SECURITIES AND EXCHANGE COMMISSION Washington, DC 20549 --------------- FORM 10-Q [X] QUARTERLY REPORT UNDER SECTION 13 OR 15 (d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the Quarterly Period Ended March 31, 2002 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 number 000-19392 DIANON SYSTEMS, INC. (exact name of registrant as specified in its charter) Delaware 06-1128081 ------------------------ ------------------- (State of incorporation) (IRS Employer Identification No.) 200 Watson Blvd, Stratford, CT 06615 ------------------------------ --------- (Address of principal executive offices) (zip code) Registrant's telephone number, including area code: (203) 381-4000 NOT APPLICABLE (Former name, former address and former fiscal year, if changed since last report) 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 --- ---- The number of shares of registrant's Common Stock, $.01 par value, outstanding on April 16, 2002 was 12,132,671 shares. DIANON SYSTEMS, INC. AND SUBSIDIARIES INDEX Part I FINANCIAL INFORMATION PAGE NO. - ---------------------------- -------- Item 1. FINANCIAL STATEMENTS Consolidated Balance Sheets as of March 31, 2002 and December 31, 2001. 3 Consolidated Statements of Operations for the three months ended March 31, 2002 and 2001. 4 Consolidated Statements of Stockholders' Equity for the three months ended March 31, 2002 and 2001. 5 Consolidated Statements of Cash Flows for the three months ended March 31, 2002 and 2001. 6 Notes to Financial Statements. 7-9 Item 2. MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS 10-14 Item 3. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK 14 Part II OTHER INFORMATION - -------------------------- Item 6. EXHIBITS AND REPORTS ON FORM 8-K 15 Signatures 16 2 DIANON SYSTEMS, INC. CONSOLIDATED BALANCE SHEETS MARCH 31, DECEMBER 31, 2002 2001 -------------------- ------------------- ASSETS (UNAUDITED) CURRENT ASSETS: Cash and cash equivalents $ 49,459,444 $ 41,229,353 Short term investments 506,405 1,071,778 Accounts receivable, net of allowances 32,338,109 29,863,129 Prepaid expenses and employee advances 3,497,956 3,767,086 Refundable income taxes 5,474,498 5,753,944 Inventory 1,891,278 1,932,713 Deferred income taxes 6,435,183 6,560,564 -------------------- ------------------- Total current assets 99,602,873 90,178,567 -------------------- ------------------- PROPERTY AND EQUIPMENT, at cost Laboratory and office equipment 20,549,250 19,539,228 Leasehold improvements 8,978,960 8,967,113 Less - accumulated depreciation and amortization (18,599,352) (17,650,512) --------------------- ------------------ 10,928,858 10,855,829 --------------------- ------------------ INTANGIBLE ASSETS, net of accumulated amortization of $4,129,089 and $3,662,150, respectively 183,450,177 183,167,116 DEFERRED INCOME TAXES -- 2,429,417 OTHER ASSETS 562,073 787,230 -------------------- ------------------- TOTAL ASSETS $ 294,543,981 $287,418,159 ==================== =================== LIABILITIES AND STOCKHOLDERS' EQUITY CURRENT LIABILITIES: Accounts payable $ 2,035,144 $ 1,621,689 Accrued employee compensation 2,608,627 6,961,747 Accrued income taxes 674,734 674,734 Current portion of capitalized lease obligations 138,986 300,102 Other accrued expenses 11,314,655 11,784,575 -------------------- ------------------- Total current liabilities 16,772,146 21,342,847 --------------------- ------------------ LONG-TERM LIABILITIES: Deferred income taxes 1,168,729 -- Long-term portion of capitalized lease obligations 219,039 439,029 -------------------- ------------------- Total Liabilities 18,159,914 21,781,876 -------------------- ------------------- STOCKHOLDERS' EQUITY: Common stock, par value $.01 per share, 20,000,000 shares authorized, 12,085,572 and 11,896,140 shares issued and outstanding at March 31, 2002 and December 31, 2001, respectively 120,855 118,961 Additional paid-in capital 248,444,313 242,987,849 Retained earnings 27,905,419 22,620,561 Common stock held in treasury, at cost - 9,034 and 9,511 shares at March 31, 2002 and December 31, 2001, respectively (86,520) (91,088) --------------------- ------------------ Total stockholders' equity 276,384,067 265,636,283 --------------------- ------------------ TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY $294,543,981 $287,418,159 ===================== ================== The accompanying notes to consolidated financial statements are an integral part of these balance sheets. 