UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, DC 20549
FORM
CURRENT REPORT
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Item 2.02. | Results of Operations and Financial Condition. |
On May 7, 2021, Meridian Bioscience, Inc. (“Meridian” or “the Company”) issued a press release announcing results for the second fiscal quarter ended March 31, 2021. A copy of the press release is attached as Exhibit 99.1 to this report and is incorporated by reference herein.
Item 7.01. | Regulation FD Disclosure. |
On May 7, 2021, Meridian is hosting a conference call for the benefit of its investors to discuss the results set forth in the press release announcing results for the second fiscal quarter ended March 31, 2021 and other business and financial highlights. A copy of the presentation related to this conference call, which is available at investor.meridianbioscience.com, is attached as Exhibit 99.2 to this report and is incorporated by reference herein.
The Company’s press release and presentation disclose certain financial results both in accordance with generally accepted accounting principles (“GAAP”) and on a non-GAAP basis with adjustments for certain items. The Company’s management believes that presentation of these non-GAAP financial measures and their related reconciliations are useful to investors because the non-GAAP financial measures provide investors with a basis for comparing current results to financial results from prior periods.
Information in the press release and presentation contains forward-looking statements regarding future events and performance of the Company. All such forward-looking statements are based largely on the Company’s experience and perception of current conditions, trends, expected future developments and other factors, and on management’s expectations, and are subject to risks and uncertainties that could cause actual results to differ materially, including, but not limited to, those factors described in the press release, presentation and the Company’s filings with the Securities and Exchange Commission. The Company disclaims any intention or obligation to update or revise any financial or other projections or other forward-looking statements, whether because of new information, future events or otherwise.
The information in each of Item 2.02 and Item 7.01 of this Form 8-K and in the press release attached as Exhibit 99.1 and the presentation attached as Exhibit 99.2 is being furnished and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that Section. The information in each of Item 2.02 and Item 7.01 of this Form 8-K and each of Exhibit 99.1 and Exhibit 99.2 shall not be incorporated by reference in any filing (whether made before or after the date hereof) or any other document under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in any such filing or document.
Item 9.01. | Financial Statements and Exhibits. |
(d) | Exhibits |
99.1 | Press Release dated May 7, 2021 | |
99.2 | Conference Call Presentation | |
104 | Cover Page Interactive Data File (embedded within the Inline XBRL document) |
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 hereunto duly authorized.
MERIDIAN BIOSCIENCE, INC. | ||
Date: May 7, 2021 |
By: /s/ Bryan T. Baldasare | |
Executive Vice President and Chief Financial Officer | ||
(Principal Financial and Accounting Officer) |
Exhibit 99.1
For Immediate Release
MERIDIAN BIOSCIENCE REPORTS STRONG GROWTH IN NET REVENUES AND EPS IN SECOND QUARTER FISCAL 2021
CINCINNATI, OHIO May 7, 2021 (GLOBE NEWSWIRE) -- Meridian Bioscience, Inc. (NASDAQ: VIVO) today announced financial results for the second quarter ended March 31, 2021.
Second Quarter 2021 Highlights (Comparison to Second Quarter Fiscal 2020):
● | Consolidated net revenues of $85.3 million, up 49% year-over-year |
● | Life Science segment delivered net revenues of $53.3 million, up 139% year-over-year |
● | Diagnostics segment net revenues decreased 9% year-over-year to $31.9 million, up 5% from the first quarter of fiscal 2021 |
● | Signed agreement for 2nd grant from the National Institutes of Health (NIH) Rapid Acceleration of Diagnostics (RADxSM) initiative - $5.5 million for ramping manufacturing of Revogene® SARS-CoV-2 Assay |
● | Submitted 510(k) for Curian® Campy assay |
● | Launched first Air-Dryable sample specific Master Mix for Blood |
Jack Kenny, Chief Executive Officer, commented, As we begin the transition into a post-COVID world, we have significant optimism for the future of Meridian. Life Science was transformed by the COVID-19 pandemic and Diagnostics is moving into a position of strength with testing returning to normal and contributions from the investments we have made.
