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ZILA > SEC Filings for ZILA > Form 10-Q on 9-Jun-2009All Recent SEC Filings

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Form 10-Q for ZILA INC


9-Jun-2009

Quarterly Report


Item 2. Management's Discussion and Analysis of Financial Condition and Results
of Operations.
The following management's discussion and analysis of financial condition and results of operations ("MD&A") should be read in conjunction with the unaudited condensed consolidated financial statements and notes thereto included elsewhere herein as well as our annual report on Form 10-K for the year ended July 31, 2008, as filed with the Securities and Exchange Commission ("SEC"), including the factors set forth in the section titled "Forward-looking Statements," as well as our other filings made with the SEC. In this MD&A, "Zila," "we," "us," or "our" refer to Zila, Inc. and its wholly-owned subsidiaries. Forward-Looking Statements
This Quarterly Report on Form 10-Q, including this MD&A, contains forward-looking statements regarding future events and our future results that are subject to the safe harbors created under the Securities Act of 1933 (the "Securities Act") and the Securities Exchange Act of 1934 (the "Exchange Act"). These statements are based on current expectations, estimates, forecasts and projections about the industries in which we operate and the beliefs and assumptions of our management. Words such as "expects," "anticipates," "targets," "goals," "projects," "intends," "plans," "believes," "seeks," "estimates," "continues," "may," "could," "foresees," "should," "likely," and variations of such words and similar expressions are intended to identify such forward-looking statements. In addition, any statements that refer to projections of our future financial performance, our anticipated growth and trends in our businesses, and other characterizations of future events or circumstances are forward-looking statements. Readers are cautioned that these forward-looking statements are only predictions and are subject to risks, uncertainties, and assumptions that are difficult to predict, including those identified in our Form 10-K for the year ended July 31, 2008 under Item 1A "Risk Factors," and in Item 1A, "Risk Factors" under Part II hereof. Therefore, actual results may differ materially and adversely from those expressed in any forward-looking statements. We undertake no obligation to revise or update any forward-looking statements for any reason. Overview
Business
Zila is a diagnostic company dedicated to the prevention, detection and treatment of oral cancer and periodontal disease. We manufacture and market ViziLite® Plus with TBlue® ("ViziLite® Plus"), our flagship product for the early detection of oral abnormalities that could lead to cancer. ViziLite® Plus is an adjunctive medical device cleared by the FDA for use in a population at increased risk for oral cancer. In addition, Zila designs, manufactures and markets a suite of proprietary products sold exclusively and directly to dental professionals for periodontal disease, including the Rotadent®Professional Powered Brush, the Pro-Select Platinum® ultrasonic scaler and a portfolio of oral pharmaceutical products for both in-office and home-care use. Our products are marketed and sold in the United States and Canada primarily through our direct field sales force and telemarketing organization. Our products are marketed and sold in other international markets through the sales forces of third party distributors. Historically, our marketing programs have reached most U.S. dental offices by direct marketing efforts and various media outlets. However, because of cost control and cash preservation initiatives, during fiscal 2009 we have significantly reduced our marketing efforts, which has impacted our reach to new and existing customers. We are an approved American Dental Association continuing education provider and recently submitted our renewal application to the Academy of General Dentistry to continue as an approved continuing education provider.
Recent Developments and Continuance of Operations Our business is sensitive to general economic conditions since our products are somewhat discretionary in nature. Accordingly, the recent global economic downturn has had a negative impact on our revenues. We implemented profit enhancement initiatives in the second half of fiscal 2008 that resulted in satisfying the Defined EBITDA covenant contained in our Third Amended and Restated Secured Notes (the "Senior Secured Convertible Notes"), which are discussed in more detail elsewhere herein, including: (i) completing the hiring of the targeted level of sales representatives and completing their training across the full portfolio of our products; (ii) improving revenues and gross profit through the implementation of selective price increases and implementing initiatives to reduce our cost of goods; (iii) reducing personnel in our non-selling workforce, temporarily reducing the salaries of our management employees and reducing certain other employee benefits; and (iv) reducing, deferring or eliminating non-critical programs across the organization while maintaining key selling initiatives. Although these initiatives proved to be effective in satisfying the Defined EBITDA covenant contained in our Senior Secured Convertible Notes during the fourth quarter of fiscal 2008, some of these initiatives, such as reducing or deferring salaries, benefits and other operating costs, are not sustainable into future periods.


