- Q1 2019 worldwide revenue of $238.3 million, up 17.4% as
reported over Q1 2018
- Q1 2019 core revenue on a comparable, constant currency basis*
up 10.0% over Q1 2018
- Q1 2019 GAAP EPS was $0.11, compared to $0.10 in Q1 2018
- Q1 2019 non-GAAP EPS* was $0.37, compared to $0.31 in Q1
2018
* Core revenue on a constant currency basis,
non-GAAP EPS, non-GAAP net income and non-GAAP gross margin are
non-GAAP financial measures. A reconciliation of these and other
non-GAAP financial measures used in this release to their most
directly comparable GAAP financial measures is included under the
heading “Non-GAAP Financial Measures” below.
Merit Medical Systems, Inc. (NASDAQ: MMSI), a leading manufacturer
and marketer of proprietary disposable devices used in
interventional, diagnostic and therapeutic procedures, particularly
in cardiology, radiology, oncology, critical care and endoscopy,
today announced revenue of $238.3 million for the quarter ended
March 31, 2019, an increase of 17.4% over revenue of $203.0
million for the quarter ended March 31, 2018. Core revenue on
a comparable, constant currency basis* for the first quarter of
2019 would have been up 10.0% when compared to the first quarter of
2018.
Merit’s GAAP net income for the first quarter of
2019 was $6.2 million, or $0.11 per share, compared to GAAP net
income of $5.3 million, or $0.10 per share, for the first quarter
of 2018. Merit’s non-GAAP net income* for the quarter ended
March 31, 2019 was $20.6 million, or $0.37 per share, compared
to $15.9 million, or $0.31 per share, for the quarter ended
March 31, 2018.
Merit's GAAP gross margin for the first quarter
of 2019 was 43.9%, compared to GAAP gross margin of 43.4% for the
first quarter of 2018. Merit's non-GAAP gross margin* for the first
quarter of 2019 was 49.2%, compared to non-GAAP gross margin* of
47.5% for the first quarter of 2018.
Merit’s revenue by category for the quarter
ended March 31, 2019, compared to the corresponding period in
2018, was as follows (unaudited, in thousands, except for
percentages):
|
|
|
|
|
|
|
Three Months Ended |
|
|
|
March 31, |
|
% Change |
|
2019 |
|
2018 |
Cardiovascular |
|
|
|
|
|
Stand-alone devices |
14.6% |
|
$ |
95,427 |
|
|
$ |
83,246 |
|
Cianna Medical |
n/a |
|
12,849 |
|
|
— |
|
Custom kits and procedure
trays |
(1.0)% |
|
32,943 |
|
|
33,272 |
|
Inflation devices |
(1.8)% |
|
22,017 |
|
|
22,419 |
|
Catheters |
27.1% |
|
43,039 |
|
|
33,865 |
|
Embolization devices |
(6.0)% |
|
11,827 |
|
|
12,587 |
|
CRM/EP |
18.3% |
|
12,378 |
|
|
10,466 |
|
Total |
17.7% |
|
230,480 |
|
|
195,855 |
|
|
|
|
|
|
|
Endoscopy |
|
|
|
|
|
Endoscopy devices |
9.6% |
|
7,869 |
|
|
7,180 |
|
|
|
|
|
|
|
Grand Total |
17.4% |
|
$ |
238,349 |
|
|
$ |
203,035 |
|
|
“Our first quarter results fulfilled our goal of
8-10% core growth by landing on the top side of our projection,”
said Fred P. Lampropoulos, Merit’s Chairman and Chief Executive
Officer. “This is particularly pleasing when we consider the
training, sales meeting and new-year startup expenses included in
this quarter.”
“Although there is substantial uncertainty as to
the outcome of the Brexit negotiations, we have prepared for the
potential outcomes with our newly operational distribution and
training center in Reading, United Kingdom,” Lampropoulos
continued. “There are several new products scheduled for
introduction in the second quarter that we believe will add to our
growth and margins.”
