1 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, 1995 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 25, 1995, there were outstanding 7,877,428 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, 1995 AND DECEMBER 31, 1994 ASSETS June 30, December 31, 1995 1994 ------------- ------------ (Unaudited) CURRENT ASSETS: Cash and cash equivalents $ 1,104,707 $ 1,880,275 Marketable securities, at cost 4,664,078 7,896,827 Marketable securities, available-for-sale 3,658,812 3,300,894 Accounts receivable 19,630 93,469 Interest receivable 119,105 140,848 Prepaid expenses and deposits 433,917 119,102 Inventory - Raw Materials 64,170 --- ------------- ------------ Total current assets 10,064,419 13,431,415 ------------- ------------ MARKETABLE SECURITIES, AT COST 7,138,256 7,172,095 ------------- ------------ PROPERTY AND EQUIPMENT: Equipment, furniture and fixtures 1,467,371 1,276,895 Leasehold improvements 398,108 368,851 ------------- ------------ Total 1,865,479 1,645,746 Accumulated depreciation and amortization (937,593) (771,274) ------------- ------------ Property and equipment, net 927,886 874,472 ------------- ------------ OTHER ASSETS: Intangible assets, net of accumulated amortization of $43,855 and $37,065 570,610 527,640 ------------- ------------ TOTAL $ 18,701,171 $ 22,005,622 ============= ============ LIABILITIES AND SHAREHOLDERS' EQUITY CURRENT LIABILITIES: Accounts payable - trade $ 572,867 $ 481,267 Accrued salaries and payroll taxes 66,375 63,000 Other accrued liabilities 176,378 195,815 Deferred revenue 162,501 75,000 ------------- ------------ Total current liabilities 978,121 815,082 ------------- ------------ 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; 7,876,578 and 7,743,078 shares issued and outstanding 7,877 7,743 Unrealized holding loss on securities available-for-sale (149,666) (396,965) Additional paid-in capital 40,341,296 39,977,455 Accumulated deficit (22,476,457) (18,397,693) ------------- ------------ Total shareholders' equity 17,723,050 21,190,540 ------------- ------------ TOTAL $ 18,701,171 $ 22,005,622 ============= ============ See notes to financial statements 2 3 ATRIX LABORATORIES, INC. STATEMENTS OF OPERATIONS FOR THE THREE MONTHS ENDED JUNE 30, 1995 AND 1994 (Unaudited) 1995 1994 ----------- ----------- REVENUE: Contract revenue $ 182,416 $ 218,390 Contract revenue from related party 3,000 3,000 Interest income 281,883 334,796 Loss on sale of marketable securities -- (42,507) ----------- ----------- Total revenue 467,299 513,679 ----------- ----------- EXPENSES: Research expenses-Perio Product 1,438,555 740,759 Research and development 886,304 966,192 Administrative 287,260 163,773 ----------- ----------- Total expenses 2,612,119 1,870,724 ----------- ----------- NET LOSS $(2,144,820) $(1,357,045) =========== =========== NET LOSS PER COMMON SHARE $ (.27) $ (.18) =========== =========== WEIGHTED AVERAGE SHARES OUTSTANDING 7,875,741 7,742,578 =========== =========== See notes to financial statements 3 4 ATRIX LABORATORIES, INC. STATEMENTS OF OPERATIONS FOR THE SIX MONTHS ENDED JUNE 30, 1995 AND 1994 (Unaudited) 1995 1994 ----------- ----------- REVENUE: Contract revenue $ 238,666 $ 312,109 Contract revenue from related party 6,000 6,000 Interest income 544,691 690,772 Loss on sale of marketable securities -- (63,595) ----------- ----------- Total revenue 789,357 945,286 ----------- ----------- EXPENSES: Research expenses-Perio Product 2,556,104 1,360,370 Research and development 1,749,220 1,963,282 Administrative 562,797 404,473 ----------- ----------- Total expenses 4,868,121 3,728,125 ----------- ----------- NET LOSS $(4,078,764) $(2,782,839) =========== =========== NET LOSS PER COMMON SHARE $ (.52) $ (.36) =========== =========== WEIGHTED AVERAGE SHARES OUTSTANDING 7,844,260 7,739,256 =========== =========== See notes to financial statements 4 5 ATRIX LABORATORIES, INC. STATEMENTS OF CHANGES IN SHAREHOLDERS' EQUITY FOR THE SIX MONTHS ENDED JUNE 30, 1995 (Unaudited) Additional Unrealized Total Common Stock Paid-in Holding Accumulated Shareholders' -------------------------- Shares Amount Capital Gain (Loss) Deficit Equity --------- ------------ ----------------------------- ------------ ------------ BALANCE, December 31, 1994 7,743,078 $ 7,743 $ 39,977,455 $ (396,965) $(18,397,693) $ 21,190,540 Exercise of stock options 133,500 134 363,841 -- -- 363,975 Unrealized holding gain -- -- -- 247,299 -- 247,299 Net loss for the period -- -- -- -- (4,078,764) (4,078,764) --------- ------------ ------------ ------------ ------------ ------------ BALANCE, June 30, 1995 7,876,578 $ 7,877 $ 40,341,296 $ (149,666) $(22,476,457) $ 17,723,050 ========= ============ ============ ============ ============ ============ See notes to financial statements 5 6 ATRIX LABORATORIES, INC. STATEMENTS OF CASH FLOWS FOR THE SIX MONTHS ENDED JUNE 30, 1995 AND 1994 (Unaudited) 1995 1994 ----------- ----------- CASH FLOWS FROM OPERATING ACTIVITIES: Net loss $(4,078,764) $(2,782,839) Adjustments to reconcile net loss to net cash used in operating activities: Depreciation 166,319 128,413 Amortization of patents 6,790 5,525 Amortization of bond premiums 125,788 178,149 Loss on sale of marketable securities -- 63,595 Write-off of obsolete patents 5,507 64,779 Net changes in current assets and liabilities: Accounts receivable 73,839 19,777 Prepaid expenses and deposits (314,815) (61,369) Inventory (64,170) -- Interest receivable 21,743 8,065 Accounts payable - trade 91,600 (46,902) Accrued salaries and payroll taxes 3,375 10,644 Other accrued liabilities (19,437) (13,636) Deferred revenue 87,501 (96,857) ----------- ----------- Net cash used in operating activities (3,894,724) (2,522,656) ----------- ----------- CASH FLOWS FROM INVESTING ACTIVITIES: Acquisition of equipment, furniture and fixtures (190,476) (139,949) Acquisition of leasehold improvements (29,257) (19,609) Investments in intangible assets (55,266) (96,403) Proceeds from sale of marketable securities available-for-sale -- 2,405,687 Proceeds from maturities of marketable securities 3,140,800 -- Investment in marketable securities (110,620) (201,947) ----------- ----------- Net cash provided by investing activities 2,755,181 1,947,779 ----------- ----------- CASH FLOWS FROM FINANCING ACTIVITIES: Proceeds from issuance of common stock and exercise of stock options 363,975 75,229 ----------- ----------- Net cash provided by financing activities 363,975 75,229 ----------- ----------- NET DECREASE IN CASH AND CASH EQUIVALENTS (775,568) (499,648) CASH AND CASH EQUIVALENTS, BEGINNING OF PERIOD 1,880,275 589,317 ----------- ----------- CASH AND CASH EQUIVALENTS, END OF PERIOD $ 1,104,707 $ 89,669 =========== =========== See notes to financial statements 6 7 ATRIX LABORATORIES, INC. NOTES TO FINANCIAL STATEMENTS SIX MONTHS ENDED JUNE 30, 1995 AND 1994 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, 1994, filed with the Securities and Exchange Commission in the Company's Annual Report Form 10-K. NOTE 2. RELATED PARTY The Company is the General Partner of Vipont Royalty Income Fund, Ltd. (the "Partnership"). The Partnership has ongoing expenses related to its status as a public partnership, including the cost of preparing and filing reports required by the Securities Exchange Act of 1934 and the Internal Revenue Service, and providing certain communications to the limited partners. It is estimated that the cost of preparing, filing and mailing the various reports, including an annual audit, is approximately $30,000 per year. The Partnership has exhausted all cash funds. The Company has agreed to advance funds to the Partnership to pay these expenses for the Partnership's calendar year ending December 31, 1995. All such advances will be due and payable, if ever, from the Partnership's share of royalties and/or proceeds from the sale of the rights to the Perio Product. As of June 30, 1995, the Partnership had approximately $148,000 in accounts payable, consisting of management fees owed to the Company, as General Partner, and trade payables. The Company expensed the amounts advanced to the Partnership to pay general and administrative expenses in accordance with generally accepted accounting principles for advances to a research and development limited partnership. 7 8 ITEM 2. MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS. RESULTS OF OPERATIONS THREE MONTHS ENDED JUNE 30, 1995 COMPARED TO THREE MONTHS ENDED JUNE 30, 1994 Contract revenue represented revenue the Company received from grants and from unaffiliated third parties for performing contract research and development activities for the ATRIGEL (TM) system, and was approximately $182,000 for the three months ended June 30, 1995, compared to approximately $218,000 for the three months ended June 30, 1994. The decrease in contract revenue was a result of the Company completing a number of contracts that were in progress in the prior period, while contracts initiated in the current period have generated less revenue to date. Contract revenue from related party represented revenue the Company earned for the management of the Partnership, and was approximately $3,000 for the three months ended June 30, 1995 compared to the same amount for the three months ended June 30, 1994. Interest income for the three months ended June 30, 1995, was approximately $282,000 compared to approximately $335,000 for the three months ended June 30, 1994. Interest income decreased due to a reduction in principal investments as a result of the funds being used in general operations. 