☒ | QUARTERLY REPORT PURSUANT TO SECTION 13 or 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
☐ | TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
Title of each class | Trading Symbol(s) | Name of each exchange on which registered | ||
Common Stock, no par value | VIVO | NASDAQ Global Select Market |
Large accelerated filer | ☒ | Accelerated filer | ☐ | |||
Non-accelerated filer | ☐ | Smaller reporting company | ☐ | |||
Emerging growth company | ☐ |
Class | Outstanding January 0 ,2023 | |
Common Stock, no par value |
MERIDIAN BIOSCIENCE, INC. AND SUBSIDIARIES
TABLE OF CONTENTS TO QUARTERLY REPORT ON FORM
Page(s) | ||||||
PART I. | ||||||
Item 1. | Financial Statements (Unaudited) | |||||
| 1 | | ||||
2 | ||||||
3 | ||||||
4-5 | ||||||
6 | ||||||
Item 2. | ||||||
Item 3. | ||||||
Item 4. | ||||||
PART II. | ||||||
Item 1. | 27 | |||||
Item 1A. | ||||||
Item 6. | ||||||
FORWARD-LOOKING STATEMENTS
This Quarterly Report on Form
Meridian’s operating results, financial condition and continued growth depends, in part, on its ability to introduce into the marketplace enhancements of existing products or new products that incorporate technological advances, meet customer requirements and respond to products developed by Meridian’s competition, its ability to effectively sell such products and its ability to successfully expand and effectively manage increased sales and marketing operations. While Meridian has introduced a number of internally developed products and acquired products, there can be no assurance that it will be successful in the future in introducing such products on a timely basis or in protecting its intellectual property, and unexpected or costly manufacturing costs associated with its introduction of new products or acquired products could cause actual results to differ from expectations. Meridian relies on proprietary, patented and licensed technologies. As such, the Company’s ability to protect its intellectual property rights, as well as the potential for intellectual property litigation, would impact its results. Ongoing consolidations of reference laboratories and formation of multi-hospital alliances may cause adverse changes to pricing and distribution. Recessionary pressures on the economy and the markets in which the Company’s customers operate, as well as adverse trends in buying patterns from customers, can change expected results. Costs and difficulties in complying with laws and regulations, including those administered by the United States Food and Drug Administration, and in
complying with the ongoing investigation of the Department of Justice described in Meridian’s reports filed with the SEC, can result in unanticipated expenses and delays and interruptions to the sale of new and existing products, as can the uncertainty of regulatory approvals and the regulatory process (including the FDA actions regarding the Company’s LeadCare products).process. The international scope of Meridian’s operations, including changes in the relative strength or weakness of the U.S. dollar and general economic conditions in foreign countries, can impact results and make them difficult to predict. One of Meridian’s growth strategies is the acquisition of companies and product lines. There can be no assurance that additional acquisitions will be consummated or that, if consummated, will be successful and that the acquired businesses will be successfully integrated into Meridian’s operations. There may be risks that acquisitions may disrupt operations and may pose potential difficulties in employee retention, and there may be additional risks with respect to Meridian’s ability to recognize the benefits of acquisitions, including potential synergies and cost savings or the failure of acquisitions to achieve their plans and objectives. Meridian cannot predict the outcome of future goodwill impairment testing and the impact of possible goodwill impairments on Meridian’s earnings and financial results. Meridian cannot predict the possible impact of any modification or repeal of any of the provisions of current U.S. health care legislation, that might be initiated by Congress or the presidential administration, and any similar initiatives in other countries on itsMeridian’s results of operations. Efforts to reduce the U.S. federal deficit, breaches of Meridian’s information technology systems, trade wars, increased tariffs, and natural disasters and other events could have a materially adverse effect on Meridian’s results of operations and net revenues. The Company can make no assurances that a material weakness in its internal control over financial reporting will not be identified in the future, which if identified and not properly corrected, could materially and adversely affect its operations and result in material misstatements in its consolidated financial statements. Meridian also is subject to risks and uncertainties related to the acquisition by SD Biosensor, Inc., as well as disruptions to or reductions in business operations or prospects due to pandemics, epidemics, widespread health emergencies, or outbreaks of infectious diseases such asCOVID-19.
Three Months Ended December 31, | ||||||||
2021 | 2020 | |||||||
NET REVENUES | $ | 88,341 | $ | 92,917 | ||||
COST OF SALES | 39,182 | 31,369 | ||||||
GROSS PROFIT | 49,159 | 61,548 | ||||||
OPERATING EXPENSES | ||||||||
Research and development | 6,194 | 5,651 | ||||||
Selling and marketing | 7,741 | 7,021 | ||||||
General and administrative | 14,660 | 11,938 | ||||||
Selected legal costs | 281 | 1,227 | ||||||
Change in fair value of acquisition consideration | 0 | 1,047 | ||||||
Total operating expenses | 28,876 | 26,884 | ||||||
OPERATING INCOME | 20,283 | 34,664 | ||||||
OTHER INCOME (EXPENSE) | ||||||||
Interest income | 1 | 9 | ||||||
Interest expense | (372 | ) | (534 | ) | ||||
RADx grant income | 0 | 800 | ||||||
Other, net | (161 | ) | (691 | ) | ||||
Total other expense, net | (532 | ) | (416 | ) | ||||
EARNINGS BEFORE INCOME TAXES | 19,751 | 34,248 | ||||||
INCOME TAX PROVISION | 4,411 | 7,469 | ||||||
NET EARNINGS | $ | 15,340 | $ | 26,779 | ||||
BASIC EARNINGS PER COMMON SHARE | $ | 0.35 | $ | 0.62 | ||||
DILUTED EARNINGS PER COMMON SHARE | $ | 0.35 | $ | 0.61 | ||||
WEIGHTED AVERAGE NUMBER OF COMMON SHARES OUTSTANDING - BASIC | 43,439 | 43,098 | ||||||
EFFECT OF DILUTIVE STOCK OPTIONS AND RESTRICTED SHARE UNITS | 589 | 681 | ||||||
WEIGHTED AVERAGE NUMBER OF COMMON SHARES OUTSTANDING - DILUTED | 44,028 | 43,779 | ||||||
ANTI-DILUTIVE SECURITIES: | ||||||||
Common share options and restricted share units | 425 | 258 | ||||||
Three Months Ended December 31, | ||||||||
2022 | 2021 | |||||||
NET REVENUES | $ | 56,902 | $ | 88,341 | ||||
COST OF SALES | 25,397 | 39,182 | ||||||
GROSS PROFIT | 31,505 | 49,159 | ||||||
OPERATING EXPENSES | ||||||||
Research and development | 6,177 | 6,194 | ||||||
Selling and marketing | 8,294 | 7,741 | ||||||
General and administrative | 11,073 | 14,660 | ||||||
Acquisition and transaction related costs | 1,188 | — | ||||||
Litigation and select legal costs | 32,888 | 281 | ||||||
Total operating expenses | 59,620 | 28,876 | ||||||
OPERATING INCOME (LOSS) | (28,115 | ) | 20,283 | |||||
OTHER INCOME (EXPENSE) | ||||||||
Interest income | 3 | 1 | ||||||
Interest expense | (148 | ) | (372 | ) | ||||
Other, net | (837 | ) | (161 | ) | ||||
