UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
WASHINGTON,
D.C. 20549
FORM
10-K
(Mark
One)
x
|
ANNUAL
REPORT PURSUANT TO SECTION 13 or 15(d) OF THE SECURITIES EXCHANGE
ACT OF
1934
|
For
the
fiscal year ended: December 31, 2007
OR
o
|
TRANSITION
REPORT PURSUANT TO SECTION 13 or 15(d) OF THE SECURITIES EXCHANGE
ACT OF
1934
|
For
the
transition period from: _______ to ________.
Commission
File No. 1-12451
NEW
YORK HEALTH CARE, INC.
(Exact
name of registrant as specified in its charter)
New
York
|
|
11-2636089
|
(State
or other jurisdiction of
|
|
(I.R.S.
Employer Identification No.)
|
incorporation
or organization)
|
|
|
|
|
|
1850
McDonald Avenue, Brooklyn, New York
|
|
11223
|
(Address
of principal executive offices)
|
|
(Zip
Code)
|
Registrant’s
telephone number, including area code:
|
718-375-6700
|
Securities
issued pursuant to Section 12(b) of the Act:
|
None
|
|
|
Name
of exchange on
|
Title
of each class
|
|
which
registered
|
Securities
registered pursuant to Section 12(g) of the Act:
Common
Stock $.01 par value
(Title
of
Class)
Indicate
by check mark if the registrant is a well-known seasoned issuer, as defined
in
Rule 405 of the Securities Act.
o
Yes
x
No
Indicate
by check mark if the registrant is not required to file reports pursuant to
Section 13 or Section 15(d) of the Act.
o
Yes
x
No
Note
–
Checking the box above will not relieve any registrant required to file reports
pursuant to Section 13 or 15(d) of the Exchange Act from their obligations
under
those Sections.
Indicate
by check mark whether the registrant (1) has filed all reports required to
be
filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 (the
“Exchange Act”) during the preceding 12 months (or for such shorter period that
the registrant was required to file such reports), and (2) has been subject
to
such filing requirements for the past 90 days.
x
Yes
o
No
Indicate
by check mark if disclosure of delinquent filers pursuant to Item 405 of
Regulation S-K (§ 229.405 of this chapter) is not contained herein, and will not
be contained, to the best of registrant’s knowledge, in definitive proxy or
information statements incorporated by reference in Part III of this Form 10-K
or any amendment to this Form 10-K.
o
Indicate
by check mark whether the registrant is a large accelerated filer, an
accelerated filer, a non-accelerated filer, or a smaller reporting company.
See
the definitions of “large accelerated filer,” “accelerated filer” and “smaller
reporting company” in Rule 12b-2 of the Exchange Act.
Large
accelerated filer
o
|
Accelerated
filer
o
|
Non-accelerated
filer
o
(Do not check if
a smaller reporting company)
|
Smaller
reporting company
x
|
Indicate
by check mark whether the registrant is a shell company (as defined in Rule
12b-2 of the Act).
o
Yes
x
No
The
aggregate market value of the registrant’s common stock held by non-affiliates
computed by reference to the price at which the common stock was last sold,
or
the average bid and asked price of such common stock, as of June 30, 2007,
the
last business day of the registrant's most recently completed second fiscal
quarter,
was
approximately
$3,538,000.
The
number of shares outstanding of the registrant’s common stock, as of April 10,
2008: 33,536,767 .
DOCUMENTS
INCORPORATED BY REFERENCE: NONE
FORWARD-LOOKING
STATEMENTS
Certain
information contained in this report is forward-looking in nature. All
statements in this report, including those made by New York Health Care, Inc.
and its subsidiaries (“we,” “our,” or the “Company”), other than statements of
historical fact, are forward-looking statements. Examples of forward-looking
statements include statements regarding the Company’s future financial
condition, operating results, business and regulatory strategies, projected
costs, services, research and development, competitive positions and plans
and
objectives of management for future operations. These forward-looking statements
are based on management’s estimates, projections and assumptions as of the date
hereof and include the assumptions that underlie such statements.
Forward-looking statements may contain words such as “may,” “will,” “should,”
“would,” “expect,” “plan,” “anticipate,” “believe,” “estimate,” “predict,”
“potential,” “continue,” or the negative of these terms or other comparable
terminology. Any expectations based on these forward-looking statements are
subject to risks and uncertainties and other important factors, including those
discussed below and in Item 7 - Management’s Discussion and Analysis of
Financial Condition and Results of Operations Other risks and uncertainties
are
disclosed in the Company’s prior SEC filings. These and many other factors could
affect the Company’s future financial operating results, and could cause actual
results to differ materially from expectations based on forward-looking
statements made in this report or elsewhere by the Company or on its behalf.
The
Company assumes no obligation to update such statements.
The
following information should be read in conjunction with the Consolidated
Financial Statements and notes thereto included in this Annual Report. All
references to fiscal year apply to the Company’s fiscal year which ends on
December 31, 2007.
Recent
Developments:
As
of
December 31, 2007, BioBalance had cash on hand of approximately $38,000, all
of
which was available to fund operations. BioBalance management estimates that
its
capital requirements for an entire year of operations are approximately
$5,000,000. This amount includes the cost of the initial up front payment for
the Phase I/II clinical trial, in the amount of $3,000,000, for the Company's
lead product PROBACTRIX® that is not expected to be started in 2008. It will be
necessary for the Company to secure additional funding in order for BioBalance
to begin the Phase I/II clinical trial, which was approved by FDA on March
24,
2006. The Company has not been able to obtain additional funding up to the
present time and the BioBalance subsidiary has been operating solely by
utilizing funds from the health care operations, which are insufficient for
BioBalance's needs. The Company is seeking potential funding sources but no
agreements with any such funding sources have been entered into. Accordingly,
since additional funding from outside sources has not been obtained, the Company
began scaling back the operations of BioBalance at the end of November 2006,
and
BioBalance operated on a substantially reduced budget in 2007.
BioBalance
management has taken steps to secure the data from clinical trials and has
produced an additional master seed of the biological strain of PROBACTRIX® and
is in the process of placing duplicates in secondary off-site secure storage.
Additionally,
BioBalance surrendered its office space to the landlord in March 2007 in
exchange for lease cancellation, incurring exit costs and losses on disposal
or
value impairments of equipment and fixtures of approximately
$74,000
.
Management has instituted temporary cutbacks in consultant compensation until
such time as additional funds or a strategic partner can be found. There can
be
no assurances that the Company will be able to raise additional capital in
the
near term to allow BioBalance to continue its normal level of
operations.
BioBalance
has also commenced preliminary studies regarding the use of
PROBACTRIX®
in the
treatment of Celiac disease (a dietary gluten intolerance). This study was
conducted as a small scale pilot study which, while not providing data that
is
clinically or statistically useful in demonstrating efficacy, produced
encouraging preliminary results. The Company is contemplating various options
including funding costs relating to clinical research and statistical analysis
for a follow up study.
In
September 2007, BioBalance completed an international, multi-center, randomized,
double-blind, placebo-controlled, clinical trial in 129 patients with irritable
bowel syndrome. PROBACTRIX® was well tolerated. However, due to an unusually
high placebo response rate (53.1%), there was no statistical difference in
the
primary endpoint (relief of abdominal pain and discomfort) when PROBACTRIX® -
and placebo-treated patients were compared. There were more placebo-treated
patients who experienced at least one adverse event and who experienced at
least
one adverse event related to study product (46 and 15, respectively) than did
PROBACTRIX® -treated patients (39 and 10, respectively). This study demonstrated
the safety of PROBACTRIX® when given for long periods of time and is consistent
with other studies that BioBalance has conducted to assess product safety.
Despite the unexpected high placebo response rate and its negative impact on
the
study's primary endpoint, BioBalance remains encouraged by the strong
improvements in stool consistency, pain and discomfort, bloating, and stool
frequency compared to baseline. BioBalance is investigating the use of higher
concentrations of the probiotic and plans to review the data derived from the
irritable bowel syndrome study as a knowledge base for new studies in order
to
target indications which the company believes on-going research
supports.
On
March
30, 2006, the Company was served with a shareholder derivative complaint
captioned Jay Glatzer v. Yitz Grossman, Emerald Asset Management, Murry Englard,
Michael Nafash, Stuart Ehrlich, and Dennis O'Donnell and New York Health Care,
Inc. (Supreme Court of State of New York County of Nassau ,Index No. 5125/06).
The lawsuit alleged that the directors breached their fiduciary duty by
approving the Emerald Settlement Agreement disclosed in the Company's Form
8-K
(Date of Report March 6, 2006) filed with the Securities Exchange Commission
on
March 10, 2006. The lawsuit claimed that such breach was a product of their
respective relationships with Mr. Grossman. The lawsuit also alleged that Mr.
Grossman and Emerald Asset Management injured the Company by engaging in the
actions underlying the November 2004 criminal conviction of Mr. Grossman. The
lawsuit was dismissed in September 2006. A notice of appeal was filed by the
plaintiff in October 2006 and the plaintiff filed its appeal brief in April
2007. On January 15, 2008, the court dismissed the appeal.
The
accompanying consolidated financial statements have been prepared assuming
that
the Company will continue as a going concern. The Company’s recurring losses and
negative working capital raises substantial doubt about its ability to continue
as a going concern. The consolidated financial statements do not include any
adjustments that might result from the outcome of this uncertainty. Management’s
plans in connection with this matter include further budget reductions in
BioBalance, selling unproductive assets and seeking additional equity
investment.
PART
I
Item
1.
BUSINESS
OVERVIEW
We
are
currently engaged in two industry segments, the delivery of home healthcare
services (sometimes referred to as the “home healthcare business”) and, since
our acquisition of BioBalance in a merger transaction in January 2003 (treated
for accounting purposes as a reverse acquisition of us by BioBalance), the
development of proprietary biotherapeutic agents for the treatment of various
gastrointestinal (“GI”) disorders. BioBalance is a wholly-owned subsidiary of
the Company. For accounting purposes, BioBalance is considered to be the
“accounting acquirer” in the transaction.
We
believe that the
PROBACTRIX®
offers a
platform technology that could ultimately achieve regulatory approval for a
wide
range of GI indications. The product is thought to work by restoring the
microbial balance within the GI tract by selective displacement of pathogenic
bacteria and prevention of their re-colonization. Clinical studies independently
conducted by Dr. Mark Pimentel in 2002 at Cedars-Sinai Medical Center in
California have confirmed the direct link of pathogenic bacterial overgrowth
with GI symptoms such as Irritable Bowel Syndrome (IBS). The Company believes
that these studies support the rationale for the Company’s lead product to
address a potential root cause of GI disease resulting in relief of symptoms
with no significant side effects.
The
Company is a New York corporation incorporated in 1983. The Company’s principal
executive office is 1850 McDonald Avenue, Brooklyn, New York 11223, telephone
718-375-6700.
For
more
information as to the financial performance of our home healthcare and
BioBalance business segments, see Part II, Item 7, “Management’s Discussion and
Analysis of Financial Condition and Results of Operations” and Note 13 of Notes
to Consolidated Financial Statements included elsewhere in this
report.
HISTORY,
DEVELOPMENT AND OVERVIEW
The
Company was initially organized to act as a licensed home healthcare agency
engaged primarily in supplying the services of paraprofessionals who provide
a
broad range of healthcare support services to patients in their
homes.
The
home
healthcare business operates in all five boroughs of New York City and the
counties of Nassau, Westchester, Rockland, Orange, Dutchess, Ulster, Putnam
and
Sullivan, in the State of New York. Services are supplied principally pursuant
to contracts with healthcare institutions and governmental agencies, such as
various county departments of social services, the New York City Human Resources
Administration, Beth Abraham Long-Term Home Health Services, and Kingsbridge
Medical Center.
BioBalance
is a development stage biopharmaceutical company incorporated in Delaware in
May
2001. BioBalance is focused on the development of innovative treatments for
various gastrointestinal (GI) disorders with significant unmet needs. BioBalance
has not generated any revenues to date.
CORPORATE
STRATEGY
We
intend
to pursue BioBalance’s business plan of developing
PROBACTRIX
®
as
a
prescription drug for treating various gastrointestinal disorders, subject
to
the availability of funding. The Company intends to finance a portion of the
continuing development of the BioBalance business, including its prescription
drug development efforts, from existing cash and cash flow from the home
healthcare business. Funding from outside sources will be needed for
BioBalance’s remaining capital requirements. Potential outside sources include
the sale of BioBalance equity, debt or convertible securities, third party
financing and strategic partnering.
BIOBALANCE
BUSINESS
Overview
BioBalance
is a development stage biopharmaceutical company focused on the identification,
licensing and development of novel treatments for GI disorders that we believe
are poorly addressed by current therapies. These include pouchitis, irritable
bowel syndrome (“
IBS
”),
Crohn’s disease, ulcerative colitis, celiac disease, and
C.
difficile
infections. We believe that our lead product candidate,
PROBACTRIX® ,
a
probiotic,
can
reduce symptoms of pouchitis, IBS and other GI disorders.
Our
current efforts consist of identifying, licensing and developing products for
GI
diseases where current therapies are inadequate or may have significant side
effects. Unlike conventional treatments, we believe that our lead product
technology restores the microbial balance in the GI tract by displacing
pathogenic bacteria and preventing their re-establishment. For example, clinical
trials conducted independently at the Cedars-Sinai Medical Center in California
have confirmed the direct link of pathogenic bacterial overgrowth with IBS
symptoms. Therefore, we believe that our products may address an underlying
root
cause of many GI disorders in addition to providing symptom relief with no
significant side effects.
Our
lead
development product,
PROBACTRIX® ,
is a
proprietary strain of
E.coli
M-17
bacteria, which we plan to develop as a prescription drug treatment for
pouchitis, IBS and other GI disorders.
BioBalance
is pursuing an accelerated regulatory approval for the use of
PROBACTRIX®
in
the
U.S. by having filed an Investigational New Drug (“IND ”) application with the
FDA for
treating
patients with chronic pouchitis for the purpose of preventing relapse of their
symptoms.
.
Pouchitis is a non-specific inflammation of the ileal reservoir, which can
be a
long-term problem for some patients. This usually occurs during the first two
years after bowel reconstruction due to ulcerative colitis. Most pouchitis
sufferers experience symptoms including steadily increasing stool frequency
that
may be accompanied by incontinence, bleeding, fever and/or a feeling of urgency.
There are no drugs currently approved in the U.S. for pouchitis. We believe
that
current treatments being used “off-label” (including antibiotics) are often
ineffective in relieving symptoms.
BioBalance
originally submitted the IND application for the pouchitis indication which
was
received by the FDA on January 2, 2005. On March 24, 2006, the FDA gave us
clearance to proceed with the Phase I/II clinical trial. This study is currently
on hold, pending the availability of third party funding, as described above
under “Recent Developments”.
We
plan
to seek orphan drug designation for treatment of pouchitis. “Orphan drug” refers
to a product that treats a rare disease affecting less than a specified number
of persons (200,000 in the U.S.). FDA approval of an IND permits the sponsor
to
conduct clinical trials in humans in the United States.
The
patented formulation used for
PROBACTRIX®
consists
of a proprietary strain of non-pathogenic
E.coli M-17
,
derived
from an organism that was originally isolated from the intestinal mircoflora
of
healthy volunteers. The technology and the processes comprise conditions that
preserve
E.coli
M-17, in
the biologically active form. Patent applications have been filed by BioBalance
for
various
formulations designed to extend the product’s shelf-life in a liquid
form.
In
addition, we received approval of the registration of
PROBACTRIX®
as
a
registered trademark in the U.S. on March 1, 2005. Our intellectual property
portfolio also includes rights to a combination of two patented Bacillus
strains,
B.
subtilis
and
B.
licheniformis
.
We
have
contracted for the manufacture of
PROBACTRIX®
with
Benchmark
Biolabs Inc. to satisfy our clinical trial needs in a state-of-the-art facility
located in Lincoln, Nebraska. At the present time, no product is being
manufactured at this or any other facility.
Regulatory
Strategy
Our
current regulatory strategy involves pursuing accelerated approval
for
PROBACTRIX®
under
the
auspices of an active IND, for treating patients with chronic pouchitis for
the
purpose of preventing relapse of their symptoms.
There
are currently no approved treatments for pouchitis. Additional clinical studies
can subsequently be conducted to determine whether there is support for broader
usage.
BioBalance
originally planned to pursue marketing of
PROBACTRIX®
as
a
medical food for IBS, given limited resources and the significant time required
for prescription drug development. Industry studies indicate that it takes
approximately eight to 10 years for the average prescription drug to progress
from the IND filing to market introduction. However, following discussions
with
regulatory consultants and potential pharmaceutical licensees, it was determined
that a shorter pathway to drug development through filing an IND for an orphan
drug indication would be the most economically attractive course. This involved
addressing pouchitis, a narrowly focused indication with unmet therapeutic
needs, rather than IBS. Pouchitis also offered the potential for orphan drug
designation and expedited FDA approval. We believe that we can achieve FDA
approval for
PROBACTRIX®
as
a
prescription drug to treat pouchitis in approximately four to five years from
the date on which we are able to commence the Phase I/II clinical trials,
dependent on our obtaining necessary funding. However, there is no assurance
that we will be able to commence the clinical trials, that such trials will
yield desired results, or that FDA approval will be granted in any
event.
Upon
receipt of funding, we plan to conduct double blind, placebo controlled studies
now that we have obtained FDA approval of our IND for the pouchitis indication.
The first step would involve a Phase I/II study in pouchitis patients. This
study would likely be followed with a pivotal Phase III trial in approximately
50-75 pouchitis patients.
A
dose-ranging study may also be required.
No
assurance can be given as to if or when approval can be obtained.
A
prescription drug can be assigned orphan drug status by the FDA and European
regulatory authorities if the indication addresses a target population of less
than 200,000 sufferers in the U.S. or less than 5 sufferers per 10,000 persons
in Europe. There is a separate Office of Orphan Drug Product Development at
the
FDA designed to help facilitate rapid approval of orphan drug applications.
Once
approved, orphan drugs are given seven year exclusivity in the U.S. and ten
years of exclusivity in Europe. Additional benefits of receiving orphan drug
status in the U.S. include study design assistance, a 50% reduction in the
filing cost of the NDA/BLA (new drug application/biological licensing
application) and may also include partial funding of clinical costs by the
FDA.
The NDA/BLA requests permission from FDA to market a drug in the U.S. In Europe,
a drug product is filed with the European Medicines Agency (EMEA) for marketing
throughout the European Commission area. The EMEA has a Committee for Orphan
Medicinal Products (COMP) whereby drugs are designated "orphan drug" status
for
the European Union.
Longer
term, we are currently considering expanding the label indication of
PROBACTRIX®
to
include a number of additional GI indications, including the treatment
of
C.
difficile
infections.
We
also
plan to explore licensing opportunities for a veterinary formulation
of
PROBACTRIX®
as
an
animal feed additive. We believe that a veterinary formulation of
PROBACTRIX®
could
be
a potential replacement for antibiotics and/or animal growth hormones. This
issue has generated significant worldwide attention as governments and consumer
groups have called for the reduction or elimination of unnecessary antibiotics
and growth hormones in farm animals. Based on studies conducted in Israel
beginning in 1996 with a number of animal species, we believe that
PROBACTRIX®
has
a
beneficial safety and efficacy profile as an animal feed additive. A veterinary
formulation of
PROBACTRIX®
was
approved in Israel in 1998 as a veterinary feed additive. However, we can not
assure you that we will ever license a veterinary formulation of
PROBACTRIX®
as
an
animal feed product.
In
September 2007, BioBalance completed an international, multi-center, randomized,
double-blind, placebo-controlled, clinical trial in 129 patients with irritable
bowel syndrome. PROBACTRIX® was well tolerated. However, due to an unusually
high placebo response rate (53.1%), there was no statistical difference in
the
primary endpoint (relief of abdominal pain and discomfort) when PROBACTRIX® -
and placebo-treated patients were compared. There were more placebo-treated
patients who experienced at least one adverse event and who experienced at
least
one adverse event related to study product (46 and 15, respectively) than did
PROBACTRIX® -treated patients (39 and 10, respectively). This study demonstrated
the safety of PROBACTRIX® when given for long periods of time and is consistent
with other studies that BioBalance has conducted to assess product safety.
Despite the unexpected high placebo response rate and its negative impact on
the
study's primary endpoint, BioBalance remains encouraged by the strong
improvements in stool consistency, pain and discomfort, bloating, and stool
frequency compared to baseline. BioBalance is investigating the use of higher
concentrations of the probiotic and plans to review the data derived from the
irritable bowel syndrome study as a knowledge base for new studies in order
to
target indications which the company believes on-going research
supports.
PRODUCTS
PROBACTRIX®
Our
initial product opportunity,
PROBACTRIX®
,
is a
non-pathogenic probiotic, which we believe addresses a root cause of many GI
disorders, including pouchitis, IBS, IBD and diarrhea, by inhibiting and
replacing the growth of pathogenic bacteria and preventing their
re-colonization. Studies conducted overseas in over 14,000 patients have
documented the safety and efficacy profile of this ingredient.
A
predecessor product was approved as a biological agent for the treatment of
a
broad range of GI disorders and diarrheas in Russia in May 1998, as a food
supplement for human use by the Ministry of Health of Israel in May 1998 and
for
use as animal food by the Ministry of Agriculture of Israel in September 1998.
In August 2000, Tetra-Pharm, an Israeli pharmaceutical company, agreed to cease
manufacture and sale of the product in conjunction with its agreement to sell
all rights relating to the product to BioBalance. Since then, production of
the
formula has been limited to supplying hospitals and universities where
BioBalance is conducting further research.
The
basic
active component in
PROBACTRIX®
is
a
selective strain of non-pathogenic
E.coli
bacteria, which is contained in a liquid suspension. This bacterium is a
commonly represented species in the healthy microflora of humans and animals.
It
has been used for the preparation of
Colibacterin, Bificon
and
other medicines and food supplements outside the U.S.
The
research on
PROBACTRIX®
originated
in Russia from studies by Dr. Nellie Kelner-Padalka, a pediatrician and our
scientific founder. These studies found liquid food supplements
containing
E.coli
M-17 to
be useful in treating intestinal infections of various origins. However, shelf
life was short and the product had a strong odor that made it difficult for
some
patients to ingest. Dr. Kelner-Padalka later brought her studies to Israel
where
several technologies were used to expand the shelf life and improve the smell
and taste.
As
part
of the regulatory approval process of
E.
coli
M-17 in
Russia, a scientific panel determined the product’s mechanism of action included
the following:
|
·
|
Rapid
suppression of pathogenic microorganisms and their
repulsion.
|
|
·
|
Restoration
of the normalization of the body’s immune system due to increased
synthesis of immunoglobulin, interferon and activation of
macrophages.
|
|
·
|
Stimulation
of the enzyme complex (protease, amylase, lipase and cellulase),
which
helps to improve digestion.
|
|
·
|
Binding,
neutralizing and withdrawing toxic substances (including heavy metals)
from the body.
|
|
·
|
Improvement
of the absorption of selected micronutrients including B-complex
vitamins
and essential amino acids.
|
The
patented formulation used for
PROBACTRIX®
consists
of a proprietary strain of non-pathogenic
E.coli
,
derived
from an organism that was originally isolated from the intestinal microflora
of
healthy volunteers, which is preserved in a liquid extract formulation. The
technology and the processes comprise conditions that preserve M-17
E.
coli
in the
biologically active form. Additional patent applications have been filed by
BioBalance for technology that could extend the product’s shelf life for two
years or longer at room temperature.
Bacillus
Product
We
have
acquired the rights to a combination of two Bacillus strains that has exhibited
anti-inflammatory, anti-bacterial and anti-viral properties, which may be
effective in treating a variety of GI diseases. We believe our Bacillus strains
are therapeutically effective against rotavirus and campylobacter pathogens,
which are the leading causes of infectious diarrhea. We believe this technology
could also be effective in treating ulcerative colitis. There was a predecessor
product (called
Biosporin)
based on
the Bacillus strains acquired, which was approved in Russia. The study conducted
by us to date was inconclusive regarding the usefulness or effectiveness of
the
strains in treating GI diseases. Therefore, we have elected not to pursue this
project further at this time.
Prior
Clinical Studies
The
active ingredient in
PROBACTRIX®
has
undergone testing by more than 14,000 patients in controlled trials as well
as
case study reports and has demonstrated safety and efficacy in adults and
children as young as six months old. The product has demonstrated effectiveness
in a broad range of GI diseases and conditions including IBS, IBD, pouchitis,
Crohn’s disease, ulcerative colitis and diarrhea caused by antibiotics,
chemotherapy and travel.
Two
clinical studies conducted independently at Cedars-Sinai Medical Center showed
the link between IBS symptoms and pathogenic bacteria and support the rationale
for the use of
PROBACTRIX®
as
an
effective treatment for IBS.
Clinical
studies conducted in Israel indicate that
PROBACTRIX®
is
effective at addressing various GI symptoms in both male and female patients
with no significant side effects. Patients typically reported a marked reduction
in abdominal symptoms. Two pilot studies have been completed in Israel with
the
current formulation. The first was an open label study conducted on 63 patients
with IBS, who were unresponsive to other therapies, and 20 patients with Crohn’s
disease. After four to six weeks of therapy, 52% of the IBS patients had an
excellent response, 35% and 30% of the Crohn’s disease patients had an excellent
and partial response, respectively, and no adverse events were
observed.
An
open-label trial, examining the impact of
PROBACTRIX®
on
patients with Crohn’s disease, reported that three of the eight patients
experienced a marked reduction in abdominal symptoms, two dropped out, two
experienced no improvement and one experienced a worsening of
symptoms.
A
randomized, double blind pilot study conducted by Tiomny, et. al. in 2003
reported that
PROBACTRIX®
relieved
major symptoms of IBS with no significant side effects. This study involved
20
patients, who were experiencing severe symptoms of diarrhea and constipation
with a mean duration of eight years. Eight of the ten patients in the placebo
group withdrew from the study due to lack of response. All ten patients in
the
treatment group completed the study. The treatment group experienced significant
improvement in IBS symptom relief with no significant side effects.
We
have
completed a randomized, multi-center double blind, placebo-controlled, clinical
trial in IBS patients to study the effectiveness of
PROBACTRIX®
as
a
medical food. Sites for this study include Cornell Medical Center in New York
City, St. Michael’s Hospital in Toronto, Canada, Bikur Cholim Hospital in
Jerusalem, Israel, and Sourasky Medical Center in Tel Aviv, Israel. This data
is
currently undergoing statistical analysis.
In
September 2007, BioBalance completed an international, multi-center, randomized,
double-blind, placebo-controlled, clinical trial in 129 patients with irritable
bowel syndrome. PROBACTRIX® was well tolerated. There were more placebo-treated
patients who experienced at least one adverse event and who experienced at
least
one adverse event related to study product (46 and 15, respectively) than did
PROBACTRIX® -treated patients (39 and 10, respectively). This study demonstrated
the safety of PROBACTRIX® when given for long periods of time and is consistent
with other studies that BioBalance has conducted to assess product safety.
Despite the unexpected high placebo response rate and its negative impact on
the
study's primary endpoint, BioBalance remains encouraged by the strong
improvements in stool consistency, pain and discomfort, bloating, and stool
frequency compared to baseline. BioBalance is investigating the use of higher
concentrations of the probiotic and plans to review the data derived from the
irritable bowel syndrome study as a knowledge base for new studies in order
to
target indications which the company believes on-going research
supports.
Veterinary
Application
Numerous
clinical studies have been conducted in farm animals to support the use
of
PROBACTRIX®
as
a
veterinary feed additive to replace antibiotics and/or animal growth hormones.
BioBalance believes that enough safety and efficacy data accumulated presents
an
attractive opportunity for licensing to leading animal health companies.
