UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, DC 20549
Form 10-Q
(Mark one)
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þ
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QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
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For the quarterly period ended October 31, 2007
OR
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o
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TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
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For the transition period from
to
Commission File Number 0-17521
Zila, Inc.
(Exact Name of Registrant as Specified in its Charter)
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Delaware
(State or Other Jurisdiction of
Incorporation)
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86-0619668
(I.R.S. Employer
Identification No.)
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5227 North 7th Street, Phoenix, Arizona, 85014-2800
(Address of Principal Executive Offices) (Zip Code)
(602) 266-6700
(Registrants telephone number, including area code)
Indicate by check mark whether the registrant (1) has filed all reports required to be filed by
Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months, and (2)
has been subject to such filing requirements for the past 90 days.
Yes
þ
. No
o
.
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer,
or a non-accelerated filer. See definition of accelerated filer and large accelerated filer in
Rule 12b-2 of the Exchange Act. (Check one):
Large accelerated filer
o
Accelerated filer
þ
Non-accelerated filer
o
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the
Exchange Act). Yes
o
No
þ
As of
November 30, 2007, 61,662,329 shares of the registrants common stock were outstanding.
PART I FINANCIAL INFORMATION
Item 1.
Financial Statements
ZILA, INC. AND SUBSIDIARIES
CONDENSED CONSOLIDATED BALANCE SHEETS
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October 31,
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July 31,
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2007
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2007
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(Unaudited)
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ASSETS
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Current assets:
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Cash and cash equivalents
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$
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8,660,176
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$
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14,859,159
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Trade receivables net of allowances of $162,000 and $173,000
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6,219,983
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4,273,580
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Inventories net
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4,027,235
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4,074,733
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Prepaid expenses and other current assets
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1,737,560
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1,646,229
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Total current assets
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20,644,954
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24,853,701
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Property and equipment net
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6,246,847
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6,219,436
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Goodwill
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10,171,351
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10,171,351
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Purchased technology net
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9,628,131
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9,884,017
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Trademarks and other intangible assets net
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11,214,608
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11,555,041
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Other assets
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1,098,315
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1,197,684
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Total assets
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$
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59,004,206
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$
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63,881,230
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LIABILITIES AND SHAREHOLDERS EQUITY
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Current liabilities:
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Accounts payable
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$
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4,282,391
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$
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3,207,480
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Accrued liabilities
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4,639,673
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5,587,825
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Warrant and common stock repurchase liability
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1,376,393
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Current portion of deferred gain on sale leaseback
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152,976
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152,976
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Short-term borrowings and current portion of long-term debt
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351,878
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77,472
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Current liabilities of discontinued operations
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309,436
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165,368
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Total current liabilities
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9,736,354
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10,567,514
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Deferred gain on sale leaseback
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37,415
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75,659
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Long-term debt net of current portion
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7,687,673
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7,258,569
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Total liabilities
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17,461,442
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17,901,742
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Shareholders equity:
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Preferred stock Series B, $.001 par value - 2,500,000
shares authorized, 100,000 shares issued and outstanding,
liquidation preference of $650,000
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462,500
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462,500
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Common stock, $.001 par value - 147,500,000 shares
authorized, 61,575,879 and 62,466,338 shares issued and
outstanding
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61,576
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62,466
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Additional paid-in capital
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122,629,464
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123,436,957
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Accumulated deficit
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(80,919,503
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)
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(76,054,251
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)
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Accumulated other comprehensive loss
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(140,202
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)
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(127,118
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)
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Treasury stock, at cost (218,411 and 1,151,243 common shares)
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(551,071
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)
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(1,801,066
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)
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Total shareholders equity
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41,542,764
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45,979,488
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Total liabilities and shareholders equity
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$
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59,004,206
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$
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63,881,230
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The accompanying notes are an integral part of these condensed consolidated financial statements.
2
ZILA, INC. AND SUBSIDIARIES
UNAUDITED CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
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Three Months Ended October 31,
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2007
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2006
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Net revenues
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$
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11,440,437
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$
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339,187
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Cost of products sold
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4,581,652
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500,022
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Gross profit (loss)
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6,858,785
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(160,835
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)
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Operating costs and expenses:
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Marketing and selling
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5,296,597
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1,423,047
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General and administrative
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3,473,677
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3,067,440
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Research and development
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1,201,785
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1,534,692
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Depreciation and amortization
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915,013
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389,341
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Loss from operations
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(4,028,287
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)
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(6,575,355
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)
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Other income (expense):
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Interest income
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124,182
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95,629
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Interest expense
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(766,708
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)
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(4,811,130
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)
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Derivative income (expense)
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(23,600
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)
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1,058,873
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Other income (expense)
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22,772
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(5,299
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)
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Other expense net
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(643,354
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)
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(3,661,927
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)
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Loss from continuing operations before income taxes
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(4,671,641
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)
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(10,237,282
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)
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Income tax benefit (expense)
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(11,592
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)
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3,864,900
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Loss from continuing operations
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(4,683,233
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)
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(6,372,382
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)
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Loss from discontinued operations
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(172,269
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)
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(1,119,301
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)
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Gain on disposal of discontinued operations
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11,110,406
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Income tax expense
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(3,877,000
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)
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Total income (loss) from discontinued operations
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(172,269
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)
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6,114,105
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Net loss
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(4,855,502
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)
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(258,277
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)
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Preferred stock dividends
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|
9,750
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|
|
9,750
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Net loss attributable to common shareholders
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$
|
(4,865,252
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)
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$
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(268,027
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)
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Basic and diluted net income (loss) per common share:
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Loss from continuing operations
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$
|
(0.08
|
)
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$
|
(0.14
|
)
|
Income from discontinued operations
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|
|
|
|
|
0.13
|
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|
|
|
|
|
|
|
|
|
|
|
|
|
|
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Net loss attributable to common shareholders
|
|
$
|
(0.08
|
)
|
|
$
|
(0.01
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average common shares outstanding basic and diluted
|
|
|
61,404,226
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|
|
|
45,798,041
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The accompanying notes are an integral part of these condensed consolidated financial statements.
3
ZILA, INC. AND SUBSIDIARIES
UNAUDITED CONDENSED CONSOLIDATED STATEMENTS OF SHAREHOLDERS EQUITY
For the Three Months Ended October 31, 2007
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Accumulated
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Additional
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Other
|
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Total
|
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|
Preferred Stock
|
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Common Stock
|
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Paid-in
|
|
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Accumulated
|
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Comprehensive
|
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Treasury
|
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Shareholders
|
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Shares
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Amount
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Shares
|
|
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Amount
|
|
|
Capital
|
|
|
Deficit
|
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|
Loss
|
|
|
Stock
|
|
|
Equity
|
|
Balance July 31, 2007
|
|
|
100,000
|
|
|
$
|
462,500
|
|
|
|
62,466,338
|
|
|
$
|
62,466
|
|
|
$
|
123,436,957
|
|
|
$
|
(76,054,251
|
)
|
|
$
|
(127,118
|
)
|
|
$
|
(1,801,066
|
)
|
|
$
|
45,979,488
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Preferred stock dividends
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(9,750
|
)
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|
|
|
|
|
|
|
|
|
|
(9,750
|
)
|
Exercise of common
stock options
|
|
|
|
|
|
|
|
|
|
|
10,000
|
|
|
|
10
|
|
|
|
11,190
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
11,200
|
|
Stock-based
compensation expense
|
|
|
|
|
|
|
|
|
|
|
32,373
|
|
|
|
33
|
|
|
|
430,379
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
430,412
|
|
Retirement of
treasury stock
|
|
|
|
|
|
|
|
|
|
|
(932,832
|
)
|
|
|
(933
|
)
|
|
|
(1,249,062
|
)
|
|
|
|
|
|
|
|
|
|
|
1,249,995
|
|
|
|
|
|
Foreign currency
translation
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(13,084
|
)
|
|
|
|
|
|
|
(13,084
|
)
|
Net loss
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(4,855,502
|
)
|
|
|
|
|
|
|
|
|
|
|
(4,855,502
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance October 31, 2007
|
|
|
100,000
|
|
|
$
|
462,500
|
|
|
|
61,575,879
|
|
|
$
|
61,576
|
|
|
$
|
122,629,464
|
|
|
$
|
(80,919,503
|
)
|
|
$
|
(140,202
|
)
|
|
$
|
(551,071
|
)
|
|
$
|
41,542,764
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
The accompanying notes are an integral part of these condensed consolidated financial statements.
4
ZILA, INC. AND SUBSIDIARIES
UNAUDITED CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended October 31,
|
|
|
|
2007
|
|
|
2006
|
|
Cash flows from operating activities:
|
|
|
|
|
|
|
|
|
Net loss
|
|
$
|
(4,855,502
|
)
|
|
$
|
(258,277
|
)
|
Adjustments to reconcile net loss to net cash used in operating activities:
|
|
|
|
|
|
|
|
|
Depreciation and amortization
|
|
|
1,023,727
|
|
|
|
597,369
|
|
Non-cash amortization of financing costs
|
|
|
99,369
|
|
|
|
2,095,234
|
|
Non-cash amortization of debt discounts
|
|
|
447,362
|
|
|
|
2,067,271
|
|
Non-cash interest on term loan
|
|
|
|
|
|
|
137,540
|
|
Non-cash derivative (income) expense
|
|
|
23,600
|
|
|
|
(1,058,873
|
)
|
Gain on disposal of discontinued operations
|
|
|
|
|
|
|
(11,110,406
|
)
|
Non-cash stock-based compensation expense
|
|
|
430,412
|
|
|
|
218,465
|
|
Other non-cash items net
|
|
|
(51,663
|
)
|
|
|
(54,041
|
)
|
Changes in operating assets and liabilities:
|
|
|
|
|
|
|
|
|
Trade receivables
|
|
|
(1,946,403
|
)
|
|
|
955,686
|
|
Inventories
|
|
|
47,498
|
|
|
|
(305,989
|
)
|
Prepaid expenses and other assets
|
|
|
183,075
|
|
|
|
7,589
|
|
Accounts payable and accrued liabilities
|
|
|
271,328
|
|
|
|
2,604,450
|
|
|
|
|
|
|
|
|
Net cash used in operating activities
|
|
|
(4,327,197
|
)
|
|
|
(4,103,982
|
)
|
|
|
|
|
|
|
|
Cash flows from investing activities:
|
|
|
|
|
|
|
|
|
Additions to property and equipment
|
|
|
(375,212
|
)
|
|
|
(172,948
|
)
|
Additions to intangible assets
|
|
|
(80,235
|
)
|
|
|
(125,380
|
)
|
Proceeds from sale of assets
|
|
|
462
|
|
|
|
|
|
Restricted cash returned from collateralized letter of credit
|
|
|
|
|
|
|
3,610,950
|
|
Proceeds from disposition of discontinued operations
|
|
|
|
|
|
|
34,705,077
|
|
Deposits for the acquisition of Pro-Dentec
|
|
|
|
|
|
|
(283,470
|
)
|
|
|
|
|
|
|
|
Net cash provided by (used in) investing activities
|
|
|
(454,985
|
)
|
|
|
37,734,229
|
|
|
|
|
|
|
|
|
Cash flows from financing activities:
|
|
|
|
|
|
|
|
|
Short-term borrowings net
|
|
|
|
|
|
|
268,554
|
|
Proceeds from issuance of common stock
|
|
|
11,200
|
|
|
|
27,975
|
|
Financing costs
|
|
|
|
|
|
|
(463,934
|
)
|
Principal payments on long-term debt
|
|
|
(18,258
|
)
|
|
|
(22,757,953
|
)
|
Payment of obligation to repurchase common stock and warrants
|
|
|
(1,399,993
|
)
|
|
|
|
|
Dividends paid to preferred stockholders
|
|
|
(9,750
|
)
|
|
|
(9,750
|
)
|
|
|
|
|
|
|
|
Net cash used in financing activities
|
|
|
(1,416,801
|
)
|
|
|
(22,935,108
|
)
|
|
|
|
|
|
|
|
Net increase (decrease) in cash and cash equivalents
|
|
|
(6,198,983
|
)
|
|
|
10,695,139
|
|
Cash and cash equivalents beginning of period
|
|
|
14,859,159
|
|
|
|
3,958,190
|
|
|
|
|
|
|
|
|
Cash and cash equivalents end of period
|
|
$
|
8,660,176
|
|
|
$
|
14,653,329
|
|
|
|
|
|
|
|
|
The accompanying notes are an integral part of these condensed consolidated financial statements.
