Site icon pharmaceutical daily

Meridian Bioscience Reports Second Quarter 2019 Operating Results, Suspends Quarterly Cash Dividend, and Provides Fiscal 2019 Guidance for Pending Acquisition

CINCINNATI–(BUSINESS WIRE)–Meridian Bioscience, Inc. (NASDAQ: VIVO) today announced financial
results for the second quarter and first six months ended March 31, 2019.

Second Quarter 2019 Highlights:

Year-to-Date Fiscal 2019 Highlights:

Second Quarter 2019 Results

Total revenue for the second quarter of fiscal 2019 decreased 11% to
$50.2 million, compared to $56.5 million in the second quarter of 2018.
This decrease was driven by a 16% decrease in Diagnostics business unit
revenues from $39.8 million to $33.5 million, as a result of continued
competitive pressures in a number of our molecular products,
particularly C. difficile, weaker respiratory product demand, and
volume and pricing declines in certain gastrointestinal products. Life
Science business unit revenues were relatively flat at $16.7 million (a
2% increase on a constant-currency basis compared to the second quarter
of 2018), as growth in both Americas and EMEA was largely offset by soft
customer order activity in China.

Reported operating income for the second quarter of fiscal 2019
increased $2.2 million to $9.8 million from the second quarter of fiscal
2018. This increase resulted from a $7.4 million decrease in operating
expenses including a $3.5 million decrease in acquisition, restructuring
and litigation costs, more than offsetting the lower amount of gross
profit from decreased revenues. Excluding the effects of the
acquisition, restructuring and litigation costs in each period,
operating income decreased 11% to $11.2 million. R&D spending was down
in the quarter compared to second quarter of fiscal 2018, due to the
timing of certain product development project expenses including
clinical trial expenses incurred in the fiscal 2018 second quarter for
the cCMV test, which launched this quarter. Sales and marketing expenses
in the quarter were down due to fiscal 2018 organization streamlining
initiatives, as well as lower sales commissions as a result of lower
revenues. General and administrative expenses were down in the quarter,
also due largely to the effects of organizational streamlining
initiatives implemented in fiscal 2018, but also due to lower FDA
Quality System remediation costs for the Billerica manufacturing
facility and lower incentive compensation costs. Fiscal 2019 second
quarter operating income in Diagnostics decreased 29%, due entirely to
the decrease in revenues, as spending was down significantly. Operating
income for the second quarter of fiscal 2019 was up 47% in Life Science,
driven by the continued benefit of fiscal 2018 restructuring activities,
including a lower-cost commercial organization.

Net earnings for the second quarter of fiscal 2019 totaled $7.1 million,
or $0.17 per diluted share, as compared to $5.3 million, or $0.12 per
diluted share, for the second quarter of fiscal 2018. On an adjusted
basis (non-GAAP), earnings were $8.2 million, or $0.19 per diluted
share, as compared to $8.9 million, or $0.21 per diluted share, for the
second quarter of fiscal 2018, decreases of 8% and 10%, respectively.
Adjusted basis excludes the effect of acquisition transaction and
litigation costs in the fiscal 2019 quarter and restructuring and
litigation costs in the fiscal 2018 quarter.

Jack Kenny, Chief Executive Officer, commented, “While I am disappointed
in our results for the second quarter for both our Diagnostics and Life
Science business units, I am excited about the shift that our pending
acquisition of GenePOC represents for Meridian. The addition upon
closing of GenePOC and its revogene™ molecular diagnostics platform is a
critical step in our strategy to invest in new products and
technologies. We believe this transaction and other initiatives are
necessary to stabilize our Diagnostics business and re-position the
Company for sustainable, long-term growth. The suspension of our
quarterly cash dividend represents a change in our capital allocation
philosophy to support this strategy and increase re-investment in the
business. We recognize the near-term trends and competitive pressures in
our business and we have recently reorganized our Diagnostics commercial
organization as an additional step to help address these pressures. For
our Life Science business unit, we are expecting customer order activity
in China to improve over the back half of the year, but not to
previously expected levels. Good growth performance this quarter in the
Americas and EMEA, however, are evidence that the Life Science business
is well-positioned, despite the recent unforeseen weakness in China.”

