SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 Form 10-Q/A (X) QUARTERLY REPORT PURSUANT TO SECTION 13 or 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the Quarterly Period Ended June 30, 1999 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 0-14902 MERIDIAN DIAGNOSTICS, INC. AND SUBSIDIARIES - -------------------------------------- ------------------------------------ Incorporated under the laws of Ohio 31-0888197 - -------------------------------------- ------------------------------------ (I.R.S. Employer Identification No.) 3471 River Hills Drive Cincinnati, Ohio 45244 (513) 271-3700 Indicate by a 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 __ Indicate the number of shares outstanding of each of the issuer's classes of common stock, as of the latest practicable date. Class Outstanding August 16, 1999 - -------------------------------- --------------------------- Common Stock, no par value 14,384,076 1 The Company's interim consolidated financial statements as of June 30, 1999 and for the three-month and nine-month periods then ended have been restated to reflect the correction of a book-keeping error which occurred in June 1999 related to sales to the Company's German subsidiary. This restatement amends the following sections of this Form 10-Q: Part I, Item 1 - Financial Statements; Part I, Item 2 - Management's Discussion and Analysis of Financial Condition and Results of Operations; and Part II, Item 5 - Exhibits and Reports on Form 8-K (Exhibit 27 - Financial Data Schedule) 2 MERIDIAN DIAGNOSTICS, INC. AND SUBSIDIARIES INDEX TO QUARTERLY REPORT ON FORM 10-Q/A Page(s) ------- PART I FINANCIAL INFORMATION Item 1. Financial Statements Consolidated Balance Sheets June 30, 1999 (Restated) and September 30, 1998 3-4 Consolidated Statements of Earnings Three Months Ended June 30, 1999 (Restated) and 1998 Nine Months Ended June 30, 1999 (Restated) and 1998 5 Consolidated Statement of Shareholders' Equity Nine Months Ended June 30, 1999 (Restated) 6 Consolidated Statements of Cash Flows Nine Months Ended June 30, 1999 (Restated) and 1998 7 Notes to Consolidated Financial Statements 8-13 Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations 14-17 PART II. OTHER INFORMATION Item 4. Other Information 17 Item 5. Exhibits and Reports on Form 8-K 18 Signature 19 Exhibit 27 Financial Data Schedule (Restated) 20-22 Exhibit 99 Forward Looking Statements 23 3 MERIDIAN DIAGNOSTICS, INC. AND SUBSIDIARIES Consolidated Balance Sheets (Restated - Note 1) (Unaudited) ASSETS ($000) June 30, 1999 September 30, (Restated) 1998 ------------- ------------- CURRENT ASSETS: Cash and cash equivalents $ 5,007 $ 19,400 Investments 2,226 4,369 Accounts receivable and notes receivable, less allowance for doubtful accounts of $457 in 1999 and $171 in 1998 11,925 9,707 Inventories 9,385 5,569 Prepaid expenses and other 1,195 379 Deferred tax assets 874 339 ------------ ----------- Total current assets 30,612 39,763 ----------- ---------- PROPERTY, PLANT AND EQUIPMENT: Land 966 332 Buildings and improvements 10,092 7,095 Machinery, equipment and furniture 11,980 8,524 Construction in progress 514 171 ------------ ----------- Total property, plant and equipment 23,552 16,122 Less-accumulated depreciation and amortization 8,877 7,313 ----------- ---------- Net property, plant and equipment 14,675 8,809 ----------- ---------- OTHER ASSETS: Long term receivables and other 752 1,035 Deferred tax assets - 740 Deferred debenture offering costs, net of accumulated amortization of $373 in 1999 and $271 in 1998 956 1,057 Other intangible assets, net of accumulated amortization of $7,651 in 1999 and $6,730 in 1998 5,968 6,537 Cost in excess of net assets acquired, net of accumulated amoritization of $1,353 in 1999 and $539 in 1998 17,454 1,206 ------------ ----------- Total other assets 25,130 10,575 ----------- ---------- TOTAL ASSETS $ 70,417 $ 59,147 =========== ========== 4 MERIDIAN DIAGNOSTICS, INC. AND SUBSIDIARIES Consolidated Balance Sheets (Restated - Note 1) (Unaudited) LIABILITIES AND SHAREHOLDERS' EQUITY ($000) June 30, 1999 September 30, (Restated) 1998 ------------- ------------- CURRENT LIABILITIES: Current portion of long-term and capital lease obligations $ 854 $ 213 Notes payable 3,424 - Accounts payable 2,273 1,050 Accrued expenses 5,998 2,606 Income taxes payable 454 - ---------- ----------- Total current liabilities 13,003 3,869 ---------- ----------- LONG-TERM AND CAPITAL LEASE OBLIGATIONS 21,610 20,595 ---------- ----------- DEFERRED INCOME TAXES 448 - ---------- ----------- SHAREHOLDERS' EQUITY: Preferred stock, no par value, 1,000,000 shares authorized; none issued - - Common stock, no par value, 50,000,000 shares authorized; 14,383,921 and 14,382,613 shares issued and outstanding, respectively, stated at 2,398 2,397 Additional paid-in capital 20,657 20,653 Retained earnings 12,684 11,935 Accumulated other comprehensive income (loss) (383) (302) ---------- ----------- Total shareholders' equity 35,356 34,683 ---------- ----------- TOTAL LIABILITIES AND SHAREHOLDERS' EQUITY $ 70,417 $ 59,147 ========== =========== 5 MERIDIAN DIAGNOSTICS, INC. AND SUBSIDIARIES Consolidated Statements of Earnings (Restated - Note 1) (Unaudited) ($000, Except Per Share Amounts) Three Months Ended Nine Months Ended June 30, June 30, --------------------- ------------------------ 1999 1998 1999 1998 (Restated) (Restated) ---------- --------- ---------- ---------- NET SALES $ 13,562 $ 8,226 $ 