The Quigley Corporation Reports First Quarter 2009 Results
May 01 2009 - 7:00AM
PR Newswire (US)
DOYLESTOWN, Pa., May 1 /PRNewswire-FirstCall/ -- The Quigley
Corporation, (NASDAQ:QGLY) http://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(R) 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(R) 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:QGLYNASDAQ: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(R) 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(R) 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 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:
Three-Months Three-Months Ended Ended March 31, 2009 March 31, 2008
($) ($) Net Sales 3,987 5,305 Gross profit 2,352 3,570 Sales &
marketing expenses 2,024 2,232 Administrative expenses 2,290 2,508
Research & development 248 1,411 Income taxes (benefit) - -
(Loss) Income from: Continuing operations (2,199) (2,445)
Discontinued operations - 876 Net Loss (2,199) (1,569) Diluted
income (loss) per share: Continuing operations ($0.17) ($0.19)
Income from discontinued operations - 0.07 Net loss ($0.17) ($0.12)
Diluted weighted average common shares outstanding: 12,908,383
12,859,433 Consolidated Balance Sheets (Unaudited) The following
represents condensed financial data (in thousands) at March 31,
2009 and December 31, 2008: 2009 2008 ($) ($) Cash & cash
equivalents 12,244 11,957 Accounts receivable, net 1,796 4,524
Inventory 3,246 3,001 Total current assets 18,019 20,666 Total
assets 21,635 24,369 Total current liabilities 6,060 6,595 Total
stockholders' equity 15,575 17,774 CONTACT: Gerard M. Gleeson Carl
Hymans Vice President, CFO G.S. Schwartz & Co. (215) 345-0919
(212) 725-4500 DATASOURCE: The Quigley Corporation CONTACT: Gerard
M. Gleeson, Vice President, CFO, The Quigley Corporation,
+1-215-345-0919, or Carl Hymans, G.S. Schwartz & Co.,
+1-212-725-4500, Web Site: http://www.quigleyco.com/
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