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During fiscal 2009, our revenues have been negatively impacted as a result of the severity of the global economic downturn and its impact on discretionary spending on our products. Our revenues have also been affected as a result of customer concern about our viability as an ongoing business. Concerns about our financial viability have also contributed to increased turnover in our field sales force and other key staff areas and have led to a reduction in our marketing effectiveness and our reach to new and existing customers. We would expect these factors to cause near term future operating results to be less favorable than our financial results for the fourth quarter of fiscal 2008 and those previously anticipated for fiscal 2009. To address the impact of this revenue decline, during fiscal 2009 we have (i) continued salary reductions for a number of management personnel; (ii) eliminated additional personnel, including an approximately 15% reduction of our field sales force as a result of the realignment of our sales territories; (iii) eliminated the employee stock purchase plan and its associated costs; (iv) furloughed certain manufacturing production personnel; (v) reduced the number of seminar programs and streamlined the cost structure of these programs; and (vi) reduced tradeshow expenditures. Excluding the effect of the $23.2 million non-cash impairment charge for goodwill and other intangible assets recognized during December 2008, these actions significantly narrowed our operating loss over the same periods in the prior year. The impairment loss is more fully described in Note 5, Goodwill and Other Intangible Assets. To address the impact of the economic downturn on our revenues, we continue to identify cost-reduction and working capital initiatives to reduce the impact on future cash flows from operations and results of operations.
While we have continued to execute a number of cost reduction strategies, the decline in our revenues has caused our cash utilization to exceed previously planned levels. As of April 30, 2009, we had approximately $3.1 million of cash and cash equivalents, compared to $2.5 million, $3.2 million and $4.5 million at January 31, 2009, October 31, 2008 and July 31, 2008, respectively. As a result of the reclassification of the Senior Secured Convertible Notes to a current liability, as of April 30, 2009 and January 31, 2009, we had working capital deficits of $5.3 million and $4.3 million, respectively, compared to positive working capital of $5.7 million and $6.6 million at October 31, 2008 and July 31, 2008, respectively. In order to continue as a going concern and fund our current level of operations over the next twelve months, we will require additional funding and need to restructure or retire our Senior Secured Convertible Notes. If we are unable to execute these strategies, we will likely be forced to file for protection under Chapter 11 of the Federal Bankruptcy Code or liquidate the Company under Chapter 7 of the Federal Bankruptcy Code. We have retained financial and legal advisors to assist us in our numerous continuing efforts to restructure our Senior Secured Convertible Notes, raise capital and explore possible strategic opportunities.
Our efforts to seek additional funding have included discussions with numerous potential financial and strategic investors as well as with the holders of the Senior Secured Convertible Notes. All potential investors with whom we have had discussions required, as a condition of their investment, that the Senior Secured Convertible Notes be repaid from the funds provided by the investor(s) and that this repayment be at a substantial discount from the $12.0 million principal outstanding to reflect the current market value of those notes. We are also engaged in discussions and negotiations with other parties regarding a variety of possible strategic transactions, including the possible sale of the Company or substantially all of its assets. One of those parties and the holders of the Senior Secured Convertible Notes have entered into an agreement (a "Note Purchase Agreement") whereby such party has the right, subject to certain conditions and for a limited period of time, to acquire all of the Senior Secured Convertible Notes from the current holders at a significant discount from the $12.0 million principal balance of these notes. The Company is not a party to the Note Purchase Agreement.
We are in compliance with the terms of the Senior Secured Convertible Notes, except for the quarterly interest payments due April 30, 2009 and January 31, 2009, which have not been made as of the date of this filing. The failures to make these payments are events of default under our Senior Secured Convertible Notes. Upon an event of default, the Senior Secured Convertible Notes bear interest at a default rate of 15.0% per annum. Although we have not received a notice of default or acceleration from the note holders as of the date of this filing, which is required prior to any of the principal amount becoming due and payable as a result of such default, we have reclassified the Senior Secured Convertible Notes to current liabilities. Pursuant to the Note Purchase Agreement, the holders of the Senior Secured Convertible Notes have agreed not to exercise their remedies under such notes unless and until the Note Purchase Agreement is terminated. However, there can be no assurance that the current or future note holders will not accelerate amounts due under the Senior Secured Convertible Notes and proceed against their collateral. In the event of acceleration, we would likely be forced to file for protection under Chapter 11 of the Federal Bankruptcy Code or liquidate the Company under Chapter 7 of the Federal Bankruptcy Code, which would likely result in our common stock becoming worthless.
We were unable to issue shares for the April 30, 2009 and January 31, 2009 interest payments because, due to our share price at such time, the number of shares to be issued would have required shareholder approval under applicable NASDAQ rules. Accordingly, as of April 30, 2009, there was approximately $0.7 million of unpaid accrued interest due the holders of the Senior Secured Convertible Notes. In addition, given our current level of cash and cash equivalents, the impact of the global economic downturn on our business and customer concern about our viability as an ongoing business, it is uncertain whether we will have sufficient cash available to pay our future quarterly interest payments due under the Senior Secured Convertible Notes.


