Exhibit
99.1
FOR IMMEDIATE
RELEASE
CONTACT:
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Gerard
M. Gleeson
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Carl
Hymans
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Vice
President, CFO
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G.S.
Schwartz & Co.
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(215)
345-0919
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(212)
725-4500
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carlh@schwartz.com
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The
Quigley Corporation Reports First Quarter 2009 Results
DOYLESTOWN, PA. – May 1, 2009 – The
Quigley Corporation, (Nasdaq: QGLY) www.quigleyco.com today reported net sales
of $4.0 million, for the first quarter ended March 31, 2009, compared to $5.3
million reported for the same period in 2008.
The
decrease in net sales for the first quarter of 2009 reflects a market-wide
decrease in consumer purchases of cold remedy products as reported by
Information Resources Inc., (“IRI”) data, general economic weakness and lower
incidence of colds by consumers.
Net sales
for the first quarter of 2009 reflect the benefits of the Kids-EEZE® Chest
Relief product line, which was launched in August 2008. As part of
ongoing initiatives to support consumer awareness, the Company continued to
implement its advertising and targeted couponing campaign to promote the
COLD-EEZE®
brand.
The loss
from continuing operations for the first quarter ended March 31, 2009 decreased
to $2.2 million, or ($0.17) per share, compared to a loss from continuing
operations of $2.4 million, or ($0.19) per share for the first quarter of
2008. The decrease in loss from continuing operations includes a
reduction in total operating expenses of $1.6 million in the 2009
period.
Net loss
for the first quarter ended March 31, 2009 was $2.2 million, or ($0.17) per
share, compared to net loss of $1.6 million or ($0.12) per share, for the
comparable period in 2008. The net loss for the first quarter of 2008
included a benefit on disposal of discontinued operations of $876,000 without
which the net loss for the period would have been $2.4 million, or ($0.19) per
share.
The
Company continued to invest in Quigley Pharma, a wholly owned Ethical
Pharmaceutical subsidiary developing natural-source potential prescription and
other products. Research and development costs associated with
Quigley Pharma for the first quarter of 2009 were $248,000 compared to $1.4
million for the first quarter of 2008. This reduction reflects the completion of
the Phase IIb clinical study for QR-333 Diabetic Peripheral Neuropathy in
November 2008, which reduced R&D investment costs for the first quarter of
2009.
On April
30, 2009, the Company announced that its Diabetic Peripheral Neuropathy Phase
IIb clinical study demonstrated a significant improvement in two key measures of
distal sensory nerve function in the group treated with QR-333. These
unexpected positive findings expand the potential for the QR-333 drug for
Diabetic Neuropathy and suggest possible disease
modification.
No tax
provision or benefits to reduce losses are provided for the first quarter of
2009 and 2008, as the Company is in a net operating loss carry-forward position
for which a valuation has been established.
The
Company continued to invest in pharmaceutical research and development including
QR448(a), a veterinary anti-viral compound against Infectious Bronchitis Virus
(IBV) in poultry, and QR-333, an investigational new formulation for treating
conditions associated with Diabetic Peripheral Neuropathy.
The
research by the Company is part of its strategic initiatives to generate future
growth. These initiatives include capitalizing on the growth potential of
Quigley Pharma by developing natural-source potential prescription products
particularly for Diabetic Peripheral Neuropathy, avian flu in animals and for
protection against ionizing radiation.
Ongoing
Quigley Pharma research and development initiatives include investing in its key
pharmaceutical formulations, QR-333. The last subject in the Phase
IIb study completed treatment at the end November 2008 and the study is now in
the final stage of data collection, evaluation and study
conclusions. The Company, after collecting all the patient
information from 21 Study centers and conferring with its panel of experts on
the data, will draft and report study conclusions
The Phase
IIb study was designed to evaluate the safety and efficacy of QR-333, a unique
topical formulation designed to offer physicians and patients an effective, easy
to administer, safe treatment for Diabetic Peripheral Neuropathy with little to
no side effects. To date there is no fully effective treatment for
diabetic neuropathy. Current treatment options are limited to
products such as NSAIDs, analgesics, anticonvulsants, antidepressants, etc.,
which are often not well tolerated by patients.
As
announced by the Company on April 30, 2009, the Diabetic Peripheral Neuropathy
Phase IIb clinical study demonstrated a significant improvement in two key
measures of distal sensory nerve function in the group treated with QR-333. The
compound was applied topically to the feet of subjects suffering from painful
diabetic neuropathy and over the course of 12 weeks, significantly improved both
maximal conduction velocity and compound sensory amplitude in the sural
nerve. The mean improvement in nerve conduction velocity exceeded the
change considered by thought leaders to be “clinically meaningful” in clinical
studies. The sural nerve carries sensation from the feet and its
pathology is the fundamental cause of foot pain and ultimately foot ulcers and
amputation in some diabetic subjects.
These
findings necessitate a change in the potential outlook for this investigational
new drug. The Diabetic Peripheral Neuropathy market has significant unmet need
for rational, mechanism-based drugs. These clinically significant
findings suggest disease modification in this (12 week) phase II b
study. The Company is aware that this is a finding in a subset of the
patient population. Since the observations obtained from the study relate to
positive effect on nerve functioning, the Company may, in the future, be
focusing on a broader therapeutic area.
