1 UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the Quarter Ended Commission File No. June 30, 1997 0-18231 ATRIX LABORATORIES, INC. ------------------------------------------------------ (Exact name of registrant as specified in its charter) Delaware 84-1043826 - ------------------------------------------------------------------------------- (State of Incorporation) (I.R.S. Employer Identification Number) 2579 Midpoint Drive Fort Collins, Colorado 80525 - ------------------------------------------------------------------------------- (Address of principal (Zip Code) executive offices) (970) 482-5868 --------------------------------------------------- (Registrant's 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 (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 [ ] As of July 30, 1997, there were 11,120,360 issued and outstanding shares of the Registrant's $.001 par value common stock. 2 PART I. FINANCIAL INFORMATION ITEM 1. FINANCIAL STATEMENTS ATRIX LABORATORIES, INC. BALANCE SHEETS June 30, December 31, 1997 1996 ------------ ------------ ASSETS (UNAUDITED) CURRENT ASSETS: Cash and cash equivalents $ 16,289,154 $ 18,368,472 Restricted cash equivalents -- 7,000,000 Marketable securities, at fair value 8,141,291 6,040,389 Accounts receivable, net of allowance for doubtful accounts of 981,878 681,290 $9,685 and $10,000 Interest receivable 147,130 154,128 Inventories 481,378 303,505 Prepaid expenses and deposits 793,839 301,321 ------------ ------------ Total current assets 26,834,670 32,849,105 ------------ ------------ PROPERTY, PLANT AND EQUIPMENT: Property, plant and equipment 6,905,093 5,888,007 Leasehold improvements 588,917 565,608 ------------ ------------ Total 7,494,010 6,453,615 Accumulated depreciation and amortization (2,040,311) (1,687,056) ------------ ------------ Property, plant and equipment, net 5,453,699 4,766,559 ------------ ------------ OTHER ASSETS - Intangible assets, net of accumulated amortization of $78,450 and $69,624 919,741 847,830 ------------ ------------ TOTAL $ 33,208,110 $ 38,463,494 ============ ============ LIABILITIES AND SHAREHOLDERS' EQUITY CURRENT LIABILITIES: Accounts payable - trade $ 1,294,027 $ 933,147 Accrued salaries and payroll taxes 95,613 88,868 Other accrued liabilities 101,640 155,657 Deferred revenue 75,000 7,002,192 ------------ ------------ Total current liabilities 1,566,280 8,179,864 ------------ ------------ COMMITMENTS AND CONTINGENCIES SHAREHOLDERS' EQUITY: Preferred stock, $.001 par value; 5,000,000 shares authorized, none issued or outstanding Common stock, $.001 par value; 25,000,000 shares authorized; 11,120,030 and 11,113,624 shares issued and outstanding 11,120 11,114 Additional paid-in capital 72,963,664 72,913,274 Unrealized holding loss on marketable securities (193,133) (152,641) Accumulated deficit (41,139,821) (42,488,117) ------------ ------------ Total shareholders' equity 31,641,830 30,283,630 ------------ ------------ TOTAL $ 33,208,110 $ 38,463,494 ============ ============ See notes to financial statements 2 3 ATRIX LABORATORIES, INC. STATEMENTS OF OPERATIONS FOR THE THREE MONTHS ENDED JUNE 30, 1997 AND 1996 (Unaudited) REVENUE: 1997 1996 ------------ ------------ Sales $ 543,929 $ 60,921 Contract revenue 237,056 281,563 Interest income 356,206 287,627 Other income 4,383 12,466 ------------ ------------ Total revenue 1,141,574 642,577 ------------ ------------ EXPENSES: Cost of goods sold 435,551 46,944 Research and development o ATRIDOX(TM)product 1,447,230 1,416,032 o Other 1,719,228 1,266,346 Administrative and marketing 527,213 572,553 ------------ ------------ Total expenses 4,129,222 3,301,875 ------------ ------------ NET LOSS $ (2,987,648) $ (2,659,298) ============ ============ NET LOSS PER COMMON SHARE $ (0.27) $ (0.27) ============ ============ WEIGHTED AVERAGE SHARES OUTSTANDING 11,115,152 9,923,803 ============ ============ See notes to financial statements 3 4 ATRIX LABORATORIES, INC. STATEMENTS OF OPERATIONS FOR THE SIX MONTHS ENDED JUNE 30, 1997 AND 1996 (Unaudited) REVENUE: 1997 1996 ----------- ----------- Sales $ 753,668 $ 119,961 Contract revenue 388,540 401,571 Sale of marketing rights 7,000,000 -- Interest income 793,716 437,549 Other income 13,351 36,419 ----------- ----------- Total revenue 8,949,275 995,500 ----------- ----------- EXPENSES: Cost of goods sold 