Merit Medical Systems, Inc. (NASDAQ: MMSI), a leading global
manufacturer and marketer of healthcare technology, today announced
revenue of $339.8 million for the quarter ended
September 30, 2024, an increase of 7.8% compared to the
quarter ended September 30, 2023. Constant currency
revenue for the third quarter of 2024 increased 7.9% compared to
the prior year period and increased 5.7% compared to the prior year
period on a constant currency revenue, organic, basis.
“We delivered better-than-expected financial
results in the third quarter, reflecting continued strong
execution,” said Fred P. Lampropoulos, Merit’s Chairman and Chief
Executive Officer. “Our constant currency, organic, revenue and our
constant currency total revenue modestly exceeded the high-end of
our expectations in the third quarter. We delivered impressive
year-over-year improvements in our non-GAAP operating margin and
our non-GAAP earnings per share, which increased 180 basis points
and 21%, respectively, year-over-year. We also delivered strong
free cash flow generation in the third quarter and have generated
more than $120 million over the first nine months of 2024,
representing an increase of 116% year-over-year.”
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 growth and profitability results
to-date. Our updated guidance continues to assume the forecasted
impacts from the acquisition of EndoGastric Solutions on July 1,
2024 and the projected impacts from our acquisition of assets from
Cook Medical announced on September 17, 2024 following the expected
closing date of November 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 nine-month periods ended September 30,
2024 and 2023 was as follows (unaudited; in thousands, except
for percentages):
|
Three Months Ended |
|
Reported |
|
|
|
|
Constant Currency * |
|
September 30, |
|
|
|
|
Impact of foreign |
|
September 30, |
|
|
|
|
2024 |
|
2023 |
|
% Change |
|
exchange |
|
2024 |
|
% Change |
Cardiovascular |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Peripheral Intervention |
$ |
137,932 |
|
$ |
128,385 |
|
7.4 |
% |
|
$ |
303 |
|
|
$ |
138,235 |
|
7.7 |
% |
Cardiac Intervention |
|
90,769 |
|
|
89,106 |
|
1.9 |
% |
|
|
(19 |
) |
|
|
90,750 |
|
1.8 |
% |
Custom Procedural Solutions |
|
50,768 |
|
|
48,624 |
|
4.4 |
% |
|
|
4 |
|
|
|
50,772 |
|
4.4 |
% |
OEM |
|
43,386 |
|
|
39,969 |
|
8.5 |
% |
|
|
(21 |
) |
|
|
43,365 |
|
8.5 |
% |
Total |
|
322,855 |
|
|
306,084 |
|
5.5 |
% |
|
|
267 |
|
|
|
323,122 |
|
5.6 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Endoscopy |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Endoscopy Devices |
|
16,990 |
|
|
9,146 |
|
85.8 |
% |
|
|
14 |
|
|
|
17,004 |
|
85.9 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total |
$ |
339,845 |
|
$ |
315,230 |
|
7.8 |
% |
|
$ |
281 |
|
|
$ |
340,126 |
|
7.9 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Nine Months Ended |
|
Reported |
|
|
|
|
Constant Currency * |
|
September 30, |
|
|
|
|
Impact of foreign |
|
September 30, |
|
|
|
|
2024 |
|
2023 |
|
% Change |
|
exchange |
|
2024 |
|
% Change |
Cardiovascular |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Peripheral Intervention |
$ |
411,805 |
|
$ |
368,077 |
|
11.9 |
% |
|
$ |
1,700 |
|
$ |
413,505 |
|
12.3 |
% |
Cardiac Intervention |
|
275,320 |
|
|
268,209 |
|
2.7 |
% |
|
|
2,186 |
|
|
277,506 |
|
3.5 |
% |
Custom Procedural Solutions |
|
149,978 |
|
|
145,709 |
|
2.9 |
% |
|
|
1,042 |
|
|
151,020 |
|
3.6 |
% |
OEM |
|
126,941 |
|
|
123,340 |
|
2.9 |
% |
|
|
2 |
|
|
126,943 |
|
2.9 |
% |
Total |
|
964,044 |
|
|
905,335 |
|
6.5 |
% |
|
|
4,930 |
|
|
968,974 |
|
7.0 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Endoscopy |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Endoscopy Devices |
|
37,312 |
|
|
27,516 |
|
35.6 |
% |
|
|
76 |
|
|
37,388 |
|
35.9 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total |
$ |
1,001,356 |
|
$ |
932,851 |
|
7.3 |
% |
|
$ |
5,006 |
|
$ |
1,006,362 |
|
7.9 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Merit’s GAAP gross margin for the third quarter
of 2024 was 46.4%, compared to GAAP gross margin of 45.1% for the
third quarter of 2023. Merit’s non-GAAP gross margin* for the third
quarter of 2024 was 50.9%, compared to non-GAAP gross margin* of
49.8% for the third quarter of 2023.