5
ZILA, INC. AND SUBSIDIARIES
NOTES TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
1. Description of Business and Basis of Presentation
The accompanying Unaudited Condensed Consolidated Financial Statements include the accounts of
Zila, Inc. and its wholly owned subsidiaries (collectively, Zila, we, us or our). Zila is
an integrated oral diagnostic company dedicated to the prevention, detection and treatment of
oral cancer and periodontal disease. During fiscal 2007, we successfully completed a multi-step
strategic redirection, which included divesting non-core businesses and acquiring the national
dental products company, Professional Dental Technologies, Inc. (Pro-Dentec).
We manufacture and market ViziLite
®
Plus with TBlue
630TM
(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 Rota-dent
®
Professional Powered Brush, the Pro-Select
®
Platinum ultrasonic scaler and a portfolio
of oral pharmaceutical products for both in-office and home-care use. All of our products are
marketed and sold in the United States and Canada primarily through our direct field sales force
and telemarketing organization. Our national marketing programs reach most of the nations dental
offices and include continuing education seminars for dentists and their staffs. We are certified
by the American Dental Association and the Academy of General Dentistry to provide continuing
education seminars. Our research and development division holds expertise in pre-cancer/cancer
detection through our patented ZTC
TM
and OraTest
®
technologies and is
developing a pipeline of products focused on oral disease detection
and treatment. In October 2006,
we divested our Nutraceuticals Business Unit and in May 2007 we divested our Peridex
®
brand of prescription periodontal rinse and as a result, these operations are presented as
discontinued for all periods presented. With the integration of the operations of Pro-Dentec with
our former Zila Pharmaceuticals Business Unit and the re-alignment of our Zila Biotechnology
Business Unit to serve as our research and development division, we have organized ourselves as one
operating segment in accordance with Statement of Financial Accounting Standards (SFAS) No. 131,
Disclosures about Segments of an Enterprise and Related Information.
These unaudited condensed consolidated financial statements have been prepared pursuant to the rules and
regulations of the Securities and Exchange Commission (the SEC). All significant intercompany
transactions and accounts have been eliminated. Certain information related to our organization,
significant accounting policies and footnote disclosures normally included in financial statements
prepared in accordance with accounting principles generally accepted in the United States (GAAP)
have been condensed or omitted. The accounting policies followed in the preparation of these
unaudited condensed consolidated financial statements are consistent with those followed in our
annual consolidated financial statements for the year ended July 31, 2007, as filed on Form 10-K.
In the opinion of management, these unaudited condensed consolidated financial statements contain
all material adjustments, consisting only of normal recurring adjustments, necessary to fairly
state our financial position, results of operations and cash flows for the periods presented and
the presentations and disclosures herein are adequate when read in conjunction with our Form 10-K
for the year ended July 31, 2007. The results reported in these interim condensed consolidated
financial statements should not be regarded as being necessarily indicative of results that might
be expected for the full year. Certain reclassifications have been made to the prior period
financial statement amounts to conform to the current presentation.
The preparation of financial statements in conformity with GAAP requires management to make
estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure
of contingent assets and liabilities at the date of the financial statements and the reported
amounts of revenue and expenses during the reporting period. Actual results could differ from those
estimates. Significant estimates include: (i) useful lives of intangibles; (ii) impairment
analyses; (iii) depreciable lives of assets; (iv) income tax valuation allowances; (v) contingency
and litigation reserves; (vi) inventory valuation; (vii) allowances for accounts receivable, cash
discounts, sales incentives and sales returns; and (viii) valuation assumptions for share-based
payments.
Basic net income (loss) per common share is computed by dividing net income (loss) available
to common shareholders by the weighted average number of common shares outstanding during the
period before giving effect to stock options, stock warrants and convertible securities
outstanding, which are considered to be dilutive common stock equivalents. Diluted net income
(loss) per common share is calculated based on the weighted average number of common and
potentially dilutive shares outstanding during the period after giving effect to convertible
preferred stock, convertible debt, stock options and warrants. Contingently issuable shares are
included in the computation of basic earnings (loss) per share when issuance of the shares is no
longer contingent. Due to the losses from continuing operations for the three months ended October
31, 2007 and 2006, basic and diluted loss per common share were the same, as the effect of
potentially dilutive securities would have been anti-dilutive.
6
ZILA, INC. AND SUBSIDIARIES
NOTES TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (Continued)
Potentially dilutive securities not included in the diluted loss per share calculation, due to
net losses from continuing operations, are as follows (unaudited) (in thousands):
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended October 31,
|
|
|
|
2007
|
|
|
2006
|
|
Options and warrants to purchase common shares
|
|
|
82
|
|
|
|
343
|
|
Common stock awards
|
|
|
19
|
|
|
|
|
|
Convertible preferred stock
|
|
|
100
|
|
|
|
100
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total potentially dilutive securities
|
|
|
201
|
|
|
|
443
|
|
|
|
|
|
|
|
|
As of October 31, 2007, we have approximately $12.0 million of Amended and Restated Secured
Notes outstanding that are convertible into 5,454,546 shares of our common stock, which have been
excluded from the above table since the conversion price of these
notes is antidilutive.
2. Recently Issued Accounting Pronouncements and Adopted Accounting
In July 2006, the Financial Accounting Standards Board (FASB) issued SFAS Interpretation No.
48,
Accounting for Uncertainty in Income Taxes an interpretation of FASB Statement No. 109
(FIN 48), which we have adopted effective August 1, 2007. FIN 48 applies to all tax positions
accounted for under SFAS No. 109. FIN 48 refers to tax positions as positions taken in a
previously filed tax return or positions expected to be taken in a future tax return, which are
reflected in measuring current or deferred income tax assets and liabilities reported in the
financial statements. FIN 48 further clarifies a tax position to include, but not be limited to,
the following:
|
|
|
an allocation or a shift of income between taxing jurisdictions,
|
|
|
|
|
the characterization of income or a decision to exclude reporting taxable income in a
tax return, or
|
|
|
|
|
a decision to classify a transaction, entity, or other position in a tax return as tax
exempt.
|
FIN 48 clarifies that a tax benefit may be reflected in the financial statements only if it is
more likely than not that a company will be able to sustain the tax position, based on its
technical merits. If a tax benefit meets this criterion, it should be measured and recognized based
on the largest amount of benefit that is cumulatively greater than 50% likely to be realized. This
is a change from previous practice, whereby companies may have recognized a tax benefit only if it
was probable a tax position would be sustained.
FIN 48 also requires that we make qualitative and quantitative disclosures, including a
discussion of reasonably possible changes that might occur in unrecognized tax benefits over the
next 12 months, a description of open tax years by major jurisdictions, and a roll-forward of all
unrecognized tax benefits, presented as a reconciliation of the beginning and ending balances of
the unrecognized tax benefits on an aggregated basis.
We are potentially subject to tax audits in the United States and Canada. Tax audits by their very
nature are often complex and can require several years to complete. We are potentially subject to
United States federal and state tax examinations for the tax years ended July 31, 1994 through July
31, 2007. All tax loss years through July 31, 2007 remain open for federal, state and foreign
operations. As a condition of the acquisition of Pro-Dentec, the merger agreement related thereto
required that the selling shareholders of Pro-Dentec indemnify Zila for any identified tax
liabilities for periods prior to the acquisition. Zilas responsibility for Canadian and Canadian
Provincial income taxes arose through the acquisition of Pro-Dentec. Zila is only responsible for
Canadian and Canadian Provincial tax examinations that may arise for the tax year ended July 31,
2007 and thereafter.
The adoption of FIN 48 did not have a material impact on our financial statements or
disclosures. As of August 1, 2007 and October 31, 2007 we did not recognize any assets or
liabilities for unrecognized tax benefits relative to uncertain tax positions nor do we anticipate
any significant unrecognized tax benefits will be recorded during the next 12 months. Any interest
or penalties resulting from examinations will be recognized as a component of the income tax
provision. However, since there are no unrecognized tax benefits as a result of tax positions
taken, there are no accrued interest and penalties.
7
ZILA, INC. AND SUBSIDIARIES
NOTES TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (Continued)
In September 2006, the FASB issued SFAS No. 157,
Fair Value Measures
(SFAS 157). SFAS 157
defines fair value, establishes a framework for measuring fair value in GAAP, expands disclosures about fair value
measurements, and applies under other accounting pronouncements that require or permit fair value
measurements. SFAS 157 does not require any new fair value measurements. However, the FASB
anticipates that for some entities, the application of SFAS 157 will change current practice.
SFAS 157 is effective for financial statements issued for fiscal years beginning after November 15,
2007, which for us will be our fiscal year beginning August 1, 2008. We are currently evaluating
the impact of SFAS 157 to determine whether its adoption will have a material effect on our
consolidated financial statements.
In February 2007, the FASB issued SFAS No. 159,
The Fair Value Option for Financial Assets
and Financial Liabilities Including an Amendment of FASB Statement No. 115, Accounting for
Certain Investments in Debt and Equity Securities
(SFAS 159). SFAS 159 permits an entity to
choose to measure many financial instruments and certain items at fair value. The objective of this
standard is to improve financial reporting by providing entities with the opportunity to mitigate
volatility in reporting earnings caused by measuring related assets and liabilities differently
without having to apply complex hedge accounting provisions. SFAS 159 permits all entities to
choose to measure eligible items at fair value at specified election dates. Entities will report
unrealized gains and losses on items for which the fair value option has been elected in earnings
at each subsequent reporting date. The fair value option: (i) may be applied instrument by
instrument, with a few exceptions, such as investments accounted for by the equity method; (ii) is
irrevocable (unless a new election date occurs); and (iii) is applied only to entire instruments
and not to portions of instruments. SFAS 159 is effective as of the beginning of an entitys first
fiscal year that begins after November 15, 2007, which for us would be our fiscal year beginning
August 1, 2008. We are currently evaluating whether to adopt SFAS 159.
3. Acquisition of Pro-Dentec
On November 28, 2006, we completed the acquisition of Pro-Dentec, a privately-held,
professional dental products company headquartered in Batesville, Arkansas, for approximately $35.6
million in cash. Through its national sales and marketing organization, Pro-Dentec offers,
directly to dental professionals, a small suite of proprietary dental products that complement our
oral cancer screening products.
The following pro forma unaudited condensed statement of operations data shows the results of
our operations for the three months ended October 31, 2006 as if the Pro-Dentec acquisition had
occurred at the beginning of fiscal 2007 (in thousands except share amounts):
|
|
|
|
|
Net revenues
|
|
$
|
9,159
|
|
|
|
|
|
Loss from continuing operations
|
|
$
|
(5,505
|
)
|
|
|
|
|
Basic and diluted net loss per common share from continuing operations
|
|
$
|
(0.09
|
)
|
|
|
|
|
Pro forma weighted average common shares outstanding basic and diluted
|
|
|
61,798
|
|
|
|
|
|
The above pro forma disclosure is provided for the three months ended October 31, 2006 because
the completion of the acquisition of Pro-Dentec did not occur until November 28, 2006. No pro
forma disclosure has been presented for the three months ended October 31, 2007 as the results of
Pro-Dentec have been consolidated for all periods subsequent to November 2006.
4. Dispositions
As part of our strategy to focus our business operations on the development and
commercialization of products within our core business and with the highest growth potential,
during fiscal 2007 we disposed of Zila Nutraceuticals, Inc. and our Peridex
®
brand of
prescription periodontal rinse.
On August 13, 2006, we entered into a stock purchase agreement to sell Zila Nutraceuticals,
Inc., our former Nutraceuticals Business Unit, to NBTY, Inc. (NBTY). Following approval of our
shareholders, we completed the sale on October 2, 2006 for a price of $37.5 million, subject to a
working capital adjustment. The transaction resulted in the receipt of $36.4 million in cash,
expenses of $1.5 million and escrowed funds of $0.3 million. We are also entitled to receive up to
an additional $3.0 million in cash contingent upon the performance of the divested division during
the one-year period after the closing. The sale resulted in a pre-tax gain of $11.0 million, which
included the disposition of approximately $2.9 million of goodwill previously carried by the
Nutraceuticals Business Unit. Under the stock purchase agreement, we agreed to indemnify NBTY for
a number of matters, including the breach of our representations, warranties and covenants
contained in the stock purchase agreement, in some cases until the expiration of the statute of
limitations applicable to claims related to such breaches. On September 28, 2006, as a requirement
of the
8
ZILA, INC. AND SUBSIDIARIES
NOTES TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (Continued)
Nutraceuticals disposition, we redeemed Industrial Development Revenue Bonds in the amount
of $2.8 million plus accrued interest. Funds in a restricted cash collateral account were utilized
for this repayment. The balance of the restricted cash collateral was returned to Zila. We recognized a $0.2 million charge for unamortized deferred financing costs at the
time of the retirement of these bonds.
