8-K
MERIDIAN BIOSCIENCE INC false 0000794172 0000794172 2020-05-08 2020-05-08

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, DC 20549

 

FORM 8-K

CURRENT REPORT

Pursuant to Section 13 or 15(d) of the

Securities Exchange Act of 1934

Date of Report (Date of earliest event reported) May 8, 2020

IMAGE

 

MERIDIAN BIOSCIENCE, INC.

 

 

(Exact Name of Registrant as Specified in Charter)

 

Ohio

 

0-14902

 

31-0888197

(State or Other Jurisdiction of

Incorporation)

 

(Commission File Number)

 

(IRS Employer

Identification No.)

3471 River Hills Drive,

Cincinnati, Ohio

 

45244

(Address of principal

executive offices)

 

(Zip Code)

Registrant’s telephone number, including area code (513) 271-3700

(Former Name or Former Address, if Changed Since Last Report.)

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):

Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Securities registered pursuant to Section 12(b) of the Act:

Title of each class

 

Trading Symbol(s)

 

Name of each exchange on which registered

Common Stock, no par value

 

VIVO

 

NASDAQ

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (17 CFR §230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (17CFR §240.12b-2 of this chapter).

Emerging growth company

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act


Item 2.02. Results of Operations and Financial Condition.

On May 8, 2020, Meridian Bioscience, Inc. (“Meridian” or the “Company”) issued a press release announcing results for the second quarter ended March 31, 2020. 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 8, 2020, Meridian is hosting a conference call for the benefit of its investors to discuss the results set forth in the earnings release, discuss key elements of its business strategy and discuss other business and financial developments. A copy of the presentation, which is available at www.meridianbioscience.com, related to this conference call 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 the 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 presentation and in 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 8, 2020

         
 

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 8, 2020

 

 

 

By: /s/ Bryan T. Baldasare

 

 

 

Executive Vice President and Chief Financial Officer

 

 

 

(Principal Financial and Accounting Officer)

EX-99.1

Exhibit 99.1

 

LOGO

For Immediate Release

MERIDIAN BIOSCIENCE REPORTS SECOND QUARTER 2020 OPERATING RESULTS; RAISES GUIDANCE ON STRENGTH OF COVID-19 RELATED PRODUCTS

CINCINNATI, OHIO May 8, 2020 (GLOBE NEWSWIRE) — Meridian Bioscience, Inc. (NASDAQ: VIVO) today announced financial results for the second quarter ended March 31, 2020.

Second Quarter Fiscal 2020 Highlights:

 

   

Consolidated Net Revenue of $57.3 million, up 14% year-over-year

 

   

Life Science segment responded early and swiftly to the COVID-19 pandemic contributing to a record $22.4 million in revenues, up 33% year-over-year

 

   

Diagnostics segment delivered over $34.9 million in revenue, the fifth consecutive quarter above $33 million and year-over-year growth for the first time in five quarters

 

   

During the quarter, the Curian® analyzer and HpSA® assay received FDA clearance, the first internally developed new product in several years and the first of several in development

Jack Kenny, Chief Executive Officer, commented: “We had an extraordinary quarter on many fronts, led by our Life Science team’s rapid response to the COVID-19 pandemic. Our raw materials were included in millions of molecular tests globally and soon will be in millions more rapid antibody tests. Our Diagnostics segment delivered growth, soon to be supplemented with the contribution from our new Curian analyzer and assay. Our strategic initiatives are setting the foundation for growth, and I am excited about what’s to come.”

Bryan Baldasare, Chief Financial Officer, commented: “Despite the turmoil of the COVID-19 pandemic, our financial position remains strong. Demand for our Life Science products is unprecedented. We have confidence in the direction of the business and are raising our guidance for the year.”