BioBalance has directed its efforts toward human clinical studies and has not
pursued licensing to animal health companies up to this point. Veterinary
experts believe that repeated applications of antibiotics often leave animals
weak and growth retarded. BioBalance believes that
PROBACTRIX®
has
a
particularly high safety and efficacy profile in many different animal species.
There are already probiotic products used today in the veterinary market but
lack well-designed scientific studies. Significantly,
PROBACTRIX®
has
been
studied for its use in preventing bacterial diarrhea in piglets and as a
replacement for gentamycin and Advocin, which are most often used to treat
diarrhea in these animals. We cannot provide any assurance that we will ever
license a veterinary formulation of
PROBACTRIX®
as
a
veterinary feed additive.
MANUFACTURING
During
2005, BioBalance transferred the manufacturing process of
PROBACTRIX®
to
Benchmark Biolabs, Inc. for pilot-lab production of clinical trial materials
in
a state-of-the-art facility located in Lincoln, Nebraska. BioBalance has not
yet
committed for commercial production of
PROBACTRIX®
,
since
it will likely rely on a marketing/licensing partner for production. The process
for growing
E.
coli
and
formulating the bacteria into a probiotic agent requires specialized
fermentation facilities maintained and operated under FDA laboratory and good
manufacturing procedure (“GMP”) requirements as a prescription drug
product.
INTELLECTUAL
PROPERTY
BioBalance
uses a combination of patents, trademarks and trade secrets to protect its
core
technology. We have 14 patents issued in the U.S. and two patent applications
filed and pending. The patent expiration dates range from 2020 to 2023. It
has
also filed patent applications covering application of its core technology
in
Japan, European, Canada, Australia, Mexico, Brazil, Poland, Russia and New
Zealand. BioBalance is also pursuing additional patent applications relating
to
its core technology. On March 1, 2005, it received notification that
PROBACTRIX®
was
approved as a registered U.S. trademark.
At
December 31, 2007, management determined that the value of the PROBACTRIX®
intellectual property was partially impaired due to the unusually high placebo
response rate in the clinical trial related to the irritable bowel syndrome
("IBS") indication. While management believes that further testing may prove
the
efficacy of PROBACTRIX® for that indication, further clinical trials would
require substantial additional funding which is currently unavailable.
Accordingly, management recorded an impairment loss of
$729,792
against
the intellectual property. The remaining carrying value after recording the
impairment loss was
$628,056
,
representing the net carrying amount of the patents and trademarks.
BioBalance
also previously acquired the global patent rights to a combination of two
patented Bacillus strains (
B.
subtilis
and
B.
licheniformis
)
(”NexGen Product Platform”) for $3,850,000 which included a one-time cash
payment of $250,000 and one million shares of Common Stock of the Company valued
at $3,600,000. See “Bacillus Product” above. At December 31, 2004 it was
determined that the investment in the NexGen Product Platform was impaired
and
as a result of the impairment analysis, a total of $1,740,326 was expensed
during the fourth quarter of 2004. The impairment was determined by an
independent valuation firm using a discounted cash flow model. At the time,
the
impairment was felt necessary due to a number of factors including the
acceleration of the Company’s efforts to obtain regulatory approval and take
other action necessary to market
PROBACTRIX®
as
a
prescription product, overall limited funding available to the Company to
develop the Bacillus product and available management time.
At
December 31, 2006, management determined that the value of the NexGen Product
Platform was impaired in its entirety due to inconclusive testing results.
While
management believes that further testing may prove the safety and efficacy
of
the NexGen Product Platform, a decision was made to devote all efforts and
funds
towards the development and clinical trials of PROBACTRIX® , if, as and when
further funding is received or a strategic partner joins the Company.
Accordingly, management recorded an impairment loss of $926,322 (intellectual
property $334,787; patents and trademarks $341,285 and; non-compete agreement
$250,250) representing the entire unamortized balance of the NexGen Product
Platform and has discontinued any further testing or development of the NexGen
product platform.
BIOBALANCE
EMPLOYEES
The
only
employees of BioBalance are the Company's two part-time executive officers,
Murry Englard, CEO and Stewart W. Robinson, CFO, who divide their time between
BioBalance and the home health care business as needed. BioBalance outsources
most of its clinical and regulatory needs through the use of part-time or
consultants. While BioBalance has no definitive plans with respect to the
ultimate size of its workforce or persons who will fill specific positions,
BioBalance plans to evaluate its staffing needs relative to research and
development, product manufacturing and marketing and finance and administration
and will seek to retain personnel as employees or consultants based on that
evaluation.
HOME
HEALTH CARE BUSINESS
Overview
We
provide a broad range of home health and personal care support services in
capacities ranging from companions to live-ins, including assistance with
personal hygiene, dressing and feeding, meal preparation, light housekeeping
and
shopping and, to a limited extent, physical therapy and standard skilled nursing
services such as the changing of dressings, injections and administration of
medications.
Our
services are provided principally by our staff of professionals and
paraprofessionals (some are bilingual), who provide personal care to patients,
and, to a lesser extent, by our staff of skilled nurses. Approximately 99%
of
our home health revenues in 2007 were attributable to services by our
paraprofessional staff.
We
are
approved by New York State Department of Health for the training and
certification of Home Health Aides and Personal Care Aides. In order to provide
a qualified and reliable staff, we continuously recruit, train, provide
continuing education for, and offer benefits and other programs to encourage
retention of, our staff. Recruiting is conducted primarily through advertising,
direct contact with community groups, employment programs, and the use of
benefits programs designed to encourage new employee referrals by existing
employees.
Organization
and Operations
We
operate 24 hours a day, seven days a week, to receive referrals and coordinate
services with physicians, case managers, patients and their families. Services
are provided through one principal office, five branch offices and one
recruitment and training office. Each office is typically staffed with an
administrator/branch manager, director of nursing, nursing supervisor, home
care
coordinators, clerical staff and nursing services staff.
Our
principal office retains functions necessary to ensure quality of patient care
and to maximize financial efficiency. Services performed at the principal office
include billing and collection, quality assurance, financial and accounting
functions, policy and procedure development, system design and development,
corporate development and marketing. We use financial reporting systems through
which we monitor data for each branch office, including collections, revenues
and staffing. Our systems also provide monthly, financial comparisons to prior
periods and comparisons among our branch offices.
Referral
Sources
We
obtain
patients primarily through contracts, referrals from hospitals, community-based
healthcare institutions and social service agencies, case management and
insurance companies. Referrals from these sources accounted for substantially
all of our net revenues in 2007. We generally conduct business with most of
our
institutional referral sources under one-year contracts that fix the rates
and
terms of all referrals but do not require that any referrals be made. Under
these contracts, the referral sources refer patients to us and we bill the
referral sources for services provided to patients. Approximately 60 such
contracts were in effect and active as of December 31, 2007.
One
or
more referring institutions have accounted for more than 5% of our net revenues
during our last fiscal year, as set forth in the following table:
Referring
Institution
|
|
Percentage
of Net Revenues for 2007
|
|
|
|
New
York City Medicaid (HRA)
|
|
56.1%
|
Guildnet
Inc.
|
|
5.4%
|
Beth
Abraham Long Term Home Health Program
|
|
6.8%
|
Overall,
our 10 largest referring institutions accounted for approximately
88.5%
of net
revenues for 2007.
Days
Sales Outstanding (“DSO”) is a measure of the average number of days required
for the Company to collect accounts receivable, calculated from the date
services are billed. For the year ended December 31, 2007 the Company's DSO
were
68
.
Reimbursement
We
are
reimbursed for services, primarily by referring institutions, such as healthcare
institutions and social service agencies, which in turn receive their
reimbursement from Medicaid, Medicare and, to a much lesser extent, through
direct payments by insurance companies and private payers. New York State
Medicaid programs constitute our largest reimbursement sources, when including
both direct Medicaid reimbursement and indirect Medicaid payments through many
of our referring institutions. For 2007, payments from referring institutions
that receive direct payments from Medicare and Medicaid, together with direct
reimbursement to us from Medicaid, accounted for approximately 99% of net
revenues. Direct reimbursements from private insurers, prepaid health plans,
patients and other private sources accounted for approximately 1% of net revenue
for 2007.
The
New
York State Department of Health, in conjunction with local Departments of Social
Services, sets annual reimbursement rates for patients covered by Medicaid.
These rates are generally established on a county-by-county basis, using a
complex reimbursement formula applied to cost reports filed by
providers.
Third
party payers, including Medicaid, Medicare and private insurers, have taken
extensive steps to contain or reduce the costs of healthcare. These steps
include reduced reimbursement rates, increased utilization review of services
and negotiated prospective or discounted pricing and adoption of a competitive
bid approach to service contracts. Home-based healthcare, which is generally
less costly to third party payers than hospital-based care, has benefited from
many of these cost containment measures.
We
negotiate contracts on the basis of services to be provided, in connection
with
contracts either currently in effect with us or with other agencies. Prevailing
market conditions are such that, despite escalating operating expenses, third
party payers are negotiating at the same or reduced contract rates are regularly
negotiated as a result of internal budget restraints and reductions mandated
by
managed care contracts between our clients and HMO's and other third party
administrators. While we anticipate that this trend is likely to continue for
the foreseeable future, we do not expect the impact on the Company to be
significant, since we believe our rates are competitive. Accordingly, we expect
to be subject to only minor rate reductions. However, as expenditures in the
home healthcare market continue to grow, initiatives aimed at reducing the
costs
of healthcare delivery at non-hospital sites are increasing. A significant
change in coverage or a reduction in payment rates by third party payers,
particularly by New York State Medicaid, would have a material adverse effect
upon our home healthcare business.
Performance
Improvement
We
believe that our reputation for quality patient care has been and will continue
to be a significant factor in our success. To this end, we have established
a
performance improvement management program, including a performance improvement
program to ensure that our service standards are implemented and that the
objectives of those standards are met.
We
believe that we have developed and implemented service standards that comply
with or exceed the service standards required by the Joint Commission on
Accreditation of Healthcare Organizations (“JCAHO”). In May 2006, the New York
offices of the Company received full accreditation from the Joint Commission;
this accreditation expires in September 2009.
Sales
and Marketing
Each
administrator/branch manager is responsible for sales activities in the branch
office's local market area. We attempt to cultivate strong, long-term
relationships with referral sources through high quality service and education
of local healthcare personnel about the appropriate role of home healthcare
in
the clinical management of patients.
Government
Regulation
The
federal government and the State of New York where we operate, regulate various
aspects of our business. Changes in the law or new interpretations of existing
laws can have a material adverse effect on permissible activities of the
Company, the relative costs associated with doing business and the amount of
reimbursement by government and other third-party payers.
We
are
licensed by New York State as a home care services agency. New York State law
requires prior approval by the New York State Public Health Council ("Council")
of any transfer of 10% or more of the stock or voting rights of a corporation
or
any transfer which results in ownership of 10% or more of the stock or voting
rights of a corporation, or any other change in "the controlling person" of
an
operator of a licensed home care services agency ("LHCSA"). Control of an entity
is presumed to exist if any person owns, controls or holds the power to vote
10%
or more of the voting securities of the LHCSA. A person seeking approval as
a
controlling person of a LHCSA, or of an entity that is the operator of a LHCSA,
must, in most cases, file an application and receive Council approval prior
to
becoming a controlling person.
We
are
subject to federal and state laws prohibiting payments for patient referrals
and
regulating reimbursement procedures and practices under Medicare, Medicaid
and
other health care benefit programs. The federal Medicare and Medicaid
legislation contains anti-kickback provisions, which prohibit any remuneration
in return for the referral of Medicare and Medicaid patients or for purchasing
or leasing equipment or services that are paid for in whole or in part by
Medicare or Medicaid. Courts have, to date, interpreted these anti-kickbacks
laws to apply to a broad range of financial relationships. Violations of these
provisions may result in civil and criminal penalties, including fines of up
to
$15,000 for each separate service billed to Medicare or Medicaid in violation
of
the anti-kickback provisions, exclusion from participation in the Medicare
and
state health programs such as Medicaid and imprisonment for up to five
years.
The
Medicare and Medicaid anti-kickback provisions of the Social Security Act are
broadly worded and often vague, and the future interpretation of these
provisions and their applicability to our operations cannot be fully predicted
with certainty. Any non-compliance or violation could have a material adverse
effect on our home healthcare business.
Federal
laws to which we are subject also include the broadly worded fraud and abuse
provisions of the Social Security Act that are applicable to the Medicare and
Medicaid programs, which prohibit various transactions involving Medicare or
Medicaid covered patients or services and the Health Insurance Portability
and
Accountability Act of 1996 (“HIPAA”), which is applicable to both public and
private health care programs. Among other things, these provisions restrict
referrals by physicians for certain designated health services, including home
health care, to entities with which the physician or the physician's immediate
family member has a "financial relationship" and the receipt of remuneration
by
anyone in return for, or to induce, the referral of a patient for treatment
or
purchasing or leasing equipment or services that are paid for, in whole or
in
part, by Medicare or Medicaid. They also prohibit false statements, false
billings and fraudulent conduct. Violations of these provisions may result
in
civil or criminal penalties for individuals or entities and/or exclusion from
participation in the Medicare and Medicaid programs. The future interpretation
of these provisions and their applicability to our operations cannot be
predicted.
New
York
also has statutes and regulations prohibiting payments for patient referrals
and
other types of financial arrangements with healthcare providers that, while
similar in many respects to the federal legislation, are often vague and have
infrequently been interpreted by courts or regulatory agencies. Sanctions for
violation of these state restrictions may include loss of licensure and civil
and criminal penalties.
We
believe that our operations, in general, comply in all material respects with
applicable federal and state anti-kickback laws, and that we will be able to
arrange our future business relationships so as to comply with the fraud and
abuse provisions.
Management
believes that the trend of federal and state legislation is to subject the
home
healthcare and nursing services industry to greater regulation and enforcement
activity, particularly in connection with third-party reimbursement and
arrangements designed to induce or encourage the referral of patients to a
particular provider of medical services. We attempt to be responsive to such
regulatory climate. However, we are unable to accurately predict the effect,
if
any, of such increased regulatory or enforcement activities on our future
results of operations.
In
addition, we are subject to laws and regulations which relate to business
corporations in general, including antitrust laws, occupational health and
safety laws, and environmental laws (which relate, among other things, to the
disposal, transportation and handling of hazardous and infectious wastes).
To
date, none of these laws and regulations has had a material adverse effect
on
our home healthcare business or the competitive position of such business or
required any material expenditure by us. We cannot assure that we will not
be
adversely affected by such laws and regulations in the future.
We
cannot
accurately predict what additional legislation, if any, may be enacted in the
future relating to our business or the healthcare industry, including
third-party reimbursement, or what affect any such legislation may have on
us.
We
have
never been denied any home healthcare license we have sought to obtain. We
believe that our home healthcare operations are in material compliance with
all
applicable state and federal regulations and licensing
requirements.
Competition
The
home
healthcare market is highly fragmented and significant competitors are often
localized in particular geographical markets. Our largest competitors include
Premiere Health Services, National Home Health Care Corp., Patient Care, Inc.,
and Personal Touch Home Care Services, Inc. The home healthcare business is
marked by low entry costs so that, given the increasing level of demand for
nursing services, significant additional competition can be expected to develop
in the future. Some of the companies with which we presently compete in home
healthcare have substantially greater financial and human resources than we
do.
We also compete with many other small temporary medical staffing
agencies.
We
believe that the principal competitive factors in our industry are quality
of
care, including responsiveness of services and quality of professional
personnel; breadth of therapies and nursing services offered; successful
referrals from referring Government agencies, hospitals and health maintenance
organizations; general reputation with physicians, other referral sources and
potential patients; and price. We believe that our competitive strengths have
been the quality, responsiveness, flexibility and breadth of services and staff
we offer, and to some extent our competitive pricing, as well as our reputation
with referral sources and patients.
The
United States healthcare industry generally faces a shortage of qualified
personnel. Accordingly, we experience intense competition from other companies
in recruiting healthcare personnel for our home healthcare operations. Our
success to date has depended, to a significant degree, on our ability to recruit
and retain qualified healthcare personnel. Most of the registered and licensed
nurses and healthcare paraprofessionals who we employ are also registered with,
and may accept placements from time to time through, our competitors. We believe
we are able to compete for nursing and paraprofessional personnel by recruitment
through newspaper advertisements, work fairs/job fairs, flexible work schedules
and competitive compensation arrangements. We cannot assure you, however, that
we will be able to continue to attract and retain sufficient qualified
personnel. The inability to either attract or retain such qualified personnel
would have a material adverse effect on our business.
HOME
HEALTH CARE EMPLOYEES
At
March
9, 2008, our home healthcare business had 1,460 employees, of whom sixty four
are salaried, including one division officer, a controller, a vice president
of
operations, a human resources administrator, an IT specialist, seven
administrators/branch managers, nine nurses, three accounting staff, eighteen
clerical staff, and twenty two field staff supervisors. The remaining 1,396
employees are paid on an hourly basis and consist of professional and
paraprofessional staff.
None
of
our home healthcare or BioBalance employees are compensated on an independent
contractor basis or represented by a labor union. A local labor union has been
attempting to organize the Company's home care health aides. The local union
recently withdrew its request from the labor board to initiate a vote.
Management believes that the Company has good relations with its employees.
Item
1A.
RISK
FACTORS
THE
COMPANY OPERATES IN A CHANGING ENVIRONMENT THAT INVOLVES NUMEROUS KNOWN AND
UNKNOWN RISKS AND UNCERTAINTIES THAT COULD MATERIALLY AND ADVERSELY AFFECT
ITS
OPERATIONS. THE FOLLOWING HIGHLIGHTS SOME OF THE FACTORS THAT HAVE AFFECTED,
AND/OR IN THE FUTURE COULD AFFECT, ITS OPERATIONS.
Risks
Relating to the BioBalance Business
BIOBALANCE
IS A DEVELOPMENT STAGE COMPANY, HAS GENERATED NO REVENUES TO DATE AND HAS A
LIMITED OPERATING HISTORY UPON WHICH IT MAY BE EVALUATED
.
BioBalance
was incorporated in May 2001, has generated no revenues from operations, and
has
no meaningful assets other than its intellectual property rights and $38,000
in
available cash at December 31, 2007. BioBalance faces all of the risks inherent
in a new business and those risks specifically inherent in the business of
developing, testing, obtaining regulatory approvals for, manufacturing,
commercializing and selling a new prescription drug product, with all of the
unforeseen costs, expenses, problems, and difficulties to which such ventures
are subject. We cannot assure you that BioBalance will be able to generate
revenues or profits from operation of its business or that BioBalance will
be
able to generate or sustain profitability in the future.
FAILURE
TO SECURE ADDITIONAL FINANCING WOULD RESULT IN IMPAIRED GROWTH AND INABILITY
TO
OPERATE.
BioBalance
will be required to expend substantial amounts of working capital in order
to
develop, test, obtain the requisite regulatory approvals, manufacture and market
its proposed product and establish the necessary relationships to implement
its
business plan. At December 31, 2007, BioBalance had available cash in the amount
of $38,000. For the year ended December 31, 2007, BioBalance’s operations were
funded entirely by capital from the Company’s health care operations. BioBalance
is entirely dependent on existing cash, working capital from the health care
operations, and its ability to attract and receive additional funding from
either the sale of securities or outside sources such as private investment
or a
strategic partner. See “Recent Developments”. If BioBalance fails to obtain
additional financing, BioBalance's clinical and regulatory programs will need
to
be further scaled back, suspended or cancelled. BioBalance has no firm
agreements or arrangements with respect to any such financing and we cannot
assure you that any needed funds will be available to BioBalance on acceptable
terms or at all. The inability to obtain sufficient funding of BioBalance’s
operations in the immediate future could cause BioBalance to curtail or cease
its operations.
THE
LOSS OF KEY EXECUTIVES OR CONSULTANTS OR THE FAILURE TO HIRE QUALIFIED EMPLOYEES
WOULD DAMAGE OUR BUSINESS
Because
of the highly technical nature of our BioBalance business, we depend greatly
on
attracting and retaining experienced management and highly qualified and trained
scientific personnel.
As
previously reported by the Company in its Form 8-K filed with the Securities
and
Exchange Commission on September 12, 2006, Mr. Dennis O'Donnell, the Company's
President and Chief Executive Officer, acting Principal Financial Officer and
a
director, resigned from all of his positions with the Company effective
September 8, 2006. Although the Board has not selected a permanent replacement
for Mr. O'Donnell, Mr. Murry Englard is presently serving in the capacity of
Chief Executive Officer and Mr. Stewart Robinson as Principal Financial Officer.
The Board believes that the part-time participation of these executive officers
is sufficient for the Company at its present size and form. Should the Board
determine at a later date that these executive positions should be filled by
full-time employees, there can be no assurance that the Company will be able
to
obtain the services of a qualified Chief Executive Officer or Chief Financial
Officer in the near term, particularly in light of BioBalance's current
financial situation, as discussed above under the risk factor “Failure to Secure
Additional Financing Would Result in Impaired Growth and Inability to
Operate.”
We
compete with other companies intensely for qualified and well trained
professionals in our industry. If we cannot hire or retain, and effectively
integrate, a sufficient number of qualified scientists and experienced
professionals, this will have a material adverse effect on our capacity to
sustain and grow our business and develop our products through the clinical
trial process and otherwise.
THE
UNILATERAL RESCISSION OF THE EMERALD SETTLEMENT AGREEMENT MAY RESULT IN FUTURE
LITIGATION
The
Company reported in the Company's Form 8-K filed on August 21, 2006 that the
Company had unilaterally rescinded the settlement between the Company and
Emerald Asset and Yitz Grossman. The settlement agreement was originally entered
into as reported in the Company's Form 8-K filed on March 6, 2006, and the
related liability was recorded on the books of the Company at December 31,
2005,
in the amount of $1,545,000. The rescission of the settlement by the Company
was
done without the consent of Emerald Asset and Yitz Grossman. Accordingly there
may be future litigation brought against the Company by Emerald Asset and Yitz
Grossman to seek enforcement of the agreement. The Company continues to retain
the accrual for the settlement agreement on its books in its entirety. If there
is litigation brought by Emerald Asset and Yitz Grossman to enforce the
settlement agreement, there can be no assurance that at a future time the
accrual that was recorded would be sufficient to offset amounts resulting from
the future litigation.
BIOBALANCE’S
PRODUCTS ARE IN DEVELOPMENT AND MAY NOT SATISFY REGULATORY REQUIREMENTS OR
BECOME COMMERCIALLY VIABLE
.
The
products that we are currently developing will require additional development,
testing, and investment in order to market them as prescription drugs. We cannot
be sure that our product research and development efforts will be successful,
that candidates will enter clinical studies as anticipated, that we will satisfy
Good Laboratory Procedures (“GLP”), medical food or prescription drug
requirements or that any required regulatory approvals will be expeditiously
applied for or obtained, or that any products, if introduced, will be
commercially successful. We have conducted anecdotal and pre-clinical trials
and
are conducting an IBS medical food clinical trial for our initial product and
have established GRAS (Generally Recognized As Safe) status to date. The results
of these pre-clinical and anecdotal trials on products under development are
not
necessarily predictive of results that will be obtained from large scale
clinical testing. We cannot be sure that clinical trials of the products under
development will demonstrate the safety and efficacy of such products or will
result in a marketable product. In addition, the administration alone or in
combination with drugs of any product developed by BioBalance may produce
undesirable side effects in humans. The failure to demonstrate adequately the
safety and efficacy of a therapeutic drug product under development could delay
or prevent regulatory approval, where required, and delay or prevent commercial
sale of the product, any of which could have a material adverse effect on
BioBalance. We may encounter difficulties in manufacturing, process development
and formulation activities that could result in delays in clinical trials,
regulatory submissions, regulatory approvals and commercialization of our
product, or cause negative financial and competitive consequences. We cannot
assure you that
PROBACTRIX®
or
any
other product will be successfully developed, be developed on a timely basis
or
prove to be more effective than competing products based on existing or newly
developed technologies. The inability to successfully complete development,
or a
determination by us, for financial or other reasons, not to undertake to
complete development of
PROBACTRIX®
or
any
other product, particularly in instances in which we have made significant
capital expenditures, could have a material adverse effect on us.
POTENTIAL
FAILURE OF PLANNED CLINICAL TRIALS TO PRODUCE STATISTICALLY SIGNIFICANT DATA
COULD IMPAIR OUR ABILITY TO OBTAIN REGULATORY APPROVAL AND DEVELOP, MANUFACTURE
AND SUCCESSFULLY MARKET OUR PRODUCTS
.
There
still is substantial risk that the studies that we are planning will not yield
sufficient statistically significant data to make strong marketing claims.
This
could impede our ability to obtain FDA approval for our products and, even
if
approval is obtained, would adversely affect marketing efforts to the medical
community, which is traditionally resistant to new treatments unless supported
by statistically significant data before recommending it to
patients.
WE
ARE DEPENDENT ON NEW PRODUCTS AND CONTINUED INNOVATION
.
The
pharmaceutical industry in general, including the market for GI treatments,
is
characterized by rapid innovation and advances. These advances result in
frequent product introductions and short product life cycles, requiring a high
level of expenditures for research and development and the timely introduction
of new products. We believe our ability to grow and succeed is partially
dependent upon our ability to introduce new and innovative products into such
markets. We cannot assure you that we will be successful in our plans to
introduce additional products to the market or expand our current label
indications.
INTELLECTUAL
PROPERTY RIGHTS MAY NOT PROTECT OUR BUSINESS
.
We
use a
combination of patents, trademarks and trade secrets to protect our proprietary
position on
PROBACTRIX®
.
We
cannot assure you that our pending or future patent and trademark registration
applications will result in issued patents and registered trademarks, or that,
if issued, our applications will be upheld if challenged. Further, even if
granted, we cannot assure you that these patents and trademarks will provide
us
with any protection from competitors or, that if they do provide any meaningful
level of protection, that we will have the financial resources necessary to
enforce our patent and trademark rights. In addition, we cannot assure you
that
others will not independently develop technologies similar to those covered
by
our pending patents and trade secrets, or design around the pending patents.
If
others are able to design around our patents, our results of operations could
be
materially adversely affected. Further, we will have very limited, if any,
protection of our proprietary rights in those jurisdictions where we have not
affected any filings or where we fail to obtain protection through our filings.
We cannot assure you that third parties will not assert intellectual property
infringement claims against us in the future with respect to current or future
products. We are responsible for defending against charges of infringement
of
third party intellectual property rights by our actions and products and such
assertion may require us to refrain from the sale of our products, enter into
royalty arrangements or undertake costly litigation. Further, challenges may
be
instituted by third parties as to the validity, enforceability and infringement
of our patents. Our adherence to industry standards with respect to our product
may limit our opportunities to provide proprietary features which may be
protected. In addition, the laws of various countries in which our product
may
be sold may not protect our product and intellectual property rights to the
same
extent as the laws of the United States.
THE
VALIDITY OF PATENTS COVERING PHARMACEUTICAL AND BIOTECHNOLOGICAL INVENTIONS
AND
THE SCOPE OF INTELLECTUAL PROPERTY CLAIMS MADE UNDER SUCH PATENTS IS UNCERTAIN;
FAILURE TO SECURE NECESSARY PATENTS COULD IMPAIR OUR ABILITY TO PRODUCE AND
MARKET OUR PRODUCTS
.
There
is
no consistent policy regarding the breadth of intellectual property claims
permitted in specialty pharmaceutical and biotechnology patents. In addition,
patents may have been granted, or may be granted, to others covering products
or
processes that we need, or may need, for testing and developing our products.
If
our products or processes infringe upon patents held by third parties, or
otherwise impermissibly utilize the intellectual property of others, we might
be
unable to develop, manufacture, or sell our products. In such event, we may
be
required to obtain licenses to from third parties to use such intellectual
property. We cannot be sure that we will be able to obtain such licenses on
acceptable terms, or at all.