Total other expense, net | (982 | ) | (532 | ) | ||||
EARNINGS (LOSS) BEFORE INCOME TAXES | (29,097 | ) | 19,751 | |||||
INCOME TAX PROVISION | 724 | 4,411 | ||||||
NET EARNINGS (LOSS) | $ | (29,821 | ) | $ | 15,340 | |||
BASIC EARNINGS (LOSS) PER COMMON SHARE | $ | (0.68 | ) | $ | 0.35 | |||
DILUTED EARNINGS (LOSS) PER COMMON SHARE | $ | (0.68 | ) | $ | 0.35 | |||
WEIGHTED AVERAGE NUMBER OF COMMON SHARES OUTSTANDING — BASIC | 43,896 | 43,439 | ||||||
EFFECT OF DILUTIVE STOCK OPTIONS AND RESTRICTED SHARE UNITS | — | 589 | ||||||
WEIGHTED AVERAGE NUMBER OF COMMON SHARES OUTSTANDING — DILUTED | 43,896 | 44,028 | ||||||
ANTI-DILUTIVE SECURITIES: | ||||||||
Common share options and restricted share units | 813 | 425 | ||||||
Three Months Ended December 31, | ||||||||
2022 | 2021 | |||||||
NET EARNINGS (LOSS) | $ | (29,821 | ) | $ | 15,340 | |||
Other comprehensive income (loss): | ||||||||
Foreign currency translation adjustment | 3,481 | (58 | ) | |||||
Unrealized gain (loss) on cash flow hedge | (68 | ) | 550 | |||||
Income taxes related to items of other comprehensive income (loss) | 17 | (135 | ) | |||||
Other comprehensive income, net of tax | 3,430 | 357 | ||||||
COMPREHENSIVE INCOME (LOSS) | $ | (26,391 | ) | $ | 15,697 | |||
Three Months Ended December 31, | ||||||||
2021 | 2020 | |||||||
NET EARNINGS | $ | 15,340 | $ | 26,779 | ||||
Other comprehensive (loss) income: | ||||||||
Foreign currency translation adjustment | (58 | ) | 3,301 | |||||
Unrealized gain on cash flow hedge | 550 | 21 | ||||||
Reclassification of amortization of gain on cash flow hedge | 0 | (77 | ) | |||||
Income taxes related to items of other comprehensive (loss) income | (135 | ) | 14 | |||||
Other comprehensive income, net of tax | 357 | 3,259 | ||||||
COMPREHENSIVE INCOME | $ | 15,697 | $ | 30,038 | ||||
Three Months Ended December 31, | ||||||||
2021 | 2020 | |||||||
CASH FLOWS FROM OPERATING ACTIVITIES | ||||||||
Net earnings | $ | 15,340 | $ | 26,779 | ||||
Non-cash items included in net earnings: | ||||||||
Depreciation of property, plant and equipment | 1,700 | 1,508 | ||||||
Amortization of intangible assets | 2,483 | 2,221 | ||||||
Stock-based compensation | 1,903 | 1,241 | ||||||
Deferred income taxes | 927 | (852 | ) | |||||
Change in fair value of acquisition consideration | 0 | 1,047 | ||||||
Change in the following: | ||||||||
Accounts receivable | 9,424 | (1,776 | ) | |||||
Inventories | 2,093 | (5,941 | ) | |||||
Prepaid expenses and other current assets | 200 | 2,682 | ||||||
Accounts payable and accrued expenses | 1,018 | (5,826 | ) | |||||
Income taxes payable | 1,113 | 4,032 | ||||||
Other, net | (646 | ) | 6 | |||||
Net cash provided by operating activities | 35,555 | 25,121 | ||||||
CASH FLOWS FROM INVESTING ACTIVITIES | ||||||||
Purchase of property, plant and equipment | (1,708 | ) | (2,086 | ) | ||||
Payment of acquisition consideration holdback | 0 | (5,000 | ) | |||||
Net cash used in investing activities | (1,708 | ) | (7,086 | ) | ||||
CASH FLOWS FROM FINANCING ACTIVITIES | ||||||||
Payment on revolving credit facility | (10,000 | ) | (10,000 | ) | ||||
Payment of deferred financing costs | (404 | ) | 0 | |||||
Proceeds from exercise of stock options | 80 | — | ||||||
Employee taxes paid upon net share settlement of restricted share units | (763 | ) | 0 | |||||
Net cash used in financing activities | (11,087 | ) | (10,000 | ) | ||||
Effect of Exchange Rate Changes on Cash and Cash Equivalents | 198 | 1,644 | ||||||
Net Increase in Cash and Cash Equivalents | 22,958 | 9,679 | ||||||
Cash and Cash Equivalents at Beginning of Period | 49,771 | 53,514 | ||||||
Cash and Cash Equivalents at End of Period | $ | 72,729 | $ | 63,193 | ||||
Three Months Ended December 31, | ||||||||
2022 | 2021 | |||||||
CASH FLOWS FROM OPERATING ACTIVITIES | ||||||||
Net earnings (loss) | $ | (29,821 | ) | $ | 15,340 | |||
Non-cash items included in net earnings (loss): | ||||||||
Depreciation of property, plant and equipment | 1,643 | 1,700 | ||||||
Amortization of intangible assets | 2,541 | 2,483 | ||||||
Stock compensation expense | 1,393 | 1,903 | ||||||
Deferred income taxes | 216 | 927 | ||||||
Estimated litigation costs | 32,000 | — | ||||||
Change in the following, net of acquisition: | ||||||||
Accounts receivable | 6,083 | 9,424 | ||||||
Inventories | (3,496 | ) | 2,093 | |||||
Prepaid expenses and other current assets | 894 | 200 | ||||||
Accounts payable and accrued expenses | (10,833 | ) | 1,018 | |||||
Income taxes payable | (2,023 | ) | 1,113 | |||||
Other, net | (946 | ) | (646 | ) | ||||
Net cash (used in) provided by operating activities | (2,349 | ) | 35,555 | |||||
CASH FLOWS FROM INVESTING ACTIVITIES | ||||||||
Purchase of property, plant and equipment | (2,654 | ) | (1,708 | ) | ||||
Acquisition, net of holdback | (2,000 | ) | — | |||||
Net cash used in investing activities | (4,654 | ) | (1,708 | ) | ||||
CASH FLOWS FROM FINANCING ACTIVITIES | ||||||||
Payment on revolving credit facility | — | (10,000 | ) | |||||
Payment of deferred financing costs | — | (404 | ) | |||||
Proceeds from exercise of stock options | 799 | 80 | ||||||
Employee taxes paid upon net share settlement of restricted share units | (3,323 | ) | (763 | ) | ||||
Net cash used in financing activities | (2,524 | ) | (11,087 | ) | ||||
Effect of Exchange Rate Changes on Cash and Cash Equivalents | 2,172 | 198 | ||||||
Net Increase (Decrease) in Cash and Cash Equivalents | (7,355 | ) | 22,958 | |||||
Cash and Cash Equivalents at Beginning of Period | 81,453 | 49,771 | ||||||
Cash and Cash Equivalents at End of Period | $ | 74,098 | $ | 72,729 | ||||
December 31, 2021 (Unaudited) | September 30, 2021 | |||||||
CURRENT ASSETS | ||||||||
Cash and cash equivalents | $ | 72,729 | $ | 49,771 | ||||
Accounts receivable, less allowances of $1,293 and $1,078, | 44,300 | 53,568 | ||||||
Inventories, net | 74,198 | 76,842 | ||||||
Prepaid expenses and other current assets | 12,426 | 12,626 | ||||||
Total current assets | 203,653 | 192,807 | ||||||
PROPERTY, PLANT AND EQUIPMENT, at Cost | ||||||||
Land | 987 | 989 | ||||||
Buildings and improvements | 33,009 | 32,765 | ||||||
Machinery, equipment and furniture | 79,438 | 78,410 | ||||||
Construction in progress | 10,352 | 9,991 | ||||||
Subtotal | 123,786 | 122,155 | ||||||
Less: accumulated depreciation and amortization | 80,500 | 78,941 | ||||||
Property, plant and equipment, net | 43,286 | 43,214 | ||||||
OTHER ASSETS | ||||||||
Goodwill | 114,713 | 114,668 | ||||||
Other intangible assets, net | 81,658 | 84,151 | ||||||
Right-of-use | 5,431 | 5,786 | ||||||
Deferred income taxes | 8,813 | 8,731 | ||||||
Other assets | 1,086 | 365 | ||||||
Total other assets | 211,701 | 213,701 | ||||||
TOTAL ASSETS | $ | 458,640 | $ | 449,722 | ||||
December 31, 2022 (Unaudited) | September 30, 2022 | |||||||
CURRENT ASSETS | ||||||||
Cash and cash equivalents | $ | 74,098 | $ | 81,453 | ||||
Accounts receivable, less allowances of $1,327 and $1,325, respectively | 41,573 | 47,235 | ||||||
Inventories, net | 72,663 | 67,814 | ||||||
Prepaid expenses and other current assets | 13,200 | 14,095 | ||||||
Total current assets | 201,534 | 210,597 | ||||||
PROPERTY, PLANT AND EQUIPMENT | ||||||||
Land | 979 | 968 | ||||||
Buildings and improvements | 33,068 | 32,983 | ||||||
Machinery, equipment and furniture | 86,732 | 79,517 | ||||||
