HYDI form 10KSB 06-30-2006
SECURITIES
AND EXCHANGE COMMISSION
WASHINGTON
D. C. 20549
FORM 10-KSB
ANNUAL REPORT PURSUANT TO SECTION 13 OR 15 (d) OF THE SECURITIES EXCHANGE ACT
OF
1934
For
the fiscal year ended June 30, 2006
Commission
File Number 0-10683
HYDROMER,
INC.
|
|
|
|
(Exact
name of registrant as specified in its charter)
|
|
|
|
New
Jersey
|
|
22-2303576
|
(State
of incorporation)
|
|
(I.R.S.
Employer
|
|
|
Identification
No.)
|
35
Industrial Parkway, Branchburg, New Jersey
|
|
08876-3424
|
(Address
of principal executive offices)
|
|
(Zip
Code)
|
|
|
|
Registrant's
telephone number, including area code:
|
|
(908)
722-5000
|
|
|
|
|
|
|
Securities
registered pursuant to Section 12 (b) of the Act:
|
|
None
|
|
|
|
Securities
registered pursuant to Section 12 (g) of the Act:
|
|
|
|
|
|
Common
Stock Without Par Value
|
(Title
of class)
|
Check
whether the issuer (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 report(s)
and
(2) has been subject to such filing requirements for the past 90 days. Yes
x
Noo
Check
if
there is no disclosure of delinquent filers in response to Item 405 of
Regulation S-B is not contained in this form, and no disclosure will 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-KSB or any amendment to this Form 10-KSB
x
The
aggregate market value of the voting stock held by non-affiliates of the
Registrant at September 1, 2006 was approximately $3,947,539.
The
number of shares of Registrant's Common Stock outstanding on September 1, 2006
was 4,644,164.
Portions
of the Audited Financials Statements for the year ended June 30, 2006 are
incorporated by reference in Part II of this report. Portions of the Proxy
Statement of
Registrant
dated September 15, 2006 are incorporated by reference in Part III of this
report.
PART I
Item
1. BUSINESS
General
Hydromer,
Inc (the “Company”) is a bio-polymer research and development company organized
as a New Jersey Corporation in 1980 for the purposes of developing polymeric
complexes
for commercial use in the medical, commercial, cosmetics and veterinary sciences
markets.
Until
September 1982, approximately 99% of the outstanding common stock, without
par
value (the “Common Stock”), of the Company, was owned by Biosearch
Medical
Products Inc. (“BMPI”), which in turn was controlled by Manfred Dyck, who is the
Company’s current Chief Executive Officer, Director and the Chairman of the
Board.
On
September 16, 1982, BMPI distributed its shareholdings in the Company pro rata
to the holders of its common stock. In connection with this distribution, the
Company granted to
BMPI
an
exclusive, worldwide perpetual, royalty-free license for the use of Hydromer
technology in connection with the development, manufacture and marketing of
biomedical
devices for enteral feeding applications. On February 4, 2000, the Company
acquired all outstanding stock of BMPI for $0.20 per share, and now manages
BMPI
as a
subsidiary.
The
Company owns several process and applications patents for Hydromer®
coatings
(“Hydromer”). These polymers become extremely lubricious (slippery) when wet.
Techniques
have been developed for grafting or applying this substance onto a broad variety
of materials, including other polymers like polyurethane, polyvinyl chloride,
and
silicone elastomers, ceramics and metals. The Company has also been issued
patents for permanent anti-fog materials, hydrophilic polyurethane foams,
hydrophilic
polyurethane blends, hydrophilic polyvinylbutyral alloys, several biocompatible
hydrogels and an anti-bacterial medical material. Currently, the Company has
two
patent applications pending. The Company continues to actively evaluate other
new market opportunities for its polymer technology specifically in neurology
and cardiology.
The
Company also owns various trademarks, including AQUADAPT®,
a
medical hydrogel, AQUAMERE®,
a water
resistant film former product with cosmetic applications,
AQUATRIX®,
a
cosmetic hydrogel, Dermaseal®,
a
dermal barrier film product for the prevention of contact dermatitis,
Sea-Slide®,
a
coating for watercraft hulls, and
T-HEXX®,
a
barrier teat dip product for the prevention of mastitis in dairy animals.
The
Company’s patents are typically broad based, having a multitude of different
applications across various industries. Accordingly, the Company currently
operates
in the medical, commercial, cosmetics and veterinary sciences markets.
MEDICAL
From
its
inception in 1980 to mid-1984, the Company was primarily engaged in R&D
activities related to Hydromer coatings used on medical devices. Since then
and
until
the
acquisition of BMPI, the Company’s business in the medical field consisted of
the sale of lubricious coatings and the licensing of its lubricious coating
technologies.
With the acquisition of BMPI in February 2000, the Company now offers a
horizontally integrated breadth of services including medical device
manufacturing,
contract coating, equipment building and design, and as of more recently,
R&D servicing and government contracts.
The
Company continues to focus on its coatings technologies as the nucleus of its
participation in the medical field. As of June 30, 2006, the Company has three
patents
pending, one on an anti-microbial coating and two on teat dip technology. The
Company was granted a patent on water-based lubricious coatings in fiscal 2006.
HYDROMER®
Lubricious Coatings
When
treated with Hydromer polymers, a medical device becomes very slippery when
wet,
allowing for easy insertion into any orifice of the body, in penetration of
the
skin
or
for device-on-device (i.e. guidewire-catheter) use. Hydromer coatings are
permanently bonded to the device unlike silicone lubricants, which must be
applied
after
each use and are often left behind in the bloodstream and body cavities.
Hydromer coatings can also be coated on complex surfaces and on the inside
walls
of
devices,
unlike the treatments by major competition. Hydromer has also been shown in
numerous studies to reduce the risk of thrombogenesis or clot formation on
devices.
Drugs
and
other substances can be readily incorporated into Hydromer, both in a bound
and
unbounded fashion, allowing for controlled release from the device for
therapeutic
purposes or the creation of permanent biocidal or biostatic surfaces. The
Company believes that the polymer-water interface of Hydromer provides surface
lubricity
superior to the quality of other currently marketed silicone-based lubricants
to
treat medical devices.
Option
and License Agreements
A
portion
of the Company's revenues is derived from option and license agreements (see
“Patents and Trademarks” section). Option agreements provide customers
the
right
for
a finite period of time (i) to use the Hydromer process to determine whether
the
customer's products lend themselves to treatment with the process and
(ii)
to
test
market such products. The option agreements have also given the customers the
right to subsequently enter into a license agreement with the Company
and
to
the market product(s) treated with Hydromer, which typically provides the
Company an initial flat fee, followed by periodic royalty payments based on
sales.
The
Company has previously reported license agreements in effect and expiring
relating to applications of the Hydromer as follows: Annual Report on Form
10-K
for the
fiscal
years ended June 30, 1983 through 1996 and Form 10-KSB for fiscal years ended
1997 through 2005.
As
of
June 30, 2006, the Company has license agreements with seven companies covering
the application of Hydromer coatings to the following devices: enteral
feeding
products,
guidewires, certain urological devices, infusion microcatheters, central venous
catheters, guiding and umbilical catheters, razor
cartridges
(non-medical related), orthodontic accessories, angioplasty balloon catheters,
embolization delivery devices, inter/intra-ocular lenses and biliary
and
pancreatic stents. The Company is actively seeking new licensing
opportunities.
Licensee/Application
Applied
Medical - certain urological and vascular devices
Corneal,
Ltd. - inter-ocular lenses
Eveready
- Schick / Warner / Wilkinson Sword Ltd. - razor cartridges
Gallini
-
certain urological devices
MXM
-
intraocular lens inserter systems
Nemed
-
inter-ocular lenses
Tyco
International / Kendall HealthCare Products - certain urological devices and
enteral feeding systems
Supply
and Support Agreements
In
order
to avail our customers to a continued material source or of technical support
on
our products, certain supply or support agreements may be entered
into.
Depending
on the specific requirements of each agreement, the Company would provide
continued support in terms of product availability or technical know-how,
some
including the escrow of formulas or data with independent agents.
Hydrogels,
Drug Delivery, Wound Dressing
Applications
of the Company’s Hydrogels are being developed for wound care, implants, drug
delivery, burn care, conductive hydrogel electrodes, ultrasonic
couplants
and cosmetic uses for several customers. The Company is also identifying
strategic partners to offer hydrogel coating services to clients who does
not
have
rolled goods coating capability and to license Hydrogel technology for cosmetic
and medical use, including drug release.
The
Company’s hydrogel technology offers biocompatibility, flexibility, and ease of
use and processing. It also allows for the stabilization of biomolecules, cell
cultures,
drugs
and
other active substances without potentially damaging external energy sources.
It
is absorbent, inherently self-adhesive but peels away cleanly and is naturally
soothing.
Other than our bio-adhesives and medical coatings, which are one part systems,
to form the gel entails simply to mix the two parts together - no heat, no
chemical
cross
linkers nor expensive high energy processing is required. Many competitive
technologies are much more process intensive and require external energy to
crosslink.
The
Company believes these products are synergistic to our existing hydrogel
technologies, and offer further opportunities in electrodes and internal and
topical
actives
delivery. The Company has a pilot coating machine to facilitate the
commercialization of its hydrogel technologies. The Company is exploring other
medical and
dental
as
well as cosmetic applications for this technology.
Aquadapt®
is the
Company’s hydrophilic polyurethane foam technology. The Company has 510K
approvals from the FDA for medical use applications in the U.S.
The
Company also has a patent on its chitosan-PVP hydrogel technology as well as
patents granted in 2000 and 2002 on polyaldehyde hydrogels.
OEM
Medical Devices
Through
its Biosearch Medical Products subsidiary, ISO 13485 certified and FDA
registered, the Company offers 510K/CE marked medical devices. The current
product
portfolio
includes: bipolar coagulation probes; jejunal, enteral and biliary catheters
and
stents; feeding accessories; guidewires; biofeedback devices for fecal and
urinary
incontinence;
and endoscopic accessories. The Company also contract manufactures products
for
several large multi-national marketers of medical devices on an OEM basis.
HYDROMER®
Coating Services
The
acquisition of BMPI allowed for the Company to realize another venue of
revenues: Coating Services. Utilizing the acquired medical device manufacturing
know how
and
by
applying its coatings technologies, the Company began offering Coating services,
in which the Company coats third party devices with its own lubricious coatings.
The
Company’s knowledge in coatings technologies allows for it to coat various types
of material, such as silicone, stainless steel, Pebax and polypropylene cost
effectively,
whereas
some of the competition is unable to. A global client is using this service
in
the urology market.
The
Company continues to expand its activity in Coating services and is actively
seeking new opportunities to provide contract development, coating and
manufacturing
services
to the medical, commercial and personal care industry, utilizing its Hydromer
and Anti-Fog coating technology and expertise. The Company further continues
to
believe
that these services will enable a broader range of customers to use our
materials in market on accelerated timelines in a more cost effective
manner.
R&D
and Engineering Services
The
medical device market continues to undergo a shift toward consolidation by
very
large multi-national players with small, entrepreneurial start-up companies
looking to
exploit
niche opportunities or unique device designs. The Company’s experience and
knowledge can significantly speed development, assessment and market readiness
for
our
clients, large and small through its research and development and engineering
services.
For
example, for medical devices such as coronary stents and brain catheters, the
Company can develop the coatings, including drug eluting coatings, establish
the
manufacturing
protocols,
design and build the coating equipment, start up scale prototype production
and
eventually transfer the process assisting the customer in the
transition.
The
Company believes that offering prototyping, process development and small-medium
scale coating/ manufacturing services is fundamental to the expansion of the
Hydromer
coatings business, and a strategic imperative. The Company will endeavor to
become a “one stop” supplier of high performance coatings and services.
INDUSTRIAL/COMMERCIAL
Hydromer
Anti-Fog/Condensation Control is an optical coating which prevents the
accumulation of vision-obscuring condensation under high humidity conditions.
The
Company is selling this material in bulk to manufacturers of greenhouse panels,
refrigerator freezer doors, industrial and medical safety and swim goggles,
aircraft
windows, automotive headlight assemblies and gauge and meter manufacturers
in
the U.S. and internationally, including China.
The
Company also offers Sea-Slide®,
a
Hydromer-based drag reducing coating that reduces friction between hull and
water, and can be used over most anti-fouling paints.
A
U.S.
patent covering this coating and other potential uses was issued in 1987.
Independent testing has confirmed that this technology significantly improves
fuel
economy
and the hull speed of watercraft. Sea-Slide is marketed through HammerHead
Products, Inc., via an exclusive distribution agreement.
COSMETICS
The
Aquamere®
series
of the Company’s cosmetic intermediaries are sold to major cosmetic companies
worldwide for use in hair dyes, hair conditioners, mascaras, eye shadows,
sunscreens
and body lotions. They are currently in test for use in shampoos, hair styling
aids, OTC dermal drug delivery and topical disinfectants. The Aquamere series
of
cosmetic
polymer solutions, introduced in 1988, are both aqueous and hydro-alcoholic
based systems. They are also offered with cationic and silicone grafted
modifications.
Formulations
have also been developed internally utilizing this technology and are being
offered for sale as turnkey products to smaller marketers of personal care
products.
The
Company’s Dermaseal®
line, a
patented
film-forming hydrogel technology,
is
currently being sold to major cosmetic companies as a base for foundations
and
other skin
care
products. It is also being tested for use in broader skin care, cosmetic and
OTC
drug delivery. Dermaseal is the registered trademark for barrier film
compositions,
patented
in fiscal 2000 along with the method for preventing contact dermatitis. Clinical
testing has demonstrated that these compositions protect the user from the
effects
of
contact with poison ivy, oak or sumac plant allergens. Technical testing has
also demonstrated protection from latex proteins, nickel and other contact
allergens.
In
2006,
the Company added a unique anti-microbial polymer to its product line. When
used
for beauty cosmetics, contamination and infections can be reduced.
