ||||||||||
Total operating expenses |
1,520,297 | 108 | % | 2,015,454 | 87 | % | ||||||||||
Loss from operations |
(582,068 | ) | -42 | % | (542,453 | ) | -23 | % | ||||||||
Other income interest & expense |
(33,817 | ) | -2 | % | 7,336 | 0 | % | |||||||||
Net loss |
$ | (615,885 | ) | -44 | % | $ | (535,117 | ) | -23 | % | ||||||
Three months ended March 31, 2008 compared to three months ended March 31, 2007
Total revenues for the three months ended March 31, 2008 and 2007 were $1,402,153 (product
sales of $1,387,990 and royalty income of $14,163) and $2,309,963 (product sales of $2,262,027 and
royalty income of $47,936) respectively. The total decrease in product sales of $874,037, 38.6% in
2008 over 2007 is a direct result of the STA product launch in the first quarter of 2007 that did
not continue into 2008 first quarter. The decrease in unit sales of domestic units $848,392, 92.2%
in 2008 over 2007, was due to a lack of sales by our exclusive distributor. In the domestic market,
handpiece sales also were lower by $107,607 or 11.5%, due to a lack of sales performance by our
exclusive distributor. On the international scene, unit sales increased in the first quarter of
2008 over 2007 by $86,981 or 170.3% principally due to the introduction of the STA product.
Internationally, handpieces also increased. The increase in handpieces internationally was $59,521,
20.3% due to an increase in CompuDent handpieces. Other revenue decreased by $74,540 principally
due to a decrease in Cool Blue tooth whitening product base. The Company decided to exit the Cool
Blue business beginning in 2007.
Royalty income resulted from granting United Systems Inc. a license to manufacture, market,
and sublicense the Ionic White to the consumer market. Royalty income for the three months ended
March 31, 2008 and 2007, respectively, was $14,163 and $47,936. The decrease of $33,773 or 70.3%
reflecting increased retail competition in this increasingly highly competitive market.
Cost of products sold for the three months ended March 31, 2008 and 2007 were $463,924 and
$831,210, respectively. The $367,286 or 44.2% decrease is primarily attributable a reduction in
sales volume.
For the three months ended March 31, 2008, Milestone generated a gross profit of $938,229 or
67% as compared to a gross profit of $1,473,001 or 64% for the three months ended March 31, 2007.
The increase in gross profit percentage was due to the launching of the STA System with an
exclusive distributor operational base. The total reduction in gross profit of $534,772 is due to a
reduction in sales volume.
Selling, general and administrative expenses for the three months ended March 31, 2008 and
2007 were $1,471,978 and $1,836,888 respectively. The $364,910 or 20% net decrease spanned several
key areas of the Company. Salaries increased by $124,474 for the three months ended March 31, 2008
over 2007. This increase for the three months ended March 31, 2008 over 2007 was primarily
attributable to the addition of a Chief Executive Officer and a marketing executive along with the
recognition of deferred compensation expense for an officer of the Company. Conversely, the STA
launch in 2007 did not reoccur in the first quarter of 2008. As a result, expenses in this category
in the first quarter of
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2008 decreased by $174,624 principally in marketing, travel, printing and
sample expenses. The new exclusive distributor operating model (initiated in 2007) resulted in a
savings to the Company of $81,348 in 2008 over 2007. Royalty expense for the sale of Milestone
products decreased by $5,752 as a result of fewer units sold during first quarter of 2008
compared to 2007. Professional fees increased by $45,151 in 2008 over 2007, including costs
incurred with a third party for the implementation of Sarbanes Oxley compliance documentation and
testing. Consultant costs increased by approximately $151,479 based on application of SFAS 123 R,
stock based Compensation.
Research and development expenses for the three months ended March 31, 2008 and 2007 were
$48,319 and $178,566, respectively. The decrease of $130,247 was attributable to a reduction in
such cost in 2008 after the launch of STA product in the first quarter of 2007.
The loss from operations for the three months ended March 31, 2008 and 2007 was $582,068 and
$542,453, respectively. The $39,615 or 7.3% increase in loss from operations is explained above.