3 DIANON SYSTEMS, INC. CONSOLIDATED STATEMENTS OF OPERATIONS FOR THE THREE MONTHS ENDED MARCH 31, 2002 AND 2001 (UNAUDITED) THREE MONTHS ENDED MARCH 31, 2002 2001 ---------------- ----------------- Net revenues $44,623,375 $26,802,607 Cost of sales 22,298,149 14,994,798 ---------------- ----------------- GROSS PROFIT 22,325,226 11,807,809 Selling, general and administrative expenses 12,728,466 7,869,837 Amortization of intangible assets 466,939 255,368 Research and development expenses 440,640 351,589 ---------------- ----------------- INCOME FROM OPERATIONS 8,689,181 3,331,015 Interest income, net 192,933 114,134 ---------------- ----------------- INCOME BEFORE PROVISION FOR INCOME TAXES 8,882,114 3,445,149 Provision for income taxes 3,597,256 1,395,285 ---------------- ----------------- NET INCOME $ 5,284,858 $ 2,049,864 ================ ================= EARNINGS PER SHARE BASIC $.44 $.28 DILUTED $.41 $.26 WEIGHTED AVERAGE SHARES OUTSTANDING BASIC 11,979,661 7,387,647 DILUTED 12,812,417 8,006,625 The accompanying notes to consolidated financial statements are an integral part of these statements. 4 DIANON SYSTEMS, INC. CONSOLIDATED STATEMENTS OF STOCKHOLDERS' EQUITY FOR THE THREE MONTHS ENDED MARCH 31, 2002 AND 2001 (UNAUDITED) Additional Common Stock Paid-In Retained Shares Amount Capital Earnings --------------------------- ------------------- ---------------- BALANCE, December 31, 2000 7,397,323 $ 73,974 $ 35,877,828 $ 16,427,788 Stock options exercised 9,500 95 79,467 -- Tax effect for stock options exercised -- -- 99,572 -- Employee stock purchase plan -- -- 13,904 -- Stock grants 245 2 9,813 -- Net income -- -- -- 2,049,864 ------------ -------------- ------------------ ----------------- BALANCE, March 31, 2001 7,407,068 $ 74,071 $ 36,080,584 $ 18,477,652 ============ ============== ================== ================= BALANCE, December 31, 2001 11,896,140 $ 118,961 $242,987,849 $ 22,620,561 Stock options exercised 189,432 1,894 3,220,759 -- Tax effect for stock options exercised -- -- 2,215,648 -- Employee stock purchase plan / other -- -- 20,057 -- Net income -- -- -- 5,284,858 ------------ -------------- ------------------- ---------------- BALANCE, March 31, 2002 12,085,572 $ 120,855 $248,444,313 $ 27,905,419 ============ ============== =================== ================ DIANON SYSTEMS, INC. CONSOLIDATED STATEMENTS OF STOCKHOLDERS' EQUITY FOR THE THREE MONTHS ENDED MARCH 31, 2002 AND 2001 (UNAUDITED) (continued) Common Stock Acquired for Treasury Shares Amount Total ---------------------------------- ----------------- BALANCE, December 31, 2000 (12,620) ($120,852) $52,258,738 Stock options exercised -- -- 79,562 Tax effect for stock options exercised -- -- 99,572 Employee stock purchase plan 502 4,807 18,711 Stock grants -- -- 9,815 Net income -- -- 2,049,864 --------------- ------------------ ------------------ BALANCE, March 31, 2001 (12,118) ($116,045) $54,516,262 =============== ================== ================== BALANCE, December 31, 2001 (9,511) ($91,088) $265,636,283 Stock options exercised -- -- 3,222,653 Tax effect for stock options exercised -- -- 2,215,648 Employee stock purchase plan / other 477 4,568 24,625 Net income -- -- 5,284,858 ---------------- ----------------- ------------------ BALANCE, March 31, 2002 (9,034) ($86,520) $276,384,067 ================ ================= ================== The accompanying notes to consolidated financial statements are an integral part of these statements. 5 DIANON SYSTEMS, INC. CONSOLIDATED STATEMENTS OF CASH FLOWS FOR THE THREE MONTHS ENDED MARCH 31, 2002 AND 2001 (UNAUDITED) 2002 2001 ------------------ ------------------ CASH FLOWS FROM OPERATING ACTIVITIES: Net income $ 5,284,858 $ 2,049,864 Adjustments to reconcile net income to net cash provided by operations - Non-cash charges Depreciation and amortization 1,428,816 1,060,052 Tax effect of stock options exercised 2,215,648 99,572 Deferred tax provision 3,723,527 93,928 Stock compensation expense -- 9,815 Loss on disposal of fixed assets 23,021 -- Changes in other current assets and liabilities Accounts receivable (2,474,980) (1,560,203) Refundable income taxes 279,446 1,345,118 Prepaid expenses and employee advances 269,130 (436,699) Inventory 41,435 (5,077) Other assets and other (33,034) 7,500 Accounts payable and other accrued liabilities (4,409,585) (442,630) ------------------ ------------------ Net cash provided by operating activities 6,348,282 2,221,240 ------------------ ------------------ CASH FLOWS FROM INVESTING ACTIVITIES: Capital expenditures (1,066,427) (554,516) Proceeds from sales of investment securities 1,073,564 -- Investment and acquisition of marketing rights (1,000,000) -- Proceeds from the sale of fixed assets 8,500 -- ------------------ ------------------ Net cash used in investing activities (984,363) (554,516) ------------------ ------------------ CASH FLOWS FROM FINANCING ACTIVITIES: Repayments of note payable -- (2,500,000) Employee stock purchase plan / other 24,625 18,711 Exercise of stock options 3,222,653 79,562 Net repayments of capitalized lease obligations (381,106) (2,556) ------------------ ------------------ Net cash provided by (used in) financing activities 2,866,172 (2,404,283) ------------------ ------------------ Net increase (decrease) in cash and cash equivalents 8,230,091 (737,559) CASH AND CASH EQUIVALENTS, beginning of period 41,229,353 12,515,424 ------------------ ------------------ CASH AND CASH EQUIVALENTS, end of period $49,459,444 $ 11,777,865 ================== ================== SUPPLEMENTAL DISCLOSURES OF CASH FLOW INFORMATION: Cash paid during the period: Interest $ 8,471 $ 47,174 Income Taxes 123,243 6,600 The accompanying notes to consolidated financial statements are an integral part of these statements. 