ProPhase Labs, Inc. - Quarter Report: 2009 June (Form 10-Q)
UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
WASHINGTON,
DC 20549
FORM
10-Q
(Mark
One)
x
|
QUARTERLY
REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF
1934
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For
the quarterly period ended June 30,
2009
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OR
o
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TRANSITION
REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES
EXCHANGE ACT OF 1934
|
For
the transition period from ______________ to
______________
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Commission
file number 0-21617
THE QUIGLEY CORPORATION
(Exact
Name of Registrant as Specified in Its Charter)
Nevada
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23-2577138
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(State
or other jurisdiction of
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(I.R.S.
Employer Identification No.)
|
|
incorporation
or organization)
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||
(MAILING
ADDRESS: PO Box 1349, Doylestown, PA 18901.)
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Kells Building, 621 Shady Retreat
Road, Doylestown,
Pennsylvania
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18901
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(Address
of principal executive offices)
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(Zip
Code)
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(215) 345-0919
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||
(Registrant’s
telephone number, including area code)
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Indicate
by check mark whether the registrant: (1) has filed all reports required to be
filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the
preceding 12 months (or for such shorter period that the registrant was required
to file such reports) and (2) has been subject to such filing requirements for
the past 90 days. Yes x No o
Indicate
by check mark whether the registrant is a large accelerated filer, an
accelerated filer, a non-accelerated filer or a smaller reporting company (See
definition of “large accelerated filer”, "accelerated filer”, “non-accelerated
filer" and “smaller reporting company” in Rule 12b-2 of the Exchange
Act. (Check one):
Large
accelerated filer o
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Accelerated
filer o
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Non-accelerated
filer o
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Smaller
reporting company x
|
Indicate
by check mark whether the registrant is a shell company (as defined in Rule
12b-2 of the Exchange Act). Yes o No x
Indicate
the number of shares outstanding of each of the issuer’s classes of common
stock, as of the latest practicable date.
Class
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Outstanding at August 14,
2009
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Common
Stock, $0.0005 par value
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12,991,883
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THE
QUIGLEY CORPORATION AND SUBSIDIARIES
TABLE
OF CONTENTS
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PAGE
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PART
I.
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FINANCIAL
INFORMATION
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|||
Item
1.
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Financial
Statements
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|||
Condensed
Consolidated Balance Sheets as of June 30, 2009 (unaudited) and December
31, 2008
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3
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|||
Condensed
Consolidated Statements of Operations for the Three Months and Six Months
Ended June 30, 2009 and 2008 (unaudited)
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4
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|||
Condensed
Consolidated Statement of Stockholders’ Equity and Comprehensive Income or
Loss for the Six Months Ended June 30, 2009 (unaudited)
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5
|
|||
Condensed
Consolidated Statements of Cash Flows for the Six Months Ended
June 30, 2009 and 2008 (unaudited)
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6
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|||
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||||
Notes
to Condensed Consolidated Financial Statements
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7
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|||
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||||
Item
2.
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Management’s
Discussion and Analysis of Financial Condition and Results of
Operations
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20
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||
Item
3.
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Quantitative
and Qualitative Disclosures About Market Risk
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32
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||
Item
4.
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Controls
and Procedures
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32
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PART
II.
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OTHER
INFORMATION
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|||
Item
1.
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Legal
Proceedings
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34
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Item
1A.
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Risk
Factors
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34
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Item
2.
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Unregistered
Sales of Equity Securities and Use of Proceeds
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36
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Item
3.
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Defaults
Upon Senior Securities
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36
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||
Item
4.
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Submission
of Matters to a Vote of Securities Holders
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36
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Item
5.
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Other
Information
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37
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||
Item
6.
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Exhibits
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38
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Signatures
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39
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Certifications
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40
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2
PART
I. FINANCIAL INFORMATION
Item
1. Financial Statements
THE
QUIGLEY CORPORATION AND SUBSIDIARIES
CONDENSED
CONSOLIDATED BALANCE SHEETS
June
30, 2009
|
December
31, 2008
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|||||||
ASSETS
|
(unaudited)
|
|||||||
Cash
and cash equivalents (Note 2)
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$ | 9,216,569 | $ | 11,956,796 | ||||
Accounts
receivable, net of doubtful accounts of $141,257 and $131,162,
respectively (Note 2 )
|
152,811 | 4,523,519 | ||||||
Inventory,
net (Note 2)
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3,099,519 | 3,001,001 | ||||||
Prepaid
expenses and other current assets
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973,974 | 1,185,113 | ||||||
Assets
held for sale (Note 2)
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198,558 | - | ||||||
Total
current assets
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13,641,431 | 20,666,429 | ||||||
Property, plant and
equipment, net of accumulated depreciation of $3,920,181
and $4,869,645, respectively (Note 2)
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2,818,165 | 3,666,748 | ||||||
Other
assets
|
35,454 | 35,454 | ||||||
$ | 16,495,050 | $ | 24,368,631 |
LIABILITIES AND STOCKHOLDERS’
EQUITY
|
||||||||
LIABILITIES:
|
||||||||
Accounts
payable
|
$ | 170,543 | $ | 693,839 | ||||
Accrued
royalties and sales commissions (Note 6)
|
3,598,987 | 3,791,519 | ||||||
Accrued
advertising
|
664,693 | 1,306,341 | ||||||
Other
current liabilities (Note 5)
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1,094,147 | 803,054 | ||||||
Total
current liabilities
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5,528,370 | 6,594,753 | ||||||
COMMITMENTS
AND CONTINGENCIES (Note 6)
|
||||||||
STOCKHOLDERS’
EQUITY:
|
||||||||
Common
stock, $.0005 par value; authorized 50,000,000;
Issued:
17,575,164 and 17,554,436 shares (Note 7)
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8,787 | 8,777 | ||||||
Additional
paid-in-capital
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37,616,184 | 37,599,405 | ||||||
Retained
earnings (accumulated deficit)
|
(1,470,132 | ) | 5,353,855 | |||||
Treasury
stock, at cost, 4,646,053 and 4,646,053 shares,
respectively
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(25,188,159 | ) | (25,188,159 | ) | ||||
Total
stockholders’ equity
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10,966,680 | 17,773,878 | ||||||
$ | 16,495,050 | $ | 24,368,631 |
See
accompanying notes to condensed consolidated financial statements
3
THE
QUIGLEY CORPORATION AND SUBSIDIARIES
CONDENSED
CONSOLIDATED STATEMENTS OF OPERATIONS
(unaudited)
Three
Months Ended
|
Six
Months Ended
|
|||||||||||||||
June
30, 2009
|
June
30, 2008
|
June
30, 2009
|
June
30, 2008
|
|||||||||||||
Net
sales (Note 2)
|
$ | 1,747,835 | $ | 2,068,285 | $ | 5,734,381 | $ | 7,373,319 | ||||||||
Cost
of sales (Note 2)
|
1,456,763 | 1,170,379 | 3,091,098 | 2,905,895 | ||||||||||||
Gross
profit
|
291,072 | 897,906 | 2,643,283 | 4,467,424 | ||||||||||||
Operating
costs and expenses:
|
||||||||||||||||
Sales
and marketing
|
792,085 | 566,273 | 2,816,240 | 2,798,514 | ||||||||||||
Administration
|
3,742,508 | 2,029,885 | 6,032,353 | 4,538,091 | ||||||||||||
Research
and development
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385,832 | 1,264,824 | 634,271 | 2,675,126 | ||||||||||||
4,920,425 | 3,860,982 | 9,482,864 | 10,011,731 | |||||||||||||
Loss
from operations
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(4,629,353 | ) | (2,963,076 | ) | (6,839,581 | ) | (5,544,307 | ) | ||||||||
Interest
and other income
|
4,433 | 84,380 | 15,594 | 220,645 | ||||||||||||
Loss
from continuing operations before income taxes
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(4,624,920 | ) | (2,878,696 | ) | (6,823,987 | ) | (5,323,662 | ) | ||||||||
Income
taxes (benefits) (Note 8)
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- | - | - | - | ||||||||||||
Loss
from continuing operations
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(4,624,920 | ) | (2,878,696 | ) | (6,823,987 | ) | (5,323,662 | ) | ||||||||
Discontinued
operations (Note 3):
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||||||||||||||||
Gain
on disposal of health and wellness operations
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- | - | - | 736,252 | ||||||||||||
Income
from discontinued operations
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- | - | - | 139,264 | ||||||||||||
Net
loss
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$ | (4,624,920 | ) | $ | (2,878,696 | ) | $ | (6,823,987 | ) | $ | (4,448,146 | ) | ||||
Basic
and diluted earnings per share
|
||||||||||||||||
Loss
from continuing operations
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$ | (0.36 | ) | $ | (0.22 | ) | $ | (0.53 | ) | $ | (0.42 | ) | ||||
Income
from discontinued operations
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- | - | - | 0.07 | ||||||||||||
Net
loss
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$ | (0.36 | ) | $ | (0.22 | ) | $ | (0.53 | ) | $ | (0.35 | ) | ||||
Weighted
average common shares outstanding
|
||||||||||||||||
Basic
and diluted
|
12,914,395 | 12,861,800 | 12,911,389 | 12,860,616 |
See
accompanying notes to condensed consolidated financial statements
4
THE
QUIGLEY CORPORATION AND SUBSIDIARIES
CONDENSED
CONSOLIDATED STATEMENT OF
STOCKHOLDERS’
EQUITY AND COMPREHENSIVE INCOME
(unaudited)
Retained
|
||||||||||||||||||||||||
Additional
|
Earnings
|
|||||||||||||||||||||||
Common
Stock
|
Par
|
Paid-In
|
(Accumulated
|
Treasury
|
||||||||||||||||||||
Shares
|
Value
|
Capital
|
Deficit)
|
Stock
|
Total
|
|||||||||||||||||||
Balance at December 31,
2008
|
12,908,383 | $ | 8,777 | $ | 37,599,405 | $ | 5,353,855 | $ | (25,188,159 | ) | $ | 17,773,878 | ||||||||||||
Net loss
|
(6,823,987 | ) | (6,823,987 | ) | ||||||||||||||||||||
Proceeds from exercise of stock
options
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20,728 | 10 | 16,779 | 16,789 | ||||||||||||||||||||
Tax benefits from exercise of
stock options
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33,391 | 33,391 | ||||||||||||||||||||||
Tax benefit
allowance
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(33,391 | ) | (33,391 | ) | ||||||||||||||||||||
Balance at June 30,
2009
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12,929,111 | $ | 8,787 | $ | 37,616,184 | $ | (1,470,132 | ) | $ | (25,188,159 | ) | $ | 10,966,680 |
See
accompanying notes to
condensed consolidated financial statements
5
THE
QUIGLEY CORPORATION AND SUBSIDIARIES
CONDENSED
CONSOLIDATED STATEMENTS OF CASH FLOWS
(unaudited)
Six
Months Ended
|
||||||||
June
30, 2009
|
June
30, 2008
|
|||||||
Cash
flows from operating activities:
|
||||||||
Net
loss
|
$ | (6,823,987 | ) | $ | (4,448,146 | ) | ||
Adjustments
to reconcile net loss to net cash provided by (used in) operating
activities:
|
||||||||
Depreciation
and amortization
|
311,948 | 372,642 | ||||||
(Gain)
loss on disposal of assets
|
(51,810 | ) | 27,039 | |||||
Sales
allowance and provision for bad debts
|
(152,827 | ) | (391,451 | ) | ||||
Inventory
valuation provision
|
(153,772 | ) | (199,725 | ) | ||||
Changes
in operating assets and liabilities:
|
||||||||
Accounts
receivable
|
4,523,535 | 5,451,466 | ||||||
Inventory
|
55,254 | 390,316 | ||||||
Accounts
payable
|
(523,296 | ) | (32,656 | ) | ||||
Accrued
royalties and sales commission
|
(192,532 | ) | (348,169 | ) | ||||
Accrued
advertising
|
(641,648 | ) | (421,190 | ) | ||||
Other
operating assets and liabilities, net
|
502,232 | (2,042,458 | ) | |||||
Net
cash used in operating activities
|
(3,146,903 | ) | (1,642,332 | ) | ||||
Cash
flows from investing activities:
|
||||||||
Capital
expenditures
|
(85,031 | ) | (95,961 | ) | ||||
Proceeds
from the sale of fixed assets
|
74,624 | 16,220 | ||||||
Proceeds
due from the sale of fixed assets
|
400,294 | - | ||||||
Net
cash flows provided by (used in) investing activities
|
389,887 | (79,741 | ) | |||||
Cash
flows from financing activities:
|
||||||||
Proceeds
from exercises of options
|
16,789 | 12,044 | ||||||
Net
cash provided by financing activities
|
16,789 | 12,044 | ||||||
Net
decrease in cash and cash equivalents
|
(2,740,227 | ) | (1,710,029 | ) | ||||
Cash
and cash equivalents at beginning of period
|
11,956,796 | 16,085,282 | ||||||
Cash
and cash equivalents at end of period
|
$ | 9,216,569 | $ | 14,375,253 | ||||
Supplemental
disclosures of cash flow information:
|
||||||||
Interest paid
|
$ | - | $ | - | ||||
Income
taxes paid
|
$ | - | $ | - |
See
accompanying notes to condensed consolidated financial statements
6
The
Quigley Corporation and Subsidiaries
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 (i) a manufacturer, marketer and distributor of a diversified range
of homeopathic and health products that are offered to the general public and
(ii) engaged 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. The Company is
organized into three business segments: (i) cold remedy, (ii) contract
manufacturing and (iii) 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.
