Page
No.
PART
I - Financial Information
PART II - Other
Information
Part I. Financial Information
Item 1. Condensed Consolidated Financial
Statements
THE
QUIGLEY CORPORATION
CONDENSED
CONSOLIDATED BALANCE SHEETS
|
|
March 31,
2009
|
|
|
December
31, 2008
|
|
ASSETS
|
|
(Unaudited)
|
|
|
|
|
CURRENT
ASSETS:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash and cash
equivalents
|
|
$ |
12,244,227 |
|
|
$ |
11,956,796 |
|
Accounts receivable
(net of doubtful accounts
of $140,942 and $131,162)
|
|
|
1,796,372 |
|
|
|
4,523,519 |
|
Inventory,
net
|
|
|
3,245,648 |
|
|
|
3,001,001 |
|
Prepaid expenses
and other current assets
|
|
|
732,511 |
|
|
|
1,185,113 |
|
TOTAL CURRENT
ASSETS
|
|
|
18,018,758 |
|
|
|
20,666,429 |
|
|
|
|
|
|
|
|
|
|
PROPERTY, PLANT AND
EQUIPMENT –
net
|
|
|
3,580,866 |
|
|
|
3,666,748 |
|
|
|
|
|
|
|
|
|
|
OTHER
ASSETS:
|
|
|
|
|
|
|
|
|
Other
assets
|
|
|
35,454 |
|
|
|
35,454 |
|
TOTAL OTHER
ASSETS
|
|
|
35,454 |
|
|
|
35,454 |
|
|
|
|
|
|
|
|
|
|
TOTAL
ASSETS
|
|
$ |
21,635,078 |
|
|
$ |
24,368,631 |
|
LIABILITIES
AND STOCKHOLDERS’ EQUITY
|
|
|
|
|
|
|
CURRENT
LIABILITIES:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Accounts
payable
|
|
$ |
290,937 |
|
|
$ |
693,839 |
|
Accrued royalties
and sales commissions
|
|
|
3,633,887 |
|
|
|
3,791,519 |
|
Accrued
advertising
|
|
|
1,092,438 |
|
|
|
1,306,341 |
|
Other current
liabilities
|
|
|
1,043,003 |
|
|
|
803,054 |
|
TOTAL CURRENT
LIABILITIES
|
|
|
6,060,265 |
|
|
|
6,594,753 |
|
|
|
|
|
|
|
|
|
|
COMMITMENTS
AND CONTINGENCIES (Note 7)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
STOCKHOLDERS’
EQUITY:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Common stock, $.0005 par value; authorized
50,000,000; Issued:
17,554,436 and 17,554,436 shares
|
|
|
8,777 |
|
|
|
8,777 |
|
Additional
paid-in-capital
|
|
|
37,599,405 |
|
|
|
37,599,405 |
|
Retained
earnings
|
|
|
3,154,790 |
|
|
|
5,353,855 |
|
Less: Treasury
stock, 4,646,053 and
4,646,053 shares, at cost
|
|
|
(25,188,159 |
) |
|
|
(25,188,159 |
) |
TOTAL STOCKHOLDERS’
EQUITY
|
|
|
15,574,813 |
|
|
|
17,773,878 |
|
|
|
|
|
|
|
|
|
|
TOTAL
LIABILITIES AND STOCKHOLDERS’ EQUITY
|
|
$ |
21,635,078 |
|
|
$ |
24,368,631 |
|
See
accompanying notes to condensed consolidated financial statements
THE
QUIGLEY CORPORATION
CONDENSED
CONSOLIDATED STATEMENTS OF OPERATIONS
(Unaudited)
|
|
Three
Months Ended
|
|
|
|
March
31, 2009
|
|
|
March
31, 2008
|
|
|
|
|
|
|
|
|
NET
SALES
|
|
$ |
3,986,547 |
|
|
$ |
5,305,034 |
|
|
|
|
|
|
|
|
|
|
COST
OF SALES
|
|
|
1,634,334 |
|
|
|
1,735,516 |
|
|
|
|
|
|
|
|
|
|
GROSS
PROFIT
|
|
|
2,352,213 |
|
|
|
3,569,518 |
|
|
|
|
|
|
|
|
|
|
OPERATING
EXPENSES:
|
|
|
|
|
|
|
|
|
Sales and
marketing
|
|
|
2,024,155 |
|
|
|
2,232,241 |
|
Administration
|
|
|
2,289,845 |
|
|
|
2,508,206 |
|
Research and
development
|
|
|
248,439 |
|
|
|
1,410,302 |
|
TOTAL
OPERATING EXPENSES
|
|
|
4,562,439 |
|
|
|
6,150,749 |
|
|
|
|
|
|
|
|
|
|
LOSS
FROM OPERATIONS
|
|
|
(2,210,226 |
) |
|
|
(2,581,231 |
) |
|
|
|
|
|
|
|
|
|
INTEREST
AND OTHER INCOME
|
|
|
11,161 |
|
|
|
136,265 |
|
|
|
|
|
|
|
|
|
|
LOSS
FROM CONTINUING OPERATIONS BEFORE TAXES
|
|
|
(2,199,065 |
) |
|
|
(2,444,966 |
) |
|
|
|
|
|
|
|
|
|
INCOME
TAXES (BENEFIT)
|
|
|
- |
|
|
|
- |
|
|
|
|
|
|
|
|
|
|
LOSS
FROM CONTINUING OPERATIONS
|
|
|
(2,199,065 |
) |
|
|
(2,444,966 |
) |
|
|
|
|
|
|
|
|
|
DISCONTINUED
OPERATIONS: |
|
|
|
|
|
|
|
|
Gain
on disposal of health and wellness operations
|
|
|
- |
|
|
|
736,252 |
|
|
|
|
|
|
|
|
|
|
Income
from discontinued operations
|
|
|
- |
|
|
|
139,264 |
|
|
|
|
|
|
|
|
|
|
NET
LOSS
|
|
$ |
(2,199,065 |
) |
|
$ |
(1,569,450 |
) |
|
|
|
|
|
|
|
|
|
Basic
earnings per common share:
|
|
|
|
|
|
|
|
|
Loss
from continuing operations
|
|
$ |
(0.17 |
) |
|
$ |
(0.19 |
) |
Income
from discontinued operations
|
|
|
- |
|
|
|
0.07 |
|
Net
Loss
|
|
$ |
(0.17 |
) |
|
$ |
(0.12 |
) |
|
|
|
|
|
|
|
|
|
Diluted
earnings per common share:
|
|
|
|
|
|
|
|
|
Loss
from continuing operations
|
|
$ |
(0.17 |
) |
|
$ |
(0.19 |
) |
Income
from discontinued operations
|
|
|
- |
|
|
|
0.07 |
|
Net
Loss
|
|
$ |
(0.17 |
) |
|
$ |
(0.12 |
) |
|
|
|
|
|
|
|
|
|
Weighted
average common shares outstanding:
|
|
|
|
|
|
|
|
|
Basic
|
|
|
12,908,383 |
|
|
|
12,859,433 |
|
|
|
|
|
|
|
|
|
|
Diluted
|
|
|
12,908,383 |
|
|
|
12,859,433 |
|
See
accompanying notes to condensed consolidated financial statements
THE
QUIGLEY CORPORATION
CONDENSED
CONSOLIDATED STATEMENTS OF CASH FLOWS
(Unaudited)
|
|
Thre
Months Ended
|
|
|
|
March
31, 2009
|
|
|
March
31, 2008
|
|
|
|
|
|
|
|
|
NET
CASH PROVIDED BY OPERATING ACTIVITIES
|
|
$ |
358,758 |
|
|
$ |
1,010,338 |
|
|
|
|
|
|
|
|
|
|
INVESTING
ACTIVITIES:
|
|
|
|
|
|
|
|
|
Capital
expenditures
|
|
|
(71,327 |
) |
|
|
(11,245 |
) |
|
|
|
|
|
|
|
|
|
NET
CASH FLOWS USED IN INVESTING ACTIVITIES
|
|
|
(71,327 |
) |
|
|
(11,245 |
) |
|
|
|
|
|
|
|
|
|
FINANCING
ACTIVITIES:
Proceeds
from exercises of options
|
|
|
- |
|
|
|
7,911 |
|
|
|
|
|
|
|
|
|
|
NET
CASH FLOWS PROVIDED BY FINANCING ACTIVITIES
|
|
|
- |
|
|
|
7,911 |
|
|
|
|
|
|
|
|
|
|
CASH
FLOWS FROM DISCONTINUED OPERATIONS:
|
|
|
|
|
|
|
|
|
Gain from
discontinued operations
|
|
|
- |
|
|
|
(875,516 |
) |
Proceeds
from sale of discontinued operations
|
|
|
- |
|
|
|
1,000,000 |
|
NET
CASH PROVIDED BY DISCONTINUED OPERATIONS
|
|
|
- |
|
|
|
124,484 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
NET
INCREASE IN CASH
|
|
|
287,431 |
|
|
|
1,131,488 |
|
|
|
|
|
|
|
|
|
|
CASH
& CASH EQUIVALENTS, BEGINNING OF PERIOD
|
|
|
11,956,796 |
|
|
|
15,133,546 |
|
|
|
|
|
|
|
|
|
|
CASH
& CASH EQUIVALENTS, END OF PERIOD
|
|
$ |
12,244,227 |
|
|
$ |
16,265,034 |
|
See
accompanying notes to condensed consolidated financial statements
THE
QUIGLEY CORPORATION
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(Unaudited)
NOTE
1 – ORGANIZATION AND BUSINESS
The
Quigley Corporation (the “Company”), organized under the laws of the state of
Nevada, is engaged in the development, manufacturing, and marketing of
homeopathic and health products that are being offered to the general public
along with the research and development of potential prescription products. The
Company is organized into three business segments: Cold Remedy, Contract
Manufacturing and Ethical Pharmaceutical. For the fiscal periods presented, the
majority of the Company’s revenues have come from the Company’s Cold Remedy
segment.
The
Company’s principal cold-remedy product, Cold-EezeÒ, a zinc gluconate glycine
formulation (ZIGG™) is an over-the-counter consumer product used to reduce the
duration and severity of the common cold. The lozenge form of
the product is manufactured by Quigley Manufacturing Inc. (“QMI”), a wholly
owned subsidiary of the Company, which was formed following the acquisition of
certain assets and assumption of certain liabilities of JoEl, Inc., the contract
manufacturer of the lozenge product prior to October 1, 2004.
In
January 2001, the Company formed an Ethical Pharmaceutical segment which is now
Quigley Pharma Inc. (“Pharma”), a wholly-owned subsidiary of the
Company. The result of that segment’s research and development
activity may enable the Company to diversify into the prescription drug
market.
On
February 29, 2008, the Company sold Darius International Inc. (“Darius”) to
InnerLight Holdings, Inc., whose major shareholder is Mr. Kevin P. Brogan, the
then president of Darius. Darius marketed health and wellness
products through its wholly-owned subsidiary, Innerlight Inc. that constituted
the Health and Wellness segment of the Company. The terms of the sale
agreement included a cash purchase price of $1,000,000 by InnerLight Holdings,
Inc. for the stock of Darius and its subsidiaries without guarantees, warranties
or indemnifications. See discussion in Note 3 to Condensed
Consolidated Financial Statements.
NOTE
2 – SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
Basis
of Presentation
The
Condensed Consolidated Financial Statements include the accounts of the Company
and its wholly owned subsidiaries. All inter-company transactions and balances
have been eliminated. Effective March 31, 2004, the financial
statements include consolidated variable interest entities (“VIEs”) of which the
Company is the primary beneficiary (see discussion in Note 4, “Variable Interest
Entity”). The business activity that gave rise to the VIE accounting
was discontinued on March 31, 2008 and therefore this accounting requirement no
longer impacts the financial statements of the Company.
