MILESTONE SCIENTIFIC INC. - Annual Report: 2009 (Form 10-K)
Table of Contents
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 10-K
(Mark One)
| þ | ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the fiscal year ended December 31, 2009
or
| o | TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the transition period from to
Commission file number 001-14053
Milestone Scientific Inc.
(Exact name of registrant as specified in its charter)
| Delaware | 13-3545623 | |
| State or other jurisdiction of | (I.R.S. Employer | |
| Incorporation or organization | Identification No.) |
45 Knightsbridge Road, Piscataway, NJ 08854
(Address of principal executive offices)
(Address of principal executive offices)
Registrant’s telephone number, including area code 973-535-2717
Securities registered pursuant to Section 12(b) of the Act:
None
Securities registered pursuant to section 12(g) of the Act:
Common Stock, par value $.001 per share
Indicate by check mark if the registrant is a well-known seasoned issuer, as defined in Rule 405
of the Securities Act. o Yes þ No
Indicate by check mark if the registrant is not required to file reports pursuant to Section 13
or Section 15(d) of the Act. o Yes þ No
Indicate by check mark whether the registrant (1) has filed all reports required to be
filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12
months (or for such shorter period that the registrant was required to file such reports),
and (2) has been subject to such filing requirements for the past 90 days. þ Yes o No
Indicate by check mark whether the registrant has submitted electronically and posted on
its corporate website, if any, every Interactive Data File required to be submitted and posted
pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12
months (or for such shorter period that the registrant was required to submit and post such
files). o Yes
o No
Indicate by check mark if disclosure of delinquent filers pursuant to Item 405 of
Regulation S-K (§ 229.405 of this chapter) is not contained herein and will not be contained, to
the best of registrant’s knowledge, in definitive proxy or information statements
incorporated by reference in Part III of this Form 10-K or any amendment of this Form 10-K. o
Indicate by check mark whether the registrant is a large accelerated filer, an
accelerated filer, a non-accelerated filer, or a smaller reporting company. See the
definitions of “large accelerated filer,” “accelerated filer” and “smaller reporting company”
in Rule 12b-2 of the Exchange Act.
| Large accelerated filer o | Accelerated filer o | Non-accelerated filer o | Smaller reporting company þ | |||
| (Do not check if a smaller reporting company) |
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of
the Act). o Yes
þ No
As of June 30, 2009, the last business day of the Company’s most recently completed second
fiscal quarter, the aggregate market value of the common stock held by non — affiliates of the
issuer was $4,186,988. This amount is based on the closing price of $0.45 per share of the
Company’s common stock as of such date, based on the Nasdaq Over-the-Counter Bulletin Board.
As of March 10, 2010 the registrant has a total of 14,792,528 shares of Common Stock, $0.001
par value outstanding.
DOCUMENTS INCORPORATED BY REFERENCE
None
MILESTONE SCIENTIFIC INC.
Form 10-K Annual Report
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EXHIBITS |
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FORWARD-LOOKING STATEMENTS
Certain statements made in this Annual Report on Form 10-K 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. Milestone’s
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 Milestone’s 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. The Company undertakes no obligation to revise or update publicly any
forward-looking statements for any reason.
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PART I
Item 1. Description of Business
All references in this report to “Milestone,” “us,” “the Company”, or “Milestone Scientific”
refer to Milestone Scientific Inc., and its former subsidiary, Spintech, Inc. (“Spintech”), unless
the context otherwise indicates. Milestone has rights to the following trademarks:
CompuDent®, CompuMed®, CompuFlo®, The
Wand®, The Wand
Plus®, The SafetyWand®, Cool Blue Wand®, Cool Blue Tooth Whitening
System™, Dynamic Pressure Sensing Technology®, STA Single Tooth
Anesthesia™, Ionic White® (light emitting diode), and Ionic White™
(whitening toothpaste). Milestone was incorporated in the State of Delaware in 1989.
BUSINESS
Background
Since its public offering in 1995, Milestone has been actively engaged in pioneering
proprietary, highly innovative, computer-controlled injection technologies and solutions for the
medical and dental markets. From its inception, the Company has focused its energy and resources
on redefining the worldwide standard of care for injection techniques by making the experience more
comfortable for the patient and by reducing the anxiety and stress of administering injections for
the healthcare provider.
Today, Milestone is widely recognized by key opinion leaders, industry experts and medical and
dental practitioners as the noted leader in the emerging, high growth, computer-controlled
injection industry; and remains intent on expanding the use and application of its proprietary,
patented technologies to achieve greater operational efficiencies, enhanced patient safety and
therapeutic adherence, and improved quality of care within a broad range of medical disciplines.
In 1997, Milestone first introduced The Wand® (CompuDent® system) and
the disposable Wand handpiece. CompuDent provides painless injections for all routine dental
treatments, including root canals, crowns, fillings and cleanings. Milestone’s Computer-Controlled
Local Anesthetic Delivery (C-CLAD) system does not look like a syringe. It does not feel like a
syringe. And, what’s 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 cosmetic surgery, hair restoration surgery, podiatry,
colorectal surgery, nasal and sinus surgery, dermatology and orthopedics, among others.
Central to Milestone’s intellectual property platform and current product development strategy
is its patented CompuFlo® technology for the precise delivery of medicaments. The
CompuFlo pressure/force C-CLAD technology is an advanced, patented and FDA-approved medical
technology for the painless and accurate delivery of drugs, anesthetics and other medicaments into
all tissue types, as well as for the aspiration of bodily fluids or previously injected substances.
Its regulation and control of flow rate continues to provide the CompuDent and CompuMed benefits
of painless injections, while its Dynamic Pressure Sensing® capability provides visual
and audible in-tissue pressure feedback, identifying tissue types to the healthcare provider. This
pressure feedback extends the benefit of painlessness from anesthetics with known viscosities to a
wide range of liquid drugs and other medicaments with varying viscosities and flow rates. Dynamic
Pressure Sensing also allows the healthcare provider to know when certain types of tissues have
been penetrated and permits the healthcare provider to inject medicaments precisely at the desired
location. Thus, pressure feedback can prevent the suffusion of tissue outside the intended target
area, a vitally important characteristic in the injection of chemotherapeutics and other toxic
substances.
The CompuFlo technology consists of two critical elements. One element is the ability to
determine exit pressure In Situ (in the injection site tissue) at the tip of the needle in real
time. This minimizes tissue damage (and eliminates the pain of the injection) because the flow
rate and pressure of the injection are controlled. The other critical element of the technology is
an integrated injection database of algorithms that have been defined which allow for the
measurement of the exit pressure. This database of algorithms contains the critical components of
specific drugs, parameters of needles, tubing and syringes and all other pertinent components for
the safe and efficacious delivery of medications for all procedures.
The CompuFlo technology also consists of a disposable injection handpiece that provides for
precise tactile control during the injection, an electromechanical (computer-controlled) fluid
delivery system and the ability to record data from the injection event. As confirmed by numerous
noted medical and dental experts within academia and the clinical practice arenas, CompuFlo has the
potential to greatly increase the safety and efficacy of many injection procedures that currently
rely upon over 150-year-old hypodermic syringe technology and the tactile senses and delivery
expertise of the administrator.
On September 14, 2004, Milestone Scientific was issued United States Patent No. 6,786,885 for
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 has numerous applications in both medicine and dentistry, including
epidural and intra-articular injections.
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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”.
In December 2005, Milestone submitted a pre-market notification to the US Food and
Drug Administration (FDA) on its CompuFlo technology, which was subsequently cleared by the FDA in
July of 2006. This initial submission was critical for Milestone’s continuing efforts to develop
and commercialize this important technology. Milestone has identified a number of potential
applications for CompuFlo, including single-tooth dental injections, self-administered drug
delivery, osteoarthritis joint pain management and epidurals.
Given the Company’s experience and established brand awareness within the dental industry, it
elected to focus its initial product development efforts on the integration of CompuFlo into its
legacy computer-controlled dental injection instrument. As a result, Milestone developed the
industry’s first solution for painlessly administering a single-tooth injection as the only
injection necessary for achieving anesthesia, foregoing the need to administer a traditional nerve
branch block. This new instrument, which also provides for use of a disposable handpiece, was
trademarked the “STA Single Tooth Anesthesia System™,” now more commonly known as the
STA System.
After receiving FDA 510(k) Pre-market Notification acceptance for the marketing and sale of
the STA System, Milestone introduced the instrument to market in February 2007 at the Chicago
Dental Society’s 143rd Midwinter Meeting. The patented STA System incorporates the
“pressure feedback” elements of Milestone’s patented CompuFlo technology, thereby allowing dentists
to administer injections accurately and painlessly into the periodontal ligament space, effectively
anesthetizing a single tooth. This injection is of significant value in that it allows the dentist
to profoundly anesthetize the patient within one or two minutes, versus up to 15-18 minutes for a
block injection which numbs. The patient will suffer neither pain nor collateral anesthesia in the
cheek, lips or tongue at any time. The STA System is capable of performing all of the injections
that can be done with a conventional dental syringe, including the palatal-anterior superior
alveolar, anterior middle superior alveolar and inferior alveolar nerve block. The STA System
achieves these injections predictably and reliably.
Initial market response to the STA System following its commercial debut in February 2007
proved to be less than robust. Moreover, at that time, the Company had granted exclusive US and
Canadian distribution and marketing rights for the STA System to Henry Schein, Inc., the largest
distributor of healthcare products and services to office-based practitioners in the combined North
American and European markets. Following several months of lackluster sales and after making
critical senior management changes, Milestone initiated an in-depth market study to reassess its
positioning and marketing strategies for the STA System. The insight gained from this study led
management to define and implement a new messaging platform, created to emphasize key benefits that
Milestone discovered are of most value to dental professionals. This refined product messaging was
launched in January 2008 and has remained in constant review.
During the second quarter of 2008, Milestone elected not to renew the exclusive marketing and
distribution agreement originally signed with Henry Schein, Inc.; instead, the Company granted
Schein non-exclusive distribution rights to both market and sell the STA System and related
disposable handpieces to dental professionals in the U.S. and Canada. In June 2008, Milestone
expanded its domestic distribution network with the addition of Patterson Dental Supply as a
non-exclusive distributor. Patterson has the largest direct sales force in the industry, totaling
approximately 1,400 sales representatives and equipment/software specialists addressing the needs
of the U.S. and Canadian dental markets. Later in the year, Benco Dental, Burkhart Dental, Goetze
Dental and Atlanta Dental Supply — all notable regional distributors — were granted non-exclusive
distribution and marketing rights to the STA System, thereby diversifying and significantly
expanding Milestone’s domestic distribution network.
Despite being granted CE Mark approval of the STA System in June 2007 by European regulatory
authorities, Milestone elected to initiate its international launch in the first quarter of 2008.
Following implementation of the STA System‘s new messaging strategy in early 2008, Milestone
granted exclusive marketing and distribution rights to two foreign distributors: Istrodent Pty Ltd
AB, a leading distributor serving the Southern Africa dental market; and Unident AB, a leading
supplier of dental products in the Scandinavian countries of Denmark, Sweden, Norway and Iceland.
In 2009, the Company sought to further expand its independent distribution network — both
domestically and in key international markets. Consequently, Milestone granted non-exclusive
distribution and marketing rights in the U.S. to Cedar Dental, Dental Health Products, Iowa Dental,
Nashville Dental, Newark Dental and Parkway Dental. To expand and enhance its reach to the dental
community in Canada, the Company also signed non-exclusive distribution and marketing agreements
with Dental 2000, Mediclub, Specialty Dental and WD Canada.
In the spring of 2009, Milestone signed an Exclusive Distribution and Marketing Agreement with
China National Medicines Corporation, dba Sinopharm, which is China’s largest domestic
manufacturer, distributor and marketer of pharmaceuticals and importer of medical devices and the
country’s largest domestic distributor of dental anesthetic carpules to the Chinese dental
industry. Prior to the end of 2009, China National Medicines issued Milestone a blanket purchase
order for 12,000 STA units and related handpieces to be delivered over 36 months, thereby marking
the Company’s initial penetration into China’s emerging dental market.
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According to a report published by the U.S. Department of Commerce, titled “China’s Emerging
Markets: Opportunities in the Dental and Dental Lab Industry,” China’s dental market lags behind
other healthcare services and has largely been neglected in the past. In fact, CS Market Research
reports that “of China’s 1.3 billion plus population, 50% of the adults and 70% of the children are
estimated to have decayed tooth problems, and over 90% have periodontal disease.” However, with
increasing affluence of the Chinese population, as well as increasing attention towards personal
care, demand for dental services has been growing. Market research firm Freedonia agrees, noting
that demand for dental products in China is expected to climb to 21.5 billion RMB (US$3.15 billion)
by 2012, due primarily to escalating personal income levels and government programs promoting
awareness of the benefits of good oral care.
Shortly before the end of the second quarter of 2009, Milestone elected to refine its
international marketing strategy to gain greater access to and penetration of the international
dental markets. The new sales strategy provides for increasing hands-on oversight and support of
its existing international distribution network, while also attracting new distributors throughout
Europe, Asia and South America. To assist in this endeavor, the Company appointed a new
International Sales Director, who is presently managing product sales for Milestone in all markets
outside of North America.
CompuFlo® Advanced Injection Technology — Core Technology
CompuFlo 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.
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 the development of CompuFlo.
Precisely controlling in-tissue pressure increases patient safety by reducing the risk of
tissue damage and post-treatment pain related to excessive pressure that may occur during certain
injections. Identification of the tissue, in which the needle tip is imbedded, is believed to be
highly important in epidural injections, intra-articular injections and numerous organ,
subcutaneous and intramuscular injections.
CompuFlo’s pressure sensing technology provides an objective tool that consistently and
accurately identifies the epidural space by correctly detecting the difference in pressure between
the ligamentum flavum and the extraligamentary tissue. In studies utilizing the CompuFlo technology
the epidural space has been correctly identified 100 % of the time. Knowing the precise location
of a needle during an epidural injection procedure provides a measure of safety not presently
available to doctors using conventional syringes, who identify the epidural space by relying on the
subjective perception of loss of resistance to air or saline.
In the absence of curative procedures, arthritis patients are obliged to endure painful
multiple annual injections for a lifetime. Often these injections are not efficacious, because the
doctor using a syringe failed to locate the intra-articular space or did not inject the appropriate
volume of hyaluronic acid or other medicament into that space. The CompuFlo technology
has been successful in administering viscous hyaluronic acid and other medicaments into the
intra-articular space in both small and large joints using its computer-controlled pressure sensing
capabilities in an independent animal study.
There are a number of injectable drugs routinely self-administered in a home or office setting
using spring loaded automatic injection devices by people who suffer from long term chronic
conditions such as Multiple Sclerosis and Rheumatoid Arthritis. The CompuFlo technology, using
pressure sensing capabilities, can serve as a painless subcutaneous injection method for these
self-administered drugs. A significant reduction in pain during delivery will have a positive
impact on compliance, which is a major consideration when physicians are determining which drugs to
prescribe.
The CompuFlo technology is patented and embedded in the STA System that is being sold
worldwide in the dental market. CompuFlo technology has been tried and proven in human and animal
studies, as well as by dentists in most parts of the world who are using the STA System in their
practices.
On December 3, 2009, Milestone announced that it signed an Agreement of Intent with China
National Medicines Corporation, Ltd. and Yichang Humanwell Pharmaceutical Co. Ltd., both
incorporated in the People’s Republic of China (PRC), to develop orthopedic and epidural drug
delivery instruments utilizing CompuFlo. Milestone and its two PRC joint venture partners will
establish a new joint venture entity for this purpose in the first quarter of 2010. The required
initial funding for the new entity, estimated by the parties at $1.4 million, will be provided by
the two PRC companies, although Milestone will determine the proposed uses of their contribution.
The Company believes that this new joint venture represents a significant step forward in
Milestone’s efforts to have its innovative computer-controlled drug delivery technology adapted for
medical usage worldwide.
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Product Platform
Milestone has developed and brought to market a highly differentiated portfolio of industry
innovations. Thus far, the Company’s proprietary solutions have succeeded in elevating the
standard of care in the professional dental arena. The product portfolio includes:
STA Single Tooth Anesthesia System™ (STA System)
The STA Single Tooth Anesthesia System™ (STA System) is a patented,
computer-controlled local anesthesia delivery system that incorporates the “pressure feedback”
elements of Milestone’s 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 available 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 anesthetize a
single tooth 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. 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 the CompuDent system, such a device provides a compelling value in the
marketplace. The STA System will generate recurring revenues from per-patient disposable
handpieces.
Since its market introduction in the spring of 2007, the STA System has received rave reviews
and awards from the dental industry. In July 2007, noted industry publication Dentistry Today
featured the STA System as one of the “Top 100 Products in 2007,” helping to promote much broader
recognition of the instrument and validating STA‘s value proposition for dentists and patients,
alike. In early 2008, Medical Device & Diagnostic Industry magazine distinguished the STA System
as a 2008 Medical Design Excellence Award winner in the “Dental Instruments, Equipment and
Supplies” product category. Of the 33 products to receive this coveted award, the STA was one of
only two winning products that serve dental practitioners. In December 2008, Milestone continued
to win broad acclaim for the STA System by winning a “Townie Choice Award”. The “Townie Choice”
awards were originally started by Dr. Howard Darran and Farran Media, publisher of Dentaltown
Magazine, to assist dentists in making product purchasing decisions, and are considered the
“people’s choice” of the products and services available to the dental industry today. That same
month, the STA System was also named as a Dental Products Report “Top 100 2008 Product of
Distinction.”
CompuDent®
CompuDent (also known as the Wand Plus® in Europe) is Milestone’s
proprietary, patented Computer-Controlled Local Anesthetic Delivery (C-CLAD) system and predecessor
of the STA System. CompuDent delivers anesthesia at a precise and consistent rate below a
patient’s pain threshold. Over the years, CompuDent has been widely heralded as a revolutionary
device, considered one of the major advances in dentistry in the 20th Century. The
instrument has been favorably evaluated in more than 50 peer reviewed or independent clinical
research reports. CompuDent, including its ergonomically designed single-use handpieces (The
Wand®), provides numerous, well documented benefits:
| • | CompuDent minimizes the pain associated with palatal, mandibular block and all other injections,
resulting in a more comfortable injection experience for the patient; |
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| • | the pencil grip used with The Wand handpieces 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 handpieces 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 handpieces minimizes the risk of cross contamination; and |
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| • | the ergonomic design of The Wand handpieces makes an injection easier and less stressful to
administer, lowering the risk of carpal tunnel syndrome. |
Despite CompuDent’s many benefits, including the administration of less painful and
more comfortable 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, Milestone believes there is a disconnect in the
way dentists perceive their patients’ attitudes toward injection by hypodermic syringe. The
CompuDent is used today by thousands of dentists around the world, many of whom have long since
abandoned the over 150-year old syringe.
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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 intravenous 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 cosmetic surgery, among others.
The Wand®
The Wand handpiece is used in conjunction with the STA, CompuDent and CompuMed systems. It is
an ergonomically designed and patented handpieces 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 mandibular 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 awaiting
profound anesthesia, the dentist is losing time and money.
The SafetyWand®
The SafetyWand is the first, patented safety-engineered injection device that
conforms to regulatory 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, Milestone’s SafetyWand
disposable handpiece, a patented injection device that incorporates safety engineered sharp
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 dentist’s 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.
Competition
Milestone’s proprietary, patented Computer-Controlled Local Anesthesia Delivery (C-CLAD)
systems compete with disposable and reusable syringes that generally sell at lower prices and that
use established and well-understood methodologies in both the dental and medical marketplaces.
Milestone’s 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 the systems
reduce fear, pain and anxiety for many patients, and Milestone believes that they can reduce
practitioner stress levels, as well. The Company’s newest product introduction, the STA System,
can be used for all dental injections that can be performed with a traditional dental syringe.