Second Quarter Fiscal 2020 Results (Comparison to Second Quarter Fiscal 2019)

Consolidated revenue for the second quarter of fiscal 2020 increased 14% to $57.3 million, compared to $50.2 million in the second quarter of 2019. Diagnostics segment revenues were up 4%, while Life Science segment revenues were up 33%. Our Diagnostics segment experienced 2% growth in revenues from our molecular products and revenues from our immunoassay/blood chemistry products grew 5%. Our Life Science segment revenues for the quarter included $5.6 million in revenue from COVID-19 related products.

Reported operating income for the second quarter of fiscal 2020 was $11.8 million, reflecting strong leverage from record sales levels in our Life Science business. Operating expenses include: (i) expectedly higher research and development spending in the Diagnostics segment; (ii) acquisition-related costs in connection with the recent Exalenz acquisition; and (iii) purchase accounting amortization related to the acquisition of the GenePOC business in June 2019, as well as a favorable adjustment in the fair value of the earnout obligation for the acquisition of the GenePOC business. On an adjusted basis, operating income was $12.1 million and achieved a margin of 21% (see non-GAAP financial measure reconciliation below).

Earnings per diluted share on a reported GAAP basis totaled $0.22 for the second quarter of 2020, and adjusted earnings per diluted share totaled $0.23 for the quarter (see non-GAAP financial measure reconciliation below).


Raising Fiscal 2020 Guidance

Our performance fiscal year-to-date was well above our expectations. We are slightly ahead of last year’s first half revenue and already delivered Adjusted Diluted EPS at the upper end of our original guidance range for the full year. We expect this strong performance to continue, with our Life Science business more than compensating for the temporary reduction in demand for non-urgent care tests in our Diagnostics business, and are raising our guidance for the year.

Net Revenues:

 

   

Consolidated $230 million to $236 million

 

   

Life Science $110 million to $114 million

 

   

Diagnostics $120 million to $122 million

Adjusted Operating Margin: Consolidated 18% to 19%

Adjusted Earnings Per Share on a Diluted Basis: $0.70 to $0.75

The revenue components of this guidance assume that our Life Science business will see COVID-19 related demand for molecular reagents used in PCR tests and immunological reagents used in serology tests ranging from $43 million to $47 million during the second half of our fiscal 2020, peaking in our third fiscal quarter and tapering in our fourth fiscal quarter. For our Diagnostics business, our assumptions include a 40% reduction in volumes for our third fiscal quarter, recovery to a 25% reduction in volumes for our fourth fiscal quarter, partially offset by modest contributions from the Exalenz acquisition and sales of a COVID-19 serology test. Our guidance also considers that our spending on clinical trials in fiscal 2020 will be lower than originally anticipated as the global COVID-19 pandemic has paused most of our clinical trial sites and also affected our ability to collect patient specimens. Overall operating expenses on an adjusted basis in fiscal 2020 are expected to be commensurate with our original expectations as additional cash incentive compensation will offset the lower spending on clinical trials.

This guidance reflects our current visibility into market conditions for our products and our current assumptions about the extent and duration of the impacts from this pandemic. We expect that our visibility will improve throughout the quarter as local governments around the world begin to relax shelter-in-place orders and healthcare systems return to normal operations with respect to diagnostic testing for infectious diseases and blood chemistry.

Financial Condition

At March 31, 2020, cash and equivalents were $49.6 million and the Company had $111.2 million of borrowing capacity under its $160.0 million commercial bank credit facility. The Company’s bank-debt obligations under the bank credit facility totaled $48.8 million as of March 31, 2020.

In connection with the April 30, 2020 acquisition of Exalenz, the Company drew an additional $50 million on the revolving credit facility, increasing the Company’s total bank-debt obligation under the bank credit facility to $98.8 million.

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 8, 2020 beginning at 10:00 a.m. Eastern Time to discuss the second quarter financial results and answer questions. A presentation to accompany the second quarter financial results and related discussion will be made available within the Investor Relations section of the Company’s 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 5872319. A replay will be available for 14 days beginning at 1:00 p.m. Eastern Time on May 8, 2020 by dialing (855) 859-2056 or (404) 537-3406 and entering pass code 5872319.


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. GAAP basis for the interim periods of fiscal 2020 and fiscal 2019.

