1 SECURITIES AND EXCHANGE COMMISSION Washington, DC 20549 FORM 10-Q (Mark One) [X] Quarterly report pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 For the quarterly period ended January 31, 2001 or [ ] Transition report pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 For the transition period from to ---------------------- ------------------------- Commission file number 0-17521 -------------------------------------------------------- ZILA, INC - ------------------------------------------------------------------------------- (Exact Name of Registrant as Specified In Its Charter) Delaware 86-0619668 - ---------------------------- ------------------------ (State or Other Jurisdiction of (I.R.S. Employer Incorporation or Organization) Identification No.) 5227 North 7th Street, Phoenix, Arizona 85014 - ----------------------------------------------------------------------------- (Address of Principal Executive Offices) (Zip Code) Registrant's Telephone Number, Including Area Code (602) 266-6700 ------------------- Former Name, Former Address and Former Fiscal Year, if Changed Since Last Report 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 (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days Yes X No___ APPLICABLE ONLY TO CORPORATE ISSUERS Indicate the number of shares outstanding of each of the issuer's classes of common stock, as of the latest practicable date. At January 31, 2001, the number of shares of common stock outstanding was 43,446,150. Exhibit Index 18 Total pages 19 1 2 TABLE OF CONTENTS Page no. -------- PART I FINANCIAL INFORMATION Item 1. Financial Statements (Unaudited) Condensed consolidated balance sheets as of January 31, 2001 and July 31, 2000 3 Condensed consolidated statements of operations and comprehensive income (loss) for the three months and six months ended January 31, 2001 and 2000 4 Condensed consolidated statements of cash flows for the six months ended January 31, 2001 and 2000 5 Notes to condensed consolidated financial statements 6-10 Item 2. Management's discussion and analysis of financial condition and results of operations 11-17 Item 3. Quantitative and qualitative disclosures about market risk 17 PART II. OTHER INFORMATION Item 1. Legal proceedings 17 Item 4. Submission of matters to a vote of security holders 18 SIGNATURES 19 2 3 ZILA, INC. AND SUBSIDIARIES CONDENSED CONSOLIDATED BALANCE SHEETS (UNAUDITED) - ------------------------------------------------------------------------------- ASSETS January 31, 2001 July 31, 2000 --------------- ------------ CURRENT ASSETS: Cash and cash equivalents $ 536,988 $ 5,558,487 Trade receivables - net 10,433,138 9,893,587 Inventories - net 17,143,037 13,204,137 Prepaid expenses and other current assets 2,579,564 2,479,072 Deferred income taxes 244,788 244,788 ------------ ------------ Total current assets 30,937,515 31,380,071 ------------ ------------ PROPERTY AND EQUIPMENT - net 10,897,469 9,442,278 PURCHASED TECHNOLOGY RIGHTS - net 5,382,755 5,600,975 GOODWILL - net 12,137,122 12,725,978 TRADEMARKS and OTHER INTANGIBLE ASSETS - net 12,531,541 12,423,632 CASH HELD BY TRUSTEE 1,377,282 2,928,001 OTHER ASSETS 3,765,284 3,210,524 ------------ ------------ TOTAL $ 77,028,968 $ 77,711,459 ============ ============ LIABILITIES AND SHAREHOLDERS' EQUITY CURRENT LIABILITIES: Accounts payable $ 6,510,361 $ 6,599,702 Accrued liabilities 2,851,805 3,622,330 Short-term borrowings 1,920,049 51,770 Current portion of long-term debt 751,247 776,866 ------------ ------------ Total current liabilities 12,033,462 11,050,668 LONG-TERM DEBT - net of current portion 4,316,115 4,548,953 ------------ ------------ Total liabilities 16,349,577 15,599,621 ------------ ------------ COMMITMENTS AND CONTINGENCIES (Note 9) SHAREHOLDERS' EQUITY: Preferred stock, $.001 par value - authorized 2,500,000 shares, none issued Common stock, $.001 par value - authorized, 65,000,000 shares, issued 43,641,150 shares (January 31, 2001) and 43,362,658 shares (July 31, 2000) 43,641 43,363 Capital in excess of par value 79,876,566 79,424,235 Accumulated other comprehensive income 100,966 71,666 Deficit (18,806,662) (17,017,676) Less: 195,000 shares (January 31, 2001) and 135,000 shares (July 31, 2000) of common stock in treasury, at cost (535,120) (409,750) ------------ ------------ Total shareholders' equity 60,679,391 62,111,838 ------------ ------------ TOTAL $ 77,028,968 $ 77,711,459 ============ ============ See notes to condensed consolidated financial statements. 3 4 ZILA, INC. AND SUBSIDIARIES CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE INCOME (LOSS) (UNAUDITED) - ------------------------------------------------------------------------------- Three months ended January 31, Six months ended January 31, ------------------------------ ------------------------------- 2001 2000 2001 2000 ---- ---- ---- ---- NET REVENUES $ 18,557,361 $ 20,216,797 $ 37,393,596 $ 39,388,390 ------------ ------------ ------------ ------------ OPERATING COSTS AND EXPENSES: Cost of products sold 10,279,699 10,366,090 20,395,362 19,868,323 Selling, general and administrative 8,212,250 8,144,042 15,551,527 16,819,326 Research and development 1,108,676 372,771 1,472,543 1,102,898 Depreciation and amortization 880,509 849,080 1,721,898 1,807,396 Impairment charge 310,000 ------------ ------------ ------------ ------------ 20,481,134 19,731,983 39,451,330 39,597,943 ------------ ------------ ------------ ------------ (LOSS) INCOME FROM OPERATIONS (1,923,773) 484,814 (2,057,734) (209,553) ------------ ------------ ------------ ------------ OTHER INCOME (EXPENSES): Interest income 96,106 97,238 155,172 175,005 Interest expense (143,540) (44,712) (166,517) (173,831) Other income (expense) 9,776 (9,063) (54,907) (23,938) Gain on sale of assets 4,519,915 4,659,127 ------------ ------------ ------------ ------------ (37,658) 4,563,378 (66,252) 4,636,363 ------------ ------------ ------------ ------------ (LOSS) INCOME BEFORE INCOME TAXES (1,961,431) 5,048,192 (2,123,986) 4,426,810 INCOME TAX BENEFIT (EXPENSE) 335,000 (3,083,940) 335,000 (2,513,940) ------------ ------------ ------------ ------------ NET (LOSS) INCOME $ (1,626,431) $ 1,964,252 $ (1,788,986) $ 1,912,870 ============ ============ ============ ============ NET (LOSS) INCOME PER SHARE: BASIC $ (0.04) $ 0.05 $ (0.04) $ 0.05 ------------ ------------ ------------ ------------ DILUTED $ (0.04) $ 0.05 $ (0.04) $ 0.05 ------------ ------------ ------------ ------------ WEIGHTED AVERAGE NUMBER OF SHARES OUTSTANDING BASIC 43,423,899 41,961,935 43,388,570 41,636,741 DILUTED 43,423,899 42,343,965 43,388,570 42,025,649 NET LOSS $ (1,626,431) $ (1,788,986) Other comprehensive (loss) income, net of tax Foreign currency translation adjustment (14,558) 31,170 Net unrealized loss on available-for-sale-securities (620) (1,870) ------------ ------------ Other comprehensive (loss) income (15,178) 29,300 ------------ ------------ COMPREHENSIVE LOSS $ (1,641,609) $ (1,759,686) ============ ============ See notes to condensed consolidated financial statements. 