In
January 2001, the Company formed an ethical pharmaceutical segment, now known as
Quigley Pharma, Inc. (“Pharma”), a wholly owned subsidiary of the
Company. The result of Pharma’s research and development activity may
enable the Company to diversify its operations into the prescription drug
market.
On
February 29, 2008, the Company sold its wholly owned subsidiary, Darius
International, Inc. (“Darius”), the former health and wellness segment of the
Company (see Note 3), to InnerLight Holdings, Inc. (“InnerLight”). On
February 29, 2008, Kevin P. Brogan, the then president of Darius was a
significant shareholder of InnerLight. In addition, Mr. Gary Quigley, an
employee and stockholder of The Quigley Corporation and also the brother of Mr.
Guy Quigley, the Company’s then Chairman, President and Chief Executive Officer
(as well as a shareholder of The Quigley Corporation), became a significant
shareholder of Innerlight either before or shortly after the sale of
Darius. Mr. Gary Quigley was also a principal of Scandasystems, Ltd.,
which entered into an agreement to receive royalties from
Innerlight.
The
results and balances associated with Darius are presented as discontinued
operations in the condensed consolidated statements of operations.
Note
2 – Summary of Significant Accounting Policies
Basis
of Presentation
The
unaudited condensed consolidated financial statements have been prepared in
accordance with generally accepted accounting principles for interim financial
statements and within the rules of the Securities and Exchange Commission
applicable to interim financial statements and therefore do not include all
disclosures that might normally be required for financial statements prepared in
accordance with generally accepted accounting principles. The
accompanying unaudited condensed consolidated financial statements have been
prepared by management without audit and should be read in conjunction with the
Company’s consolidated financial statements, including the notes thereto,
appearing 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 and six months ended June
30, 2009 are not necessarily indicative of operating results that may be
achieved over the course of the full year.
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.
7
The
Quigley Corporation and Subsidiaries
Notes to
Condensed Consolidated Financial Statements
(unaudited)
Note
2 – Summary of Significant Accounting Policies - continued
Use
of Estimates
The
preparation of financial statements and the accompanying notes thereto, in
conformity with generally accepted accounting principles, requires management to
make estimates and assumptions that affect reported amounts of assets and
liabilities and disclosure of contingent assets and liabilities at the date of
the financial statements and reported amounts of revenues and expenses during
the respective reporting periods. Examples include the provision for
bad debt, returns and allowances, inventory obsolescence, useful lives of
property and equipment and intangible assets, impairment of property and
equipment and intangible assets, deferred income taxes and assumptions related
to accrued advertising. These estimates and assumptions are based on
historical experience, current trends and other factors that management believes
to be relevant at the time the financial statements are
prepared. Management reviews the accounting policies, assumptions,
estimates and judgments on a quarterly basis. Actual results could
differ from those estimates.
The
Company is organized into three different but related business segments, (i)
cold remedy, (ii) contract manufacturing and (iii) ethical pharmaceutical. When
determining the appropriate sales returns, allowances, cash discounts and
cooperative incentive promotion costs (“Sales Allowances”), 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.
Sales
Allowances within the cold remedy segment 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 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, if appropriate, inventory valuation reserves are
established. The consolidated financial statements include a specific
reserve for excess or obsolete inventory of $1,047,031 and $1,200,803 as of June 30,
2009 and December 31, 2008, respectively. Inventories included raw
material, work in progress and packaging, aggregating approximately $775,000 and
$975,000 at June 30, 2009 and December 31, 2008, respectively, with the
remainder comprising finished goods.
Assets
Held for Sale
During
June 2009, the Company concluded the closing of the Company’s Elizabethtown
manufacturing facility. This resulted in the sale of this
facility’s machinery and equipment, the proceeds of which are reflected as a
non-trade receivable of $400,294 and included in prepaid expenses and other
current assets at June 30, 2009. In addition, the Company’s reported
assets include Assets Held For
Sale in the amount of $198,558 which relate to the Land
and Buildings of the Elizabethtown location remaining unsold at June 30,
2009. These assets have been recorded at their estimated fair value,
less estimated costs to sell
8
The
Quigley Corporation and Subsidiaries
Notes to
Condensed Consolidated Financial Statements
(unaudited)
Note
2 – Summary of Significant Accounting Policies - continued
As
defined in SFAS No. 157, fair value is based on the prices that would be
received to sell an asset or paid to transfer a liability in an orderly
transaction between market participants at the measurement date. In order to
increase consistency and comparability in fair value measurements, SFAS
No. 157 establishes a three-tier fair value hierarchy that prioritizes the
inputs used to measure fair value. These tiers include: Level 1, defined as
observable inputs such as quoted prices in active markets; Level 2, defined as
inputs other than quoted prices in active markets that are either directly or
indirectly observable; and Level 3, defined as unobservable inputs for which
little or no market data exists, therefore requiring an entity to develop its
own assumptions.
The fair
value of the reported Assets
Held For Sale was arrived at through bids generated from interested third
party purchasers thereby relating to Level 3 fair value hierarchy.
Property,
Plant and Equipment
Property,
plant and equipment is recorded at cost. The Company uses a
combination of straight-line and accelerated methods in computing depreciation
for financial reporting purposes. Depreciation expense is computed in
accordance with the following ranges of estimated asset lives: building and
improvements - twenty to thirty-nine years; machinery and equipment - five to
seven years; computer software - three 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 net sales in fiscal 2009. During the six
month periods ended June 30, 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 79% and 85% of net sales in the six month periods
ended June 30, 2009 and 2008, respectively. Net sales of the contract
manufacturing segment were approximately 21% and 15% of the Company’s net sales
for the six month periods ended June 30, 2009 and 2008.
The
primary revenue producing product of the Company’s cold remedy segment is the
Cold-EEZEÒ
zinc gluconate glycine lozenge product which is available in various flavors for
purchase by the consumer at retail stores. The Company also produces
zinc private label lozenge products for sale to retail customers. Net
sales from zinc lozenge products accounted for 98.9% and 89.9% of the cold
remedy segment net sales for the years ended December 31, 2008 and 2007,
respectively. These zinc lozenge products are manufactured by
QMI. The constituent raw materials and packaging used in the
manufacture and presentation of these items are procured from various sources
with additional suppliers having been identified in the event that alternatives
are required. While the
absence of a current raw materials or packaging source may cause short term
interruption, identified alternative sources would fill the Company’s needs in a
short time and any transition period would be mitigated by adequate levels of
finished product available for sale. Other products within the cold
remedy segment such as Cold-EEZEÒ Sugarfree
tablets, Kids-EEZEÒ
Chest Relief and Immune Support Complex 10 are manufactured for the Company by
third party contract manufacturers and while currently purchased from single
sources do not constitute a material revenue risk to the Company if product
availability was jeopardized.
9
The
Quigley Corporation and Subsidiaries
Notes to
Condensed Consolidated Financial Statements
(unaudited)
Note
2 – Summary of Significant Accounting Policies - continued
Long-lived
Assets
The Company reviews its carrying value of its
long-lived assets with
definite lives whenever events or changes in circumstances indicate that the
carrying amount of the assets may not be recoverable. When indicators of impairment exist,
the Company determines whether the estimated
undiscounted sum of the future cash flows of such assets is less than their
carrying amounts. If less, an impairment loss is recognized in the
amount, if any, by which the carrying amount of such assets exceeds their
respective fair values. The determination of fair value is based on
quoted market prices in active markets, if available, or independent appraisals;
sales price negotiations; or projected future cash flows discounted at a rate
determined by management to be commensurate with the Company’s business risk. The
estimation of fair value utilizing discounted forecasted cash flows includes
significant judgments regarding assumptions of revenue, operating and marketing
costs; selling and administrative expenses; interest rates; property and
equipment additions and retirements; industry competition; and general economic
and business conditions, among other factors.
At
December 31, 2008, the Company recorded an impairment charge of $200,000,
relative to inventory and a charge of $100,000 relative to land and building
assets of the Company’s Elizabethtown manufacturing facility. Both
amounts were a component of cost of sales and the charges were
necessary, due to adverse profit margins related to the hard candy
business. As of June 30, 2009, at which time the Elizabethtown
manufacturing facility was closed, the related impairment charge of $100,000 is
reported as a reduction to the book value of the land and building asset of that
location’s remaining asset. The land and building are reported as an
asset held for sale at June 30, 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. Sales are 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 sales. The Company
analyzes historical returns, current trends, and changes in customer and
consumer demand when evaluating the adequacy of the Sales
Allowances.
Currently,
the Company does not impose a period of time within which product may be
returned. All requests for product returns must be submitted to the
Company for pre-approval. The main components of the Company’s
returns policy are: (i) the Company will accept returns that are due to damaged
product that is un-saleable and such return request activity fall within an
acceptable range, (ii) for products of the Company that have reached or exceeded
designated expiration dates, (iii) in the event that the Company discontinues a
product, the customer will have the right to return only such item that it
purchased directly from the Company. The Company will not accept
return requests pertaining to customer inventory “Overstocking” or
“Resets”. The Company will only accept return requests for
product in its intended package configuration. The Company reserves
the right to terminate shipment of product to customers who have made
unauthorized deductions contrary to the Company’s Return Policy or pursue other
methods of reimbursement. The Company compensates the customer for authorized
returns by means of a credit applied to amounts owed or to be owed and in the
case of discontinued product only, also by way of an exchange. The
Company does not have any significant product exchange history.
10
The
Quigley Corporation and Subsidiaries
Notes to
Condensed Consolidated Financial Statements
(unaudited)
Note
2 – Summary of Significant Accounting Policies - continued
The
financial statements include Sales Allowances of $1,793,102 for future sales
returns and $283,639 for other allowances as of June 30, 2009 and $1,427,045 for
future sales returns and $280,973 for other allowances as of December 31,
2008. Additionally, the allowance for doubtful accounts of $141,257
and $131,162 at June 30, 2009 and December 31, 2008, respectively include an
estimate of the uncollectability of the Company’s accounts
receivable.