 

     Three Months Ended     Six Months Ended  
     March 31,     March 31,  
     2020     2019     2020     2019  

Net revenues

   $ 57,296   $ 50,248   $ 104,717   $ 101,728

Cost of sales

     22,842     20,910     42,823     40,818
  

 

 

   

 

 

   

 

 

   

 

 

 

Gross profit

     34,454     29,338     61,894     60,910
  

 

 

   

 

 

   

 

 

   

 

 

 

Operating expenses

        

Research and development

     5,386     3,816     10,210     7,700

Selling and marketing

     6,514     6,911     13,198     14,474

General and administrative

     10,480     7,388     19,236     16,286

Acquisition-related costs

     1,787     885     1,787     972

Change in fair value of contingent consideration obligation

     (2,491     -     (1,304     -

Restructuring costs

     252     (100     527     (100

Selected legal costs

     735     603     1,055     1,192
  

 

 

   

 

 

   

 

 

   

 

 

 

Total operating expenses

     22,663     19,503     44,709     40,524
  

 

 

   

 

 

   

 

 

   

 

 

 

Operating income

     11,791     9,835     17,185     20,386

Other income (expense), net

     856     (588     (512     (663
  

 

 

   

 

 

   

 

 

   

 

 

 

Earnings before income taxes

     12,647     9,247     16,673     19,723

Income tax provision

     3,288     2,153     4,487     4,523
  

 

 

   

 

 

   

 

 

   

 

 

 

Net earnings

   $ 9,359   $ 7,094   $ 12,186   $ 15,200
  

 

 

   

 

 

   

 

 

   

 

 

 

Net earnings per basic common share

   $ 0.22   $ 0.17   $ 0.28   $ 0.36

Basic common shares outstanding

     42,830     42,496     42,810     42,472

Net earnings per diluted common share

   $ 0.22   $ 0.17   $ 0.28   $ 0.35

Diluted common shares outstanding

     42,968     42,946     42,953     42,925

Adjusted Financial Measures

        

(see non-GAAP financial measure reconciliation below)

        

Operating income

   $ 12,074   $ 11,223   $ 19,250   $ 22,450

Net earnings

     10,004     8,159     14,183     16,783

Net earnings per diluted common share

   $ 0.23   $ 0.19   $ 0.33   $ 0.39


Condensed Balance Sheet Data

 

     March 31,  
     2020      2019  

Cash and equivalents

   $ 49,550    $ 66,097

Working capital

     98,704      120,583

Long-term debt

     48,824      47,946

Shareholders’ equity

     204,533      181,645

Total assets

     319,074      253,964

Segment Data

The following table sets forth the unaudited revenue and segment data for the interim periods in fiscal 2020 and fiscal 2019 (in thousands).

 

     Three Months Ended      Six Months Ended  
     March 31,      March 31,  
     2020      2019      2020      2019  

Net Revenues - By Product Platform/Type

           

Diagnostics

           

Molecular assays

   $ 7,238    $ 7,084    $ 14,077    $ 14,314

Immunoassays & blood chemistry assays

     27,704      26,416      55,656      55,851
  

 

 

    

 

 

    

 

 

    

 

 

 

Total Diagnostics

     34,942      33,500      69,733      70,165
  

 

 

    

 

 

    

 

 

    

 

 

 

Life Science

           

Molecular reagents

     11,534      5,390      16,892      11,998

Immunological reagents

     10,820      11,358      18,092      19,565
  

 

 

    

 

 

    

 

 

    

 

 

 

Total Life Science

     22,354      16,748      34,984      31,563
  

 

 

    

 

 

    

 

 

    

 

 

 

Total Net Revenues

   $ 57,296    $ 50,248    $ 104,717    $ 101,728
  

 

 

    

 

 

    

 

 

    

 

 

 

Net Revenues - By Disease State/Geography

           

Diagnostics

           

