10KSB
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 10-KSB
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ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the Fiscal Year ended December 31, 2006
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TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the transition period from ___to ___
Commission File Number 001-14053
Milestone Scientific Inc.
(Name of Small Business Issuer in its Charter)
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Delaware
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13-3545623 |
(State or other jurisdiction of
incorporation or organization)
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(I.R.S. Employer
Identification No.) |
220 South Orange Avenue, Livingston Corporate Park, Livingston, NJ 07039
(Address of Principal Executive Offices) (Zip Code)
Issuers telephone number (973) 535-2717
Securities registered under Section 12(b) of the Exchange Act: None
Securities registered under Section 12(g) of the Exchange Act:
Common Stock, par value $.001 per share
Warrants, each to purchase one share of common stock
Check whether the issuer is not required to file reports pursuant to Section 13 or 15(d) of the
Exchange Act. o
Check whether the registrant: (1) 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
Check if there is no disclosure of delinquent filers pursuant to Item 405 of Regulation S-B
contained herein, and no disclosure will be contained, to the best of the registrants knowledge,
in definitive proxy or information statements incorporated by reference in Part III of this Form
10-KSB or any amendment to this Form 10-KSB. þ
Indicate by check mark whether the registrant is a shell company. Yes o No þ
For the year ended December 31, 2006, the revenues of the registrant were $5,844,177
The aggregate market value of the voting and non-voting common equity held by non-affiliates
computed by reference to the price at which the common equity was sold, or the average bid and
asked price of such common equity, on the Nasdaq over-the-counter bulletin board, on March 30, 2007
of $3.05 was approximately $24,765,500.
As of March 30, 2007 the registrant has a total of 11,674,304 shares of Common Stock, $0.001
par value, outstanding.
DOCUMENTS INCORPORATED BY REFERENCE
None
Transitional Small Business Disclosure Format (Check One): Yes o No þ
MILESTONE SCIENTIFIC INC.
Form 10-KSB Annual Report
TABLE OF CONTENTS
FORWARD-LOOKING STATEMENTS
Certain statements made in this Annual Report on Form 10-KSB are forward-looking statements
(within the meaning of the Private Securities Litigation Reform Act of 1995) regarding the plans
and objectives of management for future operations. Such statements involve known and unknown
risks, uncertainties and other factors that may cause actual results, performance or achievements
of Milestone to be materially different from any future results, performance or achievements
expressed or implied by such forward-looking statements. The forward-looking statements included
herein are based on current expectations that involve numerous risks and uncertainties.
Milestones plans and objectives are based, in part, on assumptions involving the continued
expansion of business. Assumptions relating to the foregoing involve judgments with respect to,
among other things, future economic, competitive and market conditions and future business
decisions, all of which are difficult or impossible to predict accurately and many of which are
beyond the control of Milestone. Although Milestone believes that its assumptions underlying the
forward-looking statements are reasonable, any of the assumptions could prove inaccurate. In light
of the significant uncertainties inherent in the forward-looking statements included herein,
particularly in view of Milestones early stage operations, the inclusion of such information
should not be regarded as a representation by Milestone or any other person that the objectives and
plans of Milestone will be achieved. We undertake no obligation to revise or update publicly any
forward-looking statements for any reason.
2
PART I
Item 1. Description of Business
All references in this report to we, us, our Milestone or Milestone Scientific refer
to Milestone Scientific Inc., and its former subsidiary, Spintech, Inc. (Spintech), unless the
context otherwise indicates. We have rights to the following trademarks: CompuDent®,
CompuMed®, CompuFlo, The Wand®, The
WandPlus®, The
SafetyWand
and CoolBlueWand, CoolBlue Tooth Whitening System,
DPS (Dynamic Pressure Sensing Technology), STA (Single Tooth Anesthesia),
Ionic White® (light emitting diode), Ionic White (whitening toothpaste).
Milestone was incorporated in the State of Delaware in 1989.
BUSINESS
Background
Milestone is engaged in pioneering proprietary, highly innovative technological systems and
solutions for the medical and dental markets.
Central to Milestones intellectual property platform and current product development strategy
is its patented CompuFlo technology for the precise delivery of medicaments.
Specifically, the CompuFlo technology is a computer-controlled, pressure sensitive infusion,
perfusion, and aspiration technology capable of delivering critically important information, in
visual and audible forms, that allows physicians, dentists and other health care specialists to
determine the characteristics of human and other tissue into which fluids are being delivered (or
extracted). It has the potential to greatly increase the safety and efficacy of many injection
procedures that currently rely upon 150-year-old hypodermic syringe technology and the tactile
senses and delivery expertise of the administrator.
Of particular significance is the fact that successful results of four independent pilot
clinical studies confirmed the efficacy of CompuFlo in identifying the epidural space. Identifying
when a hypodermic needle has entered the epidural space is a critically important factor
in the safety and effectiveness of this injection administered during childbirth and in the
course of pain management therapy. Proper and consistent identification of the epidural space
represents a critical step towards the adoption of Milestones technology for the administration of
epidural anesthesia.
In 1997, Milestone first introduced TheWand (CompuDent system) and
disposable Wand handpiece. CompuDent provides painless injections for all routine
dental treatments including root canals, crowns, fillings and cleanings. Milestone Scientifics
computer-controlled local anesthetic delivery system doesnt look like a syringe. It doesnt feel
like a syringe. And, whats more, it works better than a syringe resulting in a more pleasant
experience for the patient and practitioner. With more than 18,000 CompuDent systems sold within
four months of its market introduction, this represented the most successful launch in the history
of small equipment sales in U.S. dentistry.
Milestone subsequently expanded its product offerings with the introduction of the
CompuMed advanced injection system, designed for use in a wide range of applications
within the Medical industry, including plastic surgery, hair restoration surgery, podiatry,
colorectal surgery, nasal and sinus surgery, dermatology and orthopedics, among others.
In February 2007, Milestone formally unveiled another potentially exciting technology based on
CompuFlo. Marketed as the Single Tooth Anesthesia (STA) computer-controlled local
anesthesia delivery system, STA provides dentists with audible and visual feedback by measuring
the pressure at the tip of the needle. Milestone received FDA 510(k) Pre-market Notification
acceptance in August 2006 for the marketing and sale of the STA system and has since named Henry
Schein, Inc, the worlds largest provider of healthcare products and services to office-based
practitioners in the combined North American and European markets, as its exclusive distributor in
the United States and Canada.
With customers spanning 25 countries, Milestones revolutionary painless injection systems
are currently sold through its global distributor network to dental and medical professionals
worldwide.
CompuFlo Advanced Injection Technology Core Technology
CompuFlo, developed by Milestone, is a revolutionary new technology for injections. CompuFlo
enables health care practitioners to monitor and precisely control pressure, rate and volume
during all injections and can be used to inject all liquid medicaments as well as anesthetics.
CompuFlo can also be used to aspirate body fluids.
3
Negative side effects from the use of traditional hypodermic drug delivery injection systems
are well documented in dental and medical literature and include risk of death, transient or
permanent paralysis, pain, tissue damage and post-operative complications. The pain and tissue
damage are a direct result of uncontrolled flow rates and pressures that are created during the
administration of drug solutions into human tissue. While several technologies have been capable of
controlling flow rate, the ability to accurately and precisely control pressure has been
unobtainable until our development of CompuFlo.
On September 14, 2004, Milestone Scientific was issued United States Patent No. 6,786,885 over
the CompuFlo technology, entitled Pressure/Force Computer Controlled Drug Delivery System with
Exit Pressure. Proprietary software, working with an innovative technology, allows the system to
continuously monitor and control the exit pressure of fluid and/or medication during an injection.
This same technology also enables doctors to accurately identify different tissue types based on
exit pressure during an injection. The technology appears to have many applications in both
medicine and dentistry including epidural injections.
In December 2004, the United States Patent Office issued a Notice of Allowance for patent
protection on two additional critical elements of the CompuFlo automated drug delivery technology:
Drug Delivery System with Profiles and Pressure/Force Computer Controlled Drug Delivery with
Automated Charging.
The Drug Delivery System with Profiles standardizes and simplifies the drug delivery process,
while reducing the risk of medical complications by controlling parameters that are essential for
the safe injection of local anesthetics and other medications, as well as the aspiration of bodily
fluids. This is accomplished through an integrated injection database in the CompuFlo technology
that contains the critical components of specific drugs, parameters of needles, tubing and syringes
and all pertinent components for the safe and efficacious delivery of medications, including
procedures such as epidural injections.
Pressure/Force Computer Controlled Drug Delivery with Automated Charging provides the means to
deliver any volume of medication or infused fluid, such as a saline solution, into the human body.
In many instances, the volume of medication or other liquid that is required for a medical
procedure exceeds the capacity of the normal vessels used. This technology allows the smaller
vessel to be automatically refilled from a larger one without interrupting the surgery or medical
procedure.
In 2004 and 2005, successful results of three independent pilot clinical studies confirmed the
efficacy of the CompuFlo pressure/force computer controlled anesthetic delivery system in
identifying the epidural space. Identifying when a hypodermic needle has entered the epidural space
is a critically important factor in the safety and effectiveness of anesthetic injections
administered for childbirth and in the course of pain management therapy. A report on the results
of the study, conducted through the University of Texas Health Science Center at Houston under the
guidance of Dr. Oscar Ghelber, Assistant Professor of Anesthesiology, was presented at the Society
for Technology in Anesthesia (STA) meeting on October 28th, 2004. Proper and consistent
identification of the epidural space represents a critical step toward the adoption of Milestones
technology for the administration of epidural anesthesia.
When administering epidural injections, it is critical to recognize the risks associated with
administering potentially neurotoxic substances into the subarachnoid space, from which 40% of
spinal fluid is produced. If local anesthesia is injected into this space, instead of the epidural
space, the patient may face a lifetime of continuing agony due to adhesive arachnoiditis. This
represents a potential disaster for any patient undergoing an epidural injection today, because
doctors must rely upon tactile feel to identify the epidural space. Clinical studies using
Milestones CompuFlo Computer Controlled Infusion Pump in the administration of epidural anesthesia
have provided highly encouraging results. In a presentation to the 2005 Annual Meeting of the
International Anesthesia Research Society last October, Dr. Ghelber noted that existing epidural
techniques use subjective feedback to identify the epidural space, while the CompuFlo technology
provides precise and objective feedback and also allows anesthesiologists to use both hands to
advance and direct the needle, thereby making it easier to perform this task. Dr. Ghelber further
advised the meeting that CompuFlo accurately identified the epidural space in 100% of the cases
tested in his pilot study.
In December 2005, Milestone submitted a pre-market notification to the US Food and Drug
Administration (FDA) on its CompuFlo Technology and which was cleared by the FDA in August of 2006.
This initial submission is critical for the continuing efforts to develop and commercialize this
important technology. Milestone has identified a number of potential applications for CompuFlo,
including the identification of the epidural space for injections of anesthetic, most notably in
child delivery and pain management.
4
Product Platform
Milestone has endeavored to develop and bring to market a highly differentiated portfolio of
industry innovations. Specifically, Milestones proprietary solutions for application in
professional dentistry, and a wide range of medical applications include:
CompuDent
CompuDent is Milestones proprietary, patented computer-controlled local anesthetic delivery
system which delivers anesthesia at a precise and consistent rate below a patients pain threshold.
CompuDent has been widely heralded as a revolutionary device, considered one of the major advances
in dentistry of the Twentieth Century and favorably evaluated in approximately 50 peer reviewed or
independent clinical research reports. CompuDent, including its ergonomically designed single-use
hand-piece (The Wand), provides numerous, well documented benefits:
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CompuDent minimizes the pain associated with palatal, mandibular block and other
injections, resulting in a more comfortable injection experience for the patient; |
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the pencil grip used with The Wand handpiece allows unprecedented tactile sense and
accurate control; |
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new injections made possible with the CompuDent technology eliminate collateral numbness
of the tongue, lips and facial muscles; |
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bi-directional rotation of The Wand handpiece eliminates needle deflection resulting in
greater success and more rapid onset of anesthesia in mandibular block injections; |
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the use of a single patient use, disposable handpiece minimizes the risk of cross
contamination; |
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the ergonomic design of The Wand handpiece makes an injection easier and less stressful
to administer, lowering the risk of carpal tunnel syndrome. |
Despite CompuDents many benefits, including the administration of painless injections,
dentists in the United States have been slow to give up the use of traditional syringes. Dentists
have all been trained to use syringes in dental school and often have become accustomed to and
comfortable with their use during many years of clinical practice, in spite of the obvious
reluctance and/or fear of the patient in relation to injections administered by hypodermic syringe.
There are approximately 40 million dental phobics, those people afraid to visit a dentist, in the
United States. Therefore, there may be a disconnect in the way dentists perceive their patients
attitudes toward injection by hypodermic syringe. As a result of this disconnect, sales were below
expectations in 1999 and 2000 following a successful launch in early 1998 to new adopters. By
the end of 2000, Milestone had limited financial resources and was forced to choose between
maintaining its leadership position in advanced injection technology and continuing to promote
sales through high levels of sales and marketing expenses, including trade show appearances.
Milestone chose to maintain its technology leadership position and drastically reduced marketing
and sales expenses, thus allowing domestic sales of new units to suffer. However, despite limited
marketing efforts, foreign sales continued to grow. Also, increasing handpiece use by the domestic
customer base resulted in rising handpiece sales.
Single Tooth Anesthesia (STA)
The STA is a patented, computer-controlled local anesthesia delivery system that incorporates
the pressure force feedback elements of Milestones patented CompuFlo technology, thereby
allowing dentists to administer injections accurately into the periodontal ligament space,
effectively anesthetizing a single tooth. While the periodontal ligament injection has been around
for some time, there has been no effective technology that allows dentists to easily perform the
procedure painlessly, safely and predictably until now. With this unique procedure dentists can
easily and predictably profoundly anesthetize a single root tooth in one minute and a multiple root
tooth in two minutes, without first administering a general blocking injection and waiting up to 15
minutes (or longer if the blocking injection needs to be re-administered) before proceeding to
anesthetize the target tooth. We believe that a device which allows dentists to effectively
anesthetize a single tooth will greatly enhance the productivity of dental practices and, when
combined with the painless injection capabilities already present in our CompuDent system, such a
device should represent a compelling value in the marketplace. As with Milestones CompuDent
system, the STA device will generate recurring revenues from per-patient disposable kits.
CompuMed
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CompuMed is a patented computer-controlled injection system geared to the needs of the medical
market and providing benefits similar to CompuDent. CompuMed allows many medical procedures, now
requiring IV sedation, to be performed with only local anesthesia due to dramatic pain
reduction. Also, dosages of local anesthetic can often be significantly reduced, thus
reducing side effects, accelerating recovery times, lowering costs and eliminating potential
complications. CompuMed has accumulated clinical evidence demonstrating benefits from use in
colorectal surgery; podiatry; dermatology, including surgery for the removal of basal cell
carcinomas and other oncological dermatologic procedures; nasal and sinus surgery, including
rhinoplasty; hair transplantation and plastic surgery, among others.
The Wand®
The Wand is used in conjunction with the STA, CompuDent or CompuMed systems, an
ergonomically designed, and patented hand piece that enables all traditional and newer injections,
such as AMSA, P-ASA and Modified-PDL, to be more comfortable and easier to deliver. Moreover, the
pen-like grasp of The Wand allows bi-directional rotation during injection, which prevents needle
deflection that occurs with a traditional syringe. A straighter path results in a more accurate
injection, meaning fewer missed blocks, and more rapid onset of anesthesia. Missed blocks are
reported in the literature to occur 30% of the time. This raises both patient anxiety and
difficulties for the dentists in managing their business. While the dentist is awaiting profound
anesthesia he is losing time and money.
The SafetyWand
The SafetyWand is the first, patented safety-engineered injection device that conforms to
standards while also meeting the clinical needs of dental and medical practitioners. Following the
adoption of the Federal Needlestick Safety and Prevention Act, Milestone developed, and in
September 2003 the FDA approved marketing of, Milestones SafetyWand disposable handpiece, a
patented injection device that incorporates safety engineering sharps protection features to aid in
the prevention of needlesticks. The SafetyWand is the first patented injection device to be fully
compliant with OSHA regulations under the federal Needlestick Safety Act while meeting the clinical
needs of dentists.
The SafetyWand represents the culmination of two years effort to develop a safer injection
device for dentists, physicians and hygienists. While safety injection devices have been mandated
since 2000 under federal law, OSHA had been unable to enforce this law against dentists because of
the inadequacy of existing devices to meet both the requirements of the law and the clinical needs
of dentists. The SafetyWand meets these requirements and provides dental practitioners with a safer
retractable needle device, with single hand activation, which is reusable multiple times during a
single patient visit, yet small and sleek enough not to obscure the dentists sometimes limited
field of view. While SafetyWand is now available commercially, OSHA has not begun, in a meaningful
way, to enforce existing regulations requiring the use of safety engineered devices. OSHA is
empowered to levy substantial fines for failure to use these devices. We believe the Safety
Wand will promote increased handpiece use by the more than 15,000 CompuDent anesthetic delivery
systems previously sold in the United States while also providing new impetus for the purchase of
these systems by new users.
Tooth Whitening
In addition to products enhancing its position in advanced injection technology, in 2004
Milestone acquired rights to a portfolio of technology centered around the use of blue light
emitting diodes (LED) for a variety of dental treatment and diagnostic applications as well as for
professional and consumer teeth whitening. The first product commercialized was a proprietary
dental enhancement system now named the CoolBlue Wand, which was launched in 2004. Subsequent to
this, Milestone successfully entered the consumer teeth whitening market with Ionic White, as well
as the CoolBlue professional Teeth Whitening System. Milestone believes that it cannot effectively
market its teeth whitening product unless it obtains patent protection, as to which there can be no
assurance.
The CoolBlue Wand
The CoolBlue Wand is a proprietary, cost efficient dental enhancement system that uses blue
light emitting diodes for fast curing of dental composite material, trans-illumination of teeth and
activation of whitening gels and pastes. In addition, the system enables dentists to interchange
attachments for use in cosmetic dentistry and diagnostics.
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Ionic White
Ionic White is a proprietary, technologically advanced light-activated teeth whitening system
developed for consumer use in the home. Ionic White whitens and brightens all tooth surfaces
within approximately 21 minutes in an easy-to-use home kit that includes a unique cool blue
intra-oral light and proprietary gel. The system provides an alternative to costly and
time-consuming trips to the dentist and/or other over-the-counter products that do not offer the
same benefits as the Ionic White system.
Competition
Our anesthetic delivery systems compete with disposable and reusable syringes that generally
sell at lower prices and that use established and well-understood methodologies and other local
anesthetic delivery systems, in both the dental and medical marketplaces. SafetyWand competes with
other safety engineered products in the medical market and against a single product claiming to be
compliant with OSHA regulations under the Needle Stick Act in the dental market.
Our systems compete on the basis of their performance characteristics and the benefits
provided to both the practitioner and the patient. Clinical studies have shown that our systems
reduce fear, pain and anxiety for some patients, and we believe that they can also reduce
practitioner stress levels. CompuDent can be used for all local anesthesia techniques that can be
performed with a syringe. CompuDent can also be used for new and modified techniques that cannot
be performed with traditional syringes. These new techniques allow for faster procedures
shortening chair-time, minimizing numbing of the lips and facial muscles, enhancing productivity,
reducing stress, and virtually eliminating pain and anxiety.
