SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 Form 10-Q X Quarterly report pursuant to Section 13 or 15(d) of the Securities --- Exchange Act of 1934. For the quarterly period ended September 30, 1999. ___ 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 0-23160 Anesta Corp. (Exact name of registrant as specified in its charter) Delaware 87-0424798 (State or other jurisdiction of (I.R.S. Employer incorporation or organization) Identification No.) 4745 Wiley Post Way Plaza 6, Suite 650 Salt Lake City, UT 84116 (801) 595-1405 (Address, including zip code, and telephone number, including area code, of principal executive offices) Securities registered pursuant to Section 12(g) of the Act: Common Stock $.001 par value (Title of Class) Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Sections 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. ---- ---- Indicate the number of shares outstanding of each of the issuer's classes of common stock, as of the latest practicable date. Common Stock $.001 par value 13,298,209 Class Outstanding at November 8, 1999 ANESTA CORP. INDEX PART I. FINANCIAL INFORMATION PAGE NO. -------- Balance Sheets - September 30, 1999 (unaudited) and December 31, 1998 2 Statements of Operations and Comprehensive Loss - for the three and nine months ended September 30, 1999 and 1998 (unaudited) and the period from inception (August 1, 1985) to September 30, 1999 (unaudited) 3 Statements of Cash Flows - for the nine months ended September 30, 1999 and 1998 (unaudited) and the period from inception (August 1, 1985) to September 30, 1999 (unaudited) 4 Notes to Financial Statements (unaudited) 6 Management's Discussion and Analysis of Financial Condition and Results of Operations 10 PART II. OTHER INFORMATION 14 SIGNATURES 15 1 ANESTA CORP. (A Development Stage Company) BALANCE SHEETS ----------- September 30, December 31, September 30, December 31, ASSETS 1999 1998 LIABILITIES AND STOCKHOLDERS' EQUITY 1999 1998 ------------ ------------ ------------- ------------ (Unaudited) (Unaudited) Current assets: Current liabilities: Cash and cash equivalents $ 30,715,656 $ 55,889,226 Accounts payable $ 133,818 $ 1,478,521 Current portion of certificate Accrued liabilities: of deposit 340,000 255,000 Accrued compensation 580,707 1,117,909 Marketable debt securities, Other 321,502 236,783 available-for-sale 38,593,745 24,661,040 Current portion of notes Accounts receivable 3,098,475 276,476 payable 333,333 250,000 ------------ ------------ Prepaid expenses and other Total current liabilities 1,369,360 3,083,213 current assets 1,545,928 194,802 ------------ ------------ Total current assets 74,293,804 81,276,544 ------------ ------------ Unearned revenues 1,628,148 526,796 Property and equipment, at cost: Notes payable 1,666,667 1,500,000 --------- --------- Furniture and equipment 1,025,994 947,598 Total liabilities 4,664,175 5,110,009 --------- --------- Leasehold improvements 2,786,238 2,330,136 Accumulated depreciation (1,359,336) (1,151,126) ------------ ------------ 2,452,896 2,126,608 Stockholders' equity: ------------ ------------ Common stock, par value, $.001 per share; Authorized: Other assets: 35,000,000 shares; Issued: Certificate of deposit 1,700,000 1,530,000 13,269,316 in 1999 and 13,054,934 Other assets 226,138 196,202 in 1998 13,269 13,055 ------------ ------------ 1,926,138 1,726,202 Additional paid-in capital 130,422,462 128,634,691 ------------ ------------ Deficit accumulated during the Total assets $ 78,672,838 $ 85,129,354 development stage (56,281,540) (48,679,075) ============ ============ Accumulated other comprehensive income (loss) (145,528) 50,674 ------------ ------------ Total stockholders' equity 74,008,663 80,019,345 ------------ ------------ Total liabilities and stockholders' equity $ 78,672,838 $ 85,129,354 ============ ============ The accompanying notes are an integral part of the financial statements 2 ANESTA CORP. (A Development Stage Company) STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS (Unaudited) -------- Three months ended Nine months ended Period from inception ------------------------------ ---------------------------- September 30 September 30 September 30, December 31, (August 1, 1985 to 1999 1998 1999 1998 September 30, 1999 -------------- -------------- -------------- ----------- --------------------- Revenues: Product sales $ 524,847 $ 76,797 $ 1,652,910 $ 151,881 $ 2,220,624 Royalty revenue 16,849 2,276 46,658 4,506 163,442 Revenues from contract research/license agreements 1,550,000 2,171,148 175,000 12,625,783 ----------- ----------- ----------- ----------- ------------ Total revenues 2,091,696 79,073 3,870,716 331,387 15,009,849 ----------- ----------- ----------- ----------- ------------ Operating costs and expenses: Cost of goods sold 113,671 21,977 484,678 42,686 658,253 Royalties 19,079 2,372 50,987 4,691 64,314 Research and development 2,301,775 2,175,320 7,014,560 5,768,521 46,376,949 