The World
Health Organization estimates, more than 171 million people have diabetes
worldwide. It is also estimated that 20 million people, representing
approximately 7% of the United States population have diabetes of which some 60%
will suffer from mild to severe nerve damage due to Diabetic Peripheral
Neuropathy. Conditions associated with Diabetic Peripheral Neuropathy include
numbness, skin ulcers, constant pain or extreme sensitivity to
stimulus.
The
Quigley Corporation makes no representation that the US Food and Drug
Administration or any other regulatory agency will allow this Investigational
New Drug to be marketed. Furthermore, no claim is made that potential
medicine discussed herein is safe, effective, or approved by the Food and Drug
Administration.
Additionally,
data that demonstrates activity or effectiveness in animals or in vitro tests do
not necessarily mean the 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
filings the Company files from time to time with the Securities and Exchange
Commission.
About The Quigley
Corporation
The
Quigley Corporation (NASDAQ: QGLY, http://www.Quigleyco.com)
is a diversified natural health medical science company. Its
Cold Remedy segment is a leading marketer and manufacturer of the COLD-EEZE®
family of lozenges, gums and sugar free tablets clinically proven to cut the
common cold nearly in half. COLD-EEZE customers include leading
national wholesalers and distributors, as well as independent and chain food,
drug and mass merchandise stores and pharmacies. The Quigley
Corporation has several wholly owned subsidiaries; Quigley Manufacturing Inc.
consists of two FDA approved facilities to manufacture COLD- EEZE® lozenges as
well as fulfill other contract manufacturing opportunities. Quigley Pharma Inc.
(http://www.QuigleyPharma.com)
conducts research in order to develop and commercialize a pipeline of patented
botanical and naturally derived potential prescription drugs.
Forward-Looking
Statements
Certain
statements in this press release are "forward-looking statements" within the
meaning of the Private Securities Litigation Reform Act of 1995 and involve
known and unknown risk, uncertainties and other factors that may cause the
Company's actual performance or achievements to be materially different from the
results, performance or achievements expressed or implied by the forward-looking
statement. Factors that impact such forward-looking statements include, among
others, changes in worldwide general economic conditions, changes in interest
rates, government regulations, and worldwide competition.
Important
Additional Information
The
Quigley Corporation (“Quigley” or the “Company”) filed a definitive proxy
statement with the Securities and Exchange Commission (the “SEC”) on April 2,
2009 in connection with the 2009 Annual Meeting of Stockholders and began the
process of mailing the definitive proxy statement and a WHITE proxy card to
stockholders. The Company’s stockholders are strongly advised to read Quigley’s
proxy statement as it contains important information. Stockholders may obtain an
additional copy of Quigley’s definitive proxy statement and any other documents
filed by the Company with the SEC for free at the SEC’s website at http://www.sec.gov.
Copies of the definitive proxy statement are available for free at:
http://www.amstock.com/ProxyServices/ViewMaterial.asp?CoNumber=07814.
In
addition, copies of the Company’s proxy materials may be requested at no charge
by contacting MacKenzie Partners, Inc. at 1-800-322-2885 or via email at quigley@mackenziepartners.com
Detailed information regarding the names, affiliations and interests of
individuals who are participants in the solicitation of proxies of Quigley’s
stockholders is available in Quigley’s definitive proxy statement filed with SEC
on April 2, 2009.
(Tables
Follow)
Consolidated Statements of
Operations (Unaudited)
The
following represents condensed financial data (in thousands) except per share
data:
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Three-Months
Ended
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Three-Months
Ended
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($)
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($)
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Net
Sales
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3,987 |
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5,305 |
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Gross
profit
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2,352 |
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3,570 |
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Sales
& marketing expenses
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2,024 |
|
|
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2,232 |
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Administrative
expenses
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2,290 |
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2,508 |
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Research
& development
|
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248 |
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1,411 |
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Income
taxes (benefit)
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- |
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- |
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(Loss)
Income from:
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Continuing
operations
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(2,199 |
) |
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(2,445 |
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Discontinued
operations
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- |
|
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876 |
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Net
Loss
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(2,199 |
) |
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(1,569 |
) |
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Diluted
income (loss) per share:
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|
|
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|
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Continuing
operations
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$ |
(0.17 |
) |
|
$ |
(0.19 |
) |
Income
from discontinued operations
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- |
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|
0.07 |
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Net
loss
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$ |
(0.17 |
) |
|
$ |
(0.12 |
) |
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|
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Diluted
weighted average common shares outstanding:
|
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12,908,383 |
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12,859,433 |
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Consolidated Balance Sheets
(Unaudited)
The
following represents condensed financial data (in thousands) at March 31, 2009
and December 31, 2008:
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|
|
|
|
|
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Cash
& cash equivalents
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12,244 |
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11,957 |
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Accounts
receivable, net
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1,796 |
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4,524 |
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Inventory
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3,246 |
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|
3,001 |
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Total
current assets
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|
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18,019 |
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20,666 |
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Total
assets
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21,635 |
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24,369 |
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Total
current liabilities
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6,060 |
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6,595 |
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Total
stockholders’ equity
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15,575 |
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17,774 |
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