Delaware
|
13-3673965
|
|
(State
or other jurisdiction of
corporation or organization)
|
(IRS.
Employer Identification
Number)
|
|
75
Adams Avenue Hauppauge, New York
|
11788
|
|
(Address
of principal executive
offices)
|
(Zip
Code)
|
PART
I
|
|
Page
|
Item
1.
|
Business
|
1
|
Item
1A
|
Risk
Factors
|
13
|
Item
1 B
|
Unresolved
Staff Comments
|
21
|
Item
2.
|
Properties
|
21
|
Item
3.
|
Legal
Proceedings
|
22
|
Item
4.
|
Submission
of Matters to a Vote of Security Holders
|
22
|
PART
II
|
|
|
|
||
Item
5.
|
Market
for Common Stock and Related Stockholder Matters
|
23
|
Item
6.
|
Selected
Financial Data
|
28
|
Item
7.
|
Management's
Discussion and Analysis of Financial Condition and Results of
Operations
|
28
|
Item
7A.
|
Quantitative
and Qualitative Disclosure About Market Risk
|
54
|
Item
8.
|
Financial
Statements and Supplementary Data
|
54
|
Item
9.
|
Changes
in and Disagreements with Accountants on Accounting and Financial
Disclosures
|
55
|
Item
9A.
|
Controls
and Procedures
|
55
|
Item
9B
|
Other
Information
|
55
|
|
||
PART
III
|
|
|
|
||
Item
10.
|
Directors
and Executive Officers of the Registrant.
|
56
|
Item
11.
|
Executive
Compensation
|
56
|
Item
12.
|
Security
Ownership of Certain Beneficial Owners and Management and Related
Stockholder Matters
|
56
|
Item
13.
|
Certain
Relationships and Related Transactions
|
56
|
|
||
Item
14.
|
Principal
Accounting Fees and Services
|
57
|
Item
15.
|
Exhibits,
Financial Statement Schedules and Reports on Form 8-K
|
57
|
|
||
Signatures
|
59
|
|
Financial
Statements
|
F-1
|
· |
hydrocodone
bitartrate and acetaminophen tablets USP, 5 mg / 500 mg;
|
· |
hydrocodone
bitartrate and acetaminophen tablets USP, 5 mg / 325 mg;
|
· |
hydrocodone
bitartrate and acetaminophen tablets USP, 10 mg / 325 mg;
|
· |
hydrocodone
bitartrate and acetaminophen tablets USP, 7.5 mg/ 500
mg;
|
· |
hydrocodone
bitartrate and acetaminophen tablets USP, 7.5 mg / 650 mg;
|
· |
hydrocodone
bitartrate and acetaminophen tablets USP, 7.5 mg / 750 mg, and
|
· |
hydrocodone
bitartrate and acetaminophen tablets USP, 10 mg / 650
mg.
|
PRODUCT
NAME
|
BRAND-NAME
PRODUCTS
|
1.
Acetaminophen, 500 mg White Tablets
|
Tylenol®
|
2.
Acetaminophen, 500 mg White Caplets
|
Tylenol®
|
3.
Acetaminophen, 325 mg White Tablets
|
Tylenol®
|
4.
Ibuprofen, 200mg White Tablets
|
Advil®
|
5.
Ibuprofen, 200mg Brown Tablets
|
Advil®
|
6.
Ibuprofen, 200mg Orange Tablets
|
Motrin®
|
|
|
7.
Ibuprofen, 200mg White Caplets
|
Advil®
|
8.
Ibuprofen, 200mg Brown Caplets
|
Advil®
|
9.
Ibuprofen, 200mg Orange Caplets
|
Motrin®
|
10.
Ibuprofen, 400mg White Tablets
|
Motrin®
|
11.
Ibuprofen, 600mg White Tablets
|
Motrin®
|
12.
Ibuprofen, 800mg White Tablets
|
Motrin®
|
13.
Isometheptene Mucate, Dichloralphenazone Acetaminophen, Red/Red
Capsule,
65mg/100mg/325mg
|
Midrin®
|
14.
Naproxen, 250mg White Tablets
|
Naprosyn®
|
15.
Naproxen, 375mg White Tablets
|
Naprosyn®
|
16.
Naproxen, 500mg White Tablets
|
Naprosyn®
|
17.
Acetaminophen and Diphenhydramine HCl Tablets, 500 mg / 25
mg
|
Tylenol
PM®
|
18.
Hydrocodone Bitartrate and Ibuprofen Tablets, 7.5 mg / 200
mg
|
Vicoprofen®
|
19.
Hydrocodone Bitartrate and Ibuprofen Tablets, 5 mg / 200
mg
|
Reprexain®
|
20.
Sulfamethoxazole
& Trimethoprim Tablets, 400 mg / 80 mg
|
Bactrim
®
|
21.
