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. September 30, 1996 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 October 21, 1996, there were 11,094,729 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 December 31, September 30, 1996 1995 --------------------------------------- ASSETS (Unaudited) CURRENT ASSETS: Cash and cash equivalents $ 925,487 $ 21,284,381 Marketable securities, available-for-sale, at fair value 10,996,847 5,889,559 Accounts receivable 190,665 560,854 Interest receivable 112,303 54,435 Prepaid expenses and deposits 572,751 619,641 Inventory 202,264 337,404 --------------------------------------- Total current assets 13,000,317 28,746,274 --------------------------------------- PROPERTY, PLANT AND EQUIPMENT: Property, plant and equipment 1,847,164 5,730,289 Leasehold improvements 506,190 545,593 --------------------------------------- Total 2,353,354 6,275,882 --------------------------------------- Accumulated depreciation (1,133,864) (1,517,953) --------------------------------------- Property, plant and equipment, net 1,219,490 4,757,929 --------------------------------------- OTHER ASSETS: Intangible assets, net of accumulated amortization of 674,116 775,239 $52,240 and $65,308 --------------------------------------- TOTAL $ 14,893,923 $ 34,279,442 ======================================= LIABILITIES AND SHAREHOLDERS' EQUITY CURRENT LIABILITIES: Accounts payable - trade $ 1,862,850 $ 990,435 Accrued salaries and payroll taxes 72,199 80,217 Other accrued liabilities 152,108 155,980 --------------------------------------- Total current liabilities 2,087,157 1,226,632 --------------------------------------- SHAREHOLDERS' EQUITY: Preferred stock, $.001 par value; authorized 5,000,000 shares; none issued or outstanding Common stock, $.001 par value; authorized 25,000,000 shares; 8,433 11,095 8,433,296 and 11,094,729 shares issued and outstanding Additional paid-in capital 43,889,473 72,192,539 Unrealized holding loss on marketable securities, available- (35,176) (242,957) for-sale Accumulated deficit (31,055,964) (38,907,867) --------------------------------------- Total shareholders' equity 12,806,766 33,052,810 --------------------------------------- TOTAL $ 14,893,923 $ 34,279,442 ======================================= See notes to financial statements 2 3 ATRIX LABORATORIES, INC. STATEMENTS OF OPERATIONS FOR THE THREE MONTHS ENDED SEPTEMBER 30, 1995 AND 1996 (Unaudited) REVENUE: 1995 1996 ---------------------------------- Sales $ --- $ 163,367 Contract revenue 169,250 343,571 Interest income 253,562 421,045 Rental income --- 5,444 Gain (loss) on sale of marketable securities (3,468) --- Gain (loss) on sale of equipment (1,702) 32,258 ---------------------------------- Total revenue 417,642 965,685 ---------------------------------- EXPENSES: Cost of goods sold --- 77,702 Research and development o ATRIDOX(TM) product 1,607,047 1,025,620 o Other 905,896 1,210,127 Administrative and marketing 161,920 1,094,750 Acquisition of rights 3,703,521 --- ---------------------------------- Total expenses 6,378,384 3,408,199 ---------------------------------- NET LOSS $ (5,960,742) $ (2,442,514) ================================== NET LOSS PER COMMON SHARE $ (0.76) $ (0.22) ================================== WEIGHTED AVERAGE SHARES OUTSTANDING 7,883,307 11,083,217 ================================== See notes to financial statements 3 4 ATRIX LABORATORIES, INC. STATEMENTS OF OPERATIONS FOR THE NINE MONTHS ENDED SEPTEMBER 30, 1995 AND 1996 (Unaudited) REVENUE: 1995 1996 --------------------------------- Sales $ --- $ 283,328 Contract revenue 413,916 745,142 Interest income 798,253 858,594 Rental income --- 5,444 Gain (loss) on sale of marketable securities (3,468) 36,419 Gain (loss) on sale of equipment (1,702) 32,272 --------------------------------- Total revenue 1,206,999 1,961,199 --------------------------------- EXPENSES: Cost of goods sold --- 165,316 Research and development o ATRIDOX(TM) product 4,177,603 3,813,512 o Other 2,638,167 3,578,008 Administrative and marketing 620,227 2,256,266 Acquisition of rights 3,810,507 --- --------------------------------- Total expenses 11,246,504 9,813,102 --------------------------------- NET LOSS $ (10,039,505) $ (7,851,903) ================================= NET LOSS PER COMMON SHARE $ (1.28) $ (0.80) ================================= WEIGHTED AVERAGE SHARES OUTSTANDING 7,857,419 9,832,847 ================================= See notes to financial statements 4 5 ATRIX LABORATORIES, INC. STATEMENTS OF CHANGES IN SHAREHOLDERS' EQUITY FOR THE NINE MONTHS ENDED SEPTEMBER 30, 1996 (Unaudited) Additional Unrealized Total Common Stock Paid-in Holding Accumulated Shareholders' Shares Capital Loss