Merit Medical Systems, Inc. (NASDAQ: MMSI), a leading global
manufacturer and marketer of healthcare technology, today announced
revenue of $338.0 million for the quarter ended
June 30, 2024, an increase of 5.6% compared to the
quarter ended June 30, 2023. Constant currency revenue
for the second quarter of 2024 increased 6.6% compared to the prior
year period and increased 5.0% compared to the prior year period on
a constant currency revenue, organic, basis.
“We delivered better-than-expected revenue and
financial results in the second quarter, reflecting continued
strong momentum over the first half of fiscal year 2024,” said Fred
P. Lampropoulos, Merit’s Chairman and Chief Executive Officer. “Our
constant currency, organic, revenue and our constant currency total
revenue exceeded the high-end of our expectations in the second
quarter and we delivered year-over-year improvements in both our
non-GAAP gross and operating margins and our non-GAAP earnings per
share. Importantly, our strong growth and profitability performance
fueled free cash flow generation of more than $80 million over the
first half of fiscal year 2024. We are also pleased to announce
that our application for premarket approval (PMA) of our Wrapsody™
Cell-Impermeable Endoprosthesis device was submitted to the FDA in
the second quarter.”
Mr. Lampropoulos continued: “We are confident in
our team’s ability to deliver our financial guidance for fiscal
year 2024, which we have updated to reflect the
stronger-than-expected organic results to-date and the forecasted
impacts of the acquisition of EndoGastric Solutions announced on
July 1, 2024. We are focused on delivering continued strong
execution, stable constant currency growth, improving profitability
and solid free cash flow in 2024, as well as continued progress in
our Continued Growth Initiatives Program and related financial
targets for the three-year period ending December 31, 2026.”
Merit’s revenue by operating segment and product
category for the three and six-month periods ended June 30, 2024
and 2023 was as follows (unaudited; in thousands, except
for percentages):
|
Three Months Ended |
|
Reported |
|
|
|
|
|
Constant Currency * |
|
June 30, |
|
|
|
|
|
Impact of foreign |
|
June 30, |
|
|
|
|
|
2024 |
|
2023 |
|
% Change |
|
exchange |
|
2024 |
|
% Change |
Cardiovascular |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Peripheral Intervention |
$ |
139,247 |
|
|
$ |
125,909 |
|
|
|
10.6 |
% |
|
$ |
1,030 |
|
|
$ |
140,277 |
|
|
|
11.4 |
% |
Cardiac Intervention |
|
93,863 |
|
|
|
93,775 |
|
|
|
0.1 |
% |
|
|
1,273 |
|
|
|
95,136 |
|
|
|
1.5 |
% |
Custom Procedural Solutions |
|
50,416 |
|
|
|
49,384 |
|
|
|
2.1 |
% |
|
|
635 |
|
|
|
51,051 |
|
|
|
3.4 |
% |
OEM |
|
44,289 |
|
|
|
42,207 |
|
|
|
4.9 |
% |
|
|
60 |
|
|
|
44,349 |
|
|
|
5.1 |
% |
Total |
|
327,815 |
|
|
|
311,275 |
|
|
|
5.3 |
% |
|
|
2,998 |
|
|
|
330,813 |
|
|
|
6.3 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Endoscopy |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Endoscopy Devices |
|
10,188 |
|
|
|
8,781 |
|
|
|
16.0 |
% |
|
|
35 |
|
|
|
10,223 |
|
|
|
16.4 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total |
$ |
338,003 |
|
|
$ |
320,056 |
|
|
|
5.6 |
% |
|
$ |
3,033 |
|
|
$ |
341,036 |
|
|
|
6.6 |
% |
|
Six Months Ended |
|
Reported |
|
|
|
|
|
Constant Currency * |
|
June 30, |
|
|
|
|
|
Impact of foreign |
|
June 30, |
|
|
|
|
|
2024 |
|
2023 |
|
% Change |
|
exchange |
|
2024 |
|
% Change |
Cardiovascular |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Peripheral Intervention |
$ |
273,873 |
|
|
$ |
239,692 |
|
|
|
14.3 |
% |
|
$ |
1,397 |
|
|
$ |
275,270 |
|
|
|
14.8 |
% |
Cardiac Intervention |
|
184,551 |
|
|
|
179,103 |
|
|
|
3.0 |
% |
|
|
2,205 |
|
|
|
186,756 |
|
|
|
4.3 |
% |
Custom Procedural Solutions |
|
99,210 |
|
|
|
97,085 |
|
|
|
2.2 |
% |
|
|
1,038 |
|
|
|
100,248 |
|
|
|
3.3 |
% |
OEM |
|
83,555 |
|
|
|
83,371 |
|
|
|
0.2 |
% |
|
|
23 |
|
|
|
83,578 |
|
|
|
0.2 |
% |
Total |
|
641,189 |
|
|
|
599,251 |
|
|
|
7.0 |
% |
|
|
4,663 |
|
|
|
645,852 |
|
|
|
7.8 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Endoscopy |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Endoscopy Devices |
|
20,322 |
|
|
|
18,370 |
|
|
|
10.6 |
% |
|
|
62 |
|
|
|
20,384 |
|
|
|
11.0 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total |
$ |
661,511 |
|
|
$ |
617,621 |
|
|
|
7.1 |
% |
|
$ |
4,725 |
|
|
$ |
666,236 |
|
|
|
7.9 |
% |
Merit’s GAAP gross margin for the second quarter
of 2024 was 47.7%, compared to GAAP gross margin of 47.7% for the
second quarter of 2023. Merit’s non-GAAP gross margin* for the
second quarter of 2024 was 51.5%, compared to non-GAAP gross
margin* of 51.4% for the second quarter of 2023.