The competition in the professional and consumer tooth whitening sectors is intense. There
are a significant number of competitors in both sectors and many of these competitors are quite
substantial. We believe the benefits of both CoolBlue and Ionic White, provided we first obtain
the patent protection now being sought, as to which there can be no assurance, will elevate
Milestone above many of the competitors while providing an entrée to the dentist heretofore made
very difficult as a single product company.
We face intense competition from many companies in the medical and dental device industry,
possessing substantially greater financial, marketing, personnel, and other resources. Most of our
competitors have established reputations, stemming from their success in the development, sale, and service of
competing dental products. Further, rapid technological change and research may affect our
products. Current or new competitors could, at any time, introduce new or enhanced products with
features that render our products less marketable or even obsolete. Therefore, we must devote
substantial efforts and financial resources to improve our existing products, bring our products to
market quickly, and develop new products for related markets. In addition, our ability to compete
successfully requires that we establish an effective distribution network as well as support this
distribution with a strong marketing plan. Historically, we have been unsuccessful in executing
the marketing plans for our products, primarily due to resource constraints. New products must be
approved by regulatory authorities before they may be marketed. We cannot assure you that we can
compete successfully; that our competitors will not develop technologies or products that render
our products less marketable or obsolete; or, that we will succeed in improving our existing
products, effectively develop new products, or obtain required regulatory approval for those
products. We have not been successful in marketing the product.
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Patents And Intellectual Property
We hold the following U.S. utility and design patents:
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U.S. PATENT |
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NUMBER |
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ISSUE |
Computer Controlled Drug Delivery Systems |
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Hypodermic Anesthetic Injection Method |
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4,747,824 |
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05/31/88 |
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Hypodermic Anesthetic Injection Apparatus & Method |
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5,180,371 |
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01/19/93 |
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(CompuFlo, CompuMed, and CompuDent ) |
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Dental Anesthetic and Delivery Injection Unit |
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6,022,337 |
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02/08/00 |
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Design for a Dental Anesthetic Delivery System Holder |
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D422,361 |
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04/04/00 |
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Design for a Dental Anesthetic Delivery System Housing |
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D423,665 |
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04/25/00 |
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Design for a Dental Anesthetic Delivery System Handle |
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D427,314 |
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06/27/00 |
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Dental Anesthetic Delivery Injection Unit |
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6,132,414 |
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10/17/00 |
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Dental Anesthetic Delivery Injection Unit |
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6,152,734 |
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11/28/00 |
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Dental Anesthetic and Delivery Injection Unit with Automated Rate Control |
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6,652,482 |
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11/25/03 |
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Pressure/Force Computer Controlled Drug Delivery System |
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6,200,289 |
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03/13/01 |
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Pressure/Force Computer Controlled Drug Delivery System with Exit Pressure |
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6,786,885 |
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09/14/04 |
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Pressure/Force Computer Controlled Drug Delivery System with Automated Charging |
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6,887,216 |
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05/03/05 |
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Drug Delivery System with Profiles |
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6,945,954 |
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09/20/05 |
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Engineered Sharps Injury Protection Devices |
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Handpiece for Injection Device with a Retractable and Rotating Needle |
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6,428,517 |
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08/06/02 |
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Safety IV Catheter Device |
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6,726,658 |
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04/27/04 |
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Safety IV Catheter Infusion Device |
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6,905,482 |
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06/14/05 |
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Handpiece for Injection Device with a Retractable and Rotating Needle |
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6,966,899 |
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11/22/05 |
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Other |
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Apparatus and Method for Sterilizing, Destroying and Encapsulating
Medical Implement Wastes |
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4,992,217 |
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02/12/91 |
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Apparatus and Method for Verifiably Sterilizing Destroying and
Encapsulating Regulated Medical Wastes |
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5,078,924 |
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01/07/92 |
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Apparatus and Method for Verifiably Sterilizing, Destroying and
Encapsulating Regulated Medical Wastes |
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5,401,444 |
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03/28/95 |
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Self-Sterilizing Hypodermic Syringe and Method |
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5,512,730 |
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04/30/96 |
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Hypodermic Syringe and Method |
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4,877,934 |
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12/19/88 |
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Self-Sterilizing Hypodermic Syringe and Method |
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5,693,026 |
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12/02/97 |
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In 2005, four U.S. patents were issued to Milestone. Two of those patents protect
elements of Milestones CompuFlo automated drug delivery technology, namely, Drug Delivery System
with Profiles and Pressure/Force Computer Controlled Drug Delivery with Automated Charging. The
Drug Delivery System with Profiles standardizes and simplifies the drug delivery process, while
reducing the risk of medical complications by controlling parameters that are essential for the
safe injection of local anesthetics and other medications, as well as aspiration of bodily fluids.
This is accomplished through an integrated injection database in the CompuFlo technology that
contains the critical components of specific drugs, parameters of needles, tubing and syringes and
all pertinent components for the safe and efficacious delivery of medications, particularly in
procedures such as epidural injections.
The Pressure/Force Computer Controlled Drug Delivery with Automated Charging provides the
means to deliver any volume of medication or infused fluid, such as a saline solution, into the
human body. In many instances, the volume of medication or other liquid that is required for a
medical procedure exceeds the capacity of the normal vessels used. This technology allows the
smaller vessel to be automatically refilled from a larger one without interrupting the surgery or
medical procedure.
We also have several patent applications pending before the U.S. Patent and Trademark Office,
and hold a number of corresponding patents and patent applications in Europe and other major
markets. During the 2006 and 2005 fiscal years, we expensed $1,005,285 and $286,260, respectively,
on research and development activities. The higher costs incurred in 2006 were primarily associated
with the intensified effort into the development of our Single Tooth Anesthetic (STA) delivery
system and continuing efforts on the CompuFlo technology.
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We rely on a combination of patent, copyright, trade secret, and trademark laws and employee
and third party nondisclosure agreements to protect our intellectual property rights. Despite the
precautions taken by us to protect our products, unauthorized parties may attempt to reverse
engineer, copy, or obtain and use products and information that we regard as proprietary, or may
design products serving similar purposes that do not infringe on our patents. In 2006 we began
infringement actions in China against four companies we believe are infringing our CompuDent
patents. These and other litigations may be necessary to protect our intellectual property rights
and could result in substantial cost to us and diversion of our efforts with no guarantee of
success. Our failure to protect our proprietary information and the expenses of doing so could have
a material adverse effect on our operating results and financial condition.
While there are no current claims that our products infringe the proprietary rights of third
parties, there can be no assurance that third parties will not assert infringement claims against
us in the future with respect to current or future products or that any such assertion may not
require us to cease selling such products, or to enter into arrangements that require us to pay
royalties, or to engage in costly litigation. Although we have received no claims of infringement,
it is possible that infringement of existing or future patents or proprietary rights of others may
occur. In the event that our products infringe upon patent or proprietary rights of others, we may
be required to modify our processes or to obtain a license. There can be no assurance that we would
be able to do so in a timely manner, upon acceptable terms and conditions, or at all. The failure
to do so would have a material adverse effect on us.
Government Regulation
The FDA cleared CompuDent system and its disposable handpiece for marketing in the U.S. for
dental applications in July 1996; the CompuMed system for marketing in the U.S. for medical
applications in May 2001; and, the SafetyWand for marketing in the U.S. for dental applications in
September 2003. For us to commercialize our other products in the U.S., we will have to submit
additional 510(k) applications with the FDA.
The manufacture and sale of medical devices and other medical products are subject to
extensive regulation by the FDA pursuant to the FDC Act, and by other federal, state and foreign
authorities. Under the FDC Act, medical devices must receive FDA clearance before they can be
marketed commercially in the U.S. Some medical products must undergo rigorous pre-clinical and
clinical testing and an extensive FDA approval process before they can be marketed. These processes
can take a number of years and require the expenditure of substantial resources. The time required
for completing such testing and obtaining such approvals is uncertain, and FDA clearance may never
be obtained. Delays or rejections may be encountered based upon changes in FDA policy during the
period of product development and FDA regulatory review of each product submitted. Similar delays
also may be encountered in other countries. Following the enactment of the Medical Device
Amendments to the FDC Act in May 1976, the FDA classified medical devices in commercial
distribution into one of three classes. This classification is based on the controls necessary to
reasonably ensure the safety and effectiveness of the medical device. Class I devices are those
devices whose safety and effectiveness can reasonably be ensured through general controls, such as
adequate labeling, pre-market notification, and adherence to the FDAs Quality System Regulation
(QSR), also referred to as Good Manufacturing Practices (GMP) regulations. Some Class I
devices are further exempted from some of the general controls. Class II devices are those devices
whose safety and effectiveness reasonably can be ensured through the use of special controls, such
as performance standards, post-market surveillance, patient registries, and FDA guidelines. Class
III devices are those which must receive pre-market approval by the FDA to ensure their safety and
effectiveness. Generally, Class III devices are limited to life-sustaining, life-supporting or
implantable devices.
If a manufacturer or distributor can establish that a proposed device is substantially
equivalent to a legally marketed Class I or Class II medical device or to a Class III medical
device for which the FDA has not required pre-market approval, the manufacturer or distributor may
seek FDA marketing clearance for the device by filing a 510(k) Pre-market Notification. The 510(k)
Pre-market Notification and the claim of substantial equivalence may have to be supported by
various types of data and materials, including test results indicating that the device is as safe
and effective for its intended use as a legally marketed predicate device. Following submission of
the 510(k) Pre-market Notification, the manufacturer or distributor may not place the device into
commercial distribution until an order is issued by the FDA. By regulation, the FDA has no specific
time limit by which it must respond to a 510(k) Pre-market Notification. At this time, the FDA
typically responds to the submission of a 510(k) Pre-market Notification within 90 days. The FDA
response may declare that the device is substantially equivalent to another legally marketed device
and allow the proposed device to be marketed in the
9
U.S.. However, the FDA may determine that the
proposed device is not substantially equivalent or may require further information, such as
additional test data, before the FDA is able to make a determination regarding substantial
equivalence. Such determination or request for additional information could delay market
introduction of our products and could have a material adverse effect on us. If a device that has
obtained 510(k) Pre-market Notification clearance is changed or modified in design, components,
method of manufacture, or intended use, such that the safety or effectiveness of the device could
be significantly affected, separate 510(k) Pre-market Notification clearance must be obtained
before the modified device can be marketed in the U.S.. If a manufacturer or distributor cannot
establish that a proposed device is substantially equivalent to a legally marketed device, the
manufacturer or distributor will have to seek pre-market approval of the proposed device, a more
difficult procedure requiring extensive data, including pre-clinical and human clinical trial data,
as well as extensive literature to prove the safety and efficacy of the device.
Though CompuDent, the SafetyWand and CompuMed have received FDA marketing clearance, there can
be no assurance that any of our other products under development will obtain the required
regulatory clearance in a timely manner, or at all. If regulatory clearance of a product is
granted, such clearance may entail limitations on the indicated uses for which the product may be
marketed. In addition, modifications may be made to our products to incorporate and enhance their
functionality and performance based upon new data and design review. There can be no assurance that
the FDA will not request additional information relating to product improvements; that any such
improvements would not require further regulatory review, thereby delaying the testing, approval
and commercialization of our development products; or, that ultimately any such improvements will
receive FDA clearance.
Compliance with applicable regulatory requirements is subject to continual review and will be
monitored through periodic inspections by the FDA. Later discovery of previously unknown problems
with a product, manufacturer, or facility may result in restrictions on such product or
manufacturer, including fines, delays or suspensions of regulatory clearances, seizures or recalls
of products, operating restrictions and criminal prosecution and could have a material adverse
effect on us.
We are subject to pervasive and continuing regulation by the FDA, whose regulations require
manufacturers of medical devices to adhere to certain QSR requirements as defined by the FDC Act.
QSR compliance requires testing, quality control and documentation procedures. Failure to comply
with QSR requirements can result in the suspension or termination of production, product recall or
fines and penalties. Products also must be manufactured in registered establishments. In addition,
labeling and promotional activities are subject to scrutiny by the FDA and, in certain
circumstances, by the Federal Trade Commission. The export of devices is also subject to regulation
in certain instances.
The Medical Device Reporting (MDR) regulation obligates us to provide information to the FDA
on product malfunctions or injuries alleged to have been associated with the use of the product or
in connection with certain product failures that could cause serious injury. If, as a result of FDA
inspections, MDR reports or other information, the FDA believes that we are not in compliance with
the law, the FDA can institute proceedings to detain or seize products, enjoin future violations,
or assess civil and/or criminal penalties against us, our officers or employees. Any action by the
FDA could result in disruption of our operations for an undetermined time.
In June 2003 we received a CE mark for marketing of the SafetyWand and The Wand Handpiece with
Needle in Europe. In July 2003, we obtained regulatory approval to sell CompuDent and its
handpieces in Australia and New Zealand.
Product Liability
Failure to use any of our products in accordance with recommended operating procedures could
potentially result in health hazards or injury. Failures of our products to function properly could
subject us to claims of liability. We maintain liability insurance in an amount that we believe is
adequate. However, there can be no assurance that our insurance coverage will be sufficient to pay
product liability claims brought against us. A partially or completely uninsured claim, if
successful and of significant magnitude, could have a material adverse effect on us.
Employees
On December 31, 2006, Milestone had a total of 17 employees, of which 15 were full time
employees,
10
consisting of three executive officers, a senior product manager, one sales support
representative, five inside sales representatives, two customer service representatives, an
assistant controller, a bookkeeper, and an administrative assistant. We also had a part-time
clinical director, a part-time director of professional relations, and three independent sales
representatives, who sell our CompuDent system.
CERTAIN RISK FACTORS THAT MAY AFFECT GROWTH AND PROFITABILITY
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 years ended December 31, 2004, 2005 and 2006 our revenues were approximately $4.8
million, $6.4 million and $5.8 million respectively. In addition, we have had losses for each year
since the commencement of operations, including net losses of approximately $2.8 million and $3.2
million for 2005 and 2006, respectively. At December 31, 2006, we had an accumulated deficit of
approximately $53.1 million. Unless we can significantly increase sales of our CompuDent units,
handpieces or other injection devices and experience a successful introduction of our Single Tooth
Anesthetic (STA) delivery system, we expect to incur losses for the foreseeable future.
We cannot become successful unless we gain greater market acceptance for our products and
technology.
As with any new technology, there is substantial risk that the marketplace will not accept the
potential benefits of this technology or be unwilling to pay for any cost differential with the
existing technologies. Market acceptance of CompuDent, STA, the SafetyWand, CompuMed and CompuFlo
depends, in large part, upon our ability to educate potential customers of their distinctive
characteristics and benefits and will require substantial marketing efforts and expense. More than
30,000 units of the CompuDent or its predecessors have been sold worldwide since 1998. We cannot
assure you that our current or proposed products will be accepted by practitioners or that any of
the current or proposed products will be able to compete effectively against current and
alternative products.
Our limited distribution channels must be expanded for us to become successful.
Our future revenues depend on our ability to market and distribute our anesthetic injection
technology successfully. In the U.S. we rely on a limited number of independent representatives and
in-house sales people. Abroad, we lack distributors in many markets. To be successful we will need
to hire and retain additional sales personnel, provide for their proper training and ensure
adequate customer support. We cannot assure you that we will be able to hire and retain an adequate
sales force or engage suitable distributors, or that our sales force or distributors will be able
to successfully market and sell our products.
We depend on three principal manufacturers. If we cannot maintain our existing relationships or
develop new ones, we may have to cease our operations.
We have informal arrangements with the manufacturer of our 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. We have 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. We have been supplied by the manufacturer of the
CompuDent and CompuMed since the commencement of production in 1998, one of the manufacturers of
our handpieces since 2002 and the other manufacturer of handpieces since 2003. However,
termination of the manufacturing relationship with any of these manufacturers could significantly
and adversely affect our ability to produce and sell our products. Though we have established an
alternate source of supply for our handpieces in China and other alternate sources of supply exist,
we would need to recover our existing tools or have new tools produced to establish relationships
with new suppliers. Establishing new manufacturing relationships could involve significant expense
and delay. Any curtailment or interruptions of the supply, whether or not as a result or
termination of the relationship, would adversely affect us.
We may be subject to product liability claims that are not fully covered by our insurance and that
could put us under financial strain.
11
We could be subject to claims for personal injury from the alleged malfunction or misuse of
our dental and medical products. While we carry liability insurance that we believe is adequate, we
cannot assure you that the insurance coverage will be sufficient to pay such claims should they be
successful. A partially or completely uninsured claim, if successful and of significant magnitude,
could have a material adverse effect on us.
We rely on the continuing services of our Chairman and Chief Executive Officer, Chief Operating
Officer, President and Director of Clinical Affairs.
We depend on the personal efforts and abilities of our Chairman and Chief Executive Officer,
our Chief Operating Officer & President who was promoted to this position from that of Senior Vice
President in September 2003, and our Director of Clinical Affairs. We maintain a key man life
insurance policy in the amount of $1,000,000 on the life of our Chairman and Chief Executive
Officer. However, the loss of his services or the services of each of our Chief Operating Officer
and President, or Director of Clinical Affairs, on whom we maintain no insurance, could have a
materially adverse effect on our business.
The market price of our common stock has been volatile and may continue to fluctuate significantly
because of various factors, some of which are beyond our control.
Our stock price has been extremely volatile, fluctuating over the last three years between
closing prices of $.83 and $4.20. The market price of our common shares could continue to fluctuate
significantly in response to a variety of factors, some of which may be beyond our control.
We are controlled by a limited number of shareholders.
Our
principal shareholders, Leonard Osser and K. Tucker Andersen,
beneficially own 28.1% of the issued and
outstanding shares of our common stock. As a result, they have the ability to exercise substantial
control over our affairs and corporate actions requiring shareholder approval, including electing
directors, selling all or substantially all of our assets, merging with another entity or amending
our certificate of incorporation. This de facto control could delay, deter or prevent a change in
control and could adversely affect the price that investors might be willing to pay in the future
for our securities.
Future sales or the potential for sale of a substantial number of shares of our common stock could
cause the trading price of our common stock and warrants to decline and could impair our ability to
raise capital through subsequent equity offerings.
Sales of a substantial number of shares of our common stock in the public markets, or the
perception that these sales may occur, could cause the market price of our stock to decline and
could materially impair our ability to raise capital through the sale of additional equity
securities. At December 31, 2006, we had outstanding options and
warrants to purchase 3,565,087,
shares of our common stock at prices ranging from $.83 to $6.00 per share with a weighted average
exercise price of $4.49. Holders of these warrants and options are given the opportunity to profit
from a rise in the market price of our common stock and are likely to exercise their securities at
a time when we would be able to obtain additional equity capital on more favorable terms. Thus, the
terms upon which we will be able to obtain additional equity capital may be adversely affected,
since the holders of outstanding options and warrants can be expected to exercise them at a time
when we would, in all likelihood, be able to obtain any needed capital on terms more favorable to
us than the exercise terms provided by such outstanding securities. The market price of our common
shares has been volatile and may continue to fluctuate significantly because of various factors,
some of which are beyond our control.
The decrease of our outstanding shares as a result of the reverse stock split, without change to
our authorized capitalization, increased the ability of our Board of Directors to issue shares
without stockholder approval. Issuance of shares may dilute the value of our outstanding shares or
have a negative impact on the trading price of the common stock.