Merit’s GAAP net income for the third quarter of
2024 was $28.4 million, or $0.48 per share, compared to GAAP net
income of $25.8 million, or $0.44 per share, for the third quarter
of 2023. Merit’s non-GAAP net income* for the third quarter of 2024
was $51.2 million, or $0.86 per share, compared to non-GAAP net
income* of $41.4 million, or $0.71 per share, for the third quarter
of 2023.
As of September 30, 2024, Merit had
cash and cash equivalents of $523.1 million, total debt obligations
of $770.5 million, and had issued letter of credit guarantees of
$2.4 million, with additional available borrowings of approximately
$697 million under the Amended Fourth A&R Credit Agreement,
compared to cash and cash equivalents of $587 million, total debt
obligations of $846.6 million, and had issued letter of credit
guarantees of $2.7 million under the Amended Fourth
A&R Credit Agreement, with additional available borrowings 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, after giving effect to the projected contribution of the
assets Merit proposes to acquire from Cook Medical Holdings LLC
(“Cook Medical”), assuming the proposed acquisition closes on or
about November 1, 2024, and absent material acquisitions,
non-recurring transactions or other factors beyond Merit’s current
expectations, Merit anticipates the following financial
results:
Revenue and Earnings Guidance*
|
|
Updated Guidance(1) |
Prior Guidance(2) |
Financial Measure |
|
Year Ending |
% Change |
Year Ending |
% Change |
|
|
December 31, 2024 |
Y/Y |
December 31, 2024 |
Y/Y |
|
|
|
|
|
|
Net
Sales |
|
$1.344 - $1.352 billion |
6.9% - 7.6% |
$1.339 - $1.351 billion |
6.5% - 7.5% |
Cardiovascular Segment |
|
$1.289 - $1.296 billion |
5.6% - 6.2% |
$1.285 - $1.295 billion |
5.3% - 6.1% |
Endoscopy Segment |
|
$55 - $56 million |
49% - 52% |
$54 - $56 million |
45% - 52% |
|
|
|
|
|
|
Non-GAAP |
|
|
|
|
|
Earnings Per Share |
|
$3.33 - $3.38 |
17% - 19% |
$3.25 - $3.34 |
14% - 17% |
|
|
|
|
|
|
*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) |
6.9% |
|
7.6% |
|
6.5% |
|
7.5% |
Estimated impact of foreign
currency exchange rate fluctuations |
0.6% |
|
0.6% |
|
0.7% |
|
0.7% |
2024 Net Sales Guidance - %
Change from Prior Year (Constant Currency) |
7.4% |
|
8.1% |
|
7.2% |
|
8.2% |
|
|
|
|
|
|
|
|
*Percentage figures approximated and may not
foot due to rounding
(1) |
“Updated
Guidance” reflects Merit’s updated full-year 2024 financial
guidance as of October 30, 2024, and continues to include the
projected impacts of the proposed acquisition of assets from Cook
Medical from a projected closing date of November 1, 2024 through
December 31, 2024, previously announced on September 17, 2024. |
|
|
(2) |
“Prior Guidance” reflects Merit’s full-year 2024 financial
guidance, previously introduced on August 1, 2024, plus the
projected impacts from a projected closing date of November 1, 2024
through December 31, 2024 of the proposed acquisition of assets
from Cook Medical announced on September 17, 2024. |
|
|
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
employee termination benefits, 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, Wednesday, October 30, 2024, at 5:00 p.m., Eastern
Time. 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.
