ProPhase Labs, Inc. - Quarter Report: 2010 September (Form 10-Q)
FORM
10-Q
UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
WASHINGTON,
DC 20549
(Mark
One)
x
|
QUARTERLY
REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF
1934
|
For the
quarterly period ended
September 30,
2010
OR
¨
|
TRANSITION
REPORT PURSUANT TO SECTION 13 OR 15(d) OF THESECURITIES EXCHANGE ACT OF
1934
|
For the
transition period from ______________ to ______________
Commission
file number 0-21617
ProPhase Labs, Inc.
(Exact
Name of Registrant as Specified in Its Charter)
Nevada
|
23-2577138
|
|
(State
or other jurisdiction of
incorporation
or organization)
|
|
(I.R.S.
Employer Identification No.)
|
621 North Shady Retreat
Road, Doylestown,
Pennsylvania 18901
(Address of principal executive
office) (Zip
Code)
(215) 345-0919
(Registrant’s
telephone number, including area code)
Indicate
by check mark whether the registrant (1) has filed all reports required to be
filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the
preceding 12 months (or for such shorter period that the registrant was required
to file such reports) and (2) has been subject to such filing requirements for
the past 90 days. Yes x No ¨
Indicate
by check mark whether the registrant has submitted electronically and posted on
its corporate Web site, if any, every Interactive Data File required to be
submitted and posted pursuant to Rule 405 of Regulation S-T during
the preceding 12 months (or shorter period that the registration was
required to submit and post such
files). Yes ¨ No ¨
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
definition of “large accelerated filer”, "accelerated filer”, “non-accelerated
filer" and “smaller reporting company” in Rule 12b-2 of the Exchange
Act. (Check one):
Large
accelerated filer ¨ Accelerated
filer ¨ Non-accelerated
filer ¨ Smaller
reporting company x
Indicate
by check mark whether the registrant is a shell company (as defined in Rule
12b-2 of the Exchange Act). Yes ¨ No
x
Indicate
the number of shares outstanding of each of the issuer’s classes of common
stock, as of the latest practicable date.
Class
|
Outstanding at November 12,
2010
|
|
Common
Stock, $0.0005 par value
|
14,665,517
|
ProPhase
Labs, Inc. and Subsidiaries
TABLE
OF CONTENTS
PAGE
|
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PART
I.
|
FINANCIAL
INFORMATION
|
||
Item
1.
|
Financial
Statements
|
||
Condensed
Consolidated Balance Sheets as of September 30, 2010
(unaudited)
|
|
||
and
December 31, 2009
|
3
|
||
Condensed
Consolidated Statements of Operations for the Three Months and
Nine
|
|||
Months
Ended September 30, 2010 and 2009 (unaudited)
|
4
|
||
Condensed
Consolidated Statement of Stockholders’ Equity for the
Nine
|
|||
Months
Ended September 30, 2010 (unaudited)
|
5
|
||
Condensed
Consolidated Statements of Cash Flows for the Nine Months
Ended
|
|||
September
30, 2010 and 2009 (unaudited)
|
6
|
||
Notes
to Condensed Consolidated Financial Statements
|
7
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||
Item
2.
|
Management’s
Discussion and Analysis of Financial Condition and Results of
Operations
|
19
|
|
Item
3.
|
Quantitative
and Qualitative Disclosures About Market Risk
|
30
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|
Item
4.
|
Controls
and Procedures
|
30
|
|
PART
II.
|
OTHER
INFORMATION
|
||
Item
1.
|
Legal
Proceedings
|
32
|
|
Item
1A.
|
Risk
Factors
|
32
|
|
Item
2.
|
Unregistered
Sales of Equity Securities and Use of Proceeds
|
32
|
|
Item
3.
|
Defaults
Upon Senior Securities
|
32
|
|
Item
5.
|
Other
Information
|
32
|
|
Item
6.
|
Exhibits
|
33
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|
Signatures
|
34
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||
Certifications
|
35
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2
PART
I. FINANCIAL INFORMATION
Item
1. Financial
Statements.
ProPhase
Labs, Inc. and Subsidiaries
Condensed
Consolidated Balance Sheets
(in
thousands, except share and per share amounts)
September 30, 2010
|
December 31, 2009
|
|||||||
(unaudited)
|
||||||||
ASSETS
|
||||||||
Cash
and cash equivalents (Note 2)
|
$ | 8,705 | $ | 12,801 | ||||
Accounts
receivable, net of doubtful accounts of $20 and
|
||||||||
$23
respectively (Note 2)
|
4,791 | 3,599 | ||||||
Inventory,
net (Note 2)
|
2,368 | 1,405 | ||||||
Prepaid
expenses and other current assets
|
325 | 803 | ||||||
Assets
held for sale (Note 2)
|
138 | 138 | ||||||
Total
current assets
|
16,327 | 18,746 | ||||||
Intangible
asset, licensed technology (Note 3)
|
3,577 | - | ||||||
Property,
plant and equipment, net of accumulated depreciation
|
||||||||
of
$3,420 and $3,155, respectively (Note 2)
|
2,453 | 2,572 | ||||||
Other
assets
|
- | 12 | ||||||
$ | 22,357 | $ | 21,330 | |||||
LIABILITIES
AND STOCKHOLDERS' EQUITY
|
||||||||
LIABILITIES:
|
||||||||
Accounts
payable
|
$ | 761 | $ | 708 | ||||
Accrued
royalties and sales commissions (Note 4)
|
3,703 | 3,681 | ||||||
Accrued
advertising and other allowances
|
2,755 | 2,124 | ||||||
Other
current liabilities
|
642 | 758 | ||||||
Total
current liabilities
|
7,861 | 7,271 | ||||||
Commitments
and contigencies (Note 4)
|
- | - | ||||||
STOCKHOLDERS'
EQUITY:
|
||||||||
Common
Stock, $.0005 par value; authorized 50,000,000;
|
||||||||
issued:
19,311,570 and 17,679,436 shares, respectively (Note 5)
|
10 | 9 | ||||||
Additional
paid-in-capital
|
40,532 | 37,726 | ||||||
Retained
earnings (deficit)
|
(858 | ) | 1,512 | |||||
Treasury
stock, at cost, 4,646,053 and 4,646,053 shares,
respectively
|
(25,188 | ) | (25,188 | ) | ||||
Total
stockholders' equity
|
14,496 | 14,059 | ||||||
$ | 22,357 | $ | 21,330 |
See
accompanying notes to condensed consolidated financial
statements
3
ProPhase
Labs, Inc. and Subsidiaries
Condensed
Consolidated Statements of Operations
(in
thousands, except per share amounts)
(unaudited)
Three Months Ended
|
Nine Months Ended
|
|||||||||||||||
September 30, 2010
|
September 30, 2009
|
September 30, 2010
|
September 30, 2009
|
|||||||||||||
Net
sales (Note 2)
|
$ | 5,204 | $ | 4,977 | $ | 8,310 | $ | 10,712 | ||||||||
Cost
of sales (Note 2)
|
1,594 | 1,362 | 3,059 | 4,454 | ||||||||||||
Gross
profit
|
3,610 | 3,615 | 5,251 | 6,258 | ||||||||||||
Operating
costs and expenses:
|
||||||||||||||||
Sales
and marketing
|
904 | 607 | 2,418 | 3,424 | ||||||||||||
Administration
|
1,303 | 1,470 | 4,532 | 7,502 | ||||||||||||
Research
and development
|
468 | 341 | 712 | 975 | ||||||||||||
2,675 | 2,418 | 7,662 | 11,901 | |||||||||||||
Income
(loss) from operations
|
935 | 1,197 | (2,411 | ) | (5,643 | ) | ||||||||||
Interest
and other income
|
12 | 5 | 41 | 20 | ||||||||||||
Income
(loss) from operations before income taxes
|
947 | 1,202 | (2,370 | ) | (5,623 | ) | ||||||||||
Income
tax (benefit) (Note 6)
|
- | - | - | - | ||||||||||||
Net
income (loss)
|
$ | 947 | $ | 1,202 | $ | (2,370 | ) | $ | (5,623 | ) | ||||||
Basic
earnings (loss) per share
|
||||||||||||||||
Income
(loss) from operations
|
$ | 0.06 | $ | 0.09 | $ | (0.17 | ) | $ | (0.43 | ) | ||||||
Net
income (loss)
|
$ | 0.06 | $ | 0.09 | $ | (0.17 | ) | $ | (0.43 | ) | ||||||
Diluted
earnings (loss) per share
|
||||||||||||||||
Income
(loss) from operations
|
$ | 0.06 | $ | 0.09 | $ | (0.17 | ) | $ | (0.43 | ) | ||||||
Net
income (loss)
|
$ | 0.06 | $ | 0.09 | $ | (0.17 | ) | $ | (0.43 | ) | ||||||
Weighted
average common shares outstanding
|
||||||||||||||||
Basic
|
14,659 | 12,996 | 14,152 | 12,940 | ||||||||||||
Diluted
|
14,659 | 13,110 | 14,152 | 12,940 |
See
accompanying notes to condensed consolidated financial
statements
4
ProPhase
Labs, Inc. and Subsidiaries
Condensed
Consolidated Statements of
Stockholders’
Equity
(in
thousands, except share data)
(unaudited)
Additional
|
Retained
|
|||||||||||||||||||||||
Common Stock
|
Par
|
Paid-In
|
Earnings
|
Treasury
|
||||||||||||||||||||
Shares
|
Value
|
Capital
|
(Deficit)
|
Stock
|
Total
|
|||||||||||||||||||
Balance
at December 31, 2009
|
13,033,383 | $ | 9 | $ | 37,726 | $ | 1,512 | $ | (25,188 | ) | $ | 14,059 | ||||||||||||
Net
loss
|
(2,370 | ) | (2,370 | ) | ||||||||||||||||||||
Proceeds
from exercise of stock options
|
130,000 | - | 133 | - | - | 133 | ||||||||||||||||||
Common
stock issued to Phosphagenics
|
||||||||||||||||||||||||
Limited
pursuant to an Exclusive
|
||||||||||||||||||||||||
License
Agreement (Note 3)
|
1,440,000 | 1 | 2,576 | - | - | 2,577 | ||||||||||||||||||
Common
stock granted pursuant to an employment agreement
|
26,299 | - | 48 | - | - | 48 | ||||||||||||||||||
Common
stock granted pursuant to a compensation plan
|
35,835 | - | 49 | - | - | 49 | ||||||||||||||||||
Tax
benefits from exercise of stock options
|
- | - | 42 | - | - | 42 | ||||||||||||||||||
Tax
benefit allowance
|
- | - | (42 | ) | - | - | (42 | ) | ||||||||||||||||
Balance
at September 30, 2010
|
14,665,517 | $ | 10 | $ | 40,532 | $ | (858 | ) | $ | (25,188 | ) | $ | 14,496 |
See
accompanying notes to condensed consolidated financial
statements
5
ProPhase
Labs, Inc. and Subsidiaries
Condensed
Consolidated Statements of Cash Flows
(in
thousands)
(unaudited)
Nine Months Ended
|
||||||||
September 30, 2010
|
September 30, 2009
|
|||||||
Cash
Flows from operating activities:
|
||||||||
Net
loss
|
$ | (2,370 | ) | $ | (5,623 | ) | ||
Adjustments
to reconcile net loss to net cash
|
||||||||
provided
by (used in) operating activities:
|
||||||||
Depreciation
and amortization
|
265 | 424 | ||||||
Share-based
compensation expense
|
97 | - | ||||||
Gain
on disposal of assets
|
- | (38 | ) | |||||
Sales
discounts and provision for bad debts
|
(26 | ) | (725 | ) | ||||
Inventory
valuation provision
|
(989 | ) | (124 | ) | ||||
Changes
in operating assets and liabilities:
|
||||||||
Accounts
receivable
|
(1,166 | ) | 2,326 | |||||
Inventory
|
26 | (55 | ) | |||||
Accounts
payable
|
53 | (348 | ) | |||||
Accrued
royalties and sales commissions
|
22 | (73 | ) | |||||
Accrued
advertising and other allowances
|
631 | (44 | ) | |||||
Other
operating assets and liabilities, net
|
374 | 770 | ||||||
Net
cash used in operating activities
|
(3,083 | ) | (3,510 | ) | ||||
Cash
flows provided by (used in) investing activities:
|
||||||||
Capital
expenditures
|
(146 | ) | (103 | ) | ||||
Acquisition
of product license
|
(1,000 | ) | - | |||||
Proceeds
from the sale of fixed assets
|
- | 475 | ||||||
Net
cash flows provided by (used in) investing activities
|
(1,146 | ) | 372 | |||||
Cash
flows from financing activities:
|
||||||||
Proceeds
from exercise of stock options
|
133 | 126 | ||||||
Net
cash provided by financing activities
|
133 | 126 | ||||||
Net
decrease in cash and cash equivalents
|
(4,096 | ) | (3,012 | ) | ||||
Cash
and cash equivalents at beginning of period
|
12,801 | 11,957 | ||||||
Cash
and cash equivalents at end of period
|
$ | 8,705 | $ | 8,945 | ||||
Supplemental
disclosures of cash flow information:
|
||||||||
Interest
paid
|
$ | - | $ | - | ||||
Income
taxes paid
|
$ | - | $ | - | ||||
Common
stock issued to Phosphagenics Limited
|
||||||||
pursuant
to a product license agreement
|
$ | 2,577 | $ | - |
See
accompanying notes to condensed consolidated financial
statements
6
ProPhase
Labs, Inc. and Subsidiaries
Notes
to Condensed Consolidated Financial Statements
(unaudited)
Note
1 – Organization and Business
ProPhase
Labs, Inc. (“we”, “us” or the “Company”), organized under the laws of the State
of Nevada, is a manufacturer, marketer and distributor of a diversified range of
homeopathic and health products that are offered to the general public. We are
also engaged in the research and development of potential over-the-counter
(“OTC”) drug, natural base health products along with supplements, personal care
and cosmeceutical products.