“Our transition of the Becton, Dickinson deal
continues on schedule with some of the acquired products now being
built in our facility in Tijuana, Mexico,” Lampropoulos said. “The
entire transition program is scheduled for completion later this
year.”
“The Cianna transition is complete and sales
continue to grow according to our expectations,” Lampropoulos
continued. “Although the complications of Brexit, consolidation of
notified bodies and the new European Medical Device Regulation
(MDR) have slowed new product approvals, we anticipate receiving
approval of the SAVI SCOUT® for sale in Europe in the near
future.”
CONFERENCE CALLMerit will hold its investor
conference call (conference ID 9197687) today, Tuesday, April 23,
2019, at 5:00 p.m. Eastern (4:00 p.m. Central, 3:00 p.m. Mountain,
and 2:00 p.m. Pacific). The domestic telephone number is (844)
578-9672 and the international number is (508) 637-5656. A live
webcast and slide deck will also be available at merit.com.
|
|
|
|
CONSOLIDATED
BALANCE SHEETS |
|
|
|
(In
thousands) |
March 31, |
|
December 31, |
|
2019 |
|
2018 |
|
(Unaudited) |
|
|
ASSETS |
|
|
|
Current Assets |
|
|
|
Cash and cash
equivalents |
$ |
49,522 |
|
|
$ |
67,359 |
|
Trade
receivables, net |
146,488 |
|
|
137,174 |
|
Other
receivables |
10,694 |
|
|
11,879 |
|
Inventories |
198,922 |
|
|
197,536 |
|
Prepaid
expenses and other assets |
11,220 |
|
|
11,326 |
|
Prepaid
income taxes |
3,620 |
|
|
3,627 |
|
Income
tax refund receivables |
1,317 |
|
|
933 |
|
Total
current assets |
421,783 |
|
|
429,834 |
|
|
|
|
|
Property and equipment,
net |
340,764 |
|
|
331,452 |
|
Intangible assets,
net |
448,707 |
|
|
462,713 |
|
Goodwill |
334,951 |
|
|
335,433 |
|
Deferred income tax
assets |
3,083 |
|
|
3,001 |
|
Operating lease
right-of-use assets |
80,453 |
|
|
— |
|
Other assets |
60,052 |
|
|
57,579 |
|
Total Assets |
$ |
1,689,793 |
|
|
$ |
1,620,012 |
|
|
|
|
|
LIABILITIES AND
STOCKHOLDERS' EQUITY |
|
|
|
Current
Liabilities |
|
|
|
Trade
payables |
$ |
51,680 |
|
|
$ |
54,024 |
|
Accrued
expenses |
91,310 |
|
|
96,173 |
|
Current
portion of long-term debt |
22,000 |
|
|
22,000 |
|
Current
operating lease liabilities |
11,825 |
|
|
— |
|
Income
taxes payable |
1,644 |
|
|
3,146 |
|
Total
current liabilities |
178,459 |
|
|
175,343 |
|
|
|
|
|
Long-term debt |
362,187 |
|
|
373,152 |
|
Deferred income tax
liabilities |
56,324 |
|
|
56,363 |
|
Long-term income taxes
payable |
392 |
|
|
392 |
|
Liabilities related to
unrecognized tax benefits |
3,013 |
|
|
3,013 |
|
Deferred compensation
payable |
12,480 |
|
|
11,219 |
|
Deferred credits |
2,227 |
|
|
2,261 |
|
Long-term operating
lease liabilities |
72,243 |
|
|
— |
|
Other long-term
obligations |
62,357 |
|
|
65,494 |
|
Total
liabilities |
749,682 |
|
|
687,237 |
|
|
|
|
|
Stockholders'
Equity |
|
|
|
Common
stock |
574,946 |
|
|
571,383 |
|
Retained
earnings |
369,713 |
|
|
363,425 |
|
Accumulated other comprehensive loss |
(4,548 |
) |
|
(2,033 |
) |
Total
stockholders' equity |
940,111 |
|
|
932,775 |
|
Total Liabilities and
Stockholders' Equity |
$ |
1,689,793 |
|
|
$ |
1,620,012 |
|
|
|
|
|
CONSOLIDATED
STATEMENTS OF INCOME |
|
|
|
(Unaudited, in thousands except per share
amounts) |
|
|
|
Three Months Ended |
|
March 31, |
|
2019 |
|
2018 |
|
|
|
|
NET SALES |
$ |
238,349 |
|
|
$ |
203,035 |
|
|
|
|
|
COST OF SALES |