FAILURE
TO DEVELOP, OR CONTRACT FOR, AN ADEQUATE SALES AND MARKETING ORGANIZATION,
OR
PARTNER WITH A LARGER PHARMACEUTICAL COMPANY WOULD RESULT IN THE INABILITY
TO
MARKET AND SELL OUR PRODUCT.
To
market
any of our products directly, we would have to develop a substantial marketing
and sales force. Alternatively, we may, for certain products, attempt to obtain
the assistance of larger pharmaceutical companies with established distributions
systems and direct sales forces. We do not know if we will be able to enter
into
agreements with other companies to assist in the marketing and sales of our
products. If we are not able to sustain such marketing efforts, we may license
marketing rights to a third party. However, we cannot be sure that we would
be
able to locate a qualified marketer or distributor or enter into any such
agreement on reasonable terms or at all.
WE
OWN NO MANUFACTURING FACILITIES AND WILL BE DEPENDENT ON THIRD PARTIES TO MAKE
OUR PRODUCT
.
We
own no
manufacturing facilities or equipment, and employ no manufacturing personnel.
We
expect to use third parties to manufacture certain of our products on a contract
basis. We may not be able to obtain contract-manufacturing services on
reasonable terms or at all. If we are not able to contract manufacturing
services, we will not be able to make our products.
WE
WILL BE REQUIRED TO COMPLY WITH GOOD MANUFACTURING
PRACTICES
.
The
manufacture of our proposed products will be subject to current Good
Manufacturing Practices ("GMP") prescribed by the FDA in the United States.
We
cannot give assurance that we or any entity manufacturing products on our behalf
will be able to comply with GMP or satisfy certain regulatory inspections in
connection with the manufacture of our proposed products. Failure or delay
by
any manufacturer of our products to comply with GMP or similar regulations
or
satisfy regulatory inspections would have a material adverse effect on
us.
POTENTIAL
SIDE EFFECTS OF OUR PRODUCT COULD IMPAIR OUR ABILITY TO CONTINUE CLINICAL
TRIALS, OBTAIN REGULATORY APPROVAL, OR SUCCESSFULLY MARKET OUR
PRODUCTS
.
Although
no significant side effects of our products have been demonstrated, it is
possible that, any time during clinical trials or patient usage, side effects
may be encountered. If they are common enough or significant enough, this could
result in the termination of our clinical trials, denial of FDA approval, the
inability to market and sell our products, our products being withdrawn from
the
market, or liability claims being asserted against us.
OUR
PRODUCTS MAY NOT BE ACCEPTED BY PHYSICIANS, PATIENTS OR THIRD PARTY
PAYERS
.
Patients,
doctors and third-party payers must accept our products as medically useful
and
cost-effective for us to be successful. Doctors and patients are very important
constituents because they directly make all medical decisions. Third party
payers are also very important because they pay for a major portion of all
medical care expenses. Third party payers consist of health maintenance
organizations (“HMOs”), health insurers, managed care providers, Medicare and
Medicaid, and their equivalent organizations in jurisdictions outside the U.S.
In order to achieve our sales targets in the jurisdictions in which we intend
to
sell our products, we must educate patients, doctors and third-party payers
on
the benefits of our products. We cannot assure you that patients, doctors or
third-party payers will accept our products, even if approved for marketing,
on
a timely basis.
GOVERNMENT
AND PRIVATE INSURANCE PLANS MAY NOT PAY FOR OUR PRODUCTS
.
The
success of our products in the United States and other significant markets
will
depend, in part, upon the extent to which a consumer will be able to obtain
reimbursement for the cost of such product from governmental authorities,
third-party payers and other organizations. We cannot determine in advance
the
reimbursement status of newly approved therapeutic products. Even if a product
is approved for marketing, we cannot be sure that adequate reimbursement will
be
available. Also, future legislation or regulation, or related announcements
or
developments, concerning the healthcare industry, or third party or governmental
coverage and reimbursement, may adversely affect our business. In particular,
legislation or regulation limiting consumers' reimbursement rights could have
a
material adverse effect on our business and revenues.
WE
MAY LOSE ANY TECHNOLOGICAL ADVANTAGE BECAUSE PHARMACEUTICAL RESEARCH
TECHNOLOGIES CHANGE RAPIDLY
.
The
pharmaceutical research field is characterized by rapid technological progress
and intense competition. As a result, our business strategy may not be
successful and our products may not reach the marketplace or be saleable
Businesses, academic institutions, governmental agencies, and other public
and
private research organizations, are conducting research to develop technologies
that may compete with those of BioBalance. It is possible that competitors
could
acquire or develop technologies that would render our technology obsolete or
noncompetitive. We cannot be certain that we will be able to access the same
technologies at an acceptable price, or at all.
WE
MAY NOT BE ABLE TO PROCURE REQUIRED INSURANCE COVERAGE.
We
will
need to procure liability insurance coverage required by clinical investigators,
patients and other third parties with respect to future clinical studies. There
can be no assurance that such coverage will be available to the Company or
that,
even if available, the Company will be able to bear the expense of such
insurance coverage. Absent such coverage, the Company will not be able to
perform required clinical studies.
WE
MAY BE SUBJECT TO PRODUCT LIABILITY CLAIMS WHICH COULD RESULT IN SIGNIFICANT
LOSSES AND ADVERSE PRODUCT PUBLICITY
.
BioBalance,
like any other manufacturer of products that are designed to be ingested, faces
an inherent risk of exposure to product liability claims and negative publicity
in the event that the use of its product results in injury. We face the risk
that materials used in the manufacture of the final product may be contaminated
with substances that may cause sickness or injury to persons who have used
the
products, or that sickness or injury to persons may occur if the product
distributed by us is ingested in dosages that exceed the dosage recommended
on
the product label. In the event that insurance coverage or contractual
indemnification is not adequate, product liability claims could have a material
adverse effect on our business. The successful assertion or settlement of any
uninsured claim, a significant number of insured claims, or a claim exceeding
any future insurance coverage, could have a material adverse effect on our
business. Additionally, we are highly dependent upon consumers' perception
of
the safety and quality of our product as well as similar products distributed
by
other companies. Thus, the mere publication of reports and negative publicity
asserting that our products, or similar products of others, may be harmful
could
have a material adverse effect on our business, regardless of whether such
reports are scientifically supported, regardless of whether the harmful effects
would be present at the dosages recommended for such products, and regardless
of
whether such adverse effects resulted from failure to consume the product as
directed.
INTENSE
COMPETITION MAY RESULT IN OUR INABILITY TO GENERATE SUFFICIENT REVENUES TO
OPERATE PROFITABLY
.
The
pharmaceutical industry is highly competitive. Numerous companies, many of
which
are significantly larger than us, and which have greater financial, personnel,
distribution and other resources than us and may be better able to withstand
volatile market conditions, will compete with us in the development, manufacture
and marketing of probiotics for the treatment of IBS or other GI disorders.
There can be no assurance that national or international companies will not
seek
to enter or increase their presence in the industry. In addition, large
nationally known companies (such as Novartis and GlaxoSmithKline) are in
competition with us in this segment, and they have already spent millions of
dollars to develop treatments for IBS or other GI disorders. Current or
increased competition could have a material adverse effect on our business,
as
many of our competitors have far greater financial and other resources and
possess extensive manufacturing, distribution and marketing capabilities far
greater than ours.
RISKS
RELATING TO THE HOME HEALTHCARE BUSINESS
RECENT
RULING REGARDING COMPANIONSHIP SERVICES EXEMPTION MAY IMPACT OUR ABILITY TO
PROVIDE HEALTHCARE SERVICES.
On
July
22, 2004, the federal Second Circuit Court of Appeals issued a ruling on the
applicability to paraprofessional field staff in New York of the Fair Labor
Standards Act “companionship services” exemption from minimum wage and overtime
requirements. Home care providers have long relied on this exemption to provide
compensation to home care aides and personal care workers with the expectation
that there is no obligation under federal laws for overtime pay. In September
2004, a request for a rehearing was submitted en banc for the full Court. On
January 13, 2005, the Court rejected the request for a rehearing on the
issue.
The
issue
was submitted to the Supreme Court and, on January 23, 2006, the Supreme Court
granted a writ of certiorari, vacated the judgment and remanded the case to
the
Second Circuit Court of Appeals to reconsider its decision in light of a
memorandum issued by the U.S. Department of Labor on December 1, 2005. In that
memo, the DOL stated that it considers its regulations allowing the
companionship exemption to be used by third party employers to be “authoritative
and legally binding”. The Second Circuit Court of Appeals reconsidered and, on
August 31, 2006, reaffirmed its decision. The Supreme Court again granted a
writ
of certiorari on January 5, 2007. In June 2007, the U.S. Supreme Court issued
its decision which upheld the "companionship exemption" as applying to
employment by "third party employers", e.g. home care agencies, such as New
York
Health Care. Based on this decision, federal law does not require payment of
premium wages for overtime, but New York State continues to require payment
of
one and one-half times the State minimum wage for overtime worked by employees
falling within the companionship exemption. Federal legislation has been
introduced that would limit the use of the companionship exemption to persons
employed “casually” as companions, i.e. to those who do not work full-time and
do not work for third-party employers such as New York Health Care. If this
legislation is enacted, challenges for the home care industry will be affording
higher overtime wages, ensuring patient continuity of care if agencies can
no
longer afford to authorize overtime, and retention of workers who cannot secure
the number of hours of work they desire. All of these factors may cause a higher
cost per hour serviced thereby adversely affecting profitability.
WE
ARE INDIRECTLY DEPENDENT UPON REIMBURSEMENT BY THIRD-PARTY PAYERS; HEALTHCARE
REFORM COULD REDUCE REVENUES
.
More
than
45% of our revenues are paid by Certified Home Health Agencies and Long-Term
Home Health Care Programs, as well as other clients who receive their payments
from "third-party payers," such as private insurance companies, self-insured
employers and HMOs. Our revenues and profitability, like those of other home
healthcare companies, are affected by the continuing efforts of third-party
payers to contain or reduce the costs of healthcare by lowering reimbursement
or
payment rates, increasing case management review of services, and negotiating
reduced contract pricing. Because home care is generally less costly than
hospital-based care, home nursing and home care providers have benefited from
cost containment initiatives aimed at reducing the costs of medical care.
However, as expenditures in the home healthcare market continue to grow, cost
containment initiatives aimed at reducing the costs of delivering services
at
non-hospital sites are likely to increase. A significant reduction in coverage
or payment rates of public or private third-party payers would reduce the
Company’s revenues and profit margins. While we are not aware of any substantive
changes in the Medicare or Medicaid reimbursement systems for home healthcare
which are about to be implemented, revised budget plans of New York State or
the
federal government could result in limitation or reduction in the reimbursement
of home care costs and in the imposition of limitations on the provision of
services which will be reimbursed. Moreover, third party payers, particularly
private insurance companies, may negotiate fee discounts and reimbursement
caps
for services we provide. These circumstances would have a material adverse
impact on our business.
SLOW
PAYMENTS AND POSSIBLE BAD DEBTS MAY CAUSE WORKING CAPITAL SHORTAGES AND
OPERATING LOSSES.
We
generally collect payments from our customers within one to three months after
services are rendered, but pay our obligations on a current basis. This timing
delay may cause working capital shortages from time to time. We have a secured
revolving credit facility. Such facility may be available to cover these
periodic shortages. However, borrowings or other methods of financing may not
be
available when needed or, if available, may not be on terms acceptable to us.
Although we have established a bad debt reserve for uncollectible accounts,
any
significant increase in bad debts would damage our revenues and
profitability.
PROFESSIONAL
LIABILITY INSURANCE MAY BECOME INADEQUATE, UNAVAILABLE OR TOO
COSTLY.
The
administration of home care and the provision of nursing services entail certain
liability risks. We maintain professional liability insurance coverage with
limits of $1,000,000 per claim and $3,000,000 annual aggregate, with an umbrella
policy providing an additional $5,000,000 of coverage. Although we believe
that
the insurance we maintain is sufficient for present operations, professional
liability insurance is increasingly expensive and sometimes difficult to obtain.
A successful claim against us in excess of, or not covered by, our insurance
could adversely affect our business and financial condition. Claims against
us,
regardless of their merit or eventual outcome, could also adversely affect
our
reputation and home healthcare business.
CHANGES
IN FEDERAL AND STATE REGULATION COULD INCREASE COSTS AND REDUCE
REVENUES.
Our
home
healthcare business is subject to substantial regulation at the state level
and
also under the federal Medicare and Medicaid laws. In particular, we are subject
to state laws regulating home care, nursing services, health planning and
professional ethics, as well as state and federal laws regarding fraud and
abuse
in government funded health programs. Changes in the law, or new interpretations
of existing laws, can increase the relative costs of doing business and reduce
the amount of reimbursement by government and private third-party payers.
Although we have not experienced any difficulties to date complying with
applicable laws, rules or regulations, our failure to obtain, renew or maintain
any required regulatory approvals or licenses could have a material adverse
effect on us and could prevent us from offering our existing services to
patients or from further expansion. Pending federal or State legislation could
substantially impact the conduct of our home healthcare business and potentially
adversely affect the cost of operations and available reimbursement. Under
the
pending legislation in New York, certain reporting requirements, as well as
caps
on permissible administrative expenses, would be imposed. If the pending
legislation becomes law in its current form, costs of operations of our home
healthcare business in New York are likely to increase. Under the pending
federal legislation, the federal companionship exemption would be eliminated
for
home care agencies, resulting in increased costs of operations.
INTENSE
COMPETITION COULD RESULT IN LOSS OF CLIENTS, LOSS OF PERSONNEL, REDUCED REVENUES
AND INABILITY TO OPERATE PROFITABLY
.
The
home
healthcare industry is marked by low entry costs and is highly fragmented and
competitive. We compete for personnel with hospitals and nursing homes, and
we
also compete for both personnel and business with other companies that provide
home healthcare services, most of which are large established companies with
significantly greater resources, access to capital and greater name recognition
than we have. Our principal business competitors include Premiere Health
Services, National Home Health Care Corp., Patient Care, Inc., and Personal
Touch Home Care Services, Inc. We also compete with many other small temporary
medical staffing agencies. Competition for qualified paraprofessional personnel
in the New York Metropolitan area is intense. We believe that, given the
increasing level of demand for nursing services, significant additional
competition can be expected to develop in the future and there are no assurances
that we will be able to remain competitive or profitable.
DEPENDENCE
ON MAJOR CUSTOMERS AND REFERRAL SOURCES MAY RESULT IN SUBSTANTIAL DECLINES
IN
REVENUES IF SUCH CUSTOMERS ARE LOST
.
The
development and growth of our home care and nursing businesses depends, to
a
significant extent, on our ability to establish close working relationships
with
hospitals, clinics, nursing homes, physician groups, HMO's, governmental
healthcare agencies and other healthcare providers. Many of our contractual
arrangements with customers are renewable annually. Existing relationships
may
not be successfully maintained and additional relationships may not be
successfully developed and maintained in existing and future markets. Our 10
largest customers accounted for approximately
88.5%
of gross
revenues during the year ended December 31, 2007. One referral source, New
York
City Medicaid, was responsible for approximately 56.1% of our gross revenues
for
the year ended December 31, 2007. The loss of, or a significant reduction in,
referrals by these sources, as well as certain other key sources, would have
a
material adverse effect on results of operations of our home healthcare
business.
RISKS
RELATING TO OUR COMMON STOCK
POSSIBLE
VOLATILITY OF COMMON STOCK MAY RESULT IN LOSSES TO
SHAREHOLDERS
.
The
trading price of our Common Stock has been subject to significant fluctuations,
and there is a limited market for our Common Stock. For the fiscal year 2007,
the price of our Common Stock has ranged from a high of $0.260 to a low of
$0.035. The price of our Common Stock is likely to continue to be affected
by
various factors, including, but not limited to, the results of our development
efforts of
PROBACTRIX®
and
other
products, variations in quarterly results of operations, announcements of new
contracts or services, or acquisitions by us or our competitors, governmental
regulatory action, general trends in the industry, and other factors, such
as
extreme price and volume fluctuations which have been generally experienced
by
the securities markets from time to time in recent years.
OUR
DELISTING FROM NASDAQ DUE TO OUR FAILURE TO SATISFY NASDAQ LISTING STANDARDS
AND
OUR STOCK BEING SUBJECT TO THE “PENNY STOCK” RULES HAS RESULTED IN REDUCED
LIQUIDITY AND LOWER STOCK PRICE
.
Our
Common Stock was delisted from the NASDAQ SmallCap market in April 2004 and
was
listed for trading in the OTC "pink sheets.” As of September 22, 2005, our
Common Stock has been listed for trading on the NASDAQ Bulletin Board which
provides significantly less liquidity than a securities exchange (such as the
American or New York Stock Exchange) or an automated quotation system (such
as
the NASDAQ National or Capital Market
)
. As a
result, the liquidity of our Common Stock is impaired, not only in the number
of
shares which can be bought and sold, but also through delays in the timing
of
transactions, reduction in security analysts' and news media's coverage, and
lower prices for our Common Stock than might otherwise be attained. There is
currently a very limited market and low volume of trading in our Common Stock,
and on many days there is no trading activity at all in our Common
Stock.
Moreover, because of the limited market and low volume of trading, our Common
Stock is more likely to be affected by and fluctuate from broad market
fluctuations, general market conditions, fluctuations in our operating results,
future securities offering by us, changes in the market’s perception of our
business, announcements made by us or our competitors, and general industry
conditions. Our Common Stock may not be accepted for a listing on an automated
quotation system or securities exchange.
In
addition, our Common Stock is subject to the low-priced security or so-called
"penny stock" rules that impose additional sales practice requirements on
broker-dealers who sell such securities. For any transaction involving a penny
stock, the rules require, among other things, the delivery, prior to the
transaction, of a disclosure schedule required by the SEC relating to the penny
stock market. The broker-dealer also must disclose the commissions payable
to
both the broker-dealer and the registered representative and current quotations
for the securities. Finally, monthly statements must be sent disclosing recent
price information for the penny stocks held in the customer's account. The
regulations relating to penny stocks could limit the ability of broker dealers
to sell our Common Stock and thus, the ability of shareholders to sell their
shares in the market.
FUTURE
ISSUANCES OR SALES OF OUR COMMON STOCK COULD ADVERSELY AFFECT THE MARKET PRICE
OF OUR COMMON STOCK AND OUR ABILITY TO RAISE ADDITIONAL
CAPITAL
.
We
have
previously issued a substantial number of shares of Common Stock, which are
eligible for resale under Rule 144 of the Securities Act, and which may become
freely tradable. We have registered, or agreed to register, a substantial number
of shares of Common Stock that are issuable upon the exercise of options and
warrants, or that were previously issued in private transactions. If holders
of
options or warrants choose to exercise their purchase rights and sell shares
of
Common Stock in the public market, or if holders of currently restricted shares
choose to sell such shares in the public market under Rule 144 or otherwise,
the
prevailing market price for the Common Stock may decline. Future public sales
of
shares of Common Stock may adversely affect the market price of our Common
Stock
or our future ability to raise capital by offering equity
securities.
ISSUANCE
OF PREFERRED STOCK COULD REDUCE THE VALUE OF COMMON STOCK AND COULD HAVE
ANTI-TAKEOVER EFFECTS.
We
are
authorized by our certificate of incorporation to issue up to 5,000,000 shares
of preferred stock, on terms which may be fixed by our board of directors
without further shareholder action. There are now no shares of preferred stock
issued and outstanding. The terms of any new series of preferred stock, which
may include priority claims to assets and dividends and special voting rights,
could adversely affect the rights of holders of the Common Stock. The issuance
of an additional series of preferred stock, depending upon the rights and
preferences of such series, could make the possible takeover of our company,
or
the removal of our management, more difficult, discourage hostile bids for
control of our company in which shareholders may receive premiums for their
shares of Common Stock, or otherwise dilute the rights of holders of Common
Stock and the market price of the Common Stock.
WE
HAVE NEVER PAID ANY DIVIDENDS ON OUR COMMON STOCK
.
We
have
never paid any dividends on our Common Stock and do not anticipate paying cash
dividends in the foreseeable future. We currently intend to retain all earnings.
The declaration and payment of future dividends, if any, will be at the sole
discretion of our board of directors and will depend upon our profitability,
financial condition, cash requirements, future prospects, the rights of any
other classes of preferred stock, and other factors deemed relevant by the
board
of directors.
SHARES
OF OUR COMMON STOCK ISSUED IN CONNECTION WITH OUR ACQUISITION OF BIOBALANCE
MAY
HAVE BEEN ISSUED WITHOUT COMPLYING WITH CERTAIN STATE SECURITIES
LAWS.
During
October 2003, it was determined that certain of the shares of common stock
that
we issued to holders of BioBalance stock in connection with our January 2003
acquisition of BioBalance may not have been exempt from the registration or
qualification requirements of the state securities laws of certain of the states
where the holders of BioBalance stock then resided, although they were
registered under the Securities Act of 1933, as amended. Although we are unable
to quantify the actual number of shares involved that are still owned by the
original recipients of our shares in the acquisition, the per share purchase
price paid by the BioBalance holders for the shares they exchanged in the
acquisition ranged from $.03 to $3.00 per share, and we currently believe that
the purchase price paid by such persons who might have certain statutory
rescission rights does not exceed approximately $345,000, exclusive of any
penalties or interest, although no assurance can be given that any such claims
will not exceed this amount. We cannot determine the effect, if any, on our
operations or financial condition that may occur from the failure to register
or
qualify these shares under applicable state securities laws. If it is determined
that we offered securities without properly registering or qualifying them
under
state laws, or securing exemption from registration, regulators could impose
on
us significant monetary fines or other sanctions. We are unable to estimate
the
amount of monetary fines, if any, or the nature or scope of any sanctions at
this time.
Item
1B.
UNRESOLVED
STAFF COMMENTS
None.
Item
2.
DESCRIPTION
OF PROPERTIES
All
of
our executive and branch offices are located in facilities leased from
unaffiliated persons.
Our
corporate headquarters is located in a building containing approximately 6,000
square feet located in Brooklyn, New York under a lease expiring in 2010, at
a
monthly rental of approximately $10,000, subject to annual increases and rent
escalations based on increases in real estate taxes. Our home healthcare
business is administered from our corporate headquarters and 7 branch and
recruitment offices located in New York under month to month tenancies and
term
leases expiring from March 2008 through June 2011 at annual rentals ranging
from
approximately $23,000 to $129,000, and additional rent based upon increases
in
real estate taxes and other cost escalations.
BioBalance's
executive office was located at 345 Seventh Avenue, New York, New York under
a
five year lease that commenced in April 2006 at a monthly rental of
approximately $15,200. BioBalance surrendered this office space to the landlord
in March 2007 in exchange for lease cancellation, incurring exit costs and
asset
disposal/impairment losses of approximately
$74,000
.
Item
3.
LEGAL
PROCEEDINGS
We
are
subject to various legal proceedings and claims, either asserted or unasserted,
which arise in the ordinary course of business. While the outcome of these
claims cannot be predicted with certainty, management does not believe that
the
outcome of any of these legal matters will have a material adverse effect on
our
results of operations or financial position, except as follows:
On
March
30, 2006, the Company was served with a shareholder derivative complaint
captioned Jay Glatzer v. Yitz Grossman, Emerald Asset Management, Murry
Englard, Michael Nafash, Stuart Ehrlich, and Dennis O'Donnell and New York
Health Care, Inc., (Supreme Court of State of New York County of Nassau, (Index
No. 5125/06). The lawsuit alleged that the directors breached their fiduciary
duty by approving the Emerald Settlement Agreement disclosed in the Company's
Form 8-K (Date of Report March 6, 2006) filed with the Securities Exchange
Commission on March 10, 2006. The lawsuit claimed that such breach was a product
of their respective relationships with Mr. Grossman. The lawsuit also alleged
that Mr. Grossman and Emerald Asset Management injured the Company by engaging
in the actions underlying the November 2004 criminal conviction of Mr. Grossman.
The lawsuit was dismissed in September 2006. A notice of appeal was filed by
the
plaintiff in October 2006 and the plaintiff filed its appeal brief in April
2007. On January 15, 2008, the court dismissed the appeal.
The
Company reported in the Company's Form 8-K filed on August 21, 2006 that the
Company had unilaterally rescinded the settlement between the Company and
Emerald Asset and Yitz Grossman. The settlement agreement was originally entered
into as reported in the Company's Form 8-K filed on March 6, 2006, and the
related liability was recorded on the books of the Company at December 31,
2005,
in the amount of $1,545,000. The rescission of the settlement by the Company
was
done without the consent of Emerald Asset and Yitz Grossman. Accordingly there
may be future litigation brought against the Company by Emerald Asset and Yitz
Grossman to seek enforcement of the agreement. The Company continues to retain
the accrual for the settlement agreement on its books in its entirety. If there
is litigation brought by Emerald Asset and Yitz Grossman to enforce the
settlement agreement, there can be no assurance that at a future time the
accrual that was recorded would be sufficient to offset amounts resulting from
the future litigation.
Item
4.
SUBMISSION
OF MATTERS TO A VOTE OF SECURITY HOLDERS
Not
applicable.
PART
II
Item
5.
MARKET
FOR REGISTRANT'S COMMON EQUITY AND RELATED STOCKHOLDER
MATTERS
Our
Common Stock traded on the National Association of Securities Dealers Automated
Quotation System (“NASDAQ”) Capital Market (formerly known as the SmallCap
Market) Market until April 6, 2004. From April 6, 2004 until September 22,
2005,
our Common Stock was traded over-the-counter on the Pink Sheets. On September
22, 2005, our Common Stock was listed for trading on the Bulletin Board. Our
Common Stock was also listed on the Boston Stock Exchange (“BSE”) until March 5,
2005, when our voluntary delisting application was granted, although no trades
of our Common Stock had been executed on the BSE for at least two years prior
to
our making the voluntary application to delist from the BSE. The following
table
sets forth, for the quarters indicated, the high and low sales prices for our
Common Stock on the NASDAQ Capital Market or the Pink Sheets or the Bulletin
Board as applicable.
|
High
|
|
Low
|
|
Fiscal
2007
|
|
|
|
|
|
|
First
Quarter
|
$
|
0.26
|
|
$
|
0.10
|
|
Second
Quarter
|
|
0.14
|
|
|
0.08
|
|
Third
Quarter
|
|
0.11
|
|
|
0.07
|
|
Fourth
Quarter
|
|
0.12
|
|
|
0.04
|
|
|
|
|
|
|
|
|
Fiscal
2006
|
|
|
|
|
|
|
First
Quarter
|
|
1.17
|
|
|
0.61
|
|
Second
Quarter
|
|
0.86
|
|
|
0.49
|
|
Third
Quarter
|
|
0.65
|
|
|
0.25
|
|
Fourth
Quarter
|
|
0.33
|
|
|
0.07
|
|
Holders
At
March
13, 2008, we had
212
holders
of record and approximately 1,400 beneficial holders of our Common
Stock.
Dividends
The
Company has not paid any cash dividends since its inception and presently
anticipates that all earnings, if any, will be retained for development of
the
Company’s business and that no dividends on the shares of Common Stock will be
declared in the foreseeable future. Any future dividends will be subject to
the
discretion of the Company’s Board of Directors and will depend upon, among other
things, future earnings, the operating and financial condition of the Company,
its capital requirements, general business conditions and other facts and
circumstances as assessed by the Board of Directors in its reasonable judgment.
There can be no assurance that any dividends on the Common Stock will be paid
in
the future.
Securities
Authorized for Issuance under Equity Compensation Plans
For
information on securities authorized for issuance and issued under the Company’s
equity compensation plans, see Part III, Item 11 of this report, “Executive
Compensation - Savings and Equity Compensation Plans.”
Item
6. SELECTED FINANCIAL DATA
Not
applicable.
Item
7.