On
February 29, 2008, the Company sold Darius, the former health and wellness
segment of the Company. Results and balances associated with Darius
are presented as discontinued operations in the Condensed Consolidated
Statements of Operations and the Condensed Consolidated Statements of Cash
Flows.
These
financial statements have been prepared by management without audit and should
be read in conjunction with the Consolidated Financial Statements and notes
thereto included in the Company’s Annual Report on Form 10-K for the year ended
December 31, 2008. 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 months ended March 31,
2009 and 2008 are not necessarily indicative of the results to be expected for
the entire year or any other period.
Use
of Estimates
The
Company’s Condensed Consolidated Financial Statements are prepared in accordance
with generally accepted accounting principles (“GAAP”) in the United States of
America. In connection with the preparation of the Condensed Consolidated
Financial Statements, the Company is required to make assumptions and estimates
about future events, and apply judgments that affect the reported amounts of
assets, liabilities, revenue, expenses and related disclosures. These
assumptions, estimates and judgments are based on historical experience, current
trends and other factors that management believes to be relevant at the time the
Condensed Consolidated Financial Statements are prepared. Management reviews the
accounting policies, assumptions, estimates and judgments on a quarterly basis
to ensure the financial statements are presented fairly and in accordance with
GAAP. However, because future events and their effects cannot be determined with
certainty, actual results could differ from these assumptions and estimates, and
such differences could be material.
The
Company is organized into three different but related business segments,
Cold-Remedy, Contract Manufacturing and Ethical Pharmaceutical. When providing
for the appropriate sales returns, allowances, cash discounts and cooperative
incentive promotion costs, each segment applies a uniform and consistent method
for making certain assumptions for estimating these provisions that are
applicable to each specific segment. Traditionally, these provisions are not
material to reported revenues in the Contract Manufacturing segment and the
Ethical Pharmaceutical segment does not have any revenues.
Provisions
to these reserves within the Cold Remedy segment include the use of such
estimates, which are applied or matched to the current sales for the period
presented. These estimates are based on specific customer tracking and an
overall historical experience to obtain an applicable effective rate. Estimates
for sales returns are tracked at the specific customer level and are tested on
an annual historical basis, and reviewed quarterly, as is the estimate for
cooperative incentive promotion costs. Cash discounts follow the terms of sales
and are taken by virtually all customers. Additionally, the monitoring of
current occurrences, developments by customer, market conditions and any other
occurrences that could affect the expected provisions for any future returns or
allowances, cash discounts and cooperative incentive promotion costs relative to
net sales for the period presented are also performed.
Cash
Equivalents
The
Company considers 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.
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 appropriate valuation reserves are established. The consolidated
financial statements include a specific reserve for excess or obsolete inventory
of $1,025,358 and $1,200,803 as of March 31, 2009 and December 31, 2008,
respectively. Inventories included raw material, work in progress and
packaging amounts of approximately $894,000 and $975,000 at March 31, 2009 and
December 31, 2008, respectively, with the remainder comprising finished
goods.
Property,
Plant and Equipment
Property,
plant and equipment are recorded at cost. The Company uses a
combination of straight-line and accelerated methods in computing depreciation
for financial reporting purposes. The annual provision for
depreciation has been 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 years;
and furniture and fixtures – seven years.
Concentration
of Risks
Financial
instruments that potentially subject the Company to significant concentrations
of credit risk consist principally of cash investments and trade accounts
receivable.
The
Company maintains cash and cash equivalents with several major financial
institutions. Due to the nature of the funds maintained by the Company, all fund
balances are completely guaranteed due to the Temporary Guarantee Program for
Money Market Funds and the unlimited FDIC coverage available to non-interest
bearing transaction accounts. The Company will continue to monitor
these programs as they contain future expiry dates and to limit the amount of
credit exposure with any one financial institution.
Trade
accounts receivable potentially subject the Company to credit
risk. The Company extends credit to its customers based upon an
evaluation of the customer’s financial condition and credit history and
generally does not require collateral. It is not anticipated that any one
customer will exceed 10% of consolidated sales in 2009. The Company’s
broad range of customers includes many large wholesalers, mass merchandisers and
multi-outlet pharmacy chains, five of which account for a significant percentage
of sales volume, representing 42% of sales volume for each of the respective
three month periods ended March 31, 2009 and 2008. Customers
comprising the five largest accounts receivable balances represented 44% and 46%
of total trade receivable balances at March 31, 2009 and 2008, respectively.
During the three month periods ended March 31, 2009 and 2008, all of the
Company’s net sales for each period were related to domestic
markets.
The
Company’s revenues are currently generated from the sale of the Cold-Remedy
products which approximated 84% and 89% of total revenues in the three month
periods ended March 31, 2009 and 2008, respectively. The revenues of
the Contract Manufacturing segment approximated 16% and 11% of the Company’s
revenues for the respective three month periods.
Raw
materials used in the production of the products are available from numerous
sources. Raw materials for the Cold-EezeÒ lozenge product are
currently procured from a single vendor in order to secure purchasing
economies. In a situation where this one vendor is not able to supply
QMI with the ingredients, other sources have been identified. Should
these product sources terminate or discontinue for any reason, the Company has
formulated a contingency plan in order to prevent such discontinuance from
materially affecting the Company’s operations. Any such termination
may, however, result in a temporary delay in production until the replacement
facility is able to meet the Company’s production requirements.
Long-lived
Assets
The
Company reviews its long-lived assets with definite lives for impairment on an
exception basis whenever events or changes in circumstances indicate that the
carrying amount of the assets may not be recoverable through future cash
flows. At December 31, 2008, the Company recognized an impairment
charge of $300,000 due to adverse profit margins related to the hard candy
business of QMI with such expense reflected in cost of sales. No
further charge was required during the first quarter of 2009.
Revenue
Recognition
Sales are
recognized at the time ownership is transferred to the customer, which for the
Cold Remedy segment is the time the shipment is received by the customer and for
the Contract Manufacturing segment, when the product is shipped 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. The Company makes estimates of potential future product
returns and other allowances related to current period revenue. The Company
analyzes historical returns, current trends, and changes in customer and
consumer demand when evaluating the adequacy of the sales returns and other
allowances. The consolidated financial statements include reserves of $1,438,843
for future sales returns and $231,174 for other allowances as of March 31, 2009
and $1,427,045 and $280,973 at December 31, 2008, respectively. The
reserves also include an estimate of the uncollectability of accounts receivable
resulting in a reserve of $140,942 and $131,162 at March 31, 2009 and December
31, 2008, respectively.
Operating
expenses
Agreements
relating to the Cold Remedy segment with a major national sales brokerage firm
are for this firm to sell the manufactured Cold-EezeÒ product to our customers.
Such related costs are presented in the financial statements as selling
expenses.
Shipping
and Handling
Product
sales relating to the Cold Remedy and Contract Manufacturing segments include
shipping and handling charges to the purchaser 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
Stock
options and warrants for purchase of the Company’s common stock have been
granted to both employees and non-employees since the date the Company became
publicly traded. Options and warrants are exercisable during a period
determined by the Company, but in no event later than ten years from the date
granted.
No stock
options were granted in the three month periods ended March 31, 2009 and
2008.
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 month periods ended March 31,
2009 and 2008 were $2,207,240 and $2,472,761, respectively. Included
in prepaid expenses and other current assets was $60,000 and $241,971 at March
31, 2009 and December 31, 2008, respectively, relating to prepaid advertising
and promotion expenses.
Research
and Development
Research
and development costs are charged to operations in the period incurred.
Expenditures for the three month periods ended March 31, 2009 and 2008 were
$248,439 and $1,410,302, respectively. Principally, research and
development costs are related to Pharma’s study activities and costs associated
with Cold-EezeÒ
products.
Income
Taxes
The
Company utilizes 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 the Company’s financial statements or tax returns.
In estimating future tax consequences, the Company generally considers 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 9 - Income
Taxes, for further discussion.
Effective
January 1, 2007, the Company adopted Financial Interpretation ("FIN") No. 48,
Accounting for Uncertainty in
Income Taxes-An Interpretation of FASB Statement No. 109. This
interpretation prescribes a recognition threshold and measurement attribute for
the financial statement recognition and measurement of a tax position taken or
expected to be taken in a tax return. The interpretation contains a two-step
approach to recognizing and measuring uncertain tax positions accounted for in
accordance with SFAS No. 109. 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. The
interpretation also provides guidance on derecognition, classification, interest
and penalties, and other matters. The adoption did not have an effect on the
Consolidated Financial Statements.
As a
result of the Company’s continuing tax losses, the Company has recorded a full
valuation allowance against a net deferred tax asset. Additionally,
the Company has not recorded a liability for unrecognized tax benefits
subsequent to the adoption of FIN 48.
The tax
years 2004-2008 remain open to examination by the major taxing jurisdictions to
which the Company is subject.
Fair
Value of Financial Instruments
Cash and
cash equivalents, accounts receivable and accounts payable are reflected in the
Consolidated Financial Statements at carrying value which approximates fair
value because of the short-term maturity of these instruments.
Recently
Issued Accounting Standards
In
September 2006, the Financial Accounting Standards Board (FASB) issued
Statement of Financial Accounting Standards No. 157, “Fair Value
Measurements” (“SFAS
157”). SFAS 157 defines fair value, establishes a framework for
measuring fair value in generally accepted accounting principles (GAAP) and
expands disclosures about fair value measurements. SFAS 157 is effective
for fiscal years beginning after November 15, 2007 and interim periods
within those fiscal years. The adoption of this standard has not had a
significant impact on the Company’s consolidated financial position, results of
operations or cash flows.
In
December 2007, the FASB issued Statement of Financial Accounting Standard
No. 160, “Noncontrolling
Interests in Consolidated Financial Statements — an amendment of ARB
No. 51” (“FAS
160”). FAS 160 establishes accounting and reporting standards
for the non-controlling interest in a subsidiary and for the retained interest
and gain or loss when a subsidiary is deconsolidated. This statement is
effective for financial statements issued for fiscal years beginning on or after
December 15, 2008 with earlier adoption prohibited. The adoption of this
standard has not had a significant impact on the Company’s consolidated
financial position, results of operations or cash flows.
In
December 2007, the FASB issued SFAS No. 141R, "Business
Combinations," (“SFAS
141R”) which establishes principles and requirements for how an acquirer
recognizes and measures in its financial statements the identifiable assets
acquired, the liabilities assumed and any non-controlling interest in the
acquiree. SFAS 141R also establishes disclosure requirements to enable the
evaluation of the nature and financial effects of the business combination. SFAS
141R applies prospectively to business combinations for which the acquisition
date is on or after the beginning of the first annual reporting period beginning
on or after December 15, 2008, and interim periods within those fiscal years.
The adoption of this standard has not had a significant impact on the Company’s
consolidated financial position, results of operations or cash
flows.
In March
2008, the Financial Accounting Standards Board issued Statement of Financial
Accounting Standard ("SFAS") No. 161
"Disclosures about Derivative Instruments and Hedging Activities". SFAS
161 is intended to improve financial reporting about derivative instruments and
hedging activities by requiring enhanced disclosures to enable investors to
better understand their effects on an entity's financial position, financial
performance, and cash flows. It is effective for financial statements issued for
fiscal years and interim periods beginning after November 15, 2008, with early
application encouraged. The adoption of this standard has not had a
significant impact on the Company’s consolidated financial position, results of
operations or cash flows.
