1 UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 ---------- FORM 10-Q [X] Quarterly Report Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 for the quarterly period ended June 30, 2001 OR [ ] Transition Report Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 for the transition period from ____ to _____. Commission File No. 000-30109 ---------- LUMINEX CORPORATION (Exact name of registrant as specified in its charter) DELAWARE 74-2747608 (State or other jurisdiction of (I.R.S. Employer incorporation or organization) Identification No.) 12212 TECHNOLOGY BLVD., AUSTIN, TEXAS 78727 (Address of principal executive offices) (Zip Code) (512) 219-8020 (Registrant's telephone number, including area code) ---------- Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes [X] No [ ] There were 28,369,410 shares of the Company's Common Stock, par value $.001 per share, outstanding on August 10, 2001. 2 INDEX <Table> <Caption> Page ---- PART I. FINANCIAL INFORMATION Item 1. Financial Statements (unaudited) Condensed Consolidated Balance Sheets as of June 30, 2001 and December 31, 2000 ...................................................................... 1 Condensed Consolidated Statements of Operations for the three and six months ended June 30, 2001 and 2000.................................................................. 2 Condensed Consolidated Statements of Cash Flows for the six months ended June 30, 2001 and 2000.................................................................. 3 Notes to Condensed Consolidated Financial Statements........................................ 4 Independent Accountants' Review Report...................................................... 6 Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations............................................................... 7 Factors That May Affect Future Results...................................................... 10 Item 3. Quantitative and Qualitative Disclosure about Market Risk................................... 17 PART II. OTHER INFORMATION Item 2. Change in Securities and Use of Proceeds.................................................... 18 Item 4. Submission of Matters to a Vote of Security Holders......................................... 18 Item 6. Exhibits and Reports on Form 8-K............................................................ 18 SIGNATURES................................................................................................ 19 </Table> i 3 PART I ITEM 1. FINANCIAL STATEMENTS LUMINEX CORPORATION CONDENSED CONSOLIDATED BALANCE SHEETS (in thousands) <Table> <Caption> ASSETS June 30, December 31, 2001 2000 ----------- ------------ (unaudited) Current assets: Cash and cash equivalents ................................... $ 46,907 $ 7,106 Short-term investments ...................................... 14,385 66,521 Accounts receivable, net .................................... 4,634 3,085 Inventories ................................................. 5,158 2,408 Other ....................................................... 1,392 1,739 --------- --------- Total current assets ............................ 72,476 80,859 Property and equipment, net ................................. 3,572 2,770 Notes receivable - related parties .......................... 439 39 --------- --------- Total assets .................................... $ 76,487 $ 83,668 ========= ========= LIABILITIES AND STOCKHOLDERS' EQUITY Current liabilities: Accounts payable ............................................ $ 1,438 $ 2,741 Accrued liabilities ......................................... 936 673 Deferred revenue ............................................ 698 666 --------- --------- Total current liabilities ....................... 3,072 4,080 Long-term deferred revenue ................................................ 600 900 --------- --------- Total liabilities ............................... 3,672 4,980 Stockholders' equity: Common stock ................................................ 28 28 Additional paid-in capital .................................. 117,602 115,651 Deferred stock compensation ................................. (1,035) (1,529) Accumulated deficit ......................................... (43,780) (35,462) --------- --------- Total stockholders' equity ...................... 72,815 78,688 --------- --------- Total liabilities and stockholders' equity ...... $ 76,487 $ 83,668 ========= ========= </Table> See Independent Accountants' Review Report. 1 4 LUMINEX CORPORATION CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (in thousands, except per share amounts) <Table> <Caption> Three Months Ended Six Months Ended June 30, June 30, ----------------------- ----------------------- 2001 2000 2001 2000 -------- -------- -------- -------- (unaudited) (unaudited) Revenue: Product ................................. $ 4,489 $ 1,394 $ 8,084 $ 2,784 Grant ................................... 223 -- 492 -- -------- -------- -------- -------- Total revenue ............... 4,712 1,394 8,576 2,784 Cost of product revenue ................. 3,918 985 6,528 1,708 -------- -------- -------- -------- Gross profit ................ 794 409 2,048 1,076 Operating expenses: Research and development ................ 1,806 2,408 4,638 3,741 Selling, general and administrative ..... 4,134 2,846 7,584 4,903 -------- -------- -------- -------- Total operating expenses .... 5,940 5,254 12,222 8,644 Loss from operations .................................. (5,146) (4,845) (10,174) (7,568) Interest income ......................... 777 1,201 1,856 1,313 -------- -------- -------- -------- Net loss .............................................. $ (4,369) $ (3,644) $ (8,318) $ (6,255) ======== ======== ======== ======== Net loss per share, basic and diluted ................. $ (0.15) $ (0.13) $ (0.30) $ (0.31) ======== ======== ======== ======== Shares used in computing net loss per share, basic and diluted ..................... 28,258 27,006 28,079 20,206 </Table> See Independent Accountants' Review Report. 2 5 LUMINEX CORPORATION CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS (in thousands) <Table> <Caption> Six Months Ended June 30, ------------------------- 2001 2000 -------- -------- (unaudited) Operating activities: Net loss ........................................... $ (8,318) $ (6,255) Adjustments to reconcile net loss to net cash used in operating activities: Depreciation and amortization .......... 751 380 Stock compensation ..................... 478 2,080 Changes in operating assets and liabilities: Accounts receivable .................... (1,549) 95 Inventories ............................ (2,750) (623) Other .................................. 347 (970) Accounts payable ....................... (1,303) 505 Accrued liabilities .................... 263 23 Deferred revenue ....................... (268) 752 -------- -------- Net cash used in operating activities ............................ (12,349) (4,013) -------- -------- Investing activities: Net maturities of short-term investments ........... 52,136 (46,006) Purchase of property and equipment ................. (1,553) (951) Notes receivable - related parties ................. (400) (74) -------- -------- Net cash provided by (used in) investing activities .............. 50,183 (47,031) -------- -------- Financing activities: Proceeds from issuance of common stock ............. 