Our
primary business is currently the manufacture, distribution, marketing and sale
of OTC cold remedy products to consumers through national chain, regional,
specialty and local retail stores. One of our principal products is
Cold-EEZEÒ,
a zinc gluconate glycine product proven in clinical studies to reduce the
duration and severity of the common cold symptoms by nearly
half. Cold-EEZEÒ
is an established product in the health care and cold remedy
market. For the three and nine months ended September 30, 2010 and
2009, our revenues from continuing operations have come principally from our
cold remedy products.
On May 5,
2010, our shareholders approved, among other corporate matters, the Board of
Directors’ proposal to change our name to ProPhase Labs, Inc. from The Quigley
Corporation.
We use a
December 31 year-end for financial reporting purposes. References
herein to the fiscal year ended December 31, 2010 shall be the term “Fiscal
2010” and references to other “Fiscal” years shall mean the year, which ended on
December 31 of the year indicated. The term “we”, “us” or the “Company” as used
herein also refer, where appropriate, to the Company, together with its
subsidiaries unless the context otherwise requires.
Our
balance sheet at December 31, 2009 has been reclassified to conform to our
current period ended September 30, 2010 presentation.
Note
2 – Summary of Significant Accounting Policies
Basis
of Presentation
The
unaudited condensed consolidated financial statements have been prepared in
accordance with generally accepted accounting principles for interim financial
statements and within the rules of the Securities and Exchange Commission
applicable to interim financial statements and therefore do not include all
disclosures that might normally be required for financial statements prepared in
accordance with generally accepted accounting principles. The
accompanying unaudited condensed consolidated financial statements have been
prepared by management without audit and should be read in conjunction with our
consolidated financial statements, including the notes thereto, appearing in our
Annual Report on Form 10-K for the year ended December 31, 2009. In
the opinion of management, all adjustments necessary for a fair presentation of
the consolidated financial position, consolidated results of operations and
consolidated cash flows, for the periods indicated, have been made. The results
of operations for the three and nine months ended September 30, 2010 are not
necessarily indicative of operating results that may be achieved over the course
of the full year.
7
ProPhase
Labs, Inc. and Subsidiaries
Notes
to Condensed Consolidated Financial Statements
(unaudited)
Note
2 – Summary of Significant Accounting Policies - continued
Seasonality
of the Business
Our net
sales are derived principally from our cold remedy
products. Currently, our sales are influenced by and subject to
fluctuations in the timing of purchase and the ultimate level of demand for our
products which are a function of the timing, length and severity of each cold
season. Generally, a cold season is defined as the period of
September to March when the incidence of the common cold rises as a consequence
of the change in weather and other factors. We generally experience
in the fourth quarter higher levels of net sales along with a corresponding
increase in marketing and advertising expenditures designed to promote our
products during the cold season. Revenues and related marketing costs
are generally at their lowest levels in the second quarter when consumer demand
generally declines and retail customers balance their inventory positions as
cold season consumer demand subsides. We track health and wellness
trends and develop retail promotional strategies to align our production
scheduling, inventory management and marketing programs to optimize consumer
purchases.
Use
of Estimates
The
preparation of financial statements and the accompanying notes thereto, in
conformity with generally accepted accounting principles, requires management to
make estimates and assumptions that affect our reported amounts of assets and
liabilities, disclosure of contingent assets and liabilities at the date of the
financial statements and reported amounts of revenues and expenses during the
respective reporting periods. Examples include the provision for bad
debt, sales returns and allowances, inventory obsolescence, useful lives of
property and equipment and intangible assets, impairment of property and
equipment and intangible assets, income tax valuations and assumptions related
to accrued advertising. These estimates and assumptions are based on
historical experience, current trends and other factors that management believes
to be relevant at the time the financial statements are
prepared. Management reviews the accounting policies, assumptions,
estimates and judgments on a quarterly basis. Actual results could
differ from those estimates.
Our
primary product, Cold-EEZEÒ,
utilizes a proprietary zinc formulation which has been clinically proven to
reduce the severity and duration of common cold symptoms. Factors
considered in estimating the appropriate sales returns and allowances for this
product include it being (i) a unique product with limited competitors, (ii)
competitively priced, (iii) promoted, (iv) unaffected for remaining shelf-life
as there is no product expiration date, and (v) monitored for inventory levels
at major customers and third-party consumption data. We added new
products to our OTC personal care product line in Fiscal 2007 and Fiscal 2008
such as ISC-10 Immune (subsequently discontinued in Fiscal 2009), Organix
Organic Cough and Sore Throat Drops and Kids-EEZEÒ
Chest Relief. In Fiscal 2010, we added two additional products to the
Kids-EEZEÒ
product line, Allergy and a Cough and Cold formulation. Each of these
new products carry shelf-life expiration dates for which we aggregate such new
product market experience data and update our sales returns and allowances
estimates accordingly. Sales allowances estimates are tracked at the
specific customer and product line levels and are tested on an annual historical
basis, and reviewed quarterly. Additionally, we monitor current developments by
customer, market conditions and any other occurrences that could affect the
expected provisions relative to net sales for the period presented.
Cash
Equivalents
We
consider all highly liquid investments with an initial maturity of three months
or less at the time of purchase to be cash equivalents. Cash
equivalents include cash on hand and monies invested in money market funds. The
carrying amount approximates the fair market value due to the short-term
maturity of these investments.
8
ProPhase
Labs, Inc. and Subsidiaries
Notes
to Condensed Consolidated Financial Statements
(unaudited)
Note
2 – Summary of Significant Accounting Policies - continued
Inventory
Valuation
Inventory
is valued at the lower of cost, determined on a first-in, first-out basis
(“FIFO”), or market. Inventory items are analyzed to determine cost
and the market value and, if appropriate, inventory valuation reserves are
established. The condensed consolidated financial statements include
a specific reserve for excess or obsolete inventory of approximately $846,000
and $1.8 million as of September 30, 2010 and December 31, 2009,
respectively. Raw material, work in progress and packaging inventory
aggregated approximately $924,000 and $610,000 at September 30, 2010 and
December 31, 2009, respectively. Finished goods inventory was $1.4
million and $795,000 at September 30, 2010 and December 31, 2009,
respectively.
Property,
Plant and Equipment
Property,
plant and equipment are recorded at cost. We use a combination of
straight-line and accelerated methods in computing depreciation for financial
reporting purposes. Depreciation expense is computed in accordance
with the following ranges of estimated asset lives: building and improvements -
twenty to thirty-nine years; machinery and equipment - five to seven years;
computer software - three to four years; and furniture and fixtures – seven
years.
Concentration
of Risks
Future
revenues, costs, margins, and profits will continue to be influenced by our
ability to maintain our manufacturing availability and capacity together with
our marketing and distribution capabilities and the regulatory requirements
associated with the development of OTC drug, personal care or other products in
order to continue to compete on a national level.
Our
business is subject to federal and state laws and regulations adopted for the
health and safety of users of our products. Cold-EEZE® and
Kids-EEZE®
product lines are cold remedies that are subject to regulations by
various federal, state and local agencies, including the Food and Drug
Administration (“FDA”) and, when applicable, the Homeopathic Pharmacopoeia of
the United States.
Financial
instruments that potentially subject us to significant concentrations of credit
risk consist principally of cash investments and trade accounts
receivable.
We
maintain cash and cash equivalents with certain major financial institutions. As
of September 30, 2010, our cash balance was $8.7 million and bank balance was
$8.9 million. Of the total bank balance, $505,000 was covered by
federal depository insurance and $8.4 million was uninsured.
Trade
accounts receivable potentially subjects us to credit concentrations from
time-to-time as a consequence of the timing, payment pattern and ultimate
purchase volumes or shipping schedules with our customers.. We extend
credit to our customers based upon an evaluation of the customer’s financial
condition and credit history and generally we do not require
collateral. Our broad range of customers includes many large
wholesalers, mass merchandisers and multi-outlet pharmacy and chain drug
stores. These credit concentrations may impact our overall exposure
to credit risk, either positively or negatively, in that our customers may be
similarly affected by changes in economic, regulatory or other conditions that
may impact the timing and collectability of amounts due to
us. Customers comprising the five largest accounts receivable
balances represented 74% and 71% of total trade receivable balances at September
30, 2010 and December 31, 2009, respectively.
9
ProPhase
Labs, Inc. and Subsidiaries
Notes
to Condensed Consolidated Financial Statements
(unaudited)
Note
2 – Summary of Significant Accounting Policies - continued
Our
revenues are principally generated from the sale of the cold remedy products
which approximated 97% and 98% of total revenues for the nine months ended
September 30, 2010 and 2009, respectively. A significant portion of
our business is highly seasonal, which causes major variations in operating
results from quarter to quarter. The third and fourth quarters
generally represent the largest sales volume for the OTC cold remedy
products. For the three months and nine months ended September 30,
2010 and 2009, all of our net sales were related to domestic markets.
Long-lived
Assets
We review
our carrying value of our long-lived assets with definite lives whenever events
or changes in circumstances indicate that the carrying amount of the assets may
not be recoverable. When indicators of impairment exist, we determine
whether the estimated undiscounted sum of the future cash flows of such assets
is less than their carrying amounts. If less, an impairment loss is
recognized in the amount, if any, by which the carrying amount of such assets
exceeds their respective fair values. The determination of fair value
is based on quoted market prices in active markets, if available, or independent
appraisals; sales price negotiations; or projected future cash flows discounted
at a rate determined by management to be commensurate with our business
risk. The estimation of fair value utilizing discounted forecasted
cash flows includes significant judgments regarding assumptions of revenue,
operating and marketing costs; selling and administrative expenses; interest
rates; property and equipment additions and retirements; industry competition;
and general economic and business conditions, among other factors.
In June
2009, we concluded the closing of our Elizabethtown manufacturing
facility. At September 30, 2010 and December 31, 2009, our
reported assets include Assets
Held For Sale aggregating $138,000 related to the land and buildings of
the Elizabethtown manufacturing facility. These assets have been
recorded at their estimated fair value, less estimated costs to
sell.
As
codified under Accounting Standards Codification (“ASC”) ASC-820, “Fair Value Measurements and
Disclosure”, fair value is based on the prices that would be received to
sell an asset or paid to transfer a liability in an orderly transaction between
market participants at the measurement date. In order to increase consistency
and comparability in fair value measurements, ASC-820 establishes a three-tier
fair value hierarchy that prioritizes the inputs used to measure fair value.
These tiers include: Level 1, defined as observable inputs such as quoted prices
in active markets; Level 2, defined as inputs other than quoted prices in active
markets that are either directly or indirectly observable; and Level 3, defined
as unobservable inputs for which little or no market data exists, therefore
requiring an entity to develop its own assumptions.
The fair
value of the reported Assets
Held For Sale was arrived at through bids generated from interested third
party purchasers and guidance from a third party real estate advisor thereby
relating to Level 3 fair value hierarchy.