VETERINARY
SCIENCES
In
Fiscal
Year 1999, the Company’s polymer technology was used to launch the Company’s
entry into the Animal Health field to combat clinical and sub-clinical mastitis,
a
problem
that costs U.S. Dairy farmers an estimated $3-5 billion per year. Marketed
under the T-HEXX®
brand,
initially through U.S. licensees, the T-HEXX Barrier
Dips and Sprays
offer
dairy farmers exceptional value and unsurpassed protection as the
first no-drip
and water resistant barrier products on the market preventing environmental
water
containing
mastitis-causing organisms, including mycoplasma, from reaching the teat
surface. The Company has received three patents for its unique barrier teat
dip
compositions
with
an
application on a fourth patent pending.
The annual
U.S. market for barrier
teat dips is estimated to be $100-130 million at the farm level. The
T-HEXX
Barrier
products contain protocol-proven active ingredients that
kill
mastitis-causing bacteria within 30 seconds of contact while continuing to
remain active up to 12 hours later.
T-HEXX
Barriers
are superior performers in its niche market
while
priced comparably or less than barrier dip products manufactured by the leading
sanitary chemical companies in the world. Our products are compatible with
existing
mechanical
equipment and milking procedures and most importantly, are easily removed using
traditional pre-milking
methods. Based on field tests, our product has
been
demonstrated to stay on the cow teat better than the competition, protecting
the
cow during the complete 8-12 hour milking cycle.
In
fiscal
2002, the Company launched a complementary product, T-HEXX®
Dry Teat
Protection Sealant, to protect cows during the non-lactation (“dry cow”) period.
T-HEXX
Dry
is
used as a non-irritating low-cost sealant during the dry-off and the critical
pre-calving period where it is estimated that over 50% of new mastitis cases
are
believed to start.
T-HEXX
Dry is
the first dry cow dip product with an antimicrobial that remains on the teat
for
3-7 days. Clinical studies show that T-HEXX
Dry is
impervious to
National
Mastitis Council (NMC) recognized mastitis-causing organisms for seven days,
yet
is comparably priced to existing dry cow teat sealants that does not offer
such
protection.
Our product is suggested to be used on cows just prior to their release to
the
dry cow pen, in conjunction with existing antibiotic therapy or internal teat
sealants.
In
fiscal 2004, two customers launched our Dry product under their private-label
name, reflecting the strength of our product.
Patent
pending and under development is a T-HEXX teat
plug, which when launched, would allow the Company to provide complete
protection against mastitis for the
entire
bovine working cycle.
The
Company has invested significantly in clinical research, patents, promotion,
vendor partnerships and advertising via print media, trade shows and the
Internet to
support
this business and continues to do so. In fiscal 2004, the Company initiated
a
claim against a former licensee and other parties citing infringement on the
Company’s
patented technology in this area. In total, through June 30, 2006, the Company
spent approximately $510,000 ($257,000 in fiscal 2006) in direct legal costs,
which
has
been expensed in the related year’s results. Settlement was made in early
calendar 2006, with the discounted value on $300,000 recorded in Other Income.
Products
Coating
solutions for use on medical devices, cosmetic intermediaries, hydrogels and
teat barrier dips/sprays are manufactured and sold by the Company to its
licensees
and
others. The Company is selling bulk quantities of anti-fog solution to
manufacturers of greenhouse panels, refrigerator freezer doors, swim goggles,
industrial safety
equipment,
aircraft
windows
and meter covers, both in the U.S. and foreign countries. The Company also
sells
OEM medical devices through its Biosearch Medical Products
subsidiary.
The
Company has no long-term contracts with any of its suppliers and believes that
there are adequate alternative sources of supply available for all raw materials
that it currently uses.
Dependence
Upon Customers
The
Company derives its revenues from two primary business segments: (1) polymer
research and the products derived there from, and (2) the sales of medical
products.
During
the fiscal years ended June 30, 2006 and June 30, 2005, the Company recognized
revenues from two major customers: Johnson & Johnson’s Cordis Division and
Cook
Endoscopy, formerly Wilson Cook Medical, Inc.
Product
sales and/or royalty payments and support fees from these customers accounted
for 32% and 29% of the Company’s total revenues for the years ended June 30,
2006
and
June
30, 2005, respectively.
Potential
Applications
The
Company continues to explore other applications of the complexing capabilities
of polymeric substances, such as anti-microbial agents. The Company currently
is
working
on further applications of its patented technologies to existing products of
other companies, including cosmetics, wound dressings, personal care and a
wide
variety
of medical devices, including vascular stents. Some of these products and
applications are in the preliminary development stage and are subject to
substantial
further
development before their feasibility can be verified.
On
the
basis of its market analyses, as well as laboratory and in-vitro testing of
certain applications of Hydromer, the Company believes that Hydromer's potential
product
applications,
classified with reference to salient Hydromer characteristics, are as
follows:
1.
Low
Coefficient of Friction.
Hydromer is a hydrophilic coating which when contacted by water becomes
extremely lubricious. The Company believes that this unique
feature
would prove beneficial to any medical device that is inserted into the body.
Medical products that would so benefit include:
urinary
products - urethral catheters, stents and urinary drainage systems;
rectal
products - enemas, rectal tubes, examination gloves and proctoscopy devices
(disposable);
nasal/oral
products - suction catheters, oxygen catheters and endotracheal
tubes;
cardiovascular
and related products - grafts, cardiac assist catheters heart-lung tubing,
stents.
2.
Ability
to be Complexed with Other Functional Chemicals.
The
Hydromer hydrophilic polymer coating can be complexed with other chemicals.
For
example,
Hydromer
coating complexed with iodine forms an effective anti-microbial barrier. The
Company believes that this unique feature would lend itself to application
on a
wide
variety of currently marketed medical products, including vascular stents,
Foley
catheters, wound drains, wart and corn dressings, burn dressings, intravenous
catheters,
surgical dressings and adhesive bandages. One of the Company’s recent patents in
the coating area, issued in April 2000, involves the covalent bonding of
infection
resistant materials into the coating, providing a non-leaching, anti-infective
surface. The Company was also granted a patent in July 2003 for covalently
bonded
radio-opaque polymeric compositions to improve the radio-opacity of materials
without needing high solid loading, metal plating or ion implantation for
applications
like
stents and vascular catheters.
3.
Cross-link
Density Can be Controlled.
The
Hydromer hydrophilic polymer coating, through controlled cross-linking, has
been
further developed into a special anti-fog
coating.
Such a coating is (a) resistant to fogging under a wide range of
temperature/humidity conditions; (b) transparent and has heat/light stability;
(c) long lasting,
i.e.,
will not chip or peel and offers more scratch resistance than do most commercial
plastics; (d) inert to most commercial glass cleaners; (e) less prone to static
dirt
pickup; and (f) applicable by dip, spray or roll coating. A U.S. Patent for
this
material was first issued to the Company in August 1984 (patent expired). This
anti-fog
product has use on greenhouse panels, refrigerator freezer doors, sports
goggles, windows, mirrors and other products, either by direct application
or by
coating
of an adhesive backed film.
Research
and Development
The
Company's research and development activities presently are, and during the
next
year are expected to be devoted primarily to the development and enhancement
of
the
products
described above and to the design and development of new products, either for
its own account, jointly with another company or strictly as a sub-contractor.
The
Company sponsors all of such activities from its own internal funding or through
charges to the contracting company. The major portion of R&D expenses was
applied
toward salaries and other expenses of personnel employed on a regular basis
in
such work. See the "Employees" section.
Competition
The
Company considers the most significant competitive factors in its market for
its
patented coatings to be product capability and performance (including
reliability
and
ease
of use), in addition to price and terms of purchase.
The
Company currently owns nineteen process and applications patents for Hydromer
coatings (see "Patents and Trademarks"). Although the medical products
market
is
highly competitive, the Company does not believe that there is any other product
available which performs functions significantly better than those
which
are
performed by the Company in terms of lubricity, complexing capabilities,
durability and cost.
While
management believes the Company has a strong position in the market for medical
device coatings in which it competes, and that its hydrophilic
foam,
anti-fog
coatings and hydrogel products are technologically superior to other products
in
the market, there can be no assurance that alternatives, with similar
properties
and applications, could not be developed by other companies. The Company is
aware that there are other similar
technologies
available and/or being developed by others. The industry in which the Company
competes is characterized by rapid technological advances
and
includes competitors that possess significantly greater financial resources
and
research and manufacturing capabilities, larger marketing and sales staffs
and
longer established relationships with customers than the Company does, at
present or will for the foreseeable future.
Marketing
The
Company markets its products and services through five principal
means:
1.
Commercialization
of its existing technologies:
The
Company intends to expand its efforts to market its current technology to the
medical, industrial, personal
care
and
veterinary sciences markets. The Company has expanded its capabilities to
prototype and manufacture for customers to demonstrate the value of
Hydromer
technology.
The Company will also seek opportunities to apply its technology in new
applications where the technology will offer a benefit. Further, the
Company
will seek customers for technologies that have been developed but are not
currently generating revenue, capitalize on the technology that has been
created
through its R&D efforts and to expand the application of current
technologies.
2.
Sale
of Development Services:
The
Company intends to continue moving its effort away from straight technology
licensing and toward contract product
development,
contract manufacturing and coating services (see “5. Coating Services”). The
Company has significant expertise in polymer development and applications.
By
exhibiting at an increased number of trade shows in the medical device fields,
the Company expects to generate interest in its technology and products, with
a
view
toward
acting as an outside product development arm and development supplier for
companies in these fields.
3.
Joint
Development:
The
Company will continue to seek joint development programs, co-marketing programs
and other business arrangements with potential partners.
4.
Licensing:
The
Company will continue its endeavors to license its technology to current market
leaders in the medical device, pharmaceutical and other fields, whereby
the
Company will grant exclusive or non-exclusive rights for the Hydromer coating
treatment of existing or new products, and the development of specific products
utilizing
its foam and hydrogel technology under its patents. In return, the Company
generally would earn royalties based on sales of such treated or new
products.
Such
licenses will usually be very narrow. The activities leading to the consummation
of a license agreement normally are lengthy and require establishing
a
scientific
dialogue with potential customers, treating samples supplied by that customer
with Hydromer coatings, determining if the treatment is feasible and cost
effective,
testing the coated products in a laboratory and then negotiating a mutually
acceptable option agreement. An option fee may be paid by the customer
which
would
give the customer exclusive rights to use the Hydromer treatment on the
specified product for a specified period. During such period, the optionee
can
test market
the
coated product and/or determine its ability to treat the product in its own
manufacturing process. If the customer determines that the subject product
should be treated
with
Hydromer coating on a commercial basis, it may either perform the Hydromer
coating treatment itself under a license agreement with the Company, through
the
Company’s
Contract Coating unit or it may have a third party perform the Hydromer coating
treatment.
5.
Coating
Services:
The
Company will serve the customer who needs products coated with lubricious or
anti-fog coatings in production runs that are economically
feasible
without substantial investments in fixturing and automation. Typically this
would be prototypes or runs of low volume, high value products. Higher volume
products
could be accommodated if they were physically small and did not require
extensive fixturing or because for technical reasons they could not be automated
and
were
of high enough value to warrant the added cost. The Company will pursue large
volume projects if they fall within a technical area where the Company has
particular
expertise.
Business
segments in Coating Services which are of particular interest include medical
devices (catheters and guidewires) and transparencies (lenses, face shields).
Contacts
will be pursued in conjunction with marketing of Hydromer coatings, at trade
shows, in mass mailings and advertisement in appropriate trade publications.
The
Company is continually upgrading its advertising copy and promotional literature
as needed to graphically highlight the properties and advantages of its
technologies.
The
same
marketing tools (traditional means of tradeshow contacts, mass mailings,
advertising, promotional activities, etc.) as well as alternative methods (such
as the Internet)
are
used
by the Company in its focus of expanding sales globally to the medical,
commercial, personal care and veterinary sciences community.
Patents
and Trademarks
Management
believes that the protection afforded by the Hydromer patents will be a
significant factor in the Company's ability to market its products. Anticipating
patent
expiration, the Company has focused on licensing and developing products based
upon its newer technologies. A U.S. patent was issued in October 1985 for a
hydrophilic
polyurethane foam that is expected to have numerous medical applications.
Foreign patents covering this material were issued in July 1990. A U.S. patent
for
hydrophilic
polymer blends, which covers the Company's coating for boats and the cosmetic
formulations, was issued in February 1987. U.S. and foreign patents
have
also
been
issued for an anti-bacterial medical material that can be incorporated in foam
or as a coating. The Company was issued a U.S. patent for non-leaching biostatic
coatings
and three United States patents for its new composition, barrier film, and
method for preventing contact dermatitis developed by the Company’s research and
development
staff. The Company has also been issued United States and foreign patents for
a
permanent anti-fog. The Company also has two patents for Chitosan gels,
which
expires in 2014. These patents are part of the new gel technology with
applications in medical, industrial, cosmetic and personal care markets. The
Company was issued
three
U.S. Patents for barrier teat dip compositions.
One
U.S.
patent that contributed approximately $2,100,000 in annual royalties expired
on
May 6, 2005. The Company was successful in reaching new supply or support
agreements
with all four former licensees of the expired patent for an approximate annual
value of $1,500,000. These new supply/support agreements have
varying
terms and cancellation provisions. It is the Company’s practice to replace any
discontinuances of income stream with other sources, including new product
revenues,
new service revenues and other license or contract revenues.
One
new
patent was awarded to the Company during the fiscal year ended June 30, 2006.
This patent covers the application of water based surface modifications for
use
in
lubricity,
anti-microbial, drug release, hydrogel, radio-opaque, animal care and unique
anti-fog/anti-frost applications.
As
of
June 30, 2006, the Company has 19 U.S. patents, three U.S. applications and
various foreign counterparts.
The
Company owns the registered trademarks “Aquadapt”, “Aquamere”, “Aquatrix”,
“Dermaseal”, "Hydromer", “Sea-Slide” and “T-HEXX” in the United States and other
countries.
Employees
As
of
June 30, 2006, the Company and its subsidiary had eighty-five active full-time
employees. The Chief Executive Officer is Manfred F. Dyck, who is also Chairman
of the Board.
The
Company does not have a collective bargaining agreement with any of its
employees and considers its relationship with its employees to be very
good.