MANAGEMENT’S
DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF
OPERATIONS
Forward
Looking Statements
Certain
information contained in this report is forward-looking in nature. All
statements in this report, including those made by the Company and its
subsidiaries (“we”, “our”, or the “Company”), other than statements of
historical fact, are forward-looking statements. Examples of forward-looking
statements include statements regarding the Company's future financial
condition, operating results, business and regulatory strategies, projected
costs, services, research and development, competitive positions and plans
and
objectives of management for future operations. These forward-looking statements
are based on management's estimates, projections and assumptions as of the
date
hereof and include the assumptions that underlie such statements.
Forward-looking statements may contain words such as “may,” “will,” “should,”
“would,” “expect,” “plan,” “anticipate,” “believe,” “estimate,” “predict,”
“potential,” “continue,” or the negative of these terms or other comparable
terminology. Any expectations based on these forward-looking statements are
subject to risks and uncertainties and other important factors, including those
discussed in Item 1A. - Risk Factors. Other risks and uncertainties are
disclosed in the Company's prior SEC filings. These and many other factors
could
affect the Company's future financial operating results, and could cause actual
results to differ materially from expectations based on forward-looking
statements made in this report or elsewhere by the Company or on its behalf.
The
Company assumes no obligation to update such statements.
Overview
We
are
currently engaged in two industry segments, the delivery of home healthcare
services (sometimes referred to as the “home healthcare business”) and the
development of proprietary biotherapeutic agents for the treatment of various
gastrointestinal (“GI”) disorders, through our acquisition
BioBalance.
The
Company is a New York corporation incorporated in 1983. The Company's principal
executive office is 1850 McDonald Avenue, Brooklyn, New York 11223, telephone
718-375-6700.
Critical
Accounting Policies
The
Company's critical accounting policies are those it believes are the most
important in determining its financial condition and results of operations,
and
require significant subjective judgment by management as a result of inherent
uncertainties. A summary of the Company’s significant accounting policies is set
out in the notes to the consolidated financial statements. Such policies are
discussed below.
The
preparation of financial statements and related disclosures in conformity with
accounting principles generally accepted in the United States of America
requires management to make estimates and assumptions that affect the amounts
reported in the Consolidated Financial Statements and accompanying notes.
Estimates are used for, but not limited to, the accounting for allowance for
doubtful accounts and potential impairment of goodwill and other intangibles.
Management bases its estimates on historical experience and on various other
assumptions that are believed to be reasonable the circumstances. Actual results
could differ from these estimates under different assumptions or
conditions.
Long-Lived
Assets and Other Intangible Assets
We
evaluate long-lived assets, such as intangible assets other than goodwill,
equipment and leasehold improvements, for impairment when events or changes
in
circumstances indicate that the carrying amounts of the assets may not be
recoverable through estimated undiscounted cash flows from the use of these
assets. When impairment exists, the related assets are written down to fair
value.
Accounting
for Income Taxes and Valuation Allowances
We
currently have significant deferred tax assets, resulting from net operating
loss carry forwards and differences between financial reporting and tax
treatment of intangible assets amortization and impairment losses. These
deferred tax assets may reduce taxable income in future periods. Based on the
Company’s losses and its accumulated deficit, the Company has provided a full
valuation allowance against the net deferred tax asset. A valuation allowance
is
required when it is more likely than not that all or a portion of a deferred
tax
asset will not be realized. Cumulative losses weigh heavily in the overall
assessment of valuation allowances.
We
expect
to continue to maintain a full valuation allowance on future tax benefits until
an appropriate level of profitability is sustained, or we are able to develop
tax strategies that would enable us to conclude that it is more likely than
not
that a portion of our deferred tax assets would be realizable.
Classification
of Amounts Due to HRA
Historically,
management has maintained a liability account to show amounts paid to the
Company under the contract with the City of New York Human Resources
Administration (“HRA”) which were required to be used for certain employee
benefits purposes and were to be paid to or on behalf of the home health aid
employees. In 2006, management determined that approximately $904,000 could
no
longer be used for the employee benefit and could not be paid to the employees
but could be expected to be required to be repaid to HRA. Accordingly, this
amount was reclassified from general accrued expenses to the caption “Due to
HRA”.
Recently
Issued Accounting Pronouncements
In
December 2007, the FASB issued SFAS No. 141 (revised 2007), "
Business
Combinations.
"
SFAS
141(R) broadens the guidance of SFAS 141, extending its applicability to all
transactions and other events in which one entity obtains control over one
or
more other businesses. It broadens the fair value measurement and recognition
of
assets acquired, liabilities assumed, and interests transferred as a result
of
business combinations. SFAS 141(R) expands on required disclosures to improve
the statement users' abilities to evaluate the nature and financial effects
of
business combinations. SFAS 141(R) is effective for our fiscal year beginning
January 1, 2009. The adoption of SFAS 141(R) is not expected to have a material
impact on the Company's financial position, results of operations or cash
flows.
In
December 2007, the FASB issued SFAS No. 160, "
Noncontrolling
Interests in Consolidated Financial Statements—an amendment of ARB No.
51.
"
SFAS
160 requires that a noncontrolling interest in a subsidiary be reported as
equity and the amount of consolidated net income specifically attributable
to
the noncontrolling interest be identified in the consolidated financial
statements. It also calls for consistency in the manner of reporting changes
in
the parent's ownership interest and requires fair value measurement of any
noncontrolling equity investment retained in a deconsolidation. SFAS 160 is
effective for our fiscal year beginning January 1, 2009. We have not yet
determined the impact of adopting SFAS 160 on the Company's financial position,
results of operations or cash flows.
In
February, 2007, FASB issued SFAS No. 159,
The
Fair Value Option for Financial Assets and Financial
Liabilities
including an amendment of FAS 115, or FAS 159. This statement provides companies
with an option to report selected financial assets and liabilities at fair
value. This statement is effective for fiscal years beginning after November
15,
2007 with early adoption permitted. Management does not believe that adoption
of
this statement will have a material impact on the financial position of the
Company.
In
September 2006, the FASB issued SFAS No. 158 Employers' Accounting for
Defined Benefit Pension and Other Postretirement Plans - an Amendment of FASB
Statements No. 87, 88, 106, and 132(R). This statement requires a company
to recognize the funded status of a benefit plan as an asset or a liability
in
its statement of financial position. In addition, a company is required to
measure plan assets and benefit obligations as of the date of its fiscal
year-end statement of financial position. The recognition provision of this
statement, along with additional disclosure requirements, is effective for
fiscal years ending after December 15, 2006, while the measurement date
provision is effective for fiscal years ending after December 15, 2008.
Management does not believe that adoption of this statement will have a material
impact on the financial position of the Company.
In
September 2006, the FASB issued SFAS No. 157, "
Fair
Value Measurements
"
which
defines fair value, establishes guidelines for measuring fair value and expands
disclosures regarding fair value measurements. SFAS 157 does not require any
new
fair value measurements but rather eliminates inconsistencies in guidance found
in various prior accounting pronouncements. SFAS 157 is effective for fiscal
years beginning after November 15, 2007. However, on February 12, 2008, the
FASB
issued proposed FASB Staff Position ("FSP") SFAS No. 157-2, "
Effective
Date of FASB Statement No. 157
,"
which
defers the effective date for adoption of fair value measurements for
nonfinancial assets and liabilities to fiscal years beginning after November
15,
2008. The Company will adopt SFAS 157 during 2008, except as it applies to
those
non-financial assets and non-financial liabilities as noted in proposed FSP
157-2. The partial adoption of SFAS 157 is not expected to have a material
impact on the Company's financial position, results of operations or cash
flows.
In
June,
2006, the FASB issued Interpretation No. 48,
Accounting for Uncertainty in Income Taxes, an Interpretation of FASB Statement
No. 109, Accounting for Income Taxes
(FIN48),
to create a single model to address accounting for uncertainty in tax positions.
FIN 48 clarifies the accounting for income taxes by prescribing a minimum
recognition threshold a tax position is required to meet before being recognized
in the financial statements. FIN 48 also provides guidance on derecognition,
measurement, classification, interest, and penalties, accounting in interim
periods, disclosure and transition. The Company adopted FIN 48 as of
January 1, 2007. Based on our evaluation, we have concluded that there are
no significant uncertain tax positions requiring recognition in our financial
statements. Our evaluation was performed for the tax years which remain subject
to examination by major tax jurisdictions as of December 31, 2007. We may from
time to time be assessed interest or penalties by major tax jurisdictions,
although any such assessments historically have been minimal and immaterial
to
our financial results. In the event we have received an assessment for interest
and/or penalties, it has been classified in the financial statements as selling,
general and administrative expense. The Company is currently subject to a three
year statue of limitations by major tax jurisdictions. The Company and its
subsidiaries file income tax returns in the U.S. federal jurisdiction, New
York
State, New York City and New Jersey.
Results
of Operations
The
following table reflects the results of operations for the years ended December
31, 2007 and 2006 for each business segment.
|
Year
Ended
|
|
Year
Ended
|
|
|
December
31, 2007
|
|
December
31, 2006
|
|
|
BioBalance
|
|
Healthcare
|
|
|
|
BioBalance
|
|
Healthcare
|
|
|
|
|
Segment
|
|
Segment
|
|
Total
|
|
Segment
|
|
Segment
|
|
Total
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Revenues
|
$
|
-
|
|
$
|
44,399,303
|
|
$
|
44,399,303
|
|
$
|
-
|
|
$
|
45,558,331
|
|
$
|
45,558,331
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost
of patient care
|
|
-
|
|
|
36,626,372
|
|
|
36,626,372
|
|
|
-
|
|
|
36,747,366
|
|
|
36,747,366
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
SG&A,
including depreciation and amortization
|
|
2,096,976
|
|
|
6,247,562
|
|
|
8,344,538
|
|
|
4,083,000
|
|
|
6,874,535
|
|
|
10,957,535
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Product
Development
|
|
648,759
|
|
|
-
|
|
|
648,759
|
|
|
1,637,558
|
|
|
-
|
|
|
1,637,558
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net
(loss) income
|
$
|
(2,745,153
|
)
|
$
|
1,692,802
|
|
$
|
(1,052,351
|
)
|
$
|
(5,492,072
|
)
|
$
|
1,736,399
|
|
$
|
(3,755,673
|
)
|
BioBalance
Segment
During
the years 2007 and 2006, the BioBalance segment had no revenues and no cost
of
sales.
Selling,
general and administrative expenses ("SG&A") for the year ended December 31,
2007 decreased
($1,986,024)
(
48.64%
)
to
$
2,096,976
from
$
4,083,000
for
the
year ended December 31, 2006. The decrease is attributable largely to
management's cost cutting efforts with reductions in rents, salaries and
benefits, share based compensation, public relations and professional fees.
The
SG&A expenses for BioBalance include charges for impairment of intangible
assets of
$729,792
in
2007
and
$926,322
in
2006.
Product
development costs for the BioBalance segment for the year ended December 31,
2007 were $
648,759
compared
to $
1,637,558
for
2006,
a decrease of
($988,799)
or
60.38%
.
The
decrease was a result of scaling back operations because of a lack of available
funding to continue clinical trials.
For
the
year ended December 31, 2007, the operations of the BioBalance segment showed
loss from continuing operations of
($2,745,153)
compared
to a loss of
($5,492,072)
in 2006,
an improvement of
$2,746,919
or
50.02%
.
The
improvement was a result of the cost cutting efforts described above as well
as
the scaling back of clinical operations.
Home
Healthcare Segment
Revenues
the year ended December 31, 2007 decreased by
($1,159,028)
or
2.54%
to
$
44,399,303
from
$
45,558,331
in
2006.
The 2006 revenue in the home health care segment includes a reversal of debt
from HRA in the amount of approximately $704,000, which relates to funds that
HRA agreed not collect for their fiscal year 2002. The Company had previously
accrued this amount as due to HRA.
Cost
of
professional care of patients decreased
($120,994)
or
0.33%
in 2007
to $
36,626,372
from
$
36,747,366
in
2006.
Selling,
general and administrative expenses (SG&A) decreased by
($626,973)
(
9.12%
)
to
$
6,247,562
in
2007
as compared to $
6,874,535
in
2006.
This decrease is due to the reduction in personnel costs, and reductions of
general operating costs at the home health care operations, particularly in
the
area of professional fees and executive compensation..
For
the
year ended December 31, 2007, the net income from the home health care segment
was $
1,692,802
as
compared to $
1,736,399
for
the
year ended December 31, 2006 a decrease of
($43,597)
or
-2.51%
.
Liquidity
and Capital Resources
For
the
year ended December 31, 2007, cash used for operating activities on a
consolidated basis was
$88,614
compared
to
$2,717,201
in
2006,
an improvement of.
$2,628,587
.
The
change resulted from a decrease in the net loss for 2007 as compared to 2006
of
$2,703,322
,
offset
by and a decrease in cash from changes in non-cash expenses of
($917,347)
and an
increase in cash provided by changes in components of operating assets and
liabilities of
$842,612
.
Net
cash
used in investing activities for the year ended December 31, 2007 totaled
$134,934
and
consisted principally of the acquisition of intangible assets.
Home
Healthcare Segment
At
December 31, 2007, the Company had no long-term debt.
Operating
leases for premises also generally contain provisions allowing rental
obligations to be accelerated upon default in the payment of rent or the
performance of other lease obligations. These leases generally contain
provisions for additional rent based upon increases in real estate taxes and
other cost escalations. The lease for the office space for BioBalance is
included in the above amounts.
The
Company has no off-balance sheet arrangements and has not entered into any
transactions involving unconsolidated, limited purpose entities or commodity
contracts.
On
September 20, 2007, New York Health Care entered into a Loan and Security
agreement with CIT Healthcare LLC, as lender (“
Lender
”).
The
term of the Loan and Security Agreement is three years. The Loan and Security
Agreement provides for a revolving line of credit facility under which the
Company may borrow, repay and re-borrow an amount not exceeding the lesser
of
$5,000,000 or the borrowing base, which is an amount that may not exceed 85%
of
the estimated net value of the Company's Eligible Accounts, as defined in the
agreement. As of December 31, 2007, approximately $3,600,000 of the line was
available for borrowing by the Company. Interest is payable on the outstanding
principal balance of the credit facility at an annual rate equal to 30-day
LIBOR
plus three and one-half percent (3.50%), adjusted monthly in accordance with
changes in 30-day LIBOR. The Company's obligations to Lender under the Loan
and
Security Agreement are secured by a first priority lien on all of the Company's
accounts receivable, general intangibles, instruments and documents, and the
proceeds thereof. However, no collateral consists of any assets or property
of
BioBalance.
New
York
Health Care is prohibited from making dividend, distributions or other
withdrawals during the term of the credit facility. However, New York Health
Care is permitted to make loans, advances or contributions to its subsidiary,
BioBalance, provided that certain liquidity requirements are met. New York
Health Care is further restricted from mergers and acquisitions, as well as
asset sales or dispositions outside the ordinary course of business, provided
that such sale restrictions are not applicable to the capital stock or assets
of
BioBalance.
Days
Sales Outstanding ("DSO") is a measure of the average number of days taken
by
the Company to collect its account receivable, calculated from the date services
are billed. For the year ended December 31, 2007, the DSO of the home care
segment of the Company was 68, compared to 58 days for the year ended
December 31, 2006. The increase in DSO was primarily caused by delays in
collection from one of the Company's contracts. Management has adequately
reserved for potential losses from this contract.
BioBalance
Segment
As
of
December 31, 2007, BioBalance has generated no revenues and has no accounts
receivable. The assets of BioBalance consist mainly of intangibles related
to
the patents it holds on its lead product
PROBACTRIX®.
As
of
December 31, 2007, BioBalance had cash on hand of approximately $38,000, all
of
which was available to fund operations. BioBalance management estimates that
its
capital requirements for an entire year of operations are approximately
$5,000,000. This amount includes the cost of the initial up front payment for
the Phase I/II clinical trial, in the amount of $3,000,000, for the Company's
lead product PROBACTRIX® that is not expected to be started in 2008. It will be
necessary for the Company to secure additional funding in order for BioBalance
to begin the Phase I/II clinical trial, which was approved by FDA on March
24,
2006. The Company has not been able to obtain additional funding up to the
present time and the BioBalance subsidiary has been operating solely by
utilizing funds from the health care operations, which are insufficient for
BioBalance's needs. The Company is in continuing discussions with potential
funding sources but no agreements with any such funding sources have been
entered into. Accordingly, since additional funding from outside sources has
not
been obtained, the Company began scaling back the operations of BioBalance
at
the end of November 2006, and BioBalance began operating on a substantially
reduced budget in 2007. BioBalance management has taken steps to secure the
data
from clinical trials and has begun the production of a duplicate of the
biological strain of PROBACTRIX® . Additionally, BioBalance surrendered its
office space to the landlord in March 2007 in exchange for lease cancellation,
incurring exit costs through the time the space was fully vacated of
approximately
$38,000
and
asset
disposal/impairment losses of approximately
$36,000
.
Management has instituted temporary cutbacks in consultant compensation until
such time as additional funds or a strategic partner can be found. There can
be
no assurances that the Company will be able to raise additional capital in
the
near term to allow BioBalance to continue its normal level of
operations.
Off-Balance
Sheet Arrangements
The
Company has not entered into any transactions with unconsolidated entities
whereby the Company has financial guarantees, subordinated retained interests,
derivative instruments or other contingent arrangements that expose the Company
to material continuing risks, contingent liabilities, or any other obligation
under a variable interest in an unconsolidated entity that provides financing,
liquidity, market risk or credit risk support to the Company.
Item
7A.
QUANTITATIVE
AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK
Not
applicable.
Item
8.
FINANCIAL
STATEMENTS AND SUPPLEMENTARY DATA
The
consolidated financial statements of the Company, together with the Independent
Registered Public Accounting Firms’ report thereon of Holtz Rubenstein Reminick
LLP, for the years ended December 31, 2007 and 2006. See Index to “Financial
Statements.”
Item
9.
CHANGES
IN AND DISAGREEMENTS WITH ACCOUNTANTS ON ACCOUNTING AND FINANCIAL
DISCLOSURE
During
the fiscal years ended December 31, 2007 and 2006, there were no disagreements
with Holtz Rubenstein Reminick LLP ("Holtz") on any matter of accounting
principles or practices, financial statement disclosure, or auditing scope
or
procedure, which disagreements, if not resolved to the satisfaction of Holtz,
would have caused them to make reference in connection with their report to
the
subject matter of the disagreement, and Holtz has not advised the Company of
any
reportable events as defined in Item 304(a)(1)(v) of Regulation
S-K.
Item
9A (T). Controls and Procedures.
(a)
Evaluation
of Disclosure Controls and Procedures.
As
of the
end of the period covered by this annual report, we carried out an evaluation,
under the supervision and with the participation of our management, including
our principal executive officer and principal financial officer, of the
effectiveness of the design and operation of our disclosure controls and
procedures (as defined in the Exchange Act Rules 13a-15(e) and 15d-15(e)).
Based
upon the foregoing evaluation, our principal executive officer and principal
financial officer have concluded that our disclosure controls and procedures
are
not effective, for the reasons discussed below, to ensure that information
required to be disclosed by us in the reports that we file or submit under
the
Exchange Act is recorded, processed, summarized and reported within the time
periods specified in the rules and forms of the SEC.
(b)
Management’s
Report on Internal Control Over Financial Reporting
Our
management is responsible for establishing and maintaining adequate internal
control over financial reporting and for the assessment of the effectiveness
of
internal control over financial reporting, as defined in Rule 13a-15(f) under
the Exchange Act. Internal control over financial reporting is a process
designed by, or under the supervision of our principal executive officer and
principal financial officer and effected by our Board of Directors, management
and other personnel, to provide reasonable assurance regarding the reliability
of financial reporting and the preparation of the financial statements in
accordance with U.S. generally accepted accounting principles.
Our
internal control over financial reporting includes those policies and procedures
that (1) pertain to the maintenance of records that, in reasonable detail,
accurately and fairly reflect our transactions and dispositions of our assets;
(2) provide reasonable assurance that transactions are recorded as necessary
to
permit preparation of the financial statements in accordance with U.S. generally
accepted accounting principles, and that our receipts and expenditures are
being
made only in accordance with authorizations of our management and directors;
and
(3) provide reasonable assurance regarding prevention or timely detection of
unauthorized acquisition, use or disposition of our assets that could have
a
material effect on the financial statements.
Because
of its inherent limitations, internal control over financial reporting may
not
prevent or detect misstatements. Also, projections of any evaluation of
effectiveness to future periods are subject to the risk that controls may become
inadequate because of changes in conditions, or that the degree of compliance
with the policies or procedures may deteriorate.
In
connection with the preparation of our annual financial statements, management
has undertaken an assessment of the effectiveness of our internal control over
financial reporting as of December 31, 2007, based on criteria established
in
Internal
Control - Integrated Framework
issued
by
the Committee of Sponsoring Organizations of the Treadway Commission, or the
COSO Framework. Management’s assessment included an evaluation of the design of
our internal control over financial reporting and testing of the operational
effectiveness of those controls.
Due
to
the inherent issue of segregation of duties in a small company, we have relied
heavily on entity or management review controls to lessen the issue of
segregation of duties.
Based
on
this evaluation, management has concluded that our internal control over
financial reporting was not effective as of December 31, 2007. Our
principal executive officer and principal financial officer have concluded
that
we have a material weakness in our internal control over financial
reporting.
A
material weakness is a deficiency, or combination of deficiencies, in internal
control over financial reporting, such that there is a reasonable possibility
that a material misstatement of the Company’s annual or interim financial
statements will not be prevented or detected on a timely basis. Management
identified the following material weaknesses as of December 31,
2007:
Supervision:
The controller is responsible for making all journal entries relating the
home
health care segment. The journal entries made by the controller are not reviewed
by another person in the organization with sufficient accounting knowledge
and
authority. This weakness also has an affect on our period end closing process
whereby the lack of supervision of the controller results in a substantial
number of journal entries made during the closing process. We believe that
if
this weakness did not exist, there would be far fewer journal entries required
during the closing process. One of our main goals in remediating this weakness
is to substantially reduce the number of entries made during the closing
process, to be fully implemented by the third quarter of 2008. We are
remediating this weakness by implementing a rearrangement of the work flow
so
that other members of the accounting staff will be responsible for preparing
and
entering certain journal entries that the controller will review. Entries
made
directly by the controller will be reviewed periodically by the Chief Financial
Officer. Additionally, we are developing a review checklist that will be
utilized by the Chief Financial Officer to periodically review the work of
the
controller at least quarterly, with some aspects being reviewed on a monthly
basis.
Information
Technology: Management did not perform tests of information technology controls
before the year end so we cannot assert that the controls functioned as designed
as of December 31, 2007. However, we were able to ascertain that the controls
were in place through certain documentation available relating to bills received
from our outside computer consultants.
This
annual report does not include an attestation report of the Company's
independent registered public accounting firm regarding internal control over
financial reporting. Management's report was not subject to attestation by
the
Company's independent registered public accounting firm pursuant to temporary
rules of the SEC that permit the Company to provide only management’s report on
internal control in this annual report.
Changes
in Internal Controls
There
have been no changes in our internal control over financial reporting during
our
most recent fiscal quarter that have materially affected, or are reasonably
likely to materially affect, our internal control over financial reporting.
Item
9B
.
OTHER
INFORMATION:
Not
applicable.
PART
III
Item
10.
DIRECTORS,
EXECUTIVE OFFICERS AND CORPORATE GOVERNANCE
The
persons who currently serve as executive officers and directors of the Company,
and who served in such capacities during the 2007 fiscal year, are as
follows:
Name
|
|
Age
|
|
Position
|
|
|
|
|
|
|
|
Murry
Englard
|
|
|
49
|
|
|
Director,
Chief Executive Officer
|
|
|
|
|
|
|
|
|
|
Stewart
W. Robinson
|
|
|
53
|
|
|
Chief
Financial Officer
|
|
|
|
|
|
|
|
|
|
Howard
Berg
|
|
|
53
|
|
|
Director
|
|
|
|
|
|
|
|
|
|
Yoram
Hacohen
|
|
|
36
|
|
|
Director
|
|
Murry
Englard was designated by the Board as Chief Executive Officer effective August
1, 2007. Murry Englard has been a director of the Company since September 2005
and acting Chief Executive Officer since November 20, 2006. Mr. Englard is
a partner of the accounting firm Harlib, Grossman & Englard, CPA's since
January 1996. He was managing partner of Englard & Company, CPA, P.C. from
January 1992 until December 1995 and a partner at Englard & Company CPA from
January 1985 until December 1991. Mr. Englard is a certified public accountant.
He received a B.A. in Accounting from Queens College in 1980 and attended
Bernard Baruch Graduate School of Business concentrating in
finance.
Effective
February 5, 2007, Stewart W. Robinson was appointed to serve as the Company’s
Chief Financial Officer on a part-time basis. Since November 1998, Mr. Robinson
has been a partner-in-charge of SEC practice and quality control in the
accounting firm of KBL, LLP and its predecessor. KBL, LLP is a Public Accounting
Company Oversight Board (“PCAOB”) registered auditing and consulting firm
concentrating in audits of small public companies and small to medium size
private companies. Mr. Robinson was previously partner in-charge of litigation
services and SEC auditing at several New York area accounting firms from 1984
through 1997. Mr. Robinson, received a B.A. in Accounting from Queens College
in
1977, attended Pace University Graduate School of Business for taxation and
completed business valuation training at both the American Society of Appraisers
and the National Association of Certified Valuation Analysts. He is a member
of
the American Institute of Certified Public Accountants and the New York State
Society of Certified Public Accountants. Mr. Robinson is also registered with
the PCAOB under the name Stewart W. Robinson, CPA.
Dr.
Howard Berg, a partner in Specialists in Otolaryngology, LLC since November
2001
and a partner in Short Hills Surgical Center since February 2005, is a
practicing physician in Otolaryngology and Head and Neck Surgery. Dr. Berg
has
served as an attending surgeon at New York Downtown Hospital in New York City
since July 1986 and as an attending surgeon at St. Barnabas Medical Center
in
Livingston, New Jersey since July 1996. Dr. Berg has been an Assistant
Professor of
Otolaryngology at New York University Medical Center since June 1985 and
participates in the Otolaryngology Surgical Resident Training Program at Mount
Sinai Medical Center.”
Since
January 2008, Yoram Hacohen is a partner in Hacohen Wolf, a law firm in
Jerusalem, Israel. From January 2007 through December 2007, Yoram Hacohen was
a
partner with the firm Jaffe, Fund & Co, Advocates, in Jerusalem, Israel,
specializing in corporate, commercial and civil law in the fields of
international trade, tax and real estate. For the preceding five years, Mr.
Hacohen was an independent practitioner in those fields of law. Mr. Hacohen
earned his law degree from London Guildhall University, London, England in
July
1995.
Michael
Nafash served as a director of the Company since August 31, 2005. He resigned
as
a director of the Company on April 3, 2007. Mr. Nafash is a Certified Public
Accountant and held various corporate finance positions throughout his career.
Directors
hold office until the next annual meeting of the stockholders and/or until
their
successors have been duly elected and qualified, or until death, resignation
or
removal. Executive officers are elected by the Board of Directors on an annual
basis and serve at the discretion of the Board. There is no family relationship
between any of the Company’s directors or its executive officers.
Audit
Committee
The
Audit
Committee of the Board of Directors previously consisted of Murry Englard and
Michael Nafash. Upon Michael Nafash’s resignation, on April 3, 2007, the Audit
Committee was effectively terminated.
Section
16(a) Beneficial Ownership Reporting and Compliance
Section
16(a) of the Exchange Act requires the Company’s directors and executive
officers and holders of more than 10% of the Company's common stock to file
reports with the SEC about their ownership of common stock and other securities
of the Company. These persons are required by SEC rules to furnish the Company
with copies of all Section 16(a) forms they file. The Company is required to
identify anyone who filed a required report late during 2007.
Based
solely on our review of forms we received and written representations from
reporting persons stating that they were not required to file these forms,
the
Company believes, that during 2007, all Section 16(a) filing requirements were
satisfied on a timely basis.