Construction in progress | 5,693 | 10,589 | ||||||
Subtotal | 126,472 | 124,057 | ||||||
Less: accumulated depreciation and amortization | 81,051 | 79,199 | ||||||
Net property, plant and equipment | 45,421 | 44,858 | ||||||
OTHER ASSETS | ||||||||
Goodwill | 120,567 | 116,302 | ||||||
Other intangible assets, net | 71,572 | 74,131 | ||||||
Right-of-use | 6,041 | 5,850 | ||||||
Deferred income taxes | 9,650 | 9,278 | ||||||
Other assets | 1,978 | 2,081 | ||||||
Total other assets | 209,808 | 207,642 | ||||||
TOTAL ASSETS | $ | 456,763 | $ | 463,097 | ||||
December 31, 2021 (Unaudited) | September 30, 2021 | |||||||
CURRENT LIABILITIES | ||||||||
Accounts payable | $ | 16,293 | $ | 11,701 | ||||
Accrued employee compensation costs | 12,029 | 16,853 | ||||||
Accrued product recall costs | 4,269 | 5,100 | ||||||
Acquisition consideration | 1,000 | 0 | ||||||
Current operating lease obligations | 2,057 | 1,990 | ||||||
Current government grant obligations | 765 | 638 | ||||||
Other accrued expenses | 8,667 | 7,027 | ||||||
Income taxes payable | 4,866 | 3,848 | ||||||
Total current liabilities | 49,946 | 47,157 | ||||||
NON-CURRENT LIABILITIES | ||||||||
Acquisition consideration | 0 | 1,000 | ||||||
Post-employment benefits | 2,169 | 2,253 | ||||||
Long-term operating lease obligations | 3,529 | 3,932 | ||||||
Long-term debt | 50,000 | 60,000 | ||||||
Government grant obligations | 5,068 | 5,176 | ||||||
Long-term income taxes payable | 469 | 469 | ||||||
Deferred income taxes | 2,067 | 1,055 | ||||||
Other non-current liabilities | 173 | 378 | ||||||
Total non-current liabilities | 63,475 | 74,263 | ||||||
COMMITMENTS AND CONTINGENCIES | 0 | 0 | ||||||
SHAREHOLDERS’ EQUITY | ||||||||
Preferred stock, 0 par value; 1,000,000 shares authorized; NaN issued | 0— | 0— | ||||||
Common shares, 0 par value; 71,000,000 shares authorized, 43,514,258 and 43,361,898 shares issued and outstanding, respectively | 0— | 0— | ||||||
Additional paid-in capital | 148,623 | 147,403 | ||||||
Retained earnings | 196,041 | 180,701 | ||||||
Accumulated other comprehensive income | 555 | 198 | ||||||
Total shareholders’ equity | 345,219 | 328,302 | ||||||
TOTAL LIABILITIES AND SHAREHOLDERS’ EQUITY | $ | 458,640 | $ | 449,722 | ||||
December 31, 2022 (Unaudited) | September 30, 2022 | |||||||
CURRENT LIABILITIES | ||||||||
Accounts payable | $ | 14,413 | $ | 17,759 | ||||
Accrued employee compensation costs | 9,894 | 17,682 | ||||||
Accrued estimated litigation costs | 42,000 | 10,000 | ||||||
Accrued product recall costs | 997 | 1,157 | ||||||
Current operating lease obligations | 1,954 | 1,830 | ||||||
Current government grant obligations | 799 | 667 | ||||||
Other accrued expenses | 6,288 | 5,048 | ||||||
Income taxes payable | 2,232 | 3,808 | ||||||
Total current liabilities | 78,577 | 57,951 | ||||||
NON-CURRENT LIABILITIES | ||||||||
Post-employment benefits | 1,728 | 1,673 | ||||||
Long-term operating lease obligations | 4,187 | 4,127 | ||||||
Long-term debt | 25,000 | 25,000 | ||||||
Government grant obligations | 4,521 | 4,620 | ||||||
Long-term income taxes payable | 395 | 395 | ||||||
Deferred income taxes | 1,104 | 578 | ||||||
Other non-current liabilities | 712 | 692 | ||||||
Total non-current liabilities | 37,647 | 37,085 | ||||||
COMMITMENTS AND CONTINGENCIES | ||||||||
SHAREHOLDERS’ EQUITY | ||||||||
Preferred stock, no par value; 1,000,000 shares authorized; none issued | — | — | ||||||
Common shares, no par value; 71,000,000 shares authorized, 43,999,659 and 43,755,188 shares issued and outstanding, respectively | — | — | ||||||
Additional paid-in capital | 154,533 | 155,664 | ||||||
Treasury stock, at cost, 9,655 shares | (259 | ) | (259 | ) | ||||
Retained earnings | 193,339 | 223,160 | ||||||
Accumulated other comprehensive loss | (7,074 | ) | (10,504 | ) | ||||
Total shareholders’ equity | 340,539 | 368,061 | ||||||
TOTAL LIABILITIES AND SHAREHOLDERS’ EQUITY | $ | 456,763 | $ | 463,097 | ||||
Common Shares | Additional Paid-In Capital | Retained Earnings | Accumulated Other Comprehensive Income (Loss) | Total Shareholders’ Equity | ||||||||||||||||
Balance at September 30, 2021 | 43,362 | $ | 147,403 | $ | 180,701 | $ | 198 | $ | 328,302 | |||||||||||
Conversion of restricted share units and exercise of stock options | 152 | (683 | ) | — | — | (683 | ) | |||||||||||||
Stock compensation expense | — | 1,903 | — | — | 1,903 | |||||||||||||||
Net earnings | — | — | 15,340 | — | 15,340 | |||||||||||||||
Foreign currency translation adjustment | — | — | — | (58 | ) | (58 | ) | |||||||||||||
Hedging activity, net of tax | — | — | — | 415 | 415 | |||||||||||||||
Balance at December 31, 2021 | 43,514 | $ | 148,623 | $ | 196,041 | $ | 555 | $ | 345,219 | |||||||||||
Balance at September 30, 2020 | 43,069 | $ | 140,195 | $ | 109,294 | $ | (1,860 | ) | $ | 247,629 | ||||||||||
Conversion of restricted share units and exercise of stock options | 55 | (41 | ) | — | — | (41 | ) | |||||||||||||
Stock compensation expense | — | 1,241 | — | — | 1,241 | |||||||||||||||
Net earnings | — | — | 26,779 | — | 26,779 | |||||||||||||||
Foreign currency translation adjustment | — | — | — | 3,301 | 3,301 | |||||||||||||||
Hedging activity, net of tax | — | — | — | (42 | ) | (42 | ) | |||||||||||||
Balance at December 31, 2020 | 43,124 | $ | 141,395 | $ | 136,073 | $ | 1,399 | $ | 278,867 | |||||||||||
Common Shares | Additional Paid-In Capital | Treasury Stock | Retained Earnings | Accumulated Other Comp. Income (Loss) | Total Shareholders’ Equity | |||||||||||||||||||||||
Sh. | Amt. | |||||||||||||||||||||||||||
Balance at September 30, 2022 | 43,755 | $ | 155,664 | (10 | ) | $ | (259 | ) | $ | 223,160 | $ | (10,504) | $ | 368,061 | ||||||||||||||
Conversion of restricted share units and exercise of stock options | 245 | (2,524 | ) | — | — | — | — | (2,524 | ) | |||||||||||||||||||
Stock compensation expense | — | 1,393 | — | — | — | — | 1,393 | |||||||||||||||||||||
Net loss | — | — | — | — | (29,821 | ) | — | (29,821 | ) | |||||||||||||||||||
Foreign currency translation adjustment | — | — | — | — | — | 3,481 | 3,481 | |||||||||||||||||||||
Hedging activity, net of tax | — | —�� | — | — | — | (51 | ) | (51 | ) | |||||||||||||||||||
Balance at December 31, 2022 | 44,000 | $ | 154,533 | (10 | ) | $ | (259 | ) | $ | 193,339 | $ | (7,074) | $ | 340,539 | ||||||||||||||
Balance at September 30, 2021 | 43,362 | $ | 147,403 | — | $ | — | $ | 180,701 | $ | 198 | $ | 328,302 | ||||||||||||||||
Conversion of restricted share units and exercise of stock options | 152 | (683 | ) | — | — | — | — | (683 | ) | |||||||||||||||||||
Stock compensation expense | — | 1,903 | — | — | — | — | 1,903 | |||||||||||||||||||||
Net earnings | — | — | — | — | 15,340 | — | 15,340 | |||||||||||||||||||||
Foreign currency translation adjustment | — | — | — | — | — | (58 | ) | (58 | ) | |||||||||||||||||||
Hedging activity, net of tax | — | — | — | — | — | 415 | 415 | |||||||||||||||||||||
Balance at December 31, 2021 | 43,514 | $ | 148,623 | — | $ | — | $ | 196,041 | $ | 555 | $ | 345,219 | ||||||||||||||||
1. | Nature of Business |
2. | Basis of Presentation |
3. | Significant Accounting Policies |
(a) | Recent Accounting Pronouncements – |
(b) | Reclassifications – |
4. | Revenue Recognition |
Three Months Ended December 31, | ||||||||||||
2021 | 2020 | Inc (Dec) | ||||||||||
Diagnostics- | ||||||||||||