On May 31, 2007 we sold the inventory and technology related to our Peridex
®
brand
of products for $9.5 million, which had previously been a part of our Pharmaceuticals Business
Unit. Expenses of the sale were approximately $0.1 million. This transaction resulted in a pre-tax
gain of approximately $5.2 million.
During fiscal 2006 and 2005 we also divested two other business lines that had previously been
part of our Pharmaceuticals Business Unit, including the assets and certain defined liabilities of
our IST swab operations and our Zilactin
®
brand of over-the-counter lip and oral care
products. Subsequent to the sale of the Zilactin
®
products, we were engaged in an
arbitration proceeding regarding the disposition, which was settled on November 3, 2006 and
required the payment of approximately $0.7 million, which was included in loss from discontinued
operations during the first quarter of fiscal 2007. Separately, we incurred approximately $0.15
million of expense in the first three months of fiscal 2008 for pending litigation with Dr. James
E. Tinnell, which is more fully described in Note 17 Commitments and Contingencies below and
relates to the previously disposed Zilactin
®
product line.
Each of the disposals discussed above meets the definition of a component of an entity and
has been accounted for as a discontinued operation under SFAS No. 144,
Accounting for the
Impairment or Disposal of Long-Lived Assets
. The results of operations for these businesses have
accordingly been classified as discontinued operations in all periods presented. The results of
these discontinued operations for the three months ended October 31, 2006 are as follows
(unaudited) (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Nutraceuticals
|
|
|
Pharmaceuticals
|
|
|
Total
|
|
Net revenues
|
|
$
|
1,629
|
|
|
$
|
1,039
|
|
|
$
|
2,668
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss from discontinued operations
|
|
$
|
(754
|
)
|
|
$
|
(365
|
)
|
|
$
|
(1,119
|
)
|
Gain (loss) on disposal of discontinued operations
|
|
|
11,135
|
|
|
|
(25
|
)
|
|
|
11,110
|
|
Income tax expense
|
|
|
(3,877
|
)
|
|
|
|
|
|
|
(3,877
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total income (loss) from discontinued operations
|
|
$
|
6,504
|
|
|
$
|
(390
|
)
|
|
$
|
6,114
|
|
|
|
|
|
|
|
|
|
|
|
As of October 31, 2007 and July 31, 2007, current liabilities of the divested operations
consisted of accounts payable and other accrued expenses related to the previously divested
Pharmaceuticals operations.
5. Inventories
Inventories consist of the following (in thousands):
|
|
|
|
|
|
|
|
|
|
|
October 31,
|
|
|
July 31,
|
|
|
|
2007
|
|
|
2007
|
|
|
|
(Unaudited)
|
|
|
|
|
|
Finished goods
|
|
$
|
1,426
|
|
|
$
|
1,413
|
|
Work-in-process
|
|
|
415
|
|
|
|
323
|
|
Raw materials
|
|
|
2,558
|
|
|
|
2,659
|
|
Inventory reserves
|
|
|
(372
|
)
|
|
|
(320
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total inventories
|
|
$
|
4,027
|
|
|
$
|
4,075
|
|
|
|
|
|
|
|
|
9
ZILA, INC. AND SUBSIDIARIES
NOTES TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (Continued)
6. Property and Equipment
Property and equipment consist of the following (in thousands):
|
|
|
|
|
|
|
|
|
|
|
October 31,
|
|
|
July 31,
|
|
|
|
2007
|
|
|
2007
|
|
|
|
(Unaudited)
|
|
|
|
|
|
Land
|
|
$
|
529
|
|
|
$
|
529
|
|
Building and improvements
|
|
|
2,162
|
|
|
|
2,181
|
|
Furniture and equipment
|
|
|
3,123
|
|
|
|
2,360
|
|
Leasehold improvements and other assets
|
|
|
821
|
|
|
|
1,360
|
|
Production, laboratory and warehouse equipment
|
|
|
4,591
|
|
|
|
4,423
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total property and equipment
|
|
|
11,226
|
|
|
|
10,853
|
|
Less: Accumulated depreciation and amortization
|
|
|
(4,979
|
)
|
|
|
(4,634
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Property and equipment net
|
|
$
|
6,247
|
|
|
$
|
6,219
|
|
|
|
|
|
|
|
|
7. Goodwill and Other Intangible Assets
Goodwill and other intangible assets consist of the following (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
October 31, 2007 (Unaudited)
|
|
|
July 31, 2007
|
|
|
|
Gross
|
|
|
|
|
|
|
Net
|
|
|
Gross
|
|
|
|
|
|
|
Net
|
|
|
|
Carrying
|
|
|
Accumulated
|
|
|
Carrying
|
|
|
Carrying
|
|
|
Accumulated
|
|
|
Carrying
|
|
|
|
Amount
|
|
|
Amortization
|
|
|
Amount
|
|
|
Amount
|
|
|
Amortization
|
|
|
Amount
|
|
Amortizable intangible assets:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Purchased technology
|
|
$
|
15,592
|
|
|
$
|
(5,964
|
)
|
|
$
|
9,628
|
|
|
$
|
15,592
|
|
|
$
|
(5,708
|
)
|
|
$
|
9,884
|
|
Trademarks
|
|
|
137
|
|
|
|
(11
|
)
|
|
|
126
|
|
|
|
132
|
|
|
|
(11
|
)
|
|
|
121
|
|
Patents
|
|
|
2,570
|
|
|
|
(383
|
)
|
|
|
2,187
|
|
|
|
2,495
|
|
|
|
(350
|
)
|
|
|
2,145
|
|
Licensing costs
|
|
|
2,674
|
|
|
|
(1,580
|
)
|
|
|
1,094
|
|
|
|
2,674
|
|
|
|
(1,514
|
)
|
|
|
1,160
|
|
Covenants not to compete and other
|
|
|
3,557
|
|
|
|
(1,198
|
)
|
|
|
2,359
|
|
|
|
3,556
|
|
|
|
(876
|
)
|
|
|
2,680
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total amortizable intangible assets
|
|
|
24,530
|
|
|
|
(9,136
|
)
|
|
|
15,394
|
|
|
|
24,449
|
|
|
|
(8,459
|
)
|
|
|
15,990
|
|
Unamortizable trademarks
|
|
|
5,449
|
|
|
|
|
|
|
|
5,449
|
|
|
|
5,449
|
|
|
|
|
|
|
|
5,449
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total other intangible assets
|
|
|
29,979
|
|
|
|
(9,136
|
)
|
|
|
20,843
|
|
|
|
29,898
|
|
|
|
(8,459
|
)
|
|
|
21,439
|
|
Goodwill
|
|
|
10,171
|
|
|
|
|
|
|
|
10,171
|
|
|
|
10,171
|
|
|
|
|
|
|
|
10,171
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total intangible assets
|
|
$
|
40,150
|
|
|
$
|
(9,136
|
)
|
|
$
|
31,014
|
|
|
$
|
40,069
|
|
|
$
|
(8,459
|
)
|
|
$
|
31,610
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Amortization of amortizable intangible assets is calculated using the following useful lives
(in years):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted Average
|
|
|
Range of
|
|
Remaining Useful Lives
|
|
|
Useful Lives
|
|
October 31, 2007
|
|
July 31, 2007
|
|
|
|
|
|
|
(Unaudited)
|
|
|
|
|
Purchased technology
|
|
|
15
|
|
|
|
14.2
|
|
|
|
14.5
|
|
Trademarks
|
|
|
7-10
|
|
|
|
7.4
|
|
|
|
7.6
|
|
Patents
|
|
|
4-17
|
|
|
|
6.1
|
|
|
|
6.2
|
|
Licensing costs
|
|
|
7-10
|
|
|
|
4.2
|
|
|
|
4.4
|
|
Covenants not to compete and other
|
|
|
2-15
|
|
|
|
1.6
|
|
|
|
1.8
|
|
10
ZILA, INC. AND SUBSIDIARIES
NOTES TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (Continued)
8. Accrued Liabilities
Accrued liabilities consist of the following (in thousands):
|
|
|
|
|
|
|
|
|
|
|
October 31,
|
|
|
July 31,
|
|
|
|
2007
|
|
|
2007
|
|
|
|
(Unaudited)
|
|
|
|
|
|
Accrued research and development
|
|
$
|
1,596
|
|
|
$
|
1,864
|
|
Accrued employee compensation and related taxes
|
|
|
1,435
|
|
|
|
1,876
|
|
Accrued professional and consulting fees
|
|
|
642
|
|
|
|
569
|
|
Accrued fee due Investors for Restructuring (see Note 9)
|
|
|
|
|
|
|
600
|
|
Other accrued expenses
|
|
|
967
|
|
|
|
679
|
|
|
|
|
|
|
|
|
|
Total accrued expenses
|
|
$
|
4,640
|
|
|
$
|
5,588
|
|
|
|
|
|
|
|
|
9. Debt
Debt consists of the following (in thousands):
|
|
|
|
|
|
|
|
|
|
|
October 31,
|
|
|
July 31,
|
|
|
|
2007
|
|
|
2007
|
|
|
|
(Unaudited)
|
|
|
|
|
|
Short-term borrowings and current portion of long-term debt:
|
|
|
|
|
|
|
|
|
Short-term borrowings
|
|
$
|
275
|
|
|
$
|
|
|
Capital lease obligations
|
|
|
77
|
|
|
|
77
|
|
|
|
|
|
|
|
|
|
Total short-term borrowings and current portion of long-term debt
|
|
$
|
352
|
|
|
$
|
77
|
|
|
|
|
|
|
|
|
Long-term debt:
|
|
|
|
|
|
|
|
|
Senior secured convertible notes net of unamortized discount of $4,898 and $5,345
|
|
$
|
7,102
|
|
|
$
|
6,655
|
|
PharmaBio
|
|
|
500
|
|
|
|
500
|
|
Capital lease obligations
|
|
|
163
|
|
|
|
181
|
|
|
|
|
|
|
|
|
|
Total long-term debt
|
|
|
7,765
|
|
|
|
7,336
|
|
Less: Current portion of long-term debt
|
|
|
(77
|
)
|
|
|
(77
|
)
|
|
|
|
|
|
|
|
|
Long-term debt net of current portion
|
|
$
|
7,688
|
|
|
$
|
7,259
|
|
|
|
|
|
|
|
|
Short-term Borrowings
As of October 31, 2007, we had short-term borrowings for installments due on an insurance
policy, with an interest rate of 6.4%.
Private Placements
In November 2006, we consummated two private placements (the Private Placements) for gross
proceeds of approximately $40.0 million.
Pursuant to the first purchase agreement, we issued and sold:
|
(i)
|
|
9,100,000 shares of Zilas common stock for $1.75 per share (the Shares);
|
|
|
(ii)
|
|
Approximately $12.1 million in aggregate principal amount of 12.0% Unsecured
Convertible Notes (the Unsecured Notes), which converted into 6,900,000 shares (the
Unsecured Note Shares) of Zilas common stock at a conversion price of $1.75 per share on
December 14, 2006, the date on which our stockholders approved, among other things, the
Private Placements;
|
11
ZILA, INC. AND SUBSIDIARIES
NOTES TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (Continued)
|
(iii)
|
|
Warrants to purchase approximately 5,403,000 shares of Zilas common stock, which
became exercisable in May 2007 for five years at an exercise price of $2.21 per share (the
Initial Warrants);
|
|
|
(iv)
|
|
Warrants to purchase approximately 3,105,000 shares of Zilas common stock, which
became exercisable for five years at an exercise price of $2.21 per share following
approval by our stockholders on December 14, 2006 (the Additional Warrants);
|
Pursuant to the second purchase agreement, we issued and sold:
|
(i)
|
|
Approximately $12.0 million in aggregate principal amount of 6.0% Senior Secured
Convertible Notes (the Secured Notes), which are due in November 2009 and became
convertible into 5,454,546 shares of Zilas common stock at a conversion price of $2.20
following approval by our stockholders on December 14, 2006; and
|
|
|
(ii)
|
|
Warrants to purchase 1,909,091 shares of Zilas common stock, which became exercisable
for five years at an exercise price of $2.21 per share following approval by our
stockholders on December 14, 2006 (the Secured Note Warrants).
|
We granted registration rights for the Shares and shares of common stock issuable upon
conversion of the debt instruments and exercise of the warrants. A dispute arose with certain
investors (the Investors) regarding the extent of the registration rights. On August 13, 2007,
we reached an agreement with the Investors to restructure the Investors holdings (the
Restructuring) and to provide us with relief from certain financial and non-financial covenants
contained in the Secured Notes (the Amendment Agreement). As amended and restated, the Amended
and Restated Secured Notes are in the same aggregate principal amount as the Secured Notes, or
approximately $12.0 million, but are due July 31, 2010. The Amended and Restated Secured Notes
bear interest, payable quarterly, at 7.0% per annum, but at our option, interest payments can be
made at an 8.0% annual rate in shares of our common stock at a price equal to 90.0% of the average
closing bid price of such common stock for the ten trading days immediately prior to the relevant
interest payment date. The Amended and Restated Secured Notes remain convertible into shares of
common stock at a conversion price of $2.20 per share at the option of the holders of such notes.