Merit’s GAAP net income for the second quarter
of 2024 was $35.7 million, or $0.61 per share, compared to GAAP net
income of $20.2 million, or $0.35 per share, for the second quarter
of 2023. Merit’s non-GAAP net income* for the second quarter of
2024 was $53.8 million, or $0.92 per share, compared to non-GAAP
net income* of $45.9 million, or $0.78 per share, for the second
quarter of 2023.
As of June 30, 2024, Merit had cash
and cash equivalents of $636.7 million, total debt obligations of
$822.5 million, and available borrowing capacity of approximately
$680 million, compared to cash and cash equivalents of $587
million, total debt obligations of $846.6 million, and available
borrowing capacity of approximately $626 million as of
December 31, 2023.
Updated Fiscal Year 2024 Financial Guidance
Based upon the information currently available
to Merit’s management, for the year ending December 31,
2024, absent material acquisitions, non-recurring transactions or
other factors beyond Merit’s current expectations, Merit now
expects the following:
Revenue and Earnings Guidance*
|
|
|
|
|
|
Updated
Guidance(1) |
Prior
Guidance(2) |
Financial Measure |
Year Ending |
% Change |
Year Ending |
% Change |
($, millions, except per share figures) |
December 31, 2024 |
Y/Y |
December 31, 2024 |
Y/Y |
|
|
|
|
|
Net
Sales |
$1,335 - $1,345 |
6% - 7% |
$1,324 - $1,340 |
5% - 7% |
Cardiovascular Segment |
$1,281 - $1,289 |
5% - 6% |
$1,272 - $1,285 |
4% - 5% |
Endoscopy Segment |
$54 - $56 |
45% - 52% |
$53 - $56 |
45% - 51% |
|
|
|
|
|
Non-GAAP |
|
|
|
|
Earnings Per Share(3) |
$3.27 - $3.35 |
15% - 17% |
$3.22 - $3.31 |
13% - 16% |
*Percentage figures approximated; dollar figures
may not foot due to rounding
2024 Net Sales Guidance - % Change from Prior
Year (Constant Currency) Reconciliation*
|
|
|
|
|
|
|
|
|
Updated
Guidance(1) |
|
Prior
Guidance(2) |
|
Low |
|
High |
|
Low |
|
High |
2024 Net Sales Guidance - %
Change from Prior Year (GAAP) |
6.2% |
|
7.0% |
|
5.3% |
|
6.6% |
Estimated impact of foreign
currency exchange rate fluctuations |
0.7% |
|
0.7% |
|
0.5% |
|
0.5% |
2024 Net Sales Guidance - %
Change from Prior Year (Constant Currency) |
6.9% |
|
7.7% |
|
5.8% |
|
7.1% |
*Percentage figures approximated and may not
foot due to rounding
(1) “Updated Guidance” reflects
Merit’s updated full-year 2024 financial guidance on a standalone
basis, plus the forecasted impacts of the acquisition of the assets
of EndoGastric Solutions, Inc. (“EGS”) from the closing date on
July 1, 2024 through December 31, 2024.
(2) “Prior Guidance” previously
introduced on April 30, 2024, and reflects Merit’s full-year 2024
financial guidance on a standalone basis, and updated on July 1,
2024 to include the forecasted impacts of the acquisition of the
assets of EGS from the closing date on July 1, 2024 through
December 31, 2024.
(3) Beginning in the second
quarter of 2024, consulting expenses associated with initiatives
conducted under our Foundations for Growth Program (“FFG Program”)
are no longer adjusted as part of our non-GAAP measures. As a
result, our non-GAAP measures for prior periods have been recast
and the associated change in comparison to prior year has been
calculated using the adjusted earnings per share. For the year
ended December 31, 2023, our non-GAAP financial measures have been
updated to no longer adjust $12.3 million for consulting fees under
our FFG Program and the related income tax effect.
Merit does not provide guidance for GAAP
reported financial measures (other than revenue) or a
reconciliation of forward-looking non-GAAP financial measures to
the most directly comparable GAAP reported financial measures
(other than revenue) because Merit is unable to predict with
reasonable certainty the financial impact of various items which
could impact Merit’s future financial results, 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,
expenses resulting from non-ordinary course litigation or
administrative proceedings and resulting settlements, governmental
proceedings, and changes in governmental or industry regulations.
These items are uncertain, depend on various factors, and could
have a material impact on GAAP reported results for the guidance
period. For the same reasons, Merit is unable to address the
significance of the unavailable information, which could be
material to future results. Specifically, Merit is not, without
unreasonable effort, able to reliably predict the impact of these
items and Merit believes inclusion of a reconciliation of these
forward-looking non-GAAP measures to their GAAP counterparts could
be confusing to investors or cause undue reliance.
Merit’s financial guidance for the year
ending December 31, 2024 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
today, Thursday, August 1, 2024, at 5:00 p.m. Eastern
(4:00 p.m. Central, 3:00 p.m. Mountain, and
2:00 p.m. Pacific). To access the conference call,
please pre-register using the following
link. Registrants will
receive confirmation with dial-in details. A live webcast
and slide deck will also be available at merit.com.