Fiscal 2019 First Half Results

Total revenue for the first half of fiscal 2019 totaled $101.7 million,
a 6% decrease from the $108.7 million achieved in fiscal 2018. This
decrease reflects a decline of 9% (also 9% on a constant-currency basis)
to $70.2 million in Diagnostics, driven largely by competitive pressures
in molecular assays, particularly C. difficile, volume and
pricing declines in gastrointestinal products, and volume declines in
respiratory assays. Revenues in the Life Science business unit were
relatively flat (up 2% on a constant-currency basis), reflecting
softness in customer order activity in China.

During the first half of fiscal 2019, operating income totaled $20.4
million, an increase of 30% or $4.6 million. This increase primarily
resulted from lower expenses for restructuring and litigation
activities. Excluding the effects of the acquisition, restructuring and
litigation costs in each period, operating income increased 1% to $22.5
million compared to the first half of fiscal 2018, despite the decline
in revenues. Operating expenses were broadly lower in all categories
across both business units, which favorably affected operating income,
despite the revenue decline in Diagnostics.

Net earnings totaled $15.2 million, or $0.35 per diluted share, for the
first half of fiscal 2019, as compared to $11.6 million, or $0.27 per
diluted share, for the same period in fiscal 2018. On an adjusted basis,
earnings were $16.8 million, or $0.39 per diluted share, increases of 9%
and 8%, respectively, over fiscal 2018’s adjusted earnings of $15.4
million, or $0.36 per diluted share. Adjusted earnings exclude the
effect of acquisition transaction and litigation costs in the first half
of fiscal 2019, and restructuring and litigation costs, and certain
one-time tax effects of the tax reform act, in the same period in fiscal
2018 period (see non-GAAP financial measure reconciliation below).

Tax Reform Impact

Our net earnings for both fiscal year-to-date periods include the
effects of the tax reform act signed into law during December 2017. The
fiscal 2019 year-to-date period reflects the lower U.S. federal tax rate
of 21% being fully phased-in, and the first six months of fiscal 2018
includes: (i) a benefit of $1.7 million ($0.04 per diluted share)
primarily related to the re-measurement of U.S. net deferred tax
liabilities based on the new federal rate; and (ii) a charge of $0.9
million ($0.02 per diluted share) for the mandatory U.S. repatriation
transition tax. The effective tax rate for both the second quarter and
first six months of fiscal 2019 was 23%.

Cash Dividend Matters

As part of the Company’s regular evaluation of its capital allocation,
upon evaluation of earnings, cash flow requirements and future business
developments, including the pending acquisition of the business of
GenePOC Inc., and other factors deemed relevant, the Board of Directors,
at its discretion, suspended the Company’s quarterly cash dividend
effective immediately. This action was taken in order to deploy cash
into new product development activities for the revogene™ molecular
diagnostics platform among other investments and to preserve capital
resources and liquidity for general corporate purposes.

Fiscal 2019 Guidance Including Effects of the Pending Acquisition

The Company provided revised guidance for full year fiscal 2019 in its
press release dated April 2, 2019. Excluding amortization expense, the
Company expects the transaction to add approximately $4 million – $5
million in operating expenses in fiscal 2019. The Company currently
estimates that the transaction will be dilutive to full year fiscal 2019
EPS by approximately $0.10 to $0.12 per share, based on current purchase
accounting estimates.

Financial Condition

The Company’s financial condition remains sound. At March 31, 2019, cash
and equivalents were $66.1 million and the Company had 100% borrowing
capacity under its $30.0 million commercial bank credit facility. The
Company’s bank-debt obligations totaled $47.9 million as of March 31,
2019.