Sulfamethoxazole
& Trimethoprim Tablets, 800 mg / 160 mg
|
Bactrim
DS ®
|
22.
and 23. Female Hormone Products
|
1. |
available
at
HTTP://WWW.CBO.GOV/SHOWDOC.CFM?INDEX=655&SEQUENCE=0
|
2. |
HTTP://WWW.FTC.GOV/OS/2002/07/GENERICDRUGSTUDY.PDF
|
· |
inability
to obtain requisite FDA approvals on a timely basis for new generic
products;
|
· |
reliance
on partners for development of certain
products;
|
· |
the
availability, on commercially reasonable terms, of raw materials,
including active pharmaceutical ingredients and other key
ingredients;
|
· |
competition
from other generic drug companies offering the same or similar
products;
|
· |
inadequate
funding available for product marketing and
sales;
|
· |
failure
to obtain market acceptance for new generic products;
|
· |
failure
to succeed in patent challenges;
|
· |
unforeseen
costs in development;
|
· |
legal
actions by brand competitors; and
|
· |
inability
to demonstrate bioequivalence in clinical studies as required by
the FDA.
|
· |
the
amount of research and development
expenditures;
|
· |
competition
for new and existing products;
|
· |
new
product launches;
|
· |
changes
in pricing for raw materials and other inputs;
and
|
· |
legal
actions.
|
ITEM 5. |
MARKET
PRICE OF AND DIVIDENDS ON THE REGISTRANT'S COMMON EQUITY AND RELATED
STOCKHOLDER MATTERS PRICE RANGE OF COMMON
STOCK
|
High
|
Low
|
||||||
2004
|
|||||||
Quarter
ended 3/31
|
5.87
|
4.30
|
|||||
Quarter
ended 6/30
|
4.80
|
2.45
|
|||||
Quarter
ended 9/30
|
3.98
|
2.25
|
|||||
Quarter
ended 12/31
|
3.49
|
2.20
|
|||||
2005
|
|||||||
Quarter
ended 3/31
|
2.58
|
1.50
|
|||||
Quarter
ended 6/30
|
1.65
|
1.23
|
|||||
Quarter
ended 9/30
|
1.82
|
1.07
|
|||||
Quarter
ended 12/31
|
1.49
|
1.21
|
|||||
2006
|
|||||||
Quarter
ended 3/31
|
1.68
|
1.24
|
|||||
Quarter
ended 6/30
|
1.56
|
1.10
|
Plan
Category
|
Number
of Securities to be
issued
upon exercise of
outstanding
options, warrants
and
rights
|
Weighted-average
exercise
price
of outstandingoptions,
warrant
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:
|
||||||||||
1997
Stock Option Plan
|
1,411,650
|
$
|
1.93
|
-0-
|
||||||
2000
Flexible Stock Plan(1)
|
10,671,288
|
0.90
|
9,004,511
|
|||||||
Total
|
12,082,938
|
1.02
|
9,004,511
|
-
Title.
|
$.01
par value per share Series A-1 Convertible Cumulative Preferred
Stock.
|
-
Voting.
|
No
voting rights.
|
-
Liquidation Preference.
|
$0.682
per share.
|
-
Dividend Rights.
|
$0.0341
per share, per year, when and as declared by our Board of
Directors.
|
-
Redemption Provisions.
|
None.
|
-
Amount Authorized.
|
5
million shares.
|
-
Amount Issued.
|
4,855,389
|
-
Conversion.
|
Converts
on a 1:1 basis into common stock
upon:
|
i. |
the
Company reaching $150 million in revenues;
|
ii. |
a
merger, consolidation, sale of assets or similar transaction;
or
|
iii. |
a
“Change in Control” which occurs if (a) any person, or any two or more
persons acting as a group, and all affiliates of such person or persons,
shall, acquire and own, beneficially, 50% or more of the common stock
outstanding, or (b) if following (i) a tender or exchange offer for
voting
securities of the Company, or (ii) a proxy contest for the election
of
directors of the Company, the persons who were directors of the Company
immediately before the initiation of such event cease to constitute
a
majority of the Board of Directors of the Company upon the completion
of
such tender or exchange offer or proxy contest or within one year
after
such completion.
|
-
Title.
|
$.01
par value per share Series B-1 Redeemable Convertible Preferred
Stock.
|
-
Voting.
|
Each
votes with the common and has a number of votes equal to the number
of
share of common into which it is convertible on the record date for
the
action to be voted upon. The current aggregate number of votes for
the
Series B-1 Stock is 6,519,755.
|
-
Liquidation Preference.
|
Upon
certain liquidation events set forth in the Certificate of Designation,
the holder of each share is entitled to a payment of $1,000 plus
accrued
but unpaid dividends.
|
-
Dividend Rights.
|
8.25%
per annum, payable quarterly in arrears in either cash or at our
option,
in restricted common stock.
|
-
Redemption Provisions.