WRAPSODY CELL-IMPERMEABLE ENDOPROSTHESIS
The Merit WRAPSODY Cell-Impermeable
Endoprosthesis is not approved or available for commercial
distribution in the United States and may not be approved or
available for sale or use in other countries. In the United States,
the device is being used under an Investigational Device Exemption
from the US Food and Drug Administration (FDA). Findings from the
WRAPSODY Arteriovenous Access Efficacy (WAVE) pivotal trial expand
on results from the first-in-human study (WRAPSODY FIRST) and
support the Premarket Approval application to the FDA for
commercial use in the United States. The device is available in
Brazil and in the European Union. For additional information on
Merit’s WAVE study, please visit:
https://clinicaltrials.gov/ct2/show/NCT04540302.
CONSOLIDATED BALANCE SHEETS |
(in thousands) |
|
|
|
|
|
|
|
September 30, |
|
|
|
|
2024 |
|
December 31, |
|
(Unaudited) |
|
2023 |
ASSETS |
|
|
|
|
|
Current Assets |
|
|
|
|
|
Cash and cash equivalents |
$ |
523,128 |
|
|
$ |
587,036 |
|
Trade receivables, net |
|
189,831 |
|
|
|
177,885 |
|
Other receivables |
|
15,325 |
|
|
|
10,517 |
|
Inventories |
|
310,527 |
|
|
|
303,871 |
|
Prepaid expenses and other assets |
|
27,105 |
|
|
|
24,286 |
|
Prepaid income taxes |
|
4,216 |
|
|
|
4,016 |
|
Income tax refund receivables |
|
8,185 |
|
|
|
859 |
|
Total current assets |
|
1,078,317 |
|
|
|
1,108,470 |
|
|
|
|
|
|
|
Property and equipment,
net |
|
389,653 |
|
|
|
383,523 |
|
Intangible assets, net |
|
372,164 |
|
|
|
325,883 |
|
Goodwill |
|
399,448 |
|
|
|
382,240 |
|
Deferred income tax
assets |
|
7,253 |
|
|
|
7,288 |
|
Operating lease right-of-use
assets |
|
68,867 |
|
|
|
63,047 |
|
Other assets |
|
62,382 |
|
|
|
54,793 |
|
Total Assets |
$ |
2,378,084 |
|
|
$ |
2,325,244 |
|
|
|
|
|
|
|
LIABILITIES AND
STOCKHOLDERS' EQUITY |
|
|
|
|
|
Current Liabilities |
|
|
|
|
|
Trade payables |
$ |
60,808 |
|
|
$ |
65,944 |
|
Accrued expenses |
|
127,255 |
|
|
|
120,447 |
|
Current operating lease liabilities |
|
11,469 |
|
|
|
12,087 |
|
Income taxes payable |
|
1,547 |
|
|
|
5,086 |
|
Total current liabilities |
|
201,079 |
|
|
|
203,564 |
|
|
|
|
|
|
|
Long-term debt |
|
750,505 |
|
|
|
823,013 |
|
Deferred income tax
liabilities |
|
5,571 |
|
|
|
5,547 |
|
Long-term income taxes
payable |
|
347 |
|
|
|
347 |
|
Liabilities related to
unrecognized tax benefits |
|
1,912 |
|
|
|
1,912 |
|
Deferred compensation
payable |
|
19,218 |
|
|
|
17,167 |
|
Deferred credits |
|
1,527 |
|
|
|
1,605 |
|
Long-term operating lease
liabilities |
|
57,178 |
|
|
|
56,259 |
|
Other long-term
obligations |
|
17,341 |
|
|
|
13,830 |
|
Total liabilities |
|
1,054,678 |
|
|
|
1,123,244 |
|
|
|
|
|
|
|
Stockholders' Equity |
|
|
|
|
|
Common stock |
|
669,207 |
|
|
|
638,150 |
|