Moreover, the STA System can also be used for new and modified dental injection techniques that
cannot be performed with traditional syringes. These new techniques allow for faster procedures
shortening chair-time, minimizing the numbing of the lips and facial muscles, enhancing practice
productivity, reducing stress and virtually eliminating pain and anxiety for both the patient and
the dentist.
Milestone faces intense competition from many companies in the medical and dental device
industry, possessing substantially greater financial, marketing, personnel, and other resources.
Most 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 the products. Current or new competitors could, at any time, introduce new or enhanced
products with features that render the products less marketable or even obsolete. Therefore, the
company must devote substantial efforts and financial resources to improve existing products, bring
products to market quickly, and develop new products for related markets. In addition, the ability
to compete successfully requires that Milestone establish an effective distribution network as well
as support this distribution with a strong marketing plan. Historically, Milestone has been
unsuccessful in executing the marketing plans for the products, primarily due to resource
constraints. New products must be approved by regulatory authorities before they may be marketed.
Milestone cannot assure you that it can compete successfully; that competitors will not develop
technologies or products that render the products less marketable or obsolete; or, that Milestone
will succeed in improving the existing products, effectively develop new products, or obtain
required regulatory approval for those products.
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Patents and Intellectual Property
Milestone holds the following U.S. utility and design patents:
| U.S. PATENT | DATE OF | |||||||
| NUMBER | ISSUE | |||||||
Computer Controlled Drug Delivery Systems |
||||||||
Hypodermic Anesthetic Injection Apparatus & Method |
5,180,371 | 1/19/1993 | ||||||
Dental Anesthetic and Delivery Injection Unit |
6,022,337 | 2/8/2000 | ||||||
Design for a Dental Anesthetic Delivery System Holder |
D422,361 | 4/4/2000 | ||||||
Design for a Dental Anesthetic Delivery System Housing |
D423,665 | 4/25/2000 | ||||||
Design for a Dental Anesthetic Delivery System Handle |
D427,314 | 6/27/2000 | ||||||
Cartridge Holder for Injection Device |
6,132,414 | 10/17/2000 | ||||||
Dental Anesthetic Delivery Injection Unit |
6,152,734 | 11/28/2000 | ||||||
Microprocessor-controlled Fluid Dispensing Apparatus |
6,159,161 | 12/12/2000 | ||||||
Pressure/Force Computer Controlled Drug Delivery System |
6,200,289 | 3/13/2001 | ||||||
Dental Anesthetic and Delivery Injection Unit with Automated Rate Control |
6,652,482 | 11/25/2003 | ||||||
Pressure/Force Computer Controlled Drug Delivery System with Exit Pressure |
6,786,885 | 9/14/2004 | ||||||
Pressure/Force Computer Controlled Drug Delivery System with Automated
Charging |
6,887,216 | 5/3/2005 | ||||||
Drug Delivery System with Profiles |
6,945,954 | 9/20/2005 | ||||||
Cartridge Holder for Anesthetic and Delivery Injection Device |
D558,340 | 12/25/2007 | ||||||
Design for Drive Unit for Anesthetic |
D566,265 | 4/8/2008 | ||||||
Design for Drive Unit for Anesthetic |
D579,540 | 10/28/2008 | ||||||
Drug Infusion Device with Tissue Identification Using Pressure Sensing |
7,449,008 | 11/11/2008 | ||||||
Computer Controlled Drug Delivery Systems with Pressure Sensing |
7,618,409 | 11/17/2009 | ||||||
Hand Piece for Fluid Administration |
7,625,354 | 12/1/2009 | ||||||
Engineered Sharps Injury Protection Devices |
||||||||
Handpiece for Injection Device with a Retractable and Rotating Needle |
6,428,517 | 8/6/2002 | ||||||
Safety IV Catheter Device |
6,726,658 | 4/27/2004 | ||||||
Safety IV Catheter Infusion Device |
6,905,482 | 6/14/2005 | ||||||
Handpiece for Injection Device with a Retractable and Rotating Needle |
6,966,899 | 11/22/2005 | ||||||
Other |
||||||||
Self-Sterilizing Hypodermic Syringe and Method |
5,693,026 | 12/2/1997 | ||||||
During the 2009 and 2008 fiscal years, Milestone expensed $241,318 and $168,516, respectively,
on research and development activities. The higher costs incurred in 2009 were primarily associated
with the continued development of the Single Tooth Anesthetic (STA) delivery system and continuing
efforts on developing medical products utilizing the CompuFlo technology.
Milestone relies on a combination of patent, copyright, trade secret, and trademark laws and
employee and third party nondisclosure agreements to protect intellectual property rights. Despite
the precautions taken by Milestone to protect the products, unauthorized parties may attempt to
reverse engineer, copy, or obtain and use products and information that Milestone regarded as
proprietary, or may design products serving similar purposes that do not infringe on Milestone’s
patents. The Company’s failure to protect its proprietary information and the expenses of doing so
could have a material adverse effect on the operating results and financial condition.
On October 2, 2008, Milestone announced that it had acquired additional patent rights with
respect to painless anesthetic injections — specifically rights related to controlling the flow
rate or pressures used in providing these injections — through the issuance of 260,000 shares of
restricted common stock. In connection with the acquisition, Milestone also agreed to terminate
its Declaratory Judgment action against Dr. Milton Hodosh related to claimed infringements of his
patent rights and Dr. Hodosh agreed to terminate his infringement action against the Company. Each
party was responsible for their own legal fees.
In the event that the products infringe upon patent or proprietary rights of others, Milestone
may be required to modify processes or to obtain a license. There can be no assurance that
Milestone 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 the Company.
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Government Regulation
The FDA cleared the CompuDent system and its disposable handpieces 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 Safety Wand for marketing in the U.S. for dental applications in
September 2003. For us to commercialize the other products in the U.S., Milestone will have to
submit additional 510(k) applications with the FDA. Milestone received FDA 510 (k) approval for
the STA System in August 2006.
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 FDA’s 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 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 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 the STA System, CompuDent, the Safety Wand and CompuMed have received FDA marketing
clearance, there can be no assurance that any of the 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 the 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 product improvements; 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 the Company.
Milestone is 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.
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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 Milestone 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, the officers or employees.
Any action by the FDA could result in disruption of operations for an undetermined time.
In June 2007, Milestone received a CE mark for the marketing of the STA System in Europe. In
June 2003 Milestone received a CE mark for marketing of the Safety Wand and The Wand Handpieces
with Needle in Europe. In July 2003, Milestone obtained regulatory approval to sell CompuDent and
its handpieces in Australia and New Zealand.
Product Liability
Failure to use any of the products in accordance with recommended operating procedures could
potentially result in health hazards or injury. Failures of the products to function properly could
subject the company to claims of liability. Milestone maintains liability insurance in an amount
that Milestone believes is adequate. However, there can be no assurance that the insurance coverage
will be sufficient to pay product liability claims brought against the Company. A partially or
completely uninsured claim, if successful and of significant magnitude, could have a material
adverse effect on the Company.
Employees
On December 31, 2009, Milestone had a total of 14 employees, consisting of two executive
officers, a director of International and Professional Relations, a director of engineering, five
sales representatives (field and internal), two customer service representatives, a staff
accountant, a bookkeeper and an administrative manager. Milestone also has a full time consultant
who serves as a Director of Clinical Affairs.
Item 1A. 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 Milestone’s securities:
Milestone has no history of profitable operations. Continuing losses could exhaust capital
resources and force us to discontinue operations.
For the years ended December 31, 2009 and 2008, revenues were approximately $8.5 million and
$6.6 million, respectively. In addition, Milestone has had losses for each year since the
commencement of operations, including net losses of approximately $1.5 million and $1.2 million for
2009 and 2008, respectively. At December 31, 2009, Milestone had an accumulated deficit of
approximately $58.8 million. At December 31, 2009, the Company had cash and cash equivalents
$1,029,129 and working capital of $1,626,073. Additionally, in 2009, the Company converted the $1.3
million Line of Credit into 822,785 shares of common stock at a conversion price of $1.58 per
share. In 2008, the Company had also borrowed $450,000 as a Long Term Note. Both the Line of Credit
and the Long Term Note were loaned from a stockholder, as discussed in Note H to the Financial
Statements. The Company achieved positive cash flow in 2009 and expects to continue the generation
of positive cash flows from operating activities through increases in revenues based upon
management’s assessment of present contracts and current negotiations and reductions in operating
expenses.
As of December 31, 2009, the Company believes that it has sufficient cash reserves to meet all
of its anticipated obligations for the next twelve months. However, if the Company requires a need
for a higher level of marketing and sales effort, or if the Company is unable to generate positive
cash flows from its operating activities, it will need to raise additional capital. There is no
assurance that the Company will be able to achieve positive operating cash flows or that additional
capital can be raised on the terms and conditions satisfactory to the Company, if at all. If
additional capital is required and it cannot be raised, then the Company would be forced to curtail
its development activities, reduce marketing expenses for existing dental products or adopt other
cost savings measures, any of which might negatively affect the Company’s operating results.
The Company’s recurring losses raise substantial doubt about its ability to continue as a
going concern.
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Milestone cannot become successful unless it gains greater market acceptance for its 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 System, the SafetyWand, CompuMed and
CompuFlo depends, in large part, upon the ability to educate potential customers of the product’s
distinctive characteristics and benefits and will require substantial marketing efforts and
expense. More than 30,000 instruments of the CompuDent and its predecessors have been sold
worldwide since 1998. Since being introduced to market in February 2007, more than 3,974
instruments of the STA System have been sold. Milestone cannot assure that its 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.
The Company’s limited distribution channels must be expanded in order to become successful.
Future revenues depend on the Company’s ability to market and distribute its
computer-controlled injection products successfully. In the U.S., Milestone relies on several
independent dental distributors, an outside sales representative group, and a team of clinical
product specialists comprised of practicing dental hygienists who help to educate, train and sell
our products to dental practitioners in key U.S. markets. Abroad, Milestone lacks appropriate
distribution in many markets. To be successful, the Company will need to engage additional
distributors, provide for their proper training and ensure adequate customer support. In the spring
of 2009, the Company signed an Exclusive Distribution and Marketing Agreement with China National
Medicines Corporation, dba Sinopharm, which is China’s largest domestic manufacturer, distributor
and marketer of pharmaceuticals and importer of medical devices and the country’s largest domestic
distributor of dental anesthetic carpules to the Chinese dental industry. Prior to the end of
2009, China National Medicines issued Milestone a blanket purchase order for 12,000 STA units
to be delivered over 36 months, thereby marking the Company’s initial
penetration into China’s emerging dental market. Milestone cannot assure that it will be able to
hire and retain an adequate sales force or engage suitable distributors, or that the sales force or
distributors will be able to successfully market and sell the products.
Milestone depends on three principal manufacturers. If the Company cannot maintain its existing
relationships or develop new ones, it may have to cease operations.
Milestone has informal arrangements with the manufacturer of the STA System, CompuDent and
CompuMed instruments and with one of the principal manufacturers of the handpieces, for those
instruments, respectively. Pursuant to the informal arrangements, they manufacture these products
under specific purchase orders without minimum purchase commitment. However, in November 2009, the
Company issued a purchase order to Tricor Corporation to manufacture 12,000 STA Systems, over the
next three years. Milestone has a manufacturing agreement with one of the principal manufacturers
of its handpieces pursuant to which they manufacture products under specific purchase orders but
without minimum purchase commitments. Milestone has been supplied by the manufacturer of the STA
System, CompuDent and CompuMed since the commencement of production in 1998, one of the
manufacturers of its 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 the ability to produce and sell the products. Though Milestone
has established an alternate source of supply for the handpieces in China and other alternate
sources of supply exist, Milestone would need to recover its 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 have an adverse
affect.
Milestone may be subject to product liability claims that are not fully covered by insurance and
that could put the Company under financial strain.
Milestone could be subject to claims for personal injury from the alleged malfunction or
misuse of the dental and medical products. While Milestone carries liability insurance that is
believed to be adequate, the Company cannot assure 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 the Company.
Milestone relies on the continuing services of the Chief Executive Officer and Director of Clinical
Affairs.
Milestone depends on the personal efforts and abilities of the Chief Executive Officer and the
Director of Clinical Affairs. Milestone maintains a key man life insurance policy in the amount of
$1,000,000 on the life of the Chief Executive Officer. However, the loss of his services or
Director of Clinical Affairs, on whom Milestone maintains no insurance, could have a materially
adverse effect on the business.
The market price of Milestone’s common stock has been volatile and may continue to fluctuate
significantly because of various factors, some of which are beyond the Company’s control.
Milestone’s stock price has been extremely volatile, fluctuating over the last two years
between closing prices of $.20 and $1.86. The market price of common shares could continue to
fluctuate significantly in response to a variety of factors, some of which may be beyond the
Company’s control.
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Milestone is controlled by a limited number of shareholders.
Milestone’s principal shareholders, Leonard Osser and K. Tucker Andersen, beneficially own
33.6% of the issued and outstanding shares of common stock. As a result, they have the ability to
exercise substantial control over the Company’s affairs and corporate actions requiring shareholder
approval, including electing directors, selling all or substantially all of the assets, merging
with another entity or amending its 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 the Company’s securities.
Future sales or the potential for sale of a substantial number of shares of Milestone’s common
stock could cause the trading price of common stock and warrants to decline and could impair the
Company’s ability to raise capital through subsequent equity offerings.
Sales of a substantial number of shares of Milestone’s common stock in the public markets, or
the perception that these sales may occur, could cause the market price of the stock to decline and
could materially impair its ability to raise capital through the sale of additional equity
securities. At December 31, 2009, Milestone had outstanding options and warrants to purchase
1,650,141 shares of common stock at prices ranging from $0.25 to $5.00 per share with a weighted
average exercise price of $3.80. Holders of these warrants and options are given the opportunity to
profit from a rise in the market price of the common stock and are likely to exercise their
securities at a time when the Company would be able to obtain additional equity capital on more
favorable terms. Thus, the terms upon which the Company 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 Milestone would, in all likelihood, be able to obtain any
needed capital on terms more favorable than the exercise terms provided by such outstanding
securities. The market price of the common shares has been volatile and may continue to fluctuate
significantly because of various factors, some of which are beyond the Company’s control.
In the first and second quarters of 2009, 2,227,946 warrants to issue the equivalent number of
shares of the Company’s common stock at an exercise price of $4.89 expired.
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 the Company.
The Management of the Company has assessed the effectiveness of internal control over
financial reporting as of December 31, 2009. In making this assessment, management used the
criteria established in Internal Control-Integrated Framework issued by the Committee of Sponsoring
Organizations of the Treadway Commission (COSO). The Company complied with Sarbanes-Oxley
requirements to include in the annual report a management report on the effectiveness of the
internal control over financial reporting. However, this annual report does not include an
attestation report of the Company’s registered public accounting firm regarding internal control
over financial reporting. In 2005, Milestone hired an outside consultant to assist with the
development and implementation of the necessary internal controls and reporting procedures. In 2009
and 2008, the Company utilized the outside consultant on a quarterly basis to review compliance
with the internal controls over financial reporting. This expense amounted to $37,773 and $71,478
in 2009 and 2008, respectively and the cost is expected to continue in 2010.
Item 1B. Unresolved Staff Comments
None.
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Item 2. Description of Property
The headquarters for the Company is located at 45 Knightsbridge Road in Piscataway, New
Jersey. The Company leases approximately 2,700 square feet of office space. The lease term expires
July 14, 2011 at a monthly cost of $4,278 which Milestone believes to be competitive. The Company
is currently in the process of reviewing the current lease and negotiating with the landlord for
possible extension of the lease term. Additionally, the Company leases approximately 6,300 square
feet of office space at 220 South Orange Avenue in Livingston, New Jersey. The lease term expires
June 30, 2014 at a monthly cost of $6,942 which Milestone believes to be competitive. Additionally,
Milestone leases a corporate apartment in Maplewood, NJ. The lease expires in November 2010 at a
monthly cost of $4,000. The leased offices space is in good condition. A third party distribution
and logistics center in Pennsylvania handles shipping and order fulfillment on a month-to-month
basis.
Milestone does not own or intend to invest in any real property. Milestone currently has 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
In October 2008, Milestone announced that it acquired additional patent rights with respect to
painless anesthetic injections — specifically rights related to the flow rate or pressure used in
providing these injections — through the issuance of 260,000 shares of restricted common stock. In
connection with this acquisition, Milestone also agreed to terminate its Declaratory Judgment
action against Dr. Milton Hodosh related to claim infringements of his patent rights and Dr. Hodosh
agreed to terminate his existing infringement action against the Milestone. Each party is
responsible for their own legal fees.
At the present time, the Company is not involved in any significant litigation.
Item 4. (Removed and Reserved)
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PART II
Item 5. Market for Common Equity and Related Stockholder Matters and Small Business Issuer
Purchases of Equity Securities
Market Information
Milestone’s Common Stock is traded on the OTC Bulletin Board (“OTCBB”) under the symbol
“MLSS”. Milestone’s warrants were traded on the OTCBB under the symbol “MLSSW” until February 2009,
when the warrants expired. The quotations reflect inter-dealer prices, without retail mark-up,
mark-down or commission, and may not necessarily represent actual transactions.
Common Stock
The following table sets forth the high and low sales prices of the Common Stock, as quoted by
the OTCBB
| HIGH | LOW | |||||||
2009 |
||||||||
First Quarter |
$ | 0.75 | $ | 0.37 | ||||
Second Quarter |
$ | 0.70 | $ | 0.25 | ||||
Third Quarter |
$ | 1.30 | $ | 0.45 | ||||
Fourth Quarter |
$ | 1.85 | $ | 0.83 | ||||
2008 |
||||||||
First Quarter |
$ | 1.57 | $ | 0.75 | ||||
Second Quarter |
$ | 1.05 | $ | 0.56 | ||||
Third Quarter |
$ | 0.80 | $ | 0.30 | ||||
Fourth Quarter |
$ | 0.40 | $ | 0.20 | ||||
Holders
According to the records of the transfer agent, there were approximately 67 and 54
shareholders of record of the common stock as of December 31, 2009 and 2008. However, the Company
believes that there are approximately 2,500 and 2,400 beneficial owners of the Company’s common
stock at December 31, 2009 and 2008, respectively.
Dividends
The holders of the Common Stock are entitled to receive such dividends as may be declared by
Milestone’s 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 the equity compensation plan, see
Item 12.
Sales of Unregistered Securities
See NOTE I — STOCKHOLDERS’ EQUITY, to the financial statements for the issuance of
unregistered securities.
Item
6. Selected Financial Data
Milestone is a “smaller reporting company” as defined by Regulations S-K and as such, is not
providing the information contained in this item pursuant to Regulation S-K.
Item
7. Management’s Discussion and Analysis of Financial condition and Results of Operations.
The following discussions of the 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. The actual results may differ materially from those anticipated in
these forward-looking statements. See “Certain Risk Factors” on page 11 of this Form 10-K.
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OVERVIEW
During 2009, we remained focused on advancing efforts to achieve our two primary objectives;
those being:
| • | Optimizing our tactical approach to product sales and marketing in
order to materially increase penetration of the global dental and
medical markets with our proprietary, patented Computer-Controlled
Local Anesthesia Delivery (C-CLAD) solution, the STA Single Tooth
Anesthesia System (STA System); and |
||
| • | Identifying and pursing strategic collaborations with third parties to
jointly develop new products utilizing our patented CompuFlo pressure
force technology for novel new medical applications. |
STA System Awards — Industry Recognition
Since its market introduction in the spring of 2007, the STA System has received rave reviews
and awards from the dental industry. In July 2007, noted industry publication Dentistry Today
featured the STA System as one of the “Top 100 Products in 2007,” helping to promote much broader
recognition of the instrument and validating the STA System’s value proposition for dentists and
patients alike. In April 2008, Medical Device & Diagnostic Industry magazine distinguished the STA
System as a 2008 Medical Design Excellence Award winner in the “Dental Instruments, Equipment and
Supplies” product category. Of the 33 products to receive this coveted award, the STA System was
one of only two winning products that serve dental practitioners.