Fair
Value of Financial Instruments
We
categorize our financial instruments into a three-level fair value hierarchy
that prioritizes the inputs to valuation techniques used to measure fair value
into three broad levels. The fair value hierarchy gives the highest priority to
quoted prices in active markets for identical assets or liabilities (Level 1)
and the lowest priority to unobservable inputs (Level 3). If the inputs used to
measure fair value fall within different levels of the hierarchy, the category
level is based on the lowest priority level input that is significant to the
fair value measurement of the instrument.
10
ProPhase
Labs, Inc. and Subsidiaries
Notes
to Condensed Consolidated Financial Statements
(unaudited)
Note
2 – Summary of Significant Accounting Policies - continued
Financial
assets recorded at fair value on our consolidated balance sheets are categorized
as either (i) Level 1: unadjusted quoted prices for identical assets in an
active market, (ii) Level 2: quoted prices in markets that are not active or
inputs that are observable either directly or indirectly for substantially the
full-term of the asset or (iii) Level 3: prices or valuation techniques that
require inputs that are both unobservable and significant to the overall fair
value measurement.
Cash and
cash equivalents, accounts receivable and accounts payable are reflected in the
Condensed Consolidated Financial Statements at carrying value which approximates
fair value because of the short-term maturity of these
instruments. Determination of fair value of related party payables,
if any, is not practicable due to their related party nature.
Revenue
Recognition
Sales are
recognized at the time ownership is transferred to the
customer. Revenue is reduced for trade promotions, estimated sales
returns, cash discounts and other allowances in the same period as the related
sales are recorded. We make estimates of potential future product returns and
other allowances related to current period revenue. We analyze historical
returns, current trends, and changes in customer and consumer demand when
evaluating the adequacy of the sales returns and other allowances.
We do not
impose a period of time within which product may be returned. All
requests for product returns must be submitted to us for
pre-approval. The main components of our returns policy are: (i) we
will accept returns that are due to damaged product that is un-saleable and such
return request activity falls within an acceptable range, (ii) we will accept
returns for products that have reached or exceeded designated expiration dates
and (iii) we will accept returns in the event that we discontinue a product
provided that the customer will have the right to return only such items that it
purchased directly from us. We will not accept return requests
pertaining to customer inventory “Overstocking” or “Resets”. We will
only accept return requests for product in its intended package
configuration. We reserve the right to terminate shipment of product
to customers who have made unauthorized deductions contrary to our return policy
or pursue other methods of reimbursement. We compensate the customer for
authorized returns by means of a credit applied to amounts owed or to be owed
and in the case of discontinued product only, also by way of an
exchange. We do not have any significant product exchange
history.
As of
September 30, 2010 and December 31, 2009, we included a provision for sales
allowances of $106,000 and $127,000, respectively, which are reported as a
reduction to account receivables. We also included an estimate of the
uncollectability of our accounts receivable as an allowance for doubtful
accounts of $20,000 and $23,000 as of September 30, 2010 and December 31, 2009,
respectively. Additionally, accrued advertising and other allowances
as of September 30, 2010 include $1.2 million for estimated future sales
returns, $717,000 for cooperative incentive promotion costs and $845,000 for
certain other advertising and marketing promotions. As of December
31, 2009 accrued advertising and other allowances include $1.5 million for
estimated future sales returns and $586,000 for cooperative incentive promotion
costs.
Shipping
and Handling
Product
sales carry shipping and handling charges to the purchaser, included as part of
the invoiced price, which is classified as revenue. In all cases,
costs related to this revenue are recorded in cost of sales.
Stock
Compensation
We
recognize all share-based payments to employees and directors, including grants
of stock options, as compensation expense in the financial statements based on
their fair values. Fair values of stock options are determined
through the use of the Black-Scholes option pricing model. The
compensation cost is recognized as an expense over the requisite service period
of the award, which usually coincides with the vesting period.
11
ProPhase
Labs, Inc. and Subsidiaries
Notes
to Condensed Consolidated Financial Statements
(unaudited)
Note
2 – Summary of Significant Accounting Policies - continued
Stock
options and warrants for purchase of our common stock, $0.0005 par value,
(“Common Stock”) have been granted to both employees and
non-employees. Options and warrants are exercisable during a period
determined by us, but in no event later than ten years from the date
granted. No stock options or warrants to purchase of our Common Stock
have been granted for the three months or nine months ended September 30, 2010
and 2009, respectively.
Variable
Interest Entity
ASC-810
establishes criterion and implementation guidance for the consolidation of
variable interest entities (“VIE”). Phusion Laboratories, LLC (the
“Joint Venture”), of which we own a 50% membership interest effective March 22,
2010, qualifies as a VIE and we have consolidated the Joint Venture beginning
with the quarter ended March 31, 2010 (see Note 3).
Advertising
and Incentive Promotions
Advertising
and incentive promotion costs are expensed within the period in which they are
utilized. Advertising and incentive promotion expense is comprised of media
advertising, presented as part of sales and marketing expense, cooperative
incentive promotions and coupon program expenses, which are accounted for as
part of net sales, and free product, which is accounted for as part of cost of
sales. Advertising and incentive promotion costs incurred for the
three months ended September 30, 2010 and 2009 were $1.9 million and $1.1
million, respectively. Advertising and incentive promotion costs
incurred for the nine months ended September 30, 2010 and 2009 were $3.2 million
and $3.6 million respectively. Included in prepaid expenses and other current
assets was zero and $170,000 at September 30, 2010 and December 31, 2009,
respectively, relating to prepaid advertising and promotion
expense.
Research
and Development
Research
and development costs are charged to operations in the period incurred. Research
and development costs for the three months ended September 30, 2010 and 2009
were $468,000 and $341,000, respectively. Research and development cost for the
nine month period ended September 30, 2010 and 2009 were $712,000 and $975,000,
respectively. Research and development costs are principally related to certain
study activities, costs associated with the development of potential new product
development initiatives and costs associated with Cold-EEZE®.
Income
Taxes
We
utilize the asset and liability approach which requires the recognition of
deferred tax assets and liabilities for the future tax consequences of events
that have been recognized in our financial statements or tax returns. In
estimating future tax consequences, we generally consider all expected future
events other than enactments of changes in the tax law or
rates. Until sufficient taxable income to offset the temporary timing
differences attributable to operations and the tax deductions attributable to
option, warrant and stock activities are assured, a valuation allowance equaling
the total deferred tax asset is being provided (see Note 6).
We
utilize a two-step approach to recognizing and measuring uncertain tax
positions. The first step is to evaluate the tax position for
recognition by determining if the weight of available evidence indicates that it
is more likely than not that the position will be sustained on audit, including
resolution of related appeals or litigation processes, if any. The second step
is to measure the tax benefit as the largest amount which is more than fifty
percent likely of being realized upon ultimate settlement.
As a
result of our continuing tax losses, we have recorded a full valuation allowance
against a net deferred tax asset. Additionally, we have not recorded
a liability for unrecognized tax benefits. The tax years 2006 through
2009 remain open to examination by the major taxing jurisdictions to which we
are subject.
12
ProPhase
Labs, Inc. and Subsidiaries
Notes
to Condensed Consolidated Financial Statements
(unaudited)
Note
2 – Summary of Significant Accounting Policies - continued
Recently
Issued Accounting Standards
In
November 2008, the SEC issued for comment a proposed roadmap regarding the
potential use by U.S. issuers of financial statements prepared in accordance
with International Financial Reporting Standards (“IFRS”). IFRS is a
comprehensive series of accounting standards published by the International
Accounting Standards Board (“IASB”). Under the proposed roadmap, we could be
required in fiscal 2014 to prepare financial statements in accordance with IFRS.
The SEC will make a determination in 2011 regarding the mandatory adoption of
IFRS. We are currently assessing the impact that this potential change would
have on our consolidated financial statements and we will continue to monitor
the development of the potential implementation of IFRS.
In June
2009, the Financial Accounting Standards Board (“FASB”) modified the accounting
standard related to consolidation. This standard, as modified,
intends to improve financial reporting by enterprises involved with variable
interest entities. This standard, as modified, addresses the effects
on certain provisions relating to the Consolidation of Variable Interest
Entities, as a result of the elimination of the qualifying special-purpose
entity concept in the accounting standard related to transfers and servicing,
and constituent concerns about the application of certain key provisions of this
standard, including those in which the accounting and disclosures under the
standard do not always provide timely and useful information about an
enterprise’s involvement in a variable interest entity. This
standard, as modified, is effective as of the beginning of each reporting
entity’s first annual reporting period that begins after November 15, 2009, for
interim periods within that first annual reporting period, and for interim and
annual reporting periods thereafter. Earlier application is
prohibited. The adoption of the consolidation standard, as modified,
did not have a material effect on our consolidated financial
statements.
In
October 2009, the FASB issued Accounting Standards Update No. 2009-13, "Multiple-Deliverable Revenue
Arrangements" ("ASU No. 2009-13"). ASU No. 2009-13 amends guidance
included within ASC Topic 605-25 to require an entity to
use an estimated selling price when vendor specific objective evidence or
acceptable third party evidence does not exist for any products or services
included in a multiple element arrangement. The arrangement consideration should
be allocated among the products and services based upon their relative selling
prices, thus eliminating the use of the residual method of allocation. ASU No.
2009-13 also requires expanded qualitative and quantitative disclosures
regarding significant judgments made and changes in applying this guidance. ASU
No. 2009-13 is effective prospectively for revenue arrangements entered into or
materially modified in fiscal years beginning on or after June 15,
2010. Early adoption and retrospective application are also
permitted. We elected to adopt ASU No. 2009-13 early and the adoption
did not have a material effect on our consolidated financial
statements.
In
January 2010, the FASB issued ASU 2010-06, “Improving Disclosures about Fair
Value Measurements”. ASU 2010-06 amends ASU 820 to require a number of
additional disclosures regarding fair value measurements. The amended guidance
requires entities to disclose the amounts of significant transfers between Level
1 and Level 2 of the fair value hierarchy and the reasons for these transfers,
the reasons for any transfers in or out of Level 3, and information in the
reconciliation of recurring Level 3 measurements about purchases, sales,
issuances and settlements on a gross basis. This ASU also clarifies the
requirement for entities to disclose information about both the valuation
techniques and inputs used in estimating Level 2 and Level 3 fair value
measurements as well as the level of disaggregation required for each class of
asset and liability disclosed. The amended guidance is effective for interim and
annual financial periods beginning after December 15, 2009. The adoption of ASU
2010-06 did not have a material effect on our consolidated financial
statements.
13
ProPhase
Labs, Inc. and Subsidiaries
Notes
to Condensed Consolidated Financial Statements
(unaudited)
Note
3 – Investment in Phusion Laboratories, LLC.
On March
22, 2010, the Company, Phosphagenics Ltd. (“PSI Parent”), an Australian
corporation, Phosphagenics Inc. (“PSI”), a Delaware corporation and subsidiary
of PSI Parent, and Phusion Laboratories, LLC (the “Joint Venture”), a Delaware
limited liability company, entered into a Limited Liability Company Agreement
(the “LLC Agreement”) of the Joint Venture and additional related agreements for
the purpose of developing and commercializing, for worldwide distribution and
sale, a wide range of non-prescription remedies using PSI Parent’s proprietary
patented TPM™ technology (“TPM”). TPM facilitates the delivery and
depth of penetration of active molecules in pharmaceutical, nutraceutical and
other products.
In
connection with the LLC Agreement, PSI Parent granted to us, pursuant to the
terms of a License Agreement, dated March 22, 2010 (the “Original License
Agreement”), (i) an exclusive, royalty-free, world-wide (subject to certain
limitations), paid-up license to exploit OTC drugs and certain other products
that embody certain of PSI Parent’s TPM-related patents and related know-how
(collectively, the “PSI Technology”) and (ii) a non-exclusive, royalty-free,
world-wide (subject to certain limitations), paid-up license to exploit certain
compounds that embody the PSI Technology for use in a product combining one or
more of such compounds with an OTC drug or in a product that is part of a
regimen that includes the application of an OTC drug.
Pursuant
to the Original License Agreement, we issued 1,440,000 shares of our Common
Stock having an aggregate value of approximately $2.6 million to PSI Parent
(such shares, the “PSI Shares”), and made a one-time payment to PSI Parent of
$1.0 million. PSI Parent has agreed, pursuant to a Share Transfer
Restriction Agreement, dated March 22, 2010 (the “Share Transfer Restriction
Agreement”), between us and PSI Parent, that, with certain exceptions, it will
not sell or otherwise dispose of any of the PSI Shares prior to June 1,
2012. The PSI Shares were issued pursuant to an exemption from
registration under the Securities Act, by virtue of Section 4(2) of the
Securities Act and by virtue of Rule 506 of Regulation D under the Securities
Act. Such sale and issuance did not involve any public offering and
was made without general solicitation or advertising. Additionally,
PSI Parent represented to us, among other things, that PSI Parent is not a US
Person (as defined in Regulation S under the Securities Act), that PSI Parent is
an accredited investor with access to all relevant information necessary to
evaluate its investment and that the PSI Shares were being acquired for
investment purposes only.