574,540 87,614 Research and development o ATRIDOX(TM)product 2,910,189 2,785,510 o Other 3,034,530 2,370,250 Administrative and marketing 1,081,720 1,161,515 ----------- ----------- Total expenses 7,600,979 6,404,889 ----------- ----------- NET INCOME (LOSS) $ 1,348,296 $(5,409,389) =========== =========== NET INCOME (LOSS) PER COMMON SHARE $ 0.12 $ (0.59) =========== =========== WEIGHTED AVERAGE SHARES OUTSTANDING 11,114,512 9,193,118 =========== =========== See notes to financial statements 4 5 ATRIX LABORATORIES, INC. STATEMENTS OF CHANGES IN SHAREHOLDERS' EQUITY FOR THE SIX MONTHS ENDED JUNE 30, 1997 (Unaudited) Additional Unrealized Total Common Stock Paid-in Holding Accumulated Shareholders' Shares Amount Capital Loss Deficit Equity ------------ ------------ ------------ ------------ ------------ ------------ BALANCE, December 31, 1996 11,113,624 $ 11,114 $ 72,913,274 $ (152,641) $(42,488,117) $ 30,283,630 Exercise of stock options 6,406 6 50,390 -- -- 50,396 Unrealized holding loss -- -- -- (40,492) -- (40,492) Net income for the period -- -- -- -- 1,348,296 1,348,296 ------------ ------------ ------------ ------------ ------------ ------------ BALANCE, June 30, 1997 11,120,030 $ 11,120 $ 72,963,664 $ (193,133) $(41,139,821) $ 31,641,830 ============ ============ ============ ============ ============ ============ See notes to financial statements 5 6 ATRIX LABORATORIES, INC. STATEMENTS OF CASH FLOWS FOR THE SIX MONTHS ENDED JUNE 30, 1997 AND 1996 (Unaudited) 1997 1996 ------------ ------------ CASH FLOWS FROM OPERATING ACTIVITIES: Net income (loss) $ 1,348,296 $ (5,409,389) Adjustments to reconcile net income (loss) to net cash provided by (used in) operating activities: Depreciation 353,258 228,540 Amortization 8,265 38,729 Gain on sale of marketable securities -- (36,419) Gain on sale of property, plant and equipment (201) -- Write off of obsolete patents -- 4,942 Net changes in current assets and liabilities: Restricted cash equivalents 7,000,000 -- Accounts receivable (300,588) (157,427) Interest receivable 6,998 46,333 Inventories (177,873) (108,033) Prepaid expenses and deposits (492,518) 124,463 Accounts payable - trade 360,880 263,151 Accrued salaries and payroll taxes 6,745 2,802 Other accrued liabilities (54,017) (26,059) Deferred revenue (6,927,192) 32,000 ------------ ------------ Net cash provided by (used in) operating activities 1,132,053 (4,996,367) ------------ ------------ CASH FLOWS FROM INVESTING ACTIVITIES: Acquisition of property, plant and equipment (1,017,086) (374,475) Acquisition of leasehold improvements (23,309) (37,714) Investments in intangible assets (80,738) (83,955) Sale of equipment 201 -- Proceeds from sale of marketable securities 991,127 4,070,501 Investment in marketable securities (3,131,962) (116,278) ------------ ------------ Net cash (used in) provided by investing activities (3,261,767) 3,458,079 ------------ ------------ CASH FLOWS FROM FINANCING ACTIVITIES: Proceeds from issuance of common stock and exercise of stock options 50,396 28,196,302 Net cash provided by financing activities 50,396 28,196,302 ------------ ------------ NET INCREASE (DECREASE) IN CASH AND CASH EQUIVALENTS (2,079,318) 26,658,014 CASH AND CASH EQUIVALENTS, BEGINNING OF PERIOD 18,368,472 925,487 ------------ ------------ CASH AND CASH EQUIVALENTS, END OF PERIOD $ 16,289,154 $ 27,583,501 ============ ============ See notes to financial statements 6 7 ATRIX LABORATORIES, INC. NOTES TO FINANCIAL STATEMENTS SIX MONTHS ENDED JUNE 30, 1997 AND 1996 NOTE 1. SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES The accompanying unaudited financial statements of Atrix Laboratories, Inc. (the "Company") have been prepared in accordance with generally accepted accounting principles for interim financial statements and with the instructions to Form 10-Q and Article 10 of Regulation S-X. In the opinion of management, all adjustments considered necessary (which consist only of normal recurring accruals) for a fair presentation have been included. These financial statements should be read in conjunction with the audited financial statements and notes thereto for the year ended December 31, 1996, filed with the Securities and Exchange Commission in the Company's Annual Report Form on 10-K. In February 1997, the Financial Accounting Standards Board issued Statement of Financial