SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q/A QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(D) OF THE SECURITIES ACT OF 1934 For Quarter Ended September 30, 1997 Commission File Number 0-23252 IGEN INTERNATIONAL, INC. (Exact name of registrant as specified in is charter) DELAWARE 94-2852543 - ---------------------------------------- ------------------- (State or other jurisdiction of (IRS Employer incorporation or organization) Identification No.) 16020 INDUSTRIAL DRIVE, GAITHERSBURG, MD 20877 - ---------------------------------------- ------------------- (Address of principal executive offices) (Zip Code) (301) 984-8000 ---------------------------------------------------- (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 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. CLASS OUTSTANDING AT OCTOBER 31, 1997 ----- ------------------------------- Common Stock, $0.001 par value 15,148,752 1 IGEN INTERNATIONAL, INC. FORM 10-Q FOR THE QUARTER ENDED SEPTEMBER 30, 1997 INDEX PAGE --------- PART I FINANCIAL INFORMATION Item 1: FINANCIAL STATEMENTS Balance Sheets--September 30, 1997 and March 31, 1997...................... 3 Statements of Operations--For the Three and Six Months Ended September 30, 1997 and 1996................................................ 4 Statements of Cash Flows--For the Six Months Ended September 30, 1997 and 1996................................................ 5 Notes to Financial Statements.............................................. 6 Item 2: MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS........................................ 8 PART II OTHER INFORMATION Item 1: LEGAL PROCEEDINGS.......................................................... 11 Item 6: EXHIBITS AND REPORTS ON FORM 8-K........................................... 12 SIGNATURES............................................................................. 13 2 IGEN INTERNATIONAL, INC. BALANCE SHEETS (IN THOUSANDS) SEPTEMBER 30, MARCH 31, 1997 1997 ------------- ----------- (unaudited) ASSETS CURRENT ASSETS: Cash and cash equivalents.............................................................. $ 493 $ 790 Short term investments................................................................. 6,584 8,254 Accounts receivable.................................................................... 1,254 1,783 Notes Receivable....................................................................... 141 417 Inventory.............................................................................. 1,711 2,075 Prepaid expenses and other current assets.............................................. 814 866 ------------- ----------- Total current assets................................................................. 10,997 14,185 ------------- ----------- EQUIPMENT, FURNITURE, AND IMPROVEMENTS................................................. 7,156 6,950 Accumulated depreciation and amortization.............................................. (4,286) (3,781) ------------- ----------- Equipment, furniture, and improvements, net.......................................... 2,870 3,169 ------------- ----------- OTHER ASSETS........................................................................... 425 440 ------------- ----------- TOTAL.................................................................................. $ 14,292 $ 17,794 ------------- ----------- ------------- ----------- LIABILITIES AND STOCKHOLDERS' EQUITY CURRENT LIABILITIES: Accounts payable and accrued expenses.................................................. $ 5,058 $ 4,266 Deferred revenue....................................................................... 6,613 5,393 Obligations under capital leases....................................................... 76 95 ------------- ----------- Total current liabilities............................................................ 11,747 9,754 ------------- ----------- OBLIGATIONS UNDER CAPITAL LEASES- NONCURRENT........................................................................... 82 158 STOCKHOLDERS' EQUITY: Common stock: $.001 par value, 50,000,000 shares authorized: 15,147,510 and 14,987,416 issued and outstanding:.................................... 15 15 Additional paid-in capital............................................................. 65,391 64,876 Accumulated deficit.................................................................... (62,657) (56,700) Notes receivable from sale of common stock............................................. (286) (309) ------------- ----------- Total stockholders' equity........................................................... 2,463 7,882 ------------- ----------- TOTAL.................................................................................. $ 14,292 $ 17,794 ------------- ----------- ------------- ----------- See notes to financial statements. 3 IGEN International, Inc. STATEMENTS OF OPERATIONS (IN THOUSANDS, EXCEPT PER SHARE DATA) THREE MONTHS ENDED SIX MONTHS ENDED SEPTEMBER 30, SEPTEMBER 30, -------------------- -------------------- 1997 1996 1997 1996 --------- --------- --------- --------- (UNAUDITED) (UNAUDITED) REVENUES: Product sales............................................................ $ 1,005 $ 1,450 $ 2,769 $ 3,333 License fees and contract revenue........................................ 2,150 2,875 2,545 5,952 Royalty income........................................................... 1,127 25 1,591 46 --------- --------- --------- --------- Total.................................................................. 