4 5 ZILA, INC. AND SUBSIDIARIES CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS (UNAUDITED) - ------------------------------------------------------------------------------ Six months ended January 31, ----------------------------- 2001 2000 ---- ---- OPERATING ACTIVITIES: Net (loss) income $(1,788,986) $ 1,912,870 Adjustments to reconcile net (loss) income to net cash (used in) provided by operating activities: Depreciation and amortization 1,721,898 1,807,396 Gain on sale of assets (4,659,127) Impairment of asset 310,000 Deferred income taxes and other (309,089) 2,445,375 Change in assets and liabilities: Receivables - net (539,551) (1,003,528) Inventories (3,938,900) 188,070 Prepaid expenses and other assets (320,252) (398,264) Accounts payable and accrued liabilities (887,366) 1,052,751 Deferred revenue 27,500 110,781 ----------- ----------- Net cash (used in) provided by operating activities (5,724,746) 1,456,324 ----------- ----------- INVESTING ACTIVITIES: Net purchases of property and equipment (2,335,265) (855,047) Net proceeds from sale of assets 7,749,927 Purchases of intangible assets (449,268) (21,418) ----------- ----------- Net cash (used in) provided by investing activities (2,784,533) 6,873,462 ----------- ----------- FINANCING ACTIVITIES: Net proceeds from short-term borrowings 1,868,279 97,646 Net proceeds from issuance of common stock 452,609 14,963 Acquisition of treasury stock (125,370) (372,413) Cash released by trustee 1,550,719 Principal payments on long-term debt (258,457) (5,248,063) ----------- ----------- Net cash provided by (used in) financing activities 3,487,780 (5,507,867) ----------- ----------- NET (DECREASE) INCREASE IN CASH AND CASH EQUIVALENTS (5,021,499) 2,821,918 CASH AND CASH EQUIVALENTS, BEGINNING OF PERIOD 5,558,487 5,770,970 ----------- ----------- CASH AND CASH EQUIVALENTS, END OF PERIOD $ 536,988 $ 8,592,888 =========== =========== CASH PAID FOR INTEREST $ 145,452 $ 147,285 =========== =========== CASH PAID FOR INCOME TAXES $ 89,686 $ -- =========== =========== SUPPLEMENTAL DISCLOSURES OF NON-CASH INVESTING AND FINANCING ACTIVITIES FOR 2001 AND 2000: Income tax benefit attributable to exercise of common stock options $ 250,000 ----------- Conversion of Series A Convertible Redeemable Preferred stock $ 8,177,190 ----------- See notes to condensed consolidated financial statements. 5 6 ZILA, INC. AND SUBSIDIARIES NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED) 1. BASIS OF PRESENTATION The condensed consolidated financial statements include the accounts of Zila, Inc. and its wholly-owned subsidiaries, Zila Pharmaceuticals, Inc., Zila International Inc., Zila Ltd., Bio-Dental Technologies Corporation ("Bio-Dental"), Zila Technologies, Inc., formerly Cygnus Imaging, Inc. ("Cygnus"), and Oxycal Laboratories, Inc. ("Oxycal"). All significant intercompany balances and transactions are eliminated in consolidation. In the opinion of management of Zila, Inc. and its subsidiaries (collectively referred to herein as "Zila" or the "Company"), all adjustments, consisting of normal recurring accruals, considered necessary for a fair presentation have been included in the condensed consolidated financial statements. The results of operations for the interim period are not necessarily indicative of the results that may be expected for the entire year. The preparation of financial statements in conformity with accounting principles generally accepted in the United States of America 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 revenues and expenses during the reporting period. Actual results could differ from those estimates. Certain reclassifications have been made to the prior year financial statements to conform to the current year presentation. 2. NET (LOSS) INCOME PER SHARE The following is a reconciliation of the numerator and denominator of basic and diluted (loss) earnings per share: For the three months ended For the six months ended January 31, January 31, 2001 2000 2001 2000 ----------------------------------------------------------------------- Net (loss) income $ (1,626,431) $ 1,964,252 $ (1,788,986) $ 1,912,870 Average outstanding common shares 43,423,899 41,961,935 43,388,570 41,636,741 Basic net income (loss) per share $ (0.04) $ 0.05 $ (0.04) $ 0.05 Diluted net (loss) income per share: Net (loss) income available for diluted earnings $ (1,626,431) $ 1,964,252 $ (1,788,986) $ 1,912,870 Average outstanding common shares from above 43,423,899 41,961,935 43,388,570 41,636,741 Additional dilutive shares related to stock options and warrants 189,856 196,734 Additional dilutive shares related to convertible preferred stock 192,174 192,174 Average outstanding and potentially dilutive common shares 42,343,965 42,025,649 Dilutive net (loss) income per share $ (0.04) $ 0.05 $ (0.04) $ 0.05 Since a loss was incurred for the quarter and six months ended January 31, 2001, options and 6 7 warrants to purchase shares of common stock that would otherwise qualify as common stock equivalents were not included in the computation of diluted net income per share because their effect would be antidilutive. 3. INVENTORIES Inventories consist of the following: January 31, July 31, 2001 2000 ------------ ------------ Finished goods $ 9,565,247 $ 9,219,343 Raw materials 7,768,838 4,168,834 Inventory reserves (191,048) (184,040) ------------ ------------ $ 17,143,037 $ 13,204,137 ============ ============ 4. INCOME TAXES Deferred income taxes reflect the tax effect of temporary differences between the amounts of assets and liabilities recognized for financial reporting and tax purposes. At the end of each fiscal quarter, the Company makes its best estimate of the effective tax rate expected to be applicable for the full fiscal year. The rate so determined is used in providing for income taxes on a current year-to-date basis. The rate is revised, if necessary, as of the end of each quarter during the fiscal year to the Company's best estimate of its annual effective tax rate. In the six months ended January 31, 2001, the Company recorded a tax benefit of $335,000. In the prior year quarter ended October 31, 1999, the Company recorded an income tax benefit of $820,000 ($250,000 of which was attributable to the exercise of common stock options in prior years and therefore was credited to capital in excess of par value). In the six months ended January 31, 2000, the Company recorded income tax expense of $2,513,940, which is net of the income tax benefit of $820,000 recorded in the first quarter of fiscal year 2000. 