Accounting Standards No. 128, "Earnings Per Share" (SFAS 128). SFAS 128 supersedes existing generally accepted accounting principles relative to the calculation of earnings per share, is effective for years ending after December 15, 1997 and requires restatement of all prior period earnings per share information upon adoption. Generally, SFAS 128 requires a calculation of basic earnings per share, which takes into consideration income (loss) available to common shareholders and the weighted average of common shares outstanding. SFAS 128 also requires the calculation of a diluted earnings per share, which takes into effect the impact of all additional common shares that would have been outstanding if all dilutive potential common shares relating to options, warrants, and convertible securities had been issued, as long as their effect is dilutive, with a related adjustment of income available for common shareholders, as appropriate. SFAS 128 requires dual presentation of basic and diluted earnings per share on the face of the statement of operations and requires a reconciliation of the numerator and denominator of the basic earnings per share computation. The Company does not expect the effect of its adoption of SFAS 128 to be material. In June 1997, the Financial Accounting Standards Board issued Statement of Financial Accounting Standards No. 130, "Reporting Comprehensive Income" (SFAS 130). Generally, SFAS 130 establishes standards for reporting and display of comprehensive income in financial statements. All components of comprehensive income shall be reported in the financial statements in the period in which they are recognized. A total amount for comprehensive income shall be displayed in the financial statement where the components of other comprehensive income are reported. The statement divides comprehensive income into net income and other comprehensive income. Items included in other comprehensive income shall be classified separately based on their nature and include foreign currency items, minimum pension liability adjustments, and unrealized gains and losses in certain investments in debt and equity securities. The total of other comprehensive income for a period shall be transferred to a component of equity that is accumulated and displayed separately from retained earnings and additional paid-in capital in the equity section of the balance sheet. SFAS 130 is effective for periods beginning after December 15, 1997, and will require reclassification of all prior periods presented in the financial statements. The company does not expect the adoption of SFAS 130 to materially effect the financial statement presentation. 7 8 NOTE 2. INVENTORIES Inventories are stated at the lower of cost, determined by the first-in, first-out (FIFO) method, or market. The components of inventories at are as follows: June 30, December 31, 1997 1996 -------- ------------ Raw Materials $344,004 $228,533 Work in Process 94,332 13,435 Finished Goods 43,042 61,537 -------- -------- $481,378 $303,505 ======== ======== NOTE 3. BLOCK DRUG COMPANY AGREEMENT On December 17, 1996, the Company entered into an agreement (the "Block Agreement") with Block Drug Company ("Block"). Under the terms of the Block Agreement, Block acquired the North American and certain European marketing rights to the Company's first three products for the treatment of periodontal disease. The Company received an advance payment of $7,000,000 for the sale of the marketing rights to the ATRISORB(R) GTR Barrier. The funds were deposited in an escrow account until February 1, 1997, at which time substantially all of the initial services required by the Block agreement were performed. The $7,000,000 was initially included in restricted cash equivalents as of December 31, 1996 and was recognized as revenue from the sale of marketing rights during the three months ended March 31, 1997. ITEM 2. MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS. The statements contained in this report, if not historical, are forward looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, and involve risks and uncertainties that could cause actual results to differ materially from the financial results described in such forward looking statements. These risks and uncertainties include, among others, whether the Company will receive regulatory