Gastrointestinal assays

   $ 14,014    $ 16,177    $ 30,060    $ 34,792

Respiratory illness assays

     10,863      7,553      18,612      15,534

Blood chemistry assays

     4,329      4,330      9,479      8,760

Other

     5,736      5,440      11,582      11,079
  

 

 

    

 

 

    

 

 

    

 

 

 

Total Diagnostics

     34,942      33,500      69,733      70,165
  

 

 

    

 

 

    

 

 

    

 

 

 

Life Science

           

Americas

     4,612      5,454      8,627      9,976

EMEA

     9,946      7,852      14,914      15,213

ROW

     7,796      3,442      11,443      6,374
  

 

 

    

 

 

    

 

 

    

 

 

 

Total Life Science

     22,354      16,748      34,984      31,563
  

 

 

    

 

 

    

 

 

    

 

 

 

Total Net Revenues

   $ 57,296    $ 50,248    $ 104,717    $ 101,728
  

 

 

    

 

 

    

 

 

    

 

 

 

Geographic Regions

Americas = North and Latin America

EMEA = Europe, Middle East and Africa

ROW = Rest of World


     Three Months Ended     Six Months Ended  
     March 31,     March 31,  
     2020     2019     2020     2019  

OPERATING INCOME

        

Diagnostics

   $ 3,842   $ 6,676   $ 8,250   $ 15,374

Life Science

     10,818     5,361     13,879     10,492

Corporate

     (2,896     (2,216     (4,983     (5,521

Eliminations

     27     14     39     41
  

 

 

   

 

 

   

 

 

   

 

 

 

Total Operating Income

   $ 11,791   $ 9,835   $ 17,185   $ 20,386
  

 

 

   

 

 

   

 

 

   

 

 

 

NON-GAAP FINANCIAL MEASURES

In this press release, we have supplemented our reported GAAP financial information with information on operating expenses, operating income, net earnings, basic earnings per share and diluted earnings per share excluding the effects of acquisition-related costs, a favorable change in fair value of the contingent consideration obligation, 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 earnings per share and diluted earnings per share amounts reported under U.S. Generally Accepted Accounting Principles for the second quarters and six-month periods ended March 31, 2020 and March 31, 2019.

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 U.S. 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,  
     2020     2019     2020     2019  

Operating Expenses -

        

U.S. GAAP basis

   $ 22,663   $ 19,503   $ 44,709   $ 40,524

Acquisition-related costs

     (1,787     (885     (1,787     (972

Change in fair value of contingent consideration obligation

     2,491     -     1,304     -

Restructuring costs

     (252     100     (527     100

Selected legal costs

     (735     (603     (1,055     (1,192
  

 

 

   

 

 

   

 

 

   

 

 

 

Adjusted Operating Expenses

   $ 22,380   $ 18,115   $ 42,644   $ 38,460
  

 

 

   

 

 

   

 

 

   

 

 

 

Operating Income -

        

U.S. GAAP basis

   $ 11,791   $ 9,835   $ 17,185   $ 20,386

Acquisition-related costs

     1,787     885     1,787     972

Change in fair value of contingent consideration obligation

     (2,491     -     (1,304     -

Restructuring costs

     252     (100     527     (100

Selected legal costs

     735     603     1,055     1,192
  

 

 

   

 

 

   

 

 

   

 

 

 

Adjusted Operating Income

   $ 12,074   $ 11,223   $ 19,250   $ 22,450
  

 

 

   

 

 

   

 

 

   

 

 

 

Net Earnings -

        

U.S. GAAP basis

   $ 9,359   $ 7,094   $ 12,186   $ 15,200

Acquisition-related costs *

     1,787     680     1,787     747

Change in fair value of contingent consideration obligation *

     (1,886     -     (985     -

Restructuring costs *

     190     (78     398     (78

Selected legal costs *

     554     463     797     914
  

 

 

   

 

 

   

 

 

   

 

 

 

Adjusted Earnings

   $ 10,004   $ 8,159   $ 14,183   $ 16,783
  

 

 

   

 

 

   

 

 

   

 

 

 

