Merit Medical Systems, Inc. (NASDAQ: MMSI), a leading manufacturer
and marketer of proprietary medical devices used in interventional,
diagnostic and therapeutic procedures, particularly in cardiology,
radiology, oncology, critical care and endoscopy, today announced
revenue of $278.5 million for the quarter ended
December 31, 2021, an increase of 7.9% compared to the
quarter ended December 31, 2020. Constant currency
revenue, organic for the fourth quarter of 2021 increased 8.4%
compared to the prior year period. For the year ended December 31,
2021, Merit's revenue was $1.075 billion, up 11.5% compared
to 2020. Constant currency revenue, organic for the year ended
December 31, 2021 increased 10.4% when compared to 2020.
Merit’s revenue by operating segment and product
category for the three and twelve-month periods ended
December 31, 2021 and 2020 was as follows (unaudited; in
thousands, except for percentages):
|
|
|
|
Three Months Ended |
|
|
|
|
Year Ended |
|
|
|
|
December 31, |
|
|
|
|
December 31, |
|
% Change |
|
2021 |
|
2020 |
|
% Change |
|
2021 |
|
2020 |
Cardiovascular |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Peripheral Intervention |
11.0 |
% |
|
$ |
105,543 |
|
|
$ |
95,080 |
|
|
18.6 |
% |
|
$ |
405,116 |
|
|
$ |
341,568 |
|
Cardiac Intervention |
11.7 |
% |
|
|
80,438 |
|
|
|
71,986 |
|
|
14.6 |
% |
|
|
320,641 |
|
|
|
279,671 |
|
Custom Procedural Solutions |
(6.3 |
)% |
|
|
50,450 |
|
|
|
53,827 |
|
|
(4.6 |
)% |
|
|
193,942 |
|
|
|
203,196 |
|
OEM |
15.8 |
% |
|
|
33,794 |
|
|
|
29,175 |
|
|
12.5 |
% |
|
|
123,528 |
|
|
|
109,767 |
|
Total |
8.1 |
% |
|
|
270,225 |
|
|
|
250,068 |
|
|
11.7 |
% |
|
|
1,043,227 |
|
|
|
934,202 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Endoscopy |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Endoscopy devices |
4.2 |
% |
|
|
8,267 |
|
|
|
7,936 |
|
|
6.2 |
% |
|
|
31,524 |
|
|
|
29,673 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total |
7.9 |
% |
|
$ |
278,492 |
|
|
$ |
258,004 |
|
|
11.5 |
% |
|
$ |
1,074,751 |
|
|
$ |
963,875 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Merit’s GAAP gross margin for the fourth quarter
of 2021 was 46.3%, compared to GAAP gross margin of 43.1% for the
prior year period. Merit’s non-GAAP gross margin for the fourth
quarter of 2021 was 50.0%, compared to non-GAAP gross margin of
47.9% for the prior year period. Merit’s GAAP gross margin for the
year ended December 31, 2021 was 45.2%, compared to GAAP gross
margin of 41.6% for the prior year. Merit’s non-GAAP gross margin
for the year ended December 31, 2021 was 49.3%, compared to
non-GAAP gross margin of 47.1% for the prior year.
Merit’s GAAP net income for the fourth quarter
of 2021 increased 34% year-over-year to $20.6 million, or $0.36 per
share, compared to GAAP net income of $15.4 million, or $0.27 per
share, for the fourth quarter of 2020. Merit’s non-GAAP net income
for the fourth quarter of 2021 increased 33% year-over-year to
$40.8 million, or $0.71 per share, compared to non-GAAP net income
of $30.8 million, or $0.54 per share, for the prior year
period.
Merit’s GAAP net income for the year ended
December 31, 2021 was $48.5 million, or $0.84 per share, compared
to GAAP net loss of ($9.8) million, or ($0.18) per share, for 2020.
Merit’s non-GAAP net income for the year ended December 31, 2021
increased 46% year-over-year to $136.2 million, or $2.37 per share,
compared to non-GAAP net income of $93.3 million, or $1.65 per
share, for 2020.
“We delivered fourth quarter performance that
drove our 2021 financial results above the high end of our revenue
and non-GAAP EPS guidance ranges, reflecting strong execution from
our team despite the challenging operating environment,” said Fred
P. Lampropoulos, Merit’s Chairman and Chief Executive Officer.
“Fourth quarter total revenue increased 8.4% on a constant
currency, organic basis, driven by 6.6% growth in the U.S. and
10.8% growth outside the U.S. during the period. By product
category, fourth quarter sales growth was driven primarily by low
double-digit growth year-over-year in sales of our peripheral
intervention and cardiac intervention products and mid-teens growth
year-over-year in sales of OEM products. We delivered strong
non-GAAP gross margin performance in the fourth quarter driven, in
part, by early benefits attributable to our Foundations for Growth
initiatives, which offset inflationary pressures in raw materials,
freight and logistics expenses in the period. The strong increase
in non-GAAP gross margins, combined with prudent operating expense
control, resulted in growth in our non-GAAP net income and non-GAAP
EPS of 33% and 31%, respectively, year-over-year.”
Mr. Lampropoulos continued: “Our operating and
financial performance in fiscal year 2021 was impressive. We
delivered more than 10% constant currency revenue growth, expanded
our non-GAAP gross and operating margins approximately 220 basis
points year-over-year, grew non-GAAP EPS 43% year-over-year and
generated more than $119 million of free cash flow. We also made
considerable progress in the first year of our Foundations for
Growth Program in 2021 and remain committed to the significant
improvements in profitability and notable free cash flow generation
we have targeted over the course of this multi-year strategic
initiative. We introduced our financial guidance for fiscal year
2022 in this afternoon’s press release which calls for total
revenue growth, on a constant currency basis, of approximately 4%
to 6% year-over-year, continued expansion in our non-GAAP gross and
operating margins and strong free cash flow generation.”