Operating
expenses
The
Company has agreements with a major national sales brokerage firm under which
this brokerage firm sells the Company’s products to our retail
customers. The compensation and related costs for the brokerage firm
are classified 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 and
these charges are classified as sales. In all cases shipping and
handling costs related to these sales are recorded as cost of
sales.
Stock
Compensation
The
Company recognizes all share-based payments to employees, including grants of
employee stock options, as compensation expense in the financial statements
based on their fair values. Fair values of stock
options are determined through the use of the Black-Scholes option pricing
model. The compensation cost is recognized as an expense over the
requisite service period of the award, which usually coincides with the vesting
period.
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 or warrants to purchase the Company’s
common stock has been granted since January 1, 2006. As a
consequence, there is no stock compensation expense for the three months or six
month periods ended June 30, 2009 or 2008, respectively.
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 (i) media
advertising, presented as a component of sales and marketing expense; (ii)
cooperative incentive promotions and coupon program expenses, which are
accounted for as a component of net sales; and (iii) free product, which is
accounted for as a component of cost of sales. Advertising and
incentive promotion costs incurred for the three month periods ended June 30,
2009 and 2008 were $212,036 and $461,937, respectively. Advertising
and incentive promotion costs incurred for the six month periods
ended June 30, 2009 and 2008 were $2,448,918 and $2,934,698,
respectively. Included in prepaid expenses and other current assets
was $39,998 and $241,971 at June 30, 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. Research
and development costs for the three month periods ended June 30, 2009 and 2008
were $385,832 and $1,264,824, respectively. Research and development
costs for the six month cost for the periods ended June 30, 2009 and 2008 were
$634,271 and $2,675,126, respectively. Research and development costs
are principally related to Pharma’s study activities and costs associated with
the development of potential ethical pharmaceuticals and other related
products.
11
The
Quigley Corporation and Subsidiaries
Notes to
Condensed Consolidated Financial Statements
(unaudited)
Note
2 – Summary of Significant Accounting Policies - continued
The three
months and six months ended June 30, 2009 reported reduced research and
development cost as compared to the three month and six months ended June 30,
2008 as a result of the completion of the Phase IIb study for QR-333 Diabetic
Peripheral Neuropathy in November 2008 and a subsequent slowdown in related
spending pending the availability of the final results of the study which were
announced by the Company on July 22, 2009.
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 8).
The
Company utilizes a two-step approach to recognizing and measuring uncertain tax
positions. The first step is to evaluate the tax position for
recognition by determining if the weight of available evidence indicates that it
is more likely than not that the position will be sustained on audit, including
resolution of related appeals or litigation processes, if any. The second step
is to measure the tax benefit as the largest amount which is more than fifty
percent likely of being realized upon ultimate settlement.
As a
result of 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.
The tax
years 2005-2008 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 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” (“SFAS 160”). SFAS 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.
12
The
Quigley Corporation and Subsidiaries
Notes to
Condensed Consolidated Financial Statements
(unaudited)
Note
2 – Summary of Significant Accounting Policies - continued
In May
2008, the FASB issued SFAS No. 162, The Hierarchy of Generally Accepted
Accounting Principles (“GAAP”). 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 April
2009, the FASB issued FSP No. FAS 157-4, “Determining Fair Value When the
Volume and Level of Activity for the Asset or Liability Have Significantly
Decreased and Identifying Transactions That Are Not Orderly” (“FSP
FAS 157-4”), which clarifies the application of SFAS 157 when there is
no active market or where the price inputs being used represent distressed
sales. Additional guidance is provided regarding estimating the fair value of an
asset or liability (financial and nonfinancial) when the volume and level of
activity for the asset or liability have significantly decreased and identifying
transactions that are not orderly. FSP FAS 157-4 is effective for interim and
annual periods ending after June 15, 2009. The adoption of FASB
157-4 is not expected to have a material impact on the Company’s financial
position.
In June
2009, the FASB issued SFAS No. 165, “Subsequent Events” (“SFAS
165”). Prior to SFAS 165, the authoritative guidance for subsequent events was
previously addressed only in U.S. auditing standards. SFAS 165 establishes
general standards of accounting for and disclosure of events that occur after
the balance sheet date but before financial statements are issued or are
available to be issued and requires the Company to disclose the date through
which it has evaluated subsequent events and whether that was the date the
financial statements were issued or available to be issued. SFAS 165 does not
apply to subsequent events or transactions that are within the scope of other
applicable GAAP that provide different guidance on the accounting treatment for
subsequent events or transactions. The Company has adopted SFAS
165 for the period ended June 30, 2009. As a consequence of the
adoption of SFAS 165, the Company has evaluated subsequent events relating to
the three months and six months ended June 30, 2009 through to and including
August 14, 2009, the date of issue of the Company’s Condensed Consolidated
Financial Statements.
In June 2009, the FASB issued SFAS No.
168, “The FASB Accounting
Standards CodificationTM
and the
Hierarchy of Generally Accepted Accounting Principles – a replacement of
FASB Statement No. 162”
(“SFAS No. 168”). SFAS No. 168 sets forth the authoritative
U.S. generally accepted accounting
principles to be applied by nongovernmental entities on a going-forward
basis. However, SFAS No. 168 is anticipated to only result in a
change of accounting standards for nonpublic entities that have not previously applied the
revenue recognition provisions of AICPA Technical Inquiry Service Section
5100. The Company does not anticipate that SFAS No. 168 will have a
material effect on its consolidated results of operations or financial
condition.
Note
3 – Discontinued Operations
On
February 29, 2008, the Company sold Darius to InnerLight Holdings,
Inc. Darius was formed by the Company as a wholly own subsidiary 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. 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. For
the three months ended March 31, 2008, the Company recorded a gain on the
disposal of Darius of $736,252 and classified the results of operations of
Darius as discontinued operations.
13
The
Quigley Corporation and Subsidiaries
Notes to
Condensed Consolidated Financial Statements
(unaudited)
Note
3 – Discontinued Operations - continued
Darius’ net sales for the period January 1,
2008 until date of disposal on February 29, 2008, were
$2,188,815. Net income for the period January 1, 2008 until date of
disposal on February 29,
2008 was $139,264. Results of operations for Darius in fiscal
2008 are presented as discontinued operations in the Condensed Consolidated Statements of Operations and Cash
Flows.
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 – Other Current Liabilities
At June
30, 2009 and December 31, 2008, included in other current liabilities are
accrued compensation of $243,983 and $215,350, respectively.
Note
6 – Commitments and Contingencies
The
Company 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
agreed to pay the developer a 3% royalty and a 2% consulting fee based on sales
collected, less certain deductions, throughout the term of this agreement, which
expired in May 2007. However, the Company and the developer are in
litigation and as such no potential offset from such litigation for these fees
have been recorded.
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 agreed to pay Dr. Rosenbloom
compensation in the amount of five percent (5%) of net sales collected, less
certain deductions, of royalty-bearing products. There have been no
sales derived from royalty-bearing products to date. As a
consequence, the Company has not incurred or paid any compensation under this
agreement.
14
The
Quigley Corporation and Subsidiaries
Notes to
Condensed Consolidated Financial Statements
(unaudited)
Note
6 – Commitments and Contingencies - continued
In 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. This agreement was amended in
July 2009 resulting
in (i) a reduction in the term of the agreement, (ii) reduction of the
exclusivity coverage and (iii) an adjustment to the remaining purchase
commitment to approximately $964,000 over the term of the
contract.
Certain
operating leases for office and warehouse space maintained by the Company
resulted in rent expense for the three month periods ended June 30, 2009 and
2008 of $11,300 and $13,966, respectively. Rent expense for the six
month periods ended June 30, 2009 and 2008 were $29,752 and $27,659,
respectively. The Company has estimated future obligations over the
next five years, including the remainder of 2009, as follows:
Year
|
Research
and
Development
|
|
Property
and Other Leases
|
Advertising
|
|
Product
and
Other Purchases
|
|
|
Total
|
|||||||||||
2009
|
$ | 151,000 | $ | 2,772 | $ | 285,000 | $ | 460,683 | $ | 899,455 | ||||||||||
2010
|
- | - | 650,000 | 866,221 | 1,516,221 | |||||||||||||||
2011
|
- | - | - | - | - | |||||||||||||||
2012
|
- | - | - | - | - | |||||||||||||||
2013
|
- | - | - | - | - | |||||||||||||||
Total
|
$ | 151,000 | $ | 2,772 | $ | 935,000 | $ | 1,326,904 | $ | 2,415,676 |
Additional
research and development and advertising costs are expected to be incurred
during the remainder of fiscal 2009.
In April
2009, a group of shareholders in the Company, including Mr. Ted Karkus, (the
“Karkus Group”) filed with the Securities and Exchange Commission a preliminary
Proxy Statement proposing an alternative slate of board of directors for the
Company (the “Alternative Ballot”) to the slate nominated by the
Company’s incumbent Board of Directors (the “Incumbent Ballot”) for vote at the
May 20, 2009 annual meeting of stockholders, (“Annual
Meeting”).
Stockholders
of the Company were solicited by both the Company and the Karkus Group (the
“Proxy Contest”) to support either the Incumbent Ballot or the Alternative
Ballot prior to the Company’s Annual Meeting.
As a
consequence of the Proxy Contest, the Company was involved in three litigation
matters during the three months ending June 30, 2009 in the Unites States
District Court for the Eastern District of Pennsylvania. In
The Quigley Corporation v.
Karkus, et al., No.09-1725, and The Quigley Corporation v. Karkus,
et al., 09-2438, the Company sought injunctive relief in federal court
based on claims under the Securities Exchange Act of 1934 and rules promulgated
thereunder. In both cases, the court denied the relief requested
following expedited proceedings. Both cases have been dismissed voluntarily. In
the third matter, Karkus v.
The Quigley Corporation, et al., No. 09-2239, Mr. Karkus sued the Company
and its former Chief Executive Officer asserting violations of the Securities
Exchange Act of 1934 and for alleged breach of fiduciary duty. This case, too,
has been dismissed voluntarily.
As a
consequence of the outcome of the Annual Meeting and the decision of the court,
the slate of directors nominated pursuant to the Alternative Ballot was elected
to the Board of Directors of the Company.
15
The
Quigley Corporation and Subsidiaries
Notes to
Condensed Consolidated Financial Statements
(unaudited)
Note
7 – Transactions Affecting Stockholders’ Equity
Stockholder
Rights Plan
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.
Stock
Repurchase Plan
Since the
inception of a stock buy-back program in January 1998, the Board of Directors
has subsequently increased the number of common shares repurchase authorization
on five occasions, for a total authorized buy-back of 5,000,000 shares or
approximately 38% of the previous common shares
outstanding. The common shares acquired under the buy-back
program are reflected as treasury stock and are available for general corporate
purposes. From the initiation of the stock buy-back program until
June 30, 2009, 4,159,191 shares of the Company’s common stock were repurchased
at a cost of $24,042,801, or an average cost of $5.78 per share. No
common shares were repurchased during fiscal 2008 or the six months ended June
30, 2009.
For the
six months ended June 30, 2009 and 2008, the Company derived net proceeds of
$16,541 and $12,020, respectively, as a consequence of the exercise of options
to acquire 20,728 and 11,000, shares, respectively, of the Company’s common
stock.