1,967 77,738 Stock issuance costs ............................... -- (1,241) -------- -------- Net cash provided by financing activities ........................ 1,967 76,497 -------- -------- Increase in cash and cash equivalents ............................ 39,801 25,453 Cash and cash equivalents, beginning of period ................... 7,106 4,083 -------- -------- Cash and cash equivalents, end of period ......................... $ 46,907 $ 29,536 ======== ======== Supplemental disclosure of noncash activities: Conversion of preferred stock ...................... $ -- $ 28,946 Accrued stock issuance cost ........................ $ -- $ 18 </Table> See Independent Accountants' Review Report. 3 6 LUMINEX CORPORATION NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED) NOTE 1--BASIS OF PRESENTATION The accompanying unaudited condensed consolidated financial statements have been prepared by Luminex Corporation (the "Company") in accordance with accounting principles generally accepted in the United States for interim financial information and the rules and regulations of the Securities and Exchange Commission. Accordingly, they do not include all of the information and footnotes required by accounting principles generally accepted in the United States for complete financial statements. The consolidated financial statements include the accounts of Luminex Corporation and its wholly-owned subsidiaries. All significant intercompany accounts and transactions have been eliminated in consolidation. In the opinion of management, all adjustments (consisting of normal recurring entries) considered necessary for a fair presentation have been included. Operating results for the three and six months ended June 30, 2001 are not necessarily indicative of the results that may be expected for the year ending December 31, 2001. These financial statements should be read in conjunction with the financial statements and notes thereto included in the Company's Form 10-K for the year ended December 31, 2000. NOTE 2--INVENTORIES Inventories consisted of the following (in thousands): <Table> <Caption> June 30, December 31, 2001 2000 -------- ------------ Parts and supplies .......................... $4,531 $2,002 Work-in-progress and finished goods ......... 627 406 ------ ------ $5,158 $2,408 ====== ====== </Table> NOTE 3--NOTES RECEIVABLE - RELATED PARTIES Notes receivable - related parties at June 30, 2001, consisted of notes from two officers of the Company. In connection with the relocation and employment of an officer, the Company received a promissory note in the amount of $400,000, secured by mortgaged real property. The promissory note is non-interest bearing and is due on the earlier of (i) the termination of the officer or (ii) May 9, 2011. Contingent upon the continued employment of the officer, beginning October 2, 2001, the principal amount will be forgiven to the extent of $50,000 each year until October 2, 2004, for a total possible reduction of $200,000. NOTE 4--NET LOSS PER SHARE In accordance with Statement of Financial Accounting Standards No. 128, Earnings Per Share, basic and diluted net loss per share is computed by dividing the net loss for the period by the weighted average number of common shares outstanding during the period. The Company has excluded all potentially dilutive securities such as convertible preferred stock, outstanding stock options and outstanding warrants to purchase common stock from the calculation of diluted loss per common share because such securities are anti-dilutive due to the Company's net loss for all periods presented. The total shares excluded from the calculations of diluted net loss per share, prior to application of the treasury stock method for options and warrants, were 3,800,960 and 3,993,234 for the three and six months ended June 30, 2001, respectively, and 3,614,270 and 11,997,450 for the three and six months ended June 30, 2000, respectively. Pro forma net loss per share amounts have been computed as described above and give effect to common equivalent shares arising from preferred stock that automatically converted upon the April 3, 2000 closing of the Company's initial public offering as if the preferred shares had converted at the original date of issuance. See Independent Accountants' Review Report. 4 7 LUMINEX CORPORATION NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (CONTINUED) (UNAUDITED) NOTE 4--NET LOSS PER SHARE (CONTINUED) The following is a reconciliation of the numerator and denominator of basic and diluted net loss per share (in thousands, except per share amounts): <Table> <Caption> Three Months Ended Six Months Ended June 30, June 30, ----------------------- ----------------------- 2001 2000 2001 2000 -------- -------- -------- -------- Basic and diluted: Net loss ......................................................... $ (4,369) $ (3,644) $ (8,318) $ (6,255) Weighted average shares of common stock outstanding .............. 28,258 27,006 28,079 20,206 Net loss per share, basic and diluted ............................ $ (0.15) $ (0.13) $ (0.30) $ (0.31) ======== ======== ======== ======== Net loss per share, basic and diluted: Shares used above ............................................ 28,258 27,006 28,079 20,206 Add: Pro forma adjustment to reflect weighted average effect of assumed conversion of preferred stock ............... -- -- -- 4,336 -------- -------- -------- -------- Shares used in computing basic and diluted pro forma net loss per share, basic and diluted pro forma ................. 28,258 27,006 28,079 24,542 Net loss per share, basic and diluted pro forma .............. $ (0.15) $ (0.13) $ (0.30) $ (0.25) ======== ======== ======== ======== </Table> NOTE 5--STOCKHOLDERS' RIGHTS PLAN On June 20, 2001, the Company's Board of Directors declared a dividend of one right for each outstanding share of the Company's common stock to stockholders of record at the close of business on July 2, 2001. Each right entitles the registered holder to purchase from the Company a unit consisting of one one-hundredth of a share of Series A Junior Participating Preferred Stock, par value $.001 per share, at a purchase price of $100 per fractional share, subject to adjustment. 5 8 INDEPENDENT ACCOUNTANTS' REVIEW REPORT To The Board of Directors of Luminex Corporation We have reviewed the accompanying condensed consolidated balance sheet of Luminex Corporation as of June 30, 2001, and the related condensed consolidated statements of operations for the three and six months ended June 30, 2001 and 2000, and the related condensed consolidated statements of cash flows for the six months ended June 30, 2001 and 2000. These financial statements are the responsibility of the Company's management. We conducted our review in accordance with standards established by the American Institute of Certified Public Accountants. A review of interim financial information consists principally of applying analytical procedures to financial data, and making inquiries of persons responsible for financial and accounting matters. It is substantially less in scope than an audit conducted in accordance with auditing standards generally accepted in the United States, which will be performed for the full year with the objective of expressing an opinion regarding the financial statements taken as a whole. Accordingly, we do not express such an opinion. Based on our review, we are not aware of any material modifications that should be made to the accompanying