Americas | $ | 26,613 | $ | 23,551 | 13 | % | ||||||
EMEA | 6,093 | 6,020 | 1 | % | ||||||||
ROW | 498 | 750 | (34 | )% | ||||||||
Total Diagnostics | 33,204 | 30,321 | 10 | % | ||||||||
Life Science- | ||||||||||||
Americas | 8,137 | 18,755 | (57 | )% | ||||||||
EMEA | 28,648 | 32,311 | (11 | )% | ||||||||
ROW | 18,352 | 11,530 | 59 | % | ||||||||
Total Life Science | 55,137 | 62,596 | (12 | )% | ||||||||
Consolidated | $ | 88,341 | $ | 92,917 | (5 | )% | ||||||
Three Months Ended December 31, | ||||||||||||
2022 | 2021 | Inc (Dec) | ||||||||||
Diagnostics- | ||||||||||||
Americas | $ | 33,182 | $ | 26,613 | 25 | % | ||||||
EMEA | 5,694 | 6,093 | (7 | )% | ||||||||
ROW | 490 | 498 | (2 | )% | ||||||||
Total Diagnostics | 39,366 | 33,204 | 19 | % | ||||||||
Life Science- | ||||||||||||
Americas | 5,859 | 8,137 | (28 | )% | ||||||||
EMEA | 6,944 | 28,648 | (76 | )% | ||||||||
ROW | 4,733 | 18,352 | (74 | )% | ||||||||
Total Life Science | 17,536 | 55,137 | (68 | )% | ||||||||
Consolidated | $ | 56,902 | $ | 88,341 | (36 | )% | ||||||
Three Months Ended December 31, | ||||||||||||
2021 | 2020 | Inc (Dec) | ||||||||||
Diagnostics- | ||||||||||||
Molecular assays | $ | 4,752 | $ | 4,590 | 4 | % | ||||||
Non-molecular assays | 28,452 | 25,731 | 11 | % | ||||||||
Total Diagnostics | $ | 33,204 | $ | 30,321 | 10 | % | ||||||
Life Science- | ||||||||||||
Molecular reagents | $ | 31,488 | $ | 46,029 | (32 | )% | ||||||
Immunological reagents | 23,649 | 16,567 | 43 | % | ||||||||
Total Life Science | $ | 55,137 | $ | 62,596 | (12 | )% | ||||||
Three Months Ended December 31, | ||||||||||||
2022 | 2021 | Inc (Dec) | ||||||||||
Diagnostics- | ||||||||||||
Molecular assays | $ | 4,490 | $ | 4,752 | (6 | )% | ||||||
Non-molecular assays | 34,876 | 28,452 | 23 | % | ||||||||
Total Diagnostics | 39,366 | 33,204 | 19 | % | ||||||||
Life Science- | ||||||||||||
Molecular reagents | 7,574 | 31,488 | (76 | )% | ||||||||
Immunological reagents | 9,962 | 23,649 | (58 | )% | ||||||||
Total Life Science | 17,536 | 55,137 | (68 | )% | ||||||||
Consolidated | $ | 56,902 | $ | 88,341 | (36 | )% | ||||||
Three Months Ended December 31, | Three Months Ended December 31, | |||||||||||||||||||||||
2021 | 2020 | Inc (Dec) | 2022 | 2021 | Inc (Dec) | |||||||||||||||||||
Diagnostics- | ||||||||||||||||||||||||
Gastrointestinal assays | $ | 21,619 | $ | 15,452 | 40 | % | $ | 21,273 | $ | 21,619 | (2 | )% | ||||||||||||
Respiratory illness assays | 6,380 | 4,806 | 33 | % | 6,714 | 6,380 | 5 | % | ||||||||||||||||
Blood chemistry assays | 78 | 4,394 | (98 | )% | 4,620 | 78 | 5823 | % | ||||||||||||||||
Other | 5,127 | 5,669 | (10 | )% | 6,759 | 5,127 | 32 | % | ||||||||||||||||
Total Diagnostics | $ | 33,204 | $ | 30,321 | 10 | % | $ | 39,366 | $ | 33,204 | 19 | % | ||||||||||||
5. | Fair Value Measurements |
Fair Value Measurements Using Inputs Considered as | ||||||||||||||||
Carrying Value | Level 1 | Level 2 | Level 3 | |||||||||||||
Interest rate swap agreements - | ||||||||||||||||
As of December 31, 2022 | $ | 1,353 | $ | — | $ | 1,353 | $ | — | ||||||||
As of September 30, 2022 | $ | 1,421 | $ | — | $ | 1,421 | $ | — |
6. | Business Combinations |
Three Months Ended December 31, | 2021 | 2020 | ||||||
Net revenues | $ | 88,341 | $ | 97,824 | ||||
Net earnings | 15,340 | 28,014 |
7. | Lead Testing Matters |
8. | Cash and Cash Equivalents |
December 31, 2021 | September 30, 2021 | |||||||
Institutional money market funds | $ | 1,020 | $ | 1,020 | ||||
Cash on hand, unrestricted | 71,709 | 48,751 | ||||||
Total | $ | 72,729 | $ | 49,771 | ||||
December 31, 2022 | September 30, 2022 | |||||||
Institutional money market funds | $ | 1,027 | $ | 1,027 | ||||
Cash on hand, unrestricted | 73,071 | 80,426 | ||||||
Total | $ | 74,098 | $ | 81,453 | ||||
9. | Inventories, Net |
December 31, 2021 | September 30, 2021 | |||||||
Raw materials | $ | 15,104 | $ | 14,843 | ||||
Work-in-process | 21,479 | 25,072 | ||||||
Finished goods - instruments | 2,699 | 2,260 | ||||||
Finished goods - kits and reagents | 34,916 | 34,667 | ||||||
Total | $ | 74,198 | $ | 76,842 | ||||
December 31, 2022 | September 30, 2022 | |||||||
Raw materials | $ | 18,063 | $ | 15,726 | ||||
Work-in-process | 25,329 | 21,570 | ||||||
Finished goods - instruments | 2,126 | 1,796 | ||||||
Finished goods - kits and reagents | 27,145 | 28,722 | ||||||
Total | $ | 72,663 | $ | 67,814 | ||||
10. | Goodwill and Other Intangible Assets, Net |
December 31, 2021 | September 30, 2021 | |||||||||||||||
Gross Carrying Value | Accumulated Amortization | Gross Carrying Value | Accumulated Amortization | |||||||||||||
Manufacturing technologies, core products and cell lines | $ | 62,421 | $ | 23,592 | $ | 62,416 | $ | 22,633 | ||||||||
Trade names, licenses and patents | 18,495 | 9,806 | 18,489 | 9,492 | ||||||||||||
Customer lists, customer relationships and supply agreements | 54,954 | 20,887 | 54,941 | 19,649 | ||||||||||||
Non-compete agreements | 110 | 37 | 110 | 31 | ||||||||||||
Total | $ | 135,980 | $ | 54,322 | $ | 135,956 | $ | 51,805 | ||||||||
December 31, 2022 | September 30, 2022 | |||||||||||||||
Gross Carrying Value | Accumulated Amortization | Gross Carrying Value | Accumulated Amortization | |||||||||||||
Manufacturing technologies, core products and cell lines | $ | 56,380 | $ | 21,366 | $ | 56,289 | $ | 20,321 | ||||||||
Trade names, licenses and patents | 18,363 | 10,906 | 18,257 | 10,491 | ||||||||||||
Customer lists, customer relationships and supply agreements | 52,829 | 23,779 | 52,703 | 22,363 | ||||||||||||
Non-compete agreements | 110 | 59 | 110 | 53 | ||||||||||||
Total | $ | 127,682 | $ | 56,110 | $ | 127,359 | $ | 53,228 | ||||||||
11. | Leasing Arrangements |
Three Months Ended December 31, | 2021 | 2020 | 2022 | 2021 | ||||||||||||
Lease costs within cost of sales | $ | 225 | $ | 158 | $ | 226 | $ | 225 | ||||||||
Lease costs within operating expenses | 388 | 374 | 349 | 388 | ||||||||||||
Right-of-use , obtained in exchange for operating lease liabilities | 218 | 80 | ||||||||||||||
Right-of-use | 423 | 218 |
December 31, 2021 | September 30, 2021 | |||||||
Weighted average remaining lease term | 3.3 years | 3.6 years | ||||||
Average discount rate | 3.2 | % | 3.2 | % |
December 31, 2022 | September 30, 2022 | |||||||
Weighted average remaining lease term | 3.6 years | 3.9 years | ||||||
Average discount rate | 3.5 | % | 3.5 | % |
2022 (represents remainder of fiscal year) | $ | 1,687 | ||
2023 | 1,690 | |||
2024 | 1,218 | |||
2025 | 908 | |||
2026 | 316 | |||
Thereafter | 62 | |||
Total lease payments | 5,881 | |||
Less amount of lease payments representing interest | (295 | ) | ||
Total present value of lease payments | $ | 5,586 | ||
2023 (represents remainder of fiscal year) | $ | 1,571 | ||
2024 | 1,796 | |||
2025 | 1,519 | |||
2026 | 796 | |||
2027 | 545 | |||
Thereafter | 136 | |||
Total lease payments | 6,363 | |||
Less amount of lease payments representing interest | (222 | ) | ||
Total present value of lease payments | $ | 6,141 | ||
Three Months Ended December 31, | 2022 | 2021 | ||||||
Cash paid for amounts included in the measurement of lease liabilities: | ||||||||
Operating cash flows from operating leases | $ | 580 | $ | 627 |
Three Months Ended December 31, | 2021 | 2020 | ||||||
Cash paid for amounts included in the measurement of lease liabilities: | ||||||||