Deficit Equity Amount ----------------------------------------------------------------------------------- BALANCE, December 31, 1995 8,433,296 $8,433 $43,889,473 $ (35,176) $(31,055,964) $12,806,766 Exercise of stock options 73,933 74 461,677 --- --- 461,751 Issuance of common stock 2,587,500 2,588 27,841,389 --- --- 27,843,977 Unrealized holding loss --- --- --- (207,781) --- (207,781) Net loss for the period --- --- --- --- (7,851,903) (7,851,903) ----------------------------------------------------------------------------------- BALANCE, September 30, 1996 11,094,729 $11,095 $72,192,539 $(242,957) $ (38,907,867) $33,052,810 =================================================================================== See notes to financial statements 5 6 ATRIX LABORATORIES, INC. STATEMENTS OF CASH FLOWS FOR THE NINE MONTHS ENDED SEPTEMBER 30, 1995 AND 1996 (Unaudited) 1995 1996 ----------------------------- CASH FLOWS FROM OPERATING ACTIVITIES: Net loss $ (10,039,505) $ (7,851,903) Adjustments to reconcile net loss to net cash used in operating activities: Depreciation 260,308 386,680 (Gain) loss on sale of equipment 1,703 (32,272) Amortization of patents 10,363 13,068 Amortization of bond premiums 143,573 39,780 (Gain) loss on sale of marketable securities 3,467 (36,419) Write-off of obsolete patents 5,507 4,942 Acquisition of rights through issuance of common stock 3,520,958 --- Net changes in current assets and liabilities: Accounts receivable 56,794 (370,189) Interest receivable (26,944) 57,868 Prepaid expenses and deposits (255,047) (46,890) Inventory (197,249) (135,140) Accounts payable - trade 317,927 (872,415) Accrued salaries and payroll taxes 3,936 8,018 Other accrued liabilities (31,572) 3,872 Deferred revenue (59,999) --- ----------------------------- Net cash used in operating activities (6,285,780) (8,831,000) ----------------------------- CASH FLOWS FROM INVESTING ACTIVITIES: Acquisition of property, plant and equipment (342,359) (4,021,236) Acquisition of leasehold improvements (29,297) (39,403) Investments in intangible assets (101,900) (119,134) Proceeds from sale of property, plant and equipment 450 167,560 Proceeds from sale of marketable securities 1,567,099 4,070,501 Proceeds from maturities of marketable securities 3,140,800 1,000,000 Investment in marketable securities (167,940) (174,122) ----------------------------- Net cash provided by investing activities 4,066,853 884,166 ----------------------------- CASH FLOWS FROM FINANCING ACTIVITIES: Proceeds from issuance of common stock and exercise of stock options 376,000 28,305,728 ----------------------------- Net cash provided by financing activities 376,000 28,305,728 ----------------------------- NET (DECREASE) INCREASE IN CASH AND CASH EQUIVALENTS (1,842,927) 20,358,894 CASH AND CASH EQUIVALENTS, BEGINNING OF PERIOD 1,880,275 925,487 ----------------------------- CASH AND CASH EQUIVALENTS, END OF PERIOD $ 37,348 $ 21,284,381 ============================= See notes to financial statements 6 7 ATRIX LABORATORIES, INC. NOTES TO FINANCIAL STATEMENTS NINE MONTHS ENDED SEPTEMBER 30, 1996 AND 1995 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, 1995, filed with the Securities and Exchange Commission in the Company's Annual Report Form 10-K. 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 September 30, 1996 are: Raw Materials $ 263,114 Work in Process 6,303 Finished Goods 67,987 ----------------- $ 337,404 ================= 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 7 8 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. RESULTS OF OPERATIONS THREE MONTHS ENDED SEPTEMBER 30, 1996 COMPARED TO THREE MONTHS ENDED SEPTEMBER 30, 1995 Sales recorded during the three months ended September 30, 1996, primarily represents revenue from sales of the ATRISORB(R) Barrier product in the United States. The Company had no product sales during 1995. 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 $344,000 for the three months ended September 30, 1996, compared to approximately $169,000 for the three months ended September 30, 1995, representing a 104% increase. The increased revenues are primarily due to the Company being awarded two federal research grants during the current year. Interest income for the three months ended September 30, 1996, was approximately $421,000 compared to approximately $254,000 for the three months ended September 30, 1995. Interest income for the current quarter increased over the comparable period in the prior year due to a substantial increase in principal investments as a result of the investment of approximately $27,000,000 from the proceeds of the common stock offering completed in May 1996. Rental income for the three months ended September 30, 1996, was