In December 2008, the STA System was again recognized as one of the dental industry’s best
technological innovations, winning a “Townie Choice Award” from Dentaltown Magazine in the category
“Anesthetics: Technique System”. This marked the second consecutive year that Milestone won a
“Townie Choice Award” in 2007, we won the same award for our CompuDent/The Wand. Also in December
2008, our STA System was named as a Dental Products Report “Top 100 2008 Product of Distinction”.
Each year, DPR spotlights the year’s Top 100 products. Of these 100 products, 50 are the ones most
often inquired about by DPR’s readers via an online and Product Information Card reader service
program. The other 50 represent “New Classics,” which recognize both old and newer products and
categories chosen by DPR’s editorial staff for their “perceived impact on driving innovation or
helping to establish a new, higher standard of care for patients.” The STA System was recognized as
a “New Classic” in the Technology category.
Second Annual Symposium on C-CLAD
In addition to winning noted acclaim among leading dental publications, our award winning STA
System has also been gaining the support of many of the world’s leading dental practitioners and
key opinion leaders. In February 2008, we hosted the First International C-CLAD Symposium in New
Orleans, welcoming a distinguished panel of dental experts who gathered to discuss advancements in
the scientific and clinical practice communities toward the common goal of advancing the science,
knowledge and art of C-CLAD in dentistry. The forum yielded a number of ideas on how we can
integrate the STA System not only into dental school curricula, but also extends messaging
regarding its many unique benefits to the dental community and patients alike.
On May 1 through 3, 2009, we hosted the Second International Annual Symposium on C-CLAD in
Amelia Island, Florida. Stanley Malamed, DDS, Professor of Anesthesia & Medicine at the University
of Southern California, School of Dentistry, again served as Chairman of the invitational event.
With attendance triple that of 2008, this year’s Symposium covered a broad range of C-CLAD related
topics including:
| • | The History of C-CLAD |
||
| • | Treating with Connection |
||
| • | Heart Rate Study |
||
| • | STA Compassionate Care in the 21st Century |
||
| • | Injection Advances and Challenges |
||
| • | Physiologic and Clinical Characteristics of PDL Anesthesia Delivered
by a High Pressure Hand piece and a Computerized Device |
||
| • | The STA for Tots and Teens |
||
| • | Computerized Local Anesthesia in Dentistry: A Review |
||
| • | Today’s Technology |
||
| • | Managing a Successful Dental Practice: Why People Keep Coming Back |
||
| • | STA — The Dental School’s Perspective |
||
| • | Futuristic Vistas: The Dentist/Hygienist Partnership |
In early 2010, we expect to publish and broadly distribute more than 100,000 copies of a
comprehensive monograph reflecting the topics discussed at the Symposium and a consensus on the
attendees’ attitudes, ideas and suggestions relating to promoting global industry adoption of
C-CLAD technologies as the new standard of care for administering dental injections.
15
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STA System Growth
Since its market introduction in early 2007, the STA System, a prior computerized controlled
local anesthesia delivery product, has been used to deliver tens of millions of safe, effective and
comfortable injections. The instrument has also been favorably evaluated in numerous peer-reviewed,
published clinical studies and associated articles. Moreover, there appears to be a growing
consensus among users that the STA System is proving to be a valuable and beneficial instrument
that is positively impacting the practice of dentistry worldwide. The utility and value of the STA
System is perhaps best summarized by Dr. Joe Blaes, who wrote in the December 2008 edition of
Dental Economics, “I tried the STA System and my patients absolutely love it. This is a no brainer
— go get one ASAP!”
Global Distribution Network
The STA System and related hand pieces are marketed to the dental industry in the United
States and Canada by many of the nation’s leading dental supply companies, including Henry Schein,
Inc., Patterson Dental Supply, Atlanta Dental, Benco Dental, Burkhart Dental, Cedar Dental, Darby
Dental Supply, Dental Health Products, Goetze Dental, Iowa Dental, Nashville Dental, Newark Dental
and Parkway Dental. In Canada, our independent distributors include Dental 2000, Mediclub,
Specialty Dental and WD Canada.
Collectively, our domestic network has more than 4,517 independent sales representatives
trained to sell the STA System and related handpieces to dentists throughout North America.
On the global front, we also have granted exclusive marketing and distribution rights for the
STA System to select dental suppliers in various international regions in Asia, Africa and Europe.
They include Istrodent in South Africa and Unident in the Scandinavian countries of Denmark,
Sweden, Norway and Iceland.
In April 2009, we signed an Exclusive Distribution and Marketing Agreement with China National
Medicines Corporation, d/b/a Sinopharm, which is China’s largest domestic manufacturer, distributor
and marketer of pharmaceuticals and importer of medical devices and the country’s largest domestic
distributor of dental anesthetic carpules to the Chinese dental industry. Prior to the end of
2009, China National Medicines issued Milestone a blanket purchase order for 12,000 STA units to be
delivered over 36 months, thereby marking the Company’s initial penetration into China’s emerging
dental market.
According to a report published by the U.S. Department of Commerce, titled “China’s Emerging
Markets: Opportunities in the Dental and Dental Lab Industry,” China’s dental market lags behind
other healthcare services and has largely been neglected in the past. In fact, CS Market Research
reports that “of China’s 1.3 billion plus population, 50% of the adults and 70% of the children are
estimated to have decayed tooth problems, and over 90% have periodontal disease.” However, with
increasing affluence of the Chinese population, as well as increasing attention towards personal
care, demand for dental services has been growing. Market research firm Freedonia agrees, noting
that demand for dental products in China is expected to climb to 21.5 billion RMB (US$3.15 billion)
by 2012, due primarily to escalating personal income levels and government programs promoting
awareness of the benefits of good oral care.
Shortly before the end of the second quarter, we announced that we were refining our
international marketing strategy to gain greater access to and penetration of the international
dental markets for the STA System, CompuDent and related disposable hand pieces. The new sales
strategy provides for increasing hands-on oversight and support of our existing international
distribution network, while also attracting new distributors throughout Europe, Asia and South
America. To assist in this endeavor, Milestone named Shaul Koren, founder and CEO of Istrodent Pty
Ltd AB and one of our strongest marketing allies outside of the U.S., as our new International
Sales Director. In collaboration with senior management, Mr. Koren will help manage product sales
for us in all markets outside of North America.
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The following table shows a breakdown of Milestone’s product sales (net), domestically and
internationally, by product category, and the percentage of product sales (net) by each product
category:
| Twelve Months Ended December 31, | ||||||||||||||||
| 2009 | 2008 | |||||||||||||||
DOMESTIC |
||||||||||||||||
Instruments |
$ | 1,786,435 | 33.2 | % | $ | 914,431 | 21.1 | % | ||||||||
Handpieces |
3,507,410 | 65.2 | % | 3,373,159 | 77.7 | % | ||||||||||
Other |
84,577 | 1.6 | % | 54,097 | 1.2 | % | ||||||||||
Total Domestic |
$ | 5,378,422 | 100.0 | % | $ | 4,341,687 | 100.0 | % | ||||||||
INTERNATIONAL |
||||||||||||||||
Instruments |
$ | 1,390,317 | 43.8 | % | $ | 695,513 | 30.9 | % | ||||||||
Handpieces |
1,769,682 | 55.8 | % | 1,550,992 | 68.8 | % | ||||||||||
Other |
10,639 | 0.4 | % | 7,333 | 0.3 | % | ||||||||||
Total International |
$ | 3,170,638 | 100.0 | % | $ | 2,253,838 | 100.0 | % | ||||||||
DOMESTIC/INTERNATIONAL
ANALYSIS |
||||||||||||||||
Domestic |
$ | 5,378,422 | 62.9 | % | $ | 4,341,687 | 65.8 | % | ||||||||
International |
3,170,638 | 37.1 | % | 2,253,838 | 34.2 | % | ||||||||||
Total Product Sales |
$ | 8,549,060 | 100.0 | % | $ | 6,595,525 | 100.0 | % | ||||||||
The Company earned gross profits of 60% in the years ended December 31, 2009 and 2008,
respectively. However, the revenues and related gross profits have not been sufficient to support
overhead, new product introduction and research and development expenses. Although the Company
anticipates expending funds for research and development in 2010, these amounts will vary based on
the operating results for each quarter. The Company has incurred operating losses and negative cash
flows from operating activities since its inception, except 2009. The Company at December 31, 2009
expects to have sufficient cash reserves to meet all of its anticipated obligations for the next
twelve months. The Company achieved positive cash flows from operating activities in 2009, through
increase in revenue, assessment of current contracts and current negotiations and reduction in
operating expenses. If positive cash flow cannot continue or if additional capital is required and
it cannot be raised, then the Company would be forced to curtail its development activities, reduce
marketing for existing dental products or adopt other cost saving measures, any of which might
negatively affect the Company’s operating results.
In 2010, the Company plans to further support increased sales and marketing activity through
trade show appearances, refined and directed advertising to dental professionals, and costs
associated with supporting of our global distribution network.
Current Product Platform
Milestone has developed and in some cases brought to market a highly
differentiated portfolio of industry innovations. Specifically, Milestone’s proprietary solutions
for application in professional dentistry and a wide range of medical applications include:
| • | STA Single Tooth Anesthesia System™ (STA System) — In February of 2007,
Milestone introduced to market the STA System, a patented C-CLAD system that incorporates
the “pressure force feedback” elements of Milestone’s patented CompuFlo technology, thereby
allowing dentists to administer injections accurately and painlessly into the periodontal
ligament space, effectively anesthetizing a single tooth. The STA System is also capable
of performing all of the injections that can be done with a conventional dental syringe,
including the palatal-anterior superior alveolar, anterior middle superior alveolar and
inferior alveolar nerve block. The STA System achieves all of these injections predictably
and reliably including the Periodontal-Intraligamentary injection (Single Tooth Anesthesia)
that provides an almost immediate onset of profound anesthesia to a single tooth.
Milestone received FDA 510(k) Pre-market Notification acceptance in August 2006 and was
granted a CE Mark by European regulatory authorities in June 2007. |
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The STA System has been the subject of numerous articles published in leading trade
magazines, dental journals and online blogging sites since its market introduction early in
2007. Since its market introduction in the spring of 2007, the STA System has received
positive reviews and awards from the dental industry. In July 2007, noted industry
publication
Dentistry Today featured the STA System as one of the “Top 100 Products in 2007,” helping to
promote much broader recognition of the instrument and validating STA‘s value proposition for
dentists and patients, alike. Earlier this year, Medical Device & Diagnostic Industry
magazine distinguished the STA System as a 2008 Medical Design Excellence Award winner in the
“Dental Instruments, Equipment and Supplies” product category. Of the 33 products to receive
this coveted award, the STA was one of only two winning products that serve dental
practitioners. In December, the STA System was again recognized as one of the dental
industry’s best technological innovations, winning a “Townie Choice Award” from Dentaltown
Magazine in the category “Anesthetics: Technique System”. This marked the second consecutive
year in a row that Milestone won a “Townie Choice Award” — in 2007, the Company won the same
award for its CompuDent/The Wand. Also in December 2008, Milestone’s STA System was named
as a Dental Products Report “Top 100 2008 Product of Distinction. Each year, DPR spotlights
the year’s Top 100 products. Of these 100 products, 50 are the ones most often inquired about
by DPR‘s readers via an online and Product Information Card reader service program. The
other 50 represent “New Classics,” which recognize both old and newer products and categories
chosen by DPR‘s editorial team for their “perceived impact on driving innovation or helping
to establish a new, higher standard of care for patients.” The STA System was recognized as
a “New Classic” in the Technology category.
| • | CompuDent® — CompuDent was distinguished by Dentaltown Magazine as the winner
of a “2006 Townie Choice Award”, CompuDent is Milestone’s proprietary, patented
computer-controlled local anesthetic delivery system which delivers anesthesia at a precise
and consistent rate below a patient’s 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 is the predecessor device to the STA System. |
||
| • | 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 intravenous 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 is now gaining growing 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® — Used in conjunction with the STA, CompuDent or CompuMed systems,
The Wand is an ergonomically designed and patented handpiece 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 can occur with a traditional
syringe. A straighter path results in a more accurate injection, meaning fewer missed
blocks, and more rapid onset of anesthesia. |
||
| • | The SafetyWand® — The Safety Wand was the first, patented safety-engineered
injection device that conforms to standards while also meeting the clinical needs of dental
and medical practitioners. The Federal Needlestick Prevention Act (U.S.) has mandated the
use of products with “engineered safety injury protection” to eliminate accidental needle
sticks, thus providing Milestone with an invaluable marketing platform to position The
SafetyWand as a powerful and capable alternative to traditional injection devices. The
SafetyWand was the first patented injection device to be fully compliant with OSHA
regulations under the Act. |
In December 2009, Milestone announced that it signed an Agreement of Intent with China
National Medicines Corporation, Ltd. and Yichang Humanwell Pharmaceutical Co. Ltd., both
incorporated in the People’s Republic of China (PRC), to develop intra-articular and epidural drug
delivery instruments utilizing Milestone’s patented CompuFlo technology. Milestone and its two PRC
joint venture partners will establish a new joint venture entity for this purpose in 2010. The
required initial funding for the new entity, estimated by the parties at $1.4 million, will be
provided by the two PRC companies, although Milestone will determine the proposed uses of their
contribution. The Company believes that this new joint venture represents a significant step
forward in Milestone’s efforts to have its innovative computer-controlled drug delivery technology
adapted for medical usage worldwide.
Technology Rights
The technology underlying the SafetyWand and CompuFlo technology and an improvement to the
controls for CompuDent were developed by the Director of Clinical Affairs and assigned to
Milestone. The Company 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, the Director of Clinical Affairs will receive additional deferred contingent payments of
2.5% of the total sales of products using some of these technologies, and 5% of the total sales of
products using some of the 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.
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Summary of Critical Accounting Policies and Significant Judgments and Estimates
Milestone’s discussion and analysis of the financial condition and results of operations are
based upon its 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, the Company evaluates its estimates, including those related to accounts receivable,
inventories, stock-based compensation and contingencies. The Company bases its 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 significant accounting policies are more fully described in Note B to the financial
statements included elsewhere in this report, the Company believes that the following accounting
policies and significant judgments and estimates are most critical in understanding and evaluating
the reported financial results.
Accounts Receivable
The realization of Accounts Receivable will have a significant impact on the Company.
Consequently, Milestone estimates losses resulting from the inability of its customers to make
payments for amounts billed. The collectability of outstanding amounts is continually assessed.
Inventories
Inventory costing, obsolescence and physical control are significant to the on-going operation
of the business. Inventories principally consist of finished goods and component parts stated at
the lower of cost (first-in, first-out method) or market. Inventory quantities on hand are reviewed
on a quarterly basis and a provision for excess and obsolete inventory is recorded if required
based on past and expected future sales.
Impairment of Long-Lived Assets
The long lived assets of the Company, principally patents and trademarks are the base features
of the business. Milestone reviews long-lived assets for impairment whenever circumstances and
situations change such that there is an indication that the carrying amounts may not be
recoverable. The carrying value of the asset is evaluated in relation to the operating performance
and future undiscounted cash flows of the underlying assets.
Revenue Recognition
Revenue from product sales is recognized net of discounts and allowances to domestic
distributor on the date of arrival of the goods at the customer’s location as shipments are FOB
destination. Shipments to international distributors are FOB the warehouse and revenue is therefore
recognized on shipment. In both cases the price to the buyer is fixed and the collectability is
reasonably assured. Further, the Company has no obligation on these sales for any post
installation, set-up or maintenance, these being the responsibility of the buyer. Customer
acceptance is considered made at delivery. Milestone’s only obligation after sale is the normal
commercial warranty against manufacturing defects if the alleged defective unit is returned within
the warranty period.
Royalty income was recognized as earned based on reports received from the licensee and
related royalty expense is accrued during the same period.
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Results of Operations
The following table sets forth for the consolidated results of operations for the year ended
December 31, 2009 compared to 2008 as a percentage of revenues. The trends suggested by this table
may not be indicative of future operating results:
| Twelve Months Ended | ||||||||||||||||
| December 31, 2009 | December 31, 2008 | |||||||||||||||
Products sales, net |
$ | 8,549,060 | 100 | % | $ | 6,595,525 | 99 | % | ||||||||
Royalty income |
— | 0 | % | 28,282 | 1 | % | ||||||||||
Total revenue |
8,549,060 | 100 | % | 6,623,807 | 100 | % | ||||||||||
Cost of products sold |
3,458,279 | 40 | % | 2,681,116 | 40 | % | ||||||||||
Gross Profit |
5,090,781 | 60 | % | 3,942,691 | 60 | % | ||||||||||
Selling, general and
administrative expenses |
6,952,976 | 81 | % | 5,502,762 | 83 | % | ||||||||||
Research and development
expenses |
241,318 | 3 | % | 168,516 | 3 | % | ||||||||||
Operating expenses |
7,194,294 | 84 | % | 5,671,278 | 86 | % | ||||||||||
Loss from operations |
(2,103,513 | ) | -25 | % | (1,728,587 | ) | -26 | % | ||||||||
Other income |
573,428 | 7 | % | 541,133 | 8 | % | ||||||||||
Net loss |
$ | (1,530,085 | ) | -16 | % | $ | (1,187,454 | ) | -18 | % | ||||||
Year ended December 31, 2009 compared to year ended December 31, 2008
Total revenues for the twelve months ended December 31, 2009 and 2008 were $8,549,060 and
$6,623,807 (product sales of $6,595,525 and royalty income of $28,282 in 2008), respectively. The
total increase in product sales of $1,953,535, or 30%, is a direct result of the continued
implementation of the new sales distribution model (non-exclusive distribution) along with
improvement in the international market. The increase in sales volume of domestic instruments by
$872,004, or 95% in 2009 over 2008, was directly related to a wider distributor base and direct
marketing of our product at national and regional industry trade shows. In the domestic market,
handpiece sales increased by $134,251, ($177,685 decrease in CompuDent sales, $311,936 increase in
STA) or 4%. The CompuDent handpiece sales decrease in the domestic market is not specifically
attributable to any marketing or sales deemphasizing of the product category. Rather it maybe
attributable to our customers purchasing handpieces on a just in time basis, due the general
economic conditions and a shift in purchasing to the STA System and handpieces, as a product
requires replacement. On the international scene, instrument sales increased in 2009 over 2008 by
$694,804, or 100%, principally due to the increase in STA instruments ($645,442), while CompuDent
units also measured an increase of $49,362. The increase in handpiece sales internationally was
$218,690 or 14% due to an increase in sales of STA handpieces of $221,868 and a minor decrease in
sales of CompuDent handpieces ($3,178)
Royalty income resulted from granting United Systems Inc. a license to manufacture, market,
and sublicense a Tooth Whitening System to the consumer market. Royalty income for the years ended
December 31, 2009 and 2008, respectively, was $0 and $28,282. In January 2009, the Company
abandoned its rights to a portfolio of technology centered around the use of blue light emitting
diodes (LED) for a variety of dental treatments and diagnostic applications. At the same time, the
Company terminated its license agreement for the use of the technology with United Systems Inc.
There were no costs or expenses related to this abandoning of rights or the termination of the
licensee agreement.
Cost of products sold for the years ended December 31, 2009 and 2008 were $3,458,279 and
$2,681,116, respectively. The $777,163 increase in product cost or 29% is primarily attributable to
the market rise in sales volume. Slow moving and overstocked inventories totaling approximately
$36,000 and $82,000 were charged off to cost of products sold during the year ended December 31,
2009 and 2008, respectively.