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 cash accounts to meet the Company's short-term operating needs. A loss on sale of marketable securities of approximately $43,000 was recognized in the three month period ended June 30, 1994. There was no loss recognized in the current quarter because certain bonds matured and provided adequate funds for current operations. The prior period loss resulted from the sale of securities, available-for-sale at a time when the bond market had substantially declined compared to the period when the securities were purchased. The proceeds from the sale of marketable securities in the prior year were used to fund normal operations. Research expenses-Perio Product for the three months ended June 30, 1995, were approximately $1,439,000 compared to approximately $741,000 for the three months ended June 30, 1994. The increase was due to the commencement of two Phase III clinical studies in January 1995. Research expenses are anticipated to increase in subsequent periods as additional expenses for the clinical studies are incurred. 8 9 Research and development expenses included activities for the development of the ATRISORB TM Barrier product and other research activities for the Company's own benefit. Research and development expenses decreased to approximately $886,000 during the three months ended June 30, 1995, from approximately $966,000 for the three months ended June 30, 1994. The decrease was primarily a result of a reduction of activity in the drug delivery research area for other applications of the ATRIGEL (TM) system due to the Company's focus on completing clinical studies related to the periodontal products during the current year. Administrative expenses increased to approximately $287,000 during the three months ended June 30, 1995, from approximately $164,000 for the three months ended June 30, 1994. The primary reasons for this increase were increased legal, accounting, and corporate marketing expenses. The Company recorded a net loss of approximately $2,145,000 for the three months ended June 30, 1995, compared to a net loss of approximately $1,357,000 for the three months ended June 30, 1994. The current period loss was higher due to decreased revenues and increased expenses associated with the commencement of two Phase III clinical studies on the Perio Product, and additional research and development on the ATRISORB (TM) Barrier product and the ATRIGEL (TM) drug delivery system. SIX MONTHS ENDED JUNE 30, 1995 COMPARED TO SIX MONTHS ENDED JUNE 30, 1994 Contract revenue represented revenue the Company received from grants and from unaffiliated third parties for performing contract research and development activities for the ATRIGEL (TM) system, and was approximately $239,000 for the six months ended June 30, 1995, compared to approximately $312,000 for the six months ended June 30, 1994. The decrease in contract revenue was a result of the Company completing a number of contracts that were in progress in the prior period, while contracts initiated in the current period have generated less revenue to date. Contract revenue from related party represented revenue the Company earned for the management of the Partnership, and was approximately $6,000 for the six months ended June 30, 1995 compared to the same amount for the six months ended June 30, 1994. Interest income for the six months ended June 30, 1995, was approximately $545,000 compared to approximately $691,000 for the six months ended June 30, 1994. Interest income decreased due to a reduction in principal investments as a result of the funds being used in general operations. 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 cash accounts to meet the Company's short-term operating needs. 