approximately $5,000 and was derived from leasing space at the Company's newly-acquired manufacturing facility. The Company had no rental income during 1995. A gain on the sale of equipment of approximately $32,000 was recognized during the three months ended September 30, 1996, compared to a loss on the sale of equipment of approximately $2,000 for the three months ended September 30, 1995. The gain for the current quarter related to the sale of certain equipment purchased with the manufacturing facility in July 1996. There were no sales of marketable securities for the three months ended September 30, 1996, whereas a loss on the sale of marketable securities of approximately $3,000 was realized for the comparable period in 1995. The proceeds from the sale of marketable securities during 1995 were used to fund normal operations. Cost of goods sold for the three months ended September 30, 1996 was primarily associated with the launch of the Company's first dental product, the ATRISORB(R) Barrier product. 8 9 Research and development expenses - ATRIDOX(TM) product for the three months ended September 30, 1996, were approximately $1,026,000 compared to approximately $1,607,000 for the three months ended September 30, 1995 representing a 36% decrease. Expenses for the ATRIDOX(TM) product were lower than in the previous year due to the completion of Phase III clinical trials in May 1996. Other research and development expenses included activities for the development of the ATRISORB(R) Barrier product and other research activities. Other research and development expenses for the three months ended September 30, 1996, were approximately $1,210,000 compared to approximately $906,000 for the three months ended September 30, 1995, representing a 34% increase. The increase was primarily a result of hiring additional personnel in the Manufacturing and Quality Assurance/Quality Control departments. Administrative and marketing expenses increased to approximately $1,095,000 for the three months ended September 30, 1996, compared to $162,000 for the three months ended September 30, 1995, representing a 576% increase. The primary reasons for this increase were expenses related to the initiation in the current year of marketing and sales efforts related to the ATRISORB(R) Barrier product and increased general operating costs. The Company recorded a net loss of approximately $2,443,000 for the three months ended September 30, 1996, compared to a net loss of approximately $5,961,000 for the three months ended September 30, 1995, representing a 59% decrease. The decrease in net loss was primarily the result of the charge in the previous year of approximately $3,704,000 associated with the acquisition of Vipont Royalty Income Fund, Ltd. NINE MONTHS ENDED SEPTEMBER 30, 1996 COMPARED TO NINE MONTHS ENDED SEPTEMBER 30, 1995 Sales recorded during the nine months ended September 30, 1996, primarily represents revenue from sales of the ATRISORB(R) Barrier product. The Company had no product sales during 1995. 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 $745,000 for the nine months ended September 30, 1996, compared to approximately $414,000 for the nine months ended September 30, 1995, representing a 80% increase. The increased revenues are partially due to the Company being awarded two federal research grants during the second quarter of the current year. Interest income for the nine months ended September 30, 1996, was approximately $859,000 compared to approximately $798,000 for the nine months ended September 30, 1995, representing a 8% increase. Interest income was higher than that of the comparable period in the prior year due to a reduction in principal investments to fund general operations, offset by 9 10 a substantial increase in principal investments during the second quarter as a result of the receipt of $27,800,000 in proceeds from the common stock offering completed in May 1996. Rental income for the nine months ended September 30, 1996, was approximately $5,000 and was derived from leasing space at the Company's newly-acquired manufacturing facility. The company had no rental income during 1995. A gain on the sale of equipment of approximately $32,000 was recognized during the nine months ended September 30, 1996, compared to a loss on the sale of equipment of approximately $2,000 for the nine months ended September 30, 1995. The gain for the current period related to the sale of certain equipment purchased with the manufacturing facility in July 1996. A gain on sale of marketable securities of approximately $36,000 was realized for the nine months ended September 30, 1996, whereas a loss of approximately $3,000 was realized for the comparable period in 1995. The