Zila, Inc. Reports Fiscal 2006 and Fourth Quarter Results.PHOENIX -- Zila, Inc. (NASDAQ NASDAQ in full National Association of Securities Dealers Automated Quotations U.S. market for over-the-counter securities. Established in 1971 by the National Association of Securities Dealers (NASD), NASDAQ is an automated quotation system that reports on GM: ZILA) reported its financial results for the fiscal year and fourth quarter ended July July: see month. 31, 2006.
Fiscal 2006 Financial Results:
-- Zila, Inc.'s (the "Company") net revenue for fiscal 2006 was $28.2
million, compared with $43.5 million for fiscal 2005. For the year,
net revenue for Zila Pharmaceuticals, Inc. ("Zila Pharmaceuticals")
increased by 34%, while the net revenue of Zila Nutraceuticals,
Inc. ("Zila Nutraceuticals") decreased by 44%.
-- Zila Pharmaceuticals' revenue increased 34%, to $6.7 million,
compared with $5.0 million in the prior year. Pharmaceuticals
represented 24% of revenue in fiscal 2006 compared with 12% of
revenue for fiscal 2005. The growth in net revenue in Zila
Pharmaceuticals was driven by increases in all product lines. Sales
of ViziLite(R) and ViziLite(R) Plus were $2.7 million, a 128%
increase over sales of ViziLite(R) in fiscal 2005. Peridex(R) sales
increased by 5% to $4.0 million in fiscal 2006 compared with fiscal
2005.
Gross margins for Zila Pharmaceuticals for the fiscal year ended
July 31, 2006 were 53%, compared with 64% for the fiscal year ended
July 31, 2005. This decrease was primarily caused by incentives to
support the launch of ViziLite(R) Plus.
-- The Nutraceuticals business was divested on October 2, 2006 to
NBTY, Inc. in a cash transaction valued at up to $40.5 million.
Zila Nutraceuticals' fiscal 2006 revenue was $21.5 million compared
with $38.5 million for the fiscal year ended July 31, 2005. The
Company believes the decline in revenue was primarily due to
decreased sales to several of its largest customers as a result of
the divestiture process.
Gross margins for Zila Nutraceuticals were 61% compared with 68%
for the fiscal year ended July 31, 2005. This decrease was caused
largely by promotional discounts offered in an effort to stimulate
sales.
-- Total operating expenses for Zila Biotechnology, Inc. ("Zila
Biotechnology") for fiscal 2006 were $9.5 million, a 9% increase,
compared with $8.7 million for fiscal 2005. This increase reflects
the commencement of the new Phase III clinical trial for
OraTest(R). Research and development expenses related to the
OraTest(R) program were $7.2 million in fiscal 2006 compared to
$6.7 million in fiscal 2005.
-- Zila completed the fiscal year with a net loss from continuing
operations of $27.7 million, or $0.61 per diluted common share,
compared with a net loss of $7.3 million, or $0.16 per diluted
common share in fiscal 2005. Discontinued operations produced a net
loss of $1.6 million, or $0.03 per diluted common share, in fiscal
2006 but generated income of $8.4 million, or $0.18 per diluted
common share, in fiscal 2005, largely from the gain on the
divestiture of the Zilactin(R) business in June 2005.
-- Cash, cash equivalents and restricted cash at July 31, 2006 totaled
$7.5 million, compared to cash, cash equivalents, restricted cash
and short-term investments of $13.4 million at July 31, 2005.
Fiscal 2006 Business Highlights:
-- In December 2005, the Company reached an agreement with the United
States Food and Drug Administration's ("FDA") regarding the FDA's
Special Protocol Assessment process, on the Company's new Phase III
clinical trial for OraTest(R), an oral cancer detection drug. To
date, enrollment to accrue the fewer than 4,000 patients needed for
the multi-center trial is proceeding on schedule. The trial may be
approaching a point where an interim analysis of the test results
could be required.
-- In January 2006, the Company rolled out ViziLite(R) Plus. This
product combines its oral screening technology, ViziLite(R) with
TBlue630, a marking system using Zila Tolonium Chloride (ZTC(R)),
the only patented, pharmaceutical-grade form of toluidine blue.
TBlue630 was FDA-cleared and contains the same active ingredient
and formulation that is used in the Company's OraTest(R) product.
-- During fiscal 2006, the Company expanded ViziLite(R) Plus insurance
coverage and added 500 group practices to its customer base,
including some of the largest practices in the country.