|
We
are required to redeem the Series B-1 Stock upon the occurrence of
specified events, including, but not limited to a change in control,
a
going private transaction, failure to pay dividends or a failure
to allow
conversion.
|
-
Amount Authorized.
|
15,000
shares.
|
-
Amount Issued.
|
10,000
|
-
Conversion.
|
The
Series B-1 Stock, as well as any accrued dividends, may be converted
at
any time by the holder into a number of shares of our common stock
determined by dividing the dollar amount to be converted by
$1.5338.
|
-
Registration Rights
|
The
holders of the Series B-1 Stock have demand registration rights pursuant
to which we must file a registration statement to cover common shares
into
which the Series B-1 Stock is convertible within 60 days of a request
to
do so.
|
-
Right to Appoint a Director
|
For
so long as Tullis-Dickerson Capital Focus III, L.P. or any of its
affiliates holds at least 25% of the Series B-1 Stock, it shall have
the
right to appoint one member of our Board of
Directors.
|
-
Title.
|
$.01
par value per share Series C-1 Convertible Preferred
Stock.
|
-
Voting.
|
Each
votes with the common and has a number of votes equal to the number
of
share of common into which it is convertible on the record date for
the
action to be voted upon. The current aggregate number of votes for
the
Series C-1 Stock is 6,519,755.
|
-
Liquidation Preference.
|
Upon
certain liquidation events set forth in the Certificate of Designation,
the holder of each share is entitled to a payment of $1,000 plus
accrued
but unpaid dividends.
|
-
Dividend Rights.
|
8.25%
per annum, payable quarterly in arrears in either cash or at our
option,
in restricted common stock.
|
-
Redemption Provisions.
|
We
are required to redeem the Series C-1 Stock upon the occurrence of
specified events, including, but not limited to a change in control,
a
going private transaction, failure to pay dividends or a failure
to allow
conversion.
|
-
Amount Authorized.
|
10,000
shares.
|
-
Amount Issued.
|
10,000
|
-
Conversion.
|
The
Series C-1 Stock, as well as any accrued dividends, may be converted
at
any time by the holder into a number of shares of our common stock
determined by dividing the dollar amount to be converted by
$1.5338.
|
-
Registration Rights
|
The
holders of the Series C-1 Stock have demand registration rights pursuant
to which we must file a registration statement to cover common shares
into
which the Series C-1 Stock is convertible within 60 days of a request
to
do so.
|
-
Right to Appoint a Director
|
For
so long as Aisling Capital II, LP or any of its affiliates holds
at least
25% of the Series C-1 Stock, it shall have Board observer
rights.
|
Year
Ended
June
30, 2006
|
Year
Ended
June
30, 2005
|
Year
Ended
June
30, 2004
|
Six
Months Ended June 30, 2003
|
Six
Months Ended June 30, 2002 (1)
|
Year
ended
December
31, 2002
|
Year
ended
December
31, 2001
|
||||||||||||||||
Net
Sales
|
$
|
63,355
|
$
|
39,911
|
$
|
41,100
|
$
|
14,953
|
$
|
11,743
|
$
|
24,312
|
$
|
18,435
|
||||||||
Net
(loss) income
|
(3,790
|
)
|
(149
|
)
|
3,123
|
724
|
611
|
1,050
|
515
|
|||||||||||||
(Loss)
Income per
common
share:
|
||||||||||||||||||||||
Basic
|
(0.15
|
)
|
(0.01
|
)
|
0.16
|
0.08
|
0.07
|
0.13
|
0.06
|
|||||||||||||
Diluted
|
(0.15
|
)
|
(0.01
|
)
|
0.04
|
0.02
|
0.02
|
0.03
|
0.01
|
|||||||||||||
Balance
Sheet Data
|
||||||||||||||||||||||
Total
Assets
|
62,867
|
46,390
|
35,168
|
20,339
|
10,904
|
11,198
|
9,646
|
|||||||||||||||
Long-term
obligations
|
14,077
|
6,706
|
7,076
|
267
|
3,461
|
3,336
|
3,591
|
|||||||||||||||
Cash
dividend per
common
share
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
ITEM 7. |
MANAGEMENT’S
DISCUSSION AND ANALYSIS OF
FINANCIAL CONDITION
AND RESULTS OF OPERATIONS
(in
Thousands except per share
data)
|
o |
Our
revenues increased by approximately 58.7%, from $39,911 for the fiscal
year ended June 30, 2005 to $63,355 for the fiscal year ended June
30,
2006. Our significant revenue growth was driven by our expansion
plan
mandates: the addition of new products, increasing efficiencies and
a
stronger marketing presence.
|
o |
Our
gross margins increased by approximately 4.8 percentage points from
22.7%
for the fiscal year ended June 30, 2005 to 27.5% for the fiscal year
ended
June 30, 2006. Our significant growth in our gross margins was a
direct
result of our mandate to add higher margin products to our line,
which we
were able to do with the addition of our female hormone products
and
generic Bactrim® and increasing sales of
Naproxen.
|
o |
We
increased our research and development spending by approximately
166.6%,
from $4,003 for the fiscal year ended June 30, 2005 to $10,674 for
the
fiscal year ended June 30, 2006, and by 2034.8% from $538 for the
fiscal
year ended June 30, 2004. The only way to add more products to our
line is
to commit research and development spending to develop the products
and
file ANDAs. We have done this, and are committed to increase the
pace of
our research and development spending in the coming fiscal year.