In addition, the Amended and Restated Secured Notes contain comprehensive covenants that restrict
the way in which we can operate, and contain financial covenants that require us to:
|
(i)
|
|
Maintain, at the end of each fiscal quarter commencing with the fiscal quarter ending
July 31, 2007, free cash in an amount not less than $2.0 million; and
|
|
|
(ii)
|
|
Maintain, at the end of each of the fiscal quarters ending July 31, 2008 and
October 31, 2008, defined EBITDA of at least $1.00.
|
Failure to satisfy these financial covenants, or to maintain compliance with the negative
covenants described in our definitive proxy statement filed with the SEC on November 24, 2006,
could, at the option of the Amended and Restated Secured Note holders, result in an event of
default under the Amended and Restated Secured Notes. Upon the occurrence of the first specified
event of default, the holders of the Amended and Restated Secured Notes could accelerate and demand
repayment of one-third of the outstanding principal balance and all accrued but unpaid interest on
the Amended and Restated Secured Notes. Upon the occurrence of the second specified event of
default, the holders of the Amended and Restated Secured Notes could accelerate and demand
repayment of one-half of the outstanding principal balance and all accrued but unpaid interest on
the Secured Notes. Upon the occurrence of the third specified event of default, the entire
principal balance and all accrued but unpaid interest may become due and payable.
As part of the Restructuring, we also agreed to:
|
(i)
|
|
Repurchase 932,832 Unsecured Note Shares from the Investors for approximately $1.25
million in cash, at a price based on the average closing bid price of our common stock for
the ten trading days prior to August 13, 2007, or $1.34 per Unsecured Note Share;
|
|
|
(ii)
|
|
Repurchase 227,270 Secured Note Warrants from the Investors for approximately $0.15
million in cash, at a price based on a Black-Scholes valuation, or $0.66 per Secured Note
Warrant; and
|
|
|
(iii)
|
|
Pay the Investors a $0.6 million fee.
|
12
ZILA, INC. AND SUBSIDIARIES
NOTES TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (Continued)
The Amended and Restated Secured Notes are secured by certain of our existing and future
property, as well as the existing and future property of each of our wholly-owned subsidiaries.
Additionally, the Amendment Agreement contained a mutual release of claims. We concluded that the
Amended and Restated Secured Notes are not substantially different from the original Secured Notes
and accordingly, the Amendment Agreement has not been accounted for as a debt extinguishment. As
of July 31, 2007, the $0.6 million fee has been accrued as the resolution of the registration
rights dispute with the Investors and the fair value of the shares and warrants has been
reclassified from permanent equity to a current liability. No income or loss was recognized as a
result of this reclassification. The increase in the fair value of these financial instruments
from July 31, 2007 to the date they were repurchased on August 13, 2007 of less than $0.1 million,
has been accounted for as a charge to earnings in the first quarter of fiscal 2008.
In connection with the Restructuring and the issuance of the Amended and Restated Secured
Notes, we also received waivers from the required majority of the holders of the Initial Warrants,
Additional Warrants and Secured Note Warrants waiving any antidilution rights to which any holder
of such warrants would otherwise be entitled in connection with the issuance of any shares as
payment for interest on the Amended and Restated Secured Notes. On August 13, 2007, we entered
into a Registration Rights Agreement (the Registration Rights Agreement) with the Investors.
Separately, a side letter that imposed certain corporate governance obligations on Zila, the most
notable of which that had not yet been fulfilled was to appoint two additional directors to our
Board of Directors, was terminated.
PharmaBio Development, Inc.
In December 2002, we entered into an agreement with PharmaBio Development, Inc. (PharmaBio),
the strategic investment group of Quintiles Transnational Corp., our contract research
organization. Under this agreement, PharmaBio invested $0.5 million in us and in return we agreed
to pay PharmaBio an amount equal to 5.0% of all net sales of the OraTest
®
product in the
European Union and the United States. The aggregated amount of the royalty cannot exceed
$1.25 million and the royalty is payable quarterly. The investment was recorded as long-term debt
and will be amortized using the effective interest method.
10. Share-Based Payments
We have one active share-based stock award plan that provides for the grant of stock options
and stock awards, such as restricted stock and restricted stock units (RSUs), to our employees,
members of our Board of Directors and non-employee consultants, as approved by our Board of
Directors. We typically grant stock option awards to our employees and to members of our Board of
Directors at prices equal to the market value of our stock on the date of grant. These awards vest
over a period determined at the time of the grant and generally range from one to three years of
continuous service, with maximum terms ranging from five to ten years. Certain awards granted to
our employees provide for accelerated vesting if there is a change in control of Zila (as defined
in the plan). There are 154,000 registered shares available for grant under the plan as of October
31, 2007, and we have submitted a proposal to our shareholders at our Annual Meeting on December
13, 2007 to increase the authorized shares in our share-based stock award plan by 3,000,000 shares.
During the three months ended October 31, 2007 and 2006, we granted options to purchase
1,097,366 and 20,000 shares of our common stock, respectively. The fair value of options granted is
estimated using the Black-Scholes option pricing model using the following assumptions:
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended October 31,
|
|
|
2007
|
|
2006
|
Risk-free interest rate
|
|
|
3
|
%
|
|
|
5
|
%
|
Expected volatility
|
|
|
60
|
%
|
|
|
44
|
%
|
Expected term (in years)
|
|
|
5.1
|
|
|
|
3.3
|
|
Dividend yield
|
|
|
0
|
%
|
|
|
0
|
%
|
The risk free interest rate is based on U.S. Treasury rates with maturity dates approximating
the expected term of the grant. The historic volatility of our stock is used as the primary basis
for the expected volatility assumption. Expected term is based on evaluations of historic and
expected future employee exercise behavior. Our ability to pay dividends is restricted and
therefore we have assumed no dividend yield.
SFAS No. 123 (revised 2004),
Share-Based Payment
requires the estimation of forfeitures when
recognizing compensation expense and that this estimate of forfeitures be adjusted over the
requisite service period should actual forfeitures differ from such estimates. Changes in
estimated forfeitures are recognized through an adjustment, which is recognized in the period of
change and
13
ZILA, INC. AND SUBSIDIARIES
NOTES TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (Continued)
which impacts the amount of unamortized compensation expense to be recognized in future
periods.
A summary of stock option activity for our stock award plan for the three months ended October
31, 2007 is as follows (in thousands except exercise price per share and option term amounts)
(unaudited):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted
|
|
|
|
|
|
|
|
|
Weighted
|
|
Average
|
|
|
|
|
|
|
|
|
Average
|
|
Remaining
|
|
Aggregate
|
|
|
Number
|
|
Exercise
|
|
Contractual
|
|
Intrinsic
|
|
|
of Options
|
|
Price
|
|
Term (Years)
|
|
Value
|
Options outstanding beginning of period
|
|
|
2,917
|
|
|
$
|
3.11
|
|
|
|
5.8
|
|
|
$
|
130
|
|
Granted
|
|
|
1,097
|
|
|
|
1.15
|
|
|
|
|
|
|
|
|
|
Exercised
|
|
|
(10
|
)
|
|
|
1.12
|
|
|
|
|
|
|
|
|
|
Expired
|
|
|
(144
|
)
|
|
|
3.28
|
|
|
|
|
|
|
|
|
|
Forfeited
|
|
|
(33
|
)
|
|
|
2.55
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Options outstanding end of period
|
|
|
3,827
|
|
|
|
2.55
|
|
|
|
6.7
|
|
|
|
42
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Options vested or expected to vest end of period
|
|
|
3,359
|
|
|
|
2.61
|
|
|
|
6.4
|
|
|
|
42
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Options exercisable end of period
|
|
|
1,965
|
|
|
|
3.11
|
|
|
|
4.8
|
|
|
|
42
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
The weighted average grant-date fair value of options granted to our employees and directors
during the three months ended October 31, 2007 was $0.63 per common share. The total intrinsic
value of options exercised and cash received from option exercises during the three months ended
October 31, 2007 was less than $0.1 million.
A summary of unvested common stock award activity within our share-based compensation plan for
the three months ended October 31, 2007 is as follows (in thousands except exercise price per share
and option term amounts) (unaudited):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted
|
|
|
|
|
|
|
Weighted
|
|
Average
|
|
|
|
|
|
|
Average
|
|
Remaining
|
|
|
Number
|
|
Grant
|
|
Recognition
|
|
|
of Shares
|
|
Value
|
|
Period (Years)
|
Unvested balance beginning of period
|
|
|
133
|
|
|
$
|
2.42
|
|
|
|
1.4
|
|
Granted
|
|
|
373
|
|
|
|
1.17
|
|
|
|
|
|
Vested
|
|
|
(140
|
)
|
|
|
1.50
|
|
|
|
|
|
Forfeited
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Unvested balance end of period
|
|
|
366
|
|
|
|
1.49
|
|
|
|
1.4
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stock-based compensation costs for stock options and restricted stock grants are reflected in
the following financial statement captions (in thousands) (unaudited):
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended October 31,
|
|
|
|
2007
|
|
|
2006
|
|
Marketing and selling expense
|
|
$
|
55
|
|
|
$
|
7
|
|
General and administrative expense
|
|
|
373
|
|
|
|
223
|
|
Research and development expense
|
|
|
1
|
|
|
|
(8
|
)
|
Inventory
|
|
|
1
|
|
|
|
2
|
|
Discontinued operations
|
|
|
|
|
|
|
(6
|
)
|
|
|
|
|
|
|
|
|
Total stock-based compensation
|
|
$
|
430
|
|
|
$
|
218
|
|
|
|
|
|
|
|
|
The above table includes a benefit of less than $0.1 million for the first three months of
fiscal 2007 for non-employee stock
14
ZILA, INC. AND SUBSIDIARIES
NOTES TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (Continued)
options, which are adjusted to current fair value each quarter
during their vesting period as services are rendered, and is included as a component of general and
administrative expense.
As of October 31, 2007, total unrecognized compensation cost related to unvested stock options
and unvested common stock awards was approximately $1.6 million and $0.4 million, respectively,
with a weighted average period over which these costs are
expected to be recognized of approximately 2.0 years and 1.4 years, respectively.
11. Warrants
As of October 31, 2007, we have exercisable warrants outstanding for the purchase of
12,696,500 shares of our common stock with a weighted average exercise price of $2.20 and a
weighted average contractual term of 4.0 years. We issued these warrants in connection with
financing arrangements and in connection with services provided by medical and financial advisors.
These warrants were valued using a Black-Scholes model, and the value of warrants issued for
services was charged to expense. As discussed elsewhere herein, on August 13, 2007, we repurchased
227,270 Secured Note Warrants for approximately $0.15 million in cash.
12. Convertible Preferred Stock
On February 5, 2001, we issued 100,000 shares of Series B Convertible Preferred Stock
(Preferred Stock) as part of an acquisition. The holders of the Preferred Stock are entitled to
receive cumulative quarterly dividends at a rate of $0.0975 per share per fiscal quarter, payable
in arrears, which represents an aggregate annual dividend of $39,000. As of October 31, 2007 and
July 31, 2007, accumulated accrued dividends were $9,750. The Preferred Stock can be redeemed at
our option if our common stock maintains a closing price on each trading day equal to or greater
than $9.00 per share for any ten trading day period. The redemption price shall be the average bid
closing price of our common stock for the five trading days immediately proceeding the date we give
notice. The Preferred Stock is convertible at the option of the holder at any time on or before
December 31, 2010 into our common stock at the ratio of one-to-one. On December 31, 2010, all of
the remaining Preferred Stock will be converted into our common stock at a ratio of one-to-one.
Holders of the preferred stock have no voting rights except as required by applicable law and have
a liquidation preference of $0.65 million.
13. Treasury Stock
In connection with the Amendment Agreement described above, on August 13, 2007 we repurchased
932,832 Unsecured Note Shares from certain Investors for approximately $1.25 million in cash, at a
price based on the average closing bid price of our common stock for the ten trading days prior to
August 13, 2007, or $1.34 per Unsecured Note Share. These shares have been treated as treasury
stock as of July 31, 2007 and during the three months ended October 31, 2007, these treasury shares
were retired.