Note
8 – Income Taxes
The
Company accounts for income taxes in accordance with SFAS No. 109,
“Accounting for Income Taxes.” Under SFAS No. 109, deferred tax assets and
liabilities are computed based on the difference between the financial statement
and income tax bases of assets and liabilities using the enacted marginal tax
rate. SFAS No. 109 requires that the net deferred tax asset be
reduced by a valuation allowance if, based on the weight of available evidence,
it is more likely than not that some portion or all of the net deferred tax
asset will not be realized. The Company has further adopted the
provisions of Interpretation No. 48 (“FIN 48”), “Accounting for Uncertainty in
Income Taxes – An interpretation of FASB Statement No. 109.” As
required by FIN 48, the Company recognizes the financial statement benefit of a
tax position only after determining that the relevant tax authority would more
likely than not sustain the position following an audit. For tax
positions meeting the more-likely-than-not threshold, the amount recognized in
the financial statements is the largest benefit that has a greater
than 50 percent likelihood of being realized upon ultimate settlement with the relevant tax authority. The
Company’s
assessments of its tax positions in accordance with FIN 48 did not result in
changes that had a material impact on results of operations, financial condition
or liquidity. As of June 30, 2009 and December 31, 2008, the Company had no
unrecognized tax benefits. While the Company does not have any interest and
penalties in the periods presented, the Company’s policy is to recognize such
expenses as tax expense.
16
The
Quigley Corporation and Subsidiaries
Notes to
Condensed Consolidated Financial Statements
(unaudited)
Note
8 – Income Taxes - continued
The
Company files U.S. federal income tax returns with the Internal Revenue Service
(“IRS”) as well as income tax returns in various states. The Company may be
subject to examination by the IRS for tax years 2005 through 2008. Additionally,
the Company may be subject to examinations by various state taxing jurisdictions
for tax years 2005 through 2008. The Company is currently not under examination
by the IRS or any state tax jurisdiction.
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 $6,838,714 are deferred and will be credited to
additional-paid-in-capital when the NOL’s attributable to these exercises are
utilized. Consequently, these NOL’s will not be available to offset
current income tax expense. The net operating loss carry-forwards
that currently approximate $28.6 million for federal purposes will be expiring
beginning 2020 through 2029. Additionally, there are net operating
loss carry-forwards of $27.2 million for state purposes that will be expiring
beginning 2018 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
9 – Earnings (Loss) Per Share
Basic
earnings per share is computed by dividing net income or loss to common
stockholders by the weighted-average number of shares of the Company’s common
stock outstanding for the period. Diluted earnings per share reflects
the potential dilution that could occur if securities or other contracts to
issue common stock were exercised or converted into common stock or resulted in
the issuance of common stock that shared in the earnings of the entity. Diluted
earnings per share also utilizes the treasury stock method which prescribes a
theoretical buy-back of shares from the theoretical proceeds of all options and
warrants outstanding during the period. Options and warrants
outstanding at June 30, 2009 and 2008 were 1,752,022 and 2,471,000
respectively
Dilutive
earnings per share for all periods presented is the same as basic earnings per
share due to (i) the inclusion of common stock, in the form of stock options and
warrants (“Common Stock Equivalents”), would have an anti-dilutive effect on
the loss per share for the three months and
six months ended June 30, 2009 and 2008 or (ii) there were no Common Stock
Equivalents for the respective period. For the three months
ended June 30, 2009 and 2008, there were 241,108 and 301,090 Common Stock Equivalents, respectively,
which were in the money, excluded from the earnings per share computation due to
their dilutive effect. For the six months ended June 30, 2009 and
2008, there were 229,744 and 293,169 Common Stock Equivalents, respectively,
which were in the money, excluded from the earnings per share computation due to
their dilutive effect.
17
The
Quigley Corporation and Subsidiaries
Notes to
Condensed Consolidated Financial Statements
(unaudited)
Note
9 – Earnings (Loss) Per Share - continued
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):
Three
Months Ended
|
Six
Months Ended
|
Three
Months Ended
|
Six
Months Ended
|
|||||||||||||||||||||||||||||||||||||||||||||
June
30, 2009
|
June
30, 2009
|
June
30, 2008
|
June
30, 2008
|
|||||||||||||||||||||||||||||||||||||||||||||
Loss
|
Shares
|
EPS
|
Loss
|
Shares
|
|
EPS
|
Loss
|
|
Shares
|
|
EPS
|
|
|
Loss
|
|
|
Shares
|
|
|
EPS
|
||||||||||||||||||||||||||||
Basic
EPS
|
$ | (4.6 | ) | 12.9 | $ | (0.36 | ) | $ | (6.8 | ) | 12.9 | $ | (0.53 | ) | $ | (2.9 | ) | 12.9 | $ | (0.22 | ) | $ | (5.3 | ) | 12.9 | $ | (0.42 | ) | ||||||||||||||||||||
Dilutives:
|
||||||||||||||||||||||||||||||||||||||||||||||||
Options/Warrants
|
- | - | - | - | - | - | - | - | - | - | - | - | ||||||||||||||||||||||||||||||||||||
Diluted
EPS
|
$ | (4.6 | ) | 12.9 | $ | (0.36 | ) | $ | (6.8 | ) | 12.9 | $ | (0.53 | ) | $ | (2.9 | ) | 12.9 | $ | (0.22 | ) | $ | (5.3 | ) | 12.9 | $ | (0.42 | ) |
Note
10 – Segment Information
Segments
are defined by SFAS No. 131, “Disclosures about Segments of an Enterprise and
Related Information,” as components of a company in which separate financial
information is available and is evaluated by the chief operating decision maker,
or a decision making group, in deciding how to allocate resources and in
assessing performance.
The
Company divides its operations into three reportable segments as
follows: (i) cold remedy, whose main product is Cold-EEZEÒ,
a proprietary zinc gluconate glycine lozenge for the common cold; (ii) contract
manufacturing, which is the manufacturing services provided to third party
customers, and (iii) ethical pharmaceutical, currently involved in research and
development activity to develop patent applications and innovations for
potential pharmaceutical products.
The
segment operating loss consists of the revenues generated by a segment, less the
direct costs of revenue and selling, general and administrative costs that are
incurred directly by the segment. Unallocated corporate costs include
costs related to administrative functions that are performed in a centralized
manner that are not attributable to a particular segment. These
administrative function costs include costs for corporate office support, all
office facility costs, costs relating to accounting and finance, human
resources, legal, marketing, information technology and company-wide business
development functions, as well as costs related to overall corporate
management.
18
The
Quigley Corporation and Subsidiaries
Notes to
Condensed Consolidated Financial Statements
(unaudited)
Note
10 – Segment Information - continued
The
following table presents information about reported segments along with the
items necessary to reconcile the segment information to the totals reported in
the accompanying consolidated financial statements:
For
the three months ended June 30, 2009
|
Cold
Remedy
|
|
Contract
Manufacturing
|
|
Ethical
Pharmaceutical
|
|
Corporate
&
Other
|
|
Total
|
|||||||||||
Revenues
|
||||||||||||||||||||
Customers-domestic
|
$ | 1,209,379 | $ | 538,456 | $ | - | $ | - | $ | 1,747,835 | ||||||||||
Segment
operating loss
|
$ | (3,720,120 | ) | $ | (369,095 | ) | $ | (477,987 | ) | $ | (62,151 | ) | $ | (4,629,353 | ) | |||||
For
the six months ended June 30, 2009
|
Cold
Remedy
|
Contract
Manufacturing
|
|
Ethical
Pharmaceutical
|
|
|
Corporate
&
Other
|
Total
|
||||||||||||
Revenues
|
||||||||||||||||||||
Customers-domestic
|
$ | 4,541,437 | $ | 1,192,944 | $ | - | $ | - | $ | 5,734,381 | ||||||||||
Segment
operating loss/profit
|
$ | (5,284,340 | ) | $ | (864,100 | ) | $ | (854,103 | ) | $ | 162,962 | $ | (6,839,581 | ) |
For
the three months ended June 30, 2008
|
Cold
Remedy
|
Contract
Manufacturing
|
Ethical
Pharmaceutical
|
Corporate
&
Other
|
Total
|
|||||||||||||||
Revenues
|
||||||||||||||||||||
Customers-domestic
|
$ | 1,532,445 | $ | 535,840 | $ | - | $ | - | $ | 2,068,285 | ||||||||||
Segment
operating loss
|
$ | (1,138,800 | ) | $ | (237,231 | ) | $ | (1,425,378 | ) | $ | (161,667 | ) | $ | (2,963,076 | ) | |||||
For
the six months ended June 30, 2008
|
Cold
Remedy
|
Contract
Manufacturing
|
Ethical
Pharmaceutical
|
Corporate
&
Other
|
Total
|
|||||||||||||||
Revenues
|
||||||||||||||||||||
Customers-domestic
|
$ | 6,244,579 | $ | 1,128,740 | $ | - | $ | - | $ | 7,373,319 | ||||||||||
Segment
operating loss
|
$ | (1,956,638 | ) | $ | (524,885 | ) | $ | (3,004,096 | ) | $ | (58,688 | ) | $ | (5,544,307 | ) |
19
The
Quigley Corporation and Subsidiaries
Management’s
Discussion and Analysis of
Financial
Condition and Results of Operations
Item
2.
General
The
Quigley Corporation (the “Company”), headquartered in Doylestown, Pennsylvania,
is a 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.
The
Company’s primary business is the manufacture and distribution of
over-the-counter cold remedy products to consumers through national chain,
regional, specialty and local retail stores. One of the Company’s key
products in its cold remedy segment is Cold-EEZEÒ,
a zinc gluconate glycine product proven in clinical studies to reduce the
duration and severity of the common cold symptoms by nearly half. Cold-EEZEÒ
is an established product in the health care and cold remedy
market.
The
Company divides its operations into three reportable segments as
follows: (i) cold remedy, whose main product is Cold-EEZEÒ,
(ii) contract manufacturing, which is the manufacturing services provided to
third party customers, and (iii) ethical pharmaceutical, currently involved in
research and development activity to develop patent applications and innovations
for potential pharmaceutical products. The Company manages each
segment separately as a consequence of different marketing, service requirement,
research and development, and distribution strategies for the respective
segments.
See Note
10 to the Condensed Consolidated Financial Statements included in this report
for a description of the operating results for each segment.
Recent
Developments
Proxy
Contest
In April
2009, a group of shareholders in the Company, including Mr. Ted Karkus, (the
“Karkus Group”) filed with the Securities and Exchange Commission a preliminary
Proxy Statement proposing an alternative slate of board of directors for the
Company (the “Alternative Ballot”) to the slate nominated by the Company’s
incumbent Board of Directors (the “Incumbent Ballot”) for vote at the May 20,
2009 annual meeting of stockholders’ (“Annual Meeting”). The reason
for the Karkus Group’s Alternative Ballot was that the Karkus Group believed it
was time for a change in the Company. The Alternative Ballot indicated, among
other matters, that over the past three fiscal years, the Company’s management
delivered declining revenues, declining gross and net profits (increasing net
losses), declining stockholders’ equity, declining stock price, with excessive
compensation paid to the Company’s management and their family
members.
Stockholders
of the Company were solicited by both the Company and the Karkus Group (the
“Proxy Contest”) to support either the Incumbent Ballot or the Alternative
Ballot prior to the Company’s Annual Meeting. The results
were certified by the independent director of elections on June 1, 2009, showing
that the Alternative ballot received more votes than the incumbent
Ballot. However, due to litigation initiated by the Company, the
election was contested by the Company and made subject to a Standstill Order by
a District Court Judge in the United States District Court for the Eastern
District of Pennsylvania. On Friday, June 12, 2009, the United States
District Court for the Eastern District of Pennsylvania issued a decision and
order rejecting the last of the Company’s challenges to the election results of
the Annual Meeting. As a consequence of this decision, the slate of
directors nominated pursuant to the Alternative Ballot was elected to the Board
of Directors of the Company.