As of December 31, 2021, Merit had
cash on hand of $68 million, long term debt obligations of $243
million, and available borrowing capacity of $490 million, compared
to cash on hand of $57 million, long term debt obligations of $352
million, and available borrowing capacity of $389 million as of
December 31, 2020.
Fiscal Year 2022 Financial Guidance
Based upon information currently available to
Merit’s management, Merit estimates for the year ending
December 31, 2022, absent material acquisitions, non-recurring
transactions or other factors beyond Merit’s current
expectations, the following:
- Net revenue in the range of $1.117
billion to $1.140 billion, representing an increase of
approximately 4% to 6% year over year, as compared to net revenue
of $1.075 billion for the twelve months ended December 31, 2021.
The fiscal year 2022 revenue guidance range assumes:
- Net revenue from the cardiovascular
segment of between $1.083 billion and $1.106 billion, representing
an increase of approximately 4% to 6% year-over-year as compared to
net revenue of $1.043 billion for the twelve months ended December
31, 2021.
- Net revenue from the endoscopy
segment of between $33.5 million and $34.1 million, representing an
increase of approximately 6% to 8% year-over-year as compared to
net revenue of $31.5 million for the twelve months ended December
31, 2021.
- GAAP net income in the range of
$75.4 million to $84.0 million, or $1.30 to $1.45 per diluted
share, compared to GAAP net income of $48.5 million, or $0.84 per
diluted share, for the twelve months ended December 31, 2021.
- Non-GAAP net income in the range of
$140.0 million to $148.7 million, or $2.41 to $2.56 per diluted
share, compared to non-GAAP net income of $136.2 million, or $2.37
per diluted share, for the twelve months ended December 31,
2021.
Merit’s financial guidance for the year
ending December 31, 2022 is subject to risks and uncertainties
identified in this release and Merit’s filings with the U.S.
Securities and Exchange Commission (the “SEC”).
CONFERENCE CALL
Merit will hold its investor conference call
(conference ID 5259615) today, Thursday, February 24, 2022, 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)
|
December 31, |
|
|
|
|
2021 |
|
December 31, |
|
(Unaudited) |
|
2020 |
ASSETS |
|
|
|
|
|
Current Assets |
|
|
|
|
|
Cash and cash equivalents |
$ |
67,750 |
|
|
$ |
56,916 |
|
Trade receivables, net |
|
152,301 |
|
|
|
146,641 |
|
Other receivables |
|
17,763 |
|
|
|
7,774 |
|
Inventories |
|
221,922 |
|
|
|
198,019 |
|
Prepaid expenses and other assets |
|
16,149 |
|
|
|
13,120 |
|
Prepaid income taxes |
|
3,550 |
|
|
|
3,688 |
|
Income tax refund receivables |
|
2,777 |
|
|
|
3,549 |
|
Total current assets |
|
482,212 |
|
|
|
429,707 |
|
|
|
|
|
|
|
Property and equipment,
net |
|
371,658 |
|
|
|
382,728 |
|
Intangible assets, net |
|
319,269 |
|
|
|
367,915 |
|
Goodwill |
|
361,741 |
|
|
|
363,533 |
|
Deferred income tax
assets |
|
6,080 |
|
|
|
4,597 |
|
Operating lease right-of-use
assets |
|
65,913 |
|
|
|
78,240 |
|
Other assets |
|
41,421 |
|
|
|
37,676 |
|
Total Assets |
$ |
1,648,294 |
|
|
$ |
1,664,396 |
|
|
|
|
|
|
|
LIABILITIES AND
STOCKHOLDERS' EQUITY |
|
|
|
|
|
Current Liabilities |
|
|
|
|
|
Trade payables |
$ |
55,624 |
|
|
$ |
49,837 |
|
Accrued expenses |
|
159,014 |
|
|
|
111,944 |
|
Current portion of long-term debt |
|
8,438 |
|
|
|
7,500 |
|
Current operating lease liabilities |
|
10,668 |
|
|
|
12,903 |
|
Income taxes payable |
|
2,536 |
|
|
|
2,820 |
|
Total current liabilities |
|
236,280 |
|
|
|
185,004 |
|
|
|
|
|
|
|
Long-term debt |
|
234,397 |
|
|
|
343,722 |
|
Deferred income tax
liabilities |
|
31,503 |
|
|
|
33,312 |
|
Long-term income taxes
payable |
|
347 |
|
|
|
347 |
|
Liabilities related to
unrecognized tax benefits |
|
932 |
|
|
|
1,016 |
|
Deferred compensation
payable |
|
18,111 |
|
|
|
16,808 |
|
Deferred credits |
|
1,815 |
|
|
|
1,923 |
|
Long-term operating lease
liabilities |
|
61,526 |
|
|
|
70,941 |
|
Other long-term
obligations |
|
23,584 |
|
|
|
52,748 |
|
Total liabilities |
|
608,495 |
|
|
|
705,821 |
|
|
|
|
|
|
|
Stockholders' Equity |
|
|
|
|
|
Common stock |
|
641,533 |
|
|
|
606,224 |
|
Retained earnings |
|
406,257 |
|
|
|
357,803 |
|
Accumulated other comprehensive loss |
|
(7,991 |
) |
|
|
(5,452 |
) |
Total stockholders' equity |
|
1,039,799 |
|
|
|
958,575 |
|
Total Liabilities and
Stockholders' Equity |
$ |
1,648,294 |
|
|
$ |
1,664,396 |
|
|
|
|
|
|
|
|
|
CONSOLIDATED STATEMENTS OF INCOME
(LOSS)(Unaudited; in thousands except per share
amounts)
|
Three Months Ended |
|
Year Ended |
|
December 31, |
|
December 31, |
|
2021 |
|
2020 |
|
2021 |
|
2020 |
Net sales |
$ |
278,492 |
|
|
$ |
258,004 |
|
|
$ |
1,074,751 |
|
|
$ |
963,875 |
