- ------------------------------------------------------------------------------- - ------------------------------------------------------------------------------- SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 ---------------- FORM 10-Q (Mark One) [X]QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ending March 31, 2001 [_]TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to -------- -------- Commission File Number: 000-29101 ---------------- SEQUENOM, INC. (Exact name of registrant as specified in its charter) DELAWARE 77-0365889 (State or other jurisdiction (I.R.S. Employer of incorporation or organization) Identification No.) 3595 John Hopkins Court, San Diego, CA 92121 (Address of principal executive offices) (858) 202-9000 (Registrant's telephone number, including area code) ---------------- Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports) [X] Yes [_] No, and (2) has been subject to such filing requirements for the 90 days. [X] Yes [_] No The number of shares of the Registrant's Common Stock outstanding as of April 30, 2001 was 24,346,644. - ------------------------------------------------------------------------------- - ------------------------------------------------------------------------------- SEQUENOM, INC. INDEX Page No. -------- PART I FINANCIAL INFORMATION.......................................... 3 Item 1. Financial Statements........................................ 3 Condensed Consolidated Balance Sheets--as of March 31, 2001 (unaudited) and December 31, 2000........................... 3 Condensed Consolidated Statements of Operations (unaudited) for the three months ended March 31, 2001 and 2000.......... 4 Condensed Consolidated Statements of Cash Flows (unaudited) for the three months ended March 31, 2001 and 2000.......... 5 Notes to Unaudited Condensed Consolidated Financial Statements.................................................. 6 Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations................................... 7 Item 3. Quantitative and Qualitative Disclosures About Market Risk... 20 PART II OTHER INFORMATION............................................. 22 Item 2. Changes in Securities and Use of Proceeds.................... 22 Item 6. Exhibits and Reports on Form 8-K............................. 22 2 PART I FINANCIAL INFORMATION Item 1. Financial Statements SEQUENOM, INC. CONDENSED CONSOLIDATED BALANCE SHEETS March 31, December 31, 2001 2000 ------------ ------------ (Unaudited) Assets Current assets: Cash and cash equivalents........................ $ 44,986,993 $ 70,045,695 Short-term investments, available-for-sale....... 83,658,892 68,378,050 Accounts receivable, net......................... 5,750,140 4,267,238 Inventories, net................................. 3,345,388 2,923,218 Other current assets and prepaid expenses........ 9,440,460 8,399,905 ------------ ------------ Total current assets........................... 147,181,873 154,014,106 Equipment and leasehold improvements, net.......... 9,580,565 8,117,600 Other assets....................................... 3,830,328 4,130,178 ------------ ------------ Total assets................................... $160,592,766 $166,261,884 ============ ============ Liabilities and stockholders' equity Current liabilities: Accounts payable and accrued expenses............ $ 10,647,357 $ 8,707,810 Deferred revenue ................................ 9,275,902 9,830,430 Current portion of capital lease obligations..... 992,574 957,042 ------------ ------------ Total current liabilities...................... 20,915,833 19,495,282 Deferred revenue, less current portion............. 250,000 750,000 Capital lease obligations, less current portion.... 881,510 1,077,200 Commitments Stockholders' equity: Convertible preferred stock, $.001 par value; 5,000,000 shares authorized and no shares issued and outstanding................................. Common stock, $.001 par value; 75,000,000 shares authorized, 24,346,917 and 24,442,092 shares issued and outstanding at March 31, 2001 and December 31, 2000 respectively.................. 24,346 24,442 Additional paid-in capital......................... 223,528,580 223,140,159 Notes receivable for stock......................... (598,500) (598,500) Deferred compensation related to stock options..... (1,327,033) (1,551,044) Accumulated other comprehensive income............. 339,009 314,843 Accumulated deficit................................ (83,420,979) (76,390,498) ------------ ------------ Total stockholders' equity..................... 138,545,423 144,939,402 ------------ ------------ Total liabilities and stockholders' equity..... $160,592,766 $166,261,884 ============ ============ See accompanying notes. 3 SEQUENOM, INC. CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS Three Months Ended March 31, ------------------------- 2001 2000 ----------- ------------ (Unaudited) Revenues: Products......................................... $ 3,709,565 $ 1,450,525 Services......................................... 1,470,925 -- Research and development grants.................. 67,026 124,141 ----------- ------------ Total revenues................................. 5,247,516 1,574,666 Costs and expenses: Cost of product and service revenue.............. 4,152,238 1,028,454 Research and development......................... 5,289,774 4,236,529 Selling, general and administrative.............. 4,526,461 5,212,372 Amortization of deferred compensation............ 291,322 2,497,803 ----------- ------------ Total costs and expenses....................... 14,259,795 12,975,158 ----------- ------------ Loss from operations............................... (9,012,279) (11,400,492) Interest income.................................... 2,087,963 1,539,415 Interest expense................................... (73,386) (4,479,620) Other (expense)/income, net........................ (32,779) 15,987 ----------- ------------ Net loss........................................... $(7,030,481) $(14,324,710) =========== ============ Historical net loss per share, basic and diluted... $ (0.29) $ (0.85) =========== ============ Weighted average shares outstanding, basic and diluted........................................... 24,317,175 16,803,894 =========== ============ Pro forma net loss per share, basic and diluted.... $ (0.65) ============ Pro forma weighted average shares outstanding, basic and diluted................................. 22,057,958 ============ See accompanying notes. 4 SEQUENOM, INC. CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS Three Months Ended March 31, -------------------------- 2001 2000 ------------ ------------ (Unaudited) Operating activities Net loss.......................................... $ (7,030,481) $(14,324,711) Adjustments to reconcile net loss to net cash used in operating activities: Non-cash items.................................. 1,816,954 9,342,898 Changes in operating assets and liabilities: Inventories..................................... (467,415) (364,518) Accounts receivable............................. (1,583,777) (1,078,994) Other current assets............................ (1,071,994) 1,283,543 Other assets.................................... 299,850 5,102 Accounts payable and accrued expenses........... 1,729,361 1,285,041 Deferred revenue................................ (1,054,529) -- Other liabilities............................... 345,335 -- ------------ ------------ Net cash used in operating activities............. (7,016,696) (3,851,639) Investing activities Purchase of equipment and leasehold improvements.. (2,979,199) (474,143) Net change in marketable investment securities.... (15,124,844) (4,201,428) ------------ ------------ Net cash used in investing activities............. (18,104,043) (4,675,571) Financing activities Net payments on capital lease obligations......... (160,158) (107,694) Repayment of long-term debt....................... (3,090,870) Net proceeds from initial public offering......... -- 144,056,842 Proceeds from sale of stock to consultants........ -- 1,486,827 Proceeds from exercise of stock options and ESPP purchases........................................ 245,324 274,418 ------------ ------------ Net cash provided by financing activities......... 