Net Earnings per Basic Common Share -

        

U.S. GAAP basis

   $ 0.22   $ 0.17   $ 0.28   $ 0.36

Acquisition-related costs

     0.04     0.02     0.04     0.02

Change in fair value of contingent consideration obligation

     (0.04     -     (0.02     -

Restructuring costs

     -     -     0.01     -

Selected legal costs

     0.01       0.01     0.02     0.02
  

 

 

   

 

 

   

 

 

   

 

 

 

Adjusted Basic EPS

   $ 0.23   $ 0.19 **   $ 0.33   $ 0.40
  

 

 

   

 

 

   

 

 

   

 

 

 


     Three Months     Six Months  
     Ended March 31,     Ended March 31,  
     2020     2019     2020     2019  

Net Earnings per Diluted Common Share -

        

U.S. GAAP basis

   $ 0.22   $ 0.17   $ 0.28   $ 0.35

Acquisition-related costs

     0.04     0.02     0.04     0.02

Change in fair value of contingent

consideration obligation

     (0.04     -     (0.02     -

Restructuring costs

     -     -     0.01     -

Selected legal costs

     0.01       0.01     0.02     0.02
  

 

 

   

 

 

   

 

 

   

 

 

 

Adjusted Diluted EPS

   $ 0.23   $ 0.19 **    $ 0.33   $ 0.39
  

 

 

   

 

 

   

 

 

   

 

 

 

 

  *

Net of tax.

  **

Does 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” 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 expects or anticipates will occur in the future, including, but not limited to, statements relating to per share diluted earnings, sales, product demand, revenue and the impact of COVID-19 on our 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 our 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 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 revenues. In the past, the Company has identified a material weakness in our internal control over financial reporting, which has been remediated, but the Company can make no assurances that a material weakness will not be identified in the future, which if identified and not properly corrected, could materially adversely affect our operations and result in material misstatements in our 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 the coronavirus disease COVID-19. In addition to the factors described in this paragraph, as well as those factors identified from time to time in our filings with the Securities and Exchange Commission, Part I, Item 1A Risk Factors of our 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 our 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.

Meridian’s shares are traded on the NASDAQ Global Select Market, symbol VIVO. Meridian’s 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

###

EX-99.2

Slide 1

FY2020 Q2 Results May 8, 2020 Exhibit 99.2


Slide 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” 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 expects or anticipates will occur in the future, including, but not limited to, statements relating to per share diluted earnings, sales, product demand, revenue, and the impact of COVID-19 on our 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 our 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 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 revenues. In the past, the Company has identified a material weakness in our internal control over financial reporting, which has been remediated, but the Company can make no assurances that a material weakness will not be identified in the future, which if identified and not properly corrected, could materially adversely affect our operations and result in material misstatements in our 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 the coronavirus disease COVID-19. In addition to the factors described in this paragraph, please also refer to additional factors identified from time to time in our filings with the Securities and Exchange Commission, including in Part I, Item 1A Risk Factors of our 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 our forward-looking statements. Forward Looking Statements


Slide 3

Certain financial measures presented in this presentation, such as operating expenses, operating income, net earnings and diluted earnings per share, excluding as applicable the effects of acquisition-related costs, a change in fair value of contingent consideration obligation, restructuring costs and selected legal costs, are not recognized under generally accepted accounting principles in the United States of America, or U.S. GAAP. Management believes this non-GAAP financial information is useful to an investor 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 U.S. 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 U.S. GAAP, and they should not be considered as alternatives to information attributable to Meridian Bioscience, Inc. determined in accordance with U.S. GAAP. See the consolidated financial statements included in our reports filed with the U.S. Securities and Exchange Commission for our U.S. GAAP results. Additionally, for reconciliations of the non-GAAP measures included herein to our closest reported U.S. GAAP measures, refer to the reconciliations included in the press release of Meridian Bioscience, Inc. dated May 8, 2020. Non-GAAP Financial Measures