Code
of Ethics
The
Company has adopted a Code of Ethics for Senior Financial Officers which applies
to the Company’s Chief Executive Officer and Chief Financial and Principal
Accounting Officer. A copy of this Code was filed with the Securities and
Exchange Commission as an exhibit to the Company’s Form 10-K for the fiscal year
ended December 31, 2003.
Item
11.
EXECUTIVE
COMPENSATION
The
following table sets forth, for the fiscal years ended December 31, 2007 and
2006, the cash compensation paid by the Company, as well as certain other
compensation paid with respect to those fiscal years, to the Company’s Chief
Executive Officer and to each of the three other most highly compensated
executive officers of the Company and its BioBalance subsidiary, whose total
salary and bonuses for the fiscal year 2007, in all capacities in which served,
was $100,000 or more (collectively, the “Named Executive
Officers”):
Name and Principal Position
|
|
Year
|
|
Salary
($)
|
|
Bonus
($)
|
|
Stock
Awards
($)
|
|
Option
Awards
($)
|
|
Non-
Equity
Incentive
Plan
($)
|
|
Change
in
Pension
Value and
Non-Qualified
Deferred Compensation Earnings
|
|
All
Other Compensation ($)
|
|
|
(a)
|
|
(b)
|
|
(c)
|
|
(d)
|
|
(e)
|
|
(f)
|
|
(g)
|
|
(h)
|
|
(i)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Murry
Englard (1)
|
|
|
2007
|
|
$
|
44,231
|
|
$
|
15,000
|
|
|
|
|
$
|
12,000
|
|
|
|
|
|
|
|
$
|
41,026
|
|
(1)
|
Director
and Chief Executive Officer
|
|
|
2006
|
|
$
|
-
|
|
$
|
-
|
|
|
|
|
$
|
25,646
|
|
|
|
|
|
|
|
$
|
18,000
|
|
(1)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stewart
W. Robinson (2)
|
|
|
2007
|
|
$
|
144,531
|
|
$
|
-
|
|
|
|
|
|
-
|
|
|
|
|
|
|
|
$
|
10,293
|
|
(2)
|
Chief
Financial Officer
|
|
|
2006
|
|
$
|
-
|
|
$
|
-
|
|
|
|
|
|
-
|
|
|
|
|
|
|
|
$
|
-
|
|
(2)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Dennis
O'Donnell (3)
|
|
|
2007
|
|
$
|
-
|
|
$
|
-
|
|
|
|
|
|
-
|
|
|
|
|
|
|
|
$
|
-
|
|
(3)
|
Former
President and
|
|
|
2006
|
|
|
155,769
|
|
|
112,500
|
|
|
|
|
|
-
|
|
|
|
|
|
|
|
$
|
24,444
|
|
|
Chief
Executive Officer
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(1)
|
Murry
Englard has been a director of the Company since September 2005.
Mr.
Englard was paid director's fees of $1,000 per month from September
2005
through August 2006, increasing to $2,500 per month staring in September
2006. The total director's fees paid to Mr. Englard were $35,200
in 2007
and $18,000 in 2006. Other compensation for Mr. Englard also includes
$11,026 in expense reimbursements. Effective August 1, 2007, the
Board
appointed Mr. Englard as Chief Executive Officer to serve on a part-time
basis at annual compensation of
$100,000.
|
(2)
|
Stewart
W. Robinson was appointed effective February 5, 2007 to serve as
the
Company’s Chief Financial Officer on a part-time basis with annual
compensation of $65,000 for between 36 and 45 days. By May 3, 2007,
Mr.
Robinson had already worked 45 days and was paid up to the contract
amount. From May 4, 2007 through December 31, 2007, Mr. Robinson
worked
for the Company for 44 more days and was paid at the per-diem rate
agreed
to in the contract. Other compensation for Mr. Robinson includes:
payment
for bookkeeping and clerical services ($4,825) provided by persons
employed by him or KBL, LLP; reimbursement for office related expenses
incurred of $877; reimbursement for software and related training
costs of
$2,340 and; continuing education and related travel costs specifically
related to his position with the company of
$2,251.
|
(3)
|
Dennis
O'Donnell became President of BioBalance on November 26, 2003 and
the
Company's Chief Executive Officer on February 24, 2005. On September
9,
2006, Mr. O'Donnell resigned from all of his positions with the
Company.
Other Compensation includes $24,444 of medical insurance premiums
paid on
behalf of Mr. O'Donnell in
2006.
|
Option/SAR
Grants in 2007
275,000
stock
options were granted to the Named Executive Officers and Directors in
2007.
Individual
Grants
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Name
|
|
Exercise
Price
Per
Share
($/sh)
|
|
Expiration Date
|
|
Grant
Date
Fair
Value
|
|
Murry
Englard
|
|
$
|
0.15
|
|
|
8/20/2017
|
|
$
|
12,000
|
|
Howard
Berg
|
|
$
|
0.13
|
|
|
2/28/2017
|
|
$
|
3,250
|
|
Howard
Berg
|
|
$
|
0.15
|
|
|
8/20/2017
|
|
$
|
6,000
|
|
Yoram
Hacohen
|
|
$
|
0.13
|
|
|
2/28/2017
|
|
$
|
3,250
|
|
Outstanding
Equity Awards at Fiscal Year End
The
following table sets forth, for the Named Executive Officers,
unexercised
options; stock that has not vested; and equity incentive plan awards
as
of
December 31, 2007.
OUTSTANDING EQUITY AWARDS AT FISCAL YEAR-END
|
|
Option Awards
|
|
Stock Awards
|
|
Name
|
|
Number of
Securities
Underlying
Unexercised
Options (#)
Exercisable
|
|
Number of
Securities
Underlying
Unexercised
Options (#)
Unexercisable
|
|
Equity
Incentive Plan
Awards:
Number of
Securities
Underlying
Unexercised
Unearned
Options (#)
|
|
Option
Exercise
Price ($)
|
|
Option
Expiration
Date
|
|
Number
of
Shares
or Units
of Stock
That
Have
Not
Vested
(#)
|
|
Market
Value of
Shares or
Units of
Stock That
Have Not
Vested ($)
|
|
Equity
Incentive
Plan
Awards:
Number of
Unearned
Shares,
Units or
Other
Rights
That Have
Not Vested
(#)
|
|
Equity
Incentive
Plan
Awards:
Market or
Payout
Value of
Unearned
Shares,
Units or
Other Rights
That Have
Not Vested
($)
|
|
(a)
|
|
(b)
|
|
(c)
|
|
(d)
|
|
(e)
|
|
(f)
|
|
(g)
|
|
(h)
|
|
(i)
|
|
(j)
|
|
Murry Englard
|
|
|
35,000
|
|
|
None
|
|
|
None
|
|
|
1.20
|
|
|
08/30/2010
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
15,000
|
|
|
None
|
|
|
None
|
|
|
0.78
|
|
|
01/04/2011
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
150,000
|
|
|
None
|
|
|
None
|
|
|
0.37
|
|
|
09/20/2016
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
150,000
|
|
|
None
|
|
|
None
|
|
|
0.15
|
|
|
08/20/2017
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stock
Option Exercises and Year End Values
The
following table sets forth, for the Named Executive Officers, the number of
shares covered by stock options as of December 31, 2007, and the value of
“in-the-money” stock options, which represents the positive spread between the
exercise price of a stock option and the market price of the shares subject
to
such option on December 31, 2007. No options were exercised by the Named
Officers in 2007.
Name
|
|
Shares
Acquired on Exercise
|
|
Value
Realized
|
|
Number
of Securities Underlying Unexercised Options/SARs at Fiscal Year-End
Exercisable/Unexercisable
|
|
Value
of Unexercised In- the-Money Options/SARs at Fiscal Year-End
Exercisable/Unexercisable
|
|
Murry
Englard
|
|
|
None
|
|
|
None
|
|
|
370,161/None
|
|
|
None/None
|
|
Compensation
of Directors
The
directors of the Company receive monthly compensation as follows: Murry Englard,
who has taken on additional responsibilities since September 2006 while serving
as a director in the absence of full-time executive management, receives
director’s fees of $2,500 per month. Prior to September 2006, Mr. Englard
received director compensation of $1,000 per month plus $700 for attendance
at
committee meetings. Michael Nafash served as director from August 31, 2005
through April 3, 2007 and received director compensation of $1,000 per month
plus $700 for attendance at committee meetings through September 2006 and $2,500
per month commencing October 2006 through his resignation on April 3, 2007.
Stuart Ehrlich served as director from August 31, 2005 through September 22,
2006 and received director compensation of $1,000 per month plus $700 for
attendance at committee meetings. Yoram Hacohen and Howard Berg, who have served
as directors since February 2007, are entitled to directors’ fees of $1,000 per
month. Howard Berg receives an additional $2,000 per month as compensation
for
his position with the Company as non-executive Chairman of Product Development.
No other amounts are payable to the directors, except for reimbursement for
expenses of attending Board meetings. Except for Mr. Englard, none of the
present directors of the Company is an employee of the Company or its BioBalance
subsidiary.
The
Company also issues common stock options or warrants to non-employee directors
from time to time in recognition of their services. In January 2006, 15,000
common stock options, and, in September 2006, 150,000 common stock options,
were
issued to each of Murry Englard, Stuart Ehrlich and Michael Nafash. When Mr.
Ehrlich resigned as a director on September 22, 2006, he relinquished all of
those options to the Company. When Mr. Nafash resigned as a director on April
3,
2007, he relinquished 75,000 of those options to the Company.
In
2007,
the Company issued an aggregate of 275,000 options to directors as
follows:
When
Mr.
Hacohen and Dr. Berg were appointed directors in February 2007, they each
received a grant of 25,000 options in consideration for their services.
When
Mr.
Englard was appointed Chief Executive Officer in August 2007, he received
150,000 options.
In
August
2007, Dr. Berg received 75,000 options in recognition of his appointment
non-executive Chairman of Product Development.
Employment
Agreements of the Named Executive Officers; Change in Control
Arrangements
Stewart
W. Robinson was appointed effective February 5, 2007 to serve as the Company’s
Chief Financial Officer on a part-time basis with annual compensation of $65,000
for between 36 and 45 days. By May 3, 2007, Mr. Robinson had already worked
45
days and was paid up to the contract amount.
Mr.
Robinson's responsibilities and duties in connection with the operations of
BioBalance and New York Health Care have increased wherein he worked a total
of
89 days in 2007 and was paid additional compensation above the contract cap
at
the per-diem rate in the contract.
From
May
4, 2007 through December 31, 2007, Mr. Robinson worked for the Company for
approximately 44 more days and was paid at the per-diem rate agreed to in the
contract. All other compensation for Mr. Robinson includes: payment for
bookkeeping and clerical services ($4,825) provided by persons employed by
him
or KBL, LLP; reimbursement for office related expenses incurred of $877;
reimbursement for software and related training costs of $2,340 and; continuing
education and related travel costs specifically related to his position with
the
company of $2,251.
Savings
and Equity Compensation Plans
401(k)
Plan
The
Company maintains an Internal Revenue Code Section 401(k) salary deferral
savings plan (the "Plan") for all of its eligible New York home healthcare
division employees who have been employed for at least one year and are at
least
21 years old (effective July 1, 1996, field staff employees at the Company's
Orange County branch office in Newburgh, New York ceased being eligible to
participate in the Plan). Subject to certain limitations, the Plan allows
participants to voluntarily contribute up to 15% of their pay on a pre-tax
basis. Under the Plan, the Company may make matching contributions on behalf
of
the pre-tax contributions made by participants.
Profit
Sharing Plan:
The
Company maintains a qualified profit sharing plan under Internal Revenue Code
Section 401 whereby it may contribute up to 15% of employee compensation.
Specified employees are generally eligible for plan participation upon their
employment commencement date with immediate vesting on the employee’s plan
entrance date. All contributions to the plan are at the discretion of Company
management.
Equity
Compensation Plans
The
following table summarizes with respect to options and warrants under the
Company’s equity compensation plans at December 31, 2007:
Plan
category
|
|
Number of
securities to be
issued upon
exercise of
outstanding
options,
warrants and
rights
|
|
Weighted-average
exercise price of outstanding options,
warrants and rights
|
|
Number of
securities
remaining
available for
future issuance
under equity
compensation
plans (excluding
securities
reflected in
column (a))
|
|
Equity
compensation plans approved by security holders(1)
|
|
|
3,135,053
|
|
$
|
1.07
|
|
|
6,305,910
|
|
Equity
compensation plans not approved by security holders(2)
|
|
|
5,726,993
|
|
$
|
0.78
|
|
|
—
|
|
Total
|
|
|
8,862,046
|
|
|
|
|
|
|
|
|
(1)
|
Represents
shares of the Company’s common stock issuable pursuant to the Company’s
Performance Incentive Plan, as amended (the "Option Plan") and the
Company’s 2004 Incentive Plan (the “2004 Plan”). The Company's board of
directors and stockholders approved and adopted the Option Plan in
March
1996 and approved the Company’s 2004 Incentive Plan on August 31, 2005.
The Company’s stockholders approved amendments to the Option Plan
(previously adopted by the board of directors) in 1998, 1999, 2000
and
2002. Under the terms of the amended Option Plan, as amended, up
to
5,000,000 shares of common stock may be granted at December 31, 2007.
The
Company's board of directors and stockholders approved and adopted
the
2004 Incentive Option Plan. The Option Plan is administered by the
standing compensation committee (the "Committee") of the board of
directors (the "Committee"), which is authorized to grant incentive
stock
options and non-qualified stock options to selected employees of
the
Company and to determine the participants, the number of options
to be
granted and other terms and provisions of each option. Options become
exercisable in whole or in part from time to time as determined by
the
Committee, but in no event may a stock option be exercisable prior
to the
expiration of six months from the date of grant, unless the grantee
dies
or becomes disabled prior to the end of the period. Stock options
have a
maximum term of 10 years from the date of grant, except that the
maximum
term of an incentive stock options granted to an employee who, at
the date
of grant, is a holder of more than 10% of the outstanding common
stock (a
“10% holder”) may not exceed five years from the date of the grant. The
exercise price of an incentive stock option or nonqualified option
granted
under the Option Plan may not be less than 100% of the fair market
value
per share of the common stock at the date of grant, except that the
exercise price of an incentive stock options granted to a 10% holder
may
not be less than 110% of the fair market value. The exercise price
of
options must be paid in full on the date of exercise and is payable
in
cash or in shares of Common Stock having a fair market value on the
exercise date.
|
|
(2)
|
5,726,993
warrants were issued in connection with the Company’s private placement on
February 25, 2005.
|
Item
12.
SECURITY
OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT AND RELATED SHAREHOLDER
MATTERS
The
following table sets forth certain information regarding shares of the Common
Stock beneficially owned as of March 12, 2008 by (i) each person, known to
the
Company, who beneficially owns more than 5% of the Common Stock, (ii) each
Named
Executive Officer, (iii) each of the Company’s directors and (iv) all officers
and directors as a group
:
Name
and Address of
Beneficial
Owner (1)
|
|
|
|
Shares
Beneficially
Owned
|
|
Percentage
of
Stock
Outstanding (1)
|
|
|
|
|
|
|
|
|
|
Murry
Englard
|
|
|
(2
|
)
|
|
776,484
|
|
|
2.29
|
%
|
|
|
|
|
|
|
|
|
|
|
|
Yoram
Hacohen
|
|
|
(3
|
)
|
|
25,000
|
|
|
0.07
|
%
|
|
|
|
|
|
|
|
|
|
|
|
Howard
Berg
|
|
|
(4
|
)
|
|
1,514,246
|
|
|
4.44
|
%
|
|
|
|
|
|
|
|
|
|
|
|
Stewart
W. Robinson
|
|
|
|
|
|
-
|
|
|
0.00
|
%
|
|
|
|
|
|
|
|
|
|
|
|
Pinchas
Stefansky
|
|
|
(5
|
)
|
|
2,024,000
|
|
|
6.04
|
%
|
Hershey
Holdings
|
|
|
|
|
|
|
|
|
|
|
Leon
House
|
|
|
|
|
|
|
|
|
|
|
Secretary’s
Lane
|
|
|
|
|
|
|
|
|
|
|
P.O.
Box 450, Gibraltar
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Bernard
Korolnick
|
|
|
(6
|
)
|
|
1,729,208
|
|
|
5.16
|
%
|
KPT
Partners
|
|
|
|
|
|
|
|
|
|
|
c/o
Alton Management
|
|
|
|
|
|
|
|
|
|
|
Splelhof
14A, Postach 536
|
|
|
|
|
|
|
|
|
|
|
8750
Glarus, Switzerland
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Rivvi
Rose
|
|
|
(7
|
)
|
|
1,950,000
|
|
|
5.81
|
%
|
Nekavim
Investors
|
|
|
|
|
|
|
|
|
|
|
1/1
Library Run
|
|
|
|
|
|
|
|
|
|
|
P.O.
Box 317, Gibraltar
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
All
executive officers and directors as a group
|
|
|
|
|
|
2,315,730
|
|
|
6.72
|
%
|
(1)
|
The
shares of Common Stock owned by each person or by the group, and
the
shares included in the total number of shares of Common Stock outstanding,
have been adjusted in accordance with Rule 13d-3 under the Securities
Exchange Act of 1934, as amended, to reflect the ownership of shares
issuable upon exercise of outstanding options, warrants or other
common
stock equivalents which are exercisable within 60 days. As provided
in
such Rule, such shares issuable to any holder are deemed outstanding
for
the purpose of calculating such holder's beneficial ownership but
not any
other holder's beneficial ownership. Unless otherwise indicated,
the
address of each shareholder is c/o the Company.
|
|
|
(2)
|
Includes
a total of
350,000
shares
issuable upon the exercise of stock options granted to Mr. Englard
and
also
20,161
shares
issuable upon the exercise of warrants.
|
|
|
(3)
|
Includes
a total of 25,000 shares issuable upon the exercise of stock options
granted to Mr. Hacohen.
|
(4)
|
Includes
a total of
100,000
shares
issuable upon the exercise of stock options granted to Mr. Berg and
also
449,192
shares
issuable upon the exercise of warrants.
|
|
|
(5)
|
All
shares are owned of record by Hershey Holdings, of which Mr. Stefansky
holds sole voting and investment
power.
|
(6)
|
All
shares are owned of record by KPT Partners, of which Mr. Korolnick
holds
sole voting and investment power.
|
(7)
|
All
shares are owned of record by Nekavim Investors, of which Ms. Rose
holds
sole voting and investment power.
|
Item
13.
CERTAIN
RELATIONSHIPS AND RELATED TRANSACTIONS AND DIRECTOR
INDEPENDENCE.
Not
applicable.
Item
14.
PRINCIPAL
ACCOUNTANT FEES AND SERVICES
The
following table presents fees for professional audit services rendered by Holtz
Rubenstein Reminick LLP, our principal accountants for the audit of the
Company’s annual financial statements for the years ended December 31, 2007 and
2006:
|
|
Fiscal Year Ended
|
|
|
|
December 31,
|
|
|
|
2007
|
|
2006
|
|
|
|
|
|
|
|
Audit
Fees(1)
|
|
$
|
264,000
|
|
$
|
234,524
|
|
Audit-related
Fees(2)
|
|
|
-
|
|
|
-
|
|
Tax
service Fees(3)
|
|
|
600
|
|
|
48,100
|
|
All
Other Fees(4)
|
|
|
45,209
|
|
|
29,000
|
|
(1)
|
Audit
Fees consist of fees billed for professional services rendered for
the
audit of the Company’s consolidated annual financial statements and review
of the interim consolidated financial statements included in quarterly
reports and services that are normally provided in connection with
statutory and regulatory filings or engagements.
|
|
|
(2)
|
Audit-Related
Fees consist of fees billed for assurance and related services that
are
reasonably related to the performance of the audit or review of the
Company’s consolidated financial statements and are not reported under
“Audit Fees.”
|
|
|
(3)
|
Tax
Service Fees consist of fees billed for professional services rendered
for
tax compliance, tax advisory and tax planning. These services include
assistance regarding federal, state and local tax compliance and
tax
planning.
|
(4)
|
The
line for all other fees for 2007 and 2006 represents the audit of
cost
reports and employee benefit plans performed by Holtz Rubenstein
Reminick,
LLP.
|
Policy
on Audit Committee Pre-Approval of Audit and Permissible Non-Audit Services
of
Independent Auditor.
The
Board
of Directors as a whole functions as the Audit Committee. The Audit Committee
had not adopted a formal pre-approval policy for audit and non-audit services.
However, the Audit Committee had pre-approved all audit, audit-related, tax
and
other services provided by Holtz Rubenstein Reminick, LLP prior to the
engagement the firm to provide these services.
PART
IV
Item
15.
EXHIBITS
AND FINANCIAL STATEMENT SCHEDULES
(a)
|
The
following documents are filed as a part of this report:
|
|
|
(1)
|
Consolidated
Financial Statements: See Index to Financial Statements on page F-1
of
this report for financial statements and supplementary data filed
as part
of this report.
|
(2)
|
Financial
Statement Schedules
|
|
Schedule
II - Valuation and Qualifying Accounts for each of the years ended
December 31, 2007 and 2006.
|
(3)
|
Exhibits:
|
|
The
exhibits listed in the accompanying Index to Exhibits are filed or
incorporated by reference as part of this
report.
|
NEW
YORK
HEALTH CARE, INC.
AND
SUBSIDIARIES
CONSOLIDATED
FINANCIAL STATEMENTS
FOR
THE
YEARS ENDED
DECEMBER
31, 2007 AND 2006
REPORT
OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
|
F-2
|
|
|
CONSOLIDATED
FINANCIAL STATEMENTS:
|
|
|
|
CONSOLIDATED
BALANCE SHEETS AT DECEMBER 31, 2007 AND 2006
|
F-3
|
|
|
CONSOLIDATED
STATEMENTS OF OPERATIONS FOR THE YEARS ENDED DECEMBER 31, 2007 AND
2006
|
F-4
|
|
|
CONSOLIDATED
STATEMENTS OF SHAREHOLDERS' EQUITY FOR THE YEARS ENDED DECEMBER 31,
2007
AND 2006
|
F-5
|
|
|
CONSOLIDATED
STATEMENTS OF CASH FLOWS FOR THE YEARS ENDED DECEMBER 31, 2007 AND
2006
|
F-6
|
|
|
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
|
F-7
- F-24
|
|
|
SCHEDULE
II - VALUATION AND QUALIFYING ACCOUNTS
|
F-25
|
REPORT
OF
INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
The
Board
of Directors
New
York
Health Care, Inc.
We
have
audited the accompanying consolidated balance sheets of New York Health Care,
Inc. and Subsidiaries (the "Company") as of December 31, 2007 and 2006 and
the
related consolidated statements of operations, shareholders' deficiency and
cash
flows for the two years then ended. Our audits also included the consolidated
financial statement Schedule II for the years ended December 31, 2007 and 2006.
These financial statements and schedule are the responsibility of the Company's
management. Our responsibility is to express an opinion on these consolidated
financial statements and schedule 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. The Company is not required to
have, nor were we engaged to perform, an audit of its internal control over
financial reporting. Our audits included consideration of internal control
over
financial reporting as a basis for designing audit procedures that are
appropriate in the circumstances, but not for the purpose of expressing an
opinion on the effectiveness of the Company's internal control over financial
reporting. Accordingly, we express no such opinion. An audit also includes
examining, on a test basis, evidence supporting the amounts and disclosures
in
the financial statements. An audit also includes assessing the accounting
principles used and significant estimates made by management, as well as
evaluating the overall consolidated financial statement presentation. We believe
that our audits provide a reasonable basis for our opinion.
In
our
opinion, the consolidated financial statements referred to above present fairly,
in all material respects, the consolidated financial position of New York Health
Care, Inc. and Subsidiaries as of December 31, 2007 and 2006 and the
consolidated results of their operations and their cash flows for the two years
then ended in conformity with accounting principles generally accepted in the
United States of America. Also, in our opinion, the related financial statement
schedule, when considered in relation to the basic financial statements taken
as
a whole, presents fairly in all material respects the information set forth
therein.
The
accompanying consolidated financial statements have been prepared assuming
that
the Company will continue as a going concern. As discussed in Note 1 to the
consolidated financial statements, the Company’s losses and negative working
capital raises substantial doubt about its ability to continue as a going
concern. The consolidated financial statements do not include any adjustments
that might result from the outcome of this uncertainty.
/s/
Holtz
Rubenstein Reminick LLP
Holtz
Rubenstein Reminick LLP
New
York, NY
April
10,
2008
NEW
YORK
HEALTH CARE, INC. AND SUBSIDIARIES
CONSOLIDATED
BALANCE SHEETS
|
|
2007
|
|
2006
|
|
ASSETS
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Current
assets:
|
|
|
|
|
|
|
|
Cash
and cash equivalents
|
|
$
|
2,246,241
|
|
$
|
2,469,789
|
|
Due
from lending institution
|
|
|
-
|
|
|
274,934
|
|
Accounts
receivable, net of allowance for uncollectible amounts of $547,887
and
$579,000, respectively
|
|
|
8,298,837
|
|
|
7,146,973
|
|
Unbilled
services
|
|
|
137,079
|
|
|
112,186
|
|
Prepaid
expenses and other current assets
|
|
|
120,857
|
|
|
227,625
|
|
|
|
|
|
|
|
|
|
Total
current assets
|
|
|
10,803,014
|
|
|
10,231,507
|
|
|
|
|
|
|
|
|
|
Property
and equipment, net
|
|
|
22,090
|
|
|
120,898
|
|
Goodwill,
net
|
|
|
783,000
|
|
|
783,000
|
|
Other
intangible assets, net
|
|
|
628,056
|
|
|
1,575,495
|
|
Other
assets
|
|
|
181,046
|
|
|
168,638
|
|
|
|
|
|
|
|
|
|
Total
assets
|
|
$
|
12,417,206
|
|
$
|
12,879,538
|
|
|
|
|
|
|
|
|
|
LIABILITIES
AND SHAREHOLDERS' DEFICIENCY
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Current
liabilities:
|
|
|
|
|
|
|
|
Note
payable under insurance financing agreement
|
|
$
|
25,054
|
|
$
|
-
|
|
Amounts
due to related parties
|
|
|
27,133
|
|
|
-
|
|
Accrued
payroll
|
|
|
871,171
|
|
|
775,808
|
|
Accounts
payable and accrued expenses
|
|
|
5,541,457
|
|
|
5,963,589
|
|
Income
tax expense payable
|
|
|
28,450
|
|
|
-
|
|
Due
to HRA
|
|
|
8,754,408
|
|
|
7,942,757
|
|
|
|
|
|
|
|
|
|
Total
current liabilities
|
|
|
15,247,673
|
|
|
14,682,154
|
|
|
|
|
|
|
|
|
|
Commitment
and contingencies
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Shareholders'
deficiency:
|
|
|
|
|
|
|
|
Preferred
stock, $.01 par value, 5,000,000 shares authorized; Class A Preferred,
590,375 shares authorized, none outstanding
|
|
|
-
|
|
|
-
|
|
Common
stock, $.01 par value, 100,000,000 shares authorized;
|
|
|
|
|
|
|
|
33,536,767
shares issued and 33,532,722 outstanding as of December
31, 2007
|
|
|
|
|
|
|
|
33,536,767
shares issued and 33,782,722 outstanding as of December
31, 2006
|
|
|
335,368
|
|
|
335,368
|
|
Additional
paid-in capital
|
|
|
37,174,185
|
|
|
37,149,685
|
|
Common
stock and options to be issued
|
|
|
774,220
|
|
|
774,220
|
|
Accumulated
deficit
|
|
|
(41,104,767
|
)
|
|
(40,052,416
|
)
|
Less:
Treasury stock (4,045 common shares at cost)
|
|
|
(9,473
|
)
|
|
(9,473
|
)
|
|
|
|
|
|
|
|
|
Total
shareholders' deficiency
|
|
|
(2,830,467
|
)
|
|
(1,802,616
|
)
|
|
|
|
|
|
|
|
|
Total
liabilities and shareholders' deficiency
|
|
$
|
12,417,206
|
|
$
|
12,879,538
|
|
The
accompanying notes are an integral part of these consolidated financial
statements.