85,166 142,619,523 Net increase (decrease) in cash and cash equivalents...................................... (25,035,573) 134,092,313 Effect of exchange rate changes on cash and cash equivalents...................................... (23,129) (134,760) Cash and cash equivalents at beginning of period.. 70,045,695 5,200,734 ------------ ------------ Cash and cash equivalents at end of period........ $ 44,986,993 $139,158,287 ============ ============ Supplemental schedule of non-cash investing and financing activities: Conversion of Preferred Stock to Common Stock..... $ -- $ 56,793,947 ============ ============ Conversion of long-term debt and interest payable to Common Stock.................................. $ -- $ 7,387,010 ============ ============ Supplemental disclosure of cash flow information: Interest paid..................................... $ 73,387 $ 98,538 ============ ============ See accompanying notes. 5 SEQUENOM, INC. NOTES TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (1) Basis of Presentation The accompanying unaudited financial statements of SEQUENOM, Inc. ("SEQUENOM" or the "Company") have been prepared in accordance with generally accepted accounting principles for interim financial information and with the instructions to Form 10-Q and Article 10 of Regulation S-X. Accordingly, they do not include all of the information and footnotes required by generally accepted accounting principles for complete financial statements. In the opinion of management, all adjustments, consisting of normal recurring adjustments, considered necessary for a fair presentation have been included. Interim results are not necessarily indicative of results for a full year. The balance sheet at December 31, 2000 has been derived from the audited financial statements at that date but does not include all of the information and footnotes required by generally accepted accounting principles for complete financial statements. These financial statements should be read in conjunction with the audited financial statements and footnotes thereto included in the SEQUENOM's Annual Report on Form 10-K for the year ended December 31, 2000, as filed with the Securities and Exchange Commission ("SEC"). (2) Comprehensive Income (Loss) SFAS No. 130, Reporting Comprehensive Income ("SFAS 130") requires reporting and displaying comprehensive income (loss) and its components which, for SEQUENOM, includes net loss and unrealized gains and losses on investments and foreign currency translation gains and losses. In accordance with SFAS 130, the accumulated balance of other comprehensive income (loss) is disclosed as a separate component of stockholders' equity. (3) Net Loss Per Share In accordance with SFAS No. 128, Earnings Per Share, basic net income (loss) per share is computed by dividing the net income (loss) for the period by the weighted average number of common shares outstanding during the period. Diluted net income (loss) per share is computed by dividing the net income (loss) for the period by the weighted average number of common and common equivalent shares outstanding during the period. Common equivalent shares are comprised of incremental common shares issuable upon the exercise of stock options and warrants, and common shares issuable on conversion of preferred stock, and were excluded from historical diluted loss per share because of their anti-dilutive effect. Pro forma net loss per share has been computed as described above and also gives effect to common equivalent shares arising from preferred stock and long-term debt that automatically converted upon the closing of the Company's initial public offering in February 2000 (using the as-if converted method from the original date of issuance) and reflects the elimination of interest expense on the debt which was converted. (4) New Accounting Pronouncements The Company adopted SFAS No. 133, Accounting for Derivative Instruments and Hedging Activities, effective January 1, 2001. The adoption of the SFAS No. 133 did not have a significant effect on its results of operations or financial position as the Company does not engage in activities covered by SFAS No. 133. 6 Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations This Form 10-Q may contain forward-looking statements. When used in this Form 10-Q, the words "anticipate," "believe," "estimate," "will," "intend" and "expect" and similar expressions identify forward-looking statements. Actual results, performance or achievements could differ materially from those contemplated, expressed or implied, by any such forward-looking statements contained in this Form 10-Q. Important factors that could cause actual results to differ materially from our forward-looking statements are set forth in this Form 10-Q, included under the heading "Risks and Uncertainties." In addition, the "Risk Factors" discussed in the Company's Annual Report on Form 10-K for the year ended December 31, 2000, filed with the Securities and Exchange Commission should be taken into consideration. All forward-looking statements attributable to us or persons acting on our behalf are expressly qualified in their entirety by the cautionary statements set forth in this Form 10-Q. We are under no obligation to update any forward-looking statement, whether as a result of new information, future events or otherwise. Overview We are a genomics company that develops and commercializes technologies, products, and services to accelerate the discovery of new genetics-based diagnostics, drugs and therapies. Our core technology components include the MassARRAY system for genetic variation and drug target validation, a broad portfolio of SNP assays and diverse human populations. These components represent enabling technology advancements that allow us to screen virtually all human genes in relation to all diseases across large human populations. Using these technologies in house and in partnerships, we are generating a portfolio of candidate disease gene markers associated to major human health disorders, including cardiovascular disease, cancer, diabetes, stress and obesity. Since we began operations in 1994, we have devoted substantially all of our resources to the development and application of products, technologies and services to analyze genetic variations, or single nucleotide polymorphisms (SNPs), and, more recently, to determine their association to disease. Our products include the MassARRAY system, disposable MassARRAY kits consisting of SpectroCHIPs and reagents, a SNP assay portfolio and a disease gene portfolio. Our services include assay design for MassARRAY customers, in-house validation projects using our MassARRAY system and disease association studies using our proprietary DNA banks. We are also using the MassARRAY technology to identify the medical utility of genes and develop SNP panels based on the correlation of SNPs to specific diseases. We sold our first product, the MassARRAY system, in January 2000. Through March 31, 2001, we have commercially placed a total of 29 systems with leading companies and institutions. We currently sell our products to genomics, pharmacogenomics, diagnostic and agricultural biotechnology companies, as well as leading research institutions, in the United States, Europe and Asia. Through March 31, 2001 our product revenues consisted of revenues from the sale of MassARRAY systems, MassARRAY kits and proprietary software, which is sold separately from the MassARRAY system. The MassARRAY kits are used in the operation of the MassARRAY system. Our service revenues consisted of SNP validation services, with revenue recognized as phases of the projects were completed. We anticipate that revenues from our collaborations with third parties will become an increasingly important component of our service revenues in the future. Since our inception, we have incurred significant losses. As of March 31, 2001, we had an accumulated deficit of $83.4 million as compared to an accumulated deficit of $57.8 million for the same period in 2000. As we increase our production, due to demand and increased product sales, we expect to incur substantial expenditures related to sales and marketing expenses and general administrative overhead. Our cost of product and service revenues includes the materials, labor and overhead expenses related to the production of and assembly of our products and the services we provide. Our research and development expenses will be an integral part