6 DIANON SYSTEMS, INC. NOTES TO CONSOLIDATED FINANCIAL STATEMENTS 1. The Company - The consolidated financial statements as of and for the three months ended March 31, 2002 and 2001 have been prepared by DIANON Systems, Inc. ("Dianon" or the "Company") without audit. In the opinion of management, all adjustments necessary to present fairly the financial position, results of operations and cash flows for such periods have been made, and the interim accounting policies followed are in conformity with generally accepted accounting principles and are consistent with those applied for annual periods as described in Dianon's annual report for the year ended December 31, 2001, previously filed on Form 10-K and 10-K/A with the Securities and Exchange Commission (the "Annual Report"). Certain information and note disclosures normally included in financial statements prepared in accordance with generally accepted accounting principles have been omitted. It is suggested that these consolidated financial statements be read in conjunction with the financial statements included in Dianon's Annual Report for the year ended December 31, 2001. The results of operations for the three months ended March 31, 2002 and 2001 are not necessarily indicative of the operating results for the full years. Acquisitions - Effective October 1, 2000, the Company acquired substantially all of the assets of John H. Altshuler, M.D., P.C., a pathology physician practice located in Englewood, Colorado, which specializes in dermatopathology and GYN pathology. The acquisition price was approximately $1.7 million and was financed through a combination of available cash and the issuance of Common Stock. Approximately $300,000 of the purchase price is being held in trust pursuant to a contingent earn-out agreement. The purchase price was primarily allocated to customer lists ($1.0 million), goodwill ($670,000), lab and office equipment ($73,000), and client receivables ($67,000), partially offset by accrued liabilities of ($110,000). The acquisition has been accounted for pursuant to the purchase method of accounting. In the fourth quarter of 2001, after the UroCor acquisition, the Company decided to close this facility and consolidate testing in other regional laboratories including the newly acquired UroCor facility in Oklahoma. As part of this decision, the Company wrote-off the remaining goodwill of approximately $524,000 and wrote-down the customer list by approximately $441,000. The shutdown was completed early in the first quarter of 2002. In the fourth quarter of 2000, the Company purchased preferred shares in and exclusive sales and distribution rights from Response Genetics, an applied genomic products and services company for an aggregate purchase price of $1.0 million. The Company allocated the total investment to the distribution rights ($500,000) and the preferred equity ($500,000) based on management's estimates of future benefits from Response Genetics. During 2001, the distribution rights were fully amortized. Additionally, during the fourth quarter of 2001, the Company wrote off the investment due to the uncertainty, in management's opinion, of the financial position of the investee as a result of the uncertainty regarding the amount of additional time required for that technology to gain widespread market acceptance in the oncology community and for acceptable reimbursement levels to be attained. In the fourth quarter of 2001, the Company acquired all outstanding shares of UroCor, Inc. ("UroCor"), an anatomic pathology laboratory located in Oklahoma City, Oklahoma, specializing in services related to urology. This acquisition has enhanced Dianon's position as a leader in the full-service cancer diagnostics market and created a leading share in the urology segment of this market. The acquisition price was approximately $202 million (including acquisition costs and assumed liabilities) and was financed primarily through the issuance of approximately 3.9 million shares of Common Stock ($171 million). In addition, the Company issued approximately 644,000 stock options in exchange for existing UroCor stock options ($21 million). The balance of the purchase price was paid using existing cash. The purchase price was allocated to goodwill ($163 million), customer list ($4 million), trade name ($4 million), and the fair value of net assets acquired ($31 million). Net assets consist primarily of cash, accounts receivable, inventory, investments and deferred income taxes. The acquisition has been accounted for pursuant to the purchase method of accounting. Pro forma historical results (unaudited) for the three months ended March 31, 2001, adjusted as if UroCor had been acquired on January 1, 