The 1-for-3 stock split effected in January 2004 reduced our outstanding shares from
18,338,033 to 6,112,678 (9,663,907 shares after giving effect to the consummation of the Public
Offering and related issuances of units). Since the reverse stock split was effected without change
in our authorized shares, the differential between outstanding shares and authorized shares
increased, thus providing the Board of Directors with increased
12
ability to effect issuances of
stock without stockholder authorization. For example, shares may be issued in capital raising
transactions, mergers or acquisitions or for compensatory reasons where other governing rules or
statutes do not separately require stockholder approval. The issuance of these shares for less than
their book value or for less than value paid by purchasers in the recently completed offering could
have a dilutive effective on purchasers in this offering. Further, the issuance of the shares could
also have a negative impact on the trading price of our then outstanding common stock, including
the stock issued in the recently completed offering.
Implementation of procedures to comply with the Sarbanes-Oxley Act and SEC rules concerning
internal controls may be so costly that compliance could have an adverse effect on us.
We must comply with Sarbanes-Oxley requirements to include in our annual report a management
report on the effectiveness of our internal control over financial reporting and an accompanying
auditors report. In 2005, the SEC extended, for an additional one year, the compliance date for
filing internal control reports by non-accelerated filers. As a result, our filing deadline is
postponed to our financial year ending December 31, 2007. In 2005, we hired an outside
consultant to assist us to develop and implement the necessary internal controls and reporting
procedures. We expect that the additional costs that we will incur due to the compliance
requirements could have an adverse effect on our profitability.
Item 2. Description of Property
Our offices are located in Livingston Corporate Park in Livingston, New Jersey. We lease
approximately 4,503 square feet of office space including 1,810 square feet of additional office
space acquired in April 2004. As part of this expansion, the lease term was extended through June
30, 2009 at a monthly cost of $7,317 which we believe to be competitive. All the properties that we
lease are in good condition. A third party distribution and logistics center in Pennsylvania
handles shipping and order fulfillment on a month-to-month basis.
We do not own or intend to invest in any real property. We currently have no policy with
respect to investments or interests in real estate, real estate mortgages or securities of, or
interests in, persons primarily engaged in real estate activities.
Item 3. Legal Proceedings
None.
Item 4. Submission of matters to a Vote of Security Holders
None.
13
PART II
Item 5. Market for Common Equity and Related Stockholder Matters and Small Business Issuer Purchases of Equity Securities
Market Information
Milestones Common Stock is traded on the Nasdaqs OTC Bulletin Board (OTCBB) under the
symbol MLSS. Milestones warrants are traded on the OTCBB under the symbol MLSSW. The
quotations reflect inter-dealer prices, without retail mark-up, mark-down or commission, and may
not represent actual transactions.
Common Stock
The following table sets forth the high and low sales prices of our Common Stock, as quoted by
the OTCBB
|
|
|
|
|
|
|
|
|
|
|
HIGH |
|
LOW |
2006 |
|
|
|
|
|
|
|
|
First Quarter |
|
$ |
1.64 |
|
|
$ |
1.00 |
|
Second Quarter |
|
$ |
1.25 |
|
|
$ |
.81 |
|
Third Quarter |
|
$ |
1.50 |
|
|
$ |
.80 |
|
Fourth Quarter |
|
$ |
1.40 |
|
|
$ |
.90 |
|
|
|
|
|
|
|
|
|
|
2005 |
|
|
|
|
|
|
|
|
First Quarter |
|
$ |
4.11 |
|
|
$ |
1.72 |
|
Second Quarter |
|
$ |
3.98 |
|
|
$ |
2.22 |
|
Third Quarter |
|
$ |
2.70 |
|
|
$ |
1.75 |
|
Fourth Quarter |
|
$ |
2.04 |
|
|
$ |
1.17 |
|
Warrants
The following table sets forth the high and low sales prices of our warrants, each to purchase
one share of common stock, as quoted by the OTCBB
|
|
|
|
|
|
|
|
|
|
|
HIGH |
|
LOW |
2006 |
|
|
|
|
|
|
|
|
First Quarter |
|
$ |
.35 |
|
|
$ |
.21 |
|
Second Quarter |
|
$ |
.40 |
|
|
$ |
.11 |
|
Third Quarter |
|
$ |
.25 |
|
|
$ |
.11 |
|
Fourth Quarter |
|
$ |
.30 |
|
|
$ |
.16 |
|
|
|
|
|
|
|
|
|
|
|
|
HIGH |
|
LOW |
2005 |
|
|
|
|
|
|
|
|
First Quarter |
|
$ |
.80 |
|
|
$ |
.27 |
|
Second Quarter |
|
$ |
.70 |
|
|
$ |
.36 |
|
Third Quarter |
|
$ |
.48 |
|
|
$ |
.25 |
|
Fourth Quarter |
|
$ |
.34 |
|
|
$ |
.22 |
|
14
Holders
According to the records of our transfer agent, there were approximately 2,880 shareholders of
record of our common stock as of December 31, 2006.
Dividends
The holders of our Common Stock are entitled to receive such dividends as may be declared by
Milestones Board of Directors. Milestone has not paid and does not expect to declare or pay any
dividends in the foreseeable future.
For information regarding securities authorized under our equity compensation plan, see Item
11
Sales of Unregistered Securities
During 2006, in satisfaction of payables owed in connection with warehousing and fulfillment
services and exhibition facilities, we issued 44,068 shares valued at $46,000 to two of our vendors
(the Vendor Shares). The Vendor Shares were issued in reliance upon the exemption from the
registration requirements of the Act, as provided in Section 4(2) thereof, as a transaction by an
issuer not involving a public offering. We reasonably believed that each vendor had such knowledge
and experience in financial and business matters to be capable of evaluating the merits and risks
of the investment, each vendor represented an intention to acquire the securities for investment
only and not with a view to distribution thereof and appropriate legends were affixed to the stock
certificates. No commissions were paid in connection with such issuances.
ITEM 6. Managements Discussion and Analysis or 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 annual report. 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 page 11 of this Form 10-KSB.
OVERVIEW
In 2006, we focused on executing a multi-point, long-term growth strategy designed to:
|
|
|
refine our tactical approach to product sales and marketing in order to increase
penetration of the global dental and medical markets with our proprietary
computer-controlled injection technologies; |
|
|
|
|
continue and enhance our product development efforts associated with our pressure force
technology for both dental and medical applications; and |
|
|
|
|
advance our regulatory, clinical and intellectual property efforts to strengthen our
product positioning in both the consumer and professional tooth whitening markets. |
Based on the results to date, we believe that we have made substantial progress toward
achieving the above objectives.
In contrast to prior years, Milestone implemented a pivotal strategy in 2006 providing for a
marked transition away from managing an inside direct sales force in favor of developing and
supporting a global multi-channel, distribution network, comprised of world leading medical and
dental distribution companies, industry resellers and independent sales agents. Consequently, beginning in the second quarter of 2006 and
continuing through year end, we reduced our direct sales team from 20 sales representatives to 6
inside sales support and customer service representatives. These 6 people are tasked with
providing support to the sales representatives affiliated
15
with companies in our global distribution
channels who are actively marketing Milestones products, as well as providing telephonic technical
support and customer attention to end users in the dental and medical markets.
In addition, Milestone elected to further enhance its sales and marketing support efforts
through outsourcing to specialized professional sales organizations. In August 2006, Milestone
engaged Corestrength, Inc., a Florida-based company that provides support services designed to
build sales and brand awareness for dental product companies. Under the terms of the agreement,
Corestrength provides and manages a team of Independent Sales Representatives that covers the U.S.
and Canada for Milestone; and together with CompuDent, will be supporting Milestones sales and
marketing activities of Milestones new Single Tooth Anesthesia (STA) system, which was introduced,
in a soft introduction, in February 2007. More specifically, Corestrength provides the training
and sales support required of the Milestones dental distributor sales force, including
co-traveling with distributor sales representatives and providing Dental show support.
Subsequent to the end of 2006, 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. Product
shipments will commence in late March 2007.
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. BMA was 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.
We are now engaged 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. While the majority of
potential applications identified in the report were in the medical fields, extra-medical
applications in the food, animal health, agriscience, bioremediation, and other industries may
provide strategic alliances and revenue contribution as well.
During 2006, we encountered several challenges with the commercialization of our proprietary
line of professional and consumer teeth whitening products.
Towards the end of 2005, we announced the market launch of the CoolBlue system, with the
intent of targeting the $5 billion worldwide teeth whitening market. The CoolBlue system was
designed to maximize long-term recurring revenues from disposable per-patient kits that are
utilized in the whitening treatment process. Although we initially received favorable feedback
from early adopters within the dental profession on CoolBlues overall performance, there were
recurring problems reported associated with product packaging. We are still addressing the
packaging issue and have made the strategic decision to forestall market re-introduction until such
time as we receive a CE mark, enabling us to re-launch CoolBlue on a global basis through our
worldwide distribution network. A CE mark is a declaration on manufactured products sold in the
European Union (EU) certifying that the item meets all the requirements of relevant EU directives.
Since its launch in early 2005, we have failed to realize the level of sales potential we
originally anticipated for the consumer teeth whitening product, Ionic White, even after factoring
the prevailing market size offset by the highly competitive landscape in the consumer teeth whitening market. Because our Ionic White
distributor has advised that significant retail sales are dependent upon our obtaining U.S. patent
protection for the product, we proceeded with filing the patent application with the U.S. Patent
and Trademark Office. Although the patent is pending, there can be no assurance that such patent
will be issued.
The following table shows a breakdown of our product sales (net), domestically and
internationally, by
16
product category, and the percentage of product sales (net) by each product
category:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Twelve Months Ended December 31, |
|
|
|
2006 |
|
|
2005 |
|
DOMESTIC |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
CompuDent |
|
$ |
968,821 |
|
|
|
23.4 |
% |
|
$ |
1,363,705 |
|
|
|
31.5 |
% |
Handpieces |
|
|
2,998,906 |
|
|
|
72.3 |
% |
|
|
2,762,944 |
|
|
|
64.0 |
% |
Other |
|
|
179,553 |
|
|
|
4.3 |
% |
|
|
196,409 |
|
|
|
4.5 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
Total Domestic |
|
$ |
4,147,280 |
|
|
|
100.0 |
% |
|
$ |
4,323,058 |
|
|
|
100.0 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
INTERNATIONAL |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
CompuDent |
|
$ |
492,871 |
|
|
|
34.7 |
% |
|
$ |
506,136 |
|
|
|
34.8 |
% |
Handpieces |
|
|
816,735 |
|
|
|
57.6 |
% |
|
|
854,718 |
|
|
|
58.9 |
% |
Other |
|
|
109,539 |
|
|
|
7.7 |
% |
|
|
91,482 |
|
|
|
6.3 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
Total International |
|
$ |
1,419,145 |
|
|
|
100.0 |
% |
|
$ |
1,452,336 |
|
|
|
100.0 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
DOMESTIC/INTERNATIONAL ANALYSIS |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Domestic |
|
$ |
4,147,280 |
|
|
|
74.5 |
% |
|
$ |
4,323,058 |
|
|
|
74.9 |
% |
International |
|
|
1,419,145 |
|
|
|
25.5 |
% |
|
|
1,452,336 |
|
|
|
25.1 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
Total Product Sales |
|
$ |
5,566,425 |
|
|
|
100.0 |
% |
|
$ |
5,775,394 |
|
|
|
100.0 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
We have earned gross profits of 48% and 60% in the years ended December 31, 2006 and
2005, respectively. However, our revenues have not been sufficient to support our overhead and
research and development expenses. We have therefore reported substantial losses for each of those
periods.
During 2006, we continued to take steps to reduce our expenses while adhering to strict
expense controls. As a result, selling, general and administrative expenses declined, in general,
largely due to our release of 14 in-house sales people during the year as part of an initiative to
transition away from supporting a direct sales team in favor of developing and supporting a global
distribution network comprised of distributors, resellers and independent sales agents. We
continued to invest heavily in research and development of new products in 2006 with particular
emphasis focused on development and commercialization of our new Single Tooth Anesthesia (STA)
Delivery System and CompuFlo technology. In addition, towards the end of the year, we implemented
an aggressive ad and promotional campaign, utilizing a combination of direct mail and telemarketing
sales, to promote special offers to dental and medical professionals on the CompuDent, CompuMed and
related disposable products.
We plan to further support increased sales and marketing activity through trade show
appearances, increased advertising to dental and medical professionals, and costs associated with
our support of our global distribution network. Since our public offering, we have provided
further support for our expanded activities through added investment in the following areas:
Tooth Whitening and Curing
|
|
|
transferring manufacturing of the Cool Blue Light System from Tricor Systems, Inc.,
our manufacturer of the CompuDent systems; |
|
|
|
|
paying fees associated with applying for U.S. patent protection on our Ionic White
consumer teeth whitening system; and |
|
|
|
|
paying fees associated with securing a CE mark for our Cool Blue professional teeth
whitening system. |
CompuFlo
|
|
|
developing new software for the epidural clinical studies; |
|
|
|
|
additional engineering effort to make the software suitable for clinical studies; |
|
|
|
|
researching related activities to support the software development and clinical trials; |
|
|
|
|
paying legal fees related to the submission of the 510(k) to the FDA; and |
|
|
|
|
commissioning an in-depth market research study from Biotech Marketing Alliance to
determine potential market applications for our CompuFlo technology. |
Single Tooth Anesthetic System
17
|
|
|
developing the next generation product for the dental market a new unit which
incorporates the pressure sensing technology from the CompuFlo and marries it to the
core technology underlying the CompuDent system; |
|
|
|
|
paying legal fees related to the submission of the 510(k) to the FDA; and |
|
|
|
|
paying fees associated with the engagement of Corestrength, Inc., a professional
sales and marketing company who will be providing comprehensive field support to
Milestone and its distributor by way of traveling with distributor sales
representatives, collaborating on sales presentations to potential customers, training
sales reps and end-users, and participating in trade shows and conferences. |
Direct to Consumer Marketing
|
|
|
developing and implementing a targeted radio campaign to increase awareness of our
computer controlled anesthetic delivery systems in the dental market; and |
|
|
|
|
launching this campaign into the Indianapolis market in August through December of
2005. |
Current Product Platform
Milestone has endeavored to develop and bring to market a highly differentiated portfolio of
industry innovations. Specifically, Milestones proprietary solutions for application in
professional dentistry, consumer teeth whitening and a wide range of medical applications include:
CompuDent
CompuDent is Milestones proprietary, patented computer-controlled local anesthetic delivery
system which delivers anesthesia at a precise and consistent rate below a patients pain threshold.
CompuDent has been widely heralded as a revolutionary device, considered one of the major advances
in dentistry of the Twentieth Century and favorably evaluated in approximately 50 peer reviewed or
independent clinical research reports. CompuDent, including its ergonomically designed single-use
hand-piece (The Wand), provides numerous, well documented benefits:
|
|
|
CompuDent minimizes the pain associated with palatal, mandibular block and other
injections, resulting in a more comfortable injection experience for the patient; |
|
|
|
|
the pencil grip used with The Wand handpiece allows unprecedented tactile sense and
accurate control; |
|
|
|
|
new injections made possible with the CompuDent technology eliminate collateral numbness
of the tongue, lips and facial muscles; |
|
|
|
|
bi-directional rotation of The Wand handpiece eliminates needle deflection resulting in
greater success and more rapid onset of anesthesia in mandibular block injections; |
|
|
|
|
the use of a single patient use, disposable handpiece minimizes the risk of cross
contamination; |
|
|
|
|
the ergonomic design of The Wand handpiece makes an injection easier and less stressful
to administer, lowering the risk of carpal tunnel syndrome. |
Despite CompuDents many benefits, including the administration of painless injections,
dentists in the United States have been slow to give up the use of traditional syringes. Dentists
have all been trained to use syringes in dental school and often have become accustomed to and
comfortable with their use during many years of clinical practice, in spite of the obvious
reluctance and/or fear of the patient in relation to injections administered
by hypodermic syringe. There are approximately 40 million dental phobics, those people afraid
to visit a dentist, in the United States. Therefore, there may be a disconnect in the way dentists
perceive their patients attitudes toward injection by hypodermic syringe. As a result of this
disconnect, sales were below expectations in 1999 and 2000 following a successful launch in early
1998 to new adopters. By the end of 2000, Milestone had limited financial resources and was
forced to choose between maintaining its leadership position in advanced injection technology and
continuing to promote sales through high levels of sales and marketing expenses, including trade
show appearances. Milestone chose to maintain its technology leadership position and drastically
reduced marketing and sales expenses, thus allowing domestic sales of new units to suffer.
However, despite limited marketing efforts, foreign sales has continued to grow. Also, increasing
handpiece use by the domestic customer base resulted in rising handpiece sales.
Historically, Milestone has not faced pricing pressures on the CompuDent system, having raised
prices several times from a low of $1,000 in 1998 to the current retail price of $2,495. Retail
pricing of its disposable handpiece currently is $1.98. However, with an objective of moving
inventory in anticipation of our launch of
18
the STA delivery system in the first quarter of 2007,
during the late third quarter and through the fourth quarter of 2006, we implemented an aggressive
direct mail and telemarketing campaign targeting dental professionals in which we offered special
discounts on these products for a limited time period.
Single Tooth Anesthesia (STA)
The STA is a patented, computer-controlled local anesthesia delivery system that incorporates
the pressure force feedback elements of Milestones patented CompuFlo technology, thereby
allowing dentists to administer injections accurately into the periodontal ligament space,
effectively anesthetizing a single tooth. While the periodontal ligament injection has been around
for some time, there has been no effective technology that allows dentists to easily perform the
procedure painlessly, safely and predictably until now. With this unique procedure dentists can
easily and predictably profoundly anesthetize a single root tooth in one minute and a multiple root
tooth in two minutes, without first administering a general blocking injection and waiting up to 15
minutes (or longer if the blocking injection needs to be re-administered) before proceeding to
anesthetize the target tooth. We believe that a device which allows dentists to effectively
anesthetize a single tooth will greatly enhance the productivity of dental practices and, when
combined with the painless injection capabilities already present in our CompuDent system, such a
device should represent a compelling value in the marketplace. As with Milestones CompuDent
system, the STA device will generate recurring revenues from per-patient disposable handpieces.
In January 2007, we named Henry Schein, Inc. as the exclusive distributor of STA and (related
disposable products) within the United States and Canada. Henry Schein is one of the largest
distributors of products used by medical and dental professionals worldwide. In anticipation of
the soft product launch of the STA system at the 142nd Chicago Dental Mid-Winter
Meeting, held in late February 2007, Henry Schein issued its first series of purchase orders to
Milestone, representing over $1.67 million in revenue. Henry Schein also maintains first right of
refusal for distribution rights in all international markets, excluding Poland, Norway, Sweden,
Denmark and South Africa.
Prior to the soft product launch of the STA in Chicago, we also initiated a comprehensive
teaser print advertisement campaign in a leading trade publication regarding our participation at
the show and the official unveiling of the STA. We followed this with additional trade
advertisements detailing the system after the show. We anticipate continued expenses in relation
to advertisements and promotional campaigns throughout 2007, to drive brand awareness and sales
lead flow for our U.S. and Canadian distribution network.
CompuMed
CompuMed is a patented computer-controlled injection system geared to the needs of the medical
market and providing benefits similar to CompuDent. CompuMed allows many medical procedures, now
requiring IV sedation, to be performed with only local anesthesia due to dramatic pain
reduction. Also, dosages of local anesthetic can often be significantly reduced, thus
reducing side effects, accelerating recovery times, lowering costs and eliminating potential
complications. CompuMed has accumulated clinical evidence demonstrating benefits from use in
colorectal surgery; podiatry; dermatology, including surgery for the removal of
basal cell carcinomas and other oncological dermatologic procedures; nasal and sinus surgery,
including rhinoplasty; hair transplantation and plastic surgery, among others.