In
accordance with a Contribution Agreement, dated March 22, 2010 (the
“Contribution Agreement”), by and among us, PSI Parent, PSI, and the Joint
Venture, we transferred, conveyed and assigned to the Joint Venture all of our
rights, title and interest in, to and under the Original License Agreement, and
the Joint Venture assumed, and undertook to pay, discharge and perform when due,
all of our liabilities and obligations under and arising pursuant to the
Original License Agreement (such actions, collectively, the “Assignment and
Assumption”). Additionally, we contributed cash of $500,000 to the
Joint Venture as part of our initial capital contribution. At
September 30, 2010, cash and equivalents includes $425,000 related to the Joint Venture which is
expected to be used by the Joint
Venture to fund future product development initiatives currently under
consideration by PSI Parent, PSI and us.
14
ProPhase
Labs, Inc. and Subsidiaries
Notes
to Condensed Consolidated Financial Statements
(unaudited)
Note
3 – Investment in Phusion Laboratories, LLC. – continued
Pursuant
to the Contribution Agreement and in order to reflect the Assignment and
Assumption, we, PSI Parent and the Joint Venture entered into an Amended and
Restated License Agreement, dated March 22, 2010 (the “Amended License
Agreement”), which amends and restates the Original License Agreement to reflect
that the Joint Venture is the licensee thereunder and which otherwise contains
substantially the same terms as the Original License Agreement. The
Joint Venture has the right to grant one or more sub-licenses of the rights
granted under the Amended License Agreement to one or more third parties for
reasonable consideration in any part of the applicable territory. The
Amended License Agreement provides that PSI Parent shall not, directly or
through third parties, exploit the covered intellectual property during the term
thereof, subject to certain limitations. The Amended License
Agreement will remain in effect until the expiration of the last to expire of
the patents included within the PSI Technology or any extensions
thereof. Either party may terminate the Amended License Agreement
upon written notice to the other party in the event of certain events involving
bankruptcy or insolvency. The Amended License Agreement also
contains, among other things, provisions concerning the treatment of
confidential information, the ownership of intellectual property and
indemnification obligations.
Pursuant
to the LLC Agreement, we and PSI each own a 50% membership interest in the Joint
Venture. PSI Parent will conduct and oversee much of the product
development, formulation, testing and other research and development needed by
the Joint Venture, and we will oversee much of the production, distribution,
sales and marketing. The LLC Agreement provides that each member may
be required, from time to time and subject to certain limitations, to make
capital contributions to the Joint Venture to fund its operations, in accordance
with agreed upon budgets for products to be developed. Specifically
we contributed $500,000 in cash as initial capital and we are committed to fund
up to $2.0 million, subject to agreed upon budgets (which have not yet been
established), toward the initial development and marketing costs of new products
for the Joint Venture.
The Joint
Venture is managed by a four-person Board of Managers, with two managers
appointed by each member. The initial Board of Managers is comprised
of four representatives, two representatives from each of the Company and PSI
Parent. The initial Company representatives on the Board of Managers
are Mr. Ted Karkus and Mr. Robert Cuddihy. Mr. Karkus, on our behalf,
and Mr. Harry Rosen, on behalf of PSI, are the Co-Chief Executive Officers of
the Joint Venture. The LLC Agreement contains other normally found
terms in such arrangements, including provisions relating to governance of the
Joint Venture, indemnification obligations of the Joint Venture, allocation of
profits and losses, the distribution of funds to the members and restrictions on
transfer of a member’s interest.
Our
initial determination is that the Joint Venture qualifies as a
VIE. As a consequence, we have consolidated the Joint Venture
financial statements beginning with the quarter ended March 31,
2010. For the nine months ended September 30, 2010, the newly formed
Joint Venture has not engaged in any financial transactions, other than certain
organizational expenses and general market and product analysis, as formal
operations are not expected to commence until Fiscal
2011. Furthermore, the liabilities and other obligations incurred, if
any, by the Joint Venture is without recourse to us and do not create a claim on
our general assets. At September 30, 2010, we have recorded the $3.6
million payment representing the estimated fair value to acquire the product
license as an intangible asset. We currently estimate the
expected useful life of the product license to be approximately 12 years which
we will begin amortizing the cost of intangible asset once production
commercialization is completed with PSI Parent and the OTC drug products begin
to ship to our retail customers. As of September 30, 2010, we have
not established a formal commercialization program timeline for any specific OTC
drug covered under the product license but we do not project that any OTC drug
products will be available for shipment within the next twelve
months.
15
ProPhase
Labs, Inc. and Subsidiaries
Notes
to Condensed Consolidated Financial Statements
(unaudited)
Note
4 – Commitments and Contingencies
We have
maintained a separate representation and distribution agreement relating to the
development of the zinc gluconate glycine product formulation. In
return for exclusive distribution rights, we agreed to pay the developer a 3%
royalty and a 2% consulting fee based on sales collected, less certain
deductions, throughout the term of this agreement, which expired in May
2007. However, we and the developer are in litigation and as such no
potential offset from such litigation for these fees have been
recorded.
Certain
operating leases for office and warehouse space maintained by us resulted in
rent expense for the three month periods ended September 30, 2010 and 2009 of
zero and $10,000, respectively. For the nine month period ended September 30,
2010 and 2009, rent expense was $10,000 and $40,000, respectively.
We have
estimated future obligations over the next five years, including the remainder
of Fiscal 2010, as follows (in thousands):
Fiscal
Year
|
|
Employment
Contracts
|
|
|
Product
Purchases
|
|
|
Total
|
|
|||
2010
|
|
$
|
269 |
|
|
$
|
702 |
|
|
$
|
971 |
|
2011
|
|
1,075 |
|
|
760 |
|
|
1,835 |
|
|||
2012
|
|
582 |
|
|
- |
|
|
582 |
|
|||
2013
|
|
- |
|
|
- |
|
|
- |
|
|||
2014
|
|
- |
|
|
- |
|
|
- |
|
|||
Total
|
|
$
|
1,926 |
|
|
$
|
1,462 |
|
|
$
|
3,388 |
|
Note
5 – Transactions Affecting Stockholders’ Equity
Stockholder
Rights Plan
On
September 8, 1998, our Board of Directors declared a dividend distribution of
Common Stock Purchase Rights (each individually, a “Right” and collectively, the
“Rights”) payable to the stockholders of record on September 25, 1998, thereby
creating a Stockholder Rights Plan (the “Rights Agreement”). The Plan
was amended effective May 23, 2008 (“First Amendment”) and further amended
effective August 18, 2009 (“Second Amendment”). The Rights Agreement,
as amended, provides that each Right entitles the stockholder of record to
purchase from the Company that number of common shares having a combined market
value equal to two times the Rights exercise price of $45. The Rights
are not exercisable until the distribution date, which will be the earlier of a
public announcement that a person or group of affiliated or associated persons
has acquired 15% or more of the outstanding common shares, or the announcement
of an intention by a similarly constituted party to make a tender or exchange
offer resulting in the ownership of 15% or more of the outstanding common
shares. The dividend has the effect of giving the stockholder a 50%
discount on the share’s current market value for exercising such
right. In the event of a cashless exercise of the Right, and the
acquirer has acquired less than 50% beneficial ownership of the Company, a
stockholder may exchange one Right for one common share of the
Company. The Rights Agreement, as amended, includes a provision
pursuant to which our Board of Directors may exempt from the provisions of the
Rights Agreement an offer for all outstanding shares of our Common Stock that
the directors determine to be fair and not inadequate and to otherwise be in the
best interests of the Company and its stockholders, after receiving advice from
one or more investment banking firms. The expiration date of the Rights
Agreement, as amended, is September 25, 2018.
16
ProPhase
Labs, Inc. and Subsidiaries
Notes
to Condensed Consolidated Financial Statements
(unaudited)
Note
5 – Transactions Affecting Stockholders’ Equity – continued
The
2010 Equity Compensation Plan
On May 5,
2010, our shareholders approved the 2010 Equity Compensation
Plan. The 2010 Equity Compensation Plan provides that the total
number of shares of Common Stock that may be issued is equal to 900,000 shares
plus up to 900,000 shares that are authorized for issuance but unissued under
the 1997 Plan Stock Options Plan (the “1997 Plan”), an aggregate of 1.8 million
shares. The 1997 Plan expired on December 2, 2007 and no additional
awards may be made; however, as of March 31, 2010, there remained 1,449,750
shares subject to vested options that were authorized for issuance (the “Issued
Options”) but were unissued under the 1997 Plan. As of September 30,
2010, 881,500 of the Issued Options under the 1997 Plan expired unexercised or
were terminated (the “Expired Options”). As a consequence, these
shares are deemed and remain unissued which up to a maximum of 900,000 shares
become available for issuance under the 2010 Equity Compensation
Plan. As a consequence of the additional Expired Options there are
1,781,500 shares of Common Stock that may be issued pursuant to the terms of the
2010 Equity Compensation Plan as of September 30, 2010.
All of
the Company’s employees, including employees who are officers or members of the
Board are eligible to participate in the 2010 Equity Compensation
Plan. Consultants and advisors who perform services for the Company
are also eligible to participate in the 2010 Equity Compensation
Plan. At September 30, 2010, we have not granted any stock options
under the 2010 Equity Compensation Plan.
The
2010 Directors Equity Compensation Plan
On May 5,
2010, our shareholders approved the 2010 Directors’ Equity Compensation
Plan. A primary purpose of the 2010 Directors’ Equity Compensation
Plan is to provide us with the ability to pay all or a portion of the fees of
Directors in restricted stock instead of cash. The 2010
Directors’ Equity Compensation Plan provides that the total number of shares of
Common Stock that may be issued under the 2010 Directors’ Equity Compensation
Plan is equal to 200,000. As of September 30, 2010, we granted 35,835 shares of
our Common Stock valued at $49,500 for director compensation.
Stock
Option Exercise and Stock Grants
For the
nine months ended September 30, 2010 and 2009, we derived net proceeds of
$133,000 and $126,000, respectively as a consequence of the exercise of options
to acquire 130,000 and 125,000 shares, respectively, of our Common
Stock. Additionally, for the nine months ended September 30, 2010, we
issued in the form of a grant 26,299 shares of Common Stock pursuant to the
terms of an employment agreement.
Note
6 – Income Taxes
Certain
exercises of options and warrants, and restricted stock issued for services that
became unrestricted resulted in reductions to taxes currently payable and a
corresponding increase to additional-paid-in-capital for prior
years. In addition, certain tax benefits for option and warrant
exercises totaling $6.9 million are deferred and will be credited to
additional-paid-in-capital when our net operating loss carry-forward
attributable to these exercises are utilized. Consequently, these net
operating loss carryforward will not be available to offset our current income
tax expense. As of December 31, 2009, we had net operating loss
carry-forwards of approximately $25.7 million for federal purposes that will
expire through 2029. Additionally, there are net operating loss
carry-forwards of $20.3 million for state purposes that will expire through
2029. Until sufficient taxable income to offset the temporary timing
differences attributable to operations, the tax deductions attributable to
option, warrant and stock activities and alternative minimum tax credits of
$26,000 are assured, we have recorded a full valuation allowance equaling the
total deferred tax asset at September 30, 2010 and December 31,
2009. As of September 30, 2010 and December 31, 2009, we have no
unrecognized tax benefits.
17
ProPhase
Labs, Inc. and Subsidiaries
Notes
to Condensed Consolidated Financial Statements
(unaudited)
Note
6 – Income Taxes – continued
The major
jurisdiction for which we file income tax returns is the United
States. The Internal Revenue Service (“IRS”) has examined our tax
year ended September 30, 2005 and has made no changes to the filed tax
returns. The tax years 2006 and forward remain open to examination by
the IRS. The tax years 2004 and forward remain open to examination by
the various state taxing authorities to which we are subject.
Effective
December 31, 2009, we elected to conform our tax reporting year, historically a
fiscal period ending September 30, to our financial reporting period ending
December 31. As a consequence, we filed a full period tax return for
the fiscal year ended September 30, 2009 and a “short period return” for the
three months ended December 31, 2009 with the IRS in compliance with the
election. In future fiscal periods, our tax and financial reporting
periods will be the same, the annual period ending December 31.