Second Quarter Fiscal 2021 Results (Comparison to Second Quarter Fiscal 2020)
Consolidated net revenues for the second quarter of fiscal 2021 increased 49% to $85.3 million, compared to $57.3 million last year. Diagnostics segment net revenues were down 9% year-over-year, but continued its recovery, up 5% from the first quarter of fiscal 2021 and up 48% from the low seen in the third quarter of fiscal 2020. Life Science segment revenues were up 139% year-over-year including an estimated $31 million in net revenues from COVID-19 related products, with approximately $28 million in molecular products and $3 million in immunological products. This implies core (non-COVID-19 related) Life Science segment net revenues were up over 30% year-over-year.
Reported operating income for the second quarter of fiscal 2021 was $34.2 million. Operating expenses included: (i) higher research and development spending in the Diagnostics segment; (ii) higher amortization related to the acquisition of Exalenz Bioscience Ltd. (Exalenz) in April 2020; (iii) lower acquisition-related expenses associated with the Exalenz transaction; and (iv) a downward adjustment in the fair value of the contingent consideration related to the fiscal 2019 GenePOC transaction. On an adjusted basis, operating income was $32.2 million, a margin of 38% (see non-GAAP financial measure reconciliation below), up from $12.1 million and a margin of 21% in the prior year, representing year-over-year growth of nearly 170%.
Financial Condition
At March 31, 2021, cash and cash equivalents were $63.4 million and the Company had $110.0 million of borrowing capacity under its $160.0 million commercial bank credit facility. The Companys obligations under the commercial bank credit facility totaled $50.0 million as of March 31, 2021.
Bryan Baldasare, Chief Financial Officer, commented, Our cash generation continues to be a strength and we remain focused on putting our balance sheet to work to drive both organic and inorganic growth opportunities.
Adjusting Fiscal 2021 Guidance
As a result of the voluntary withdrawal of the emergency use authorization (EUA) application for the Revogene SARS-CoV-2 assay in February, Meridian is adjusting the Diagnostics segment guidance and the impact on consolidated operating margin and diluted net earnings per share, both on an adjusted basis.
FY2021 Net Revenues:
● | Consolidated $305 million to $335 million |
● | Diagnostics segment $125 million to $135 million |
● | Life Science segment $180 million to $200 million |
FY2021 Adjusted Operating Margin: Consolidated 30% to 33%
FY2021 Adjusted Net Earnings Per Share on a Diluted Basis (EPS): $1.60 to $1.80 (44.3M shares)
While the Life Science segment net revenues were somewhat below the Companys expectations in the second quarter, we continue to see good demand for its reagents. As a result, guidance for the Life Science segments net revenues has not changed. The $15 million reduction in net revenues guidance only reflects the removal of any significant contribution from the Diagnostics segments COVID-19 products as a result of our voluntary withdrawal of our Revogene SARS-COV-2 EUA application and expected timing of re-submission, as well as no clear line of sight as to when our current partner will submit its rapid antigen SARS-CoV-2 test for EUA clearance. Adjusted EPS includes the impact of removal of the net revenues from these tests during our second half of fiscal 2021.
This guidance reflects our current visibility into market conditions and customer order patterns for our products and our current assumptions about the impacts from the COVID-19 pandemic in the U.S. and around the globe.
Conference Call Information
Jack Kenny, Chief Executive Officer, and Bryan Baldasare, Executive Vice President and Chief Financial Officer, will host a conference call on Friday, May 7, 2021 beginning at 10:00 a.m. Eastern Time to discuss the second quarter financial results and answer questions. A presentation to accompany the quarterly financial results and related discussion will be made available within the Investor Relations section of the Companys website, www.meridianbioscience.com, prior to the conference call.
To participate in the live call by telephone from the U.S., dial (866) 443-5802, or from outside the U.S., dial (513) 360-6924, and enter the audience pass code 9948805. A replay will be available for 14 days beginning at 1:00 p.m. Eastern Time on May 7, 2021 by dialing (855) 859-2056 or (404) 537-3406 and entering pass code 9948805.
