- ------------------------------------------------------------------------------- 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 QUARTERLY PERIOD ENDED SEPTEMBER 30, 2001 COMMISSION FILE NUMBER 000-21930 BIOSOURCE INTERNATIONAL, INC. (Exact name of Registrant as specified in its charter) DELAWARE 77-0340829 (State or other jurisdiction of (I.R.S. Employer incorporation or organization) Identification No.) 542 FLYNN ROAD, CAMARILLO, CALIFORNIA 93012 (Address of principal executive offices) (Zip Code) Registrant's telephone number, including area code: (805) 987-0086 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 periods 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 ____ The number of shares of the Registrant's common stock, $.001 par value, outstanding as of November 6, 2001 was 10,446,731. - ------------------------------------------------------------------------------- BIOSOURCE INTERNATIONAL, INC. AND SUBSIDIARIES FORM 10-Q SEPTEMBER 30, 2001 INDEX PAGE NO. PART I. FINANCIAL INFORMATION ITEM 1. FINANCIAL STATEMENTS Condensed Consolidated Balance Sheets as of September 30, 2001 (unaudited) and December 31, 2000 3 Condensed Consolidated Statements of Operations for the three and nine months ended September 30, 2001 and 2000 (unaudited) 4 Condensed Consolidated Statements of Cash Flows for the nine months ended September 30, 2001 and 2000 (unaudited) 5 Notes to Condensed Consolidated Unaudited Financial Statements 6 ITEM 2. MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS 11 ITEM 3. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK 24 PART II. OTHER INFORMATION ITEM 1. LEGAL PROCEEDINGS 25 ITEM 2. CHANGES IN SECURITIES AND USE OF PROCEEDS 25 ITEM 3. DEFAULTS UPON SENIOR SECURITIES 25 ITEM 4. SUBMISSION OF MATTERS TO A VOTE OF SECURITY HOLDERS 25 ITEM 5. OTHER INFORMATION 26 ITEM 6. EXHIBITS AND REPORTS ON FORM 8-K 26 SIGNATURES 27 Page 2 BIOSOURCE INTERNATIONAL, INC. AND SUBSIDIARIES CONDENSED CONSOLIDATED BALANCE SHEETS (Amounts in thousands) (Unaudited) SEPTEMBER 30, DECEMBER 31, 2001 2000 ------------- ------------ ASSETS Current assets: Cash and cash equivalents $ 10,846 10,633 Accounts receivable, less allowance for doubtful accounts of $214 at September 30, 2001 and $143 at December 31, 2000 5,963 5,611 Inventories, net (See Note 3) 6,790 6,693 Prepaid expenses and other current assets 1,242 1,261 Deferred income taxes 2,317 2,222 ----------- ---------- Total current assets 27,158 26,420 Property and equipment, net (See Note 4) 4,848 4,353 Intangible assets net of accumulated amortization of $3,103 at September 30, 2001 and $2,279 at December 31, 2000 11,928 12,752 Other assets 432 382 Deferred tax assets 6,457 6,457 ----------- ---------- $ 50,823 50,364 =========== ========== LIABILITIES AND STOCKHOLDERS' EQUITY Current liabilities: Accounts payable $ 3,286 3,316 Accrued expenses 2,559 2,688 Deferred income 253 314 Income tax payable - - ----------- ---------- Total current liabilities 6,098 6,318 Commitments and contingencies (See Note 8) Stockholders' equity: Common stock, $.001 par value. Authorized 20,000,000 shares: issued outstanding 10,443,607 shares at September 30, 2001; issued 10,616,889 shares and outstanding 10,326,458 shares at December 31, 2000 10 10 Additional paid-in capital 49,308 49,304 Accumulated deficit (2,281) (3,071) Accumulated other comprehensive loss (2,312) (2,197) ----------- ---------- Net stockholders' equity 44,725 44,046 ----------- ---------- $ 50,823 50,364 =========== ========== The accompanying notes are an integral part of these condensed consolidated financial statements Page 3 BIOSOURCE INTERNATIONAL, INC. AND SUBSIDIARIES CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS Three and Nine Months Ended September 30, 2001 and 2000 (Amounts in thousands, except per share data) (Unaudited) THREE MONTHS ENDED NINE MONTHS ENDEDD SEPTEMBER 30, SEPTEMBER 30, ----------------------- ----------------------- 2001 2000 2001 2000 ----------- --------- ---------- --------- Net sales $ 8,587 8,150 26,004 24,490 Cost of sales 3,761 3,395 11,397 9,710 --------- --------- ---------- --------- Gross profit 4,826 4,755 14,607 14,780 Operating expenses: Research and development 1,051 872 2,930 2,593 Sales and marketing 1,806 1,325 5,552 4,065 General and administrative 1,751 3,420 4,918 6,184 Amortization of intangibles 275 275 824 818 --------- --------- ---------- --------- Total operating expenses 4,883 5,892 14,224 13,660 --------- --------- ---------- --------- Operating income (loss) (57) (1,137) 383 1,120 Interest income (expense), net 85 13 330 (180) Other income (expense), net (28) (47) 47 47 --------- --------- ---------- --------- Income (loss) before income taxes - (1,171) 760 987 Provision for (benefit from) income taxes (266) (609) (30) 60 --------- --------- ---------- --------- Net income (loss) 266 (562) 790 927 Redeemable preferred stock dividend and accretion of beneficial conversion - (2,384) - (3,853) --------- --------- ---------- --------- Net income (loss) available to common stockholders $ 266 (2,946) 790 (2,926) ========= ========= ========== ========= Net income (loss) per share available to common stockholders Basic $ 0.03 (0.35) 0.08 (0.37) ========= ========= ========== ========= Diluted $ 0.02 (0.35) 0.07 (0.37) ========= ========= ========== ========= Shares used to compute net income (loss) available to common shareholders Basic 10,443 8,362 10,400 7,997 ========= ========= ========== ========= Diluted 10,868 8,362 11,003 7,997 ========= ========= ========== ========= The accompanying notes are an integral part of these condensed consolidated financial statements. Page 4 BIOSOURCE INTERNATIONAL, INC. AND SUBSIDIARIES CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS NINE MONTHS ENDED SEPTEMBER 30, 2001 AND 2000 (AMOUNTS IN THOUSANDS) (UNAUDITED) 2001 2000 ----------- ---------- Cash flows from operating activities: Net income $ 790 927 Adjustments to reconcile net income to net cash provided by operating activities: Depreciation and amortization 1,662 1,588 Stock compensation (388) - Changes in assets and liabilities: Accounts receivable (476) (1,296) Inventories (102) (1,104) Prepaid expenses and other current assets 19 (761) Deferred taxes (94) 347 Other assets 305 466 Accounts payable 355 652 Accrued expenses (151) 1,052 Deferred income (61) (22) Income tax payable 101 (200) ----------- ---------- Net cash provided by operating activities 1,960 1,649 ----------- ---------- Cash flows from investing activities: Purchase of property and equipment (1,625) (1,084) ----------- ---------- Net cash used in investing activities (1,625) (1,084) ----------- ---------- Cash flows from financing activities: Proceeds from the exercise of options 295 2,909 Proceeds from the exercise of warrants - 750 Proceeds from the issuance of common stock 5,350 Proceeds from the issuance of preferred stock - 8,414 Repayments to bank - (12,991) Payments on capital lease obligations - (13) ----------- ---------- Net cash provided by financing activities 295 4,419 ----------- ---------- Net increase in cash and cash equivalents 630 4,984 Effect of exchange rates on cash and cash equivalents (417) (402) Cash and cash equivalents at beginning of period 10,633 4,645 ----------- ---------- Cash and cash equivalents at end of period $ 10,846 9,227 =========== ========== Supplemental disclosure of cash flow information: Cash paid during the period for: Interest $ 1 325 =========== ========== Income taxes - 473 =========== ========== Supplemental disclosure of non-cash information Preferred stock accretion - 2,426 =========== ========== Income tax benefit from exercise of stock options 94 2,472 =========== ========== The accompanying notes are an integral part of these condensed consolidated financial statements. Page 5 BIOSOURCE INTERNATIONAL, INC. AND SUBSIDIARIES NOTES TO CONDENSED CONSOLIDATED UNAUDITED FINANCIAL STATEMENTS 1. BASIS OF PRESENTATION The accompanying condensed consolidated financial statements of BioSource International, Inc. (the "Company") are unaudited and have been prepared pursuant to the rules and regulations of the Securities and Exchange Commission regarding interim financial reporting. Accordingly, they do not include all of the information and footnotes required by generally accepted accounting principles for complete financial statements and should be read in conjunction with the consolidated financial statements and notes thereto included in our Annual Report on Form 10-K, for the fiscal year ended December 31, 2000. In the opinion of management, the accompanying unaudited condensed consolidated financial statements include all adjustments that are necessary for a fair presentation. The results of operations for the three and nine months ended September 30, 2001 are not necessarily indicative of results to be expected for the full fiscal year. 2. GENERAL Our company develops, manufactures, markets and distributes products and services that are widely used in biomedical research. Our products and services enable scientists to better understand the biochemistry, immunology and cell biology of the human body, aging and certain diseases such as cancer, arthritis and other inflammatory diseases, AIDS and certain other infectious diseases. We have a wide variety of products, including immunoassay and ELISA test kits; immunological reagents, including bioactive proteins (cytokines, growth factors and adhesion molecules), oligonucleotides, and monoclonal and polyclonal antibodies. We also manufacture and market custom oligonucleotides, peptides and antibodies to the specifications of our customers. We use recombinant DNA technology to produce cytokines and other proteins. RECENTLY ISSUED ACCOUNTING STANDARDS In July 2001, the Financial Accounting Standards