in expanding our business and will therefore increase appreciably with new product lines. We expect to incur losses for the foreseeable future, and expect all expenses to increase, as we expand development and 7 commercialization of new information-based products, establish a high throughput genotyping center, and fully implement our SNP validation business strategies. Our move in March 2001 to expanded facilities in San Diego has also added to our expenses. If we are unable to lease our old facilities in San Diego, we may incur costs of approximately $1.0 million relating to exiting the lease agreement for our old facilities. Results of Operations for the Three Months Ended March 31, 2001 and 2000 Revenues Total revenues increased to $5.2 million for the three months ended March 31, 2001, from approximately $1.6 million in the same period of the prior year. Product revenues were $3.7 million for the three months ended March 31, 2001 compared to $1.5 million for the three months ended March 31, 2000. These revenues were derived from the sale of MassARRAY systems and disposable kits containing our proprietary SpectroCHIP. During the quarter, we placed 7 of our MassARRAY systems and continued to sell our disposables to customers who already have our system. Service revenues were $1.5 million for the quarter ended March 31, 2001. These revenues consisted of completion of significant phases in SNP validation projects. Research and development grant revenues were approximately $67,000 for the quarter ended March 31, 2001 compared to approximately $124,000 for the same period of the prior year. Research and development expenses Research and development expenses increased to $5.3 million in the quarter ended March 31, 2001, from $4.2 million in the same period of 2000. These expenses consist primarily of salaries and related personnel costs, and materials and other costs related to product development. The expenses in 2001 consisted of approximately $3.2 from personnel costs associated with recruiting and hiring additional research and development personnel, and approximately $2.1 million from material costs and other product development costs. $1.3 million of the expenses in 2000 consisted of a charge from forgiveness of loans granted to executives in 1999 in connection with the exercise of stock options. Selling, general and administrative expenses Selling, general and administrative expenses decreased to $ 4.5 million for the three months ended March 31, 2001, from $5.2 million in the same period of 2000. The expenses in 2001 consist primarily of salaries and related costs for executive, sales, business development, finance and other administrative personnel, and general and patent-related legal expenses. Approximately $1.6 of the expenses resulted from hiring selling, general and administrative personnel and approximately $2.9 from expenses associated with our facilities. Approximately $2.5 million of the expenses in 2000 consisted of a charge from forgiveness of loans granted to executives in 1999 in connection with the exercise of stock options. Amortization of deferred stock-based compensation Deferred stock compensation represents the difference between the estimated fair value of our common stock and the exercise price of options at the date of grant. During the three months ended March 31, 2001, we recorded amortization of deferred stock compensation totaling approximately $291,000 compared to $2.5 million in the same period of 2000. The deferred compensation is being amortized over the vesting periods of the individual stock options using the graded vesting method. We expect to record amortization for deferred compensation approximately as follows:$939,000 in 2001, $432,000 in 2002, and $187,000 in 2003. Interest income Interest income increased to approximately $2.1 million for the quarter ended March 31, 2001 from approximately $1.5 in the same period of 2000. The increase resulted from higher average balances of cash and cash equivalents and short-term investments, from the investment of the net proceeds from our initial public offering in February 2000. 8 Interest expense Interest expense was approximately $73,000 in the quarter ended March 31, 2001 compared to approximately $4.5 million in the same period of 2000. The decrease was a result of long-term debt being repaid and converted to common stock upon the completion of our initial public offering in February 2000, leaving only capital lease obligations outstanding. The $4.5 million is comprised of approximately $4.8 million of non-cash interest expense recorded upon conversion of debt of $2.2 million (4.0 million German deutsche marks exchanged at a rate of 1.84 deutsche marks per 1 US dollar) into common stock and approximately $100,000 of interest related to capital lease obligations, offset in part by approximately $400,000 of a non-cash gain recorded upon issuance of common stock to extinguish long-term interest payable. Income taxes As of December 31, 2000, we had federal and state net operating loss carryforwards of approximately $60.1 million and $25.8 million, respectively. We also have federal and state research and development tax credit carryforwards of approximately $1.2 million and $894,000, respectively, and German net operating loss carryforwards of approximately $9.8 million. The research and development tax credit carryforwards will begin to expire in 2010, unless previously utilized. The federal and state net operating loss and credit carryforwards will begin to expire in 2000 and 2008, respectively. The German net operating losses may be carried forward indefinitely. Pursuant to Internal Revenue Code Sections 382 and 388, our net operating loss and credit carryforwards may be limited due to a cumulative change in ownership of more than 50%, which occurred during 1998 and also in connection with our initial public offering in February 2000. However, we do not believe these limitations will materially impact the use of the net operating loss and credit carryforwards. Liquidity and capital resources In February 2000, we completed our initial public offering (IPO) raising net proceeds of approximately $144.1 million. At March 31, 2001, cash, cash equivalents and short-term investments totaled $128.6 million compared to $159.7 million at March 31, 2000. Our cash reserves are held in a variety of interest-bearing instruments including investment-grade corporate bonds, commercial paper and money market accounts. Cash used in operations for the quarter ended March 31, 2001 was $7.0 million compared with $3.9 million for the same period in 2000. A net loss of $7.0 million for the three months ended March 31, 2001 was partially offset by non-cash charges of $1.4 million for depreciation and amortization expense, $367,000 for amortization of deferred compensation and we used approximately $1.8 million for changes in operating assets and liabilities. Investing activities, other than the changes in our short-term investments, consumed $2.9 million in cash during the first quarter of 2001 due to expenditures for leasehold improvements at our new facility and laboratory equipment. Cash provided by financing activities was $85,000 for the quarter ended March 31, 2001 compared to $142.6 million for the same period in 2000. Financing activities in 2001 included the receipt from proceeds from the exercise of stock options and ESPP purchases, offset by net payments on our capital lease. During the same period of 2000, we received $145.8 from financing activities, including $144.1 million of which was received from the sale of common stock in our initial public offering, which was partially offset by $3.2 million repayment of long-term debt and capital lease obligations. Working capital decreased to $126.3 million at March 31, 2001 from $155.7 million at March 30, 2000. The decrease in working capital was principally due to our use of cash in operations. As of March 31, 2001, we had an aggregate of $1.9 million in future obligations of principal payments under capital leases, $1.0 million of which we plan to repay within the next year. Based on our current plans, we believe our existing cash, cash equivalents and short-term investments will be sufficient to fund our operating expenses, debt obligations and capital requirements through at least the next 9 12 months. However, the actual amount