In May 2008, the FASB
issued SFAS
No. 162, The Hierarchy of Generally Accepted Accounting Principles. SFAS
162 identifies the sources of accounting principles and the framework for
selecting the principles to be used in the preparation of financial statements
of nongovernmental entities that are presented in conformity with GAAP. SFAS 162
directs the GAAP hierarchy to the entity, not the independent auditors, as the
entity is responsible for selecting accounting principles for financial
statements that are presented in conformity with GAAP. SFAS 162
is effective 60 days following the SEC’s approval of PCAOB Auditing Standard No.
6, Evaluating Consistency of Financial Statements (AS/6). The adoption of FASB
162 is not expected to have a material impact on the Company’s financial
position.
In June
2008, the FASB ratified EITF Issue No. 07-5, Determining
whether an Instrument (or Embedded Feature) is indexed to an Entity’s Own
Stock (“EITF 07-5”). EITF 07-5 is effective for financial
statements issued for fiscal years beginning after December 15, 2008, and
interim periods within those fiscal years. Early application is not permitted.
EITF 07-5 provides a new two-step model to be applied in determining whether a
financial instrument or an embedded feature is indexed to an issuer’s own stock
and thus able to qualify for the SFAS No. 133 paragraph 11(a) scope
exception. The adoption of this standard has not had a significant
impact on the Company’s consolidated financial position, results of operations
or cash flows.
NOTE
3 – DISCONTINUED
OPERATIONS
On
February 29, 2008, the Company sold Darius to InnerLight Holdings, Inc., whose
major shareholder is Mr. Kevin P. Brogan, the then president of
Darius. Darius was formed by The Quigley Corporation in 2000 to
introduce new products to the marketplace through a network of independent
distributor representatives. Darius marketed health and wellness
products through its wholly-owned subsidiary, Innerlight Inc. that constituted
the Health and Wellness segment of the Company. The terms of the sale
agreement include a cash purchase price of $1,000,000 by InnerLight Holdings,
Inc. for the stock of Darius and its subsidiaries without guarantees, warranties
or indemnifications.
Darius
sales in 2008, until date of disposal on February 29, 2008, were
$2,188,815. Net income for 2008 until date of disposal on February
29, 2008 was $139,264. Results of operations for Darius in 2008 are
presented as discontinued operations in the Condensed Consolidated Statements of
Operations and Cash Flows.
For the
three months ended March 31, 2008, the Company recorded a gain on the disposal
of Darius of $736,252, as a result of sales proceeds of $1,000,000 less residual
investment of $5,000 and net assets of Darius of $258,748 on the date of sale,
which are reported as discontinued operations.
NOTE
4 – VARIABLE INTEREST ENTITY
In
December 2003, the FASB issued FASB Interpretation No. 46 (revised December
2003), Consolidation of
Variable Interest Entities (FIN 46R), to address certain implementation
issues. FIN 46R varies significantly from FASB Interpretation No. 46,
Consolidation of Variable
Interest Entities (“VIE”) (FIN 46), which it supersedes. FIN
46R requires the application of either FIN 46 or FIN 46R by “Public
Entities” to
all Special Purpose Entities (“SPEs”)
at the end of the first interim or annual
reporting period ending after December 15, 2003. FIN 46R is
applicable to all non-SPEs created prior to February 1, 2003 by Public Entities
that are not small business issuers at the end of the first interim or annual
reporting period ending after March 15, 2004. Effective March 31,
2004, the Company adopted FIN 46R for VIE’s formed prior to February 1,
2003. The Company had determined that Scandasystems, a related party,
qualified as a variable interest entity and the Company consolidated
Scandasystems beginning with the quarter ended March 31, 2004. Due to
the fact that the Company had no long-term contractual commitments or
guarantees, the maximum exposure to loss was insignificant.
The
Company has determined that the conditions that applied in the past giving rise
to the application of FIN 46R to the relationship between the Company and
Scandasystems no longer apply. Therefore, effective with quarter
ended March 31, 2008, Scandasystems balances are no longer consolidated with the
Company’s financial results and balances.
NOTE
5 – PATENT RIGHTS AND RELATED ROYALTY COMMITMENTS
The
Company has maintained a separate representation and distribution agreement
relating to the development of the zinc gluconate glycine product
formulation. In return for exclusive distribution rights, the Company
must 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. The Company and the developer are in litigation
and as such no potential offset from such litigation for these fees have been
recorded.
The
expenses for the respective periods relating to such agreement amounted to zero
for each of the three month periods ended March 31, 2009 and 2008. Amounts
accrued for these expenses at both March 31, 2009 and December 31, 2008 were
$3,524,031.
NOTE
6 – OTHER CURRENT LIABILITIES
Included
in other current liabilities are $516,121 and $215,350 related to accrued
compensation at March 31, 2009 and December 31, 2008, respectively.
NOTE
7 – COMMITMENTS AND CONTINGENCIES
Certain
operating leases for office and warehouse space maintained by the Company
resulted in rent expense for the three month periods ended March 31, 2009 and
2008 of $18,452 and $13,693, respectively. The Company has approximate future
obligations over the next five years, including the remainder of 2009, as
follows:
Year
|
|
Research
and
Development
|
|
|
Property
and
Other
Leases
|
|
|
Product
Purchases
|
|
|
Total
|
|
2009
|
|
$ |
486,422 |
|
|
$ |
11,089 |
|
|
$ |
- |
|
|
$ |
497,511 |
|
2010
|
|
|
- |
|
|
|
- |
|
|
|
748,000 |
|
|
|
748,000 |
|
2011
|
|
|
- |
|
|
|
- |
|
|
|
1,321,000 |
|
|
|
1,321,000 |
|
2012
|
|
|
- |
|
|
|
- |
|
|
|
671,000 |
|
|
|
671,000 |
|
2013
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
Total
|
|
$ |
486,422 |
|
|
$ |
11,089 |
|
|
$ |
2,740,000 |
|
|
$ |
3,237,511 |
|
Additional
research and development costs are expected to be incurred during the remainder
of 2009.
During
July 2008, the Company entered into an agreement with a vendor to purchase a
minimum amount of product, over a three year period in its capacity as an
exclusive reseller, marketer and distributor of a cough and cold product
incorporating a patented, proprietary delivery system. The total
minimum commitment amounted to approximately $3,900,000 of which $2,740,000
remained as of March 31, 2009 as indicated in the table preceding.
On July
2, 2008, the Company entered into an agreement with Dr. Richard Rosenbloom,
Executive Vice President and Chief Operating Officer of Pharma, whereby the
Company agreed to compensate Dr. Rosenbloom for assigning, to the Company, the
entire right, title and interest in and to Dr. Rosenbloom’s concepts and/or
inventions made prior to the date he became an employee of The Quigley
Corporation. In consideration of, and as full compensation for, the
covenants made in the agreement, the Company shall pay Dr. Rosenbloom
compensation in the amount of five percent (5%) of net sales collected, less
certain deductions, of royalty bearing products. This agreement has
no current financial impact to the Company due to the absence of Pharma related
sales.
See also
Note 5 – Patent Rights and Related Royalty Commitments.
TERMINATED LEGAL
PROCEEDINGS
TESAURO AND ELEY, ET AL VS.
THE QUIGLEY CORPORATION
(CCP OF PHILA., AUGUST TERM
2000, NO. 001011)
In
September, 2000, the Company was sued by two individuals (Jason Tesauro and
Elizabeth Eley, both residents of Georgia), allegedly on behalf of a "nationwide
class" of "similarly situated individuals," in the Court of Common Pleas of
Philadelphia County, Pennsylvania. The Complaint further alleges that
the plaintiffs purchased certain Cold-EezeÒ products between August
1996 and November 1999, based upon cable television, radio and internet
advertisements, which allegedly misrepresented the qualities and benefits of the
Company's products. The Complaint, as pleaded originally, requested
an unspecified amount of damages for violations of Pennsylvania's consumer
protection law, breach of implied warranty of merchantability and unjust
enrichment, as well as a judicial determination that the action be maintained as
a class action. In October 2000, the Company filed Preliminary
Objections to the Complaint seeking dismissal of the action. The
court sustained certain objections, thereby narrowing plaintiffs'
claims.
In May
2001, plaintiffs filed a motion to certify the putative class. The
Company opposed the motion. In November 2001, the court held a
hearing on plaintiffs' motion for class certification. In January
2002, the court denied in part and granted in part plaintiffs'
motion. The court denied plaintiffs' motion to certify a class based
on plaintiffs' claims under Pennsylvania consumer protection law, under which
plaintiffs sought treble damages, effectively dismissing this cause of action;
however, the court certified a class based on plaintiffs' secondary breach of
implied warranty and unjust enrichment claims. In August 2002, the
court issued an order adopting a form of Notice of Class Action to be published
nationally. Significantly, the form of Notice approved by the court
included a provision which limits the potential class members who may
potentially recover damages in this action to those persons who present a proof
of purchase of Cold-EezeÒ during the period from
August 1996 through November 1999.
Afterward,
a series of pre-trial motions were filed raising issues concerning trial
evidence and the court's jurisdiction over the subject matter of the
action. In March, 2005, the court held oral argument on these
motions. Significantly, on November 8, 2006, the Court entered an
Order dismissing the case in its entirety on the basis that the action was
preempted by federal law. The plaintiffs appealed the Court's decision in
December 2006 to the Superior Court of the Commonwealth of
Pennsylvania. On February 19, 2008, the Superior Court upheld
defendant's appeal and remanded the case to the Philadelphia County Court of
Common Pleas for trial.
This case
was tried before a jury on February 2 through February 6, 2009, with the jury
returning a verdict in favor of the Company on all counts. No
post-trial motions were filed and the plaintiffs did not perfect an
appeal. A final judgment has been taken on the jury verdict in favor
of the Company.
NOTE
8 – TRANSACTIONS AFFECTING STOCKHOLDERS’ EQUITY
On
September 8, 1998, the Company’s Board of Directors declared a dividend
distribution of Common Stock Purchase Rights (individually, a “Right”
and collectively, the “Rights”),
thereby creating a Stockholder Rights Plan (the
“Plan”). The dividend was payable to the
stockholders of record on September 25, 1998. 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 final expiration
date of the Plan was September 25, 2008, prior to the
amendment.
On May
23, 2008, the Company entered into an amendment ("Amendment No. 1") to the
Rights Agreement, dated as of September 15, 1998, between the Company and
American Stock Transfer & Trust Company (the "Rights Agreement") dated as of
May 20, 2008, pursuant to which the term of the Rights Agreement was extended
until September 25, 2018. In addition, Amendment No. 1 added a provision
pursuant to which the Company's board of directors may exempt from the
provisions of the
Rights Agreement an offer for all outstanding shares of the Company's 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.
Since the
inception of the stock buy-back program in January 1998, the Board has
subsequently increased the authorization on five occasions, for a total
authorized buy-back of 5,000,000 shares or approximately 38% of the previous
shares outstanding. Such shares are reflected as treasury stock and
will be available for general corporate purposes. From the initiation
of the plan until March 31, 2009, 4,159,191 shares have been repurchased at a
cost of $24,042,801 or an average cost of $5.78 per share. No shares
were repurchased during 2008 and 2009 to date.
During
the three months ended March 31, 2009, no options were exercised, compared to
7,000 options exercised in the comparable 2008 period.
NOTE
9 – 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 $6,805,323 are deferred and will be credited to
additional-paid-in-capital when the NOL’s attributable to these exercises are
utilized. As a result, these NOL’s will not be available to offset
income tax expense. The net operating loss carry-forwards that
currently approximate $24.0 million for federal purposes will be expiring
through 2029. Additionally, there are net operating loss
carry-forwards of $23.1 million for state purposes that will be expiring 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
$110,270 are assured, a valuation allowance equaling the total deferred tax
asset is being provided.
