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Meridian Bioscience Reports Strong Fourth Quarter and Record Full-Year Fiscal 2020 Operating Results and Provides Fiscal 2021 Guidance

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CINCINNATI, Nov. 13, 2020 (GLOBE NEWSWIRE) -- Meridian Bioscience, Inc. (NASDAQ: VIVO) today announced financial results for the fourth quarter and fiscal year ended September 30, 2020.

Fourth Quarter 2020 Highlights (Comparison to Fourth Quarter Fiscal 2019):

  • Consolidated Net Revenue of $64.2 million, up 26% year-over-year
  • Life Science segment delivers revenue of $34.4 million, up 97% year-over-year
  • Diagnostics segment revenues decreased 11% year-over-year to $29.8 million, a stronger than expected rebound from Q3 FY20, up 38% quarter-over-quarter
  • Launched various SARS-CoV-2 antibody pairs, designed for highly sensitive rapid antigen tests (for saliva and nasopharyngeal samples)

Full Fiscal Year 2020 Highlights (Comparison to Full Year Fiscal 2019):

  • Consolidated Net Revenue of $253.7 million, up 26% year-over-year
  • Life Science segment delivers record revenue of $132.5 million, up 106% year-over-year, with the contribution of $71.5 million from COVID-19 related products for immunological and molecular tests
  • Diagnostics segment revenues decreased 11% year-over-year to $121.1 million, due to headwinds from COVID-19 pandemic in the second half
  • Launched the Curian® analyzer and HpSA® assay, the first internally developed new product in several years
  • Completed assay design lock of a PCR COVID-19 test on the Revogene® system and preparing submission to the FDA for Emergency Use Authorization
  • Closed the acquisition of Exalenz Bioscience, adding the BreathID® instrument and its Urea Breath Test for H. pylori to the diagnostics product portfolio

Fourth Quarter Fiscal 2020 Results (Comparison to Fourth Quarter Fiscal 2019)
Consolidated revenue for the fourth quarter of fiscal 2020 increased 26% to $64.2 million, compared to $50.8 million last year.  Diagnostics segment revenues rebounded strongly from the pandemic headwinds seen in the third fiscal quarter, but were still down 11% year-over-year.  Life Science segment revenues were up 97%.  Our Diagnostics segment experienced a 23% decrease in revenues from our molecular products and revenues from our non-molecular assay products decreased 8%.  Our Life Science segment revenues for the quarter included $18.1 million in revenue from COVID-19 related products with $14.6 million coming from molecular products and $3.5 million coming from immunological products.

Reported operating income for the fourth quarter of fiscal 2020 was $9.5 million.  Operating expenses included: (i) 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 Exalenz in April 2020, as well as an upward adjustment in the fair value of the earnout obligation for the acquisition of the GenePOC business in 2019.  On an adjusted basis, operating income was $12.0 million, a margin of 19% (see non-GAAP financial measure reconciliation below).    

Jack Kenny, Chief Executive Officer, commented, “This was truly a transformative year for Meridian.  All our hard work over the previous two years prepared us to both weather the storm in Diagnostics and excel as a critical partner to the IVD industry battling a global pandemic.  Heading into fiscal 2021, we will build on the momentum in Diagnostics and continue the strength in Life Science to deliver another record year.”

Full Fiscal Year 2020 Results (Comparison to Full Year Fiscal 2019)
Consolidated revenue for the fiscal year ended September 30, 2020 increased 26% to $253.7 million, compared to $201.0 million in fiscal 2019.  Diagnostics segment revenues were down 11%, while Life Science segment revenues were up 106%.  Our Diagnostics segment experienced a 17% decrease in revenues from our molecular products and revenues from our non-molecular assay products decreased 10%.  Our Life Science segment revenues for the fiscal year included $71.5 million in revenue from COVID-19 related products with $52.2 million coming from molecular products and $19.3 million coming from immunological products.

Reported operating income for fiscal 2020 was $61.3 million.  Operating expenses included: (i) 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 acquisitions of Exalenz and the GenePOC business in April 2020 and June 2019, respectively, as well as a net downward adjustment in the fair value of the earnout obligation for the acquisition of the GenePOC business.  On an adjusted basis, operating income was $61.7 million, a margin of 24% (see non-GAAP financial measure reconciliation below).   

Bryan Baldasare, Chief Financial Officer, commented, “Fiscal 2020 marked not only a record year in revenues and earnings, but also cash flows from operations, allowing us to repay borrowings under our revolving credit facility and increase our available credit capacity.”

Fiscal 2021 Guidance
Our fiscal 2021 guidance reflects a big rebound of the Diagnostics segment and continued strong demand for our Life Science reagents used in COVID-19 assays.  We expect continued headwinds to our core diagnostics products through the first half, with anticipated full recovery in the second half of the fiscal year.  COVID-19 related diagnostics products are expected to supplement that recovery in the fiscal second quarter.  Life Science demand is expected to be strong throughout fiscal 2021, between $80 and $85 million, albeit, subject to the same quarter-to-quarter volatility that was seen in fiscal 2020.  Adjusted operating margin reflects significant investment in R&D and manufacturing, coupled with costs associated with the acquisition of Exalenz and annualization of headcount increases during fiscal 2020.  Gross margin is expected to be relatively flat on a consolidated basis, reflecting a modest improvement for Diagnostics driven by higher volumes from rebounding demand, and a modest decline for Life Science driven by investments to fortify capacity for larger scale manufacturing.  Diagnostics investment in new product development is forecast to be 18% of Diagnostics revenue as a result of costs for clinical trials delayed from fiscal 2020, which are added to anticipated spend on products advancing through the development pipeline.  Life Science is also investing in infrastructure across sales and R&D to support the new scale of the business.