For the year ended December 31, 2009, Milestone’s gross profit dollars increased by 29% over
the prior year ended December 31, 2008, due to significantly increased sales volume. Milestone
generated a gross profit of $5,090,781, or 60% in 2009 as compared to a gross profit of $3,942,691,
or 60% in 2008. The total dollar increase in gross profit was $1,148,090 in 2009.
Selling, general and administrative expenses for the years ended December 31, 2009 and 2008
were $6,952,976 and $5,502,762, respectively. The $1,450,214, or 26%, net increase was focused into
a several expense categories. Sales and Marketing expense increased in 2009 by $242,446. This
increase was primarily in the areas of media placement $65,563, marketing key opinion leaders and
also promotions at trade shows (national and regional). Payroll expenses increased by $199,745,
principally due to an increase in Achievement Bonus for the Chief Executive Officer of
approximately $290,000 and in increase in stock based compensation of approximately $100,000 due to
officers stock options issued in December 2009, offset by salary and deferred compensation expense
of approximately $104,000. Legal and patent expenses increase by $86,309 in the aggregate due to
general litigation expenses and customary patent annuity payments. General and administrative
expenses increased by $805,824 due to payment of an international commission of $262,167 (effective
July 1, 2009), increased royalties of $194,778 as a result of increased sales volume, an
international travel expense increase of $61,317, directly related to our current and future sales
growth, business consulting and success fees for domestic and international business of $363,463.
In addition, the Company realized expense reductions in the areas of professional accounting and
audit fees of $78,797, reduced insurance costs of $28,957, and savings in the area of proxy and
regulatory electronic filing expenses of $23,017.
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Research and development expenses for the years ended December 31, 2009 and 2008 were $241,318
and $168,516, respectively. The increase of $72,802 was attributable to research on the development
of a C-CLAD device(s) for the medical field and clinical studies on the STA System.
The loss from operations for the years ended December 31, 2009 and 2008 was $2,103,513 and
$1,728,587, respectively. The $374,926, or 22% increase in loss from operations is explained above.
Interest expense for the years ended December 31, 2009 and 2008 was $154,027 and $116,374,
respectively and amortization of debt issuance for the same years was $53,300 and $27,446,
respectively. The interest expense is related to the Line of Credit and Long Term Note. See Note H
to the Financial Statements.
Other Income includes $777,609 and $675,930 in 2009 and 2008, respectively, and represents the
sale of tax credits under the New Jersey Technology Business Tax Certificate Program, for the
respective periods.
For the reasons explained above, net loss for the year ended December 31, 2009 was $1,530,085
as compared to a net loss of $1,187,454 for the year ended December 31, 2008. The $342,631, or 29%,
increase in net loss is primarily a result of a significant increase in Gross Margin dollars
($1,148,090) offset by an increase in Selling General and Administrative expenses of $1,450,214.
Liquidity and Capital Resources
As of December 31, 2009, the Company had cash and cash equivalents of $1,029,129 and working
capital of $1,626,073. The working capital increased by $93,385 from December 31, 2008. Net current
assets increased by approximately $446,000, principally in cash ($286,000), accounts receivable
($138,000) and inventories ($85,000) offset by a decrease in advances to contract manufacturers
($98,000). Current liabilities increased by net $353,000, principally due to an increase in
accounts payable of approximately $325,000, relating to increases in inventory purchases and
advances of approximately $171,000, royalty payments of $113,000 and consulting fees of $69,000,
and an increase in accrued expenses, ($28,000). The Company has taken positive steps to maintain
adequate inventory levels and advances to contract manufacturers to maintain available inventory to
meet our increasing domestic and international sales requirements. Milestone incurred net losses of
$1,530,085 and $1,187,454 for the year ended 2009 and 2008, respectively. Cash flows from
operating activities for the year ended December 31, 2009 was a positive $402,951 and for the year
ended December 31, 2008 was a negative $442,006.
For the year ended December 31, 2009, net cash provided in operating activities was $402,951.
This was attributable primarily to a net loss of $1,530,085 adjusted for noncash items of
$1,670,764 and changes in operating assets and liabilities of $262,270. The increase in noncash
items in 2009 of $1,163,482 as compared to 2008 is principally due the increase in Common Stock
issued for compensation; consulting and vendor services ($1,093,821) and amortization of debt
discount ($25,854).
For the year ended December 31, 2009, Milestone used $144,353 in investing activities,
primarily attributable to legal fees related to payment for patent rights.
As of December 31, 2008, Milestone recorded on the Balance Sheet a $1.3 million, Line of
Credit from a stockholder. The borrowings required a one percent fee at the date of borrowing and
an interest rate of six percent per annum, payable at the maturity of the note. In December 2009,
the Company converted the $1.3 million Line of Credit into 822,785 shares of Common Stock at a
price of $1.58 per share. There were no additional expenses related to the conversion of the Line
of Credit. The Company borrowed an additional $450,000 from the same shareholder in 2008. In
December 2008, the Company refinanced the $450,000 note, extending the due date to June 30, 2012.
The $450,000 Note is classified as a Long Term Note Payable on the Balance Sheet at December 31,
2009. See Note H — Line of Credit to the Financial Statements.
The Company has incurred operating losses and negative cash flows from operating activities
since its inception, except for 2009. However, the Company achieved positive cash flow in 2009 and
expects to continue the generation of positive cash flows from operating activities through
increases in revenues based upon management’s assessment of present contracts and current
negotiations and reductions in operating expenses. The Company continues to pursue the generation
of positive cash flows from operating activities through an increase in revenue based upon
management’s assessment of present contracts and current negotiations and reductions in operating
expenses. As of December 31, 2009, the Company believes that it has sufficient cash reserves to
meet all of its anticipated obligations for the next twelve months. However, if the Company
requires a need for a higher level of marketing and sales effort, or if the Company is unable to
continue generating positive cash flows from its operating activities it will need to raise
additional capital. There is no assurance that the Company will be able to continue to achieve
positive operating cash flows or that additional capital can be raised on the terms and conditions
satisfactory to the Company if at all. If additional capital is required and it cannot be raised,
then the Company would be forced to curtail its development activities, reduce marketing expenses
for existing dental products or adopt other cost savings measures, any of which might negatively
affect the Company’s operating results.
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The Company’s recurring losses and negative operating cash flows raises substantial doubt
about its ability to continue as a going concern. The accompanying financial statements do not
include any adjustment that might result from the outcome of this uncertainty.
Off-Balance Sheet Arrangements
The Company does not have any off-balance sheet arrangements that are currently material or
reasonably likely to be material to the financial position or results of operations.
Contractual Obligations
The impact of the contractual obligations at December 31, 2009, expected on the liquidity and
cash flows in future periods, is as follows:
| Payments Due by Period | ||||||||||||||||
| Total | Less than 1 Year | 1-3 Years | 3-5 Years | |||||||||||||
Long-term debt obligations |
$ | 450,000 | $ | — | $ | 450,000 | $ | — | ||||||||
Capital lease obligations |
— | — | — | — | ||||||||||||
Operating lease obligations |
454,633 | 156,278 | 173,397 | 124,958 | ||||||||||||
Purchase obligations (1) |
7,542,499 | 4,034,739 | 3,507,760 | — | ||||||||||||
Total |
$ | 8,447,132 | $ | 4,191,017 | $ | 4,131,157 | $ | 124,958 | ||||||||
| (1) | Purchase obligations include agreements for the purchase of units and handpieces. |
The agreements are referred as purchase orders.
Recent Accounting Pronouncements
See “Note B-19 — Summary of Significant Accounting Policies” to the financial statements for
explanation of recent accounting pronouncements impacting the Company.
Item 7A. Quantitative and Qualitative Disclosures about Market Risk
Milestones is a “smaller reporting company” as defined by Regulation S-K and as such, is not
providing the information contained in this item pursuant to Regulation S-K.
Item 8. Financial Statements
The financial statements of Milestone required by this Item are set forth beginning on page
F-1.
Item 9. Change in and Disagreements with Accountants on Accounting and Financial Disclosure
None.
Item 9A. Controls and Procedures
The Company’s management, including the Chief Executive Officer and Chief Financial Officer,
has evaluated the effectiveness of the design and operation of the Company’s disclosure controls
and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) as of the end of the
period covered by this report. Based upon that evaluation, the Company’s Chief Executive Officer
and Chief Financial Officer have concluded that the disclosure controls and procedures as of
December 31, 2009 are effective to ensure that information required to be disclosed in the reports
the Company files or submits under the Exchange Act is recorded, processed, summarized and reported
within the time periods specified in the SEC’s rules and forms and that such information is
accumulated and communicated to the Company’s management, including the Chief Executive Officer and
Chief Financial Officer, to allow timely decisions regarding disclosure.
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Management’s Annual Report on Internal Control Over Financial Reporting
Milestone management is responsible for establishing and maintaining an adequate system of
internal control over financial reporting. The internal control over financial reporting includes
those policies and procedures that:
| • | pertain to the maintenance of records that, in reasonable detail,
accurately and fairly reflect the transactions and dispositions of
the assets; |
||
| • | provide reasonable assurance that transactions are recorded as
necessary to permit preparation of the financial statements in
accordance with generally accepted accounting principles in the
United States, and that the receipts and expenditures are being
made only in accordance with authorizations of the management and
directors; and |
||
| • | provide reasonable assurance regarding prevention or timely
detection of unauthorized acquisition, use or disposition of the
assets that could have a material effect on the financial
statements. |
Because of its inherent limitations, internal control over financial reporting may not prevent
or detect misstatements. Projections of any evaluation of effectiveness to future periods are
subject to the risk that controls may become inadequate because of changes in conditions, or that
the degree of compliance with the policies or procedures may deteriorate. All internal control
systems, no matter how well designed, have inherent limitations. Therefore, even those systems
determined to be effective can provide only reasonable assurance with respect to financial
statement preparation and presentation. Because of the inherent limitations of internal control,
there is a risk that material misstatements may not be prevented or detected on a timely basis by
internal control over financial reporting. However, these inherent limitations are known features
of the financial reporting process. Therefore, it is possible to design into the process safeguards
to reduce, though not eliminate, this risk.
Milestone management assessed the effectiveness of its system of internal control over
financial reporting as of December 31, 2009. In making this assessment, management used the
framework in Internal Control — Integrated Framework issued by the Committee of Sponsoring
Organizations of the Treadway Commission (“COSO”). Based on the assessment and the criteria set
forth by COSO, management believes that the Company maintained effective internal control over
financial reporting as of December 31, 2009.
This annual report does not include an attestation report of the Company’s registered
independent public accounting firm regarding internal control over financial reporting.
Management’s report was not subject to attestation by the Company’s registered independent public
accounting firm pursuant to temporary rules of the Securities and Exchange Commission that permit
the Company to provide only management’s report in this annual report.
There have been no significant changes in the Company’s internal control over financial
reporting identified in connection with the evaluation that occurred during the Company’s last
fiscal quarter that have materially affected, or that are reasonably likely to materially affect,
the Company’s internal controls over financial reporting.
Item 9B. Other Information
None.
23
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PART III
Item 10. Directors, Executive Officers, Promoters, Control Persons and Corporate Governance;
Compliance with Section 16 (a) of the Exchange Act.
Milestone’s directors are elected annually by the shareholders and serve for one-year terms
until his/her successor is elected and qualified or until such director’s earlier death,
resignation or removal. The executive officers and key personnel are appointed by and serve as the
pleasure of the Board of Directors.
The current executive officers and directors of Milestone and their respective ages as of
March 10, 2010 are as follows:
| NAME | AGE | POSITION | DIRECTOR SINCE | |||||||
Leslie Bernhard (2)
|
66 | Chairman of the Board | 2003 | |||||||
Leonard A. Osser
|
63 | Chief Executive Officer | 1991 | |||||||
Joseph D’Agostino
|
58 | Chief Financial Officer | ||||||||
Pablo Felipe Serna Cardenas (2)
|
34 | Director | 2006 | |||||||
Leonard M. Schiller(1)(2)
|
68 | Director | 1997 | |||||||
Jeffrey Fuller(1)
|
64 | 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 16, 2010:
| NAME | AGE | POSITION | ||||
Eugene Casagrande, D.D.S.
|
66 | Director of Professional Relations | ||||
Mark Hochman, D.D.S.
|
52 | Director of Clinical Affairs | ||||
Leslie Bernhard, Chairman of the Board
In October 2009, Leslie Bernhard assumed the position of Chairman of the Board, filing a
position left vacant by Mr. Osser who assumed the position of Chief Executive Officer. Leslie
Bernhard has served as an Independent Director of Milestone since May 2003 and was named Chairman
of the Board in September of 2009. She co-founded AdStar, Inc. and since 1986 has served as its
President, Chief Executive Officer and Executive Director. AdStar is an application service
provider for the newspaper classified advertising industry. She served on the Board of Directors of
Universal Power Group (AMEX:UPG) of Dallas, Texas and have done so since 2006. Ms. Bernhard’s
professional experience and background with AdStar and with us, as one of our directors since 2003,
have given her the expertise needed to serve as chairman of the Board.
Leonard Osser, Chief Executive Officer
In March of 2009, Mr. Osser assumed the position of Milestone’s Acting Chief Executive
Officer. Mr. Osser in September 2009 resigned as Chairman of the Company and assumed the position
of Chief Executive Officer. He served as the Company’s Chairman from 1991 until September of 2009,
and from 1991 and 2007, was Chief Executive Officer of the Company. From 1980 until the
consummation of Milestone’s public offering in November 1995, Mr. Osser was primarily engaged as
the principal owner and Chief Executive Officer of U.S. Asian Consulting Group, Inc., a New
Jersey-based provider of consulting services specializing in distressed or turnaround situations in
both the public and private markets.
Joseph D’Agostino, Chief Financial Officer
Joining Milestone in January 2008 as Acting CFO, Joseph D’Agostino brings to Milestone a
wealth of finance and accounting experience earned over 25 years serving both publicly and
privately held companies. Following a nine month performance assessment by the Board of Directors,
Mr. D’Agostino was officially named Milestone’s Chief Financial Officer in October 2008. A
results-oriented and decisive leader, he has specific proven expertise in treasury and cash
management, strategic planning, information technology, internal controls, Sarbanes-Oxley
compliance, operations and financial and tax accounting. Immediately prior to joining Milestone,
Mr. D’Agostino served as Senior Vice President and Treasurer of Summit Global Logistics, a publicly
traded, full service international freight forwarder and customs broker with operations in the
United States and China. Previous executive posts also included Executive Vice President and CFO
of Haynes Security, Inc., a leading electronic and manned security solutions company serving
government agencies and commercial enterprises; Executive Vice President of Finance and
Administration for Casio, Inc., the U.S. subsidiary of Casio Computer Co., Ltd., a leading
manufacturer of consumer electronics with subsidiaries throughout the world; and Manager of
Accounting and Auditing for Main Hurdman’s National Office in New
York City (merged into KPMG). Mr. D’Agostino is a Certified Public Accountant and holds memberships
in the American Institute of CPA’s, New Jersey Society of CPA’s, Financial Executive Institute,
Consumer Electronics Industry Association and Homeland Security Industry Association. He is a
graduate of William Paterson University where he earned a Bachelor of Arts degree in Science.
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Mark Hochman, D.D.S., Director of Clinical Affairs
Dr. Hochman has served as 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 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. Recognized as a world authority on Advanced Drug Delivery
Systems, Dr. Hochman has published numerous articles in this area, and shares in the responsibility
for inventing much of the technology currently available from Milestone.
Dr. Eugene Casagrande, Director of International & Professional Relations
Since 1998, Dr. Casagrande has served as Director of International and Professional Relations,
charged with pursuing a broad range of clinical and industry-related strategic business
opportunities for the Company. He has also lectured both nationally and internationally at over 35
dental schools and in over 22 countries on Computer-Controlled Local Anesthesia Delivery. Dr.
Casagrande is past president of the California State Board of Dentistry and the Los Angeles Dental
Society and is a Fellow of the American and International Colleges of Dentists and has served on
the faculty of the University of Southern California, School of Dentistry.
Leonard M. Schiller, Director
Mr. 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. Mr. Schiller became a Director of the Gravitas Cayman Corporation in February
2010. Gravitas Cayman Corporation is an Investment Fund. Mr. Schiller’s professional experience and
background as an attorney and a partner of a law firm and with us, as one of our directors since
1997, have given him the expertise needed to serve as one of our directors.
Jeffrey Fuller, Director
Mr. 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
2002-2004 at Berkeley College, NY, teaching several courses including Accounting. Mr. Fuller has
not been involved in any legal proceedings and has not been a director of any other business entity
in the past 10 years.
Pablo Felipe Serna Cardenas, Director
Mr. Serna Cardenas 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 Cardenas 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 Cardenas 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 Cardenas was the general manager with Estudios, Consultorias
y Asesorias Financieras, a Financial Consulting firm in Columbia. He has been a director of
Pairstech Fund, a UK hedge Fund since 2008. Mr. Cardenas’ professional experience and background as
an entrepreneur and as a financial consultant and with us, as one of our directors since 2006, have
given him the expertise needed to serve as one of directors.
Milestone’s 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
Milestone’s officers, employees, directors and consultants. All compensation arrangements between
Milestone and its directors, officers and affiliates are reviewed by the Compensation Committee;
two of the members are independent directors. The Audit Committee meets with management and
Milestone’s 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 NYSE Alternext.
25
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Section 16(a) Beneficial Ownership Reporting Compliance
Section 16(a) of the Securities Exchange Act of 1934 requires Milestone’s officers and
directors, and persons who own more than ten percent (10%) of a registered class of Milestone’s
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 Milestone’s 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 2009.
Code of Ethics
Milestone has adopted a code of ethics that applies to its 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 Milestone’s web site at
www.milesci.com. Milestone will also provide a copy of the Code of Ethics to any person
without charge, upon written request addressed to the Chief Financial Officer, Joseph D’Agostino at
the principal executive office, located at 220 South Orange Avenue, Livingston, NJ, 07039.
Item 11. Executive Compensation.
The following Summary Compensation Table sets forth all compensation earned, in all
capacities, during the fiscal years ended December 31, 2009 and 2008 by (i) Milestone’s CEO and
(ii) the most highly compensated executive officers, other than the CEO who were serving as
executive officers at the end of the 2009 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
| Other | Option | |||||||||||||||||||||||||||
| NAME AND PRINCIPAL POSITION | YEAR | Salary | Bonuses | Compensation | Awards (2) | Total | ||||||||||||||||||||||
Leonard A. Osser Chief Executive Officer-effective 9-1-2009 |
2009 | $ | 300,000 | $ | 400,000 | (1) | $ | 298,734 | $ | 998,734 | ||||||||||||||||||
Chairman of the Board |
2008 | $ | 200,000 | (1 | ) | — | $ | 18,408 | (1) | $ | — | $ | 218,408 | |||||||||||||||
Joe W. Martin |
2009 | $ | — | (3 | ) | $ | — | $ | — | $ | — | $ | — | |||||||||||||||
Chief Executive Officer |
2008 | $ | 300,000 | $ | 70,000 | $ | 3,696 | $ | 80,000 | (2) | $ | 453,696 | ||||||||||||||||
Joseph D’Agostino |
2009 | $ | 171,600 | $ | 25,000 | (4) | $ | — | $ | 135,975 | $ | 332,575 | ||||||||||||||||
Chief Financial Officer |
2008 | $ | 165,000 | $ | 28,000 | $ | 2,737 | $ | 195,737 | |||||||||||||||||||
| (1) | Includes $200,000 and $100,000 in deferred compensation in 2009 and 2008, respectively,
in accordance with his employment agreement to be paid in common stock and not paid until
the termination of the agreement in 2014 (under new employment agreement) or thereafter, if
further extended. Other compensation represents payments made for health insurance coverage. |
|
| (2) | The amounts in this column reflects the fair value of the options at date of grant. For
details used in the assumption calculating the fair value of the option reward, see Note B
to the Financial Statements for the year ended December 31, 2009, which is located on pages
F-7 through F-11 of the Annual Report on Form 10-K. Compensation cost is generally
recognized over the vesting period of the award. See the table below entitled “Outstanding
Equity Awards at December 31, 2009. |
|
| (3) | Mr. Martin resigned from the Company effective March 31, 2009. |
|
| (4) | Includes $25,000 in deferred compensation in 2009, is accordance with agreement to be
paid in common stock and not paid until the termination of his employment with the Company. |
Employment Contracts
In March 2009, the Chairman assumed the position of Milestone’s Acting Chief Executive
Officer. In September 2009 The Chairman stepped down as Chairman to fill the position of Chief
Executive Officer. The Chief Executive Officer entered into a new employment agreement with the
Company effective September 1, 2009. This new agreement suspends the previous agreement scheduled
to terminate on December 31, 2012. The new agreement is for five years ending on August 31, 2014.