financial statements at June 30, 2001, and for the three and six month periods ended June 30, 2001 and 2000, for them to be in conformity with accounting principles generally accepted in the United States. We have previously audited in accordance with auditing standards generally accepted in the United States, the consolidated balance sheet of Luminex Corporation as of December 31, 2000, and the related consolidated statements of operations, stockholders' equity, and cash flows for the year then ended [not presented herein] and in our report dated January 26, 2001, we expressed an unqualified opinion on those financial statements. In our opinion, the information set forth in the accompanying condensed consolidated balance sheet as of December 31, 2000, is fairly stated, in all material aspects, in relation to the consolidated balance sheet from which it has been derived. /s/ Ernst & Young LLP Austin, Texas July 19, 2001 6 9 ITEM 2. MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS The following information should be read in conjunction with the condensed consolidated financial statements and the accompanying notes included in Item 1 of this report, our Form 10-K for the year ended December 31, 2000 and "Factors That May Affect Future Results" in this report. SAFE HARBOR CAUTIONARY STATEMENT All statements in this report that do not discuss past results are forward-looking statements. Generally, the words "believe," "expect," "intend," "estimate," "anticipate," "will" and similar expressions identify forward-looking statements. All statements which address our outlook for our businesses and their respective markets, such as projections of future performance, statements of management's plans and objectives, forecasts of market trends and other matters are forward-looking statements. It is important to note that our actual results or performance could differ materially from those projected in such forward-looking statements. Forward-looking statements are based on management's current expectations and are therefore subject to certain risks and uncertainties, including those discussed under the section titled "Factors That May Affect Future Results" included in this report. Specific uncertainties which could cause our actual results to differ materially from those projected include risks and uncertainties relating to market demand for and acceptance of our products, our dependence on strategic partners for development and distribution of products, competition, our ability to scale-up manufacturing operations, potential shortages of components and the timing and content of regulatory approvals and rulings. We expressly disclaim any intent, obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained in this report to reflect any change in our expectations with regard to such statements or any change in events, conditions or circumstances on which any such statements are based. OVERVIEW Since inception, we have incurred significant losses and, as of June 30, 2001, we had an accumulated deficit of $43.8 million. Our limited operating history makes accurate predictions of future operations difficult or impossible. Moreover, we anticipate that our quarterly results of operations will fluctuate for the foreseeable future due to several factors, including the rate of market acceptance of current and new products, the timing of the introduction by our strategic partners of commercial products based on our technology, the timing of regulatory approvals, our ability to scale up manufacturing operations and avoid component shortages, the introduction of new products by our competitors, the timing and extent of our research and development efforts and the timing of significant orders. Our ability to achieve sustained profitability will depend upon our ability to continue to enter into strategic partnerships with companies that will develop and market products incorporating our technology and market and distribute our systems and consumables. Certain of our strategic partners develop application-specific bioassay kits for use on our systems that they sell to their customers generating royalties for us. Other strategic partners perform testing services for third parties using our technology that also result in royalties for us. Some strategic partners buy our products and then resell those products to their customers. Through June 30, 2001, we have entered into strategic partnerships with 29 companies. Revenue on sales of our products is recognized when persuasive evidence of an agreement exists, delivery has occurred, the fee is fixed and determinable, and collectibility is probable. Generally, these criteria are met at the time our product is shipped. We expect that each system's sale will generate a recurring revenue stream from the sale of consumable products. In addition, we expect to generate royalty revenue from some of our strategic partners as they sell products incorporating our technology or provide testing services to third parties using our technology. Cost of product revenue consists of direct and indirect instrument and reagent manufacturing, quality control, training, field service, customer service and warranty costs. Our operating expenses have consisted primarily of costs incurred in research and development, manufacturing scale-up and business development and from general and administrative costs associated with our operations. We expect our research and development expenses for each of the next two quarters to approximate our second quarter spending level. Our selling and 7 10 marketing expenses will increase as we continue to commercialize our products, and general and administrative expenses will increase as we add personnel and expand our facilities. Deferred stock compensation represents the difference between the deemed fair value of our common stock and the exercise price of options or warrants or the fair market value of restricted stock grants. For options and restricted stock granted to employees and directors, this difference is calculated as of the grant date and amortized ratably over the vesting period. For options or warrants granted to consultants, the difference is recognized as of the vesting date with adjustments made to the recognized deferred compensation amount up and until that time based on the market value of our common stock. As a result of stock options, warrants and restricted stock grants, we recorded $244,000 and $1.3 million in deferred stock compensation expense for the three months ended June 30, 2001 and 2000, respectively, and $478,000 and $2.1 million in deferred stock compensation expense for the six months ended June 30, 2001 and 2000, respectively. Total unamortized deferred stock compensation as of June 30, 2001 was $1.0 million. Total deferred revenue as of June 30, 2001 was $1.3 million and consisted of (i) payments received for sales to customers with rights of return that had not yet expired, (ii) upfront payments from strategic partners to be used for the purchase of instruments or to be applied towards future royalty payments and (iii) payments received for service, maintenance and training revenue not yet earned. Upfront payments from our strategic partners are nonrefundable and will be recognized as revenue as our strategic partners purchase systems or apply such amounts against royalty payments or instrument purchases. RESULTS OF OPERATIONS THREE MONTHS ENDED JUNE 30, 2001 COMPARED TO THREE MONTHS