of funds that we will need during or after the next 12 months will be determined by many factors, some of which are beyond our control, and we may need funds sooner than currently anticipated. These factors include: . the level of our success in selling our MassARRAY systems, consumables, assays and services; . the level of our sales and marketing expenses; . the extent to which we enter into collaborations or joint ventures; . our progress with research and development; . our ability to introduce and sell new products and services; . the costs and timing of obtaining new patent rights; . the extent to which we acquire technologies or companies; . regulatory changes and competition and technological developments in the market; and . the level of our expenses associated with litigation. We have a $25.0 million bank line of credit, all of which is available for borrowing. In addition, we have established an $8.0 million capital equipment financing agreement, $6.1 million of which was available for utilization at March 31, 2001. We have no commitments for any additional financings. If additional funds are required and we are unable to obtain them on terms favorable to us, we may be required to cease or reduce further commercialization of our products, to sell some or all of our technology or assets or to merge with another entity. If we raise additional funds by selling shares of our capital stock, the ownership interest of our stockholders will be diluted. 10 RISKS AND UNCERTAINTIES The following is a summary of the many risks we face in our business. You should carefully read these risks and uncertainties in evaluating our business. We have a limited operating history. We are a relatively new company, and for the most part, our technologies are still in the early stages of development. We commercially launched our first product, the MassARRAY system, in December 1999. As a result, our business is subject to all of the risks inherent in the development of a new business enterprise, such as the need to: . obtain substantial capital to support the expenses of further developing our technology and commercializing our products and services; . develop a market for our products and services; and . attract and retain qualified management, sales, technical and scientific staff. Our operations may also be affected by problems frequently encountered with the use of new technologies and by the competitive environment in which we operate, as well as the risks detailed below. We have a history of operating losses, expect to incur future losses and cannot be certain that we will become profitable. We have experienced significant operating losses in each period since inception, and we expect these losses to continue. It is uncertain when, if ever, we will become profitable. As of March 31, 2001, our accumulated deficit was $83.4 million. Our losses have resulted principally from costs incurred in research and development and from selling, general and administrative costs associated with our operations. These costs have exceeded revenues and interest income in each period since inception. We have generated revenues principally from MassARRAY system and disposable sales, validation services and government research grants. We expect to incur increasing operating losses as a result of expenses associated with production, marketing and sales, research and product development and selling, general and administrative costs. Our operating results may fluctuate significantly. Our revenues and results of operations may fluctuate significantly, depending on a variety of factors, including the following: . our success in selling, and changes in the demand for, our products and services; . variations in the timing of payments from customers and collaborative partners and the recognition of these payments as revenues; . the pricing of our products and services; . the timing of any new product or service offerings; . changes in the research and development budgets of our customers and partners; . the introduction of new products and services by our competitors; . changes in the regulatory environment affecting health care and health care providers; . expenses related to, and the results of, any litigation or other proceedings relating to intellectual property rights; . the cost and timing of our adoption of new technologies; and 11 . the cost, quality and availability of oligonucleotides, tissue samples, reagents and related components and technologies. In particular, our revenues and operating results are unpredictable because the sales cycle for our MassARRAY and service products is lengthy. Our revenues and operating results depend to a large extent on the number and timing of MassARRAY system placements that we make during the quarter and the duration of revenue generating license agreements and collaborative programs with partners. We expect to recognize a substantial portion of our quarterly revenues in the last month of a quarter, with a concentration of these revenues in the last weeks or days of the third month. Our expense levels are relatively fixed in the short term and are based, in part, on our expectations of our future revenues. Any delay in generating or recognizing revenues could cause significant variations in our operating results from quarter to quarter and could result in increased operating losses. We believe that period-to-period comparisons of our financial results will not necessarily be meaningful. You should not rely on these comparisons as an indication of our future performance. If our operating results in any future period fall below the expectations of securities analysts and investors, our stock price will likely fall. A reduction in revenues from sales of MassARRAY systems would harm our business. A decline in the demand for MassARRAY Systems would reduce our total revenues and harm our business. We expect that the MassARRAY system will continue to account for a substantial portion of our total revenues for the foreseeable future. The following factors may reduce the demand for MassARRAY systems: . competition from other products; . failure of SNPs to demonstrate medical relevance; . negative publicity or evaluation; or . intellectual property claims or litigation. If we are unable to obtain additional funds, we would have to reduce or cease operations, attempt to sell some or all of our operations or merge with another entity. If we require additional funds and we are unable to obtain them on terms favorable to us, we may be required to cease or reduce further commercialization of our products and services, sell some or all of our technology or assets or merge with another entity. If we raise additional funds by selling additional shares of our capital stock, the ownership interest of our stockholders will be diluted. We may not be able to successfully adapt our products for commercial applications. A number of potential applications of our MassARRAY technology will require significant enhancements in our core technology, including adaptation of our software and further miniaturization. In addition, we need to enhance our population-based DNA bank, expand databases for determining the medical importance of SNPs and rapidly design assays for SNP analysis in sufficient quantities to meet the high throughput that we expect our future customers will require. If we are unable, for technological or other reasons, to complete the development, introduction or scale-up of the manufacturing of any product or genotyping facility, or if any of our products does not achieve a significant level of market acceptance, our business, financial condition and results of operations could be seriously harmed. Market acceptance will depend on many factors, including demonstrating to customers that our technology is superior to other technologies and products which are available now or which may become available in the future. We believe that our revenue growth and profitability will substantially depend on our ability to overcome significant technological challenges and successfully introduce our products and services into the marketplace. 