-- In line with the Company's strategy to focus on cancer detection
and divest non-core assets, the Company divested IST in July 2006
and closed on the sale of Zila Nutraceuticals in October 2006.
Further, the Company entered into a non-binding letter of intent to
acquire a privately-held dental products company in order to reach
the nation's dentists through a national sales force. There can be
no assurance that this potential acquisition will be completed.
"Fiscal 2006 began a revolutionary transition for Zila as we continued our strategy to focus our business on high-growth cancer detection technologies. We succeeded in that mission with growth in ViziLite[R] Plus product awareness, dental dental /den·tal/ (den´t'l) pertaining to a tooth or teeth. den·tal adj. 1. Of, relating to, or for the teeth. 2. Of, relating to, or intended for dentistry. office integration and insurance reimbursement Reimbursement Payment made to someone for out-of-pocket expenses has incurred. , while OraTest OraTest® ENT A toluidine blue mouthrinse for detecting oral cancer, specifically SCC which accounts for 95% of oral CA. See Oral cancer, Toluidin blue. [R] moved closer to completion of its regulatory reg·u·late tr.v. reg·u·lat·ed, reg·u·lat·ing, reg·u·lates 1. To control or direct according to rule, principle, or law. 2. objectives. We were also able to divest To deprive or take away. Divest is usually used in reference to the relinquishment of authority, power, property, or title. If, for example, an individual is disinherited, he or she is divested of the right to inherit money. our Nutraceuticals business at a fair valuation in October October: see month. 2006," said Zila Chairman, President and CEO (1) (Chief Executive Officer) The highest individual in command of an organization. Typically the president of the company, the CEO reports to the Chairman of the Board. , Doug DOUG Dumb Old Utility Guy Burkett, Ph.D. Dr. Burkett continued, "As our ongoing efforts will be focused on growing ViziLite[R] Plus and subsequently OraTest[R], we sought to acquire a dental company with a national sales force in order to provide the infrastructure required to establish our oral cancer detection products as the standard of care within dental offices nationally. We reviewed over 200 potential dental companies and we have entered into a non-binding letter of intent to acquire a privately-held dental products business. We believe this potential acquisition will enable us to reach the nation's dentists Dentists can refer to one of the following:
The acquisition, if completed, would provide Zila with a national sales and marketing organization that has a small suite of proprietary, high margin dental products that would complement Zila's cancer screening and detection products. The sales and marketing programs currently conducted by the target company reflect the focused, hands-on hands-on adj. Involving active participation; applied, as opposed to theoretical: "We're involved in hands-on operations, pulling levers, pushing buttons" Arthur R. Taylor. approach that is required to integrate ViziLite[R] Plus into dental practices Noun 1. dental practice - the practice of dentistry practice - the exercise of a profession; "the practice of the law"; "I took over his practice when he retired" and to establish the test as the standard of care. The target company generates approximately ap·prox·i·mate adj. 1. Almost exact or correct: the approximate time of the accident. 2. $35 million in annual revenue and is profitable. The anticipated acquisition price is $34 million. There can be no assurance that this potential acquisition will be completed. Fiscal 2006 Fourth Quarter Results: -- The Company's net revenue for the fourth quarter of fiscal 2006 was $4.2 million, compared with net revenue of $11.2 million in the fourth quarter of fiscal 2005. -- Zila Pharmaceuticals' revenue decreased 40% in the fourth quarter to $1.0 million, compared with $1.7 million during the same quarter of fiscal 2005. The decline in fourth quarter revenue was primarily due to lower ViziLite(R) Plus sales as we prepared for a potential acquisition of a company with a national sales force that would provide Zila the option to offer ViziLite(R) Plus directly to dentists. Zila focused its fourth quarter efforts toward the adoption and integration of ViziLite(R) Plus within dental offices resulting in continued increases in acceptance, growth and repeat orders by dental offices as they purchased from dental distributors. However, deliberate reductions in sales into our existing distribution channel were made as we optimized our flexibility to modify and expand our means of distribution. The upward trend of quarterly ViziLite(R), and subsequently ViziLite(R) Plus, revenues that were generated during the preceding seven quarters has been temporarily disrupted to maximize our future growth options. -- Zila Nutraceuticals' revenue in the fourth quarter was $3.2 million, compared with $9.5 million during the prior year's fourth quarter. Zila believes the decrease in sales was affected by the process of seeking to divest the business unit. Gross margins for Zila Nutraceuticals were 53% for the three months ended July 31, 2006 compared with 63% for the three months ended July 31, 2005. This decrease was caused primarily by discounts offered to customers to stimulate sales. -- Total operating expenses for Zila Biotechnology in the fourth quarter was $2.1 million compared with $2.3 million