Board ("FASB") issued Statement of Financial Accounting Standards ("Statement") No. 141, BUSINESS COMBINATIONS, and Statement No. 42,GOODWILL AND OTHER INTANGIBLE ASSETS. Statement No. 141 requires that the purchase method of accounting be used for all business combinations initiated after June 30, 2001 as well as all purchase method business combinations completed after June 30, 2001. Statement 141 also specifies criteria intangible assets acquired in a purchase method business combination must meet to be recognized and reported apart from goodwill, noting that any purchase price allocable to an assembled workforce may not be accounted for separately. Statement 142 will require that goodwill and intangible assets with indefinite useful lives no longer be amortized, but instead tested for impairment at least annually in accordance with the provisions of Statement 142. Statement 142 will also require that intangible assets with definite useful lives be amortized over their respective estimated useful lives to their estimated residual values, and reviewed for impairment in accordance with SFAS No. 121, ACCOUNTING FOR THE IMPAIRMENT OF LONG-LIVED ASSETS AND FOR LONG-LIVED ASSETS TO BE DISPOSED OF. The Company is required to adopt the provisions of Statement 141 and Statement 142 effective January 1, 2002. Furthermore, any goodwill and any intangible asset determined to have an indefinite useful life that are acquired in a purchase business combination completed after June 30, 2001 will not be amortized, but will continue to be evaluated for impairment in accordance with the appropriate pre-Statement 142 accounting literature. Goodwill and intangible assets acquired in business combinations completed before July 1, 2001 will continue to be amortized prior to the adoption of Statement 142. Statement 141 will require upon adoption of Statement 142, that the Company evaluate its existing intangible assets and goodwill that were acquired in a prior purchase business combination, and to make any necessary reclassifications in order to conform with the new criteria in Statement 141 for recognition apart from goodwill. Upon adoption of Statement 142, the Company will be required to reassess the useful Page 6 lives and residual values of all intangible assets acquired in purchase business combinations, and make any necessary amortization period adjustments by the end of the first interim period after adoption. In addition, to the extent an intangible asset is identified as having an indefinite useful life, the Company will be required to test the intangible asset for impairment in accordance with the provisions of Statement 142 within the first interim period. Any impairment loss will be measured as of the date of adoption and recognized as the cumulative effect of a change in accounting principle in the first interim period. In connection with the transitional goodwill impairment evaluation, Statement 142 will require the Company to perform an assessment of whether there is an indication that goodwill is impaired as of the date of adoption. To accomplish this the Company must identify its reporting units and determine the carrying value of each reporting unit by assigning the assets and liabilities, including the existing goodwill and intangible assets, to those reporting units as of the date of adoption. The Company will then have up to nine months from the date of adoption to determine the fair value of each reporting unit and compare it to the reporting unit's carrying amount. To the extent a reporting unit's carrying amount exceeds its fair value, an indication exists that the reporting unit's goodwill may be impaired and the Company must perform the second step of the transitional impairment test. In the second step, the Company must compare the implied fair value of the reporting unit's goodwill, determined by allocating the reporting unit's fair value to all of it assets (recognized and unrecognized) and liabilities in a manner similar to a purchase price allocation in accordance with Statement 141, to its carrying amount, both of which would be measured as of the date of adoption. This second step is required to be completed as soon as possible, but no later than the end of the year of adoption. Any transitional impairment loss will be recognized as the cumulative effect of a change in accounting principle in the Company's statement of earnings. Because of the extensive effort needed to comply with adopting Statements 141 and 142, it is not practicable to reasonably estimate the impact of adopting these Statements on the Company's financial statements at the date of this report. In October 2001, the FASB issued Statement No. 144, "Accounting for the Impairment of Long-Lived Assets"" which addresses financial accounting and reporting for the impairment or disposal of long-lived assets. While Statement No. 144 supersedes Statement No. 121, "Accounting for the Impairment of Long-Lived Assets and for Long-Lived Assets to be Disposed Of," it retains many of the fundamental provisions of that statement. The standard is effective for fiscal years beginning after December 15, 2001. The Company expects that the adoption of Statement 144 will not have a material impact on its financial statements or results of operations. 3. INVENTORIES (AMOUNTS IN THOUSANDS) SEPT. 30, 2001 DEC. 31, 2000 -------------- ------------- Raw materials..................... $ 2,037 1,921 Work in process................... 298 553 Finished goods.................... 4,455 4,219 -------------- -------------- $ 6,790 6,693 ============== ============== Page 7 4. PROPERTY AND EQUIPMENT (AMOUNTS IN THOUSANDS) SEPT. 30, 2001 DEC. 31, 2000 -------------- ------------- Machinery and equipment............... $ 6,197 5,356 Office furniture and equipment........ 2,519 2,155 Leasehold improvements................ 884 779 -------------- -------------- 9,600 8,290 Less accumulated depreciation and amortization........................ 4,752 3,937 -------------- -------------- $ 4,848 4,353 ============== ============== 5. EARNINGS PER SHARE The reconciliation of basic to diluted weighted average shares is as follows (amounts in thousands): THREE MONTHS ENDED NINE MONTHS ENDED SEPTEMBER 30, SEPTEMBER 30, --------------------- ------------------------- 2001 2000 2001 2000 -------- ---------- ---------- ---------- Net income (loss) available to common stockholders $ 266 $ (2,946) $ 790 $ (2,926) ======== ========== ========== ========== Weighted average shares used in basic computation 10,443 8,362 10,400 7,997 Dilutive stock options and warrants 425 - 603 - -------- ---------- ---------- ---------- Weighted average shares used for diluted computation 10,868 8,362 11,003 7,997 ======== ========== ========== ========== Options to purchase 1,039,613 and 1,750,942 shares were not included in the computation of diluted net income (loss) available to common shareholders per share for the three month periods ended September 30, 2001 and 2000, respectively because their effect would be anti-dilutive. Options to purchase 822,443 and 1,750,942 shares were not included in the computation of diluted net income (loss) available to common shareholders per share for the nine month periods ended September 30, 2001 and 2000, respectively, because their effect would be anti-dilutive. Warrants to purchase 1,287,000 shares at a weighted average exercise price of $7.07 per share were outstanding as of September 30, 2001 but were not included in the computation of diluted net income available to common shareholders per share for the three months ended September 30, 2001 because their effect would be anti-dilutive. On September 20, 2000, 389,143 shares of the Series B Redeemable Preferred stock were converted into 1,556,574 shares of common stock at a weighted average common stock conversion price of $6.06. These shares, for the period prior to their conversion, were not included in the computation of diluted loss per share for the three and nine-month periods ended September 30, 2000 because their effect would be anti-dilutive. Page 8 6. STOCKHOLDERS' EQUITY Comprehensive income (loss) is determined as follows (amounts in thousands): THREE MONTHS ENDED NINE MONTHS ENDED SEPTEMBER 30, SEPTEMBER 30, ---------------------- ------------------------ 2001 2000 2001 2000 ---------- ---------- ---------- ---------- Net income (loss) available to common stockholders $ 266 (2,946) 790 (2,926) Foreign currency translation adjustments 409 (406) (115) (747) ---------- ---------- ---------- ---------- Total comprehensive income (loss) $ 675 (3,352) 675 (3,673) ========== ========== ========== ========== 7. BUSINESS SEGMENTS The Company is engaged in a single industry, the licensing, development, manufacture, marketing and distribution of immunological reagents, test kits and oligonucleotides used in biomedical research and human diagnostics. Our customers are not concentrated in any specific geographic region and no single customer accounts for a significant amount of our sales. Management of the Company has determined its reportable segments are strategic business units that offer both sales to external customers from geographic company facilities and sales to external customers in certain geographic regions. Significant reportable business segments are the United States and European facilities, and sales to external customers are summarized as those located in the United States, Europe, Japan and other. We evaluate performance for the "Sales-from" segments on net revenue and profit and loss from operations. Our reportable segments are strategic business units that offer geographical product availability. They are managed separtely because each business requires different marketing and distribution strategies. Business information