133,713 |
|
|
114,979 |
|
|
|
|
|
GROSS PROFIT |
104,636 |
|
|
88,056 |
|
|
|
|
|
OPERATING EXPENSES |
|
|
|
Selling,
general and administrative |
78,270 |
|
|
64,913 |
|
Research
and development |
16,043 |
|
|
14,322 |
|
Acquired
in-process research and development |
25 |
|
|
— |
|
Contingent consideration expense |
775 |
|
|
40 |
|
Total |
95,113 |
|
|
79,275 |
|
|
|
|
|
INCOME FROM
OPERATIONS |
9,523 |
|
|
8,781 |
|
|
|
|
|
OTHER INCOME
(EXPENSE) |
|
|
|
Interest
income |
357 |
|
|
146 |
|
Interest
expense |
(2,764 |
) |
|
(2,398 |
) |
Other
expense - net |
(270 |
) |
|
(170 |
) |
Total
other income (expense) - net |
(2,677 |
) |
|
(2,422 |
) |
|
|
|
|
INCOME BEFORE INCOME
TAXES |
6,846 |
|
|
6,359 |
|
|
|
|
|
INCOME TAX EXPENSE |
651 |
|
|
1,090 |
|
|
|
|
|
NET INCOME |
$ |
6,195 |
|
|
$ |
5,269 |
|
|
|
|
|
EARNINGS PER COMMON
SHARE: |
|
|
|
Basic |
$ |
0.11 |
|
|
$ |
0.10 |
|
|
|
|
|
Diluted |
$ |
0.11 |
|
|
$ |
0.10 |
|
|
|
|
|
AVERAGE COMMON
SHARES: |
|
|
|
Basic |
54,917 |
|
|
50,277 |
|
|
|
|
|
Diluted |
56,490 |
|
|
51,910 |
|
Non-GAAP Financial MeasuresAlthough Merit’s
financial statements are prepared in accordance with accounting
principles generally accepted in the United States of America
(“GAAP”), Merit’s management believes that certain non-GAAP
financial measures referenced in this release provide investors
with useful information regarding the underlying business trends
and performance of Merit’s ongoing operations and can be useful for
period-over-period comparisons of such operations. Non-GAAP
financial measures used in this release include:
- constant currency revenue,
- core revenue,
- core revenue on a constant currency basis,
- non-GAAP gross margin,
- non-GAAP net income, and
- non-GAAP earnings per share.
Merit’s management team uses these non-GAAP
financial measures to evaluate Merit’s profitability and
efficiency, to compare operating results to prior periods, to
evaluate changes in the operating results of its operating
segments, and to measure and allocate financial resources
internally. However, Merit’s management does not consider such
non-GAAP measures in isolation or as an alternative to measures
determined in accordance with GAAP.
Readers should consider non-GAAP measures used
in this release in addition to, not as a substitute for, financial
reporting measures prepared in accordance with GAAP. These non-GAAP
financial measures generally exclude some, but not all, items that
may affect Merit's net income. In addition, they are subject to
inherent limitations as they reflect the exercise of judgment by
management about which items are excluded. Merit believes it is
useful to exclude such items in the calculation of non-GAAP
earnings per share, non-GAAP gross margin and non-GAAP net income
(in each case, as further illustrated in the reconciliation tables
below) because such amounts in any specific period may not directly
correlate to the underlying performance of Merit’s business
operations and can vary significantly between periods as a result
of factors such as acquisition transactions, non-cash expenses
related to amortization or write-off of previously acquired
tangible and intangible assets, severance expenses, expenses
resulting from non-ordinary course litigation, governmental
proceedings or changes in tax regulations, and debt issuance costs.