CONSOLIDATED BALANCE SHEETS(in thousands) |
|
|
|
|
|
|
|
June 30, |
|
|
|
|
|
2024 |
|
|
|
December 31, |
|
|
(Unaudited) |
|
|
2023 |
|
ASSETS |
|
|
|
|
|
Current Assets |
|
|
|
|
|
Cash and cash equivalents |
$ |
636,658 |
|
|
$ |
587,036 |
|
Trade receivables, net |
|
182,415 |
|
|
|
177,885 |
|
Other receivables |
|
10,612 |
|
|
|
10,517 |
|
Inventories |
|
298,224 |
|
|
|
303,871 |
|
Prepaid expenses and other assets |
|
26,179 |
|
|
|
24,286 |
|
Prepaid income taxes |
|
4,123 |
|
|
|
4,016 |
|
Income tax refund receivables |
|
4,335 |
|
|
|
859 |
|
Total current assets |
|
1,162,546 |
|
|
|
1,108,470 |
|
|
|
|
|
|
|
Property and equipment,
net |
|
385,939 |
|
|
|
383,523 |
|
Intangible assets, net |
|
303,422 |
|
|
|
325,883 |
|
Goodwill |
|
381,433 |
|
|
|
382,240 |
|
Deferred income tax
assets |
|
7,013 |
|
|
|
7,288 |
|
Operating lease right-of-use
assets |
|
69,903 |
|
|
|
63,047 |
|
Other assets |
|
61,583 |
|
|
|
54,793 |
|
Total Assets |
$ |
2,371,839 |
|
|
$ |
2,325,244 |
|
|
|
|
|
|
|
LIABILITIES AND
STOCKHOLDERS' EQUITY |
|
|
|
|
|
Current Liabilities |
|
|
|
|
|
Trade payables |
$ |
55,573 |
|
|
$ |
65,944 |
|
Accrued expenses |
|
117,574 |
|
|
|
120,447 |
|
Current operating lease liabilities |
|
11,743 |
|
|
|
12,087 |
|
Income taxes payable |
|
1,325 |
|
|
|
5,086 |
|
Total current liabilities |
|
186,215 |
|
|
|
203,564 |
|
|
|
|
|
|
|
Long-term debt |
|
801,321 |
|
|
|
823,013 |
|
Deferred income tax
liabilities |
|
5,510 |
|
|
|
5,547 |
|
Long-term income taxes
payable |
|
347 |
|
|
|
347 |
|
Liabilities related to
unrecognized tax benefits |
|
1,912 |
|
|
|
1,912 |
|
Deferred compensation
payable |
|
18,588 |
|
|
|
17,167 |
|
Deferred credits |
|
1,553 |
|
|
|
1,605 |
|
Long-term operating lease
liabilities |
|
58,036 |
|
|
|
56,259 |
|
Other long-term
obligations |
|
15,912 |
|
|
|
13,830 |
|
Total liabilities |
|
1,089,394 |
|
|
|
1,123,244 |
|
|
|
|
|
|
|
Stockholders' Equity |
|
|
|
|
|
Common stock |
|
658,724 |
|
|
|
638,150 |
|
Retained earnings |
|
639,150 |
|
|
|
575,184 |
|
Accumulated other comprehensive loss |
|
(15,429 |
) |
|
|
(11,334 |
) |
Total stockholders' equity |
|
1,282,445 |
|
|
|
1,202,000 |
|
Total Liabilities and
Stockholders' Equity |
$ |
2,371,839 |
|
|
$ |
2,325,244 |
|
CONSOLIDATED STATEMENTS OF INCOME(Unaudited, in
thousands except per share amounts) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
Six Months Ended |
|
June 30, |
|
June 30, |
|
|
2024 |
|
|
|
2023 |
|
|
|
2024 |
|
|
|
2023 |
|
Net sales |
$ |
338,003 |
|
|
$ |
320,056 |
|
|
$ |
661,511 |
|
|
$ |
617,621 |
|
Cost of sales |
|
176,903 |
|
|
|
167,274 |
|
|
|
348,696 |
|
|
|
326,477 |
|
Gross profit |
|
161,100 |
|
|
|
152,782 |
|
|
|
312,815 |
|
|
|
291,144 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
Selling, general and administrative |
|
94,585 |
|
|
|
100,927 |
|
|
|
189,013 |
|
|
|
191,071 |
|
Research and development |
|
20,263 |
|
|
|
20,129 |
|
|
|
41,745 |
|
|
|
41,443 |
|
Impairment charges |
|
— |
|
|
|
270 |
|
|
|
— |
|
|
|
270 |
|
Contingent consideration expense |
|
306 |
|
|
|
1,094 |
|
|
|
189 |
|
|
|
1,615 |
|
Acquired in-process research and development |
|
— |
|
|
|
1,550 |
|
|
|
— |
|
|
|
1,550 |
|
Total operating expenses |
|
115,154 |
|
|
|
123,970 |
|
|
|
230,947 |
|
|
|
235,949 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Income from operations |
|
45,946 |
|
|
|
28,812 |
|
|
|
81,868 |
|
|
|
55,195 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Other income (expense): |
|
|
|
|
|
|
|
|
|
|
|
Interest income |
|
7,561 |
|
|
|
221 |
|
|
|
14,837 |
|
|
|
352 |
|
Interest expense |
|
(7,679 |
) |
|
|
(3,682 |
) |
|
|
(15,725 |
) |
|
|
(5,693 |
) |
Other income (expense) — net |
|
15 |
|
|
|
(451 |
) |
|
|
(789 |
) |
|
|
546 |
|
Total other expense — net |
|
(103 |
) |
|
|
(3,912 |
) |
|
|
(1,677 |
) |
|
|
(4,795 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
Income before income
taxes |
|
45,843 |
|
|
|
24,900 |
|
|
|
80,191 |
|
|
|
50,400 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Income tax expense |
|
10,117 |
|
|
|
4,655 |
|
|
|
16,225 |
|
|
|
9,452 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income |
$ |
35,726 |
|
|
$ |
20,245 |
|
|
$ |