2001 approximates $42.2 million in revenue, $6.1 million in net income and $0.50 in diluted earnings per share. The pro forma revenue of $42.2 million, stated above, includes $0.6 million from the discontinued therapeutics division. The $6.1 million pro forma net income, stated above, includes a one-time, non-recurring gain on a termination of a therapeutic distribution agreement of $4.6 million (or $0.38 diluted 7 earnings per share). The pro forma results are not necessarily indicative of what actually would have occurred if the acquisition had been completed as of January 1, 2001, nor are they necessarily indicative of future results. In the first quarter of 2002, the Company paid MDdatacor, Inc. ("MDdatacor") $1.0 million for exclusive marketing rights for patient medical records to urology and gastroenterology physician practice group customers and a 13.7% interest in MDdatacor. The Company allocated the total investment to the marketing rights ($750,000) and equity ($250,000) based on management's estimates of fair value. 2. Recent Accounting Pronouncements - In June 2001, the Financial Accounting Standards Board issued Statement of Financial Accounting Standards No. 141, "Business Combinations" and Statement of Financial Accounting Standards No. 142, "Goodwill and Other Intangible Assets". Statement No. 141 requires that all business combinations initiated after June 30, 2001 be accounted for using the purchase method, thus eliminating the use of the pooling-of-interests accounting for business combinations. Statement No. 142 changes the accounting for goodwill from an amortization method to an impairment-only approach, whereby goodwill amortization was no longer required after December 31, 2001. The Statement requires an annual assessment of goodwill for impairment and more frequent assessments if circumstances indicate a possible impairment. The initial test for impairment must be completed by June 30, 2002, but any impairment would be reflected as an accounting change recorded retroactively in the first quarter of 2002. The Company does not believe the adoption of Statement No. 142 will have a material impact on its financial position. In August 2001, the Financial Accounting Standards Board issued Statement of Financial Accounting Standards No. 143, "Accounting for Asset Retirement Obligations," which is effective in 2003. It requires the recording of an asset equal to the present value of the estimated costs associated with the retirement of long-lived assets where a legal or contractual obligation exists. The asset is required to be depreciated over the life of the related equipment or facility, and the liability accreted each year based on a present value interest rate. The Company does not believe that the adoption of Statement No. 143 will have a material impact on its financial position. In October 2001, the Financial Accounting Standards Board issued Statement of Financial Accounting Standards No. 144, "Accounting for the Impairment or Disposal of Long-Lived Assets". Statement No. 144 supersedes Accounting Standards No. 121, "Accounting for the Impairment of Long-Lived Assets and for Long-Lived Assets to be Disposed of". It establishes a single accounting model for the impairment of long-lived assets to be held and used or to be disposed of by sale or abandonment and broadens the definition of discontinued operations. The provisions of this Statement are effective for financial statements issued for fiscal years beginning after December 15, 2001. The adoption of Statement No. 144 did not have a material impact on the Company's financial position. 3. Earnings per share - Basic earnings per share have been computed based on the weighted average number of common shares outstanding during each year. Diluted earnings per share have been computed based on the weighted average number of common shares and common equivalent shares outstanding during each year. Common equivalent shares outstanding include the common equivalent shares calculated for warrants and stock options under the treasury stock method. Below is a reconciliation of the numerators and denominators of the basic and diluted earnings per share computations for the three month periods ended March 31, for both 2002 and 2001. 8 Three months ended March 31, 2002 2001 --------------------- BASIC EARNING PER SHARE: Weighted-average number of common shares outstanding 11,979,661 7,387,647 DILUTIVE EFFECT OF: Stock options 832,756 618,978 ----------- ---------- DILUTED EARNINGS PER SHARE: Weighted-average number of common shares outstanding 12,812,417 8,006,625 =========== ========== NET INCOME $5,284,858 $2,049,864 =========== ========== BASIC EARNINGS PER SHARE $0.44 $0.28 =========== ========== DILUTED EARNINGS PER SHARE $0.41 $0.26 =========== ========== As of March 31, 2002, all outstanding options to purchase shares of common stock were included in the computation of diluted earnings per share. As of March 31, 2001, outstanding options to purchase 344,515 shares of common stock, at prices ranging from $35.50 to $40.06 per share, were not included in the computation of diluted earnings per share because the exercise price of the options was greater than the average market price of common shares. 