NOTE
10 – EARNINGS PER SHARE
Basic
loss per share (“EPS”) excludes dilution and is computed by dividing income
available to common stockholders by the weighted - average number of common
shares outstanding for the period. Diluted EPS 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 EPS 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. Since there is a large number of options and
warrants outstanding, fluctuations in the actual market price can have a variety
of results for each period presented.
A reconciliation of the applicable
numerators and denominators of the income statement periods presented, as
reflects the results of continuing operations, is as follows (millions, except
per share amounts):
|
|
March
31, 2009
|
|
|
March
31, 2008
|
|
|
|
Net
Loss
|
|
|
Shares
|
|
|
EPS
|
|
|
Net
Loss
|
|
|
Shares
|
|
|
EPS
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic
EPS
|
|
$ |
(2.2 |
) |
|
|
12.9 |
|
|
$ |
(0.17 |
) |
|
$ |
(2.4 |
) |
|
|
12.8 |
|
|
$ |
(0.19 |
) |
Dilutives:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Options/Warrants
|
|
|
- |
|
|
|
- |
|
|
|
|
|
|
|
- |
|
|
|
- |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Diluted
EPS
|
|
$ |
(2.2 |
) |
|
|
12.9 |
|
|
$ |
(0.17 |
) |
|
$ |
(2.4 |
) |
|
|
12.8 |
|
|
$ |
(0.19 |
) |
Options
and warrants outstanding at March 31, 2009 and 2008 were 2,113,750 and
2,475,000 respectively. They were not included in the computation of diluted
earnings for the periods with a net loss because the effect would be
anti-dilutive.
NOTE
11 – SEGMENT INFORMATION
The basis
for presenting segment results generally is consistent with overall Company
reporting. The Company reports information about its operating segments in
accordance with Financial Accounting Standard Board Statement No. 131, “Disclosure About Segments of an
Enterprise and Related Information,” which establishes standards for
reporting information about a company’s operating segments. All consolidating
items are included in Corporate & Other.
The
Company divides its operations into three reportable segments as follows: The
Quigley Corporation (Cold-Remedy), whose main product is Cold-EezeÒ, a proprietary zinc
gluconate glycine lozenge for the common cold; Quigley
Manufacturing
(Contract Manufacturing), which is the production facility for the
Cold-EezeÒ lozenge
product and also performs contract manufacturing services for third party
customers, and Pharma, (Ethical Pharmaceutical), currently involved in research
and development activity to develop patent applications for potential
pharmaceutical products.
Financial
information relating to 2009 and 2008 continuing operations, by business
segment, follows:
For
the three months ended March 31, 2009
|
|
Cold
Remedy
|
|
|
Contract
Manufacturing
|
|
|
Ethical
Pharmaceutical
|
|
|
Corporate
&
Other
|
|
|
Total
|
|
Revenues
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Customers-domestic
|
|
$ |
3,332,059 |
|
|
$ |
654,488 |
|
|
$ |
- |
|
|
$ |
- |
|
|
$ |
3,986,547 |
|
Inter-segment
|
|
$ |
- |
|
|
$ |
385,148 |
|
|
$ |
- |
|
|
$ |
(
385,148 |
) |
|
$ |
- |
|
Segment
operating profit (loss)
|
|
$ |
(1,564,219 |
) |
|
$ |
(495,006 |
) |
|
$ |
(
376,116 |
) |
|
$ |
225,115 |
|
|
$ |
(2,210,226 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
For
the three months ended March 31, 2008
|
|
Cold
Remedy
|
|
|
Contract
Manufacturing
|
|
|
Ethical
Pharmaceutical
|
|
|
Corporate
&
Other
|
|
|
Total
|
|
Revenues
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Customers-domestic
|
|
$ |
4,712,134 |
|
|
$ |
592,900 |
|
|
$ |
- |
|
|
$ |
- |
|
|
$ |
5,305,034 |
|
Inter-segment
|
|
$ |
- |
|
|
$ |
1,050,051 |
|
|
$ |
- |
|
|
$ |
(1,050,051 |
) |
|
$ |
- |
|
Segment
operating profit (loss)
|
|
$ |
(817,838 |
) |
|
$ |
(287,654 |
) |
|
$ |
(1,578,718 |
) |
|
$ |
102,979 |
|
|
$ |
(2,581,231 |
) |
Item 2. Management’s Discussion and Analysis of
Financial Condition and Results of Operations
Forward-Looking
Statements
In
addition to historical information, this Report contains forward-looking
statements. These forward-looking statements are subject to certain risks and
uncertainties that could cause actual results to differ materially from those
reflected in these forward-looking statements. Factors that might cause such a
difference include, but are not limited to, management of growth, competition,
pricing pressures on the Company’s products, industry growth and general
economic conditions. Readers are cautioned not to place undue reliance on these
forward-looking statements, which reflect management’s opinions only as of the
date hereof. The Company undertakes no obligation to revise or publicly release
the results of any revision to these forward-looking statements.
Certain Risk
Factors
The
Quigley Corporation makes no representation that the United States Food and Drug
Administration (“FDA”) or any other regulatory agency will grant an
Investigational New Drug (“IND”) or take any other action to allow its
formulations to be studied or/and for any granted IND to be
marketed. Furthermore, no claim is made that potential medicine
discussed herein is safe, effective, or approved by the
FDA. Additionally, data that demonstrates activity or effectiveness
in animals or in vitro tests do not necessarily mean such formula test compound,
referenced herein, will be effective in humans. Safety and
effectiveness in humans will have to be demonstrated by means of adequate and
well controlled clinical studies before the clinical significance of the formula
test compound is known. Readers should carefully review the risk
factors described in other sections of the filing as well as in other documents
the Company files from time to time with the Securities and Exchange Commission
(“SEC”).
Overview
The
Company, headquartered in Doylestown, Pennsylvania, is a leading manufacturer,
marketer and distributor of a diversified range of homeopathic and health
products which comprise the Cold Remedy and Contract Manufacturing
segments. The Company is also involved in the research and
development of potential natural base health products, including, but not
limited to, prescription medicines along with supplements and cosmeceuticals for
human and veterinary use, which comprise the Ethical Pharmaceutical
segment.
The
Company’s primary business is the manufacture and distribution of cold remedy
products to the consumer through the over-the-counter
marketplace. One of the Company’s key products in its Cold Remedy
segment is Cold-EezeÒ,
a zinc gluconate glycine product proven in two double-blind 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.
Effective
October 1, 2004, the Company acquired substantially all of the assets of JoEl,
Inc., the previous manufacturer of the Cold-EezeÒ lozenge
product. This manufacturing entity, now called QMI, a wholly-owned
subsidiary of the Company, will continue to produce lozenge product along with
performing such operational tasks as warehousing and shipping the Company’s
Cold-EezeÒ
products. In addition, QMI, which is an FDA approved facility, has
produced a variety of hard and organic candy for sale to third party customers
in addition to performing contract manufacturing activities for non-related
entities. On February 2, 2009, the Company announced its intention to
close the Elizabethtown location of QMI and discontinue the hard candy business
resulting in the consolidation of manufacturing operations at the Lebanon
location. This consolidation, which will be completed in the coming
months, will have no impact on the production or distribution of the
Cold-EezeÒ brand of
cold remedy products.
The
Cold-Remedy segment reported a decrease in net sales in the first quarter of
2009 as compared to the same period in 2008. The decrease in net
sales reflects a market-wide decrease in consumer purchases of cold remedy
products as reported by Information Resources Inc., (“IRI”) data. The
decrease was also attributed to by historic lows in the incidence of cold by
consumers and general economic weakness in the
marketplace. Sales activity for the first quarter of 2009
include that of the Kids-EezeÒ Chest Relief product which
was launched in August 2008.
The
Contract Manufacturing segment reported an increase in third party net sales in
the first quarter of 2009 as compared to such sales in the 2008 comparative
period. The primary function of the manufacturing segment is the
production, warehousing and shipping of Cold-EezeÒ related
products.
On
February 29, 2008, the Company sold Darius to InnerLight Holdings, Inc. The sale
of this former business segment is reported as discontinued
operations.
In
January 2001, the Company formed an Ethical Pharmaceutical segment, Pharma, that
is under the direction of its Executive Vice President and Chairman of its
Medical Advisory Committee. Pharma was formed for the purpose of
developing potential natural base health products, including, but not limited
to, prescription medicines along with supplements and cosmeceuticals for human
and veterinary use. Pharma is currently undergoing
research and development activity in compliance with
regulatory requirements. The Company is in the initial stages of what
may be a lengthy process to develop these patent applications into commercial
products. The Company continues to invest significantly with ongoing
research and development activities of this segment.The Company continues to
invest significantly in ongoing research and development activities of this
segment. Such investment amounted to $248,439 in the first quarter of
2009, compared to $1,410,302 in the 2008 comparative period. The
decreased spending in the 2009 period was due to the completion of the Phase IIb
study for QR-333 Diabetic Peripheral Neuropathy in November 2008 with the study
conclusion being awaited.
Future
revenues, costs, margins, and profits will continue to be influenced by the
Company’s ability to maintain its manufacturing availability and capacity
together with its marketing and distribution capabilities and the requirements
associated with the development of Pharma’s potential prescription drugs and
other medicinal products in order to continue to compete on a national and
international level. The business development of the Company 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.
Cold-Remedy
Products
In May
1992, the Company entered into an exclusive agreement for the worldwide
representation, manufacturing and marketing of Cold-EezeÒ products in the United
States. Cold-EezeÒ, a zinc gluconate glycine
formulation (ZIGG™), is an over-the-counter consumer product used to reduce the
duration and severity of the common cold and is available in lozenge, sugar-free
tablet and gum form. The Company has substantiated the effectiveness
of Cold-EezeÒ through
a variety of studies. A randomized double-blind placebo-controlled
study, conducted at Dartmouth College of Health Science, Hanover, New Hampshire,
concluded that the lozenge formulation treatment, initiated within 48 hours of
symptom onset, resulted in a significant reduction in the total duration of the
common cold.
On May
22, 1992, “Zinc and the Common
Cold, a Controlled Clinical Study,” was published in England in the
“Journal of International Medical Research,” Volume 20, Number 3, Pages
234-246. According to this publication, (a) flavorings used in other
Zinc lozenge products (citrate, tartrate, separate, orotate, picolinate,
mannitol or sorbitol) render the Zinc inactive and unavailable to the patient’s nasal
passages, mouth and throat where cold symptoms have to be treated, (b) this
patented formulation delivers approximately 93% of the active Zinc to the
mucosal surfaces and (c) the patient has the same sequence of symptoms as in the
absence of treatment but goes through the phases at an accelerated rate and with
reduced symptom severity.
On July
15, 1996, results of a new randomized double-blind placebo-controlled study on
the common cold, which commenced at the Cleveland Clinic Foundation
on October 3, 1994, were published. The study called “Zinc Gluconate Lozenges for Treating
the Common Cold” was completed and published in the Annals of Internal Medicine – Vol.
125 No. 2. Using a 13.3mg lozenge (almost half the strength of
the lozenge used in the Dartmouth Study), the result still showed a 42%
reduction in the duration of common cold symptoms.
In April
2002, the Company announced the statistical results of a retrospective clinical
adolescent study at the Heritage School facility in Provo, Utah that suggests
that Cold-EezeÒ is
also an effective means of preventing the common cold and statistically (a)
lessens the number of colds an individual suffers per year, reducing the median
from 1.5 to zero and (b) reduces the use of antibiotics for respiratory
illnesses from 39.3% to 3.0% when Cold-EezeÒ is administered as a first
line treatment approach to the common cold.
In April
2002, the Company was assigned a Patent Application which was filed with the
Patent Office of the United States Commerce Department for the use of
Cold-EezeÒ as a
prophylactic for cold prevention. The new patent application follows
the results of the adolescent study at the Heritage School
facility.