Depreciation and amortization 73,987 70,737 221,504 224,272 1,614,895 Marketing, general and administrative 2,623,919 2,060,412 6,628,243 5,367,371 30,939,587 ----------- ----------- ----------- ----------- ------------ Total costs and expenses 5,132,431 4,330,818 14,399,972 11,407,541 79,653,998 ----------- ----------- ----------- ----------- ------------ Loss from operations (3,040,735) (4,251,745) (10,529,256) (11,076,154) (64,644,149) Non operating income (expense): Interest income 928,483 231,297 3,035,398 978,019 10,706,091 Interest expense (31,597) (35,342) (89,872) (105,642) (725,179) Other (104) 459 (3,733) (46,916) ----------- ----------- ----------- ----------- ------------ Loss before provision for income taxes, extraordinary item and cumulative effect of change in accounting (2,143,953) (4,055,790) (7,583,271) (10,207,510) (54,710,153) Provision for income taxes (4,394) (485) (19,194) (4,626) (60,751) ----------- ----------- ----------- ----------- ------------ Loss before extraordinary item and cumulative effect of change in accounting (2,148,347) (4,056,275) (7,602,465) (10,212,136) (54,770,904) Extraordinary item - reduction of income taxes arising from carryforward of prior years' operating losses 22,296 Cumulative effect of change in accounting (1,041,047) ----------- ----------- ----------- ----------- ------------ Net loss (2,148,347) (4,056,275) (7,602,465) (10,212,136) (55,789,655) Other comprehensive income (loss): Foreign currency translation adjustment 8,933 17,650 (9,069) 19,460 6,535 Unrealized gain (loss) on marketable debt securities, available-for-sale 16,375 47,221 (187,133) 36,711 (152,063) ----------- ----------- ----------- ----------- ------------ Total other comprehensive income (loss) 25,308 64,871 (196,202) 56,171 (145,528) ----------- ----------- ----------- ----------- ------------ Comprehensive loss $(2,123,039) $(3,991,404) $(7,798,667) $10,155,965) $(55,935,183) =========== =========== =========== =========== ============ Basic and diluted loss per common share-- Net loss per common share $ (0.16) $ (0.42) $ (0.58) $ (1.06) =========== =========== =========== =========== Weighted average shares outstanding 13,261,574 9,631,302 13,201,154 9,595,081 =========== =========== =========== =========== The accompanying notes are an integral part of the financial statements 3 ANESTA CORP. (A Development Stage Company) STATEMENTS OF CASH FLOWS (Unaudited) ------------- Nine months ended ---------------------------- Period from inception September 30, September 30, (August 1, 1985) to 1999 1998 September 30, 1999 ------------- ------------- --------------------- Cash flows from operating activities: Net loss $ (7,602,465) $ (10,212,136) $ (55,789,655) Adjustments to reconcile net loss to net cash used in operating activities: Cumulative effect of change in accounting 1,041,047 Depreciation and amortization 221,504 224,272 1,614,895 Debt conversion expense 101,330 Interest converted to equity 94,104 Compensatory stock options and stock 3,539 (Gain) loss on retirement of assets (332) 3,778 78,114 Increase (decrease) due to changes in: Accounts receivable (2,821,999) (129,274) (3,098,475) Prepaid expenses and other current assets (1,351,126) 104,792 (1,545,928) Other assets (29,936) (6,746) (228,716) Accounts payable (1,344,703) (78,682) (182,601) Accrued liabilities (452,483) 204,476 718,459 Unearned revenues 1,101,352 52,500 1,811,898 ------------- ------------- --------------------- Net cash used in operating activities (12,280,188) (9,837,020) (55,381,989) ------------- ------------- --------------------- Cash flows from investing activities: Capital expenditures (547,948) (93,126) (3,871,513) Proceeds from sales of assets 488 50 12,384 Costs associated with license agreements (1,109,533) Advances to employees (1,650) Purchase of treasury bills (1,174,419) Proceeds from maturity of treasury bills 1,174,419 Purchase of marketable debt securities, available-for-sale (53,181,535) (14,404,574) (134,489,201) Maturities of marketable debt securities, available-for-sale 39,061,697 18,775,551 95,724,989 Purchase of certificate of deposit (510,000) (2,346,000) Proceeds from maturity of certificate of deposit 255,000 255,000 306,000 ------------- ------------- --------------------- Net cash provided by (used in) investing activities (14,922,298) 4,532,901 (45,774,524) ------------- ------------- --------------------- Cash flows from financing activities: Proceeds from issuance of notes payable 500,000 3,587,700 Principal payments on notes payable (250,000) (250,000) (587,500) Principal payments on obligations under capital leases (194,488) Net proceeds from issuance of common stock 1,787,985 496,192 128,730,584 Collections on notes receivable from issuance of common stock 65,000 Proceeds from issuance of preferred stock 756,222 Dividends paid on preferred stock (491,884) ------------- ------------- --------------------- Net cash provided by financing activities 