Note
7 – Earnings (Loss) Per Share
Basic
earnings per share is computed by dividing net income or loss to common
stockholders by the weighted-average number of shares of our Common Stock
outstanding for the period. Diluted earnings per share reflects the
potential dilution that could occur if securities or other contracts to issue
Common Stock were exercised or converted into Common Stock or resulted in the
issuance of Common Stock that shared in the earnings of the
entity. Diluted earnings per share also utilizes the treasury stock
method which prescribes a theoretical buy-back of shares from the theoretical
proceeds of all options and warrants outstanding during the
period. Options and warrants outstanding to acquire shares of our
Common Stock at September 30, 2010 and 2009 were 453,250 and 1,487,750,
respectively.
For the
nine months ended September 30, 2010 and 2009, dilutive earnings per share is
the same as basic earnings per share due to (i) the inclusion of Common Stock,
in the form of stock options and warrants (“Common Stock Equivalents”), would
have an anti-dilutive effect on the loss per share or (ii) there were no
Common Stock Equivalents for the respective period. For the nine
months ended September 30, 2010 and 2009, there were 4,814 and
140,714 Common Stock Equivalents, respectively, which were in the
money, that were excluded from the earnings per share
computation. For the three months ended September 30, 2010 and 2009,
there were 155 and 255,765 Common Stock Equivalents, respectively, which were in
the money, that were included in the earnings per share
computation.
A
reconciliation of the applicable numerators and denominators of the income
statement periods presented, as reflected in the results of continuing
operations, is as follows (in millions, except per share amounts):
Three Months Ended
|
Nine Months Ended
|
Three Months Ended
|
Nine Months Ended
|
|||||||||||||||||||||||||||||||||||||||||||||
September 30, 2010
|
September 30, 2010
|
September 30, 2009
|
September 30, 2009
|
|||||||||||||||||||||||||||||||||||||||||||||
Income
|
Shares
|
EPS
|
Loss
|
Shares
|
EPS
|
Income
|
Shares
|
EPS
|
Loss
|
Shares
|
EPS
|
|||||||||||||||||||||||||||||||||||||
Basic
income (loss) per share
|
$ | 0.9 | 14.7 | $ | 0.06 | $ | (2.4 | ) | 14.1 | $ | (0.17 | ) | $ | 1.2 | 12.9 | $ | 0.09 | $ | (5.6 | ) | 12.9 | $ | (0.43 | ) | ||||||||||||||||||||||||
Dilutives:
|
||||||||||||||||||||||||||||||||||||||||||||||||
Options/Warrants
|
- | - | - | - | - | - | - | 0.2 | - | - | - | - | ||||||||||||||||||||||||||||||||||||
Diluted
income (loss) per share
|
$ | 0.9 | 14.7 | $ | 0.06 | $ | (2.4 | ) | 14.1 | $ | (0.17 | ) | $ | 1.2 | 13.1 | $ | 0.09 | $ | (5.6 | ) | 12.9 | $ | (0.43 | ) |
18
ProPhase
Labs, Inc. and Subsidiaries
Management’s
Discussion and Analysis of
Financial
Condition and Results of Operations
Item
2. Managements
Discussion and Analysis of Financial Condition and Results of
Operations.
General
ProPhase
Labs, Inc. (“we”, “us” or the “Company”), organized under the laws of the State
of Nevada, is a manufacturer, marketer and distributor of a diversified range of
homeopathic and health products that are offered to the general public. We are
also engaged in the research and development of potential over-the-counter
(“OTC”) drug, natural base health products along with supplements, OTC personal
care and cosmeceutical products.
Our
primary business is currently the manufacture, distribution, marketing and sale
of OTC cold remedy products to consumers through national chain, regional,
specialty and local retail stores. One of our principal products is
Cold-EEZEÒ,
a zinc gluconate glycine product proven in clinical studies to reduce the
duration and severity of the common cold symptoms by nearly
half. Cold-EEZEÒ
is an established product in the health care and cold remedy
market. For the three and nine months ended September 30, 2010 and
2009, our revenues from continuing operations have come principally from our
cold remedy products.
On May 5,
2010, our shareholders approved, among other corporate matters, the Board of
Directors’ proposal to change our name to ProPhase Labs, Inc. from The Quigley
Corporation.
Recent
Developments
Joint Venture – Phusion
Laboratories, LLC
On March
22, 2010, the Company, Phosphagenics Limited (“PSI Parent”), an Australian
corporation, Phosphagenics Inc. (“PSI”), a Delaware corporation and subsidiary
of PSI Parent, and Phusion Laboratories, LLC (the “Joint Venture”), a Delaware
limited liability company, entered into a Limited Liability Company Agreement
(the “LLC Agreement”) of the Joint Venture and additional related agreements for
the purpose of developing and commercializing, for worldwide distribution and
sale, a wide range of non-prescription remedies using PSI Parent’s proprietary
patented TPM™ technology (“TPM”). TPM facilitates the delivery and
depth of penetration of active molecules in pharmaceutical, nutraceutical, and
other products. Pursuant to the LLC Agreement, we and PSI each own a 50%
membership interest in the Joint Venture.
In
connection with the LLC Agreement, PSI Parent granted to us, pursuant to the
terms of a License Agreement, dated March 22, 2010 (the “Original License
Agreement”), (i) an exclusive, royalty-free, world-wide (subject to certain
limitations), paid-up license to exploit OTC drugs (and certain other products)
that embody certain of PSI Parent’s TPM-related patents and related know-how
(collectively, the “PSI Technology”) and (ii) a non-exclusive, royalty-free,
world-wide (subject to certain limitations) paid-up license to exploit certain
compounds that embody the PSI Technology for use in a product combining one or
more of such compounds with an OTC drug or in a product that is part of a
regimen that includes the application of an OTC drug.
Pursuant
to the Original License Agreement, we issued 1,440,000 shares of our $0.0005 par
value common stock (“Common Stock”) having an aggregate value of approximately
$2.6 million to PSI Parent (such shares, the “PSI Shares”), and made a one-time
payment to PSI Parent of $1.0 million. In accordance with a
Contribution Agreement, dated March 22, 2010 (the “Contribution Agreement”), by
and among us, PSI Parent, PSI, and the Joint Venture, we transferred, conveyed
and assigned to the Joint Venture all of our rights, title and interest in, to
and under the Original License Agreement, and the Joint Venture assumed, and
undertook to pay, discharge and perform when due, all of our liabilities and
obligations under and arising pursuant to the Original License Agreement (such
actions, collectively, the “Assignment and
Assumption”). Additionally, we contributed $500,000 to the Joint
Venture as part of our initial capital contribution. At September 30,
2010, cash and equivalents includes $425,000 related to the Joint Venture which is
expected to be used by the Joint
Venture to fund future product development initiatives currently under
consideration by PSI Parent, PSI and us.
19
ProPhase
Labs, Inc. and Subsidiaries
Management’s
Discussion and Analysis of
Financial
Condition and Results of Operations
PSI
Parent will conduct and oversee much of the product development, formulation,
testing and other research and development needed by the Joint Venture, and we
will oversee much of the production, distribution, sales and
marketing. The LLC Agreement provides that each member may be
required, from time to time and subject to certain limitations, to make capital
contributions to the Joint Venture to fund its operations, in accordance with
agreed upon budgets for products to be developed. Specifically, we
contributed $500,000 of initial capital and are committed to fund up to $2.0
million, subject to agreed upon budgets (which have not yet been established),
toward the initial development and marketing costs of new products for the Joint
Venture. The newly formed Joint Venture has not engaged in any
financial transactions, other than certain organizational expenses and general
market and product analysis, as formal operations are not expected to commence
until Fiscal 2011. As of September 30, 2010, we have not established
a formal commercialization program timeline for any specific OTC drug covered
under the product license and we do not project that any OTC drug products will
be available for shipment within the next twelve months.
As part
of our continuing efforts to focus on products and projects that are believed to
be likely to generate sustainable profits, we have examined the commercial
viability of our QR-333 compound for diabetic neuropathy treatment and our
QR-448(a) veterinary drug compound. At present, there are no third parties who
have expressed a current interest or willingness to co-develop, license or
otherwise commercially exploit these compounds. As a consequence, we
are not likely to expend any significant additional sums on developing any
formulations in the Quigley Pharma subsidiary or make any further investments in
Quigley Pharma.
Certain
Risk Factors
Our
business is regulated by various agencies of the states and localities where our
products are sold. Governmental regulations in foreign countries
where we plan to commence or expand sales may prevent or delay entry into a
market or prevent or delay the introduction, or require the reformulation of
certain of our products. In addition, no prediction can be made as to
whether new domestic or foreign legislation regulating our activities will be
enacted. Any new legislation could have a material adverse effect on
our business, financial condition and operations. Non-compliance with
any applicable requirements may subject us or the manufacturers of our products
to agency action, including warning letters, fines, product recalls, seizures
and injunctions.
The
manufacturing, processing, formulation, packaging, labeling and advertising of
our cold remedy products are subject to regulation by several federal agencies,
including (i) the FDA, (ii) the Federal Trade Commission (“FTC”), (iii) the
Consumer Product Safety Commission, (iv) the United States Department of
Agriculture, (v) the United States Postal Service, (vi) the United States
Environmental Protection Agency and (vii) the United States Occupational Safety
and Health Administration.
In
addition to OTC and prescription drug products, the FDA regulates the safety,
manufacturing, labeling and distribution of dietary supplements, including
vitamins, minerals and herbs, food additives, food supplements, OTC and
prescription drugs and cosmetics. The FTC also has overlapping
jurisdiction with the FDA to regulate the promotion and advertising of vitamins,
OTC drugs, cosmetics and foods. In addition, certain of our cold
remedy products are homeopathic remedies which are subject to standards
established by the Homeopathic Pharmacopoeia of the United States
(“HPUS”). HPUS sets the standards for source, composition and
preparation of homeopathic remedies which are officially recognized under the
Federal Food, Drug and Cosmetics Act, as amended.
20
ProPhase
Labs, Inc. and Subsidiaries
Management’s
Discussion and Analysis of
Financial
Condition and Results of Operations
Preclinical
development, clinical trials, product manufacturing, labeling, distribution and
marketing of potential new products are also subject to federal and state
regulation in the United States and other countries. Clinical trials
and product marketing and manufacturing are subject to the rigorous review and
approval processes of the FDA and foreign regulatory authorities. To obtain
approval of a new drug product, a company must demonstrate through adequate and
well-controlled clinical trials that the drug product is safe and effective for
its intended use. Obtaining FDA and other required regulatory
approvals is lengthy and expensive. Typically, obtaining regulatory
approval for pharmaceutical products requires substantial resources and takes
several years. The length of this process depends on the type,
complexity and novelty of the product and the nature of the disease or other
indication to be treated. Preclinical studies must comply with FDA
regulations. Clinical trials must also comply with FDA regulations to
ensure safety of the human subjects in the trial and may require large numbers
of test subjects, complex protocols and possibly lengthy follow-up
periods. Consequently, satisfaction of government regulations may
take several years, may cause delays in introducing potential new products for
considerable periods of time and may require imposing costly procedures upon our
activities. If regulatory approval of new products is not obtained in
a timely manner or not at all, we could be materially adversely
affected. Even if regulatory approval of new products is obtained,
such approval may impose limitations on the indicated uses for which the
products may be marketed which could also materially adversely affect our
business, financial condition and future operations.
Future
revenues, costs, margins, and profits will continue to be influenced by our
ability to maintain our manufacturing availability and capacity together with
our marketing and distribution capability and the requirements associated with
the development of potential OTC drug and other medicinal products in order to
continue to compete on a national and international level. Our
business development is dependent on continued conformity with government
regulations, a reliable information technology system capable of supporting
continued growth and continued reliable sources for product and materials to
satisfy consumer demand.
Readers
should carefully review the risk factors described in other sections of this
filing as well as in other documents we file from time to time with the
Securities and Exchange Commission.