On June
12, 2009, Mr. Guy Quigley, Chairman, President and Chief Executive Officer of
the Company, resigned his positions with the Company. Mr. Quigley’s
resignation had been preceded by the resignation of Mr. Charles Phillips,
formerly the Executive Vice President and Chief Operating Officer of the
Company, effective May 29, 2009.
20
The
Quigley Corporation and Subsidiaries
Management’s
Discussion and Analysis of
Financial
Condition and Results of Operations
Additionally
on June 12, 2009, following the seating of the newly elected board of directors
of the Company, Mr. Karkus was elected Chairman of the Board of Directors and
the board elected members to its audit committee, compensation committee, and
corporate governance and nominating committee. Subsequently, Mr.
Karkus was appointed interim Chief Executive Officer of the Company effective
June 18, 2009. Effective July 15, 2009, the Company appointed (i) Mr.
Karkus as the permanent Chief Executive Officer and (ii) Mr. Robert V. Cuddihy,
Jr. as the Executive Vice President and Chief Operating Officer.
As a
consequence of the Proxy Contest between the Incumbent Ballot and the
Alternative Ballot, for the three months ended June 30, 2009 the Company charged
to operations approximately $2.4 million in costs associated with the proxy
solicitation and related litigation.
Manufacturing Facility
Consolidation
The
Company’s wholly owned subsidiary, Quigley Manufacturing, Inc. (“QMI”), produces
the Cold-EEZE® lozenge
products along with performing such operational tasks as warehousing and
shipping the Company’s Cold-EEZE® and
other cold remedy products. Additionally, QMI maintains a United
States Food and Drug Administration (“FDA”) approved facility that engages in
contract manufacturing and distribution activities of lozenge-based products for
unaffiliated third parties. QMI also produces and sells therapeutic
lozenges to whole sale and distribution outlets. On February 2, 2009,
the Company announced its intention to close QMI’s hard and organic candy
production facility in Elizabethtown, PA and consolidate its manufacturing
operations at its Lebanon, PA facility. Effective in June 2009, the
QMI Elizabethtown facility was closed and as a result QMI will evaluate
opportunities to outsource the production of its organic candy products to third
party contract manufacturers. The QMI Lebanon facility continues its
production and distribution of the Cold-EEZE® brand
and other cold remedy products. Total annualized cost savings to the
Company as a result of this consolidation is estimated to be
$750,000.
Research and
Development
On April
30, 2009, the Company announced preliminary results 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 its
investigational new drug, 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.
On July
22, 2009, the Company announced the final results from its Phase IIb
double-blind, placebo-controlled, study of topical compound QR-333 for the
treatment of symptomatic diabetic peripheral neuropathy. The study was completed
with fewer than expected evaluable patients with the final and comprehensive
conclusions revealing that (i) the compound is safe and well tolerated, and (ii)
there were nominal trends, but no statistical differences, between active and
placebo groups for the primary and secondary endpoints measuring efficacy by (a)
the reduction of pain, (b) symptomatic improvements, (c) improved quality of
life and (d) improved sleep.
However,
the Company is encouraged by the positive, clinical and statistically
significant improvement for efficacy in sural nerve conduction velocity and
amplitude unexpectedly found in a sub-set of the patient
population. Those data may indicate the potential benefit of this
compound as a disease modifying agent which, if validated through additional
clinical trials, potentially broadens the therapeutic market opportunity.
Additional clinical work would be required and future study considerations might
include, a longer duration period to improve patient compliance as well as an
assessment of sural nerve function and measures of distal nerve sensory
thresholds in the feet to provide more detail to the potential for disease
modification. There can be no assurance the Company will undertake additional
clinical studies or that the results thereof would lead to a marketable product
that can achieve regulatory approvals.
21
The
Quigley Corporation and Subsidiaries
Management’s
Discussion and Analysis of
Financial
Condition and Results of Operations
A
preliminary analysis of the lack of adequate primary and secondary end point
data indicates that the results may have been attributed to fewer then expected
evaluable patients due to a shortage of drug and a high number of patients
terminated early due to a lack of compliance with application and usage
protocols.
All
required end of study regulatory and reporting documentation and procedures will
be completed. The Company will continue to consider licensing, partnering or
collaborative relationship opportunities to further the development and
potential commercialization of the QR-333 candidate and other
formulations.
Ethical
Pharmaceutical
The
current activity of the Company’s wholly-owned subsidiary, Quigley Pharma Inc.
(“Pharma”), 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 activities focus on the identification, isolation and direct use
of active medicinal substances. One aspect of Pharma’s research focus
is on the potential synergistic benefits of combining isolated active
constituents and whole plant components. The Company searches 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. 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 its patent
applications into commercial products. The Company has invested
significantly in ongoing research and development activities.
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.
The
operations of the Company support 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.
Such funding through equity means would result in the dilution of stockholder
ownership in the Company. Should research activity progress on
certain formulations, resulting expenditures may require substantial financial
support and may necessitate the consideration of alternative
approaches such as, licensing, joint venture, or partnership arrangements that
meet the Company’s long term goals and objectives. Ultimately, should
internal working capital be insufficient and external funding methods or other
business arrangements become unattainable, such eventualities would
likely result in the deferral or abandonment of future growth and development
relative to current and prospective Pharma formulations.
The
Company recently engaged an independent consultant to conduct a thorough review
of the entire research and development portfolio of potential products in the
Pharma pipeline. The Company will wait for this review to be
completed before determining the next steps in the development of products such
as QR-333 and other product formulations still under development and/or testing
phases.
22
The
Quigley Corporation and Subsidiaries
Management’s
Discussion and Analysis of
Financial
Condition and Results of Operations
Certain
Risk Factors
The
Company makes no representation that the 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 this filing as well as in other documents
the Company files from time to time with the Securities and Exchange
Commission.
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.
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 capability 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.
Critical Accounting
Policies
The
preparation of financial statements in conformity with generally accepted
accounting principles require management to make estimates and
assumptions. Those estimates and assumptions affect the reported
amounts of assets and liabilities, disclosure of contingent assets and
liabilities, and the reported revenues and expenses of the
Company. The Company’s significant accounting policies are
described in Note 2 of Notes to Condensed Consolidated Financial Statements
included under Item 1 of this Part I. However, certain accounting policies are
deemed “critical”, as they require management’s highest degree of judgment,
estimates and assumptions. These accounting estimates and disclosures
have been discussed with the Audit Committee of the Company’s Board of Directors. A
discussion of the
Company’s critical
accounting policies, the judgments and uncertainties affecting their application
and the likelihood that materially different amounts would be reported under
different conditions or using different assumptions are as
follows:
Sales Returns and
Allowances
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.
23
The
Quigley Corporation and Subsidiaries
Management’s
Discussion and Analysis of
Financial
Condition and Results of Operations
The
primary product in the cold remedy segment, Cold-EEZEÒ,
has been clinically proven to reduce the severity and duration of common cold
symptoms. Accordingly, factors considered in estimating the appropriate sales
returns and allowances for this product include it being (i) a unique product
with limited competitors, (ii) competitively priced, (iii) promoted, (iv)
unaffected for remaining shelf-life as there is no product expiration date, and
(v) monitored for inventory levels at major customers and third-party
consumption data. The Company has recently added new products to the
cold remedy segment such as Kids-EEZEÒ
Chest Relief, ISC-10 immune product and Organix Organic Cough and Sore Throat
Drops. Each of these new products do carry shelf-life expiration
dates for which the Company aggregates such new product market experience data
and updates its sales returns and allowances estimates accordingly.
Currently,
the Company does not impose a period of time within which product may be
returned. All requests for product returns must be submitted to the
Company for pre-approval. The main components of the Company’s
returns policy are: (i) the Company will accept returns that are due
to damaged product that is un-saleable and such return request activity fall
within an acceptable range, (ii) for products of the Company that have reached
or exceeded designated expiration dates, (iii) in the event that the Company
discontinues a product, the customer will have the right to return only such
item that it purchased directly from the Company. The Company will
not accept return requests pertaining to customer inventory “Overstocking” or
“Resets”. The Company will only accept return requests for
product in its intended package configuration. The Company reserves
the right to terminate shipment of product to customers who have made
unauthorized deductions contrary to the Company’s Return Policy or pursue other
methods of reimbursement. The Company compensates the customer for authorized
returns by means of a credit applied to amounts owed or to be owed and in the
case of discontinued product only, also by way of an exchange. The
Company does not have any significant product exchange history.
At June
30, 2009 and December 31, 2008, the Company included reductions to accounts
receivable for sales returns and allowances of $1,793,000 and $1,427,000,
respectively, and cash discounts of $73,000 and $150,000, respectively.
Additionally, current liabilities at June 30, 2009 and December 31, 2008 include
$499,305 and $1,058,962, respectively, for cooperative incentive promotion
costs.
Revenue
Provisions
to reduce revenues for cold remedy products 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 allowance provisions for the three
month periods ended June 30, 2009, and 2008 would affect net sales by
approximately $28,000 and $26,000, respectively and the six month periods ended
June 30, 2009 and 2008 by approximately $81,000 and $92,000. A one percent
deviation for cooperative incentive promotion allowance provisions for the three
month periods ended June 30, 2009 and 2008 would affect net sales by
approximately $22,000 and $21,000, respectively, and the six month periods ended
June 30, 2009 and 2008 by approximately $69,000 and $81,000,
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.
24
The
Quigley Corporation and Subsidiaries
Management’s
Discussion and Analysis of
Financial
Condition and Results of Operations
Financial
Condition and Results of Operations
Results
from Operations for the Three months Ended June 30, 2009
as
Compared to the Three Months Ended June 30, 2008
Net sales
for the three months ended June 30, 2009 decreased by $320,450 to $1,747,835 as
compared to $2,068,285 for the three months ended June 30,
2008. For the three months ended June 30, 2009, the cold remedy
segment reported net sales of $1,209,379 representing a decrease of $323,066, or
21.1%, as compared to net sales for three months ended June 30, 2008 period of
$1,532,445. The contract manufacturing segment reported net sales to
third party customers of $538,456 for the three months ended June 30, 2009
period as compared to $535,840 for the three months ended June 30,
2008.
The
decrease in the cold remedy segment net sales reflects a market-wide decrease in
consumer purchases of cold remedy products at retail as reported by a third
party data provider Information Resources, Inc. (“IRI”). The decrease
was also attributed to (i) historic lows in the incidence of colds by consumers
and (ii) general economic weakness in the marketplace and (iii) the Company’s
new products have experienced lower net sales than initial estimates and may
require additional advertising and promotional support. In
addition to seasonal factors and weaknesses in the general market and consumer
demand, the cold remedy segment sales for the three months ended June 30, 2009
period were also adversely impacted by unfavorable inventory management programs
implemented by retail customers, and an increase in product return estimates due
to pending product expiration dates,. The increase in estimated sales
returns is principally due to the most recent new product additions which carry
shelf-life expiration dates such as Kids-EEZEÒ
Chest Relief, ISC-10 immune product and Organix Organic Cough and Sore Throat
Drops. The aggregate reduction to net sales for the three month
period ended June 30, 2009 as compared to the three month period ended June 30,
2008 for these three products was approximately $604,000. The Company
continues to strongly promote its cold remedy products through media and
in-store marketing along with direct-to-the-consumer promotional
programs.
Net sales
of the contract manufacturing segment reported a small increase of $2,616 for
the three months ended June 30, 2009 as compared to the three months ended June
30, 2008. Contract manufacturing is performed for non-related
third party entities to produce lozenge-based
products. Fluctuations in net sales from period-to-period are a
consequence of the manufacturing schedules required by its
customers.