2,037,985 246,192 131,865,634 ------------- ------------- --------------------- Effect of exchange rate changes on cash (9,069) 19,460 6,535 ------------- ------------- --------------------- Net increase (decrease) in cash and cash equivalents (25,173,570) (5,038,467) 30,715,656 Cash and cash equivalents at beginning of period 55,889,226 9,760,765 ------------- ------------- --------------------- Cash and cash equivalents at end of period $ 30,715,656 $ 4,722,298 $ 30,715,656 ============= ============= ===================== - Continued - The accompanying notes are an integral part of the financial statements 4 ANESTA CORP. (A Development Stage Company) STATEMENTS OF CASH FLOWS, Continued (Unaudited) -------- Nine months ended --------------------------- Period from inception September 30, September 30, (August 1, 1985) to 1999 1998 September 30, 1999 ------------ ------------ -------------------------- Supplemental schedule of noncash activities: The Company issued stock and stock options for: Purchase of additional license agreement $ 5,400 Notes receivable 71,000 The Company purchased leasehold improvements using accounts payable 251,507 The Company entered into various capital lease arrangements 204,610 The Company received stock as payment of a note receivable 4,226 The accompanying notes are an integral part of the financial statements 5 ANESTA CORP. (A Development Stage Company) NOTES TO FINANCIAL STATEMENTS (Unaudited) ------------- 1. Significant Accounting Policies: ------------------------------- In the opinion of management, the accompanying financial statements contain all adjustments (consisting only of normal recurring items) necessary to present fairly the financial position of Anesta Corp. (a development stage company) (the Company) as of September 30, 1999, the results of its operations for the three and nine months ended September 30, 1999 and 1998 and for the period from inception (August 1, 1985) to September 30, 1999, and its cash flows for the nine months ended September 30, 1999 and 1998 and for the period from inception (August 1, 1985) to September 30, 1999. The results of operations for the periods presented are not necessarily indicative of the results to be expected for the full year period. Certain information and footnote disclosures normally included in financial statements prepared in accordance with generally accepted accounting principles have been condensed or omitted. It is suggested that these financial statements be read in conjunction with the Company's Annual Report on Form 10-K for the period ended December 31, 1998 and the Company's quarterly reports on Form 10-Q for the quarters ended March 31, 1999 and June 30, 1999. Net Loss Per Share ------------------ Basic and diluted earnings per share are computed in accordance with Statement of Financial Accounting Standards (SFAS) No. 128, Earnings per ------------ Share (EPS). Basic EPS excludes dilution and is computed by dividing ----- income available to common stockholders by the weighted-average number of common shares outstanding for the period. Diluted EPS reflects the potential dilution from securities or contracts to issue common stock. Common equivalent shares are excluded from the computation of diluted EPS when their effect is antidilutive. As of September 30, 1999, options to purchase 1,696,120 shares of common stock at prices between $5.25 and $25.1875 per share were outstanding. As of September 30, 1998, options to purchase 1,640,610 shares of common stock at prices between $5.00 and $19.25 were outstanding. None of these options were included in the computation of diluted loss per share because the effect would have been antidilutive. Capital Stock ------------- On June 29, 1999, stockholders approved an Amendment to the Company's Certificate of Incorporation increasing the Company's authorized shares from 15,000,000 to 35,000,000. 2. Cash, Cash Equivalents and Marketable Debt Securities: ----------------------------------------------------- At September 30, 1999, the Company maintained a majority of its cash, cash equivalents and marketable debt securities in two banks in San Francisco, California. 3. Income Taxes: ------------ The provision for income taxes for the three and nine months ended September 30, 1999 and 1998 is related solely to state income taxes. 