The Wand®
The Wand is used in conjunction with the STA, CompuDent or CompuMed systems, an
ergonomically designed, and patented hand piece that enables all traditional and newer injections,
such as AMSA, P-ASA and Modified-PDL, to be more comfortable and easier to deliver. Moreover, the
pen-like grasp of The Wand allows bi-directional rotation during injection, which prevents needle
deflection that occurs with a traditional syringe. A straighter path results in a more accurate
injection, meaning fewer missed blocks, and more rapid onset of anesthesia. Missed blocks are
reported in the literature to occur 30% of the time. This raises both patient anxiety and
difficulties for the dentists in managing their business. While the dentist is awaiting profound
anesthesia he is losing time and money.
The SafetyWand
The SafetyWand is the first, patented safety-engineered injection device that conforms to
standards while also meeting the clinical needs of dental and medical practitioners. Following the
adoption of the Federal Needlestick Safety and Prevention Act, Milestone developed, and in
September 2003 the FDA approved marketing of, Milestones SafetyWand disposable handpiece, a
patented injection device that incorporates safety engineering sharps protection features to aid in
the prevention of needlesticks. The SafetyWand is the first
19
patented injection device to be fully
compliant with OSHA regulations under the federal Needlestick Safety Act while meeting the clinical
needs of dentists.
The SafetyWand represents the culmination of two years effort to develop a safer injection
device for dentists, physicians and hygienists. While safety injection devices have been mandated
since 2000 under federal law, OSHA had been unable to enforce this law against dentists because of
the inadequacy of existing devices to meet both the requirements of the law and the clinical needs
of dentists. The SafetyWand meets these requirements and provides dental practitioners with a safer
retractable needle device, with single hand activation, which is reusable multiple times during a
single patient visit, yet small and sleek enough not to obscure the dentists sometimes limited
field of view. Since SafetyWand is now available commercially, OSHA has begun to enforce existing
regulations requiring the use of safety engineered devices. OSHA is empowered to levy substantial
fines for failure to use these devices. We believe the Safety Wand will promote increased
handpiece use by the more than 15,000 CompuDent anesthetic delivery systems previously sold in the
United States while also providing new impetus for the purchase of these systems by new users.
Tooth Whitening
In addition to products enhancing its position in advanced injection technology, in 2004
Milestone acquired rights to a portfolio of technology centered around the use of blue light
emitting diodes (LED) for a variety of dental treatment and diagnostic applications as well as for
professional and consumer teeth whitening. The first product commercialized was a proprietary
dental enhancement system now named the CoolBlue Wand, which was launched in 2004. Subsequent to
this, Milestone successfully entered the consumer teeth whitening market by licensing Ionic White,
as well as the CoolBlue professional Teeth Whitening System.
|
|
The CoolBlue Wand |
|
|
|
The CoolBlue Wand is a proprietary, cost efficient dental enhancement system that uses blue
light emitting diodes for fast curing of dental composite material, trans-illumination of teeth
tacking of veneers, and activation of whitening gels and pastes. In addition, the system enables
dentists to interchange attachments for use in cosmetic dentistry and diagnostics. |
|
|
|
Towards the end of 2005, we announced the market launch of the CoolBlue system, with the
intent of targeting the $5 billion worldwide teeth whitening market. The CoolBlue system was
designed to maximize long-term recurring revenues from disposable per-patient kits that are
utilized in the whitening treatment process. Although we initially received favorable feedback from
early adopters within the dental profession on CoolBlues overall performance, there were
reoccurring problems reported associated with product packaging. We have since
addressed the packaging issue and have made the strategic decision to forestall market
re-introduction until such time as we receive a CE mark, enabling us to re-launch CoolBlue on a
global basis through our worldwide distribution network. A CE mark is a declaration on
manufactured products sold in the European Union (EU) certifying that the item meets all the
requirements of relevant EU directives. |
Ionic White
Ionic White is a proprietary, technologically advanced light-activated teeth whitening system
developed for consumer use in the home. Ionic White whitens and brightens all tooth surfaces
within approximately 21 minutes in an easy-to-use home kit that includes a unique cool blue
intra-oral light and proprietary gel. The system provides an alternative to costly and
time-consuming trips to the dentist and/or other over-the-counter products that do not offer the
same benefits as the Ionic White system.
Since its launch in early 2005, we have failed to realize the level of sales potential we
originally anticipated for our consumer teeth whitening product, Ionic White, even after factoring
the prevailing market size offset by the highly competitive landscape in the consumer teeth
whitening market. Because our Ionic White distributor has advised that significant retail sales
are dependent upon our obtaining U.S. patent protection for the product, we proceeded with filing
the patent application with the U.S. Patent and Trademark Office. Although the patent is pending,
there can be no assurance that such patent will be issued and sales have been largely suspended.
Technology Rights
20
The technology underlying our SafetyWand, 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.
The technology underlying our CoolBlue professional whitening and Ionic White consumer
whitening products was acquired from DaVinci Systems. We pay a 7% royalty to DaVinci Systems on
the amount paid to us by our joint venture partner as a result of its sales of the consumer
whitening product. We also pay a 5% fee to Strider, Inc. on the amounts paid to us by our joint
venture partner as a result of its sales of the consumer and professional whitening products.
Strider assisted in bringing the CoolBlue and Ionic White product lines to Milestone. Currently,
sales of both CoolBlue and Ionic White have been indefinitely suspended pending the issuance of a
CE mark and U.S. patent coverage, respectively.
Summary of Critical Accounting Policies and Significant 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, 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.
While our significant accounting policies are more fully described in Note B to our financial
statements included elsewhere in this report, we believe that the following accounting policies and
significant judgments and
estimates are most critical in understanding and evaluating our reported financial results.
Accounts Receivable
Milestone estimates losses resulting from the inability of its customers to make payments for
amounts billed. The collectibility of outstanding amounts is continually assessed.
Inventories
Inventories principally consist of finished goods and component parts stated at the lower of
cost (first-in, first-out method) or market. Inventory quantities on hand are reviewed on a
quarterly basis and a provision for excess and obsolete inventory is recorded if required based on
past and expected future sales.
Impairment of Long-Lived Assets
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.
Revenue Recognition
Revenue from product sales is recognized net of discounts and allowances when title passes at
the time of shipment, collectibility is reasonably assured and Milestone has no further performance
obligations.
Royalty income is recognized as earned based on reports received from the licensee and related
royalty expense is accrued during the same period.
Results of Operations
21
The consolidated results of operations for the year ended December 31, 2006 compared to 2005
reflect our focus and development into the Single Tooth Anesthetic (STA) delivery system and
continuing efforts on the CompuFlo technology. In that regard, although our selling, general and
administrative expenses were reduced due to successful cost cutting programs, research and
development expenses increased primarily associated with our intensified effort into STA and
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.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Twelve Months Ended |
|
|
|
December 31, 2006 |
|
|
December 31, 2005 |
|
Products sales, net |
|
$ |
5,566,425 |
|
|
|
95 |
% |
|
$ |
5,775,394 |
|
|
|
90 |
% |
Royalty income |
|
|
277,752 |
|
|
|
5 |
% |
|
|
657,754 |
|
|
|
10 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
Total revenue |
|
|
5,844,177 |
|
|
|
100 |
% |
|
|
6,433,148 |
|
|
|
100 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost of products sold |
|
|
3,002,615 |
|
|
|
51 |
% |
|
|
2,521,022 |
|
|
|
39 |
% |
Royalty expense |
|
|
33,031 |
|
|
|
1 |
% |
|
|
78,930 |
|
|
|
1 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
Total cost of revenue |
|
|
3,035,646 |
|
|
|
52 |
% |
|
|
2,599,952 |
|
|
|
40 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
Gross Profit |
|
|
2,808,531 |
|
|
|
48 |
% |
|
|
3,833,196 |
|
|
|
60 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
Selling, general and
administrative expenses |
|
|
5,326,032 |
|
|
|
91 |
% |
|
|
6,794,032 |
|
|
|
106 |
% |
Research and
development expenses |
|
|
1,005,285 |
|
|
|
17 |
% |
|
|
286,260 |
|
|
|
4 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating expenses |
|
|
6,331,317 |
|
|
|
108 |
% |
|
|
7,080,292 |
|
|
|
110 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss from operations |
|
|
(3,522,786 |
) |
|
|
-60 |
% |
|
|
(3,247,096 |
) |
|
|
-50 |
% |
Other income |
|
|
283,107 |
|
|
|
5 |
% |
|
|
400,000 |
|
|
|
6 |
% |
Interest Income |
|
|
87,411 |
|
|
|
1 |
% |
|
|
92,869 |
|
|
|
2 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss |
|
$ |
(3,152,268 |
) |
|
|
-54 |
% |
|
$ |
$(2,754,227 |
) |
|
|
-42 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
Year ended December 31, 2006 compared to year ended December 31, 2005
Total revenues for the years ended December 31, 2006 and 2005 were $5,844,177 (product sales
of $5,566,425 and royalty income of $277,752) and $6,433,148, (product sales of $5,775,394 and
royalty income of $657,754) respectively. The 3.6% decrease in product sales is primarily related
to a $395,000 or 29.0% decrease in domestic sales of CompuDent and CompuMed, and a decrease of
$13,000 or 2.6% in international CompuDent and CompuMed
sales offset by a $198,000 or 5.5%
increase in worldwide sales of the Wand handpieces. Total domestic sales, including CompuDent,
CompuMed, handpieces, and CoolBlue products decreased
$176,000 or 4.1%, while total international
sales decreased by $33,000 or 2.3% in 2006. Domestic handpiece sales
increased $236,000 or 8.5%,
while international handpiece sales decreased by $38,000 or 4.4%. The amount of $277,752 or 5% of
total revenue in 2006 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 $334,103 or 57.7% reflecting increased retail competition in this increasingly
highly competitive market.
Cost of products sold for the years ended December 31, 2006 and 2005 were $3,002,615 and
$2,521,022, respectively. The $481,593 or 19.1% increase is primarily attributable to write down
of slow moving inventory of safety wand handpieces of $146,422 and whitening inventory of $275,000.
Royalty expense related to the royalty income from the sales of the Ionic White Tooth Whitening
System was $33,031 in fiscal year 2006.
For the year ended December 31, 2006, Milestone generated a gross profit of $2,808,531 or 48%
as compared to a gross profit of $3,833,196 or 60% for the year ended December 31, 2005. Excluding
the net royalty income (net of royalty expense) of $244,721, which has a gross profit of 88%, gross
profit of products sales was 46% in 2006. The decrease in gross profit percentage was due to the
write down of $421,422 in inventory. Excluding the writedown, the cost of products sold percentage
increased from 43.6% to 46.4% due to sales incentive programs initiated during the last six months
of the year.
22
Selling, general and administrative expenses for the years ended December 31, 2006 and 2005
were $5,326,032 and $6,794,032, respectively. The $1,468,000 or 21.6% decrease is pursuant to a
plan to decrease salaries, professional fees, and travel expenses. Salaries declined approximately
$619,000, professional fees were reduced approximately $510,000 and travel was approximately $
127,000 lower than 2005 levels. Payroll taxes and employee benefits due to the lower staffing
levels declined $91,000 from 2005.
Research and development expenses for the years ended December 31, 2006 and 2005 were
$1,005,285 and $286,620, respectively. These costs are associated with the intensified effort into
the development of our Single Tooth Anesthetic (STA) delivery system and continuing efforts on the
CompuFlo technology..
The loss from operations for the years ended December 31, 2006 and 2005 was $3,522,786 and
$3,247,096, respectively. The $275,690 or 8.5% increase in loss from operations is explained
above.
Interest income of $87,411 was earned through December 31, 2006 compared with $92,869 for the
prior year. Interest income declined due to lower cash balances and was partially offset by
slightly higher interest rates.
Other income of $283,107 was earned in 2006. This amount represents the sale of tax credits
under the New Jersey Technology Business Tax Certificate Program. Other income in 2005 consists of
$400,000 paid to Milestone for the purchase of certain rights held by the company.
For the reasons explained above, net loss for the year ended December 31, 2006 was $3,152,268
as compared to a net loss of $2,754,227 for the year ended December 31, 2005. The $398,041 or 14.5%
increase in net
loss is primarily a result of the decreased royalty revenue and write down of inventory which
is partially offset by the decreased operating expenses.
Liquidity and Capital Resources
As of December 31, 2006, we had cash and cash equivalents of $1,160,116 and working capital of
$2,636,941. Milestone incurred net losses of $3,152,268 and $2,754,227 and negative cash flows
from operating activities of $1,650,718 and $3,266,317 during the years ended December 31, 2006 and
2005, respectively.
For the year ended December 31, 2006, our net cash used in operating activities was
$1,650,718. This was attributable primarily to a net loss of $3,152,268 adjusted for noncash items
of $655,404 and changes in operating assets and liabilities of $846,146.
For the year ended December 31, 2006, Milestone used $81,845 in investing activities. This
was primarily attributable to $62,967 of legal fees related to new patent application. Capital
expenditures of $18,878 were primarily for the purchase of molds and tooling for new products.
Management believes that the company has sufficient resources to meet its obligations over the
next twelve months.
Recent Accounting Pronouncements
In June 2006, the Financial Accounting Standards Board (FASB) issued FASB interpretation No.
48, Accounting for Uncertainty in Income Taxes (Fin No. 48). The interpretation clarifies the
accounting for uncertainty in income taxes recognized in a companys financial statements in
accordance with SFAS No. 109, Accounting for Income Taxes. Specifically, Fin No. 48 prescribes
a recognition threshold and measurement attribute for the financial statement recognition and
measurement of a tax position taken or expected to be taken in a tax return. FIN 48 also provides
guidance on derecognition, classification, interest and penalties, accounting in interim periods,
disclosure and transition of uncertain tax positions. FIN 48 is effective for fiscal years
beginning after December 15, 2006. The company is evaluating the impact of this new pronouncement
on its financial statements.
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
23
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. The
company is evaluating the impact of this new pronouncement on its financial statements.
In February 2006, the Financial Accounting Standards Board (FASB) issued SFAS No. 155,
Accounting for Certain Hybrid Financial Instruments an amendment of FASB Statement No. 133 and
140. FAS 155 permits fair value remeasurement for any hybrid financial instrument that contains an
embedded derivative that otherwise would require bifurcation. It resolves issues in the
implementation of Statement 133 and amends Statement 140 to eliminate the prohibition on a
qualifying special-purpose entity from holding a derivative financial instrument that pertains to a
beneficial interest other than another derivative financial instrument. FAS 155 is effective for
all financial instruments acquired or issued after the beginning of an entitys first fiscal year
that begins after September 15, 2006. Milestone does not expect this standard to have any impact
on Milestones results of operations or financial position.
In May 2005, the FASB issued SFAS No. 154, Accounting Changes and Error Corrections, which
replaces APB Opinion No. 20 and FASB Statement No. 3. FAS 154 amends APB No. 20 to require
retrospective application of voluntary changes in accounting principle to prior periods financial
statements. The statement also
requires that a change in depreciation, amortization, or depletion method for long-lived,
nonfinancial assets be accounted for as a change in accounting estimate effected by a change in
accounting principles. FAS 154 is effective for accounting changes and corrections of errors made
in fiscal years beginning after December 15, 2005. We do not expect this standard to have any
impact on Milestones results of operations or financial position.
In December 2004, the FASB issued SFAS No. 123 (revised 2004), Share-Based Payment (FAS
123R), which replaces FAS 123 and supersedes APB No. 25. FAS 123R requires all share-based
payments to employees, including grants of employee stock options, to be recognized in the
financial statements based on their fair values. For public entities that file as small business
issuers, the effective date is the first interim or annual reporting period beginning after
December 15, 2005. The pro-forma disclosures previously permitted under FAS 123 no longer will be
an alternative to financial statement recognition. Milestone adopted FAS 123R effective January
1, 2006.
In November 2004, the FASB issued SFAS No. 151, Inventory Costs, an amendment of ARB No. 43,
Chapter 4 (FAS 151). FAS 151 amends Accounting Research Bulletin no. 43, Chapter 4, to clarify
that abnormal amounts of idle facility expense, freight, handling costs and wasted materials
(spoilage) should be recognized as current-period charges. In addition, FAS No 151 requires that
allocation of fixed production overhead to inventory be based on the normal capacity of the
production facilities. FAS 151 was adopted as of January 1, 2006 and is not expected to have a
significant impact on Milestones financial position.
Item 7. Financial Statements
The financial statements of Milestone required by this Item are set forth beginning on page
F-1.
Item 8. Change in and Disagreements with Accountants on Accounting and Financial Disclosure
None.
Item 8A. Controls and Procedures
Our management, with the participation of our chief executive officer and chief financial
officer, has evaluated the effectiveness of our disclosure controls and procedures (as such term is
defined in Rules 13a-15(e) and 15d-15(e) under the Exchange Act) as of the end of the period
covered by this report. Based on that evaluation, our chief executive officer and chief financial
officer have concluded that, as of the end of such period, our disclosure controls and procedures
are effective to ensure that information required to be disclosed by us in the reports that we file
or submit under the Exchange Act is (i) recorded, processed, summarized and reported, within the
time periods specified in the SECs rules and forms; and (ii) accumulated and communicated to
management, including our chief executive officer and chief financial officer, as appropriate to
allow timely decisions regarding required disclosure.
24
There were no changes in our internal controls over financial reporting which occurred
during the most recent fiscal quarter covered by this report that has materially affected, or is
reasonably likely to materially affect our internal controls over financial reporting.
Item 8B. Other Information
None.
PART III
Item 9. Directors, Executive Officers, Promoters, Control Persons and Corporate Governance; Compliance With Section 16 (a) of the Exchange Act.
The current executive officers and directors of Milestone and their respective ages as of
March 30, 2007 are as follows:
|
|
|
|
|
|
|
NAME |
|
AGE |
|
POSITION |
|
DIRECTOR SINCE |
Leonard A. Osser |
|
59 |
|
Chairman and Chief Executive Officer |
|
1991 |
Thomas R. Ronca |
|
60 |
|
Chief Operating Officer & President |
|
|
David Cohn |
|
55 |
|
Chief Financial Officer |
|
|
|
|
|
|
|
|
|
Pablo F.Serna C |
|
31 |
|
Director |
|
2006 |
Leonard M. Schiller(1)(2) |
|
65 |
|
Director |
|
1997 |
Jeffrey Fuller(1)(2) |
|
61 |
|
Director |
|
2003 |
Leslie Bernhard(1) |
|
62 |
|
Director |
|
2003 |
|
|
|
(1) |
|
Member of the Audit Committee |
|
(2) |
|
Member of the Compensation Committee |
Key Personnel
The following are the names of individuals who are not executive officers of Milestone but are
deemed key personnel of Milestone, their respective ages and positions as of March 30, 2007:
|
|
|
|
|
|
|
NAME |
|
AGE |
|
POSITION |
Eugene Casagrande, D.D.S.
|
|
|
62 |
|
|
Director of Professional Relations |
Mark Hochman, D.D.S.
|
|
|
48 |
|
|
Director of Clinical Affairs |
Leonard A. Osser has been our Chairman and Chief Executive Officer since July 1991. From
1980 until the consummation of Milestones Public Offering in November 1995, he was engaged
primarily as the principal owner and Chief Executive Officer of U.S. Asian Consulting Group, Inc.,
a New Jersey based provider of consulting services in work-out and turnaround situations for
publicly and privately owned companies in financial difficulty.