Critical Accounting
Policies
The
preparation of financial statements in conformity with accounting principles
generally accepted in the United States (“GAAP”) requires management to make
estimates and assumptions that affect the reported amounts of assets and
liabilities and disclosure of contingent liabilities at the dates of the
financial statements and the reported amounts of revenues and expenses during
the reporting periods. Actual results could differ from those
estimates. Our significant accounting policies are described in Note
2 of Notes to Condensed Consolidated Financial Statements included under Item 1
of this Part I. However, certain accounting policies are deemed
“critical”, as they require management’s highest degree of judgment, estimates
and assumptions. These accounting estimates and disclosures have been
discussed with Audit Committee of our Board of Directors. A
discussion of our critical accounting policies, the judgments and uncertainties
affecting their application and the likelihood that materially different amounts
would be reported under different conditions or using different assumptions are
as follows:
Revenue Recognition – Sales
Allowances
When
providing for the appropriate sales returns, allowances, cash discounts and
cooperative incentive promotion costs (“Sales Allowances”), we apply a uniform
and consistent method for making certain assumptions for estimating these
provisions. These estimates and assumptions are based on historical
experience, current trends and other factors that management believes to be
relevant at the time the financial statements are
prepared. Management reviews the accounting policies, assumptions,
estimates and judgments on a quarterly basis. Actual results could
differ from those estimates.
21
ProPhase
Labs, Inc. and Subsidiaries
Management’s
Discussion and Analysis of
Financial
Condition and Results of Operations
Our
primary product, Cold-EEZEÒ,
has been clinically proven to reduce the severity and duration of common cold
symptoms. Accordingly, factors considered in estimating the
appropriate sales returns and allowances for this product include it being (i) a
unique product with limited competitors, (ii) competitively priced, (iii)
promoted, (iv) unaffected for remaining shelf-life as there is no product
expiration date, and (v) monitored for inventory levels at major customers and
third-party consumption data. We added new products to our OTC
personal care product line in Fiscal 2007 and Fiscal 2008 such as ISC-10 Immune
(discontinued in Fiscal 2009), Organix Organic Cough and Sore Throat Drops and
Kids-EEZEÒ. In
Fiscal 2010, we added two additional products to the Kids-EEZEÒ
product line, Allergy and a Cough and Cold formulation. Each of these
new products carry shelf-life expiration dates for which we aggregate such new
product market experience data and update our sales returns and allowances
estimates accordingly. Sales Allowances estimates are tracked at the
specific customer and product line levels and are tested on an annual historical
basis, and reviewed quarterly. Additionally, we monitor developments
by customer, market conditions and any other occurrences that could affect the
expected provisions relative to net sales for the period presented.
We do not
impose a period of time within which product may be returned. All
requests for product returns must be submitted to us for
pre-approval. The main components of our returns policy are: (i) we
will accept returns that are due to damaged product that is un-saleable and such
return request activity fall within an acceptable range, (ii) we will accept
returns for products that have reached or exceeded designated expiration dates
and (iii) we will accept returns in the event that we discontinue a product
provided that the customer will have the right to return only such item that it
purchased directly from us. We will not accept return requests
pertaining to customer inventory “Overstocking” or “Resets”. We
will only accept return requests for product in its intended package
configuration. We reserve the right to terminate shipment of product
to customers who have made unauthorized deductions contrary to our return policy
or pursue other methods of reimbursement. We compensate the customer
for authorized returns by means of a credit applied to amounts owed or to be
owed and in the case of discontinued product only, also by way of an
exchange. We do not have any significant product exchange
history.
We
classify product returns into principally three categories, (i) non-routine
returns, (ii) obsolete product and (iii) product mix realignment by certain of
our customers. “Non-routine” returns are defined as product returned
to us as a consequence of unanticipated circumstances principally due to (i)
retail store closings or (ii) unexpected poor retail sell through to consumers
causing us to discontinue the product. “Obsolete” returns are defined
as product returned to us as a consequence of product shelf-life “use by”
expiration date. “Product mix realignment”
returns are defined as product returned to us due to initiatives by the trade to
discontinue purchasing certain of our products. Product mix
realignment returns are generally nominal and are frequently related to
discontinued or soon to be discontinued products.
Our
return policy accommodates returns for (i) discontinued products, (ii) store
closings and (iii) products that have reached or exceeded their designated
expiration date. As of September 30, 2010 and December 31, 2009, we included a
provision for Sales Allowances of $106,000 and $127,000 respectively for other
allowances which is reported as a reduction to account
receivables. Additionally, accrued advertising and other allowances
as of September 30, 2010 include $1.2 million for estimated future sales returns
and $717,000 for cooperative incentive promotion costs and $845,000 for certain
other advertising and marketing promotions. As of December 31, 2009,
accrued advertising and other allowances included $1.5 million for estimated
future sales returns and $586,000 for cooperative incentive promotion costs. We
also included an estimate of the uncollectability of our accounts receivable as
an allowance for doubtful accounts of $20,000 and $23,000 as of September 30,
2010 and December 31, 2009, respectively.
A one
percent deviation for these Sales Allowance provisions for the three months
ended September 30, 2010 and 2009 would affect net sales by approximately
$67,000 and $127,000, respectively. A one percent deviation for these
Sales Allowance provisions for the nine months ended September 30, 2010 and 2009
would affect net sales by approximately $107,000 and $277,000,
respectively.
22
ProPhase
Labs, Inc. and Subsidiaries
Management’s
Discussion and Analysis of
Financial
Condition and Results of Operations
Income
Taxes
As of
December 31, 2009, we have net operating loss carry-forwards of approximately
$25.7 million for federal purposes that will expire beginning in Fiscal 2020
through Fiscal 2029. Additionally, there are net operating loss
carry-forwards of $20.3 million for state purposes that will expire beginning in
Fiscal 2018 through Fiscal 2029. Until sufficient taxable income to
offset the temporary timing differences attributable to operations, the tax
deductions attributable to option, warrant and stock activities and alternative
minimum tax credits of $26,000 are assured, a valuation allowance equaling the
total deferred tax asset is being provided. Management believes that
this allowance is required due to the uncertainty of realizing these tax
benefits in the future. The uncertainty arises largely due to
substantial research and development costs.
Seasonality
of the Business
Our net
sales are derived principally from our cold remedy
segment. Currently, our sales are influenced by and subject to
fluctuations in the timing of purchase and the ultimate level of demand for our
products which are a function of the timing, length and severity of each cold
season. Generally, a cold season is defined as the period of
September to March when the incidence of the common cold rises as a consequence
of the change in weather and other factors. We generally experience
in the fourth quarter higher levels of net sales along with a corresponding
increase in marketing and advertising expenditures designed to promote our
products during the cold season. Revenues and related marketing costs are
generally at their lowest levels in the second quarter when consumer demand
generally declines and retail customers balance their inventory positions as
cold season consumer demand subsides. We track health and wellness
trends and develop retail promotional strategies to align its production
scheduling, inventory management and marketing programs to optimize consumer
purchases.
Financial
Condition and Results of Operations
Results
from Operations for the Three Months Ended September 30, 2010
as
Compared to the Three Months Ended September 30, 2009
For the
three months ended September 30, 2010, net sales were $5.2 million as compared
to $5.0 million for the three months ended September 30, 2009. For
the three months ended September 30, 2010, net sales of OTC cold remedy products
were $5.0 million as compared to net sales of $4.9 million for three months
ended September 30, 2009. For the three months ended September 30,
2010 and 2009, our contract manufacturing operations generated net sales to
third party customers of $173,000 and $116,000, respectively.
Net sales
of cold remedy products increase of $170,000 for the three months ended
September 30, 2010 as compared to the three months ended September 30, 2009 is
due principally to the net effect of (i) the introduction during the three
months ended September 30, 2010 of three new cold remedy products, (a) two new
Kids-EEZE production line extensions, Allergy and Cough Cold and (b) a new
flavor of Cold-EEZE®, Mint
Frost, offset by (ii) an increase in promotional incentives to consumers to
purchase our products. Data suggests that the highest incidence
of upper respiratory disorders for the 2009-2010 cold season occurred in the
fourth quarter of Fiscal 2009 and were at significantly lower levels during the
nine months of Fiscal 2010 when compared to the 2008-2009 and prior cold
seasons. Our flagship product, Cold-EEZE®
continues to compete for market share with new products entering the category
and many retailer initiatives to reduce the number of products it carries on
shelf within the cold and flu remedy category. We are continuing to
support Cold-EEZE® as a
clinically proven cold remedy product through in-store promotion, media
advertising and coupon programs.
The
contract manufacturing operations net sales increase of $57,000 for the three
months ended September 30, 2010 as compared to September 30, 2009 is due
principally to fluctuations in contract manufacturing orders from non-related
third party entities to produce lozenge-based products.
23
ProPhase
Labs, Inc. and Subsidiaries
Management’s
Discussion and Analysis of
Financial
Condition and Results of Operations
Cost of
sales for the three months ended September 30, 2010 were $1.6 million as
compared to $1.4 million for the three months ended September 30,
2009. Although our sales increased 4.6% during the three months ended
September 30, 2010 as compared to the three months ended September 30, 2009, we
realized a gross margin of 69.4% and 72.6%, respectively. Our decline
of 3.2% in gross margin is principally due to increased product promotion with
retailers to support the launch of our new products. Gross margins
are influenced by fluctuations in quarter-to-quarter production volume, fixed
production costs and related overhead absorption, and the timing of shipments to
customers which are factors of the seasonality of our sales activities and
products.
Sales and
marketing expense for the three months ended September 30, 2010 increased
$297,000 to $904,000 as compared to $607,000 for the three months ended
September 30, 2009. The increase in sales and marketing expense for
the three months ended September 30, 2010 as compared to the three months ended
September 30, 2009 was principally due to an increase in the scope, timing and
cost of our marketing campaigns for the 2010 – 2011 cold season.
General
and administration expense for the three months ended September 30, 2010
decreased $167,000 to $1.3 million as compared to $1.5 million for the three
months ended September 30, 2009. The decrease in general and
administration expense for the three months ended September 30, 2010 as compared
to the three months ended September 30, 2009 was principally due to a decrease
in professional service costs.
Research
and development costs during the three months ended September 30, 2010 increased
$127,000 to $468,000 as compared to $341,000 for the three months ended
September 30, 2009. The increase of $127,000 in research and
development costs for the three months ended September 30, 2010 period as
compared to the three months ended September 30, 2009 was due to development
costs of the new two Kids-EEZE® products
and improved flavors in the Cold-EEZE® product
line. Additionally in Fiscal 2009 and as a result of a strategic review, we
determined to curtail and now have discontinued further investment in certain of
our wholly owned subsidiary’s, Quigley Pharma, Inc. (“Pharma”), existing
products under development in light of our view concerning market opportunities,
regulatory pathways, the need for further robust and consistent preclinical and
clinical testing and continued requirements in the areas of commercial
formulation and development. However, we continue to engage in other
research and development activities that we determine are appropriate and we may
increase our research and development activities in future periods as a
consequence of the Joint Venture.
Interest
and other income for the three months ended September 30, 2010 was $12,000
as compared to $5,000 for the three months ended September 30,
2009. The increase of $7,000 for the three months ended September 30,
2010 as compared to the three months ended September 30, 2009 was
principally the result of the allocation of funds into interest
bearing accounts.
As a
consequence of the effects of the above, the net income for the three months
ended September 30, 2010, was $947,000, or $0.06 per share, as compared to a net
income of $1.2 million, or $0.09 per share, for the three months ended September
30, 2009.
24
ProPhase
Labs, Inc. and Subsidiaries
Management’s
Discussion and Analysis of
Financial
Condition and Results of Operations
Financial
Condition and Results of Operations
Results
from Operations for the Nine Months Ended September 30, 2010
as
Compared to the Nine Months Ended September 30, 2009
For the
nine months ended September 30, 2010, net sales were $8.3 million as compared to
$10.7 million for the nine months ended September 30, 2009. For the
nine months ended September 30, 2010, net sales of cold remedy products were
$7.9 million as compared to net sales of $9.4 million for nine months ended
September 30, 2009. For the nine months ended September 30, 2010 and
2009, the contract manufacturing operations generated net sales to third party
customers of $386,000 and $1.3 million, respectively.
Net sales
of cold remedy products decline of $1.5 million for the nine months ended
September 30, 2010 as compared to the nine months ended September 30, 2009 was
due principally to an acceleration of our retail customer purchases and stocking
for the 2009-2010 cold season into the fourth quarter of Fiscal 2009 which
skewed net sales for that cold season. Data suggests that the highest
incidence of upper respiratory disorders for the 2009-2010 cold season occurred
in the fourth quarter of Fiscal 2009 and were at significantly lower levels
during the first and second quarters of Fiscal 2010 when compared to the
2008-2009 and prior cold seasons. As a consequence, there was a
reduced consumer demand at retail and therefore a corresponding reduction in
retailer purchases and stocking during the first and second quarters of Fiscal
2010 as compared to the comparable period in Fiscal 2009. Our
flagship product, Cold-EEZE®
continues to compete for market share with new products entering the category
and many retailer initiatives to reduce the number of products it carries on
shelf within the cold and flu remedy category. We are continuing to
support Cold-EEZE® as a
clinically proven cold remedy product through in-store promotion, media
advertising and coupon programs.