Operating cash flows from operating leases | $ | 627 | $ | 494 | ||||
12. | Bank Credit Arrangements |
13. | Contingent Obligations and Non-Current Liabilities |
December 31, 2021 | September 30, 2021 | December 31, 2022 | September 30, 2022 | |||||||||||||
Current liabilities | $ | 765 | $ | 638 | $ | 799 | $ | 667 | ||||||||
Non-current liabilities | $ | 5,068 | $ | 5,176 | $ | 4,521 | $ | 4,620 |
14. | National Institutes of Health Contracts |
15. | Reportable Segment and Major Customers Information |
Diagnostics | Life Science | Corporate (1) | Eliminations (2) | Total | ||||||||||||||||
Three Months Ended December 31, 2021 | ||||||||||||||||||||
Net revenues - | ||||||||||||||||||||
Third-party | $ | 33,204 | $ | 55,137 | $ | — | $ | — | $ | 88,341 | ||||||||||
Inter-segment | 34 | 55 | — | (89 | ) | — | ||||||||||||||
Operating (loss) income | (2,612 | ) | 26,517 | (3,637 | ) | 15 | 20,283 | |||||||||||||
Goodwill (December 31, 2021) | 94,908 | 19,805 | — | — | 114,713 | |||||||||||||||
Other intangible assets, net (December 31, 2021) | 81,656 | 2 | — | — | 81,658 | |||||||||||||||
Total assets (December 31, 2021) | 352,318 | 106,339 | — | (17 | ) | 458,640 | ||||||||||||||
Three Months Ended December 31, 2020 | ||||||||||||||||||||
Net revenues - | ||||||||||||||||||||
Third-party | $ | 30,321 | $ | 62,596 | $ | — | $ | — | $ | 92,917 | ||||||||||
Inter-segment | 69 | 18 | — | (87 | ) | — | ||||||||||||||
Operating (loss) income | (1,182 | ) | 39,797 | (3,963 | ) | 12 | 34,664 | |||||||||||||
Goodwill (September 30, 2021) | 94,904 | 19,764 | — | — | 114,668 | |||||||||||||||
Other intangible assets, net (September 30, 2021) | 84,149 | 2 | — | — | 84,151 | |||||||||||||||
Total assets (September 30, 2021) | 339,208 | 110,536 | — | (22 | ) | 449,722 | ||||||||||||||
Diagnostics | Life Science | Corporate (1) | Eliminations (2) | Total | ||||||||||||||||
Three Months Ended December 31, 2022 | ||||||||||||||||||||
Net revenues - | ||||||||||||||||||||
Third-party | $ | 39,366 | $ | 17,536 | $ | — | $ | — | $ | 56,902 | ||||||||||
Inter-segment | 86 | 8 | — | (94 | ) | — | ||||||||||||||
Operating income (loss) | 3,160 | 5,383 | (36,693 | ) | 35 | (28,115 | ) | |||||||||||||
Goodwill (December 31, 2022) | 94,432 | 26,135 | — | — | 120,567 | |||||||||||||||
Other intangible assets, net (December 31, 2022) | 71,570 | 2 | — | — | 71,572 | |||||||||||||||
Total assets (December 31, 2022) | 353,997 | 102,775 | — | (9 | ) | 456,763 | ||||||||||||||
Three Months Ended December 31, 2021 | ||||||||||||||||||||
Net revenues - | ||||||||||||||||||||
Third-party | $ | 33,204 | $ | 55,137 | $ | — | $ | — | $ | 88,341 | ||||||||||
Inter-segment | 34 | 55 | — | (89 | ) | — | ||||||||||||||
Operating income (loss) | (1,763 | ) | 26,602 | (4,571 | ) | 15 | 20,283 | |||||||||||||
Goodwill (September 30, 2022) | 94,412 | 21,890 | — | — | 116,302 | |||||||||||||||
Other intangible assets, net (September 30, 2022) | 74,129 | 2 | — | — | 74,131 | |||||||||||||||
Total assets (September 30, 2022) | 357,630 | 105,511 | — | (44 | ) | 463,097 | ||||||||||||||
(1) | Includes |
(2) | Eliminations consist of inter-segment transactions. |
Three Months Ended December 31, | 2022 | 2021 | ||||||
Operating income (loss): | ||||||||
Diagnostics segment | $ | 3,160 | $ | (1,763) | ||||
Life Science segment | 5,383 | 26,602 | ||||||
Eliminations | 35 | 15 | ||||||
Total operating income | 8,578 | 24,854 | ||||||
Corporate expenses | (36,693 | ) | (4,571 | ) | ||||
Interest income | 3 | 1 | ||||||
Interest expense | (148 | ) | (372 | ) | ||||
Other, net | (837 | ) | (161 | ) | ||||
Consolidated earnings (loss) before income taxes | $ | (29,097 | ) | $ | 19,751 | |||
Three Months Ended December 31, | 2021 | 2020 | ||||||
Operating (loss) income: | ||||||||
Diagnostics segment | $ | (2,612 | ) | $ | (1,182 | ) | ||
Life Science segment | 26,517 | 39,797 | ||||||
Eliminations | 15 | 12 | ||||||
Total operating income | 23,920 | 38,627 | ||||||
Corporate expenses | (3,637 | ) | (3,963 | ) | ||||
Interest income | 1 | 9 | ||||||
Interest expense | (372 | ) | (534 | ) | ||||
RADx initiative grant income | 0 | 800 | ||||||
Other, net | (161 | ) | (691 | ) | ||||
Consolidated earnings before income taxes | $ | 19,751 | $ | 34,248 | ||||
Three Months Ended December 31, | 2021 | 2020 | 2022 | 2021 | ||||||||||||
Diagnostics | ||||||||||||||||
Customer A | 10 | % | 12 | % | 7 | % | 10 | % | ||||||||
Customer B | 11 | % | 10 | % | 10 | % | 11 | % | ||||||||
Customer C | 11 | % | 11 | % | 12 | % | 11 | % | ||||||||
Life Science | ||||||||||||||||
Customer D | 14 | % | 19 | % | — | % | 23 | % | ||||||||
Customer E | 23 | % | 2 | % | 4 | % | 14 | % | ||||||||
Customer F | 12 | % | 5 | % |
Three Months Ended December 31, | 2021 | 2020 | ||||||
Life Science | ||||||||
Customer D | 9 | % | 13 | % | ||||
Customer E | 14 | % | 2 | % |
Three Months Ended December 31, | 2022 | 2021 | ||||||
Life Science | ||||||||
Customer D | — | % | 14 | % |
16. | Income Taxes |
17. |
18. | Subsequent Events |
National Association, as administrative agent, PNC Capital Markets LLC, as joint lead arranger and sole bookrunner, and Fifth Third Bank, National Association, as joint lead arranger and syndication agent; and |
ITEM 2. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
Refer to “Forward-Looking Statements” following the Table of Contents in front of this Form
The purpose of Management’s Discussion and Analysis is to provide an understanding of the financial condition, changes in financial condition and results of operations of Meridian Bioscience, Inc. (“Meridian”, the “Company”, “We”). This discussion should be read in conjunction with the Condensed Consolidated Financial Statements and notes. It should be noted that the terms revenue and/or revenues are utilized throughout the Management’s Discussion and Analysis of Financial Condition and Results of Operations (“MD&A”) to indicate net revenue and/or net revenues. In addition, throughout the MD&A, we refer to certain product tradenames and trademarks, which are protected under applicable intellectual property laws and are our property. Solely for convenience, these tradenames and trademarks are referred to without the
Reportable Segments
Our reportable segments are Diagnostics and Life Science. The Diagnostics segment consists of manufacturing operations for infectious disease products in Cincinnati, Ohio; Quebec City, Canada; and Modi’in, Israel; and manufacturing operations for blood chemistry products in Billerica, Massachusetts. These diagnostic test products are sold and distributed in the countries comprising North and Latin America (the “Americas”); Europe, Middle East and Africa (“EMEA”); and other countries outside of the Americas and EMEA (rest of the world, or “ROW”). The Life Science segment consists of manufacturing operations in Memphis, Tennessee; Boca Raton, Florida; North Brunswick, New Jersey; London, England; and Luckenwalde, Germany, and the sale and distribution of bulk antigens, antibodies, immunoassay blocking reagents, various Polymerase Chain Reaction (“PCR”) and isothermal amplification master mixes, and bioresearch reagents domestically and abroad, including a sales and business development facility, with outsourced distribution capabilities, in Beijing, China to further pursue growing revenue opportunities in Asia.