In connection with the pending acquisition of GenePOC, the Company also
expects to execute a new five-year $125 million revolving credit
facility that would replace its existing $30 million credit facility.
The new credit facility is expected to be secured by substantially all
of the Company’s assets and include certain restrictive financial
covenants. The Company expects to use this new facility and cash on-hand
to repay the existing term loan outstanding at March 31, 2019 and fund
the closing payment for the acquisition of GenePOC.

Conference Call Information

Jack Kenny, Chief Executive Officer, and Eric Rasmussen, Chief Financial
Officer, will host a conference call on Tuesday, April 30, 2019
beginning at 10:00 a.m. Eastern Time to discuss the second quarter
financial results and answer questions.

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 3893028. A replay will be available for 14 days
beginning at 1:00 p.m. Eastern Time on April 30, 2019 by dialing (855)
859-2056 or (404) 537-3406 and entering pass code 3893028.

     
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
2019 and fiscal 2018.

 

 
Three Months Ended Six Months Ended
March 31, March 31,
2019   2018 2019   2018
Net revenues $ 50,248 $ 56,451 $ 101,728 $ 108,734
Cost of sales 20,910   21,882   40,818   42,155  
Gross profit 29,338   34,569   60,910   66,579  
 
Operating expenses
Research and development 3,816 4,491 7,700 8,895
Selling and marketing 6,911 8,647 14,474 17,461
General and administrative 7,388 8,842 16,286 18,090
Acquisition and restructuring costs 785 3,458 872 4,192
Litigation costs 603   1,453   1,192   2,202  
Total operating expenses 19,503   26,891   40,524   50,840  
 
Operating income 9,835 7,678 20,386 15,739
Other expense, net (588 ) (454 ) (663 ) (857 )
Earnings before income taxes 9,247 7,224 19,723 14,882
Income tax provision 2,153   1,936   4,523   3,292  
Net earnings $ 7,094   $ 5,288   $ 15,200   $ 11,590  
   
Net earnings per basic common share $ 0.17 $ 0.12 $ 0.36 $ 0.27
Basic common shares outstanding 42,496 42,323 42,472 42,289
 
Net earnings per diluted common share $ 0.17 $ 0.12 $ 0.35 $ 0.27
Diluted common shares outstanding 42,946 42,732 42,925 42,693
 
Adjusted Financial Measures
(see non-GAAP financial measure reconciliation below)
Operating income $ 11,223 $ 12,589 $ 22,450 $ 22,133
Net earnings 8,159 8,863 16,783 15,404
Net earnings per diluted common share $ 0.19 $ 0.21 $ 0.39 $ 0.36
 
 

Condensed Balance Sheet Data

 
March 31,
2019   2018
Cash and equivalents $ 66,097 $ 56,400
Working capital 120,583 113,691
Long-term debt 47,946 52,414
Shareholders’ equity 181,645 174,336
Total assets 253,964 254,547
 
     
Segment Data

The following table sets forth the unaudited revenue and segment
data for the interim periods in fiscal 2019 and fiscal 2018 (in
thousands).

 

Three Months Ended Six Months Ended
March 31, March 31,
2019   2018 2019   2018

Net Revenues – By Product Platform/Type

Diagnostics
Molecular assays $ 7,132 $ 9,976 $ 14,434 $ 18,692
Immunoassays & blood chemistry assays 26,368 29,806 55,731 58,580
Total Diagnostics 33,500 39,782 70,165 77,272
Life Science
Molecular reagents 5,390 6,143 11,998 11,832
Immunological reagents 11,358 10,526 19,565 19,630
Total Life Science 16,748 16,669 31,563 31,462
Total Net Revenues $ 50,248 $ 56,451 $ 101,728 $ 108,734

 

Net Revenues – By Disease State/Geography

Diagnostics
Gastrointestinal assays $ 16,177 $ 19,149 $ 34,792 $ 39,419
Respiratory illness assays 7,553 9,543 15,534 17,029
Blood chemistry assays 4,330 4,257 8,760 8,523
Other 5,440 6,833 11,079 12,301
Total Diagnostics 33,500 39,782 70,165 77,272
Life Science
Americas 5,453 5,121 9,975 10,373
EMEA 7,901 7,478 15,376 12,659
ROW 3,394 4,070 6,212 8,430
Total Life Science 16,748 16,669 31,563 31,462
Total Net Revenues $ 50,248 $ 56,451 $ 101,728 $ 108,734
 