Cost of
sales for the three months ended June 30, 2009 were $1,456,763 as compared to
$1,170,379 for the three months ended June 30, 2008. Gross margin for
the three months ended June 30, 2009 was 16.7% as compared to 43.4% for the
three months ended June 30, 2008, a decrease of 26.7%. The cold
remedy segment’s gross margin for the three months ended June 30, 2009 was 34.1%
compared to 59.8% for the three months ended June 30, 2008, a decrease of 25.7%. The decreased cold remedy gross margin of 25.7% for the three
months ended June 30, 2009
as compared to the
comparable period in 2008, was principally due to the adverse impact to
net sales of the unfavorable retail
inventory management programs implemented by retail customers and an increase in
product return estimates for non-Cold-EEZEÒ products due to pending product
expiration dates along with charges related to obsolete
inventory.
The
contract manufacturing segment contributed a negative impact to 2009 cost of
sales, influenced by lower production volume and fixed production costs which
are factors of the seasonality of the Company’s sales activities.
Sales and
marketing expense for the three months ended June 30, 2009 increased by $225,812
to $792,085, as compared to $566,273 for the three months ended June 30, 2008.
The increase in sales and marketing expense was principally due to an increase
in expenditures associated with product promotions and advertising.
25
The
Quigley Corporation and Subsidiaries
Management’s
Discussion and Analysis of
Financial
Condition and Results of Operations
General
and administration expense for the three months ended June 30, 2009 increased
$1,712,623 to $3,742,508 as compared to $2,029,885 for the three months ended
June 30, 2008. The increase in general and administration expense for
the three months ended June 30, 2009 was principally due to the net effects of
(i) an increase in stock promotion cost of approximately $2,400,000, relating to
the Proxy Contest, offset by (ii) a decrease in personnel costs of approximately
$376,798, principally as a consequence of a decrease in executive salaries and
bonuses along with a decrease in legal costs of $173,969.
Research
and development costs during the three months ended June 30, 2009 were $385,832
compared to $1,264,824 for the three months ended June 30, 2008. The
decrease of $878,992 in research and development costs for the three months
ended June 30, 2009 period as compared to the three months ended June 30, 2008
was due to the completion of the Phase IIb study for QR-333 Diabetic Peripheral
Neuropathy in November 2008 and a subsequent slowdown in related 2009 spending
pending the availability of the final results of the study (see above for the
results of the study). Research and development costs are principally
related to Pharma’s study activities and costs associated with the development
of potential ethical pharmaceuticals and other related products.
Interest and other income for the three
months ended June 30, 2009 were $4,433 as compared to $84,380 for the three
months ended June 30, 2008. The decrease of $79,947 for the three
months ended June 30, 2009 as compared to the three months ended June 30, 2008
was due to the decrease in deposit interest rates and reducing bank balances during the
three-month period.
As a
result of the above, the net loss for the three month period ended June 30,
2009, was $4,624,920, or ($0.36) per share, as compared to a net loss of
$2,878,696, or ($0.22) for the three months ended June 30, 2008.
Financial
Condition and Results of Operations
Results
from Operations for the Six months Ended June 30, 2009
as
Compared to the Six Months Ended June 30, 2008
Net sales
for the six month period ended June 30, 2009 decreased $1,638,938 to $5,734,381
as compared to net sales of $7,373,319 for the six months ended June 30,
2008. The cold remedy segment reported net sales in the six
months ended June 30, 2009 of $4,541,437, a decrease of $1,703,142, or 27.3%, as
compared to net sales of $6,244,579 for six months ended June 30,
2008. The contract manufacturing segment reported an increase in net
sales of $64,204 to $1,192,944 for the six months ended June 30, 2009 as
compared to $1,128,740 for the six months ended June 30, 2008.
Cold
remedy net sales for the six month ended June 30, 2009 reflect the ongoing
impact of the lower incidence of the common cold over the past several months
which was apparent during the 2008/2009 cough cold season. IRI
reports during fiscal 2008 and continuing into fiscal 2009 indicated reduced
unit consumption of Cold-EEZEÒ
and considerable consumption fluctuations within the cough/cold retail category
generally. Additionally, the Company’s new products have experienced
lower net sales than initial estimates and may require additional advertising
and promotional support. Cold remedy segment sales for the six months
ended June 30, 2009 period were also adversely impacted by unfavorable inventory
management programs implemented by retail customers and an increase in product
returns due to pending product expiration dates,. The increase in
sales returns are principally due to the most recent new product additions which
carry shelf-life expiration dates such as Kids-EEZEÒ
Chest Relief, ISC-10 immune product and Organix Organic Cough and Sore Throat
Drops. The aggregate net sales decrease between the six months ended
June 30, 2009 and the six months ended June 30, 2008 for these three products
was approximately $709,000. The Company continues to strongly promote
its cold remedy products through media and in-store marketing along with
direct-to-the-consumer promotional programs.
Net sales
of the contract manufacturing segment reported a small increase of $64,204 for
the six months ended June 30, 2009 as compared to the six months ended June 30,
2008. Contract manufacturing is performed for non-related
third party entities to produce lozenge-based
products. Fluctuations in net sales from period-to-period are a
consequence of the manufacturing schedules required by its
customers.
26
The
Quigley Corporation and Subsidiaries
Management’s
Discussion and Analysis of
Financial
Condition and Results of Operations
Cost of
sales for the six months ended June 30, 2009 were $3,091,098 as compared to
$2,905,895 for the six months ended June 30, 2008. Gross margin for
the six months ended June 30, 2009 was 46.1% compared to 60.6% for the six
months ended June 30, 2008 period, a decrease of 14.5%. The cold
remedy segment’s gross margin decreased by 9.7% for the six months ended June
30, 2009 to 58.6% as compared to 68.3% for the six months ended June 30,
2008. The decrease in gross margin for the six months ended June 30,
2009 as compared to the six months ended June 30, 2008 for the cold remedy
segment principally due to the impact to net sales of the unfavorable
inventory management programs implemented by retail customers and an increase in
product return estimates for non-Cold-EEZEÒ products due to pending product
expiration dates and charges related to obsolete inventory. The contract manufacturing
segment had a negative impact to 2009 cost of sales which is a factor of lower
production volume and fixed costs which are factors of the seasonality of the
Company’s sales activities.
Sales and
marketing expense for the six months ended June 30, 2009 increased $17,726 to
$2,816,240, as compared to the six months ended June 30, 2008 of
$2,798,514. The increase in sales and marketing expense was
primarily due to the net effect of (i) a reduction in sales broker costs, offset
by, (ii) an increase in product promotion and advertising expense.
General
and administration expense for the six month period ended June 30, 2009
increased by $1,494,262 to $6,032,353, compared to $4,538,091 for the six months
ended June 30, 2008. The increase in general and administration
expense for the six months ended June 30, 2009 was principally due to the net
effects of (i) an increase in stock promotion costs of $2,300,000, primarily
related to the Proxy Contest, offset by, (ii) a decrease in personnel costs of
$783,505 principally due to a decrease in executive salaries and
bonuses.
Research
and development expenses decreased by $2,040,855 to $634,271 for the six months
ended June 30, 2009 as compared to $2,675,126 for the six months ended June 30,
2008. The decreased spending for the six months ended June 30, 2009 as compared to the six months ended June
30, 2008 was principally due to the completion of the Phase IIb
study for QR-333 Diabetic Peripheral Neuropathy in November 2008 and a
subsequent slowdown in related 2009 spending pending the availability of the final results
of the study (see above for
the results of the study).
Research and development
costs are principally related to Pharma’s study activities and costs associated
with the development of potential ethical pharmaceuticals and other related
products.
Interest and other income for the six
months ended June 30, 2009 were $15,594 as compared to $220,645 for the six
months ended June 30, 2008. The decrease of $205,051 for the six
months ended June 30, 2009 as compared to the six months ended June 30, 2008 was
due to decreased deposit
interest rates and reducing bank balances during the
six-month period.
On February 29,
2008, the Company sold Darius to InnerLight
Holdings, Inc. For the three months ended March 31, 2008, the Company
has classified the results from operations of this former business segment as
discontinued operations.
As a result of the above, the net loss
for the six month period ended June 30, 2009, was
$6,823,987, or ($0.53) per share, as compared to a net loss of $4,448,146, or ($0.35) for the six months ended June 30, 2008.
27
The
Quigley Corporation and Subsidiaries
Management’s
Discussion and Analysis of
Financial
Condition and Results of Operations
Liquidity
and Capital Resources
The
Company’s working capital was $8,113,061 and $14,071,676 at June 30, 2009 and
December 31, 2008, respectively. Changes
in working capital for the six months ended
June 30, 2009
were primarily due to (i) cash used
in operations of $3,146,903 due to seasonal factors and approximately $2,400,000
of costs incurred as a consequence of the proxy contest, (ii) capital
expenditures of $85,031, offset by, (iii) proceeds of $474,918 from the sale of
fixed assets relating to the closure of the Elizabethtown facility of QMI in
June 2009 and (iv) proceeds of $16,789 from the exercise of stock
options. Significant factors impacting working capital during the
first six months of fiscal 2009 were the decrease in accounts receivable
balances and reduced advertising accruals, both reflective of seasonal factors
and that the second quarter has historically produced the least cold remedy
sales and related activity during the Company’s fiscal year. The
aggregate cash and cash equivalents at June 30, 2009 were $9,216,569 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 support 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.
Such funding through equity means would result in the dilution of stockholder
ownership in the Company. Should research progress on certain
formulations, these expenditures may require substantial financial support
and may necessitate the consideration of alternative approaches such
as, licensing, joint venture, or partnership arrangements that meet the
Company’s long term goals and objectives. Ultimately, should internal
working capital be insufficient and external funding methods or other business
arrangements become unattainable, such eventualities would likely result in the
deferral or abandonment of future growth and development relative to current and
prospective Pharma 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. The Company’s business is subject to seasonal variations
thereby impacting liquidity and working capital during the course of the
Company’s fiscal year.
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. However, in the
longer term, as previously discussed, the Company may require additional capital
to support, among other items, (i) new product introductions, (ii) expansion of
the Company’s product marketing and promotion activities, (iii) additional
research development activities for its Pharma segment and/or (iv) support
current operations. During recent months, there has been substantial
volatility and a decline in the capital and financial markets due at least
in part to the deteriorating global economic environment resulting in
substantial uncertainty 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.
28
The
Quigley Corporation and Subsidiaries
Management’s
Discussion and Analysis of
Financial
Condition and Results of Operations
Capital
Expenditures
Capital
expenditures during the remainder of fiscal 2009 are not expected to be
material.
Other
As a
consequence of the recent Proxy Contest the former Chief Executive Officer and
former Chief Operating Officer of the Company resigned without the benefit of a
transition period between the effective date of their respective resignation and
the recruitment of new management. The Company has filled both these
positions with personnel who are new to the Company. Due to the lack of
continuity of management, with limited/no transition or consultation period with
prior management, current management may have similar as well as different
strategic vision and/or initiatives than that of previous
management.
Due to
the management changes, new management is conducting a review of all
of its documentation and structure of current and prior business dealings and
transactions. To date, new management has (i) retained a new
marketing agency to assist the Company in the promotion of the Company’s
products, (ii) retained a pharmaceutical research expert to assist the Company
in its evaluation of its ethical pharmaceutical product development pipeline,
(iii) restructured certain operations to eliminate redundant costs, and (iv)
restructured certain vendor supply or service agreements with terms
more favorable to the Company.