Page 19
Recent Developments
Agreement and Plan of Merger
On July 7, 2022, the Company entered into an Agreement and Plan of Merger (as it may be amended, supplemented or otherwise modified from time to time, the “Merger Agreement”) with SD Biosensor, Inc., a corporation with limited liability organized under the laws of the Republic of Korea (“SDB”), Columbus Holding Company, a Delaware corporation (“Parent”), and Madeira Acquisition Corp., an Ohio corporation and a direct wholly owned subsidiary of Parent (“Merger Sub,” and together with SDB and Parent, the “Parent Parties”). Pursuant to the Merger Agreement, Merger Sub merged with and into Meridian (the “Merger”), with Meridian surviving the Merger as a direct wholly owned subsidiary of Parent.
On December 9, 2022, Meridian and the Parent Parties entered into a Letter Agreement (the “Letter Agreement”), modifying the Merger Agreement, such that all of the conditions to the Parent Parties’ obligation to complete the Merger have been satisfied (and are deemed to remain satisfied through the completion of the Merger), provided that Meridian is required to comply with certain covenants in the Merger Agreement through the completion of the Merger. Under the Letter Agreement, Meridian and the Parent Parties also agreed to, among other things, consummate the Merger on January 31, 2023.
On January 31, 2023, the Merger was consummated in accordance with the terms of the Merger Agreement and the Letter Agreement, and Parent, which at the time of Closing was wholly-owned and controlled by SDB, became the sole shareholder of Meridian. Pursuant to the terms of the Merger Agreement, at the effective time of the Merger, each issued and outstanding share of Meridian’s common stock (subject to certain exceptions set forth in the Merger Agreement) was canceled and converted into the right to receive $34.00 in cash, without interest (the “Merger Consideration”). See Note 18, “Subsequent Events” of the Condensed Consolidated Financial Statements regarding consummation of the Merger.
The foregoing description of the Merger, the Merger Agreement, and the Letter Agreement does not purport to be complete and is subject to, and qualified in its entirety by, the full text of (i) the Merger Agreement, a copy of which was filed by Meridian as Exhibit 2.1 to Meridian’s Current Report on Form 8-K filed on July 7, 2022 and is incorporated herein by reference, and (ii) the Letter Agreement, a copy of which was filed by Meridian as Exhibit 2.1 to Meridian’s Current Report on Form 8-K filed on December 12, 2022 and is incorporated herein by reference.
The Company incurred transaction related costs of approximately $1,160 during the three months ended December 31, 2022 related to the Merger, which is recorded in acquisition and transaction related costs in the Condensed Consolidated Statement of Operations.
Impact of
Starting in the latter half of fiscal 2020 and continuing to the date of this filing, the
Our Life Science segment’s products have beenwere well positioned to respond to in vitro device (“IVD”) manufacturers’ increased demand for reagents used in the manufacture of molecular, rapid antigen and serology tests. Consequently, through the end of the second quarter of fiscal 2022, our Life Science segment has consistently delivered significantly higher levels of net revenues and operating income than those achieved prior to the COVID-19 pandemic, with the peak to date peak in such levels occurring during the thirdsecond quarter of fiscal 2020 and2022. This revenue peak has been followed by a significant decrease in such net revenue levels since the firstsecond quarter of fiscal 2021, respectively.
Our Diagnostics segment, on the other hand, has generally been negatively impacted by health systems’ increased focus on
There continues to thebe many uncertainties surrounding the
Page 20
Employee Safety
While the majority of our employee base in the U.S. has returned to working
Supply Chains
Supply chains supporting our products have generally remained intact, providing access to sufficient inventory of the key materials needed for manufacturing. While we have experienced extended lead times for certain select raw materials, delays and allocations for raw materials have to date been limited and have not had a material impact on our results of operations. From time to time, we identify alternative suppliers to address the risk of a current supplier’s inability to deliver materials in volumes sufficient to meet our manufacturing needs; or we may choose to purchase certain materials in bulk volumes where we have supply chain scarcity concerns. It remains possible that we may experience some sort of interruption to our supply chains, and such an interruption could materially affect our ability to timely manufacture and distribute our products and unfavorably impact our results of operations.
Since the second half of fiscal 2021, we have experienced input cost inflation, including materials, labor and labor.transportation costs. Pricing actions and supply chain productivity initiatives have mitigated and are expected to continue to mitigate some of these inflationary pressures, but we may not be successful in fully offsetting these incremental costs, which could have an impact on the Company’s consolidated results of operations and cash flows during 2022 and beyond.
Product Development and Clinical Trials
Our Diagnostics segment’s new product development programs are continuing to progress at a slower pace than normal, due in part to the prevalence of certain infectious diseases having been lower than normal during the
Lead Testing Matters
On September 1, 2021, the Company’s wholly owned subsidiary Magellan announced the expansion of the Class I voluntary recall of its LeadCare test kits for the detection of lead in blood, which it had initiated in May 2021 after identifying an ongoing issue with the testing controls included in certain manufactured lots of its LeadCare test kits. As a result of the identified issue, impacted test kit lots could potentially underestimate blood lead levels when processing patient blood samples. Although it was initially believed that the root cause of the issue related to the plastic containers used for the treatment reagent, additional studies have indicated that the root cause relatesrelated to the third-party-sourced cardboard trays that hold the containers used forheld the treatment reagent.reagent containers. Upon correction of the identified supplier issue, shipment of product resumed during the second quarter of fiscal 2022. The Company continues to work closely with the FDA in its execution of the recall activities, which includehas included Magellan notifying customers and distributors affected by the recall and providing instructions for the return of impacted test kits. The evaluation of theRemaining accrued LeadCare product recall the related notification processcosts totaling approximately $177 and correction of the identified supplier issue is ongoing. Of the approximate $5,100 estimated and accrued as of September 30, 2021 to cover the estimated costs of the recall, approximately $4,300 remains accrued and is$430 are reflected inwithin the Condensed Consolidated Balance Sheet as ofSheets at December 31, 2021.2022 and September 30, 2022, respectively. Anticipated recall-related costs primarily include temporary labor costs, product replacement and/or refund costs, mailing/shipping costs, attorneys’ fees and other miscellaneous costs.