From July
1, 2005, to the date of this Annual Report, our research and development
spending has resulted in the filing of 17 new ANDAs, and we anticipate
the
filing of at least an additional 20 ANDAs for the fiscal year ending
June
30, 2007. As disclosed in prior filings, we had previously projected
only
25 filings by June 30, 2007, but are now on a pace for at least
37.
|
o |
We
have started development on products in all of our five primary targeted
product areas and are continuing to target and file ANDAs for products
in
our sixth area - products coming off patent and for which patents
have
expired. Each of these product areas was chosen because of the higher
margins that are available and because we anticipate limited competition.
Our progress to date in our targeted product areas is allowing us
to move
further towards our goals of having a full line to offer in each
product
area and further increasing gross margins and per tablet revenues.
Our
five primary targeted product areas are: Female Hormone Products,
Scheduled Narcotic Products, Soft Gelatin Capsule Products Special
Release
Characteristic Products and Liquid
Products.
|
o |
We
have obtained all of the financing we require to meet our current
plan, as
well as to finance additional projects which may become available
to
us:
|
§ |
On
February 9, 2006, we obtained a new $41,500 credit facility from
Wells
Fargo to replace our previous $21,000 facility from
HSBC;
|
§ |
On
May 26, 2006, we closed the sale of $10,000 of our Series B-1 Convertible
Preferred Stock and warrants; and
|
§ |
On
September 11, 2006, we closed the sale of $10,000 of our Series C-1
Convertible Preferred Stock and warrants.
|
o |
We
continued our hiring of qualified research and development, marketing
and
other personnel, including a national sales manager, so that we have
most
of the personnel necessary to complete our plan. We are continuing
our
hiring and are adding additional research and development and marketing
personnel, including a second national sales
manager.
|
o |
We
have increased production to over 4.2 billion tablets during the
fiscal
year ended June 30, 2006. In addition, we have substantially completed
the
build out of our new Yaphank facility which we believe will come
on line
by December 31, 2006. We anticipate further increases in our revenue
per
tablet to complement our production and efficiency improvements.
|
o |
We
have elected to develop internally, certain research and development
projects that had been previously outsourced, such as certain off-patent
products, to expedite development and to take advantage of our increased
research and development capabilities with greater staff and space
in our
Yaphank facility.
|
o |
We
have significantly decreased contract manufacturing
activities.
|
For
the Fiscal
Year
Ended
June
30, 2006
|
For
the Fiscal
Year
Ended
June
30, 2005
|
||||||
SALES,
Net
|
$
|
63,355
|
$
|
39,911,
|
|||
COST
OF SALES
|
45,927
|
30,8389
|
|||||
GROSS
PROFIT
|
17,428
|
9,072
|
|||||
Gross
Profit Percentage
|
27.51
|
%
|
22.73
|
%
|
|||
OPERATING
EXPENSES
|
|||||||
Selling,
general and administrative expenses
|
11,449
|
5,092
|
|||||
Related
party rent expense
|
72
|
72
|
|||||
Research
and development
|
10,674
|
4,003
|
|||||
TOTAL
OPERATING EXPENSES
|
22,195
|
9,167
|
|||||
OPERATING
LOSS
|
(4,767
|
)
|
(95
|
)
|
|||
OTHER
INCOME (EXPENSES)
|
|||||||
Gain
on sale of marketable securities
|
—
|
9
|
|||||
Loss
on Sale of Fixed Asset
|
(5
|
)
|
—
|
||||
Interest
expense
|
(719
|
)
|
(136
|
)
|
|||
Interest
and other income
|
1
|
—
|
|||||
TOTAL
OTHER EXPENSES
|
(723
|
)
|
(127
|
)
|
|||
(LOSS)
INCOME BEFORE INCOME TAXES
|
(5,490
|
)
|
(222
|
)
|
|||
BENEFIT
FROM
INCOME
TAXES
|
(1,700
|
)
|
(73
|
)
|
|||
NET
LOSS
|
$
|
(3,790
|
)
|
$
|
(149
|
)
|
Product
|
Year
over year
increase
in net sales
|
|||
Ibuprofen
|
$
|
5,866
|
||
Naproxen
|
7,721
|
|||
Hydrocodone
/ Ibuprofen
|
1,166
|
|||
Total
|
$
|
14,753
|
§ |
The
increase in net sales of Ibuprofen was primarily the result of an
expanded
customer base and improvements in manufacturing and packaging which
enabled us to increase output and modest cost of materials reductions.