INTERIM UNAUDITED OPERATING RESULTS
(In Thousands, Except per Share Data)
The following table sets forth the unaudited comparative results of Meridian on a U.S. generally accepted accounting principles (GAAP) basis for the interim periods of fiscal 2021 and fiscal 2020.
Three Months Ended | Six Months Ended | |||||||||||||||
March 31, | March 31, | |||||||||||||||
2021 | 2020 | 2021 | 2020 | |||||||||||||
Net revenues |
$ | 85,264 | $ | 57,296 | $ | 178,181 | $ | 104,717 | ||||||||
Cost of sales |
27,492 | 22,750 | 58,861 | 42,520 | ||||||||||||
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Gross profit |
57,772 | 34,546 | 119,320 | 62,197 | ||||||||||||
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Operating expenses |
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Research and development |
6,065 | 5,315 | 11,716 | 10,078 | ||||||||||||
Selling and marketing |
6,540 | 6,529 | 13,561 | 13,257 | ||||||||||||
General and administrative |
12,925 | 10,628 | 24,863 | 19,612 | ||||||||||||
Acquisition-related costs |
- | 1,787 | - | 1,787 | ||||||||||||
Change in fair value of acquisition consideration |
(2,989 | ) | (2,491 | ) | (1,942 | ) | (1,304 | ) | ||||||||
Restructuring costs |
- | 252 | - | 527 | ||||||||||||
Selected legal costs |
1,030 | 735 | 2,257 | 1,055 | ||||||||||||
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Total operating expenses |
23,571 | 22,755 | 50,455 | 45,012 | ||||||||||||
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Operating income |
34,201 | 11,791 | 68,865 | 17,185 | ||||||||||||
Other income (expense), net |
(1,149 | ) | 856 | (1,565 | ) | (512 | ) | |||||||||
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Earnings before income taxes |
33,052 | 12,647 | 67,300 | 16,673 | ||||||||||||
Income tax provision |
6,750 | 3,288 | 14,219 | 4,487 | ||||||||||||
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Net earnings |
$ | 26,302 | $ | 9,359 | $ | 53,081 | $ | 12,186 | ||||||||
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Net earnings per basic common share |
$ | 0.61 | $ | 0.22 | $ | 1.23 | $ | 0.28 | ||||||||
Basic common shares outstanding |
43,244 | 42,830 | 43,171 | 42,810 | ||||||||||||
Net earnings per diluted common share |
$ | 0.60 | $ | 0.22 | $ | 1.21 | $ | 0.28 | ||||||||
Diluted common shares outstanding |
44,122 | 42,968 | 43,960 | 42,953 |
Adjusted Financial Measures (in thousands, except per share data)
(see non-GAAP financial measure reconciliation below)
Three Months Ended | Six Months Ended | |||||||||||||||
March 31, | March 31, | |||||||||||||||
2021 | 2020 | 2021 | 2020 | |||||||||||||
Operating income |
$ | 32,242 | $ | 12,074 | $ | 69,180 | $ | 19,250 | ||||||||
Net earnings |
24,832 | 10,004 | 53,318 | 14,183 | ||||||||||||
Net earnings per diluted common share |
$ | 0.56 | $ | 0.23 | $ | 1.21 | $ | 0.33 |
Condensed Consolidated Balance Sheet Data (in thousands)
March 31, | September 30, | |||||||
2021 | 2020 | |||||||
Cash and cash equivalents |
$ | 63,374 | $ | 53,514 | ||||
Working capital |
137,984 | 109,666 | ||||||
Long-term debt |
50,000 | 68,824 | ||||||
Shareholders equity |
309,473 | 247,629 | ||||||
Total assets |
439,169 | 405,261 |
Segment Data
The following table sets forth the unaudited net revenues and segment data for the interim periods in fiscal 2021 and fiscal 2020 (in thousands):
Three Months Ended | Six Months Ended | |||||||||||||||
March 31, | March 31, | |||||||||||||||
2021 | 2020 | 2021 | 2020 | |||||||||||||
Net Revenues - By Product Platform/Type |
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Diagnostics |
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Molecular assays |
$ | 4,395 | $ | 7,238 | $ | 8,985 | $ | 14,077 | ||||||||
Non-molecular assays |
27,554 | 27,704 | 53,285 | 55,656 | ||||||||||||
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Total Diagnostics |
31,949 | 34,942 | 62,270 | 69,733 | ||||||||||||
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Life Science |
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Molecular reagents |
37,752 | 11,534 | 83,776 | 16,902 | ||||||||||||