The contract shall be extended for successive one-year periods, unless prior to August 1 of any
year, either party notifies the other that he or it chooses not to extend the New Employment Term.
As part of this agreement the Chairman relinquished the title and position of Chairman. Under the
new agreement, the Chief Executive Officer will receive a base compensation of $300,000 per year.
In addition, the CEO,
may earn annual bonuses up to an aggregate of $400,000, payable one half in cash and one half
in common stock, contingent upon achieving targets set for each year by the Compensation Committee
of the Board of Directors of the Company.
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In addition, if in any year of the term of the agreement the CEO earns a bonus, he shall also
be granted five-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 the 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.
In accordance with the employment contract, as of September 30, 2009 and January 1, 2008,
676,676 shares and 504,639 shares of common stock are to be paid out at the end of the contract in
settlement of $925,000 as December 31, 2009 and $700,000 as of December 31, 2008 of accrued
deferred compensation and, accordingly, such shares have been classified in stockholders’ equity
with the common shares classified as to be issued.
Milestone entered into an agreement with a new Chairman effective October 1, 2009. The term of
the contract is for a nine month period ending on June 30, 2010. Under this agreement the Chairman
will receive a base compensation of $190,000 per year, payable $5,000 per month in cash starting in
January 2010 and the remainder in stock issued at the closing price on September 1, 2009. 84,783
shares were issued in September 2009.
Objective of Executive Compensation Program
The primary objective of the executive compensation program is to attract and retain
qualified, energetic managers who are enthusiastic about the mission and culture. A further
objective of the compensation program is to provide incentives and reward each manager for their
contribution. In addition, Milestone strives to promote an ownership mentality among key leadership
and the Board of Directors.
The Compensation Committee reviews and approves, or in some cases recommends for the approval
of the full Board of Directors, the annual compensation procedures for the Named Executive
Officers.
The compensation program is designed to reward teamwork, as well as each manager’s individual
contribution. In measuring the Named Executive Officers’ contribution, the Compensation Committee
considers numerous factors including the growth, strategic business relationships and financial
performance. Regarding most compensation matters, including executive and director compensation,
the management provides recommendations to the Compensation Committee; however, the Compensation
Committee does not delegate any of its functions to others in setting compensation. Milestone does
not currently engage any consultant to advice on executive and/or director compensation matters.
Stock price performance has not been a factor in determining annual compensation because the
price of Milestone’s common stock is subject to a variety of factors outside of the control.
Milestone does not have an exact formula for allocating between cash and non-cash compensation.
Annual executive chief officer compensation consists of a base salary component and periodic
stock option grants. It is the Compensation Committee’s intention to set totals for the chief
executive officer for 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 the other
stakeholders. The chief executive officer receives stock option grants under the stock option plan.
The number of stock options granted to the executive officer is made on a discretionary rather than
a formula basis by the Compensation Committee. The chief executive officer’s current and prior
compensation is considered in setting future compensation. In addition, Milestone reviews the
compensation practices of 28 other companies. To some extent, the compensation plan is based on the
market and the companies that compete for executive management. The elements of the 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 the competing
objectives of fairness to all stakeholders and attracting/retaining executive managers.
27
Table of Contents
Outstanding Equity Awards at December 31, 2009
The following table includes certain information with respect to the value of all unexercised
options previously awarded to the Named Executive Officers. There were no stock awards granted in
2009.
| 2009 Options Awards | 2009 Options Awards | |||||||||||||||
| Number of Securities | Number of Securities | |||||||||||||||
| Underlying Unexercised | Underlying Unexercised | Option Exercise | Option Expiration | |||||||||||||
| Name | Options Exercisable | Options Unexercisable | Price ($) | Date | ||||||||||||
Leonard Osser |
84,388 | 168,776 | $ | 1.74 | 12/17/2014 | |||||||||||
Joseph D’Agostino |
— | 60,000 | $ | 0.40 | 03/31/2014 | |||||||||||
| — | 50,000 | $ | 1.15 | 09/01/2014 | ||||||||||||
| — | 50,000 | $ | 1.15 | 12/28/2014 | ||||||||||||
| 10,548 | 21,098 | $ | 1.58 | 12/17/2014 | ||||||||||||
The above amounts for Mr. Osser do not include 666,667 Performance Options reserved for a
special bonus for obtaining a three year purchase order for the sale of 12,000 STA Systems and
related handpieces over a four year period. These options were reserved but will not be granted
until specific performance targets are achieved. The options will be issued upon achievement of the
specific target on a yearly basis. The exercise price of the options is $1.49 per share.
Compensation of Directors
Milestone paid no cash or stock based compensation to its directors in 2009 and 2008. On June
4, 2009 and June 5, 2008, Milestone awarded to each of its independent directors stock options
expiring on June 4, 2014 and June 3,2013, respectively, for the purchase of 25,000 and 20,000
shares for each year respectively, of its common stock, one half of each grant was exercisable
immediately and the remaining one half exercisable one year after the grant, at $0.55 and $0.74
per share for the options granted on June 4, 2009 and June 5, 2008, respectively, with respect to
the years ending with Milestone’s 2009 and 2008 annual meeting.
The following table provides compensation information for the year ended December 31, 2009 and
2008 for each of the independent directors. Milestone does not pay any directors’ fees. Directors
are reimbursed for the costs relating to attending board and committee meetings.
Director Compensation
| 2009 | ||||
| Name | Option Awards (1) | |||
Leonard M. Schiller |
$ | 13,750 | (2) | |
Jeffrey Fuller |
$ | 13,750 | (2) | |
Leslie Bernhard |
$ | 13,750 | (2) | |
Pablo Felipe Serna Cardenas |
$ | 13,750 | (2) | |
| (1) | Amounts are calculated using the provisions of FASB ASC 718. |
|
| (2) | On June 4, 2009, each of Milestone’s independent directors was awarded options
exercisable for 25,000 shares of common stock at $0.55 per share. |
28
Table of Contents
Item 12. 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 10, 2010, regarding stock ownership of all persons known by Milestone to own beneficially
more than 5% of Milestone’s outstanding common stock, Named Executives, all directors, and all
directors and officers of Milestone as a group:
| March 10, 2010 | ||||||||
| Shares of Common Stock | Percentage | |||||||
| Names of Beneficial Owner (1) | Beneficially Owned (2) | of Ownership | ||||||
Executive Officers and Directors |
||||||||
Leonard Osser |
2,283,253 | (3) | 15.44 | % | ||||
Joseph D’Agostino |
236,700 | (4) | * | |||||
Leonard Schiller |
138,228 | (5) | * | |||||
Pablo Felipe Serna Cardenas |
75,000 | (6) | * | |||||
Jeffrey Fuller |
115,000 | (7) | * | |||||
Leslie Bernhard |
189,783 | (8) | * | |||||
All directors & executive officers as group (7 persons) |
2,646,572 | 17.89 | % | |||||
K. Tucker Andersen |
2,686,230 | (9) | 18.16 | % | ||||
Tom Cheng |
752,852 | (10) | 5.09 | % | ||||
| * | Less than 1% |
|
| (1) | The addresses of the persons named in this table are as follows: Leonard Osser and Joseph
D’Agostino are at 45 Knightsbridge Road in Piscataway, New Jersey 08854; Leonard M. Schiller,
c/o Schiller, Klein & McElroy, P.C., 33 North Dearborn Street, Suite 1030, Chicago, Illinois
60602; Pablo Felipe Serna Cardenas, Via Camillo Golgi 2 Opera, Italy 20090; Jeffrey Fuller,
Eagle Chase, Woodbury, NY 11797; Leslie Bernhard, c/o 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 16, 2010 and 2009, as applicable, upon the exercise of
options and warrants or conversion of convertible securities. Each beneficial owner’s
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 14,792,528 outstanding shares on March
10, 2010, plus those shares underlying options exercisable within 60 days from the filing of
this report held by the named individual or the group. |
|
| (3) | March 10, 2010 excludes 666,667 Performance Options reserved for a special bonus for
obtaining a three year purchase order for the sale of 12,000 STA Systems and related
handpieces over a four year period. These options were reserved but not granted until
specific performance targets are achieved. The options will be issued upon achievement of the
specific target on a yearly basis. Included in this total is 253,164 shares subject to option
at $1.74, one third immediately exercisable and one third each year after the grant date.
Also included in March 10, 2010, 676,676 Shares to Be Issued at the termination of his
employment agreement. |
|
| (4) | Includes 29,231 shares held by Mr. D’Agostino at March 10, 2010. Additionally, this
includes 15,823 Shares to Be Issued at the termination of his employment; 191,646 shares
subject to options. 60,000 shares at $0.40, fully vested at October 2010, 100,000 options,
one third exercisable one year after the grant date and one third each subsequent years as
follows ; 100,000 shares at $1.15; and 31,646 at $1.58, one half immediately exercisable and
one half each year after the grant date. |
|
| (5) | March 10, 2010, includes 125,000 stock options; one half of each grant was exercisable
immediately and the remaining one half exercisable one year after the grant date as follows:
25,000 shares at $0.55 issued in June 2009;: 20,000 shares at $3.27 per share, 20,000 shares
at $1.40 per share, 20,000 shares at $0.83 per share and 20,000 shares at $1.68 and 20,000
shares at $0.74. Also included is 13,228 shares held by Mr. Schiller. |
|
| (6) | March 10, 2010 includes 75,000 stock options; one half of each grant was exercisable
immediately and the remaining one half exercisable one year after the grant date as follows:
25,000 shares at $0.55 issued in June 2009, 10,000 shares at $0.83 per share, 20,000 shares
at $1.68 and 20,000 shares at $0.74. |
|
| (7) | March 10, 2010 includes 115,000 stock options; one half of each grant was exercisable
immediately and the remaining one half exercisable one year after the grant date as follows:
20,000 shares at $3.27 per share, 20,000 shares at $1.40 per share, 10,000 shares at $0.83
and 20,000 shares at $1.68 per share and 20,000 at $0.74. |
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| (8) | March 10, 2010 includes 84,783 shares owned by Ms. Bernhard, 105,000 stock options; one
half of each grant was exercisable immediately and the remaining one half exercisable one
year after the grant date as follows: 20,000 shares at $3.27, 20,000 shares at $1.40, 20,000
shares at $1.68 and 20,000 shares at $0.74 and 25,000 shares at $0.55. |
|
| (9) | March 10, 2010 includes 175,000 stock options, 130,000 at $5.00 and 45,000 at $0.32. |
|
| (10) | March 10, 2010 includes 752,852 shares of stock. Mr. Cheng purchased 333,333 shares in
August 2009 and 34,783 shares were issued for services provided in October 2009. |
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, 2009. 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) | ||||||||||||
| Number of Securities (1) to | Weighted-average exercise | remaining available for | ||||||||||
| be issued upon exercise of | price of outstanding | future issuance under | ||||||||||
| outstanding options and warrants | options and warrants | equity compensation plan | ||||||||||
Equity compensation plan approved by
stockholders (1) |
||||||||||||
Grants under our 2004 Stock Option Plan |
1,000,142 | 1.16 | 428,000 | |||||||||
Equity compensation plan not approved by
stockholders (2) |
Not applicable | |||||||||||
Aggregate individual option and warrants grants |
589,999 | 2.50 | ||||||||||
Total |
1,590,141 | 1.72 | ||||||||||
| (1) | Consisting of the 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, 333 options
which were exercised in April 2005 and 26,666 shares exercised in 2007. 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 the 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. The plan expired
in 2008. |
|
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
Milestone’s 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. No options were exercised in 2009. |
||
In March 2008, the Board of Directors authorized an additional 250,000 options to this plan. |
||
| (2) | The aggregate individual option grants outside the Stock Option Plans 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. |
30
Table of Contents
Stock Plan
In 2006 Milestone adopted an equity compensation plan for the issuance of up to 300,000 shares
of the 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 the Company to adequately compensate existing employees, officers,
directors and consultants, or new employees, officers, directors and consultants, whose performance
will contribute to the long-term success and growth. Milestone believe that the availability of
these shares will also strengthen the ability to attract and retain employees, officers, directors
and consultants of high competence, increase the identity of interests of such people with those of
the 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 2009, 45,304 shares of common stock valued at $24,725, were granted under the 2006
Stock Plan as part of Officer’s Compensation.
During 2008, no shares were issued under this plan.
As of December 31, 2009 there are no shares remaining under this plan. As of December 31,
2008, shares available to be issued under this plan were 45,304.
In December 2007, the Board of Directors authorized the Company to issue up to $2 million of
its Company stock to vendors or employees, and to grant them piggy back registration rights in the
usual form, at a value of not less than 90% of the market value on the date of the agreement for
the vendor or employee to accept said shares. Such future shares are not included in the above
noted shares reserved for future issuance.
In 2009, the Company issued the following shares under this Plan; 151 shares valued at of $275
for Officer Deferred Compensation, 518,367 shares valued at $500,500 for consulting services,
323,009 shares valued at $160,325 for employee compensation, 84,783 valued at $97,500 for advances
to the Chairman, 3,333 shares valued at $1,866 for the exercise of options, and 142,405 shares
valued at $225,000 for shares to be issued to officers of the Company.
Additionally, the Company with Board of Directors approval, issued 333,333 shares, purchased
by a shareholder for $150,000 and 822,785 shares valued at $1.3 million on conversion of the Line
of Credit (see Note H to the financial statements). Neither of these transactions was charged
against any of the current Stock Plans.
At December 31, 2009 and 2008 there was $143,670 and $1,129,136, respectively, available to
be issued under this plan.
The Vendor Shares were issued in reliance upon the exemption from the registration
requirements of the Act, as provided in Section 4(6) and thereof, as a transaction by an issuer not
involving a public offering. Milestone 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 13. Certain Relationships and Related Transactions and Director Independence.
On June 28, 2007 the Company secured a $1 million line of credit from a stockholder. This
borrowing was amended to $1,300,000 as of September 30, 2008 under the same terms and conditions as
the original. Borrowings bear interest at 6% per annum, with one year’s interest at 1% payable in
advance on each draw. Monies may be drawn by Milestone under the line in multiples of $100,000 upon
5 days written notice to the stockholder from either Milestone’s Chief Executive Officer or Chief
Financial Officer. Monies under the line in excess of $1,000,000 may be drawn in multiples of
$25,000. Borrowings may be prepaid at any time in multiples of $100,000, without penalty. All
borrowings and interest thereon must be repaid by June 30, 2010, and after the expiration date of
the line, may be repaid by Milestone in cash or, at its option, in shares of common stock valued at
the lower of $2.00 per share or 80% of the average closing price of its shares during the 20
trading days ending with December 31, 2008. At December 31, 2008, the conversion price at 80% of
the average closing price of the Company’s stock was $0.26 per share. After December 31, 2008, and
before June 30, 2010, the lender may convert all or any part of the then outstanding balance and
interest thereon into shares of Common Stock at $4.00 per share. Three year warrants exercisable at
$5.00 per share, in an amount determined by dividing 50% of the amount borrowed by $5.00 will be
issued on each drawdown. There is no facility fee on the line. The warrants have been valued as of
each draw down using the Black-Scholes model and are reflected as a discount against the debt
incurred under this line of credit. At December 31, 2008 the remaining balance of debt discount was
$52,530. The full amount of the line of credit and amendment, $1.3 million, has been drawn at
September 30, 2008. This borrowing was amended to $1,300,000 as of September 30, 2008 under the
same terms and conditions as the original borrowing. In December 2009, the Company converted the
$1.3 million Line of Credit into 822,785 shares of Common Stock at a price of $1.58 per share.
Additionally, the interest due on this note is payable over a two year period (quarterly payments
of $23,000). The Company borrowed an additional $450,000 from the same shareholder in 2008. The
borrowing was originally on short term loan with a maturity date of January 19, 2009. In December
2008, this borrowing was refinanced with the shareholder with a due date of June 30, 2012. The
borrowing includes a twelve percent interest rate, interest compound quarterly, with interest and
principle due at the maturity. Further, the note provides for the issuance of warrants to the
stockholder that is exercisable for five years at the price of $0.32 per share for 45,000 shares of
stock. The warrants were valued using the Black-Scholes model and are reflected as a discount
against the debt. The Company did not have any other related party transactions pursuant to Item
404 of Regulation S-K of the Exchange Act. Milestone have adopted a policy that, in the future, the
Audit Committee must review all transactions with any officer,
director or 5% stockholder.
31
Table of Contents
Director Independence
The Board has determined that Leonard M. Schiller, Jeffrey Fuller and Pablo Felipe Serna
Cardenas (the “Independent Directors”) are independent as that term is defined in the listing
standards of the NYSE Alternext. As disclosed above, Leonard M.
Schiller, Jeffrey Fuller is the sole member of the Audit Committee and is independent for such
purposes, and Leonard M. Schiller, Leslie Bernhard and Pablo Felipe Serna Cardenas 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, 2009, 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 14. Principal Accounting Fees and Services
Audit Fees
Milestone incurred audit and financial statement review fees totaling $148,119 and $137,975,
respectively from Holtz Rubenstein Reminick LLP, the principal accountant for 2009 and 2008.
Audit Related Fees
There were no audit related fees to the principal accountant Holtz Rubenstein Reminick LLP in
2009 and 2008.
Tax Fees
There were no fees for services related to tax compliance, tax advice and tax planning billed
by the principal accountant in 2009 and 2008.
All Other Fees
There were no other fees billed during 2009 and 2008 by Milestone’s principal accountants.
Audit Committee Administration of the Engagement
The engagement with Holtz Rubenstein Reminick LLP, the principal accountants, was approved in
advance by the Board of Directors and the Audit Committee. No non-audit or non-audit related
services were approved by the audit committee in 2009.
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 the 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 the independent accountants have been pre-approved by the Audit
Committee to assure that such services do not impair the auditors’ independence from us.