During fiscal 2001, we began acquiring shares of our common stock under a stock repurchase
program announced in November 1999. The program authorized the repurchase of up to 1.0 million
shares of Zila common stock from time to time on the open market depending on market conditions and
other factors. Under this repurchase program, we purchased 225,100 shares of common stock at an
aggregate cost of approximately $0.6 million, and made the last purchases under this program in
fiscal 2003, after which we suspended purchases under the program.
14. Income Taxes
As of October 31, 2007, we have recorded a valuation allowance for our net deferred tax assets
of $13.9 million due to our lack of earnings history, and we had federal net operating loss
carryforwards of approximately $52.3 million that expire in years 2009 to 2028. Income tax expense
for the three months ended October 31, 2007 was de minimis and primarily relates to state income
taxes. Income tax benefit of $3.9 million for the three months ended October 31, 2006 resulted from
the utilization of net operating loss carryforwards to offset the income tax expense on the taxable
gain on the sale of our Nutraceuticals Business Unit, which is presented as discontinued
operations.
15
ZILA, INC. AND SUBSIDIARIES
NOTES TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (Continued)
15. Supplemental Cash Flow Information
Supplemental cash flow information is as follows (unaudited) (in thousands):
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended October 31,
|
|
|
2007
|
|
2006
|
Interest paid
|
|
$
|
227
|
|
|
$
|
620
|
|
Income taxes paid
|
|
|
35
|
|
|
|
23
|
|
Insurance policy financed with short-term borrowings
|
|
|
275
|
|
|
|
|
|
16. Comprehensive Loss
Comprehensive loss includes the effects of foreign currency translation and does not reflect
an income tax effect due to the recording of valuation allowances. Comprehensive loss is as
follows (unaudited) (in thousands):
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended October 31,
|
|
|
|
2007
|
|
|
2006
|
|
Net loss
|
|
$
|
(4,856
|
)
|
|
$
|
(258
|
)
|
Foreign currency translation adjustment
|
|
|
(13
|
)
|
|
|
(9
|
)
|
|
|
|
|
|
|
|
|
Comprehensive loss
|
|
$
|
(4,869
|
)
|
|
$
|
(267
|
)
|
|
|
|
|
|
|
|
17. Commitments and Contingencies
Legal Proceedings
Except as described below, as of October 31, 2007, we were not a party to any pending legal
proceedings other than ordinary routine claims that arise in the conduct of our business. While we
currently believe that the ultimate outcome of these proceedings discussed below will not have a
material adverse effect on our consolidated financial condition or results of operations,
litigation is subject to inherent uncertainties. If an unfavorable ruling were to occur, there
exists the possibility of a material adverse impact on our net income in the period in which such
ruling occurs. Our estimate of the potential impact of the following legal proceedings on our
financial position and our results of operation could change in the future.
In connection with the acquisition of patent rights in 1980, we agreed to pay to Dr. James E.
Tinnell (Tinnell), the inventor of one of our former treatment compositions, a royalty of 5.0% of
gross sales of the invention disclosed in his then pending patent application. In September 2000,
we notified Tinnell that we would no longer pay such royalties because the obligations ceased in
August 1998 when the related product patents expired and we requested reimbursement of royalties
paid since August 1998. We then filed suit on November 8, 2000, in the United States District Court
for the District of Nevada requesting a declaratory judgment that we had no royalty obligations to
Tinnell and requested judgment for the overpaid royalties. On April 22, 2004, the Court, in part,
ruled in our favor, stating that our royalty obligations to Tinnell ceased in August 1998, however,
our request for reimbursement of overpaid royalties was dismissed. Tinnell filed a notice of appeal
and we have filed a notice of cross-appeal. On September 5, 2007, the Ninth Circuit Court of
Appeals reversed the decision of the lower court and remanded the case for a determination of
whether or not Tinnell should be credited with inventing the improvement embodied in the 1992
patent.
An antitrust case was filed in
2000 in the United States District Court in Delaware by several dental
laboratories as class representatives for all dental labs that had purchased Dentsply artificial
teeth. The suit alleges that Dentsply, the major supplier of artificial teeth, required each of its
distributors to agree not to supply the teeth of its competitors as a condition of Dentsplys
supplying its artificial teeth to a distributor. According to the complaint this requirement
resulted in a lack of choices for the laboratories and increased costs for the Dentsply teeth
because it permitted Dentsply to limit the supply of its competitors teeth so as to give it a
monopoly and the power to set prices. Plaintiffs also alleged that each of the distributors agreed
with Dentsply to this condition in violation of Sections 1 and 2 of the Sherman Act and Section 6
of the Clayton Act. At the same time the U.S. Department of Justice was criminally prosecuting
Dentsply for the same activities. Ultimately Dentsply was found guilty of the charges. The civil
lawsuit, in which Ryker Dental of Kentucky, Inc. (Ryker), our inactive wholly-owned subsidiary,
is one of about 15 defendants, was stayed for years because of appeals taken by the plaintiffs from
orders by the trial court that since the plaintiffs had not purchased artificial teeth
directly from Dentsply, it could not, as a matter of law, have any liability to the plaintiffs
or class members. The Third Circuit Court of Appeals largely agreed with Dentsply, except that it
permitted a claim to proceed that Dentsply and the distributors had conspired to
16
ZILA, INC. AND SUBSIDIARIES
NOTES TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (Continued)
monopolize the
artificial teeth market. On September 26, 2007, the Court dismissed the case against Ryker for lack
of personal jurisdiction and improper venue.
Indemnifications
During the normal course of business, we make certain indemnities, commitments and guarantees
under which we may be required to make payments in relation to certain transactions. These include:
(i) intellectual property indemnities to customers in connection with the use, sales and/or license
of products and services; (ii) indemnities to customers in connection with losses incurred while
performing services on their premises; (iii) indemnities to vendors and service providers
pertaining to claims based on negligence or willful misconduct; and (iv) indemnities involving the
representations and warranties in certain contracts. In addition, under our by-laws we are
committed to our directors and officers for providing for payments upon the occurrence of certain
prescribed events. The majority of these indemnities, commitments and guarantees do not provide for
any limitation on the maximum potential for future payments that we could be obligated to make. To
help address these risks, we maintain general business liability insurance coverage, including
product, commercial, general, fiduciary, employment practices and directors and officers
liability coverages. We have not recorded a liability for these indemnities, commitments and other
guarantees.
Registration Payment Arrangements
As of October 31, 2007, we have 1,200,000 warrants outstanding that were issued in March 2006
in connection with a financing transaction and are subject to a registration rights agreement.
Under the terms of this agreement, we agreed to register the underlying common shares and were
obligated to have the registration statement declared effective at the later of July 15, 2006 and
the date upon which at least twenty-five percent (25.0%) of the shares underlying the warrant have
been acquired upon exercise of the warrant. The registration statement was declared effective on
June 26, 2006. We are obligated to maintain the effectiveness of the registration statement until
the earlier to occur of the date upon which all shares registered thereunder have been sold and, in
general, the date on which the shares registered thereunder can be sold pursuant to Rule 144(k)
under the Securities Act of 1933, as amended (the Securities Act). If we fail to maintain the
effectiveness of the registration statement for this period of time, we are obligated to pay to the
warrant holder at the end of each 30 day period, in cash, an amount equal to $40,000 for the first
30 days such registration is not effective, pro-rated on a daily basis, and $40,000 per each 30-day
period thereafter, pro-rated on a daily basis.
In November 2006, concurrent with the closing of the Private Placements described elsewhere
herein, we entered into two registration rights agreements (the Private Placement Registration
Rights Agreements) whereby we agreed to file an initial registration statement registering the
Shares and shares of common stock underlying the Initial Warrants (the Initial Registration
Statement) and to file a subsequent registration statement registering shares of common stock
underlying the Additional Warrants, Secured Note Warrants, Unsecured Notes and Secured Notes (the
Subsequent Registration Statement). Under the Private Placement Registration Rights Agreements,
if the Initial Registration Statement or Subsequent Registration Statement is not filed, or
declared effective, by certain predetermined deadlines, then, in addition to any other rights the
investors may have, we will be required to pay liquidated damages, in cash, equal to one percent
per month (pro rata for each day beyond each deadline) of the aggregate purchase price paid by such
investors for the securities being registered on either the Initial Registration Statement or
Subsequent Registration Statement, as applicable, up to a maximum of 24.0% of each such investors
investment. We are obligated to maintain the effectiveness of the Initial Registration Statement
and the Subsequent Registration Statement until the earlier of the date on which all securities
registered thereby have been sold and the date on which all securities registered thereby may be
sold pursuant to Rule 144(k) under the Securities Act. If we do not maintain the effectiveness of
the Initial Registration Statement and the Subsequent Registration Statement, as required, then we
are subject to the above described liquidated damages.
We did not incur any liquidated damages in connection with the Initial Registration Statement
because we filed it on December 28, 2006, and it was declared effective on March 23, 2007, both of
which were within the time periods prescribed by the Private Placement Registration Rights
Agreements. We filed the Subsequent Registration Statement on January 12, 2007, which was within
the time period prescribed by the Private Placement Registration Rights Agreements. However, the
Subsequent Registration Statement was not declared effective until May 4, 2007, which was after the
April 13, 2007 effectiveness deadline. Several of the investors waived their rights to liquidated
damages, but we did incur liquidated damages of approximately $0.1 million for the period from
April 13, 2007 to May 4, 2007 as a result of this delay.
As discussed elsewhere herein, a dispute arose regarding the extent of the registration rights
to certain Investors. The SEC reviewed and provided extensive comments on the Subsequent
Registration Statement and, as a condition precedent to declaring the Subsequent Registration
Statement effective, the SEC required that we either remove the Investors or identify the Investors
as underwriters in the Subsequent Registration Statement. Rather than be designated as
underwriters, the Investors preferred to have
the shares that were issued to them, and the shares that were issuable to them upon conversion
of the Secured Notes and exercise of
17
ZILA, INC. AND SUBSIDIARIES
NOTES TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (Continued)
Additional Warrants and Secured Note Warrants, as applicable,
removed from the Subsequent Registration Statement. As a result, Zila believes its obligation to
pay liquidated damages to these Investors for the period after May 4, 2007 was extinguished at that
time. However, certain of the Investors disputed our position and indicated that they believed that
our obligation to pay liquidated damages was ongoing and would continue until their securities were
registered, subject to the contractually agreed limitation of 24.0% of the amount of each
Investors investment.
On August 13, 2007 and in connection with the Restructuring, we entered into a Registration
Rights Agreement with the Investors, under which we agreed to cooperate with the Investors to
attempt to persuade the SEC to permit the registration of Unsecured Note Shares and shares that are
issuable upon exercise of Additional Warrants and Secured Note Warrants and upon conversion of the
Amended and Restated Secured Notes, in each case to the extent not already registered, and to file
a resale registration statement covering such shares within 30 days after the date, if ever, on
which the SEC indicates that it would be willing to declare such a registration statement
effective. In addition, in the event that shares our common stock have been issued as payment for
interest on the Amended and Restated Secured Notes and the market value of such shares exceeds
$0.25 million, we are required to file additional registration statements promptly following the
end of each of our fiscal years, but no later than October 31 of each year. After each filing
deadline, we are required to use commercially reasonable efforts to have each registration
statement declared effective by the SEC 90 days after the date on which the 30 day filing period
began to run, or 120 days after such time if the SEC reviews the registration statement. We are
obligated to use reasonable efforts to maintain the effectiveness of each registration statement
until the earlier of the date on which all securities covered by such registration statement have
been sold and the date on which such securities can be sold pursuant to Rule 144(k) under the
Securities Act. We will become obligated to pay liquidated damages equal to 1.0% of the aggregate
market value of the shares that should have been included in any such registration statement if we
fail to file any such registration statement within the timeframes described above, and will incur
additional liquidated damages equal to 1.0% of the aggregate market value of the shares that should
have been included in any such registration statement if we fail to cause any such registration
statement to become effective within the timeframes described above, up to an aggregate cap of $3.0
million. In connection with the Restructuring, those registration rights agreements to which the
Investors were a party were terminated as to the Investors, but will remain in effect as to those
other investors in the Private Placements.
While the dispute with respect to certain Investors was resolved through the Restructuring, a
dispute remains with respect to one investor. This dispute will likely be contractual in nature,
and we cannot predict whether we will prevail although we will vigorously defend our position.
Should we prevail, we would not be obligated to pay additional liquidated damages, although we
would most likely incur costs and expenses associated with participating in an alternative dispute
resolution.