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,

2019

 

2018

 

2019

2018

OPERATING INCOME

Diagnostics $ 7,561 $ 10,684 $ 16,346 $ 19,310
Life Science 5,361 3,638 10,492 6,580
Corporate (3,101 ) (6,723 ) (6,493 ) (10,334 )
Eliminations 14   79   41   183  
Total Operating Income $ 9,835   $ 7,678   $ 20,386   $ 15,739  
 

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 transaction costs, restructuring
costs, litigation costs, and certain one-time tax effects of the tax
reform act, 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,
2019 and March 31, 2018.

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.

Revenue reported on a constant-currency basis is also a non-GAAP measure
and is calculated by applying current period average foreign currency
exchange rates to each of the comparable periods. Management analyzes
revenue on a constant-currency basis to better measure the comparability
of results between periods. Because changes in foreign currency exchange
rates have a non-operating impact on revenue, management believes that
evaluating revenue changes on a constant-currency basis provides an
additional and meaningful assessment of revenue to both management and
investors.

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 RECONCILATION TABLES

(In Thousands, Except per Share Data)

 
Three Months Six Months
Ended March 31, Ended March 31,
2019   2018 2019   2018
Operating Expenses –
U.S. GAAP basis $ 19,503 $ 26,891 $ 40,524 $ 50,840
Acquisition and restructuring costs (785 ) (3,458 ) (872 ) (4,192 )
Litigation costs   (603 )   (1,453 )   (1,192 )   (2,202 )
Adjusted Operating Expenses $ 18,115   $ 21,980   $ 38,460   $ 44,446  
 
 
Operating Income –
U.S. GAAP basis $ 9,835 $ 7,678 $ 20,386 $ 15,739
Acquisition and restructuring costs 785 3,458 872 4,192
Litigation costs   603     1,453     1,192     2,202  
Adjusted Operating Income $ 11,223   $ 12,589   $ 22,450   $ 22,133  
 
 
Net Earnings –
U.S. GAAP basis $ 7,094 $ 5,288 $ 15,200 $ 11,590
Acquisition and restructuring costs * 602 2,517 669 3,052
Litigation costs* 463 1,058 914 1,603
One-time benefit from tax law change (1,695 )
Repatriation transition tax               854  
Adjusted Earnings $ 8,159   $ 8,863   $ 16,783   $ 15,404  
 
 
Net Earnings per Basic Common Share –
U.S. GAAP basis $ 0.17 $ 0.12 $ 0.36 $ 0.27
Acquisition and restructuring costs 0.01 0.06 0.02 0.07
Litigation costs 0.01 0.02 0.02 0.04
One-time benefit from tax law change (0.04 )
Repatriation transition tax               0.02  
Adjusted Basic EPS $ 0.19   $ 0.21   ** $ 0.40   $ 0.36  
 
      Three Months     Six Months
Ended March 31, Ended March 31,
2019   2018 2019   2018
Net Earnings per Diluted Common Share –
U.S. GAAP basis $ 0.17 $ 0.12 $ 0.35 $ 0.27
Acquisition and restructuring costs 0.01 0.06 0.02 0.07
Litigation costs 0.01 0.02

 

0.02 0.04
One-time benefit from tax law change (0.04 )
Repatriation transition tax         0.02  
Adjusted Diluted EPS $ 0.19 $ 0.21 ** $ 0.39 $ 0.36  
       
* 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”, “should” 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 and revenue, 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.

Contacts

Jack Kenny
Chief Executive Officer
Meridian Bioscience, Inc.
Phone:
513.271.3700
Email: mbi@meridianbioscience.com

Read full story here

Exit mobile version