ENDED JUNE 30, 2000 Revenue. Product revenue increased 222% to $4.5 million for the three months ended June 30, 2001. The increase was primarily attributable to increased sales of Luminex 100 systems and peripheral components, as well as increased consumable sales. During the second quarter of 2001, we placed 174 Luminex 100 systems, 1 HTS system, 107 Luminex XY Platforms and 91 SD units compared with 51 Luminex 100 systems, 46 XY Platforms and no HTS systems or SD units placed in the second quarter of 2000. Consumable sales increased by 282% to $711,000, which is attributable to the increase in the installed base of Luminex 100 systems. Included in the three months ended June 30, 2001 is $223,000 of revenue associated with a government grant. The original government grant was reinstated July 1, 2000 with a new joint venture partner after being temporarily suspended in September of 1999. On July 1, 2001, the reinstated grant was suspended due to the withdrawal of the new joint venture partner. As a result, we do not expect to realize any further grant revenue in future periods. A breakdown of revenue for the three months ended June 30, 2001 and 2000 is as follows (in thousands): <Table> <Caption> Three Months Ended June 30, ------------------ 2001 2000 ------ ------ System sales ................. $3,502 $1,184 Consumable sales ............. 711 186 Grant revenue ................ 223 -- Other revenue ................ 276 24 ------ ------ Total revenue ......... $4,712 $1,394 ====== ====== </Table> Gross Profit. Gross profit increased by 94% to $794,000 for the three months ended June 30, 2001. Gross margin (gross profit as a percentage of total revenue) decreased from 29% for the three months ended June 30, 2000 to 17% for the three months ended June 30, 2001. The decrease in gross margin was primarily attributable to lower average selling prices of our systems, resulting from discounted sales to early adopting strategic partners. 8 11 Research and Development Expense. Research and development expenses decreased 25% to $1.8 million for the three months ended June 30, 2001. The decrease was attributable to several factors, including decreased consumption of parts and supplies of $416,000 and decreased stock compensation expense of $369,000 which was offset by increased personnel cost of $140,000 due to an increased number of employees. Selling, General and Administrative Expense. Selling, general and administrative expenses increased by 45% to $4.1 million for the three months ended June 30, 2001. The increase was attributable to several factors, including (i) increased personnel costs of $786,000 due to growth in employment, (ii) increased professional expenses of $477,000 including marketing activities, (iii) increased corporate insurance costs of $293,000 and (iv) increased sales and marketing expenses, including travel and entertainment, of $238,000 incurred to support business development activities. These increases were partially offset by a $682,000 reduction of non-cash stock compensation expenses. Interest Income. Interest income decreased by 35% to $777,000 for the three months ended June 30, 2001. The decrease was attributable to a decrease in the average cash and short-term investment balances, resulting from increased operating expenses, and a lower yield on the investment balances. SIX MONTHS ENDED JUNE 30, 2001 COMPARED TO SIX MONTHS ENDED JUNE 30, 2000 Revenue. Product revenue increased 190% to $8.1 million for the six months ended June 30, 2001. The increase was primarily attributable to increased sales of Luminex 100 systems and peripheral components, as well as increased consumable sales. During the first six months of 2001, we placed 289 Luminex 100 systems, 2 HTS systems, 197 Luminex XY Platforms and 115 SD units compared with 87 Luminex 100 systems, 109 XY Platforms and no HTS systems or SD units placed in the first six months of 2000. Consumable sales increased by 288% to $1.3 million, which is attributable to the increase in the installed base of Luminex 100 systems. Included in the six months ended June 30, 2001 is $492,000 of revenue associated with a government grant. The original government grant was reinstated July 1, 2000 with a new joint venture partner after being temporarily suspended in September of 1999. On July 1, 2001, the reinstated grant was suspended due to the withdrawal of the new joint venture partner. As a result, we do not expect to realize any further grant revenue in future periods. A breakdown of revenue for the six months ended June 30, 2001 and 2000 is as follows (in thousands): <Table> <Caption> Six Months Ended June 30, ------------------ 2001 2000 ------ ------ System sales ................. $6,287 $2,362 Consumable sales ............. 1,339 345 Grant revenue ................ 492 -- Other revenue ................ 458 77 ------ ------ Total revenue ......... $8,576 $2,784 ====== ====== </Table> Gross Profit. Gross profit increased by 90% to $2.0 million for the six months ended June 30, 2001. Gross margin (gross profit as a percentage of total revenue) decreased from 39% for the six months ended June 30, 2000 to 24% for the six months ended June 30, 2001. The decrease in gross margin was primarily attributable to lower average selling prices of our systems, resulting from discounted sales to early adopting strategic partners. 9 12 Research and Development Expense. Research and development expenses increased 24% to $4.6 million for the six months ended June 30, 2001. The increase was attributable to several factors, including (i) increased personnel cost of $580,000 due to an increased number of employees and (ii) increased consumption of parts and supplies of $532,000 related to the development of new products. These increases in research and development expenses were partially offset by a $451,000 reduction of non-cash stock compensation expense. Selling, General and Administrative Expense. Selling, general and administrative expenses increased by 55% to $7.6 million for the six months ended June 30, 2001. The increase was attributable to several factors, including (i) increased personnel costs of $1.6 million due to growth in employment, (ii) increased professional expenses of $877,000, (iii) increased corporate insurance costs of $742,000 and (iv) increased sales and marketing expenses including travel and entertainment of $476,000 incurred to support business development activities. These increases were partially offset by a $1.2 million reduction of non-cash stock compensation expenses. Interest Income. Interest income increased by 41% to $1.9 million for the six months ended June 30, 2001. The increase was attributable to an increase in the average cash and short-term investment balances, resulting from investment of the net proceeds of our initial public offering received in April 2000. LIQUIDITY AND CAPITAL RESOURCES We have funded our operations to date primarily through the issuance of equity securities. At June 30, 2001, we held cash, cash equivalents and short-term investments of $61.3 million and had working capital of $69.4 million. At December 31, 2000, we held cash, cash equivalents and short-term investments of $73.6 million. Our cash reserves are held directly or indirectly in a variety of short-term, interest-bearing instruments, including obligations of the United States government or agencies thereof and U.S. corporate debt securities. Cash used in operations was $12.3 million