9 MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS THREE MONTHS ENDED MARCH 31, 2002 AND 2001 (UNAUDITED) The descriptive analysis contained herein compares the financial results of the three months ended March 31, 2002 ("First Quarter-2002") to the three months ended March 31, 2001 ("First Quarter-2001"). RESULTS OF OPERATIONS o NET REVENUES Net revenues increased 66% to $44.6 million in the First Quarter-2002 from $26.8 million in the First Quarter-2001. This increase reflects the acquisition of UroCor as well as the effects of strong volume gains in pathology and genetics testing and a favorable reimbursement climate for some of our most commonly performed tests. UroCor represents approximately $11.5 million in revenues in the First Quarter-2002. Anatomic pathology net revenues increased to $31.6 million in 2002 from $18.6 million in 2001, representing a 70% increase. The revenue growth reflects the UroCor acquisition as well as increased market penetration in the anatomic pathology area. Genetic net revenues increased to $5.4 million in 2002 from $4.4 million in 2001, representing a 23% increase. The revenue growth reflects increased market penetration. Clinical chemistry net revenues increased to $7.6 million in 2002 from $3.8 million in 2001, representing a 98% increase. This increase is primarily related to the UroCor acquisition. The clinical laboratory industry, which includes both clinical chemistry and anatomic pathology, has seen steady and continuing downward pressure on prices exerted by both government and private third-party payers. Payment for services such as those provided by Dianon is and will likely continue to be affected by periodic reevaluations made by payers concerning the level of reimbursement for services provided by Dianon. Over time, Congress has reduced the national cap on Medicare laboratory fee schedules (under which Dianon's clinical chemistry services are reimbursed) to 74% of the national median. In addition, the Balanced Budget Act of 1997 ("BBA") freezes fee schedule payments (i.e., no increases or decreases) for the 1998-2002 period. The clinical laboratory industry has also recently experienced increases in the payment rate for certain tests, including some of those performed by the Company. Beginning in 1998, Medicare began covering screening pap smears for certain Medicare beneficiaries, and the Balanced Budget Refinement Act of 1999 ("BBRA") required the Secretary of the Department of Health and Human Services to establish a national minimum payment amount equal to $14.60 for diagnostic or screening pap smear laboratory tests furnished on or after January 1, 2000. Previously, the national payment cap for a pap smear was approximately $7.15. The BBRA also encouraged the Centers for Medicare and Medicaid Services ("CMS") (formerly known as the Health Care Financing Administration or "HCFA") to institute an appropriate increase in the payment rate for new cervical cancer screening technologies, such as the technologies used by Dianon, that have been approved by the FDA as significantly more effective than a conventional pap smear. In March 2001, CMS established a national limit of $28 for the new pap smear technologies used by Dianon, which is nearly twice the level of reimbursement for the conventional pap smear. Payments in states in which Dianon has laboratories that furnish the new pap smear tests range from $27.90 to $28.00. The Medicare, Medicaid, and SCHIP Benefits Improvement and Protection Act of 2000 ("BIPA"), signed into law on December 21, 2000, requires that the national limitation amount for new lab tests equal 100% of the national median for such tests (versus the 74% applied to other tests). In addition, BIPA included a provision to change the frequency of covered screening pap smears from at least every three years to at least every two years. The addition of Medicare coverage for more frequent pap tests and higher reimbursement for certain types of pap tests have provided and are expected to continue to provide additional revenues for Dianon. 