6 ANESTA CORP. (A Development Stage Company) NOTES TO FINANCIAL STATEMENTS, Continued (Unaudited) -------------- 4. Revolving/Term Promissory Note Agreements: ----------------------------------------- On January 11, 1995, the Company entered into a revolving/term promissory note in the amount of $1.5 million. On May 15, 1995, the term of the revolving promissory note ended and the Company entered into a 10 year term note in the amount of $1.5 million. On March 20, 1997, the Company entered into an 8 year term note for an additional $800,000, for a total of $2.3 million. Additionally, on July 15, 1999, the Company entered into an 6 year term note for an additional $500,000, for a total of $2.8 million. The agreements provide for a constant interest rate of "160 basis points" above the financial institution's certificate of deposit rate (5.40% at September 30, 1999). As of September 30, 1999, four payments totaling $800,000 had been made leaving a balance of $2,000,000. Annual payments in the amount of $333,333 will be made on approximately July 15 for the next 6 years beginning on July 15, 2000. As of September 30, 1999, borrowings under the agreement are collateralized by a certificate of deposit in the amount of $2,040,000, which is maintained in a bank in Salt Lake City, Utah. 5. Collaborative Relationships: --------------------------- Effective August 31, 1995, the Company entered into an amendment to a prior agreement between Abbott International (A.I.) and the Company to provide the Company the right to terminate or cause to become nonexclusive A.I.'s license rights to OT-fentanyl products in one or more countries in the world except the U.S. The amendment also eliminated $100,000 of the $450,000 unearned advance royalty obligation, which amount was recognized as royalty revenue during the year ended December 31, 1995. In January 1998, the Company exercised its right to terminate A.I.'s license rights to OT-fentanyl products in all countries in the A.I. territory. As the Company receives payments related to international partnering for OT-fentanyl products, the Company is obligated to make certain payments to A.I. until the remaining $350,000 has been fully repaid, at which time such payments to A.I. will cease. As of September 30, 1999, the Company had made payments of $166,250, leaving a balance of $183,750 owed to A.I. which was paid subsequent to quarter end. On January 28, 1998, the Company announced the signing of an exclusive agreement with Grupo Ferrer for the marketing, sales and distribution of Anesta's OT-fentanyl product line, including Actiq, in Spain and Portugal. Under terms of the agreement, Grupo Ferrer made a payment to the Company in 1998, a portion of which will be recognized as revenue in future years over the term of the agreement. The OT-fentanyl product line will be manufactured for Grupo Ferrer by Anesta, however, the Company does not believe commercial manufacturing will begin before December 31, 1999. Grupo Ferrer is a private Spanish pharmaceutical company. On June 4, 1998, the Company announced the signing of an exclusive agreement with Laboratoire L. Lafon (Lafon) for the marketing, sales and distribution of Anesta's OT-fentanyl product line, including Actiq, in France. Under terms of the agreement, Lafon made payments to the Company in 1998, a portion of which will be recognized as revenue in future years over the term of the agreement. The OT-fentanyl product line will be manufactured for Lafon by Anesta, however, the Company does not believe commercial manufacturing will begin before December 31, 1999. Lafon is a private French pharmaceutical company. 7 ANESTA CORP. (A Development Stage Company) NOTES TO FINANCIAL STATEMENTS, Continued (Unaudited) -------------- 5. Collaborative Relationships, Continued --------------------------- On February 23, 1999, the Company announced the signing of an option agreement with Novartis involving the Company's proprietary Oral Transmucosal System (OTS(TM)) for drug delivery. Under terms of the agreement, Novartis made a payment to the Company in 1999, which will be recognized as revenue over the term of the agreement. Novartis and the Company will assess the worldwide commercial opportunity of potential products which combine the OTS with undisclosed compounds, with the goal of entering into an exclusive licensing agreement. On May 6, 1999, the Company announced the signing of an exclusive agreement with Swedish Orphan AB for the marketing, sales and distribution of Anesta's OT-fentanyl product line, including Actiq, for Scandinavia (Denmark, Finland, Iceland, Norway, and Sweden). Under terms of the agreement, Swedish Orphan made a payment to the Company which was recognized as revenue. The OT-fentanyl product line will be manufactured for Swedish Orphan by Anesta, however, the Company does not believe commercial manufacturing will begin before December 31, 1999. On September 30, 1999, the Company signed an exclusive agreement with Elan Pharma International (a unit of Elan Corporation, plc) for the marketing, sales and distribution of Anesta's OT-fentanyl product line, including Actiq, for Austria, Belgium, Germany, Greece, Ireland, Italy, Luxembourg, Netherlands, Philippines, Switzerland, Taiwan, and the United Kingdom. Under terms of the agreement, Elan made a payment to the Company, a portion of which will be recognized as revenue in future years over the term of the agreement. The OT-fentanyl product line will be manufactured for Elan by Anesta, however, the Company does not believe commercial manufacturing will begin before December 31, 1999. 