63,966 |
|
|
$ |
40,948 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Earnings per common share |
|
|
|
|
|
|
|
|
|
|
|
Basic |
$ |
0.61 |
|
|
$ |
0.35 |
|
|
$ |
1.10 |
|
|
$ |
0.71 |
|
Diluted |
$ |
0.61 |
|
|
$ |
0.35 |
|
|
$ |
1.09 |
|
|
$ |
0.70 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average shares
outstanding |
|
|
|
|
|
|
|
|
|
|
|
Basic |
|
58,139 |
|
|
|
57,537 |
|
|
|
58,049 |
|
|
|
57,445 |
|
Diluted |
|
58,740 |
|
|
|
58,473 |
|
|
|
58,653 |
|
|
|
58,329 |
|
CONSOLIDATED STATEMENTS OF CASH FLOWS(Unaudited,
in thousands) |
|
|
|
|
|
|
|
Six Months Ended |
|
June 30, |
|
|
2024 |
|
|
|
2023 |
|
CASH FLOWS FROM OPERATING
ACTIVITIES: |
|
|
|
Net income |
$ |
63,966 |
|
|
$ |
40,948 |
|
Adjustments to reconcile net income to net cash provided by
operating activities: |
|
|
|
|
|
Depreciation and amortization |
|
47,690 |
|
|
|
42,316 |
|
Write-off of certain intangible assets and other long-term
assets |
|
280 |
|
|
|
328 |
|
Amortization of right-of-use operating lease assets |
|
6,063 |
|
|
|
5,935 |
|
Fair value adjustments related to contingent consideration
liabilities |
|
189 |
|
|
|
1,615 |
|
Acquired in-process research and development |
|
— |
|
|
|
1,550 |
|
Stock-based compensation expense |
|
12,245 |
|
|
|
9,549 |
|
Other adjustments |
|
2,981 |
|
|
|
5,087 |
|
Changes in operating assets and liabilities, net of acquisitions
and divestitures |
|
(28,692 |
) |
|
|
(75,497 |
) |
Total adjustments |
|
40,756 |
|
|
|
(9,117 |
) |
Net cash, cash equivalents,
and restricted cash provided by operating activities |
|
104,722 |
|
|
|
31,831 |
|
|
|
|
|
|
|
CASH FLOWS FROM INVESTING
ACTIVITIES: |
|
|
|
|
|
Capital expenditures for property and equipment |
|
(22,309 |
) |
|
|
(18,556 |
) |
Issuance of note receivables |
|
(6,162 |
) |
|
|
— |
|
Cash paid in acquisitions and investments, net of cash
acquired |
|
(8,493 |
) |
|
|
(138,349 |
) |
Other investing, net |
|
(1,574 |
) |
|
|
(846 |
) |
Net cash, cash equivalents,
and restricted cash used in investing activities |
|
(38,538 |
) |
|
|
(157,751 |
) |
|
|
|
|
|
|
CASH FLOWS FROM FINANCING
ACTIVITIES: |
|
|
|
Proceeds from issuance of common stock |
|
10,931 |
|
|
|
9,463 |
|
Proceeds from (payments on) long-term debt |
|
(24,063 |
) |
|
|
141,812 |
|
Long-term debt issuance costs |
|
— |
|
|
|
(5,240 |
) |
Contingent payments related to acquisitions |
|
(142 |
) |
|
|
(3,434 |
) |
Payment of taxes related to an exchange of common stock |
|
(1,592 |
) |
|
|
(1,592 |
) |
Net cash, cash equivalents,
and restricted cash provided by (used in) financing activities |
|
(14,866 |
) |
|
|
141,009 |
|
Effect of exchange rates on
cash |
|
(1,750 |
) |
|
|
(1,497 |
) |
Net increase in cash, cash
equivalents and restricted cash |
|
49,568 |
|
|
|
13,592 |
|
|
|
|
|
|
|
CASH, CASH EQUIVALENTS AND
RESTRICTED CASH: |
|
|
|
|
|
Beginning of period |
|
589,144 |
|
|
|
60,558 |
|
End of period |
$ |
638,712 |
|
|
$ |
74,150 |
|
|
|
|
|
|
|
RECONCILIATION OF CASH, CASH
EQUIVALENTS AND RESTRICTED CASH TO THE CONSOLIDATED BALANCE
SHEETS: |
|
|
|
|
|
Cash and cash equivalents |
|
636,658 |
|
|
|
72,084 |
|
Restricted cash reported in prepaid expenses and other current
assets |
|
2,054 |
|
|
|
2,066 |
|
Total cash, cash equivalents
and restricted cash |
$ |
638,712 |
|
|
$ |
74,150 |
|
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 the non-GAAP financial measures referenced
in this release may 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;
- non-GAAP gross
profit and 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 gross
profit and margin, non-GAAP operating income and margin, non-GAAP
net income, and non-GAAP earnings per share (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, 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 their most
directly comparable GAAP financial measures included herein, 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. dollar. The constant currency revenue adjustments of $3.0
million and $4.7 million to reported revenue for the three and
six-month periods ended June 30, 2024, respectively, were
calculated using the applicable average foreign exchange rates for
the three and six-month periods ended June 30, 2023.