10 With respect to Dianon's anatomic pathology services, which are reimbursed under the Medicare physician fee schedule rather than the Medicare laboratory fee schedule, Medicare reimbursement amounts generally declined with the implementation of the resource-based relative value scale ("RBRVS") system, which went into effect in 1992 and was fully phased in by the end of 1996. Under this system, relative value units ("RVUs") are established for the physician work, practice expense and malpractice expense involved with each physician service. Of these three, however, the physician work and practice expense components comprise the vast majority of the value of a service. The RVUs for a service may be changed from time to time, and once the RVUs are finalized each year, they are multiplied by a "conversion factor" in order to calculate the actual payment for a service. The conversion factor is a monetary amount which changes from year to year based on a variety of factors, including changes in health-related and overall economic indicators. Generally, anatomic pathology reimbursement rates declined during the fee schedule phase-in period, despite an increase in payment rates for certain pathology services performed by Dianon. Due to a five-year review, in 1997 there was an overall decrease in the physician work RVUs established for pathology services. Another five-year review of the work value component was completed in 2001, was published in the Federal Register on June 8, 2001, and went into effect on January 1, 2002. The changes recommended as a result of this more recent review are not expected to have any significant effect on payment for pathology services. In the final 2002 physician fee schedule, published in November 2001, CMS estimated that refinements and changes in the RVUs for physician work and practice expense would result in a 3% increase in payments for pathology services in 2002, compared to what would have occurred in 2002 had the rule not been published. This estimate is primarily due to the use of new data to calculate the practice expense component of the RVUs. However, due to budget neutrality requirements and other economic factors, the conversion factor used to calculate the fee schedule payments was reduced approximately 5.4% in 2002, which offset some of the expected increase in payments for pathology services. However, for Dianon's most frequently billed service, the 88305 surgical biopsy, reimbursement from Medicare increased approximately 5.5%. The BBA also required the Secretary of the Department of Health and Human Services to use a negotiated rulemaking process to adopt uniform coverage, administration and payment policies for lab tests. A proposed rule was published on March 10, 2000, and the final rule was published on November 23, 2001. This rule establishes national coverage policies for many of the most commonly ordered lab tests, thereby replacing local Medicare policies, which sometimes varied, and it establishes other uniform requirements related to submission of claims for lab tests. The Company believes that the new rule will level the playing field and result in more consistent reimbursement among providers of laboratory testing services. CMS had announced that effective January 1, 2001, independent labs would no longer be allowed to bill Medicare for the technical component ("TC") of pathology services furnished to Medicare beneficiaries who are hospital inpatients. Independent labs would still be able to bill and be paid for the TC of pathology services provided to beneficiaries who are in non-hospital settings, but for the TC of services provided to a hospital inpatient, the independent lab would have to make arrangements with the hospital in order to receive payment. Also beginning on January 1, 2001, under new regulations for hospital outpatient reimbursement, independent labs would be limited to billing the hospital for the TC of any pathology services furnished to hospital outpatients. In other words, under the regulation, independent laboratories that perform the technical component of pathology services for hospital outpatient services would no longer be allowed to bill Medicare for these services and must, instead, bill the hospital. However, BIPA included a "grandfathering" provision allowing independent labs to continue to bill and be paid for the TC of services provided to both hospital inpatients and outpatients for an additional two years, until January 2003. Since Dianon does only minimal testing for hospital inpatients and outpatients, these changes are not expected to have a material financial impact on Dianon. The BBA contained measures to establish market-oriented purchasing for Medicare, including prospective payment systems ("PPS") for hospital outpatient services, home health care, and nursing home care. All of these systems have now been implemented. Since Dianon does only minimal clinical laboratory testing for hospital outpatient, home health care and nursing facility patients, these changes are not expected to have a material financial impact on Dianon. Dianon's Form 10-K and 10-K/A for the year ended December 31, 2001, previously filed with the Securities and Exchange Commission, contains additional information regarding the complex area of reimbursement. 