39,936 $ 26,217 COST OF SALES 4,801 2,366 14,467 8,407 ---------- --------- ---------- ---------- Gross profit 8,761 5,860 25,469 17,810 ---------- --------- ---------- ---------- OPERATING EXPENSES: Research and development 620 378 1,603 1,531 Selling and marketing 2,810 2,062 8,471 5,713 General and administrative 2,268 892 6,925 3,448 Merger integration costs 630 - 1,842 - ---------- --------- ---------- ---------- Total operating expenses 6,328 3,332 18,841 10,692 ---------- --------- ---------- ---------- Operating income 2,433 2,528 6,628 7,118 OTHER INCOME (EXPENSE): Interest income 114 240 383 888 Interest expense (646) (406) (1,837) (1,210) Other, net (64) (4) (206) 4 ---------- --------- ---------- ---------- Total other income (expense) (596) (170) (1,660) (318) ---------- --------- ---------- ---------- Earnings before income taxes 1,837 2,358 4,968 6,800 INCOME TAXES 741 929 2,062 2,696 ========== ========= ========== ========== NET EARNINGS $ 1,096 $ 1,429 $ 2,906 $ 4,104 ========== ========= ========== ========== BASIC WEIGHTED AVERAGE NUMBER OF COMMON SHARES OUTSTANDING 14,383 14,380 14,383 14,374 ========== ========== ========== ========== BASIC EARNINGS PER COMMON SHARE $ 0.08 $ 0.10 $ 0.20 $ 0.29 ========== ========== ========= ========== DILUTED WEIGHTED AVERAGE NUMBER OF COMMON SHARES OUTSTANDING 14,609 14,774 14,574 14,768 ========== ========== ========= ========== DILUTED EARNINGS PER COMMON SHARE $ 0.08 $ 0.10 $ 0.20 $ 0.28 ========== ========== ========= =========== 6 MERIDIAN DIAGNOSTICS, INC. AND SUBSIDIARIES Consolidated Statement of Shareholders' Equity (Restated - Note 1) For the Nine Months Ended June 30, 1999 (Unaudited) ($000, Except Number of Shares) Number of Accumulated Shares Additional Other Issued and Comprehensive Common Paid in Comprehensive Retained Outstanding Income Stock Capital Income(Loss) Earnings Total ------------ ------------- -------- ---------- ------------- --------- -------- Balance at September 30, 1998 14,382,613 - $2,397 $20,653 $(302) $11,935 $34,683 Stock Issuance 400 - - 2 - - 2 Exercised Stock Options 908 - 1 2 - - 3 Dividends - - - - - (2,157) (2,157) Comprehensive Income Net earnings - 2,906 - - - 2,906 2,906 Other comprehensive income (loss) Foreign currency translation adjustment - (81) - - (81) - (81) ----------- Comprehensive Income - 2,825 - - - - - ----------- =========== ------ ---- ------- ------- ------- Balance at June 30, 1999 14,383,921 $2,398 $20,657 $(383) $12,684 $35,356 ========== ====== ======= ====== ======= ======= 7 MERIDIAN DIAGNOSTICS, INC. AND SUBSIDIARIES Consolidated Statements of Cash Flows (Restated - Note 1) (Unaudited) ($000) Nine Months Ended June 30, ------------------------- 1999 1998 (Restated) ---------- ----------- CASH FLOWS FROM OPERATING ACTIVITIES: Net earnings $ 2,906 $ 4,104 Non cash items: Depreciation of property, plant and equipment 1,563 1,018 Amortization of intangible assets and deferred royalties 1,836 1,162 Deferred income taxes (1,037) (199) Change in current assets and current liabilities net of effects of acquisition: Change in current assets excluding cash/cash equivalents and investments 1,922 (1,021) Change in current liabilities, excluding current portion of long-term obligations (121) 87 Long-term receivable and payable 208 (48) --------- -------- Net cash provided by operating activities 7,277 5,103 --------- --------- CASH FLOWS FROM INVESTING ACTIVITIES: Acquisition of Gull Laboratories, Inc., net of acquired cash 18,440) - Purchase of property, plant and equipment, net (1,813) (1,327) Sale (purchase) of short term investments 2,143 (795) Advance royalty - (25) Purchase of product license (200) - --------- -------- Net cash used for investing activities 18,310) (2,147) ---------- -------- CASH FLOWS FROM FINANCING ACTIVITIES: Proceeds from long-term obligations 3,354 180 Repayment of long-term obligations (4,380) (219) Dividends paid (2,157) (2,408) Proceeds from issuance of common stock 5 19 --------- -------- Net cash used for financing activities (3,178) (2,428) --------- -------- EFFECT OF EXCHANGE RATE CHANGES ON CASH (182) (106) --------- -------- NET INCREASE (DECREASE) IN CASH AND CASH EQUIVALENTS (14,393) 422 CASH & CASH EQUIVALENTS AT BEGINNING OF PERIOD 19,400 10,523 --------- -------- CASH & CASH EQUIVALENTS AT END OF PERIOD $ 5,007 $ 10,945 =========== ========= SUPPLEMENTAL DISCLOSURE OF CASH FLOW INFORMATION: Cash paid during the period for: Income taxes $ 1,600 $ 3,054 Interest 1,250 752 8 MERIDIAN DIAGNOSTICS, INC. AND SUBSIDIARIES Notes to Consolidated Financial Statements (Restated) (Unaudited) 1. Basis of Presentation: The consolidated financial statements included herein have not been examined by independent public accountants, but include all adjustments (consisting of normal recurring entries) which are, in the opinion of management, necessary for a fair presentation of the results for such periods. Certain information and footnote disclosure normally included in financial statements prepared in accordance with generally accepted accounting principles have been omitted pursuant to the requirements of the Securities and Exchange Commission, although the Company believes that the disclosures included in these consolidated financial statements are adequate to make the information not misleading. It is suggested that these consolidated financial statements be read in conjunction with the consolidated financial statements and notes thereto included