in 2005. This decrease is primarily due to reduced cost within the Zila Tolonium Chloride manufacturing facility that was undergoing a recommissioning in the prior year quarter. The Company made progress in the furtherance fur·ther·ance n. The act of furthering, advancing, or helping forward: "Pakistan does not aspire to any . . . role in furtherance of the strategies of other powers" Ismail Patel. of its OraTest[R] regulatory program during the quarter. We believe that the current study enrollment can be completed in approximately one year from the beginning of enrollment at most clinical sites in spring 2006, although no assurances can be given in this regard. The on-going Adj. 1. on-going - currently happening; "an ongoing economic crisis" ongoing current - occurring in or belonging to the present time; "current events"; "the current topic"; "current negotiations"; "current psychoanalytic theories"; "the ship's current position" trial is expected to require fewer than 4,000 patients. Upon completion of the clinical program and assuming that all clinical requirements are achieved, we estimate that it will require approximately six months to complete our regulatory objectives in order to prepare the NDA (Non Disclosure Agreement) An agreement signed between two parties that have to disclose confidential information to each other in order to do business. In general, the NDA states why the information is being divulged and stipulates that it cannot be used for any supplement for submission to the FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. . Conference Call Zila, Inc. will host a conference call to discuss these results today at 4:30 p.m. EDT EDT abbr. Eastern Daylight Time EDT Eastern Daylight Time EDT n abbr (US) (= Eastern Daylight Time) → hora de verano de Nueva York EDT (1:30 p.m. PDT PDT abbr. Pacific Daylight Time PDT Pacific Daylight Time PDT n abbr (US) (= Pacific Daylight Time) → hora de verano del Pacífico PDT ). To participate in the teleconference, please call toll-free 877-407-8031 (or 201-689-8031 for international callers) approximately 10 minutes prior to the above start time. You may also listen to the teleconference live via the internet at www.zila.com. Investors should visit the website prior to the call to download To receive a file transmitted over a network. In any communications session, "download" means receive, and "upload" means send. The download/upload often implies a big/little scenario, in which data is being downloaded from the "big" server into the "little" user's computer. any necessary audio software. A telephone playback Playback could mean:
About Zila, Inc. Zila, Inc., headquartered in Phoenix, is a leading cancer diagnostic company initially focused on oral cancer: * Zila Pharmaceuticals is dedicated to establishing ViziLite([R])Plus as the new standard of care within dental offices nationally for the early detection of oral abnormalities that could lead to cancer. * Zila Biotechnology biotechnology, the use of biological processes, as through the exploitation and manipulation of living organisms or biological systems, in the development or manufacture of a product or in the technological solution to a problem. is focused on achieving regulatory approval for the next generation oral cancer diagnostic, OraTest([R]), followed by the development of additional applications of its cancer detection technologies including products for the early detection of cervical cervical /cer·vi·cal/ (ser´vi-k'l) 1. pertaining to the neck. 2. pertaining to the neck or cervix of any organ or structure. cer·vi·cal adj. and esophageal cancer Esophageal Cancer Definition Esophageal cancer is a malignancy that develops in tissues of the hollow, muscular canal (esophagus) along which food and liquid travel from the throat to the stomach. . For more information about Zila, visit www.zila.com. This press release contains forward-looking statements forward-looking statement A projected financial statement based on management expectations. A forward-looking statement involves risks with regard to the accuracy of assumptions underlying the projections. within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. These forward-looking statements are based largely on Zila's expectations or forecasts of future events, can be affected by inaccurate assumptions and are subject to various business risks and known and unknown uncertainties, a number of which are beyond the Company's control. Therefore, actual results could differ materially from the forward-looking statements contained herein. A wide variety of factors could cause or contribute to such differences and could adversely impact revenue, profitability, cash flows and capital needs. There can be no assurance that the forward-looking statements contained in this press release will, in fact, transpire or prove to be accurate. The Company makes no commitment, and disclaims any duty, to update or revise any forward-looking statements to reflect future events or changes in expectations. For a more detailed description of these and other cautionary factors that may affect Zila's future results, please refer to Zila's Form 10-K Form 10-K A report required by the SEC from exchange-listed companies that provides for annual disclosure of certain financial information. Form 10-K See 10-K. for its fiscal year ended July 31, 2006 [TABLE OMITTED] [TABLE OMITTED] [TABLE OMITTED] [TABLE OMITTED] |
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