Government
Regulations
The
uses
of the Company's medical, agricultural and cosmetic products come under the
jurisdiction of the FDA, as well as other federal, state and local agencies,
and
similar
agencies
in other countries.
In
connection with the Company's license agreements, it is generally the obligation
of the licensee to conform to any required FDA pre-market notification or other
regulations.
To
the
Company's knowledge, all such licensees who are marketing FDA regulated licensed
products are in such compliance. The Company may in the future desire to
market
additional applications of Hydromer to existing products, or products introduced
by it, which may be subject to such FDA approval procedures as proof of safety
and
effectiveness of the applications or products, or adherence to prescribed design
standards. There can be no assurance that such approvals would be forthcoming
or
of
compliance
with such standards. Any such failure to obtain approvals or non-compliance
might have a significant adverse effect on the Company. However, the
Company
intends to make every effort to obtain all necessary approvals and to comply
with such standards, and in the case of its licensed applications, to require
the
licensees
to obtain such approvals.
The
Company manufactures medical products through its Biosearch Medical Products
subsidiary (“Biosearch”), whose activities come under the jurisdiction of the
FDA.
It
is the
policy of the Company to use the FDA regulations as guidelines during
manufacturing of Hydromer coatings.
The
Company is also subject to federal and state regulations dealing with
occupational health and safety and environmental protection. It is the policy
of
the Company to
comply
with these regulations and be responsive to its obligations to its employees
and
the public.
The
Company’s electronically filed reports are available at www.sec.gov.
Executive
Officers
The
executive officers of the Company are as follows:
|
Age
as of
|
Name
|
Position
with Company
|
|
Aug
31, 2006
|
Manfred
F. Dyck -
|
Chairman
of the Board,
|
|
|
|
Chief
Executive Officer and President
|
|
71
|
Martin
C. Dyck -
|
Executive
Vice-President,
|
|
|
|
Operations
and President Biosearch
|
|
|
|
Medical
Products subsidiary
|
|
44
|
Rainer
Gruening -
|
Vice-President,
|
|
|
|
Intellectual
Property
|
|
63
|
John
Konar -
|
Vice-President,
Quality Assurance
|
|
|
|
and
Director of Human Resources
|
|
57
|
Robert
Y. Lee -
|
Vice-President,
Finance,
|
|
|
|
Chief
Financial Officer and Treasurer
|
|
40
|
Robert
J. Moravsik
|
Senior
Vice-President,
|
|
63
|
Manfred
F. Dyck has been Chairman of the Board of the Company since June 1983 and a
Director of the Company since its inception. Mr. Dyck served as
Chief
Executive Officer of the Company from its inception until October 1986, and
as
of August 1989, reassumed the duties of Chief Executive Officer. Mr. Dyck was
President
of Biosearch Medical Products Inc. from 1975 until 1998 and a Director of
Biosearch Medical Products Inc. from 1975 until 2000.
Martin
C.
Dyck has been Executive Vice-President, Operations since June of 2001. He was
previously Vice-President of Operations since February 2000 when the
Company
purchased Biosearch Medical Products. Mr. Dyck has been President of Biosearch
since 1998, a position which he still maintains. Mr. Dyck has been employed
by
Biosearch
since 1986 and has served in various capacities including Director of New
Product Development, where he developed several new medical devices and authored
six
FDA
510(k) pre-market submissions. After becoming President of Biosearch in 1998,
Mr. Dyck changed the focus of Biosearch to become a contract medical coatings
service
provider
using proprietary technology unique to Biosearch.
Rainer
Gruening joined the Company as Vice-President of Research and Development in
June 2001, and in May 2006 became VP of Intellectual Property. With a PhD in
Chemistry
from the University of Marburg in Germany, his background
includes
service with Bayer AG/Deutsche Solvay Werke, Troy, G+G International and AM
Cosmetics in areas including international regulatory affairs, coatings
technology
and
anti-microbials. Mr. Gruening authored and/or co-authored 17 patents and 35
publications on synthesis and formulation of anti-microbials for paint and
coatings,
cosmetics,
personal care products, adhesives, marine anti-fouling and metal working fluids
and developed dossiers, safety assessments and GMP documentation.
Additionally,
he implemented FDA/CTFA, European and Japanese compliance requirements for
raw
materials and formulation restrictions.
John
Konar has been the Vice-President of Quality Assurance since February 2004
and
Director of Human Resources since February 2000. Mr. Konar joined Biosearch
in
1986
and
served as the Director of Human Resources with Biosearch from 1996 until its
acquisition by the Company in 2000, when he then assumed responsibilities for
both
companies.
He also served, with Biosearch, as the Director of Sales from 1996 until 2000,
Director of Manufacturing from 2000 to 2001 and Director of QA from 1998 until
2004.
Robert
Y.
Lee joined the Company in the capacities of Vice-President of Finance, Chief
Financial Officer and Treasurer in June 2001. He earned a MBA in Finance and
International
Business, and a Bachelors of Science in Accounting and Information Systems,
both
from New York University's Stern School of Business. His professional
experience
includes tenure with the New York office of Coopers & Lybrand (currently
Pricewaterhouse Coopers) in their Emerging Business Group, the Bristol Myers
Squibb
Internal Auditing group, ASARCO's Southern Peru Copper Corporation, now Southern
Copper Corporation, part of Grupo Mexico, and Citigroup.
Robert
J.
Moravsik has been Senior Vice-President, General Counsel and Secretary since
February 2000. He holds a B.S. in Aerospace Engineering, an M.S. in
Computer
Science
and a Doctorate in Law. He was Vice-President and General Counsel since April
1998. He also serves in the same capacity for Biosearch Medical Products, Inc.
an
affiliated
company since 1987. Prior to that, he was Vice-President and General Counsel
to
Fisher Stevens, Inc., a subsidiary of the Bureau of National Affairs. He is
an
attorney
admitted
in the state of New Jersey and New York.
Item
2. PROPERTIES
In
June
1998, the Company purchased the building and land at 35 Industrial Parkway,
Branchburg, NJ from Biosearch Medical Products, then an affiliated party. The
facility,
currently
its sole facility, is secured by mortgages through banks. See the financial
statements included herein for the terms of the agreements.
In
2002,
the Company completed its 10,400 square feet expansion at its primary location
of 35 Industrial Parkway. This allowed the Company to consolidate certain
manufacturing
and quality assurance functions operations formerly located on leased space.
The
expanded facility will be adequate for the Company’s operations for the
foreseeable future.
Item
3. LEGAL PROCEEDINGS
The
Company has been named as a defendant in two product liability actions. Both
actions are covered within the Company’s Product Liability Insurance
policy.
Item
4. SUBMISSION OF MATTERS TO A VOTE OF SECURITY HOLDERS
Not
applicable.
PART
II
Item
5. MARKET FOR THE REGISTRANT'S COMMON EQUITY AND RELATED STOCKHOLDER
MATTERS
Prior
to
January 9, 1986, the Company’s Common Stock was traded in the over-the-counter
market on the National Association of Securities Dealer’s Automated
Quotation
System (NASDAQ) under the symbol “HYDI”. Subsequent to January 9, 1986,
reporting of trading was transferred to the National Daily Quotation
Service
(commonly
known as the “Pink Sheets”). For the past twenty years, trading in the Company’s
stock has been limited.
On
February 13, 2002 the Company became a listed security on the Boston Stock
Exchange (“BSX”) under the trading symbol “HDO”. Hydromer remains listed as
“HYDI”
on
the
OTC reporting services.
The
Company’s common stock traded at prices ranging between $0.75 and $1.35 in the
fiscal year 2006 and between $0.80 and $3.05 in the fiscal year 2005. These
prices
may
not
include retail mark-ups or mark-downs or any commission to the broker
dealer.
The
approximate number of holders of record of the Common Stock on September 1,
2006
was 232. There are approximately 700 individual shareholders of the common
stock.
Item
6. MANAGEMENT DISCUSSION AND ANALYSIS
The
below
discussion analyzes major factors and trends regarding the results of operations
and the financial condition of the Company as of June 30, 2006,
and
its
results of operations for the prior fiscal period. It should be read in
conjunction with the Financial Statements and Notes thereto.
Revenues
for the year ended June 30, 2006 were $7,869,729 as compared to $8,501,374
for
the same period last year, a decrease of $631,645 (-7.4%).
Product
sales and services revenues were $5,933,167 for the 2006 fiscal year as compared
to $6,200,992 the prior fiscal year, a 3.4% decrease or $207,825.
License
royalties and option payments were $1,876,562 in fiscal 2006, down 18.4% from
fiscal 2004’s results of $2,300,382.
Management
Comment:
Lower
customer orders in the medical device business negated the fiscal 2006 growth
from our contract coating services and medical coating sales.
In
fiscal
2006, there were two medical device customers with reduced volume: one which
is
transferring their orders to in-house production and the second, who purchased
the
OEM
product line from another of our customers, lost focus on the product line
during the transition. The Company expects a turn around from these particular
customers,
as
in the
former, the Company will replace lost medical device revenues with the sales
of
lubricious coatings (along with a cost reduction to staffing from to the
elimination of a
product
line). With regards to the second customer, the Company has brought to their
attention of the business reduction and we are currently working on
re-establishing
volume.
In
addition, there was an one-time $250,000 in technology transfer revenues in
fiscal 2005.
The
Company’s patent 4,642,267 expired on May 6, 2005. It was the subject of four
licenses which provided approximately $1.9 million of royalty and option income
in
fiscal
2005. The Company was able to enter into supply agreements or support fees,
with
varying terms and termination conditions, with all four of the licensees,
recovering
$1.6 million of the former royalty stream in fiscal 2006.
Total
Expenses for the year ended June 30, 2006 were $8,649,106, $416,913 or 5.1%
higher than fiscal year 2005’s results of $8,232,123.
Cost
of
Goods Sold was $3,526,039 for fiscal 2006 as compared to $3,228,875 for fiscal
2005. Operating expenses were $5,494,366 and $4,783,188, for the years ended
June
30,
2006 and 2005, respectively. There was a $238,172 impairment of goodwill charge
in fiscal 2006. Fiscal 2006 includes Other income of $143,974 compared with
Other
Expenses of $109,995 in fiscal 2005. There was a Benefit from Income Taxes
of
$465,497 in fiscal 2006 as compared with a provision for Income taxes of
$110,065 for
the
twelve months ended June 30, 2005.
Management
Comment: A
change
in the Company’s inventory standard costs impacted the beginning fiscal 2006
inventory value by $138,459, which is included in the fiscal
2006
Cost
of Sales. Higher wages and benefits paid added another $99,879 to Cost of Sales
in fiscal 2006. A portion of the capital expenditures incurred have been for
equipment
to
automate production -- to increase productivity. The redesign of various medical
devices, including that of the component materials used, is expected to reduce
a
portion
of
Cost
of Sales in the future. This initiative is underway and first requires the
acceptance of the redesign by our customers.
The
capitalization of [inventory] overhead on higher June 30, 2005 ending inventory
levels reduced fiscal 2005 Operating Expenses by $290,112. A SBIR (Small
Business
Innovation
Research) grant of $93,650 further reduced fiscal 2005 costs. These reductions
to the fiscal 2005 costs were compounded with higher fiscal 2006 expenses,
primarily
of $82,885 in higher litigation expenses related to our patent infringement
claim (see below and the following page) and a $74,900 bad debt write-off
relating to
R&D
services performed in 2005 which is now deemed uncollectible, yielding the
large
swing that we see in Operating Expenses year-over-year. Our patent
infringement
claim
against a former licensee and other parties has been settled, entailing over
$509,000 expended in legal fees since 2004. Taking this action not only
substantiated the
validity
of our patents, but put the world on notice that we would not allow for
infringement of our intellectual property. With the settlement, we are now
able
to focus
on
selling our products with reduced concerns of counterfeit products stealing
our
markets once we establish them. We do not anticipate any significant amounts
to
be
spent
further on this matter. Also included in Operating Expenses is the Company’s
investment into Research and Development (primarily salaries and benefits)
of
$1,000,987 and $1,012,091, or 18.2% and 21.2% of total Operating
Expenses,
for
the
years ended June 30, 2006 and 2005, respectively, and the amortized investment
on the patent estate ($144,327 and $151,175 for the years ended June 30, 2006
and 2005, respectively).
After
years of realized synergies, the most recent evaluation of the Company’s
carrying value of goodwill, created from the acquisition of Biosearch in 2000,
determined an
impairment
of goodwill of $238,172, recorded in the year ended June 30, 2006, eliminating
the remaining balance of goodwill carried. There was no required charge for
the
year
ended
June 30, 2005. This charge in fiscal 2006 did not provide for a current tax
benefit resulting in a lower tax benefit realized.
Other
income in fiscal 2006 includes $284,238, the discounted value on $300,000,
from
the settlement of a patent infringement case against a former licensee and
other
parties.
Reducing
Other income is interest expense from the Company’s mortgage loans and
Line-of-Credit borrowings, which is the primary component of Other Expenses
for
fiscal 2005.
An
Income
Tax Benefit was recorded for the year ended June 30, 2006 based on the pre-tax
loss. This benefit includes provisions for federal income taxes, state income
taxes
and
R&D tax credits as offset by the non-current deductibility of the impairment
of goodwill charge (which resulted in a deferred tax asset, however as
realization is highly
unlikely,
a valuation allowance fully reserving for the benefit has been recorded). This
compares with a tax provision for the year ended June 30, 2005.
A
Net
Loss of $779,377 is reported for the 2006 fiscal year compared with Net Income
of $269,251 for the 2005 fiscal year.
A
Net
Loss of $779,377 or $0.17 per share is reported for fiscal 2006 as compared
with
Net Income of $269,251 or $0.06 per share for fiscal 2005.
Management
Comment:
Lower
revenues combined with higher expenses, including an impairment charge of
$238,172 to goodwill, as reduced by a tax benefit arising from the
operating
loss, resulted in a net loss of $779,377.
The
conclusion of various matters (patent infringement costs, impairment of goodwill
charges) and the cost reduction initiatives underway along with new developments
and
projects, is expected to improve the Company’s results down the
road.