Page 21
On April 17, 2018, the Company’s wholly owned subsidiary Magellan received a subpoena from the U.S. Department of Justice (“DOJ”) regarding its LeadCare product line. The subpoena outlined documents to be produced, and the Company is cooperating with the DOJ in this matter. The Company maintains rigorous policies and procedures to promote compliance with applicable regulatory agencies and requirements and is working with the DOJ to promptly respond to the subpoena, including responding to additional information requests that have followed receipt of the subpoena in April 2018. The Company has executed tolling agreements to extend the statute of limitations. In March and April 2021, DOJ issued two subpoenas, both to former employees of Magellan, calling for witnesses to testify before a federal grand jury related to this matter. The March 2021 subpoena was issued to a former employee of Magellan, and the April 2021 subpoena was issued to a current employee of Magellan. In September and October 2021, DOJ issued additional subpoenas to individuals seeking testimony and documents in connection with its ongoing investigation. It is the Company’s understanding that multiple witnesses have testified before the federal grand jury and the DOJ’s activity beforeinvestigation is ongoing. Discussions continue with the federal grand juryDOJ to explore resolution of the matter. The Company believes a loss is ongoing.probable in the DOJ LeadCare legal matter and, in accordance with applicable accounting guidance, has accrued $42,000 and $10,000 as of December 31, 2022 and September 30, 2022, respectively, as an estimate of the cost to resolve the DOJ LeadCare legal matter. The increase in the estimated cost to resolve the DOJ LeadCare legal matter is based upon additional information received by the Company during discussions held with the DOJ subsequent to September 30, 2022. The $32,000 expense resulting from the increase in the accrual is reflected in litigation and select legal costs within the Condensed Consolidated Statement of Operations for the three months ended December 31, 2022. The Company cannot predict when the investigation will be resolved or the outcome of the investigation, or its potential impact onand the ultimate resolution of the DOJ LeadCare legal matter may exceed the amount accrued at December 31, 2022 and could be material to the Company. Approximately $281$814 and $1,227$281 of expense for attorneys’ fees related to this matter is included within the Condensed Consolidated Statements of Operations for the three months ended December 31, 2022 and 2021, and 2020, respectively.
RESULTS OF OPERATIONS
Three Months Ended December 31, 2021
A net loss of $29,821, or $0.68 per diluted share, was generated during the first quarter of fiscal 2022 decreased 43%2023, compared to $15,340 of net earnings, or $0.35 per diluted share, from net earnings forduring the first quarter of fiscal 2021 of $26,779, or $0.61 per diluted share.2022. The level of net earningsloss in the first quarter of fiscal 2022 resulted2023 reflects primarily from the decreaseoverall increase in operating expenses described in the Operating Expenses section below, along with the decline in net revenues and operating income in our Life Science segment, when compared tostemming from the recorddramatic softening in demand for theCOVID-19 related reagents utilized in
Consolidated net revenues for the first quarter of fiscal 20222023 totaled $88,341,$56,902, a decrease of 5%36% compared to the first quarter of fiscal 2021.
Net revenues from the Diagnostics segment for the first quarter of fiscal 20222023 increased 10%19% to $39,366, compared to the first quarter of fiscal 2021,2022, comprised of a 4%23% increase in molecularnon-molecular assay products, and an 11% increasepartially offset by a 6% decrease in
With a 32%76% decrease in net revenues from molecular reagentreagents products and a 43% increase58% decrease in net revenues from immunological reagentreagents products, net revenues for our Life Science segment decreased 12%68% during the first quarter of fiscal 20222023 compared to the first quarter of fiscal 2021, the period in which the Life Science segment experienced near unprecedented demand from diagnostic test manufacturers for use in
Page 22
REVENUE OVERVIEW
Below are analyses of the Company’s net revenues, provided for each of the following:
- By Reportable Segment & Geographic Region
- By Product Platform/Type
Revenue Overview- By Reportable Segment & Geographic Region
Revenues for the Diagnostics segment, in the normal course of business, may be affected from quarteryear to quarteryear by buying patterns of major distributors and reference laboratories, seasonality and severity of seasonal diseases and outbreaks (including the
See the “Revenue Disaggregation” section of Note 4,
Following is a discussion of the net revenues generated by these product platforms/types and/or disease states:
Diagnostics Segment Products
During the first quarter of fiscal 2023, Diagnostics segment’s overall 10%segment net revenues increased $6,162, or 19%, compared to the first quarter of fiscal 2022. This growth primarily resulted from the $4,542 increase in net revenues from sales of blood chemistry products, as sales of the LeadCare product have continued to rebound since shipment of the product resumed in the second quarter of fiscal 2022. LeadCare shipments resumed upon correction of the identified supplier issue that caused the LeadCare product recall, which commenced in May 2021 (see Note 7, “Lead Testing Matters” of the Condensed Consolidated Financial Statements).
Life Science Segment Products
During the first quarter of fiscal 2023, net revenues for our Life Science segment decreased 68% compared to the first quarter of fiscal 2022. While the level of net revenues during the first quarter of fiscal 2022 compared to2023 reflects the first quartersignificant decline in demand for COVID-19 related reagents, such level of fiscal 2021, primarily results fromquarterly net revenues significantly outpaced the combined effects of the following:
Significant Customers
Revenue concentrations related to certain customers within our Diagnostics and Life Science segments are set forth in Note 15,
Gross Profit
Three Months Ended December 31, | ||||||||||||
2021 | 2020 | Change | ||||||||||
Gross Profit | $ | 49,159 | $ | 61,548 | (20 | )% | ||||||
Gross Profit Margin | 56 | % | 66 | % | -10 points |
Three Months Ended December 31, | ||||||||||||
2022 | 2021 | Change | ||||||||||
Gross Profit | $ | 31,505 | $ | 49,159 | (36 | )% | ||||||
Gross Profit Margin | 55 | % | 56 | % | -1 point |
Overall gross profit margins during the first quarter of fiscal 2023 are relatively consistent with the fiscal 2022 have been unfavorably impacted by afirst quarter margins, with the slight decline largely reflecting the shift in net revenues contributions from our Life Science segment’s molecular reagent products, which are some of our highest margin products.segment revenue mix. During the first quarter of fiscal 2022,2023, approximately 36%31% of consolidated net revenues related to sales of molecular reagent products, compared to approximately 50% during the first quarter of fiscal 2021, whenwere generated from the Life Science segment, experienced the to date peak in net revenues from salesproducts of molecular reagent products.
Page 23
In addition, Diagnostics segment gross profit margins were favorably impacted by the previously discussed LeadCareresumption of blood chemistry product recallsales in the second quarter of fiscal 2022 (see “Lead Testing Matters”“Diagnostics Segment Products” above) and production capacity
Operating Expenses – Segment Detail and Corporate
Research & Development | Selling & Marketing | General & Administrative | Other | Total Operating Expenses | ||||||||||||||||
Fiscal 2021 First Quarter: | ||||||||||||||||||||
Diagnostics | $ | 5,070 | $ | 5,728 | $ | 5,748 | $ | 1,047 | $ | 17,593 | ||||||||||
Life Science | 581 | 1,293 | 3,454 | — | 5,328 | |||||||||||||||
Corporate | — | — | 2,736 | 1,227 | 3,963 | |||||||||||||||
Total 2021 First Quarter Expenses | $ | 5,651 | $ | 7,021 | $ | 11,938 | $ | 2,274 | $ | 26,884 | ||||||||||
Fiscal 2022 First Quarter: | ||||||||||||||||||||
Diagnostics | $ | 5,556 | $ | 6,009 | $ | 7,143 | $ | — | $ | 18,708 | ||||||||||
Life Science | 638 | 1,732 | 4,161 | — | 6,531 | |||||||||||||||
Corporate | — | — | 3,356 | 281 | 3,637 | |||||||||||||||
Total 2022 First Quarter Expenses | $ | 6,194 | $ | 7,741 | $ | 14,660 | $ | 281 | $ | 28,876 | ||||||||||
Research & Development | Selling & Marketing | General & Administrative | Other | Total Operating Expenses | ||||||||||||||||
Fiscal 2023 First Quarter: |
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Diagnostics | $ | 5,230 | $ | 6,280 | $ | 6,010 | $ | — | $ | 17,520 | ||||||||||
Life Science | 947 | 2,014 | 2,418 | 28 | 5,407 | |||||||||||||||
Corporate | — | — | 2,645 | 34,048 | 36,693 | |||||||||||||||
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Total 2023 First Quarter Expenses | $ | 6,177 | $ | 8,294 | $ | 11,073 | $ | 34,076 | $ | 59,620 | ||||||||||
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Fiscal 2022 First Quarter: |
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Diagnostics | $ | 5,556 | $ | 6,009 | $ | 6,294 | $ | — | $ | 17,859 | ||||||||||
Life Science | 638 | 1,732 | 4,076 | — | 6,446 | |||||||||||||||
Corporate | — | — | 4,290 | 281 | 4,571 | |||||||||||||||
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Total 2022 First Quarter Expenses | $ | 6,194 | $ | 7,741 | $ | 14,660 | $ | 281 | $ | 28,876 | ||||||||||
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Compared to the prior year period,first quarter, operating expenses increased $1,992$30,744 to $28,876$59,620 in the first quarter of fiscal 2022.2023. Major components of this increase were as follows:
A $32,607 increase in litigation and select legal costs, reflecting increased clinical trial spendingreflected within Corporate and product development costs within our Diagnostics segment;
• | A $1,188 increase in acquisition and transaction related costs, primarily within Corporate and related to the previously discussed merger (see “Agreement and Plan of Merger” above). |
Partially offsetting these increases was a $2,124 decrease in incentive compensation the timing of certain outside services costs and increased commercial insurance costs for Directors & Officers and Property & Casualty coverages.