Merit may incur similar types of expenses in the future, and the
non-GAAP financial information included in this release should not
be viewed as a statement or indication that these types of expenses
will not recur. Additionally, the non-GAAP financial measures used
in this release may not be comparable with similarly titled
measures of other companies. Merit urges investors and potential
investors to review the reconciliations of its non-GAAP financial
measures to the comparable GAAP financial measures, and not to rely
on any single financial measure to evaluate Merit’s business or
results of operations.
Constant Currency RevenueMerit’s revenue on a
constant currency basis is prepared by translating the
current-period reported revenue of subsidiaries whose functional
currency is other than the U.S. dollar at the applicable foreign
exchange rates in effect during the comparable prior-year period.
The constant currency revenue adjustment of $4.8 million for the
three months ended March 31, 2019, was calculated using the
applicable average foreign exchange rates for the three months
ended March 31, 2018.
Core Revenue and Core Revenue on a Constant
Currency BasisMerit’s core revenue is defined (a) with respect to
prior fiscal year periods, as GAAP revenue, and (b) with respect to
current fiscal year periods, as GAAP revenue, less revenue from
certain acquisitions and strategic transactions. For the
three-month period ended March 31, 2019, Merit’s core revenue
excludes revenues attributable to (i) the acquisition of (1)
certain divested assets of Becton, Dickinson and Company in
February 2018 (excluded January 2019), (2) the assets of
DirectACCESS Medical, LLC in May 2018, (3) Cianna Medical, Inc. in
November 2018, and (4) the assets of Vascular Insights, LLC in
December 2018, and (ii) distribution arrangements executed with
NinePoint Medical, Inc. in April 2018 and QXMedical, LLC in May
2018. Core revenue on a constant currency basis is defined as core
revenue (as described in the first sentence of this paragraph)
adjusted to eliminate the foreign exchange impact related to those
core revenues for the relevant period, using the applicable average
foreign exchange rates in effect for the comparable prior-year
periods presented.
Non-GAAP Gross MarginNon-GAAP gross margin is
calculated by reducing GAAP cost of sales by amounts recorded for
amortization of intangible assets and inventory mark-up related to
acquisitions.
Non-GAAP Net IncomeNon-GAAP net income is
calculated by adjusting GAAP net income for certain items which are
deemed by Merit’s management to be outside of core operations and
vary in amount and frequency among periods, such as expenses
related to new acquisitions, non-cash expenses related to
amortization or write-off of previously acquired tangible and
intangible assets, severance expenses, expenses resulting from
non-ordinary course litigation, governmental proceedings or changes
in tax regulations, and debt issuance costs, as well as other items
set forth in the tables below.
Non-GAAP EPSNon-GAAP EPS is defined as non-GAAP
net income divided by the diluted shares outstanding for the
corresponding period.
Other Non-GAAP Financial Measure
ReconciliationThe tables in this release set forth supplemental
financial data and corresponding reconciliations of non-GAAP net
income and non-GAAP earnings per share to Merit’s net income and
earnings per share prepared in accordance with GAAP for the
three-month periods ended March 31, 2019 and 2018. The non-GAAP
income adjustments referenced in these tables do not reflect
stock-based compensation expense of approximately $1.8 million and
$1.3 million for the three-month periods ended March 31, 2019 and
2018, respectively.