Liquidity
and Capital Resources
Working
Capital as of June 30, 2006 was $970,112, down from $2,471,207 the prior
year.
Long-term
investments (capital expenditures and the funding of the patent estate) along
with the working capital needs arising from operations decreased working capital
during
the 2006 fiscal year.
Management
Comment:
We
continue our re-investment back into the Company, primarily in terms of R&D
(personnel as well as equipment) and to our patent estate, to support
future
growth of our business. During the fiscal year ended June 30, 2006, the Company
expended $338,283 for capital expenditures and $213,449 in patent and trademarks
costs.
In
addition, long-term debt was reduced by $177,679.
Item
7. FINANCIAL STATEMENTS AND SUPPLEMENTARY DATA
For
information concerning this item, see pages F-1 through F-8 of the “Audited
Financial Statements for the year ended June 30, 2006,” which information is
incorporated
herein
by
reference.
Item
8. CHANGES IN AND DISAGREEMENTS WITH ACCOUNTANTS ON ACCOUNTING AND FINANCIAL
DISCLOSURE
Not
applicable.
Item
8a. DISCLOSURE CONTROLS AND PROCEDURES
As
of the
period covered by this report, the Company carried out an evaluation, under
the
supervision and with the participation of our management, including the
Chief
Executive Officer and President and the Chief Financial Officer, of the
effectiveness of the design and operation of the disclosure controls and
procedures.
Based
upon this evaluation, our Chief Executive Officer and Chief Financial Officer
concluded that, our disclosure controls and procedures were effective and that
there
were
no
changes to our Company’s internal control over financial reporting that have
materially affected, or is reasonably likely to materially affect the Company’s
internal
control over financial reporting during the period covered by the Company’s
annual report.
PART
III
Item
9. DIRECTORS AND EXECUTIVE OFFICERS OF THE REGISTRANT
For
information concerning this item, see "Item 1. Business - Executive Officers"
and pages 3 through 9 in the Proxy Statement filed with respect to the 2006
Annual
Meeting of Shareholders (the “Proxy Statement”), which information is
incorporated herein by reference.
Item
10. EXECUTIVE COMPENSATION
For
information concerning this item, see page 7 of the Proxy Statement, which
information is incorporated herein by
reference.
Item
11. SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND
MANAGEMENT
For
information concerning this item, see page 8 of the Proxy Statement, which
information is incorporated herein by reference.
Item
12. CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS
During
the past fiscal year, there have been no related party
transactions.
PART IV
Item
13. EXHIBITS, FINANCIAL STATEMENT SCHEDULES AND REPORTS ON FORM
8-K
(a)
1. Financial Statements:
The
financial statements of the Company incorporated by reference in this Report
are
listed in the attached Index to the Financial Statements and Supplementary
Data.
(a)
2. Financial Statement Schedules:
The
financial statement schedules of the Company filed in this Report are listed
in
the attached Index to Financial Statements and Supplementary Data.
(a)
3. Exhibits (not included)
The
exhibits required to be filed as part of this Report are listed in the attached
Index to Exhibits.
(b)
Current Reports on Form 8-K:
The
Company did not file any Form 8-K during the quarter ended June 30, 2006.
POWER
OF ATTORNEY
The
Company and each person whose signature appears below hereby appoint Manfred
F.
Dyck and Robert Y. Lee as attorneys-in-fact with full power of substitution,
severally,
to execute in the name and on behalf of the registrant and each such person,
individually and in each capacity stated below, one or more amendments to the
annual
report which amendments may make such changes in the report as the
attorney-in-fact acting deems appropriate and to file any such amendment to
the
report with the
Securities
and Exchange Commission.
SIGNATURES
Pursuant
to the requirements of Section 13 or 15(d) of the Securities Exchange Act of
1934, the registrant has duly caused this report to be signed on its behalf
by
the
undersigned
thereunto duly authorized.
HYDROMER,
INC.
|
|
|
|
|
|
/s/
Manfred F. Dyck
|
President,
Principal Executive Officer,
|
August
23, 2006
|
Manfred
F. Dyck
|
Chairman
of the Board of Directors
|
|
|
|
|
/s/
Robert Y. Lee
|
Chief
Accounting Officer
|
August
23, 2006
|
Robert
Y. Lee
|
|
|
|
|
|
Pursuant
to the requirements of the Securities and Exchange Act of 1934, this
report has been signed below by the
following
persons on behalf of the registrant and in the capacities and on
the dates
indicated:
|
|
|
|
|
/s/
Manfred F. Dyck
|
President,
Principal Executive Officer,
|
August
23, 2006
|
Manfred
F. Dyck
|
Chairman
of the Board of Directors
|
|
|
|
|
/s/
Robert H. Bea
|
Director
|
August
23, 2006
|
Robert
H. Bea
|
|
|
|
|
|
/s/
Maxwell Borow
|
Director
|
August
23, 2006
|
Maxwell
Borow, MD
|
|
|
|
|
|
/s/
Ursula M. Dyck
|
Director
|
August
23, 2006
|
Ursula
M. Dyck
|
|
|
|
|
|
/s/
Dieter Heinemann
|
Director
|
August
10, 2006
|
Dieter
Heinemann
|
|
|
|
|
|
/s/
Klaus J.H. Meckeler
|
Director
|
August
23,2006
|
Klaus
J.H. Meckeler, MD
|
|
|
|
|
|
/s/
Frederick L. Perl
|
Director
|
August
23, 2006
|
Frederick
L. Perl, MD
|
|
|
|
|
|
/s/
Michael F. Ryan
|
Director
|
August
23, 2006
|
Michael
F. Ryan, PhD
|
|
|
INDEX
TO 2005 10-KSB CERTIFICATIONS
Exhibit
No.
|
Description
|
31.1
|
|
31.2
|
|
32.1
|
|
32.2
|
|
Hydromer,
Inc. & Subsidiary
Consolidated
Financial Statements
June
30, 2006 and 2005
Report
of Independent Registered Public Accounting Firm
To
the
Board of Directors and Stockholders of
Hydromer,
Inc. and Subsidiary
We
have
audited the accompanying balance sheets of Hydromer, Inc. and Subsidiary as
of
June 30, 2006 and 2005 and the related statements of income, stockholders’
equity
and cash flows for each of the years in the two year period ended June 30,
2006.
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 the standards of the Public Company
Accounting Oversight Board (United States). Those standards require that we
plan
and
perform
the audit to obtain reasonable assurance about whether the financial statements
are free of material misstatement. An audit includes examining, on a test basis,
evidence
supporting
the amounts and disclosures in the financial statements. An audit also includes
assessing the accounting principles used and significant estimates made by
management,
as well as evaluating the overall financial statement presentation. We believe
that our audits provide a reasonable basis for our opinion.
In
our
opinion, the financial statements referred to above present fairly, in all
material respects, the financial position of Hydromer, Inc. and Subsidiary
as of
June 30, 2006 and
2005,
and
the results of its operations and its cash flows for each of the two in the
two-year period ended June 30, 2006 in conformity with accounting principles
generally
accepted
in the United States of America.
Rosenberg
Rich Baker
Berman & Company
Rosenberg
Rich Baker Berman & Company
Rosenberg
Rich Baker Berman & Company
Rosenberg
Rich Baker Berman & Compan
Bridgewater,
New Jersey
September
27, 2006
Hydromer,
Inc. & Subsidiary
Index
to the Consolidated Financial Statements
June
30, 2006 and 2005
|
|
|
|
|
Page
|
|
|
|
Financial
Statements
|
|
|
|
|
|
Consolidated
Balance Sheets
|
F-1
|
|
|
|
|
Consolidated
Statements of Income
|
F-2
|
|
|
|
|
Consolidated
Statements of Stockholders’ Equity
|
F-2
|
|
|
|
|
Consolidated
Statements of Cash Flows
|
F-3
|
|
|
|
|
Notes
to the Consolidated Financial Statements
|
F-4
to F-8
|
|
|
|
Hydromer,
Inc. & Subsidiary
Consolidated
Balance Sheets
|
June
30,
|
.
|
2006
|
2005
|
Assets
|
|
|
|
|
Current
Assets:
|
|
|
|
|
Cash
and cash equivalents
|
$
|
434,865.
|
$
|
1,376,656.
|
Trade
receivables less allowance for doubtful accounts of $44,479
and
$32,753
as of June 30, 2006 and 2005, respectively
|
|
1,198,089.
|
|
1,220,258.
|
Inventory
|
|
988,086.
|
|
1,094,927.
|
Prepaid
expenses
|
|
118,436.
|
|
126,762.
|
Deferred
tax asset
|
|
8,976.
|
|
8,976.
|
Income
Tax Refund Receivable
|
|
91,436.
|
|
38,801.
|
Other
|
|
127,776.
|
|
14,841.
|
Total
Current Assets
|
|
2,967,664.
|
|
3,881,221.
|
|
|
|
|
|
Property
and equipment, net
|
|
3,377,473.
|
|
3,276,258.
|
Deferred
tax asset, non-current
|
|
507,426.
|
|
83,013.
|
Intangible
Assets, net
|
|
849,262.
|
|
780,140.
|
Goodwill
|
|
-
|
|
238,172.
|
Other,
non-current
|
|
114,377.
|
|
-
|
Total
Assets
|
$
|
7,816,202.
|
$
|
8,258,804..
|
|
|
|
|
|
Liabilities
and Stockholders’ Equity
|
|
|
|
|
Current
Liabilities:
|
|
|
|
|
Accounts
payable
|
$
|
635,010.
|
$
|
466,993.
|
Short-term
borrowings
|
|
656,255.
|
|
206,663.
|
Accrued
expenses
|
|
374,043.
|
|
287,417.
|
Bonus
payable
|
|
-..
|
|
77,267.
|
Current
portion of deferred revenue
|
|
128,941.
|
|
161,317.
|
Current
portion of mortgage payable
|
|
202,204.
|
|
178,029.
|
Income
tax payable
|
|
1,100.
|
|
32,328.
|
Total
Current Liabilities
|
|
1,997,553.
|
|
1,410,014.
|
|
|
|
|
|
Deferred
tax liability
|
|
271,058.
|
|
243,864.
|
Long-term
portion of deferred revenue
|
|
93,176.
|
|
176,979.
|
Long-term
portion of mortgage payable
|
|
2,093,437.
|
|
2,295,292.
|
Total
Liabilities
|
|
4,455,224.
|
|
4,126,149.
|
Contingencies
Stockholders’
Equity
|
|
-
|
|
-
|
Preferred
stock - no par value, authorized 1,000,000 shares, no shares
issued
and outstanding
|
|
-
|
|
-
|
Common
stock - no par value, authorized 15,000,000 shares;
as
of June 30, 2006, 4,655,081 shares issued and 4,644,164 shares outstanding;
as of June 30, 2005, 4,634,859 shares issued and 4,623,942
shares
outstanding
|
|
3,639,315.
|
|
3,631,615.
|
Contributed
capital
|
|
577,750.
|
|
577,750.
|
Accumulated
deficit
|
|
(849,947)
|
|
(70,570)
|
Treasury
stock, 10,917 common shares at cost
|
|
(6,140)
|
|
(6,140)
|
Total
Stockholders’ Equity
|
|
3,360,978.
|
|
4,132,655.
|
Total
Liabilities and Stockholders’ Equity
|
$
|
7,816,202.
|
$
|
8,258,804.
|
See
notes to the consolidated financial statements.
Hydromer,
Inc. & Subsidiary
Consolidated
Statements of Income
|
|
Year
Ended
|
|
|
2006
|
|
2005
|
Revenues
|
|
|
|
|
Sale
of products
|
$
|
4,752,991.
|
$
|
4,871,283
|
Service
revenues
|
|
1,240,176.
|
|
1,329,709
|
Royalties
and Contract Revenues
|
|
1,876,562.
|
|
2,300,382
|
Total
Revenues
|
|
7,869,729.
|
|
8,501,374
|
Expenses
|
|
|
|
|
Cost
of Sales
|
|
3,526,039.
|
|
3,228,875
|
Operating
Expenses
|
|
5,494,366.
|
|
4,783,188
|
Impairment
of Goodwill
|
|
238,172.
|
|
-
|
Other
(Income) / Expenses, net
|
|
(143,974)
|
|
109,995
|
(Benefit
from)/Provision for Income Taxes
|
|
(465,497)
|
|
110,065
|
Total
Expenses
|
|
8,649,106.
|
|
8,232,123
|
Net
(Loss) Income
|
$
|
(779,377)
|
$
|
269,251
|
(Loss)
/ Earnings Per Common Share
|
$
|
(0.17)
|
$
|
0.06
|
(Loss)
/ Earnings Per Common Share - Assuming Dilution
|
$
|
(0.17)
|
$
|
0.06
|
Weighted
Average Number of Common Shares Outstanding
|
|
4,638,843
|
|
4,614,500
|
Weighted
Average Number of Common Shares Outstanding - Assuming
Dilution
|
|
4,638,843
|
|
4,781,500
|
For the year ended June 30, 2006, common stock equivalents were not included
in
computing diluted earnings per share as their effect would be
anti-dilutive.
See
notes to the consolidated financial statements.
Hydromer,
Inc. & Subsidiary
Consolidated
Statements of Stockholders’ Equity
|
|
|
|
|
|
|
|
|
|
|
|
Common
Stock
|
|
Contributed
|
|
Accumulated
|
|
Treasury
Stock
|
|
|
|
|
Shares
|
|
Amount
|
|
Capital
|
|
Deficit
|
|
Shares
|
|
Amount
|
|
Total
|
|
Balance
June 30, 2004
|
4,608,904
|
$
|
3,615,615
|
$
|
577,750
|
$
|
(339,821)
|
|
10,917
|
$
|
(6,140)
|
$
|
3,847,404.
|
|
Exercise
of Stock Options
Net
Income
|
25,955
|
|
16,000
|
|
|
|
269,251.
|
|
|
|
|
|
16,000.