12 We may not be able to expand our business to offer services to our customers. We are currently expanding our business to run multiple assays and validate SNPs at our facilities for some of our customers. To do this, we recently leased additional facilities, and will need to purchase equipment and hire additional personnel. If we are unable to successfully implement or manage an expanded business, or are delayed in doing so, our relationships with our customers may be harmed. We and our collaborative partners may not be successful in developing or commercializing therapeutic, diagnostic or other products using our products or services. Development of therapeutic, diagnostic and other products based on our discoveries and/or our collaborative partners' discoveries will also be subject to other risks of failure inherent in their development or commercial viability. These risks include the possibility that any such products will: . fail to receive necessary regulatory approvals; . fail to be developed prior to the successful marketing of similar products by competitors; . be found to be ineffective; . be difficult or impossible to manufacture on a commercial scale; . be uneconomical to market; . be found to be toxic; or . be impossible to market because they infringe on the proprietary rights of third parties or compete with products marketed by third parties that are superior. If a partner or we discover therapeutic, diagnostic or other products using our products or services, we may rely on that partner for product development, regulatory approval, manufacturing and marketing of those products before we can realize some of the milestone payments, royalties and other payments we may be entitled to under the terms of our collaboration agreements. Our collaboration agreements typically allow the partner significant discretion in electing whether to pursue any of these activities. We cannot control the amount and timing of resources our collaborators may devote to our programs or potential products. As a result, we cannot be certain that our collaborators will choose to develop or commercialize any products or will be successful in doing so. In addition, if a collaborator is involved in a business combination, such as a merger or acquisition or changes its business focus, its performance in its agreement with us may suffer and, as a result, we may not generate any revenues from the royalty, milestone and similar payment provisions of our agreement with that collaborator. We may not successfully develop or derive revenues from our genotyping and gene discovery programs. Our genotyping and gene discovery programs are still in the early stages of development and may not result in marketable products. We are directing our technology and development focus primarily toward identifying genes that are believed to be responsible for, or indicate the presence of, certain diseases. We have only identified a limited number of specific candidate genes under our research programs and have not yet validated any disease genes. Our technologies and approach to gene discovery may not enable us to successfully identify the specific genes that cause or predispose individuals to the complex diseases that are the targets of our efforts to identify genetic variations that have medical utility. In addition, the diseases we are targeting are generally believed to be caused by a number of genetic and environmental factors. It may not be possible to address such diseases through gene-based therapeutic or diagnostic products. Accordingly, even if we are successful in identifying specific genes, our discoveries may not lead to the development of commercial products. 13 If the medical relevance of SNPs becomes questionable, we may have less demand for our products and services. Some of the products we hope to develop involve new and unproven approaches. They are based on the assumption that information about genes may help scientists better understand complex disease processes. Scientists generally have a limited understanding of the role of genes in diseases, and few products based on gene discoveries have been developed. We cannot be certain that genetic information will play a key role in the development of drugs and diagnostics in the future. If we are unable to generate valuable information that can be used to develop these drugs and diagnostics, the demand for our products and services will be reduced and our business is likely to be harmed. If we do not succeed in obtaining development and marketing rights for some of the assays developed in collaboration with our customers, our revenue and profitability could be reduced. Our business strategy includes the development of assays in collaboration with customers, and we intend to obtain commercialization rights to those assays. If we are unable to obtain rights to those assays, our revenue and profitability could be reduced. To date, we have initiated limited activities towards the exploitation of any commercialization rights or products developed in collaboration with third parties. Even if we obtain commercialization rights, commercialization of products may require resources that we do not currently possess and may not be able to develop or obtain. We depend on sales of SpectroCHIPs and other disposables for a significant portion of our revenues. Our system and related disposable sales may be limited if our MassARRAY system is used below its capacity. Sales of SpectroCHIPs and other disposables will become an increasingly important source of revenue. Factors which may limit the use of SpectroCHIPs and other disposables include: additional sales of MassARRAY systems, the acceptance of our technology by our customers, the extent of our customers' level of utilization of their MassARRAY systems, and the training of customer personnel. If our customers do not purchase sufficient quantities of SpectroCHIPs and other disposables, our revenues will be lower than expected. If our customers are unable to adequately prepare samples as required by our MassARRAY system, the overall market demand for our products may decline. Before using our MassARRAY system, customers must prepare samples by following several steps that are prone to human error, including DNA isolation and DNA segment amplification. If DNA samples are not prepared appropriately, our MassARRAY system will not generate a reading. If our customers experience similar difficulties, they may achieve lower levels of throughput than those for which our system was designed. If our customers are unable to generate expected levels of throughput, they may not continue to purchase our disposables, they may express their discontent with our products in the marketplace, potentially driving down demand for our products, or they may collaborate with others to jointly use our products. Any or all of these actions would reduce the overall market demand for our products. We have limited commercial production capability and experience and may encounter production problems or delays, which could result in lower revenue. We assemble the MassARRAY system and manufacture the SpectroCHIP and MassARRAY kit. To date, we have only produced these products in limited quantities. Our customers require that we comply with current good manufacturing practices that we may not be able to meet. We may not be able to maintain acceptable quality standards as we ramp up production. To achieve anticipated customer demand levels, we will need to scale-up our production capability and maintain adequate levels of inventory. We may not be able to produce sufficient quantities to meet market demand. If we cannot achieve the required level and quality of production, we may need to outsource production or rely on licensing and other arrangements with third parties. This reliance could reduce our gross margins and expose us to the risks inherent in relying on others. We may not be able to 14 successfully outsource our production or enter into licensing or other arrangements with these third parties, which could adversely affect our business. If ethical, privacy or other concerns surrounding the use of genetic information become widespread, we may have less demand for our products and services. Our customers use our products and services for genetic testing. Genetic testing has raised ethical issues regarding privacy and the appropriate uses of the resulting information. For these reasons, governmental authorities may call for limits on or regulation of the use of genetic testing or prohibit testing for genetic predisposition to certain