Thomas R. Ronca has been our Chief Operating Officer since May 2005 and in mid 2006 his role
and title was expanded to include President. In 2004, Mr. Ronca was a self-employed business
consultant. From 1994 until 2003, Mr. Ronca was a Senior Vice President and General Manager of the
Medical Technology Division of B. Braun Medical, Inc., a subsidiary of B. Braun Melsungen AG. From
1996 through 2000, he simultaneously served as President and Chief Operating Officer of B. Braun
Biotech, Inc., which provides fermenters, bioreactors and laboratory equipment to over 200
customers in the pharmaceutical and biotechnology industries.
25
David Cohn has been our Chief Financial Officer since July 2006. Previously, Mr. Cohn served
as Controller of Bookazine Co., Inc., a book wholesaler and distributor. In addition, Mr. Cohn has
over 20 years of experience as Controller in various companies, including Arbee Associates, an
office furniture dealership, and as an accountant and auditor in various public accounting
practices. A graduate of Rutgers University, Mr. Cohn earned a Bachelor of Science degree in
Accounting and is a Certified Public Accountant.
Dr. Mark Hochman has been a clinical consultant to Milestone since 1997 and has served on a
part-time basis as the Director of Clinical Affairs and Director of Research and Development since
1999. He has a doctorate of dental surgery with advanced training in the specialties of
periodontics and orthodontics from New York University College of Dentistry and has been practicing
dentistry since 1984. He holds a faculty appointment as a
clinical associate professor at NYU School of Dental Surgery. Dr. Hochman is a recognized
world authority on advanced drug delivery systems, has published numerous articles in this area and
is personally responsible for inventing much of the technology currently available from Milestone.
Dr. Eugene Casagrande has been the Director of Professional Relations for Milestone since
September 1998. In his capacity, Dr. Casagrande represents Milestone in a variety of clinical and
industry related opportunities. Dr. Casagrande is the President and founder of Casagrande
Consulting Services, an entity devoted to quality management to the dental industry.
Leonard M. Schiller has been a director of Milestone since April 1997. Mr. Schiller has been a
partner in the Chicago law firm of Schiller, Klein & McElroy, P.C. since 1977. He has also been
President of The Dearborn Group, a residential property management and real estate acquisition
company since 1980.
Jeffrey Fuller has been a director of Milestone since January 2003. Mr. Fuller has been
president and owner of two municipal water supply systems, Hudson Valley Water Co. and Lake Lenape
Water Co. since 1983 and in addition has been an executive recruiter since 1995. Early in his
career, for a period of two years, he was an auditor with Arthur Andersen LLP, and thereafter, for
four years, a senior internal auditor with the Dreyfus Corp. Mr. Fuller has been an adjunct
professor since 2002 at Berkeley College, NY, teaching several courses including Accounting.
Leslie Bernhard has been a director of Milestone since May 2003. Ms. Bernhard co-founded
AdStar, Inc., and since 1986 has been its President, Chief Executive Officer and a director. AdStar
is an application service provider for the newspaper classified advertising industry.
Pablo F. Serna C. has been a director of Milestone since June 2006. He is the founder of SPOT
Investments, a European-based financial services firm. Previously, from 2001 to 2005, he was a
director and Senior Manager at Dynamic Decisions Group Ltd, an equity research and valuation
consulting firm. In that capacity, Mr. Serna C. led the corporate finance team at Dynamic
Decisions in investment banking and project valuation consulting. Prior to joining Dynamic
Decisions, from 1999-2001, Mr. Serna C. served as an associate with Real Options Group. Real
Options Group is an international academic research center consulting to business entities. Before
joining Real Options Group, Mr. Serna C was the general manager with Estudios, Consultorias y
Asesorias Financieras, a Financial Consulting firm in Columbia .
Milestones Board of Directors has established compensation and audit committees. The
Compensation Committee reviews and recommends to the Board of Directors the compensation and
benefits of all the officers of Milestone, reviews general policy matters relating to compensation
and benefits of employees of Milestone, and administers the issuance of stock options to
Milestones officers, employees, directors and consultants. All compensation arrangements between
Milestone and its directors, officers and affiliates are reviewed by the Compensation Committee,
the majority of which is made up of independent directors. The Audit Committee meets with
management and Milestones independent auditors to determine the adequacy of internal controls and
other financial reporting matters. The Board of Directors has determined that Jeffrey Fuller
qualifies as an Audit Committee Financial Expert pursuant to Item 407 (d)(5) of Regulation S-B. Mr.
Fuller is independent, as that term is defined in the listing standards of the AMEX.
Section 16(a) Beneficial Ownership Reporting Compliance
26
Section 16(a) of the Securities Exchange Act of 1934 requires Milestones officers and
directors, and persons who own more than ten percent (10%) of a registered class of Milestones
equity securities to file reports of ownership and changes in ownership with the Securities and
Exchange Commission (SEC). Officers, directors and greater than ten percent (10%) stockholders
are required by SEC regulations to furnish Milestone with copies of all Section 16(a) forms they
file.
To the best of Milestones knowledge, based solely on review of the copies of such forms
furnished to Milestone, or written representations that no other forms were required, Milestone
believes that all Section 16(a)
filing requirements applicable to its officers, directors and greater than ten percent (10%)
shareholders were complied with during 2006.
Code of Ethics
Milestone has adopted a code of ethics that applies to Milestones principal executive
officer, principal financial officer and other persons performing similar functions. This code of
ethics is filed herewith as an exhibit to this annual report and is posted on Milestones web site
at www.milesci.com. We will also provide a copy of the Code of Ethics to any person without
charge, upon written request addressed to our Chief Financial Officer, David Cohn, at our principal
executive office, located at 220 South Orange Avenue, Livingston, NJ, 07039.
Item 10. Executive Compensation.
The following Summary Compensation Table sets forth all compensation earned, in all
capacities, during the fiscal year ended December 31, 2006 by (i) Milestones Chief Executive
Officer and (ii) the most highly compensated executive officers, other than the CEO, who were
serving as executive officers at the end of the 2006 fiscal year and whose salary as determined by
Regulation S-B, Item 402, exceeded $100,000 (the individuals falling within categories (i) and (ii)
are collectively referred to as the Named Executive Officers).
SUMMARY OF COMPENSATION TABLE
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Option |
|
|
NAME AND PRINCIPAL POSITION |
|
YEAR |
|
Salary |
|
Awards |
|
Total |
Leonard A. Osser |
|
|
2006 |
|
|
$ |
300,000 |
(1) |
|
|
|
|
|
$ |
300,000 |
|
Chief Executive Officer |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Thomas R. Ronca |
|
|
2006 |
|
|
$ |
192,970 |
(2) |
|
$ |
10,844 |
(3) |
|
$ |
203,814 |
|
President and Chief Operating Officer |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(1) |
|
Includes $150,000 in deferred compensation in accordance with his employment
agreement to be paid in common stock and not paid until the termination of the agreement in
2010 or thereafter, if further extended. Excludes $1,299 paid by Milestone to Marilyn Elson, a
certified public accountant, in payment of tax consultation services. Ms. Elson is the wife of
Mr. Osser. |
|
(2) |
|
$28,333 of Mr. Roncas base salary for 2006 was paid in 26,984 shares of restricted common
stock. |
|
(3) |
|
The amounts in this column reflect the expense recognized for financial statement
reporting purposes for the fiscal year ended December 31, 2006, in accordance with FAS 123(R),
Share-based Payments. for outstanding stock options granted as part of the stock option
plan. For details used in the assumption calculating the fair value of the option reward, see
Note B to our Financial Statements for the year ended December 31, 2006, which is located on
pages F-7 through F-11 of our Annual Report on Form 10-KSB. Compensation cost is generally
recognized over the vesting period of the award. The number of shares underlying this option
award totaled 10,000 shares. See the table below entitled Outstanding Equity Awards at
December 31, 2006. |
27
Employment Contracts
In December 2003, Milestone entered into a new employment agreement with Mr. Osser for a
five-year term commencing January 1, 2004. Under the new agreement Mr. Osser receives base
compensation of $300,000 per year, payable one half in cash and one half in common stock valued at
the average closing price of the common stock during the first 15 trading days in the month of
December during each year of the term. While the number of shares to be issued will be determined
each year, the stock will not be issuable until the end of the term of the agreement. In addition,
Mr. Osser may earn annual bonuses up to an aggregate of $300,000, payable one half in cash and one
half in common stock, contingent upon Milestone achieving predetermined annual operating cash flow,
revenue and earnings targets. For 2006 none of the predetermined annual operating targets were
achieved, although he could have earned a $100,000 bonus based upon Milestone achieving break-even
cash flow from operations, a $100,000 bonus based upon Milestone achieving net revenues of
$7,000,000 and a $100,000 bonus based upon Milestone achieving break-even earnings determined in
accordance with generally accepted accounting principles. The cash flow bonus and the earnings
bonus will not be payable to the extent that the payment thereof will reduce operating cash flow or
earnings below break-even, respectively. For purposes of the agreement operating cash flow shall
mean cash flow from operations plus accounts receivable increases and less accounts payable
increases. Shares of common stock issued in partial payment of bonuses will be valued at the
average closing price of the common stock during the first 15 trading days in the month of December
during each year of the term. The stock portion of the bonus awards, if any, will be paid at the
end of the term of the agreement.
In addition, if during any year of the term of the agreement Mr. Osser earns a bonus under the
above formula, he shall also be granted 5-year stock options to purchase twice the number of shares
earned under the above formula, each such option to be exercisable at a price per share equal to
the fair market value of a share on the date of grant (110% of fair market value if Mr. Osser is a
10% or greater stockholder on the date of grant). The options shall vest and become exercisable to
the extent of one-third of the shares covered at the end of each of the first three years following
the date of grant, but shall only be exercisable while Mr. Osser is employed by Milestone or within
30 days after the termination of his employment.
Objective of Our Executive Compensation Program
The primary objective of our executive compensation program is to attract and retain
qualified, energetic managers who are enthusiastic about our mission and culture. A further
objective of our compensation program is to provide incentives and reward each manager for their
contribution. In addition, we strive to promote an ownership mentality among key leadership and
the Board of Directors.
Our Compensation Committee reviews and approves, or in some cases recommends for the approval
of the full Board of Directors, the annual compensation procedures for our Named Executive
Officers.
Our compensation program is designed to reward teamwork, as well as each managers individual
contribution. In measuring the Named Executive Officers contribution, the Compensation Committee
considers numerous factors including our growth, strategic business relationships and financial
performance. Regarding most compensation matters, including executive and director compensation,
our management provides recommendations to the Compensation Committee; however, the Compensation
Committee does not delegate any of its functions to others in setting compensation. We do not
currently engage any consultant to advise on executive and/or director compensation matters.
Stock price performance has not been a factor in determining annual compensation because the
price of Milestones common stock is subject to a variety of factors outside of our control. We do
not have an exact formula for allocating between cash and non-cash compensation.
Annual executive officer compensation consists of a base salary component and periodic stock
option grants. It is the Compensation Committees intention to set total executive cash
compensation sufficiently high enough to attract and retain a strong motivated leadership team, but
not so high that it creates a negative perception with our other stakeholders. Each of our
executive officers receives stock option grants under our stock option plan. The number of stock
options granted to each executive officer is made on a discretionary
rather than a formula basis by the Compensation Committee. Each executives current and prior
compensation is considered in setting future compensation. In addition, we review the compensation
practices of other
28
companies. To some extent, our compensation plan is based on the market and the
companies we compete against for executive management. The elements of our plan (e.g., base
salary, bonus and stock options) are similar to the elements used by many companies. The exact
base pay, stock option grant, and bonus amounts are chosen in an attempt to balance our competing
objectives of fairness to all stakeholders and attracting/retaining executive managers.
Outstanding Equity Awards at December 31, 2006
The following table includes certain information with respect to the value of all unexercised
options previously awarded to our Named Executive Officers. There were no outstanding stock awards
at December 31, 2006.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Option Awards |
|
|
Number of |
|
|
|
|
|
|
Securities |
|
|
|
|
|
|
Underlying |
|
|
|
|
|
|
Unexercised |
|
Option |
|
Option |
|
|
Options |
|
Exercise |
|
Expiration |
Name |
|
Exercisable |
|
Price ($) |
|
Date |
Leonard Osser |
|
|
16,667 |
(1) |
|
|
1.65 |
|
|
|
1/1/2007 |
|
|
|
|
16,667 |
(2) |
|
|
0.87 |
|
|
|
1/1/2008 |
|
Thomas Ronca |
|
|
10,000 |
(3) |
|
|
1.50 |
|
|
|
9/26/2011 |
|
|
|
|
(1) |
|
Fully vested |
|
(2) |
|
Fully vests on 7-1-06 |
|
(3) |
|
Options for 5,000 shares of Common Stock vest on 3/26/2008 and 9/26/2009 |
Compensation of Directors
Milestone paid no cash or stock based compensation to the directors in 2006. On June 20,
2006, Milestone awarded, to each of its independent directors, options expiring June 19, 2011 for
the purchase of 20,000 shares of its common stock, half of which are exercisable immediately and
the remaining half exercisable on June 20, 2007 at $.83 per share with respect to the year starting
with Milestones 2006 annual meeting and ending with Milestones 2006 annual meeting.
The following table provides compensation information for the year ended December 31, 2006 for
each of the independent directors. We do not pay any directors fees. Directors are reimbursed
for the costs relating to attending board and committee meetings.
Director Compensation
29
|
|
|
|
|
|
|
|
|
Name |
|
Option Awards (1) |
|
Total |
Leonard M. Schiller |
|
$ |
16,600 |
(2) |
|
$ |
16,600 |
|
Jeffrey Fuller |
|
$ |
16,600 |
(2) |
|
$ |
16,600 |
|
Leslie Bernhard |
|
$ |
16,600 |
(2) |
|
$ |
16,600 |
|
Pablo F. Serna C. |
|
$ |
16,600 |
(2) |
|
$ |
16,600 |
|
|
|
|
(1) |
|
Amounts are calculated using the provisions of
Statement of Financial Accounting Standards (SFAS) No. 123R,
Share-based Payments. |
|
(2) |
|
On June 20, 2006, each of Milestones independent
directors was awarded options exercisable for 20,000 shares of our
common stock at $0.83 per share. |
30
Item 11. Security Ownership of Certain Beneficial Owners and Management and Related
Stockholder Matters
The following table, together with the accompanying footnotes, sets forth information, as of
March 30, 2007, regarding stock ownership of all persons known by Milestone to own beneficially
more than 5% of Milestones outstanding common stock, Named Executives, all directors, and all
directors and officers of Milestone as a group:
|
|
|
|
|
|
|
|
|
|
|
Shares of |
|
|
|
|
Common Stock |
|
|
|
|
Beneficially |
|
Percentage of |
Name of Beneficial Owner (1) |
|
Owned (2) |
|
Ownership |
Executive Officers and Directors |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Leonard Osser |
|
|
1,670,135 |
(3) |
|
|
14.32 |
% |
Thomas R. Ronca |
|
|
36,205 |
|
|
|
* |
|
David Cohn |
|
|
10,994 |
|
|
|
* |
|
Leonard M. Schiller |
|
|
68,432 |
(4) |
|
|
* |
|
F. Pablo
Serda C. |
|
|
20,000 |
|
|
|
|
|
Jeffrey Fuller |
|
|
66,667 |
(5) |
|
|
* |
|
Leslie Bernhard |
|
|
66,667 |
(6) |
|
|
* |
|
All directors & executive
officers as a group (7 persons) |
|
|
1,939,100 |
|
|
|
16.14 |
% |
K. Tucker Andersen |
|
|
1,603,582 |
(7) |
|
|
13.75 |
% |
|
|
|
* |
|
Less than 1% |
|
(1) |
|
The addresses of the persons named in this table are as follows: Leonard A. Osser, Thomas
R. Ronca, and David Cohn are all at 220 South Orange Avenue, Livingston Corporate Park,
Livingston, NJ 07039; Leonard M. Schiller, Schiller, Klein & McElroy, P.C., 33 North Dearborn
Street, Suite 1030, Chicago, Illinois 60602; Jeffrey Fuller, Eagle Chase, Woodbury, NY 11797;
Leslie Bernhard, AdStar, Inc., 4553 Glencoe Avenue, Suite 325, Marina del Rey, California
90292; K. Tucker Anderson, c/o Cumberland Associates LLC, 1114 Avenue of the Americas, New
York, New York 10036. |
|
(2) |
|
A person is deemed to be a beneficial owner of securities that can be acquired by such
person within 60 days from March 30, 2007 upon the exercise of options and warrants or
conversion of convertible securities. Each beneficial owners percentage ownership is
determined by assuming that options, warrants and convertible securities that are held by
such person (but not held by any other person) and that are exercisable or convertible within
60 days from the filing of this report have been exercised or converted. Except as otherwise
indicated, and subject to applicable community property and similar laws, each of the persons
named has sole voting and investment power with respect to the shares shown as beneficially
owned. All percentages are determined based on the number of all shares, including those
underlying options exercisable within 60 days from the filing of this report held by the
named individual, divided by 11,674,304 outstanding shares on March 30, 2007 plus those
shares underlying options exercisable within 60 days from the filing of this report held by
the named individual or the group. |
|
(3) |
|
Includes 325,722 shares issuable upon exercise of stock options within 60 days of the
date hereof as follows: 204,728 shares at $6.00 per share and 120,994 shares issuable upon
the exercise of warrants within 60 days of the date hereof, which are exercisable at $4.89. |
|
(4) |
|
Includes 66,667 shares subject to stock options, exercisable within 60 days of the date
hereof as follows: 6,667 shares at $1.50 per share, 20,000 shares at $3.27 per share, 20,000
shares at $1.40 per share and 20,000 shares at $.83 per share. |
|
(5) |
|
Includes 66,667 shares subject to stock options, exercisable within 60 days of the date
hereof as follows: 6,667 shares at $1.50 per share, 20,000 shares at $3.27 per share, 20,000
shares at $1.40 per |
31
|
|
|
|
|
share. and 20,000 shares at $.83 per share. |
|
(6) |
|
Includes 66,667 shares subject to stock options, exercisable within 60 days of the date
hereof as follows: 6,667 shares at $1.50 per share, 20,000 shares at $3.27 per share, 20,000
shares at $1.40 per share. and 20,000 shares at $.83 per share. |
|
(7) |
|
Includes 303,559 shares subject to warrants all of which are exercisable within 60
days of the date hereof at prices ranging from $4.89 to $6.00. |
Securities Authorized for Issuance Under Equity Compensation Plans
Equity Compensation Plan Information
The following table summarizes the (i) options granted under the Milestone 1997 and 2004 Stock
Option Plans, and (ii) options and warrants granted outside the Milestone 1997 and 2004 Stock
Option Plans, as of December 31, 2006. The shares covered by outstanding options and warrants are
subject to adjustment for changes in capitalization, stock splits, stock dividends and similar
events. No other equity compensation has been issued.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Number of Securities (1) to |
|
|
|
|
|
Number of securities (1) |
|
|
be issued upon exercise of |
|
Weighted-average exercise |
|
remaining available for |
|
|
outstanding options and |
|
price of outstanding |
|
future issuance under |
|
|
warrants |
|
options and warrants |
|
equity compensation plan |
Equity compensation plan
approved by stockholders (1) |
|
|
|
|
|
|
|
|
|
|
|
|
Grants under our 1997 Stock Option Plan |
|
|
171,834 |
|
|
$ |
2.81 |
|
|
|
142,166 |
|
Grants under our 2004 Stock Option Plan |
|
|
256,000 |
|
|
|
1.21 |
|
|
|
244,000 |
|
Equity compensation plan
not approved by stockholders (2) |
|
|
|
|
|
|
|
|
|
|
|
|
Aggregate individual option and warrant grants |
|
|
3,137,253 |
|
|
|
4.80 |
|
|
Not applicable |
|
|
|
|
|
|
|
|
|
|
|
|
|
Total |
|
|
3,565,087 |
|
|
|
4.48 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(1) |
|
Consisting of our 1997 stock option plan covering a total of 333,333 common shares
underlying options issuable to officers and other key employees and excluding 2,333 options,
which were exercised in October 2003, 16,667 options, which were exercised in December 2003,
and 333 options which were exercised in April 2005. The plan has a term of 10 years and is
administered by a committee appointed by the board of directors. The committee, in its sole
discretion, determines who is eligible to receive these incentive stock options, how many
options they will receive, the term of the options, the exercise price and other conditions
relating to the exercise of the options. Stock options granted under the plan must be
exercised within a maximum of 10 years from the date of grant at an exercise price that is
not less than the fair market value of the common shares on the date of the grant. Options
granted to shareholders owning more than 10% of our outstanding common shares must be
exercised within five years from the date of grant and the exercise price must be at least
110% of the fair market value of the common shares on the date of the grant. |
|
|
|
In July 2004 the Board of Directors approved the adoption of the 2004 Stock Option Plan. The
2004 Stock Option Plan provides for the grant of options to purchase up to 500,000 shares of
Milestones common stock. Options may be granted to employees, officers, directors and
consultants of Milestone for the purchase of common stock of Milestone at a price not less
than the fair market value of the common stock on the date of the grant. In general, options
become exercisable over a three-year period from the grant date and expire five years after
the date of grant. |
|
(2) |
|
The aggregate individual option grants outside the Stock Option Plan referred to in the
table above include options issued as payment for services rendered to us by outside
consultants and providers of certain services. The aggregate individual warrant grants
referred to in the table above include warrants granted to investors in Milestone as part of
private placements and credit line arrangements. |
32
Stock Plan
In 2006 we adopted an equity compensation plan for the issuance of up to 300,000 shares of our
common stock in lieu of cash compensation for services performed by employees, officers, directors
and consultants (the 2006 Stock Plan). The purpose of the 2006 Stock Plan is to conserve cash
while allowing use to adequately compensate existing employees, officers, directors and
consultants, or new employees, officers directors and consultants, whose performance will
contribute to our long-term success and growth. We believe that the availability of these shares
will also strengthen our ability to attract and retain employees, officers, directors and
consultants of high competence, increase the identity of interests of such people with those of our
stockholders and help maintain loyalty to us through recognition and the opportunity for stock
ownership. All shares granted under this plan will be at fair market value, or at a premium to
that value, on the date of grant.