4,282 4,350 6,905 9,331 --------- --------- --------- --------- OPERATING COSTS AND EXPENSES: Product costs............................................................ 301 613 944 1,237 Research and development................................................. 2,703 3,079 5,604 6,634 Marketing, general and administrative.................................... 3,530 2,543 6,241 5,103 --------- --------- --------- --------- Total.................................................................. 6,534 6,235 12,789 12,974 --------- --------- --------- --------- LOSS FROM OPERATIONS....................................................... (2,252) (1,885) (5,884) (3,643) INTEREST (EXPENSE) INCOME--net............................................. (34) 175 (73) 409 --------- --------- --------- --------- NET LOSS................................................................... $ (2,286) $ (1,710) $ (5,957) $ (3,234) --------- --------- --------- --------- --------- --------- --------- --------- NET LOSS PER SHARE......................................................... $ (0.15) $ (0.11) $ (0.40) $ (0.22) --------- --------- --------- --------- --------- --------- --------- --------- SHARES USED IN COMPUTING NET LOSS PERSHARE................................. 15,107 14,958 15,053 14,941 --------- --------- --------- --------- --------- --------- --------- --------- See notes to financial statements. 4 IGEN International, Inc. STATEMENTS OF CASH FLOWS (IN THOUSANDS) SIX MONTHS ENDED SEPTEMBER 30, -------------------- 1997 1996 --------- --------- (UNAUDITED) CASH FLOWS FROM OPERATING ACTIVITIES: Net loss................................................................................... $ (5,957) $ (3,234) Adjustments to reconcile net income to net cash provided by (used in) operating activities: Interest on notes receivable from sale of common stock................................... -- (3) Amortization of deferred compensation.................................................... -- 55 Depreciation and amortization............................................................ 505 653 Deferred revenue......................................................................... 1,220 (5,120) Add (deduct) items not affecting cash: Decrease in accounts receivable........................................................ 529 21 Decrease in notes receivable........................................................... 276 -- Decrease (increase) in inventory....................................................... 364 (160) (Increase) decrease in prepaid expenses and other assets............................... 67 533 Increase (decrease) accounts payable and accrued expenses............................. 792 (156) --------- --------- Net cash used in operating expenses................................................. (2,204) (7,411) --------- --------- CASH FLOWS FROM INVESTING ACTIVITIES: Expenditures for equipment, furniture and improvements..................................... (206) (223) Sale of short-term investments............................................................. 1,670 5,619 --------- --------- Net cash provided by investing activities........................................... 1,464 5,396 --------- --------- CASH FLOWS FROM FINANCING ACTIVITIES: Repayment of notes receivable form sale of common stock, net............................... 23 21 Issuance of common stock -- net............................................................ 515 145 Principal payments under capital lease obligations......................................... (95) (238) --------- --------- Net cash provided by (used in) financing activities................................. 443 (72) --------- --------- NET DECREASE IN CASH AND CASH EQUIVALENTS.................................................... (297) (2,087) CASH AND CASH EQUIVALENTS, BEGINNING OF PERIOD............................................... 790 4,001 --------- --------- CASH AND CASH EQUIVALENTS, END OF PERIOD..................................................... $ 493 $ 1,914 --------- --------- --------- --------- See notes to financial statements. 5 IGEN International, Inc. Form 10-Q/A For the Quarter Ended September 30, 1997 1. BASIS OF PRESENTATION AND ACCOUNTING POLICIES The financial statements of IGEN International, Inc. (the "Company") reflect, in the opinion of management, all adjustments, consisting only of normal and recurring adjustments, necessary to present fairly the Company's financial position at September 30, 1997 and the Company's results of operations for the three and six month periods ended September 30, 1997 and 1996 respectively. Interim period results are unaudited and are not necessarily indicative of results of operations or cash flows for a full year period. The balance sheet at March 31, 1997 was derived from audited financial statements at such date. Pursuant to accounting requirements of the Securities and Exchange Commission applicable to quarterly reports on Form 10-Q, the accompanying financial statements and these notes do not include all disclosures required by generally accepted accounting principles for complete financial statements. Accordingly, these statements should be read in conjunction with the Company's most recent annual financial statements included in the Company's Annual Report for the fiscal year ended March 31, 1997. 2. SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES Cash Equivalents and Short-Term Investments--Cash equivalents include cash in banks, money market funds, securities of the U.S. Treasury and certificates of deposit with original maturities of three months or less. Concentration of Credit Risks--The Company has invested its excess cash generally in securities of the U.S. Treasury, money market funds, certificates of deposit and corporate bonds. The Company invests its excess cash in accordance with a policy objective that seeks to ensure both liquidity and safety of principal. The policy limits investments to certain types of instruments issued by institutions with strong investment grade credit ratings and places restrictions on their terms and concentrations by type and issuer. Inventory is recorded at the lower of cost or market using the first-in, first-out method and consists of the following (in thousands): SEPTEMBER 30, 1997 MARCH 31, 1997 ------------------- --------------- Finished goods......................... $ 906 $ 1,095 Work in process........................ 187 150 Raw materials.......................... 618 830 ------ ------ Total.................................. $ 1,711 $ 2,075 ------ ------ ------ ------ 6 IGEN International, Inc. Form 10-Q/A For the Quarter Ended September 30, 1997 Notes to Financial Statements (continued) Equipment, Furniture, and Improvements are carried at cost. Depreciation is computed over the estimated useful lives of the assets, generally five years, using accelerated methods. Revenue Recognition--Nonrefundable license fees, option fees, royalty income, and milestone payments in connection with research and development contracts or commercialization agreements with corporate partners are recognized when they are earned in accordance with the applicable performance requirements and contractual terms. Amounts received in advance of performance under contracts or commercialization agreements are recorded as deferred revenue until earned. Product sales revenue is recorded as products are shipped. Loss Per Share has been computed based on the weighted average number of common shares and common equivalent shares outstanding. Statement of Financial Accounting Standards (SFAS) No. 128 "Earnings Per Share," was recently issued by the Financial Accounting Standards Board. SFAS No. 128 is effective for periods ending after December 15, 1997 and early adoption is not permitted. SFAS No. 128 requires the Company to compute and present a basic and fully diluted earnings per share. Had the company computed earnings per share in accordance with SFAS No. 128, the resulting Loss Per Share would not be different than that which has been reported for the periods ended September 30, 1997 and 1996. 3. BOEHRINGER MANNHEIM GMBH LITIGATION In 1992, the Company entered into a License and Technology Development Agreement with Boehringer Mannheim GmbH ("BMG"), pursuant to which BMG launched its Elecsys product line, which is based on the Company's ORIGEN technology. For the three and six-month periods ended September 30, 1997, royalties reported by BMG and recorded by the Company under the Agreement totaled $1.0 million and $1.4 million, respectively. These amounts were charged against deferred revenues represented by a $6 million advance from BMG in January 1997, on which there is a $3.9 million balance at September 30, 1997. As more fully set forth in Part II --Item 1, the Company is involved in litigation with BMG arising out of the Agreement. One of the disputes at issue in the litigation relates to the computation of royalties to which the Company is entitled under the Agreement, which the Company believes have been understated by BMG. For the three and six months ended September 30, 1997 the Company calculates that royalties due from BMG which have not been recorded in the financial statements are $722,000 and $1.5 million, respectively. 4. RESTATEMENT Subsequent to the issuance of the September 30, 1997 financial statements, the Company restated royalty income and deferred revenue to defer recognition of amounts in dispute with Boehringer Mannheim. Due to the restatement, royalty income decreased by $722,000 and $1.5 milllion for the three and six months ended September 30, 1997. Restated Loss Per Share of $0.15 and $0.40 for the three and six months ended September 30, 1997 compares to Loss Per Share of $0.10 and $0.29 as previously reported. 7 IGEN International, Inc. Form 10-Q/A For the Quarter Ended September 30, 1997 ITEM 2. MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS OVERVIEW The Company devotes substantially all of its resources to the research and development of its proprietary technologies, primarily the ORIGEN technology for clinical diagnostic and life science research products. The Company's sources of revenue have consisted primarily of license or research payments pursuant to licensing or collaborative research agreements and from product sales. The Company has entered into collaborative arrangements with corporate collaborators that provide for the development and marketing of certain ORIGEN systems. These agreements provide fees and royalties payable to the Company in exchange for licenses to produce and sell the resulting products. In the near term, the Company may selectively pursue additional strategic alliances although, over time, it expects an increasing amount of its revenues to be derived from sales of its products and royalties from corporate collaborations. Certain statements in this Form 10-Q are "forward-looking statements" made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements involve a number of risks and