for the six months ended June 30, 2001, compared with $4.0 million for the six months ended June 30, 2000. Purchases of property and equipment for the six months ended June 30, 2001 totaled $1.6 million, compared with $1.0 million for the six months ended June 30, 2000. Our future capital requirements will depend on a number of factors, including our success in developing and expanding markets for our products, payments under possible future strategic arrangements, continued progress of our research and development of potential products, the timing and outcome of regulatory approvals, the costs involved in preparing, filing, prosecuting, maintaining, defending and enforcing patent claims and other intellectual property rights, the need to acquire licenses to new technology and the status of competitive products. We believe that our existing cash, cash equivalents and short term-investments will be sufficient to fund our operating expenses and capital equipment requirements through at least June 30, 2002. We have no credit facility or other committed sources of capital. To the extent capital resources are insufficient to meet future capital requirements, we will have to raise additional funds. There can be no assurance that additional funds will be available on favorable terms, if at all. To the extent that additional capital is raised through the sale of equity or convertible debt securities, the issuance of those securities could result in dilution to our stockholders. Moreover, incurring debt financing could result in a substantial portion of our operating cash flow being dedicated to the payment of principal and interest on such indebtedness, could render us more vulnerable to competitive pressures and economic downturns and could impose restrictions on our operations. If adequate funds are not available, we may be required to curtail operations significantly or to obtain funds through entering into agreements on unattractive terms. FACTORS THAT MAY AFFECT FUTURE RESULTS IF OUR TECHNOLOGY AND PRODUCTS DO NOT BECOME WIDELY USED IN THE LIFE SCIENCES INDUSTRY, IT IS UNLIKELY THAT WE WILL EVER BECOME PROFITABLE. Life sciences companies have historically conducted biological tests using a variety of technologies, including bead-based analysis. However, compared to certain other technologies, our LabMAP(TM) technology is new and relatively unproven, and the use of our technology by life sciences companies is limited. The commercial success of our technology will depend upon its widespread adoption as a method to perform bioassays. In order to 10 13 be successful, we must convince potential customers to utilize our system instead of competing technologies. Market acceptance will depend on many factors, including our ability to: o convince prospective strategic partners and customers that our technology is an attractive alternative to other technologies for pharmaceutical, research, clinical and biomedical testing and analysis; o manufacture products in sufficient quantities with acceptable quality and at an acceptable cost; and o place and service sufficient quantities of our products. Because of these and other factors, our products may not gain sufficient market acceptance to achieve profitability. OUR BUSINESS PLAN MAY NOT SUCCEED UNLESS WE ESTABLISH MEANINGFUL AND SUCCESSFUL RELATIONSHIPS WITH OUR STRATEGIC PARTNERS. Our strategy for the development and commercialization of our LabMAP technology is highly dependent on our ability to establish successful strategic relationships with a number of partners. Our ability to enter into agreements with additional partners depends in part on convincing them that our technology can help achieve and accelerate their goals or efforts. We will expend substantial funds and management efforts with no assurance that any additional strategic relationships will result. We cannot assure you that we will be able to negotiate additional strategic agreements in the future on acceptable terms, if at all, or that current or future partners will not pursue or develop alternative technologies either on their own or in collaboration with others. Some of the companies we are targeting as strategic partners offer products competitive with our LabMAP technology, which may hinder or prevent strategic relationships. Termination of strategic relationships, or the failure to enter into a sufficient number of additional agreements on favorable terms, could reduce sales of our products, lower margins on our products and limit the creation of market demand and acceptance. Our business plan contemplates that a significant portion of our future revenues will come from sales of our systems and the development and sale of bioassay kits utilizing our technology by our strategic partners and from use of our technology by our strategic partners in performing services offered to third parties. We believe that our strategic partners will have economic incentives to develop and market these products, but we cannot predict future sales and royalty revenues because our existing strategic partner agreements do not include minimum purchase requirements. In addition, we do not have the right or ability to provide incentives to our strategic partners' sales personnel to sell products based on LabMAP technology or to control the timing of the release of products by our strategic partners. The amount of these revenues will depend on a variety of factors that are outside our control, including the amount and timing of resources that current and future strategic partners devote to develop and market products incorporating our technology. Further, the development and marketing of certain bioassay kits will require our strategic partners to obtain governmental approvals, which could delay or prevent their commercialization efforts. If our current or future strategic partners do not successfully develop and market products based on our technology and obtain necessary government approvals, our revenues from product sales and royalties will be significantly reduced. THE LIFE SCIENCES INDUSTRY IS HIGHLY COMPETITIVE AND SUBJECT TO RAPID TECHNOLOGICAL CHANGE AND WE MAY NOT HAVE THE RESOURCES NECESSARY TO SUCCESSFULLY COMPETE. We compete with companies in the United States and abroad that are engaged in the development and production of similar products. We will continue to face intense competition from existing competitors as well as other companies seeking to develop new technologies. Many of our competitors have access to greater financial, technical, scientific, research, marketing, sales, distribution, service and other resources than we do. These companies may develop technologies that are superior alternatives to our technologies or may be more effective at commercializing their technologies in products. The life sciences industry is characterized by rapid and continuous technological innovation. We may need to develop new technologies for our products to remain competitive. Our present or future products could be rendered obsolete or uneconomical by technological advances by one or more of our current or future competitors. 