Revenues

  • Consolidated – $290 to $310 million
  • Diagnostics segment – $140 to $150 million
  • Life Science segment – $150 to $160 million

Adjusted Operating Margin

  • Consolidated – 23.5% to 24.5%

Effective Tax Rate

  • 23% to 24%

Adjusted Earnings Per Share on a Diluted Basis (based on 44.3M shares)

  • $1.14 to $1.28

The higher tax rate compared to 2020 reflects a larger amount of taxable income coming from the United States.  Adjusted operating margin and adjusted earnings per share on a diluted basis for fiscal 2021 exclude costs associated with restructuring activities, changes in the fair value of the earnout obligation and selected legal matters that we expect to continue in fiscal 2021.  Current customer order patterns for our Life Science segment coupled with the current trends with the pandemic, indicate revenues for the segment could favor the first half of the fiscal year and are incorporated in our guidance.  Finally, this guidance reflects our current line of sight and assumes that we do not encounter any significant reductions in manufacturing capacity as a result of the pandemic causing either partial or full site closures for an extended period of time, or adversely affecting our supply chain for raw materials.

Financial Condition
At September 30, 2020, cash and equivalents were $53.5 million and the Company had $91.2 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 $68.8 million as of September 30, 2020.

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, November 13, 2020 beginning at 10:00 a.m. Eastern Time to discuss the fourth quarter and full fiscal year financial results and answer questions.  A presentation to accompany the quarterly and full fiscal year 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 3958286.  A replay will be available for 14 days beginning at 1:00 p.m. Eastern Time on November 13, 2020 by dialing (855) 859-2056 or (404) 537-3406 and entering pass code 3958286.   


FOURTH QUARTER AND FISCAL 2020 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 and annual periods of fiscal 2020 and fiscal 2019.

   Three Months Ended Twelve Months Ended
   September 30, September 30,
   2020  2019  2020  2019 
                
Net revenues$64,153  $50,846  $253,667  $201,014 
Cost of sales 25,822   21,664   97,419   82,286 
  Gross profit 38,331   29,182   156,248   118,728 
              
Operating expenses           
 Research and development 6,983   5,607   23,729   17,760 
 Selling and marketing 7,210   7,140   26,486   27,995 
 General and administrative 12,109   8,872   44,345   34,044 
 Acquisition-related costs 462   363   3,890   1,808 
 Change in fair value of contingent           
 consideration obligation 1,135   -   (6,293)  - 
 Restructuring costs 67   1,138   687   2,839 
 Selected legal costs 891   213   2,080   1,583 
  Total operating expenses 28,857   23,333   94,924   86,029 
              
Operating income 9,474   5,849   61,324   32,699 
Other expense, net (1,727)  (493)  (2,031)  (1,142)
 Earnings before income taxes 7,747   5,356   59,293   31,557 
 Income tax provision 1,254   1,253   13,107   7,175 
 Net earnings$6,493  $4,103  $46,186  $24,382 
              
Net earnings per basic common share$0.15  $0.10  $1.08  $0.57 
Basic common shares outstanding 42,940   42,711   42,855   42,571 
              
Net earnings per diluted common share$0.15  $0.10  $1.07  $0.57 
Diluted common shares outstanding 43,642   42,916   43,174   42,899 
                


  Three Months Ended Twelve Months Ended  
  September 30, September 30,
  2020  2019  2020  2019 
Adjusted Financial Measures            
(see non-GAAP financial measure reconciliation below)            
Operating income$12,029 $7,563 $61,688 $38,929 
Net earnings 8,289  5,399  46,301  29,142 
Net earnings per diluted common share$0.19 $0.13 $1.07 $0.68 
             

Condensed Balance Sheet Data

  September 30,
 2020  2019
Cash and equivalents$53,514 $62,397
Working capital 109,666  123,847
Long-term debt 68,824  75,824
Shareholders’ equity 247,629  190,967
Total assets 405,261  325,478
      

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

  Three Months Ended Twelve Months Ended 
  September 30, September 30, 
  2020 2019 2020 2019 

Net Revenues - By Product Platform/Type
            
Diagnostics            
 Molecular assays$4,648 $6,074 $21,907 $26,283 
 Non-molecular assays 25,153
Meridian Bioscience Inc.

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About VIVO

Meridian Bioscience Inc. is a fully integrated life science company that develops, manufactures, markets and distributes a broad range of innovative diagnostic products.The company is 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, Meridian provides critical life science raw materials used in immunological and molecular tests for human, animal, plant, and environmental applications. Through diagnosis, Meridian provides diagnostic solutions in areas including gastrointestinal and upper respiratory infections and blood lead level testing. The company builds 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.