Interest income of $3,236 was earned for the three months ended March 31, 2008 compared with
$7,336 for the same period in 2007. Interest income declined due to lower cash balances and lower
interest rates.
Interest expense was $37,052 (interest $30,923 and amortization of debt issuance of $6,129),
related to the line of credit established in June 2007 (second quarter).
For the reasons explained above, net loss for the three months ended March 31, 2008 was
$615,885 as compared to a net loss of $535,117 for the three months ended March 31, 2007. The
$80,764 or 15% increase in net loss is primarily a result of the decreased sales and gross margin
dollars, partially benefited by a reduction in selling, general and administrative expenses.
Liquidity and Capital Resources
As of March 31, 2008, we had cash and cash equivalents of $237,716 and working capital of
$1,551,088 Milestone incurred net losses of $615,885 and $535,117 and negative cash flows from
operating activities of $407,598 and $693,600 for the three months ended March 31, 2008 and 2007,
respectively.
For the three months ended March 31, 2008, our net cash used in operating activities was
$507,287. This was attributable primarily to a net loss of $615,885 adjusted for noncash items of
$674,771 and changes in operating assets and liabilities of $466,485, principally common stock and
options issued for compensation, consulting and vendor services.
For the three months ended March 31, 2008, Milestone used $99,689 in investing activities.
This was primarily attributable to $96,758 of legal fees related to new patent application. Capital
expenditures of $2,931 were primarily for the purchase of molds and tooling for new products.
As of March 31, 2008, Milestone, had recorded on the Balance Sheet a $1.0 million Line of
Credit from a stockholder, originally issued in June 2007. The full line was utilized at year end.
Subsequent to March 31, 2008 the line of credit was increased by $300,000 to $1,300,000. All terms
and conditions remained unchanged.
The Company has incurred operating losses and negative cash flows from operating activities
since its inception. The Company is actively pursuing the generation of positive cash flows from
operating activities through increase in revenue based upon managements assessment of present
contracts and current negotiations and reductions in operating expenses; however, the Company does
not have sufficient cash reserves to meet all of its anticipated obligations for the next twelve
months. The Company anticipates the need for a higher level of marketing and sales efforts that at
present it cannot fund. If the Company is unable to generate positive cash flows from its operating
activities it will need to raise additional capital. There is no assurance that the Company will be
able to achieve positive operating cash flows or that traditional capital can be raised on terms
and conditions satisfactory to the Company. If additional capital is required and 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.
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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.
Item 3. Quantitative and Qualitative Disclosures about Market Risk
During the three months ended March 31, 2008, Milestone did not hold a portfolio of securities
instruments for trading or speculative purposes.
Reference is made to Item 2 of Part I of this quarterly report. Management Discussion and Analysis
or Plan of Operation-Forward Looking Statements.
Item 4. Controls and Procedures
The Companys management, including the Chief Executive Officer and Chief Financial Officer, has
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, 2008
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.
Managements Report on Internal Control over Financial Reporting
There have been no significant changes in the Companys internal control over financial reporting
identified in connection with the evaluation that occurred during the Companys last fiscal quarter
that have materially affected, or that are reasonably likely to materially affect, the Companys
internal controls over financial reporting.
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PART II OTHER INFORMATION
ITEM 1. LEGAL PROCEEDINGS
In August of 2007 Milestone commenced a Declaratory Judgment Action against Milton Hodosh, DMD
in the United States District Court for the District of New Jersey seeking a determination by that
Court that neither its STA Injection System nor its CompuDent® system infringed claims
set forth in United States Patent No. 6159161 filed by Dr. Hodosh on July 8, 1998 and issued by the
United States Patent Office on December 12, 2000. Milestones basic patents covering these systems
were issued by the United States Patent Office in January 1993. Subsequent to the commencement of
Milestones action for a Declaratory Judgment, Dr. Hodosh commenced a patent infringement suit in
the United States District Court for the Southern District of New York alleging that he is the
owner of all rights to a patent issued to him in 2000 that relates to a method and system for
painlessly delivering oral anesthesia to dental patients by controlling the rate of flow or
pressure of the anesthetic and that Milestone has infringed and is continuing to infringe his
patent by manufacturing and selling its products, including the STA Injection System, the
CompuDent® Computer Controlled Anesthetic Delivery System and a product line of CompuMed®
anesthetic and fluid delivery products. Dr. Hodosh seeks a declaration that his patent is valid
and enforceable and is being infringed upon by Milestone, an injunction from further infringement,
unspecified damages but in no event less than a reasonable royalty, and that such damages be
trebled due to the alleged willful nature of the infringement.