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As a result of the foregoing, there is substantial doubt about our ability to continue as a going concern. Accordingly, realization values may be substantially different from carrying values as shown, and these financial statements do not give effect to adjustments that would be necessary to the carrying values and classification of assets and liabilities should we be unable to continue as a going concern.
Other Key Operating Initiatives
During May 2009, Zila and other experts on oral oncology and oral cancer diagnostics testified at a congressional hearing on innovative technology for Veterans. Legislators were urged to press the U.S. Department of Veterans Affairs to expand the use of ViziLite® Plus for Veterans, who are at a dramatically higher risk of oral cancer. In December 2007, the U.S. Department of Veterans Affairs awarded Zila a five-year contract to market ViziLite®Plus to 58 Veterans Administration dental clinics and 154 Department of Defense dental clinics; however, screens performed using our ViziLite® Plus product by these clinics have not been as numerous as expected since the time this contract was entered into. We believe ViziLite® Plus provides a significant opportunity for Veterans and the early detection of oral abnormalities that could lead to cancer. We believe there is also a significant opportunity for Zila should the clinics covered by the contract with the Department of Defense realize the benefits of ViziLite® Plus for Veterans who utilize these clinics and expand their screening with ViziLite® Plus.
During the second quarter of fiscal 2009, we completed the first phase of the global rollout of our proprietary oral cancer screening product, ViziLite® Plus. Beginning in North America and through our direct sales force, we now market ViziLite® Plus in all 50 states of the U.S., as well as Canada. Since May 2008, we have expanded to Western Europe by forming strategic alliances to distribute ViziLite® Plus in a number of European markets. ViziLite® Plus is now available in the United Kingdom, Ireland, Germany, Spain, Portugal, France and Greece. For the next phase of our expansion, we have formed distribution agreements in other international markets, including Russia and Belarus, where product registration is in process. During February 2009, we furthered this expansion initiative with the selection of Getwell Life Sciences to distribute ViziLite® Plus throughout India. We expect these markets and others in the Pacific Rim region, especially China and India, will form the bulk of our continued global expansion for ViziLite® Plus.
During October 2008, the U.K. Medicines and Healthcare products Regulatory Agency issued an indefinite renewal of the marketing authorization for OraTest®, our proprietary oral cancer diagnostic kit. Under the European Union's ("EU") mutual recognition process, we expect to receive renewal licenses for member states including Finland, Greece, Luxembourg, The Netherlands, Belgium, the U.K. and Portugal. We are seeking marketing partners in the seven EU countries. Adding OraTest® to our international product portfolio provides the opportunity to expand the potential market for our oral cancer screening and testing product franchise. The OraTest® diagnostic kit and ViziLite® Plus are complementary products with distinct indications, which will allow us to market to a more diverse group of healthcare professionals within the EU.
During November 2008, Essex Dental Benefits began offering coverage for ViziLite®Plus examinations. Essex Dental Benefits joins the growing list of premiere and national insurance plans that provide coverage for ViziLite® Plus, which also includes Humana, United Healthcare, Cigna, Guardian, SafeGuard, Northeast Delta Dental and a number of regional plans and self-insured employers. With the addition of Essex Dental Benefits, approximately 25 million lives are part of dental plans that cover oral cancer screening; however, not all dental professionals in these plans have made ViziLite® Plus available to their patients. We are actively working with several large dental plans to co-promote ViziLite® Plus to their national contracted dentist networks. Additionally, there has been an increased focus by Zila sales staff on dentists contracted with dental plans that offer coverage for ViziLite® Plus.