5. ACCOUNTING FOR THE IMPAIRMENT OF LONG-LIVED ASSETS The Company accounts for impairment of long-lived assets in accordance with Statement of Financial Accounting Standards ("SFAS") No. 121, "Accounting for the Impairment of Long-Lived Assets and for Long-Lived Assets to be Disposed of" which was issued in March 1995. SFAS No. 121 requires that long-lived assets be reviewed for impairment whenever events or changes in circumstances indicate that the book value of the asset may not be recoverable. In the quarter ended October 31, 2000, the Company recorded a non-cash charge of $310,000, in the Nutraceuticals segment, to write down the carrying amount of the land and buildings located at 533 Madison Avenue, Prescott, Arizona to an estimated fair value related to its anticipated sale. The building was sold in March 2001. 7 8 6. NEW ACCOUNTING PRONOUNCEMENTS In May 2000, the Financial Accounting Standards Board's Emerging Issues Task Force ("EITF") issued Issue No. 00-14, Accounting for Certain Sales Incentives. The Issue addresses the recognition, measurement, and income statement classification for certain sales incentives including coupons, rebates and free products. The consensus on EITF 00-14 will be effective for the Company in the fourth quarter of fiscal year 2001. The implementation of this consensus will require the Company to change the way it classifies certain sales incentives, which are currently recorded as selling, general and administrative expenses. The cost of coupons and rebates will be recorded as a reduction of net sales. The cost of free product will be recorded as a reduction of products sold. In addition, the EITF has added Issue No. 00-25 Vendor Income Statement Characterization of Consideration from a Vendor to a Retailer to its agenda. This issue discusses the income statement classification of "trade spending" costs. The Company is in the process of analyzing the requirements of these pronouncements. 7. SALE OF ASSETS On October 28, 1999, Cygnus completed the sale of substantially all of its assets and certain liabilities to Procare Laboratories, Inc. ("Procare"), of Scottsdale, Arizona for approximately $4.0 million. Procare is controlled by the former owner and President of Cygnus. The purchase price was paid through the issuance of a $4.0 million note receivable that was collateralized by the assets of Procare and matured and was paid in full on November 10, 1999. The net book value of the assets sold and liabilities assumed was $3.9 million. The sale resulted in a $139,000 gain. On December 20, 1999, the Company, through its wholly-owned subsidiary Integrated Dental Technologies, Inc. ("IDT"), completed the sale of substantially all of its assets and liabilities related to its PracticeWorks division located in Gold River, California to InfoCure Corporation ("InfoCure"), of Atlanta, Georgia for approximately $4.65 million. InfoCure is a national provider of healthcare practice management software products and services to targeted healthcare practice specialties. The following unaudited pro forma information presents the condensed consolidated results of operations as if the sales had occurred as of the beginning of the six month period ended January 31, 2000 and does not purport to be indicative of what would have occurred had the sale been made as of that date. Six months ended ---------------- January 31, 2000 ---------------- (in thousands) Net revenues $37,680 Operating income 360 Income before income taxes 832 8 9 8. SEGMENT INFORMATION The Company is organized into five major product groups, all of which have distinct product lines, brand names and are managed as autonomous business units. The Company has identified the following segments for purposes of applying SFAS No. 131: Consumer which includes Zila Pharmaceuticals, Inc. and the Zilactin(R) line of products, Professional which includes Peridex(R) and Pro-Ties(TM), OraTest(R) products, Dental Supply, which includes Bio-Dental Technologies Corporation and Ryker Dental of Kentucky, Inc. (a subsidiary of Bio-Dental Technologies Corporation) which does business under the name Zila Dental Supply, and Nutraceuticals, which includes Oxycal Laboratories, Inc. and its wholly-owned subsidiary, Inter-Cal, Inc. The Company evaluates performance and allocates resources to segments based on operating results. Corporate overhead expenses have been combined with the OraTest(R) segment. The Dental Imaging and Dental Software businesses, sold in fiscal year 2000, are combined into the Other segment. Prior to August 1, 2000, the Consumer and Professional segment were combined and shown as the Pharmaceutical segment. The Professional segment was removed from the Pharmaceutical segment as a result of the change in management reporting structure. Previous segment disclosures have been restated to reflect this presentation. The table below presents information about reported segments as of and for the six months ended January 31 (in thousands): Dental Consumer Professional Supply OraTest Nutraceuticals Other Total Net revenues: 2001 $6,621 $2,644 $20,343 $ 73 $ 7,713 $ 0 $37,394 2000 5,685 2,643 19,670 62 9,620 1,708 39,388 (Loss) income before Income taxes: 2001 3,145 (112) 35 (5,216) 24 $ 0 (2,124) 2000 2,027 392 287 (5,045) 2,675 4,091 4,427 Depreciation and amortization: 2001 40 541 139 449 553 $ 0 1,722 2000 21 483 149 504 505 145 1,807 Total assets: 2001 3,430 12,482 11,594 13,239 36,284 $0 77,029 2000 3,343 10,462 11,760 18,225 29,233 424 73,447 9. COMMITMENTS AND CONTINGENCIES The Company and certain officers of the Company have been named as defendants in a consolidated First Amended Class Action Complaint filed July 6, 1999 in the United States District Court for the District of Arizona under the caption In re Zila Securities Litigation, No. CIV 99 0115 PHX EHC. The First Amended Class Action Complaint seeks damages in an unspecified amount on behalf of a class consisting of purchasers of the Company's securities from November 14, 1996 through January 