is summarized as follows: SALES-FROM SEGMENTS (AMOUNTS IN THOUSANDS): THREE MONTHS ENDED NINE MONTHS ENDED SEPTEMBER 30, SEPTEMBER 30, 2001 2000 2001 2000 ---------- ---------- ---------- --------- Net sales to external customers from: United States: Domestic $ 5,241 4,933 15,348 14,301 Export 1,040 1,009 3,403 3,224 ---------- ---------- ---------- ---------- Total United States 6,281 5,942 18,751 17,525 Europe 2,306 2,208 7,253 6,965 ---------- ---------- ---------- ---------- Consolidated $ 8,587 8,150 26,004 24,490 ========== ========== ========== ========== Operating income (loss): United States $ (483) (1,817) (1,359) (547) Europe 426 680 1,742 1,667 ---------- ---------- ---------- ---------- Consolidated $ (57) (1,137) 383 1,120 ========== ========== ========== ========== SALES-TO SEGMENTS: Net sales to external customers in: United States $ 5,241 4,933 15,348 14,301 Europe 2,093 1,880 6,706 6,360 Japan 721 762 2,276 2,358 Other 532 575 1,674 1,471 ----------- ----------- ----------- ----------- Consolidated $ 8,587 8,150 26,004 24,490 =========== =========== =========== =========== Page 9 8. COMMITMENTS AND CONTINGENCIES On June 14, 2000, one of our former employees, Jordan Fishman, Ph.D., filed a legal action against us in the United States Central District Court of California. Mr. Fishman's complaint asserts a number of claims for relief against BioSource and alleges that BioSource breached Mr. Fishman's employment agreement by failing to register his stock options on a Form S-8 Registration Statement by December 8, 1999. Second, Fishman claims that this breach, coupled with BioSource's representations regarding a planned public offering (which prevented Company insiders from trading in the Company's common stock) and BioSource's subsequent termination of Fishman's employment, were each part of a larger scheme to interfere with, and ultimately prevent, the sale of his common stock. On August 11, 2000, we filed a motion to dismiss five of Mr. Fishman's six causes of action, and on September 29, 2000, the court dismissed three of the causes. On October 4, 2000, Mr. Fishman filed a first amended complaint. BioSource moved to dismiss two of the remaining causes of action, one based on new California Supreme Court precedent, and the other based on deficiencies in Mr. Fishman's allegations. The Court granted BioSource's motion as to both of these causes of action. As a consequence, the only two remaining causes of action in this litigation were (1) breach of contract and (2) fraud. In December 2000, BioSource answered the First Amended Complaint, and filed a counter-claim against Jordan Fishman. Discovery has concluded. Trial is scheduled to commence August 28, 2001. BioSource filed a motion for summary judgment against plaintiff's case and that motion was heard on August 6, 2001. The Court granted BioSource's motion as to the fraud claim. Therefore, only the breach of contract claim and BioSource's counterclaim remain for trial. Trial is set to commence in January 2002. The Company has also commenced an arbitration proceeding against the former shareholders of its QCB division, including Mr. Fishman, to recover damages management believes it has suffered in connection with misrepresentations and omissions made by those shareholders in the representations and warranties contained in the original Stock Purchase Agreement for QCB executed on December 9, 1998. The Company's claim to recover the $1,347,000 of Escrowed Funds is based on QCB's breach of the representations and warranties made in the Stock Purchase Agreement. The parties have selected a panel of three arbitrators who will hear the dispute in March 2002. The Company has also asserted a claim for punitive damages against Jordan Fishman in the arbitration. Page 10 ITEM 2. MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS This discussion and analysis of financial condition and results of operations should be read in conjunction with the consolidated financial statements, the notes thereto and other information, including information set forth in our 10-K for the fiscal year ended December 31, 2000, and all other recent filings we have made with the Securities and Exchange Commission. This Form 10-Q contains forward-looking statements, which are made pursuant to the safe-harbor provisions of the Private Securities Litigation Reform Act of 1995. Within this Form 10-Q, words such as "believes", "designed", "anticipates", and similar expressions are intended to identify forward-looking statements, but are not the exclusive means of identifying such statements. These forward-looking statements involve a number of risks and uncertainties, including the timely development and market acceptance of our products and technologies and other factors described throughout this Form 10-Q and in our other filings with the Securities and Exchange Commission. The actual results that we achieve may differ from any forward-looking statements due to such risks and uncertainties. We do not undertake any obligation to revise or update any forward-looking statements in order to reflect events or circumstances that may arise after the date of this report. OVERVIEW Our company develops, manufactures, markets and distributes products and services that are widely used in biomedical research. Our products and services enable scientists to better understand the biochemistry, immunology and cell biology of the human body, aging and certain diseases such as cancer, arthritis and other inflammatory diseases, AIDS and certain other infectious diseases. We have a wide variety of products, including immunoassay and ELISA test kits; immunological reagents, including bioactive proteins (cytokines, growth factors and adhesion molecules), oligonucleotides, and monoclonal and polyclonal antibodies. We also manufacture and market custom oligonucleotides, peptides and antibodies to the specifications of our customers. We use recombinant DNA technology to produce cytokines and other proteins. We have registered our analyte specific reagents with the FDA and have received a license to sell these products as Class I Medical Devices. We market these products to in vitro diagnostic manufacturers and clinical reference laboratories as "active ingredients" in the tests they produce to identify various specific diseases or conditions. In order to market these products as medical devices, we are required to be in compliance with the FDA's Current Good Manufacturing Practices and Regulations. RESULTS OF OPERATIONS FOR THE THREE MONTHS ENDED SEPTEMBER 30, 2001 REVENUES: Net sales for the three months ended September 30, 2001 and 2000 were $8,587,000 and $8,150,000, respectively, representing an increase of $437,000 or 5% (6% in local currency) in 2001 as compared to 2000. Geographically, our sales for the three months ended September 30, 2001 to customers in North America increased by 8% as compared to the comparable prior year period. European sales increased 11% (15% in local currency) for the three months ended September 30, 2001 as compared to the three months ended September 30, 2000. Sales in the rest of the world decreased 16% for the three months ended September 30, 2001 as compared to the comparable prior year period. GROSS PROFIT: Gross profit for the three months ended September 30, 2001 and 2000 was $4,826,000 and $4,755,000 respectively, representing a gross margin of 56% and 58% for three months ended September 30, 2001 and 2000, respectively. The decrease in gross profit margin was due to the higher infrastructure cost within manufacturing, increased depreciation expense, and increased raw material costs. RESEARCH AND DEVELOPMENT: Research and development expense for the three months ended September 30, 2001 and 2000 amounted to $1,051,000 and $872,000, respectively. As a percentage of net sales, research and development expenditures remained constant at 12% and 11% for the quarters ended September 30, 2001 and 2000, respectively. This increase in expenses reflects the Company's continued efforts on new product development. Page 11 SALES AND MARKETING: Sales and marketing expense for the three months ended September 30, 2001 and 2000 amounted to $1,806,000 and $1,325,000, respectively, an increase of $481,000. This increase represents the Company's investment in its infrastructure through increased personnel and marketing programs. As a percentage of net sales, sales and marketing expenditures were 21% and 16% for the quarter ended September 30, 2001 and 2000, respectively. GENERAL AND ADMINISTRATIVE: General and administrative expense for the three months ended September 30, 2001 and 2000 amounted to $1,751,000 and $3,420,000 respectively, a decrease of $1,669,000. In the three months ended September 30, 2001, we incurred additional increased costs of $429,000 related to an employee severance package and legal fees related to an employee termination. These increased costs were offset by higher increased costs of $2,098,000 in the third quarter of 2000 including transition costs and non-cash stock compensation charges from the hiring of a new CEO in September of 2000 and legal costs related to an employee termination. As a percentage of sales, general and administrative expense were 20% and 42% for the three months ended September 30, 2001 and 2000, respectively. AMORTIZATION OF INTANGIBLE ASSETS: Amortization of intangible assets for each of the three months ended September 30, 2001 and 2000 amounted to $275,000 and is related to the amortization of the intangible assets from the QCB and Biofluids acquisitions. INTEREST INCOME, NET: Interest income for the three months ended September 30, 2001 was $85,000 which was related to interest income on cash invested in short-term securities during the quarter. Interest income