We
believe sales of Ibuprofen should remain at current levels for fiscal
2007, however, there can be no assurance that this will
occur.
|
§ |
An
expanded customer base, as well as obtaining a U.S.
Government contract to supply Naproxen to various governmental agencies
valued at approximately $3,900 for the twelve month period beginning
September 2005 were key factors contributing to the $7,721 increase
in
sales of Naproxen. The contract includes four one-year option periods.
We
believe sales volume should continue or may increase slightly, however,
there can be no assurance that this will occur.
|
§ |
On
a fiscal year over year basis, we had an increase of more than $1,166
from
sales of Hydrocodone 7.5 mg/Ibuprofen 200 mg, our generic version
of
Vicoprofen®, which was launched during the three month period ended
December 31, 2004, and Reprexain® (Hydrocodone 5.0 mg/Ibuprofen 200 mg).
Both products are sold to and marketed by, Watson Pharmaceuticals,
Inc.
and therefore it is difficult to project future sales. The results
for the
periods reported include additional revenue derived from a profit
sharing
arrangement for these products.
|
§ |
As
reported in our Current Report on Form 8-K filed with the SEC on
July 18,
2005, we entered into an agreement with Centrix Pharmaceutical, Inc.
(“Centrix”) for the sale of a female hormone product, which is distributed
in two strengths. This
product generates a higher gross margin compared to our other
products.
The agreement commenced upon the first shipment of the product to
Centrix
in August, 2005. Centrix was required to purchase a minimum $11,500
of the
product during the first twelve month period with the option to purchase
an additional $2,000 of product. For the twelve month period ended
June
30, 2006, we shipped approximately $8,100 of the female hormone product
to
Centrix. We will ship approximately $5,400 of product by September
30,
2006. We have renegotiated the agreement with Centrix for the up
coming
year and we anticipate sales during fiscal 2007 of the product to
exceed
fiscal year 2006 totals. In the event that the agreement is terminated
at
any time, or for any reason, we maintain the right to market the
product
alone or with a third party.
|
§ |
In
September, 2005, we launched Sulfamethoxazole and Trimethoprim (“SMT”)
single and double strength tablets, which are sold under the name
Bactrim®. SMT is a widely used antibiotic used to treat infections such as
urinary tract infections, bronchitis, ear infections (otitis), traveler's
diarrhea, and Pneumocystis carinii pneumonia. Sales during fiscal
2006 of
these products approximated $4,200. While we believe that sales of
for
these products should increase during fiscal 2007, market conditions
could
affect our results.
|
Due
in less
|
Due
|
Due
|
Due
|
|||||||||||||
than
1
|
in
2-3
|
in
4-5
|
after
5
|
|||||||||||||
Obligation
|
Total
|
Year
|
Years
|
Years
|
Years
|
|||||||||||
Real
Estate and M&E Term Loans (a)
|
$
|
15,638
|
$
|
1,686
|
$
|
3,228
|
$
|
10,724
|
$
|
—
|
||||||
Operating
lease and
software
license
|
6,710
|
604
|
1,146
|
960
|
4,000
|
|||||||||||
Tris
|
1,000
|
1,000
|
—
|
—
|
—
|
|||||||||||
Total
cash obligations
|
$
|
23,348
|
$
|
3,290
|
$
|
4,374
|
$
|
11,684
|
$
|
4,000
|
For
the Fiscal
Year
Ended
June
30, 2005
|
For
the Fiscal
Year
Ended
June
30, 2004
|
||||||
SALES,
Net
|
$
|
39,911
|
$
|
41,100
|
|||
COST
OF SALES
|
30,839
|
31,305
|
|||||
GROSS
PROFIT
|
9,072
|
9,795
|
|||||
Gross
Profit Percentage
|
22.73
|
%
|
23.83
|
%
|
|||
OPERATING
EXPENSES
|
|||||||
Selling,
general and administrative expenses
|
5,092
|
4,124
|
|||||
Related
party rent expense
|
72
|
72
|
|||||
Research
and development
|
4,003
|
_538
|
|||||
TOTAL
OPERATING EXPENSES
|
9,167
|
4,734
|
|||||
OPERATING
(LOSS) INCOME
|
(95
|
)
|
5,061
|
||||
OTHER
INCOME (EXPENSES)
|
|||||||
Gain
on sale of marketable securities
|
9
|
—
|
|||||
Interest
expense
|
(136
|
)
|
(21
|
)
|
|||
Interest
and other income
|
—
|
69
|
|||||
TOTAL
OTHER (EXPENSES) INCOME
|
(127
|
)
|
48
|
||||
(LOSS)
INCOME BEFORE INCOME
TAXES
|
(222
|
)
|
5,109
|
||||
(BENEFIT
FROM) PROVISION FOR
INCOME
TAXES
|
(73
|
)
|
1,986
|
||||
NET
(LOSS) INCOME
|
$
|
(149
|
)
|
$
|
3,123
|
· |
The
$7,400 mortgage loan is to be repaid with 119 monthly principal
installments of $31 commencing on August 1, 2004 with the balance
due June
1, 2014.