|
Cost of sales |
|
149,686 |
|
|
|
146,841 |
|
|
|
589,418 |
|
|
|
562,698 |
|
Gross profit |
|
128,806 |
|
|
|
111,163 |
|
|
|
485,333 |
|
|
|
401,177 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
Selling, general and administrative |
|
76,629 |
|
|
|
79,934 |
|
|
|
335,690 |
|
|
|
297,724 |
|
Research and development |
|
20,406 |
|
|
|
15,133 |
|
|
|
71,247 |
|
|
|
57,537 |
|
Legal settlement |
|
10,036 |
|
|
|
484 |
|
|
|
10,036 |
|
|
|
18,684 |
|
Impairment charges |
|
— |
|
|
|
8,199 |
|
|
|
4,283 |
|
|
|
36,504 |
|
Contingent consideration expense (benefit) |
|
(161 |
) |
|
|
(8,844 |
) |
|
|
3,161 |
|
|
|
(7,960 |
) |
Acquired in-process research and development |
|
— |
|
|
|
250 |
|
|
|
— |
|
|
|
250 |
|
Total operating expenses |
|
106,910 |
|
|
|
95,156 |
|
|
|
424,417 |
|
|
|
402,739 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Income (loss) from
operations |
|
21,896 |
|
|
|
16,007 |
|
|
|
60,916 |
|
|
|
(1,562 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
Other income (expense): |
|
|
|
|
|
|
|
|
|
|
|
Interest income |
|
101 |
|
|
|
370 |
|
|
|
769 |
|
|
|
604 |
|
Interest expense |
|
(1,105 |
) |
|
|
(1,938 |
) |
|
|
(5,261 |
) |
|
|
(9,994 |
) |
Other expense - net |
|
(711 |
) |
|
|
(1,194 |
) |
|
|
(2,507 |
) |
|
|
(2,279 |
) |
Total other expense — net |
|
(1,715 |
) |
|
|
(2,762 |
) |
|
|
(6,999 |
) |
|
|
(11,669 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
Income (loss) before income
taxes |
|
20,181 |
|
|
|
13,245 |
|
|
|
53,917 |
|
|
|
(13,231 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
Income tax expense
(benefit) |
|
(432 |
) |
|
|
(2,133 |
) |
|
|
5,463 |
|
|
|
(3,388 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
Net income (loss) |
$ |
20,613 |
|
|
$ |
15,378 |
|
|
$ |
48,454 |
|
|
$ |
(9,843 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
Earnings (loss) per common
share |
|
|
|
|
|
|
|
|
|
|
|
Basic |
$ |
0.36 |
|
|
$ |
0.28 |
|
|
$ |
0.86 |
|
|
$ |
(0.18 |
) |
Diluted |
$ |
0.36 |
|
|
$ |
0.27 |
|
|
$ |
0.84 |
|
|
$ |
(0.18 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average shares
outstanding |
|
|
|
|
|
|
|
|
|
|
|
Basic |
|
56,489 |
|
|
|
55,577 |
|
|
|
56,145 |
|
|
|
55,434 |
|
Diluted |
|
57,624 |
|
|
|
56,736 |
|
|
|
57,359 |
|
|
|
55,434 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
CONSOLIDATED STATEMENTS OF CASH
FLOWS(In thousands - unaudited)
|
Year Ended |
|
December 31, |
|
2021 |
|
2020 |
CASH FLOWS FROM OPERATING
ACTIVITIES: |
|
|
|
Net income (loss) |
$ |
48,454 |
|
|
$ |
(9,843 |
) |
Adjustments to reconcile net income (loss) to net cash provided by
operating activities: |
|
|
|
|
|
Depreciation and amortization |
|
84,066 |
|
|
|
94,070 |
|
Write-off of certain intangible assets and other long-term
assets |
|
4,412 |
|
|
|
36,609 |
|
Amortization of right-of-use operating lease assets |
|
11,718 |
|
|
|
12,746 |
|
Fair value adjustments to contingent consideration |
|
3,161 |
|
|
|
(7,960 |
) |
Deferred income taxes |
|
(4,631 |
) |
|
|
(11,295 |
) |
Stock-based compensation expense |
|
16,090 |
|
|
|
14,339 |
|
Other adjustments |
|
1,799 |
|
|
|
2,366 |
|
Changes in operating assets and liabilities, net of acquisitions
and divestitures |
|
(17,838 |
) |
|
|
34,238 |
|
Total adjustments |
|
98,777 |
|
|
|
175,113 |
|
Net cash provided by operating
activities |
|
147,231 |
|
|
|
165,270 |
|
|
|
|
|
|
|
CASH FLOWS FROM INVESTING
ACTIVITIES: |
|
|
|
|
|
Capital expenditures for property and equipment |
|
(27,939 |
) |
|
|
(45,988 |
) |
Cash paid in acquisitions, net of cash acquired |
|
(7,171 |
) |
|
|
(10,953 |
) |
Other investing, net |
|
(2,051 |
) |
|
|
(1,711 |
) |
Net cash used in investing
activities |
|
(37,161 |
) |
|
|
(58,652 |
) |
|
|
|
|
|
|
CASH FLOWS FROM FINANCING
ACTIVITIES: |
|
|
|
Proceeds from issuance of common stock |
|
21,306 |
|
|
|
6,635 |
|
Payments on long-term debt, net |
|
(108,500 |
) |
|
|
(88,375 |
) |
Contingent payments related to acquisitions |
|
(10,665 |
) |
|
|
(13,100 |
) |
Payment of taxes related to an exchange of common stock |
|
(576 |
) |
|
|
(866 |
) |
Net cash used in financing
activities |
|
(98,435 |
) |
|
|
(95,706 |
) |
Effect of exchange rates on
cash |
|
(801 |
) |
|
|
1,684 |
|
Net increase in cash and cash
equivalents |
|
10,834 |
|
|
|
12,596 |
|
|
|
|
|
|
|
CASH AND CASH
EQUIVALENTS: |
|
|
|
|
|
Beginning of period |
|
56,916 |
|
|
|
44,320 |
|
End of period |
$ |
67,750 |
|
|
$ |
56,916 |
|
|
|
|
|
|
|
|
|
Non-GAAP Financial Measures
Although 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;
- constant currency revenue, organic;
- core revenue;
- non-GAAP gross margin;
- non-GAAP operating income and margin;
- non-GAAP net income;
- non-GAAP earnings per share; and
- free cash flow.