During 2006, 98,089 shares of common stock valued at $105,833 were granted under the 2006
Stock Plan for the following reasons:
|
|
|
for consulting services, 17,493 shares valued at $20,250; and |
|
|
|
|
as part of annual compensation and severance, 80,596 shares valued at $85,583 were
issued to three employees and two former employees. |
Additionally, in satisfaction of payables owed in connection with warehousing and fulfillment
services and exhibition facilities, we issued 44,068 shares valued at $46,000 to two of our
vendors (the Vendor Shares). The Vendor Shares were issued in reliance upon the exemption from
the registration requirements of the Act, as provided in Section 4(2) thereof, as a transaction by
an issuer not involving a public offering. We reasonably believed that each vendor had such
knowledge and experience in financial and business matters to be capable of evaluating the merits
and risks of the investment, each vendor represented an intention to acquire the securities for
investment only and not with a view to distribution thereof and appropriate legends were affixed to
the stock certificates. No commissions were paid in connection with such issuances.
Item 12. Certain Relationships and Related Transactions and Director Independence
Since the beginning of our fiscal year ended December 31, 2006, we did not have any related
party transactions pursuant to Item 404 of Regulation S-B of the Exchange Act. We have
adopted a policy that, in the future, the Audit Committee must review all transactions with
any officer, director or 5% stockholder.
Director Independence
The Board has determined that Leonard M. Schiller, Jeffrey Fuller, Leslie Bernhard and Pablo Felipe
Serna Cardenas (the Independent Directors) are independent as that term is defined in the listing
standards of the AMEX. As disclosed above, Leonard M. Schiller, Jeffrey Fuller and Leslie Bernhard
are the sole members of the Audit Committee and are independent for such purposes, and Leonard M.
Schiller and Jeffrey Fuller are the sole members of the Compensation Committee and are independent
for such purposes.
In determining director independence, the Board considered the option awards to the Independent
Directors for the year ended December 31, 2006, disclosed in Item 10 Executive Compensation
Director Compensation above, and determined that such awards were compensation for services
rendered to the Board and therefore did not impact their ability to continue to serve as
Independent Directors.
Item 13. Exhibits
Exhibits
Certain of the following exhibits were filed as Exhibits to previous filings filed by
Milestone under the Securities Act of 1933, as amended, or reports filed under the Securities and
Exchange Act of 1934, as amended, and are hereby incorporated by reference.
33
|
|
|
EXHIBIT |
|
|
NO. |
|
DESCRIPTION |
3.1
|
|
Certificate of Incorporation of Milestone (1) |
|
|
|
3.2
|
|
Certificate of Amendment filed July 13, 1995 (2) |
|
|
|
3.3
|
|
Certificate of Amendment filed December 6, 1996 (3) |
|
|
|
3.4
|
|
Certificate of Amendment filed December 17, 1997 (4) |
|
|
|
3.5
|
|
Certificate of Amendment filed July 23, 2003 (6) |
|
|
|
3.6
|
|
Certificate of Amendment filed January 8, 2004. (6) |
|
|
|
3.7
|
|
Certificate of Designation filed January 15, 2004 (6) |
|
|
|
3.8
|
|
By-laws of Milestone (1) |
|
|
|
4.1
|
|
Specimen stock certificate (2) |
|
|
|
4.2
|
|
Intentionally Left Blank |
|
|
|
4.3
|
|
Form of warrant agreement, including form of warrant (8) |
|
|
|
10.1
|
|
Lease dated November 25, 1996 between Livingston Corporate Park Associates, L.L.C. and
Milestone (3) |
|
|
|
10.2
|
|
Agreement with DaVinci Systems dated July 30, 2003 (6) |
|
|
|
10.3
|
|
Agreement with Strider dated September 3, 2003 (6) |
|
|
|
10.4
|
|
Agreement with Len Osser and K. Tucker Andersen, dated October 9, 2003 (6) |
|
|
|
10.5
|
|
Agreement with Morse, Zelnick, Rose & Lander dated December 22, 2003 (6) |
|
|
|
10.6**
|
|
Employment Agreement with Leonard Osser dated December 20, 2003 (6) |
|
|
|
10.7
|
|
Agreement with United Systems dated October 20, 2004 (9) |
|
|
|
10.8
|
|
Agreement with Mark Hochman dated as of January 1, 2005 (9) |
|
|
|
10.9
|
|
Lease amendment dated April 28, 2004 between Livingston Corporate Park Associates, L.L.C. and
Milestone (9) |
|
|
|
10.10
|
|
Agreement with DaVinci regarding
exclusive license over patented products dated June 1, 2004 (10) |
|
|
|
14
|
|
Code of Ethics (7) |
|
|
|
23.1
|
|
Consent of Eisner LLP* |
|
|
|
31.1
|
|
Rule 13a-14(a) Certifications Chief Executive Officer* |
|
|
|
31.2
|
|
Rule 13a-14(a) Certifications Chief Financial Officer* |
|
|
|
32.1
|
|
Section 1350 Certifications Chief Executive Officer* |
|
|
|
32.2
|
|
Section 1350 Certifications Chief Financial Officer* |
|
|
|
* |
|
Filed herewith. |
|
** |
|
Indicates management contract or compensatory plan or arrangement |
|
(1) |
|
Incorporated by reference to Milestones Registration Statement on Form SB-2 No. 33-92324. |
|
(2) |
|
Incorporated by reference to Amendment No. 1 to Milestones Registration Statement on Form
SB-2 No. 333-92324. |
|
(3) |
|
Incorporated by reference to Milestones Form 10-KSB for the year ended December 31, 1996. |
|
(4) |
|
Incorporated by reference to Milestones Form 10-KSB for the year ended December 31, 1999. |
|
(5) |
|
Incorporated by reference to Milestones Registration Statement on Form S-2 No. 333-110376,
Amendment No. 1. |
|
(6) |
|
Incorporated by reference to Milestones Registration Statement on Form S-2 No. 333-110376,
Amendment No. 3. |
|
(7) |
|
Incorporated by reference to Milestones Form 10-KSB for the year ended December 31, 2003. |
34
|
|
|
(8) |
|
Incorporated by reference to Milestones Registration Statement on Form S-2 No. 333-110367,
Amendment No. 5. |
|
(9) |
|
Incorporated by reference to Milestones Form 10-KSB for the year ended December 31, 2004. |
|
(10) |
|
Incorporated by reference to Milestones Form 10-KSB for
the year ended December 31, 2005. |
35
Item 14. Principal Accountant Fees and Services
Audit Fees
We incurred audit and financial statement review fees totaling $220,000 and $215,000 from
Eisner LLP, our principal accountants, for the years ended December 31, 2006 and 2005,
respectively.
Audit Related Fees
Audit related fees to our principal accountant, consisting of fees in connection with our
filing of registration statements on Forms S-3 and S-8 filings and related services were $11,500 in
2006 and $34,000 for 2005.
Tax Fees
There were no fees for services related to tax compliance, tax advice and tax planning billed
by our principal accountants in 2005 and 2006.
All Other Fees
There were no other fees billed during 2006 and 2005 by Milestones principal accountant.
Audit Committee Administration of the Engagement
The engagement with Eisner LLP, our principal accountant, was approved in advance by our Audit
Committee. No non-audit or non-audit related services were approved by the audit committee in
2006.
Audit Committee Pre-Approval Policies and Procedures
The Audit Committee charter provides that the Audit Committee will pre-approve audit services and
non-audit services to be provided by our independent auditors before the accountant is engaged to
render these services. The Audit Committee may consult with management in the decision-making
process, but may not delegate this authority to management. The Audit Committee may delegate its
authority to preapprove services to one or more committee members, provided that the designees
present the pre-approvals to the full committee at the next committee meeting. All audit and
non-audit services performed by our independent accountants have been pre-approved by our Audit
Committee to assure that such services do not impair the auditors independence from us.
36
SIGNATURES
In accordance with Section 13 or 15(d) of the Securities Exchange Act of 1934, the registrant
caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
|
|
|
|
|
|
Milestone Scientific Inc.
|
|
|
By: |
/s/ Leonard Osser
|
|
|
|
Chairman and Chief Executive Officer |
|
|
|
|
|
|
Date: April 2, 2007
In accordance with the Exchange Act, this report has been signed below by the following persons on
behalf of the Registrant and in the capacities and on the dates indicated..
|
|
|
|
|
|
|
Signature |
|
|
|
Date |
|
Title |
/s/ Leonard Osser
Leonard Osser
|
|
|
|
April 2, 2007
|
|
Chairman, and Chief Executive Officer |
|
|
|
|
|
|
|
/s/ David Cohn
David Cohn
|
|
|
|
April 2, 2007
|
|
Chief Financial Officer |
|
|
|
|
|
|
|
/s/ Leonard Schiller
Leonard Schiller
|
|
|
|
April 2, 2007
|
|
Director |
|
|
|
|
|
|
|
/s/ Jeffrey Fuller
Jeffrey Fuller
|
|
|
|
April 2, 2007
|
|
Director |
|
|
|
|
|
|
|
/s/ Leslie Bernhard
Leslie Bernhard
|
|
|
|
April 2, 2007
|
|
Director |
37
INDEX TO FINANCIAL STATEMENTS
|
|
|
|
|
|
|
Page |
|
|
|
F-2 |
|
|
|
|
|
|
|
|
|
F-3 |
|
|
|
|
|
|
|
|
|
F-4 |
|
|
|
|
|
|
|
|
|
F-5 |
|
|
|
|
|
|
|
|
|
F-6 |
|
|
|
|
|
|
|
|
|
F-7 |
|
F-1
Report of Independent Registered Public Accounting Firm
To the Board of Directors and Stockholders
Milestone Scientific Inc.
We have audited the accompanying balance sheet of Milestone Scientific Inc. as of
December 31, 2006, and the related statements of operations, changes in
stockholders equity and cash flows for the years ended December 31, 2006 and 2005.
These financial statements are the responsibility of Milestones management. Our
responsibility is to express an opinion on these financial statements based on our
audits.
We conducted our audits in accordance with the standards of the Public Company
Accounting Oversight Board (United States). Those standards require that we plan
and perform the audit to obtain reasonable assurance about whether the financial
statements are free of material misstatement. An audit includes examining, on a
test basis, evidence supporting the amounts and disclosures in the financial
statements. An audit also includes assessing the accounting principles used and
significant estimates made by management, as well as evaluating the overall
financial statement presentation. We believe that our audits provide a reasonable
basis for our opinion.
In our opinion, the financial statements referred to above present fairly, in all
material respects, the financial position of Milestone Scientific Inc. as of
December 31, 2006, and the results of its operations and its cash flows for the
years ended December 31, 2006 and 2005, in conformity with United States
generally accepted accounting principles.
As discussed in Note B 15 to the financial statements, the Company changed
its method of accounting for stock-based compensation effective January 1,
2006.
/s/Eisner LLP
New York, NY
March 27, 2007
F-2
MILESTONE SCIENTIFIC INC.
BALANCE SHEET
December 31, 2006
|
|
|
|
|
ASSETS |
|
|
|
|
Current Assets: |
|
|
|
|
Cash and cash equivalents |
|
$ |
1,160,116 |
|
Accounts receivable , net of allowance for doubtful accounts of $16,519 |
|
|
346,619 |
|
Royalty receivable |
|
|
60,107 |
|
Inventories |
|
|
1,323,338 |
|
Advances to contract manufacturer |
|
|
1,077,871 |
|
Prepaid expenses |
|
|
97,073 |
|
|
|
|
|
Total current assets |
|
|
4,065,124 |
|
Investment in distributor, at cost |
|
|
76,319 |
|
Equipment, net of accumulated depreciation of $402,914 |
|
|
459,259 |
|
Patents, net of accumulated amortization of $41,938 |
|
|
526,753 |
|
Other assets |
|
|
14,153 |
|
|
|
|
|
Total assets |
|
$ |
5,141,608 |
|
|
|
|
|
|
|
|
|
|
LIABILITIES AND STOCKHOLDERS EQUITY |
|
|
|
|
Current Liabilities: |
|
|
|
|
Accounts payable |
|
$ |
1,196,107 |
|
Accrued expenses |
|
|
232,076 |
|
|
|
|
|
Total current liabilities |
|
|
1,428,183 |
|
|
|
|
|
|
|
|
|
|
Commitments (Note M) |
|
|
|
|
|
|
|
|
|
Stockholders Equity |
|
|
|
|
Common stock, par value $.001; authorized 50,000,000 shares; 11,692,636
shares issued, 337,036 shares to be issued, and 11,659,303 shares outstanding |
|
|
12,031 |
|
Additional paid-in capital |
|
|
57,720,129 |
|
Accumulated deficit |
|
|
(53,107,219 |
) |
Treasury stock, at cost, 33,333 shares |
|
|
(911,516 |
) |
|
|
|
|
Total stockholders equity |
|
|
3,713,425 |
|
|
|
|
|
Total liabilities and stockholders equity |
|
$ |
5,141,608 |
|
|
|
|
|
See Notes to Financial Statements
F-3
MILESTONE SCIENTIFIC INC.
STATEMENTS OF OPERATIONS
YEARS ENDED DECEMBER 31, 2006 AND 2005
|
|
|
|
|
|
|
|
|
|
|
2006 |
|
|
2005 |
|
Product sales, net |
|
$ |
5,566,425 |
|
|
$ |
5,775,394 |
|
Royalty income |
|
|
277,752 |
|
|
|
657,754 |
|
|
|
|
|
|
|
|
Total revenue |
|
|
5,844,177 |
|
|
|
6,433,148 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost of products sold |
|
|
3,002,615 |
|
|
|
2,521,022 |
|
Royalty expense |
|
|
33,031 |
|
|
|
78,930 |
|
|
|
|
|
|
|
|
Total cost of revenue |
|
|
3,035,646 |
|
|
|
2,599,952 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Gross profit |
|
|
2,808,531 |
|
|
|
3,833,196 |
|
|
|
|
|
|
|
|
|
|
Selling, general and administrative expenses |
|
|
5,326,032 |
|
|
|
6,794,032 |
|
Research and development expenses |
|
|
1,005,285 |
|
|
|
286,260 |
|
|
|
|
|
|
|
|
|
|
|
6,331,317 |
|
|
|
7,080,292 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss from operations |
|
|
(3,522,786 |
) |
|
|
(3,247,096 |
) |
|
|
|
|
|
|
|
|
|
Other income |
|
|
|
|
|
|
|
|
Other income |
|
|
283,107 |
|
|
|
400,000 |
|
Interest income |
|
|
87,411 |
|
|
|
92,869 |
|
|
|
|
|
|
|
|
Total other income |
|
|
370,518 |
|
|
|
492,869 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss |
|
|
(3,152,268 |
) |
|
|
(2,754,227 |
) |
|
|
|
|
|
|
|
|
|
Dividends applicable to preferred stock |
|
|
|
|
|
|
(1,691 |
) |
|
|
|
|
|
|
|
Net loss applicable to common stockholders |
|
$ |
(3,152,268 |
) |
|
$ |
(2,755,918 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss per share applicable to common stockholders -
basic and diluted |
|
$ |
(0.27 |
) |
|
$ |
(0.25 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average shares outstanding and to be issued -
basic and diluted |
|
|
11,788,690 |
|
|
|
11,007,755 |
|
|
|
|
|
|
|
|
See Notes to Financial Statements
F-4
MILESTONE SCIENTIFIC INC.