32
Table of Contents
PART IV
Item 15. Exhibits
(a) 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.
| 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) |
|||
| 10.11 | ** | Employment Agreement with Leonard Osser dated January 1, 2008 (11) |
||
| 10.12 | ** | Employment Agreement with Joe W. Martin dated May 2, 2007 (11) |
||
| 10.13 | ** | Employment Agreement with Leonard Osser dated September 1, 2009.* |
||
| 14 | Code of Ethics (7) |
|||
| 23.1 | Consent of Holtz Rubenstein Reminick 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 |
33
Table of Contents
| (1) | Incorporated by reference to Milestone’s Registration Statement on Form SB-2 No. 33-92324. |
|
| (2) | Incorporated by reference to Amendment No. 1 to Milestone’s Registration Statement on Form
SB-2 No. 333-92324. |
|
| (3) | Incorporated by reference to Milestone’s Form 10-KSB for the year ended December 31, 1996. |
|
| (4) | Incorporated by reference to Milestone’s Form 10-KSB for the year ended December 31, 1999. |
|
| (5) | Incorporated by reference to Milestone’s Registration Statement on Form S-2 No. 333-110376,
Amendment No. 1. |
|
| (6) | Incorporated by reference to Milestone’s Registration Statement on Form S-2 No. 333-110376,
Amendment No. 3. |
|
| (7) | Incorporated by reference to Milestone’s Form 10-KSB for the year ended December 31, 2003. |
|
| (8) | Incorporated by reference to Milestone’s Registration Statement on Form S-2 No. 333-110367,
Amendment No. 5. |
|
| (9) | Incorporated by reference to Milestone’s Form 10-KSB for the year ended December 31, 2004. |
|
| (10) | Incorporated by reference to Milestone’s Form 10-KSB for the year ended December 31, 2005. |
|
| (11) | Incorporated by reference to Milestone’s Form 10-KSB for the year ended December 31, 2007. |
|
| (12) | Incorporated by reference to Milestone’s Form 10-KSB for the year ended December 31, 2008. |
34
Table of Contents
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 | |||
| Chief Executive Officer | ||||
Date: March 10, 2010
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
|
March 10, 2010 | Chief Executive Officer | ||
/s/ Joseph D’Agostino
|
March 10, 2010 | Chief Financial Officer | ||
/s/ Leonard Schiller
|
March 10, 2010 | Director | ||
/s/ Jeffery Fuller
|
March 10, 2010 | Director | ||
/s/ Leslie Bernard
|
March 10, 2010 | Chairman | ||
/s/ Pablo Felipe Serna Cardenas
|
March 10, 2010 | Director |
35
Table of Contents
INDEX TO FINANCIAL STATEMENTS
| Page | ||||
| F-2 | ||||
| F-3 | ||||
| F-4 | ||||
| F-5 | ||||
| F-6 | ||||
| F-7 | ||||
F-1
Table of Contents
Report of Independent Registered Public Accounting Firm
Board of Directors and Stockholders
Milestone Scientific Inc.
Milestone Scientific Inc.
We have audited the accompanying balance sheets of Milestone Scientific Inc. as of December 31,
2009 and 2008 and the related statements of operations, stockholders’ equity, and cash flows for
the two years then ended. These financial statements are the responsibility of the Company’s
management. Our responsibility is to express an opinion on these financial statements based on our
audits.
We conducted our audits in accordance with 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. The
Company is not required to have, nor were we engaged to perform, an audit of its internal control
over financial reporting. Our audits included consideration of internal control over financial
reporting as a basis for designing audit procedures that are appropriate in the circumstances, but
not for the purpose of expressing an opinion on the effectiveness of the Company’s internal control
over financial reporting. Accordingly, we express no such opinion. An audit also includes
examining, on a test basis, evidence supporting the amounts and disclosures in the financial
statements, 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, 2009 and 2008 and
the results of its operations and its cash flows for the two years then ended in conformity with
accounting principles generally accepted in the United States of America.
The accompanying financial statements have been prepared assuming that the Company will continue as
a going concern. As discussed in Note A to the financial statements, the Company has suffered
recurring losses from operations since inception, which raises substantial doubt about its ability
to continue as a going concern. Management’s plans in regard to these matters are described in Note
A. The financial statements do not include any adjustments that might result from the outcome of
this uncertainty.
/s/ Holtz Rubenstein Reminick LLP
New York, New York
March 10, 2010
March 10, 2010
F-2
Table of Contents
MILESTONE SCIENTIFIC INC.
BALANCE SHEETS
December 31, 2009 and 2008
| December 31, 2009 | December 31, 2008 | |||||||
ASSETS |
||||||||
Current Assets: |
||||||||
Cash and cash equivalents |
$ | 1,029,129 | $ | 743,665 | ||||
Accounts receivable, net of allowance for doubtful accounts of $5,000 in 2009 and 2008 |
1,063,742 | 925,742 | ||||||
Inventories |
804,736 | 719,902 | ||||||
Advances to contract manufacturer |
151,995 | 250,110 | ||||||
Prepaid expenses and other current assets |
254,501 | 218,296 | ||||||
Total current assets |
3,304,103 | 2,857,715 | ||||||
Advances to contract manufacturer |
311,230 | 415,780 | ||||||
Investment in distributor, at cost |
76,319 | 76,319 | ||||||
Furniture, Fixtures & Equipment net of accumulated depreciation of $395,630
as of December 31, 2009 and $345,377 as of December 31, 2008 |
77,353 | 152,574 | ||||||
Patents, net of accumulated amortization of $211,539 as of December 31, 2009
and $135,406 as of December 31, 2008 |
947,315 | 901,045 | ||||||
Other assets |
133,674 | 7,317 | ||||||
Total assets |
$ | 4,849,994 | $ | 4,410,750 | ||||
LIABILITIES AND STOCKHOLDERS’ EQUITY |
||||||||
Current Liabilities: |
||||||||
Accounts payable |
$ | 1,154,013 | $ | 829,130 | ||||
Accrued expenses and other payable |
524,017 | 495,897 | ||||||
Total current liabilities |
1,678,030 | 1,325,027 | ||||||
Long-term Liabilities: |
||||||||
Accrued Interest - 6% note |
92,000 | — | ||||||
Line of credit-net of discount of $52,530 in 2008 |
— | 1,247,470 | ||||||
Notes Payable-net of discount of $11,157 and $11,927, respectively |
438,843 | 438,073 | ||||||
Total long-term liabilities |
530,843 | 1,685,543 | ||||||
Commitments and Contingencies |
||||||||
Stockholders’ Equity |
||||||||
Common stock, par value $.001; authorized 50,000,000 shares; 14,781,295 shares issued
692,498 shares to be issued and 14,747,962 shares outstanding as of December 31, 2009;
12,695,685 shares issued, 504,639 shares to be issued, and 12,662,352 shares outstanding
as of December 31, 2008 |
15,472 | 13,200 | ||||||
Additional paid-in capital |
62,300,619 | 59,531,865 | ||||||
Accumulated deficit |
(58,763,454 | ) | (57,233,369 | ) | ||||
Treasury stock, at cost, 33,333 shares |
(911,516 | ) | (911,516 | ) | ||||
Total stockholders’ equity |
2,641,121 | 1,400,180 | ||||||
Total liabilities and stockholders’ equity |
$ | 4,849,994 | $ | 4,410,750 | ||||
See Notes to Financial Statements
F-3
Table of Contents
MILESTONE SCIENTIFIC INC.
STATEMENTS OF OPERATIONS
YEARS ENDED DECEMBER 31, 2009 AND 2008
| 2009 | 2008 | |||||||
Product sales, net |
$ | 8,549,060 | $ | 6,595,525 | ||||
Royalty income |
— | 28,282 | ||||||
Total revenue |
8,549,060 | 6,623,807 | ||||||
Cost of products sold |
3,458,279 | 2,681,116 | ||||||
Gross profit |
5,090,781 | 3,942,691 | ||||||
Selling, general and administrative expenses |
6,952,976 | 5,502,762 | ||||||
Research and development expenses |
241,318 | 168,516 | ||||||
| 7,194,294 | 5,671,278 | |||||||
Loss from operations |
(2,103,513 | ) | (1,728,587 | ) | ||||
Other income (expense) |
||||||||
Other income |
777,609 | 675,930 | ||||||
Interest income |
3,146 | 9,023 | ||||||
Interest expense |
(154,027 | ) | (116,374 | ) | ||||
Amortized debt issuance |
(53,300 | ) | (27,446 | ) | ||||
Total other income |
573,428 | 541,133 | ||||||
Net loss |
$ | (1,530,085 | ) | $ | (1,187,454 | ) | ||
Net loss applicable to common stockholders |
$ | (1,530,085 | ) | $ | (1,187,454 | ) | ||
Loss per share applicable to common stockholders —
basic and diluted |
$ | (0.11 | ) | $ | (0.09 | ) | ||
Weighted average shares outstanding and to be issued —
basic and diluted |
13,389,872 | 12,666,979 | ||||||
See Notes to Financial Statements
F-4
Table of Contents
MILESTONE SCIENTIFIC INC.
STATEMENTS OF CHANGES IN STOCKHOLDERS’ EQUITY
YEARS ENDED DECEMBER 31, 2009 AND 2008
| Additional | ||||||||||||||||||||||||
| Common Stock | Paid-in | Accumulated | Treasury | |||||||||||||||||||||
| Shares | Amount | Capital | Deficit | Stock | Total | |||||||||||||||||||
Balance, December 31, 2007 |
12,208,878 | 12,210 | 58,483,539 | (56,045,915 | ) | (911,516 | ) | 1,538,318 | ||||||||||||||||
Options issued to employees and consultants |
— | — | 151,920 | 151,920 | ||||||||||||||||||||
Common stock issued for payment of
services to settle accounts payable |
156,448 | 156 | 262,590 | 262,746 | ||||||||||||||||||||
Common stock issued for
payment of consulting services
to settle accounts payable |
356,063 | 356 | 315,743 | 316,099 | ||||||||||||||||||||
Common stock issued for
payment of employee compensation |
135,602 | 135 | 98,284 | 98,419 | ||||||||||||||||||||
Common shares to be issued in
settlement of deferred compensation |
83,333 | 83 | 99,917 | 100,000 | ||||||||||||||||||||
Common stock issued for patents in settlement
of lawsuit |
260,000 | 260 | 93,340 | 93,600 | ||||||||||||||||||||
Warrants issued in connection with
amendment to Line of Credit |
12,579 | 12,579 | ||||||||||||||||||||||
Warrants issued in connection with
refinancing of Notes Payable |
13,953 | 13,953 | ||||||||||||||||||||||
Net loss |
(1,187,454 | ) | (1,187,454 | ) | ||||||||||||||||||||
Balance, December 31, 2008 |
13,200,324 | $ | 13,200 | $ | 59,531,865 | $ | (57,233,369 | ) | $ | (911,516 | ) | $ | 1,400,180 | |||||||||||
Options issued to employees and consultants |
285,835 | 285,835 | ||||||||||||||||||||||
Common stock issued for payment of consulting
services to settle accounts payable |
518,367 | 518 | 499,982 | 500,500 | ||||||||||||||||||||
Common stock issued for payment of employee
compensation |
323,009 | 323 | 160,002 | 160,325 | ||||||||||||||||||||
Common stock issued in advance of services-Chairman |
84,783 | 85 | 97,415 | 97,500 | ||||||||||||||||||||
Common stock to be issued for settlement of
deferred compensation |
45,455 | 45 | 24,955 | 25,000 | ||||||||||||||||||||
Common stock to be issued for bonus |
142,405 | 142 | 224,858 | 225,000 | ||||||||||||||||||||
Sale of common stock |
333,333 | 333 | 149,667 | 150,000 | ||||||||||||||||||||
Proceeds from exercising stock options |
3,333 | 3 | 1,863 | 1,866 | ||||||||||||||||||||
Conversion of Line of Credit |
822,785 | 823 | 1,299,177 | 1,300,000 | ||||||||||||||||||||
Proceeds on the sale of stock option agreement |
25,000 | 25,000 | ||||||||||||||||||||||
Net loss |
(1,530,085 | ) | (1,530,085 | ) | ||||||||||||||||||||
Balance, December 31, 2009 |
15,473,794 | $ | 15,472 | $ | 62,300,619 | $ | (58,763,454 | ) | $ | (911,516 | ) | $ | 2,641,121 | |||||||||||
See Notes to Financial Statements
F-5
Table of Contents
MILESTONE SCIENTIFIC INC.
STATEMENTS OF CASH FLOWS
YEARS ENDED DECEMBER 31, 2009 AND 2008
| 2009 | 2008 | |||||||
Cash flows from operating activities: |
||||||||
Net loss |
$ | (1,530,085 | ) | $ | (1,187,454 | ) | ||
Adjustments to reconcile net loss to net cash provided by (used in) operating activities: |
||||||||
Depreciation expense |
50,253 | 71,336 | ||||||
Amortization of patents |
76,133 | 55,908 | ||||||
Amortization of debt discount |
53,300 | 27,446 | ||||||
Common stock and options issued for compensation, consulting,
and vendor services |
1,444,159 | 350,339 | ||||||
Loss on sale/disposal of equipment |
46,918 | 2,255 | ||||||
Increase in inventory reserve |
36,000 | 82,000 | ||||||
Changes in operating assets and liabilities: |
||||||||
(Increase) in accounts receivable |
(138,000 | ) | (579,395 | ) | ||||
Decrease in royalty receivable |
— | 15,358 | ||||||
(Increase) Decrease in inventories |
(120,834 | ) | 834,842 | |||||
Decrease to advances to contract manufacturer |
202,665 | 526,694 | ||||||
(Increase) to prepaid expenses and other current assets |
(36,205 | ) | (48,569 | ) | ||||
(Increase) Decrease in other assets |
(126,357 | ) | 19,980 | |||||
Increase (Decrease) in accounts payable |
324,883 | (891,707 | ) | |||||
Increase in accrued expenses |
125,120 | 282,294 | ||||||
(Decrease) in deferred compensation |
(5,000 | ) | (3,333 | ) | ||||
Net cash provided by (used in) operating activities |
402,951 | (442,006 | ) | |||||
Cash flows from investing activities: |
||||||||
Purchases of property and equipment |
(51,950 | ) | (13,106 | ) | ||||
Proceeds on sale of equipment |
30,000 | 7,749 | ||||||
Payment for patent rights |
(122,403 | ) | (303,975 | ) | ||||
Net cash used in investing activities |
(144,353 | ) | (309,332 | ) | ||||
Cash flows from financing activities: |
||||||||
Proceeds from the sale of stock options |
25,000 | — | ||||||
Proceeds from the exercise of stock options |
1,866 | — | ||||||
Proceeds from Long term borrowing-other |
— | 300,000 | ||||||
Proceeds from Notes Payable |
— | 450,000 | ||||||
Net cash provided by financing activities |
26,866 | 750,000 | ||||||
NET INCREASE (DECREASE) IN CASH AND CASH EQUIVALENTS |
285,464 | (1,338 | ) | |||||
Cash and cash equivalents at beginning of year |
743,665 | 745,003 | ||||||
Cash and cash equivalents at end of year |
$ | 1,029,129 | $ | 743,665 | ||||
Supplemental disclosure of cash flow information: |
||||||||
Interest expense paid in cash |
$ | — | $ | 7,500 | ||||
Income tax paid |
$ | 8,225 | $ | 4,720 | ||||
Supplemental disclosure of non cash activities: |
||||||||
Warrants issued in connection with Line of Credit |
$ | — | $ | 12,579 | ||||
Warrants issued in connection with refinancing notes payble |
$ | — | $ | 13,953 | ||||
Shares issued for conversion of note |
$ | 1,300,000 | $ | — | ||||
Shares issued to employees in lieu of cash compensation |
$ | 160,325 | $ | 98,419 | ||||
Shares issued to officer in advance of services |
$ | 97,500 | $ | — | ||||
Shares issued for patents in settlement of litigation |
$ | — | $ | 93,600 | ||||
Shares issued to settle accounts payable |
$ | 500,500 | $ | 578,845 | ||||
See Notes to Financial Statements
F-6
Table of Contents
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, Wand Plus and STA (Single Tooth Anesthesia) 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. Milestone’s products are manufactured by a third-party contract manufacturer.
The Company had incurred operating losses since its inception. The company had positive cash flows
from operating activities at December 31, 2009 of $402,951 and a negative cash flow from operating
activities at December 31, 2008 of $442,006. At December 31, 2009, the Company had cash and cash
equivalents and working capital of $1,029,129 and $1,626,073, respectively. Additionally, as
discussed in Note H, on June 28, 2007, the Company secured a revolving line of credit in the
aggregate amount of $1,000,000 from a stockholder which line was fully borrowed at December 31,
2007. The borrowing was amended to $1,300,000 as of September 30, 2008 under the same terms and
conditions as the original borrowing. In December 2009, the Company converted the $1.3 million Line
of Credit into 822,785 shares of common stock at a conversion price of $1.58 per share.
Additionally, the company borrowed an additional $450,000 in 2008 from the same shareholder, with a
due date of January 2009. This additional borrowing was refinanced at December 31, 2008 and the due
date was extended to June 30, 2012. The Company is actively pursuing the generation of positive
cash flows from operating activities through an increase in revenue based upon management’s
assessment of present contracts and current negotiations and reductions in operating expenses. As
of December 31, 2009, the Company expects to have sufficient cash reserves to meet all of its
anticipated obligations for the next twelve months. The Company may require the need for a higher
level of marketing and sales efforts that at present it cannot fund. If the Company is unable to
generate positive cash flows from its operating activities it will need to raise additional
capital. There is no assurance that the Company will be able to achieve positive operating cash
flows or that traditional capital can be raised on terms and conditions satisfactory to the
Company, if at all. If positive cash flow cannot be achieved or if additional capital is required
and it cannot be raised, then the Company would be forced to curtail its development activities,
reduce marketing expenses for existing dental products or adopt other cost saving measures, any of
which might negatively affect the Company’s operating results.
The Company’s recurring losses raise substantial doubt about its ability to continue as a going
concern. The accompanying financial statements do not include any adjustments that might result
from the outcome of this uncertainty.
NOTE B — SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
1. Cash and Cash Equivalents
Milestone considers all highly liquid investments purchased with an original maturity of three
months or less to be cash equivalents.
2. Accounts Receivable
The realization of Accounts Receivable will have a significant impact on the Company. Consequently,
Milestone estimates losses resulting from the inability of its customers to make payments for
amounts billed. The collectability of outstanding amounts is continually assessed.
3. Royalty Receivable
Royalty Receivable represents the royalty due from the licensee of Milestone’s proprietary consumer
dental whitening product, which is sold under Milestone’s distributor’s trademark of Ionic White.
The royalties are received on a quarterly basis. As of December 31, 2009, the licensee has not been
able to sell any additional dental whiting product.
4. Product Return and Warranty
Milestone does not accept non-defective returns from its customers on a routine basis. Product
returns under warranty are accepted, evaluated and repaired or replaced in accordance with the
Warranty Policy. Returns not within the Warranty Policy are charged to the customer. Warranty
expense was $45,461 and $20,590 for 2009 and 2008, respectively. Non Warranty repairs are collected
from the customers. Non Warranty repair income was $81,913 and $61,198 for 2009 and 2008,
respectively.
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5. 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.
6. Furniture, Fixture and 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 five
to seven years. The costs of maintenance and repairs are charged to operations as incurred.
7. Investments
Investments in less than twenty percent owned entities are accounted for under the cost basis and
are reviewed for impairment periodically.
8. Patents
Patents are recorded at actual cost to prepare and file the applicable documents with the United
States Patent Office, or internationally with the applicable governmental office in the respective
country. Although certain patents have not yet been approved, the costs related to these patents
are being amortized using the straight-line method over the estimated useful life of the patent. If
the applicable patent application is ultimately rejected, the remaining unamortized balance will be
expensed in the period in which the Company receives a notice of such rejection. Patent
applications filed and patents obtained in foreign countries are subject to the laws and procedures
that differ from those in the United States. Patent protection in foreign countries may be
different from patent protection under United States laws and may not be favorable to the Company.
The Company also attempts to protect the proprietary information through the use of confidentiality
agreements and by limiting access to the facilities. There can be no assurance that the program of
patents, confidentiality agreements and restricted access to the facilities will be sufficient to
protect the proprietary technology.
9. Impairment of Long-Lived Assets
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. The Company has reviewed long-lived assets for impairment and concluded
no impairment exist as of December 31, 2009 and December 31, 2008, respectively.