On November 5, 2007, Milestone filed an Answer, Affirmative Defenses and Counterclaims against
Dr. Hodosh. The answer denied the material allegations of the complaint and asserted thirteen
affirmative defenses including that the products offered by Milestone involve apparatus and methods
that are not infringing on Dr. Hodoshs patent and that Dr. Hodoshs patent is invalid and/or
unenforceable. The Counterclaims seek, inter alia, a declaration of non-infringement and
that Dr. Hodoshs patent is invalid. Milestone has received opinions from patent counsel, not
involved in the litigations, that neither the STA system nor the Compudent
system infringe any of the claims of Dr. Hodoshs patents. After the commencement of Dr. Hodoshs
action, Milestone withdrew its prior action so that the entire matter could be determined in one
forum. Milestone believes that it has meritorious defenses to Dr. Hodoshs claims and intends to
vigorously defend the action and pursue counterclaims. The case is currently in the discovery
phase.
ITEM 1A. RISK FACTORS
The following factors may affect the growth and profitability of Milestone and should be
considered by any prospective purchaser or current holder of Milestones securities:
We have no history of profitable operations. Continuing losses could exhaust our capital resources
and force us to discontinue operations.
For the months ended March 31, 2008 and 2007 our revenues were approximately $1.4 million and
$2.3 million respectively. In addition, we have had losses for each year since the commencement
of operations, including net losses of approximately $616,000 and $535,000 for 2008 and 2007,
respectively. At March 31, 2008, we had an accumulated deficit of approximately $56.7 million. At
March 31, 2008, the Company had cash and cash equivalents $237,715 and working capital of
$1,551,088. Additionally, the Company secured a line of credit in the aggregate amount $1.0 million
from a stockholder which line was fully borrowed at December 31, 2007, as discussed in Note B, item
10. Subsequent to March 31, 2008, the line of credit was increased by $300,000 to $1,300,000. All
terms and conditions remained unchanged. 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;
however, the Company does not now have sufficient cash reserves to meet all of its anticipated
obligations for the next 12 months. The Company anticipates a need for a higher level of marketing
and sales efforts that at present it cannot fund. If the Company is unable to generate positive
cash flows from its operating activities it will need to raise additional capital. There is no
assurance that the Company will be able to achieve positive operating cash flows or that additional
capital can be raised on 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.
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The Companys recurring losses and negative operating cash flows raise substantial doubt about
its ability to continue as a going concern.
There are no other changes to our risk factors from those disclosed in our Annual Report on
Form 10-KSB for the year ended December 31, 2007.
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ITEM 2. UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS
Recent Sales of Unregistered Securities
In the quarter ended March 31, 2008, Milestone issued total 331,542 shares valued at $504,679
as follows:
Shares | $ | |||||||
Shares issued for Employee Compensation |
9,314 | $ | 15,832 | |||||
Shares issued to Vendors for services |
156,448 | 262,748 | ||||||
Shares issued for services |
165,780 | 226,099 | ||||||
331,542 | $ | 504,679 |
Additionally, in the quarter ending March 31, 2008, shares to be issued was increased by
83,333 shares of common stock (valued at $100,000) in settlement of deferred compensation with an
officer of the Company.
In the quarter ending March 31, 2007, Milestone issued a total of 15,001 shares valued at
$22,300.
ITEM 3. DEFAULT UPON SENIOR SECURTIES
NONE
ITEM 4. SUBMISSION OF MATTERS TO A VOTE OF SECURITY HOLDERS
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. |
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SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly
caused this report to be signed on
its behalf by the undersigned thereunto duly authorized.
MILESTONE SCIENTIFIC INC. | ||||
/s/ Joe W. Martin
|
||||
Chief Executive Officer | ||||
/s/ Joseph DAgostino
|
||||
Chief Financial Officer |
Date: May 15, 2008