Immunological reagents |
15,563 | 10,820 | 32,135 | 18,082 | ||||||||||||
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Total Life Science |
53,315 | 22,354 | 115,911 | 34,984 | ||||||||||||
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Total Net Revenues |
$ | 85,264 | $ | 57,296 | $ | 178,181 | $ | 104,717 | ||||||||
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Three Months Ended | Six Months Ended | |||||||||||||||
March 31, | March 31, | |||||||||||||||
2021 | 2020 | 2021 | 2020 | |||||||||||||
Net Revenues - By Disease State/Geography | ||||||||||||||||
Diagnostics |
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Gastrointestinal assays |
$ | 15,666 | $ | 14,014 | $ | 31,118 | $ | 30,060 | ||||||||
Respiratory illness assays |
3,686 | 10,863 | 8,492 | 18,612 | ||||||||||||
Blood chemistry assays |
4,358 | 4,194 | 8,753 | 9,142 | ||||||||||||
Other |
8,239 | 5,871 | 13,907 | 11,919 | ||||||||||||
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Total Diagnostics |
31,949 | 34,942 | 62,270 | 69,733 | ||||||||||||
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Life Science |
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Americas |
13,550 | 4,612 | 32,296 | 8,623 | ||||||||||||
EMEA |
21,773 | 9,946 | 54,066 | 14,907 | ||||||||||||
ROW |
17,992 | 7,796 | 29,549 | 11,454 | ||||||||||||
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Total Life Science |
53,315 | 22,354 | 115,911 | 34,984 | ||||||||||||
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Total Net Revenues |
$ | 85,264 | $ | 57,296 | $ | 178,181 | $ | 104,717 | ||||||||
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OPERATING INCOME (LOSS) |
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Diagnostics |
$ | 2,421 | $ | 4,729 | $ | 1,239 | $ | 9,870 | ||||||||
Life Science |
36,089 | 9,931 | 75,886 | 12,259 | ||||||||||||
Corporate |
(4,325 | ) | (2,896 | ) | (8,288 | ) | (4,983 | ) | ||||||||
Eliminations |
16 | 27 | 28 | 39 | ||||||||||||
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Total Operating Income |
$ | 34,201 | $ | 11,791 | $ | 68,865 | $ | 17,185 | ||||||||
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Geographic Regions
Americas = North and Latin America
EMEA = Europe, Middle East and Africa
ROW = Rest of World
NON-GAAP FINANCIAL MEASURES
In this press release, we have supplemented our reported GAAP financial information with information on operating expenses, operating income, operating margin, net earnings, basic net earnings per share and diluted net earnings per share, each on an adjusted basis excluding the effects of certain acquisition-related costs, changes in fair value of the acquisition consideration, restructuring costs, and selected legal costs, each of which is a non-GAAP measure. We have provided in the tables below reconciliations to the operating expenses, operating income, net earnings, basic net earnings per share and diluted net earnings per share amounts reported under GAAP for the three- and six-month periods ended March 31, 2021 and 2020.
We believe this information is useful to an investor in evaluating our performance because:
1. | These measures help investors to more meaningfully evaluate and compare the results of operations from period to period by removing the impacts of these non-routine items; and |
2. | These measures are used by our management for various purposes, including evaluating performance against incentive bonus achievement targets, comparing performance from period to period in presentations to our board of directors, and as a basis for strategic planning and forecasting. |
These non-GAAP measures may be different from non-GAAP measures used by other companies. In addition, the non-GAAP measures are not based on any comprehensive set of accounting rules or principles. Non-GAAP measures have limitations, in that they do not reflect all amounts associated with our results as determined in accordance with GAAP. Therefore, these measures should only be used to evaluate our results in conjunction with corresponding GAAP measures.