for the three months ended September 30, 2000 was $13,000. $42,000 is related to interest income on cash invested in short-term securities during the quarter, offset by $29,000 of interest expense related to a loan on the Company's previous headquarters. PROVISION FOR (BENEFIT FROM) INCOME TAXES: The income tax benefit for the three months ended September 30, 2001 and 2000 was $266,000 and $609,000, respectively. Due to the Company's lower net income for each of the three months ended September 30, 2001 and 2000, the Company re-evaluated and adjusted its effective tax rates for those periods. This, along with the Company's current permanent tax benefits including an R & D tax credit and the manufacturing investment tax credit, have caused the Company's to record a benefit for each of the three months ended September 30, 2001 and 2000 respectively. In the third quarter of 2000, the Company recognized a $2,384,000 charge for non-cash redeemable preferred stock dividends and accretion related to a beneficial conversion feature associated with the issuance to Genstar Capital Partners II, L.P. of Series B Redeemable Preferred Stock and detachable stock purchase warrants in the first quarter of 2000. The redeemable preferred stock involved in the transaction converted to common stock in September 2000 and accordingly, all remaining non-cash charges were accounted for at such time. RESULTS OF OPERATIONS FOR THE NINE MONTHS ENDED SEPTEMBER 30, 2001 REVENUES: Net sales for the nine months ended September 30, 2001 and 2000 were $26,004,000 and $24,490,000, respectively, representing an increase of $1,514,000 or 6% (8% in local currency) in 2001 as compared to 2000. Geographically, our sales for the nine months ended September 30, 2001 to customers in North America increased by 10% as compared to the comparable prior year period. European sales increased 5% (11% in local currency) for the nine months ended September 30, 2001 as compared to the nine months ended September 30, 2000. Sales in the rest of the world decreased 7% for the nine months ended September 30, 2001, as compared to the comparable prior year period. GROSS PROFIT: Gross profit for the nine months ended September 30, 2001 and 2000 was $14,607,000 and $14,780,000 respectively, representing a gross margin of 56% and 60% for nine months ended September 30, 2001 and 2000, respectively. The decrease in gross profit margin was due to the higher infrastructure cost within manufacturing, increased depreciation expense, underabsorbed overhead costs in our custom peptides, antibodies and signal transduction product lines due in part to excess capacity and improvements in our production process, and increased raw material costs. Page 12 RESEARCH AND DEVELOPMENT: Research and development expense for the nine months ended September 30, 2001 and 2000 amounted to $2,930,000 and $2,593,000, respectively. As a percentage of net sales, research and development expenditures were 11% of net sales for each of the nine months ended September 30, 2001 and 2000. This increase in expenses reflects the Company's continued efforts on new product development. SALES AND MARKETING: Sales and marketing expense for the nine months ended September 30, 2001 and 2000 amounted to $5,552,000 and $4,065,000, respectively, an increase of $1,487,000. This increase represents the Company's investment in its infrastructure through increased personnel and marketing programs. As a percentage of net sales, sales and marketing expenditures were 21% and 17% of net sales for the nine months ended September 30, 2001 and 2000, respectively. GENERAL AND ADMINISTRATIVE: General and administrative expense for the nine months ended September 30, 2001 and 2000 amounted to $4,918,000 and $6,184,000 respectively, a decrease of $1,266,000. In the nine months ended September 30, 2001, in addition to increased costs related primarily to personnel and other administrative costs of $657,000, we incurred additional increased costs of $1,089,000 related to an employee severance package and legal fees related to an employee termination as well as $388,000 of a net expense recovery from a non-cash stock compensation adjustment. These increased costs were offset by higher increased costs during the nine months ended September 30, 2000 including a $523,000 charge related to a failed follow on offering in the second quarter of 2000 and $2,100,000 in the third quarter of 2000 including transition costs and non-cash stock compensation charges from the hiring of a new CEO in September of 2000 and legal costs related to an employee termination. As a percentage of sales, general and administrative expense were 19% and 25% for the nine months ended September 30, 2001 and 2000, respectively. AMORTIZATION OF INTANGIBLE ASSETS: Amortization of intangible assets for the nine months ended September 30, 2001 and 2000 amounted to $824,000 and $818,000, respectively, and are related to the amortization of the intangible assets from the QCB and Biofluids acquisitions. INTEREST INCOME (EXPENSE), NET: Net interest income for the nine months ended September 30, 2001 was $330,000 which was related to interest income on cash invested in short-term securities during the quarter. Net interest expense was $180,000 for the nine months ended September 30, 2000. $326,000 is related to interest expense associated with the loan on the Company's old building and interest expense on the loans associated with the acquisitions of QCB and Bioluids in December 1998. This is offset by $146,000 of interest income on cash invested in short-term securities during the nine months ended September 30, 2000. PROVISION FOR (BENEFIT FROM) INCOME TAXES: Income tax benefit for the nine months ended September 30, 2001 was $30,000 and the income tax expense for the nine months ended September 30, 2000 was $60,000. Due to the Company's lower net income for each of the nine months ended September 30, 2001 and 2000, the Company re-evaluated and adjusted its effective tax rates for those periods. This, along with the Company's current permanent tax benefits including an R & D tax credit and the manufacturing investment tax credit, results in the Company's effective tax rate to be -4% and 6% for the nine months ended September 30, 2001 and 2000 respectively. In the first nine months of 2000, the Company recognized a $3,853,000 charge for non-cash redeemable preferred stock dividends and accretion related to a beneficial conversion feature associated with the issuance to Genstar Capital Partners II L.P. of Series B Redeemable Preferred Stock and detachable stock purchase warrants in the first quarter of 2000. The redeemable preferred stock involved in the transaction converted to common stock in September 2000 and accordingly, all remaining non-cash charges were accounted for at this time. LIQUIDITY AND CAPITAL RESOURCES: Cash and cash equivalents as of September 30, 2001 of $10,846,000 increased by $213,000 from $10,633,000 at December 31, 2000. The increase in cash was due primarily from net cash provided from operating activities of $1,960,000 offset by capital expenditures of $1,625,000. Working capital, which is Page 13 the excess of current assets over current liabilities, was $21,060,000 at September 30, 2001 as compared to $20,102,000 at December 31, 2000 representing an increase of $958,000. In the nine months ended September 30, 2001, the Company received $295,000 from the issuance of common stock related to the exercise of stock options. In September of 2001, the Company announced that its Board of Directors had approved a stock repurchase program. The Board has authorized the Company to repurchase up to $5,000,000 of its common stock. The repurchases are to be made at the discretion of management and can be made at any time, as market conditions warrant. The stock repurchase program will end June 30, 2003. The Company has never paid dividends on common stock and has no plans to do so in fiscal 2001. Our earnings will be retained for reinvestment in the business. The Company expects to be able to meet its future cash and working capital requirements for operations and capital additions through currently available funds and cash generated from operations, if any. However, we may raise additional capital or secure debt financing from time to time to take advantage of favorable conditions in the market or in connection with our corporate development activities. RISK FACTORS You should carefully consider the following risk factors and all other information contained in this report before purchasing shares of our common stock. Investing in our common stock involves a high degree of risk. If any of the following events or outcomes actually occur, our business, operating results and financial condition would likely suffer. As a result, the trading price of our common stock could decline, and you may lose all or part of the money you paid to purchase our common stock. RISKS RELATED TO OUR BUSINESS FAILURE TO MANAGE OUR GROWTH AND EXPANSION COULD IMPAIR OUR BUSINESS. We historically have sought, and will continue to seek, to increase our sales and profitability primarily through the acquisition or internal development of new product lines, additional customers and new businesses. Our historical revenue growth is primarily attributable to our acquisitions and new product development and, to a lesser extent, to increased revenues from our existing products. We expect that future acquisitions, if successfully consummated, will create increased working capital requirements, which will likely precede by several months any material contribution of an acquisition to our net income. Our ability to achieve our expansion objectives and to manage our growth effectively and profitably depends upon a variety of