conditions, particularly for those that have no known cure. Similarly, such concerns may lead individuals to refuse to use genetics tests even if permissible. Any of these scenarios could reduce the potential markets for our products and services, which could seriously harm our business, financial condition and results of operations. We depend on third-party products and services and sole or limited sources of supply to develop and manufacture components and materials used in our products. We rely on outside vendors to supply the components and materials used in our products. Some of these components and materials are obtained from a single supplier or a limited group of suppliers. We have experienced quality problems with, and delays in receiving, oligonucleotides, which are necessary materials used in connection with the operation of the MassARRAY system. Our reliance on outside vendors generally, and a sole or a limited group of suppliers in particular, involves several risks, including: . the inability to obtain an adequate supply of required components and materials due to capacity constraints, a discontinuance of a product by a supplier or other supply constraints; . reduced control over quality and pricing of components and materials; and . delays and long lead times in receiving components or materials from vendors. If our access to necessary tissue samples or information is restricted, we will not be able to continue to develop our business. We need access to normal and diseased human tissue samples, other biological materials and related clinical and other information to continue to develop our products and services. We compete with many other companies for these materials and information. We may not be able to obtain or maintain access to these materials and information. In addition, government regulation in the United States and foreign countries could result in restricted access to, or use of, human and other tissue samples. If we lose access to sufficient numbers or sources of tissue samples, or if tighter restrictions are imposed on our use of the information generated from tissue samples, our business will suffer. We may not successfully integrate future acquisitions. In the future, we may acquire additional complementary companies or technologies. Managing these acquisitions will entail numerous operational and financial risks, including: . exposure to unknown liabilities; . higher than expected acquisition and integration costs which may cause our quarterly and annual operating results to fluctuate; . combining the operations and personnel of acquired businesses with our own, which may be difficult and costly, and integrating or completing the development and application of any acquired technologies, which may disrupt our business and divert our management's time and attention; 15 . impairment of relationships with key customers of acquired businesses due to changes in management and ownership of the acquired businesses; . inability to retain key employees of any acquired businesses or hire enough qualified personnel to staff any new or expanded operations; and . increased amortization expenses if an acquisition results in significant goodwill or other intangible assets. Our industry is highly competitive and we may not have the resources required to successfully compete. The biotechnology industry is highly competitive. We compete with a broad range of companies in the United States and abroad that are engaged in the development and production of products, services and strategies to analyze genetic information. They include: . biotechnology, pharmaceutical, chemical and other companies; . academic and scientific institutions; . governmental agencies; and . public and private research organizations. Many of our competitors have much greater financial, technical, research, marketing, sales, distribution, service and other resources than we do. Moreover, our competitors may offer broader product lines, services and have greater name recognition than we do, and may offer discounts as a competitive tactic. In addition, several early stage companies are currently making or developing products that compete with or will compete with our products. Our competitors may develop or market technologies, products or services that are more effective or commercially attractive than our current or future products and services, or that may render our technologies and products obsolete. We may also compete against some of our customers, which may adversely affect our relationships with them. We are highly dependent on our Board of Directors and principal members of our management and scientific staff, the loss of whom would impair our ability to compete. The loss of the services of any of these persons could delay or reduce our product development and commercialization efforts. In addition, we will require additional personnel in the areas of scientific research, diagnostic testing, manufacturing and marketing. We may not be able to attract and retain qualified personnel at the Board of Directors level or any management level, which could seriously harm our business, financial condition and results of operations. Our ability to compete in the market may decline if we lose some of our intellectual property rights due to lawsuits to protect or enforce our patents. Our success will depend on our ability to obtain and protect patents on our technology and to protect our trade secrets. Our patents, which have been or may be issued, may not afford meaningful protection for our technology and products. Others may challenge our patents and, as a result, our patents could be narrowed, invalidated or unenforceable. In addition, our current and future patent applications may not result in the issue of patents in the United States or foreign countries. Competitors may develop products similar to ours that do not conflict with our patents. In addition, others may develop products for use in the MassARRAY system in violation of our patents that could reduce sales of disposables. In order to protect or enforce our patent rights, we may initiate interference proceedings, oppositions, or patent litigation against third parties, such as infringement suits. These lawsuits could be expensive, take significant time and divert management's attention from other business concerns. The patent position of biotechnology firms generally is highly uncertain, involves complex legal and factual questions, and has recently been the subject of much litigation. No consistent policy has emerged from the U.S. Patent and Trademark Office or the courts regarding the breadth of claims allowed or the degree of protection afforded under biotechnology patents. In addition, there is a substantial backlog of 16 biotechnology patent applications at the U.S. Patent and Trademark Office, and the approval or rejection of patent applications may take several years. The rights we rely upon to protect the intellectual property underlying our products may not be adequate, which could enable third parties to use our technology and would reduce our ability to compete in the market. We require our employees, consultants and advisors to execute confidentiality agreements. However, we cannot guarantee that these agreements will provide us with adequate protection against improper use or disclosure of confidential information. In addition, in some situations, these agreements may conflict with, or be subject to, the rights of third parties with whom our employees, consultants or advisors have prior employment or consulting relationships. Further, others may independently develop substantially equivalent proprietary information and techniques, or otherwise gain access to our trade secrets. Our success will depend partly on our ability to operate without infringing on or misappropriating the proprietary rights of others. We may be sued for infringing on the patent rights of others. Intellectual property litigation is costly, and, even if we prevail, the cost of such litigation could adversely affect our business, financial condition and results of operations. In addition, litigation is time consuming and could divert management attention and resources away from our business. If we do not prevail in any litigation, in addition to any damages we might have to pay, we could be required to stop the infringing activity or