In May
2003, the Company announced the findings of a prospective study, conducted at
the Heritage School facility in Provo, Utah, in
which 178 children, ages 12 to 18 years, were given Cold-EezeÒ lozenges both
symptomatically and prophylactically from October 5, 2001 to May 30, 2002. The
study found a 54% reduction in the most frequently observed cold
duration. Those subjects not receiving treatment most frequently
experienced symptom duration of 11 days compared with 5 days when Cold-EezeÒ lozenges were
administered, a reduction of 6 days.
The
business of the Company is subject to federal and state laws and regulations
adopted for the health and safety of users of the Company’s products. Cold-Eeze®
is a homeopathic remedy that is subject to regulations by various federal, state
and local agencies, including the FDA and the Homeopathic Pharmacopoeia of the
United States.
Contract
Manufacturing
From
October 1, 2004, QMI has continued to produce lozenge product along with
performing such operational tasks as warehousing and shipping the Company’s
Cold-EezeÒ
products. In addition to that function, QMI produces a variety of
hard and organic candy for sale to third party customers in addition to
performing contract manufacturing activities for non-related
entities. QMI is an FDA-approved facility.
On
February 2, 2009, the Company announced its intention to close the Elizabethtown
location of QMI and discontinue the hard candy business resulting in the
consolidation of manufacturing operations at the Lebanon
location. This consolidation, which will be completed in the coming
months, will have no impact on the production or distribution of the
Cold-EezeÒ brand of
cold remedy products.
Ethical
Pharmaceutical
Pharma’s
current activity is the research and development of potential natural base
health products, including, but not limited to, prescription medicines along
with supplements and cosmeceuticals for human and veterinary
use. Research and development will focus on the identification,
isolation and direct use of active medicinal substances. One aspect
of Pharma’s research will focus on the potential synergistic benefits of
combining isolated active constituents and whole plant components. The Company
will search for new natural sources of medicinal substances from plants and
fungi from around the world while also investigating the use of traditional and
historic medicinals and therapeutics.
The
pre-clinical development, clinical trials, product manufacturing and marketing
of Pharma's
potential new products are subject to federal and state regulation in the United
States and other countries. Obtaining FDA regulatory approval for these
pharmaceutical products can require substantial resources and take 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 indications to be
treated. If the Company cannot obtain regulatory approval of these new products
in a timely manner or if the patents are not granted or if the patents are
subsequently challenged, these possible events could have a material effect on
the business and financial condition of the Company. The strength of
the Company’s patent position may be important to its long-term
success. There can be no assurance
that these patents and patent applications will effectively protect the
Company’s products from duplication by others. Additionally,
the operations of the Company contribute to the current research and development
expenditures of the Ethical Pharmaceutical segment. In addition
to the funding from operations, the Company may in the short and long term raise
capital through the issuance of equity securities or secure other financing
resources to support such research. As research progresses on certain
formulations, expenditures of the Pharma segment will require substantial
financial support and would necessitate the consideration of other approaches
such as, licensing or partnership arrangements that meet the Company’s long term
goals and objectives. Ultimately, should internal working capital or
internal funding be insufficient, there is no guarantee that other financing
resources will become available, thereby deferring future growth and development
of certain formulations.
Patents
and chronological summary of QR formulations, which may or may not be areas of
current focus, are:
·
|
A
Patent (No. 6,555,573 B2) entitled “Method and Composition for the Topical
Treatment of Diabetic Neuropathy.” The patent extends through March 27,
2021.
|
·
|
A
Patent (No. 6,592,896 B2) entitled “Medicinal Composition and Method of
Using It” (for Treatment of Sialorrhea and other Disorders) for a product
to relieve sialorrhea (drooling) in patients suffering from Amyotrophic
Lateral Sclerosis (ALS), otherwise known as Lou Gehrig’s
Disease. The patent extends through August 5,
2021.
|
·
|
A
Patent (No. 6,596,313 B2) entitled “Nutritional Supplement and Method of
Using It” for a product to relieve sialorrhea (drooling) in patients
suffering from Amyotrophic Lateral Sclerosis (ALS), otherwise known as Lou
Gehrig’s Disease. The patent extends through April 14,
2022.
|
·
|
A
Patent (No. 6,753,325 B2) entitled “Composition and Method for Prevention,
Reduction and Treatment of Radiation Dermatitis,” a composition for
preventing, reducing or treating radiation dermatitis. The
patent extends through November 5,
2021.
|
·
|
A
Patent (No. 6,827,945 B2) entitled “Nutritional Supplements and Method of
Using Same” for a method for treating at least one symptom of
arthritis. The patent extends through April 22,
2023.
|
·
|
A
Patent (No. 7,083,813 B2) entitled “Methods for The Treatment of
Peripheral Neural and Vascular Ailments.” The patent extends
through August 4, 2023.
|
·
|
A
Patent (No. 7,166,435 B2) entitled “Compositions and Methods for Reducing
the Tranmissivity of Illnesses.” This patent will provide
additional protection to an existing composition patent (number
6,592,896), which the Company received in July 2003 and will support
on-going investigations and potential commercialization opportunities. The
Company will be continuing its studies to test the effects of the
referenced compound against avian flu and human influenza. The patent
extends through November 5, 2021.
|
·
|
A
Patent (No. 7,175,987 B2) entitled “Compositions and Methods for The
Treatment of Herpes.” The patent extends through November 5,
2021.
|
·
|
A
Patent (No. 7,396,546 B2) entitled “Anti-Microbial Compositions and
Methods of Using Same” The patent extends through August 6,
2021.
|
·
|
A
Patent (No. 7,399,783 B2) entitled “Methods for the Treatment of Scar
Tissue.” The patent extends through September 4,
2026.
|
·
|
A
Patent (No. 7,405,046 B2) entitled “Compositions and Methods for Treatment
of Rhinovirus.” The patent extends through August 6,
2021.
|
·
|
A
Patent (No. 7,410,659 B2) entitled “Methods for the Treatment of
Peripheral Neural and Vascular Ailments.” The patent extends
through November 6, 2022.
|
·
|
A
Patent (No. 7,435,725 B2) entitled “Oral Compositions and Methods for
Prevention, Reduction and Treatment of Radiation Injury.” The
patent extends through January 14,
2022.
|
·
|
A
Mexican Patent (No. 236311) entitled “Method and Composition for the
Treatment of Diabetic Neuropathy.” The patent extends through
December 18, 2020.
|
·
|
A
Mexican Patent (No. 259329) entitled “Nutritional Supplements and Methods
for Prevention, Reduction, and Treatment of Radiation Injury” the
patent extends through April 30,
2022.
|
·
|
A
New Zealand Patent (No. 533439) entitled “Methods for The Treatment of
Peripheral Neural and Vascular Ailments.” The patent extends
through November 6, 2022.
|
·
|
A
New Zealand Patent (No. 526041) entitled “Method and Composition for the
Treatment of Diabetic Neuropathy.” The patent extends through December 18,
2021.
|
·
|
A
New Zealand Patent (No. 530187) entitled “Nutritional Supplements and
Methods of Using Same.” The patent extends through August 6,
2022.
|
·
|
A
New Zealand Patent (No. 537821) entitled “Anti-Microbial Compositions and
Methods of Using Same.” The patent extends through July 23,
2023.
|
·
|
A
New Zealand Patent (No. 532775) entitled “Topical Compositions and Methods
for Treatment of Adverse Effects of Ionizing Radiation,” The patent
extends through November 6, 2022.
|
·
|
An
Australian Patent (No. 2002231095) entitled “Method and Composition for
the Treatment of Diabetic Neuropathy.”The patent extends through December
18, 2021.
|
·
|
An
Australian Patent (No. 2002352501) entitled “Method for The Treatment of
Peripheral Neural and Vascular Ailments.”The patent extends through
November 5, 2022.
|
·
|
An
Australian Patent (No. 2002232464) entitled “Nutritional Supplements and
Methods of Using Same.”The patent extends through August 5,
2022.
|
·
|
An
Australian Patent (No. 2002365155) “Topical Compositions and Methods for
Treatment of Adverse Effects of Ionizing Radiation,” the patent extends
through November 5, 2022.
|
·
|
An
Australian Patent (No. 2002309615) “Nutritional Supplements and Methods
for Prevention, Reduction and Treatment of Radiation Injury” the patent
extends through April 30, 2022.
|
·
|
A
South African Patent (No. 2003/4247) entitled “Methods and Composition for
the Treatment of Diabetic Neuropathy.”The patent extends through December
18, 2021.
|
·
|
A
South African Patent (No. 2004/3364) “Nutritional Supplements and Methods
for Prevention, Reduction and Treatment of Radiation Injury” the patent
extends through May 1, 2022.
|
·
|
A
South African Patent (No. 2003/9802) entitled “Nutritional Supplements and
Methods of Using Same” for a method for treating at least one symptom of
arthritis. The patent extends through August 5,
2022.
|
·
|
A
South African Patent (No. 2004/4614) entitled “Methods for The Treatment
of Peripheral Neural and Vascular Ailments.” The patent extends
through November 5, 2022.
|
·
|
A
South African Patent (No. 2005/0517) entitled “Anti-Microbial Compositions
& Methods for Using Same,” the patent extends through July 23,
2023.
|
·
|
A
South African Patent (No. 2004/3365) “Topical Compositions and Methods for
Treatment of Adverse Effects of Ionizing Radiation,” the patent extends
through November 5, 2022.
|
·
|
An
Israeli Patent (No. 159357) entitled “Nutritional Supplements and Methods
of Using Same,” the patent extends through August 6,
2022.
|
·
|
An
Indian Patent (No. 00004/MUMP/2004) entitled “A Nutritional
Supplement.” The patent extends through August 6,
2022.
|
QR-333 – In April 2002, the
Company initiated a Proof of Concept Study in France for treatment of diabetic
neuropathy, which was concluded in 2003. In April 2003, the Company
announced that an independently monitored analysis of the
Proof of Concept Study concluded that subjects using
this formulation had 67% of their
symptoms improve, suggesting efficacy. In March 2004, the Company
announced that it had completed its first meeting at the FDA prior to submitting
the Company’s IND application for the relief of symptoms of diabetic symmetrical
peripheral neuropathy. The FDA’s pre-IND meeting programs are
designed to provide sponsors with advance guidance and input on drug development
programs. In September 2005, the Company announced that a preliminary
report of its topical compound for the treatment of diabetic neuropathy was
recently featured in the Journal of Diabetes and Its
Complication. Authored by Dr. C. LeFante and Dr. P. Valensi,
the article appeared in the June 1, 2005 issue, and included findings that
showed the compound reduced the severity of numbness, and irritation from
baseline values. In October 2005, the Company announced the results
of pre-clinical toxicology studies that showed no irritation, photo
toxicity, contact hypersensitivity or photo allergy when applied topically to
hairless guinea pigs and another study that showed no difference in the dermal
response of the compound or placebo when applied to Gottingen Minipigs. (Both
animal models are suggested for the evaluation of topical drugs, by
the FDA). In March 2006, the Company announced the filing of an IND
application with the FDA for its topical compound for
the treatment of
Diabetic Peripheral Neuropathy. This filing
allowed the Company to begin human clinical trials following a 30-day review
period. If no further comments were forthcoming from the FDA, studies
with human subjects could commence pending the availability of study
drug. This application included a compilation of all of the
supporting development data and regulatory documentation required to file an IND
application with the FDA. In April 2006, upon FDA approval for its IND, the
Company announced its intent to commence human studies on its
formulation.