10. Revenue Recognition
Revenue from product sales is recognized net of discounts and allowances to the domestic
distributor on the date of arrival of the goods at the customer’s location as shipments are FOB
destination. Shipments to the international distributors are FOB the warehouse and revenue is
therefore recognized on shipment. In both cases, the price to the buyer is fixed and the
collectability is reasonably assured. Further, Milestone has no obligation on these sales for any
post sale installation, set-up or maintenance, these being the responsibility of the buyer.
Customer acceptance is considered made at delivery. The only obligation after sale is the normal
commercial warranty against manufacturing defects if the alleged defective unit is returned within
the warranty period.
Royalty income was recognized as earned based on reports received from the licensee and related
royalty expense is accrued during the same period.
11. Shipping and Handling Costs
The Company includes shipping and handling costs in cost of goods sold. These costs are billed to
customers at the time of shipment for domestic shipments. International shipments are FOB the
warehouse, therefore no costs are incurred by the Company.
12. Research and Development
Research and development costs, which consist principally of new product development costs incurred
to third parties, are expensed as incurred.
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13. Advertising Expenses
Milestone expenses advertising costs as they are incurred. For the years ended December 31, 2009
and 2008, Milestone recorded advertising expenses of $333,572 and $268,009, respectively.
14. 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 basis 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.
15. 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 ASP Topic 260. Basic
earnings (loss) per common share is calculated by dividing net income or loss applicable to common
stockholders by the weighted average number of common shares outstanding and to be issued during
each period. The calculation of diluted earnings per common share is similar to that of basic
earnings per common share, except that the denominator is increased to include the number of
additional common shares that would have been outstanding if all potentially dilutive common
shares, such as those issuable upon the exercise of stock options, warrants, and the conversion of
debt were issued during the period.
Since Milestone had net losses for 2009 and 2008, the assumed effects of the exercise of
outstanding stock options and warrants, as well convertible debt were not included in the
calculation as their effect would have been anti-dilutive. Such outstanding options and warrants
totaled 1,650,141 at December 31, 2009 and 3,601,245 at December 31, 2008. The 1,650,151 options
and warrants outstanding as of December 31, 2009 does not include 666,667 Performance Options in
2009, that are not granted until earned over the next four years, if such performance targets are
achieved. See Note J.
16. Use of Estimates
The preparation of financial statements in conformity with accounting principles generally accepted
in the United States of America requires management to make estimates and assumptions in
determining the reported amounts of assets and liabilities and disclosure of contingent assets and
liabilities at the date of the financial statements and reported amounts of revenues and expenses
during the reporting period. The most significant estimates relate to the allowance for doubtful
accounts, inventory valuation, and 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.
17. Fair Value of Financial Instruments
Fair Value Measurements: We follow the provisions of ASC 820, Fair Value Measurements and
Disclosures related to financial assets and liabilities that are being measured and reported on a
fair value basis. Fair value is the price that would be received to sell an asset or paid to
transfer a liability in an orderly transaction between market participants in the principal market
at the measurement date (exit price). We are required to classify fair value measurements in one of
the following categories:
Level 1 inputs which are defined as quoted prices (unadjusted) in active markets for identical
assets or liabilities that the reporting entity has the ability to access at the measurement date.
Level 2 inputs which are defined as inputs other than quoted prices included within Level 1 that
are observable for the assets or liabilities, either directly or indirectly.
Level 3 inputs are defined as unobservable inputs for the assets or liabilities.
Financial assets and liabilities are classified based on the lowest level of input that is
significant to the fair value measurement. Our assessment of the significance of a particular input
to the fair value measurement requires judgment, and may effect the valuation of the fair value of
assets and liabilities and their placement within the fair value hierarchy levels.
The carrying amounts reported in the consolidated balance sheet for cash, accounts receivable,
advances to contract manufacturer, accounts payable and accrued expenses approximate fair value
based on the maturity of these instruments.
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18. Stock-Based Compensation
Milestone accounts for stock-based compensation under ASC Topic 718, “Share-Based Payment, an
Amendment of FASB Statement No. 123” (SFAS No. 123R). ASC Topic 718 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.
The weighted-average fair value of the individual options granted during 2009 and 2008 was
estimated as $0.91 and $0.84, respectively, on the date of grant. The fair value for 2009 and 2008
was determined using the Black-Scholes option-pricing model with the following weighted average
assumptions:
| December 31, | ||||||||
| 2009 | 2008 | |||||||
Volatility |
203 | % | 372 | % | ||||
Risk-free interest rate |
1.83 | % | 2.86 | % | ||||
Expected life |
3 years | 3 years | ||||||
Dividend yield |
0 | % | 0 | % | ||||
Forefeiture Rate |
6 | % | 6 | % | ||||
In accordance with the provisions of ASC Topic 718, 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 ASC Topic 718, 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 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 Milestone’s common stock over a period
commensurate with expected term. Milestone uses historical data to estimate option exercise and
employee termination within the valuation model.
19. Concentration of Credit Risk
Milestone’s financial instruments that are exposed to concentrations of credit risk consist
primarily of cash and trade accounts receivable, and advances to contract manufacturer. Milestone
places its cash and cash equivalents with large financial institutions. At times, such investments
may be in excess of the Federal Deposit Insurance Corporation insurance limit. Milestone has not
experienced any losses in such accounts and believes it is not exposed to any significant credit
risks. Financial instruments which potentially subject Milestone to credit risk consist principally
of trade accounts receivable, as Milestone does not require collateral or other security to support
customer receivables, and advances to contract manufacturer. Milestone entered into a purchase
agreement with a vendor to supply Milestone with 5,000 instruments of CompuDent. As part of this
agreement, Milestone has advanced approximately $463,000 and $666,000 to the vendor for purchase of
materials at December 31, 2009 and 2008, respectively. The advance will be credited to Milestone as
the goods are delivered. Milestone does not believe that significant credit risk exists with
respect to this advance to the contract manufacturer at December 31, 2009 and 2008.
Milestone closely monitors the extension of credit to its customers while maintaining allowances,
if necessary, for potential credit losses. On a periodic basis, Milestone evaluates its accounts
receivable and establishes an allowance for doubtful accounts, based on a history of past
write-offs and collections and current credit conditions. Management does not believe that
significant credit risk exists with respect to accounts receivable at December 31, 2009 and 2008.
20. Recent Accounting Pronouncements
In June 2009, the FASB issued SFAS No. 168 (“SFAS 168”), “Accounting Standards Codification ™ and
the Hierarchy of Generally Accepted Accounting Principles”. The FASB Accounting Standards
Codification™ (“Codification”) has become the source of authoritative accounting principles
recognized by the FASB to be applied by nongovernmental entities in the preparation of financial
statements in accordance with GAAP. All existing accounting standard documents are superseded by
the Codification and any accounting literature not included in the Codification will not be
authoritative. However, rules and interpretive releases of the Securities Exchange Commission
(“SEC”) issued under the authority of federal securities laws will continue to be sources of
authoritative GAAP for SEC registrants.
SFAS 168 is effective for interim and annual reporting periods ending after September 15, 2009.
Therefore, beginning with our quarter ending September 30, 2009, all references made by it to GAAP
in its consolidated financial statements now use the new Codification numbering system. The
Codification does not change or alter existing GAAP and, therefore, it is not having an impact on
the Company’s financial position, results of operations and cash flows.
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Table of Contents
FASB ASC Topic 350-30-65-2, formerly, Emerging Issue Task Force (EIFT) No 08-7 Accounting for
Defensive Intangible Assets, issued in November 2007, provides accounting and reporting guidance
when an intangible acquired though a business combination or an asset acquisition that an entity
does not intend to use but does intend to prevent others from using, commonly called a defensive
asset or a locked up asset, because while the asset is not being actively used, it is likely
contributing to an increase in the value of the other assets owned by the entity. This issue is
effective for intangible assets acquired on or after the beginning of the first annual period
beginning on or after December 15, 2008. This Statement does not currently impact the financial
statements of the Company.
FASB ASC Topic 808-10-05, Accounting for Collaborative Agreements, issued in November 2007, defines
a Collaborative Arrangement and establishes the reporting requirements for transactions between
participants in a collaborative arrangement and between participants in an arrangement with third
parties. This issue shall be effective beginning after December 15, 2008 and interim periods within
those fiscal years. This Statement does not currently impact the financial statements of the
Company.
FASB ASC Topic 805-10-65-1, “Summary No. 141 (revised 2007)”. SFAS No. 141 (revised) provides for
improving the relevance, representational faithfulness, and comparability of the information that
an entity provides in its financial reports about a business combination and its effects. SFAS
No. 141 (revised) applies prospectively to business combinations for which the acquisition date is
on or after December 15, 2008. This statement does not currently impact the financial statements of
the Company.
FASB ASC Topic 810, “Non controlling Interests in Consolidated Financial Statements- an amendment
of ARB No. 51”. SFAS No. 160 establishes accounting and reporting standards for non-controlling
interests, sometimes called minority interests for the portion of equity in a subsidiary not
attributable, directly or indirectly, to a parent. SFAS No. 160 is effective for fiscal years, and
interim periods within those fiscal years, beginning after December 15, 2008. This statement does
not currently impact the financial statements of the Company.
FASB ASC Topic 815-10-20, “Disclosure about Derivative Instruments and Hedging Activities — an
amendment of FASB No. 133”. This Statement requires enhanced disclosure about an entity’s
derivative and hedging activities. The effective date for this Statement is for financial
statements issued for fiscal years and interim periods beginning after November 15, 2008. This
Statement does not currently impact the financial statements of the Company.
In May 2008, the FASB issued FSP Accounting Principles Board (APB) Opinion 14-1, “Accounting for
Convertible Debt Instruments That May Be Settled in Cash upon Conversion (Including Partial Cash
Settlement)” (FASB ASC 470-20-65-3) which applies to all convertible debt instruments that have a
net settlement feature; which means that such convertible debt instruments, by their terms, may be
settled either wholly or partially in cash upon conversion. FASB ASC 470-20-65-3 requires issuers
of convertible debt instruments that may be settled wholly or partially in cash upon conversion to
separately account for the liability and equity components in a manner reflective of the issuer’s
nonconvertible debt borrowing rate. Previous guidance provided for accounting for this type of
convertible debt instrument entirely as debt. FASB ASC 470-20-65-3 is effective for financial
statements issued for fiscal years beginning after December 15, 2008 and interim periods within
those fiscal years. This statement does not currently impact the financial statements of the
Company.
FASB ASC Topic 944, “Accounting for Financial Guarantee Insurance Contracts”. The Statement
requires that an insurance enterprise recognize a claim liability prior to an event of default,
when there is evidence that credit deterioration has occurred in an insured financial obligation.
This Statement is effective for fiscal years beginning after December 15, 2008, and interim periods
within the fiscal year. This Statement does not currently impact the financial statements of the
Company.
FASB ASC Topic 855, “Subsequent Events” — (SFAS No. 165) a statement that requires disclosure of
events that occur after the balance sheet date, but before the financial statements are issued. The
effective date of this statement is for interim or annual financial periods after June 15, 2009. In
accordance with the ASC, the Company reviewed the events for inclusion in the financial statements
through the filing date.
FASB ASC Topic 860 — “Accounting for Transfers of Financial Assets (SFAS 166) — an amendment of
FASB No. 140” was issued in June 2009. The purpose of this Statement was to address practices that
developed subsequent to the issuance of SFAS No. 140, that were not consistent with the intent or
key requirements of that Statement. This Statement must be applied as of the beginning of each
entity’s first annual reporting period that begins after November 15, 2009. This Statement does not
currently impact the financial statements of the Company.
Fair Value Measurements and Disclosures (Topic 820): Improving Disclosures about Fair Value
Measurements. Effective for interim and annual reporting periods beginning after December 15, 2009,
except for the disclosures about purchases, sales, issuances, and settlements in the roll forward
of activity in Level 3 fair value measurements. Those disclosures are effective for fiscal years
beginning after December 15, 2010, and for interim periods within those fiscal years. Early
adoption is permitted.
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NOTE C — INVENTORIES
| December 31 | ||||||||
| 2009 | 2008 | |||||||
Inventories consist of the following: |
||||||||
Finished Goods |
$ | 775,126 | 609,279 | |||||
Component parts and other materials |
29,610 | 110,623 | ||||||
| $ | 804,736 | 719,902 | ||||||
Slow moving and overstocked inventories totaling approximately $36,000 and $82,000 were charged off
to cost of products sold during the year ended December 31, 2009 and 2008, respectively.
NOTE D — ADVANCES TO CONTRACT MANUFACTURER
The net advances to contract manufacturer represent funding of future STA, CompuDent and Wand Plus
inventory purchases. The balance of the net advances as of December 31, 2009 and 2008 totaled
$463,225 and $665,890, respectively. The portion of this advance expected to be utilized in the
next twelve months is classified as current asset, with the remainder classified as non-current
asset.
NOTE E — FURNITURE, FIXTURE AND EQUIPMENT
| December 31 | ||||||||
| 2009 | 2008 | |||||||
Furniture, Fixture and Equipment consist of the following: |
||||||||
Leasehold improvements |
$ | 22,317 | $ | 22,317 | ||||
Artwork |
— | 76,918 | ||||||
Office furniture and equipment |
98,268 | 88,848 | ||||||
Trade show displays |
86,121 | 57,463 | ||||||
Computers and software |
179,048 | 176,276 | ||||||
Tooling equipment-STA |
12,377 | 12,377 | ||||||
STA Trials Units |
63,752 | 63,752 | ||||||
Tooling equipment |
11,100 | — | ||||||
Total |
472,983 | 497,951 | ||||||
Less accumulated depreciation |
(395,630 | ) | (345,377 | ) | ||||
| $ | 77,353 | $ | 152,574 | |||||
Depreciation expense was $50,253 and $71,336 for the years ended December 31, 2009 and 2008,
respectively.
NOTE F — INVESTMENT IN DISTRIBUTOR
In December 2004, Milestone purchased a 19.9% equity interest in a German distribution company
which is an affiliate of Milestone’s principal international distributor.
NOTE G — 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 $76,133 in 2009 and $55,908 in 2008. Estimated amortization expense of existing patents for each
of the next five fiscal years amounts to approximately $80,000 per year.
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NOTE H— LINE OF CREDIT and NOTES PAYABLE
On June 28, 2007 the Company secured a $1 million line of credit from a stockholder. This borrowing
was amended to $1,300,000 as of September 30, 2008 under the same terms and conditions as the
original. Borrowings bear interest at 6% per annum, with one year’s interest at 1% payable in
advance on each draw. All borrowings and interest thereon must be repaid by June 30, 2010, and
after the expiration date of the line, may be repaid by Milestone in cash or, at its option, in
shares of common stock valued at the lower of $2.00 per share or 80% of the average closing price
of its shares during the 20 trading days ending with December 31, 2008. At December 31, 2008, the
conversion price at 80% of the average closing price of the Company’s stock was $0.26 per share.
After December 31, 2008, and before June 30, 2010, the lender may convert all or any part of the
then outstanding balance and interest thereon into shares of Common Stock at $4.00 per share. Three
year warrants exercisable at $5.00 per share, in an amount determined by dividing 50% of the amount
borrowed by $5.00 will be issued on each drawdown. There is no facility fee on the line. The
warrants have been valued as of each draw down using the Black-Scholes model and are reflected as a
discount against the debt incurred under this line of credit. At December 31, 2008 the remaining
balance of Debt Discount was $52,530. The full amount of the line of credit and amendment, $1.3
million, has been drawn at December 31, 2008. The $1.3 million Line of Credit was converted into
shares of Milestone’s common stock in December 2009 at a conversion rate of $1.58 per share. A
total of 822,785 shares were issued and the debt liquated at that date. Interest on the Line of
Credit of aggregated $176,655 was accrued as of December 31, 2009. This interest will be paid in
equal quarterly payments of $23,000 over the next two years. These payments will represent the
initial interest accrued plus and aggregate of $7,335 of interest on the outstanding interest debt.
The Company borrowed an additional $450,000 from the same shareholder in 2008. The borrowing was
originally on short term loan with a maturity date of January 19, 2009. In December 2008, this
borrowing was refinanced with the shareholder with a due date of June 30, 2012. The borrowing
includes a twelve percent interest rate, interest compound quarterly, with interest and principle
due at the maturity. Further, the note has warrants exercisable for five years at the price of
$0.32 per share for 45,000 shares of stock. The warrants were valued using the Black-Scholes model
and are reflected as a discount against the debt. At December 31, 2009, the discount was $11,157.
Interest expense on this Line of Credit for the year ended December 31, 2009 and 2008 is $154,027
and $116,374, respectively. Accrued interest related to this line of credit was $245,426 and
$98,437 at December 31, 2009 and December 31, 2008, respectively. The charge for amortization of
Debt Discount related to this Line of Credit is $53,330 and $27,446 for the year ended December 31,
2009 and December 31, 2008, respectively.
NOTE I— STOCKHOLDERS’ EQUITY
ISSUANCES OF COMMON STOCK
During 2009, Milestone issued 518,367 shares valued at $500,500 for payment of consulting services.
During 2009, Milestone issued 323,009 shares valued at $160,325 for payment of employee
compensation.
During 2009, Milestone issued in advance 84,783 shares valued at $97,500 for future services of the
Chairman.
During 2009, Milestone issued 333,333 share valued at $150,000 for vendor compensation.
During 2009, Milestone issued 3,333 shares valued at $1,866 for exercising stock options
During 2009, Milestone issued 822,785 shares valued at $ 1,300,000 for the conversion of note.
During 2009, Milestone’s to be issued shares are 45,455 valued at $25,000 for the officer’s
deferred compensation.
During 2009, Milestone’s to be issued shares are 142,405 valued at $225,000 for the bonus
compensation.
SHARES TO BE ISSUED
As of December 31, 2009 and 2008, there were 692,498 and 504,639 shares that have been deferred
from being issued, subject to employment agreements with the Chief Executive Officer and Chief
Financial Officer of the Company. Such shares will be issued to each party upon termination of
their employment.
OUTSTANDING WARRANTS
At December 31, 2009, there were 175,000 warrants outstanding. Warrants issued in connection with
the $1.3 million Line of Credit, 130,000 warrants, exercisable at $5.00 per share expiring on
several dates in 2010 and 2011. Additionally, there were 45,000 warrants in connection with the
Long Term note of $450,000, exercisable at $0.32 per share, expiring in June 2012.
In first and second quarters of 2009, 2,227,946 warrants at $4.89 per share, to issue the
equivalent number of shares of the Company’s common stock expired.
There were no warrants issued in 2009.
SHARES RESERVED FOR FUTURE ISSUANCE
At December 31, 2009 and 2008 there were 3,438,974 and 4,853,216 shares reserved for future
issuance including 429,667 shares in 2009 and 747,332 shares in 2008 underlying stock options
available under the Stock Option Plans, respectively; 1,650,141 and 3,601,245 shares underlying
other stock options and warrants that were outstanding at December 31, 2009 and 2008, respectively:
692,498 shares in 2009 and 504,639 shares in 2008 to be issued in settlement of deferred
compensation to Officers of the Company; and 666,667 shares in 2009 for Performance Options issued
to an Officer of the Company.
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Table of Contents
In December 2007, the Board of Directors authorized the Company to issue up to $2 million of
its Company stock to vendors or employees, and to grant them piggy back registration rights in the
usual form, at a value of not less than 90% of the market value on the date of the agreement for
the vendor or employee to accept said shares. Such future shares are not included in the above
noted shares reserved for future issuance.
NOTE J — 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 Milestone’s
common stock. In 1999, the Plan was amended, providing for the grant of options to purchase up to
333,333 shares of Milestone’s 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. The 1997 plan expired in 2008.
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 Milestone’s
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.