13, 1999 for alleged violations of the federal securities laws. Specifically, the plaintiffs allege that in certain public statements and filings with the Securities and Exchange Commission the defendants made false or misleading statements and concealed material adverse information related to OraTest(R) that artificially inflated the price of the Company's common stock in violation of the federal securities laws. In February 2001, the parties entered into a settlement agreement. The settlement agreement is subject to court approval. If approved, Zila's insurers will pay the entire $5.75 million settlement amount and 9 10 the litigation will be dismissed. On September 8, 1999, the Securities and Exchange Commission (the "Commission") entered an order directing an investigation entitled "In the Matter of Zila, Inc." The Commission is investigating whether (i) there were purchases or sales of securities of the Company by persons while in possession of material non-public information concerning the prospects that the Oncologic Drugs Advisory Committee for the FDA would recommend approval of the OraTest(R) NDA and whether the FDA would subsequently approve the NDA; (ii) such persons conveyed information regarding these matters to other persons who effected transactions in securities of the Company without disclosing the information; and (iii) there were false and misleading statements in press releases, filings with the Commission, or elsewhere concerning these matters. The Company does not believe it has violated any of the federal securities laws and is cooperating fully with the Commission in its investigation. The Company is subject to other legal proceedings and claims, which arise in the ordinary course of business. In the opinion of management, the amount of ultimate liability with respect to these other actions will not materially affect the financial position or results of operations of the Company. 10. SUBSEQUENT EVENT On February 5, 2001, the Company announced it had acquired the patent rights and Antioch, Illinois manufacturing operations for swab products from National Healthcare Manufacturing Corporation, headquartered in Winnipeg, Canada. Intellectual property, inventory, plus molding, labeling, filling and sealing equipment were included in the acquisition. The business unit will be known as Innovative Swab Technologies, Inc. Zila paid approximately $2.4 million in a combination of stock and cash for the unit. 10 11 ITEM 2. MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS ZILA, INC. AND SUBSIDIARIES FORWARD LOOKING INFORMATION This Report contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. The words "believe," "expect," "anticipate," "intend," "estimate" and other expressions that are predictions of or indicate future events and trends and which do not relate to historical matters identify forward-looking statements. These forward-looking statements are based largely on the Company's expectations or forecasts of future events, can be affected by inaccurate assumptions and are subject to various business risks and known and unknown uncertainties, a number of which are beyond the Company's control. Therefore, actual results could differ materially from the forward-looking statements contained in this document, and readers are cautioned not to place undue reliance on such forward-looking statements. The Company undertakes no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise. A wide variety of factors could cause or contribute to such differences and could adversely impact revenues, profitability, cash flows and capital needs. Included among the factors affecting OraTest(R) are the FDA's ultimate decision regarding OraTest(R); the length and expense of the new clinical study and the FDA review process; the limitations on indicated uses for which OraTest(R) may be marketed; and, if approved, the market reception to OraTest(R) and any post-marketing reports or surveillance programs to monitor usage or side effects of OraTest(R). There can be no assurance that the forward-looking statements contained in this document will, in fact, transpire or prove to be accurate. For a more detailed description of these and other cautionary factors that may affect the Company's future results, please refer to the Company's Annual Report on Form 10-K for its fiscal year ended July 31, 2000 filed with the Securities and Exchange Commission. COMPANY OVERVIEW: Zila is a worldwide manufacturer and marketer of pharmaceutical, biomedical, dental and nutritional products. The Company has five major operating groups: Consumer Pharmaceuticals, Professional Pharmaceuticals, OraTest(R) Products, Dental Supplies and Nutraceuticals. The Consumer Pharmaceuticals group consists of over-the-counter products, including the Zilactin(R) family of over-the-counter products. The Professional Pharmaceuticals group includes Peridex(R) prescription mouth rinse, and Pro-Ties(TM), a bundling system for instrument sterilization. The OraTest(R) Products group includes OraTest(R), an oral cancer detection system, and the Dental Supply group includes Zila Dental Supply, a national distributor of professional dental supplies. The Nutraceuticals group is comprised of Oxycal Laboratories, Inc. ("Oxycal") and its Inter-Cal ("Inter-Cal") subsidiary, a manufacturer and distributor of mineral and botanical products including a patented and unique form of Vitamin C under the trademark Ester-C(R) and the Palmettx(R) botanical line of products. On October 28, 1999, Cygnus completed the sale of substantially all of its assets and certain liabilities to Procare Laboratories, Inc. ("Procare"), of Scottsdale, Arizona for approximately $4.0 million. Procare is controlled by the former owner and President of Cygnus. The purchase price was paid through the issuance of a note receivable, which was collateralized by the assets of Procare and was paid in full on November 10, 1999. The sale resulted in a $139,000 gain. On December 20, 1999, the Company, through its wholly-owned subsidiary, Integrated Dental Technologies, Inc. ("IDT"), completed the sale of substantially all of IDT's assets and liabilities related 11 12 to its PracticeWorks division located in Gold River, California to InfoCure Corporation ("InfoCure"), of Atlanta, Georgia for approximately $4.65 million. InfoCure is a national provider of healthcare practice management software products and services to targeted healthcare practice specialties and is listed on the NASDAQ under the symbol INCX. Under the terms of