269,251.
|
|
Balance
June 30, 2005
|
4,634,859
|
$
|
3,631,615
|
$
|
577,750
|
$
|
(70,570)
|
|
10,917
|
$
|
(6,140)
|
$
|
4,132,655.
|
|
Exercise
of Stock Options
|
20,222
|
|
7,700
|
|
|
|
|
|
|
|
|
|
7,700.
|
|
Net
Loss
|
|
|
|
|
|
|
(779,377)
|
|
|
|
|
|
(779,377)
|
|
Balance
June 30, 2006
|
4,655,081
|
$
|
3,639,315
|
$
|
577,750
|
$
|
(849,947)
|
|
10,917
|
$
|
(6,140)
|
$
|
3,360,978.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
See
notes to the consolidated financial statements.
Hydromer,
Inc. & Subsidiary
Consolidated
Statements of Cash Flows
|
|
Year
Ended June 30,
|
|
|
2006
|
|
2005
|
Cash
Flows From Operating Activities:
|
|
|
|
|
Net
(Loss) / Income
|
$
|
(779,377)
|
$
|
269,251.
|
Adjustments
to reconcile net income to net cash provided by operating
activities
|
|
|
|
|
Depreciation
and amortization
|
|
381,395.
|
|
360,117.
|
Impairment
of Goodwill
|
|
238,172.
|
|
-.
|
Deferred
income taxes
|
|
(397,219)
|
|
102,173.
|
Changes
in Assets and Liabilities
|
|
|
|
|
Trade
receivables
|
|
22,169.
|
|
495,051.
|
Inventory
|
|
106,841.
|
|
(285,938)
|
Prepaid
expenses
|
|
8,327.
|
|
(1,963)
|
Other
assets
|
|
(234,679)
|
|
24,570.
|
Accounts
payable and accrued liabilities
|
|
177,374.
|
|
(133,367)
|
Deferred
revenues
|
|
(116,179)
|
|
208,296.
|
Income
taxes payable
|
|
(83,863)
|
|
(95,090)
|
Net
Cash (Used for) Provided by Operating Activities
|
|
(677,039)
|
|
943,100.
|
Cash
Flows From Investing Activities:
|
|
|
|
|
Cash
purchases of property and equipment
|
|
(338,283)
|
|
(560,277)
|
Cash
payments on Patents and Trademarks
|
|
(213,449)
|
|
(258,387)
|
Cash
purchases of Short-term investments
|
|
(392,633)
|
|
-
|
Maturity
of Short-term investments
|
|
400,000.
|
|
-
|
Net
Cash Used for Investing Activities
|
|
(544,365)
|
|
(818,664)
|
Cash
Flows From Financing Activities:
|
|
|
|
|
Net
borrowings/(payments) against Line of Credit
|
|
449,592.
|
|
75,653.
|
Proceeds
from long-term borrowings
|
|
-..
|
|
1,990,000.
|
Repayment
of long-term borrowings
|
|
(177,679)
|
|
(971,909)
|
Proceeds
from the issuance of common stock
|
|
7,700.
|
|
16,000.
|
Net
Cash Provided by Financing Activities
|
|
279,613.
|
|
1,109,744.
|
Net
(Decrease) Increase in Cash and Cash Equivalents:
|
|
(941,791)
|
|
1,234,180.
|
Cash
and Cash Equivalents at Beginning of Period
|
|
1,376,656.
|
|
142,476.
|
Cash
and Cash Equivalents at End of Period
|
$
|
434,865.
|
$
|
1,376,656.
|
Cash
paid during the year for:
|
|
|
|
|
Interest
|
$
|
172,823.
|
$
|
115,216.
|
Income
taxes
|
$
|
32,907.
|
$
|
102,500.
|
See
notes to the consolidated financial statements.
Hydromer,
Inc. & Subsidiary
Notes
to the Consolidated Financial Statements
1.
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
Nature
of Operations
Hydromer,
Inc. & Subsidiary (the “Company”) is a bio-polymer research and development
company based in Branchburg, New Jersey. The Company develops polymer
complexes
for commercial markets in both the United States and abroad for the medical,
cosmetics, veterinary sciences and industrial fields. The Company obtains patent
rights
on
certain products from which royalty revenues are received. Its wholly owned
subsidiary, Biosearch Medical Products, Inc., a U.S. based corporation, is
an
OEM
manufacturer
for various medical products companies as well as the manufacturer of its own
line of endoscopic products sold to hospitals, domestically and
internationally,
through
a
network of dealers. The Company also offers R&D, engineering and contract
coating services in its array of capabilities.
Principles
of Consolidation
The
consolidated financial statements include the accounts of Hydromer, Inc. and
its
wholly owned subsidiary. All significant intercompany balances and transactions
have
been
eliminated.
Cash
and Cash Equivalents
Cash
and
cash equivalents consist of short-term investments with original maturities
of
three months or less.
Short-Term
Investments
Short-term
investments consist of investments other than cash and cash equivalents with
original maturities of greater than three months and less than one year. There
were
no
short-tem investments as of June 30, 2006 and June 30, 2005.
Inventories
Inventories
are valued at the lower of cost, determined by the first-in, first-out method,
or market and include appropriate amounts of labor and overhead.
Depreciation
The
cost
of property and equipment, which includes a reasonable portion of labor costs
for equipment built in-house, is depreciated on a straight-line method over
the
estimated
useful lives of the assets: 5-10 years for machinery and equipment, 3-5 years
for furniture and office equipment and 40 years for the building. When assets
are
retired
or otherwise disposed of, the cost and related accumulated depreciation are
removed from the accounts, and any resulting gain or loss is reflected in
income
for
the period. Repairs and maintenance which do not extend the useful lives of
the
related assets are expensed as incurred.
Patents
Expenses
associated with patents are prepaid and amortized over the expected life of
the
patent, typically 20 years. Prepaid expenses associated with patents which
are
not
approved or abandoned are expensed in the period in which such patents are
not
approved or abandoned. Maintenance fees associated with existing patents are
written
off over 12 months. Amortization expense for the years ended June 30, 2006
and
2005 were $144,327 and $151,175, respectively. One new patent was granted during
the
year
ended June 30, 2006.
Goodwill
Goodwill
represents the excess of the purchase price of Biosearch Medical Products,
Inc.
over the fair market value of their net assets at the date of acquisition and
through
June
30,
2002, was amortized on the straight line method over 40 years. The Company
adopted Statement of Financial Accounting Standards (“SFAS”) No. 142,
Goodwill
and
Other Intangible Assets,
on July
1, 2002 in which goodwill is no longer amortized but tested for impairment
on at
least an annual basis. The carrying value is reviewed
if
the
facts and circumstances, such as significant declines in sales, earnings or
cash
flows or material adverse changes in the business climate, suggest that it
may
be impaired.
If
this
review indicates that goodwill will not be recoverable, the impairment is
determined by comparing the carrying value of goodwill to fair value. Fair
value
can be
determined
based on quoted market values, discounted cash flows or appraisals. The Company
uses the present value of expected future cash inflows method.
During
the year ended June 30, 2006, the Company determined that the carrying amount
of
the goodwill exceeded its fair value. A goodwill impairment loss of $238,172
was
recognized. As of June 30, 2006, the original goodwill balance has been fully
written off.
Long-Lived
Assets
The
Company assesses long-lived assets for impairment as required under SFAS No.
144, Accounting
for the Impairment or Disposal of Long-Lived Assets.
The
Company
reviews
for impairment whenever events or circumstances indicate that the carrying
amount of these assets may not be recoverable. The Company assesses these assets
for
impairment based on estimated future cash flows from these assets.
Revenue
Recognition
Revenues
from product and services sales are recognized at the time of shipment or
services rendered provided that collection of the resulting receivable is
probable. Revenues
from
royalties are recognized upon the sale of certain products by licensees with
whom the Company has licensing agreements. Contract Revenues, which includes
payments
from Option, Supply or Support agreements that are typically based on time
frames, are recognized in the periods to which it pertains. Deferred revenues
are
recorded
when agreements call for payment ahead of when the amounts are
earned.
Shipping
and Handling Charges
The
Company includes costs of shipping and handling billed to customers in Revenues
and the related expense of shipping and handling costs in Cost of
Sales.
Advertising
Advertising
costs are expensed as incurred except for tangible assets, such as printed
advertising materials, which are expensed as consumed. Advertising expense
was
$42,671 and $47,267 for the years ended June 30, 2006 and 2005, respectively.
Research
and Development
Research
and development costs, primarily employee salaries and benefits, are charged
to
operations when incurred and are included in operating expenses. The amounts
charged
to expense for the years ended June 30, 2006 and 2005 were approximately
$1,000,987 and $1,040,110, respectively.
Stock-Based
Compensation
As
permitted by SFAS No. 123, Accounting
for Stock-Based Compensation,
the
Company has elected to follow Accounting Principle Board Opinion No. 25,
Accounting
for
Stock
Issued to Employees,
(“APB
25”) and related interpretations in accounting for its employee stock option
plans. Under APB 25, no compensation expense is
recognized
at the time of option grant when the exercise price of the Company’s employee
stock options equals the fair market value of the underlying common stock
on
the
date of grant. Effective January 1, 2006, the Company is accounting for stock
options under SFAS No. 123(R) (see footnote 2. “New Accounting
Pronouncements”)
Income
Taxes
Income
taxes are provided for the tax effects of transactions reported in the financial
statements and consist of taxes currently due plus deferred taxes related
primarily to
differences
between the bases of assets and liabilities for financial and income tax
reporting. The deferred tax assets and liabilities represent the future tax
return
Hydromer,
Inc. & Subsidiary
Notes
to the Consolidated Financial Statements
consequences
of those differences, which will either be taxable or deductible when the assets
and liabilities are recovered or settled.
Deferred
taxes are also recognized for operating
losses
that are available to offset future federal and state income taxes.
Earnings
Per Share
Earnings
per share, in accordance with the provisions of SFAS No. 128, Earnings Per
Share, is computed by dividing net income by the weighted average number of
common
stock
shares outstanding during the period.
Use
of Estimates
The
preparation of financial statements in conformity with generally accepted
accounting principles requires management to make estimates and assumptions
that
affect
the
reported amounts of assets and liabilities and disclosure of contingent assets
and liabilities at the date of the financial statements and the reported amounts
of revenues
and
expenses during the reporting period. Actual results could differ from those
estimates.
Reclassification
Certain
amounts previously reported have been reclassified to conform to the 2006
presentation.
[Missing
Graphic Reference]
2.
NEW ACCOUNTING PRONOUNCEMENTS
The
Company adopted SFAS No. 123(R), Share-Based
Payment,
on
January 1, 2006. SFAS No. 123(R) establishes the standards for transactions
where an entity exchanges its
equity
instruments for goods or services. This standard requires an issuer to measure
the cost of employee services received in exchange for an award of equity
instruments
based
on
the grant-date fair value of the award and eliminated the exception to account
for such awards using the intrinsic method previously allowable under APB No.
25.
SFAS
No.
123(R) requires all equity compensation to be expensed during the related
periods. There were no transactions subject to the accounting of SFAS No. 123(R)
this year.
[Missing
Graphic Reference]
3.
CONCENTRATION OF CREDIT AND BUSINESS RISK
The
Company is exposed to additional credit and business risks due to its
concentration of activity with certain parties. For example, at times throughout
the year, the Company
may
maintain certain bank accounts in excess of FDIC insured limits.
In
addition, the Company provides credit in the normal course of business to
customers. Ongoing credit evaluations of its customers are performed, and
allowances for
doubtful
accounts are based on factors surrounding the credit risk of specific customers,
historical trends and other information.
For
the
year ended June 30, 2006, the Company sold products and services and collected
royalty income, totaling 29% of its total revenues, to two customers, Cordis
Neurovascular
Systems and Cook Endoscopy (formerly Wilson Cook Medical, Inc.) who individually
accounted for 18% and 14%, respectively, of the consolidated revenues.
There
were
no outstanding accounts receivable from these customers at June 30,
2006.
During
the fiscal year ended June 30, 2005 Cordis Neurovascular Systems and Cook
Endoscopy individually accounted for 15% and 14%, respectively, of total
revenues.
Accounts
receivable from these customers accounted for 22% of total accounts receivable
at June 30, 2005.
The
Company’s patent 4,642,267 expired on May 6, 2005. This patent was the subject
of four licenses with a total annual royalty income to the Company of
approximately $2.1
million.
The Company was able to enter into supply agreements or support fees, with
varying terms and termination conditions, with all four of the licensees, valued
at $1.5
million
annually. Patent no. 4,769,013, the subject of three royalty licenses, expired
during the fiscal year ended June 30, 2006 and another patent (no. 4,875,287
with one royalty
license)
is to expire in November 2006. The total annual royalty income from these two
patents approximated $0.1 million.
[Missing
Graphic Reference]
4.
INVENTORY
Inventory
consists of:
|
|
June
30,
|
|
|
|
2006
|
|
2005
|
|
Finished
goods
|
$
|
328,777
|
$
|
336,078
|
|
Work
in process
|
|
211,422
|
|
314,345
|
|
Raw
materials
|
|
447,887
|
|
444,504
|
|
|
$
|
998,086
|
$
|
1,094,927
|
|
|
|
|
|
|
|
[Missing
Graphic Reference]
5.
OTHER ASSETS
Included
in Other assets as of June 30, 2006 is $123,776 and $114,377, current and
non-current portion, respectively, representing the $250,000 remaining
receivable
\ from
the legal settlement arising from the Company’s patent infringement claim
settled in February 2006. The receivable, $125,000 each due in January 2007
and
January 2008, is
discounted
at 5%.
[Missing
Graphic Reference]
6.
PROPERTY AND EQUIPMENT
Property
and equipment consists of the following:
|
|
June
30,
|
|
|
|
2006
|
|
2005
|
|
Land
|
$
|
472,410..
|
$
|
472,410.
|
|
Building
|
|
2,148,681..
|
|
2,121,092.
|
|
Machinery
and equipment
|
|
3,819,631..
|
|
3,556,839.
|
|
Furniture
and fixtures
|
|
605,558..
|
|
733,595.
|
|
|
|
7,046,280..
|
|
. 6,883,936.
|
|
Less:
Accumulated
depreciation
and amortization
|
|
(3,668,807).
|
|
(3,607,678)
|
|
Property
and Equipment, net
|
$
|
3,377,473..
|
$
|
3,276,258.
|
|
|
|
|
|
|
|
Depreciation
expense charged to operations was $236,558 and $205,579 for the years ended
June
30, 2006 and 2005, respectively.