Slide 4

Life Science rapidly responds to COVID-19 & record revenue YoY quarterly revenue growth for Diagnostics segment Curian® analyzer and HpSA ® assay receive FDA clearance Acquisition of Exalenz Bioscience Ltd. and BreathID ® platform Q2 FY2020 Business Highlights Diagnostics Life Science


Slide 5

FY2020 Second Quarter Earnings Summary ($000’s except Per Share Amounts) Adjusted (Non-GAAP) FY2020 FY2019 Change Revenue $57,296 $50,248 +14% Gross Margin % 60.1% 58.4% +1.7 pts Operating expenses(1) Ratio $22,380 39.1% $18,115 36.1% +24% +3.0 pts Operating income Margin % $12,074 21.1% $11,223 22.3% +8% -1.2 pts Net earnings EPS $10,004 $0.23 $8,159 $0.19 +23% +21% GAAP FY2020 FY2019 Change Operating expenses $22,663 $19,503 +16% Operating income Margin % $11,791 20.6% $9,835 19.6% +20% +1.0 pts Net earnings EPS $9,359 $0.22 $7,094 $0.17 +32% +29% Highlights Both Diagnostics and Life Science delivered revenue growth above expectations -Diagnostics +4% -Life Science +33% 2020 Gross margin reflects positive effects of mix of Life Science products (molecular vs. immuno) and larger-than-normal batch sizes for RNA master mixes in response to COVID-19 pandemic 2020 Operating expenses reflect additional investment in Diagnostics new product development; purchase accounting amortization for the GenePOC acquisition; and additional investment in incentive compensation 1) Includes Corporate segment expenses of $2.2M and $1.6M in FY2020 and FY2019, respectively.


Slide 6

FY2020 Second Quarter Operating Segment Highlights ($000’s) Diagnostics (Adjusted Non-GAAP) FY2020 FY2019 Change Revenue $34,942 $33,500 +4% Operating income Margin % $3,337 9.6% $7,436 22.2% -55% -12.6 pts Diagnostics revenue by: Technology: Molecular assays $7,238 $7,084 +2% Immunoassays & blood chemistry 27,704 26,416 +5% Disease State: GI (Gastrointestinal) $14,014 $16,177 -13% RI (Respiratory Illnesses) 10,863 7,553 +44% Blood Chemistry (Lead) 4,329 4,330 - % Other 5,736 5,440 +5% Life Science (Adjusted Non-GAAP) FY2020 FY2019 Change Revenue $22,354 $16,748 +33% Operating income Margin % $10,921 48.9% $5,386 32.2% +103% +16.7 pts Life Science revenue by: Technology: Molecular reagents $11,534 $5,390 +114% Immunological reagents 10,820 11,358 -5% Region: Americas $4,612 $5,454 -15% EMEA 9,946 7,852 +27% ROW 7,796 3,442 +126% China (included in ROW) 5,312 1,328 +300% Product / Customer Highlights: RI volume growth strong in Flu, GAS and Mycoplasma GI affected by volume declines in most major assays, as well as Hp contract price changes Blood Chemistry experienced lower order patterns in March (non-critical care assay) Product / Customer Highlights: Record-level molecular reagent shipments ($5.6M related to COVID-19) Shipments to industrial customers increased ~40%


Slide 7

FY2020 Fiscal Year Guidance Meridian Bioscience Consolidated net revenues: Flat to Down 3% Adjusted operating margin: 9% to 10% Tax rate: 23.5% to 24.5% Adjusted earnings per share: $0.28 to $0.34 Research and development spend: $27 to $28 Million Diagnostics Net revenues: Down 3% to 5% Adjusted operating margin: Mid-single-digits Life Science Net revenues: Up 2% to 6% Adjusted operating margin: 50 to 100 basis point improvement over 2019 Prior Guidance Updated FY2020 Guidance Meridian Bioscience Consolidated net revenues: $230 to $236 Million Adjusted operating margin: 18% to 19% Adjusted earnings per share: $0.70 to $0.75 Diagnostics Net revenues: $120 to $122 million Life Science Net revenues: $110 to $114 million