We do not believe it is probable that penalty payments will be made for the registration
rights agreements discussed above and accordingly have not accrued for such potential penalties as
of October 31, 2007 or July 31, 2007.
18
Item 2. Managements Discussion and Analysis of Financial Condition and Results of Operations.
The following discussion 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, 2007, as filed with the SEC, including the factors
set forth in the section titled Forward-looking Statements, as well as our other filings made
with the SEC.
Forward-Looking Statements
This Quarterly Report on Form 10-Q, including this Managements Discussion and Analysis of
Financial Condition and Results of Operations, 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, 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, 2007 under Item 1A Risk
Factors, and elsewhere herein. 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.
Company Overview and Recent Developments
Zila
is an integrated oral diagnostic company dedicated to the prevention, detection and
treatment of oral cancer and periodontal disease. During fiscal 2007, we successfully completed a
multi-step strategic redirection, which included divesting non-core businesses and acquiring the
national dental products company, Professional Dental Technologies, Inc. (Pro-Dentec).
We manufacture and market ViziLite
®
Plus with TBlue
630TM
(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. During
November 2007, we commenced a global expansion initiative with the launch of ViziLite
®
Plus in Canada. In addition, Zila designs, manufactures and markets a suite of proprietary products
sold exclusively and directly to dental professionals for periodontal disease, including the
Rota-dent
®
Professional Powered Brush, the Pro-Select
®
Platinum ultrasonic
scaler and a portfolio of oral pharmaceutical products for both in-office and home-care use. All
of our products are marketed and sold in the United States and Canada primarily through our direct
field sales force and telemarketing organization. Our national marketing programs reach most of
the nations dental offices and include continuing education seminars for dentists and their
staffs. We are certified by the American Dental Association and the Academy of General Dentistry to
provide continuing education seminars. Our research and development division holds expertise in
pre-cancer/cancer detection through our patented ZTC
TM
and OraTest
®
technologies and is developing a pipeline of products focused on oral disease detection and
treatment. In October 2006, we divested our Nutraceuticals Business Unit and in May 2007 we
divested our Peridex
®
brand of prescription periodontal rinse and as a result, these
operations are presented as discontinued for all periods presented. With the integration of the
operations of Pro-Dentec with our former Zila Pharmaceuticals Business Unit and the re-alignment of
our Zila Biotechnology Business Unit to serve as our research and development division, we have
organized ourselves as one operating segment.
On August 13, 2007, we entered into an Amendment Agreement with certain of the investors in
the Private Placements (the Investors), which were originally completed in November 2006, to
restructure their holdings, modify the registration rights granted to these Investors and, with
respect to the Investors in the senior notes, provide relief from certain financial and
non-financial covenants. We believe that the restructuring strengthens our financial position by
relaxing the minimum cash and EBITDA covenants and allowing future interest to be paid in kind with
common stock. The Amended and Restated Secured Notes are in the same aggregate principal amount as
the original Secured Notes, but are now due July 31, 2010 and bear interest, payable quarterly, at
7.0% per annum, but at our option, interest payments can be made at an 8.0% annual rate in shares
of our common stock at a price equal to 90.0% of the average closing bid price of such common stock
for the ten trading days immediately prior to the relevant interest payment date. The required cash
balance was reduced from $10.5 million to $2.0 million commencing July 31, 2007 and EBITDA, as
defined, of at least $1.00 is required for each of the fiscal quarters ending July 31, 2008 and
October 31, 2008. As part of this agreement, we also (i) repurchased 932,832 common shares from the
investors for $1.25 million in cash, (ii) repurchased 227,270 warrants from the investors for $0.15
million in cash and (iii) paid the investors a $0.6 million fee.
19
As we more fully reported in our Annual Report on Form 10-K filed on October 15, 2007, we
recently conducted a comprehensive review of Zilas strategic direction, including all aspects of
the OraTest
®
program. The review included the history, present status and future
prospects of the OraTest
®
program, including the regulatory path to approval of
OraTest
®
with the FDA and its post-approval commercial potential and challenges. Our
strategic review also considered the growing market acceptance for its adjunctive oral cancer
screening product, ViziLite
®
Plus with T-Blue
630TM
, and the fact that we
currently have toluidine blue on the market today in the T-Blue
630TM
marker. We
believe that in order to maximize shareholder value, our resources must be directed to those
products and programs with the greatest probability of financial return. Our analysis concluded
that the incremental market potential of OraTest
®
, considering the availability of
ViziLite
®
Plus, does not justify the cost, time and uncertain study outcomes associated
with continuing the program in its current form.
Also as previously reported, we initiated the process of seeking a partner in an effort to
realize the value of the ZTC
TM
platform. ZTC
TM
, the active staining component
in OraTest
®
, may have additional applications, including the detection of high-risk
lesions of the cervix, esophagus and skin. We believe that the potential of these additional
therapeutic applications could appeal to a partner.
Finally, in early October 2007, we ceased enrollment in the clinical trial and are taking the
steps necessary to capture, secure and analyze the clinical and program data obtained to date,
which we intend to use to support the growth of the ViziLite
®
Plus program.
Results of Operations
The following table summarizes our results of continuing operations and related statistical
information for the three months ended October 31, 2007 and 2006 (dollars in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
For the Three Months Ended October 31,
|
|
|
|
|
|
|
|
% of
|
|
|
|
|
|
|
% of
|
|
|
%
|
|
|
|
2007
|
|
|
Revenue
|
|
|
2006
|
|
|
Revenue
|
|
|
Change
|
|
Net revenues
|
|
$
|
11,440
|
|
|
|
100.0
|
%
|
|
$
|
339
|
|
|
|
100.0
|
%
|
|
|
3,274.6
|
%
|
Cost of products sold
|
|
|
4,581
|
|
|
|
40.0
|
|
|
|
500
|
|
|
|
147.5
|
|
|
|
816.2
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Gross profit (loss)
|
|
|
6,859
|
|
|
|
60.0
|
|
|
|
(161
|
)
|
|
|
(47.5
|
)
|
|
|
(4,360.2
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating costs and expenses:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Marketing and selling
|
|
|
5,297
|
|
|
|
46.3
|
|
|
|
1,423
|
|
|
|
419.8
|
|
|
|
272.2
|
|
General and administrative
|
|
|
3,473
|
|
|
|
30.4
|
|
|
|
3,067
|
|
|
|
904.7
|
|
|
|
13.2
|
|
Research and development
|
|
|
1,202
|
|
|
|
10.5
|
|
|
|
1,535
|
|
|
|
452.8
|
|
|
|
(21.7
|
)
|
Depreciation and amortization
|
|
|
915
|
|
|
|
8.0
|
|
|
|
389
|
|
|
|
114.7
|
|
|
|
135.2
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss from operations
|
|
|
(4,028
|
)
|
|
|
(35.2
|
)
|
|
|
(6,575
|
)
|
|
|
(1,939.5
|
)
|
|
|
(38.7
|
)
|
Other expense net
|
|
|
(644
|
)
|
|
|
(5.6
|
)
|
|
|
(3,662
|
)
|
|
|
(1,080.3
|
)
|
|
|
(82.4
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss from
continuing operations before income taxes
|
|
|
(4,672
|
)
|
|
|
(40.8
|
)
|
|
|
(10,237
|
)
|
|
|
(3,019.8
|
)
|
|
|
(54.4
|
)
|
Income tax benefit (expense)
|
|
|
(11
|
)
|
|
|
(0.1
|
)
|
|
|
3,865
|
|
|
|
1,140.2
|
|
|
|
(100.3
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss from continuing operations
|
|
$
|
(4,683
|
)
|
|
|
(40.9
|
)%
|
|
$
|
(6,372
|
)
|
|
|
(1,879.6
|
)%
|
|
|
(26.5
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net Revenues
Net revenues were $11.4 million and $0.3 million for the three months ended October 31, 2007
and 2006, respectively, an increase of $11.1 million or in excess of 100.0%. The growth in net
revenues for the first three months of fiscal 2008 is largely driven by our acquisition of
Pro-Dentec on November 28, 2006, as well as its effect on ViziLite
®
Plus net revenues.
ViziLite
®
Plus net revenues increased 881.4% to $3.1 million in the first three months
of fiscal 2008 from the first three months of fiscal 2007, primarily as a result of selling direct
to dental offices through Pro-Dentecs national sales organization. ViziLite
®
Plus net
revenues were affected by our deliberate reductions in sales to our then existing distribution
channel in the first quarter of fiscal 2007 as we prepared to modify our means of distribution upon
the completion of the Pro-Dentec acquisition.
Gross Profit
Gross profit (loss) was $6.9 million and $(0.2) million for the three months ended October 31,
2007 and 2006, respectively, an
20
increase of $7.1 million or in excess of 100.0%. Gross profit as a
percentage of net revenues was 60.0% and (47.5)% for the three months ended October 31, 2007 and
2006, respectively. The improved gross profit margin for the first three months of fiscal 2008
primarily relates to our sales of ViziLite
®
Plus made direct to dental offices
through Pro-Dentecs national sales organization, as well as sales of other Pro-Dentec products
including the Rota-dent
®
Professional Powered Brush and the Pro-Select
®
Platinum ultrasonic scaler. Prior-years gross profit reflects our distributor-only business model
and the impact of discounts and incentives offered in support of the launch of ViziLite
®
Plus. The gross profit margin for the first quarter of the prior-year was also negatively impacted
as a result of providing reserves for ViziLite
®
inventory that was approaching its
expiration date.
Marketing and Selling Expense
Marketing and selling expense was $5.3 million and $1.4 million for the three months ended
October 31, 2007 and 2006, respectively, an increase of $3.9 million or in excess of 100.0%.
Pro-Dentecs dedicated national sales force, which sells directly to dental offices, represented
the majority of the increase in marketing and selling expense. Increased ViziLite
®
Plus
related marketing and selling expenditures also contributed to the overall increase, which reflects
our continued efforts to establish ViziLite
®
Plus as the standard of care for dental
offices in the detection of abnormalities.
General and Administrative Expense
General and administrative expense was $3.5 million and $3.1 million for the three months
ended October 31, 2007 and 2006, respectively, an increase of $0.4 million or 13.2%. The increase
in general and administrative expense primarily relates to the acquisition of Pro-Dentec. The
addition of Pro-Dentecs general and administrative costs of $0.9 million and implementation costs
for Pro-Dentecs new enterprise financial systems of $0.1 million for the three months ended
October 31, 2007 were offset by general corporate expense reductions of $0.7 million. Non-cash
general and administrative stock-based compensation expense increased by $0.2 million for the first
three months of fiscal 2008 compared to the first three months of fiscal 2007.
Research and Development Expense
Research and development expense was $1.2 million and $1.5 million for the three months ended
October 31, 2007 and 2006, respectively, a decrease of $0.3 million or 21.7%. We recently
conducted an extensive review and analysis of our strategic direction, including the
OraTest
®
regulatory program, and in the first quarter of
fiscal 2008, we closed
enrollment in the OraTest
®
clinical trial and ceased expenditures for CMC and
non-clinical aspects of the regulatory program. The curtailment of the regulatory program is the
primary driver of the overall decrease in research and development expense. While activities
continue to preserve the value of the ZTC
TM
asset, we believe that our level of
expenditures for research and development in fiscal 2008 will be
substantially reduced from
historical levels.
Depreciation and Amortization Expense
Depreciation and amortization expense was $0.9 million and $0.4 million for the three months
ended October 31, 2007 and 2006, respectively, an increase of $0.5 million or in excess of 100.0%.
As a percentage of revenue, depreciation and amortization expense was 8.0% and 114.7% for the three
months ended October 31, 2007 and 2006, respectively. The increased level of depreciation and
amortization expense is primarily related to the acquisition of Pro-Dentec and its related
property, plant, equipment and amortizable intangible assets.
Other Expense Net
Other expense, net was $0.6 million and $3.7 million for the three months ended October 31,
2007 and 2006, respectively. Other expense primarily consists of interest expense, which is
summarized as follows:
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended October 31,
|
|
|
|
2007
|
|
|
2006
|
|
Senior secured convertible notes
|
|
$
|
216
|
|
|
$
|
|
|
BDCF secured term loan
|
|
|
|
|
|
|
520
|
|
Amortization of financing costs
|
|
|
99
|
|
|
|
2,223
|
|
Amortization of debt discounts
|
|
|
447
|
|
|
|
2,067
|
|
Capital leases
|
|
|
5
|
|
|
|
1
|
|
|
|
|
|
|
|
|
|
Total interest expense
|
|
$
|
767
|
|
|
$
|
4,811
|
|
|
|
|
|
|
|
|
21
The decrease in interest expense primarily relates to interest incurred on a $20.0 million
secured term loan with Black Diamond Commercial Finance, LLC (BDCF), which was repaid in the
first quarter of fiscal 2007. As a result of this repayment, we expensed $3.6 million of
unamortized debt issue costs and discounts during the three months ended October 31, 2006.