Merit’s management team uses these non-GAAP
financial measures to evaluate Merit’s profitability and
efficiency, to compare operating and financial results to prior
periods, to evaluate changes in the 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, non-GAAP operating
income and 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 or other extraordinary transactions, non-cash expenses
related to amortization or write-off of previously acquired
tangible and intangible assets, certain severance expenses,
expenses resulting from non-ordinary course litigation or
administrative proceedings and resulting settlements, corporate
transformation expenses, governmental proceedings or changes in tax
or industry regulations, gains or losses on disposal of certain
assets, 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 readers 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 Revenue
Merit’s constant currency revenue is prepared by
converting the current-period reported revenue of subsidiaries
whose functional currency is a currency other than the U.S. dollar
at the applicable foreign exchange rates in effect during the
comparable prior-year period, and adjusting for the effects of
hedging transactions on reported revenue, which are recorded in the
U.S. The constant currency revenue adjustments of $1.1 million and
($10.3) million to reported revenue for the three and twelve-month
periods ended December 31, 2021 were calculated using the
applicable average foreign exchange rates for the three and
twelve-month periods ended December 31, 2020,
respectively.
Constant Currency Revenue, Organic
Merit’s constant currency revenue, organic, is
defined, with respect to prior fiscal year periods, as GAAP
revenue. With respect to current fiscal year periods, constant
currency revenue, organic, is defined as constant currency revenue
(as defined above), less revenue from certain acquisitions. For the
three and twelve-month periods ended December 31, 2021,
Merit’s constant currency revenue, organic, excludes revenues
attributable to the acquisition of KA Medical, LLC in November 2020
(excluded through October 2021).
Core Revenue
For the three and twelve-month periods ended December 31, 2020,
Merit’s core revenue excludes revenues attributable to its
distribution agreement with NinePoint Medical, Inc., which was
suspended during the first quarter of 2020, revenues attributable
to the manufacture of Merit’s Hypotube product which was divested
in August 2020, revenues attributable to the ITL Healthcare Pty Ltd
(“ITL”) procedure pack business in Australia which was closed in
December 2020, and revenue attributable to sales of the
Cultura™ nasopharyngeal swabs and test kits (which benefited
from high demand in 2020 resulting from the COVID-19 pandemic but
which are not expected to contribute significant revenue in the
future).
With respect to the three and twelve-month
periods ended December 31, 2021, core revenue is defined as
constant currency revenue, organic (as defined above), less revenue
attributable to sales of the Cultura nasopharyngeal swabs and test
kits and revenue attributable to the final sales of products from
the closed ITL procedure pack business.
Non-GAAP Gross Margin
Non-GAAP gross margin is calculated by reducing
GAAP cost of sales by amounts recorded for amortization of
intangible assets, certain inventory write-offs, and inventory
mark-up related to acquisitions, divided by reported net sales.
Non-GAAP Operating Income and Margin
Non-GAAP operating income is calculated by
adjusting GAAP operating income (loss) 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 acquisitions or other extraordinary transactions,
non-cash expenses related to amortization or write-off of
previously acquired tangible and intangible assets, certain
severance expenses, performance-based stock compensation expenses,
corporate transformation expenses, expenses resulting from
non-ordinary course litigation or administrative proceedings and
resulting settlements, governmental proceedings or changes in
industry regulations, as well as other items referenced in the
tables below. Non-GAAP operating margin is calculated by dividing
non-GAAP operating income by reported net sales.
Non-GAAP Net Income
Non-GAAP net income is calculated by adjusting
GAAP net income (loss) for the items set forth in the definition of
non-GAAP operating income above, as well as for expenses related to
debt issuance costs, gains or losses on disposal of certain assets,
changes in tax regulations, and other items set forth in the tables
below.
Non-GAAP EPS
Non-GAAP EPS is defined as non-GAAP net income
divided by the diluted shares outstanding for the corresponding
period.
Free Cash Flow
Free cash flow is defined as cash flow from
operations calculated in accordance with GAAP, less capital
expenditures for property and equipment calculated in accordance
with GAAP, as set forth in the consolidated statement of cash
flows.