|
· |
Two
advised secured credit lines aggregating $6,600 primarily for acquisitions
of equipment and for renovations of our plant. The balance of the
funds
accessed through these credit lines will convert into fully amortizing
60
month term loans.
|
· |
A
$2,000 advised non-revolving secured facility for equipment purchases.
Each advance cannot exceed 90% of the invoice amount of the new equipment
and is convertible into fully amortizing 60 month term loans.
|
· |
The
$5,000 advised secured line of credit is primarily for working capital
and
general corporate purposes.
|
ITEM7A. |
QUANTITIVE
AND QUALITATIVE DISCLOSURES ABOUT MARKET
RISKS
|
ITEM 12. |
SECURITY
OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND
MANAGEMENT
AND RELATED STOCKHOLDER
MATTERS
|
Number
|
Description
|
3.1
|
Certificate
of Incorporation of the Company; (1)
|
3.2
|
Certificate
of Amendment of Certificate of Incorporation, filed October 21,
1992;
(1)
|
3.3
|
By-laws
of the Company; (1)
|
3.4
|
Certificate
of Amendment of Certificate of Incorporation, filed December 22,
1992;
(1)
|
3.5
|
Certificate
of Powers, Designations, Preferences and Rights of the Series A-1
Convertible Preferred Stock; (1)
|
3.6
|
Certificate
of Powers, Designations, Preferences and Rights of the Series B-1
Convertible Preferred Stock; (6)
|
3.7
|
Certificate
of Powers, Designations, Preferences and Rights of the Series C-1
Convertible Preferred Stock;
|
4.7
|
Form
of Common Stock Certificate; (1)
|
4.9
|
Form
of Preferred Stock Certificate; (1)
|
10.3
|
Form
of Employment Agreements for Interpharm Holdings, Inc. employees
(3);
|
10.6
|
Supply
Agreement between Interpharm Holdings, Inc. and Tris Pharma, Inc.
for
Development of Liquid Products (5);
|
10.7
|
February
24, 2005 Agreement between Interpharm Holdings, Inc. and Tris Pharma,
Inc.
for development of Solid Products (5);
|
10.8
|
July
6, 2005 amendment to February 24, 2005 Agreement between Interpharm
Holdings, Inc. and Tris Pharma, Inc. for development of
Solid
Products (5);
|
10.9
|
Supply
Agreement between Interpharm Holdings, Inc. and Centrix Pharmaceutical,
Inc. (4)
|
21.1
|
List
of Subsidiaries;
|
23.1
|
Consent
of Marcum & Kliegman, LLP;
|
31.1
|
Certification
of Cameron Reid pursuant to Exchange Act Rules 13a-15(d) and 15d-15(e),
as
adopted pursuant to Section 302 of the Sarbanes-Oxley Act of
2002;
|
31.2
|
Certification
of George Aronson pursuant to Exchange Act Rules 13a-15(d) and
15d-15(e),
as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of
2002;
|
32.1
|
Certification
pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section
906 of
the Sarbanes-Oxley Act of 2002;
|
1. |
Incorporated
by reference from Registration Statement on Form SB-2 registration
no.
33-54356 filed by the Company with the Securities and Exchange Commission
on November 9, 1992.
|
2. |
Annexed
to our Current Report on Form 8-K filed on November 26, 2002 and
incorporated herein by reference;
|
3. |
Annexed
to our Transition Report on Form 10-K filed on September 29, 2003
and
incorporated herein by reference.
|
4. |
Annexed
to our Current Report on Form 8-K filed on July 18, 2005 and incorporated
herein by reference.
|
5. |
Annexed
to our Annual Report on Form 10-K filed on September 28, 2005 and
incorporated herein by reference.
|
6. |
Annexed
to our Current Report on Form 8-K filed on June 2, 2006 and incorporated
herein by reference.