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Results of Operations
   The following table summarizes our results of operations and related
statistical information for the three and nine months ended April 30, 2009 and
2008 (dollars in thousands):

                                                       For the Three Months Ended April 30,
                                                       % of                            % of             %
                                       2009          Revenue           2008          Revenue          Change

Net revenues                         $  8,467           100.0 %      $ 11,245           100.0 %        (24.7) %
Cost of products sold                   3,459            40.9           4,438            39.5           (22.1 )


Gross profit                            5,008            59.1           6,807            60.5           (26.4 )

Operating costs and expenses:
Marketing and selling                   3,165            37.4           6,046            53.8           (47.7 )
General and administrative              1,773            20.9           3,281            29.1           (46.0 )
Research and development                   90             1.1             247             2.2           (63.6 )
Depreciation and amortization             308             3.6             952             8.5           (67.6 )


Total operating costs and
expenses                                5,336            63.0          10,526            93.6           (49.3 )


Loss from operations                     (328 )          (3.9 )        (3,719 )         (33.1 )         (91.2 )
Other expense - net                    (1,121 )         (13.2 )          (758 )          (6.7 )          47.9


Loss from continuing operations
before income taxes                    (1,449 )         (17.1 )        (4,477 )         (39.8 )         (67.6 )
Income tax benefit (expense)              (32 )          (0.4 )            34             0.3          (194.1 )


Loss from continuing operations      $ (1,481 )        (17.5) %      $ (4,443 )        (39.5) %         (66.7 )




                                                         For the Nine Months Ended April 30,
                                                        % of                              % of             %
                                       2009            Revenue           2008           Revenue          Change

Net revenues                         $  26,620            100.0 %      $  33,176           100.0 %        (19.8) %
Cost of products sold                   11,006             41.3           13,264            40.0           (17.0 )


Gross profit                            15,614             58.7           19,912            60.0           (21.6 )

Operating costs and expenses:
Marketing and selling                   10,884             40.9           16,564            49.9           (34.3 )
General and administrative               5,810             21.9            9,883            29.8           (41.2 )
Impairment of goodwill and
other intangible assets                 23,193             87.1                -               -
Research and development                   335              1.3            2,237             6.7           (85.0 )
Depreciation and amortization            1,843              6.9            2,811             8.5           (34.4 )


Total operating costs and
expenses                                42,065            158.0           31,495            94.9            33.6


Loss from operations                   (26,451 )          (99.4 )        (11,583 )         (34.9 )         128.4
Other expense - net                     (3,012 )          (11.3 )         (2,155 )          (6.5 )          39.8


Loss from continuing operations
before income taxes                    (29,463 )         (110.7 )        (13,738 )         (41.4 )         114.5
Income tax benefit (expense)               (45 )           (0.1 )             23             0.1          (295.7 )


Loss from continuing operations      $ (29,508 )        (110.8) %      $ (13,715 )        (41.3) %         115.2