Retained earnings |
|
667,594 |
|
|
|
575,184 |
|
Accumulated other comprehensive loss |
|
(13,395 |
) |
|
|
(11,334 |
) |
Total stockholders' equity |
|
1,323,406 |
|
|
|
1,202,000 |
|
Total Liabilities and
Stockholders' Equity |
$ |
2,378,084 |
|
|
$ |
2,325,244 |
|
|
|
|
|
|
|
|
|
CONSOLIDATED STATEMENTS OF INCOME |
(Unaudited, in thousands except per share amounts) |
|
|
Three Months Ended |
|
Nine Months Ended |
|
September 30, |
|
September 30, |
|
2024 |
|
2023 |
|
2024 |
|
2023 |
Net sales |
$ |
339,845 |
|
|
$ |
315,230 |
|
|
$ |
1,001,356 |
|
|
$ |
932,851 |
|
Cost of sales |
|
182,310 |
|
|
|
173,031 |
|
|
|
531,006 |
|
|
|
499,508 |
|
Gross profit |
|
157,535 |
|
|
|
142,199 |
|
|
|
470,350 |
|
|
|
433,343 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
Selling, general and administrative |
|
99,644 |
|
|
|
86,854 |
|
|
|
288,657 |
|
|
|
277,925 |
|
Research and development |
|
20,527 |
|
|
|
19,646 |
|
|
|
62,272 |
|
|
|
61,089 |
|
Impairment charges |
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
270 |
|
Contingent consideration expense |
|
103 |
|
|
|
562 |
|
|
|
292 |
|
|
|
2,177 |
|
Acquired in-process research and development |
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
1,550 |
|
Total operating expenses |
|
120,274 |
|
|
|
107,062 |
|
|
|
351,221 |
|
|
|
343,011 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Income from operations |
|
37,261 |
|
|
|
35,137 |
|
|
|
119,129 |
|
|
|
90,332 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Other income (expense): |
|
|
|
|
|
|
|
|
|
|
|
Interest income |
|
6,652 |
|
|
|
181 |
|
|
|
21,489 |
|
|
|
533 |
|
Interest expense |
|
(7,501 |
) |
|
|
(4,841 |
) |
|
|
(23,226 |
) |
|
|
(10,534 |
) |
Other income (expense) — net |
|
245 |
|
|
|
(255 |
) |
|
|
(544 |
) |
|
|
291 |
|
Total other expense — net |
|
(604 |
) |
|
|
(4,915 |
) |
|
|
(2,281 |
) |
|
|
(9,710 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
Income before income
taxes |
|
36,657 |
|
|
|
30,222 |
|
|
|
116,848 |
|
|
|
80,622 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Income tax expense |
|
8,213 |
|
|
|
4,388 |
|
|
|
24,438 |
|
|
|
13,840 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income |
$ |
28,444 |
|
|
$ |
25,834 |
|
|
$ |
92,410 |
|
|
$ |
66,782 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Earnings per common share |
|
|
|
|
|
|
|
|
|
|
|
Basic |
$ |
0.49 |
|
|
$ |
0.45 |
|
|
$ |
1.59 |
|
|
$ |
1.16 |
|
Diluted |
$ |
0.48 |
|
|
$ |
0.44 |
|
|
$ |
1.57 |
|
|
$ |
1.14 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average shares
outstanding |
|
|
|
|
|
|
|
|
|
|
|
Basic |
|
58,231 |
|
|
|
57,682 |
|
|
|
58,110 |
|
|
|
57,525 |
|
Diluted |
|
59,537 |
|
|
|
58,375 |
|
|
|
58,948 |
|
|
|
58,345 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