uncertainties. Factors which may cause the Company's actual results in future periods to differ materially from forecast results include, but are not limited to: the risk factors set forth in the Company's annual report on Form 10-K for the fiscal year ended March 31, 1997, including, without limitation, reliance on collaborations and license patents and proprietary rights, uncertainty of health-care reform measures and third-party reimbursements, the ability to attract and retain qualified personnel, including scientists and consultants to perform research and development work; general economic and business conditions, both nationally and internationally; and the outcome of the pending litigation involving the Company. IGEN disclaims any intent or obligation to update these forward-looking statements. RESULTS OF OPERATIONS THE QUARTER AND SIX MONTHS IN REVIEW The Company reported a net loss of $2.3 million ($.15 per share) on revenue of $4.3 million for the second quarter ended September 30, 1997 compared to a net loss of $1.7 million ($.11 per share) on revenue of $4.4 million for the same period in the prior year. The net loss for the first six months of fiscal 1998 was $6 million ($.40 per share) on revenue of $6.9 million compared to $3.2 million ($.22 per share) on revenue of $9.3million in prior fiscal 1997. Revenues during the six months ending September 30, 1997 reflect a significant change in revenue mix compared to prior years, as the Company's license and contract revenue converted to royalty income based on product sales by corporate licensees. During this period, $4.4 million (63%) of revenue was generated from the sale of products, either directly by IGEN or from royalties on licensees' sales. In the prior year, IGEN revenue related to the sale of products totaled only $3.4 million (36% of total revenue). Accordingly, revenue from license fees and for contract research decreased to $2.5 million for the six months ended September 30, 1997 from $5.9 million in the prior year. 8 IGEN International, Inc. Form 10-Q/A For the Quarter Ended September 30, 1997 ITEM 2. MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS (continued) In 1992, the Company entered into a License and Technology Development Agreement with Boehringer Mannheim GmbH ("BMG"), pursuant to which BMG launched its Elecsys product line, which is based on the Company's ORIGEN technology. For the three and six-month periods ended September 30, 1997, royalties reported by BMG and recorded by the Company under the Agreement totaled $1 million and $1.4 million, respectively. These amounts were charged against deferred revenues represented by a $6 million advance from BMG in January 1997, on which there is a $3.9 million balance at September 30, 1997. As more fully set forth in Part II --Item 1, the Company is involved in litigation with BMG arising out of the Agreement. One of the disputes at issue in the litigation relates to the computation of royalties to which the Company is entitled under the Agreement, which the Company believes have been understated by BMG. For the three and six months ended September 30, 1997 the Company calculates that royalties due from BMG which have not been recorded in the financial statements are $722,000 and $1.5 million, respectively. Operating costs remained relatively constant totaling $6.5 million and $12.8 million in the current quarter and first six months of fiscal 1998 compared to $6.2 million and $13 million in the same periods last year. Due to expiring external collaborations, research and development expenditures decreased to $2.7 million and $5.6 million in the quarter and first six months of the current year, compared to amounts in the same prior year periods of $3.1 million and $6.6 million, respectively. Marketing and general and administrative costs increased to $3.5 million and $6.2 million during the current year periods from $2.5 million and $5.1 million in the same prior year periods due in part to professional and legal fees associated with the Company's litigation with Boehringer Mannheim. Income (loss) from operations over the next several years is likely to fluctuate substantially from quarter to quarter as a result of differences in the timing of revenues earned under license and product development agreements, and associated product development expenses. As of March 31, 1997, the Company had federal net operating loss and general business credit tax carry forwards of approximately $41.9 million and $2.4 million, respectively. The Company's ability to utilize its net operating loss and general business credit tax carry forwards may be subject to an annual limitation in future periods pursuant to the "change in ownership rules" under Section 382 of the Internal Revenue Service Code of 1986, as amended. 