New Accounting
Pronouncements
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 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” (“SFAS 160”). SFAS 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 May
2008, the FASB issued SFAS No. 162, “The Hierarchy of Generally Accepted
Accounting Principles” (“GAAP”). 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 April
2009 the FASB issued FSP No. FAS 157-4, “Determining Fair Value When the
Volume and Level of Activity for the Asset or Liability Have Significantly
Decreased and Identifying Transactions That Are Not Orderly” (“FSP
FAS 157-4”), which clarifies the application of SFAS 157 when there is
no active market or where the price inputs being used represent distressed
sales. Additional guidance is provided regarding estimating the fair value of an
asset or liability (financial and nonfinancial) when the volume and level of
activity for the asset or liability have significantly decreased and identifying
transactions that are not orderly. FSP FAS 157-4 is effective
for interim and annual periods ending after June 15, 2009. The
adoption of FASB 157-4 is not expected to have a material impact on the
Company’s financial position.
29
The
Quigley Corporation and Subsidiaries
Management’s
Discussion and Analysis of
Financial
Condition and Results of Operations
In June
2009, the FASB issued SFAS No. 165, “Subsequent Events” (“SFAS
165”). Prior to SFAS 165, the authoritative guidance for subsequent events was
previously addressed only in U.S. auditing standards. SFAS 165 establishes
general standards of accounting for and disclosure of events that occur after
the balance sheet date but before financial statements are issued or are
available to be issued and requires the Company to disclose the date through
which it has evaluated subsequent events and whether that was the date the
financial statements were issued or available to be issued. SFAS 165 does not
apply to subsequent events or transactions that are within the scope of other
applicable GAAP that provide different guidance on the accounting treatment for
subsequent events or transactions. The Company has adopted SFAS
165 for the period ended June 30, 2009. As a consequence of the
adoption of SFAS 165, the Company has evaluated subsequent events relating to
the three months and six months ended June 30, 2009 through to and including
August 14, 2009.
In June 2009, the FASB issued SFAS No.
168, “The FASB Accounting
Standards
CodificationTM
and the
Hierarchy of Generally Accepted Accounting Principles – a replacement of
FASB Statement No. 162”
(“SFAS No. 168”). SFAS No. 168 sets forth
the authoritative U.S. generally accepted accounting
principles to be applied by nongovernmental entities on a going-forward
basis. However, SFAS No. 168 is anticipated to only result in a
change of accounting standards for nonpublic entities that have not previously
applied the revenue recognition provisions of AICPA Technical Inquiry
Service Section 5100. The
Company does not anticipate that SFAS No. 168 will have a material effect on its
consolidated results of operations or financial condition.
Forward-Looking
Statements
Some of
the information in this Quarterly Report on Form 10-Q (including the section
titled Management’s Discussion and Analysis of Financial Condition and Results
of Operations) contains forward looking statements within the meaning of the
federal securities laws that relate to future events or our future financial
performance and involve known and unknown risks, uncertainties and other factors
that may cause the Company or the Company’s industry’s actual results, levels of
activity, performance or achievements to be materially different from any future
results, levels of activity, performance or achievements expressed or implied by
the forward-looking statements. You should not rely on
forward-looking statements in this report. Forward-looking statements
typically are identified by use of terms such as “anticipate”, “believe”,
“plan”, “expect”, “intend”, “may”, “will”, “should”, “estimate”, “predict”,
“potential”, “continue” and similar words, although some forward-looking
statements are expressed differently. This report may contain
forward-looking statements attributed to third parties relating to their
estimates regarding the growth of the Company’s markets or other
factors. All forward-looking statements address matters that involve
risk and uncertainties, and there are many important risks, uncertainties and
other factors that could cause the Company’s actual results as well as those of
the markets it serves, levels of activity, performance, achievements and
prospects to differ materially from the forward-looking statements contained in
this report. You should also consider carefully the statements under
other sections of this report that address additional factors that could cause
our actual results to differ from those set forth in any forward-looking
statements. The Company undertakes no obligation to publicly update
or review any forward-looking statements, whether as a result of new
information, future developments or otherwise. Additional factors
that could cause actual results to differ materially from those expressed in
these forward-looking statements include, among others, the
following:
·
|
the
loss of, or failure to replace, significant
customers;
|
·
|
the
loss of significant product vendors, raw material vendors or manufacturing
sources;
|
·
|
the
ineffectiveness of our sales and marketing strategies as pertains to the
Company’s primary product Cold-EEZEÒ,
particularly during the cough/cold season;
|
·
|
a
cough/cold season with low levels of incidences of the common
cold;
|
30
The
Quigley Corporation and Subsidiaries
Management’s
Discussion and Analysis of
Financial
Condition and Results of Operations
·
|
inability
of the Company to develop existing or future formulations related to the
ethical pharmaceutical segment due to inadequate funding, insufficient
scientific data, lack of a sufficient market, or challenges to
intellectual property;
|
·
|
changes
to government regulations or actions by regulatory bodies such as the Food
and Drug Administration, the Federal Trade Commission, the Consumer
Product Safety Commission, the United States Department of Agriculture,
the Unites States Environmental Protection Agency or the Occupational
Safety and Health
Administration;
|
·
|
the
effective recruitment, integration and/or success of new key management
following the recent Proxy
Contest;
|
·
|
the
inability to successfully resolve pending and unanticipated legal
matters;
|
·
|
a
continued downturn in industry and general economic or business
conditions.
|
In light
of these risks and uncertainties, there can be no assurance that the
forward-looking statements contained in this report will prove to be accurate.
We undertake no obligation to publicly update or revise any forward-looking
statements, or any facts, events, or circumstances after the date hereof that
may bear upon forward-looking statements.
31
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
4. Controls and Procedures
Disclosure Controls and
Procedures
The
Company maintains disclosure controls and procedures designed to provide
reasonable assurance that material information required to be disclosed by the
Company in the reports filed or submitted under the Securities Exchange Act of
1934 is recorded, processed, summarized and reported within the time periods
specified in the Securities and Exchange Commission (“SEC”) rules and forms, and
that the information is accumulated and communicated to our management,
including our Chief Executive Officer and Chief Financial Officer, as
appropriate to allow timely decisions regarding required disclosure. The Company
performed an evaluation, under the supervision and with the participation of our
management, including the Chief Executive Officer and Chief Financial Officer of
the Company, of the effectiveness of the design and operation of the disclosure
controls and procedures as of the end of the period covered by this report.
Based on the existence of the material weaknesses discussed below under the
heading “Material Weaknesses” the Company’s management, including our Chief
Executive Officer and Chief Financial Officer, concluded that the Company’s
disclosure controls and procedures were not effective at the reasonable
assurance level as of the end of the period covered by this report.
The
Company does not expect that its disclosure controls and procedures will prevent
all errors and all instances of fraud. Disclosure controls and procedures, no
matter how well conceived and operated, can provide only reasonable, not
absolute, assurance that the objectives of the disclosure controls and
procedures are met. Further, the design of disclosure controls and procedures
must reflect the fact that there are resource constraints, and the benefits must
be considered relative to their costs. Because of the inherent limitations in
all disclosure controls and procedures, no evaluation of disclosure controls and
procedures can provide absolute assurance that the Company has detected all of
its control deficiencies and instances of fraud, if any. The design of
disclosure controls and procedures also is based partly on certain assumptions
about the likelihood of future events, and there can be no assurance that any
design will succeed in achieving its stated goals under all potential future
conditions.
Material
Weaknesses
As a
consequence of management’s review of its effectiveness of the design and
operation of the disclosure controls and procedures, and management’s
determination of the existence of material weaknesses, the Company’s management,
including our Chief Executive Officer and Chief Financial Officer, concluded
that the Company’s disclosure controls and procedures were not effective at the
reasonable assurance level as of the end of the period covered by this
report. A material weakness is a significant deficiency, or a
combination of significant deficiencies, that results in more than a remote
likelihood that a material misstatement of the annual or interim financial
statements will not be prevented or detected.
32
Material Weakness – Control
environment
·
Lack of management continuity due to
changes in executive management of the Company. As a
consequence of the recent Proxy Contest the former Chief Executive Officer and
former Chief Operating Officer of the Company resigned without the benefit of a
transition period between the effective date of their respective resignation and
the recruitment of new management. The Company has filled both these
positions with personnel who are new to the Company. As a consequence of a lack
of continuity of management with limited/no transition or consultation period
with prior management, current management has concluded that this control
deficiency constitutes a material weakness.
·
Lack of documentation and/or the
availability of documentation or records in the Company’s files of business
transactions, contracts and/or evaluations engaged by the
Company. As new management was installed by the Board of
Directors, it was discovered during the second quarter of 2009 that the Company
was either missing or lacked pertinent information regarding its operations,
including but not limited to certain business commitments to product supply
agreements, advertising programs, product placement initiatives and other
promotional initiatives, and asset sales. As a consequence of this
lack of documentation or availability of documentation or records, management
has concluded that this control deficiency constitutes a material
weakness.
·
Lack of sufficient subject matter
expertise. Management has determined that it lacks certain
subject matter expertise in at least two significant areas (i) accounting for
and the disclosure of complex transactions and (ii) the selection, monitoring
and evaluation of certain vendors that provided services to Quigley
Pharma. The financial staff of the Company currently lacks sufficient
training or experience in accounting for complex transactions and the required
disclosure therein.
The new
management of the Company as part of their review of the Company’s internal
control over financial reporting identified the above
material weaknesses. New management has not concluded their review
and as this review continues additional material weaknesses may be
identified.
Other
matters
Furthermore,
as previously reported by the Company, on May 19, 2009, Quigley Pharma’s
Executive Vice President and Chief Operating Officer, Dr. Richard Rosenbloom was
suspended from the Company for allegedly receiving payments from external
sources, including vendors of the Company, without disclosure to the Company’s
management. On June 23, 2009, the Board of Directors of the Company
agreed to reinstate Dr. Rosenbloom and to form a Special Committee of the Board
of Directors to investigate the allegations with respect to Dr. Rosenbloom’s
alleged receipt of payments and in due course to report its findings and
recommendations to the full Board of Directors. The Special Committee
is in the preliminary stages of its investigation.
Remediation Plan for
Material Weaknesses
The
material weaknesses described above comprise control deficiencies that we
discovered during the financial close process for the three months and six
months ended June 30, 2009.
As the
new management becomes familiar with the administration of the business of the
Company, the Company will formulate a remediation plan and implement remedial
action to address the above material weaknesses. The initial
remediation plan includes (i) obtaining and reviewing the underlying
documentation for significant agreements, contracts, transactions and other
material commitments entered into by the Company, (ii) the implementation of a
training program for the Company’s financial staff, (iii) the addition of a
financial and operations professional, Robert V. Cuddihy, Jr., to the Company’s
executive management, (iv) retention of outside financial consultants
to augment the financial staff of the Company with certain subject matter
expertise, (v) retention of outside consultants to augment Quigley Pharma staff
with certain subject matter expertise and to conduct a thorough review of the
entire research and development portfolio of potential products and (vi) the
formation of the Special Committee Board of Directors to investigate the
allegations with respect to Dr. Rosenbloom.
33
The
Company believes that these measures, if effectively implemented and maintained,
will remediate the material weaknesses discussed above.
Changes in Internal Control
Over Financial Reporting
The
Company is currently undertaking a number of measures to remediate the material
weaknesses discussed under “Management’s Report on Internal Control Over
Financial Reporting,” above. Those measures, described under “Remediation Plan
for Material Weaknesses,” to be implemented during the third quarter of fiscal
year 2009, will materially affect, or are reasonably likely to materially
affect, our internal control over financial reporting. Other than as described
above, there have been no changes in our internal control over financial
reporting during the three months or six months ended June 30, 2009 that have
materially affected, or are reasonably likely to materially affect, our internal
control over financial reporting.