approval to market any products besides the ATRISORB(R) Barrier product, the results of current and future clinical trials, the time, costs and expenses associated with the regulatory approval process for products. The success of the Company's business operations is in turn dependent on factors such as the effectiveness of the Company's marketing strategies to market its current and any future products, the Company's ability to manufacture products on a commercial scale, the appeal of the Company's mix of products, the Company's success at entering into and collaborating with others to conduct effective strategic alliances and joint ventures, general competitive conditions within the biotechnology and drug delivery industry and general economic conditions. Further, any forward looking statement or statements speak only as of the date on which such statement or statements were made, and the Company undertakes no obligation to update any forward looking statement or statements to reflect events or circumstances after the date on which such statement is made or to reflect the occurrence of unanticipated events. Therefore, forward looking statements should not be relied upon as a prediction of actual future results. 8 9 RESULTS OF OPERATIONS THREE MONTHS ENDED JUNE 30, 1997 COMPARED TO THREE MONTHS ENDED JUNE 30, 1996 The Company had revenue from product sales of approximately $544,000 during the three months ended June 30, 1997 compared to approximately $61,000 for the three months ended June 30, 1996. The increase is primarily due to the increased sales of the ATRISORB(R) GTR Barrier in the United States as a result of the Block Agreement. The Company expects to receive additional future revenue upon the achievement of certain milestones which, under the Block Agreement, result in substantial payments. Additionally, the Company anticipates to receive increased royalties from Block as sales of the ATRISORB(R) GTR Barrier product increase. Contract revenue represents revenue the Company received from grants and from unaffiliated third parties for performing contract research and development activities utilizing the ATRIGEL(R) system, and was approximately $237,000 for the three months ended June 30, 1997, compared to approximately $282,000 for the three months ended June 30, 1996. Interest income for the three months ended June 30, 1997, was approximately $356,000 compared to approximately $288,000 for the three months ended June 30, 1996, representing a 24% increase. Interest income increased due to additions in principal investments as a result of the proceeds from a common stock offering completed in the second quarter 1996 and the $7,000,000 payment received under the Block Agreement. The majority of the funds were invested in U.S. government bond funds, long-term U.S. government and government agency investments. The remaining cash and cash equivalents were invested in interest bearing accounts to fund the Company's short-term operations. Cost of goods sold recorded for the three months ended June 30, 1997 was approximately $436,000 compared to approximately $47,000 for the period ended June 30, 1996. The increase is primarily due to increased sales of the ATRISORB(R) GTR Barrier in the United States as a result of the Block Agreement. Research and development expenses - ATRIDOX(TM) product for the three months ended June 30, 1997, were approximately $1,447,000 compared to approximately $1,416,000 for the three months ended June 30, 1996, representing a 2% increase. Other research and development expenses, which included activities for the ATRISORB(R) Barrier and other research activities for the three months ended June 30, 1997, were approximately $1,719,000 compared to approximately $1,266,000 for the three months ended June 30, 1996, representing a 36% increase. The increase was primarily a result of additional expenditures in the Manufacturing and Quality Assurance/Quality Control departments associated with the increase in sales. Administrative and marketing expenses decreased to approximately $527,000 for the three months ended June 30, 1997, from approximately $573,000 for the three months ended June 30, 1996, representing an 8% decrease. The primary reason for this decrease was the reduction in sales and marketing expenses related to the ATRISORB(R) GTR Barrier product, since those functions are now performed by Block. The Company expects sales and marketing expenses to continue to decrease as a result of the Block Agreement. The Company recorded net loss of approximately $2,988,000 for the three months ended June 30, 1997, compared to a net loss of approximately $2,659,000 for the three months ended June 30, 1996, representing a 12% increase. The increased loss was primarily the result of the increase in research and development expenses. 