Operating Income (Loss)
An operating loss of acquisition consideration in the fiscal 2021 first quarter; and (ii) lower spending on selected legal costs.
Income Taxes
The effective rate for income taxes was approximately(2%) and 22% for both the first quarter of fiscalthree months ended December 31, 2022 and fiscal 2021.
Impact of Inflation
To the extent feasible, we have consistently followed the practice of reviewing our prices to consider the impacts of inflation on salaries and fringe benefits for employees, and the cost of purchased materials and services.services, and transportation costs. Inflation and changing prices did not have a material adverse impact on our gross margin, revenues or operating income (loss) in the first quarter of fiscal 20222023 or fiscal 2021.2022.
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Liquidity and Capital Resources
Liquidity
Our cash flow and financing requirements are determined by analyses of operating and capital spending budgets and debt service. We have historically maintained a credit facility to augment working capital requirements and to respond quickly to acquisition opportunities.
We have an investment policy that guides the holdings of our investment portfolio, which presently consists of bank savings accounts and institutional money market mutual funds. Our objectives in managing the investment portfolio are to: (i) preserve capital; (ii) provide sufficient liquidity to meet working capital requirements and fund strategic objectives such as acquisitions; and (iii) capture a market rate of return commensurate with market conditions and our policy’s investment eligibility criteria. As we look forward, we will continue to manage the holdings of our investment portfolio with preservation of capital being the primary objective.
We intend to continue to fund our working capital requirements from current cash flows from operating activities and cash on hand, and such sources are anticipated to be adequate to fund working capital requirements, capital expenditures and debt service during the next twelve months. However, if needed, we also have an additional source of liquidity through the amount remaining available on our $200,000 bank revolving credit facility, which totaled $150,000$175,000 as of December 31, 2021.2022 (see Note 18, “Subsequent Events” of the Condensed Consolidated Financial Statements for a discussion of activities related to the Company’s bank credit arrangements occurring subsequent to the December 31, 2022 Condensed Consolidated Balance Sheet date). Our liquidity needs may change if overall economic conditions worsen and/or liquidity and credit within the financial markets tightens for an extended period, and such conditions impact the collectability of our customer accounts receivable, impact credit terms with our vendors, or disrupt the supply of raw materials and services.
As of December 31, 2021,2022, our cash and cash equivalents balance was $72,729$74,098 or $22,958 higher$7,355 lower than at September 30, 2021.2022. This increasedecrease primarily results primarily from generating $35,555the combined effects of: (i) $2,349 of cash flow from operations, an increase of 42% over the first quarter of fiscal 2021,used in operations; and (ii) using cash to acquire property, plant and equipment ($2,654) and the useassets of cash to pay down $10,000 onEstel Biosciences, Inc. ($2,000) (see Note 6, “Business Combinations” of the revolving credit facility.
Considering these factors, our balance of cash and cash equivalents on hand exceeded our total debt (defined as bank debt, government grant obligations and obligations related to acquisitions) by approximately $16,000$41,800 at December 31, 2021.
Capital Resources
As described in Note 12,
During fiscal 20222023 our capital expenditures are estimated to total approximately $15,000,$10,000, comprised of approximately $12,000$6,500 and $3,000$3,500 in the Diagnostics and Life Science segments, respectively. Included within the Diagnostics segment capital expenditures estimate is approximately $10,400 related to completion of the manufacturing capacity
License Agreements
The Company has entered into various license agreements that require payment of royalties based on a specified percentage of sales of related products. During the first quarter of fiscal 2022,2023, royalty expense totaled approximately $800,$150, with 35%70% and 65%30% of such expense relating to our Diagnostics and Life Science segments, respectively. This compares to a total of approximately $450$800 of royalty expense in the first quarter of fiscal 2021,2022, with 70%35% and 30%65% relating to our Diagnostics and Life Science segments, respectively. The Company expects that payments under these agreements will amount to approximately $3,000$700 in fiscal 2022,2023, a decrease from the $5,200$2,300 in fiscal 2021.2022, with the anticipated decrease largely resulting from the last of the licensed patents applicable to the Alethia product line having expired during fiscal 2022.
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Off-Balance
We utilize foreign currency exchange forward contracts to limit exposure to volatility in foreign currency gains and losses related to financial assets denominated in other than the holding subsidiary’s functional currency. These contracts are generally settled within a
ITEM 3. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK
As of December 31, 2021,2022, there were no material changes to the information provided under Item 7A, “Quantitative and Qualitative Disclosures About Market Risk” in the Company’s Form
ITEM 4. CONTROLS AND PROCEDURES
Evaluation of Disclosure Controls and Procedures
Under the supervision and with the participation of the Company’s management, including the Chief Executive Officer and Principal AccountingChief Financial Officer, we have evaluated the effectiveness of the Company’s disclosure controls and procedures, as defined in Rules
Control systems, no matter how well designed and operated, can provide only reasonable, not absolute, assurance that control objectives are met. Because of inherent limitations in all control systems, no evaluation of controls can provide assurance that all control issues and instances of fraud, if any, within a company will be detected. Additionally, controls can be circumvented by individuals, by collusion of two or more people or by management override. Over time, controls can become inadequate because of changes in conditions or the degree of compliance may deteriorate. Further, the design of any system of controls is based in part upon assumptions about the likelihood of future events. There can be no assurance that any design will succeed in achieving its stated goals under all future conditions. Because of the inherent limitations in any cost-effective control system, misstatements due to errors or fraud may occur and not be detected.
Changes in Internal Control over Financial Reporting
In the ordinary course of business, we routinely enhance our information systems by either upgrading current systems or implementing new ones. There were no changes in our internal control over financial reporting (as that term is defined in Rules
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PART II. OTHER INFORMATION
ITEM 1. LEGAL PROCEEDINGS
Information with respect to legal proceedings can be found in Note 7,
ITEM 1A. RISK FACTORS
In addition to the other information set forth in this report, careful consideration should be given to the factors discussed in Item 1A, “Risk Factors” in our Annual Report on Form
ITEM 6. EXHIBITS
The following exhibits are being filed or furnished as a part of this Quarterly Report on Form
101.INS | Inline XBRL Instance Document | ||
101.SCH | Inline XBRL Instance Extension Schema | ||
101.CAL | Inline XBRL Instance Extension Calculation Linkbase | ||
101.DEF | Inline XBRL Instance Extension Definition Linkbase | ||
101.LAB | Inline XBRL Instance Extension Label Linkbase | ||
101.PRE | Inline XBRL Instance Extension Presentation Linkbase | ||
104 | Cover Page Interactive Data File (formatted as Inline XBRL and contained in Exhibit 101) |
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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.
MERIDIAN BIOSCIENCE, INC. | ||||||
Date: February | By: | /s/ Andrew S. Kitzmiller | ||||
Andrew S. Kitzmiller | ||||||
Executive Vice President and Chief Financial Officer (Principal Financial Officer) | ||||||
Date: February 9, 2023 | By: | /s/ Julie Smith | ||||
Julie Smith | ||||||
Senior Vice President and Controller (Principal Accounting Officer) |
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