Business and Finance
DOYLESTOWN, Pa. (Map) -
The fourth quarter ended
Despite the aforementioned occurrences offsetting sales gains, the Company believes in the viability of the COLD-EEZE brand to garner acceptance among consumers who want Natural Common Cold remedies that demonstrate proven clinical efficacy and safety. As part of ongoing initiatives to generate future growth, the introduction of two new COLD-EEZE brand extensions, Organix(TM) Cough and Sore Throat Drops and COLD-EEZE Immune Support Complex-10 (ISC-10) will enable consumers to choose two new options to support their health during the Cold and Flu Season.
Organix Cough and Sore Throat Drops is a proprietary product manufactured in the Company's certified organic manufacturing facility, the first facility of its kind to obtain USDA organic certification. COLD-EEZE ISC-10 will compete in the growing immune boosting dietary supplement marketplace and features a proprietary blend of 10 important immune supporting nutrients, minerals and herbs shown to support proper immune system functioning. Both of these new products are currently being sold in many major market retailers.
The Health and Wellness segment net sales declined by
Net income for the fourth quarter ended
The increase in net income for the fourth quarter ended
The increase in net loss for the twelve-months ended
As previously announced today by The Quigley Corporation, it completed the
sale on
Over the last few years, net sales of the Health and Wellness segment have declined significantly resulting in continued losses, which is due to the continued reduction in the number of active independent distributor representatives, and the effects of ongoing litigation with the sponsor of its product line.
As the Company continues to review its current structure, ownership of Darius is no longer a benefit since losses by this segment have been a drain for the ongoing research and development costs associated with the ethical pharmaceutical segment. Also, separating this segment will help streamline the structure of the Company, which will focus on continuing operations in OTC product marketing and pharmaceutical research.
Pharmaceutical research and development costs associated with clinical
studies for QR-333, including the Phase II(b), an investigational new drug for
treating conditions associated with diabetic peripheral neuropathy, increased
significantly during 2007 to
According to 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
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, a wholly owned Ethical Pharmaceutical subsidiary, by developing natural-source potential prescription products particularly for Diabetic Peripheral Neuropathy, Avian Flu in animals, Rheumatoid Arthritis and for protection against ionizing Radiation and other items.
The following is a summary of ethical pharmaceutical activities that occurred during 2007:
Diabetic Peripheral Neuropathy - QR-333: The number of enrolled subjects
continue to increase in our Phase II(b) study designed to evaluate the safety
and efficacy of the topical formulation on subjects with diabetic peripheral
neuropathy. Subject screening and enrollment will continue to ensure at least
a 140 evaluable patient study population. Once enrolled, subject treatment
time is 12 weeks. To date the in-progress safety profile for this study has
been consistent with favorable safety results of the previous human proof of
concept study conducted in
Avian Flu Compound - QR-441(a): Positive results were achieved in a preliminary study which demonstrated the compound to be a potential antiviral agent for Infectious Bronchitis and New Castle Disease, two viral poultry diseases that have a significant annual economic impact on the poultry industry. Previous in vitro studies have demonstrated QR-441(a) to be a potent antiviral agent against H5N1 (Avian Flu).
In addition, an agreement was signed with the State of
Patent For Prophylactic And Anti-Transmissivity Uses Of An Anti-Microbial Composition - This patent provides additional protection to an existing composition patent and further supports on-going investigations and potential commercialization opportunities for compounds against avian flu QR-441(a) and human influenza (QR-435).
Cachexia Treatment Compound - QR-443: Further positive results were obtained for the QR-443 compound for the treatment of Cachexia, a debilitating and life threatening muscle wasting condition associated with cancer, AIDS, renal failure, COPD and rheumatoid arthritis, where inflammation has a significant impact and patients experience loss of weight, muscle atrophy, fatigue, weakness and decreased appetite. A preliminary follow up Cachexia study, evaluating weight loss in mice concluded that QR-443 was as effective in delaying the progression of Cachexia when given orally as it had been shown to be when administered intra-peritoneally in a previous study. The data complements the previous study results demonstrating a correlation between effectiveness and the frequency of administration of the QR-443 compound.
Human clinical safety trial designed to evaluate the effects of QR-449: Based on positive preclinical animal data and Institutional Review Board (IRB) approval human clinical safety trials designed to evaluate the effects of QR- 449 on subjects with Metabolic Syndrome were initiated. People suffering from Metabolic Syndrome are vulnerable to the most dangerous heart attack risk factors; diabetes, abdominal obesity, high cholesterol and high blood pressure.
Presentation at the New York Society of Security Analysts (NYSSA): Senior
management of the Quigley Corporation made a presentation at the 11th Annual
Biotech/Specialty Pharma Industry investor conference in
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(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.
(Tables Follow) Consolidated Statements of Operations (Unaudited) The following represents condensed financial data (in thousands) except per share data: Three-Months Three-Months Year Year Ended Ended Ended Ended December December December December 31, 2007 31, 2006 31, 2007 31, 2006 ($) ($) ($) ($) Net Sales 13,568 14,196 39,475 42,125 Gross profit 8,597 8,997 22,648 22,878 Sales & marketing expenses 1,341 3,530 5,977 8,326 Administrative expenses 4,050 3,122 13,417 13,124 Research & development 1,694 1,286 6,490 3,820 Income taxes (benefit) - - - 89 Net income (loss) 1,661 1,246 (2,458) (1,748) Diluted income (loss) per share: Net income (loss) $0.12 $0.09 ($0.19) ($0.14) Diluted weighted average common shares outstanding: 13,396,497 13,162,534 12,728,706 12,245,073 Consolidated Balance Sheets (Unaudited) The following represents condensed financial data (in thousands) at
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