in the Company's latest annual report on Form 10-K. The results of operations for the interim periods are not necessarily indicative of the results to be expected for the year. The fiscal period 1999 consolidated financial statements included herein have been restated to reflect the correction of a bookkeeping error which occurred in June 1999 related to sales to the Company's German subsidiary. The impact of this restatement to earnings for the three and nine-month periods ended June 30, 1999 is as follows (in thousands except per share amounts): Three Months Ended June 30, 1999 Nine Months Ended June 30, 1999 -------------------------------- -------------------------------- As As As As Reported Correction Restated Reported Correction Restated -------- ---------- -------- ---------- ---------- -------- Net sales $13,825 $(263) $13,562 $40,199 $(263) $39,936 Cost of sales 4,660 141 4,801 14,326 141 14,467 -------- ------ -------- ------- ------ -------- Gross profit 9,165 (404) 8,761 25,873 (404) 25,469 Earnings before income taxes 2,241 (404) 1,837 5,372 (404) 4,968 Provision for income taxes 896 (155) 741 2,217 (155) 2,062 Net income 1,345 (249) 1,096 3,155 (249) 2,906 Basic earnings per share 0.09 (0.01) 0.08 0.22 (0.02) 0.20 Dilutive earnings per share 0.09 (0.01) 0.08 0.22 (0.02) 0.20 9 2. Acquisition of Gull Laboratories, Inc.: On November 5, 1998, the Company acquired all of the common stock of Gull Laboratories, Inc. (Gull) for approximately $18.0 million, in cash. The purchase price was financed by cash and cash equivalents on hand. Gull is engaged in the development, manufacture and marketing of high-quality diagnostic test kits for the detection of infectious diseases and autoimmune disorders. Gull also offers a line of instrumentation for laboratory automation and products for blood grouping and HLA tissue typing for transplantation. Fresenius AG, a German stock company and the former majority shareholder of Gull ("Fresenius"), is subject to certain non-competition agreements, as are certain employees of Gull upon their leaving the employment of the Company. One June 16, 1999, the Company paid $1,716,000 of the amounts Gull owed to Fresenius, including interest at 7.5%, as agreed to in the purchase agreement. The final settlement of amounts Gull owed to Fresenius at October 31, 1998, are subject to various adjustments as agreed to in the purchase agreement and are scheduled to be paid on December 31, 1999, with annual interest at 7.5%. For accounting purposes, the acquisition was effective on October 31, 1998 and the results of operations of Gull are included in the consolidated results of operations of the Company from that date forward. The resulting goodwill from this transaction is being amortized over twenty years. The following unaudited pro forma combined results of operations for the year ended September 30, 1998, the quarter ended June 30, 1999, and the nine months ended June 30, 1998 and June 30, 1999, assume the Gull acquisition occurred as of October 31, 1997 (dollars in thousands, except per share data). Pro forma adjustments consist of reductions in interest income due to the use of cash and investments to fund the acquisition, additional amortization based on a preliminary estimate of goodwill and adjustments to the tax provision assuming an effective tax rate of 38%, the utilization of a portion of Gull U.S. losses and the establishment of valuation reserves for potentially unrealizable deferred tax assets related to pro forma operating losses. The unaudited pro forma financial information presented is not necessarily indicative of either the results of operations that would have occurred had the acquisition taken place on October 1, 1997 or the results of operations of the combined companies. 9 Months Ended June 30, ------------------------ Year Ended 3 Months Ended 1999 September 30, 1998 June 30, 1998 (Restated) 1998 ------------------ -------------- ----------- ---------- Net sales................ $ 53,535 $ 13,135 $ 41,426 $ 41,673 Net earnings (loss)...... $ 92 $ (203) $ 2,979 $ 287 Earnings (loss) per share: Basic............... $ 0.01 $ (.01) $ .21 $ .02 Diluted............. $ 0.01 $ (.01) $ .20 $ .02 In connection with the acquisition of Gull, assets were acquired and liabilities were assumed as follows, based upon preliminary estimates of fair values (dollars in thousands): 10 FAIR VALUE OF ASSETS ACQUIRED INCLUDING: Cash and cash equivalents ................................... $ 640 Accounts and notes receivable ............................... 3,210 Inventories ................................................. 5,065 Other current assets ........................................ 640 Property, plant and equipment ............................... 5,620 Other non-current assets .................................... 675 Goodwill .................................................... 16,605 ------- 32,455 Less: Cash paid for net assets ............................. 18,000 ------- $14,455 ======= LIABILITIES ASSUMED INCLUDING: Liabilities assumed ......................................... $ 4,915 Additional purchase liabilities ............................. 1,835 Debt ........................................................ 5,680 Deferred tax liabilities .................................... 500 Acquisition costs ........................................... 