obtain a license. Any required license may not be available to us on acceptable terms, or at all. In addition, some licenses may be non-exclusive, and therefore, our competitors may have access to the same technology licensed to us. If we fail to obtain a required license or are unable to design around a patent, we may be unable to sell some of our products, which could have a material adverse affect on our business, financial condition and results of operations. From time to time, we receive letters from companies regarding their issued patents and patent applications alleging or suggesting possible infringement. We may be unable to obtain licenses to patented SNPs, which could prevent us from obtaining significant revenue or becoming profitable. The U.S. Patent and Trademark Office has issued and continues to issue patents claiming SNP discoveries and their related associations and functions. If important SNPs are patented, we will need to obtain rights to those SNPs in order to develop, use and sell related assays. Required licenses may not be available on commercially acceptable terms, or at all. If we fail to obtain licenses to important patented SNPs, we may never achieve significant revenue or become profitable. Because our products currently depend on components licensed or supplied from third parties, our breach of any of the terms of these licenses or supply agreements could result in our loss of access to these components and could delay or suspend our commercialization efforts. We have acquired or licensed components of our technology from third parties. Our failure to maintain the right to use these components could seriously harm our business, financial condition and results of operations. In addition, changes to or termination of our agreements with these third parties could result in the loss of access to these aspects of our technology and could delay or suspend our commercialization efforts. Our grants from the government give the government certain license rights to inventions resulting from funded work in the event that we fail to commercialize the technology developed using government funds. Our business could be harmed if the government exercises those rights. 17 Failure to expand our international sales as we intend would reduce our ability to become profitable. We expect that a significant portion of our sales will be made outside the United States. A successful international effort will require us to develop relationships with international customers and partners. We may not be able to identify, attract or retain suitable international customers and partners. As a result, we may be unsuccessful in our international expansion efforts. Furthermore, expansion into international markets will require us to continue to establish and grow foreign operations, hire additional personnel to run these operations and maintain good relations with our foreign customers and partners. International operations involve a number of risks not typically present in domestic operations, including: . currency fluctuation risks; . changes in regulatory requirements; . costs and risks of deploying systems in foreign countries; . licenses, tariffs and other trade barriers; . political and economic instability; . difficulties in staffing and managing foreign operations; . potentially adverse tax consequences; . the burden of complying with a wide variety of complex foreign laws and treaties; and . different rules, regulations, and policies governing intellectual property protection and enforcement. Our international operations are also be subject to the risks associated with the imposition of legislation and regulations relating to the import or export of high technology products. We cannot predict whether tariffs or restrictions upon the importation or exportation of our products will be implemented by the United States or other countries. We may lose money when we exchange foreign currency received from international sales into U.S. dollars. A significant portion of our business is expected to be conducted in currencies other than the U.S. dollar. We recognize foreign currency gains or losses arising from our operations in the period incurred. As a result, currency fluctuations between the U.S. dollar and the currencies in which we do business will cause foreign currency translation gains and losses. We cannot predict the effects of exchange rate fluctuations upon our future operating results because of the variability of currency exposure and the potential volatility of currency exchange rates. We do not currently engage in foreign exchange hedging transactions to manage our foreign currency exposure. Our revenues are derived primarily from, and are subject to risks faced by, pharmaceutical and biotechnology companies and governmental and others research institutions. We expect that our revenues in the foreseeable future will be derived primarily from products and services provided to pharmaceutical and biotechnology companies and governmental and other research institutions. Accordingly, our success will depend upon their demand for our products and services. Our operating results may fluctuate substantially due to reductions and delays in research and development expenditures by these customers. These reductions and delays may result from factors such as: . changes in economic conditions; . changes in government programs that provide funding; . changes in the regulatory environment affecting health care and health care providers; 18 . pricing pressures and reimbursement policies; . market-driven pressures on companies to consolidate and reduce costs; and . other factors affecting research and development spending. None of these factors is within our control. We may not have adequate insurance and if we become subject to product liability claims, we may experience reduced demand for our products and services or be required to pay damages that exceed our insurance limitations. Our business exposes us to potential product liability claims that are inherent in the life science field. Any product liability claim in excess of our insurance coverage would have to be paid out of our cash reserves, which would have a detrimental effect on our financial condition. It is difficult to determine whether we have obtained sufficient insurance to cover potential claims. Also, we cannot assure you that we can or will maintain our insurance policies on commercially acceptable terms, or at all. Responding to claims relating to improper handling, storage or disposal of hazardous chemicals and radioactive and biological materials which we use, could be time consuming and costly. We use controlled hazardous and radioactive materials in our business. The risk of accidental contamination or injury from these materials cannot be completely eliminated. If an accident with these substances occurs, we could be liable for any damages that result, which could seriously harm our business. Additionally, an accident could damage our research and manufacturing facilities and operations, resulting in delays and increased costs. If our production and laboratory facilities are damaged, we could experience lost revenue and our business would be seriously harmed. Our only production facility is located in San Diego, California. We have laboratories located in San Diego, Sudbury, Massachusetts and Hamburg, Germany. Damage to our facilities due to fire, natural disaster, power loss, communications failure, unauthorized entry or other events could result in a loss of important data or cause us to cease development and production of our products. We have limited insurance to protect against business interruption; however, there can be no assurance this insurance will be adequate or will continue to be available to us on commercially reasonable terms, or at all. If we do not effectively manage our growth, it could affect our ability to pursue business opportunities and expand our business. Growth in our business has placed, and will continue to place, a significant strain on our personnel, facilities, management systems and resources. We will need to continue to improve our operational and financial systems and managerial controls and procedures and expand, train and manage our workforce. We will rely heavily on software systems, including an enterprise resource planning system and a laboratory