[Missing
Graphic Reference]
7.
INTANGIBLE ASSETS
Intangible
Assets are comprised of the following:
|
|
June
30,
|
|
|
|
2006
|
|
2005
|
|
Patents
|
$
|
1,101,153.
|
$
|
975,940.
|
|
Trademarks
|
|
72,955.
|
|
72,412.
|
|
Less:
Accumulated amortization
|
|
(324,846)
|
|
(268,212)
|
|
Intangible
Assets, net
|
$
|
849,262.
|
$
|
780,140.
|
|
|
|
|
|
|
|
Future
amortization of the Intangible Assets, as of June 30, 2006, are as
follows:
Year
ending June 30,
|
|
|
|
2007
|
$
|
81,567
|
|
2008
|
|
77,323
|
|
2009
|
|
73,310
|
|
2010
|
|
69,366
|
|
2011
|
|
68,727
|
|
Thereafter
|
|
478,9690
|
|
|
$
|
849,262
|
|
|
|
|
|
|
|
|
|
Hydromer,
Inc. & Subsidiary
Notes
to the Consolidated Financial Statements
8.
LONG-TERM DEBT AND CREDIT FACILITY
The
Company’s facility is financed by a ten-year mortgage note bearing interest at a
6.52% fixed rate. The note amortizes with monthly payments and is secured by
the
real
estate and improvements and all rents from leases subsequently entered into.
As
of June 30, 2006, the book value of the real estate and improvements was
$2,327,405.
The
last
complete appraisal was conducted in 2003 and reflected a market value of
$3,200,000.
On
June
30, 2005, the Company closed on a long-term financing facility of $1,990,000
in
the form of a second mortgage on its property. This facility has a ten year
term
with
a
6.38%
fixed rate. $886,414 was used to pay off a construction loan/continuing loan
provided by New Millennium Bank with the remainder put in short-term investments
or
to
be
used for working capital and possible acquisitions. The facility was financed
through Wachovia Bank, NA which also holds a $555,000 first Mortgage on the
Company's
property.
As
of
June 30, 2006, the Company did not meet certain financial ratios required under
the loan documents. A waiver has been granted by the lender.
The
Company also has a revolving line of credit agreement with a financial
institution, which allows borrowings of up to $750,000, secured by all trade
receivables and inventories.
The
line
bore interest, payable monthly at LIBOR plus 3.15% until June 2005 at which
was
then reduced to LIBOR plus 2.25%. As of June 30, 2006, the interest rate was
7.59%.
This
line
had a maturity date of July 31, 2006 which was extended until January 31, 2007
during the year at the same terms. As of June 30, 2006 and 2005, $656,255 and
$206,663
were
outstanding on the line of credit respectively.
Long-term
debt is comprised of the following:
|
|
June
30,
|
|
|
|
2006
|
|
2005
|
|
Mortgage
note
|
$
|
438,234.
|
$
|
483,321.
|
|
Second
Mortgage Loan
|
|
1,857,407.
|
|
1,990,000.
|
|
Less:
Current Maturities
|
|
(202,204)
|
|
(178,029)
|
|
Long-term
Debt,
Net
of Current Maturities
|
$
|
2,093,437.
|
$
|
2,295,292.
|
|
|
|
|
|
|
|
Total
maturities of long-term debt are as follows:
Year
ending June 30,
|
|
|
|
2007
|
$
|
202,204
|
|
2008
|
|
215,393
|
|
2009
|
|
230,182
|
|
2010
|
|
245,604
|
|
2011
|
|
262,060
|
|
Thereafter
|
|
1,140,198
|
|
|
$
|
2,295,641
|
|
|
|
|
|
[Missing
Graphic Reference]
9.
FAIR VALUE OF FINANCIAL INSTRUMENTS
The
carrying amount of cash and cash equivalents, short-term investments, accounts
receivable, accounts payable and accrued expenses approximates fair value
because
of
the
short maturity of these instruments. The fair value of the Company’s long-term
debt approximates its carrying value as it is based on or about the current
rates
offered
to the Company for debt of the same remaining maturities with similar collateral
requirements.
Limitations
Fair
value estimates are made at a specific point in time, based on relevant market
information about the financial instrument. These estimates are subjective
in
nature
and
involve uncertainties and matters of significant judgment and therefore cannot
be determined with precision. Changes in assumptions could significantly affect
the
estimates.
10.
INCOME TAXES
The
income tax (benefit) provision is comprised of the following:
|
|
Federal
|
|
State
|
|
Total
|
|
Year
Ended June 30, 2006
|
|
|
|
|
|
|
|
Current
|
$
|
(71,185)
|
$
|
2,907.
|
$
|
(68,278)
|
|
Deferred
|
|
(296,253)
|
|
(100,966)
|
|
(397,219)
|
|
|
$
|
(367,438)
|
$
|
(98,059)
|
$
|
(465,497)
|
|
Year
Ended June 30, 2005
|
|
|
|
|
|
|
|
Current
|
$
|
1,513
|
$
|
5,764.
|
$
|
7,277
|
|
Deferred
|
|
90,843
|
|
11,945.
|
|
102,788
|
|
|
$
|
92,356
|
$
|
17,709.
|
$
|
110,065
|
|
|
|
|
|
|
|
|
|
The Company’s deferred tax asset and liability as presented in the Company’s
financial statements are comprised of the following temporary
differences:
|
|
June
30,
|
|
|
|
2006
|
|
2005
|
|
Deferred
Tax Asset
|
|
|
|
|
|
Net
Operating Losses
|
$
|
345,510.
|
$
|
201,628.
|
|
Adjustment
of Goodwill
|
|
196,069.
|
|
100,800.
|
|
Research
& Development Credits
|
|
346,643.
|
|
9,829.
|
|
Valuation
allowance
|
|
(371,820)
|
|
(220,268)
|
|
Total
Deferred Tax Assets
|
|
516,402.
|
|
91,989.
|
|
|
|
|
|
|
|
Deferred
Tax Liability
|
|
|
|
|
|
Depreciation
|
|
(271,058)
|
|
(243,864)
|
|
Total
Deferred Tax Liability
|
$
|
(271,058)
|
$
|
(243,864)
|
|
|
|
|
|
|
|
Deferred
taxes are recognized for temporary differences between the bases of assets
and
liabilities for financial statement and income tax purposes. The differences
relate
primarily to depreciable assets (using accelerated depreciation methods for
income tax purposes). The Company’s adjustment to Goodwill in 2004 and 2006
created
a
deferred tax asset, which although has an indefinite life, has been fully
reserved for as realization of its benefit is unlikely.
The
Company has net operating loss carry forwards of approximately $144,051 and
$508,813 for Federal and State tax purposes respectively. These net operating
loss carry
forwards
may be used to reduce federal and state taxable income and tax liabilities
in
future years and expire in various years through June 30, 2019 and June 30,
2011
for
Federal
and State tax purposes, respectively. In addition, the Company has Research
and
Development Tax Credits for State tax purposes of approximately $329,643 which
expires
in various years through June 30, 2019.
The
Company’s provision for income taxes differs from applying the statutory U.S.
federal income tax rate to the income before income taxes. The primary
differences
result
from providing for state income taxes, generation of allowable tax credits
and
from deducting certain expenses for financial statement purposes but not for
federal
income
tax purposes.
Hydromer,
Inc. & Subsidiary
Notes
to the Consolidated Financial Statements
A reconciliation between taxes computed at the federal statutory rate and the
consolidated effective tax rate follows:
|
June
30,
|
|
|
2006
.
|
|
2005
.
|
|
Federal
statutory tax rate
|
|
(34.0)
|
%
|
|
34.0
|
%
|
State
income tax - net of federal
tax
benefit
|
|
(4.5)
|
|
|
3.2
|
|
R
& D credits
Adjustment
to prior year accrual for income tax
|
|
(7.8)
.
.-.
|
|
|
-
(8.2)
|
|
Permanent
and other differences
|
|
8.9. .
|
|
|
0.9
|
|
|
|
(37.4)
|
%
|
|
29.9
|
%
|
|
|
|
|
|
|
|
11.
STOCK OPTIONS AND AWARDS
On
February 22, 2000 the Board of Directors approved an option plan that granted
each active director 2,000 options for each meeting attended, awarded at the
annual meeting at the 5-day market price average.
The
following options were awarded to the Board of Directors under this
plan:
Issuance
Date
|
Options
Issued
|
Exercise
Price
|
Expiration
Date
|
Options
Exercised
|
Oct
24, 2000
|
62,000
|
$0.55
|
Oct
23, 2005
|
23,700
|
Nov
14, 2001
|
64,000
|
$1.11
|
Nov
13, 2006
|
-
|
Nov
13, 2002
|
80,000
|
$0.45
|
Nov
13, 2007
|
-
|
Nov
19, 2003
|
52,000
|
$1.10
|
Nov
19, 2008
|
-
|
Nov
17, 2004
|
56,000
|
$2.10
|
Nov
17, 2009
|
-
|
Nov
16, 2005
|
62,000
|
$0.95
|
Nov
16, 2010
|
-
|
There were no other stock option issuances during the 2005 and 2006 fiscal
years.
A summary of activity under the plan for the years ending June 30, 2006 and
2005
is as follows:
|
|
|
|
Common
Stock Options Outstanding
|
|
|
|
|
|
Weighted
Average
|
|
|
|
Shares
|
|
Exercise
Price
|
|
Balance,
June 30, 2004
|
|
501,524.
|
|
$
0.94
|
|
Granted
Exercised
|
|
56,000.
(30,000)
|
|
2.10
0.83
|
|
Canceled
|
|
(5,000)..
|
|
0.80
|
|
Balance,
June 30, 2005
|
|
522,524.
|
|
$
1.08
|
|
Granted
|
|
62,000.
|
|
0.95
|
|
Exercised
|
|
(23,700)..
|
|
0.55
|
|
Canceled
|
|
(158,824)..
|
|
1.18
|
|
Balance,
June 30, 2006
|
|
402,000.
|
|
$
1.04
|
|
Following is a summary of the status of options outstanding as of June 30,
2006:
Outstanding
Options .
|
|
Exercisable
Options .
|
Exercise
Price
Range
|
|
Number
|
|
Weighted
Average Remaining Contractual Life
|
|
Weighted
Average Exercise
Price
|
|
Number
|
|
Weighted
Average Exercise
Price
|
$0.45
- $0.85
|
|
100,000
|
|
1.2
years
|
|
$0.49
|
|
100,000
|
|
$0.49
|
$0.86
- $1.68
|
|
246,000
|
|
1.9
years
|
|
$1.03
|
|
246,000
|
|
$1.03
|
$1.69
- $2.10
|
|
56,000
|
|
3.4
years
|
|
$2.10
|
|
56,000
|
|
$2.10
|
|
|
402,000
|
|
1.9
years
|
|
$1.04
|
|
402,000
|
|
$1.04
|
PRO
FORMA INFORMATION
Prior
to
January 1, 2006, the Company followed the disclosure only provisions of SFAS
No.
123, Accounting
for Stock Based Compensation.
Accordingly, no
compensation
expense has been recognized for stock options issued. Had compensation expense
for the options which vested in 2006 and 2005 been determined based
on
the
fair value at the grant date commensurate with the provisions of SFAS No. 123,
the Company’s net income and net income per share for 2006 and 2005,
respectively,
would
have been reflected as to the pro forma amounts indicated below:
|
|
2006
|
|
2005
|
Net
(Loss) Income:
|
|
|
|
|
As
reported
|
$
|
(779,377)
|
$
|
269,251
|
Pro
forma
|
|
(809,460)
|
|
209,396
|
Basic
(Loss) Income per Share:
|
|
|
|
|
As
reported
|
$
|
(0.17)
|
$
|
0.06
|
Pro
forma
|
|
(0.17)
|
|
0.05
|
The
fair
value of each option grant is estimated on the date of grant using the
Black-Scholes pricing model with the following weighted average assumptions
for
grants
in
2006 and 2005, respectively: dividend yield of 0% and 0%; expected volatility
of
115% and 115%; risk-free interest rate of 5.1% and 4.1%; and expected lives
of
5
years
in both years.
12.
RETIREMENT PLAN
The
Company sponsors a qualified 401(k) plan covering substantially all full time
employees under which eligible employees can defer a portion of their annual
compensation.
The
Company determines annually, the amount of matching contributions, which
recently has been 25% on 6% of the employees’ salary. The Company’s matching
contribution
made to the plan during the years ended June 30, 2006 and 2005 were $35,094
and
$22,929, respectively.
[Missing
Graphic Reference]
13.
LEASES
There
were no material non-cancelable lease terms in excess of one year as of June
30,
2006.
14.
EARNINGS PER SHARE
The
following table sets forth the computation of earnings per share and earnings
per share - assuming dilution:
|
|
2006
|
|
2005
|
Numerator:
|
|
|
|
|
Net
(loss) income
|
$
|
(779,377)
|
$
|
269,251
|
Denominator:
|
|
|
|
|
Denominator
for earnings per share
-
weighted average shares outstanding
|
|
4,638,843
|
|
4,614,500
|
Effect
of dilutive securities - stock options
|
|
n/a
.
|
|
167,000
|
Denominator
for earnings per share
assuming dilution - adjusted weighted
average shares outstanding
|
|
4,638,843
|
|
4,781,500
|
(Loss)
Earnings per share
|
$
|
(0.17)
|
$
|
0.06
|
(Loss)
Earnings per share - assuming dilution
|
$
|
(0.17)
|
$
|
0.06
|
|
|
|
|
|
Common
stock equivalents of 402,000 and 355,524 for the years ended June 30, 2006
and
2005, respectively, were not included in computing diluted earnings per share
as
their
effect would be anti-dilutive.
Hydromer,
Inc. & Subsidiary
Notes
to the Consolidated Financial Statements
15.
INDUSTRY SEGMENT INFORMATION
The
Company operates two primary business segments: (1) Polymer Research and (2)
Medical Products.