Slide 8

COVID-19 Response


Slide 9

COVID-19 Products & Pipeline DIAGNOSTICS LIFE SCIENCE Reagent Master Mixes Recombinant Antigens RI Panel w/ SARS-CoV-2 (In Development) Rapid Immunoassay For Tests to check for SARS-CoV-2 Antibodies For Tests to check for SARS-CoV-2 Virus Spike proteins Nucleocapsid Molecular Immunological Molecular Immunological


Slide 10

Exalenz Bioscience Ltd. Acquisition


Slide 11

Exalenz Strategic Fit and Rationale Adds multi-configuration BreathID® diagnostics platform Flexible configurations span the continuum from large reference labs to point-of-care H. pylori urea breath test compliments stool antigen tests Strengthens opportunity to convert of H. pylori serology testing to Meridian products FDA-cleared / CE marked assay with customer base In-market product with immediate revenue and gross profit contribution Leverage of Meridian commercial infrastructure Experienced sales and marketing team to drive H. pylori market penetration Established manufacturing with cost reduction initiatives Capacity to scale production for growth and opportunities to reduce consumable cost


Slide 12

High volume Independent Labs LAB Large Hospitals Automated benchtop system for press and walk away batch testing Samples collected in physician office using breath bags sent to centralized location Test up to 10 patients at a time 100% sensitivity / 97.9% specificity Low volume Physician Office Labs Mid volume Medium Hospitals Small Hospitals Compact automated benchtop system for press-and-walk-away batch testing Samples collected in physician office using breath bags sent to centralized location Test up to 4 patients at a time 100% sensitivity / 97.9% specificity POC test system using a continuous flow of patient breath through a nasal canula Samples in the physician office with results after 15 minutes Test 1 patient at a time 100% sensitivity / 99.2% specificity Exalenz Bioscience BreathID® System


Slide 13

Breath bags are placed on analyzer and results are read within 2 minutes POST-INGESTION breath sample collected by patient blowing into GRAY breath bag Patient drinks 13C Urea labeled solution and waits 20 minutes BASELINE breath sample collected by patient blowing into BLUE breath bag Specimen Collection Workflow (for BreathID Lab and BreathID Smart)


Slide 14

Scan bag barcode Batch set up Press start Step 1 Step 2 Step 3 Start Results In 2 minutes BreathID® Assay Workflow


Slide 15

Historical Financial Overview Source: Exalenz Bioscience Ltd. 2019 consolidated financial statements prepared in accordance with IFRS; accounting policies under IFRS may differ from Meridian’s accounting under U.S. GAAP.


Slide 16

Curian® Analyzer


Slide 17

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® Advantage


Slide 18

C. difficile GDH/Toxin Campy EHEC Future Assay Roadmap Current Menu HpSA® Launched May 1st, 2020 Curian® Present and Future


Slide 19

Discharge sample & vortex Add sample to device card Place card into analyzer and start Step 1 Step 2 Step 3 Curian® Assay Workflow Standardized Simplified Workflow Curian Video


Slide 20

Contact: mbi@meridianbioscience.com

v3.20.1
Document and Entity Information
May 08, 2020
Cover [Abstract]  
Entity Registrant Name MERIDIAN BIOSCIENCE INC
Amendment Flag false
Entity Central Index Key 0000794172
Document Type 8-K
Document Period End Date May 08, 2020
Entity Incorporation State Country Code OH
Entity File Number 0-14902
Entity Tax Identification Number 31-0888197
Entity Address, Address Line One 3471 River Hills Drive
Entity Address, City or Town Cincinnati
Entity Address, State or Province OH
Entity Address, Postal Zip Code 45244
City Area Code (513)
Local Phone Number 271-3700
Written Communications false
Soliciting Material false
Pre Commencement Tender Offer false
Pre Commencement Issuer Tender Offer false
Security 12b Title Common Stock, no par value
Trading Symbol VIVO
Security Exchange Name NASDAQ
Entity Emerging Growth Company false