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Net Revenues
Net revenues were $8.5 million and $11.2 million for the three months ended April 30, 2009 and 2008, respectively, a decrease of $2.7 million or 24.7%. Net revenues were $26.6 million and $33.2 million for the nine months ended April 30, 2009 and 2008, respectively, a decrease of $6.6 million or 19.8%. ViziLite® Plus net revenues decreased to $2.7 million and $8.5 million for the three and nine months ended April 30, 2009, a decrease of 25.5% and 13.1% from the same periods in the previous year, respectively. Also contributing to the decrease in net revenues were lower sales of our Rotadent® Professional Powered Brush and Pro-Select Platinum®ultrasonic scalers. Although we have recently been successful in increasing the utilization of ViziLite® Plus, expanding our international programs and driving increases in the number of insurance companies reimbursing for the ViziLite® Plus examination, the deepening of the global economic downturn and customer concern about our viability as an ongoing business have had a significant negative impact on our business. As discussed above, our business is sensitive to general economic conditions since our products are somewhat discretionary in nature. Gross Profit
Gross profit was $5.0 million and $6.8 million for the three months ended April 30, 2009 and 2008, respectively, a decrease of $1.8 million or 26.4%. Gross profit was $15.6 million and $19.9 million for the nine months ended April 30, 2009 and 2008, respectively, a decrease of $4.3 million or 21.6%. Gross profit as a percentage of net revenues was 59.1% and 60.5% for the three months ended April 30, 2009 and 2008, respectively, and 58.7% and 60.0% for the nine months ended April 30, 2009 and 2008, respectively. Our gross profit margin for the three and nine months ended April 30, 2009 was negatively impacted by selective discounting programs that were implemented in the first half of fiscal 2009 in an effort to stimulate sales and counteract the revenue declines discussed above. At times in fiscal 2009, we have also experienced product cost increases as a result of decreased purchasing volumes and the resulting impact on discounts for products purchased.
Marketing and Selling Expense
Marketing and selling expense was $3.2 million and $6.0 million for the three months ended April 30, 2009 and 2008, respectively, a decrease of $2.8 million or 47.7%. Marketing and selling expense was $10.9 million and $16.6 million for the nine months ended April 30, 2009 and 2008, respectively, a decrease of $5.7 million or 34.3%. The decline in marketing and selling expense for the three and nine months ended April 30, 2009 resulted from the reduction in the level of commissions and bonuses paid to the sales force as a result of reduced sales levels, reduced sales force personnel as a result of a realignment of our sales territories to gain efficiencies and reductions in expenditures in non-direct selling related expenses. Additionally, we have continued the temporary reduction of our marketing expenditures in connection with our profit enhancement initiatives, which include reductions in expenditure levels for tradeshows, seminars and other marketing activities. Concerns about our financial viability have also contributed to increased turnover in our field sales force and other key staff areas and have led to a reduction in our marketing effectiveness and our reach to new and existing customers. General and Administrative Expense
General and administrative expense was $1.8 million and $3.3 million for the three months ended April 30, 2009 and 2008, respectively, a decrease of $1.5 million or 46.0%. General and administrative expense was $5.8 million and $9.9 million for the nine months ended April 30, 2009 and 2008, respectively, a decrease of $4.1 million or 41.2%. The decrease in general and administrative expense primarily relates to profitability initiatives that were implemented during the second half of fiscal 2008 and the first part of fiscal 2009. These profitability initiatives included reducing personnel in our non-selling workforce by approximately 35% through the third quarter of fiscal 2009, the temporary reduction of the salaries of certain management employees, reducing certain other employee benefits and reducing, deferring or eliminating non-critical programs across the organization. Professional fees declined for the three and nine months ended April 30, 2009 as fees incurred in the prior-year for investment banking expenses to explore financing alternatives and Sarbanes Oxley compliance costs were lower in fiscal 2009, but were offset to some extent by increased professional fees associated with analysis of our impairment charge relative to goodwill and other intangible assets, which is described more fully below.


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General and administrative expense consists of the following for the three and nine months ended April 30, 2009 and 2008 (in thousands):

                                                 Three Months Ended April 30,                Nine Months Ended April 30,
                                                  2009                  2008                 2009                  2008

Cash basis salaries and benefits              $         696         $       1,300        $       2,176         $       3,572
Audit, accounting and other professional
fees                                                    425                   718                1,302                 1,994
Investment banking fees and shareholder
related expense                                          86                    55                  433                   373
Legal and intellectual property related
fees                                                    147                   253                  477                   905
Insurance                                               113                   135                  338                   384
Non-cash stock-based compensation
expense                                                  65                   344                  246                 1,200
Other general and administrative expense                241                   476                  838                 1,455


Total general and administrative expense      $       1,773         $       3,281        $       5,810         $       9,883

Impairment of Goodwill and Other Intangible Assets We have historically assessed the impairment of goodwill annually in our fourth fiscal quarter, or whenever events or changes in circumstances indicate that the carrying value of goodwill may not be recoverable. During fiscal 2009, our revenues have been negatively impacted as a result of the severity of the global economic downturn and its impact on discretionary spending on our products. Our revenues have also been affected as a result of customer concern about our viability as an ongoing business. We would expect these factors to cause near term future operating results to be less favorable than previously anticipated for fiscal 2009. We also experienced a decline in our stock price and a corresponding decline in our market capitalization and enterprise value throughout fiscal 2009. Finally, as of December 2008, we anticipated we would fail to make the interest payment due January 31, 2009 on our Senior Secured Convertible Notes, which is an event of default under such notes. As of the date . . .

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