In November 2009, the Board of Directors authorized 666,667 options be reserved for a special bonus
to the Chief Executive Officer of the Company, for obtaining a three year purchase order for the
sale of 12,000 STA Systems and related handpieces over a four year period. These options were
reserved but not granted until specific performance targets are achieved. The options will be
issued upon achievement of the specific target on a yearly basis. The options were valued at $1.49
per share.
A summary of option activity for employees under the plans as of December 31, 2008 and 2009, and
changes during the year then ended is presented below:
| Weighted | ||||||||||||||||
| Weighted | Average | Aggregate | ||||||||||||||
| Number | Averaged | Remaining | Intrinsic | |||||||||||||
| of | Exercise | Contractual | Options | |||||||||||||
| Options | Price | Life (Years) | Value | |||||||||||||
Outstanding, January 1, 2008 |
391,334 | 1.86 | 2.85 | 108,800 | ||||||||||||
Granted |
230,832 | 0.85 | 4.20 | 75 | ||||||||||||
Exercised |
— | — | — | — | ||||||||||||
Forfeited or expired |
(51,334 | ) | 1.19 | — | — | |||||||||||
Outstanding, December 31, 2008 |
570,832 | 1.51 | 3.01 | 75 | ||||||||||||
Exercisable, December 31, 2008 |
366,442 | 1.83 | 2.43 | — | ||||||||||||
Granted |
872,866 | 1.02 | 4.59 | |||||||||||||
Exercised during 2009 |
(3,333 | ) | 0.56 | — | ||||||||||||
Forfeited or expired |
(380,223 | ) | 0.88 | — | ||||||||||||
Outstanding, December 31, 2009 |
1,060,142 | 1.33 | 3.61 | 632,624 | ||||||||||||
Exercisable, December 31, 2009 |
559,154 | 1.45 | 2.62 | 94,336 | ||||||||||||
F-14
Table of Contents
| Weighted | Weighted | |||||||||||
| Number | Averaged | Average | ||||||||||
| of | Exercise | Grant Date | ||||||||||
| Options | Price | Fair Value | ||||||||||
VESTED OPTIONS |
||||||||||||
Outstanding, January 1, 2008 |
314,334 | 1.94 | — | |||||||||
Exercised during 2008 |
— | — | — | |||||||||
Vested Options during 2008 |
103,442 | — | — | |||||||||
Forfeited during 2008 |
(51,334 | ) | 1.19 | — | ||||||||
Outstanding, December 31, 2008 |
366,442 | 1.83 | — | |||||||||
Exercised during 2009 |
(3,333 | ) | 0.56 | — | ||||||||
Vested Options during 2009 |
232,378 | 1.45 | — | |||||||||
Forfeited during 2009 |
(36,333 | ) | 3.62 | — | ||||||||
Outstanding, December 31, 2009 |
559,154 | 1.45 | — | |||||||||
NONVESTED OPTIONS |
||||||||||||
Nonvested, January 1, 2008 |
77,000 | 1.56 | 1.00 | |||||||||
Granted during 2008 |
230,832 | 0.85 | 0.84 | |||||||||
Vested during 2008 |
(103,442 | ) | 1.19 | 0.89 | ||||||||
Forfeited during 2008 |
— | — | — | |||||||||
Nonvested, December 31, 2008 |
204,390 | 0.94 | 0.87 | |||||||||
Granted Options during 2009 |
872,866 | 1.02 | 0.41 | |||||||||
Vested during 2009 |
232,378 | 1.45 | 0.47 | |||||||||
Forfeited during 2009 |
(343,890 | ) | 0.59 | 0.59 | ||||||||
Nonvested, December 31, 2009 |
500,988 | 1.20 | 0.45 | |||||||||
Milestone recognizes compensation expense on a straight line basis over the requisite service
period. During the years ended December 31, 2009 and 2008 Milestone recognized $193,600 and
$100,968 of total compensation cost related to options that vested each year, respectively. As of
December 31, 2009 and 2008, there was $362,938 and $111,189 of total unrecognized compensation
cost related to non-vested options which Milestone expects to recognize over a weighted average
period of 2.5 years and 2 years for December 31, 2009 and December 31, 2008, respectively.
A summary of option activity for non-employees under the plans as of December 31, 2008 and 2009,
and changes during the year ended is presented below:
| Weighted | ||||||||||||||||
| Weighted | Average | Aggregate | ||||||||||||||
| Number | Averaged | Remaining | Intrinsic | |||||||||||||
| of | Exercise | Contracted | Options | |||||||||||||
| Options | Price | Life (years) | Value | |||||||||||||
Outstanding, January 1, 2008 |
639,133 | 3.15 | 2.56 | 20,667 | ||||||||||||
Exercisable, December 31, 2008 |
514,133 | 3.49 | 2.19 | 1,667 | ||||||||||||
Granted during 2008 |
— | — | — | — | ||||||||||||
Forfeited during 2008 |
(11,666 | ) | 3.75 | — | — | |||||||||||
Outstanding, December 31, 2008 |
627,467 | 3.14 | 1.61 | — | ||||||||||||
Exercisable, December 31, 2008 |
564,967 | 3.29 | 1.44 | — | ||||||||||||
Granted during 2009 |
156,666 | 0.41 | 3.08 | — | ||||||||||||
Forfeited during 2009 |
(369,134 | ) | 3.38 | — | — | |||||||||||
Outstanding, December 31, 2009 |
414,999 | 1.90 | 2.70 | 263,083 | ||||||||||||
Exercisable, December 31, 2009 |
336,387 | 1.91 | 2.71 | 234,638 | ||||||||||||
F-15
Table of Contents
| Weighted | ||||||||
| Number | Averaged | |||||||
| of | Exercise | |||||||
| Options | Price | |||||||
VESTED OPTIONS |
||||||||
Outstanding, January 1, 2008 |
514,133 | 3.49 | ||||||
Exercised during 2008 |
— | — | ||||||
Vested during 2008 |
62,500 | 1.77 | ||||||
Forfeited during 2008 |
(11,666 | ) | 3.75 | |||||
Outstanding, December 31, 2008 |
564,967 | 3.29 | ||||||
Exercised during 2009 |
— | — | ||||||
Vested during 2009 |
140,554 | 0.32 | ||||||
Forfeited during 2009 |
(369,134 | ) | 3.38 | |||||
Outstanding, December 31, 2009 |
336,387 | 1.96 | ||||||
NONVESTED OPTIONS |
||||||||
Nonvested January 1, 2008 |
125,000 | 1.77 | ||||||
Exercised during 2008 |
— | — | ||||||
Vested during 2008 |
(62,500 | ) | 1.77 | |||||
Forfeited during 2008 |
— | — | ||||||
Nonvested December 31, 2008 |
62,500 | 1.77 | ||||||
Granted during 2009 |
156,666 | 0.41 | ||||||
Exercised during 2009 |
— | — | ||||||
Vested during 2009 |
(140,554 | ) | 0.32 | |||||
Forfeited during 2009 |
— | — | ||||||
Outstanding, December 31, 2009 |
78,612 | 1.64 | ||||||
The fair value of the options was estimated on the date of grant using the Black Scholes
option-pricing model. For the year ended December 31, 2009, the following weighted average
assumptions were used in calculating fair value; excepted life of 3 years; volatility of 222.15%
and risk-free interest rate of 1.24%. There were no options granted to non-employees during 2008.
During the year ended December 31, 2009 and 2008 Milestone recognized $92,235 and $50,952 of
expense related to non-employee options that vested, respectively. The total unrecognized
compensation cost related to nonvested options was $14,305 and $59,484 as of December 31, 2009 and
2008.
NOTE K — EMPLOYMENT CONTRACT AND DEFERRED COMPENSATION
Employment Contracts
In March 2009, the Chairman assumed the position of Milestone’s Acting Chief Executive Officer. In
September 2009 The Chairman stepped down as Chairman to fill the position of Chief Executive
Officer. The Chief Executive Officer entered into a new employment agreement with the Company
effective September 1, 2009. This new agreement suspends the previous agreement scheduled to
terminate on December 31, 2012. The new agreement is for five years ending on August 31, 2014. The
contract shall be extended for successive one-year periods, unless prior to August 1 of any year,
either party notifies the other that he or it chooses not to extend the New Employment Term. As
part of this agreement the Chairman relinquished the title and position of Chairman. Under the new
agreement, the Chief Executive Officer will receive a base compensation of $300,000 per year
payable. In addition, the CEO, may earn annual bonuses up to an aggregate of $400,000, payable one
half in cash and one half in common stock, contingent upon achieving targets set for each year by
the Compensation Committee of the Board of Directors of the Company.
In addition, if in any year of the term of the agreement the CEO earns a bonus, he shall also be
granted five-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 the 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.
In accordance with the employment contract, as of September 30, 2009 and January 1, 2008, 676,676
shares and 504,639 shares of common stock are to be paid out at the end of the contract in
settlement of $925,000 as December 31, 2009 and $700,000 as of
December 31, 2008 of accrued deferred compensation and, accordingly, such shares have been
classified in stockholders’ equity with the common shares classified as to be issued.
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Table of Contents
Milestone entered into an agreement with a new Chairman effective October 1, 2009. The term of the
contract is for a nine month period ending on June 30, 2010. Under this agreement the Chairman will
receive a base compensation of $190,000 per year, payable $5,000 per month in cash starting in
January 2010 and the remainder in stock issued at the closing price on September 1, 2010. 84,783
shares were issued in September 2009.
In accordance with the respective employment contracts, as of September 30, 2009 and December 31,
2008, 676,676 shares and 504,639 shares of common stock are to be paid out at the end of the
contract in settlement of $925,000 as December 31, 2009 and $700,000 as of December 31, 2008 of
accrued deferred compensation and, accordingly, such shares have been classified in stockholders’
equity with the common shares classified as to be issued.
NOTE L — INCOME TAXES
The Company’s expected federal income tax benefit computed at the statutory rate (34%) on the
pre-tax loss amounted to $520,000, in 2009 and $400,000 in 2008. Such benefit was not recognized in
the accompanying financial statements due to Milestone’s history of past operating losses, which
required full valuation allowances for all of Milestone’s deferred tax assets at December 31, 2009
and 2008.
Deferred tax attributes resulting from differences between financial accounting amounts and tax
bases of assets and liabilities at December 31, 2009 and 2008 are as follows:
| 2009 | 2008 | |||||||
Current Assets |
||||||||
Allowance for doubtful accounts |
$ | 2,000 | $ | 2,000 | ||||
Inventory allowance |
79,000 | 70,000 | ||||||
Warranty reserve |
10,000 | 10,000 | ||||||
Deferred officers compensation |
77,000 | 40,000 | ||||||
Subtotal |
168,000 | 122,000 | ||||||
Valuation allowance |
(168,000 | ) | (122,000 | ) | ||||
Current deferred tax asset |
$ | — | $ | — | ||||
Non-current assets |
||||||||
Net operating loss carryforward |
$ | 16,500,000 | $ | 16,500,000 | ||||
Valuation allowance |
$ | (16,500,000 | ) | $ | (16,500,000 | ) | ||
Non-current deferred tax asset |
$ | — | $ | — | ||||
The allowance increased by $46,000 for the years ended December 31, 2009 and decreased by $36,000
for the year ended December 31, 2008, respectively.
As of December 31, 2009 and 2008, Milestone has federal net operating loss carryforwards of
approximately $48,361,000 and $46,861,000, respectively that will be available to offset future
taxable income, if any, through December 2029. Milestone has state net operating losses of
$1,500,000 and $9,800,000 in 2009 and 2008, respectively, expiring
through December 2014. The
utilization of Milestone’s 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 carry
forwards 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.
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Table of Contents
A reconciliation of the statutory tax rates for the years ended December 31, is as follows:
| 2009 | 2008 | |||||||
Statutory rate |
(34 | )% | (34 | )% | ||||
State income tax — all states |
(6 | )% | (6 | )% | ||||
| (40 | )% | (40 | )% | |||||
Current year valuation allowance |
40 | % | 40 | % | ||||
Benefit for income taxes |
0 | % | 0 | % | ||||
As a matter of course, the Company can be audited by federal and state authorities. At this
time, there are no audits identified or in process from any taxing authority.
In 2009 and 2008, Milestone received $777,609 and $675,930, respectively, for sale of tax credits
under the New Jersey Technology Business Tax Certificate Transfer Program. These amounts reduced
the State of New Jersey net operating loss carryforward to approximately $1,500,000 and $9,800,000
for 2009 and 2008, respectively. Such amounts are included in other income as of December 31, 2009
and 2008, respectively.
Accounting for Uncertain Tax Positions:
The Company follows the Income Taxes Topic of the FASB Accounting Standards Codification, which
provides clarification on accounting for uncertainty in income taxes recognized in an enterprise’s
financial statements. The guidance 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, and also provides guidance on derecognition, classification, interest and
penalties, disclosure and transition. At December 31, 2009, no significant income tax
uncertainties have been included in the Company’s Balance Sheets. The Company’s policy is to
recognize interest and penalties on unrecognized tax benefits in income tax expense in the
Statements of Operations. No interest and penalties are present for periods open. Tax returns for
the 2006, 2007, and 2008 years are subject to audit by federal and state jurisdictions.
NOTE M — PRODUCT SALES AND SIGNIFICANT CUSTOMERS AND VENDORS
Milestone’s sales by product and by geographical region are as follows:
| Year End December 31, | ||||||||
| 2009 | 2008 | |||||||
Instruments |
$ | 3,176,752 | $ | 1,609,944 | ||||
Handpieces |
5,277,092 | 4,924,151 | ||||||
Other |
95,216 | 61,430 | ||||||
| $ | 8,549,060 | $ | 6,595,525 | |||||
United States |
$ | 5,378,422 | $ | 4,341,687 | ||||
Canada |
630,108 | 513,651 | ||||||
Other foreign |
2,540,530 | 1,740,187 | ||||||
| $ | 8,549,060 | $ | 6,595,525 | |||||
In January 2007, Milestone finalized an Exclusive Distribution and Supply Agreement with Henry
Schein, Inc. Henry Schein, Inc. will be the exclusive distributor of STA and CompuDent systems (and
ancillary products) in both North America and Canada, for a one year period. The exclusive period
may be extended upon the distributor achieving specific inventory purchases from Milestone during
that one year period. The Distributor was also granted the right of first refusal on distribution
rights of the same products in the international marketplace excluding Poland, Norway, Sweden,
Denmark and South Africa, where Milestone has in place other sales and distribution partners.
The Company has informal arrangements with the manufacturer of the STA, CompuDent and CompuMed
instruments, one of the principal manufacturers for those instruments pursuant to which they
manufacture these products under specific purchase orders but without any long-term contract or
minimum purchase commitment. Purchases from this supplier were $1,960,480 (55.8%) and $182,875 (42.7%) in 2009 and 2008, respectively. The Company has a manufacturing agreement with one
of the principal manufacturers of the handpieces pursuant to which they manufacture products under
specific purchase orders but without minimum purchase commitments. Purchases from this supplier for
handpieces were $167,752 (4.8%) and $156,698 (12.4%) in 2009 and 2008, respectively. The Company
has established an alternate source of supply for the handpieces in China and other alternate
sources of supply exist. Purchases of handpieces from China represent one supplier. Purchases from
this supplier were $1,383,788 (39.4%) and $920,267 (73.0%) in 2009 and 2008, respectively. All
other purchases from other suppliers were not significant in either 2009 or 2008.
F-18
Table of Contents
For the year ended December 31, 2009, Milestone had four customers (distributors) with each
accounting for approximately 73% of its net product sales. Accounts receivable for these four
customers amounted to approximately $533,191, or 44% of gross accounts receivable. For the year
ended December 31, 2008, Milestone had two major customers (distributors) with each accounting for
approximately 81% of its net product sales. Accounts receivable from these two customers amounted
to approximately and $865,000, or (79% of gross accounts receivable.
During 2008, Milestone earned royalty income of $28,282 from the licensee of Milestone’s
proprietary consumer dental whitening product, which is sold under Milestone’s distributor’s
trademark, Ionic White.
NOTE N — COMMITMENTS AND OTHER
(1) Lease Commitments
Milestone leases two office spaces under a non-cancelable operating lease with a base rental of two
offices at $108,974 per annum. Milestone renewed one lease in June 2009 and that lease expires in
June 2014. Milestone entered into a new lease July 2009 and that lease expires in June 2011. This
lease provides for escalations of Milestone’s share of utilities and operating expenses. In
addition to the office spaces, Milestone leases a corporate apartment for $48,000 per annum.
Milestone also leases office and telecom equipment under operating leases with payments ranging
from $71-$522 per month.
Aggregate minimum rental commitments under noncancelable operating leases are as follows:
| Year Ending December 31, | ||||
| 2009 | ||||
2010 |
156,278 | |||
2011 |
89,570 | |||
2012 |
83,828 | |||
2013 |
83,306 | |||
2014 |
41,653 | |||
| $ | 454,633 | |||
For the years ended December 31, 2009 and 2008, respectively, rent expense amounted to
approximately $116,350 and $92,000 respectively.
(2) Contract Manufacturing Arrangement
Milestone has informal arrangements for the manufacture of its products. CompuDent and CompuMed
instruments 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
Milestone’s 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 Milestone’s ability to produce and sell its products. Although alternate
sources of supply exist and new manufacturing relationships could be established, Milestone would
need to recover its existing tools or have new tools produced. Establishment of new manufacturing
relationships could involve significant expense and delay. Any curtailment or interruption of the
supply, whether or not as a result of termination of such a relationship, would adversely affect
Milestone.
(3) Other Commitments
The technology underlying the SafetyWand and CompuFlo, and an improvement to the controls for
CompuDent were developed by the Director of Clinical Affairs and assigned to us. Milestone
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, the Director
will receive additional payments of 2.5% of the total sales of products using certain of these
technologies, and 5% of the 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 the 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 Milestone for such sale or license. In 2009 and 2008 Milestone paid the Director
royalty expenses of $277,514 and $82,737, respectively. In 2009 and 2008, respectively, Milestone
paid the Director $154,000 and $144,000 and granted him 33,332 and zero options.
F-19
Table of Contents
In January 2010, the Company issued a purchase order to Tricor Systems for the purchase of 12,000
STA Systems to be delivered over the next three years. The purchase order is for $5,261,640. The
Company will be required to make periodic payments over the next eighteen months to purchase the
parts necessary to complete this production.
(4) Litigation
In October 2008, Milestone announced that it acquired additional patent rights with respect to
painless anesthetic injections — specifically rights related to the flow rate or pressure used in
providing these injections — through the issuance of 260,000 shares of restricted common stock. In
connection with this acquisition, Milestone also agreed to terminate its Declaratory Judgment
action against Dr. Milton Hodosh related to claim infringements of his patent rights and Dr. Hodosh
agreed to terminate his existing infringement action against the Milestone. Each party is
responsible for their own legal fees.
(5) Other Events
In December 2009, Milestone announced that it signed an Agreement of Intent with China National
Medicines Corporation, Ltd. and Yichang Humanwell Pharmaceutical Co. Ltd., both incorporated in the
People’s Republic of China (PRC), to develop intra-articular and epidural drug delivery instruments
utilizing Milestone’s patented CompuFlo technology. Milestone and its two PRC joint venture
partners will establish a new joint venture entity for this purpose in 2010. The required initial
funding for the new entity, estimated by the parties at $1.4 million, will be provided by the two
PRC companies, although Milestone will determine the proposed uses of their contribution. The
Company believes that this new joint venture represents a significant step forward in Milestone’s
efforts to have its innovative computer-controlled drug delivery technology adapted for medical
usage worldwide. The Joint Venture Agreement is expected to signed and funded in 2010.
NOTE O — PENSION PLAN
Milestone has a Defined Contribution Plan that allows eligible employees to contribute part of
their salary through payroll deductions. Milestone does not contribute to this plan, but does pay
the administrative costs of the plan.
F-20