The
Company also announced that in anticipation of receiving this IND, it had
previously held its investigators meeting to organize its multi-center Phase IIb
trials. This would allow the Company to begin these trials as soon as study drug
is available.
In May
2006, the Company announced that it had begun screening patients to start
testing their investigational new drug QR-333 and patients suffering from
diabetic peripheral neuropathy would be given doses in an escalating fashion to
provide pharmacokinetics data.
In
September 2006, the Company announced that the results from its human study,
titled "Single Center, Dose Escalating, Safety, Tolerability, And
Pharmacokinetics Study Of QR-333 In Subjects With Diabetic Peripheral
Neuropathy", demonstrated that QR-333 can be administered safely to patients
suffering from diabetic peripheral neuropathy and it would proceed to conducting
Phase IIb clinical trials. The essential CMC (Chemistry Manufacturing
and Controls) stage would provide the Company with the necessary information
needed to produce larger quantities of drug for the Phase IIb trial involving
approximately 180 patients.
The
pharmacokinetics trial was the first study in the U.S. conducted under the FDA
issued IND. The positive data showed that QR-333 is safe, it is not systemically
absorbed and it is well tolerated after multiple doses. These findings are
consistent with prior animal toxicity data and the human Proof of Concept study
performed in France.
In
November 2006, the Company announced that patient enrollment in a Phase IIb
multi center clinical study of QR-333 for the treatment of symptomatic Diabetic
Peripheral Neuropathy (DPN) had commenced. The Phase IIb trial will
evaluate the safety and efficacy of QR-333 applied three times daily compared to
placebo-treated patients over 12 weeks. Efficacy will be determined by Symptom
Assessment Scores, a Visual Analogy Scale (VAS), Quality of Life and Sleep
Questionnaires. Safety will be determined by medical history, physical
examination, vital signs, 12-lead ECG, laboratory tests and nerve conduction
studies. The study will involve approximately 140 randomized male and female
patients with Type 1 & 2 diabetes, as defined by the ADA (American Diabetes
Association) and distal symmetric diabetic polyneuropathy.
The Study
Chairman is Dr. Philip Raskin, Professor of Medicine University of Texas
Southwestern Medical Center at Dallas, Texas. The study protocol was approved by
the FDA as a part of Pharma’s IND submission and has been approved by the
required Investigational Review Boards. The completion of the study is dependent
upon enrollment rates that may affect the overall length of the study and the
communication of its results.
In
September 2007, the Company issued an update on a Phase IIb Clinical Study of
QR-333 on Diabetic Peripheral Neuropathy. The update on the study
noted that over 100 subjects have been enrolled, 52 subjects have completed
treatment and over 225 subjects have been screened for the Phase IIb study
designed to evaluate the safety and efficacy of the topical formulation on
subjects with diabetic peripheral neuropathy. Subject screening and
enrollment will continue to ensure an approximately 140 evaluable patient study
population. Once enrolled, subject treatment time is 12
weeks. To date the in-progress safety profile for this study has been
consistent with the findings from the favorable safety results of the previous
human proof of concept study conducted in France. Subsequently, in
March 2008, the Company indicated that the number of subjects increased in the
study.
In
November 2008, the Company announced that the last subject in the Phase IIb
study would complete treatment at the end November 2008 and the study is in the
final stage of data collection, evaluation and study conclusions. The
Company, after collecting all the patient information from 21 study centers and
conferring with its panel of experts on the data, will draft and report study
conclusions, as they are available.
On April
30, 2009, the Company announced that the Diabetic Peripheral Neuropathy Phase
IIb clinical study demonstrated a significant improvement in two key measures of
distal sensory nerve function in the group treated with QR-333. The compound was
applied topically to the feet of subjects suffering from painful diabetic
neuropathy and over the course of 12 weeks, significantly improved both maximal
conduction velocity and compound sensory amplitude in the sural
nerve. The mean improvement in nerve conduction velocity exceeded the
change considered by thought leaders to be “clinically meaningful” in clinical
studies. The sural nerve carries sensation from the feet and its
pathology is the fundamental cause of foot pain and ultimately foot ulcers and
amputation in some diabetic subjects.
These
findings necessitate a change in the potential outlook for this investigational
new drug. The Diabetic Peripheral Neuropathy market has significant unmet need
for rational, mechanism-based drugs. These clinically significant
findings suggest disease modification in this (12 week) Phase IIb
study. The Company is aware that this is a finding in a subset of the
patient population. Since the observations obtained from the study relate to
positive effect on nerve functioning, the Company may, in the future, be
focusing on a broader therapeutic area.
QR-448(a) – In May 2008, the
Company announced positive results from a study conducted in chickens to
evaluate the anti-viral activity of its compound QR448(a). The compound was
administered to chicks that had been infected with Infectious Bronchitis Virus
(IBV). The data from the study indicated that QR448(a) is efficacious against an
IBV challenge in two week old specific pathogen free (SPF) chicks, confirming
previous results indicating that treatment with QR448(a) before or after viral
exposure has the potential to lessen or prevent disease.
The
Company initiated its investigations into the effectiveness of this compound
based on feedback from poultry industry leaders who expressed an increasing need
for additional products to combat IBV. With the completion of this latest study
and the current dossier of data, the Company plans to solicit the poultry
industry for additional guidance and potential interest and opportunities for
developing this compound jointly toward
commercialization.
In
September 2008, the Company announced successful results from a follow up study
conducted with its veterinary anti-viral compound QR448(a). The Study
was designed to determine the duration of the anti-viral effect of QR448(a)
against IBV in commercial broiler chickens, a consumer meat type
bird. Results demonstrate longer duration of protection from
infectious bronchitis and reduction of clinical signs in
chickens. Additionally, in September 2008, the Company announced that
the anti-viral compound successfully prevents transmission of infectious
bronchitis in chickens. Veterinary poultry products industry experts
and those familiar with prevention and control of IBV recognize that abating
transmission is perhaps one of the most important ways to economically prevent,
control and manage potential losses due to IBV outbreaks.
The
formulation was initially identified as QR441(a) and for its anti-viral activity
against Highly Pathogenic Avian Influenza H5N1.
QR-336 – In April 2004, the
Company announced the results of a preliminary, pre-clinical animal study which
measured the effect of its proprietary patent applied for formulation against
ionizing (nuclear) radiation. This study determined that parenteral
(injection) administration of the study compound was protective against the
effects of a lethal, whole body ionizing radiation dose in a mouse
model. This compound is being investigated to potentially reduce the
effects of radiation exposure on humans.
In April
2006, the Company announced that it signed an agreement with Dr. William H.
McBride, the Vice Chair of Research, Department of Oncology at UCLA to help
develop an appropriate animal model radio protective research program for QR-336
to comply with New Food and Drug Administration animal efficacy rules for
radio-protective pharmacological compounds.
In
October 2006, the Company announced that it had received significant data
identifying 50 microliters as the least toxic and most effective
radiation protection dose in mice when administered ip (intraperitoneal), po (by
mouth) or sc (under the skin) prior to radiation exposure. These experiments
were essential for providing the Company with data to optimize the formulation
for efficacy and route of administration, which is required for filing under the
FDA’s "Animal Efficacy Rule".
QR-337 – In September 2003,
the Company announced its intention to file for permission to study its patent
pending potential treatment for psoriasis and other skin
disorders. Continued testing will therefore have to be conducted
under an IND application following positive preliminary results.
QR-435 – In May 2004, the
Company announced that an intranasal spray application of the anti-viral test
compound demonstrated efficacy by significantly reducing the severity of illness
in ferrets that had been infected with the Influenza A virus. In pre-clinical
studies, the antiviral formulation demonstrates antiviral activity against
Ocular and Genital Herpes, indicating a new research and development path for
the versatile compound. The Company is pleased with the progress and indicated
that continued research is required to confirm the compound's safety and
efficacy profiles.
In May
2006, the Company announced that it would begin a series of studies to evaluate
the ocular antiviral efficacy and toxicity of its naturally-derived topical
compound QR-435. Studies will be completed at The Campbell Ophthalmic
Microbiology Laboratory at the University of Pittsburgh in the same lab where
previous successful in vitro studies of QR-435 were performed.
In
December 2006, the Company announced that a series of studies were conducted on
the advice of Campbell Laboratories, University of Pittsburgh, to assess QR-435
(Pharma’s broad spectrum anti-viral) potential for treating Herpes
Keratitis. While the in-vitro studies were very successful at killing
the herpes virus on direct contact, the HSV-1/NZW rabbit keratitis model study
showed that the compound, in its aqueous form, did not remain in the eye long
enough to penetrate the corneal epithelial cells where the virus resides in an
infection. The HSV-1/NZW rabbit keratitis model is a recognized standard for
evaluating potential therapeutic agents in this class and is only utilized based
on prior positive experimentation, as was the case.
Pharma
may continue to pursue research and development objectives of this compound in
the treatment of respiratory viruses on the strength of prior successful
in-vitro and ferret model in-vivo studies. The Company's naturally derived
formula has shown significant antiviral properties against various strains of
H3N2 and H5N1 Influenza viruses in these studies.
QR-437 – In January 2004, the
Company reported that its compound, which was demonstrating antiviral activity,
had shown virucidal and virustatic activity against the strain 3B of the Human
Immunodeficiency Virus Type 1 (HIV-1) in an in-vitro
study. Additionally, the Company decided that the derivative
compound of the anti-viral formulation previously found to be effective for
treating Sialorrhea would probably postpone further development on the
Sialorrhea indication and concentrate on further qualification and development
of the anti-viral capabilities of the compound in humans.
QR-439 – In December 2003, the
Company announced positive test results of a preliminary independent in vitro
study indicating that a test compound of the Company previously tested on the
Influenza virus showed “significant virucidal activity against a strain of the
Severe Acute Respiratory Syndrome (SARS) virus.”
In
January 2004, the Company announced that it would conduct two further studies
evaluating the compound which had shown activity against Influenza and
SARS. The first study was intended to repeat the previously announced
results, which demonstrated the compound to be 100 percent effective in
preventing non-infected ferrets in close proximity to an infected ferret from
becoming infected with the Influenza A virus. The second study was a
dose ranging study on the test compound. Upon dosage determination and
confirmation results from these forthcoming animal model studies, a human proof
of concept study using a virus challenge with Influenza A virus in a quarantine
unit would be a viable next step.
QR-440 (a) – The Company received an additional
Investigational New Animal Drug (INAD) number from the Center for Veterinary
Medicine of the FDA. In previous studies, QR-440 has been shown to reduce
inflammation and also suggests possible disease-modifying
potential.
QR-441(a) – In November 2005,
the Company was assigned nine INADs for a broad anti-viral agent by the Center
for Veterinary Medicine of the FDA. Eight of the INADs are for investigating the
compound use against avian flu H5N1 virus in chickens, turkeys, ducks, pigs,
horses, dogs, cats and non-food birds. In January 2006, a ninth INAD
was assigned for investigating its compound for treating arthritis in dogs. In
March 2006, the Company announced that it is planning a series of controlled
experiments designed to test its all natural broad spectrum anti-viral compound
in poultry stocks. The Company also announced that Dr. Timothy S.
Cummings, MS, DVM, ACPV Clinical Poultry Professor at the College of Veterinary
Medicine at Mississippi State University and Thomas G. Voss, Ph.D. Assistant
Professor Tulane University School of Medicine will be assisting the Company in
the development of the INAD bird challenge studies.
In July
2006, the Company announced that it has obtained positive results that support
Pharma's continued progress in developing
the natural broad spectrum anti-viral QR441(a) for use in preventing the spread
of avian flu in poultry stocks. The results of the healthy chicken medical feed
study confirmed that food or water dose forms provide an opportunity for
potential commercialization if the compound demonstrates efficacy within these
dose forms. The results clearly showed that the chickens tolerated
and consumed all concentrations of QR441 (a) in the medicated feed. They also
tolerated and consumed the low concentration of drug in the medicated
water.