proceeds from the sale of marketable securities were used to fund normal operations. Cost of goods sold recorded for the nine months ended September 30, 1996 was primarily associated with the launch of the Company's first dental product, the ATRISORB(R) Barrier product in certain European countries and the United States. Research and development expenses - ATRIDOX(TM) product for the nine months ended September 30, 1996, were approximately $3,814,000 compared to approximately $4,178,000 for the nine months ended September 30, 1995, representing a 9% decrease due to the completion of Phase III clinical trials in May 1996. Other research and development expenses, which included activities for the ATRISORB(R) Barrier product and other research activities for the nine months ended September 30, 1996, were approximately $3,578,000 compared to approximately $2,638,000 for the nine months ended September 30, 1995, representing a 36% increase. The increase was primarily a result of hiring additional personnel in the Manufacturing and Quality Assurance/Quality Control departments. Administrative and marketing expenses increased to approximately $2,256,000 for the nine months ended September 30, 1996, compared to $620,000 for the nine months ended September 30, 1995, representing a 264% increase. The primary reasons for this increase were expenses related to the initiation of marketing and sales efforts related to the ATRISORB(R) Barrier product and increased general operating costs. The Company recorded a net loss of approximately $7,852,000 for the nine months ended September 30, 1996, compared to a net loss of approximately $10,040,000 for the nine months ended September 30, 1995, representing a 22% decrease. The decrease in net loss was 10 11 primarily the result of the charge in the previous year of approximately $3,811,000 associated with the acquisition of Vipont Royalty Income Fund, Ltd. LIQUIDITY AND CAPITAL RESOURCES During the second quarter of 1996, the Company completed the sale of 2,587,500 shares of common stock for $115/8 per share, which provided the Company with net proceeds of approximately $27,844,000. The majority of the proceeds were invested in commercial paper with A1P1 ratings, and the remaining cash and cash equivalents were invested in interest bearing accounts to fund the Company's short-term operations. The Company intends to use the net proceeds of the offering to fund further research of its products, commercialize its dental products in the United States and Europe, expand its manufacturing capability, and for working capital purposes. As of September 30, 1996, the Company had cash and cash equivalents of approximately $21,284,000, marketable securities, available-for-sale, at fair value of approximately $5,890,000 and other current assets of approximately $1,572,000, for total current assets of approximately $28,746,000. Current liabilities totaled approximately $1,227,000, which resulted in working capital of approximately $27,519,000. During the nine months ended September 30, 1996, the Company used net cash in operating activities of $8,831,000. This was primarily a result of the net loss for the period of approximately $7,852,000, adjusted for certain non-cash expenses, and changes in other operating assets and liabilities as set forth in the statement of cash flows. Net cash provided by investing activities was approximately $884,000 during the nine months ended September 30, 1996, primarily as a result of the proceeds from sales and maturities of marketable securities, offset by the acquisition of property, plant and equipment. Net cash provided by financing activities was approximately $28,306,000. The increase was primarily the result of the issuance and sale of 2,587,500 shares of common stock during the second quarter. The Company's long-term capital 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. Capital expenditures for the nine months ended September 30, 1996 totaled approximately $4,061,000 of which approximately $3,400,000 was for the purchase of the new manufacturing facility and its existing equipment. 11 12 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 September 30, 1996. 12 13 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) November 11, 1996 By:/s/ John E. Urheim - ----------------- ------------------------------------------- John E. Urheim Vice Chairman of the Board of Directors and Chief Executive Officer November 11, 1996 By:/s/ Kimberly A. Marks - ----------------- ------------------------------------------- Kimberly A. Marks Corporate Controller, Assistant Secretary, and Assistant Treasurer 14 EXHIBIT INDEX Exhibit No. Exhibit Description - ------- ------------------- 27 Financial Data Schedule