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 six-month periods ended June 30, 2024, Merit’s
constant currency revenue, organic, excludes revenues attributable
to certain assets acquired from AngioDynamics, Inc.
(“AngioDynamics”) in June 2023.
Non-GAAP Gross Profit and Margin
Non-GAAP gross profit 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 gross margin is calculated by dividing non-GAAP gross
profit by reported net sales.
Non-GAAP Operating Income and Margin
Non-GAAP operating income is calculated by
adjusting GAAP operating 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
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, expenses resulting
from non-ordinary course litigation or administrative proceedings
and resulting settlements, governmental proceedings, and changes in
governmental or 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 for the items set forth in the definition of
non-GAAP operating income above, as well as for expenses related to
debt issuance costs 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
six-month periods ended June 30, 2024 and 2023. The
non-GAAP income adjustments referenced in the following tables do
not reflect non-performance-based stock compensation expense of
approximately $3.4 million and $3.2 million for the three-month
periods ended June 30, 2024 and 2023, respectively and
$6.5 million and $5.8 million for the six-month periods ended
June 30, 2024 and 2023, respectively.
Reconciliation of GAAP Net Income to
Non-GAAP Net Income(Unaudited, in thousands except per
share amounts)
|
Three Months Ended |
|
June 30, 2024 |
|
Pre-Tax |
|
Tax Impact |
|
After-Tax |
|
Per Share Impact |
GAAP net income |
$ |
45,843 |
|
|
$ |
(10,117 |
) |
|
$ |
35,726 |
|
|
$ |
0.61 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Non-GAAP adjustments: |
|
|
|
|
|
|
|
|
|
|
|
Cost of Sales |
|
|
|
|
|
|
|
|
|
|
|
Amortization of intangibles |
|
13,126 |
|
|
|
(3,104 |
) |
|
|
10,022 |
|
|
|
0.17 |
|
Operating Expenses |
|
|
|
|
|
|
|
|
|
|
|
Contingent consideration expense |
|
306 |
|
|
|
(72 |
) |
|
|
234 |
|
|
|
0.00 |
|
Amortization of intangibles |
|
1,744 |
|
|
|
(413 |
) |
|
|
1,331 |
|
|
|
0.02 |
|
Performance-based share-based compensation (b) |
|
3,532 |
|
|
|
(563 |
) |
|
|
2,969 |
|
|
|
0.05 |
|
Corporate restructuring (c) |
|
(54 |
) |
|
|
13 |
|
|
|
(41 |
) |
|
|
(0.00 |
) |
Acquisition-related |
|
1,221 |
|
|
|
(288 |
) |
|
|
933 |
|
|
|
0.02 |
|
Medical Device Regulation expenses (d) |
|
1,930 |
|
|
|
(456 |
) |
|
|
1,474 |
|
|
|
0.03 |
|
Other (e) |
|
55 |
|
|
|
(12 |
) |
|
|
43 |
|
|
|
0.00 |
|
Other (Income) Expense |
|
|
|
|
|
|
|
|
|
|
|
Amortization of long-term debt issuance costs |
|
1,477 |
|
|
|
(349 |
) |
|
|
1,128 |
|
|
|
0.02 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Non-GAAP net income |
$ |
69,180 |
|
|
$ |
(15,361 |
) |
|
$ |
53,819 |
|
|
$ |
0.92 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Diluted shares |
|
|
|
|
|
|
|
|
|
|
58,740 |
|
|
Three Months Ended |
|
June 30, 2023 (a) |
|
Pre-Tax |
|
Tax Impact |
|
After-Tax |
|
Per Share Impact |
GAAP net income |
$ |
24,900 |
|
|
$ |
(4,655 |
) |
|
$ |
20,245 |
|
|
$ |
0.35 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Non-GAAP adjustments: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost of Sales |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Amortization of intangibles |
|
11,448 |
|
|
|
(2,753 |
) |
|
|
8,695 |
|
|
|
0.15 |
|
Inventory mark-up related to acquisitions |
|
260 |
|
|
|
(62 |
) |
|
|
198 |
|
|
|
0.00 |
|
Operating Expenses |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Contingent consideration expense |
|
1,094 |
|
|
|
47 |
|
|
|
1,141 |
|
|
|
0.02 |
|
Impairment charges |
|
270 |
|
|
|
— |
|
|
|
270 |
|
|
|
0.00 |
|
Amortization of intangibles |
|
1,965 |
|
|
|
(474 |
) |
|
|
1,491 |
|
|
|
0.03 |
|
Performance-based share-based compensation (b) |
|
2,377 |
|
|
|
(340 |
) |
|
|
2,037 |
|
|
|
0.03 |
|
Corporate restructuring (c) |
|
5,577 |
|
|
|
(1,338 |
) |
|
|
4,239 |
|
|
|
0.07 |
|
Acquisition-related |
|
4,856 |
|
|
|
(1,166 |
) |
|
|
3,690 |
|
|
|
0.06 |
|
Medical Device Regulation expenses (d) |
|
3,010 |
|
|
|
(722 |
) |
|
|
2,288 |
|
|
|
0.04 |
|
Other (e) |
|
1,603 |
|
|
|
(385 |
) |
|
|
1,218 |
|
|
|
0.02 |
|
Other (Income) Expense |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Amortization of long-term debt issuance costs |
|
478 |
|
|
|
(115 |
) |
|
|
363 |
|
|
|
0.01 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Non-GAAP net income |
$ |
57,838 |
|
|
$ |
(11,963 |
) |
|
$ |
45,875 |
|
|
$ |
0.78 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Diluted shares |
|
|
|
|
|
|
|
|
|
|
|
|
58,473 |
|
____________________________
Note: Certain per-share impacts may not sum to totals due to
rounding.