Products
included in the polymer research segment are Aquadapt®,
Aquamere®,
Aquatrix®,
Dermaseal®,
Hydromer®
Anti-Fog/Condensation Control Coatings,
Hydromer®
Lubricious Coatings, Sea-Slide®
and
T-Hexx®
Barrier
Dips and Sprays. Research and Development services and all of the Company’s
royalties, options and
license
revenues are reported in this segment.
The
medical products segment includes an OEM product line of bipolar coagulation
probes, bilary catheters and stents, jejunal and enteral feeding accessories,
guidewires,
biofeedback
devices for fecal and urinary incontinence and other endoscopic accessories.
Service revenues, including coating services and engineering services, are
included
in
this
segment.
Due
to
the multitude of products offered and the product gross margins, the Company
does not track sales volumes by products.
The
Company operates globally in its segments with several large customers that
are
important to their operating results. One such customer accounted for 26% and
23%
of
the
polymer research segment sales for the 2006 and 2005 fiscal years, respectively.
For the medical products segment, the top three customers accounted for 48%
and
50%
of
that
segment’s 2006 and 2005 sales, respectively.
The
Company evaluates the segments by revenues, total expenses and earnings before
income taxes. The Company’s assets are not reviewed by business segment.
The
accounting policies of these segments are described in the summary of
significant accounting policies.
Corporate
Overhead, primarily the salaries and fringes of senior management, support
services (Accounting, Legal, Human Resources and Purchasing) and other
shared
services (Building maintenance and warehousing), is reflected separately from
the results of the business segments in the following:
|
|
Polymer
Research*
|
|
Medical
Products
|
|
Corporate
Overhead
|
|
Total
|
Year
Ended June 30, 2006
|
|
|
|
|
|
|
|
Revenue
|
$
|
4,315,794.
|
$
|
3,547,574.
|
|
|
$
|
7,863,368.
|
Expenses
|
|
(3,623,388)
|
|
(3,761,704)
|
$
|
(1,484,978)
|
|
(8,870,070)
|
Earnings
(Loss) before
Income
Taxes
|
$
|
692,406.
|
$
|
(214,130).
|
$
|
(1,484,978)
|
$
|
(1,006,702)..
|
Year
Ended June 30, 2005
|
|
|
|
|
|
|
|
|
Revenue
|
$
|
4,878,364.
|
$
|
3,607,640.
|
|
|
$
|
8,486,004..
|
Expenses
|
|
(3,536,202)
|
|
(3,140,312)
|
$
|
(1,430,174)
|
|
(8,106,688)
|
Earnings
(Loss) before
Income
Taxes
|
$
|
1,342,162..
|
$
|
467,328.
|
$
|
(1,430,174)
|
$
|
379,316..
|
|
|
|
|
|
|
|
|
|
* Excludes
the Fiscal 2006 Impairment of Goodwill of $238,172 as such charge-off is not
included in the periodic reporting segment evaluations.
Geographic revenues were as follows for the years ended June 30,
|
|
2006
|
2005
|
|
Domestic
|
82%
|
84%
|
|
Foreign
|
18%
|
16%
|
|
16.
CONTINGENCIES
Royalty
revenues recorded by the Company’s are based on the sales of licensee products
as reported by the Company’s licensees which has the risk of being under- or
over-reported. To minimize such risks, the Company’s management utilizes its
knowledge and understanding of the licensee’s business, the market and other
pertinent factors in assessing the validity of reported royalties. In addition,
the Company has a right to audit the amounts reported.
The
Company has not received any claims by licensees for possible overpayment of
royalties.
17.
SUBSEQUENT EVENTS
In
July
2006, the Company renewed its $750,000 revolving line of credit agreement
extending the maturity from July 31, 2006 to January 31, 2007.
INDEX
TO EXHIBITS
3.a
Certificate of Incorporation of the Company, as amended to date
3.b
By-Laws of the Company, as amended to date
10.a
Minutes of Meeting of the Board of Directors of the Company held on March 5,
1981 with respect to stock options granted to Manfred F. Dyck (Incorporated
by
reference
to Exhibit 10.i to the Registration Statement).
10.b
Agreement dated August 11, 1981 between Horizon Concepts, Inc., and the Company
(Incorporated by reference to Exhibit 10.c to the Registration
Statement).
10.c
Agreement dated January 27, 1982 between Reliable Pharmaceutical Company, Inc.
and the Company (Incorporated by reference to Exhibit 10.d to the Registration
Statement).
10.d
License Agreement dated July 14, 1982 between Biosearch Medical Products Inc.
and the Company (Incorporated by reference to Exhibit 10.g to the Registration
Statement).
10.e
Management Services Agreement dated July 14, 1982 between Biosearch Medical
Products Inc. and the Company (Incorporated by reference to Exhibit 10.h to
the
Registration
Statement).
10.f
Amendment dated October 7, 1982 to Agreement dated January 27, 1982 between
Reliable Pharmaceutical Company, Inc. and the Company, together with letter
dated
October 14, 1982 from Reliable Pharmaceutical Company, Inc. to the Company
(Incorporated by reference to Exhibit 10.f to the 1983 Annual
Report).
10.g
Hydromer Coating agreement dated February 11, 1983 between Pacesetter Systems,
Inc. and the Company (Incorporated by reference to Exhibit 10.g to the
1983
Annual
Report).
10.h
Lease Agreement dated April 5, 1983 between Salem Realty and the Company
(Incorporated by reference to Exhibit 10.h to the 1983 Annual
Report).
10.i
License Agreement dated April 25, 1983 between CardioSearch Inc. and the Company
(Incorporated by reference to Exhibit 10.i to the 1983 Annual
Report).
10.j
Trademark License Agreement dated April 25, 1983 between CardioSearch Inc.
and
the Company (Incorporated by reference to Exhibit 10.j to the 1983 Annual
Report).
10.k
Agreement dated August 31, 1983 between Becton, Dickinson & Company and the
Company (Incorporated by reference to Exhibit 10.l to the 1983 Annual
Report).
10.l
Current Report on Form 8-K filed May 30, 1986
10.m
Hydromer Coating License Agreement dated September 30, 1984 between Axiom
Medical, Inc. and the Company (Incorporated by reference to Exhibit 10.m to
the
1984
Annual Report).
10.n
1982
Stock Option Plan of the Company (Incorporated by reference to Exhibit 10.m
to
the 1983 Annual Report).
10.o
Amendment dated June 26, 1984 to Agreement dated August 3, 1983 between Becton,
Dickinson & Company and the Company (Incorporated by reference to
Exhibit
10.o to the 1984 Annual Report).
10.p
License Agreement dated July 31, 1984 between Kendall Company and the Company
(Incorporated by reference to Exhibit 10.p to the 1984 Annual
Report).
10.q
License Agreement dated March 1, 1985 between Van-Tec Inc. and the Company
and
Letter of Amendment thereto dated June 13, 1985 (Incorporated by reference
to
Exhibit 10.o to the 1985 Annual Report).
10.r
Telex dated June 24, 1985 terminating License Agreement with CardioSearch Inc.
(Incorporated by reference to Exhibit 10.p to the 1984 Annual
Report).
10.s
Amendment dated as of December 31, 1984 to Management Services Agreement dated
July 14, 1982 between Biosearch Medical Products Inc. and the Company
(Incorporated
by reference to Exhibit 10.q to the 1985 Annual Report).
10.t
Lease Renewal Agreement dated April 15, 1985 between Salem Realty and the
Company (Incorporated by reference to Exhibit 10.r to the 1985 Annual
Report).
10.u
Lease Agreement dated December 4, 1984 between Biosearch Medical Products Inc.
and the Company (Incorporated by reference to Exhibit 10.s to the 1985
Annual
Report).
10.v
License Agreement dated April 11, 1986 between Axiom Medical, Inc. and the
Company (Incorporated by reference to Exhibit 10.i to the 1986 Annual
Report).
10.w
License Agreement dated September 13, 1985 between U. S. Viggo and the Company
(Incorporated by reference to Exhibit 10.c to the 1986 Annual
Report).
10.x
License Agreement dated March 27, 1986 between Wilkinson Sword Limited and
the
Company (Incorporated by reference to Exhibit 10.f of the 1986 Annual
Report).
10.y
Lease Renewal Agreement dated April 15, 1987 between Salem Realty and the
Company (Incorporated by reference to Exhibit 10.y to the 1987 Annual
Report).
10.z
License Agreement dated April 30, 1986 between HPK International and the Company
(Incorporated by reference to Exhibit 10.j to the 1986 Annual
Report).
10.aa
License Agreement dated August 1, 1986 between Film Specialties, Inc. and the
Company (Incorporated by reference to Exhibit 10.aa to the 1987 Annual
Report).
10.ab
Lease Renewal Agreement dated April 15, 1988 between Salem Realty and the
Company (Incorporated by reference to Exhibit 10.ab to the 1988 Annual
Report).
10.ac
License Agreement dated June 30, 1987 between Richards Medical Company and
the
Company (Incorporated by reference to Exhibit 10.ac to the 1988 Annual
Report).
10.ad
License Agreement dated December 1, 1987 between Mallinckrodt, Inc. and the
Company (Incorporated by reference to Exhibit 10.ad to the 1988 Annual
Report).
10.ae
Option Agreement dated January 28, 1988 between Cordis Corporation and the
Company (Incorporated by reference to Exhibit 10.ae to the 1988 Annual
Report).
10.af
Lease Agreement dated April 15, 1988 between Biosearch Medical Products Inc.
and
the Company (Incorporated by reference to Exhibit 10.ag of the 1988 Annual
Report).
10.ag
Letters dated June 11, 1987 and September 22, 1987 to U. S. Viggo, Inc.
modifying License Agreement dated September 13, 1985, to cover only central
venous
catheters
(Incorporated by reference to Exhibit 10.ag to the 1988 Annual
Report).
10.ah
Lease Renewal Agreement dated April 15, 1989 between Salem Realty and the
Company (Incorporated by reference to Exhibit 10.ah to the 1989 Annual
Report).
10.ai
Amendment dated October 1, 1988 to License Agreement dated September 13, 1985,
between U. S. Viggo and the Company (Incorporated by reference to Exhibit 10.ai
to the
1989
Annual Report).
10.aj
License Agreement dated October 20, 1988 between Cordis Corp. and the Company
(Incorporated by reference to Exhibit 10.aj to the 1989 Annual
Report).
10.ak
License Agreement dated March 31, 1989 between Cathlab Corp. and the Company
(Incorporated by reference to Exhibit 10.ak to the 1989 Annual
Report).
10.al
Amendment dated December 1, 1988 to License Agreement dated August 1, 1986
between Film Specialties, Inc. and the Company (Incorporated by reference to
Exhibit
10.al to the 1989 Annual Report).
10.am
Finders Agreement dated August 20, 1987 between Phoenix Chemical, Inc. and
the
Company (Incorporated by reference to Exhibit 10.am to the 1989 Annual
Report).
10.an
License Agreement dated September 10, 1989 between the Stent Division of
Schneider and the Company (Incorporated by reference to Exhibit 10.an to the
1990 Annual Report).
10.ao
License Agreement dated March 30, 1990 between Cosmo Ikko Company and the
Company (Incorporated by reference to Exhibit 10.ao to the 1990 Annual
Report).
10.ap
License Agreement dated April 12, 1990 between Interventional Therapeutics,
Inc.
and the Company and amendment dated May 7, 1990 to the Agreement dated April
12,
1990 between Interventional Therapeutics, Inc. and the Company (Incorporated
by
reference to Exhibit 10.ap to the 1990 Annual Report).
10.aq
Amended License Agreement dated January 1, 1990 between the Wilkinson Sword
group of companies and the Company (Incorporated by reference to Exhibit 10.aq
the 1990 Annual Report).
10.ar
Lease Agreement dated April 15, 1990 between Salem Realty and the Company
(Incorporated by reference to Exhibit 10.ar to the 1990 Annual
Report).
10.as
Amendment to the Agreement dated July 31, 1984 between Kendall Company and
the
Company (Incorporated by reference to Exhibit 10.as to the 1990 Annual
Report).
10.at
License Agreement dated January 11, 1991 between Biosearch Medical Products
Inc.
and the Company (Incorporated by reference to Exhibit 10.at to the 1991 Annual
Report).
10.au
License Agreement dated May 16, 1991 between I E Sensors and the Company
(Incorporated by reference to Exhibit 10.au to the 1991 Annual
Report).
10.av
Lease Renewal Agreement dated April 15, 1991 between Salem Realty and The
Company (Incorporated by reference to Exhibit 10.av to the 1991 Annual
Report).
10.aw
License Agreement dated July 25, 1991 between Johnson & Johnson Orthopaedics
and the Company (Incorporated by reference to Exhibit 10.aw to the 1992 Annual
Report).
10.ax
License Agreement dated August 19, 1991 between Navarre Laboratories Ltd. and
the Company (Incorporated by reference to Exhibit 10.ax to the 1992 Annual
Report).
10.ay
Amended License Agreement dated September 15, 1991 between Boston Scientific
Corp. and the Company (Incorporated by reference to Exhibit 10.ay to the 1992
Annual Report).
10.az
Option/License Agreement dated September 23,1991 between Elan Corp. PLC and
the
Company (Incorporated by reference to Exhibit 10.az to the 1992 Annual
Report).
10.ba
Lease Agreement dated November 1, 1991 between Morton Street Realty and the
Company (Incorporated by reference to Exhibit 10.ba to the 1992 Annual
Report).
10.bb
License Agreement dated August 17, 1992 between SCIMED Peripheral Interventions,
division of SCIMED Life Systems, Inc. and the Company. (Incorporated by
reference to Exhibit 10.bb to the 1993 Annual Report).
10.bc
License Agreement dated March 9, 1993 between Arrow International, Inc. and
the
Company. (Incorporated by reference to Exhibit 10.bc to the 1993 Annual
Report).
10.bd
License Agreement dated April 28, 1993 between St. Jude Medical, Inc. and the
Company. (Incorporated by reference to Exhibit 10.bd to the 1993 Annual
Report).