1,525 ------- $14,455 ======= The estimates presented above are subject to change pending the completion of certain appraisals and other analyses of the fair value of assets acquired and liabilities assumed, and finalization of October 31, 1998 audit adjustments. The allocation of purchase price may include an allocation to in-process research and development. In fiscal 2000, the Company plans to close the Salt Lake City and certain other facilities of Gull, sell the Gull land and buildings in Salt Lake City, transfer equipment, technology and manufacturing capabilities to the Company's headquarters in Cincinnati and terminate substantially all Gull employees located in Salt Lake City. Additional purchase liabilities recorded to date include approximately $1.8 million for severance and stay bonus reserves and costs related to the shut down and consolidation of the acquired facilities in Salt Lake City and Germany, plus certain deferred tax liabilities. To date, Gull research and development activities have been consolidated into Meridian's, production facilities in Germany have been shut down, renovation of the Cincinnati facilities is underway to accommodate the manufacture of Gull products and certain Gull products are already being produced in Cincinnati. Approximately one-third of the Gull positions at the time of the acquisition have been eliminated to date. The major components of the merger integration costs incurred during the nine-month period are as follow: Amount -------- Materials for product testing $ 240 Travel and training 425 Consulting primarily related to reorganization of European operation 275 Termination payments to distributors 430 Other 472 -------- $ 1,842 ======== 11 Additional costs are expected to be incurred related to materials for product testing, travel, moving and facility closing costs. The amount of total merger integration costs is not expected to exceed $2,500. 3. Inventories: Inventories are comprised of the following (amounts in thousands): June 30, 1999 September 30, 1998 ------------- ------------------ Raw materials $3,096 $1,480 Work-in-process 2,241 1,715 Finished goods 4,048 2,374 =========== =========== $9,385 $5,569 =========== =========== 4. Income Taxes: The provisions for income taxes were computed at the estimated annualized effective tax rates utilizing current tax law in effect, after giving effect to research and experimentation credits and recognizing the benefit of Gull post-acquisition losses incurred in Europe. 5. Earnings Per Common Share: Basic earnings per share (EPS) is computed by dividing income available to common shareholders by the weighted average number of common shares outstanding. Diluted EPS is computed by adding to the weighted average number of common shares outstanding, the dilutive effect of additional common shares that would have been outstanding if dilutive potential common shares had been issued. The table below shows the amounts used in computing earnings per share and the effect on income and the weighted average number of shares for the three-month and nine-month periods ended June 30, 1999 and June 30, 1998 of dilutive potential common stock. 12 QUARTER ENDED June 30, 1999 (Restated) June 30, 1998 ------------------------------------------- -------------------------------------------- Income Shares Per Share Income Shares Per Share (Numerator) (Denominator) Amount (Numerator) (Denominator) Amount ----------- ------------- --------- ----------- ------------- --------- In thousands, except per share amounts BASIC EARNINGS PER SHARE Net income available to common shareholders $1,096 14,383 $0.08 $1,429 14,380 $0.10 ------------------------------------------------------------------------------------------------------------------------ EFFECT OF DILUTIVE SECURITIES Stock Options - 226 - 394 ------------------------------------------------------------------------------------------------------------------------ DILUTED EARNINGS PER SHARE Net income available to common shareholders and assumed conversions $1,096 14,609 $0.08 $1,429 14,774 $0.10 ======================================================================================================================== 13 NINE MONTHS ENDED June 30, 1999 (Restated) June 30, 1998 ------------------------------------------- -------------------------------------------- Income Shares Per Share Income Shares Per Share (Numerator) (Denominator) Amount (Numerator) (Denominator) Amount ----------- ------------- --------- ----------- ------------- --------- In thousands, except per share amounts BASIC EARNINGS PER SHARE Net income available to common shareholders $2,906 14,383 $0.20 $4,104 14,374 $0.29 ---------------------------------------------------------------------------------------------------------------------- EFFECT OF DILUTIVE SECURITIES Stock Options - 191 - - 394 ---------------------------------------------------------------------------------------------------------------------- DILUTED EARNINGS PER SHARE Net income available to common shareholders and assumed conversions $2,906 14,574 $0.20 $4,104 14,768 $0.28 ====================================================================================================================== The following table outlines items excluded from diluted EPS, as they are anti-dilutive. Quarter Ended Nine-Months Ended June 30, June 30, --------------------- ---------------------- 1999 1998 1999 1998 --------- -------- --------- --------- Options 442 230 481 230 Convertible debentures 1,243 1,243 1,243 1,243 ========= ======== ======== ======== 1,685 1,473 1,724 1,473 ========= ======== ======== ======== At both June 30, 1999 and 1998, the impact of assuming the 1996 convertible debentures were converted, net of the impact of pro forma, after tax interest expense, was anti-dilutive. 