Interest expense for the first quarter of fiscal 2008 primarily relates to interest incurred on our
Amended and Restated Secured Notes, which was paid in cash in the first quarter of fiscal 2008, and
amortization of the related financing costs and discounts.
During the first quarter of fiscal 2007 we recognized $1.1 million of non-cash derivative
income for changes in the fair value of a warrant to purchase 1,200,000 common shares that was
issued to BDCF in connection with the term loan discussed above. Prior to our adoption of FASB
Staff Position No. EITF 00-19-2,
Accounting for Registration Payment Arrangements
on November 1,
2006, we were required to account for this warrant as a freestanding derivative financial
instrument, with changes in the fair value of the warrant reported as non-cash charges or credits
to earnings. The derivative income recognized was due primarily to a decrease in the trading price
of our common stock during the first quarter of fiscal 2007.
Income Tax Benefit (Expense)
As of October 31, 2007, we have recorded a valuation allowance for our net deferred tax assets
of $13.9 million due to our lack of earnings history, and we had federal net operating loss
carryforwards of approximately $52.3 million that expire in years 2009 to 2028. Income tax expense
for the three months ended October 31, 2007 was de minimis and primarily relates to state income
taxes. Income tax benefit of $3.9 million for the three months ended October 31, 2006 resulted from
the utilization of net operating loss carryforwards to offset the income tax expense on the taxable
gain on the sale of our Nutraceuticals Business Unit.
Inflation and Seasonality
We do not believe that inflation has a unique or material effect on the operations or
financial condition of our businesses. Sales for the dental industry are generally strongest in
our second and third fiscal quarters and weaker in our first and fourth fiscal quarters, due
primarily to the effects of summer vacation seasonality. Subsequent to the Pro-Dentec acquisition
in November 2006, we sell directly to dental professionals and accordingly, we would expect our
sales to be subject to these seasonal trends.
Liquidity and Capital Resources
Historically, our liquidity needs arise from working capital requirements, the funding of our
research and development program, the launch of our new products, acquisitions and debt service. We
have traditionally met these cash requirements through our cash and cash equivalents, financing
transactions, cash from operations, working capital management, the sale of non-core operations and
proceeds from the issuance of common stock under our employee stock option and stock purchase
programs.
Our research and development program required the commitment of substantial resources to
conduct the time-consuming research and development, clinical studies and regulatory activities
necessary to bring any potential product to market and to establish production, marketing and sales
capabilities. As more fully described above, we recently evaluated the strategic direction of Zila,
including an assessment of the OraTest
®
regulatory program, and we believe that in order
to maximize shareholder value our resources must be directed to those products and programs with
the greatest probability of financial return. We believe that our greatest potential lies within
the synergies created with the acquisition of Pro-Dentec, which increases our ability to develop
and commercialize our already existing oral cancer screening product, ViziLite
®
Plus.
Our analysis concluded that the incremental market potential of OraTest
®
, considering
the availability of ViziLite
®
Plus, does not justify the cost, time and uncertain study
outcomes associated with continuing the program in its current form. In order to pursue our
strategy with our currently available funds, we believe that it is necessary to reduce future
research and development expenditures on the OraTest
®
regulatory program. Accordingly,
during the first quarter of fiscal 2008, we curtailed activity and spending related to the
regulatory program. As a result of this curtailment, regulatory program related expenses declined
to $1.0 million for the first three months of fiscal 2008 from $1.5 million in the first three
months of fiscal 2007, a reduction of $0.5 million or 35.2%. While activities continue to preserve
the value of the ZTC
TM
asset, we believe that our level of expenditures for research and
development in fiscal 2008 will be substantially reduced over historic levels.
Separately, in the fourth quarter of fiscal 2007, we took actions to streamline our operations
and reduce overhead expenditures by approximately $3.0 million annually. With our cost reduction
measures and with the anticipated growth in ViziLite
®
Plus and our other core products,
we believe that our cash and cash equivalents along with cash flows generated from operations and
working capital management should allow us to fund our planned operations over the next 12 months.
22
Selected cash flow and working capital information is summarized as follows (dollars in
thousands):
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended October 31,
|
|
|
2007
|
|
2006
|
Net cash used in operating activities
|
|
$
|
(4,327
|
)
|
|
$
|
(4,104
|
)
|
Net cash provided by (used in) investing activities
|
|
|
(455
|
)
|
|
|
37,734
|
|
Net cash used in financing activities
|
|
|
(1,417
|
)
|
|
|
(22,935
|
)
|
|
|
|
October 31,
|
|
July 31,
|
|
|
2007
|
|
2007
|
Cash and cash equivalents
|
|
$
|
8,660
|
|
|
$
|
14,859
|
|
Working capital
|
|
|
10,909
|
|
|
|
14,286
|
|
Current ratio
|
|
|
2.1
|
|
|
|
2.4
|
|
As of October 31, 2007, our primary sources of liquidity included cash and cash equivalents of
$8.7 million compared to $14.9 million as of July 31, 2007. Our working capital was $10.9 million
as of October 31, 2007 compared to $14.3 million as of July 31, 2007. The decrease in working
capital primarily relates to our decreased cash balance, offset by increased trade receivables.
Trade receivables increased $1.9 million or 45.5%, primarily due to the implementation of new
financial systems at Pro-Dentec, which resulted in a delay in billings in the first three months of
fiscal 2008. Our current ratio has declined to 2.1 as of October 31, 2007 compared to 2.4 as of
July 31, 2007, primarily as a result of the net decreases in working capital outlined above.
Cash Flows from Operating Activities
Cash used in operating activities was $4.3 million and $4.1 million for the three months ended
October 31, 2007 and 2006, respectively. The increase in cash used in operating activities
primarily relates to cash provided by (used in) working capital components, which was $(1.4)
million and $3.3 million for the three months ended October 31, 2007, respectively, or a $4.7
million change. The working capital decrement for the three months ended October 31, 2007
primarily relates to increased accounts receivable balances at Pro-Dentec, which is discussed
above. Cash provided by working capital changes in the first three months of fiscal 2007 relates
to reduced levels of accounts receivable as a result of the disposition of our Nutraceuticals
Business Unit and increased levels of accounts payable. Exclusive of cash flows for working
capital changes, the improvement in cash used in operating activities relates to (i) cash flows
from our Pro-Dentec operations, which were acquired during the second quarter of fiscal 2007, (ii)
synergies created as a result of this acquisition, which increases our ability to develop and
commercialize our already existing oral cancer screening product, ViziLite
®
Plus, (iii)
the elimination of cash flows from our recently disposed Nutraceuticals Business Unit and
Peridex
®
product line and (iv) the curtailment of activity and spending related to the
OraTest
®
regulatory program.
Cash Flows from Investing Activities
Cash provided by (used in) investing activities was $(0.5) million and $37.7 million for the
three months ended October 31, 2007 and 2006, respectively. During the three months ended October
31, 2007 we spent $0.5 million for additional property and equipment and development of intangible
assets. Cash provided by investing activities during the first three months of fiscal 2007 relates
to net proceeds of $34.7 million from the sale of our Nutraceuticals Business Unit and $3.6 million
for the return of collateral upon the retirement of Industrial Development Revenue Bonds, which
related to the disposition of the Nutraceuticals Business Unit, offset by $0.3 million of cash
spent towards the acquisition of Pro-Dentec, which was completed in the second quarter of fiscal
2007, and $0.3 million of cash spent for additional property and equipment and the development of
intangible assets.
Cash Flows from Financing Activities
Cash used in financing activities was $1.4 million and $22.9 million for the three months
ended October 31, 2007 and 2006, respectively. During the first three months of fiscal 2008, we
paid $1.4 million for the repurchase of common stock and warrants, which is described in more
detail elsewhere herein. During the first three months of fiscal 2007, we used $22.8 million for
the
repayment of debt, which primarily relates to the repayment of the BDCF credit facility and
the Industrial Development Revenue Bonds. During the first three months of fiscal 2007, we also
incurred $0.5 million for financing costs, offset by $0.3 million of short-term borrowings and
proceeds from the issuance of common stock.
23
Private Placements
In November 2006, we consummated two private placements (the Private Placements) for gross
proceeds of approximately $40.0 million.
Pursuant to the first purchase agreement, we issued and sold:
|
(i)
|
|
9,100,000 shares of Zilas common stock for $1.75 per share (the Shares);
|
|
|
(ii)
|
|
Approximately $12.1 million in aggregate principal amount of 12.0% Unsecured
Convertible Notes (the Unsecured Notes), which converted into 6,900,000 shares (the
Unsecured Note Shares) of Zilas common stock at a conversion price of $1.75 per share on
December 14, 2006, the date on which our stockholders approved, among other things, the
Private Placements;
|
|
|
(iii)
|
|
Warrants to purchase approximately 5,403,000 shares of Zilas common stock, which
became exercisable in May 2007 for five years at an exercise price of $2.21 per share (the
Initial Warrants);
|
|
|
(iv)
|
|
Warrants to purchase approximately 3,105,000 shares of Zilas common stock, which
became exercisable for five years at an exercise price of $2.21 per share following
approval by our stockholders on December 14, 2006 (the Additional Warrants);
|
Pursuant to the second purchase agreement, we issued and sold:
|
(i)
|
|
Approximately $12.0 million in aggregate principal amount of 6.0% Senior Secured
Convertible Notes (the Secured Notes), which are due in November 2009 and became
convertible into approximately 5,454,546 shares of Zilas common stock at a conversion
price of $2.20 following approval by our stockholders on December 14, 2006; and
|
|
|
(ii)
|
|
Warrants to purchase 1,909,091 shares of Zilas common stock, which became exercisable
for five years at an exercise price of $2.21 per share following approval by our
stockholders on December 14, 2006 (the Secured Note Warrants).
|
As more fully described in the notes to the accompanying unaudited condensed consolidated
financial statements, on August 13, 2007, we reached an agreement with certain Investors in the
Private Placements to restructure their holdings and provide relief from certain financial and
non-financial covenants contained in the Secured Notes. As more fully described elsewhere in this
filing, these Investors, and one other, had also previously disputed the extent of certain
registration rights granted in connection with the securities issued in the Private Placements. In
an effort to resolve the aforementioned dispute and to obtain covenant relief, Zila and certain of
the Investors with whom we had the dispute, agreed to take certain actions and restructure the
Investors holdings (the Restructuring). As part of the Restructuring, on August 13, 2007, Zila
entered into an Amendment Agreement (the Amendment Agreement) with Visium Balanced Offshore Fund,
Ltd., Visium Balanced Fund, LP, Visium Long Bias Offshore Fund, Ltd., Visium Long Bias Fund, LP and
Atlas Master Fund, Ltd., which provides for, among other things, the following:
|
(i)
|
|
Zila repurchased 932,832 Unsecured Note Shares from the Investors for approximately
$1.25 million in cash, at a price based on the average closing bid price of our common
stock for the ten trading days prior to August 13, 2007, or $1.34 per Unsecured Note Share;
|
|
|
(ii)
|
|
Zila repurchased 227,270 Secured Note Warrants from the Investors for approximately
$0.15 million in cash, at a price based on a BlackScholes valuation, or $0.66 per Secured
Note Warrant;
|
|
|
(iii)
|
|
Zila and the Investors agreed to amend and restate the Secured Notes (the Amended and
Restated Secured Notes) on the terms set forth below and elsewhere herein; and
|
|
|
(iv)
|
|
Zila paid the Investors a $0.6 million fee.
|
We believe that the Restructuring strengthens our cash position by relaxing the minimum cash
and EBITDA based covenants and allows future interest to be paid in kind with common stock. The
Amended and Restated Secured Notes are in the same aggregate principal amount as the Secured Notes,
or $12.0 million, but are now due July 31, 2010. They bear interest, payable quarterly, at 7.0% per
annum, but at our option, interest payments can be made at an 8.0% annual rate in shares of our
common stock at a price equal to 90.0% of the average closing bid price of such common stock for
the 10 trading days immediately prior to the relevant interest payment date. The required cash
balance was reduced from $10.5 million to $2.0 million commencing July 31, 2007 and defined
24
EBITDA
of at least $1.00 is required for each of the fiscal quarters ending July 31, 2008 and October 31,
2008.
Failure to satisfy the financial covenants, or to maintain compliance with the negative
covenants could, at the option of the Amended and Restated Secured Note holders, result in an event of
default under the Amended and Restated Secured Notes. Upon the occurrence of the first specified
event of default, the holders of the Amended and Restated Secured Notes could accelerate and demand
repayment of one-third of the outstanding principal balance and all accrued but unpaid interest.