11 o COST OF SALES Cost of sales, which consists primarily of payroll, laboratory supplies, outside services, logistics and depreciation expense, increased to $22.3 million in the First Quarter-2002 from $15.0 million in the First Quarter-2001. As a percentage of revenues, cost of sales improved to 50% in the First Quarter-2002 from 56% in the First Quarter-2001, as a result of strong sales, cost control initiatives and the effective use of operating leverage. o GROSS PROFIT Gross profit totaled $22.3 million in the First Quarter-2002 versus $11.8 million in the First Quarter-2001, reflecting a gross profit margin of 50% and 44%, respectively. The increase in gross profits is a result of increased revenues, cost control initiatives and favorable product line mix. o SELLING, GENERAL AND ADMINISTRATIVE EXPENSES Selling, general and administrative expenses increased to $12.7 million in the First Quarter-2002 from $7.9 million in the First Quarter-2001. This increase is primarily the result of the acquisition of UroCor as well as insurance premiums and commission expense associated with increased revenues. While absolute expenses increased, they remained constant, as a percentage of sales, at 29% for both the First Quarter-2002 and the First Quarter-2001. o AMORTIZATION OF INTANGIBLE ASSETS Amortization of intangible assets increased to $467,000 in the First Quarter-2002 from $255,000 in the First Quarter-2001. These increases are primarily a result of the amortization of the customer list acquired in the UroCor acquisition and the amortization of the marketing rights from MDdatacor. The amortization expense for the First Quarter-2002 is net of the effect of the Company's adoption of Statement of Financial Accounting Standards No. 142, "Goodwill and Other Intangible Assets", which resulted in a decrease of amortization expense of approximately $47,000 for the First-Quarter-2002. o RESEARCH AND DEVELOPMENT EXPENSES Research and development expenses increased to $441,000 in the First Quarter-2002 from $352,000 in the First Quarter-2001. This increase is primarily the result of the acquisition of UroCor and the continued development of CarePath(TM), a proprietary disease management system designed for patients, physicians and managed care organizations. o INCOME FROM OPERATIONS Income from operations increased to $8.7 million in the First Quarter-2002 from $3.3 million in the First Quarter-2001. This increase is primarily due to increased sales and cost control initiatives. Earnings before interest, taxes, depreciation and amortization ("EBITDA") increased to $10.1 million in the First Quarter-2002 from $4.4 million in the First Quarter-2001. As a percentage of sales, EBITDA increased to 22.7% in the First Quarter-2002 from 16.4% in the First Quarter-2001. EBITDA is defined as income before interest expense, income tax expense and depreciation and amortization. Non-recurring items and gains and losses from sales of real estate and investments are also excluded from EBITDA as these items do not impact operating results on a recurring basis. Dianon had no such items for the three months ended March 31, 2002 and 2001, respectively. Management considers EBITDA to be one measure of the cash flows from operations of Dianon before debt service that provides a relevant basis for comparison, and EBITDA is presented to assist investors in analyzing the performance of Dianon. This information should not be considered as an alternative to any measure of performance as promulgated under accounting principles generally accepted in the United States, nor should it be considered as an indicator of the overall financial performance of Dianon. Dianon's calculation of EBITDA may be different from the calculation used by other companies and, therefore, comparability may be limited. 12 EBITDA for the first quarters ended 2002 and 2001 are as follows: First Quarter ------------- 2002 2001 ---- ---- EBITDA $10,117,997 $4,391,067 EBITDA as a percentage of 22.7% 16.4% sales o INTEREST INCOME, NET Net interest income increased to $193,000 in the First Quarter-2002 from $114,000 in the First Quarter-2001, due to the reduction of debt and the corresponding reduction in interest expense, as well as higher cash balances earning interest income. o PROVISION FOR INCOME TAXES The provision for income taxes reflects a 40.5% effective tax rate for the three months ended 2002 and 2001, totaling $3.6 million in the First Quarter-2002 and $1.4 million in the First Quarter-2001. o NET INCOME Net income increased 158% to $5.3 million in the First Quarter-2002 from $2.0 million in the First Quarter-2001. Basic earnings per share increased to $0.44 per share in the First Quarter-2002 from $0.28 per share in the First Quarter-2001, while diluted earnings per share increased to $0.41 per share in the First Quarter-2002 from $0.26 per share in the First Quarter-2001. LIQUIDITY AND CAPITAL RESOURCES At March 31, 2002, Dianon had total cash and cash equivalents of $49.5 million, substantially all of which was invested in a fund holding U.S. Treasury securities with maturities of less than three months. Working capital was $82.8 million and $68.8 million as of March 31, 2002 and December 31, 2001, respectively, and the current ratios (current assets divided by current liabilities) were 5.9:1 and 