Reconciliation of GAAP Net Income to
Non-GAAP Net Income(Unaudited; in thousands except per
share amounts)
|
Six Months Ended |
|
June 30, 2024 (a) |
|
Pre-Tax |
|
Tax Impact |
|
After-Tax |
|
Per Share Impact |
GAAP net income |
$ |
80,191 |
|
|
$ |
(16,225 |
) |
|
$ |
63,966 |
|
|
$ |
1.09 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Non-GAAP adjustments: |
|
|
|
|
|
|
|
|
|
|
|
Cost of Sales |
|
|
|
|
|
|
|
|
|
|
|
Amortization of intangibles |
|
25,931 |
|
|
|
(6,132 |
) |
|
|
19,799 |
|
|
|
0.34 |
|
Operating Expenses |
|
|
|
|
|
|
|
|
|
|
|
Contingent consideration expense |
|
189 |
|
|
|
(25 |
) |
|
|
164 |
|
|
|
0.00 |
|
Amortization of intangibles |
|
3,508 |
|
|
|
(830 |
) |
|
|
2,678 |
|
|
|
0.05 |
|
Performance-based share-based compensation (b) |
|
5,660 |
|
|
|
(857 |
) |
|
|
4,803 |
|
|
|
0.08 |
|
Corporate restructuring (c) |
|
(54 |
) |
|
|
13 |
|
|
|
(41 |
) |
|
|
(0.00 |
) |
Acquisition-related |
|
1,259 |
|
|
|
(297 |
) |
|
|
962 |
|
|
|
0.02 |
|
Medical Device Regulation expenses (d) |
|
4,137 |
|
|
|
(977 |
) |
|
|
3,160 |
|
|
|
0.05 |
|
Other (e) |
|
177 |
|
|
|
(42 |
) |
|
|
135 |
|
|
|
0.00 |
|
Other (Income) Expense |
|
|
|
|
|
|
|
|
|
|
|
Amortization of long-term debt issuance costs |
|
2,954 |
|
|
|
(697 |
) |
|
|
2,257 |
|
|
|
0.04 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Non-GAAP net income |
$ |
123,952 |
|
|
$ |
(26,069 |
) |
|
$ |
97,883 |
|
|
$ |
1.67 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Diluted shares |
|
|
|
|
|
|
|
|
|
|
58,653 |
|
|
Six Months Ended |
|
June 30, 2023 (a) |
|
Pre-Tax |
|
Tax Impact |
|
After-Tax |
|
Per Share Impact |
GAAP net income |
$ |
50,400 |
|
|
$ |
(9,452 |
) |
|
$ |
40,948 |
|
|
$ |
0.70 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Non-GAAP adjustments: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost of Sales |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Amortization of intangibles |
|
22,064 |
|
|
|
(5,306 |
) |
|
|
16,758 |
|
|
|
0.29 |
|
Inventory mark-up related to acquisitions |
|
260 |
|
|
|
(62 |
) |
|
|
198 |
|
|
|
0.00 |
|
Operating Expenses |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Contingent consideration expense |
|
1,615 |
|
|
|
2 |
|
|
|
1,617 |
|
|
|
0.03 |
|
Impairment charges |
|
270 |
|
|
|
— |
|
|
|
270 |
|
|
|
0.00 |
|
Amortization of intangibles |
|
3,630 |
|
|
|
(876 |
) |
|
|
2,754 |
|
|
|
0.05 |
|
Performance-based share-based compensation (b) |
|
3,664 |
|
|
|
(427 |
) |
|
|
3,237 |
|
|
|
0.06 |
|
Corporate restructuring (c) |
|
7,203 |
|
|
|
(1,728 |
) |
|
|
5,475 |
|
|
|
0.09 |
|
Acquisition-related |
|
5,111 |
|
|
|
(1,227 |
) |
|
|
3,884 |
|
|
|
0.07 |
|
Medical Device Regulation expenses (d) |
|
6,668 |
|
|
|
(1,600 |
) |
|
|
5,068 |
|
|
|
0.09 |
|
Other (e) |
|
1,637 |
|
|
|
(393 |
) |
|
|
1,244 |
|
|
|
0.02 |
|
Other (Income) Expense |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Amortization of long-term debt issuance costs |
|
629 |
|
|
|
(151 |
) |
|
|
478 |
|
|
|
0.01 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Non-GAAP net income |
$ |
103,151 |
|
|
$ |
(21,220 |
) |
|
$ |
81,931 |
|
|
$ |
1.40 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Diluted shares |
|
|
|
|
|
|
|
|
|
|
|
|
58,329 |
|
____________________________
Note: Certain per-share impacts may not sum to totals due to
rounding.