Non-GAAP Financial Measure Reconciliations
The following tables set forth supplemental
financial data and corresponding reconciliations of non-GAAP
financial measures to Merit’s corresponding financial measures
prepared in accordance with GAAP, in each case, for the three and
twelve-month periods ended December 31, 2021 and 2020. The non-GAAP
income adjustments referenced in the following tables do not
reflect non-performance-based stock compensation expense of
approximately $3.5 million and $3.0 million for the three-month
periods ended December 31, 2021 and 2020, respectively,
and approximately $11.1 million and $10.6 million for the
twelve-month periods ended December 31, 2021 and 2020.
Reconciliation of GAAP Net Income (Loss) to
Non-GAAP Net Income(Unaudited; in thousands except per
share amounts)
|
Three Months Ended |
|
December 31, 2021 |
|
Pre-Tax |
|
Tax Impact |
|
After-Tax |
|
Per Share Impact |
GAAP net income |
$ |
20,181 |
|
|
$ |
432 |
|
|
$ |
20,613 |
|
|
$ |
0.36 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Non-GAAP adjustments: |
|
|
|
|
|
|
|
|
|
|
|
Cost of Sales |
|
|
|
|
|
|
|
|
|
|
|
Amortization of intangibles |
|
10,570 |
|
|
|
(2,625 |
) |
|
|
7,945 |
|
|
|
0.14 |
|
Operating Expenses |
|
|
|
|
|
|
|
|
|
|
|
Contingent consideration benefit |
|
(161 |
) |
|
|
53 |
|
|
|
(108 |
) |
|
|
(0.00 |
) |
Amortization of intangibles |
|
1,786 |
|
|
|
(447 |
) |
|
|
1,339 |
|
|
|
0.02 |
|
Performance-based share-based compensation (a) |
|
1,036 |
|
|
|
(110 |
) |
|
|
926 |
|
|
|
0.02 |
|
Corporate transformation and restructuring (b) |
|
1,605 |
|
|
|
(398 |
) |
|
|
1,207 |
|
|
|
0.02 |
|
Acquisition-related |
|
(2 |
) |
|
|
— |
|
|
|
(2 |
) |
|
|
(0.00 |
) |
Medical Device Regulation expenses (c) |
|
1,513 |
|
|
|
(375 |
) |
|
|
1,138 |
|
|
|
0.02 |
|
Other (d) |
|
10,118 |
|
|
|
(2,508 |
) |
|
|
7,610 |
|
|
|
0.13 |
|
Other (Income) Expense |
|
|
|
|
|
|
|
|
|
|
|
Amortization of long-term debt issuance costs |
|
151 |
|
|
|
(37 |
) |
|
|
114 |
|
|
|
0.00 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Non-GAAP net income |
$ |
46,797 |
|
|
$ |
(6,015 |
) |
|
$ |
40,782 |
|
|
$ |
0.71 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Diluted shares |
|
|
|
|
|
|
|
|
|
|
57,624 |
|
|
Three Months Ended |
|
December 31, 2020 |
|
Pre-Tax |
|
Tax Impact |
|
After-Tax |
|
Per Share Impact |
GAAP net income |
$ |
13,245 |
|
|
$ |
2,133 |
|
|
$ |
15,378 |
|
|
$ |
0.27 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Non-GAAP adjustments: |
|
|
|
|
|
|
|
|
|
|
|
Cost of Sales |
|
|
|
|
|
|
|
|
|
|
|
Amortization of intangibles |
|
12,543 |
|
|
|
(3,233 |
) |
|
|
9,310 |
|
|
|
0.16 |
|
Inventory write-off (e) |
|
(24 |
) |
|
|
7 |
|
|
|
(17 |
) |
|
|
(0.00 |
) |
Inventory mark-up related to acquisitions |
|
4 |
|
|
|
(1 |
) |
|
|
3 |
|
|
|
0.00 |
|
Operating Expenses |
|
|
|
|
|
|
|
|
|
|
|
Contingent consideration benefit |
|
(8,844 |
) |
|
|
(93 |
) |
|
|
(8,937 |
) |
|
|
(0.16 |
) |
Impairment charges |
|
8,199 |
|
|
|
(2,751 |
) |
|
|
5,448 |
|
|
|
0.10 |
|
Amortization of intangibles |
|
1,893 |
|
|
|
(508 |
) |
|
|
1,385 |
|
|
|
0.02 |
|
Performance-based share-based compensation (a) |
|
1,112 |
|
|
|
(141 |
) |
|
|
971 |
|
|
|
0.02 |
|
Corporate transformation and restructuring (b) |
|
7,890 |
|
|
|
(1,985 |
) |
|
|
5,905 |
|
|
|
0.10 |
|
Acquisition-related |
|
393 |
|
|
|
(101 |
) |
|
|
292 |
|
|
|
0.01 |
|
Medical Device Regulation expenses (c) |
|
365 |
|
|
|
(98 |
) |
|
|
267 |
|
|
|
0.00 |
|
Other (d) |
|
962 |
|
|
|
(304 |
) |
|
|
658 |
|
|
|
0.01 |
|
Other (Income) Expense |
|
|
|
|
|
|
|
|
|
|
|
Amortization of long-term debt issuance costs |
|
151 |
|
|
|
(39 |
) |
|
|
112 |
|
|
|
0.00 |
|
Gain on disposal of business unit |
|
(10 |
) |
|
|
2 |
|
|
|
(8 |
) |
|
|
(0.00 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
Non-GAAP net income |
$ |
37,879 |
|
|
$ |
(7,112 |
) |
|
$ |
30,767 |
|
|
$ |
0.54 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Diluted shares |
|
|
|
|
|
|
|
|
|
|
56,736 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
_______________Note: Certain per share impacts may not sum to
totals due to rounding.