In
January 2007, the Company announced positive results from a study evaluating its
anti-viral compound QR-441(a) in embryonating egg and VERO E6 cell test models.
The preliminary study demonstrated QR-441(a) as a potential antiviral agent in
reducing Infectious Bronchitis and New Castle Disease, two viral poultry
diseases that have a significant economic impact to the poultry industry on an
annual basis. Previous in vitro studies have demonstrated that QR-441(a) to be a
potent antiviral agent against H5N1 (Avian Flu).
In
February 2007, the Company announced that it had signed an agreement with the
State of Israel Ministry of Agriculture & Rural Development (MOAG) and the
Kimron Veterinary Institute to conduct a clinical trial testing the anti-viral
capacity of the Company’s compound QR-441(a) administered as a medical feed and
water to chickens exposed to HPAI (Highly Pathogenic Avian Influenza)
H5N1.
If
successful this study could potentially provide data on the efficacy of
QR-441(a) in preventing the infection of food grade poultry through the use of
formulated feed and water. Positive data could be used to continue the
development of the compound in the U.S with guidance from the FDA under the
INAD’s issued to the Company in 2005 and might also be useful for development
outside the United States, where the impact of disease has already been
felt. See also QR-448(a).
QR-443 – In August 2006, the
Company announced that it had obtained positive results for its QR-443 compound
for the treatment of Cachexia. Cachexia is an extremely debilitating
and life threatening, wasting syndrome associated with chronic diseases such as
cancer, AIDS, chronic renal failure, COPD and rheumatoid arthritis, where
inflammation has a significant impact and patients’ experience loss of weight,
muscle atrophy, fatigue, weakness and decreased appetite. The results of an
animal study found a 75% efficacy rate in the treatment of mice with this
condition.
In
January 2007, the Company announced that it had completed a preliminary follow
up Cachexia study, evaluating weight loss in mice. The tumor burden Cachexia
model study concluded that QR-443 was as effective in delaying the progression
of Cachexia when given orally as it had been shown to be when administered
intra-peritoneally in a previous study.
The new
data compliments the previous study results demonstrating a correlation between
effectiveness and the frequency of administration of the QR-443
compound.
On June
20, 2007, the Company announced that it had completed a follow-up study to
evaluate the impact of QR-443 on levels of a pro-inflammatory cytokine
Interleukin-6 (IL-6) in a cachexia model. This new data concluded that
responding mice had lower levels of serum IL-6 when administered QR-443 orally
than mice that received placebo. This reduction in IL-6 suggests a method of
action for the delayed onset and reduced severity of cachexia observed in this
study as well as the previously conducted cachexia model study.
QR-449 – In July 2007, the
Company announced that it had initiated a human clinical safety trial to
evaluate the effects of QR-449 on subjects with Metabolic
Syndrome. The primary objectives for the studies are to determine the
safety of QR-449 when administered in a range dosing fashion and determine the
effects of QR-449 on metabolic imbalances.
QR-340 – On February 24, 2009,
the Company announced that it had signed a license with assignment of ownership
agreement for its patented formulation QR-340 developed by its wholly owned
subsidiary, Pharma. The compound has been clinically tested and shown
to improve the appearance of scars in a comparative study. The Agreement is with
Levlad, LLC/Natures Gate, a manufacturer and marketer of personal care products
based on botanicals. The general terms of the agreement allow the
assignee to further refine, develop and commercialize the product with
exclusivity and eventual full ownership of the patent within five years,
beginning January 2009. The agreement is based on required royalty payments
totaling $1.1 million to the Company over the time period. Under the terms of
the agreement, if the minimum payments and terms are not met within the
five-year period, the Company retains full rights and ownership of the property.
However, Levlad can continue to pay per unit royalties beyond five years for a
non-exclusive license.
Recently
Issued Accounting Standards
In
September 2006, the Financial Accounting Standards Board (FASB) issued
Statement of Financial Accounting Standards No. 157, “Fair Value
Measurements” (“SFAS
157”). SFAS 157 defines fair value, establishes a framework for
measuring fair value in generally accepted accounting principles (GAAP) and
expands disclosures about fair value measurements. SFAS 157 is effective
for fiscal years beginning after November 15, 2007 and interim periods
within those fiscal years. The adoption of this standard has not had a
significant impact on the Company’s consolidated financial position, results of
operations or cash flows.
In
December 2007, the FASB issued Statement of Financial Accounting Standard
No. 160, “Noncontrolling
Interests in Consolidated Financial Statements — an amendment of ARB
No. 51” (“FAS
160”). FAS 160 establishes accounting and reporting standards
for the non-controlling interest in a subsidiary and for the retained interest
and gain or loss when a subsidiary is deconsolidated. This statement is
effective for financial statements issued for fiscal years beginning on or after
December 15, 2008 with earlier adoption prohibited. The adoption of this
standard has not had a significant impact on the Company’s consolidated
financial position, results of operations or cash flows.
In
December 2007, the FASB issued SFAS No. 141R, "Business
Combinations," (“SFAS
141R”) which establishes principles and requirements for how an acquirer
recognizes and measures in its financial statements the identifiable assets
acquired, the liabilities assumed and any non-controlling interest in the
acquiree. SFAS 141R also establishes disclosure requirements to enable the
evaluation of the nature and financial effects of the business combination. SFAS
141R applies prospectively to business combinations for which the acquisition
date is on or after the beginning of the first annual reporting period beginning
on or after December 15, 2008, and interim periods within those fiscal years.
The adoption of this standard has not had a significant impact on the Company’s
consolidated financial position, results of operations or cash
flows.
In March
2008, the Financial Accounting Standards Board issued Statement of Financial
Accounting Standard ("SFAS") No. 161
"Disclosures about Derivative
Instruments and Hedging Activities". SFAS 161 is intended to improve
financial reporting about derivative instruments and hedging activities by
requiring enhanced disclosures to enable investors to better understand their
effects on an entity's financial position, financial performance, and cash
flows. It is effective for financial statements issued for fiscal years and
interim periods beginning after November 15, 2008, with early application
encouraged. The adoption of this standard has not had a significant impact
on the Company’s consolidated financial position, results of operations or cash
flows.
In May 2008, the FASB
issued SFAS
No. 162, The Hierarchy of Generally Accepted Accounting Principles. SFAS
162 identifies the sources of accounting principles and the framework for
selecting the principles to be used in the preparation of financial statements
of nongovernmental entities that are presented in conformity with GAAP. SFAS 162
directs the GAAP hierarchy to the entity, not the independent auditors, as the
entity is responsible for selecting accounting principles for financial
statements that are presented in conformity with GAAP. SFAS 162
is effective 60 days following the SEC’s approval of PCAOB Auditing Standard No.
6, Evaluating Consistency of Financial Statements (AS/6). The adoption of FASB
162 is not expected to have a material impact on the Company’s financial
position.
In June
2008, the FASB ratified EITF Issue No. 07-5, Determining
whether an Instrument (or Embedded Feature) is indexed to an Entity’s Own
Stock (“EITF 07-5”). EITF 07-5 is effective for financial
statements issued for fiscal years beginning after December 15, 2008, and
interim periods within those fiscal years. Early application is not permitted.
EITF 07-5 provides a new two-step model to be applied in determining whether a
financial instrument or an embedded feature is indexed to an issuer’s own stock
and thus able to qualify for the SFAS No. 133 paragraph 11(a) scope
exception. The adoption of this standard has not had a significant
impact on the Company’s consolidated financial position, results of operations
or cash flows.
Critical Accounting
Estimates
The
preparation of financial statements in conformity with accounting principles
generally accepted in the United States 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.
The
Company is organized into three different but related business segments, Cold
Remedy, Contract Manufacturing and Ethical Pharmaceutical. When providing for
the appropriate sales returns, allowances, cash discounts and cooperative
incentive promotion costs, each segment applies a uniform and consistent method
for making certain assumptions for estimating these provisions that are
applicable to that specific segment. Traditionally, these provisions are not
material to net income in the Contract Manufacturing segment. The Ethical
Pharmaceutical segment does not have any revenues.
The
primary product in the Cold Remedy segment, Cold-EezeÒ, has been clinically
proven in two double-blind studies 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: a unique product
with limited competitors; competitively priced; promoted; unaffected for
remaining shelf life as there is no expiration date; monitored for inventory
levels at major customers and third-party consumption data, such as
IRI.
At March
31, 2009 and December 31, 2008, the Company included reductions to accounts
receivable for sales returns and allowances of $1,439,000 and $1,427,000,
respectively, and cash discounts of $90,000 and $150,000, respectively.
Additionally, current liabilities at March 31, 2009 and December 31, 2008
include $849,954 and $1,058,962, respectively, for cooperative incentive
promotion costs.
Management
believes there are no material charges to net income in the current period
related to sales from a prior period.
Revenue
Provisions
to reserves to reduce revenues for cold remedy products, with almost all of the
revenues coming from products that do not have an expiration date, include the
use of estimates, which are applied or matched to the current sales for the
period presented. These estimates are based on specific customer tracking and an
overall historical experience to obtain an effective applicable rate, which is
tested on an annual basis and reviewed quarterly to ascertain the most
applicable effective rate. Additionally, the monitoring of current occurrences,
developments by customer, market conditions and any other occurrences that could
affect the expected provisions relative to net sales for the period presented
are also performed.
A one
percent deviation for these consolidated reserve provisions for the three month
periods ended March 31, 2009, and 2008 would affect net sales by approximately
$53,000 and $66,000, respectively. A one percent deviation for cooperative
incentive promotion reserve provisions for the three month periods ended March
31, 2009 and 2008 would affect net sales by approximately $46,000 and $60,000,
respectively.
Income
Taxes
The
Company has recorded a valuation allowance against its net deferred tax
assets. 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 in
the Company’s Ethical Pharmaceutical segment.
Three months ended March 31,
2009 compared with three months ended March 31, 2008
Net sales
for the three month period ended March 31, 2009 were $3,986,547, reflecting a
decrease of $1,318,487 over the net sales of $5,305,034 for the comparable three
month period ended March 31, 2008. The Cold Remedy segment
reported net sales in the 2009 period of $3,332,059 a decrease of $1,380,075, or
29.3%, over the comparable 2008 period of $4,712,134. The Contract
Manufacturing segment reported third party net sales of $654,488 in the 2009
period compared to $592,900 in the comparable 2008 period, an increase of
$61,588 or 10.4%.
The
decrease in Cold Remedy net sales reflects a market-wide decrease in consumer
purchases of cold remedy products as reported by IRI data. The
decrease was also attributed to by historic lows in the incidence of cold by
consumers and general economic weakness in the
marketplace. Sales activity for the first quarter of 2009
include that of the Kids-EezeÒ Chest Relief product which
was launched in August 2008. The Company continues to strongly promote its cold
remedy products through media and in-store along with direct-to-the-consumer
programs.
Net sales
of the Contract Manufacturing segment reported a small increase in
2009. The primary purpose of the Contract Manufacturing segment is to
manufacture, warehouse and distribute Cold-EezeÒ. Contract
manufacturing is performed for non-related third party entities to compensate
for the necessary fixed costs associated with this segment.
Cost of
sales as a percentage of net sales for the three months ended March 31, 2009 was
41.0% compared to 32.7% for the comparable 2008 period, an increase of
8.3%. The Cold Remedy segment’s cost of sales in the 2009 period was
32.6% compared to 28.9% in the 2008 comparable period, an increase of
3.7%. Of this 3.7% increase, 2.2% was attributable to fluctuating
components of the net sales between the periods such as cooperative incentive
promotion and coupon costs, both a deduction from sales, with the effect of
impacting the calculated cost of sales percentage.