the agreement, ten percent (10%) of the sales price was held in escrow for one year in order to secure the representations, warranties, and covenants made by the Company to InfoCure. The trustee released approximately $422,000 in January 2001. On February 5, 2001, the Company announced it had acquired the patent rights and Antioch, Illinois manufacturing operations for swab products from National Healthcare Manufacturing Corporation, headquartered in Winnipeg, Canada. Intellectual property, inventory, plus molding, labeling, filling and sealing equipment were included in the acquisition. The business unit will be known as Innovative Swab Technologies, Inc. Zila paid approximately $2.4 million in a combination of stock and cash for the unit. RESULTS OF OPERATIONS THREE MONTHS ENDED JANUARY 31, 2001 AND 2000 Total net revenues declined 8.2% to $18.6 million for the quarter ended January 31, 2001, compared to revenues of $20.2 million during the second quarter of the prior fiscal year. Excluding the second quarter revenues in the prior fiscal year for the PracticeWorks division of $398,000, which was sold in the prior fiscal year, net revenues decreased 6.4%. Net revenues for Zila Dental Supply increased slightly to $10.2 million for the quarter ended January 31, 2001, compared to $10.1 million for the corresponding fiscal quarter in 2000. This increase was primarily due to an increase in sales of full service supplies and internet sales. Consumer Pharmaceuticals had net revenues of $2.9 million for the quarter ended January 31, 2001, an 11.4% decline over the $3.3 million recorded during the corresponding quarter last year. The decrease was due primarily to a higher than normal level of sales for all of the Zilactin products in the prior year quarter. Also effecting sales for the second quarter of fiscal year 2001 were increased sales in the first quarter of fiscal year 2001 of $3.7 million, a 54.3% over the prior year quarter. Net revenues for Professional Pharmaceuticals were $1.5 million, an increase of 11.3% from $1.4 million during the prior year quarter. The increase was due primarily to approximately $483,000 of revenue generated from an agreement executed during the quarter, whereby the Company granted a customer the right to use it's technology related to Chlorhexidine Gluconate to produce a generic form of the product for distribution. Under the agreement, fees will be paid over four years. Sales of Peridex(R) declined 24.6% during the quarter caused by decreased demand due to pricing pressures and substitutions made by pharmacists with generic brands. During the quarter, Professional Pharmaceuticals began to ship Pro-Ties(TM), a bundling system for instrument sterilization. Net revenues for Inter-Cal for the quarter ended January 31, 2001, were $3.9 million, a 22.2% decrease when compared to $5.1 million for the corresponding 2000 fiscal quarter. The decrease is largely attributable to an overall slowdown in the domestic vitamin and food supplement markets and the affects of aggressive discounting programs in prior periods. Inter-Cal's international sales during the quarter were approximately equal to the previous year's quarter amount. OraTest(R) products had net revenue of $18,000 for the quarter ended January 31, 2001. No revenue was derived from OraTest(R) products in the corresponding quarter last year. Sales of OraTest(R) were made in the United Kingdom and China during the current quarter. 12 13 For the quarter ended January 31, 2001, cost of products sold was $10.3 million, a slight decrease from the $10.4 million recorded in the quarter ended January 31, 2000. Cost of products sold as a percentage of net revenues increased to 55.4% in the quarter ended January 31, 2001 from 51.3% in the quarter ended January 31, 2000. The increase for the quarter reflects primarily the growth of Zila Dental Supply as a percentage of total revenues, 54.8% for the quarter ended January 31, 2001, compared to 50.0% for the previous year quarter. Margins for Zila Dental Supply are lower as compared to the other operating groups resulting in a higher cost of products sold as a percentage of revenues. Cost of products sold as a percentage of net revenues for Zila Dental Supply decreased slightly to 73.6% for the quarter ended January 31, 2001 when compared to the 74.8% recorded in the prior year quarter, primarily due to a decrease in vendor rebates. Cost of products sold as a percentage of net revenues for Consumer Pharmaceuticals increased to 24.5% in the quarter ended January 31, 2001, from 20.9% in the quarter ended January 31, 2000. The increase for the quarter is a result of a change in the mix of products sold. Cost of products sold as a percentage of net product sales for Professional Pharmaceuticals increased to 32.8% for the quarter ended January 31, 2001 from 27.6% in the quarter ended January 31, 2000. The increase is due primarily to a reduction in the average sales price of Peridex(R) sold during the quarter related to increased pricing pressures from generic equivalents. Cost of products sold as a percentage of net revenues for Inter-Cal increased to 39.6% in the quarter ended January 31, 2001 from 28.9% in the quarter ended January 31, 2000. The increase was caused by a change in the mix of products sold including the new Palmettx(TM) botanical line of products as well as an increase in costs related to the validation of the manufacturing equipment in the new facility during the quarter. The Company incurred selling, general and administrative expenses of $8.2 million consistent with the $8.1 million in the same period in fiscal 2000. Selling, general and administrative expenses as a percentage of net sales increased to 44.3% in the current fiscal quarter from 40.2% in the quarter ended January 31, 2000 due to the decrease in sales volume. Research and development expenses increased $736,000, or approximately 200%, from $373,000 in the second quarter of fiscal year 2000 to $1.1 million for the same period in fiscal year 2001. The increase is primarily due to increased costs related to the FDA-required clinical study associated with the Company's ongoing efforts to obtain FDA approval of OraTest(R). Depreciation and amortization expenses increased slightly to $881,000 in the second quarter of fiscal year 2001 from $849,000 for the same period in fiscal year 2000. The increase is due primarily to the increased depreciation of assets associated with Inter-Cal's new manufacturing facility. The Company recorded interest expense of $143,000 for the quarter ended January 31, 2001 compared to $45,000 in the same period of the previous year. The increase was attributable to increased bank borrowings and debt obligations incurred during the second quarter of fiscal year 2001 as compared to the previous year period. At the end of each fiscal quarter, the Company makes its best estimate of the effective tax rate expected to be applicable for the full fiscal year. The rate so determined is used in providing for income taxes on a current year-to-date basis. The rate is revised, if necessary, as of the end of each quarter during the fiscal year to the Company's best current estimate of its effective rate. The effective tax rate could change significantly in future interim periods if there is a change in the Company's estimates because of (i) the proportion of non-deductible amortization of intangible assets in relation to pre-tax income (loss) for financial reporting purposes and (ii) the non-deductibility of foreign operating losses. 13 14 In the three months ended January 31, 2001, the Company recorded an income tax benefit of $335,000 as compared to an income tax expense of $3.1 million recorded in the same period of the prior year. For the quarter ended January 31, 2001, the Company had a net loss of $1.6 million compared to net income of $2.0 million for the prior year quarter. The decrease in profitability is primarily attributable to the decrease in sales at Inter-Cal and increased research and development expenses during the current quarter and the gain due to the sale of PracticeWorks assets in the prior year quarter. SIX MONTHS ENDED JANUARY 31, 2001 AND 2000 Total net revenues declined 5.1% to $37.4 million for the six months ended January 31, 2001, compared to revenues of $39.4 million for the six months ended January 31, 2000. Excluding the year-to-date revenues in the prior fiscal year for the PracticeWorks and Cygnus divisions of $1.7 million, which were sold in the prior fiscal year, net revenues decreased less than 1%. Net revenues for Zila Dental Supply increased 3.4% to $20.3 million for the six months ended January 31, 2001, compared to $19.7 million for the corresponding six months in 2000. This increase was primarily attributable to an increase in full-service operations and increases in internet sales. Consumer Pharmaceuticals had net revenues of $6.6 million for the six months ended January 31, 2001, a 16.5% increase over the $5.7 million recorded during the corresponding period last year. The increase was due primarily to increased sales of all of the Zilactin products due to the use of discount programs. Net revenues for Professional Pharmaceuticals stayed consistent at $2.7 million for the six months ended January 31, 2001 as compared to the prior year period. The current year period includes $483,000 of revenue generated from an agreement executed during the quarter, whereby the Company granted a customer the right to use it's technology related to Chlorhexidine Gluconate to produce a generic form of the product for distribution. Under the agreement, fees will be paid over four years. Net revenues for Inter-Cal for the six months ended January 31, 2001, were $7.7 million, a 19.8% decrease when compared to the $9.6 million for the corresponding period in fiscal year 2000. The decrease is attributable to an overall slowdown in the domestic vitamin market and promotional discounting in prior year periods. Inter-Cal's international sales decreased 7.2% to $2.7 million during the first six months of the current fiscal year as compared to the previous year amount as international customers have excess inventory levels. For the six months ended January 31, 2001, cost of products sold was $20.4 million, a 2.7% increase from $19.9 million for the six months ended January 31, 2000. Cost of products sold as a percentage of net revenues increased to 54.5% in the six months ended January 31, 2001 from 50.4% in the corresponding 2000 period. The increase for the period reflects primarily the growth of Zila Dental Supply as a percentage of total revenues, 54.4% for the six months ended January 31, 2001 compared to 49.9% for same period of the previous fiscal year. Gross profit margins for Zila Dental Supply are lower as compared to the other operating groups resulting in a higher cost of products sold as a percentage of revenues. Cost of products sold as a percentage of net revenues for Zila Dental Supply decreased slightly to 73.7% for the six months ended January 31, 2001 from 74.3% for the six months ended January 31, 2000 primarily due to an increase in vendor rebate programs in the first quarter of fiscal 2001. Cost of products sold as a percentage of net revenues for Consumer Pharmaceuticals increased to 23.1% in the six months ended January 31, 2001, compared to 21.6% for the corresponding period in fiscal 2000. The increase for the quarter is a result of a change in the mix of products sold. Cost of products sold as a 14 15 percentage of net product sales for Professional Pharmaceuticals increased to 28.6% in the six months ended January 31, 2001, compared to 24.3% for the corresponding period in fiscal 2000. The increase is due primarily to a reduction in the average sales price per case of Peridex(R) sold during the period related to increased pricing pressures from generic equivalents. Cost of products sold as a percentage of net revenues for Inter-Cal increased to 36.6% in the six months ended January 31, 2001 from 27.9% in the six months ended January 31, 2000. The increase was caused by costs associated with the manufacturing of the new Palmettx(TM) botanical line of products as well as the duplicate overhead, moving and equipment validation costs related to the relocation of the manufacturing equipment to the new facility during the period. The Company incurred selling, general and administrative expenses of $15.6 million, or 41.6% of net revenues during the first six months of fiscal year 2001 compared to $16.8 million, or 42.7% of net revenue in the same period in fiscal 2000. The decrease in selling, general and administrative expenses as a percentage of revenue is attributable to a reduction in costs related to the Cygnus and PracticeWorks businesses partially offset by increased costs related to the expansion of the sales force and service department at Zila Dental Supply's full service branches, increased selling and administrative costs related to the OraTest(R) international product launches, increased marketing and selling expenses at Inter-Cal