NEW
YORK HEALTH CARE, INC. AND SUBSIDIARIES
CONSOLIDATED
STATEMENTS OF OPERATIONS
|
|
Year
Ended December 31,
|
|
|
|
2007
|
|
2006
|
|
|
|
|
|
|
|
Net
patient service revenue
|
|
$
|
44,399,303
|
|
$
|
45,558,331
|
|
|
|
|
|
|
|
|
|
Expenses:
|
|
|
|
|
|
|
|
Professional
care of patients
|
|
|
36,626,372
|
|
|
36,747,366
|
|
Operating
income before other operating expenses
|
|
|
7,772,931
|
|
|
8,810,965
|
|
|
|
|
|
|
|
|
|
Other
operating expenses:
|
|
|
|
|
|
|
|
General
and administrative
|
|
|
7,151,284
|
|
|
9,104,897
|
|
Product
development
|
|
|
648,759
|
|
|
1,637,558
|
|
Impairment
of intangible assets
|
|
|
729,792
|
|
|
926,322
|
|
Loss
on disposal and impairment of property and equipment
|
|
|
58,840
|
|
|
-
|
|
Bad
debts expense
|
|
|
-
|
|
|
253,732
|
|
Depreciation
and amortization
|
|
|
404,622
|
|
|
672,584
|
|
Total
other operating expenses
|
|
|
8,993,297
|
|
|
12,595,093
|
|
|
|
|
|
|
|
|
|
Loss
from operations
|
|
|
(1,220,366
|
)
|
|
(3,784,128
|
)
|
|
|
|
|
|
|
|
|
Other
income (expenses):
|
|
|
|
|
|
|
|
Interest
income
|
|
|
77,893
|
|
|
164,969
|
|
Interest
expense
|
|
|
(29,066
|
)
|
|
(61,394
|
)
|
Other
income
|
|
|
193,815
|
|
|
-
|
|
Other
income, net
|
|
|
242,642
|
|
|
103,575
|
|
|
|
|
|
|
|
|
|
(Loss)
from operations before provision for income taxes
|
|
|
(977,724
|
)
|
|
(3,680,553
|
)
|
|
|
|
|
|
|
|
|
Provision
for income taxes
|
|
|
74,627
|
|
|
75,120
|
|
|
|
|
|
|
|
|
|
Net
(loss)
|
|
$
|
(1,052,351
|
)
|
$
|
(3,755,673
|
)
|
|
|
|
|
|
|
|
|
Basic
and diluted income (loss) per share:
|
|
|
|
|
|
|
|
Net
(loss) per share:
|
|
$
|
(0.03
|
)
|
$
|
(0.11
|
)
|
|
|
|
|
|
|
|
|
Weighted
and diluted average shares outstanding
|
|
|
33,536,767
|
|
|
33,250,740
|
|
The
accompanying notes are an integral part of these consolidated financial
statements.
NEW
YORK
HEALTH CARE, INC. AND SUBSIDIARIES
CONSOLIDATED
STATEMENTS OF SHAREHOLDERS' EQUITY
FOR
THE
YEARS ENDED DECEMBER 31, 2007, and 2006
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total
|
|
|
|
Preferred Stock
|
|
Common Stock
|
|
|
|
options to
|
|
Accumulated
|
|
Treasury Stock
|
|
Shareholders'
|
|
|
|
Shares
|
|
Amount
|
|
Shares
|
|
Amount
|
|
in
Capital
|
|
be
issued
|
|
Deficit
|
|
Shares
|
|
Amount
|
|
Deficiency
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance
at January 1, 2006
|
|
|
-
|
|
$
|
-
|
|
|
33,236,767
|
|
$
|
332,368
|
|
$
|
36,667,281
|
|
$
|
990,220
|
|
$
|
(36,296,743
|
)
|
|
4,045
|
|
$
|
(9,473
|
)
|
$
|
1,683,653
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Shares
issued in accordance with the Corval Settlement Agreements
|
|
|
-
|
|
|
-
|
|
|
300,000
|
|
|
3,000
|
|
|
213,000
|
|
|
(216,000
|
)
|
|
-
|
|
|
-
|
|
|
-
|
|
|
-
|
|
Options
earned for services
|
|
|
-
|
|
|
-
|
|
|
-
|
|
|
-
|
|
|
269,404
|
|
|
-
|
|
|
-
|
|
|
-
|
|
|
-
|
|
|
269,404
|
|
Shares
issued to public relations consultant
|
|
|
-
|
|
|
-
|
|
|
250,000
|
|
|
2,500
|
|
|
-
|
|
|
-
|
|
|
-
|
|
|
-
|
|
|
-
|
|
|
2,500
|
|
Cancellation
of shares issued to public relations consultant (actual share cancellation
effectuated in March 2007)
|
|
|
|
|
|
|
|
|
(250,000
|
)
|
|
(2,500
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(2,500
|
)
|
Net
loss
|
|
|
-
|
|
|
-
|
|
|
-
|
|
|
-
|
|
|
-
|
|
|
-
|
|
|
(3,755,673
|
)
|
|
-
|
|
|
-
|
|
|
(3,755,673
|
)
|
Balance
at December 31, 2006
|
|
|
-
|
|
|
-
|
|
|
33,536,767
|
|
|
335,368
|
|
|
37,149,685
|
|
|
774,220
|
|
|
(40,052,416
|
)
|
|
4,045
|
|
|
(9,473
|
)
|
|
(1,802,616
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Options
earned for services
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
24,500
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
24,500
|
|
Net
loss
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(1,052,351
|
)
|
|
|
|
|
|
|
|
(1,052,351
|
)
|
Balance
at December 31, 2007
|
|
|
-
|
|
$
|
-
|
|
|
33,536,767
|
|
$
|
335,368
|
|
$
|
37,174,185
|
|
$
|
774,220
|
|
$
|
(41,104,767
|
)
|
|
4,045
|
|
$
|
(9,473
|
)
|
$
|
(2,830,467
|
)
|
The
accompanying notes are an integral part of these consolidated financial
statements.
NEW
YORK HEALTH CARE, INC. AND SUBSIDIARIES
CONSOLIDATED
STATEMENTS OF CASH FLOWS
|
|
For
the Year Ended
|
|
|
|
December
31
|
|
|
|
2007
|
|
2006
|
|
Cash
flows from operating activities:
|
|
|
|
|
|
|
|
Net
(loss)
|
|
$
|
(1,052,351
|
)
|
$
|
(3,755,673
|
)
|
Adjustments
to reconcile net (loss) to net cash used in operations (excluding
the
effect of disposition) Impairment of intangible
assets
|
|
|
729,792
|
|
|
926,322
|
|
Stock-based
compensation
|
|
|
24,500
|
|
|
269,404
|
|
Depreciation
and amortization
|
|
|
404,622
|
|
|
672,584
|
|
Bad
debts expense (recovery)
|
|
|
(31,113
|
)
|
|
208,678
|
|
Impairment
of property and equipment
|
|
|
58,840
|
|
|
27,000
|
|
|
|
|
|
|
|
|
|
Changes
in operating assets and liabilities, net of effects of
disposition
|
|
|
|
|
|
|
|
(Increase)
decrease in accounts receivable and unbilled services
|
|
|
(1,145,644
|
)
|
|
(108,665
|
)
|
Decrease
(increase) in due from lending institution
|
|
|
274,934
|
|
|
(75,993
|
)
|
Decrease
in prepaid expenses and other current assets
|
|
|
106,768
|
|
|
153,838
|
|
(Increase)
in other assets
|
|
|
(24,481
|
)
|
|
(111,426
|
)
|
Increase
in note payable under insurance financing agreement
|
|
|
25,054
|
|
|
-
|
|
Increase
in due to related parties
|
|
|
27,133
|
|
|
-
|
|
Increase
in accrued payroll
|
|
|
95,363
|
|
|
62,614
|
|
(Decrease)
in accounts payable and accrued expenses
|
|
|
(422,132
|
)
|
|
(2,768,729
|
)
|
Increase
in due to HRA
|
|
|
811,651
|
|
|
1,782,845
|
|
Increase
in taxes payable
|
|
|
28,450
|
|
|
-
|
|
Net
cash used in operating activities
|
|
|
(88,614
|
)
|
|
(2,717,201
|
)
|
|
|
|
|
|
|
|
|
Cash
flows from investing activities:
|
|
|
|
|
|
|
|
Acquisition
of property and equipment - net
|
|
|
-
|
|
|
(43,370
|
)
|
Acquisition
of intangible assets
|
|
|
(134,934
|
)
|
|
(291,728
|
)
|
Net
cash (used in) investing activities
|
|
|
(134,934
|
)
|
|
(335,098
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net
(decrease) in cash and cash equivalents
|
|
|
(223,548
|
)
|
|
(3,052,299
|
)
|
|
|
|
|
|
|
|
|
Cash
and cash equivalents at beginning of year
|
|
|
2,469,789
|
|
|
5,522,088
|
|
Cash
and cash equivalents at end of year
|
|
$
|
2,246,241
|
|
$
|
2,469,789
|
|
The
accompanying notes are an integral part of these consolidated financial
statements.
NEW
YORK HEALTH CARE, INC. AND SUBSIDIARIES
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
December
31, 2007 and 2006
NOTE
1 - ORGANIZATION AND SUMMARY OF SIGNIFICANT ACCOUNTING
POLICIES
Organization
and Basis of Consolidation and Presentation:
New
York
Health Care, Inc. (“New York Health Care”) was organized under the laws of the
State of New York in 1983. New York Health Care provides services of registered
nurses and paraprofessionals to patients throughout New York. The BioBalance
Corp. (“BioBalance”), a Delaware corporation, was formed in May 2001. BioBalance
is a biopharmaceutical company focused on the development of treatments for
gastrointestinal diseases that are poorly addressed by current therapies.
BioBalance is currently pursuing prescription drug development of its lead
product, PROBACTRIX® for the prevention of pouchitis. On March 24, 2006, the
Company received approval from the FDA to start Phase II clinical trials. There
can be no assurance that BioBalance will be successful in obtaining regulatory
approval or in marketing any such products. The consolidated entity,
collectively referred to, unless the context otherwise requires, as the
“Company”, “we”, “our” or similar pronouns, includes New York Health Care and
its wholly-owned subsidiaries, BioBalance and NYHC Newco Paxxon, Inc. D/B/A
Helping Hands Healthcare (“Helping Hands”).
On
January 2, 2003, BioBalance consummated a business combination with New York
Health Care, Inc., a public company. As a result of the merger BioBalance
shareholders exchanged all their BioBalance shares for 2,475,154 shares of
common stock and 590,375 shares of preferred stock of New York Health Care.
Because the former BioBalance shareholders own a majority of the common stock
(89.7%) of the merged company, BioBalance is considered to be the accounting
acquirer in the transaction.
The
accompanying consolidated financial statements have been prepared assuming
that
the Company will continue as a going concern. The Company’s recurring losses and
negative working capital raises substantial doubt about its ability to continue
as a going concern. The consolidated financial statements do not include any
adjustments that might result from the outcome of this uncertainty. Management’s
plans in connection with this matter include drawing down the line of credit
as
necessary and continuing the search for a strategic partner for the BioBalance
operations.
As
of
December 31, 2007, BioBalance had cash on hand of approximately $38,000, all
of
which was available to fund operations. BioBalance management estimates that
its
capital requirements for an entire year of operations is approximately
$5,000,000. This amount includes the cost of the initial up front payment for
the Phase I/II clinical trial, in the amount of $3,000,000, for the Company's
lead product PROBACTRIX® that is not expected to be started in 2008. It will be
necessary for the Company to secure additional funding in order for BioBalance
to begin the Phase I/II clinical trial, which was approved by FDA on March
24,
2006. The Company has not been able to obtain additional funding up to the
present time and the BioBalance subsidiary has been operating solely by
utilizing funds from the health care operations, which are insufficient for
BioBalance's needs. Management is continuing to search for potential funding
sources but none have been found thus far. Accordingly, since additional funding
from outside sources has not been obtained, the Company began scaling back
the
operations of BioBalance at the end of November 2006, and BioBalance began
operating on a substantially reduced budget in 2007. BioBalance management
has
taken steps to secure the data from clinical trials and has begun the production
of a duplicate of the biological strain of PROBACTRIX®. Additionally, BioBalance
surrendered its office space to the landlord in March 2007 in exchange for
lease
cancellation, incurring exit costs through the time the space was fully vacated
of $38,998 and asset disposal losses of approximately
$36,000
.
Management has instituted temporary cutbacks in consultant compensation until
such time as additional funds or a strategic partner can be found. There can
be
no assurances that the Company will be able to raise additional capital in
the
near term to allow BioBalance to continue its normal level of
operations.
BioBalance
has also commenced preliminary studies regarding the use of PROBACTRIX® in the
treatment of Celiac disease (a dietary gluten intolerance). This study was
conducted as a small scale pilot study which, while not providing data that
is
clinically or statistically useful in demonstrating efficacy, produced
encouraging preliminary results. The Company is contemplating various options
including funding costs relating to clinical research and statistical analysis
for a follow up study.
Summary
of Significant Accounting Policies
Estimates:
The
preparation of financial statements in conformity with accounting principles
generally accepted in the United States of America requires management to make
estimates and assumptions that could 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.
Accounts
Receivable:
Accounts
receivable consists of trade receivables recorded at original invoice amount,
less an estimated allowance for uncollectible accounts. Trade credit is
generally extended on a short-term basis; thus trade receivables do not bear
interest, although a finance charge may be applied to receivables that are
past
due. Trade receivables are periodically evaluated for collectiblity based on
past credit history with customers and their current financial condition.
Changes in the estimated collectiblity of trade receivables are recorded in
the
results of operations for the period in which the estimate is revised. Trade
receivables that are deemed uncollectible are offset against the allowance
for
uncollectible accounts. The Company generally does not require collateral for
trade receivables.
Revenue
Recognition:
The
Company recognizes patient service revenue on the date services are rendered.
Unbilled services represent amounts due for services rendered that had not
been
billed at the end of each period because written authorization had not been
received from the referral source.
Property
and Equipment:
Property
and equipment is carried at cost and is depreciated under the straight-line
method over the following estimated useful lives of the assets. Leasehold
improvements are amortized over the estimated useful lives of the improvements
or the life of the lease, whichever is shorter.
|
Machinery
and equipment
|
3-5
years
|
|
Furniture
and fixtures
|
5-7
years
|
Goodwill
and Other Intangible Assets:
Statement
of Financial Accounting Standards (SFAS No. 142) "Goodwill and Other Intangible
Assets" requires that goodwill and intangible assets having indefinite lives
not
be amortized, but instead be tested for impairment at least annually. Intangible
assets determined to have definite lives are amortized over their remaining
useful lives.
Income
Taxes:
The
Company used the asset and liability method to calculate deferred tax assets
and
liabilities. Deferred taxes are recognized based on the differences between
financial reporting and income tax bases of assets and liabilities using enacted
income tax rates. Deferred tax assets and liabilities are measured using enacted
tax rates in effect for the years in which those temporary differences are
expected to be recovered or settled. The effect on deferred tax assets and
liabilities of a change in tax rates is recognized in income in the period
that
includes the enactment date.
Long-Lived
Assets:
Long-lived
assets, such as intangible assets other than goodwill, furniture, equipment
and
leasehold improvements, are evaluated for impairment when events or changes
in
circumstances indicate that the carrying amount of the assets may not be
recoverable through estimated undiscounted future cash flows from the use of
these assets. When any such impairment exists, the related assets will be
written down to fair value.
Cash
Equivalents:
The
Company considers all highly liquid investments with maturities of three months
or less when purchased to be cash equivalents.
Stock
Based Compensation:
On
January 1, 2006 the Company adopted Statement of Financial Accounting
Standards (SFAS) No. 123 (revised 2004), “Share-Based Payment,” (“SFAS
123(R)”). SFAS 123(R) requires the Company to recognize expense related to the
fair value of employee stock option awards and 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. This eliminated the exception to account
for
such awards using the intrinsic method previously allowable under Accounting
Principles Board Opinion No. 25, “Accounting for Stock issued to Employees”
(“APB 25”). Prior to January 1, 2006, we accounted for the stock based
compensation plans under the recognition and measurement provisions of APB
25,
as permitted by SFAS No. 123, “Accounting for Stock-Based
Compensation.”
Effective
January 1, 2006, the Company adopted the fair value recognition provisions
of SFAS 123(R), using the modified-prospective-transition method. Under that
transition method, compensation cost recognized in 2006 and beyond includes:
(a) compensation cost for all share-based payments granted prior to, but
not yet vested as of January 1, 2006, based on the grant date fair value
estimated in accordance with the original provisions of SFAS No. 123, and
(b) compensation cost for all stock-based payments granted subsequent to
January 1, 2006, based on the grant-date fair value estimated in accordance
with the provisions of SFAS 123(R).
Loss
Per Share:
Basic
(loss) per share excludes dilution and is computed by dividing net (loss)
available to common shareholders by the weighted average number of shares of
Common Stock outstanding for the period.
Diluted
earnings per share is computed by dividing income available to common
shareholders by the weighted average number of common shares outstanding for
the
period, adjusted to reflect potentially dilutive securities. Due to losses
from
continuing operations for the years ended December 31, 2007 and 2006, potential
common stock attributable to options, warrants and preferred stock outstanding
of
8,862,046
for
2007
and
8,996,212
for
2006
were not included in the computation of diluted earnings per share, because
to
do so would be antidilutive. During the years ended December 31, 2007 and 2006
potential dilutive securities also include common stock and options to be issued
of 1,500,000.
Classification
of Amounts Due to HRA:
Historically,
management has maintained a liability account to show amounts paid to the
Company under the contract with the City of New York Human Resources
Administration (“HRA”) which were required to be used for certain employee
benefits purposes and were to be paid to or on behalf of the home health aid
employees. In 2006, management determined that approximately $904,000 could
no
longer be used for the employee benefit and could not be paid to the employees
but could be expected to be required to be repaid to HRA. Accordingly, this
amount was reclassified from general accrued expenses to the caption “Due to
HRA”.
Recently
Issued Accounting Pronouncements:
In
December 2007, the FASB issued SFAS No. 141 (revised 2007), "
Business
Combinations.
"
SFAS
141(R) broadens the guidance of SFAS 141, extending its applicability to all
transactions and other events in which one entity obtains control over one
or
more other businesses. It broadens the fair value measurement and recognition
of
assets acquired, liabilities assumed, and interests transferred as a result
of
business combinations. SFAS 141(R) expands on required disclosures to improve
the statement users' abilities to evaluate the nature and financial effects
of
business combinations. SFAS 141(R) is effective for our fiscal year beginning
January 1, 2009. The adoption of SFAS 141(R) is not expected to have a material
impact on the Company's financial position, results of operations or cash
flows.
In
December 2007, the FASB issued SFAS No. 160, "
Noncontrolling
Interests in Consolidated Financial Statements—an amendment of ARB No.
51.
"
SFAS
160 requires that a noncontrolling interest in a subsidiary be reported as
equity and the amount of consolidated net income specifically attributable
to
the noncontrolling interest be identified in the consolidated financial
statements. It also calls for consistency in the manner of reporting changes
in
the parent's ownership interest and requires fair value measurement of any
noncontrolling equity investment retained in a deconsolidation. SFAS 160 is
effective for our fiscal year beginning January 1, 2009. We have not yet
determined the impact of adopting SFAS 160 on the Company's financial position,
results of operations or cash flows.
In
February, 2007, FASB issued SFAS No. 159,
The
Fair Value Option for Financial Assets and Financial
Liabilities
including an amendment of FAS 115, or FAS 159. This statement provides companies
with an option to report selected financial assets and liabilities at fair
value. This statement is effective for fiscal years beginning after November
15,
2007 with early adoption permitted. We believe that adoption of FAS No. 159
will
not have a material affect on our results of operations or financial
position.
In
September 2006, the FASB issued SFAS No. 158 Employers' Accounting for
Defined Benefit Pension and Other Postretirement Plans - an Amendment of FASB
Statements No. 87, 88, 106, and 132(R). This statement requires a company
to recognize the funded status of a benefit plan as an asset or a liability
in
its statement of financial position. In addition, a company is required to
measure plan assets and benefit obligations as of the date of its fiscal
year-end statement of financial position. The recognition provision of this
statement, along with additional disclosure requirements, is effective for
fiscal years ending after December 15, 2006, while the measurement date
provision is effective for fiscal years ending after December 15, 2008.
Management does not believe that adoption of this statement will have a material
impact on the financial position of the Company.
In
September 2006, the FASB issued SFAS No. 157, "
Fair
Value Measurements
"
which
defines fair value, establishes guidelines for measuring fair value and expands
disclosures regarding fair value measurements. SFAS 157 and eliminates
inconsistencies in guidance found in various prior accounting pronouncements.
SFAS 157 is effective for fiscal years beginning after November 15, 2007.
However, on February 12, 2008, the FASB issued proposed FASB Staff Position
("FSP") SFAS No. 157-2, "
Effective
Date of FASB Statement No. 157
,"
which
defers the effective date for adoption of fair value measurements for
nonfinancial assets and liabilities to fiscal years beginning after November
15,
2008. The Company will adopt SFAS 157 during 2008, except as it applies to
those
non-financial assets and non-financial liabilities as noted in proposed FSP
157-2. The partial adoption of SFAS 157 is not expected to have a material
impact on the Company's financial position, results of operations or cash
flows.
In
June,
2006, the FASB issued Interpretation No. 48,
Accounting for Uncertainty in Income Taxes, an Interpretation of FASB Statement
No. 109, Accounting for Income Taxes
(FIN48),
to create a single model to address accounting for uncertainty in tax positions.
FIN 48 clarifies the accounting for income taxes by prescribing a minimum
recognition threshold a tax position is required to meet before being recognized
in the financial statements. FIN 48 also provides guidance on derecognition,
measurement, classification, interest, and penalties, accounting in interim
periods, disclosure and transition. The Company adopted FIN 48 as of
January 1, 2007. Based on our evaluation, we have concluded that there are
no significant uncertain tax positions requiring recognition in our financial
statements. Our evaluation was performed for the tax years which remain subject
to examination by major tax jurisdictions as of December 31, 2007. We may from
time to time be assessed interest or penalties by major tax jurisdictions,
although any such assessments historically have been minimal and immaterial
to
our financial results. In the event we have received an assessment for interest
and/or penalties, it has been classified in the financial statements as selling,
general and administrative expense. The Company is currently subject to a three
year statue of limitations by major tax jurisdictions. The Company and its
subsidiaries file income tax returns in the U.S. federal jurisdiction, New
York
State, New York City and New Jersey.
NOTE
2 - PROPERTY AND EQUIPMENT
Property
and equipment, at cost consist of the following at December 31:
|
|
2007
|
|
2006
|
|
Machinery
and equipment
|
|
$
|
190,874
|
|
$
|
280,696
|
|
Furniture
and fixtures
|
|
|
29,083
|
|
|
46,033
|
|
Leasehold
improvements
|
|
|
52,136
|
|
|
52,136
|
|
|
|
|
272,093
|
|
|
378,865
|
|
Less:
accumulated depreciation
|
|
|
250,003
|
|
|
257,967
|
|
|
|
$
|
22,090
|
|
$
|
120,898
|
|
Depreciation
expense for the years ended December 31, 2007 and 2006 was approximately $40,000
and $52,000 respectively.
NOTE
3 - GOODWILL AND INTANGIBLE ASSETS:
The
annual changes in the carrying amount of goodwill relating entirely to the
home
healthcare business since 2006 were as follows:
|
|
New York
Health Care
|
|
BioBalance
|
|
|
|
|
|
|
|
|
|
Balance
as of January 1, 2006
|
|
$
|
783,000
|
|
|
-
|
|
Impairment
for year Ended December 31, 2006
|
|
|
-
|
|
|
-
|
|
|
|
|
|
|
|
|
|
Balance
as of December 31, 2006
|
|
|
783,000
|
|
|
-
|
|
Impairment
for year Ended December 31, 2007
|
|
|
-
|
|
|
-
|
|
|
|
|
|
|
|
|
|
Balance
as of December 31, 2007
|
|
$
|
783,000
|
|
$
|
-
|
|
The
major
classifications of intangible assets and their respective estimated useful
lives
are as follows:
|
|
December 31, 2007
|
|
|
|
Gross Amount
|
|
Accumulated
Amortization
|
|
Net Carrying
Amount
|
|
Estimated
Useful Life in Years
|
|
|
|
|
|
|
|
|
|
|
|
Patents
and trademarks
|
|
$
|
910,195
|
|
$
|
282,139
|
|
$
|
628,056
|
|
|
10
|
|
Customer
base
|
|
|
316,000
|
|
|
316,000
|
|
|
-
|
|
|
5
|
|
|
|
$
|
1,226,195
|
|
$
|
598,139
|
|
$
|
628,056
|
|
|
|
|
|
|
December 31, 2006
|
|
|
|
Gross Amount
|
|
Accumulated
Amortization
|
|
Net Carrying
Amount
|
|
Estimated
Useful Life in
Years
|
|
|
|
|
|
|
|
|
|
|
|
Intellectual
property
|
|
$
|
2,036,500
|
|
$
|
1,103,053
|
|
$
|
933,447
|
|
|
10
|
|
Patents
and trademarks
|
|
|
775,260
|
|
|
196,296
|
|
|
578,964
|
|
|
10
|
|
Customer
base
|
|
|
316,000
|
|
|
252,916
|
|
|
63,084
|
|
|
5
|
|
|
|
$
|
3,127,760
|
|
$
|
1,552,265
|
|
$
|
1,575,495
|
|
|
|
|
On
August 20, 2003, the Company purchased from NexGen Bacterium Inc. ("NexGen")
certain proprietary technology and intellectual property assets that did not
constitute a business.
At
December 31, 2006, management determined that the remaining value of the NexGen
Platform was impaired in its entirety due to inconclusive testing results.
While
management believes that further testing may prove the safety and efficacy
of
the NexGen Platform, a decision was made to devote all efforts and funds towards
the development and clinical trials of PROBACTRIX® , if, as and when further
funding is received or a strategic partner joins the Company. Accordingly,
during the year ended December 31, 2006, management recorded an impairment
loss
of $926,322 (intellectual property $334,787; patents and trademarks $341,285
and; non-compete agreement $250,250), representing the entire unamortized
balance of the NexGen Platform and has discontinued any further testing or
development of the Platform at this time.
At
December 31, 2007, management determined that the value of the PROBACTRIX®
intellectual property was partially impaired due to the results of clinical
studies related to the Irritable Bowel Syndrome ("IBS") indication (unusually
high placebo response rate). Accordingly, during the year ended December 31,
2007, management recorded an impairment loss of $729,792. As of December 31,
2007, the net carrying value of $628,056 of intangible assets representing
the
cost of patents net of accumulated amortization, were attributable to
BioBalance. BioBalance is a research and development company and has had
significant losses since inception. In November 2006, as described in Note
1, a
decision was made to scale back the operations of BioBalance by surrendering
its
office space in March 2007 and continuing to operate on a substantially reduced
budget.
Amortization
expense for intangible assets amounted to
$340,509
and
$620,061, for the years ended December 31, 2007 and 2006, respectively.
Amortization of deferred loan costs in 2007 was $12,073.