14 6. Translation of Foreign Currency: Assets and liabilities of foreign operations are translated using quarter end exchange rates. Revenues and expenses are translated using exchange rates prevailing during the period with gains or losses resulting from translation included in a separate component of other comprehensive income (loss). Gains and losses resulting from transactions in foreign currencies were immaterial. 7. Comprehensive Income: During 1997, the Financial Accounting Standards Board (FASB) issued Statement No. 130 (Statement 130) on "Reporting Comprehensive Income". The Company adopted this standard effective October 1,1998. The objective of Statement 130 is to report a measure of all changes in the equity of an enterprise that result from transactions and other economic events of the period other than transactions with owners ("comprehensive income"). Comprehensive income (loss) is the total of net income (loss) and all other non-owner changes in equity. For the Company, this reporting involves gains and losses resulting from the translation of assets and liabilities of foreign operations. 8. Segment Information: During 1997, the FASB issued Statement No. 131 (Statement 131) on "Disclosure About Segments of an Enterprise and Related Information". The Company will adopt Statement 131 this fiscal year; however, there are no interim reporting requirements in the initial year of adoption. The Company is still evaluating the impact of the new disclosure requirements in light of the Gull acquisition. New disclosure requirements, if any, will not impact the Company's financial position or results of operation. 9. Reclassifications: Certain reclassifications have been made to the accompanying financial statements to conform to the June 30, 1999 presentation. 10. Recently Issued Accounting Standards: In June 1998, the Financial Accounting Standards Board issued Statement of Financial Accounting Standards No. 133, Accounting for Derivative Instruments and Hedging Activities. The Statement establishes accounting and reporting standards requiring that every derivative instrument (including certain derivative instruments embedded in other contracts) be recorded in the balance sheet as either an asset or liability measured at its fair value. The Company does not currently hold nor invest in any type of derivative instruments. In March 1998, the AICPA issued SOP98-1- "Accounting for the Costs of Computer Software Developed or Obtained for Internal Use" which requires capitalization of external direct costs of materials and services consumed in developing or obtaining internal-use computer software; payroll and payroll-related costs for employees who are directly associated with and who devote time to the internal-use computer software project (to the extent of the time spent directly on the project); and interest costs incurred when developing computer software for internal use. Training 15 costs, data conversion costs, costs incurred in the preliminary project stage and maintenance fees should be expensed as incurred. Additionally, significant updates and enhancements are capitalized if it is probable that the result will be significant additional functionality or an increase in the life of the software. The capitalization of computer software developed or obtained for internal use should be amortized on a straight-line basis unless another systematic and rational manner is more representative of the use of the software. This SOP is effective for financial statements for fiscal years beginning after December 15, 1998 (the Company's fiscal year 2000), and should be applied to internal-use computer software costs incurred in those fiscal years for all projects, including projects in progress upon initial application of the SOP. The Company does not expect adoption of this accounting pronouncement will have a material impact on the Company's financial position or operating results. Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations Background On November 5, 1998, the Company acquired all of the approximately eight million shares of common stock of Gull Laboratories, Inc. (Gull) for approximately $18.0 million, in cash. The purchase price was financed by cash and cash equivalents on hand. Gull is engaged in the development, manufacture and marketing of high-quality diagnostic test kits for the detection of infectious diseases and autoimmune disorders. Gull also offers a line of instrumentation for laboratory automation and products for blood grouping and HLA tissue typing for transplantation. For accounting purposes, the acquisition was effective October 31, 1998. The results of operations of Gull are included in the consolidated results of operations of the Company from that date forward. The resulting goodwill from this transaction is being amortized over twenty years. See Note 2 of the Notes to Consolidated Financial Statements for further information. Results of Operations The fiscal period 1999 interim consolidated financial statements included herein, and the comparative discussion that follows, have been restated to reflect the correction of a bookkeeping error which occurred in June 1999 related to sales to the Company's German