9 10 A loss on sale of marketable securities of approximately $64,000 was recognized in the six month period ended June 30, 1994. There was no loss recognized in the current quarter because certain bonds matured and provided adequate funds for current operations. The prior period loss resulted from the sale of securities, available-for-sale at a time when the bond market had substantially declined compared to the period when the securities were purchased. The proceeds from the sale of marketable securities in the prior year were used to fund normal operations. Research expenses-Perio Product for the six months ended June 30, 1995, were approximately $2,556,000 compared to approximately $1,360,000 for the six months ended June 30, 1994. The increase was due to the commencement of two Phase III clinical studies in January 1995. Research expenses are anticipated to increase in subsequent periods as additional expenses for the clinical studies are incurred. Research and development expenses included activities for the development of the ATRISORB (TM) Barrier product and other research activities for the Company's own benefit. Research and development expenses decreased to approximately $1,749,000 during the six months ended June 30, 1995, from approximately $1,963,000 for the six months ended June 30, 1994. The decrease was primarily a result of a reduction of activity in the drug delivery research area for other applications of the ATRIGEL (TM) system due to the Company's focus on completing clinical studies related to the periodontal products during the current year. Administrative expenses increased to approximately $563,000 during the six months ended June 30, 1995, from approximately $404,000 for the six months ended June 30 1994. The primary reasons for this increase were increased legal, accounting, and corporate marketing expenses. The Company recorded a net loss of approximately $4,079,000 for the six months ended June 30, 1995, compared to a net loss of approximately $2,783,000 for the six months ended June 30, 1994. The current period loss was higher due to decreased revenues and increased expenses associated with the commencement of two Phase III clinical studies on the Perio Product, and additional research and development on the ATRISORB (TM) Barrier product and the ATRIGEL (TM) drug delivery system. LIQUIDITY AND CAPITAL RESOURCES As of June 30, 1995, the Company had cash and cash equivalents of approximately $1,105,000, marketable securities at cost of approximately $4,664,000, marketable securities available-for-sale of approximately $3,659,000, and other current assets of approximately $636,000, for total current assets of approximately $10,064,000. Current liabilities totaled approximately $978,000, which resulted in working capital of approximately $9,086,000. 10 11 The Company had funds available of approximately $16,566,000 to fund working capital requirements and capital expenditures. This included approximately $1,105,000 in cash and cash equivalents, approximately $4,664,000 in marketable securities with a maturity date of less than twelve months from the current period end, approximately $3,659,000 of marketable securities available- for-sale and approximately $7,138,000 in marketable securities with a maturity date greater than twelve months from the current period end. During the six months ended June 30, 1995, the Company used net cash from operating activities of approximately $3,895,000. This was primarily a result of a net loss of approximately $4,079,000, which was increased by prepaid expenses and inventory. This total cash used was partially offset by changes in other operating assets, depreciation, amortization and accounts payable. Changes in other operating assets and liabilities included a decrease in cash for prepaids of approximately $315,000 due to payments for clinical studies, an increase in cash for accounts receivable of approximately $74,000 and an increase in cash for deferred revenue of approximately $88,000. Net cash provided by investing activities was approximately $2,755,000 during the six months ended June 30, 1995, primarily as a result of the proceeds from maturities of marketable securities. This was reduced by cash used for the acquisition of capital equipment and leasehold improvements, investments in intangible assets, and investments in marketable securities. Net cash provided from financing activities was approximately $364,000. The increase was a result of the exercise of stock options by certain directors and employees. 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 $220,000 for property, equipment and leasehold improvements, and approximately $55,000 for patent development in the six month period ending June 30, 1995. The Partnership has ongoing expenses related to its status as a public partnership, including the cost of preparing and filing reports required by the Securities Exchange Act of 1934 and the Internal Revenue Code, and providing certain communications to the limited partners. It is estimated that the cost of preparing, filing and mailing the various reports, including an annual audit will be approximately $30,000. The Partnership has exhausted all cash funds. The Company has agreed to advance additional funds to the Partnership to pay these expenses for the Partnership's calendar year ending December 31, 1995. All such advances will be due and payable, if ever, from the Partnership's share of royalties and/or proceeds from the sale of the rights to the Perio Product. 