9 10 SIX MONTHS ENDED JUNE 30, 1997 COMPARED TO SIX MONTHS ENDED JUNE 30,1996 The Company had revenue from product sales of approximately $754,000 during the six months ended June 30, 1997 compared to approximately $120,000 for the six months ended June 30, 1996. The increase is primarily due to the increased sales of the ATRISORB(R) GTR Barrier in the United State as a result of the Block Agreement. The Company expects to receive additional future revenue upon the achievement of certain milestones which, under the Block Agreement, result in substantial payments. Additionally, the Company anticipates to receive increased royalties from Block as sales of the ATRISORB(R) GTR Barrier product increase. Contract revenue represents revenue the Company received from grants and from unaffiliated third parties for performing contract research and development activities utilizing the ATRIGEL(R) system, and was approximately $389,000 for the six months ended June 30, 1997, compared to approximately $402,000 for the six months ended June 30, 1996. Interest income for the six months ended June 30, 1997, was approximately $794,000 compared to approximately $438,000 for the six months ended June 30, 1996, representing an 81% increase. Interest income increased due to additions in principal investments as a result of the proceeds from a common stock offering completed in the second quarter 1996 and the $7,000,000 payment received under the Block Agreement. The majority of the funds were invested in U.S. government bond funds, long-term U.S. government and government agency investments. The remaining cash and cash equivalents were invested in interest bearing accounts to fund the Company's short-term operations. Cost of goods sold recorded for the six months ended June 30, 1997 was approximately $575,000 compared to approximately $88,000 for the period ended June 30, 1996. The increase is primarily due to the increased sales of the ATRISORB(R) GTR Barrier in the United States as a result of the Block Agreement. Research and development expenses - ATRIDOX(TM) product for the six months ended June 30, 1997, were approximately $2,910,000 compared to approximately $2,786,000 for the six months ended June 30, 1996, representing a 4% increase. Other research and development expenses, which included activities for the ATRISORB(R) GTR Barrier and other research activities were approximately $3,035,000 for the six months ended June 30, 1997, compared to approximately $2,370,000 for the six months ended June 30, 1996, representing a 28% increase. The increase was primarily a result of additional expenditures in the Manufacturing and Quality Assurance/Quality Control departments associated with the increase in sales and automation of the manufacturing process. Administrative and marketing expenses decreased to approximately $1,082,000 for the six months ended June 30, 1997, from approximately $1,162,000 for the six months ended June 30, 1996, representing a 7% decrease. The primary reason for this decrease was the reduction in sales and marketing expenses related to the ATRISORB(R) GTR Barrier product, since those functions are currently performed by Block. The Company expects sales and marketing expenses to continue to decrease as a result of the Block Agreement. The Company recorded net income of approximately $1,348,000 for the six months ended June 30, 1997, compared to a net loss of approximately $5,409,000 for the six months ended June 30, 1996, representing a 125% increase. The net income was primarily the result of the receipt of the payment of $7,000,000 from Block. 