factors, including: o our ability to internally develop new products; o our ability to make profitable acquisitions; o integration of new facilities into existing operations; o hiring, training and retention of qualified personnel; o establishment of new relationships or expansion of existing relationships with customers and suppliers; and o availability of capital. Page 14 In addition, the implementation of our growth strategy will place significant strain on our administrative, operational and financial resources and increased demands on our financial systems and controls. Our ability to manage our growth successfully will require us to continue to improve and expand these resources, systems and controls. If our management is unable to manage growth effectively, our operating results could be adversely affected. Moreover, there can be no assurance that our historic rate of growth will continue, that we will continue to successfully expand or that growth or expansion will result in profitability. WE CANNOT GUARANTEE THAT OUR FUTURE ACQUISITIONS WILL BE SUCCESSFUL. We compete for acquisition and expansion opportunities with companies which have significantly greater financial and management resources than us. There can be no assurance that suitable acquisition or investment opportunities will be identified, that any of these transactions can be consummated, or that, if acquired, these new businesses can be integrated successfully and profitably into our operations. These acquisitions and investments may also require a significant allocation of resources, which will reduce our ability to focus on the other portions of our business, including many of the factors listed in the prior risk factor. REDUCTION OR DELAYS IN RESEARCH AND DEVELOPMENT BUDGETS AND IN GOVERNMENT FUNDING MAY NEGATIVELY IMPACT OUR SALES. Our customers include researchers at pharmaceutical and biotechnology companies, academic institutions and government and private laboratories. Fluctuations in the research and development budgets of these researchers and their organizations could have a significant effect on the demand for our products. Research and development budgets fluctuate due to numerous factors that are outside our control and are difficult to predict, including changes in available resources, spending priorities and institutional budgetary policies. Our business could be seriously damaged by any significant decrease in life sciences research and development expenditures by pharmaceutical and biotechnology companies, academic institutions or government and private laboratories. A significant portion of our sales has been to researchers, universities, government laboratories and private foundations whose funding is dependent upon grants from government agencies such as the U.S. National Institutes of Health and similar domestic and international agencies. Although the level of research funding has increased during the past several years, we cannot assure that this trend will continue. Government funding of research and development is subject to the political process, which is inherently fluid and unpredictable. Our revenues may be adversely affected if our customers delay purchases as a result of uncertainties surrounding the approval of government budget proposals. Also, government proposals to reduce or eliminate budgetary deficits have sometimes included reduced allocations to the NIH and other government agencies that fund research and development activities. A reduction in government funding for the NIH or other government research agencies could seriously damage our business. Many of our customers receive funds from approved grants at particular times of the year, as determined by the federal government. Grants have, in the past, been frozen for extended periods or have otherwise become unavailable to various institutions without advance notice. The timing of the receipt of grant funds affects the timing of purchase decisions by our customers and, as a result, can cause fluctuations in our sales and operating results. WE RELY ON RAW MATERIALS AND SPECIALIZED EQUIPMENT FOR OUR MANUFACTURING, WHICH WE MAY NOT ALWAYS BE ABLE TO OBTAIN ON FAVORABLE TERMS. Our manufacturing process relies on the continued availability of high-quality raw materials and specialized equipment. It is possible that a change in vendors, or in the quality of the raw materials supplied to us, could have an adverse impact on our manufacturing process and, ultimately, on the sale of our finished products. We have from time to time experienced a disruption in the quality or availability of key raw materials, which has created minor delays in our ability to fill orders for specific test kits. This could occur again in the future, resulting in significant delays, and could have a detrimental impact on the sale of Page 15 our products and our results of operations. In addition, we rely on highly specialized manufacturing equipment that if damaged or disabled could adversely affect our ability to manufacture our products and therefore negatively impact our business. OUR ABILITY TO RAISE THE CAPITAL NECESSARY TO EXPAND OUR BUSINESS IS UNCERTAIN. In the future, in order to expand our business through internal development or acquisitions, we may need to raise substantial additional funds through equity or debt financings, research and development financings or collaborative relationships. However, this additional funding may not be available or, if available, it may not be available on economically reasonable terms. In addition, any additional funding may result in significant dilution to existing stockholders. If adequate funds are not available, we may be required to curtail our operations or obtain funds through collaborative partners that may require us to release material rights to our products. OUR RESEARCH AND DEVELOPMENT EFFORTS FOR NEW PRODUCTS MAY BE UNSUCCESSFUL. We incur significant research and development expenses to develop new products and technologies. There can be no assurance that any of these products or technologies will be successfully developed or that if developed, will be commercially successful. In the event that we are unable to develop commercialized products from our research and development efforts or we are unable or unwilling to allocate amounts beyond our currently anticipated research and development investment, we could lose our entire investment in these new products and technologies. Any failure to translate research and development expenditures into successful new product introductions could have an adverse effect on our business. FAILURE TO LICENSE NEW TECHNOLOGIES COULD IMPAIR OUR NEW PRODUCT DEVELOPMENT. Our business model of providing products to researchers working on a variety of genetic projects requires us to develop a wide spectrum of products. To generate broad product lines it is advantageous to sometimes license technologies from others rather than depending exclusively on our own employees. As a result, we believe our ability to license new technologies from third parties is and will continue to be important to our ability to offer new products. In addition, from time to time we are notified or become aware of patents held by third parties that are related to technologies we are selling or may sell in the future. After a review of these patents, we may decide to obtain a license for these technologies from these third parties or discontinue the products. There can be no assurance that we will be able to continue to successfully identify new technologies developed by others. Even if we are able to identify new technologies of interest, we may not be able to negotiate a license on favorable terms, or at all. If we lose the rights to patented technology, we may need to discontinue selling certain products or redesign our products, and we may lose a competitive advantage. Potential competitors could in-license technologies that we fail to license and potentially erode our market share for certain products. Our licenses typically subject us to various commercialization, sublicensing, minimum payment, and other obligations. If we fail to comply with these requirements, we could lose important rights under a license. In addition, certain rights granted under the license could be lost for reasons out of our control. For example, the licensor could lose patent protection for a number of reasons, including invalidity of the licensed patent. We do not always receive significant indemnification from a licensor against third party claims of intellectual property infringement. We are currently in the process of negotiating several of these licenses and expect that we will also negotiate these types of licenses in the future. There can be no assurances that we will be able to negotiate these licenses on favorable terms, or at all. OUR FUTURE SUCCESS DEPENDS ON THE TIMELY INTRODUCTION OF NEW PRODUCTS AND THE ACCEPTANCE OF THESE NEW PRODUCTS IN THE MARKETPLACE. Our ability to gain access to technologies needed for new products and services also depends in part on our ability to convince licensors that we can successfully commercialize their inventions. We cannot assure Page 16 that we will be able to continue to identify new technologies developed by others. Even if we are able to identify new technologies of interest, we may not be able to negotiate a license on favorable terms, or at all. IF WE FAIL TO INTRODUCE NEW PRODUCTS, OR OUR NEW PRODUCTS ARE NOT ACCEPTED BY POTENTIAL CUSTOMERS, WE MAY LOSE MARKET SHARE. Rapid technological change and frequent new product introductions are typical for the markets we serve. Our future success will depend in part on continuous, timely development and introduction of new products that address evolving market requirements. We believe