The
contract manufacturing operations net sales decline of $923,000 for the nine
months ended September 30, 2010 as compared to September 30, 2009 is due
principally to (i) the decline in candy product sales as a consequence of the
closure of the Elizabethtown manufacturing facility in June 2009 and (ii)
fluctuations in contract manufacturing orders from non-related third party
entities to produce lozenge-based products.
Cost of
sales for the nine months ended September 30, 2010 were $3.1 million as compared
to $4.5 million for the nine months ended September 30,
2009. Although our sale volume declined during the nine months ended
September 30, 2010 as compared to the nine months ended September 30, 2009, we
realized an increase in gross margin of 4.8 % to 63.2% for the nine months ended
September 30, 2010 as compared to 58.4% for the nine months ended September 30,
2009. Our improved gross margin reflects the net effect of (i)
the elimination of the production and facility overhead expenses attributable to
the closing of the Elizabethtown manufacturing facility, (ii) improved
production margins of the cold remedy segment (iii) improved overhead cost
management at our Lebanon production and distribution facility, (iv) a reduction
in sales returns experienced from period to period, offset by (v) an adverse
impact of a reduction to net sales to absorb fixed production overhead expenses
at our manufacturing facility and (vi) increased product promotion with
retailers to support the launch of our new products. Gross margins
are influenced by fluctuations in quarter-to-quarter production volume, fixed
production costs and related overhead absorption, and the timing of shipments to
customers which are factors of the seasonality of our sales activities and
products.
25
ProPhase
Labs, Inc. and Subsidiaries
Management’s
Discussion and Analysis of
Financial
Condition and Results of Operations
Sales and
marketing expense for the nine months ended September 30, 2010 decreased $1.0
million to $2.4 million as compared to $3.4 million for the nine months ended
September 30, 2009. The decrease in sales and marketing expense for
the nine months ended September 30, 2010 as compared to the nine months ended
September 30, 2009 was principally due to (i) the implementation
of more cost effective and targeted marketing programs, (ii) improved
timing of marketing campaigns to better match the timing and product demand of
the 2010-2011 cold season, (iii) improved in-store marketing and communications
programs, (iv) the discontinuation of certain ineffective marketing programs and
(v) an increase in marketing research and development costs associated with the
development of new product packaging for our Cold-EEZE® and
Kids-EEZE® product
lines to be introduced during the 2010-2011 cold season.
General
and administration expense for the nine months ended September 30, 2010
decreased $3.0 million to $4.5 million as compared to $7.5 million for the nine
months ended September 30, 2009. The decrease in general and
administration expense for the nine months ended September 30, 2010 as compared
to the nine months ended September 30, 2009 was principally due to (i) a
decrease of $2.3 million in costs incurred as a consequence of the Board of
Directors 2009 proxy contest and (ii) a reduction in personnel
costs.
Research
and development costs during the nine months ended September 30, 2010 decreased
$263,000 to $712,000 as compared to $975,000 for the nine months ended September
30, 2009. The decrease of $263,000 in research and development costs
for the nine months ended September 30, 2010 period as compared to the nine
months ended September 30, 2009 was due to a decline in the scope, timing and
amount of research and development activity from period to period. In
Fiscal 2009 and as a result of a strategic review, we determined to curtail and
now have discontinued further investment in certain of our wholly owned
subsidiary’s, Pharma, existing products under development in light of our view
concerning market opportunities, regulatory pathways, the need for further
robust and consistent preclinical and clinical testing and continued
requirements in the areas of commercial formulation and development. However, we
continue to engage in other research and development activities that we
determine are appropriate and we may increase our research and development
activities in future periods as a consequence of the Joint Venture.
Interest
and other income for the nine months ended September 30, 2010 was $41,000 as
compared to $20,000 for the nine months ended September 30, 2009. The
increase of $21,000 for the nine months ended September 30, 2010 as compared to
the nine months ended September 30, 2009 was principally the result of the
allocation of funds into interest bearing accounts.
As a
consequence of the effects of the above, the net loss for the nine months ended
September 30, 2010, was $2.4 million, or ($.17) per share, as compared to a net
loss of $5.6 million, or ($0.43) per share, for the nine months ended September
30, 2009.
Liquidity
and Capital Resources
Our
aggregate cash and cash equivalents as of September 30, 2010 were $8.7 million
as compared to $12.8 million at December 31, 2009. Our working
capital was $8.5 million and $11.5 million as of September 30, 2010 and December
31, 2009, respectively. Changes in working capital for the nine
months ended September 30, 2010 were primarily due to (i) cash used by
operations of $3.1 million, (ii) capital expenditures of $146,000 and (iii) the
cash payment of $1.0 million to acquire the product license in connection with
the Joint Venture, offset by (iv) net proceeds of $133,000 realized from the
exercise of stock options. Significant factors impacting working capital for the
nine months ended September 30, 2010 included (i) an increase in accounts
receivable balances of $1.1 million and (ii) an increase in other operating
assets and liabilities of $1.1 million, each reflective of seasonal
factors.
26
ProPhase
Labs, Inc. and Subsidiaries
Management’s
Discussion and Analysis of
Financial
Condition and Results of Operations
Management
believes that its strategy to maintain Cold-EEZEÒ
as a recognized brand name, its broader range of products, its adequate
manufacturing capacity, together with its current working capital, should
provide an internal source of capital to fund normal business
operations. Our operations support the current research and
development expenditures related to new products. In addition to the
funding from operations, we may in the short and long term raise capital through
the issuance of securities or secure other financing sources to support such
product development research, new product acquisitions or a venture investment
or acquisition. Such funding through the issuance of equity
securities would result in the dilution of current stockholders’ ownership in
the Company. Should our product development initiatives progress on
certain formulations, additional development expenditures may require
substantial financial support and may necessitate the consideration of
alternative approaches such as licensing, joint venture, or partnership
arrangements that we determine will meet our long term goals and
objectives. Ultimately, should internal working capital be
insufficient and external funding methods or other business arrangements become
unattainable, it would likely result in the deferral or abandonment of future
development relative to current and prospective product development initiatives
and formulations.
Management
is not aware of any trends, events or uncertainties that have or are reasonably
likely to have a material negative impact upon our (i) short-term or long-term
liquidity, or (ii) net sales or income from continuing
operations. Any challenge to our patent rights could have a material
adverse effect on our future financial results; however, we are not aware of any
condition that would make such an event probable. Our business is
subject to seasonal variations thereby impacting liquidity and working capital
during the course of our fiscal year.
Management
believes that cash generated from operations, along with the Company’s current
cash balances, will be sufficient to finance working capital and capital
expenditure requirements for at least the next twelve
months. However, in the longer term, we may require additional
capital to support, among other items, (i) new product introductions, (ii)
expansion of our product marketing and promotion activities, (iii) additional
research development activities, (iv) further investment in our Joint Venture,
(v) venture investments or acquisitions and/or (vi) support current
operations. Since late Fiscal 2008, there has been volatility
in the capital and financial markets due at least in part to the
constricted global economic environment resulting in uncertainty and access to
financing is uncertain. Moreover, consumer and as a consequence, customer
spending habits may be adversely affected by the current uncertain economic
environment. These conditions could have an adverse effect on our
industry and business, including our financial condition, results of operations
and cash flows.
To the
extent that we do not generate sufficient cash from operations, we may need to
incur indebtedness to finance plans for growth. Volatility in the
credit markets and the liquidity of major financial institutions may have an
adverse effect on our ability to fund our business strategy through borrowings,
under either existing or newly created instruments in the public or private
markets on terms that we believe to be reasonable, if at all.
Capital
Expenditures
Capital
expenditures during the remainder of Fiscal 2010 are not expected to be
material.
Recently
Issued Accounting Standards
In
November 2008, the SEC issued for comment a proposed roadmap regarding the
potential use by U.S. issuers of financial statements prepared in accordance
with International Financial Reporting Standards (“IFRS”). IFRS is a
comprehensive series of accounting standards published by the International
Accounting Standards Board (“IASB”). Under the proposed roadmap, we could be
required in fiscal 2014 to prepare financial statements in accordance with IFRS.
The SEC will make a determination in 2011 regarding the mandatory adoption of
IFRS. We are currently assessing the impact that this potential change would
have on our consolidated financial statements and we will continue to monitor
the development of the potential implementation of IFRS.
27
ProPhase
Labs, Inc. and Subsidiaries
Management’s
Discussion and Analysis of
Financial
Condition and Results of Operations
In June
2009, the Financial Accounting Standards Board (“FASB”) modified the accounting
standard related to consolidation. This standard, as modified,
intends to improve financial reporting by enterprises involved with variable
interest entities. This standard, as modified, addresses the effects
on certain provisions relating to the Consolidation of Variable
Interest Entities, as a result of the elimination of the qualifying
special-purpose entity concept in the accounting standard related
to transfers and servicing, and constituent concerns about the
application of certain key provisions of this standard, including those in which
the accounting and disclosures under the standard do not always provide timely
and useful information about an enterprise’s involvement in a variable interest
entity. This standard, as modified, is effective as of the beginning
of each reporting entity’s first annual reporting period that begins after
November 15, 2009, for interim periods within that first annual reporting
period, and for interim and annual reporting periods thereafter. Earlier
application is prohibited. The adoption of the consolidation
standard, as modified, did not have a material effect on our consolidated
financial statements.
In
October 2009, the FASB issued Accounting Standards Update No. 2009-13, "Multiple-Deliverable Revenue
Arrangements" ("ASU No. 2009-13"). ASU No. 2009-13 amends guidance
included within Accounting Standards Codification ("ASC") Topic 605-25 to require an entity to
use an estimated selling price when vendor specific objective evidence or
acceptable third party evidence does not exist for any products or services
included in a multiple element arrangement. The arrangement consideration should
be allocated among the products and services based upon their relative selling
prices, thus eliminating the use of the residual method of allocation. ASU No.
2009-13 also requires expanded qualitative and quantitative disclosures
regarding significant judgments made and changes in applying this guidance. ASU
No. 2009-13 is effective prospectively for revenue arrangements entered into or
materially modified in fiscal years beginning on or after June 15,
2010. Early adoption and retrospective application are also
permitted. We elected to adopt ASU No. 2009-13 early and the adoption
did not have a material effect on our consolidated financial
statements.
In
January 2010, the FASB issued ASU 2010-06, “Improving Disclosures about Fair
Value Measurements”. ASU 2010-06 amends ASU 820 to require a number of
additional disclosures regarding fair value measurements. The amended guidance
requires entities to disclose the amounts of significant transfers between Level
1 and Level 2 of the fair value hierarchy and the reasons for these transfers,
the reasons for any transfers in or out of Level 3, and information in the
reconciliation of recurring Level 3 measurements about purchases, sales,
issuances and settlements on a gross basis. This ASU also clarifies the
requirement for entities to disclose information about both the valuation
techniques and inputs used in estimating Level 2 and Level 3 fair value
measurements as well as the level of disaggregation required for each class of
asset and liability disclosed. The amended guidance is effective for interim and
annual financial periods beginning after December 15, 2009. The adoption of ASU
2010-06 did not have a material effect on our consolidated financial
statements.
28
ProPhase
Labs, Inc. and Subsidiaries
Management’s
Discussion and Analysis of
Financial
Condition and Results of Operations
Forward-Looking
Statements
This
Quarterly Report on Form 10-Q contains “forward looking statements” within the
meaning of Section 27A of the Securities Act of 1933, as amended (the
“Securities Act”) and Section 21E of the Securities Exchange Act of 1934, as
amended (the “Exchange Act”). These forward looking statements relate
to future events or our future financial performance and involve known and
unknown risks, uncertainties and other factors that may cause our or our
industry’s actual results, levels of activity, performance or achievements to be
materially different from any future results, levels of activity, performance or
achievements expressed or implied by the forward-looking
statements. Many of these factors are beyond our ability to
predict. Given the risks and uncertainties surrounding
forward-looking statements, you should not place undue reliance on these
statements. Forward-looking statements typically are identified by
use of terms such as “anticipate”, “believe”, “plan”, “expect”, “intend”, “may”,
“will”, “should”, “estimate”, “predict”, “potential”, “continue” and similar
words although some forward-looking statements are expressed
differently. This Report may contain forward-looking statements
attributed to third parties relating to their estimates regarding the growth of
our markets. You are cautioned that such forward looking statements
are not guarantees of future performance and that all forward-looking statements
address matters that involve risk and uncertainties, and there are many
important risks, uncertainties and other factors that could cause our actual
results, levels of activity, performance, achievements and prospects, as well as
those of the markets we serve, to differ materially from the forward-looking
statements contained in this Report.