subsidiary. The impact of this restatement to earnings for the fiscal periods ended June 30, 1999 is discussed in Note 1 to the interim consolidated financial statements included herein. Consolidated net sales increased $5,336,000, or 65%, to $13,562,000 for the third fiscal quarter and increased $13,719,000, or 52%, to $39,936,000, for the nine months ended June 30, 1999, principally from the impact of the Gull acquisition and the continued strong performance of the Gull products. These increases of $5,336,000 and $13,719,000 respectively, for the quarter are comprised of volume growth of $4,916,000, or 60%, pricing of $480,000, or 6%, and unfavorable currency of $60,000, or (1%); for the nine months, volume growth of $12,391,000 or 47%, pricing of $1,229,000, or 5%, and currency of $99,000. Core business product sales increased about 11% for the quarter versus the prior year, a major turnaround from the first six months which were down 2% versus the previous year as a result of distributor order patterns in the U.S. and Europe. New product sales led by Premier Platinum HpSA(TM) (H. pylori) and the IC Stat! line of products, contributed approximately $500,000 and $1,460,000 of incremental revenues for the quarter and nine-month periods respectively. C. difficile sales were up $169,000, or 9% for the quarter, but remained about 7% below the prior year nine months results. All other key product groups were performing ahead of the prior year through June 30. 16 Gross profit increased $2,901,000, or 50%, to $8,761,000 for the quarter and $7,659,000, or 43%, to $25,469,000 or the nine-month period compared to the sales increase of 65% for the quarter and 52% for the nine-month period. Gross profit decreased as a percentage of sales to 65% from 71% for the quarter and to 64% from 68% for the nine-month period. For the quarter, the gross profit reflects improved pricing as noted above, offset primarily by the impact of the lower margins for Gull product sales compared to the historical Meridian margins resulting in an overall decrease of five points as a percent of sales. These same factors contributed to the decline in gross profit for the nine-month period compared to the prior year. The Company expects that this drag on the overall gross profit will continue until the Company completes the integration of Gull's production into its Cincinnati facilities and the sellout of Gull's Salt Lake City production, which is expected to occur in about nine months. Gross profit in the third quarter increased six percentage points over the second quarter primarily due to sales in the third quarter shifting to a higher percentage of historical Meridian products. Total operating expenses increased $2,996,000, or 90%, to $6,328,000 for the third fiscal quarter versus the prior year, and increased to 47% of sales from 41% versus the same period last year, primarily due to the Gull acquisition. Similarly, operating expenses for the nine-month period compared to the prior year were up approximately 76%, and increased to 47% from 41% as a percent of sales. Research and development costs increased $242,000 to 5% of sales, comparable with the prior year quarter and increased $72,000, declining to 4% of sales from 6% for the nine month period. This increase for the nine months ended June 30, 1999 reflects a combination of Gull research and development expenses and increases in Meridian research personnel costs, largely offset by the prior year clinical study costs associated with Premier Platinum HpSA, which was cleared for marketing in May 1998. As of March 1, 1999, all research and development activity was consolidated at Meridian's headquarters in Cincinnati. Selling and marketing expenses increased $748,000, or 36%, for the third fiscal quarter and $2,758,000 or 48%, for the nine-month period. Selling and marketing costs declined approximately four points from 25% of sales to 21% for the third fiscal quarter and remained relatively flat at 21% of sales for the nine-month period. General and administrative costs increased $1,376,000, or 154%, and increased as a percent of sales to 17% from 11% for the third quarter; increased $3,477,000 or 101% for the nine-month period to 17% of sales versus 13% the prior year. This increase is also attributable to the Gull acquisition, including $254,000 of amortization of Gull-related goodwill for the quarter and $667,000 for the nine-month period. In connection with the Gull acquisition, the Company incurred merger integration costs of approximately $630,000 during the third fiscal quarter and $1,842,000 for the nine-month period. These costs consist of payments made to distributors to terminate contracts in markets with duplicate distributor agreements or in markets that will now be covered by the Company sales forces, training, travel, product validation and consulting charges in connection with the integration of the Gull business. Additional merger integration costs are expected to be incurred in connection with the ongoing integration efforts. Total merger integration costs are not expected to exceed $2.5 million. Operating income decreased $95,000, or 4%, and declined as a percent of sales to 18% from 31% for the quarter, and decreased $490,000, declining as a percent of sales to 17% from 27% for the nine-month period. Excluding the merger integration costs of $630,000 for the quarter and $1,842,000 for the nine-month period, operating income increased $535,000, or 