11 14 In addition, the introduction or announcement of new products by us or by others could result in a delay of or decrease in sales of existing products, as customers evaluate these new products. Our future success will depend on our ability to compete effectively against current technologies as well as to respond effectively to technological advances. THE INTELLECTUAL PROPERTY RIGHTS WE RELY UPON TO PROTECT THE TECHNOLOGY UNDERLYING OUR PRODUCTS MAY NOT BE ADEQUATE, WHICH COULD ENABLE THIRD PARTIES TO USE OUR TECHNOLOGY OR VERY SIMILAR TECHNOLOGY AND COULD REDUCE OUR ABILITY TO COMPETE IN THE MARKET. Our success will depend on our ability to obtain, protect and enforce patents on our technology and to protect our trade secrets. Any patents we own 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 rendered unenforceable. In addition, our current and future patent applications may not result in the issuance of patents in the United States or foreign countries. Competitors may develop products similar to ours that are not covered by our patents. Further, there is a substantial backlog of patent applications at the U.S. Patent and Trademark Office, and the approval or rejection of patent applications may take several years. We have obtained and filed a number of patents in the United States on various aspects and applications of our technology and have pending applications in certain foreign jurisdictions. In Japan, due to a procedural omission by our previous patent counsel, we are unable to obtain patent protection for our method of "real time" detection and quantification of multiple analyses from a single sample similar to the protection we have obtained in the United States, although we are pursuing patent protection in Japan for other aspects of our technology. As a result, we may not be able to prevent competitors from developing and marketing technologies similar to our LabMAP technology in Japan. We require our employees and consultants 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 failure to protect our proprietary information and techniques may inhibit or limit our ability to exclude certain competitors from the market. In order to protect or enforce our patent rights, we may have to initiate legal proceedings against third parties, such as infringement suits or interference proceedings. These legal proceedings could be expensive, take significant time and divert management's attention from other business concerns. If we lose, we may lose the benefit of some of our intellectual property rights, the loss of which may inhibit or remove our ability to exclude certain competitors from the market. We may also provoke these third parties to assert claims against us. The patent position of companies like ours 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 patents like ours. 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 intellectual property rights of others. In addition, we may find it necessary, if threatened, to initiate a lawsuit seeking a declaration from a court that we do not infringe the proprietary rights of others or that their rights are invalid or unenforceable. Intellectual property litigation is costly, and, even if we prevail, the cost of such litigation could affect our profitability. 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 nonexclusive, 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 12 15 our products, which could have a material adverse affect on our business, financial condition and results of operations. We are aware of a European patent granted to Dr. Ioannis Tripatzis, which covers certain testing agents and certain methods of their use. Dr. Tripatzis has publicly stated his belief that his patent covers aspects of our technology. This patent expires in 2004. We cannot assure you that a dispute with Dr. Tripatzis will not arise or that any dispute with him will be resolved in our favor. WE HAVE ONLY PRODUCED OUR PRODUCTS IN LIMITED QUANTITIES AND WE MAY EXPERIENCE PROBLEMS IN SCALING UP OUR MANUFACTURING OPERATIONS OR DELAYS OR COMPONENT SHORTAGES THAT COULD LIMIT THE GROWTH OF OUR REVENUE. To date, we have produced our products in limited quantities compared to the quantities necessary to achieve projected revenues. We may not be able to produce sufficient quantities or maintain consistency between differing lots of consumables. If we encounter difficulties in scaling up our manufacturing operations due to, among other things, quality control and quality assurance and component and raw material supplies, we will likely experience reduced sales of our products, increased repair or re-engineering costs due to product returns and defects and increased expenses due to switching to alternate suppliers, any of which would reduce our revenues and gross margins. We presently outsource certain aspects of the assembly of our systems to contract assemblers. In addition, certain key components of our product line are currently purchased from a limited number of outside sources and may only be available through a few sources. We do not have agreements with all of our suppliers. Our reliance on our suppliers and contract assemblers exposes us to risks including: o the possibility that one or more of our suppliers or our assemblers could terminate their services at any time without penalty; o the potential inability of our suppliers to obtain required components; o the potential delays and expenses of seeking alternate sources of supply or manufacturing services; and o reduced control over pricing, quality and timely delivery due to the difficulties in switching to alternate suppliers or assemblers. Consequently, in the event that supplies of components or work performed by any of our assemblers are delayed or interrupted for any reason, our ability to produce and supply our products could be impaired. OUR NEWLY FORMED BIOINFORMATICS GROUP IS SUBJECT TO ADDITIONAL RISKS AND UNCERTAINTIES. Our bioinformatics group seeks to identify associations among the proteins in blood that cause disease. We intend to identify these associations by testing different blood samples for a large number of protein markers. The creation of this database will be dependent on our ability to obtain a sufficient number of blood samples and related medical histories to permit the observation of these associations. These blood samples may need to include multiple samples from persons who developed diseases over the period of time during which the samples were collected. In addition, we will need to create large panels of bioassays to test the blood samples. To the extent we are unable to obtain sufficient quantities of relevant blood samples and medical histories, or cannot develop a large panel of bioassays to test the samples, we will not be able to create the database or to produce meaningful information from it. If we encounter difficulties in developing the bioinformatics software that will be used to analyze the database information or in maintaining the database, our ability to identify useful information from the database will be adversely affected. Our efforts to create the database and create algorithms to analyze the information that will be contained in the database have only recently begun. There can be no assurance that these efforts will be successful or lead to useful scientific information. Our ability to attract customers for any information that may be developed will be heavily dependent upon the successful completion of the database and the analyses thereof within the expected time frames. In addition, because our bioinformatics business will require manipulating and analyzing 13 16 large amounts of data, we will be dependent on the continuous, effective, reliable and secure operation of our computer hardware, software, networks and