8 ANESTA CORP. (A Development Stage Company) 6. Stockholders' Equity: The table below presents the activity in stockholders' equity from January 1, 1999 to September 30, 1999: Deficit Common Stock Accumulated Accumulated --------------------------------------------- Additional During the Other Paid-in Development Comprehensive Shares Amount Capital Stage Income (loss) Total ------------- ----------- ---------------- -------------- -------------- ---------- Balance at January 1, 1999 $ 13,054,934 $ 13,055 $ 128,634,691 $ (48,679,075) $ 50,674 $80,019,345 Exercise of stock options in Jan. 1999 for cash (at $8.00 to $16.50 per share) 41,991 42 511,610 511,652 Exercise of stock options in Feb. 1999 for cash (at $5.25 to $14.125 per share) 11,629 12 80,940 80,952 Exercise of stock options in Mar. 1999 for cash and stock (at $5.25 to $14.125 per share) 51,479 51 293,430 293,481 Exercise of stock options in Apr. 1999 for cash (at $6.75 to $14.125 per share) 38,097 38 308,290 308,328 Exercise of stock options in May 1999 for cash and stock (at $5.25 to $14.125 per share) 15,004 15 177,897 177,912 Exercise of stock options in June 1999 for cash and stock (at $5.25 to $14.125 per share) 35,757 36 277,364 277,400 Exercise of stock options in July 1999 for cash (at $13.00 per share) 3,812 4 49,552 49,556 Exercise of stock options in August 1999 for cash (at $7.88 per share) 10,000 10 78,790 78,800 Exercise of stock options in September 1999 for cash and stock (at $5.375 to $5.75 per share) 6,613 6 9,898 9,904 Net loss (7,602,465) (7,602,465) Other comprehensive loss (196,202) (196,202) ----------- --------- -------------- -------------- ----------- ------------ Balance at September 30, 1999 13,269,316 $ 13,269 $ 130,422,462 $ (56,281,540) $ (145,528) $ 74,008,663 =========== ========= ============== ============== =========== ============ 9 Item 2. MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS The following Management's Discussion and Analysis of Financial Condition and Results of Operations contains forward-looking statements which involve risks and uncertainties. The Company's actual results could differ materially from those anticipated in these forward-looking statements as a result of certain factors discussed in this section. Additional risks and uncertainties are described in the Company's most recently filed Annual Report on Form 10-K for the fiscal year ended December 31, 1998. Results of Operations Revenues. Total revenues increased by $2,012,600 or 2,544% for the three months ended September 30, 1999 as compared to the corresponding period in 1998 and by $3,539,300 or 1,068% for the nine months ended September 30, 1999 as compared to the corresponding period in 1998. The increase is primarily a result of the U.S. launch of Actiq, licensing revenue from a new option agreement with Novartis involving the Company's proprietary OTS for drug delivery, and licensing revenue from new agreements with Swedish Orphan AB and Elan Pharma International involving the Company's OT-fentanyl product line (See Notes 5 and 6 to Financial Statements). On November 4, 1998, the FDA approved the new drug application for Actiq. Actiq is indicated only for the management of breakthrough cancer pain in patients with malignancies who are already receiving and who are tolerant to opioid therapy. Actiq was launched by Abbott Laboratories (Abbott) on March 31, 1999. Under the Company's agreements with Abbott, Abbott manufactures Anesta's OT- fentanyl product line (Fentanyl Oralet and Actiq) and sells these products to the Company at a price which reflects Abbott's cost of manufacturing. The Company then sells the products to Abbott at a price related to Abbott's selling price which results in a gross profit to the Company ranging from approximately 40-70%. In addition, the Company is entitled to receive a royalty on OT-fentanyl product sales by Abbott. Operating Expenses. Research and development expenses increased by $126,500 or 5.8% for the three months ended September 30, 1999 as compared to the corresponding period in 1998, and by $1,246,000 or 21.6% for the nine months ended September 30, 1999 as compared to the corresponding period in 1998. The increase is due to higher expenditures in 1999 related to additional research and development programs, increased number of personnel, manufacturing activities and continuing clinical support for Actiq. The Company expects that its research and development expenses will increase in the future as a result of increased expenses related to the hiring of additional personnel, preclinical studies, clinical trials, product development, manufacturing process development and clinical manufacturing activities. Depreciation and amortization expense increased by $3,300 or 4.7% for the three months ended September 30, 1999 as compared to the corresponding period in 1998, and decreased by $2,800 or 1.2% for the nine months ended September 30, 