Reconciliation of GAAP Net Income to Non-GAAP Net Income |
|
|
|
(Unaudited,
in thousands except per share amounts) |
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
March 31, 2019 |
|
Pre-Tax |
Tax Impact (a) |
After-Tax |
Per Share Impact |
GAAP net income |
$ |
6,846 |
|
$ |
(651 |
) |
$ |
6,195 |
|
$ |
0.11 |
|
|
|
|
|
|
Non-GAAP
adjustments: |
|
|
|
|
Cost of
Sales |
|
|
|
|
Amortization of intangibles |
11,978 |
|
(3,067 |
) |
8,911 |
|
0.16 |
|
Inventory
mark-up related to acquisitions |
672 |
|
(173 |
) |
499 |
|
0.01 |
|
Operating
Expenses |
|
|
|
|
Severance |
327 |
|
(84 |
) |
243 |
|
0.00 |
|
Acquisition-related (b) |
565 |
|
(145 |
) |
420 |
|
0.01 |
|
Fair
value adjustment to contingent consideration (c) |
775 |
|
(141 |
) |
634 |
|
0.01 |
|
Long-term
asset impairment charge (d) |
211 |
|
(54 |
) |
157 |
|
0.00 |
|
Acquired
in-process research and development |
25 |
|
(7 |
) |
18 |
|
0.00 |
|
Amortization of intangibles |
2,809 |
|
(739 |
) |
2,070 |
|
0.04 |
|
Special
legal expense (e) |
1,663 |
|
(428 |
) |
1,235 |
|
0.02 |
|
Other (Income)
Expense |
|
|
|
|
Amortization of long-term debt issuance costs |
201 |
|
(52 |
) |
149 |
|
0.00 |
|
Tax expense related to
restructuring (f) |
— |
|
91 |
|
91 |
|
0.00 |
|
Non-GAAP net
income |
$ |
26,072 |
|
$ |
(5,450 |
) |
$ |
20,622 |
|
$ |
0.37 |
|
|
|
|
|
|
Diluted shares |
|
|
|
56,490 |
|
|
|
|
|
|
|
Three Months Ended |
|
March 31, 2018 |
|
Pre-Tax |
Tax Impact (a) |
After-Tax |
Per Share Impact |
GAAP net income |
$ |
6,359 |
|
$ |
(1,090 |
) |
$ |
5,269 |
|
$ |
0.10 |
|
|
|
|
|
|
Non-GAAP
adjustments: |
|
|
|
|
Cost of
Sales |
|
|
|
|
Amortization of intangibles |
6,463 |
|
(1,606 |
) |
4,857 |
|
0.10 |
|
Inventory
mark-up related to acquisitions |
1,873 |
|
(481 |
) |
1,392 |
|
0.03 |
|
Operating
Expenses |
|
|
|
|
Acquisition-related (b) |
1,970 |
|
(506 |
) |
1,464 |
|
0.03 |
|
Fair
value adjustment to contingent consideration (c) |
40 |
|
(10 |
) |
30 |
|
0.00 |
|
Long-term
asset impairment charge (d) |
56 |
|
(14 |
) |
42 |
|
0.00 |
|
Amortization of intangibles |
2,000 |
|
(532 |
) |
1,468 |
|
0.03 |
|
Special
legal expense (e) |
1,691 |
|
(435 |
) |
1,256 |
|
0.02 |
|
Other
(Income) Expense |
|
|
|
|
Amortization of long-term debt issuance costs |
201 |
|
(52 |
) |
149 |
|
0.00 |
|
Non-GAAP net
income |
$ |
20,653 |
|
$ |
(4,726 |
) |
$ |
15,927 |
|
$ |
0.31 |
|
|
|
|
|
|
Diluted shares |
|
|
|
51,910 |
|
(a) Reflects the tax effect associated
with pre-tax income and the tax effect of non-GAAP adjustments
based on statutory tax rates within the applicable markets with
adjustments(b) Represents transaction costs and certain
integration costs, including travel, related to
acquisitions(c) Represents changes in the fair value of
contingent consideration liabilities and contingent receivables
associated with prior acquisitions(d) Represents abandoned
patents and other long-term assets(e) Costs incurred in
responding to an inquiry from the U.S. Department of
Justice(f) Net tax expense related to non-recurring tax
withholdings in connection with restructuring of certain
international subsidiaries
Reconciliation of Reported Revenue to Core Revenue
(Non-GAAP), Constant Currency Revenue (Non-GAAP), and Core Revenue
on a Constant Currency Basis (Non-GAAP) |
(Unaudited; in
thousands except percentages) |
|
|
|
|
|
Three Months Ended |
|
|
March 31, |