SECOND QUARTER AND SIX MONTH YEAR-TO-DATE
GAAP TO NON-GAAP RECONCILIATION TABLES
(In Thousands, Except per Share Data)
Three Months | Six Months | |||||||||||||||
Ended March 31, | Ended March 31, | |||||||||||||||
2021 | 2020 | 2021 | 2020 | |||||||||||||
Operating Expenses - |
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GAAP basis |
$ | 23,571 | $ | 22,755 | $ | 50,455 | $ | 45,012 | ||||||||
Acquisition-related costs |
- | (1,787 | ) | - | (1,787 | ) | ||||||||||
Change in fair value of acquisition consideration |
2,989 | 2,491 | 1,942 | 1,304 | ||||||||||||
Restructuring costs |
- | (252 | ) | - | (527 | ) | ||||||||||
Selected legal costs |
(1,030 | ) | (735 | ) | (2,257 | ) | (1,055 | ) | ||||||||
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Adjusted Operating Expenses |
$ | 25,530 | $ | 22,472 | $ | 50,140 | $ | 42,947 | ||||||||
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Operating Income - |
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GAAP basis |
$ | 34,201 | $ | 11,791 | $ | 68,865 | $ | 17,185 | ||||||||
Acquisition-related costs |
- | 1,787 | - | 1,787 | ||||||||||||
Change in fair value of acquisition consideration |
(2,989 | ) | (2,491 | ) | (1,942 | ) | (1,304 | ) | ||||||||
Restructuring costs |
- | 252 | - | 527 | ||||||||||||
Selected legal costs |
1,030 | 735 | 2,257 | 1,055 | ||||||||||||
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Adjusted Operating Income |
$ | 32,242 | $ | 12,074 | $ | 69,180 | $ | 19,250 | ||||||||
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Net Earnings - |
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GAAP basis |
$ | 26,302 | $ | 9,359 | $ | 53,081 | $ | 12,186 | ||||||||
Acquisition-related costs |
- | 1,787 | - | 1,787 | ||||||||||||
Change in fair value of acquisition consideration * |
(2,244 | ) | (1,886 | ) | (1,458 | ) | (985 | ) | ||||||||
Restructuring costs * |
- | 190 | - | 398 | ||||||||||||
Selected legal costs * |
774 | 554 | 1,695 | 797 | ||||||||||||
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Adjusted Earnings |
$ | 24,832 | $ | 10,004 | $ | 53,318 | $ | 14,183 | ||||||||
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Basic Earnings per Common Share - |
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GAAP basis |
$ | 0.61 | $ | 0.22 | $ | 1.23 | $ | 0.28 | ||||||||
Acquisition-related costs |
- | 0.04 | - | 0.04 | ||||||||||||
Change in fair value of acquisition consideration |
(0.05 | ) | (0.04 | ) | (0.03 | ) | (0.02 | ) | ||||||||
Restructuring costs |
- | - | - | 0.01 | ||||||||||||
Selected legal costs |
0.02 | 0.01 | 0.04 | 0.02 | ||||||||||||
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Adjusted Basic EPS ** |
$ | 0.57 | $ | 0.23 | $ | 1.24 | $ | 0.33 | ||||||||
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Three Months | Six Months | |||||||||||||||
Ended March 31, | Ended March 31, | |||||||||||||||
2021 | 2020 | 2021 | 2020 | |||||||||||||
Diluted Earnings per Common Share - |
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GAAP basis |
$ | 0.60 | $ | 0.22 | $ | 1.21 | $ | 0.28 | ||||||||
Acquisition-related costs |
- | 0.04 | - | 0.04 | ||||||||||||
Change in fair value of acquisition consideration |
(0.05 | ) | (0.04 | ) | (0.03 | ) | (0.02 | ) | ||||||||
Restructuring costs |
- | - | - | 0.01 | ||||||||||||
Selected legal costs |
0.02 | 0.01 | 0.04 | 0.02 | ||||||||||||
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Adjusted Diluted EPS *** |
$ | 0.56 | $ | 0.23 | $ | 1.21 | $ | 0.33 | ||||||||
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* Net of tax, as applicable.