Future
amortization of existing intangible assets for their remaining useful
lives:
For the Years Ending
December 31,
|
|
|
|
|
|
|
|
2008
|
|
$
|
91,354
|
|
2009
|
|
|
91,354
|
|
2010
|
|
|
91,354
|
|
2011
|
|
|
91,354
|
|
2012
|
|
|
91,354
|
|
Thereafter
|
|
|
171,286
|
|
|
|
$
|
628,056
|
|
NOTE
4 - ACCOUNTS PAYABLE AND ACCRUED EXPENSES:
Accounts
payable and accrued expenses consist of the following at December
31:
|
|
2007
|
|
2006
|
|
Accounts
payable
|
|
$
|
492,446
|
|
$
|
561,445
|
|
Accrued
expenses
|
|
|
505,995
|
|
|
765,150
|
|
Accrued
settlement per consulting agreement
|
|
|
1,131,100
|
|
|
1,131,100
|
|
Accrued
employee benefits (a)
|
|
|
3,411,916
|
|
|
3,505,894
|
|
|
|
$
|
5,541,457
|
|
$
|
5,963,589
|
|
(a)
Accrued
employee benefits include a component of amounts collected by the Company from
HRA that is required to be used for employee recruitment and retention. In
the
even that the Company does not use these funds for the specified purposes,
it
may be required to return those funds to HRA.
NOTE
5 - LINE OF CREDIT:
On
September 20, 2007 (amended on December 13, 2007), New York Health Care entered
into a Loan and Security Agreement with CIT Healthcare LLC, as lender
(“
Lender
”).
The
term of the Loan and Security Agreement is three years. The Loan and Security
Agreement provides for a revolving line of credit facility under which New
York
Health Care may borrow, repay and re-borrow an amount not exceeding the lesser
of $5,000,000 or the borrowing base, which is an amount that may not exceed
85.00% of the estimated net value of New York Health Care's Eligible Accounts,
as defined in the agreement. As of December 31, 2007, approximately $3,600,000
of the line was available for borrowing by the Company.
Interest
is payable on the outstanding principal balance of the credit facility at an
annual rate equal to 30-day LIBOR plus three and one-half percent (3.50%),
adjusted monthly in accordance with changes in 30-day LIBOR. At December 31,
2007, the interest rate on this facility was
8.1%
.
Additionally, the Company is required to pay an Unused Line Fee and a Collateral
Management Fee, the total of which represent 0.50% per annum of the line
amount.
New
York
Health Care's obligations to Lender under the Loan and Security Agreement are
secured by a first priority lien on all of New York Health Care's accounts
receivable, general intangibles, instruments and documents, and the proceeds
thereof. However, no collateral will consist of any assets or property of
BioBalance.
Beginning
with the quarter ended September 30, 2007, the Company is subject to meeting
periodic financial covenants contained in the Loan and Security Agreement.
As of
December 31, 2007, the Company was in compliance with all of the specified
financial covenants.
The
Company is prohibited from making dividends, distributions and other withdrawals
during the term of the credit facility. However, New York Health Care is
permitted to make loans, advances or contributions to its subsidiary, BioBalance
provided that certain liquidity requirements are met. The Company is further
restricted from mergers and acquisitions, as well as asset sales or dispositions
outside the ordinary course of business, provided that such sale restrictions
are not applicable to the sale of the stock or assets of BioBalance.
As
of
December 31, 2007, there was no balance due on this line of credit. For the
year
ended December 31, 2007, the company incurred interest expense of $11,492 on
this line of credit.
New
York
Health Care previously had an agreement with G.E. Capital Health Care Financial
Services ("G.E. Capital") that expired on March 30, 2007 providing for a
$4,000,000 line of credit and lockbox collection services. The lender did not
allow any borrowing on this line in 2007 and 2006.
At
December 31, 2006, there was an amount due from G.E. Capital of
$274,934
.
This
resulted from collections deposited with G.E. Capital through a lockbox and
then
transferred to the Company's bank account.
NOTE
6 - INCOME TAXES:
Deferred
tax attributes resulting from differences between financial accounting amounts
and tax bases of assets and liabilities at December 31, 2007 and 2006 follows
(rounded to the nearest thousand).
|
|
2007
|
|
2006
|
|
Current
assets:
|
|
|
|
|
|
|
|
Allowance
for doubtful accounts
|
|
$
|
230,000
|
|
$
|
243,000
|
|
Prepaid
expenses
|
|
|
41,000
|
|
|
(78,000
|
)
|
|
|
|
271,000
|
|
|
165,000
|
|
Valuation
allowance
|
|
|
(271,000
|
)
|
|
(165,000
|
)
|
Net
current deferred tax asset
|
|
$
|
-
|
|
$
|
-
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Noncurrent
assets:
|
|
|
|
|
|
|
|
Net
operating loss carryforwards
|
|
$
|
7,359,000
|
|
$
|
7,033,000
|
|
Depreciation
|
|
|
(1,000
|
)
|
|
(7,000
|
)
|
Amortization
of goodwill
|
|
|
-
|
|
|
-
|
|
Amortization
of intangibles
|
|
|
1,613,000
|
|
|
455,000
|
|
|
|
|
8,971,000
|
|
|
7,481,000
|
|
Valuation
allowance
|
|
|
(8,971,000
|
)
|
|
(7,481,000
|
)
|
Net
deferred deferred tax asset
|
|
$
|
-
|
|
$
|
-
|
|
As
of
December 31, 2007, the Company had net operating loss carry forwards of
approximately
$17,000,000
which
expire between 2022 through 2027.
The
provision (benefit) for income taxes, consist of the following:
|
|
Year Ended December 31,
|
|
|
|
2007
|
|
2006
|
|
|
|
|
|
|
|
Current
tax expense
|
|
$
|
74,627
|
|
$
|
75,120
|
|
Deferred
tax expense (benefit)
|
|
|
1,596,000
|
|
|
2,370,000
|
|
Net
change in valuation allowance
|
|
|
(1,596,000
|
)
|
|
(2,370,000
|
)
|
|
|
|
|
|
|
|
|
|
|
$
|
74,627
|
|
$
|
75,120
|
|
The
provision (benefit) for income taxes is comprised of the following:
|
|
Year Ended December 31,
|
|
|
|
2007
|
|
2006
|
|
Current:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Federal
income
|
|
$
|
-
|
|
$
|
-
|
|
State
income taxes
|
|
|
74,627
|
|
|
75,120
|
|
|
|
|
|
|
|
|
|
|
|
$
|
74,627
|
|
$
|
75,120
|
|
The
statutory Federal income tax rate and the effective rate is reconciled as
follows:
|
|
Year Ended December 31,
|
|
|
|
2007
|
|
2006
|
|
Statutory
Federal income tax rate
|
|
|
34
|
%
|
|
34
|
%
|
|
|
|
|
|
|
|
|
State
taxes, net of Federal tax benefit
|
|
|
12
|
%
|
|
12
|
%
|
|
|
|
|
|
|
|
|
Valuation
allowance
|
|
|
-45
|
%
|
|
-45
|
%
|
|
|
|
|
|
|
|
|
Over/under
accrual
|
|
|
-1
|
%
|
|
-1
|
%
|
|
|
|
|
|
|
|
|
|
|
|
0
|
%
|
|
0
|
%
|
NOTE
7 - FAIR VALUE OF FINANCIAL INSTRUMENTS:
As
of
December 31, 2007 and 2006, the carrying amount of cash and cash equivalents,
accounts receivable, accounts payable and accrued expenses, accrued payroll
and
due to HRA, approximates fair value due to their short-term
nature.
NOTE
8 - SHAREHOLDERS' EQUITY:
On
March
6, 2006, the Company agreed to issue 400,000 shares of common stock (valued
at
$312,000) and 1,100,000 options (valued at $462,220) to settle with Emerald
Asset, who provided services as a consultant to the Company, as part of a final
settlement with the Emerald Asset. These amounts were recorded as common stock
and options to be issued at December 31, 2005.
On
March
9, 2006, the Company agreed to issue 300,000 shares of Common Stock (valued
at
$216,000) to a former consultant of the Company as part of a final settlement
with the consultant. At December 31, 2005, these shares were recorded as common
stock and options to be issued. These shares were subsequently issued in October
2006. Warrants that were previously granted to the consultant expired while
held
in suspension by the Company. The consultant has asserted that these warrants
were wrongfully held in suspension and had expired prior to being released
by
the Board of Directors.
In
July
2006, the Company issued 250,000 shares to a public relations consultant. All
of
the shares were unconditionally returned to the Company in March
2007.
NOTE
9 - STOCK OPTION/WARRANTS:
For
the
years ended December 31, 2007 and 2006, no consultant warrants were issued
and
no expense was recognized.
The
shareholders approved an option plan on August 31, 2005, that allows for the
issuance of warrants and options to consultants.
Performance
Incentive Plan:
On
August
31, 2005, the shareholders approved the Company's 2004 Incentive Plan, (the
"Incentive Plan"). Under the terms of the Incentive Plan, up to 5,000,000 shares
of common stock may be granted. The Incentive Plan is administered by the
Compensation Committee which is appointed by the Board of Directors. The
Committee determines which key employee, officer or director on the regular
payroll of the Company, or outside consultants shall receive stock options.
Granted options are exercisable after the date of grant in accordance with
the
terms of the grant up to ten years after the date of the grant. The exercise
price of any incentive stock option or nonqualified option granted under the
Incentive Plan may not be less than 100% of the fair market value of the shares
of common stock of the Company at the time of the grant.
On
March
26, 1996, the Company's Board of Directors adopted the Performance Incentive
Plan, (the "Option Plan"). The Option plan has substantially the same terms
as
the Incentive Plan above.
Options/Warrants:
The
following options and warrants were issued to employees and non-employee Board
of Directors and consultants in accordance with the Company's Performance
Incentive Plan. However, they may not be outstanding at each year
end.
Grant Date
|
|
Number of Options
|
|
Exercise
Price
|
|
Expiration Term
|
|
|
|
|
|
|
|
|
|
February
28, 2007
|
|
|
50,000
|
|
$
|
0.13
|
|
|
10
years
|
|
August
20, 2007
|
|
|
225,000
|
|
$
|
0.15
|
|
|
10
years
|
|
|
|
|
|
|
|
|
|
|
|
|
January
4, 2006
|
|
|
45,000
|
|
$
|
0.78
|
|
|
5
years
|
|
March
6, 2006
|
|
|
1,100,000
|
|
$
|
0.78
|
|
|
4
years
|
|
July
19, 2006
|
|
|
250,000
|
|
$
|
0.57
|
|
|
5
years
|
|
July
27, 2006
|
|
|
20,000
|
|
$
|
0.60
|
|
|
10
years
|
|
September
20, 2006
|
|
|
450,000
|
|
$
|
0.37
|
|
|
10
years
|
|
At
December 31, 2007, the Company has shares of common stock reserved for issuance
of these options/warrants and for options/warrants granted
previously.
Valuation
assumptions for these options are as follows:
|
|
2007
|
|
2006
|
|
Risk
free interest rate
|
|
|
4.64%
|
|
|
4.3%
- 5.1%
|
|
Expected
volatility of common stock
|
|
|
108%
|
|
|
0%
- 102%
|
|
Dividend
yield
|
|
|
0%
|
|
|
0%
|
|
Expected
option term
|
|
|
10
years
|
|
|
2-5
years
|
|
Activity
in stock options and warrants, including those outside the Performance Incentive
Plan, for each
of
the
three years ended December 31, is summarized as follows:
|
|
|
|
|
|
|
|
Shares
Under Options/Warrants
|
|
Weighted
Average Exercise Price
|
|
|
|
|
|
|
|
Balance
at January 1, 2006
|
|
|
7,906,778
|
|
$
|
0.98
|
|
|
|
|
|
|
|
|
|
Options
granted
|
|
|
1,865,000
|
|
$
|
0.65
|
|
Options
exercised
|
|
|
-
|
|
|
-
|
|
Options
cancelled/expired
|
|
|
(775,566
|
)
|
$
|
1.29
|
|
|
|
|
|
|
|
|
|
Balance
at December 31, 2006
|
|
|
8,996,212
|
|
$
|
0.93
|
|
|
|
|
|
|
|
|
|
Options
granted
|
|
|
275,000
|
|
$
|
0.14
|
|
Options
exercised
|
|
|
-
|
|
|
-
|
|
Options
cancelled/expired
|
|
|
(409,166
|
)
|
$
|
0.81
|
|
|
|
|
|
|
|
|
|
Balance
at December 31, 2007
|
|
|
8,862,046
|
|
$
|
0.88
|
|
*Includes
the performance based warrants discussed above.
All
of
the options listed in the above table have no intrinsic value as their exercise
prices are all in excess of the market value of the Company’s common stock as of
December 31, 2007.
During
the years ended December 31, 2007 and 2006, the Company incurred $24,500 and
$
269,404
of
stock
compensation expense, respectively.
On
November 26, 2003, the Company suspended the 100,000 options granted on March
7,
2003, to Paul Stark, the former President of BioBalance. The options are
considered outstanding but can not be exercised until the Company gives notice
that they may be exercised. The options have been recorded under the intrinsic
value method.
The
following table summarizes information about options and warrants outstanding
and exercisable at December 31, 2007:
|
|
|
Options/Warrants
Outstanding
|
|
|
Options/Warrants
Exercisable
|
|
Range
of Exercise Price
|
|
|
Options/
Warrants Outstanding
|
|
|
Weighted
Average Remaining Contractual Life
|
|
|
Weighted
Average Exercise Price
|
|
|
Options
Warrants Exercisable
|
|
|
Weighted
Average Options Warrants Exercisable
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$3.69
|
|
|
100,000
|
|
|
0.71
|
|
$
|
3.69
|
|
|
100,000
|
|
$
|
3.69
|
|
$3.22-3.47
(A)
|
|
|
48,387
|
|
|
0.01
|
|
$
|
3.31
|
|
|
48,387
|
|
$
|
3.31
|
|
$3.14
|
|
|
160,000
|
|
|
5.19
|
|
$
|
3.14
|
|
|
160,000
|
|
$
|
3.14
|
|
$2.55
|
|
|
75,333
|
|
|
0.42
|
|
$
|
2.55
|
|
|
75,333
|
|
$
|
2.55
|
|
$2.44
|
|
|
6,667
|
|
|
0.42
|
|
$
|
2.44
|
|
|
6,667
|
|
$
|
2.44
|
|
$1.50
|
|
|
51,333
|
|
|
0.98
|
|
$
|
1.50
|
|
|
51,333
|
|
$
|
1.50
|
|
$1.21
|
|
|
150,000
|
|
|
2.67
|
|
$
|
1.21
|
|
|
150,000
|
|
$
|
1.21
|
|
$1.21
|
|
|
50,000
|
|
|
3.01
|
|
$
|
1.21
|
|
|
50,000
|
|
$
|
1.21
|
|
$1.20
|
|
|
105,000
|
|
|
2.67
|
|
$
|
1.20
|
|
|
105,000
|
|
$
|
1.20
|
|
$1.00
|
|
|
200,000
|
|
|
3.42
|
|
$
|
1.00
|
|
|
200,000
|
|
$
|
1.00
|
|
$0.97
|
|
|
66,667
|
|
|
1.87
|
|
$
|
0.97
|
|
|
66,667
|
|
$
|
0.97
|
|
$0.89
|
|
|
133,333
|
|
|
3.01
|
|
$
|
0.92
|
|
|
133,333
|
|
$
|
0.92
|
|
$0.78
|
|
|
5,726,993
|
|
|
2.15
|
|
$
|
0.78
|
|
|
5,726,993
|
|
$
|
0.78
|
|
$0.78
|
|
|
45,000
|
|
|
3.01
|
|
$
|
0.78
|
|
|
45,000
|
|
$
|
0.78
|
|
$0.78
|
|
|
1,100,000
|
|
|
2.18
|
|
$
|
0.78
|
|
|
1,100,000
|
|
$
|
0.78
|
|
$0.75
|
|
|
133,333
|
|
|
2.58
|
|
$
|
0.75
|
|
|
133,333
|
|
$
|
0.75
|
|
$0.75
|
|
|
200,000
|
|
|
2.52
|
|
$
|
0.75
|
|
|
200,000
|
|
$
|
0.75
|
|
$0.60
|
|
|
10,000
|
|
|
8.58
|
|
$
|
0.60
|
|
|
10,000
|
|
$
|
0.60
|
|
$0.37
|
|
|
225,000
|
|
|
8.72
|
|
$
|
0.37
|
|
|
225,000
|
|
$
|
0.37
|
|
$0.13
|
|
|
50,000
|
|
|
9.16
|
|
$
|
0.13
|
|
|
50,000
|
|
$
|
0.13
|
|
$0.15
|
|
|
225,000
|
|
|
9.64
|
|
$
|
0.15
|
|
|
225,000
|
|
$
|
0.15
|
|
Total
|
|
|
8,862,046
|
|
|
2.64
|
|
$
|
0.88
|
|
|
8,862,046
|
|
$
|
0.88
|
|
(A)
-
Expired on January 1, 2008
NOTE
10 - COMMITMENTS AND CONTINGENCIES:
Compliance
with State Securities Laws
During
October 2004, it was determined that certain of the shares of Common Stock
that
the Company issued to holders of BioBalance stock in connection with the
Company's January 2003 acquisition of BioBalance may not have been exempt from
the registration or qualification requirements of the state securities laws
of
certain of the states where the holders of BioBalance stock then resided
although they were registered under the Securities Act of 1933, as amended.
Although the Company is unable to quantify the actual number of shares involved
that are still owned by the original recipients of the Company's Common Stock
received in the BioBalance acquisition, the per share purchase price paid by
the
BioBalance holders for the BioBalance shares they exchanged in the acquisition
ranged from $.03 to $3.00 per share and the Company currently believes that
the
purchase price paid by such persons who might have certain statutory rescission
rights does not exceed approximately $345,000, exclusive of any penalties or
interest, although no assurance can be given that any such claims will not
exceed this amount. The Company cannot determine the effect, if any, on its
operations or financial condition that may occur from the failure to register
or
qualify these shares under applicable state securities laws. If it is determined
that the Company offered Common Stock in connection with the BioBalance
acquisition without properly registering or qualifying the shares under state
laws, or securing exemption from registration, regulators could impose on the
Company monetary fines or other sanctions as provided under these laws. The
Company is unable to estimate the amount of monetary fines, if any, or the
nature or scope of any sanctions at this time and is continuing its
investigation of this matter.
Risk
Factors Associated with Fair Labor Standards Act:
On
July
22, 2004, the federal Second Circuit Court of Appeals issued a ruling on the
applicability to paraprofessional field staff in New York of the Fair Labor
Standards Act “companionship services” exemption from minimum wage and overtime
requirements. Home care providers have long relied on this exemption to provide
compensation to home care aides and personal care workers with the expectation
that there is no obligation under federal laws for overtime pay. In September
2004, a request for a rehearing was submitted en banc for the full Court. On
January 13, 2005, the Court rejected the request for a rehearing on the
issue.
The
issue
was submitted to the Supreme Court and, on January 23, 2006, the Supreme Court
granted a writ of certiorari, vacated the judgment and remanded the case to
the
Second Circuit Court of Appeals to reconsider its decision in light of the
memorandum issued by the U.S. Department of Labor on December 1, 2005. In that
memo, the DOL stated that it considers its regulations allowing the
companionship exemption to be used by third party employers to be “authoritative
and legally binding”. The Second Circuit Court of Appeals reconsidered and, on
August 31, 2006, reaffirmed its decision. The Supreme Court again granted a
writ
of certiorari on January 5, 2007. In June 2007, the U.S. Supreme Court issued
its decision which upheld the "companionship exemption" as applying to
employment by "third party employers", e.g. home care agencies, such as New
York
Health Care.
Lease
Commitments
The
Company leases office space under non-cancelable operating leases which expire
between June 2008 and June 2011.
At
December 31, 2007, future minimum lease payments due under operating leases
approximate:
For the Years Ending December 31,
|
|
|
|
2008
|
|
$
|
285,000
|
|
2009
|
|
|
275,000
|
|
2010
|
|
|
136,000
|
|
2011
|
|
|
43,000
|
|
Thereafter
|
|
|
-
|
|
|
|
$
|
739,000
|
|
Rent
expense for Company facilities charged to operations, including real estate
taxes, was approximately $355,000 and $461,000 for the years ended December
31,
2007 and 2006.
In
April
2006, the Company entered into a five year non-cancelable operating lease for
office space in New York, New York at an average annual rental of approximately
$182,000 for its BioBalance subsidiary. In March 2007, the Company entered
into
an agreement with the landlord whereby it was released from its obligation
under
the lease going forward from the date of the agreement. Pursuant to the
agreement, the Company surrendered the premises. The Company incurred a loss
of
approximately
$101,000
in
connection with terminating the lease of which $27,000 was charged to property
impairment in 2006 and approximately
$74,000
was
charged to operations during 2007. Rent expense incurred by the Company relating
to this lease for the years ended December 31, 2007 and 2006 was approximately
$26,000
and
$118,000, respectively. This lease has been eliminated from the table above
due
to its termination in 2007.
Employment
Agreements:
In
June
2004, the Company entered into an employment agreement with Dennis O'Donnell
the
president and CEO of the Company that expired on May 5, 2006 at an annual
compensation of $200,000. The board approved an increase of $25,000 upon the
closing of the Offering of securities that took place on February 24, 2005.
On
May 6, 2005, the board of directors approved a bonus of $90,000 and granted
him
100,000 options to acquire common stock. In 2006, the Board approved a bonus
of
$112,500. On September 6, 2006, Mr. O’Donnell resigned his positions as
President, Chief Executive Officer and a Director of New York Health Care Inc.
and its subsidiary BioBalance Corporation.
Effective
February 5, 2007, Stewart W. Robinson was appointed to serve as the Company’s
Chief Financial Officer on a part-time basis. The Company has agreed to pay
Mr.
Robinson on a per diem basis, with total compensation for the 2007 calendar
year
capped at
$65,000
for
36
days up to a maximum of 45 days per calendar year. Due to increased
responsibilities not originally contemplated, Mr. Robinson worked approximately
44 additional days and received additional compensation of
$79,531
for
a
total salary of
$144,531
in
2007.
Other compensation for Mr. Robinson includes: payment for bookkeeping and
clerical services ($4,825) provided by persons employed by him or KBL, LLP;
reimbursement for office related expenses incurred of $877; reimbursement for
software and related training costs of $2,340 and; continuing education and
related travel costs specifically related to his position with the company
of
$2,251.
Effective
August 20, 2007, the Board of Directors appointed Murry Englard Chief Executive
Officer of the Company. Prior to such appointment, Mr. Englard was serving
as
Acting Chief Executive Officer and a Director. Mr. Englard will continue to
serve as a Director of the Company. Mr. Englard will receive a monthly salary
of
$8,333 for his services as Chief Executive Officer. The term for Mr. Englard’s
service as Chief Executive Officer will be one year, renewable monthly, and
the
Company will continue its search for a full-time Chief Executive Officer. In
2007, Mr. Englard received salaries of
$44,231
,
a bonus
of
$15,000
,
director's fees of $35,200 and, expense reimbursements of $11,026. In 2006,
Mr.
Englard received director's fees of
$18,000
.
401(k)
Plan:
The
Home
Healthcare segment maintains an Internal Revenue Code Section 401(k) salary
deferred savings plan (the "Plan") for eligible employees who have been employed
for at least one year and are at least 21 years old. Subject to certain
limitations, the Plan allows participants to voluntarily contribute up to 15%
of
their pay on a pretax basis. The Company currently contributes 50% of each
dollar contributed to the Plan by participants up to a maximum of 3% of the
participant's salary. The Plan also provides for certain discretionary
contributions by the Company as determined by the Board of Directors. The
Company's contributions offset by unvested, forfeited matching funds amounted
to
approximately $45,000 and $46,000 for the years ended December 31, 2007 and
2006, respectively.
Profit
Sharing Plan:
The
Company maintains a qualified profit sharing plan under Internal Revenue Code
Section 401 whereby it may contribute up to 15% of employee compensation.
Specified employees are generally eligible for plan participation upon their
employment commencement date with immediate vesting on the employee’s plan
entrance date. All contributions to the plan are at the discretion of Company
management. The Company made contributions to the plan of $162,583 and $169,739
for the years ended December 31, 2007, and 2006 respectively.
Bonus
Plan:
The
Home
Healthcare segment of the Company has established a bonus plan pursuant to
which
10% of the Company's pre-tax net income is contributed to a bonus pool which
is
available for distribution to all employees as decided by the Company's
Compensation Committee. All allocated amounts were paid before year end and
no
bonus was accrued for 2007 and 2006..
Concentrations
of Credit Risk:
Financial
instruments that potentially subject the Company to concentrations of credit
risk consist of temporary cash investments, which from time-to-time exceed
the
Federal depository insurance coverage and commercial accounts receivable. The
Company has cash investment policies that restrict placement of these
investments to financial institutions evaluated as highly creditworthy. Cash
and
cash equivalents held in one bank exceed federally insured limits by
approximately
$2,038,000
at
December 31, 2007. The Company does not require collateral on commercial
accounts receivable as the customer base generally consists of large,
well-established institutions.
Major
Customers:
One
major
customer accounted for approximately 56% and 55% of net patient service revenue
for the years ended December 31, 2007 and 2006. In addition, three customers
represented approximately 41% and 38% of accounts receivable at December 31,
2007 and 2006, respectively.
Business
Risks:
The
Company's primary business, offering home healthcare services, is heavily
regulated at both the federal and state levels. While the Company is unable
to
predict what regulatory changes may occur or the impact on the Company of any
particular change, the Company's operations and financial results could be
negatively affected.
Further,
the Company operates in a highly competitive industry, which may limit the
Company's ability to price its services at levels that the Company believes
appropriate. These competitive factors may adversely affect the Company's
financial results.
Cautionary
Statement
BioBalance
operates in a competitive environment that involves a number of risks, some
of
which are beyond its control. Although we believe the expectations for
BioBalance are based on reasonable assumptions, we can give no assurance that
our expectations will be attained. Factors that could cause actual events or
results to differ materially from expected results involve both known and
unknown risks. Key factors include, among others: our need to secure additional
financing and at acceptable terms; the high cost and uncertainty of clinical
trials and other development activities involving pharmaceutical products;
the
dependence on third parties to manufacture its products; the unpredictability
of
the duration and results of regulatory approval for our products; our dependence
on our lead biotherapeutic agent, PROBACTRIX® and the uncertainty of its market
acceptance; the possible impairment of, or inability to enforce, intellectual
property rights and the subsequent costs of defending these rights; and the
loss
of key executives or consultants.
Litigation
We
are
subject to various legal proceedings and claims, either asserted or unasserted,
which arise in the ordinary course of business. While the outcome of these
claims cannot be predicted with certainty, management does not believe that
the
outcome of any of these legal matters will have a material adverse effect on
our
results of operations or financial position, except as follows:
On
March
30, 2006, the Company was served with a shareholder derivative complaint
captioned Jay Glatzer v. Yitz Grossman, Emerald Asset Management, Murry Englard,
Michael Nafash, Stuart Ehrlich, and Dennis O'Donnell and New York Health Care,
Inc., (Supreme Court of State of New York County of Nassau, (Index No. 5125/06).
The lawsuit alleged that the directors breached their fiduciary duty by
approving the Emerald Settlement Agreement disclosed in the Company's Form
8-K
(Date of Report March 6, 2006) filed with the Securities Exchange Commission
on
March 10, 2006. The lawsuit claimed that such breach was a product of their
respective relationships with Mr. Grossman. The lawsuit also alleged that Mr.
Grossman and Emerald Asset Management injured the Company by engaging in the
actions underlying the November 2004 criminal conviction of Mr. Grossman. The
lawsuit was dismissed in September 2006. A notice of appeal was filed by the
plaintiff in October 2006 and the plaintiff filed its appeal brief in April
2007. On January 15, 2008, the court dismissed the appeal.
On
March
9, 2006, the Company entered into a final settlement agreement (the "Corval
Settlement Agreement") with Mark Olshenitsky related to the resolution of
disputes under a consulting agreement dated April 14, 2003 (the "Corval
Consulting Agreement") between the Company and Corval International, Inc.