Part II. Other
Information
Item
1. Legal Proceedings
In April
2009, a group of shareholders in the Company, including Mr. Ted Karkus, (the
“Karkus Group”) filed with the Securities and Exchange Commission a preliminary
Proxy Statement proposing an alternative slate of board of directors for the
Company (the “Alternative Ballot”) to the slate nominated by the Company’s
incumbent Board of Directors (the “Incumbent Ballot”) for vote at the May 20,
2009 annual meeting of stockholders (“Annual Meeting”).
Shareholders
of the Company were solicited by both the Company and the Karkus Group (the
“Proxy Contest”) to support either the Incumbent Ballot or the Alternative
Ballot prior to the Company’s Annual Meeting.
As a
consequence of the Proxy Contest, the Company was involved in three litigation
matters during the three months ending June 30, 2009 in the Unites States
District Court for the Eastern District of Pennsylvania. In
The Quigley Corporation v.
Karkus, et al., No.09-1725, and The Quigley Corporation v. Karkus,
et al., 09-2438, the Company sought injunctive relief in federal court
based on claims under the Securities Exchange Act of 1934 and rules promulgated
thereunder. In both cases, the court denied the relief requested
following expedited proceedings. Both cases have been dismissed voluntarily. In
the third matter, Karkus v.
The Quigley Corporation, et al., No. 09-2239, Mr. Karkus sued the Company
and its former Chief Executive Officer asserting violations of the Securities
Exchange Act of 1934 and for alleged breach of fiduciary duty. This case, too,
has been dismissed voluntarily.
As a
consequence of the outcome of the Annual Meeting and the decision of the court,
the slate of directors nominated pursuant to the Alternative Ballot was elected
to the Board of Directors of the Company.
Item
1A. Risk
Factors
The
Change in Executive Management Due to the Change in Management of the Company
Resulting From the Recent Proxy Contest.
The
recent Proxy Contest resulted in the resignation of the former Chief Executive
Officer and former Chief Operating Officer of the Company with both these
positions now being occupied by personnel who are new to the
Company. This change in management may cause some concern amongst
vendors, customers, investors or stockholders during the period of time within
which the new management becomes familiar with the administration of the
business 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
and obtain additional regulatory approvals for prescription medications
developed by Pharma, particularly in the United States 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.
34
The
Company may need to obtain additional financing to support the cold remedy
segment and 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 and any equity financing would necessarily dilute
stockholder ownership in the Company. Access to, and availability of
funding for such activities may prove difficult or unattainable due to, among
other reasons, weak current and future economic conditions, reduction in the
availability of credit, financial market volatility and current
economic recession.
The
amount of capital that may be needed to complete product development of Pharma’s
products will depend on many factors, including;
●
|
the
cost involved in applying for and obtaining FDA and international
regulatory approvals;
|
●
|
whether
the Company elects to establish partnering arrangements for development,
sales, manufacturing and marketing of such
products;
|
●
|
the
level of future sales of Cold-EEZE®
products, and expense levels for international sales and marketing
efforts;
|
●
|
whether
the Company can establish and maintain strategic arrangements for
development, sales, manufacturing and marketing of its products;
and
|
●
|
whether
any or all of the outstanding options are exercised and the timing and
amount of these exercises.
|
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. Should research activity progress on certain formulations,
resulting expenditures may require substantial financial support
and may necessitate the consideration of alternative approaches such
as, licensing, joint venture, or partnership arrangements that meet the
Company’s long term goals and objectives.
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.
The Company has identified material
weaknesses in its internal control environment for the period from April 1, 2009
through June 30, 2009.
These
material weaknesses, if not properly remediated, could result in material
misstatements in the Company’s financial statements in future periods and impair
its ability to comply with the accounting and reporting requirements applicable
to public companies. A material weakness is a control deficiency, or combination
of control deficiencies, that results in more than a remote likelihood that a
material misstatement of financial statements will not be prevented or detected
by our internal controls.
35
In
relation to the condensed consolidated financial statements for the period from
April 1, 2009 through June 30, 2009, the Company identified material weaknesses
in its internal control environment as follows: (i) lack of management
continuity due to changes in executive management of the Company, (ii) lack of
documentation and/or the availability of documentation or records in the
Company’s files of business transactions, contracts and/or evaluations engaged
by the Company and (iii) lack of sufficient subject matter expertise in at least
two significant areas (a) accounting for and the disclosure of complex
transactions and (b) the selection, monitoring and evaluation of certain vendors
that provided services to Quigley Pharma.
Following
the identification of these material weaknesses, in the Company’s internal
control environment, management took measures and plans to continue to take
measures to remediate these weaknesses and deficiencies. However, the
implementation of these measures may not fully address these weaknesses. A
failure to correct these weaknesses or other control deficiencies or a failure
to discover and address any other control deficiencies could result in
inaccuracies in the Company’s condensed consolidated financial statements and
could impair its ability to comply with applicable financial reporting
requirements and related regulatory filings on a timely basis and could cause
investors to lose confidence in the Company’s reported financial information,
which could have a negative impact on our financial condition and stock price.
Management of the Company identified the above material weaknesses as part of
their review of the Company’s internal control over financial
reporting. Management has not concluded their review and as this
review continues additional material weaknesses may be identified.
Item
2. Unregistered Sales of Equity Securities and Use of
Proceeds.
Not
applicable
Item
3. Defaults Upon Senior Securities.
Not
applicable
Item
4. Submission of Matters to a Vote of Security
Holders
The
Annual Meeting of the Company was held on May 20, 2008 with 12,908,383 shares
eligible to vote.
In April
2009, a group of shareholders in the Company, including Mr. Ted Karkus, (the
“Karkus Group”) filed with the Securities and Exchange Commission a preliminary
Proxy Statement proposing an alternative slate of board of directors for the
Company (the “Alternative Ballot”) to the slate nominated by the Company’s
incumbent Board of Directors (the “Incumbent Ballot”) for vote at the May 20,
2009 Annual Meeting. The reason for the Karkus Group’s Alternative
Ballot was that the Karkus Group believed it was time for a change in the
Company. The Alternative Ballot indicated, among other matters, that over the
past three fiscal years, the Company’s management delivered declining revenues,
declining gross and net profits (increasing net losses), declining stockholders’
equity, declining stock price with excessive compensation paid to the Company’s
management and their family members.
Stockholders
of the Company were solicited by both the Company and the Karkus Group to
support either the Incumbent Ballot or the Alternative Ballot prior to the
Company’s Annual Meeting. The results were certified by
the independent director of elections on June 1, 2009, showing that the
Alternative ballot received more votes than the incumbent
Ballot. However, due to litigation initiated by the Company, the
election was contested by the Company and made subject to a Standstill Order by
a District Court Judge in the United States District Court for the Eastern
District of Pennsylvania. On Friday, June 12, 2009, the United States
District Court for the Eastern District of Pennsylvania issued a decision and
order rejecting the last of the Company’s challenges to the election results of
the Annual Meeting. As a consequence of the outcome of the Annual
Meeting and the decision of the Court, the slate of directors nominated pursuant
to the Alternative Ballot was elected to the Board of Directors of the
Company.
36
At the
Annual Meeting, the holders of 11,446,952 shares of the Company’s Common Stock
were represented in person or by proxy, constituting a quorum.
The
proposals put forth by the incumbent Board of Directors were:
(i)
|
To
elect a Board of Directors to serve for the ensuing year until the next
Annual Meeting of Stockholders and until their respective successors have
been duly elected and
qualified.
|
(ii)
|
To
ratify the appointment of Amper, Politziner & Mattia, LLP as
independent auditors for the year ending December 31,
2009.
|
For
proposals (i) and (ii) above, the votes were cast as follows:
Proposal
|
Position
|
For
|
Against
|
Withhold
Authority
|
Abstentions
|
Broker
Non-Votes
|
(i) By
nominee:
Guy
J. Quigley
Charles
A. Phillips
Gerard
M. Gleeson
Jacqueline
F. Lewis
Rounsevelle
W. Schaum
Stephen
W. Wouch
Terrence
O. Tormey
|
Chairman
of the Board,
President,
CEO
Executive
Vice President,
COO
and Director
Vice
President,
CFO
and Director
Director
Director
Director
Director
|
5,480,597
5,479,497
5,478,397
5,477,297
5,476,197
5,475,097
5,473,997
|
144,636
145,736
146,836
147,936
149,036
150,136
151,236
|
|||
(ii)
Amper, Politziner &
Mattia,
LLP
|
Independent
Auditors
|
11,357,522
|
26,050
|
-
|
63,380
|
-
|
The proposals put forth by the
Shareholder Nominees were:
(i)
|
To elect Ted Karkus, Mark Burnett, John DeShazo, Mark
Frank, Louis Gleckel, MD, Mark Leventhal and James McCubbin (collectively,
the “Shareholder Nominees”) as the Company’s Board of Directors to
serve for the ensuing year until the next Annual Meeting of Stockholders
and until their respective successors have been duly elected and
qualified.
|
(ii)
|
To
ratify the appointment of Amper, Politziner & Mattia, LLP as
independent auditors for the year ending December 31,
2009.
|
For
proposals (i) and (ii) above, the votes were cast as follows:
Proposal
|
Position
|
For
|
Against
|
Withhold
Authority
|
Abstentions
|
Broker
Non-Votes
|
(iii) By
nominee:
Ted
Karkus
Mark
Burnett
John
DeShazo
Mark
Frank
Louis
Gleckel, MD
Mark
Leventhal
James
McCubbin
|
Shareholder
Nominee
Shareholder
Nominee
Shareholder
Nominee
Shareholder
Nominee
Shareholder
Nominee
Shareholder
Nominee
Shareholder
Nominee
|
5,801,486
5,801,245
5,801,004
5,800,763
5,800,522
5,800,281
5,800,040
|
20,233
20,474
20,715
20,956
21,197
21,438
21,679
|
|||
(ii)
Amper, Politziner &
Mattia,
LLP
|
Independent
Auditors
|
11,357,522
|
26,050
|
-
|
63,380
|
-
|
Item
5. Other Information
Not
applicable
37
Item
6. Exhibits
(1)
|
Exhibit
31.1
|
Certification
by the Chief Executive Officer pursuant to Section 302 of the
Sarbanes-Oxley Act of 2002
|
||
(2)
|
Exhibit
31.2
|
Certification
by the Chief Financial Officer pursuant to Section 302 of the
Sarbanes-Oxley Act of 2002
|
||
(3)
|
Exhibit
32.1
|
Certification
by the Chief Executive Officer pursuant to Section 906 of the
Sarbanes-Oxley Act of 2002
|
||
(4)
|
Exhibit
32.2
|
Certification
by the Chief Financial Officer pursuant to Section 906 of the
Sarbanes-Oxley Act of 2002
|
||
(5)
|
Exhibit
10.1
|
Royalty
Agreement between The Quigley Corporation and Dr. Richard
Rosenbloom
|
38
SIGNATURES
Pursuant
to the requirements of the Securities Exchange Act of 1934, the registrant has
duly caused this report to be signed on its behalf by the undersigned thereunto
duly authorized.
THE QUIGLEY CORPORATION | |||
|
By:
|
/s/ Ted Karkus | |
Ted Karkus | |||
Chairman of the Board and Chief Executive Officer | |||
(Principal Executive Officer) |
Date:
August 14, 2009
|
By:
|
/s/ Gerard M. Gleeson | |
Gerard M. Gleeson | |||
Vice President, Chief Financial Officer | |||
(Principal Accounting and Financial Officer) |
Date:
August 14, 2009
39