|
INTERPHARM HOLDINGS, INC. | ||
|
|
|
Date: September 28, 2006 | By: | /s/ Cameron Reid |
Cameron Reid, Chief Executive Officer |
||
/s/
George Aronson
|
September
28, 2006
|
|
George
Aronson, Chief Financial Officer
|
||
/s/
Bhupatlal K. Sutaria
|
September
28, 2006
|
|
Bhupatlal
K. Sutaria, President and Treasurer
|
||
/s/
Dr. Maganlal K. Sutaria
|
September
28, 2006
|
|
Dr
Maganlal K. Sutaria, Chairman of the Board of Directors
|
||
/s/Stewart
Benjamin
|
September
28, 2006
|
|
Stewart
Benjamin, Director
|
||
/s/David
Reback
|
September
28, 2006
|
|
David
Reback, Director
|
||
/s/
Kennith C Johnson
|
September
28, 2006
|
|
Kennith
C Johnson, Director
|
||
/s/
Rick Miller
|
September
28, 2006
|
|
Rick
Miller, Director
|
||
/s/
Joan Neuscheler
|
September
28, 2006
|
|
Joan
Neuscheler
|
|
Page
|
|||
REPORT OF INDEPENDENT REGISTERED
PUBLIC
ACCOUNTING FIRM
|
F-1 | |||
CONSOLIDATED FINANCIAL STATEMENTS | ||||
Consolidated
Balance Sheets
|
F-2 | |||
Consolidated
Statements of Operations
|
F-4 | |||
Consolidated
Statements of Stockholders’ Equity
|
F-5 | |||
Consolidated
Statements of Comprehensive (Loss)
Income
|
F-6 | |||
Consolidated
Statements of Cash Flows
|
F-7 | |||
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS | F-10 |
|
June
30,
|
||||||
2006
|
2005
|
||||||
CURRENT
ASSETS
|
|||||||
Cash
|
$
|
1,438
|
$
|
536
|
|||
Accounts
receivable, net
|
13,592
|
7,664
|
|||||
Inventories
|
8,706
|
8,941
|
|||||
Prepaid
expenses and other current assets
|
1,936
|
1,156
|
|||||
Deferred
tax assets
|
1,321
|
87
|
|||||
Total
Current Assets
|
26,993
|
18,384
|
|||||
Land,
building and equipment, net
|
29,069
|
21,872
|
|||||
Deferred
tax assets
|
4,849
|
4,326
|
|||||
Investment
in APR, LLC
|
1,023
|
1,023
|
|||||
Other
assets
|
933
|
785
|
|||||
TOTAL
ASSETS
|
$
|
62,867
|
$
|
46,390
|
|
June
30,
|
||||||
2006
|
2005
|
||||||
CURRENT
LIABILITIES
|
|||||||
Current
maturities of long-term debt
|
$
|
1,686
|
$
|
10,340
|
|||
Accounts
payable, accrued expenses and other liabilities
|
12,650
|
6,233
|
|||||
Deferred
revenue
|
3,399
|
--
|
|||||
Total
Current Liabilities
|
17,735
|
16,573
|
|||||
OTHER
LIABILITIES
|
|||||||
Long-term
debt, less current maturities
|
13,952
|
6,691
|
|||||
Other
liabilities
|
125
|
15
|
|||||
Total
Other Liabilities
|
14,077
|
6,706
|
|||||
TOTAL
LIABILITIES
|
31,812
|
23,279
|
|||||
COMMITMENTS
AND CONTINGENCIES
|
|||||||
Series
B-1 Redeemable Convertible Preferred Stock:
15,000
shares authorized; issued and outstanding - 10,000 at
June
30, 2006; liquidation preference of $10,000
|
8,225
|
--
|
|||||
STOCKHOLDERS’
EQUITY
|
|||||||
Preferred
stocks, 10,000 shares authorized; issued and
outstanding
- 5,141 and 6,608, respectively; aggregate
liquidation
preference of $4,291 and $5,483, respectively
|
51
|
66
|
|||||
Common
stock, $0.01 par value,70,000 shares authorized;
shares
issued - 64,537 and 32,339 respectively
|
645
|
323
|
|||||
Additional
paid-in capital
|
26,059
|
19,382
|
|||||
Stock
subscription receivable
|
(90
|
)
|
--
|
||||
Accumulated
other comprehensive loss
|
98
|
--
|
|||||
Unearned
stock based compensation
|
(1,863
|
)
|
--
|
||||
Retained
(deficit) earnings
|
(2,070
|
)
|
3,340
|
||||
TOTAL
STOCKHOLDERS’ EQUITY
|
22,830
|
23,111
|
|||||
TOTAL
LIABILITIES AND STOCKHOLDERS’ EQUITY
|
$
|
62,867
|
$
|
46,390
|
|
Year
Ended June 30,
|