related infrastructure. We expect that this database and the bioinformatics software will be complex and sophisticated, and as such, could contain data, design or software errors that could be difficult to detect and correct. OUR SUCCESS WILL DEPEND ON OUR ABILITY TO ATTRACT AND TO RETAIN OUR MANAGEMENT AND STAFF. We depend on the principal members of our management and scientific staff, including our research and development, customer support, technical service and sales staff. The loss of services of any of our key members of management could delay or reduce our product development, sales and customer support efforts. In addition, recruiting and retaining qualified scientific and other personnel to perform research and development, customer support, technical service and sales work will be critical to our success. There is a shortage in our industry of qualified management and scientific personnel, and competition for these individuals is intense. There can be no assurance that we will be able to attract additional and retain existing personnel. IF WE FAIL TO COMPLY WITH THE EXTENSIVE GOVERNMENTAL REGULATIONS THAT AFFECT OUR BUSINESS, WE COULD BE SUBJECT TO ENFORCEMENT ACTIONS, INJUNCTIONS AND CIVIL AND CRIMINAL PENALTIES THAT COULD DELAY OR PREVENT MARKETING OF OUR PRODUCTS. The production, labeling, distribution and marketing of our products for some purposes and products based on our technology expected to be produced by our strategic partners are subject to governmental regulation by the Food and Drug Administration in the United States and by similar agencies in other countries. Some of our products and products based on our technology expected to be produced by our strategic partners for in vitro diagnostic purposes are subject to approval or clearance by the FDA prior to marketing for commercial use. To date, only one such approval or clearance has been obtained by our strategic partners. The process of obtaining necessary FDA clearances or approvals can be time-consuming, expensive and uncertain. Further, clearance or approval may place substantial restrictions on the indications for which the product may be marketed or to whom it may be marketed. In addition, we are also required to comply with FDA requirements relating to laser safety. Approved or cleared products are subject to continuing FDA requirements relating to quality control and quality assurance, maintenance of records and documentation and labeling and promotion of medical devices. Our inability, or the inability of our strategic partners, to obtain required regulatory approval or clearance on a timely or acceptable basis could harm our business. In addition, failure to comply with applicable regulatory requirements could subject us or our strategic partners to enforcement action, including product seizures, recalls, withdrawal of clearances or approvals, restrictions on or injunctions against marketing our products or products based on our technology, and civil and criminal penalties. Medical device laws and regulations are also in effect in many countries outside the United States. These range from comprehensive device approval requirements for some or all of our medical device products to requests for product data or certifications. The number and scope of these requirements are increasing. Failure to comply with applicable federal, state and foreign medical device laws and regulations may harm our business, financial condition and results of operations. We are also subject to a variety of other laws and regulations relating to, among other things, environmental protection and work place safety. Our bioinformatics group will also be subject to various governmental regulations, which may delay or prohibit certain planned activities. Certain biological testing has raised issues regarding confidentiality and the appropriate uses of the resulting information. For example, concerns have been expressed towards insurance carriers and employers using such tests to discriminate on the basis of such information, resulting in barriers to the acceptance of such tests by consumers. This could lead to governmental authorities calling for limits on or regulation of the use of testing of the type proposed to be performed. Such regulations would likely reduce the potential markets for any products that might be developed. 14 17 IF WE BECOME SUBJECT TO PRODUCT LIABILITY CLAIMS, WE MAY BE REQUIRED TO PAY DAMAGES THAT EXCEED OUR INSURANCE COVERAGE. Our business exposes us to potential product liability claims that are inherent in the testing, production, marketing and sale of human diagnostic and therapeutic products. While we believe that we are reasonably insured against these risks, there can be no assurance that we will be able to obtain insurance in amounts or scope sufficient to provide us with adequate coverage against all potential liabilities. A product liability claim in excess of our insurance coverage or a recall of one of our products would have to be paid out of our cash reserves. BECAUSE WE RECEIVE REVENUES PRINCIPALLY FROM LIFE SCIENCE COMPANIES, THE CAPITAL SPENDING POLICIES OF THESE ENTITIES HAVE A SIGNIFICANT EFFECT ON THE DEMAND FOR OUR PRODUCTS. Our customers include clinical diagnostic, pharmaceutical, biotechnological, chemical and industrial companies, and the capital spending policies of these companies can have a significant effect on the demand for our products. These policies are based on a wide variety of factors, including governmental regulation or price controls, the resources available for purchasing research equipment, the spending priorities among various types of analytical equipment and the policies regarding capital expenditures during recessionary periods. Any decrease in capital spending by life sciences companies could cause our revenues to decline and impact our profitability. IF THIRD-PARTY PAYORS INCREASINGLY RESTRICT PAYMENTS FOR HEALTHCARE EXPENSES OR FAIL TO ADEQUATELY PAY FOR MULTI-ANALYTE TESTING, WE MAY EXPERIENCE REDUCED SALES WHICH WOULD HURT OUR BUSINESS AND OUR BUSINESS PROSPECTS. Third-party payors, such as government entities, health maintenance organizations and private insurers, are restricting payments for healthcare. These restrictions may decrease demand for our products and the price we can charge. Increasingly, Medicaid and other third-party payors are challenging the prices charged for medical services, including clinical diagnostic tests. They are also attempting to contain costs by limiting coverage and the reimbursement level of tests and other healthcare products. Without adequate coverage and reimbursement, consumer demand for tests will decrease. Decreased demand could cause sales of our products, and sales and services by our strategic partners, to fall. In addition, decreased demand could place pressure on us or our strategic partners to lower prices on these products or services, resulting in lower margins. Reduced sales or margins by us or our strategic partners would hurt our business, profitability and business prospects. OUR LIMITED OPERATING HISTORY AND RELIANCE ON STRATEGIC PARTNERS TO MARKET OUR PRODUCTS MAKES FORECASTING DIFFICULT. Because of our limited operating history, it is difficult to accurately forecast future operating results. Our operating expenses are largely based on anticipated revenue trends and a high percentage of our expenses are, and will continue to be, fixed in the short-term. As a result, if