successful new product introductions provide a significant competitive advantage because customers make an investment of time in selecting and learning to use a new product, and then are reluctant to switch. To the extent we fail to introduce new and innovative products, we may lose market share to our competitors, which will be difficult or impossible to regain. Any inability, for technological or other reasons, to successfully develop and introduce new products could reduce our growth rate or damage our business. In the past we have experienced, and are likely to experience in the future, delays in the development and introduction of products. We cannot assure that we will keep pace with the rapid rate of change in life sciences research, or that our new products will adequately meet the requirements of the marketplace or achieve market acceptance. Some of the factors affecting market acceptance of new products include: o availability, quality and price relative to competitive products; o the timing of introduction of the product relative to competitive products; o customers' opinion of the products utility; o ease of use; o consistency with prior practices; o scientists' opinion of the product's usefulness; o citation of the product in published research; and o general trends in life sciences research. The expenses or losses associated with unsuccessful product development activities or lack of market acceptance of our new products could materially adversely affect our business, operating results and financial condition. The development, introduction and marketing of innovative products in our rapidly evolving markets will require significant sustained investment. We cannot assure their cash from operations or other sources will be sufficient to meet these ongoing requirements. FAILURE TO ATTRACT AND RETAIN QUALIFIED SCIENTIFIC OR PRODUCTION PERSONNEL OR LOSS OF KEY MANAGEMENT OR KEY PERSONNEL COULD HURT OUR BUSINESS. Recruiting and retaining qualified scientific and production personnel to perform research and development work and product manufacturing is critical to our success. Because the industry in which we compete is very competitive, we face significant challenges attracting and retaining this qualified personnel base. Although we believe we have been and will be able to attract and retain these personnel, there can be no assurance that we will be able to continue to successfully attract qualified personnel. In addition, our anticipated growth and expansion into areas and activities requiring additional expertise, such as clinical testing, government approvals, production and marketing, will require the addition of new management Page 17 personnel and the development of additional expertise by existing management personnel. The failure to attract and retain these personnel or, alternatively, to develop this expertise internally would adversely affect our business. We generally do not enter into employment agreements requiring these employees to continue in our employment for any period of time. Our success also will continue to depend, to a significant extent on the members of our management team. We do not maintain any "key man" insurance policies regarding any of these individuals. We may not be able to retain the services of our executive officers and key personnel or attract additional qualified members to management in the future. The loss of services any of our other key management or employees, could have a material adverse effect upon our business. MANY OF OUR CUSTOMERS ARE OBTAINING OUR PRODUCTS THROUGH NEW DISTRIBUTION CHANNELS AND METHODS THAT MAY ADVERSELY IMPACT OUR RESULTS OF OPERATIONS AND FINANCIAL CONDITION. A number of our customers have developed purchasing initiatives to reduce the number of vendors they purchase from in order to lower their supply costs. In some cases, these customers have established agreements with large distributors which include discounts and the distributors' direct involvement with the purchasing process. For similar reasons, many larger customers, including the federal government, have special pricing arrangements, including blanket purchase agreements. These agreements may limit our pricing flexibility with respect to our products, which could adversely impact our business, financial condition and results of operations. In addition, although we accept and process some orders through our Internet website, we also implement sales through a third party Internet vendor. Internet sales through third parties will negatively impact our gross margins because we pay commission on these Internet sales. On the other hand, if we do not enter into arrangements with third-party e-commerce providers, we may lose customers who prefer to purchase products using these Web sites. Our business may be harmed as a result of these Web sites or other sales methods which may be developed in the future. WE RELY ON INTERNATIONAL SALES, WHICH ARE SUBJECT TO ADDITIONAL RISKS. International sales accounted for approximately 41% and 42% of our revenues in the first nine months of 2001 and 2000, respectively. International sales can be subject to many inherent risks that are difficult or impossible for us to predict or control, including: o unexpected changes in regulatory requirements and tariffs; o difficulties and costs associated within staffing and managing foreign operations, including foreign distributor relationships; o longer accounts receivable collection cycles in certain foreign countries; o adverse economic or political changes; o unexpected changes in regulatory requirements; o more limited protection for intellectual property in some countries; o changes in our international distribution network and direct sales force; o potential trade restrictions, exchange controls and import and export licensing requirements; o problems in collecting accounts receivable; and o potentially adverse tax consequences of overlapping tax structure. Page 18 We intend to continue to generate revenues from sales outside North America in the future. Future distribution of our products outside North America also may be subject to greater governmental regulation. These regulations, which include requirements for approvals or clearance to market, additional time required for regulatory review and sanctions imposed for violations, as well as the other risks indicated in the bullets listed above, vary by country. We may not be able to obtain regulatory approvals in the countries in which we currently sell our products or in countries where we may sell our products in the future. In addition, we may be required to incur significant costs in obtaining necessary regulatory approvals. Failure to obtain necessary regulatory approvals or any other failure to comply with regulatory requirements could result in a material reduction in our revenues and earnings. We also depend on third-party distributors for a material portion of our international sales. If we lose or suffer any significant reduction in sales to any material distributor, our business could be materially adversely affected. In addition, approximately 20% of our sales are made in foreign currencies, primarily Belgian francs, British pounds, and German marks. Although a significant portion of the foreign currencies in which we conduct our business is currently, or may in the future be, denominated in Euros as a result of the European Monetary Union, we are not certain about the effect of the Euro on our business, financial condition or results of operations. In the past, gains and losses on the collection of our accounts receivable arising from international operations have contributed to negative fluctuations in our results of operations. In general, increases in the exchange rate of the United States dollar to foreign currencies cause our products to become relatively more expensive to customers in those countries, leading to a reduction in sales or profitability in some cases. We historically have not, and currently are not, using hedging transactions or other means to reduce our exposure to fluctuations in the value of the United States dollar as compared to the foreign currencies in which many of our sales are made. OUR OPERATING RESULTS MAY FLUCTUATE. Our operating results may vary significantly quarter to quarter and from year to year as a result of a variety of factors. These factors include: o level of demand for our products; o changes in our customer and product mix; o timing of acquisitions and investments in infrastructure; o competitive conditions; o timing and extent of intellectual property litigation; o exchange rate fluctuations; and o general economic conditions. We believe that quarterly comparisons of our financial results may not necessarily be meaningful and should not be relied upon as an indication of future performance. Additionally, if our operating results in one or more quarters do not meet the expectations of security analysts or others, the price of our common stock could be materially adversely affected. Our continued investment in product development and sales and marketing are significantly ongoing expenses. If revenue in a particular period falls short of expectations, we may not be able to reduce significantly our expenditures for that period, which would materially adversely affect the operating results for that period. Page 19 WE MAY BE UNABLE TO PROTECT OUR TRADEMARKS, TRADE SECRETS AND OTHER INTELLECTUAL PROPERTY RIGHTS THAT ARE IMPORTANT TO OUR BUSINESS. We regard our trademarks, trade secrets and other intellectual property as a component of our success. We rely on trademark law and trade secret protection and confidentiality and/or license agreements with employees, customers, partners and others to protect our intellectual property. Effective