Reconciliation of Reported Operating Income to Non-GAAP
Operating Income
(Unaudited, in thousands except percentages)
|
Three Months Ended |
|
Three Months Ended |
|
Six Months Ended |
|
Six Months Ended |
|
June 30, 2024 |
|
June 30, 2023 (a) |
|
June 30, 2024 (a) |
|
June 30, 2023 (a) |
|
Amounts |
|
% Sales |
|
Amounts |
|
% Sales |
|
Amounts |
|
% Sales |
|
Amounts |
|
% Sales |
Net Sales as Reported |
$ |
338,003 |
|
|
|
|
|
$ |
320,056 |
|
|
|
|
|
|
$ |
661,511 |
|
|
|
|
|
$ |
617,621 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
GAAP Operating Income |
|
45,946 |
|
|
|
13.6 |
% |
|
|
28,812 |
|
|
|
9.0 |
% |
|
|
81,868 |
|
|
|
12.4 |
% |
|
|
55,195 |
|
|
|
8.9 |
% |
Cost of Sales |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Amortization of intangibles |
|
13,126 |
|
|
|
3.9 |
% |
|
|
11,448 |
|
|
|
3.6 |
% |
|
|
25,931 |
|
|
|
3.9 |
% |
|
|
22,064 |
|
|
|
3.6 |
% |
Inventory mark-up related to acquisitions |
|
— |
|
|
|
— |
|
|
|
260 |
|
|
|
0.1 |
% |
|
|
— |
|
|
|
— |
|
|
|
260 |
|
|
|
0.0 |
% |
Operating Expenses |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Contingent consideration expense |
|
306 |
|
|
|
0.1 |
% |
|
|
1,094 |
|
|
|
0.3 |
% |
|
|
189 |
|
|
|
0.0 |
% |
|
|
1,615 |
|
|
|
0.3 |
% |
Impairment charges |
|
— |
|
|
|
— |
|
|
|
270 |
|
|
|
0.1 |
% |
|
|
— |
|
|
|
— |
|
|
|
270 |
|
|
|
0.0 |
% |
Amortization of intangibles |
|
1,744 |
|
|
|
0.5 |
% |
|
|
1,965 |
|
|
|
0.6 |
% |
|
|
3,508 |
|
|
|
0.5 |
% |
|
|
3,630 |
|
|
|
0.6 |
% |
Performance-based share-based compensation (b) |
|
3,532 |
|
|
|
1.0 |
% |
|
|
2,377 |
|
|
|
0.7 |
% |
|
|
5,660 |
|
|
|
0.9 |
% |
|
|
3,664 |
|
|
|
0.6 |
% |
Corporate restructuring (c) |
|
(54 |
) |
|
|
(0.0 |
)% |
|
|
5,577 |
|
|
|
1.7 |
% |
|
|
(54 |
) |
|
|
(0.0 |
)% |
|
|
7,203 |
|
|
|
1.2 |
% |
Acquisition-related |
|
1,221 |
|
|
|
0.4 |
% |
|
|
4,856 |
|
|
|
1.5 |
% |
|
|
1,259 |
|
|
|
0.2 |
% |
|
|
5,111 |
|
|
|
0.8 |
% |
Medical Device Regulation expenses (d) |
|
1,930 |
|
|
|
0.6 |
% |
|
|
3,010 |
|
|
|
0.9 |
% |
|
|
4,137 |
|
|
|
0.6 |
% |
|
|
6,668 |
|
|
|
1.1 |
% |
Other (e) |
|
55 |
|
|
|
0.0 |
% |
|
|
1,603 |
|
|
|
0.5 |
% |
|
|
177 |
|
|
|
0.0 |
% |
|
|
1,637 |
|
|
|
0.3 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Non-GAAP Operating Income |
$ |
67,806 |
|
|
|
20.1 |
% |
|
$ |
61,272 |
|
|
|
19.1 |
% |
|
$ |
122,675 |
|
|
|
18.5 |
% |
|
$ |
107,317 |
|
|
|
17.4 |
% |
____________________________
Note: Certain percentages may not sum to totals due to
rounding.
(a) Beginning in the second quarter of 2024,
consulting expenses associated with initiatives conducted under our
FFG Program are no longer adjusted as part of our non-GAAP
measures. As a result, our non-GAAP measures for prior periods have
been recast for comparability. For the three-month period ended
June 30, 2023, our non-GAAP financial measures have been updated to
no longer adjust $2.3 million for consulting fees under our FFG
Program and the related income tax effect. For the six-month
periods ended June 30, 2024 and 2023, our non-GAAP financial
measures have been updated to no longer adjust $1.0 million and
$4.2 million, respectively, for consulting fees under our FFG
Program and the related income tax effects. As of December 31,
2023, we completed the final year of our FFG Program.
(b) Represents performance-based share-based
compensation expense, including stock-settled and cash-settled
awards.
(c) Includes $(0.1) million for both the three
and six-month periods ended June 30, 2024 for employee termination
benefits associated with activities related to corporate
restructuring initiatives. Includes employee termination benefits
associated with restructuring activities related to corporate
initiatives of $1.3 million and $2.9 million for the three and
six-month periods ended June 30, 2023, respectively; and includes
$4.3 million for the write-off of other long-term assets associated
with the divestiture or exit of certain businesses or product lines
for both the three and six-month periods ended June 30, 2023.
(d) Represents incremental expenses incurred to
comply with the E.U. Medical Device Regulation (“MDR”).
(e) Represents costs to comply with
Merit’s corporate integrity agreement with the U.S.
Department of Justice (the “DOJ”). The 2023 periods also include
acquired in-process research and development charges of $1.6
million.