|||||||||
2006
|
2005
|
2004
|
||||||||
SALES,
Net
|
$
|
63,355
|
$
|
39,911
|
$
|
41,100
|
||||
COST
OF SALES
(including related party
rent
expense of $408)
|
45,927
|
30,839
|
31,305
|
|||||||
GROSS
PROFIT
|
17,428
|
9,072
|
9,795
|
|||||||
OPERATING
EXPENSES
|
||||||||||
Selling,
general and administrative
|
11,449
|
5,092
|
4,124
|
|||||||
Related
party rent
|
72
|
72
|
72
|
|||||||
Research
and development
|
10,674
|
4,003
|
538
|
|||||||
TOTAL
OPERATING EXPENSES
|
22,195
|
9,167
|
4,734
|
|||||||
OPERATING
(LOSS) INCOME
|
(4,767
|
)
|
(95
|
)
|
5,061
|
|||||
OTHER
INCOME (EXPENSES)
|
||||||||||
Gain
on sale of marketable securities
|
--
|
9
|
--
|
|||||||
Loss
on sale of fixed asset
|
(5
|
)
|
--
|
--
|
||||||
Interest
expense
|
(719
|
)
|
(136
|
)
|
(21
|
)
|
||||
Interest
and other income
|
1
|
--
|
69
|
|||||||
TOTAL
OTHER (EXPENSES) INCOME
|
(723
|
)
|
(127
|
)
|
48
|
|||||
(LOSS)
INCOME BEFORE INCOME TAXES
|
(5,490
|
)
|
(222
|
)
|
5,109
|
|||||
(BENEFIT
FROM) PROVISION FOR INCOME TAXES
|
(1,700
|
)
|
(73
|
)
|
1,986
|
|||||
NET
(LOSS) INCOME
|
(3,790
|
)
|
(149
|
)
|
3,123
|
|||||
Series
B-1 preferred stock beneficial conversion feature
|
1,418
|
--
|
--
|
|||||||
Preferred
stock dividends
|
312
|
166
|
360
|
|||||||
NET
(LOSS) INCOME ATTRIBUTABLE TO COMMON STOCKHOLDERS
|
$
|
(5,520
|
)
|
$
|
(315
|
)
|
$
|
2,763
|
||
(LOSS)
EARNINGS PER SHARE ATTRIBUTABLE TO COMMON STOCKHOLDERS
|
||||||||||
Basic
(loss) earnings per share
|
$
|
(0.15
|
)
|
$
|
(0.01
|
)
|
$
|
0.16
|
||
Diluted
(loss) earnings per share
|
$
|
(0.15
|
)
|
$
|
(0.01
|
)
|
$
|
0.04
|
||
Basic
weighted average shares outstanding
|
36,521
|
25,684
|
17,595
|
|||||||
Diluted
weighted average shares and equivalent shares outstanding
|
36,521
|
25,684
|
68,637
|
Preferred
Stock
|
Common
Stock
|
Additional
|
Stock
|
Unearned StockBased
|
Accumulated
Other
Compre-
hensive
|
Retained
|
Total Stock-holders
|
||||||||||||||||||||||||||||||
Shares
|
|
|
Amount
|
|
|
Shares
|
Amount
|
|
Paid-In
Capital
|
|
Subscription
Receivable
|
|
|
Compen-
sation
|
|
Income
(Loss)
|
|
Earnings
(Deficit)
|
|
|
Shares
|
|
|
Amount
|
|
|
Equity
|
||||||||||
BALANCE
-
June 30, 2003
|
7,301
|
$
|
73
|
15,672
|
$
|
157
|
$
|
12,355
|
$
|
--
|
$
|
--
|
$
|
12
|
$
|
669
|
624
|
$
|
(798
|
)
|
$
|
12,468
|
|||||||||||||||
Shares
issued for options and warrants exercised
|
--
|
--
|
3,535
|
35
|
3,485
|
--
|
--
|
--
|
--
|
3,520
|
|||||||||||||||||||||||||||
Tax
benefit in connection with exercise of stock options
|
--
|
--
|
--
|
--
|
3,679
|
--
|
--
|
--
|
--
|
3,679
|
|||||||||||||||||||||||||||
Adjustments
related to reverse merger
|
--
|
--
|
4
|
--
|
4
|
--
|
--
|
--
|
--
|
4
|
|||||||||||||||||||||||||||
Conversion
of Series J preferred stock
|
(105
|
)
|
(1
|
)
|
105
|
1
|
--
|
--
|
--
|
--
|
--
|
--
|
|||||||||||||||||||||||||
Conversion
of Series K preferred stock
|
(293
|
)
|
(3
|
)
|
6,275
|
63
|
(60
|
)
|
--
|
--
|
--
|
--
|
--
|
||||||||||||||||||||||||
Unrealized
loss on marketable securities, net
|
--
|
--
|
--
|
--
|
--
|
(12
|
)
|
--
|
--
|
--
|
(12
|
)
|
|||||||||||||||||||||||||
Net
income
|
--
|
--
|
--
|
--
|
--
|
--
|
--
|
--
|
3,123
|
--
|
--
|
3,123
|
|||||||||||||||||||||||||
BALANCE
-
June 30, 2004
|
6,903
|
69
|
25,591
|
256
|
19,463
|
--
|
--
|
--
|
3,792
|
624
|
(798
|
)
|
22,782
|
||||||||||||||||||||||||