|
% Change |
2019 |
2018 |
Reported Revenue |
17.4% |
$ |
238,349 |
|
$ |
203,035 |
|
|
|
|
|
Add: Impact of foreign
exchange (a) |
|
4,790 |
|
— |
|
|
|
|
|
Constant
Currency Revenue |
19.8% |
$ |
243,139 |
|
$ |
203,035 |
|
|
|
|
|
|
|
Three Months Ended |
|
|
March 31, |
|
% Change |
2019 |
2018 |
Reported Revenue |
17.4% |
$ |
238,349 |
|
$ |
203,035 |
|
|
|
|
|
Less: Revenue from
certain acquisitions (b) |
|
(19,802 |
) |
— |
|
|
|
|
|
Core
Revenue |
7.6% |
$ |
218,547 |
|
$ |
203,035 |
|
|
|
|
|
Add: Impact of foreign
exchange (a) |
|
4,790 |
|
— |
|
|
|
|
|
Core Revenue on
a Constant Currency Basis |
10.0% |
$ |
223,337 |
|
$ |
203,035 |
|
(a) The constant currency revenue adjustment of
$4.8 million to reported revenue and to core revenue, for the three
months ended March 31, 2019, was calculated using the
applicable average foreign exchange rates for the three months
ended March 31, 2018.
(b) Merit’s core revenue is defined (a) with
respect to prior fiscal year periods, as GAAP revenue, and (b) with
respect to current fiscal year periods, as GAAP revenue, less
revenue from certain acquisitions and strategic transactions. For
the three-month period ended March 31, 2019, Merit’s core revenue
excludes revenues attributable to (i) the acquisition of (1)
certain divested assets of Becton, Dickinson and Company in
February 2018 (excluded January 2019), (2) the assets of
DirectACCESS Medical, LLC in May 2018, (3) Cianna Medical, Inc. in
November 2018, and (4) the assets of Vascular Insights, LLC in
December 2018, and (ii) distribution arrangements executed with
NinePoint Medical, Inc. in April 2018 and QXMedical, LLC in May
2018. Core revenue on a constant currency basis is defined as core
revenue (as described in the first sentence of this paragraph)
adjusted to eliminate the foreign exchange impact related to those
core revenues for the relevant period, using the applicable average
foreign exchange rates in effect for the comparable prior-year
periods presented.
Reconciliation of Reported Gross Margin to Non-GAAP Gross
Margin (Non-GAAP) |
(Unaudited,
as a percentage of reported revenue) |
|
|
|
|
|
|
|
Three months ended |
|
March 31, |
|
2019 |
|
2018 |
Reported Gross
Margin |
43.9 |
% |
|
43.4 |
% |
|
|
|
|
Add back impact
of: |
|
|
|
Amortization of intangibles |
5.0 |
% |
|
3.2 |
% |
Inventory
mark-up related to acquisitions |
0.3 |
% |
|
0.9 |
% |
|
|
|
|
Non-GAAP Gross
Margin |
49.2 |
% |
|
47.5 |
% |
ABOUT MERITFounded in 1987, Merit Medical
Systems, Inc. is engaged in the development, manufacture and
distribution of proprietary disposable medical devices used in
interventional, diagnostic and therapeutic procedures, particularly
in cardiology, radiology, oncology, critical care and
endoscopy. Merit serves client hospitals worldwide with a
domestic and international sales force and clinical support team
totaling in excess of 300 individuals. Merit employs
approximately 6,000 people worldwide with facilities in South
Jordan, Utah; Pearland, Texas; Richmond, Virginia; Malvern,
Pennsylvania; Rockland, Massachusetts; San Jose and Aliso Viejo,
California; Maastricht and Venlo, The Netherlands; Paris, France;
Galway, Ireland; Beijing, China; Tijuana, Mexico; Joinville,
Brazil; Markham, Ontario, Canada; Melbourne, Australia; Tokyo,
Japan; Reading, United Kingdom; Johannesburg, South Africa; and
Singapore.
