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Quotes & Info
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| ZILA > SEC Filings for ZILA > Form 10-Q on 9-Jun-2009 | All Recent SEC Filings |
9-Jun-2009
Quarterly Report
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.
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.
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.
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
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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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