The
Contract Manufacturing segment contributed to the negative impact on cost of
sales, influenced by production volume and fixed production
costs.
Sales and
marketing expense for the three month period ended March 31, 2009 were
$2,024,155, a decrease of $208,086 over the comparable 2008 period amount of
$2,232,241. The decrease was primarily due to reduced media
advertising expense in 2009 of approximately $194,000.
General
and administration costs for the three month period ended March 31, 2009 was
$2,289,845 compared to $2,508,206 for the 2008 period, a decrease of $218,361
between the periods. The decrease in 2009 was primarily due to
decreased payroll costs of approximately $407,000, largely the result of reduced
executive salaries in 2009 and the absence of 2009 bonus costs. Legal
expenses increased in the 2009 period by approximately $201,000 due to the
conclusion of certain litigation.
Research
and development costs during the three months ended March 31, 2009 were $248,439
compared to $1,410,302 during the 2008 comparable period, reflecting a decrease
in 2009 of $1,161,863, primarily as a result of decreased Pharma
costs. The decreased spending in the 2009 period was due to the
completion of the Phase IIb study for QR-333 Diabetic Peripheral Neuropathy in
November 2008 with the study conclusion being awaited.
Liquidity and Capital
Resources
The
Company had working capital of $11,958,493 and $14,071,676 at March 31, 2009 and
December 31, 2008, respectively. Changes in working capital overall
have been primarily due to the following items: cash balances
increased by $287,431; account receivable balances decreased by $2,727,147 due
to seasonal factors and effective collection practices; inventory increased by
$244,647; accrued advertising decreased by $213,903 due to the seasonal nature
of the Cold-Remedy segment, accrued royalties, consulting fees and sales
commissions decreased by $157,632 largely due to sales related seasonal
factors. Other current liabilities increased by $239,949 mainly due
to increased payroll related balances. Total cash balances at March
31, 2009 were $12,244,227 compared to $11,956,796 at December 31,
2008.
Management
believes that its strategy to establish 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 the Company’s normal business operations. The
operations of the Company contribute to the current research and development
expenditures of the Ethical Pharmaceutical segment. In addition
to the funding from operations, the Company may in the short and long term raise
capital through the issuance of equity securities or secure other financing
resources to support such research. As research progresses on certain
formulations, expenditures of the Pharma segment will require substantial
financial support and would necessitate the consideration of other approaches
such as licensing or partnership arrangements that meet the Company’s long term
goals and objectives. Ultimately, should internal working capital or
internal funding
be insufficient, there is no guarantee that other financing resources will
become available, thereby deferring future growth and development of certain
formulations.
Management
is not aware of any trends, events or uncertainties that have or are reasonably
likely to have a material negative impact upon the Company’s (a) short-term or
long-term liquidity, or (b) net sales or income from continuing
operations. Any challenge to the Company’s patent rights could have a
material adverse effect on future liquidity of the Company; however, the Company
is not aware of any condition that would make such an event
probable.
Management
believes that cash generated from operations, along with its current cash
balances, will be sufficient to finance working capital and capital expenditure
requirements for at least the next twelve months.
Capital
Expenditures
Capital
expenditures during the remainder of 2009 are not expected to be
material.
Item 3. Quantitative and Qualitative Disclosures about Market
Risk
The
Company's operations are not subject to risks of material foreign currency
fluctuations, nor does it use derivative financial instruments in its investment
practices. The Company places its marketable investments in instruments that
meet high credit quality standards. The Company does not expect material losses
with respect to its investment portfolio or exposure to market risks associated
with interest rates. The impact on the Company's results of one percentage point
change in short-term interest rates would not have a material impact on the
Company’s 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 the Company’s business and financial performance
including the collection of accounts receivables, realization of inventory and
recoverability of assets. In addition, the Company’s 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 4T. Controls and Procedures
Based on
their evaluation as of the end of the period covered by this report, the
Company’s Chief Executive Officer and Chief Financial Officer have
concluded that the Company’s disclosure controls and procedures (as defined in
Rules 13a-15 and 15d-15 under the Securities Exchange Act of 1934, as amended)
are effective. There have been no significant changes in internal controls or in
other factors that could significantly affect these controls subsequent to the
date of their evaluation, including any corrective actions with regard to
significant deficiencies and material weaknesses. In accordance with the
Sarbanes-Oxley Act of 2002, as amended, the Company has included an assessment
of its internal control over financial reporting and attestation from an
independent registered public accounting firm in its Annual Reports on Form 10-K
for the fiscal year ended December 31, 2008. The Company has undergone an
ongoing comprehensive effort in preparation for compliance with Section 404 of
the Sarbanes-Oxley Act of 2002. This has involved the documentation, testing and
review of our internal controls under the direction of senior
management.
Part
II. Other Information
Item 1. Legal Proceedings
TERMINATED LEGAL
PROCEEDINGS
TESAURO AND ELEY, ET AL VS.
THE QUIGLEY CORPORATION
(CCP OF PHILA., AUGUST TERM
2000, NO. 001011)
In
September, 2000, the Company was sued by two individuals (Jason Tesauro and
Elizabeth Eley, both residents of Georgia), allegedly on behalf of a "nationwide
class" of "similarly situated individuals," in the Court of Common Pleas of
Philadelphia County, Pennsylvania. The Complaint further alleges that
the plaintiffs purchased certain Cold-EezeÒ products between August
1996 and November 1999, based upon cable television, radio and internet
advertisements, which allegedly misrepresented the qualities and benefits of the
Company's products. The Complaint, as pleaded originally, requested
an unspecified amount of damages for violations of Pennsylvania's consumer
protection law, breach of implied warranty of merchantability and unjust
enrichment, as well as a judicial determination that the action be maintained as
a class action. In October 2000, the Company filed Preliminary
Objections to the Complaint seeking dismissal of the action. The
court sustained certain objections, thereby narrowing plaintiffs'
claims.
In May
2001, plaintiffs filed a motion to certify the putative class. The
Company opposed the motion. In November 2001, the court held a
hearing on plaintiffs' motion for class certification. In January
2002, the court denied in part and granted in part plaintiffs'
motion. The court denied plaintiffs' motion to certify a class based
on plaintiffs' claims under Pennsylvania consumer protection law, under which
plaintiffs sought treble damages, effectively dismissing this cause of action;
however, the court certified a class based on plaintiffs' secondary breach of
implied warranty and unjust enrichment claims. In August 2002, the
court issued an order adopting a form of Notice of Class Action to be published
nationally. Significantly, the form of Notice approved by the court
included a provision which limits the potential class members who may
potentially recover damages in this action to those persons who present a proof
of purchase of Cold-EezeÒ during the period August
1996 through November 1999.
Afterward,
a series of pre-trial motions were filed raising issues concerning trial
evidence and the court's jurisdiction over the subject matter of the
action. In March, 2005, the court held oral argument on these
motions. Significantly, on November 8, 2006, the Court entered an
Order dismissing the case in its entirety on the basis that the action was
preempted by federal law. The plaintiffs appealed the Court's decision in
December 2006 to the Superior Court of the Commonwealth of
Pennsylvania. On February 19, 2008, the Superior Court upheld
defendant's appeal and remanded the case to the Philadelphia County Court of
Common Pleas for trial.
This case
was tried before a jury on February 2 through February 6, 2009, with the jury
returning a verdict in favor of the Company on all counts. No
post-trial motions were filed and the plaintiffs did not perfect an
appeal. A final judgment has been taken on the jury verdict in favor
of the Company.
The
Company Will Need To Obtain Additional Capital To Support Long-Term Product
Development And Commercialization Programs.
The
Company’s ability to achieve and sustain operating profitability depends in
large part on the ability to commence, execute and complete clinical programs
for, and obtain additional regulatory approvals for, prescription medications
developed by Pharma, particularly in the U.S. and Europe. There is no
assurance that the Company will ever obtain such approvals or achieve
significant levels of sales. The current sales levels of Cold-Eeze®
products may not generate all the funds the Company anticipates will be needed
to support current plans for product development.
The
Company may need to obtain additional financing to support its long-term product
development and commercialization programs. Additional funds may be
sought through public and private stock offerings, arrangements with corporate
partners, borrowings under lines of credit or other sources. Access
to, and availability of, funding for such activities may prove difficult or
unattainable due to weak current and future economic conditions, reduction in
the availability of credit, financial market volatility, recession,
etc.
The
amount of capital that may be needed to complete product development of Pharma’s
products will depend on many factors, including;
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the
cost involved in applying for and obtaining FDA and international
regulatory approvals;
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whether
the Company elects to establish partnering arrangements for development,
sales, manufacturing and marketing of such
products;
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the
level of future sales of Cold-Eeze® products, and expense levels for
international sales and marketing
efforts;
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whether
the Company can establish and maintain strategic arrangements for
development, sales, manufacturing and marketing of its products;
and
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whether
any or all of the outstanding options are exercised and the timing and
amount of these exercises.
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Many of
the foregoing factors are not within the Company’s control. If
additional funds are required and such funds are not available on reasonable
terms, the Company may have to reduce its capital expenditures, scale back its
development of new products, reduce its workforce and out-license to others,
products or technologies that the Company otherwise would seek to commercialize
itself. Any additional equity financing will be dilutive to
stockholders, and any debt financing, if available, may include restrictive
covenants.
Instability
And Volatility In The Financial Markets Could Have A Negative Impact On The
Company’s Business, Financial Condition, Results Of Operations And Cash
Flows.
During
recent months, there has been substantial volatility and a decline
in financial markets due at least in part to the deteriorating global
economic environment. In addition, there has been substantial uncertainty in the
capital markets and access to financing is uncertain. Moreover, customer
spending habits may be adversely affected by the current economic crisis.
These conditions could have an adverse effect on the Company’s industry and
business, including the Company’s financial condition, results of operations and
cash flows.
To the
extent that the Company does not generate sufficient cash from operations, it
may need to incur indebtedness to finance plans for growth. Recent turmoil in
the credit markets and the potential impact on the liquidity of major financial
institutions may have an adverse effect on the Company’s ability to fund its
business strategy through borrowings, under either existing or newly created
instruments in the public or private markets on terms that the Company believes
to be reasonable, if at all.
Actions taken by stockholders may divert the time and
attention of the Company's board of directors and management from its business
operations.
Campaigns by investors to effect changes at publicly
traded companies have increased in recent years. On April 6, 2009, Ted Karkus
announced his plans to launch a proxy contest seeking to replace the board of
directors of the Company. This proxy contest could result in substantial expense to the
Company and consume significant attention of its management and board of
directors. Moreover, if the Company is unsuccessful in defeating this proxy
contest, the Company may lose the services of key personnel. The time
and expense of the proxy contest, as well as the potential loss of experienced
management, may have a material adverse effect on the Company's business and
operations.
(1)
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Exhibit
31.1
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Certification
by the Chief Executive Officer pursuant to Section 302 of the
Sarbanes-Oxley Act of 2002
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(2)
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Exhibit
31.2
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Certification
by the Chief Financial Officer pursuant to Section 302 of the
Sarbanes-Oxley Act of 2002
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(3)
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Exhibit
32.1
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Certification
by the Chief Executive Officer pursuant to Section 906 of the
Sarbanes-Oxley Act of 2002
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(4)
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Exhibit
32.2
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Certification
by the Chief Financial Officer pursuant to Section 906 of the
Sarbanes-Oxley Act of 2002
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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.
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THE
QUIGLEY CORPORATION
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By:
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Name:
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Gerard
M. Gleeson
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Title:
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Vice
President, Chief Financial Officer
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Date: May
6, 2009