FORWARD-LOOKING STATEMENTSStatements contained
in this release which are not purely historical, including, without
limitation, statements regarding Merit's forecasted plans, net
sales, net income (GAAP and non-GAAP), gross margin (GAAP and
non-GAAP), earnings per share (GAAP and non-GAAP), effective tax
rate and other financial results, anticipated or completed
acquisitions, or the introduction of new products, are
forward-looking statements within the meaning of the Private
Securities Litigation Reform Act of 1995 and are subject to risks
and uncertainties such as those described in Merit's Annual Report
on Form 10-K for the year ended December 31, 2018 and subsequent
filings with the Securities and Exchange Commission. Such
risks and uncertainties include inherent risks and uncertainties
relating to Merit’s internal models or the projections in this
release; risks relating to Merit's potential inability to
successfully manage growth through acquisitions generally,
including the inability to effectively integrate acquired
operations or products or commercialize technology acquired through
completed, proposed or future transactions; expenditures relating
to research, development, testing and regulatory approval or
clearance of Merit's products and risks that such products may not
be developed successfully or approved for commercial use;
governmental scrutiny and regulation of the medical device
industry, including governmental inquiries, investigations and
proceedings involving Merit; restrictions on Merit's
liquidity or business operations resulting from its debt
agreements; infringement of Merit's technology or the assertion
that Merit's technology infringes the rights of other parties;
product recalls and product liability claims; changes in customer
purchasing patterns or the mix of products Merit sells; risks and
uncertainties associated with Merit’s information technology
systems, including the potential for breaches of security and
evolving regulations regarding privacy and data protection; the
potential of fines, penalties or other adverse consequences if
Merit's employees or agents violate the U.S. Foreign Corrupt
Practices Act or other laws or regulations; the pending exit of the
United Kingdom from the European Union and uncertainties about
when, how or if such exit will occur; laws and regulations
targeting fraud and abuse in the healthcare industry; potential for
significant adverse changes in governing regulations, including
reforms to the procedures for approval or clearance of Merit's
products by the U.S. Food & Drug Administration or comparable
regulatory authorities in other jurisdictions; changes in tax laws
and regulations in the United States or other countries; increases
in the prices of commodity components; negative changes in economic
and industry conditions in the United States or other countries;
termination or interruption of relationships with Merit's
suppliers, or failure of such suppliers to perform; fluctuations in
exchange rates; uncertainties relating to the LIBOR calculation
method and the potential phasing out of LIBOR; concentration of a
substantial portion of Merit's revenues among a few products and
procedures; development of new products and technology that could
render Merit's existing products obsolete; market acceptance of new
products; volatility in the market price of Merit's common stock;
modification or limitation of governmental or private insurance
reimbursement policies; changes in healthcare policies or markets
related to healthcare reform initiatives; failure to comply with
applicable environmental laws; changes in key personnel; work
stoppage or transportation risks; introduction of products in a
timely fashion; price and product competition; availability of
labor and materials; fluctuations in and obsolescence of inventory;
and other factors referred to in Merit's Annual Report on Form 10-K
for the year ended December 31, 2018 and other materials filed with
the Securities and Exchange Commission. All subsequent
forward-looking statements attributable to Merit or persons acting
on its behalf are expressly qualified in their entirety by these
cautionary statements. Actual results will likely differ, and may
differ materially, from anticipated results. Financial estimates
are subject to change and are not intended to be relied upon as
predictions of future operating results, and Merit assumes no
obligation to update or disclose revisions to those estimates.
TRADEMARKSUnless noted otherwise, trademarks and
registered trademarks used in this release are the property of
Merit Medical Systems, Inc. and its subsidiaries in the United
States and other jurisdictions.
Contact: Anne-Marie Wright,
Vice President, Corporate CommunicationsPhone:
(801) 208-4167 e-mail: awright@merit.com Fax: (801)
253-1688
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