Such
risks and uncertainties include, but are not limited to:
|
·
|
The
ability of our new management to successfully implement our business plan
and strategy;
|
|
·
|
Our
ability to fund our operations including the cost and availability of
capital and credit;
|
|
·
|
Our
ability to compete effectively including our ability to maintain and
increase our market share in the markets in which we do
business;
|
|
·
|
Our
dependence on sales from our main product, Cold-EEZEÒ,
and our ability to successfully develop and commercialize new
products;
|
|
·
|
The
uncertain length and severity of the current general financial and
economic downturn, the timing and strength of an economic recovery, if
any, and their impacts on our business including demand for our
products;
|
|
·
|
Our
ability to protect our proprietary
rights;
|
|
·
|
Our
continued ability to comply with regulations relating to our current
products and any new products we develop including our ability to
effectively respond to changes in laws and regulations or the
interpretation thereof including changing market rules and evolving
federal, state and regional laws and
regulations;
|
|
·
|
Potential
disruptions in our ability to manufacture our products or our access to
raw materials;
|
|
·
|
Seasonal
fluctuations in demand for our
products;
|
|
·
|
Our
ability to attract, retain and motivate key
employees;
|
|
·
|
The
ability of the Joint Venture to successfully implement its business plan
and strategy to develop and commercialize one or more non-prescription
remedies using TPM; and
|
|
·
|
Other
risks identified in this Report.
|
You
should also consider carefully the statements under other sections of this
Report and our Annual Report on Form 10-K for the year ended December 31, 2009,
which address additional risks that could cause our actual results to differ
from those set forth in any forward-looking statements. Our
forward-looking statements speak only as the date of this Report. We
undertake no obligation to publicly update or review any forward-looking
statements, whether as a result of new information, future developments or
otherwise.
29
Item
3. Quantitative and Qualitative Disclosures About Market Risk.
Our
operations are not subject to risks of material foreign currency fluctuations,
nor do we use derivative financial instruments in its investment practices. We
place our marketable investments in instruments that meet high credit quality
standards. We do not expect material losses with respect to our
investment portfolio or exposure to market risks associated with interest rates.
The impact on our results of one percentage point change in short-term interest
rates would not have a material impact on our future earnings, fair value, or
cash flows related to investments in cash equivalents or interest-earning
marketable securities.
Current
economic conditions may cause a decline in business and consumer spending which
could adversely affect our business and financial performance including the
collection of accounts receivables, realization of inventory and recoverability
of assets. In addition, our business and financial performance may be
adversely affected by current and future economic conditions, including due to a
reduction in the availability of credit, financial market volatility and
recession.
Item
4. Controls and Procedures.
Disclosure Controls and
Procedures
We
maintain disclosure controls and procedures designed to provide reasonable
assurance that material information required to be disclosed by us in the
reports filed or submitted under the Securities Exchange Act of 1934, as
amended, is recorded, processed, summarized and reported within the time periods
specified in the Securities and Exchange Commission (“SEC”) rules and forms, and
that the information is accumulated and communicated to our management,
including our Chief Executive Officer and Interim Chief Financial Officer, as
appropriate to allow timely decisions regarding required disclosure. We
performed an evaluation, under the supervision and with the participation of our
management, including the Chief Executive Officer and Interim Chief Financial
Officer, of the effectiveness of the design and operation of the disclosure
controls and procedures as of the end of the period covered by this report.
Based on the existence of the material weaknesses discussed below under the
heading “Material Weaknesses” our management, including our Chief Executive
Officer and Interim Chief Financial Officer, concluded that our disclosure
controls and procedures were not effective at the reasonable assurance level as
of the end of the period covered by this Report.
Material
Weaknesses
As a
consequence of management’s review of its effectiveness of the design and
operation of the disclosure controls and procedures, and management’s
determination of the existence of material weaknesses, our management, including
our Chief Executive Officer and Interim Chief Financial Officer, concluded that
our disclosure controls and procedures were not effective at the reasonable
assurance level as of the end of the period covered by this report. A
material weakness is a significant deficiency, or a combination of significant
deficiencies, that results in more than a remote likelihood that a material
misstatement of the annual or interim financial statements will not be prevented
or detected.
Material Weakness – Control
Environment
Lack of management continuity due to
changes in executive management of the Company. As a
consequence of the results from the 2009 meeting of our shareholders whereby a
new slate of directors were confirmed by a major vote of our shareholders, our
former Chief Executive Officer and our former Chief Operating Officer resigned
without the benefit of a transition period between the effective date of their
respective resignations and the recruitment of new management. We
have filled both these positions with personnel who were new to the
Company. Additionally, in October 2009, the employment of our Chief
Financial Officer ended and the role was consolidated with that of the new Chief
Operating Officer. As a consequence of a lack of continuity of
management with limited or no transition or consultation period with prior
management, current management has concluded that this control deficiency
constitutes a material weakness.
30
Lack of documentation and/or the
availability of documentation or records in the Company’s files of business
transactions, contracts and/or evaluations engaged by the
Company. When new management was installed by the Board of
Directors, it was discovered during the second quarter of Fiscal 2009 that the
Company was either missing or lacked pertinent information regarding its
operations, including, but not limited to, certain business commitments to
product supply agreements, advertising programs, product placement initiatives
and other promotional initiatives, and asset sales. As a consequence
of this lack of documentation or availability of documentation or records,
management has concluded that this control deficiency constitutes a material
weakness.
Remediation Plan for
Material Weaknesses
The
material weaknesses described above comprise control deficiencies that we
discovered during the financial close process for the June 30, 2009 fiscal
period. Management is making progress on its remediation plan which
includes (i) obtaining and reviewing the underlying documentation for
significant agreements, contracts, transactions and other material commitments
entered into by the Company and (ii) meeting with retail customers and
vendors. We believe that these measures, if effectively implemented
and maintained, will remediate the material weaknesses discussed
above.
As of
December 31, 2009, management determined that it had lacked certain subject
matter expertise in at least two of the following significant areas: (i)
accounting for and the disclosure of complex transactions and (ii) the
selection, monitoring and evaluation of certain vendors that provided services
to Pharma. At that time, our financial staff lacked sufficient
training or experience in accounting for complex transactions and the required
disclosure thereof.
As part
of our remediation program implemented in Fiscal 2009, we (i) recruited a
financial and operations professional, Mr. Cuddihy, to our executive management,
(ii) completed the reorganization of the financial staff, including personnel
changes and recruitment, (iii) implemented a continuous education and training
program for our financial staff, (iv) retained outside financial consultants to
augment our financial staff with certain subject matter expertise, (v) completed
the reorganization of Pharma staff and retained outside consultants to augment
such Pharma staff with certain subject matter expertise and conducted a thorough
review of the entire research and development portfolio of potential products,
and (vi) completed the formation of the Joint Venture which improves our OTC
drug industry, formulation and research expertise with our international partner
and professional resources. As a consequence of these actions,
management believes that it has sufficiently remediated this material weakness
in the quarter ended March 31, 2010.
Changes in Internal Control
Over Financial Reporting
We are
currently undertaking a number of measures to remediate the material weaknesses
discussed above. Those measures, described under “Remediation Plan
for Material Weaknesses,” implemented during the third and fourth quarter of
Fiscal 2009, will materially affect, or are reasonably likely to materially
affect, our internal control over financial reporting. In addition,
during June 2010 we successfully migrated to and implemented a new enterprise
resource planning and financial reporting software system (the “ERP System”)
designed to further enhance our operational and internal controls, our system of
financial reporting and improve our general operational
efficiencies. Although our basic internal control system has not and
will not change as a direct consequence of our the implementation of the new ERP
System, we believe that our ERP System provides significant improvement to our
financial and operational visibility further consolidating and streamlining our
operations while providing significantly more relevant, easy to assess data to
manage our day-to-day operations. Other than as described above,
there have been no changes in our internal control over financial reporting
during the nine months ended September 30, 2010 that have materially affected,
or are reasonably likely to materially affect, our internal control over
financial reporting.
Because
of its inherent limitations, a system of internal control over financial
reporting can provide only reasonable assurance and may not prevent or detect
misstatements. Further, because of changes in conditions,
effectiveness of internal controls over financial reporting may vary over
time. Our system contains self-monitoring mechanisms, and actions are
taken to correct deficiencies as they are identified.
31
Part
II. Other Information
Item
1. Legal Proceedings.
PROPHASE LABS, INC. VS. GUY
QUIGLEY, GARY QUIGLEY, SCANDA SYSTEMS LIMITED, SCANDA SYSTEMS LTD, CHILESHA
HOLDINGS LTD, KEVIN BROGAN, INNERLIGHT HOLDINGS, INC., GEORGE LONGO, GRAHAM
BRANDON, PACIFIC RIM PHARMACEUTICALS LTD AND JOHN DOE
DEFENDANTS
On August
23, 2010, we initiated an action in the Court of Common Pleas for Bucks County,
Pennsylvania. This
action is against certain former officers and directors of the Company, and
against certain third parties (a “Complaint”). The Company has asserted claims
arising from, among other things, a variety of transactions and payments
previously made or entered into by the Company. All of the transactions and
events that are the subject of the Complaint occurred prior to June 2009 and the
installation of the current Board of Directors.
Item
1A. Risk Factors.
The Company has identified material
weaknesses in its internal control environment for the period from April 1, 2009
through September 30, 2010.
These
material weaknesses, if not properly remediated, could result in material
misstatements in our financial statements in future periods and impair its
ability to comply with the accounting and reporting requirements applicable to
public companies. A material weakness is a control deficiency, or combination of
control deficiencies, that results in more than a remote likelihood that a
material misstatement of financial statements will not be prevented or detected
by our internal controls.
In
relation to the condensed consolidated financial statements for the period from
April 1, 2009 through September 30, 2010, we identified material weaknesses in
our internal control environment as follows: (i) lack of management
continuity due to changes in executive management of the Company and (ii) lack
of documentation and/or the availability of documentation or records in the
Company’s files with respect to business transactions, contracts and/or
evaluations engaged in the Company.
Following
the identification of these material weaknesses in our internal control
environment, management took measures and plans to continue to take measures to
remediate these weaknesses and deficiencies. However, the implementation of
these measures may not fully address these weaknesses. A failure to correct
these weaknesses or other control deficiencies or a failure to discover and
address any other control deficiencies could result in inaccuracies in our
condensed consolidated financial statements and could impair our ability to
comply with applicable financial reporting requirements and related regulatory
filings on a timely basis and could cause investors to lose confidence in our
reported financial information, which could have a negative impact on our
financial condition and stock price. Our management identified the above
material weaknesses as part of its review of the Company’s internal control over
financial reporting.
Item
2. Unregistered Sales of Equity Securities and Use of
Proceeds.
Not
applicable
Item
3. Defaults Upon Senior Securities.
Not
applicable
Item
5. Other Information.
Not
applicable
32
Item
6. Exhibits
(1)
|
Exhibit
31.1
|
Certification
by the Chief Executive Officer pursuant to Section 302 of the
Sarbanes-Oxley Act of 2002
|
(2)
|
Exhibit
31.2
|
Certification
by the Chief Financial Officer pursuant to Section 302 of the
Sarbanes-Oxley Act of 2002
|
(3)
|
Exhibit
32.1
|
Certification
by the Chief Executive Officer pursuant to Section 906 of the
Sarbanes-Oxley Act of 2002
|
(4)
|
Exhibit
32.2
|
Certification
by the Chief Financial Officer pursuant to Section 906 of the
Sarbanes-Oxley Act of
2002
|
33
SIGNATURES
Pursuant
to the requirements 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.
ProPhase
Labs, Inc.
|
||
By:
|
/s/
Ted Karkus
|
|
Ted
Karkus
|
||
Chairman
of the Board and Chief Executive Officer
|
||
(Principal
Executive Officer)
|
||
Date:
November 12, 2010
|
||
By:
|
/s/
Robert V. Cuddihy, Jr.
|
|
Robert
V. Cuddihy, Jr.
|
||
Chief
Operating Officer and Interim Chief Financial Officer
|
||
(Principal
Accounting and Financial Officer)
|
||
Date:
November 12, 2010
|
34