information management system that have been or will be installed and utilized. Furthermore, we will have to maintain close coordination among our technical, accounting, marketing, sales and research departments. If we fail to effectively manage our growth and address the above concerns, it could affect our ability to pursue business opportunities and expand our business. Our stock price could be volatile and your investment could suffer a decline in value. The trading price of our common stock has been volatile and could be subject to wide fluctuations in price in response to various factors, many of which are beyond our control, including: . actual or anticipated variations in quarterly operating results; . announcements of technological innovations by us or our competitors; 19 Inflation We do not believe that inflation has had a material adverse impact on our business or operating results during the periods presented. . announcements related to patent and other intellectual property developments; . new products or services introduced or announced by us or our competitors; . changes in financial estimates by securities analysts; . conditions or trends in the biotechnology, pharmaceutical and genomics industries; . changes in the market valuations of other similar companies; . announcements by us of significant acquisitions, strategic partnerships, joint ventures or capital commitments; . additions or departures of key personnel; and . sales of our common stock. In addition, the stock market in general, and the Nasdaq National Market and the market for technology companies in particular, has experienced extreme price and volume fluctuations that have often been unrelated or disproportionate to the operating performance of those companies. Further, there has been particular volatility in the market prices of securities of biotechnology and life sciences companies. These broad market and industry factors may seriously harm the market price of our common stock, regardless of our operating performance. In the past, following periods of volatility in the market price of a company's securities, securities class-action litigation has often been instituted against that company. Such litigation, if instituted against us, could result in substantial costs and a diversion of management's attention and resources, which could seriously harm our business, financial condition and results of operations. Anti-takeover provisions in our charter documents and Delaware law could make a third-party acquisition of us difficult. This could limit the price investors might be willing to pay in the future for our common stock. The anti-takeover provisions in our certificate of incorporation, our bylaws and Delaware law could make it more difficult for a third party to acquire us without approval of our board of directors. As a result of these provisions, we could delay, deter or prevent a takeover attempt or third party acquisition that our stockholders consider to be in their best interests, including a takeover attempt that results in a premium over the market price for the shares held by our stockholders. Item 3. Quantitative and Qualitative Disclosures About Market Risk Short-term investments The primary objective of our investment activities is to preserve principal while at the same time maximizing the income we receive from our investments without significantly increasing risk. Some of the securities that we invest in may have market risk. This means that a change in prevailing interest rates may cause the fair value of the principal amount of the investment to fluctuate. For example, if we hold a security that was issued with a fixed interest rate at the then-prevailing rate and the prevailing interest rate later rises, the fair value of the principal amount of our investment will probably decline. To minimize this risk in the future, we intend to maintain our portfolio of cash equivalents and short-term investments in a variety of securities, including commercial paper, money market funds, government and non-government debt securities. The average duration of all of our investments has generally been less than one year. Due to the short-term nature of these investments, we believe we have no material exposure to interest rate risk arising from our investments. Therefore, no quantitative tabular disclosure is provided. 20 Foreign currency rate fluctuations The functional currency for our German subsidiary is the deutsche mark. The German subsidiary's accounts are translated from the German deutsche mark to the US dollar using the current exchange rate in effect at the balance sheet date, for balance sheet accounts, and using the average exchange rate during the period for revenues and expense accounts. The effects of translation are recorded as a separate component of stockholders' equity. Our German subsidiary conducts its business with customers in local European currencies. Exchange gains and losses arising from these transactions are recorded using the actual exchange differences on the date of the transaction. We have not taken any action to reduce our exposure to changes in foreign currency exchange rates, such as options or futures contracts, with respect to transactions with our German subsidiaries or transactions with our European customers. The net liabilities of our German subsidiary totaled $2.4 million at March 31, 2001. A 1% decrease in the value of the German deutsche mark relative to the US dollar would result in an approximately $24,000 unrealized foreign translation loss. As of January 2002, the functional currency of our German subsidiary will be the Euro. We do not foresee that this transition from the deutsche mark to the Euro will have a material impact on the Companys financial position. 21 PART II OTHER INFORMATION Item 2 Changes in Securities and Use of Proceeds On January 31, 2000, the Company's Form S-1 registration statement (File No. 333-91665) was declared effective by the Securities and Exchange Commission. The registration statement, as amended, covered the offering of 5,250,000 shares of common stock. The offering commenced on January 31, 2000 and the sale to the public of shares of common stock at $26.00 per share was completed on February 3, 2000 for an aggregate price of approximately $136.5 million. The registration statement covered an additional 787,500 shares of common stock that the underwriters had the option to purchase solely to cover over-allotments. These shares were purchased on February 2, 2000 at $26.00 per share for an aggregate price of approximately $20.5 million. The managing underwriters for the offering were Warburg Dillon Read LLC, FleetBoston Robertson Stephens Inc. and SG Cowen Securities Corporation. Expenses incurred through March 31, 2001 in connection with the issuance and distribution of common stock in the offering included underwriting discounts, commissions and allowances of approximately $11.0 million and other expenses of approximately $1.9 million. Total offering expenses of approximately $12.9 million resulted in net offering proceeds to the Company of approximately $144.1 million. No payments or expenses were paid to directors, officers or affiliates of the Company or 10% owners of any class of equity securities of the Company. Of the net offering proceeds, through March 31, 2001, approximately $3.9 million has been used to payoff long-term and other debt, approximately $8.8 million to purchase equipment and improve leaseholds and approximately $45.4 million for general corporate purposes, including hiring additional personnel, development and manufacturing of products, expansion of facilities and expenses for filing and pursing patent applications. The balance is invested in a variety of interest-bearing instruments including investment-grade corporate bonds, commercial paper and money market accounts. Item 6 Exhibits and Reports on Form 8-K (a) Exhibits No exhibits were filed during the quarter ended March 31, 2001. (b) Reports on Form 8-K No reports on Form 8-K were filed during the quarter ended March 31, 2001. 22 SEQUENOM, INC. 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. SEQUENOM, Inc. /s/ Stephen L. Zaniboni Date: May 15, 2001 By: _________________________________ Stephen L. Zaniboni Chief Financial Officer (Duly Authorized Officer and Principal Financial and Accounting Officer) 23