** Three months ended March 31, 2021 does not sum to total due to rounding.
*** Three and six months ended March 31, 2021 do not sum to total due to rounding.
FORWARD-LOOKING STATEMENTS
The Private Securities Litigation Reform Act of 1995 provides a safe harbor from civil litigation for forward-looking statements accompanied by meaningful cautionary statements. Except for historical information, this report contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, which may be identified by words such as continues, estimates, anticipates, projects, plans, seeks, may, will, expects, intends, believes, signals, should, can, guidance and similar expressions or the negative versions thereof and which also may be identified by their context. All statements that address operating performance or events or developments that Meridian Bioscience, Inc. (Meridian or the Company) expects or anticipates will occur in the future, including, but not limited to, statements relating to per share diluted net earnings, sales, product demand, net revenues, operating margin, other guidance and the impact of COVID-19 on its business and prospects, are forward-looking statements. Such statements, whether expressed or implied, are based upon current expectations of the Company and speak only as of the date made. Specifically, Meridians forward-looking statements are, and will be, based on managements then-current views and assumptions regarding future events and operating performance. Meridian assumes no obligation to publicly update or revise any forward-looking statements even if experience or future changes make it clear that any projected results expressed or implied therein will not be realized. These statements are subject to various risks, uncertainties and other factors that could cause actual results to differ materially, including, without limitation, the following:
Meridians 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 Meridians 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 Companys 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 Companys 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, 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 currently ongoing study and other FDA actions regarding the Companys LeadCare products). The international scope of Meridians 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 Meridians 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 the acquired businesses will be successfully integrated into Meridians 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 Meridians 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 Meridians earnings and financial results. Meridian cannot predict the possible impact of U.S. health care legislation enacted in 2010 the Patient Protection and Affordable Care Act, as amended by the Health Care and Education Reconciliation Act and any modification or repeal of any of the provisions thereof initiated by Congress or the presidential administration, and any similar initiatives in other countries on its results of operations. Efforts to reduce the U.S. federal deficit, breaches of Meridians information technology systems, trade wars, increased tariffs, and natural disasters and other events could have a materially adverse effect on Meridians 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 adversely affect its operations and result in material misstatements in its consolidated financial statements. Meridian also is subject to risks and uncertainties related to disruptions to or reductions in business operations or prospects due to pandemics, epidemics, widespread health emergencies, or outbreaks of infectious diseases such as COVID-19. In addition to the factors described in this paragraph, as well as those factors identified from time to time in the Companys filings with the Securities and Exchange Commission, Part I, Item 1A Risk Factors of the Companys most recent Annual Report on Form 10-K contains a list and description of uncertainties, risks and other matters that may affect the Company. Readers should carefully review these forward-looking statements and risk factors, and not place undue reliance on the Companys forward-looking statements.
About Meridian Bioscience, Inc.
Meridian is a fully integrated life science company that develops, manufactures, markets and distributes a broad range of innovative diagnostic products. We are dedicated to developing and delivering better solutions that give answers with speed, accuracy and simplicity that are redefining the possibilities of life from discovery to diagnosis. Through discovery and development, we provide critical life science raw materials used in immunological and molecular tests for human, animal, plant, and environmental applications. Through diagnosis, we provide diagnostic solutions in areas including gastrointestinal and upper respiratory infections and blood lead level testing. We build relationships and provide solutions to hospitals, reference laboratories, research centers, veterinary testing centers, physician offices, diagnostics manufacturers, and biotech companies in more than 70 countries around the world.
Meridians shares are traded on the NASDAQ Global Select Market, symbol VIVO. Meridians website address is www.meridianbioscience.com.