9 IGEN International, Inc. Form 10-Q/A For the Quarter Ended September 30, 1997 ITEM 2. MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS (continued) LIQUIDITY AND CAPITAL RESOURCES The Company has financed its operations through the sale of Preferred and Common Stock, aggregating approximately $65 million through September 30, 1997, collaborative research and licensing agreements, royalty payments, and sales of its ORIGEN line of products. As of September 30, 1997, the Company had $7.1 million in cash, cash equivalents and short-term investments. Working capital excluding current deferred revenue, which is classified as a current liability, was $5.9 million at September 30, 1997. Including current deferred revenue, working capital was a deficit of $750,000. Net cash used in operating activities was $2.2 million for the six months ended September 30, 1997, as compared to $7.4 million for the corresponding prior year period. This decrease was due primarily to a $4.75 million payment IGEN received during the current quarter from one of its corporate partners, Eisai Co., Ltd. This payment represents Eisai's final license fee payment of $2 million recorded in this period with the balance representing a non-refundable royalty advance on Eisai's future product sales of the Picolumi Immunodiagnostic System, which commenced distribution in Japan during the summer of 1997. The Company used $206,000 and $223,000 of net cash for investing activities, substantially related to the acquisition of laboratory equipment, furniture and leasehold improvements, during the six months ended September 30, 1997 and 1996, respectively. The Company expects to incur substantial additional research and development expenses, manufacturing costs and marketing and distribution expenses. It is the Company's intention to selectively seek additional collaborative or license agreements with suitable corporate collaborators although there can be no assurance the Company will be able to enter into such agreements or that amounts received under such agreements will reduce substantially the Company's funding requirements. Additional equity or debt financing may be required, and there can be no assurance that these funds may be available on favorable terms, if at all. The Company's future capital requirements depend on many factors, including continued scientific progress in its diagnostics programs, the magnitude of these programs, the time and costs involved in obtaining regulatory approvals, the costs involved in filing, prosecuting and enforcing patent claims, competing technological and market developments, changes in its existing license and other agreements, the ability of the Company to establish development arrangements, the cost of manufacturing scale-up and effective commercialization activities and arrangements. 10 IGEN International, Inc. Form 10-Q For the Quarter Ended September 30, 1997 PART II OTHER INFORMATION ITEM 1: LEGAL PROCEEDINGS On September 15, 1997, the Company filed a lawsuit in Maryland against Boehringer Mannheim GmbH ("BMG"), a German company to which the Company has licensed certain rights to develop and commercialize diagnostic products based on the Company's ORIGEN technology. That lawsuit is pending in the Southern Division of the United States District Court for the District of Maryland. The Company's dispute with BMG arises out of a 1992 License and Technology Development Agreement (the "Agreement"), pursuant to which BMG developed and launched its "Elecsys" line of diagnostic products, which is based on ORIGEN technology. The Company alleges that BMG has failed to perform certain material obligations under the Agreement, including development and commercialization of ORIGEN technology according to the contractual timetable; exploitation of the license to the extent contemplated by the parties; phase out of certain non-royalty-bearing product lines; exploitation of ORIGEN technology only within BMG's licensed fields; proper treatment of intellectual property rights regarding ORIGEN technology; maintenance of records essential to the computation of royalties; and proper computation of royalties; and BMG has breached its duty of good faith and fair dealing. In its lawsuit, the Company seeks damages as well as injunctive and declaratory relief, including a judicial determination of its entitlement to terminate the Agreement. On September 15, 1997, shortly after the Company filed its lawsuit in Maryland, BMG filed a lawsuit in the United States District Court for the Southern District of Indiana (Indianapolis Division) seeking a declaration that it did not breach the Agreement and a preliminary injunction precluding the Company from terminating the Agreement pending the judicial resolution of the dispute between the parties. In addition, BMG sought and obtained a temporary restraining order that precludes the Company from terminating the Agreement until such time as BMG's motion for preliminary injunction is adjudicated. The Company has requested that the Indiana court transfer BMG's action to Maryland or stay the Indiana action pending the outcome of the Company's Maryland lawsuit. Likewise, BMG has requested that the Maryland court dismiss the Company's Maryland action or, alternatively, transfer it to Indiana or stay it pending the outcome of the Indiana action. The Indiana court will not rule on BMG's motion for preliminary injunction until the venue dispute is resolved, and the temporary restraining order will remain in place until that time. 11 IGEN International, Inc. Form 10-Q For the Quarter Ended September 30, 1997 ITEM 6: EXHIBITS AND REPORTS ON FORM 8-K. (a) Exhibits 11.1 Statements regarding computation of per share earnings for the three and six months ended September 30, 1997 and 1996. 27 Financial Data Schedule --Dagger--Confidential treatment requested. (b) Reports on Form 8-K NONE 12 IGEN International, Inc. Form 10-Q For the Quarter Ended September 30, 1997 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. IGEN INTERNATIONAL, INC. DATE: NOVEMBER 14, 1997 /s/ George V. Migausky ----------------------------------------- GEORGE V. MIGAUSKY VICE PRESIDENT OF FINANCE AND CHIEF FINANCIAL OFFICER (ON BEHALF OF THE REGISTRANT AND AS PRINCIPAL FINANCIAL OFFICER) 13