10 11 LIQUIDITY AND CAPITAL RESOURCES As of June 30, 1997, the Company had cash and cash equivalents of approximately $16,289,000, marketable securities of approximately $8,141,000 and other current assets of approximately $2,405,000, for total current assets of approximately $26,835,000. Current liabilities totaled approximately $1,566,000, which resulted in working capital of approximately $25,269,000. During the six months ended June 30, 1997, net cash provided by operating activities was approximately $1,132,000. This was primarily a result of the net income for the period of approximately $1,348,000, adjusted for certain non-cash expenses, and changes in other operating assets and liabilities as set forth in the statements of cash flows. Net cash used in investing activities was approximately $3,262,000 during the six months ended June 30, 1997, primarily as a result of the net investment in marketable securities during the period and the acquisition of property, plant and equipment. The Company's long-term capital expenditure requirements will depend on numerous factors, including the progress of the Company's research and development programs, the time required to file and process regulatory approval applications, the development of the Company's commercial manufacturing facilities, the ability of the Company to obtain additional licensing arrangements, and the demand for the Company's products, if and when approved. The Company expended approximately $1,040,000 for property, plant and equipment and leasehold improvements, and approximately $81,000 for patent development in the six month period ending June 30, 1997. The Company expects its capital expenditures to approximate $1,800,000 for the year ended December 31, 1997, the remainder will be primarily used to complete the manufacturing facility. 11 12 PART II - OTHER INFORMATION ITEM 4. SUBMISSION OF MATTERS TO A VOTE OF SECURITY HOLDERS An annual meeting of the Shareholders of the Company was held on April 27, 1997, in Fort Collins, Colorado, for the purpose of re-electing Mr. John E. Urheim, Dr. D. Walter Cohen, Dr. Jere E. Goyan and Dr. R. Bruce Merrifield to the Board of Directors as Class A directors, approving the Company's 1997 Employee Stock Purchase Plan, approving an amendment to the Company's Amended and Restated Performance Stock Option Plan and ratifying the appointment of the Company's independent auditors. The following votes were cast by the Shareholders with respect to the election of directors: Shares Shares Shares Voted Voted Voted Broker For Against Abstained Non-Votes --------- ------- --------- --------- Mr. John E. Urheim 8,983,535 184,233 0 0 Dr. D. Walter Cohen 8,983,410 184,358 0 0 Dr. Jere E. Goyan 8,983,535 184,233 0 0 Dr. R. Bruce Merrifield 8,983,410 184,358 0 0 The other directors whose term continues after the meeting are Dr. G. Lee Southard, C. Rodney O'Connor, H. Stuart Campbell, William C. O'Neil, Jr. and David Bethune. The following votes were cast by the Shareholders with respect to the approval of the Company's 1997 Employee Stock Purchase Plan: Shares Shares Shares Voted Voted Voted Broker For Against Abstained Non-Votes --------- ------- --------- --------- 4,273,537 419,076 160,095 0 The following votes were cast by the Shareholders with respect to the approval of an amendment to the Company's Amended and Restated Performance Stock Option Plan: Shares Shares Shares Voted Voted Voted Broker For Against Abstained Non-Votes --------- ------- --------- --------- 3,391,863 729,069 0 0 12 13 The following votes were cast by the Shareholders with respect to the resolution to ratify the Board of Directors' selection of Deloitte & Touche LLP as the Company's independent auditors for the fiscal year ending December 31, 1997: Shares Shares Shares Voted Voted Voted Broker For Against Abstained Non-Votes --------- ------- --------- --------- 9,034,403 96,593 56,562 0 ITEM 6. EXHIBITS AND REPORTS ON FORM 8-K (a) Exhibits 27. Financial Data Schedule. (b) Reports on Form 8-K No reports on Form 8-K were filed during the period ended June 30, 1997. 13 14 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. ATRIX LABORATORIES, INC. (Registrant) August 1, 1997 By: /s/ John E. Urheim ---------------------------------------- John E. Urheim Vice Chairman of the Board of Directors and Chief Executive Officer August 1, 1997 By: /s/ Brian G. Richmond ---------------------------------------- Brian G. Richmond Corporate Controller, Assistant Secretary, and Assistant Treasurer 14 15 INDEX TO EXHIBITS EXHIBIT NUMBER DESCRIPTION - ------- ----------- 27 - Financial Data Schedule