21% and $1,352,000, or 19%, respectively. Other expense increased $426,000 for the third fiscal quarter and $1,342,000 for the nine-month period. These increases are primarily related to $366,000 in net interest expense for the quarter and $1,132,000 for the nine-month period for Gull-related obligations coupled with the effect of a reduction in interest income due to the use of cash and investments to acquire Gull. The Company's effective tax rate was relatively flat at 40% for the third quarter and up approximately two points to 42% for the nine-month period. Based on tax planning strategies, the Company elected to record a benefit for the full amount of post-acquisition operating losses incurred to date in Gull's foreign operations. The increase in the tax rate over last year is due to the amortization of Gull acquisition-related goodwill, which is not deductible for book or tax purposes. 17 Liquidity and Capital Resources The Company's cash flow requirements mainly consist of working capital for operations, capital expenditures, dividends on common stock and debt repayment. Net cash flows provided by operations increased $2,174,000 for the nine months ended June 30, 1999, primarily due to cash funded by working capital items. The total of net earnings and depreciation/amortization were relatively flat despite approximately $1,800,000 of pretax merger integration costs incurred to date. Net cash used for investing activities increased $16,163,000 which is more than accounted for by cash paid during the nine-month period for the acquisition Gull of $18,440,000 which includes transaction costs of $1,080,000 paid during the nine-month period and is net of cash acquired of $640,000. Net cash flows used for financing activities increased $750,000 for the nine months, largely due to payments made on debt obligations assumed in the Gull acquisition net of proceeds from new obligations. Net cash flows from operations are anticipated to fund working capital requirements for the balance of the fiscal year. The Company has an unused $11,646,000 line of credit with a commercial bank and cash/cash equivalent and short-term investments of $7,233,000 at June 30, 1999. For the year, the Company expects to incur capital expenditures of approximately $4,200,000, which includes $3,000,000 for the renovation of the Cincinnati manufacturing facilities related to the integration of Gull product manufacturing and $500,000 related to new computer systems in Europe. Year 2000 Readiness Disclosure The Year 2000 issue results from date sensitive computer programs that only use the last two digits to refer to a year. Such computer programs may not properly recognize years subsequent to 1999. This issue impacts the Company and virtually every business that relies on a computer. If not corrected, system failures or miscalculations could occur causing disruption of the Company's operations, including among other things, a temporary inability to process transactions or to engage in similar normal business activities. A project team has been formed to address the Company's Year 2000 readiness. Information technology (IT) systems, such as any hardware or software used to process daily operational data and information, as well as non-information technology systems, such as computer chips embedded in manufacturing, laboratory and telecommunications equipment, are being assessed for Year 2000 compliance. This assessment is substantially complete. In November 1997, the Company completed a major upgrade of its computer hardware and primary business system applications in the U.S. as part of planned system enhancements to support the business. The cost of the upgrades, which are Year 2000 compliant, was approximately $400,000. The Company has substantially completed its assessment of the compliance of other IT and non-IT systems in the U.S. Remediation efforts which include modifications or replacement of software and certain hardware. The Company anticipates completion of all remediation and testing of its systems by December 31, 1999. The Company's current business systems in Belgium and Germany are being replaced and the system in Italy has been upgraded to a Year 2000 compliant version. These locations are primarily involved in sales and distribution functions and do not manufacture product. Non-IT systems in European locations are being assessed in connection with planned office and warehouse relocations expected to occur prior to December 31, 1999. The Company expects that many of the existing Gull operations and related systems in the U.S. will be integrated into the Meridian operation during the 18 last quarter of fiscal year 1999 and the first quarter of fiscal 2000. The Company has also addressed the status of instrumentation equipment leased to customers and is in the process of replacing or upgrading the equipment to the extent it is not compliant. The Company is evaluating the status of significant customers and suppliers to determine the extent to which it is vulnerable to these third parties. Ongoing evaluation will continue through 1999; however, the Company believes its broad customer base and availability of alternate suppliers will mitigate the risks associated with these third parties. The Company is developing a contingency plan. The contingency plan addresses critical business processes in the event Year 2000 efforts are not completed in a timely manner. The contingency plans for IT systems include