4.2:1, respectively. Accounts receivable totaled $32.3 million as of March 31, 2002 representing approximately 65 days of sales outstanding, compared to $29.9 million or 63 days as of December 31, 2001. This increase is due to the UroCor acquisition. Capital expenditures for the First Quarter-2002 totaled approximately $1.1 million. Expenditures were primarily related to building expansion and information system enhancements. Effective February 17, 1998, Dianon entered into a three-year, $15 million line of credit agreement with a bank. The agreement includes various provisions regarding borrowings under the facility, including financial and negative covenants. In December 2000, the loan was extended to August 2003, and certain covenants were modified. As of March 31, 2002, no debt was outstanding on the line of credit and the Company was compliant with all covenants. Dianon's Board of Directors previously authorized the repurchase of approximately 1.7 million shares of Dianon's Common Stock on the open market or in private transactions. Total expenditures for share repurchases are limited to $12.0 million. As of March 31, 2002, Dianon had repurchased approximately 336,000 shares of Dianon's Common Stock for approximately $2.8 million. Dianon believes that cash flows from operations and available cash and cash equivalents are adequate to fund Dianon's operations for the foreseeable future. RISK FACTORS; FORWARD-LOOKING STATEMENTS The Management's Discussion and Analysis contains forward-looking statements regarding Dianon's future plans, objectives, and expected performance. These statements are based on assumptions that Dianon believes are reasonable, but are subject to a wide range of risks and uncertainties, and a number of factors could cause Dianon's actual results to differ materially from those expressed in 13 the forward-looking statements referred to above. These factors include, among others, the uncertainties in reimbursement rates and reimbursement coverage of various tests sold by Dianon to beneficiaries of the Medicare and Medicaid programs; the possibility of being deemed to be not in compliance with Federal or state regulatory requirements; the uncertainties relating to the ability of Dianon to convince physicians and/or managed care organizations to use Dianon as a provider of anatomic pathology testing services; the ability of Dianon to maintain superior quality relative to its competitors; the ability of Dianon to maintain its hospital-based business in light of the competitive pressures and changes occurring in hospital healthcare delivery; the uncertainties relating to states erecting barriers to the performance of national anatomic laboratories, together with the competitive pressures from small specialized laboratories and well established local pathologists; and the uncertainties which would arise if integrated delivery systems closed to outside providers emerged as the dominant form of healthcare delivery. We qualify any forward-looking statements entirely by these cautionary factors, and readers are cautioned not to place undue reliance on forward-looking statements. The words "believe," "may," "will," "could," "should," "would," "anticipate," "estimate," "expect," "intend," "project," "objective," "seek," "strive," "might," "seeks," "likely result," "build," "grow," "plan," "goal," "expand," "position," or similar words, or the negatives of these words, or similar terminology, identify forward-looking statements. The forward-looking statements contained in this report only speak as of the date of this report. The Company disclaims any obligation or undertaking to provide any updates or revisions to any forward-looking statements to reflect any change in management's expectations or any change in events, conditions or circumstances on which the forward-looking statements are based. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK Dianon is not subject to market risk with respect to its cash and cash equivalents since substantially all amounts are invested in a fund holding U.S. Treasury securities with maturities of less than three months. 14 PART II OTHER INFORMATION Item 6 Exhibits and Reports on Form 8-K (a) Exhibits: 11.1 Statement regarding computation of per share earnings is not required because the relevant computation can be determined from the material contained in the Financial Statements included herein. (b) Reports: No Form 8-K Current Report was filed with the Securities and Exchange Commission during the first quarter of 2002. 15 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. DIANON Systems, Inc. /s/ KEVIN C. JOHNSON -------------------- April 30, 2002 By: Kevin C. Johnson Chairman of the Board, President and Chief Executive Officer (Principal Executive Officer) /s/ DAVID R. SCHREIBER ---------------------- April 30, 2002 By: David R. Schreiber Senior Vice President, Finance and Chief Financial Officer (Principal Financial Officer and Principal Accounting Officer) 16