trademark and trade secret protection may not be available in every country in which our products are available. We cannot be certain that we have taken adequate steps to protect our intellectual property, especially in countries where the laws may not protect our rights as fully as in the United States. In addition, our third-party confidentiality agreements can be breached and, if they are, there may not be an adequate remedy available to us. If our trade secrets become known, we may lose our competitive position. INTELLECTUAL PROPERTY OR OTHER LITIGATION COULD HARM OUR BUSINESS. Litigation regarding patents and other intellectual property rights is extensive in the biotechnology industry. We are aware that patents have been applied for, and in some cases issued to others, claiming technologies that are closely related to ours. As a result, and in part due to the ambiguities and evolving nature of intellectual property law, we periodically receive notices of potential infringement of patents held by others. Although to date we have successfully resolved these types of claims, we may not be able to do so in the future. In the event of an intellectual property dispute, we may be forced to litigate. This litigation could involve proceedings declared by the U.S. Patent and Trademark Office or the International Trade Commission, as well as proceedings brought directly by affected third parties. Intellectual property litigation can be extremely expensive, and these expenses, as well as the consequences should we not prevail, could seriously harm our business. If a third party claimed an intellectual property right to technology we use, we might need to discontinue an important product or product line, alter our products and processes, pay license fees or cease our affected business activities. Although we might under these circumstances attempt to obtain a license to this intellectual property, we may not be able to do so on favorable terms, or at all. In addition to intellectual property litigation, other substantial, complex or extended litigation could result in large expenditures by us and distraction of our management. For example, lawsuits by employees, stockholders, collaborators or distributors could be very costly and substantially disrupt our business. Disputes from time to time with companies or individuals are not uncommon in our industry, and we cannot assure you that we will always be able to resolve them out of court. ACCIDENTS RELATED TO HAZARDOUS MATERIALS COULD ADVERSELY AFFECT OUR BUSINESS. Portions of our operations require the controlled use of hazardous and radioactive materials. Although we believe our safety procedures comply with the standards prescribed by federal, state, local and foreign regulations, the risk of accidental contamination of property or injury to individuals from these materials cannot be completely eliminated. In the event of an accident, we could be liable for any damages that result, which could seriously damage our business and results of operations. OUR SALES ARE SUBJECT TO SEASONALITY, WHICH MEANS THAT WE HAVE LESS REVENUE IN SOME MONTHS. We experience a slowing of sales in Europe during the summer months and worldwide during the Christmas holidays. Generally, our fourth quarter revenues are lower than our revenues in each of the first three quarters of the year. We believe that period to period comparisons of our operating results may not necessarily be reliable indicators of our future performance. It is likely that in some future period our operating results will not meet expectations or those of public market analysts, which could result in reductions in the market price of our common stock. Page 20 POTENTIAL PRODUCT LIABILITY CLAIMS COULD AFFECT OUR EARNINGS AND FINANCIAL CONDITION. We face a potential risk of liability claims based on our products and services, and we have faced such claims in the past. We carry product liability insurance coverage which is limited in scope and amount but which we believe to be adequate. We cannot assure you, however, that we will be able to maintain this insurance at reasonable cost and on reasonable terms. We also cannot assure that this insurance will be adequate to protect us against a product liability claim, should one arise. THE LABOR LAWS APPLICABLE TO OUR EMPLOYEES IN EUROPE MAY RESTRICT THE FLEXIBILITY OF OUR MANAGEMENT. As of September 30, 2001, 62 of our 240 employees worked for our BioSource Europe subsidiary, which is located in Nivelles, Belgium. As a result of Belgian labor laws, we are required to make specified severance payments in the event we terminate a European employee. Accordingly, our management may be limited by the application of the Belgian labor laws in the determination of staffing levels, and may have less flexibility in making such determinations than our competitors whose employees are not subject to similar labor laws. RISKS ASSOCIATED WITH OUR INDUSTRY THE BIOMEDICAL RESEARCH PRODUCTS INDUSTRY IS VERY COMPETITIVE, AND WE MAY BE UNABLE TO CONTINUE TO COMPETE EFFECTIVELY IN THIS INDUSTRY IN THE FUTURE. We are engaged in a segment of the biomedical research products industry that is highly competitive. We compete with many other suppliers and new competitors continue to enter the markets. Many of our competitors, both in the United States and elsewhere, are major pharmaceutical, chemical and biotechnology companies, and many of them have substantially greater capital resources, marketing experience, research and development staffs, and facilities than we do. Any of these companies could succeed in developing products that are more effective than the products that we have or may develop and may also be more successful than us in producing and marketing their products. We expect this competition to continue and intensify in the future. Competition in our markets is primarily driven by: o product performance, features and liability; o price; o timing of product introductions; o ability to develop, maintain and protect proprietary products and technologies; o sales and distribution capabilities; o technical support and service; o brand royalty; o applications support; and o breadth of product line. If a competitor develops superior technology or cost-effective alternatives to our products, our business, financial condition and results of operations could be materially adversely affected. Our competitors have in the past and may in the future compete by lowering prices. We may respond by lowering our prices, which could reduce revenues and profits. Conversely, failure to anticipate and respond to price competition may damage our market share. Page 21 Our industry has also seen substantial consolidation in recent years, which has led to the creation of competitors with greater financial and intellectual property resources than us. In addition, we believe that the success that others have had in our industry will attract new competitors. Some of our current and future competitors also may cooperate to better compete against us. We may not be able to compete effectively against these current or future competitors. Increased competition could result in price reductions for our products, reduced margins and loss of market share, any of which could adversely impact our business, financial condition and results of operations. AS A RESULT OF CONSOLIDATION IN THE PHARMACEUTICAL INDUSTRY, WE MAY LOSE EXISTING CUSTOMERS OR HAVE GREATER DIFFICULTY OBTAINING NEW CUSTOMERS. In recent years, the United States pharmaceutical industry has undergone substantial consolidation. As part of many business combinations, companies frequently reduce the number of suppliers used and we may not be selected as a supplier after any business combination. Further, mergers or corporate consolidations in the pharmaceutical industry could cause us to lose existing customers and potential future customers, which could have a material adverse effect on our business, financial condition and results of operations. WE ARE CURRENTLY SUBJECT TO GOVERNMENT REGULATION. Our business is currently subject to regulation, supervision and licensing by federal, state and local governmental authorities. Also, from time to time we must expend resources to comply with newly adopted regulations, as well as changes in existing regulations. If we fail to comply with these regulations, we could be subject to disciplinary actions or administrative enforcement actions. These actions could result in penalties, including fines. RISKS ASSOCIATED WITH OUR COMMON STOCK OUR STOCK PRICE HAS BEEN VOLATILE. Our common stock is quoted on the Nasdaq National Market, and there has been substantial volatility in the market price of our common stock. The trading price of our common stock has been, and is likely to continue to be, subject to significant fluctuations due to a variety of factors, including: o fluctuations in our quarterly operating and earnings per share results; o the gain or loss of significant contracts; o loss of key personnel; o announcements of technological innovations or new products by us or our competitors; o delays in the development and introduction of new products; o legislative or regulatory changes; o general trends in the industry; o recommendations and/or changes in estimates by equity and market research analysts; o biological or medical discoveries; Page 22 o disputes and/or developments concerning intellectual property, including patents and litigation matters; o public concern as to the safety of new technologies; o sales of common stock of existing holders; o securities class action or other litigation o developments in our relationships with current or future customers and suppliers; and o general economic conditions, both in the United States and abroad. As a