Reconciliation of GAAP Net Income (Loss) to
Non-GAAP Net Income(Unaudited; in thousands except per
share amounts)
|
Year Ended |
|
December 31, 2021 |
|
Pre-Tax |
|
Tax Impact |
|
After-Tax |
|
Per Share Impact |
GAAP net income |
$ |
53,917 |
|
|
$ |
(5,463 |
) |
|
$ |
48,454 |
|
|
$ |
0.84 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Non-GAAP adjustments: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost of Sales |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Amortization of intangibles |
|
42,453 |
|
|
|
(10,543 |
) |
|
|
31,910 |
|
|
|
0.56 |
|
Inventory write-off (e) |
|
1,620 |
|
|
|
(202 |
) |
|
|
1,418 |
|
|
|
0.02 |
|
Operating Expenses |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Contingent consideration expense |
|
3,161 |
|
|
|
52 |
|
|
|
3,213 |
|
|
|
0.06 |
|
Impairment charges |
|
4,283 |
|
|
|
(481 |
) |
|
|
3,802 |
|
|
|
0.07 |
|
Amortization of intangibles |
|
7,183 |
|
|
|
(1,798 |
) |
|
|
5,385 |
|
|
|
0.09 |
|
Performance-based share-based compensation (a) |
|
5,035 |
|
|
|
(604 |
) |
|
|
4,431 |
|
|
|
0.08 |
|
Corporate transformation and restructuring (b) |
|
18,649 |
|
|
|
(4,620 |
) |
|
|
14,029 |
|
|
|
0.24 |
|
Acquisition-related |
|
8,473 |
|
|
|
(2,100 |
) |
|
|
6,373 |
|
|
|
0.11 |
|
Medical Device Regulation expenses (c) |
|
4,036 |
|
|
|
(1,001 |
) |
|
|
3,035 |
|
|
|
0.05 |
|
Other (d) |
|
16,652 |
|
|
|
(2,977 |
) |
|
|
13,675 |
|
|
|
0.24 |
|
Other (Income) Expense |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Amortization of long-term debt issuance costs |
|
604 |
|
|
|
(150 |
) |
|
|
454 |
|
|
|
0.01 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Non-GAAP net income |
$ |
166,066 |
|
|
$ |
(29,887 |
) |
|
$ |
136,179 |
|
|
$ |
2.37 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Diluted shares |
|
|
|
|
|
|
|
|
|
|
|
|
57,359 |
|
|
Year Ended |
|
December 31, 2020 |
|
Pre-Tax |
|
Tax Impact |
|
After-Tax |
|
Per Share Impact |
GAAP net loss |
$ |
(13,231 |
) |
|
$ |
3,388 |
|
|
$ |
(9,843 |
) |
|
$ |
(0.18 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
Non-GAAP adjustments: |
|
|
|
|
|
|
|
|
|
|
|
Cost of Sales |
|
|
|
|
|
|
|
|
|
|
|
Amortization of intangibles |
|
50,696 |
|
|
|
(13,065 |
) |
|
|
37,631 |
|
|
|
0.67 |
|
Inventory write-off (e) |
|
1,752 |
|
|
|
(465 |
) |
|
|
1,287 |
|
|
|
0.02 |
|
Inventory mark-up related to acquisitions |
|
191 |
|
|
|
(49 |
) |
|
|
142 |
|
|
|
0.00 |
|
Operating Expenses |
|
|
|
|
|
|
|
|
|
|
|
Contingent consideration benefit |
|
(7,960 |
) |
|
|
466 |
|
|
|
(7,494 |
) |
|
|
(0.13 |
) |
Impairment charges |
|
36,504 |
|
|
|
(7,115 |
) |
|
|
29,389 |
|
|
|
0.52 |
|
Amortization of intangibles |
|
7,943 |
|
|
|
(2,141 |
) |
|
|
5,802 |
|
|
|
0.10 |
|
Performance-based share-based compensation (a) |
|
3,735 |
|
|
|
(475 |
) |
|
|
3,260 |
|
|
|
0.06 |
|
Corporate transformation and restructuring (b) |
|
14,175 |
|
|
|
(3,700 |
) |
|
|
10,475 |
|
|
|
0.19 |
|
Acquisition-related |
|
1,229 |
|
|
|
(317 |
) |
|
|
912 |
|
|
|
0.02 |
|
Medical Device Regulation expenses (c) |
|
1,379 |
|
|
|
(359 |
) |
|
|
1,020 |
|
|
|
0.02 |
|
Other (d) |
|
24,438 |
|
|
|
(3,815 |
) |
|
|
20,623 |
|
|
|
0.37 |
|
Other (Income) Expense |
|
|
|
|
|
|
|
|
|
|
|
Amortization of long-term debt issuance costs |
|
604 |
|
|
|
(155 |
) |
|
|
449 |
|
|
|
0.01 |
|
Gain on disposal of business unit |
|
(517 |
) |
|
|
133 |
|
|
|
(384 |
) |
|
|
(0.01 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
Non-GAAP net income |
$ |
120,938 |
|
|
$ |
(27,669 |
) |
|
$ |
93,269 |
|
|
$ |
1.65 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Diluted shares (f) |
|
|
|
|
|
|
|
|
|
|
56,374 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
_______________Note: Certain per share impacts
may not sum to totals due to rounding.