("Corval"). Pursuant to the Corval Consulting Agreement, Corval was issued
warrants to purchase 500,000 shares of the Company's Common Stock for $2.50
per
share until April 21, 2004 (the "Warrants"). Mark Olshenitsky ("Olshenitsky")
is
the sole owner of Corval and is the assignee/successor to Corval.
In
November 2003, the Company suspended the Warrants in response to the indictment
of one of its directors and officer of BioBalance and a consultant to BioBalance
as reported in the Company's Form 10-K for the year ended December 31,
2003.
Both
Corval and Olshenitsky have continually denied any involvement in the events
leading up to the indictments and have threatened litigation alleging breach
of
contract and related compensatory damages as a result of the suspension of
the
Warrants. Neither Corval nor Olshenitsky was indicted.
Pursuant
to the Corval Settlement Agreements and in order avoid the cost and uncertainty
of litigation, the Company agreed to issue 300,000 (valued at $216,000) shares
of common stock to Olshenitsky in return for a general release of all claims
Corval and Olshenitsky may have against the Company. The common stock are
"restricted shares" and may only be resold after registration of such shares
or
the availability of an exemption from registration, including under Rule 144
of
the Securities Act of 1933 as amended (the "Securities Act").
On
March
6, 2006, the Company entered into a settlement agreement (the "Emerald
Settlement Agreement") with Emerald Asset Management, Inc. ("Emerald") and
Yitz
Grossman ("Grossman") related to the resolution of disputes under a consulting
agreement dated June 1, 2001 (the "Emerald Consulting Agreement") between the
Company and Emerald. Grossman is the sole owner of Emerald. Pursuant to the
Emerald Consulting Agreement, Emerald was entitled to $250,000 per year through
2011, additional payments equal to bonuses paid to the Chief Executive Officer
of the Company and reimbursement for expenses.
In
November 2003, the Company terminated the Emerald Consulting Agreement in
response to the indictment of one of its directors and officer of BioBalance,
and a consultant as reported in the Company's Form 10-K for the year ended
December 31, 2003. As of September 2004, BioBalance notified the consultant
in
writing that the consulting agreement was terminated for cause. At December
31,
2004, the Company had accrued had approximately $359,000 relating to this
consulting agreement as reported in the 2004 10-K.
Emerald
and Grossman have threatened litigation alleging breach of contract and related
compensatory damages as a result of the termination of the Emerald Consulting
Agreement. Emerald asserts that the Emerald Consulting Agreement was terminated
"without cause" as defined in the agreement entitling Emerald to certain
payments that Emerald estimates at approximately $2,225,000.
Pursuant
to the Emerald Settlement Agreement and in order avoid the cost and uncertainty
of uncertainty of litigation, the Company agreed to (i) the immediate payment
of
$700,000 to Emerald, (ii) payment of $22,000 per month for eighteen months
beginning January 1, 2006, (iii) the issuance of 400,000 shares of common stock,
(iv) options to purchase 1,100,000 shares of common stock at $0.78 per share
until March 1, 2010 and (v) health insurance for Grossman and his family for
the
eighteen month period ending June 30, 2008 amounting to approximately $35,100.
In return, Emerald and Grossman have executed a general release of all claims
they may have against the Company. The common stock to be issued and the common
stock issuable pursuant to the options are "restricted shares" and may only
be
resold after registration of such shares or the availability of an exemption
from registration, including under Rule 144 of the Securities Act. The Company
has granted Emerald a one-time demand registration right and unlimited piggy
back registrant rights. The Company has not paid any of this liability and
has
expensed $1,545,931 for the above settlement during the year ended December
31,
2005. As of December 31, 2005, the Company has recorded a liability of
$1,131,100 and common stock and options to be issued valued at $774,220 as
of
March 6, 2006. On April 17, 2006, Emerald Asset and Grossman have agreed not
to
demand the cash portion of the settlement agreement until such time as New
York
Health Care receives any additional monies from any source.
On August
21, 2006, the Company unilaterally rescinded the settlement between the Company
and Emerald Asset and Yitz Grossman. The rescission of the settlement by the
Company was done without the consent of Emerald Asset and Yitz Grossman.
Accordingly there may be future litigation brought against the Company by
Emerald Asset and Yitz Grossman to seek enforcement of the agreement. The
Company continues to retain the accrual for the settlement agreement on its
books in its entirety. If there is litigation brought by Emerald Asset and
Yitz
Grossman to enforce the settlement agreement, there can be no assurance that
at
a future time the accrual that was recorded would be sufficient to offset
amounts resulting from the future litigation.
NOTE
11 - THIRD-PARTY RATE ADJUSTMENTS AND REVENUE AND CERTAIN CONTRACTS RELATED
TO
OPERATIONS:
Approximately
4% of net patient service revenue was derived under New York State Medicaid
reimbursement programs during each of the years ended December 31, 2007 and
2006. These revenues are based, in part, on cost reimbursement principles and
are subject to audit and retroactive adjustment. Differences between current
rates and subsequent revisions are reflected in the year that the revisions
are
determined.
The
Company has an agreement with the City of New York acting through the Department
of Social Services of The Human Resources Administration ("HRA") to provide
personal care services to certain qualified individuals as determined by HRA.
The agreement with HRA sets a fixed direct labor cost in the reimbursement
rate.
Should the Company incur direct costs of home attendant services below this
fixed rate, the Company must repay the difference to HRA, subject to final
audit
by the City of New York. As of December 31, 2007 and 2006, the amount included
in due to HRA relating to direct labor costs amounted to $618,589 and
$1,461,063, respectively. In addition, the City's reimbursement methodology
for
general and administrative expenses is based on a fixed amount per client based
on the number of cases. The Company is reimbursed at an hourly rate. Any amount
over this fixed rate must be repaid to HRA. As of December 31, 2007 and 2006,
this amount was $8,135,819 and $6,481,694, respectively, subject to final audit
by the City of New York. The aggregate amount due to HRA was $8,754,408 and
$7,942,757
at
December 31, 2007 and 2006, respectively. HRA has completed their field work
relating to the audit for the fiscal year ended June 30, 2004.
In
January 2003, the New York State Department of Health ("DOH") approved
additional funding to home healthcare agencies in a form of a rate increase.
The
additional funding is to be used exclusively for the recruitment and retention
of home healthcare employees. Any unspent money relating to recruitment and
retention is recorded as an accrued liability until such time as it is spent.
As
of December 31, 2007 and 2006, the Company accrued approximately $1,484,000
and
$1,699,000, respectively, related to recruitment and retention funds not yet
expended and is included in accrued employee benefits.
NOTE
12- SUPPLEMENTAL CASH FLOW DISCLOSURES:
|
|
Year Ended December 31,
|
|
|
|
2007
|
|
2006
|
|
Supplemental
cash flow disclosures:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash
paid during the period for:
|
|
|
|
|
|
|
|
Interest
|
|
$
|
29,066
|
|
$
|
31,394
|
|
Income
Taxes
|
|
$
|
34,402
|
|
$
|
62,198
|
|
|
|
|
|
|
|
|
|
Supplemental
schedule of noncash investing and financing activities:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Issuance
of common stock in payment of accrued expenses in connection with
Corval
Settlement Agreement
|
|
$
|
-
|
|
$
|
216,000
|
|
|
|
|
|
|
|
|
|
Shares
issued to public relations consultant returned in 2007
|
|
$
|
(2,500
|
)
|
$
|
2,500
|
|
NOTE
13 - SEGMENT REPORTING:
The
Company has two reportable business segments: New York Health Care, a home
health care agency that provides a broad range of health care support services
to patients in their homes, and BioBalance, a company that is developing a
patented biotherapeutic agent for the treatment of gastrointestinal disorders.
BioBalance has not generated any revenue as of December 31, 2007.
|
|
Health Care
Segment
|
|
BioBalance
Segment
|
|
Elimination of
Intersegment
Activity
|
|
Consolidated
|
|
Year
ended December 31, 2007
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Revenue:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net
patient service revenue
|
|
$
|
44,399,303
|
|
$
|
-
|
|
$
|
-
|
|
$
|
44,399,303
|
|
Total
revenue
|
|
$
|
44,399,303
|
|
$
|
-
|
|
$
|
-
|
|
$
|
44,399,303
|
|
Income
(loss) before provision for income taxes
|
|
$
|
1,768,204
|
|
$
|
(2,745,928
|
)
|
$
|
-
|
|
$
|
(977,724
|
)
|
Depreciation
and amortization
|
|
$
|
104,430
|
|
$
|
300,192
|
|
$
|
-
|
|
$
|
404,622
|
|
Interest
income
|
|
$
|
77,825
|
|
$
|
68
|
|
$
|
-
|
|
$
|
77,893
|
|
Interest
expense
|
|
$
|
28,803
|
|
$
|
263
|
|
$
|
-
|
|
$
|
29,066
|
|
Income
tax expense
|
|
$
|
73,852
|
|
$
|
775
|
|
$
|
-
|
|
$
|
74,627
|
|
Total
assets
|
|
$
|
17,906,954
|
|
$
|
697,670
|
|
$
|
(6,187,418
|
)
|
$
|
12,417,206
|
|
Expenditures
for long-lived assets
|
|
$
|
-
|
|
$
|
134,934
|
|
$
|
-
|
|
$
|
134,934
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Year
ended December 31, 2006
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Revenue:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net
patient service revenue
|
|
$
|
45,558,331
|
|
$
|
-
|
|
$
|
-
|
|
$
|
45,558,331
|
|
Total
revenue
|
|
$
|
45,558,331
|
|
$
|
-
|
|
$
|
-
|
|
$
|
45,558,331
|
|
Income
(loss) before provision for income taxes
|
|
$
|
1,811,519
|
|
$
|
(5,492,072
|
)
|
$
|
-
|
|
$
|
(3,680,553
|
)
|
Depreciation
and amortization
|
|
$
|
97,797
|
|
$
|
574,787
|
|
$
|
-
|
|
$
|
672,584
|
|
Interest
income
|
|
$
|
160,983
|
|
$
|
3,986
|
|
$
|
-
|
|
$
|
164,969
|
|
Interest
expense
|
|
$
|
31,394
|
|
$
|
30,000
|
|
$
|
-
|
|
$
|
61,394
|
|
Income
tax expense
|
|
$
|
75,120
|
|
$
|
-
|
|
$
|
-
|
|
$
|
75,120
|
|
Total
assets
|
|
$
|
15,706,627
|
|
$
|
1,898,800
|
|
$
|
(4,725,889
|
)
|
$
|
12,879,538
|
|
Expenditures
for long-lived assets
|
|
$
|
-
|
|
$
|
335,098
|
|
$
|
-
|
|
$
|
335,098
|
|
SCHEDULE
II - VALUATION AND QUALIFYING ACCOUNTS
Column
A
|
|
Column
B
|
|
Column
C
|
|
Column
D
|
|
Column
E
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance
at Beginning of Period
|
|
Charged
to Costs and Expenses
|
|
Additions
Charged to Other Accounts
|
|
Deductions
|
|
Balance
at End of Period
|
|
Description
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Year
ended December 31, 2007
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Deducted
from asset accounts:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Allowance
for doubtful accounts
|
|
$
|
579,000
|
|
$
|
0
|
|
$
|
0
|
|
$
|
(31,113
|
)
|
$
|
547,887
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Deferred
tax asset valuation allowance
|
|
$
|
7,646,000
|
|
$
|
1,596,000
|
|
$
|
|
|
$
|
-
|
|
$
|
9,242,000
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Year
ended December 31, 2006
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Deducted
from asset accounts:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Allowance
for doubtful accounts
|
|
$
|
465,000
|
|
$
|
208,678
|
|
$
|
-
|
|
$
|
(94,678
|
)
|
$
|
579,000
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Deferred
tax asset valuation allowance
|
|
$
|
5,276,000
|
|
$
|
2,370,000
|
|
$
|
-
|
|
$
|
-
|
|
$
|
7,646,000
|
|
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.
|
NEW
YORK HEALTH CARE, INC.
|
|
|
|
April
14, 2008
|
By:
|
/s/ Stewart
W. Robinson
|
|
|
Name:
Stewart W. Robinson
|
|
|
Title:
Chief Financial Officer
|
Pursuant
to the requirements of the Securities Exchange Act of 1934, this Report been
signed below by the following persons on behalf of the Registrant and in the
capacities and on the dates indicated.
SIGNATURE
|
|
TITLE
|
|
DATE
|
|
|
|
|
|
/s/
Murry Englard
|
|
Director,
Chief Executive Officer
|
|
April
14, 2008
|
Murry
Englard
|
|
|
|
|
|
|
|
|
|
/s/
Stewart W. Robinson
|
|
Chief
Financial Officer
|
|
April
14, 2008
|
Stewart
W. Robinson
|
|
|
|
|
|
|
|
|
|
/s/
Howard Berg
|
|
Director
|
|
April
14, 2008
|
Howard
Berg
|
|
|
|
|
|
|
|
|
|
/s/
Yoram Hacohen
|
|
Director
|
|
April
14, 2008
|
Yoram
Hacohen
|
|
|
|
|
INDEX
TO EXHIBITS
These
Exhibits are numbered in accordance with Exhibit Table of Item 601 of Regulation
S-K.
Exhibit
|
|
|
Number
|
|
Description
of Exhibit
|
|
|
|
2.1
|
|
Stock
for Stock Exchange Agreement between the Company and BioBalance dated
October 11, 2001, as amended by Amendment No. 1 dated February 13,
2002,
Amendment No. 2 dated July 10, 2002, Amendment No. 3 dated August
13, 2002
and Amendment No. 4 dated October 25, 2002 (Incorporated by reference
to
Exhibits No. 2.1-2.4, inclusive, to the Company's Registration Statement
on Form S-4, SEC File No. 333-85054).
|
|
|
|
2.2
|
|
Asset
Purchase Agreement dated as of April 11, 2005 by and among Accredited
Health Services, Inc., the Company and NYHC Newco Paxxon Inc. Incorporated
by reference to Exhibit 2.1 to the Company's Form 8-K filed (on May
26,
2005).
|
|
|
|
3.1
|
|
Restated
Certificate of Incorporation filed on March 26, 1996. (Incorporated
by
reference to Exhibit 3.2 to the Company's Registration Statement
on Form
SB-2, SEC File No. 333-08152, declared effective on December 20,
1996).
|
|
|
|
3.2
|
|
Certificate
of Correction of Restated Certificate of Incorporation filed on March
26,
1996. Incorporated by reference to Exhibit 3.3 to the Company's
Registration Statement on Form SB-2, SEC File No. 333-08152, declared
effective on December 20, 1996).
|
|
|
|
3.3
|
|
Amendment
to the Certificate of Incorporation filed October 17,
1996. (Incorporated by reference to Exhibit 3.4 to the
Company's Registration Statement on Form SB-2, SEC File No. 333-08152,
declared effective on December 20, 1996).
|
|
|
|
3.4
|
|
Amendment
to the Certificate of Incorporation filed December 4,
2006. (Incorporated by reference to Exhibit 3.6 to the
Company's Registration Statement on Form SB-2, SEC File No. 333-08152,
declared effective on December 20, 1996).
|
|
|
|
3.5
|
|
Amendment
to the Certificate of Incorporation filed February 5,
2001. (Incorporated by reference to Exhibit 3.5 to the
Company's Form 10-K filed on April 17, 2006).
|
|
|
|
3.6
|
|
Amendment
to the Certificate of Incorporation filed January 7, 2002. (Incorporated
by reference to Exhibit 3.6 to the Company's Form 10-K filed on April
17,
2006).
|
|
|
|
3.7
|
|
Certificate
of Amendment to the Restated Certificate of Incorporation filed on
September 10, 2004 (Incorporated by reference to Exhibit 3.1 to the
Company's 8-K filed on September 15, 2004).
|
|
|
|
3.8
|
|
Amended
and Restated Bylaws (Incorporated by reference to Appendix B to the
Company's Definitive Proxy Statement on Schedule 14A filed on August
5,
2005 with respect to the Company's Annual Meeting of Stockholders
held on
August 31, 2005).
|
4.1
|
|
Form
of certificate evidencing shares of Common Stock. (Incorporated by
reference to Exhibit 4.1 to the Company's Registration Statement
on Form
SB-2, SEC File No. 333-08152, declared effective on December 20,
1996).
|
|
|
|
++10.1
|
|
Employment
Agreement for Dennis O'Donnell. (Incorporated by reference to Exhibit
10.1
to the Company's Form 10-Q filed on August 16, 2004 for the quarter
ended
June 30, 2004).
|
|
|
|
++10.3
|
|
Option
Agreement dated September 14, 2004 between the Company and Dennis
O'Donnell. (Incorporated by reference to Exhibit 10.1 to the Company's
Form 10-Q filed on November 22, 2004 for the quarter ended September
30,
2004).
|
|
|
|
++10.4
|
|
Option
Agreement between the Company and Dennis O'Donnell dated May 6, 2005.
(Incorporated by reference to Exhibit 10.2 to the Company's Form
10-Q
filed on August 17, 2005 for the quarter ended June 30,
2005).
|
|
|
|
++10.5
|
|
Employment
Agreement between the Company and A. James Forbes, Jr. dated June
1, 2005.
(Incorporated by reference to Exhibit 10.1 to the Company's Form
10-Q
filed on August 17, 2005 for the quarter ended June 30,
2005).
|
|
|
|
++10.6
|
|
Amended
Performance Incentive Plan (Stock Option Plan). (Incorporated by reference
to Exhibit 10.50 to the Company's Form 10-K filed on March 17, 2003
for
the year ended December 31, 2003).
|
|
|
|
++10.7
|
|
2004
Stock Incentive Plan (incorporated by reference to Appendix A to
the
Company's Definitive Proxy Statement on Schedule 14A filed on August
9,
2005 with respect to the Company's Annual Meeting of Stockholders
held on
August 31, 2005).
|
|
|
|
10.8
|
|
Loan
Security Agreement among the Company, NYHC Newco Paxxon, Inc. and
Heller
Healthcare Finance, Inc. dated November 28, 2000. (Incorporated by
reference to Exhibit 10.45 to the Company's Form 8-K filed on December
8,
2000).
|
|
|
|
10.9
|
|
Amendment
No. 1 to Loan and Security Agreement and Consent and Waiver with
Heller
Healthcare Finance, Inc. dated November 27, 2002. (Incorporated by
reference to Exhibit 10.49 to the Company's Form 8-K filed on December
4,
2002).
|
|
|
|
10.10
|
|
Amendment
No. 2 to Loan and Security Agreement among GE HFS Holding, Inc.,
the
Company and Newco Paxxon, Inc. dated March 29, 2004. (Incorporated
by
reference to Exhibit 10.2 to the Company's Form 10-Q filed on May
17, 2004
for the quarter ended March 31, 2004).
|
|
|
|
10.11
|
|
Amendment
No. 3 to Loan and Security Agreement among GE HFS Holdings, Inc.,
the
Company and Newco Paxxon, Inc. dated November 29, 2004 (Incorporated
by
reference to Exhibit 10.1 the Company's Form 8-K filed on December
2,
2004).
|
|
|
|
10.12
|
|
Amendment
No. 4 to Loan and Security Agreement among the Company, NYHC Newco
Paxxon,
Inc. and GE HFS Holdings, Inc. dated January 13, 2005. (Incorporated
by
reference to Exhibit 10.1 to the Company's Form 8-K filed on January
19,
2005).
|
|
|
|
10.13
|
|
Amendment
No. 5 to Loan and Security Agreement among the Company, NYHC Newco
Paxxon,
Inc. and GE HFS Holdings, Inc. dated August 12, 2005. (Incorporated
by
reference to Exhibit 10.3 to the Company's Form 10-Q filed on August
17,
2005 for the quarter ended June 30,
2005).
|
10.14
|
|
Amendment
No. 6 to Loan and Security Agreement among the Company, NYHC Newco
Paxxon,
Inc. and GE HFS Holdings, Inc. dated November 29, 2005.
|
|
|
|
10.15
|
|
Engagement
Letter Agreement between the Company and Sterling Financial Investment
Group, Inc. dated May 6, 2004. (Incorporated by reference to Exhibit
10.1
to the Company's Form 10-Q filed on May 17, 2004 for the quarter
ended
March 31, 2004).
|
|
|
|
10.16
|
|
Placement
Agreement between the Company and Sterling Financial Investment Corp.,
Inc. dated November 19, 2004. (Incorporated by reference to Exhibit
10.1
to the Company's Form 8-K filed on November 23, 2004).
|
|
|
|
10.18
|
|
Amendment
dated February 7, 2005 to the Placement Agreement between the Company
and
Sterling Financial Group, Inc. dated November 19, 2004. (Incorporated
by
reference to Exhibit 10.2 to the Company's Form 10-Q filed on May
23, 2005
for the quarter ended March 31, 2005).
|
|
|
|
10.19
|
|
Amendment
dated February 18, 2005 to the Placement Agreement between the Company
and
Sterling Financial Group, Inc. dated November 19, 2004. (Incorporated
by
reference to Exhibit 10.3 to the Company's Form 10-Q filed on May
23, 2005
for the quarter ended March 31, 2005).
|
|
|
|
10.19
|
|
State
of New York Department of Health Office of Health Systems Management
Home
Care Service Agency License for the Company doing business in Rockland,
Westchester and Bronx Counties dated May 8, 1995. (Incorporated by
reference to Exhibit 10.8 to the Company's Registration Statement
on Form
S-4, SEC File No. 333-85054).
|
|
|
|
10.20
|
|
State
of New York Department of Health Office of Health Systems Management
Home
Care Service Agency License for the Company doing business in Dutchess,
Orange, Putnam, Sullivan and Ulster Counties dated May 8, 1995.
(Incorporated by reference to Exhibit 10.9 to the Company's Registration
Statement on Form S-4, SEC File No. 333-85054).
|
|
|
|
10.21
|
|
State
of New York Department of Health Office of Health Systems Management
Home
Care Service Agency License for the Company doing business in Nassau,
Suffolk and Queens Counties dated May 8, 1995. (Incorporated by reference
to Exhibit 10.10 to the Company's Registration Statement on Form
S-4, SEC
File No. 333-85054).
|
|
|
|
10.22
|
|
State
of New York Department of Health Office of Health Systems Management
Home
Care Service Agency License for the Company doing business in Orange
and
Rockland Counties dated July 1, 1995. (Incorporated by reference
to
Exhibit 10.11 to the Company's Registration Statement on Form S-4,
SEC
File No. 333-85054).
|
|
|
|
10.23
|
|
Personal
Care Aide Agreement by and between the Company and Nassau County
Department of Social Services dated October 18, 1995. (Incorporated
by
reference to Exhibit 10.15 to the Company's Registration Statement
on Form
S-4, SEC File No. 333-85054).
|
|
|
|
10.24
|
|
State
of New York Department of Health Offices of Health Systems Management
Home
Care Service Agency License for the Company doing business in Bronx,
Kings, New York, Queens and Richmond Counties dated December 29,
1995.
(Incorporated by reference to Exhibit 10.17 to the Company's Registration
Statement on Form S-4, SEC File No. 333-85054).
|
|
|
|
10.25
|
|
Homemaker
and Personal Care Agreements by and between the Company and the County
of
Rockland Department of Social Services dated January 1, 1996.
(Incorporated by reference to Exhibit 10.19 to the Company's Registration
Statement on Form S-4, SEC File No. 333-85054).
|
|
|
|
10.26
|
|
Termination
Agreement and Release among the Company, NYHC Newco Paxxon, Inc.,
New York
Health Care, LLC, Jerry Braun and Jacob Rosenberg dated July 27,
2005.
(Incorporated by reference to Exhibit 10.1 to the Company's Form
8-K filed
on August 10, 2005).
|
|
|
|
10.27
|
|
Settlement
Agreement among Corval International, Inc., Mark Olshenitsky and
the
Company dated March 9, 2006. (Incorporated by reference to Exhibit
10.2 to
the Company's Form 8-K filed on March 10,
2006).
|
10.28
|
|
Settlement
Agreement among Emerald Asset Management, Inc., Yitz Grossman and
the
Company dated March 1, 2006. (Incorporated by reference to Exhibit
10.4 to
the Company's Form 8-K filed on March 10, 2006).
|
|
|
|
10.29
|
|
Engagement
Letter of Corval International Inc. (“Corval”) and BioBalance dated April
21, 2003 with warrant agreement in favor of Corval attached (Incorporated
by reference to Exhibit 10.1 filed as part of the Company's Form
8-K on
March 10, 2006).
|
|
|
|
10.30
|
|
Consulting
Agreement dated June 1, 2001 between The Zig Zag Corp., Emerald
Asset
Management, Inc. (“Emerald”), and Yitz Grossman (Incorporated by reference
to Exhibit 10.3 filed as part of the Company's Form 8-K on March
10,
2006).
|
|
|
|
10.31
|
|
Revival
Press Release dated January 17, 2006 (Incorporated by reference
to Exhibit
10.5 filed as part of the Company's Form 8-K on March 10,
2006)
|
|
|
|
10.32
|
|
Amendment
to Emerald Settlement Agreement dated April 17, 2006 between the
Company,
Emerald and Yitz Grossman (Incorporated by reference to Exhibit
10.1 filed
as part of the Company's Form 8-K on April 19, 2006).
|
|
|
|
10.33
|
|
Engagement
Agreement between Stewart Robinson and the Company dated February
5, 2007
(Incorporated by reference to Exhibit 10.1 filed as part of the
Company's
Form 8-K on February 8, 2007).
|
|
|
|
10.34
|
|
Non-Qualified
Stock Option Agreement dated September 20, 2006 between the Company
and
Michael Nafash. 2007 (Incorporated by reference to Exhibit 10.34
filed as
part of the Company's Form 10-K on April 19, 2007).
|
|
|
|
10.35
|
|
Non-Qualified
Stock Option Agreement dated February 28, 2007 between the Company
and
Howard Berg. (Incorporated by reference to Exhibit 10.35 filed
as part of
the Company's Form 10-K on April 19, 2007).
|
|
|
|
10.36
|
|
Non-Qualified
Stock Option Agreement dated February 28, 2007 between the Company
and
Yoram Hacohen. (Incorporated by reference to Exhibit 10.36 filed
as part
of the Company's Form 10-K on April 19, 2007).
|
|
|
|
10.37
|
|
Surrender
Agreement dated March 8, 2007 between the Company and 345 Seventh
Avenue
LLC. (Incorporated by reference to Exhibit 10.37 filed as part
of the
Company's Form 10-K on April 19, 2007).
|
|
|
|
10.38
|
|
Loan
and Security Agreement, dated September 20, 2007, between New York
Health
Care, Inc. and CIT
Healthcare
LLC. (Incorporated by reference to Exhibit 10.1 filed as part of
the
Company's Form 8-K on September 24, 2007).
|
|
|
|
10.39
|
|
Revolving
Credit Note, dated September 20, 2007, delivered by New York Health
Care,
Inc. to CIT Healthcare
LLC.
(Incorporated by reference to Exhibit 10.2 filed as part of the
Company's
Form 8-K on September 24, 2007).
|
|
|
|
14.1
|
|
Code
of Ethics for Senior Financial Officers. (Incorporated by reference
to
Exhibit 14.1 of the Company's Form 10-K filed on March 31, 2004
for the
fiscal year ended December 31, 2003.
|
|
|
|
23.1*
|
|
Consent
of Holtz Rubenstein Reminick, LLP.
|
|
|
|
31.1
and 31.2*
|
|
Certification
of Chief Executive Officer and Principal Financial Officer Pursuant
to
Section 302 of the Sarbanes-Oxley Act of 2002.
|
|
|
|
32.1
and 32.2*
|
|
Certification
of Chief Executive Officer and Principal Financial Officer Pursuant
to 18
U.S.C. 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley
Act
of 2002.
|
*
Filed
herewith.
++
Compensation plan.
New York Health Care (CE) (USOTC:BBAL)
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New York Health Care (CE) (USOTC:BBAL)
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