result of these factors, and potentially others, the sales price of our common stock has ranged from $2.41 to $32.00 per share from January 1, 1998 through November 9, 2001 and from $5.00 to $13.38 per share from January 1, 2001 through November 9, 2001. In addition, the stock market in general has experienced extreme price and volume fluctuations that have affected the market price of our common stock, as well as the stock of many biotechnology companies. Often, price fluctuations are unrelated to operating performance of the specific companies whose stock is affected. In the past, following periods of volatility in the market price of a company's stock, securities class action litigation has occurred against the issuing company. If we were subject to this type of litigation in the future, we could incur substantial costs and a diversion of our management's attention and resources, each of which could have a material adverse effect on our revenue and earnings. Any adverse determination in this type of litigation could also subject us to significant liabilities. ANTI-TAKEOVER PROVISIONS IN OUR GOVERNING DOCUMENTS AND UNDER APPLICABLE LAW COULD IMPAIR THE ABILITY OF A THIRD PARTY TO TAKE OVER OUR COMPANY. We are subject to various legal and contractual provisions that may impede a change in our control, including the following: o our adoption of a stockholders' rights plan, which could result in the significant dilution of the proportionate ownership of any person that engages in an unsolicited attempt to take over our company; and o the ability of our board of directors to issue additional shares of our preferred stock, which shares may be given superior voting, liquidation, distribution and other rights as compared to our common stock. These provisions, as well as other provisions in our certificate of incorporation and bylaws and under the Delaware General Corporations Law, may make it more difficult for a third party to acquire our company, even if the acquisition attempt was at a premium over the market value of our common stock at that time. Our principal stockholders and management own a significant percentage of our capital stock and will be able to exercise significant influence over our affairs. Our executive officers, directors and principal stockholders will continue to beneficially own 20.4% of our outstanding common stock, based upon the beneficial ownership of our common stock as of November 1, 2001. In addition, these same persons also hold options to acquire additional shares of our common stock, which may increase their percentage ownership of the common stock further in the future. Accordingly, these stockholders: o will be able to significantly influence the composition of our board of directors; Page 23 o will significantly influence all matters requiring stockholder approval, including change of control transactions; and o will continue to have significant influence over our business. This concentration of ownership of our common stock could have the effect of delaying or preventing a change of control of us or otherwise discouraging a potential acquirer from attempting to obtain control of us. This in turn could have a negative effect on the market price of our common stock. It could also prevent our stockholders from realizing a premium over the market prices for their shares of common stock. OUR PRINCIPAL STOCKHOLDERS AND MANAGEMENT OWN A SIGNIFICANT PERCENTAGE OF OUR CAPITAL STOCK AND WILL BE ABLE TO EXERCISE SIGNIFICANT INFLUENCE OVER OUR AFFAIRS. Our executive officers, directors and principal stockholders beneficially own approximately 20.4% of our outstanding common stock, based upon the beneficial ownership of our common stock as of November 1, 2001. As a result, these stockholders, if they act together, could exert substantial influence over matters requiring stockholder approval, including the election of directors and approval of mergers and other significant corporate transactions. The voting power of such persons may have the effect of delaying, preventing or deterring a change in control, and could affect the market price of our common stock. ABSENCE OF DIVIDENDS COULD REDUCE OUR ATTRACTIVENESS TO YOU. Some investors favor companies that pay dividends, particularly in general downturns in the stock market. We have never declared or paid any cash dividends on our common stock. We currently intend to retain any future earnings for funding growth and we do not currently anticipate paying cash dividends on our common stock in the foreseeable future. Because we may not pay dividends, the return on this investment likely depends on selling this stock at a profit. ITEM 3. QUANTITATIVE AND QUALITATIVE DISCLOSURES OF MARKET RISK: We conduct business in various foreign currencies and are therefore subject to the transaction exposures that arise from foreign exchange rate movements between the dates that foreign currency transactions are initiated and the date that they are converted. We are also subject to certain exposures arising from the translation and consolidation of the financial results of our foreign subsidiaries. There can be no assurance that actions taken to manage such exposures will continue to be successful or that future changes in currency exchange rates will not have a material impact on our future cash collections and operating results. We do not currently hedge either our transaction risk or our economic risk. Page 24 PART II OTHER INFORMATION ITEM 1. LEGAL PROCEEDINGS On June 14, 2000, one of our former employees, Jordan Fishman, Ph.D., filed a legal action against us in the United States Central District Court of California. Mr. Fishman's complaint asserts a number of claims for relief against BioSource and alleges that BioSource breached Mr. Fishman's employment agreement by failing to register his stock options on a Form S-8 Registration Statement by December 8, 1999. Second, Fishman claims that this breach, coupled with BioSource's representations regarding a planned public offering (which prevented Company insiders from trading in the Company's common stock) and BioSource's subsequent termination of Fishman's employment, were each part of a larger scheme to interfere with, and ultimately prevent, the sale of his common stock. On August 11, 2000, we filed a motion to dismiss five of Mr. Fishman's six causes of action, and on September 29, 2000, the court dismissed three of the causes. On October 4, 2000, Mr. Fishman filed a first amended complaint. BioSource moved to dismiss two of the remaining causes of action, one based on new California Supreme Court precedent, and the other based on deficiencies in Mr. Fishman's allegations. The Court granted BioSource's motion as to both of these causes of action. As a consequence, the only two remaining causes of action in this litigation were (1) breach of contract and (2) fraud. In December 2000, BioSource answered the First Amended Complaint, and filed a counter-claim against Jordan Fishman. Discovery has concluded. Trial is scheduled to commence in November 2001. BioSource filed a motion for summary judgment against plaintiff's case and that motion was heard on August 6, 2001. The Court granted BioSource's motion as to the fraud claim. Therefore, only the breach of contract claim and BioSource's counterclaim remain for trial. Trial is scheduled to commence in January 2002. The Company has also commenced an arbitration proceeding against the former shareholders of its QCB division, including Mr. Fishman, to recover damages management believes it has suffered in connection with misrepresentations and omissions made by those shareholders in the representations and warranties contained in the original Stock Purchase Agreement for QCB executed on December 9, 1998. The Company's claim to recover the $1,347,000 of Escrowed Funds is based on QCB's breach of the representations and warranties made in the Stock Purchase Agreement. The parties have selected a panel of three arbitrators who will hear the dispute in March 2002. The Company has also asserted a claim for punitive damages against Jordan Fishman in the arbitration. ITEM 2. CHANGE IN SECURITIES AND USE OF PROCEEDS None ITEM 3. DEFAULTS UPON SENIOR SECURITIES None. ITEM 4. SUBMISSION OF MATTERS TO A VOTE OF SECURITY HOLDERS. On July 26, 2001, the Company held its Annual Meeting of Stockholders. The following sets forth the identity of directors elected for one year and until their respective successors have been elected. In addition, the results of the voting on the ratification of appointment of the company's auditors are included FOR WITHHELD --------- --------- 1. Election of directors Jean-Pierre L. Conte 9,403,360 35,142 Leonard M. Hendrickson 9,423,125 15,377 David J. Moffa 9,422,770 15,732 John R. Overturf, Jr. 9,422,866 15,636 Robert D. Weist 9,422,770 15,732 Robert J. Weltman 9,403,324 35,178 Page 25 FOR AGAINST ABSTAIN --------- ------- ------- 2. Ratification of Auditors 9,426,972 8,601 2,929 ITEM 5. OTHER INFORMATION None. ITEM 6. EXHIBITS AND REPORTS ON FORM 8-K (a) Exhibits None (b) Reports on Form 8-K Current Report on Form 8-K dated July 24, 2001, reporting Item 5 and filed with the Securities and Exchange Commission on August 3, 2001. Current Report on Form 8-K dated September 26, 2001, reporting Item 5 and filed with the Securities and Exchange Commission on October 4, 2001. Page 26 SIGNATURES Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized. BIOSOURCE INTERNATIONAL, INC. (Registrant) Date: November 7, 2001 /S/ LEONARD M. HENDRICKSON ---------------------------------- Leonard M. Hendrickson President and Chief Executive Officer Date: November 7, 2001 /S/ CHARLES C. BEST ---------------------------------- Charles C. Best Executive Vice President and Chief Financial Officer Page 27