Reconciliation of Reported Operating Income (Loss) to
Non-GAAP Operating Income
(Unaudited; in thousands except percentages)
|
Three Months Ended |
|
Three Months Ended |
|
Year Ended |
|
Year Ended |
|
December 31, 2021 |
|
December 31, 2020 |
|
December 31, 2021 |
|
December 31, 2020 |
|
Amounts |
|
% Sales |
|
Amounts |
|
% Sales |
|
Amounts |
|
% Sales |
|
Amounts |
|
% Sales |
Net Sales as Reported |
$ |
278,492 |
|
|
|
|
|
$ |
258,004 |
|
|
|
|
|
$ |
1,074,751 |
|
|
|
|
$ |
963,875 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
GAAP Operating Income
(Loss) |
|
21,896 |
|
|
7.9 |
% |
|
|
16,007 |
|
|
6.2 |
% |
|
|
60,916 |
|
5.7 |
% |
|
|
(1,562 |
) |
|
(0.2 |
)% |
Cost of Sales |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Amortization of intangibles |
|
10,570 |
|
|
3.8 |
% |
|
|
12,543 |
|
|
4.9 |
% |
|
|
42,453 |
|
4.0 |
% |
|
|
50,696 |
|
|
5.3 |
% |
Inventory write-off (e) |
|
— |
|
|
— |
|
|
|
(24 |
) |
|
(0.0 |
)% |
|
|
1,620 |
|
0.2 |
% |
|
|
1,752 |
|
|
0.2 |
% |
Inventory mark-up related to acquisitions |
|
— |
|
|
— |
|
|
|
4 |
|
|
0.0 |
% |
|
|
— |
|
— |
|
|
|
191 |
|
|
0.0 |
% |
Operating Expenses |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Contingent consideration expense (benefit) |
|
(161 |
) |
|
(0.1 |
)% |
|
|
(8,844 |
) |
|
(3.4 |
)% |
|
|
3,161 |
|
0.3 |
% |
|
|
(7,960 |
) |
|
(0.8 |
)% |
Impairment charges |
|
— |
|
|
— |
|
|
|
8,199 |
|
|
3.2 |
% |
|
|
4,283 |
|
0.4 |
% |
|
|
36,504 |
|
|
3.8 |
% |
Amortization of intangibles |
|
1,786 |
|
|
0.6 |
% |
|
|
1,893 |
|
|
0.7 |
% |
|
|
7,183 |
|
0.7 |
% |
|
|
7,943 |
|
|
0.8 |
% |
Performance-based share-based compensation (a) |
|
1,036 |
|
|
0.4 |
% |
|
|
1,112 |
|
|
0.4 |
% |
|
|
5,035 |
|
0.5 |
% |
|
|
3,735 |
|
|
0.4 |
% |
Corporate transformation and restructuring (b) |
|
1,605 |
|
|
0.6 |
% |
|
|
7,890 |
|
|
3.1 |
% |
|
|
18,649 |
|
1.7 |
% |
|
|
14,175 |
|
|
1.5 |
% |
Acquisition-related |
|
(2 |
) |
|
(0.0 |
)% |
|
|
393 |
|
|
0.2 |
% |
|
|
8,473 |
|
0.8 |
% |
|
|
1,229 |
|
|
0.1 |
% |
Medical Device Regulation expenses (c) |
|
1,513 |
|
|
0.5 |
% |
|
|
365 |
|
|
0.1 |
% |
|
|
4,036 |
|
0.4 |
% |
|
|
1,379 |
|
|
0.1 |
% |
Other (d) |
|
10,118 |
|
|
3.6 |
% |
|
|
962 |
|
|
0.4 |
% |
|
|
16,652 |
|
1.5 |
% |
|
|
24,438 |
|
|
2.5 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Non-GAAP Operating Income |
$ |
48,361 |
|
|
17.4 |
% |
|
$ |
40,500 |
|
|
15.7 |
% |
|
$ |
172,461 |
|
16.0 |
% |
|
$ |
132,520 |
|
|
13.7 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
_______________Note: Certain percentages may not sum to totals
due to rounding
a) Represents performance-based share-based
compensation expense, including stock-settled and cash-settled
awards. b) Includes severance related to corporate initiatives,
write-offs and valuation adjustments of other long-term assets
associated with restructuring activities, expenses related to the
Foundations for Growth Program, and other transformation costs.c)
Represents incremental expenses incurred to comply with the Medical
Device Regulation (“MDR”) in Europe.d) The 2021 periods include
accrued class action litigation settlement costs in the fourth
quarter of approximately $10 million, net of expected insurance
proceeds, accrued contract termination costs of approximately $6
million to renegotiate certain terms of an acquisition agreement,
and costs to comply with Merit’s settlement agreement with the U.S.