using manual systems, and resetting internal clocks to an earlier date for many non-IT systems. The contingency plan will be further expanded, as required, as remediation and testing procedures are completed throughout the remainder of 1999. Costs specifically associated with the Company's Year 2000 efforts to date have consisted mainly of internal costs and capital expenditures such as systems software and hardware replacements or upgrades and non-IT systems replacements or upgrades and are estimated to be $750,000 when complete. Although the Company has not yet completed its Year 2000 efforts, after certain upgrades and replacements are made, it believes the Year 2000 issue will not pose significant operational problems. However, if such modifications are not made or are not completed in time, or if a material third party fails to properly remediate its Year 2000 issues, or if the costs are higher than expected, the Year 2000 issue could have a material effect on the Company's operations. While the Company is not currently aware of any significant exposure, there can be no assurance that the Year 2000 issue will not have a material impact on the business and operations of the Company. The Company is also in the process of assessing the impact of the conversion to the Euro on its systems and business operations. The conversions and upgrades of the European systems noted above will also enable these operations to process Euro transactions. Currently, the Company has significant sales in Europe, certain of which are denominated in U.S. dollars. When fully adopted, the use of a single currency in participating countries may affect pricing of transactions due to the transparency of prices. Factors such as local taxes, freight and handling costs, and customer preferences may eliminate the need for price adjustments. With the acquisition of Gull and the related increase in European sales, the Company is currently evaluating the impact of this conversion. PART II. OTHER INFORMATION Item 4 Other Information On June 24, 1999, William J. Motto, a founder of the Company and Chief Executive Officer, received The Cincinnati/Northern Kentucky 1999 Ernst & Young Entrepreneur of the Year Award in the Technology division. This Award is sponsored nationally by Ernst & Young, USA Today, the Kauffman Center for Entrepreneurial Leadership at the Ewing Marion Kauffman Foundation, the Nasdaq-Amex Market Group, CNN and CNNfn. 19 On July 3, 1999, The Lancet published an article entitled, "Diagnosis of Helicobacter pylori infection with a new non-invasive antigen-based assay," (Dr. D. Vaira, et. al.). This article reported on a study designed to confirm the accuracy of Meridian's Premier Platinum HpSATM (HpSA), our new test for the detection of the H. pylori antigen which causes stomach ulcers. Approximately 500 patients were tested using the HpSA test, the C13-Urea Breath Test and four endoscopies for H. pylori detection. The HpSA test displayed excellent results with an overall accuracy in excess of 90%. H. pylori infections affect up to 50% and 80% of the population in developed countries and in developing regions, respectively. The cost to manage peptic ulcer disease has reached $6 billion each year. On June 25, 1999, the United States Food and Drug Administration (FDA) gave clearance to market two diagnostic tests for the herpes simplex virus. These tests, Premier(TM) Type-Specific HSV-1 IgG ELISA Test and Premier Type-Specific HSV-2 IgG ELISA Test, are the first medical tests cleared by the FDA that have been proven to distinguish Herpes Simplex Virus (HSV) Type 1 (oral) from Type 2 (genital) herpes infections via serological blood test methods. With the FDA clearance of these two blood tests, discrimination between HSV-1 and HSV-2 infections now can be made routinely in any clinical laboratory. Between 200,000 to 500,000 people contract the HSV infection, the third most prevalent sexually transmitted disease in the United States, annually with as many as 30 million Americans infected with HSV-2. On July 14, 1999, the Company announced that Premier EHEC was used to diagnose young adults impacted by an outbreak of toxigenic E. coli in Texas caused by the bacteria Escherichia coli (E. coli) strain O111. Meridian's Premier EHEC assay indicated the presence of Shiga toxins, the toxins produced by all strains of enterohemorrhagic E. coli (EHEC). On August 11, 1999, the Company received clearance from the United States Food and Drug Administration to market ImmunoCard STAT!(TM) E. coli 0157 Plus. The rapid test will detect the most prevalent toxigenic strain of E. coli, E. coli 0157:H7, which is often transmitted via ground beef vegetables and other foods. ImmunoCard STAT!(TM) E. coli 0157 Plus, which can be performed in approximately 10 minutes, will enable laboratories to report accurate results much sooner than conventional culture methods that can take 24-72 hours to process. Item 5 Exhibits and Reports on Form 8-K (a) Exhibits: Exhibit No. Description Page(s) ----------- --------------------------------- ------- 27 Financial Data Schedule (Restated) 20-22 99 Forward Looking Statements 23 (b) Reports on Form 8-K: None 20 Signature: 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 there-unto duly authorized. MERIDIAN DIAGNOSTICS, INC. AND SUBSIDIARIES Date: August 4, 2000 /s/ Melissa Lueke ------------------------------------------- Melissa Lueke Corporate Controller (Acting Principal Accounting Officer)