10.be
License Agreement dated November 11, 1993 between Katoh Hatsujyo Kaisha, Ltd.
and the Company. (Incorporated by reference to Exhibit 10.be to the 1994 Annual
Report).
10.bf
Lease Agreement dated June 9, 1995 between Salem Realty and the Company
(Incorporated by reference to Exhibit 10.bf to the 1995 Annual
Report).
10.bg
Amendment dated September 20, 1995 to License Agreement dated April 28, 1993
between St. Jude Medical, Inc. and the Company. (Incorporated by reference
to
Exhibit 10.bg to the 1996 Annual Report).
10.bh
License Agreement dated April 12, 1990 between Interventional Therapeutics
and
the Company was terminated effective December 22, 1995. (Incorporated by
reference to Exhibit 10.bh to the 1996 Annual Report).
10.bi
License Agreement dated May 16, 1991 between I E Sensors and the Company was
terminated effective December 31, 1995. (Incorporated by reference to Exhibit
10.bi to the 1996 Annual Report).
10.bj
Consented to the assignment of license agreement dated April 28,1993 between
St.
Jude Medical, Inc. and the Company to CR Bard dated January 18, 1996.
(Incorporated by reference to Exhibit 10.bj to the 1996 Annual
Report).
10.bk
License Agreement dated April 30, 1986 between HPK International and the Company
was terminated effective February 19, 1996. (Incorporated by reference to
Exhibit 10.bk to the 1996 Annual Report).
10.bl
License Agreement dated June 6, 1996 between Biosearch Medical Products Inc.
and
the Company. (Incorporated by reference to Exhibit 10.bl to the 1996 Annual
Report).
10.bm
License Agreement dated August 1, 1996 between Biosearch Medical Products Inc.
and the Company.
10.bn
Amended License Agreement dated September 4, 1996 between SCIMED (Boston
Scientific Corporation) and the Company.
10.bo
License Agreement dated January 6, 1997 between Sherwood Davis & Geck and
the Company.
10.bp
Use
permit for certain designated area dated May 4, 1997 between Biosearch Medical
Products Inc. and the Company
10.bq
Contract of sale between Biosearch Medical Products and the Company for the
sale
of 35 Industrial Parkway dated 3/31/98
10.br
Note and mortgage with PNC Bank dated 6/12/98
10.bs
3
year lease agreement with Biosearch Medical Products dated 6/12/98 for 35
Industrial Parkway
10.bt
License of technology, supply and stock purchase agreement with C.R.Bard dated
2/25/99
10.bu
Trademark and technology license agreement with AST dated 3/9/99
10.bv
License of two gel patents from Ridge Scientific dated 11/1/98
10.bw
License and Supply agreement with Gallini SRL dated 6/28/00
10.bx
Standstill agreement with license option with IMED Pharma Inc. dated
3/30/00
10.by
License of technology with Symbiotech Medical Inc. dated 3/28/00
10.bz
License and supply agreement with TP Orthodontics Inc. dated
3/30/00
10.ca
License Agreement dated July 1, 2000 between Becton Dickinson and Company,
Inc.
and the Company.
10.cb
License Agreement dated January 1, 2001 between LHS Limited and LHS Holding
Limited, English dba KLEENCARE and the Company.
10.cc
License Agreement dated April 17, 2001 between Tyco
Healthcare Group LP
and the
Company.
10.cd
Construction Contract dated April 19, 2001 between REDCO Engineering &
Construction Corp and the Company.
10.ce
Service Agreement dated April 23, 2001 between Tyco
Healthcare Group LP
and the
Company.
10.cf
Loan Agreement dated June 7, 2001 between New Millenium Bank and the Company.
10.cg
By-Laws Articles of Incorporation.
10.ch
Loan Agreement dated June 30, 2005 between Wachovia Bank, N.A. and the
Company.
24.
Power
of Attorney (see "Power of Attorney" in the Annual Report on Form
10-KSB).
31.1
Certification of Manfred F. Dyck, Chief Executive Officer, pursuant to
Securities Exchange Act Rule 13a-14(a).
31.2
Certification of Robert Y. Lee, Chief Financial Officer, pursuant to
Securities Exchange Act Rule 13a-14(a).
32.1
Certification pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section
906 of the Sarbanes-Oxley Act of 2002, signed by Manfred F. Dyck, Chief
Executive Officer of Hydromer, Inc.
32.2
Certification pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section
906 of the Sarbanes-Oxley Act of 2002, signed by Robert Y. Lee, Chief Financial
Officer of Hydromer, Inc.
REFERENCES
AND PERTINENT LITERATURE
Bach,
A.,
Darby, D., Boettiger, B., Boehrer, H., Motsch, J. and Martin, E. “Retention of
the antibiotic teicoplanin on a hydromer-coated central venous catheter to
prevent
bacterial
colonization in postoperative surgical patients” Intensive
Care Medicine,
1996,
Vol. 22, No. 10, pp 1066-1069
Bayston,
R., Bhunda, C. and Ashraf, W. “Hydromer-coated catheters to prevent shunt
infection?” J
Neurosurg (Pediatrics 2),
2005,
No. 102, pp 207
Belknap,
D.C., Seifert, C.F. and Petermann, M. “Administration of Medications Through
Enteral Feeding Catheters” American
Journal of Critical Care,
1997,
Vol. 6, No. 5,
pp
382-392
Borow,
M.
and Crowley, J.G. “Prevention of thrombosis of central venous catheters”
Journal
of Cardiovascular Surgery,
1986,
Vol. 27, No. 5, pp 571-574
Borow,
M.
and Crowley, J.G. “Evaluation of Central Venous Catheter Thrombogenicity”
Acta
anaesthesiologica Scandinavia, Supplementum,
1985,
Suppl. 81, pp 59-64
Bridgett,
M.J., Davies, M.C., Denyer, S.P. and Eldridge, P.R. “In vitro assessment of
bacterial adhesion to Hydromer-coated cerebrospinal fluid shunts” Biomaterials,
1993,
Vol.
14,
No. 3, pp 184-188
Bylock,
A., Hultman, E., Gustavsson, B., Lindner, L.E. and Curlaru, I. “Surface
Morphology Of Unused And Used Hydromer-Coated Intravenous Catheters”
Scanning
Electron
Microscopy
(I),
1986, pp 157-164
Costamagna,
G., Mutignani, M., Rotondano, G., Cipoletta, L., Ghezzo, L., Foco, A. and
Zambelli, A. “Hydrophilic hydromer-coated polyurethane stents versus uncoated
stents
in
malignant biliary obstruction: a randomized trial” Gastrointestinal
Endoscopy,
2000,
Vol. 51, No. 1, pp 8-11
Craig,
Silvis S. “Performance and acceptability of Entiflex enternal feeding tube with
Hydromer lubricated lumen and mercury weight and with placement stylet”
Therapeutic
Gastrointestinal
Endoscopy,
1985, pp
185-197
DePalma,
G. and Puzziello, A. “Ultrasonography-guided endoscopic stent placement for
malignant biliary obstruction” Endoscopy,
2004,
Vol 36, No. 4, pp 334-336
DePalma,
G., Puzziello, A., Aprea, G., etc. “Ultrasound-guided endoscopic drainage,…, in
patients with neoplastic biliary obstruction”, Minerva
Chir.,
2004,
Vol. 59, No. 4, pp 347-350
Elliott
“Can Antimicrobial Central Venous catheters prevent associated infection?”
British
Journal of Hematology 1999,
Vol. 107,
pp
234-241
Elliott
T.S. “The prevention of central venous catheter-related sepsis” Journal
of Chemotherapy,
2001,
Vol. 13, No. 1 (1), pp 234-238
Elliott
T.S.J. “Role of antimicrobial central venous catheters for the prevention of
associated infections” Journal
of Antimicrobial Chemotherapy 1999,
Vol. 43, pp 441-446
Faigel,
D.O. “Preventing biliary stent occlusion” Gastrointestinal
Endoscopy,
2000,
Vol. 51, No. 1, Jan 2000
Francois,
P., Vaudaux, P., Lew, D.P., Nurdin, N., Mathieu, H.J. and Descounts, P.
“Physical and biological effects of a surface coating procedure on polyurethane
catheter”
Biomaterials,
1996,
Vol. 17, No. 7, pp 667-678
Galloway,
S. and Bodenham, A. “Long-term central venous access” British
Journal of Anaesthesia,
2004,
Vol. 92, No. 5, pp 722-734
Garvin,
J., Button, N.F., Watson-Craik, I.A. and Logan, N.A. “Observation of Soft
Contact Lens Disinfection with Fluorescent Metabolic Stains” Applied
and Environmental
Microbiology,
2000,
Vol. 66, No. 2, pp 874-875
Gupta,
P., Vermani, K. and Garg, S. “Hydrogels: from controlled release to
pH-responsive drug delivery” Drug
Discovery Today,
2002,
Vol. 7, No. 10, pp 569-579
Gupta,
S., Batra, Y.K., Puri, G.D., Panigrahi, D. and Roy, S. “Infection rates in
single- and double-lumen central venous catheters in critically ill patients.”
The
National Medical Journal of India,
1995,
Vol. 8, No. 3, pp 114-117
Hoff,
B.H., Hawke, M., Fletcher, S. and Matjesko, M.J., “The Spectrum of
Thromboembolization in the Central Circulation.” Anesthesiology Res. 534 MSTF
University of
Maryland
1992
Jansen,
B., Goodman, L.P. and Ruiten, D. “Bacterial adherence to hydrophilic
polymer-coated polyurethane stents” Gastrointestinal
Endoscopy,
1993,
Vol. 39, No. 5, pp 670-673
John,
S.F., Hillier, V.F., Handley, P.S. and Derrick, M.R. “Adhesion of staphylococci
to polyurethane and hydrogel-coated polyurethane catheters assayed by an
improved
radiolabelling
technique.” Journal
of Medical Microbiology,
1995,
Vol. 43, No. 2, pp 133-140
Jones,
D.S., McMeel, S., Adair, C.G. and Gorman, S.P. “Characterisation and evaluation
of novel surfactant bacterial anti-adherent coatings for endotracheal tubes…”,
Journal
of
Pharmacy
and Pharmacology,
2003,
Vol. 55, No. 1, pp 43-52
Kristinsson,
K.G. “Adherance of staphylococci to intravascular cartheters.” Journal
of Med. Microbiology,
1989,
Vol. 28,
pp
249-257
Leung,
J.W., Liu, Y., Cheung, S., Chan, R.C.Y., Inciardi, J.F. and Cheng, A.F. “Effect
of antibiotic-loaded hydrophilic stents in the prevention of bacterial
adherence: A study of
charge,
discharge, and recharge concept using ciprofloxacin” Gastrointestinal
Endoscopy,
2001,
Vol. 53, No. 4, pp 431-437
Levy,
M.,
Baron, T. and Gostout, C. “Palliation of Malignant Extrahepatic Biliary
Obstruction with Plastic vs. Expandable Metal Stents” Clincial
Gastroenterology Hepatitis,
2004,
No.
2, pp
273
Luque,
A.G., Simonet, N.H., Ramos, M.I.V., Palacios, M.M. and Pardo, P.E.H. “Profilaxis
de las complicaciones infecciosas de los catheteres venosos centrales “
Esp.
Anestesiol.
Reanim.,
2002,
Rev No. 49, pp 17-33
Menemse,
Kiremitci-Gumu Derelioglu and Arzu, Pesmen “Microbial adhesion to ionogenic
PHEMA, PU and PP implants” Biomaterials,
1996,
Vol. 17, No. 4, pp 443-449
Moss,
H.S., Tebbs, S.E., Faroqui, M.H., Herbst, T., Isaac, J.L., Brown, J. and
Elliott, T.S.J. “A central venous catheter coated with benzalkonium chloride for
the prevention of
catheter-related
microbial colonization.” European
Journal of Anesthesiology,
2000,
Vol. 17, No. 11, pp 680
Palma,
G.D., Galloro, G., Siciliano, S., Iovino, P., Catanzano, C. “Unilateral versus
bilateral endoscopic hepatic duct drainage in patients with malignant hilar
bilary
obstruction”
Gastrointestinal
Endoscopy,
2001
Vol. 53, No. 6, pp 547-553
Piozzi,
A., Francolini, I. Occhiaperti, etc. “Antimicrobial activity of polyurethanes
coated with antibiotics” International
Journal of Pharmaceutics,
2004
Vol. 280, Issues 1-2, pp
173-183
Risbud,
M.V., Bhonde, M.R., Bhonde, R.R. “Effect of chitosan-polyvinyl pyrrolidone
hydrogel on proliferation and cytokine expression of endothelial cells”
Journal
of
Biomedical
Matter Research,
2001,
Vol. 57, pp 300-305
Risbud,
M.V., Bhonde, M.R., Bhonde, R.R. “Chitosan-polyvinyl pyrrolidone hydrogel does
not activate macrophages: potentials for transplantation applications”
Cell
Transplant,
March
2001, Vol. 10, pp 195-202
Risbud,
M.V., Hardikar, A.A., Bhat, S.V., Bhonde, R.R. “pH-sensitive freeze-dried
chitosan-polyvinyl pyrrolidone hydrogels as controlled release system for
antibiotic delivery”
Journal
of Controlled Release,
July
2000, Vol. 68, pp 23-30
Schierholz,
J.M., Pulverer, G. and Rump, A.F.E. “Schwierige Suche nach neuen Werkstoffen -
Katheter Materialien” Deutsches
Aerzteblatt,
1998,
Vol. 95, No. 17, A1006
Seitz,
U.
and Soehendra, N. “Which stents do we need? The case for plastic stents”
Endoscopy,
1998
Vol. 30, No. 9, A242-6,
Tebbs,
S.E. and Elliott, T.S.J. “Modification of central venous catheter polymers to
prevent in vitro microbial colonization.” European
Journal of Clinical Microbial Infectious
Diseases,
1994,
Vol. 13, pp 111-117
Wu,
Gang;
Wan, Changxiu; Duan, Yourong and Yue, Yilun “Researches on Surface Modification
for Prevention of Bacterial Adhesion to Implementing Biomaterials” Implanting
Journal
of Biomedical Engineering,
2000,
Vol. 1, No. 17