Department of Justice (the “DOJ”). The 2020 periods include $18.7
million of settlement costs to fully resolve an investigation
conducted by the DOJ, costs incurred in responding to the DOJ
inquiry, activist shareholder settlement fees, and expense from
abandoned patents. e) Represents the write-off of inventory related
to the divestiture or exit of certain businesses or product
lines.f) For the twelve-month period ended December 31, 2020, the
non-GAAP net income per diluted share calculation includes
approximately 940,000 shares that were excluded from the GAAP net
loss per diluted share calculation.Reconciliation of
Reported Revenue to Constant Currency Revenue (Non-GAAP), Constant
Currency Revenue, Organic (Non-GAAP), and Core Revenue
(Non-GAAP)(Unaudited; in thousands
except percentages)
|
|
|
|
Three Months Ended |
|
|
|
|
Year Ended |
|
|
|
|
December 31, |
|
|
|
|
December 31, |
|
% Change |
|
2021 |
|
2020 |
|
% Change |
|
2021 |
|
2020 |
Reported Revenue |
7.9 |
% |
|
$ |
278,492 |
|
|
$ |
258,004 |
|
|
11.5 |
% |
|
$ |
1,074,751 |
|
|
$ |
963,875 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Add:
Impact of foreign exchange |
|
|
|
|
1,135 |
|
|
|
— |
|
|
|
|
|
|
(10,307 |
) |
|
|
— |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Constant
Currency Revenue (a) |
8.4 |
% |
|
$ |
279,627 |
|
|
$ |
258,004 |
|
|
10.4 |
% |
|
$ |
1,064,444 |
|
|
$ |
963,875 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Less:
Revenue from certain acquisitions |
|
|
|
|
(18 |
) |
|
|
— |
|
|
|
|
|
|
(227 |
) |
|
|
— |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Constant
Currency Revenue, Organic (a) |
8.4 |
% |
|
$ |
279,609 |
|
|
$ |
258,004 |
|
|
10.4 |
% |
|
$ |
1,064,217 |
|
|
$ |
963,875 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Less:
Revenue from certain dispositions |
|
|
|
|
— |
|
|
|
(2,532 |
) |
|
|
|
|
|
(179 |
) |
|
|
(11,273 |
) |
Less:
Revenue from Cultura |
|
|
|
|
(951 |
) |
|
|
(4,946 |
) |
|
|
|
|
|
(3,257 |
) |
|
|
(19,115 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Core
Revenue (a) |
11.2 |
% |
|
$ |
278,658 |
|
|
$ |
250,526 |
|
|
13.6 |
% |
|
$ |
1,060,781 |
|
|
$ |
933,487 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
_______________(a) A non-GAAP financial measure. For a
definition of this and other non-GAAP financial measures, see the
Non-GAAP Financial Measures section above in this release.
Reconciliation of Reported Gross Margin to Non-GAAP
Gross Margin (Non-GAAP)(Unaudited; as
a percentage of reported revenue)
|
Three Months Ended |
|
Year Ended |
|
December 31, |
|
December 31, |
|
2021 |
|
2020 |
|
2021 |
|
2020 |
Reported Gross Margin |
46.3 |
% |
|
43.1 |
% |
|
45.2 |
% |
|
41.6 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
Add back impact of: |
|
|
|
|
|
|
|
|
|
|
|
Amortization of intangibles |
3.8 |
% |
|
4.9 |
% |
|
4.0 |
% |
|
5.3 |
% |
Inventory write-off (a) |
— |
|
|
(0.0 |
)% |
|
0.2 |
% |
|
0.2 |
% |
Inventory mark-up related to acquisitions |
— |
|
|
0.0 |
% |
|
— |
|
|
0.0 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
Non-GAAP Gross Margin |
50.0 |
% |
|
47.9 |
% |
|
49.3 |
% |
|
47.1 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
_______________Note: Certain percentages may not sum to totals
due to rounding
(a) Represents the write-off of inventory related to the
divestiture or exit of certain businesses or product lines.
ABOUT MERIT
Founded in 1987, Merit Medical
Systems, Inc. is a leading manufacturer and marketer of
proprietary 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 500
individuals. Merit employs approximately 6,700 people
worldwide with facilities in South Jordan, Utah; Pearland, Texas;
Richmond, Virginia; Aliso Viejo, California; Maastricht and Venlo,
The Netherlands; Paris, France; Galway, Ireland; Beijing, China;
Tijuana, Mexico; Joinville, Brazil; Ontario, Canada; Melbourne,
Australia; Tokyo, Japan; Reading, United Kingdom; Johannesburg,
South Africa; and Singapore.
CAUTIONARY STATEMENT REGARDING FORWARD-LOOKING STATEMENTS
Statements contained in this release which are
not purely historical, including, without limitation, statements
regarding Merit’s forecasted plans, net sales, net income or loss
(GAAP and non-GAAP), operating income and margin (GAAP and
non-GAAP), gross margin (GAAP and non-GAAP), earnings per share
(GAAP and non-GAAP), free cash flow, and other financial measures,
the potential impact, scope and duration of, and Merit’s response
to, the COVID-19 pandemic and the potential for recovery from that
pandemic, future growth and profit expectations or forecasted
economic conditions, or the implementation of, and results achieved
through, Merit’s Foundations for Growth Program or other expense
reduction initiatives, or the development and commercialization of
new products, are 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, as amended, 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,
2020 (the “2020 Annual Report”) and other filings with the SEC.
Such risks and uncertainties include inherent risks and
uncertainties relating to Merit’s internal models or the
projections in this release; risks and uncertainties associated
with the COVID-19 pandemic and Merit’s response thereto;
disruptions in Merit’s supply chain, manufacturing or sterilization
processes; reduced availability of, and price increases associated
with, commodity components; 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
developed internally or acquired through completed, proposed or
future transactions; negative changes in economic and industry
conditions in the United States or other countries; 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;
governmental scrutiny and regulation of the medical device
industry, including governmental inquiries, investigations and
proceedings involving Merit; litigation and other judicial
proceedings affecting 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; 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; 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; 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;
termination of relationships with Merit’s suppliers, or failure of
such suppliers to perform; fluctuations in exchange rates;
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 or future 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;
failure to introduce products in a timely fashion; price and
product competition; availability of labor and materials;
fluctuations in and obsolescence of inventory; and other factors
referenced in the 2020 Annual Report and other materials filed with
the SEC. 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. Those
estimates and all other forward-looking statements included in this
document are made only as of the date of this document, and except
as otherwise required by applicable law, Merit assumes no
obligation to update or disclose revisions to estimates and all
other forward-looking statements.
TRADEMARKS
Unless 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.
Contacts: |
|
|
|
|
|
PR/Media Inquiries:Teresa Johnson Merit
Medical+1-801-208-4295tjohnson@merit.com |
|
Investor Inquiries:Mike Piccinino, CFA, IRCWestwicke -
ICR+1-443-213-0509mike.piccinino@westwicke.com |
|
|
|
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