1999 as compared to the corresponding period in 1998. The increase for the three months ended September 30, 1999 as compared to the corresponding period in 1998, is due to the completion of additional office space. The decrease for the nine months ended September 30, 1999 as compared to the corresponding period in 1998, is due to a larger number of fully depreciated assets. Marketing, general and administrative expenses increased by $563,500 or 27.3% for the three months ended September 30, 1999 as compared to the corresponding period in 1998 and by $1,260,800 or 23.5% for the nine months ended September 30, 1999 as compared to the corresponding period in 1998. The increase in marketing, general and administrative expenses is due primarily to higher expenditures for European operations including clinical studies, Actiq market launch activities, personnel, corporate 10 development activities and marketing research. The Company expects that its marketing, general and administrative expenses will increase in the future as a result of the increased support required for European operations, Actiq marketing activities, corporate development activities and marketing research. Non Operating Income (Expense). Interest income increased by $697,200 or 301% for the three months ended September 30, 1999 as compared to the corresponding period in 1998 and by $2,057,400 or 210% for the nine months ended September 30, 1999 as compared to the corresponding period in 1998. The increase is primarily due to invested net proceeds of $64,478,400 from the Company's public offering in December 1998. Interest expense decreased by $3,700 or 10.5% for the three months ended September 30, 1999 as compared to the corresponding period in 1998 and by $15,700 or 14.9% for the nine months ended September 30, 1999 as compared to the corresponding period in 1998. The decrease is primarily due to lower borrowings under the term note as a result of the related payments thereon (See Note 4 to Financial Statements). Income Taxes. The provision for income taxes in 1999 and 1998 relates solely to state income taxes. The Company recognized no tax benefit from its losses in those years. Net Loss. As a result of the increase in total revenues, the increase in research and development activities, the increase in marketing, general and administrative expenses, the increase in interest income and other factors discussed above, the net loss for the three months ended September 30, 1999 was $2,123,039 or $0.16 per share as compared to $3,991,404 or $0.42 per share for the same period in 1998. The net loss for the nine months ended September 30, 1999 was $7,798,666 or $0.58 per share as compared to $10,155,965 or $1.06 per share for the same period in 1998. Liquidity and Capital Resources As of September 30, 1999, the Company had cash and cash equivalents totaling $30,715,600, $2,040,000 in a certificate of deposit used as collateral for a revolving/term loan (See Note 4 to Financial Statements) and $38,593,800 in marketable debt securities which are available for sale. Thus cash, cash equivalents, a certificate of deposit and marketable debt securities totaled $71,349,400 as of September 30, 1999. Cash in excess of immediate requirements is invested according to the Company's investment policy, which provides guidelines with regard to liquidity and return, and, wherever possible, seeks to minimize the potential effects of concentration of credit risk. The Company used cash in operating activities of $12,280,200 for the nine months ended September 30, 1999 compared to $9,837,000 for the corresponding period in 1998. The increase in cash used in the period is a direct result of higher working capital requirements in 1999. During the nine months ended September 30, 1999, the Company made capital expenditures of approximately $548,000 as compared to capital expenditures of $93,100 during the corresponding period in 1998. The increase is primarily due to the completion of additional office space and quality control laboratory. During the nine months ended September 30, 1999, the Company made net purchases of marketable debt securities of $14,119,800. This compares to a net decrease in marketable debt securities of $4,371,000 during the corresponding period in 1998. 