11 12 As of June 30, 1995, the Partnership had approximately $148,000 in accounts payable, consisting of management fees owed to the Company, as General Partner, and trade payables. The Company expensed the amounts owed to the Partnership to pay general and administrative expenses in accordance with generally accepted accounting principles for advances to a research and development limited partnership. The Company expects to incur substantial expenditures over the next two years for research and development, testing and regulatory compliance and for hiring additional management, scientific, manufacturing and administrative personnel. The Company will use significant funds to undertake any clinical testing. The Company expects to incur substantial operating losses for the foreseeable future. Depending on the results of the Company's research and development activities, the Company may determine to accelerate or expand its efforts in one or more of its proposed areas and may therefore require additional funds earlier than presently anticipated. Further, the Company will require significant additional funds or arrangements with third parties to commercialize any of its products. The Company will also require substantial additional funds if it proceeds to manufacture and market any products on a commercial scale. Such funds will be needed to construct additional facilities and to hire manufacturing and marketing personnel. There can be no assurance that additional financing will be available when needed on terms favorable to the Company. Management believes that under the current operating plan its existing capital resources will be sufficient to meet its operating expenses and capital expenditure requirements through at least 1996. However, as the Company's goal is to maintain a cash and investment balance sufficient to fund its operating expenses for at least two years, the Company expects to seek additional capital through debt and/or equity financings in the next twelve to eighteen months. There can be no assurance that such funds will be available to the Company on favorable terms, if at all. In addition, the availability of such funds may be adversely affected by increasing governmental pressures on the pharmaceutical industry. Management currently has no commitments or arrangements for raising additional capital. The Company cannot predict the effect that health care reforms may have on the Company. The Company's long-term success depends on sales of products that must undergo an extensive regulatory approval process. There can be no assurance that regulatory agency approvals will be obtained for any products or drugs developed or discovered by the Company, or that the Company will be successful in developing any products or drugs. 12 13 PART II - OTHER INFORMATION ITEM 4. SUBMISSION OF MATTERS TO A VOTE OF SECURITY HOLDERS An Annual Shareholders Meeting was held on April 30, 1995, in Fort Collins, Colorado, for the purpose of re-electing Mr. William C. O'Neil and electing Mr. David R. Bethune to the Board of Directors as Class B directors, 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 named in the Proxy Statement: Shares Shares Shares Voted Voted Voted Broker For Against Abstained Non-Votes --------- ------- --------- --------- Mr. William C. O'Neil 6,047,175 58,000 0 0 Mr. David R. Bethune 6,047,017 58,158 0 0 The following votes were cast by 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, 1995: Shares Shares Shares Voted Voted Voted Broker For Against Abstained Non-Votes --------- ------- --------- --------- 6,031,800 38,236 35,139 0 ITEM 6. EXHIBITS AND REPORTS ON FORM 8-K (a) Exhibits 27. Financial Data Schedule. (b) Reports on Form 8-K A Current Report on Form 8-K, dated April 28, 1995, was filed with the Securities and Exchange Commission under Item 5 regarding license agreements signed with Paravax, Inc., and Gensia, Inc. No other reports on Form 8-K were filed during the period ended June 30, 1995. 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, 1995 By: /s/ John E. Urheim ----------------------------------------- John E. Urheim Vice Chairman of the Board of Directors and Chief Executive Officer August 1, 1995 By: /s/ Kimberly A. Marks ----------------------------------------- Kimberly A. Marks Corporate Controller, Assistant Secretary, and Assistant Treasurer 15 EXHIBIT INDEX Exhibit No. Exhibit Description Page - ----------- -------------------- ---- 27 Financial Data Schedule