and increased corporate legal, professional and insurance expenses. Research and development expenses increased $370,000 or 33.5%, from the $1.1 million incurred in the first six months of fiscal year 2000 to $1.5 million for the same period in fiscal year 2001. The increase was primarily due to an increase in expenses related to research and clinical activities associated with OraTest(R), partially offset by a reduction of costs incurred in the Cygnus and PracticeWorks businesses. Depreciation and amortization expenses decreased $85,000 from $1.8 million in the six months of fiscal year 2000 to $1.7 million for the same period in fiscal year 2001. The decrease is due primarily to the reduction in costs related to the Cygnus and PracticeWorks businesses partially offset by the increase in the depreciation of assets associated with Inter-Cal's new manufacturing facility that were placed in service during the current six month period. In October 2000, the Company recorded a non-cash impairment charge of $310,000 to write down the carrying value of the land and buildings located at 533 Madison Avenue, Prescott, Arizona to an estimated fair value related to its anticipated sale. The building was sold in March 2001. The Company recorded interest expense of $167,000 for the six months ended January 31, 2001 compared to $174,000 in the same period of the previous year. The decrease was attributable to decreases in debt obligations incurred during the current year period as compared to the previous year period. In the six months ended January 31, 2001, the Company recorded an income tax benefit of $335,000. The Company's effective tax rate for the six-month period is significantly lower than the statutory rate due primarily to the non-deductibility of foreign operating losses and non-deductible amortization of intangible assets. In the six months ended January 31, 2000, the Company recorded income tax expense of $2,513,940 which is net of the income tax benefit of $820,000 recorded in the first quarter of fiscal year 2000 ($250,000 of which was attributable to the exercise of common stock options in prior years and therefore was credited to capital in excess of par value). 15 16 LIQUIDITY AND CAPITAL RESOURCES At January 31, 2001, the Company's primary sources of liquidity included cash and cash equivalents of $537,000 and the bank line of credit discussed below. Working capital decreased slightly to $18.9 million at January 31, 2001 from $20.3 million at July 31, 2000, and the current ratio decreased to 2.6 at January 31, 2001 from 2.8 at July 31, 2000. On December 1, 2000, the Company renewed its $9 million line of credit with Bank One for an additional 12 months under similar terms and conditions, including a variable interest rate equal to the prime rate ("the Index"), which was 8.5% at January 31, 2001. In the event the Company does not achieve certain operating results for any cumulative financial quarters, 0.25% will be added to the Index for the next fiscal quarter, however, in no event will the interest rate be greater than the Index plus 0.25%. In the event the Company's year-to-date operating results improve, the interest rate will be adjusted to be equal to the Index for the next fiscal quarter. As of January 31, 2001, the Company did not achieve the required operating results so the interest rate will be raised by 0.25%. Under the line of credit, the Company is required to comply with financial covenants based on certain financial ratios. At January 31, 2001, the Company was in compliance with such covenants. At January 31, 2001, the Company had borrowings of $1.75 million against the line of credit. Subsequent to January 31, 2001, the Company borrowed an additional $1.75 million to fund the acquisition of National Healthcare Manufacturing Corporation made in February. (See Note 10 to the Condensed Consolidated Financial Statements). Net cash used in operating activities was $5.7 million during the six months ended January 31, 2001, attributable to the net loss of $1.8 million plus changes in operating assets and liabilities totaling $5.6 million partially offset by non-cash items of $1.7 million. Significant changes in operating assets and liabilities were primarily comprised of (i) an increase in accounts receivable of $540,000 related to certain legal fees which were paid by the Company but are expected to be reimbursed by an insurance company, (ii) an increase in inventory of $3.9 million related to the new Palmettx(TM) botanical line of products and other raw materials at Inter-Cal, and (iii) a decrease in accounts payable and accrued expenses of $887,000 primarily due to vendor payments made during the period for inventory purchases. Net cash used in investing activities was $2.8 million related to manufacturing additions for the new Inter-Cal facility, the purchase of the patent and other rights related to the Pro-Ties(TM) bundling system and patent filings for Inter-Cal. Net cash provided by financing activities of $3.5 million was comprised of bank borrowings of $1.7 million, net borrowings of approximately $217,000 related to the financing of insurance policies, proceeds received from the exercise of warrants and stock options of $453,000 and $1.5 million of bond proceeds received from the trustee related to the construction of the new Inter-Cal facility (as discussed further below). In addition, $125,000 was used to repurchase 60,000 shares of Zila common stock on the open market. At January 31, 2001, the Company had income tax net operating loss carryforwards of approximately $10.1 million, which expire in years 2007 through 2019. During October 2000, Inter-Cal moved into its new manufacturing and laboratory facility in Prescott, AZ. The facility was financed through a transaction with The Industrial Development Authority of the County of Yavapai (the "Authority") in which the Authority issued $5.0 million in Industrial Development Revenue Bonds (the "Bonds"), the proceeds of which were loaned to Oxycal for the construction of the facility. The Bond proceeds are being held by the trustee, Bank One, Arizona 16 17 until such time as the remaining invoices for building construction and new equipment are submitted for payment. The Bonds consist of $3.9 million Series A and $1.1 million Taxable Series B which, as of January 31, 2001, carried interest rates of 4.75% and 5.90%, respectively. The Bonds were marketed and sold by Banc One Capital Markets and carry a maturity of 20 years. In connection with the issuance of the Bonds, the Authority required that Oxycal obtain, for the benefit of the Bondholders, an irrevocable direct-pay letter of credit to secure payment of principal and interest. The letter of credit is guaranteed by Zila. The Company believes that cash generated from its operations, its investing activities and the availability of cash under its line of credit are sufficient to finance its level of operations and anticipated capital expenditures. The Company will require additional financing to support the production and future OraTest(R) clinical, regulatory, manufacturing and marketing costs or to make any significant acquisitions. There can be no assurance that such funds will be available on terms acceptable to the Company. ITEM 3. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK Market risk refers to the potential effects of unfavorable changes in certain prices and rates on the Company's financial results and conditions, primarily foreign currency exchange rates and interest rates on debt obligations. The Company transacts business in various foreign countries. Foreign currency exposures are primarily, but not limited to, vendor and customer payments and inter-company balances in currencies other than the functional currency. Fluctuations in foreign currencies could have a material adverse effect on the Company's results of operations. The Company is exposed to interest rate fluctuations on its Industrial Development Revenue Bonds and the line of credit with Bank One Corporation as the interest charged is based on variable rates. The Bonds bear interest based on a floating rate and adjusted weekly by Banc One Capital Markets. Interest on the outstanding balance of the line of credit is charged at the prime rate of Bank One. The Company does not trade in derivative financial instruments. The Company does not believe that near-term changes in foreign currency exchange rates or interest rates will have a material effect on its future earnings, fair values or cash flows. PART II - OTHER INFORMATION ITEM 1.- Legal Proceedings The Company and certain officers of the Company have been named as defendants in a consolidated First Amended Class Action Complaint filed July 6, 1999 in the United States District Court for the District of Arizona under the caption In re Zila Securities Litigation, No. CIV 99 0115 PHX EHC. The First Amended Class Action Complaint seeks damages in an unspecified amount on behalf of a class consisting of purchasers of the Company's securities from November 14, 1996 through January 13, 1999 for alleged violations of the federal securities laws. Specifically, the plaintiffs allege that in certain public statements and filings with the Securities and Exchange Commission the defendants made false or misleading statements and concealed material adverse information related to OraTest(R) that artificially inflated the price of the Company's common stock in violation of the federal securities laws. In February 2001, the parties entered into a settlement agreement. The settlement agreement is subject to court approval. If approved, Zila's insurers will pay the entire $5.75 million settlement amount and the litigation will be dismissed. On September 8, 1999, the Securities and Exchange Commission (the "Commission") entered an 17 18 order directing an investigation entitled "In the Matter of Zila, Inc." The Commission is investigating whether (i) there were purchases or sales of securities of the Company by persons while in possession of material non-public information concerning the prospects that the Oncologic Drugs Advisory Committee for the FDA would recommend approval of the OraTest(R) NDA and whether the FDA would subsequently approve the NDA; (ii) such persons conveyed information regarding these matters to other persons who effected transactions in securities of the Company without disclosing the information; and (iii) there were false and misleading statements in press releases, filings with the Commission, or elsewhere concerning these matters. The Company does not believe it has violated any of the federal securities laws and is cooperating fully with the Commission in its investigation. The Company is subject to other legal proceedings and claims, which arise in the ordinary course of business. In the opinion of management, the amount of ultimate liability with respect to these other actions will not materially affect the financial position or results of operations of the Company. ITEM 2 CHANGES IN SECURITIES AND USE OF PROCEEDS Not Applicable. ITEM 3. DEFAULTS UPON SENIOR SECURITIES. Not Applicable. ITEM 4. SUBMISSION OF MATTERS TO A VOTE OF SECURITY HOLDERS. (a) The Company held its annual meeting of stockholders in Phoenix, Arizona on December 7, 2000. A total of 40,233,762 shares of Common Stock, 92.46% of the outstanding shares, were represented in person or by proxy. (b) The following six directors were each elected to a one-year term expiring in 2001: NUMBER OF SHARES NAME FOR WITHHELD Joseph Hines 39,311,876 921,886 Carl A. Schroeder 39,406,935 826,827 Michael S. Lesser 39,340,919 892,843 Curtis M. Rocca, III 38,587,416 1,646,346 Christopher D. Johnson 39,487,351 746,411 Kevin J. Tourek 39,396,175 837,587 (c) The Company's stockholders approved the selection of Deloitte & Touche LLP as auditors for the Company for its 2001 fiscal year as follows: 39,777,658 shares voted in favor; 277,933 shares voted against; and 228,171 shares abstained (including broker non-votes). (d) The Company's stockholders approved the amendment of the 1997 Stock Option Award Plan to increase the number of authorized shares under the Plan from 1,000,000 to 3,000,000 as follows: 11,845,732 shares voted in favor; 3,705,089 shares voted against; and 24,682,941 shares abstained (including broker non-votes). (e) The Company's stockholders approved the adoption of the Employee Stock Purchase Plan as follows: 13,708,745 shares voted in favor; 1,812,867 shares voted against; and 18 19 24,712,150 shares abstained (including broker non-votes). ITEM 5. OTHER INFORMATION Not Applicable. ITEM 6. EXHIBITS AND REPORTS ON FORM 8-K (a) Exhibits (b) Reports on Form 8-K None 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. Date: March 19, 2001 By /s/Joseph Hines ---------------- --------------------------------- Joseph Hines President, Chairman of the Board (Principal Executive Officer) By /s/Bradley C. Anderson --------------------------------- Bradley C. Anderson Vice President and Chief Financial Officer (Principal Financial & Accounting Officer) 19