STATEMENT OF CHANGES IN STOCKHOLDERS EQUITY
YEARS ENDED DECEMBER 31, 2006 AND 2005
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Additional |
|
|
|
|
|
|
|
|
|
|
|
|
Preferred Stock |
|
|
Common Stock |
|
|
Paid-in |
|
|
Accumulated |
|
|
Treasury |
|
|
|
|
|
|
Shares |
|
|
Amount |
|
|
Shares |
|
|
Amount |
|
|
Capital |
|
|
Deficit |
|
|
Stock |
|
|
Total |
|
Balance January 1, 2005 |
|
|
25,365 |
|
|
$ |
25 |
|
|
|
9,824,287 |
|
|
$ |
9,824 |
|
|
$ |
52,618,913 |
|
|
$ |
(47,196,539 |
) |
|
$ |
(911,516 |
) |
|
$ |
4,520,707 |
|
Common stock and options issued
for payments of patent rights acquired |
|
|
|
|
|
|
|
|
|
|
43,424 |
|
|
|
44 |
|
|
|
98,122 |
|
|
|
|
|
|
|
|
|
|
|
98,166 |
|
Common stock issued for payment of
vendor services |
|
|
|
|
|
|
|
|
|
|
156,098 |
|
|
|
156 |
|
|
|
306,219 |
|
|
|
|
|
|
|
|
|
|
|
306,375 |
|
Common stock and options issued for
payment of consulting services |
|
|
|
|
|
|
|
|
|
|
139,362 |
|
|
|
140 |
|
|
|
348,583 |
|
|
|
|
|
|
|
|
|
|
|
348,723 |
|
Common stock issued for payment of
employee compensation |
|
|
|
|
|
|
|
|
|
|
23,461 |
|
|
|
23 |
|
|
|
44,977 |
|
|
|
|
|
|
|
|
|
|
|
45,000 |
|
Common stock issued for exercised options |
|
|
|
|
|
|
|
|
|
|
333 |
|
|
|
0 |
|
|
|
749 |
|
|
|
|
|
|
|
|
|
|
|
749 |
|
Common shares to be issued in
settlement of deferred compensation |
|
|
|
|
|
|
|
|
|
|
207,726 |
|
|
|
208 |
|
|
|
299,792 |
|
|
|
|
|
|
|
|
|
|
|
300,000 |
|
Proceeds from equity financings, net |
|
|
|
|
|
|
|
|
|
|
1,356,440 |
|
|
|
1,356 |
|
|
|
3,451,357 |
|
|
|
|
|
|
|
|
|
|
|
3,452,713 |
|
Conversion of preferred stock |
|
|
(25,365 |
) |
|
|
(25 |
) |
|
|
4,391 |
|
|
|
4 |
|
|
|
21 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Stock dividends applied to preferred stock |
|
|
|
|
|
|
|
|
|
|
2,683 |
|
|
|
3 |
|
|
|
4,182 |
|
|
|
(4,185 |
) |
|
|
|
|
|
|
|
|
Net loss |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(2,754,227 |
) |
|
|
|
|
|
|
(2,754,227 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance, December 31, 2005 |
|
|
|
|
|
|
|
|
|
|
11,758,205 |
|
|
|
11,758 |
|
|
|
57,172,915 |
|
|
|
(49,954,951 |
) |
|
|
(911,516 |
) |
|
|
6,318,206 |
|
Common stock and options issued for
payment of consulting services |
|
|
|
|
|
|
|
|
|
|
8,491 |
|
|
|
9 |
|
|
|
204,822 |
|
|
|
|
|
|
|
|
|
|
|
204,831 |
|
Common stock issued for payment of
vendor services |
|
|
|
|
|
|
|
|
|
|
53,070 |
|
|
|
53 |
|
|
|
57,197 |
|
|
|
|
|
|
|
|
|
|
|
57,250 |
|
Common stock and options issued for
payment of employee compensation |
|
|
|
|
|
|
|
|
|
|
80,596 |
|
|
|
81 |
|
|
|
135,325 |
|
|
|
|
|
|
|
|
|
|
|
135,406 |
|
Common shares to be issued in
settlement of deferred compensation |
|
|
|
|
|
|
|
|
|
|
129,310 |
|
|
|
130 |
|
|
|
149,870 |
|
|
|
|
|
|
|
|
|
|
|
150,000 |
|
Net loss |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$ |
(3,152,268 |
) |
|
|
|
|
|
|
(3,152,268 |
) |
|
|
|
Balance, December 31, 2006 |
|
|
|
|
|
$ |
|
|
|
|
12,029,672 |
|
|
$ |
12,031 |
|
|
$ |
57,720,129 |
|
|
$ |
(53,107,219 |
) |
|
$ |
(911,516 |
) |
|
$ |
3,713,425 |
|
|
|
|
See Notes to Financial Statements
F-5
MILESTONE SCIENTIFIC INC.
STATEMENTS OF CASH FLOWS
YEARS ENDED DECEMBER 31, 2006 AND 2005
|
|
|
|
|
|
|
|
|
|
|
2006 |
|
|
2005 |
|
Cash flows from operating activities: |
|
|
|
|
|
|
|
|
Net loss |
|
$ |
(3,152,268 |
) |
|
$ |
(2,754,227 |
) |
Adjustments to reconcile net loss to net cash used in operating activities: |
|
|
|
|
|
|
|
|
Depreciation expense |
|
|
95,914 |
|
|
|
99,060 |
|
Amortization of patents |
|
|
22,849 |
|
|
|
19,090 |
|
Common stock and options issued for compensation, consulting,
and vendor services |
|
|
547,487 |
|
|
|
700,098 |
|
Bad debt (recovery) expense |
|
|
(10,846 |
) |
|
|
33,111 |
|
Changes in operating assets and liabilities: |
|
|
|
|
|
|
|
|
Accounts receivable |
|
|
11,292 |
|
|
|
41,163 |
|
Royalty receivable |
|
|
125,595 |
|
|
|
(185,702 |
) |
Inventories |
|
|
48,016 |
|
|
|
(435,133 |
) |
Advances to contract manufacturer |
|
|
(58,208 |
) |
|
|
(957,629 |
) |
Prepaid expenses |
|
|
12,618 |
|
|
|
(5,129 |
) |
Other assets |
|
|
10,044 |
|
|
|
(3,789 |
) |
Accounts payable |
|
|
688,063 |
|
|
|
33,969 |
|
Accrued expenses |
|
|
8,726 |
|
|
|
(1,199 |
) |
Deferred compensation |
|
|
|
|
|
|
150,000 |
|
|
|
|
|
|
|
|
Net cash used in operating activities |
|
|
(1,650,718 |
) |
|
|
(3,266,317 |
) |
|
|
|
|
|
|
|
Cash flows from investing activities: |
|
|
|
|
|
|
|
|
Payment for capital expenditures |
|
|
(18,878 |
) |
|
|
(23,092 |
) |
Payment for patent rights |
|
|
(62,967 |
) |
|
|
(306,317 |
) |
Investment in distributor |
|
|
|
|
|
|
(6,363 |
) |
|
|
|
|
|
|
|
Net cash used in investing activities |
|
|
(81,845 |
) |
|
|
(335,772 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash flows from financing activities: |
|
|
|
|
|
|
|
|
Proceeds from equity financing, net |
|
|
|
|
|
|
3,452,713 |
|
Proceeds from exercise of option |
|
|
|
|
|
|
749 |
|
|
|
|
|
|
|
|
Net cash provided by financing activities |
|
|
|
|
|
|
3,453,462 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
NET DECREASE IN CASH AND CASH EQUIVALENTS |
|
|
(1,732,563 |
) |
|
|
(148,627 |
) |
Cash and cash equivalents at beginning of year |
|
|
2,892,679 |
|
|
|
3,041,306 |
|
|
|
|
|
|
|
|
Cash and cash equivalents at end of year |
|
$ |
1,160,116 |
|
|
$ |
2,892,679 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
See Notes to Financial Statements
F-6
MILESTONE SCIENTIFIC INC.
NOTES TO FINANCIAL STATEMENTS
NOTE A ORGANIZATION, BUSINESS AND BASIS OF PRESENTATION
Milestone Scientific Inc. (Milestone) was incorporated in the State of Delaware in
August 1989. Milestone has developed a proprietary, computer-controlled anesthetic
delivery system, through the use of The Wand, a single use disposable handpiece. The
system is marketed in dentistry under the trademark CompuDent and Wand Plus and in
medicine under the trademark CompuMed. CompuDent is suitable for all dental
procedures that require local anesthetic. CompuMed and Wand Plus are suitable for
many medical procedures regularly performed in Plastic Surgery, Hair Restoration
Surgery, Podiatry, Colorectal Surgery, Dermatology, Orthopedics and a number of other
disciplines. The systems are sold in the United States and in over 25 countries
abroad. Milestones products are manufactured by a third-party contract manufacturer.
The Companys financial statements have been prepared assuming that it will continue
as a going concern. The Company has incurred recurring operating losses and negative
operating cash flows since its inception. At December 31, 2006 the Company had cash
and cash equivalents and working capital of $1,160,000 and $2,637,000, 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 the calendar year ending December 31, 2007.
NOTE B SUMMARY OF SIGNIFICANT 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. Royalty Receivable
Royalty receivable represents the royalty due from the licensee of Milestones
proprietary consumer dental whitening product, which is sold under Milestones
distributors trademark of Ionic White. The royalties are received on a quarterly
basis.
3. Inventories
Inventories principally consist of finished goods and component parts stated at the
lower of cost (first-in, first-out method) or market.
4. Equipment
Equipment is recorded at cost, less accumulated depreciation. Depreciation expense is
computed using the straight-line method over the estimated useful lives of the assets,
which range from 5 to 7 years. The costs of maintenance and repairs are charged to
operations as incurred.
5. Investments
Investments in less than 20% owned entities are accounted for under the cost basis and
are reviewed for impairment periodically.
6. Patents
Patents are recorded at cost and are being amortized by the straight-line method over
their estimated remaining useful lives. Legal fees related to new patent applications
are capitalized as patent cost. Litigation costs incurred to protect and enforce
Milestones patents are charged to expense as incurred.
7. Impairment of Long-Lived Assets
F-7
MILESTONE SCIENTIFIC INC.
NOTES TO FINANCIAL STATEMENTS
Milestone reviews patents and equipment for impairment whenever events or
circumstances indicate that the carrying amounts may not be recoverable. The carrying
value of the assets is evaluated in relation to the operating performance and future
undiscounted cash flows of the underlying assets. Milestone adjusts the net book
value of an underlying asset if its fair value is determined to be less than its book
value.
8. Revenue Recognition
Revenue from product sales is recognized net of discounts and allowances when title
passes at the time of shipment, collectibility is reasonably assured and Milestone has
no further performance obligations.
Royalty income is recognized as earned based on reports received from the licensee and
related royalty expense is accrued during the same period.
9. Research and Development
Research and development costs, which consist principally of new product development
costs incurred to third parties, are expensed as incurred.
10. Advertising Expenses
Milestone expenses advertising costs as they are incurred. For the years ended
December 31, 2006 and 2005, Milestone recorded advertising expenses of $308,865 and
$329,930, respectively.
11. Income Taxes
Milestone accounts for income taxes pursuant to the asset and liability method which
requires deferred income tax assets and liabilities to be computed for temporary
differences between the financial statement and tax bases of assets and liabilities
that will result in taxable or deductible amounts in the future based on enacted tax
laws and rates applicable to the periods in which the differences are expected to
affect taxable income. Valuation allowances are established when necessary to reduce
deferred tax assets to the amount expected to be realized. The income tax provision or
credit is the tax payable or refundable for the period plus or minus the change during
the period in deferred tax assets and liabilities.
12. 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.
Since Milestone had net losses for 2006 and 2005, the assumed effects of the exercise
of outstanding stock options and warrants, and the conversion in 2005 of preferred
stock into common stock were not included in the calculation as their effect would
have been anti-dilutive. Such outstanding options and warrants totaled
3,565,087 at December 31, 2006 and 3,687,085 at December 31, 2005.
Net loss applicable to common stockholders is computed after providing for cumulative
dividends at a rate of 8% per year applicable to preferred stock prior to conversion
into common stock in November 2005.
13. Use of Estimates
The preparation of financial statements in conformity with accounting principles
generally accepted in the United
F-8
MILESTONE SCIENTIFIC INC.
NOTES TO FINANCIAL STATEMENTS
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.
14. Fair Value of Financial Instruments
The carrying amounts reported in the consolidated balance sheet for cash, accounts
receivable, advances to contract manufacturer, accounts payable and accrued expenses
approximate fair value based on the short-term maturity of these instruments.
15 Accounting for Stock-Based Compensation
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 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.
As of
December 31, 2006, there were 171,834 outstanding options
granted under the Milestone 1997 Stock Option Plan and 256,000
outstanding options granted under the Milestone 2004 Stock
Option Plan. As a result of adopting SFAS No. 123R,
the Company recognized $41,489 in share-based compensation
expense and a corresponding increase in net loss for the year ended
December 31, 2006. This share-based compensation expense had
minimal impact on the Companys basic and diluted earnings per
share.
The
following table illustrates net loss and loss per share applicable to
common stockholders for the year ended December 31, 2005 if Milestone
had applied the fair value based method prescribed by SFAS No. 123:
|
|
|
|
|
|
|
|
|
Net loss applicable to common stockholders |
|
$ |
(2,755,918 |
) |
Deduct total stock-based employee compensation
expenses determined under the fair value
based method for all awards* |
|
|
469,362 |
|
|
|
|
|
|
|
|
|
|
Net loss applicable to common stockholders, pro forma |
|
$ |
(3,225,280 |
) |
|
|
|
|
Loss per share applicable to common stockholders: |
|
|
|
|
Basic and diluted |
|
|
|
|
As reported |
|
$ |
(0.25 |
) |
|
|
|
|
Pro forma |
|
$ |
(0.29 |
) |
|
|
|
|
|
|
|
* |
|
Excludes common stock issued as compensation. |
The weighted-average fair value of the individual options granted during 2006 and 2005
was estimated as $.93 and $1.52, respectively, on the date of grant. The fair value
for 2006 and 2005 was determined using the Black-Scholes option-pricing model with the
following weighted average assumptions:
F-9
MILESTONE SCIENTIFIC INC.
NOTES TO FINANCIAL STATEMENTS
|
|
|
|
|
|
|
|
|
|
|
December 31, |
|
|
2006 |
|
2005 |
Volatility |
|
|
118 |
% |
|
|
127 |
% |
Risk-free interest rate |
|
|
4.6 |
% |
|
|
4.0 |
% |
Expected life |
|
4 years |
|
5 years |
Dividend yield |
|
|
0 |
% |
|
|
0 |
% |
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.
16. 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 $1.1 million to the vendor for purchase of materials. The advance will
be credited to Milestone as the goods are delivered. Milestone does not believe that
significant credit risk exits with respect to this advance to the contract
manufacturer at December 31, 2006.
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 December 31, 2006.
17. Recent Accounting Pronouncements
F-10
MILESTONE SCIENTIFIC INC.
NOTES TO FINANCIAL STATEMENTS
In June 2006, the Financial Accounting Standards Board (FASB) issued FASB
interpretation No. 48, Accounting for Uncertainty in Income Taxes (Fin No. 48). The
interpretation clarifies the accounting for uncertainty in income taxes recognized in a
companys financial statements in accordance with SFAS No. 109, Accounting for Income
Taxes. Specifically, Fin No. 48 prescribes a recognition threshold and measurement
attribute for the financial statement recognition and measurement of a tax position taken or
expected to be taken in a tax return. FIN 48 also provides guidance on derecognition,
classification, interest and penalties, accounting in interim periods, disclosure and
transition of uncertain tax positions. . FIN 48 is effective for fiscal years beginning
after December 15, 2006. The company is evaluating the impact of this new pronouncement on
its financial statements.
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. The company is evaluating the impact of this new
pronouncement on its financial statements.
In February 2006, the Financial Accounting Standards Board (FASB) issued SFAS No. 155,
Accounting for Certain Hybrid Financial Instruments an amendment of FASB Statement No. 133
and 140. FAS 155 permits fair value remeasurement for any hybrid financial instrument that
contains an embedded derivative that otherwise would require bifurcation. It resolves
issues in the implementation of Statement 133 and amends Statement 140 to eliminate the
prohibition on a qualifying special-purpose entity from holding a derivative financial
instrument that pertains to a beneficial interest other than another derivative financial
instrument. FAS 155 is effective for all financial instruments acquired or issued after the
beginning of an entitys first fiscal year that begins after September 15, 2006. Milestone
does not expect this standard to have any impact on Milestones results of operations or
financial position.
In May 2005, the FASB issued SFAS No. 154, Accounting Changes and Error Corrections, which
replaces APB Opinion No. 20 and FASB Statement No. 3. FAS 154 amends APB No. 20 to require
retrospective application of voluntary changes in accounting principle to prior periods
financial statements. The statement also requires that a change in depreciation,
amortization, or depletion method for long-lived, nonfinancial assets be accounted for as a
change in accounting estimate effected by a change in accounting principle. FAS 154 is
effective for accounting changes and corrections of errors made in fiscal years beginning
after December 15, 2005. We do not expect this standard to have any impact on Milestones
results of operations or financial position.
In December 2004, the FASB issued SFAS No. 123 (revised 2004), Share-Based Payment (FAS
123R), which replaces FAS 123 and supersedes APB No. 25. FAS 123R requires all share-based
payments to employees, including grants of employee stock options, to be recognized in the
financial statements based on their fair values. For public entities that file as small
business issuers, the effective date is the first interim or annual reporting period
beginning after December 15, 2005. The pro-forma disclosures previously permitted under FAS
123 no longer will be an alternative to financial statement recognition. . Milestone adopted
FAS 123R effective January 1, 2006.
In November 2004, the FASB issued SFAS No. 151, Inventory Costs, an amendment of ARB No. 43,
Chapter 4 (FAS 151). FAS 151 amends Accounting Research Bulletin no. 43, Chapter 4, to
clarify that abnormal amounts of idle facility expense, freight, handling costs and wasted
materials (spoilage) should be recognized as current-period charges. In addition, FAS No 151
requires that allocation of fixed production overhead to inventory be based on the normal
capacity of the production facilities. FAS 151 was adopted as of January 1, 2006 and is not
expected to have a significant impact on Milestones
financial position.
F-11
MILESTONE SCIENTIFIC INC.
NOTES TO FINANCIAL STATEMENTS
NOTE C INVENTORIES
|
|
|
|
|
Inventories consist of the following: |
|
|
|
|
Finished goods |
|
$ |
1,079,983 |
|
Component parts and other materials |
|
|
243,355 |
|
|
|
|
|
|
|
$ |
1,323,338 |
|
|
|
|
|
Slow moving and overstocked inventories totaling approximately $421,000 were
charged off to cost of products sold during the year ended December 31, 2006.
NOTE D ADVANCES TO CONTRACT MANUFACTURER
Advances to contract manufacturer represent funding of future inventory purchases.
The balance of advances as of December 31, 2006 totaled $1,077,871.
NOTE E EQUIPMENT
|
|
|
|
|
Equipment consists of the following: |
|
|
|
|
Leasehold improvements |
|
$ |
6,913 |
|
Artwork |
|
|
85,550 |
|
Office furniture and equipment |
|
|
101,092 |
|
Trade show displays |
|
|
51,575 |
|
Computers and software |
|
|
220,385 |
|
Tooling equipment |
|
|
396,658 |
|
|
|
|
|
Total |
|
|
862,173 |
|
Less accumulated depreciation & amortization |
|
|
(402,914 |
) |
|
|
|
|
|
|
$ |
459,259 |
|
|
|
|
|
Depreciation expense was $95,914 and $99,060 for the years ended December 31, 2006 and
2005, respectively.
NOTE F
PATENTS
Patents are being amortized by the straight-line method over estimated useful lives
ranging from 10 to 20 years, with a weighted average amortization period of 16 years.
Amortization expense amounted to $22,849 in 2006 and $19,090 in 2005. Estimated amortization expense of existing patents for each of the next five
fiscal years amounts to $22,848 per year.
NOTE G INVESTMENT IN DISTRIBUTOR
In December 2004 Milestone purchased a 19.9% equity interest in a German distribution
company which is an affiliate of Milestones principal international distributor.