Contact:
Charlie Wood
Vice President Investor Relations
Meridian Bioscience, Inc.
Phone: +1 513.271.3700
Email: mbi@meridianbioscience.com
###
FY2021 Q2 Results May 7, 2021 Exhibit 99.2
The Private Securities Litigation Reform Act of 1995 provides a safe harbor from civil litigation for forward-looking statements accompanied by meaningful cautionary statements. Except for historical information, this presentation contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, which may be identified by words such as “continues”, “estimates”, “anticipates”, “projects”, “plans”, “seeks”, “may”, “will”, “expects”, “intends”, “believes”, “signals”, “should”, “can”, “guidance” and similar expressions or the negative versions thereof and which also may be identified by their context. All statements that address operating performance or events or developments that Meridian Bioscience, Inc. (“Meridian” or “the Company”) expects or anticipates will occur in the future, including, but not limited to, statements relating to per share diluted net earnings, sales, product demand, net revenues, operating margin, other guidance and the impact of COVID-19 on its business and prospects, are forward-looking statements. Such statements, whether expressed or implied, are based upon current expectations of the Company and speak only as of the date made. Specifically, Meridian’s forward-looking statements are, and will be, based on management’s then-current views and assumptions regarding future events and operating performance. Meridian assumes no obligation to publicly update or revise any forward-looking statements even if experience or future changes make it clear that any projected results expressed or implied therein will not be realized. These statements are subject to various risks, uncertainties and other factors that could cause actual results to differ materially, including, without limitation, the following: 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, 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 currently ongoing study and other FDA actions regarding the Company’s LeadCare products). 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 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 U.S. health care legislation enacted in 2010 – the Patient Protection and Affordable Care Act, as amended by the Health Care and Education Reconciliation Act – and any modification or repeal of any of the provisions thereof initiated by Congress or the presidential administration, and any similar initiatives in other countries on its 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 disruptions to or reductions in business operations or prospects due to pandemics, epidemics, widespread health emergencies, or outbreaks of infectious diseases such as COVID-19. In addition to the factors described in this paragraph, please also refer to additional factors identified from time to time in the Company’s filings with the Securities and Exchange Commission, including in Part I, Item 1A Risk Factors of the Company’s most recent Annual Report on Form 10-K, which contains a list and description of uncertainties, risks and other matters that may affect the Company. Readers should carefully review these forward-looking statements and risk factors, and not place undue reliance on the Company’s forward-looking statements. Forward Looking Statements
Certain financial measures presented in this presentation, such as operating expenses, operating income, operating margin, net earnings and net earnings per diluted share, each on an adjusted basis, excluding as applicable the effects of acquisition-related costs, changes in fair value of acquisition consideration, restructuring costs and selected legal costs, are not recognized under United States generally accepted accounting principles, or GAAP. Management believes this non-GAAP financial information is useful to investors in evaluating our performance, as these measures: (i) help investors to more meaningfully evaluate and compare the results of operations from period to period by removing the impacts of these non-routine items; and (ii) are used by management for various purposes, including evaluating performance from period to period in presentations to our board of directors, and as a basis for strategic planning and forecasting. While we believe these financial measures are commonly used by investors to evaluate our performance and that of our competitors, the non-GAAP measures in this presentation may be different from non-GAAP measures used by other