Reconciliation of Reported Revenue to Constant Currency
Revenue (Non-GAAP), and Constant Currency Revenue, Organic
(Non-GAAP)(Unaudited, in thousands
except percentages)
|
|
|
|
|
Three Months Ended |
|
|
|
|
|
Six Months Ended |
|
|
|
|
|
June30, |
|
|
|
|
|
June30, |
|
|
% Change |
|
|
2024 |
|
|
2023 |
|
|
% Change |
|
|
2024 |
|
|
2023 |
Reported Revenue |
|
5.6 |
% |
|
$ |
338,003 |
|
|
$ |
320,056 |
|
|
|
7.1 |
% |
|
$ |
661,511 |
|
|
$ |
617,621 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Add: Impact of foreign
exchange |
|
|
|
|
|
3,033 |
|
|
|
— |
|
|
|
|
|
|
|
4,725 |
|
|
|
— |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Constant Currency Revenue
(a) |
|
6.6 |
% |
|
$ |
341,036 |
|
|
$ |
320,056 |
|
|
|
7.9 |
% |
|
$ |
666,236 |
|
|
$ |
617,621 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Less: Revenue from certain
acquisitions |
|
|
|
|
|
(4,835 |
) |
|
|
— |
|
|
|
|
|
|
|
(11,563 |
) |
|
|
— |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Constant Currency Revenue,
Organic (a) |
|
5.0 |
% |
|
$ |
336,201 |
|
|
$ |
320,056 |
|
|
|
6.0 |
% |
|
$ |
654,673 |
|
|
$ |
617,621 |
|
____________________________
(a) A non-GAAP financial measure. For a
definition of this and other non-GAAP financial measures, see the
section of this release entitled “Non-GAAP Financial Measures.”
Reconciliation of Reported Gross Margin to Non-GAAP
Gross Margin (Non-GAAP)(Unaudited, as
a percentage of reported revenue)
|
Three Months Ended |
|
Six Months Ended |
|
June30, |
|
June30, |
|
|
2024 |
|
|
|
2023 |
|
|
|
2024 |
|
|
|
2023 |
|
Reported Gross Margin |
|
47.7 |
% |
|
|
47.7 |
% |
|
|
47.3 |
% |
|
|
47.1 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Add back impact of: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Amortization of intangibles |
|
3.9 |
% |
|
|
3.6 |
% |
|
|
3.9 |
% |
|
|
3.6 |
% |
Inventory mark-up related to acquisitions |
|
— |
% |
|
|
0.1 |
% |
|
|
— |
% |
|
|
0.0 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Non-GAAP Gross Margin |
|
51.5 |
% |
|
|
51.4 |
% |
|
|
51.2 |
% |
|
|
50.8 |
% |
____________________________
Note: Certain percentages may not sum to totals due to
rounding.
ABOUT MERIT
Founded 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 more than 700 individuals.
Merit employs approximately 7,000 people worldwide.
CAUTIONARY STATEMENT REGARDING FORWARD-LOOKING STATEMENTS
This release contains forward-looking statements
within the meaning of the Section 27A of the Securities Act of
1933, as amended, and Section 21E of the Securities Act of 1934, as
amended. Forward-looking statements include, among others:
- statements that
are not purely historical, including, without limitation,
statements regarding Merit’s forecasted plans, revenues, net sales,
gross profit and margin (GAAP and non-GAAP), operating income and
margin (GAAP and non-GAAP), net income (GAAP and non-GAAP),
earnings per share (GAAP and non-GAAP), free cash flow and other
financial measures, future growth and profit expectations or
forecasted economic conditions, or the implementation of, and
results which may be achieved through, Merit’s Continued Growth
Initiatives Program or other expense reduction initiatives;
and
- statements
proceeded or followed by, or that include the words, “may,” “will,”
“expects,” “plans,” “anticipates,” “intends,” “seeks,” “believes,”
“estimates,” “potential,” “target,” “forecasts,” “continue,” or
other forms of these words or similar words or expressions, or the
negative thereof or other comparable terminology.
Forward-looking statements contained in this
release are based on management’s current expectations and
assumptions regarding future events or outcomes, all of which 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,
2023 (the “2023 Annual Report”) and other filings with the SEC.
While the following list not comprehensive, such risks and
uncertainties include inherent risks and uncertainties associated
with Merit’s integration of products acquired from EGS and its
ability to achieve anticipated financial results, product
development and other anticipated benefits of the EGS acquisition;
uncertainties as to whether Merit will achieve sales, gross and
operating margins, net income and earnings per share performance
consistent with its forecasts associated with that acquisition;
disruptions in Merit’s supply chain, manufacturing or sterilization
processes; reduced availability of, and price increases associated
with, commodity components and other raw materials; adverse changes
in freight, shipping and transportation expenses; negative changes
in economic and industry conditions in the United States or other
countries, including inflation; 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; risks associated with Merit’s ongoing or
prospective manufacturing transfers and facility consolidations;
fluctuations in interest or foreign currency exchange rates; 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; consequences associated with a
Corporate Integrity Agreement executed between Merit and the DOJ;
difficulties, delays and expenditures relating to development,
testing and regulatory approval or clearance of Merit’s products,
including the pursuit of approvals under the MDR, and risks that
such products may not be developed successfully or approved for
commercial use; outcomes of ongoing and future clinical trials and
market studies relating to Merit’s products; litigation and other
judicial proceedings affecting Merit; 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; 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; 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 jurisdictions;
termination of relationships with Merit’s suppliers, or failure of
such suppliers to perform; development of new products and
technology that could render Merit’s existing or future products
obsolete; market acceptance of new products; dependance on
distributors to commercialize Merit’s products in various
jurisdictions outside the United States; 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; fluctuations in and obsolescence of inventory;
extreme weather events; geopolitical events; and other factors
referenced in the 2023 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., its subsidiaries, or its
licensors.
Contacts: |
|
PR/Media Inquiries:Teresa Johnson
Merit Medical |
Investor Inquiries:Mike
Piccinino, CFA, IRCWestwicke – ICR |
+1-801-208-4295 |
+1-443-213-0509 |
tjohnson@merit.com |
mike.piccinino@westwicke.com |
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