NOTE
H STOCKHOLDERS EQUITY
PRIVATE PLACEMENTS
On April, 4, 2005, Milestone completed a $2,999,996 private placement of 101,044 Units
to accredited investors. Each Unit consists of 10 shares of common stock and two
warrants. Each warrant entitles the holder to purchase a share of common stock at
$4.89 per share through the close of business on February 16, 2009. I-Bankers
Securities, Inc. acted as placement agent for Milestone in this transaction and
received a fee of $209,978 and 101,044 warrants identical in terms to those issued to
the investors. Net proceeds from the private placement, after commissions and other
offering expenses, were $2,655,659.
F-12
MILESTONE SCIENTIFIC INC.
NOTES TO FINANCIAL STATEMENTS
On June 30, 2005, Milestone completed an $847,960 private placement of 34,000 Units to
accredited investors. Each Unit consists of 10 shares of common stock and two
warrants. Each warrant entitles the holder to purchase a share of common stock at
$4.89 per share through the close of business on February 16, 2009. Proceeds from
this private placement were recorded net of a fee of $50,878 and 600 identical units
to the investment advisor. Net proceeds from this private placement, after
commissions and other offering expenses, were $797,054.
OTHER ISSUANCES OF COMMON STOCK
In February, 2006 Milestone issued 44,068 shares valued at $46,000 to two vendors owed
in connection with exhibition facilities and inventory purchases.
In August, 2006 Milestone issued 48,810 shares valued at $51,250 to two current and
two former employees as part of annual compensation.
In September, 2006 Milestone issued 17,493 shares valued at $20,250 to one vendor in
settlement of investor relation fees.
In December, 2006 Milestone issued 31,786 shares valued at $34,333 to three employees
as part of annual compensation.
In January 2005, Milestone issued 43,424 shares valued at $70,000 to Milestones
outside director of clinical affairs pursuant to a technology agreement to provide
Milestone with patent rights.
In 2005, Milestone issued 139,362 shares valued at $372,000 to seven consultants for
current and future services, of which $238,166 was recorded as
expense in 2005 and $100,501 was recorded as expense in 2006.
Milestone also issued options to various consultants and its outside general counsel
for which it recorded expense of $110,557 in 2005.
In 2005, Milestone issued 13,496 shares, of which 6,061 shares was bonus and 7,435
shares as part of annual compensation, valued at $30,000 (of which $21,668 was
expensed in 2005 and $8,333 was expensed in 2006) to two employees. Milestone also issued 9,965 shares valued at
$23,333 to a former employee as part of a severance agreement.
In 2005, Milestone issued 156,098 shares to two vendors in satisfaction of $306,375
payables owed in connection
with warehousing and fulfillment services and exhibition facilities.
PREFERRED STOCK
The 25,365 shares of 8% convertible preferred stock outstanding at December 31, 2004
were converted to 4,391 shares of common stock on November 1, 2005 based on a
conversion factor of 1:0.1731.
On November 1, 2005, Milestone issued 2,683 common shares in satisfaction of
cumulative dividends totaling $4,185 applicable to the 8% convertible preferred stock.
OUTSTANDING WARRANTS
At December 31, 2006 there were 2,614,787 warrants exercisable at prices ranging from
$4.89 to $6.00 per share expiring at various dates between January 31, 2007 through
April 17, 2009.
In March 2005, as part of the March 2005 private placement, Milestone issued 303,132
warrants exercisable at $4.89 through 2009, of which 202,088 were issued to investors
and 101,044 were issued to consultants.
In June 2005, as part of the private placement, Milestone issued 69,200 warrants
exercisable at $4.89 through 2009,
F-13
MILESTONE SCIENTIFIC INC.
NOTES TO FINANCIAL STATEMENTS
of which 68,000 were issued to investors and 1,200
to consultants.
SHARES RESERVED FOR FUTURE ISSUANCE
At
December 31, 2006 there were 4,288,288 shares reserved for future issuance
including 813,999 shares underlying stock options available under the
Plans, 3,173,253 shares underlying other stock options and warrants that were outstanding at December
31, 2006 and 337,036 shares to be issued in settlement of deferred compensation.
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 December 31, 2006, no shares have been purchased.
NOTE I STOCK OPTION PLANS
In 1997, the Board of Directors approved the adoption of the 1997 Stock Option Plan.
The 1997 Stock Option Plan provides for the grant of options to purchase up to 166,667
shares of Milestones common stock. In 1999, the Plan was amended, providing for the
grant of options to purchase up to 333,333 shares of Milestones common stock.
Options may be granted to employees, officers, and directors of Milestone for the
purchase of common stock of
Milestone at a price not less than the fair market value of the common stock on the
date of the grant. In general, options become exercisable over a three-year period
from the grant date and expire five years after the date of grant.
In July 2004, the Board of Directors approved the adoption of the 2004 Stock Option
Plan. The 2004 Stock Option Plan provides for the grant of options to purchase up to
500,000 shares of Milestones common stock. Options may be granted to employees,
officers, directors and consultants of Milestone for the purchase of common stock of
Milestone at a price not less than the fair market value of the common stock on the
date of the grant. In general, options become exercisable over a three-year period
from the grant date and expire five years after the date of grant.
A summary of option activity for employees under the plans as of December 31, 2006,
and changes during the year then ended is presented below:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted |
|
|
|
|
|
|
|
|
|
|
Weighted |
|
|
Average |
|
|
Aggregate |
|
|
|
Number |
|
|
Average |
|
|
Remaining |
|
|
Intrinsic |
|
|
|
of |
|
|
Exercise |
|
|
Contractual |
|
|
Options |
|
|
|
Options |
|
|
Price |
|
|
Life (Years) |
|
|
Value |
|
Outstanding, January 1, 2006 |
|
|
453,167 |
|
|
|
2.63 |
|
|
|
3.60 |
|
|
|
|
|
Granted |
|
|
147,000 |
|
|
|
1.12 |
|
|
|
4.92 |
|
|
|
|
|
Exercised |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Forfeited or expired |
|
|
172,333 |
|
|
|
3.26 |
|
|
|
2.62 |
|
|
|
|
|
Outstanding, December 31, 2006 |
|
|
427,834 |
|
|
|
1.85 |
|
|
|
3.34 |
|
|
$ |
32,360 |
|
Exercisable, December 31, 2006 |
|
|
277,167 |
|
|
|
2.05 |
|
|
|
3.22 |
|
|
$ |
14,883 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
WEIGHTED |
|
|
WEIGHTED |
|
|
|
NUMBER |
|
|
AVERAGE |
|
|
AVERAGE |
|
|
|
OF |
|
|
EXERCISE |
|
|
GRANT DATE |
|
|
|
OPTIONS |
|
|
PRICE |
|
|
FAIR VALUE |
|
Vested
Options |
|
|
|
|
|
|
|
|
|
|
|
|
Outstanding at beginning of period |
|
|
366,166 |
|
|
$ |
2.40 |
|
|
|
|
|
Exercised |
|
|
0 |
|
|
$ |
0.00 |
|
|
|
|
|
Vested Options |
|
|
75,334 |
|
|
$ |
2.84 |
|
|
|
|
|
Expired |
|
|
(164,333 |
) |
|
$ |
3.18 |
|
|
|
|
|
Outstanding at end of period |
|
|
277,167 |
|
|
$ |
2.05 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
NONVESTED OPTIONS |
|
|
|
|
|
|
|
|
|
|
|
|
Nonvested at beginning of period |
|
|
87,001 |
|
|
$ |
3.60 |
|
|
$ |
0.78 |
|
Granted |
|
|
147,000 |
|
|
$ |
1.12 |
|
|
$ |
0.93 |
|
Vested |
|
|
(75,334 |
) |
|
$ |
2.84 |
|
|
$ |
1.01 |
|
Forfeited |
|
|
(8,000 |
) |
|
$ |
4.92 |
|
|
$ |
1.38 |
|
Nonvested at end of period |
|
|
150,677 |
|
|
$ |
1.49 |
|
|
$ |
0.78 |
|
Milestone recognizes compensation expense on a straight line basis over the requisite
service period. During the year ended December 31, 2006 Milestone recognized $41,489 of
total compensation cost related to options that vested during the year. As of December
31, 2006, there was $109,313 of total unrecognized compensation cost related to nonvested options which Milestone expects to recognize over a
weighted average period of one and a quarter years.
A summary of option activity for non-employees under the plans as of December 31, 2006,
and changes during the year ended is presented below:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted |
|
|
|
|
|
|
|
|
|
|
Weighted |
|
|
Average |
|
|
Aggregate |
|
|
|
Number |
|
|
Average |
|
|
Remaining |
|
|
Intrinsic |
|
|
|
of |
|
|
Exercise |
|
|
Contractual |
|
|
Options |
|
|
|
Options |
|
|
Price |
|
|
Life (Years) |
|
|
Value |
|
Outstanding, January 1, 2006 |
|
|
574,131 |
|
|
|
4.11 |
|
|
|
|
|
|
|
|
|
Granted |
|
|
100,000 |
|
|
|
3.50 |
|
|
|
|
|
|
|
|
|
Exercised |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Forfeited or expired |
|
|
(151,665 |
) |
|
|
5.78 |
|
|
|
|
|
|
|
|
|
Outstanding, December 31, 2006 |
|
|
522,466 |
|
|
|
3.51 |
|
|
|
3.17 |
|
|
|
|
|
Exercisable, December 31, 2006 |
|
|
310,910 |
|
|
|
3.43 |
|
|
|
3.17 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
WEIGHTED |
|
|
|
NUMBER |
|
|
AVERAGE |
|
|
|
OF |
|
|
EXERCISE |
|
|
|
OPTIONS |
|
|
PRICE |
|
Vested Options |
|
|
|
|
|
|
|
|
Outstanding at beginning of period |
|
|
222,862 |
|
|
$ |
4.30 |
|
Exercised |
|
|
0 |
|
|
$ |
0.00 |
|
Vested Options |
|
|
139,711 |
|
|
$ |
3.56 |
|
Expired |
|
|
(51,663 |
) |
|
$ |
2.55 |
|
Outstanding at end of period |
|
|
310,910 |
|
|
$ |
3.43 |
|
|
|
|
|
|
|
|
|
|
NONVESTED OPTIONS |
|
|
|
|
|
|
|
|
Nonvested at beginning of period |
|
|
351,267 |
|
|
$ |
4.00 |
|
Granted |
|
|
100,000 |
|
|
$ |
3.50 |
|
Vested |
|
|
(139,711 |
) |
|
$ |
3.56 |
|
Forfeited |
|
|
(100,000 |
) |
|
$ |
4.89 |
|
Nonvested at end of period |
|
|
211,556 |
|
|
$ |
3.63 |
|
The weighted average grant date fair value of options granted to non-employees during the
year ended December 31, 2006 was $0.47. 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: excepted life of 2 years; volatility of 123% and risk-free
interest rate of 4.52%. During the year ended December 31, 2006 Milestone recognized
$95,328 of expense related to non-employee options that vested during the year.
F-14
MILESTONE SCIENTIFIC INC.
NOTES TO FINANCIAL STATEMENTS
F-15
MILESTONE SCIENTIFIC INC.
NOTES TO FINANCIAL STATEMENTS
NOTE J EMPLOYMENT CONTRACT AND DEFERRED COMPENSATION
Milestone entered into an employment agreement with the CEO for a five-year term
commencing January 1, 2004. Under the new agreement, the CEO will receive base
compensation of $300,000 per year, payable one half in cash and one half in common
stock valued at the average closing price of the common stock during the first 15
trading days in the month of December during each year of the term. While the number
of shares to be issued will be determined each year, the stock will not be issuable
until the end of the term of the agreement. In addition, the CEO may earn annual
bonuses up to an aggregate of $300,000, payable one half in cash and one half in
common stock, contingent upon Milestone achieving predetermined annual operating cash
flow, revenue and earning targets as defined in the employment agreement. No bonuses
were earned in 2005 or 2006.
In addition, if during any year of the term of the agreement the CEO earns a bonus, he
shall also be granted 5-year stock options to purchase twice the number of shares
earned. Each such option is to be exercisable at a price per share equal to the fair
market value of a share on the date of grant (110% of fair market value if the CEO is
a 10% or greater stockholder on the date of grant). The options shall vest and become
exercisable to the extent of one-third of the shares covered at the end of each of the
first three years following the date of grant, but shall only be exercisable while the
CEO is employed by Milestone or within 30 days after the termination of his
employment.
F-16
MILESTONE SCIENTIFIC INC.
NOTES TO FINANCIAL STATEMENTS
In accordance with the employment contract, as of December 31, 2006, 337,036 shares of
common stock are to be paid out at the end of the contract in settlement of $450,000
of accrued deferred compensation and, accordingly, such amount has been classified in
stockholders equity with the common shares classified as to be issued.
NOTE K INCOME TAXES
The Companys expected federal income tax benefit computed at the statutory rate (34%)
on the pre-tax loss amounted to $1,071,000 in 2006 and $936,000 in 2005. Such benefit
was not recognized in the accompanying financial statements due to Milestones history
of past operating losses, which required full valuation allowances for all of
Milestones deferred tax assets at December 31, 2006 and 2005.
Deferred tax attributes resulting from differences between financial accounting
amounts and tax bases of assets and liabilities at December 31, 2006 and 2005 are as
follows:
|
|
|
|
|
|
|
|
|
|
|
2006 |
|
|
2005 |
|
Current assets |
|
|
|
|
|
|
|
|
Allowance for doubtful accounts |
|
$ |
7,000 |
|
|
$ |
11,000 |
|
Inventory allowance |
|
|
179,000 |
|
|
|
11,000 |
|
Deferred compensation |
|
|
150,000 |
|
|
|
120,000 |
|
|
|
|
|
|
|
|
Subtotal |
|
|
336,000 |
|
|
|
142,000 |
|
Valuation allowance |
|
|
(336,000 |
) |
|
|
(142,000 |
) |
|
|
|
|
|
|
|
Current deferred tax asset |
|
$ |
|
|
|
$ |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Non-current assets |
|
|
|
|
|
|
|
|
Net operating loss carryforward |
|
$ |
17,000,000 |
|
|
$ |
15,800,000 |
|
Valuation allowance |
|
$ |
(17,000,000 |
) |
|
|
(15,800,000 |
) |
|
|
|
|
|
|
|
Non-current deferred tax asset |
|
$ |
|
|
|
$ |
|
|
|
|
|
|
|
|
|
The
allowance increased by $1,424,000 and $3,061,000 for the years ended
December 31, 2006 and 2005, respectively.
As of December 31, 2006, Milestone has Federal net operating loss carryforwards of
approximately $42,500,000 that will be available to offset future taxable income, if
any, through December 2026. The utilization of Milestones net
operating losses may be subject to a substantial limitation due to the change of
ownership provisions under Section 382 of the Internal Revenue Code and similar state
provisions. Such limitation may result in the expiration of the net operating loss
carryforwards before their utilization. Milestone has established a 100% valuation
allowance for all of its deferred tax assets due to uncertainty as to their future
realization.
NOTE L PRODUCT SALES AND SIGNIFICANT CUSTOMERS
Milestones sales by product and by geographical region are as follows:
F-17
MILESTONE SCIENTIFIC INC.
NOTES TO FINANCIAL STATEMENTS
|
|
|
|
|
|
|
|
|
|
|
Year Ended December 31, |
|
|
|
2006 |
|
|
2005 |
|
CompuDent |
|
$ |
1,461,692 |
|
|
$ |
1,869,841 |
|
Handpieces |
|
|
3,815,641 |
|
|
|
3,617,662 |
|
Other |
|
|
289,092 |
|
|
|
287,891 |
|
|
|
|
|
|
|
|
|
|
$ |
5,566,425 |
|
|
$ |
5,775,394 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
United States |
|
$ |
4,147,280 |
|
|
$ |
4,323,058 |
|
Canada |
|
|
309,451 |
|
|
|
338,255 |
|
Other foreign |
|
|
1,109,694 |
|
|
|
1,114,081 |
|
|
|
|
|
|
|
|
|
|
$ |
5,566,425 |
|
|
$ |
5,775,394 |
|
|
|
|
|
|
|
|
During the years ended December 31, 2006 and 2005, Milestone had sales to one customer
(a worldwide distributor of Milestones products based in South Africa) of
approximately $944,543 and $893,435, respectively. This represented 17% and 16% of
the total net product sales for 2006 and 2005, respectively. Accounts receivable from
this customer amounted to approximately $249,320 representing 72% of net accounts
receivable at December 31, 2006.
During 2006, Milestone earned royalty income of $277,752 from the licensee of
Milestones proprietary consumer dental whitening product, which is sold under
Milestones distributors trademark, Ionic White.
NOTE M COMMITMENTS AND OTHER
(1) Lease Commitments
Milestone leases office space under a noncancelable operating lease with a base rental
of $87,808 per annum which was amended in April 2004 to extend the lease expiration
date through June 30, 2009. This lease provides for escalations of Milestones share
of utilities and operating expenses. Milestone also leases office and telecom
equipment under operating leases with payments ranging from $825-$6,264 per annum.
Aggregate minimum rental commitments under noncancelable operating leases are as
follows:
|
|
|
|
|
Year Ending December 31, |
|
2007 |
|
$ |
103,484 |
|
2008 |
|
|
100,801 |
|
2009 |
|
|
54,696 |
|
2010 |
|
|
9,564 |
|
2011 |
|
|
4,698 |
|
|
|
|
|
|
|
$ |
273,243 |
|
|
|
|
|
For the years ended December 31, 2006 and 2005, rent expense amounted to approximately
$98,066 and $107,404, respectively.
(2) Contract Manufacturing Arrangement
F-18
MILESTONE SCIENTIFIC INC.
NOTES TO FINANCIAL STATEMENTS
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.
(3) Other Commitments
The technology underlying our SafetyWand, the CompuFlo 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, payable on April
1, 2005. In addition, he will receive additional payments of 2.5% of our total sales
of products using certain of these technologies, and 5% of our total sales of products
using certain other of the technologies. In addition, he is granted, pursuant to the
agreement, an option to purchase, at fair market value on the date of the grant, 8,333
shares of our common stock upon the issuance of each additional patent relating to
these technologies. If products produced by third parties use any of these
technologies (under license from us) then he will receive the corresponding percentage
of the consideration received by us for such sale or license. In 2006 Milestone paid
the Director royalty expenses of $39,412 and granted him 10,000 options.
We 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 fees resulting from the sales of
the consumer whitening product. A royalty of 7% of licensing fees resulting from the
sales of the consumer whitening product will be paid. In 2006
Milestone paid royalty expenses of $19,443 and in 2005 Milestone paid royalty
expenses of $46,042. In addition, Milestone committed to pay royalties of 5% of our
licensing fees generated from the sale of the consumer whitening product to an
unrelated entity which assisted in bringing the CoolBlue and Ionic White product lines
to Milestone. Royalties paid to this entity were $13,588 for the year ended
December 31, 2006 and $32,888 for 2005.
(4) Other Income
Other income in 2006 consists of $283,107 paid to Milestone for sale of tax credits
under the New Jersey Technology Business Tax Certificate Transfer Program. Other
income in 2005 consists of $400,000 paid to Milestone for the purchase of certain
rights held by Milestone.
NOTE N RELATED PARTY TRANSACTIONS
For the years ended December 31, 2006 and 2005 Milestone paid $1,299 and $28,830 to
the wife of Milestones CEO, for professional services, principally related to income
tax compliance.
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