11 During the nine months ended September 30, 1999, the Company realized cash proceeds of $1,788,000 relating to the exercise of stock options. During the nine months ended September 30, 1998, the Company realized cash proceeds of $496,200 relating to the exercise of stock options. The Company's future capital requirements could be substantial and will depend on, and could increase as a result of, many factors, including progress of the Company's research and development programs; the results and costs of preclinical and clinical testing of the Company's products, if developed; the time and costs involved in obtaining regulatory approvals; the costs involved in filing patents; the time and costs involved in developing and maintaining collaborative research relationships; the costs associated with potential commercialization of its products; and administrative and legal costs. The Company believes that existing capital resources will be sufficient to meet the Company's capital needs through at least the end of 2000. The Company believes that it is prudent to monitor existing cash balances in order to fund the activities which the Company believes are necessary to continue its growth. Therefore, the Company periodically evaluates market conditions and various financing alternatives for obtaining funds to augment existing cash balances. Year 2000 Compliance. Many currently installed computer systems are unable to distinguish between the year 1900 and the year 2000. This is commonly known as the Year 2000 (Y2K) issue. As a result, business entities are at risk for possible miscalculations or systems failures causing disruptions in their business operations. The Company utilizes management information systems and software technology that may be affected by Y2K issues throughout its business. The Company considers its finance and accounting, clinical database, and laboratory data acquisition and analysis software mission critical. The Company's information systems group is finishing the remediation and testing phases to ensure those systems, along with additional internal and external systems, continue to meet its requirements. To date, one software system was identified which is not Y2K compliant and has been upgraded. The cost of this upgrade was less than $10,000. The Company continually upgrades its software in the ordinary course of business, thereby helping to meet its Y2K requirements. The Company believes that the costs associated with purchasing or upgrading other specific software systems to meet the requirements of Y2K will be minimal. The Company's information systems group continues to review non-information technology systems to determine the extent of any changes that may be necessary and believes that there will be minimal changes needed. As a result of the Company's growth, its phone system has been replaced in order to provide adequate access for the Company's requirements as well as being Y2K compliant. The Company believes all remaining Y2K testing, internal reviews and updates can be completed by November 30, 1999. The Company continues to contact key suppliers and customers regarding their Y2K compliance to determine any impact on operations. In general, the suppliers and customers have developed or are in the process of developing plans to address Y2K issues. The Company will continue to actively monitor and evaluate the progress of its suppliers and customers on this critical matter. Because of the availability of alternative suppliers and the diversity of the Company's customer base, the Company believes that any failure of any management information systems or software technology at any supplier or customer which has not responded to the Company's inquiries regarding Y2K compliance will not have a material adverse effect on the Company. Based on the progress the Company has made in addressing its Y2K issues and the Company's plan and timeline to complete its compliance program, the Company does not foresee significant risks associated with its Y2K compliance at this time. As of September 30, 1999, the Company has spent less than $10,000 on assessment, remediation and testing associated with the Y2K issue. However, the Company will 12 continue to discuss Y2K compliance issues with its key suppliers and customers in an effort to minimize any potential Y2K compliance impact. Although unlikely, the Company might be adversely affected by Y2K disruptions at its customers and suppliers. To address this possibility, the Company plans to accumulate sufficient supplies to conduct normal business operations for a reasonable period of time. If the Company's preparations are insufficient, the Company's business and financial condition would be materially and adversely affected. Other Matters. The Company has reviewed recently issued, but not yet adopted, accounting standards in order to determine their effects, if any, on the results of operations or financial position of the Company. Based on that review, the Company believes that none of these pronouncements will have a significant effect on current or future earnings or operations. 13 Part II. Other Information Item 6. Exhibits and Reports on Form 8-K. a) Exhibits. (27) Financial Data Schedule b) Reports on Form 8-K. None. 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. Date: November 12, 1999 ANESTA CORP. By: /s/ Thomas B. King ------------------------------- Thomas B. King, President and Chief Executive Officer (Authorized Signatory) By: /s/ Roger P. Evans ------------------------------- Roger P. Evans, Vice President- Finance and Administration (Principal Accounting Officer) 15