we do not achieve our expected revenues, our operating results will be below our expectations. The level of our revenues will depend upon the rate and timing of the adoption of our technology as a method to perform bioassays. Due to our limited operating history, predicting this timing and rate of adoption is difficult. In addition, we anticipate that a large percentage of future sales of our products, and products incorporating our technology, will be made by our strategic partners. For the following reasons, estimating the timing and amount of sales of these products that may be made by our strategic partners is particularly difficult: o We have no control over the timing or extent of product development, marketing or sale of our products by our strategic partners. o Our strategic partners are not committed to minimum purchase commitments and we do not have control over the incentives provided by our strategic partners to their sales personnel. o A significant number of our strategic partners intend to produce clinical diagnostic applications that may need to be approved by the United States FDA. 15 18 o Certain strategic partners may have unique requirements for their applications and systems. Assisting the various strategic partners may strain our research and development and manufacturing resources. To the extent that we are not able to timely assist our strategic partners, the commercialization of their products will likely be delayed. We have and expect to maintain a limited marketing, sales and distribution staff. As a result, if our strategic partners fail to achieve projected levels of sales, we will likely not achieve our estimated operating results. OUR PRODUCTS HAVE LENGTHY SALES CYCLES, WHICH COULD CAUSE OUR OPERATING RESULTS TO FLUCTUATE SIGNIFICANTLY FROM QUARTER TO QUARTER. The sale of bioassay testing devices typically involves a significant technical evaluation and commitment of capital by customers. Accordingly, the sales cycle associated with our products typically is lengthy and subject to a number of significant risks, including customers' budgetary constraints and internal acceptance reviews that are beyond our control. Due to this lengthy and unpredictable sales cycle, our operating results could fluctuate significantly from quarter to quarter. OUR STOCK PRICE HAS BEEN AND IS LIKELY TO CONTINUE TO BE VOLATILE. The trading price of our common stock has been and is likely to continue to be highly volatile and subject to wide fluctuations in price. This volatility is in response to various factors, many of which are beyond our control, including: o general economic conditions and interest rates; o actual or anticipated variations in quarterly operating results from historical results or estimates of results prepared by us or by securities analysts; o announcements of technological innovations by us or our competitors; o new products or services introduced or announced by us or our competitors; o changes in financial estimates by us or by securities analysts; o conditions or trends in the life science, biotechnology and pharmaceutical industries; o announcements by us of significant acquisitions, strategic partnerships, joint ventures or capital commitments; o additions or departures of key personnel; and o 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 significant 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 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. A securities class action suit against us could result in substantial costs, potential liabilities and the diversion of management's attention and resources. OUR DIRECTORS AND EXECUTIVE OFFICERS HAVE SUBSTANTIAL CONTROL OVER LUMINEX, WHICH COULD DELAY OR PREVENT A MERGER OR OTHER CHANGE IN CONTROL TRANSACTION. Our directors and executive officers beneficially owned approximately 44% of our outstanding common stock as of August 1, 2001. These persons will be able to exercise significant influence over all matters requiring 16 19 stockholder approval, including the election of directors and the approval of significant corporate transactions. This concentration of ownership may also delay or prevent a change in control of the company even if beneficial to our stockholders. ANTI-TAKEOVER PROVISIONS IN OUR CHARTER AND BYLAWS AND DELAWARE LAW AND OUR STOCKHOLDER RIGHTS PLAN COULD MAKE A THIRD-PARTY ACQUISITION OF US DIFFICULT. Our certificate of incorporation, bylaws and stockholder rights plan contain provisions that could make it more difficult for a third party to acquire us, even if doing so would be beneficial to our stockholders. These provisions could limit the price that investors might be willing to pay in the future for shares of our common stock. We are also subject to certain provisions of Delaware law that could delay, deter or prevent a change in control of us. ITEM 3. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK Our interest income is sensitive to changes in the general level of U.S. interest rates, particularly since the majority of our investments are in short-term instruments held to maturity. Due to the nature of our short-term investments, we have concluded that we are not subject to material market risk exposure. 17 20 PART II ITEM 2. CHANGES IN SECURITIES AND USE OF PROCEEDS (a) On June 20, 2001, the Company's Board of Directors declared a dividend of one right for each outstanding share of the Company's common stock to stockholders of record at the close of business on July 2, 2001. Each right entitles the registered holder to purchase from the Company a unit consisting of one one-hundredth of a share of Series A Junior Participating Preferred Stock, par value $.001 per share, at a purchase price of $100 per fractional share, subject to adjustment. The description and terms of the rights are set forth in a Rights Agreement dated as of June 20, 2001, between the Company and Mellon Investor Services LLC, as Rights Agent, which is filed as Exhibit 4 to the Company's Report on Form 8-K dated June 20, 2001. ITEM 4. SUBMISSION OF MATTERS TO A VOTE OF SECURITY HOLDERS At the Company's 2001 Annual Meeting of Stockholders, which was held on May 24, 2001, the stockholders of the Company elected C. Thomas Caskey, Robert J. Cresci and William L. Roper to serve as Class I directors for a term of three years by the following votes: <Table> <Caption> Number of Shares -------------------------- For Against ---------- ------- C. Thomas Caskey ...................................... 21,100,568 22,355 Robert J. Cresci ...................................... 21,093,844 29,079 William L. Roper ...................................... 21,100,573 22,350 </Table> The other directors whose terms of office as a director continue after the meeting are as follows: Fred C. Goad, Jr., Laurence E. Hirsch, Jim D. Kever, Mark B. Chandler, John E. Koerner, III and G. Walter Loewenbaum. ITEM 6. EXHIBITS AND REPORTS ON FORM 8-K (a) Exhibits: No exhibits have been filed as a part of this report. (b) Reports on Form 8-K: A Current Report on Form 8-K was filed on June 20, 2001 to report pursuant to Item 5 thereof that the Board of Directors of the Company has adopted a stockholder rights plan. 18 21 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, on August 14, 2001. LUMINEX CORPORATION By: /s/ Frank J. Reeves ------------------------------------------ Frank J. Reeves Executive Vice President, Treasurer and Chief Financial Officer (Principal Financial Officer) 19