Upon the occurrence of the second specified event of default, the holders of the Amended and
Restated Secured Notes could accelerate and demand repayment of one-half of the outstanding
principal balance and all accrued but unpaid interest. Upon the occurrence of the third specified
event of default, the entire principal balance and all accrued but unpaid interest may become due
and payable.
In connection with the Restructuring and the issuance of the Amended and Restated Secured
Notes, Zila also received waivers from the required majority of the holders of the Initial
Warrants, Additional Warrants and Secured Note Warrants waiving any antidilution rights to which
any holder of such warrants would otherwise be entitled in connection with the issuance of any
shares as payment for interest on the Amended and Restated Secured Notes. Also, on August 13,
2007, Zila and the Investors entered into a Registration Rights Agreement (the Registration Rights
Agreement), which is described further in the notes to the accompanying unaudited condensed
consolidated financial statements; however, a registration rights dispute remains with one
investor. Separately, a side letter that imposed certain corporate governance obligations on Zila
was terminated.
PharmaBio Investment
In December 2002, we entered into an agreement with PharmaBio Development, Inc. (PharmaBio),
the strategic investment group of Quintiles Transnational Corp., our contract research
organization. Under this agreement, PharmaBio invested $0.5 million in us and in return we agreed
to pay PharmaBio an amount equal to 5.0% of all net sales of the OraTest
®
product in the
European Union and the United States. The aggregated amount of the royalty cannot exceed $1.25
million and the royalty is payable quarterly. The investment was recorded as long-term debt and
will be amortized using the effective interest method.
Convertible Preferred Stock
On February 5, 2001, we issued 100,000 shares of Series B Convertible Preferred Stock
(Preferred Stock) as part of an acquisition. The holders of the Preferred Stock are entitled to
receive cumulative quarterly dividends at a rate of $0.0975 per share per fiscal quarter, payable
in arrears, which represents an aggregate annual dividend of $39,000. As of October 31, 2007 and
July 31, 2007, accumulated accrued dividends were $9,750. The Preferred Stock can be redeemed at
our option if our common stock maintains a closing price on each trading day equal to or greater
than $9.00 per share for any ten trading day period. The redemption price shall be the average bid
closing price of our common stock for the five trading days immediately proceeding the date we give
notice. The Preferred Stock is convertible at the option of the holder at any time on or before
December 31, 2010 into our common stock at the ratio of one-to-one. On December 31, 2010, all of
the remaining Preferred Stock will be converted into our common stock at a ratio of one-to-one.
Holders of the preferred stock have no voting rights except as required by applicable law and have
a liquidation preference of $0.65 million.
EBITDA
We utilize EBITDA (earnings (loss) before interest, taxes, depreciation and amortization) to
monitor compliance with the covenants contained in our Amended and Restated Secured Notes, some of
which are based on EBITDA. The Amended and Restated Notes are
material agreements to us and, therefore, its covenants are material
to an investors understanding of our financial condition and
liquidity. Although we use EBITDA as a financial measure to monitor compliance with
debt covenants, it does not include certain material costs, expenses and other items necessary to
operate our business. Because EBITDA does not include these items, a stockholder, potential
investor or other user of our financial information should not consider this non-GAAP financial
measure as a substitute for net cash used in operating activities or as the sole indicator of our
financial performance since net cash used in operating activities provides a more complete measure
of our financial performance. In other words, EBITDA should only be
used on a supplemental basis combined with GAAP results when
evaluating our financial performance.
25
The following is a reconciliation of EBITDA to GAAP measures (unaudited) (in thousands):
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended October 31,
|
|
|
|
2007
|
|
|
2006
|
|
EBITDA
|
|
$
|
(3,178
|
)
|
|
$
|
5,290
|
|
Non-cash derivative (income) expense
|
|
|
24
|
|
|
|
(1,059
|
)
|
Gain from disposition of discontinued operations
|
|
|
|
|
|
|
(11,110
|
)
|
Non-cash stock-based compensation expense
|
|
|
430
|
|
|
|
218
|
|
Other non-cash items net
|
|
|
(50
|
)
|
|
|
(54
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Defined EBITDA (a)
|
|
|
(2,774
|
)
|
|
|
(6,715
|
)
|
Interest income
|
|
|
124
|
|
|
|
125
|
|
Interest expense
|
|
|
(767
|
)
|
|
|
(5,064
|
)
|
Income tax expense
|
|
|
(11
|
)
|
|
|
(12
|
)
|
Amortization of financing costs
|
|
|
99
|
|
|
|
2,095
|
|
Amortization of debt discounts
|
|
|
447
|
|
|
|
2,067
|
|
Non-cash interest on term loan
|
|
|
|
|
|
|
138
|
|
Changes in operating assets and liabilities:
|
|
|
|
|
|
|
|
|
Trade receivables
|
|
|
(1,946
|
)
|
|
|
956
|
|
Inventories
|
|
|
47
|
|
|
|
(306
|
)
|
Prepaid expenses and other assets
|
|
|
183
|
|
|
|
8
|
|
Accounts payable and accrued liabilities
|
|
|
271
|
|
|
|
2,604
|
|
|
|
|
|
|
|
|
|
Net cash used in operating activities
|
|
$
|
(4,327
|
)
|
|
$
|
(4,104
|
)
|
|
|
|
|
|
|
|
|
|
|
(a)
|
|
Defined EBITDA, is EBITDA as defined in the Amended and Restated Secured Note
Agreement.
|
Off-Balance Sheet Financing Arrangements
We do not have any off-balance sheet financing arrangements.
Summary of Critical Accounting Policies and Estimates
The discussion and analysis of our financial condition and results of operations are based
upon our condensed consolidated financial statements, which have been prepared pursuant to the
rules and regulations of the SEC. Certain information related to our organization, significant
accounting policies and footnote disclosures normally included in financial statements prepared in
accordance with accounting principles generally accepted in the United States have been condensed
or omitted. The preparation of the financial statements in accordance with accounting principles
generally accepted in the United States requires us to make estimates and assumptions that affect
the amounts reported in the financial statements and accompanying notes. On an ongoing basis, we
evaluate our estimates related to (i) useful lives of intangibles; (ii) impairment analyses; (iii)
depreciable lives of assets; (iv) income tax valuation allowances; (v) contingency and litigation
reserves; (vi) inventory valuation; (vii) allowances for accounts receivable, cash discounts, sales
incentives and sales returns; and (viii) valuation assumptions for share-based payments. We base
our estimates on historic experience and various other factors related to each circumstance. Actual
results could differ from those estimates based upon future events, which could include, among
other risks, changes in the business environment in which we operate and changes in the regulations
governing the manner in which we manufacture and/or sell our products.
There are several accounting policies that we believe are significant to the presentation of
our financial statements and require managements most difficult, complex or subjective judgments
about matters that are inherently uncertain. We believe our most critical accounting policies
include (i) revenue recognition; (ii) use of estimates, which is described more fully above and
(iii) the carrying values of goodwill and other long-lived assets. Our significant accounting
policies and critical accounting estimates are disclosed more fully in our Annual Report on Form
10-K for the year ended July 31, 2007. We do not believe there have been
significant changes to our critical accounting policies and estimates subsequent to July 31,
2007.
Recently Issued Accounting Pronouncements and Adopted Accounting
The recently issued accounting pronouncements and adopted accounting are discussed in the
notes to the unaudited condensed consolidated financial statements included elsewhere herein.
26
Item 3. Quantitative and Qualitative Disclosures about Market Risk.
Our exposure to market risk for a change in interest rates relates primarily to our
investments, which consists of cash and cash equivalents. The primary objective of our investment
activities is to preserve principal while maximizing yields without significantly increasing risk.
We maintain our portfolio in high credit quality cash deposits and money market funds with carrying
values that approximate market value. Because our investments consist of cash and cash equivalents,
a hypothetical 100 basis point change in interest rates is not likely to have a material effect on
our consolidated financial statements.
We also have market risk arising from changes in foreign currency exchange rates through our
subsidiaries that conduct business in Canada and Europe and have functional currencies denominated
in Canadian dollars and British pounds. We believe that such exposure does not present a
significant risk due to the limited number of transactions and/or accounts denominated in foreign
currency.
Item 4. Controls and Procedures.
Evaluation of Disclosure Controls and Procedures.
We maintain disclosure controls and procedures (as defined in Rules 13a-15(e) and 15d-15(e)
under the Securities Exchange Act of 1934, as amended (the Exchange Act)) that are designed: (i)
to ensure that information required to be disclosed in the reports that we file or submit under the
Exchange Act is recorded, processed, summarized and reported within the time periods specified in
the SECs rules and forms and (ii) to ensure that such information is accumulated and communicated
to management, including our Principal Executive Officer and Principal Financial Officer, as
appropriate, to allow for timely decisions regarding required disclosure. Our management, with the
participation of our Principal Executive Officer and Principal Financial Officer, evaluated the
effectiveness of our disclosure controls and procedures as of the end of the period covered by this
report, and, based on that evaluation, our Principal Executive Officer and Principal Financial
Officer have concluded that our disclosure controls and procedures (as defined in Rules 13a-15(e)
and 15d-15(e)) are effective.
Changes in Internal Control over Financial Reporting
.
During the first quarter of fiscal 2008, we integrated Pro-Dentec into our financial
accounting systems as well as implemented a new customer relations management system. Pro-Dentec is
a subsidiary that was acquired in November 2006. Our internal control over financial reporting has
been altered accordingly for this change in accounting systems. We continue to develop our control
procedures surrounding the implementation of the new financial accounting systems and customer
relations management system at Pro-Dentec. We believe that we are adequately controlling the
integration and do not expect any sustained material impact on our internal control over financial
reporting. There were no other changes in our internal control over financial reporting (as such
term is defined in Rules 13a-15(f) and 15d-15(f) of the Exchange Act) during the most recent fiscal
quarter that have materially affected, or are reasonably likely to materially affect, our internal
control over financial reporting.
Part II OTHER INFORMATION
Item 1. Legal Proceedings.
Information regarding our legal proceedings may be found under the Legal Proceedings section
of Note 17, Commitments and Contingencies to our Unaudited Condensed Consolidated Financial
Statements contained elsewhere herein.
Item 1A. Risk Factors.
There have been no material changes in risk factors previously disclosed in our Form 10-K for
the year ended July 31, 2007.
27
Item 2. Unregistered Sales of Equity Securities and Use of Proceeds.
Issuer Purchases of Equity Securities
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(c) Total
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Number of
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(d) Maximum
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Shares
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Number of
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Purchased
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Shares that
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as Part of
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May Yet Be
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(a) Total
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(b) Average
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Publicly
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Purchased
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Number of
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Price
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Announced
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Under the
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Shares
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Paid per
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Plans or
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Plans or
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Period
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Purchased
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Share
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Programs
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Programs
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August 1, 2007 to
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August 31, 2007
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932,832
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$
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1.34
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(a
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)
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(a
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)
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September 1, 2007 to
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September 30, 2007
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(a
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(a
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October 1, 2007 to
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October 31, 2007
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(a
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(a
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(a)
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The above purchases were made as part of an Amendment Agreement with certain
Investors, which is more fully described in the notes to the unaudited condensed
consolidated financial statements included elsewhere in this
Quarterly Report on Form 10-Q.
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There were no sales of equity securities during the most recent fiscal quarter.
Item 3. Defaults Upon Senior Securities.
None
Item 4. Submission of Matters to a Vote of Security Holders
.
None
Item 5. Other Information.
None
Item 6. Exhibits.
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Exhibit
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Number
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Description
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31.1
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Section 302 Certification of the Principal Executive Officer
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31.2
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Section 302 Certification of the Principal Financial Officer
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32.1
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Section 1350 Certification of the Principal Executive Officer and Principal Financial Officer
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28
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly
caused this report to be signed on its behalf by the undersigned thereunto duly authorized.
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Date: December 10, 2007
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Zila, Inc.
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By:
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/s/ FRANK J. BELLIZZI
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Frank J. Bellizzi
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Executive Vice President
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(Principal Executive Officer)
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By:
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/s/ DIANE E. KLEIN
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Diane E. Klein
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Vice President Finance and Treasurer
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(Principal Financial Officer)
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Exhibit
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Number
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Description
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31.1
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Section 302 Certification of the Principal Executive Officer
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31.2
|
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Section 302 Certification of the Principal Financial Officer
|
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32.1
|
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Section 1350 Certification of the Principal Executive Officer and Principal Financial Officer
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29
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