companies and should not be considered as an alternative to performance measures derived in accordance with GAAP. In addition, the non-GAAP measures presented herein are not based on any comprehensive set of accounting rules or principles. These non-GAAP measures have limitations, in that they do not reflect all amounts associated with our results as determined in accordance with GAAP, and they should not be considered as alternatives to information attributable to Meridian Bioscience, Inc. determined in accordance with GAAP. See the consolidated financial statements included in our reports filed with the U.S. Securities and Exchange Commission for our GAAP results. Additionally, for reconciliations of the non-GAAP measures included herein to our closest reported GAAP measures, refer to the reconciliations included in the press release of Meridian Bioscience, Inc. dated May 7, 2021. Non-GAAP Financial Measures
Signed agreement for 2nd RADx grant - $5.5M for ramping manufacturing of Revogene® SARS-CoV-2 Assay Submitted 510(k) for Curian ® Campy assay Launched first Air-Dryable sample specific Master Mix for Blood Q2 FY2021 Business Highlights Diagnostics Life Science
FY2021 Second Quarter Earnings Summary ($000’s except Per Share Amounts) Adjusted (Non-GAAP) FY2021 FY2020 Change Net revenues $85,264 $57,296 +49% Gross margin % 68% 60% +8 pts Operating expenses(1) Ratio $25,530 30% $22,472 39% +14% -9 pts Operating income Margin % $32,242 38% $12,074 21% +167% +17 pts Net earnings Diluted EPS $24,832 $0.56 $10,004 $0.23 +148% +143% GAAP FY2021 FY2020 Change Operating expenses $23,571 $22,755 +4% Operating income Margin % $34,201 40% $11,791 21% +190% +19 pts Net earnings Diluted EPS $26,302 $0.60 $9,359 $0.22 +181% +173% Highlights Diagnostics segment net revenues -9% YoY and +5% to Q1 FY21. Life Science segment net revenues +139%. Gross margin affected favorably by Life Science segment net revenues contribution, particularly molecular reagents. Operating expenses include a full quarter of costs from the Exalenz acquisition, consummated April 30, 2020. GAAP operating expenses reflect selected legal costs of $1.0M and a decrease in the fair value of the GenePOC contingent consideration of $3.0M. 1) Includes Corporate expenses of $3.3M in 2021 and $2.2M in 2020.
FY2021 Second Quarter Operating Segment Highlights ($000’s) Diagnostics segment (Adjusted Non-GAAP) FY2021 FY2020 Change Net revenues $31,949 $34,942 -9% Operating income / (loss) Margin % ($568) NMF $4,224 12% NMF NMF Diagnostics segment revenue by: Technology: Molecular assays $4,395 $7,238 -39% Non-molecular assays 27,554 27,704 -1% Disease State: GI (Gastrointestinal) $15,666 $14,014 +12% RI (Respiratory Illnesses) 3,686 10,863 -66% Blood Chemistry (Lead) 4,358 4,194 +4% Other 8,239 5,871 +40% Life Science segment (Adjusted Non-GAAP) FY2021 FY2020 Change Net revenues $53,315 $22,354 +139% Operating income Margin % $36,089 68% $10,034 45% +260% +23 pts Life Science segment revenue by: Technology: Molecular reagents $37,752 $11,534 +227% Immunological reagents 15,563 10,820 +44% Region: Americas $13,550 $4,612 +194% EMEA 21,773 9,946 +119% ROW 17,992 7,796 +131% China (included in ROW) 4,626 5,312 -13% Product / Customer Highlights: Respiratory assay volumes adversely affected by COVID-19 pandemic Double-digit growth in H. pylori family from BreathID® system Blood chemistry shows recovery Other includes DiaSorin royalty contributions Product / Customer Highlights: Significant growth across all regions except China Core (non-COVID) growth in China up over 80%
FY2021 Fiscal Year Guidance Meridian Bioscience Diagnostics Life Science Prior Guidance (2/5/2021) Updated FY2021 Guidance Meridian Bioscience Consolidated net revenues: $305 to $335 Million Adjusted operating margin: 30% to 33% Adjusted net earnings per share*: $1.60 to $1.80 Diagnostics Net revenues: $125 to $135 million Life Science Net revenues: $180 to $200 million Consolidated net revenues: $320 to $350 Million Adjusted operating margin: 31% to 33% Adjusted net earnings per share*: $1.70 to $1.90 Net revenues: $140 to $150 million Net revenues: $180 to $200 million * Assumes 44.3M diluted share count
Fluorescent analyzer Improved performance with no subjectivity Intuitive user interface Intuitive, fast, and easy-to-use improves productivity Simple sample prep Clean, comfortable handling of samples Easy, standardized workflow Implement & train only once The Curian® Campy Advantage
Contact: mbi@meridianbioscience.com
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