CONSOLIDATED STATEMENTS OF CASH FLOWS |
(Unaudited, in thousands) |
|
|
Nine Months Ended |
|
September 30, |
|
2024 |
|
2023 |
CASH FLOWS FROM OPERATING
ACTIVITIES: |
|
|
|
Net income |
$ |
92,410 |
|
|
$ |
66,782 |
|
Adjustments to reconcile net income to net cash provided by
operating activities: |
|
|
|
|
|
Depreciation and amortization |
|
74,093 |
|
|
|
66,359 |
|
Write-off of certain intangible assets and other long-term
assets |
|
401 |
|
|
|
461 |
|
Amortization of right-of-use operating lease assets |
|
9,043 |
|
|
|
8,621 |
|
Fair value adjustments related to contingent consideration
liabilities |
|
292 |
|
|
|
2,177 |
|
Acquired in-process research and development |
|
— |
|
|
|
1,550 |
|
Stock-based compensation expense |
|
18,958 |
|
|
|
15,346 |
|
Other adjustments |
|
4,569 |
|
|
|
5,427 |
|
Changes in operating assets and liabilities, net of acquisitions
and divestitures |
|
(47,711 |
) |
|
|
(83,823 |
) |
Total adjustments |
|
59,645 |
|
|
|
16,118 |
|
Net cash, cash equivalents,
and restricted cash provided by operating activities |
|
152,055 |
|
|
|
82,900 |
|
|
|
|
|
|
|
CASH FLOWS FROM INVESTING
ACTIVITIES: |
|
|
|
|
|
Capital expenditures for property and equipment |
|
(31,668 |
) |
|
|
(27,151 |
) |
Issuance of note receivables |
|
(6,662 |
) |
|
|
— |
|
Cash paid in acquisitions and investments, net of cash
acquired |
|
(113,743 |
) |
|
|
(138,278 |
) |
Other investing, net |
|
(2,133 |
) |
|
|
(1,575 |
) |
Net cash, cash equivalents,
and restricted cash used in investing activities |
|
(154,206 |
) |
|
|
(167,004 |
) |
|
|
|
|
|
|
CASH FLOWS FROM FINANCING
ACTIVITIES: |
|
|
|
Proceeds from issuance of common stock |
|
15,424 |
|
|
|
11,446 |
|
Proceeds from (payments on) long-term debt |
|
(76,063 |
) |
|
|
88,875 |
|
Long-term debt issuance costs |
|
— |
|
|
|
(5,240 |
) |
Contingent payments related to acquisitions |
|
(209 |
) |
|
|
(3,502 |
) |
Payment of taxes related to an exchange of common stock |
|
(1,592 |
) |
|
|
(5,123 |
) |
Net cash, cash equivalents,
and restricted cash provided by (used in) financing activities |
|
(62,440 |
) |
|
|
86,456 |
|
Effect of exchange rates on
cash |
|
724 |
|
|
|
(2,181 |
) |
Net increase (decrease) in
cash, cash equivalents and restricted cash |
|
(63,867 |
) |
|
|
171 |
|
|
|
|
|
|
|
CASH, CASH EQUIVALENTS AND
RESTRICTED CASH: |
|
|
|
|
|
Beginning of period |
|
589,144 |
|
|
|
60,558 |
|
End of period |
$ |
525,277 |
|
|
$ |
60,729 |
|
|
|
|
|
|
|
RECONCILIATION OF CASH, CASH
EQUIVALENTS AND RESTRICTED CASH TO THE CONSOLIDATED BALANCE
SHEETS: |
|
|
|
|
|
Cash and cash equivalents |
|
523,128 |
|
|
|
58,673 |
|
Restricted cash reported in prepaid expenses and other current
assets |
|
2,149 |
|
|
|
2,056 |
|
Total cash, cash equivalents
and restricted cash |
$ |
525,277 |
|
|
$ |
60,729 |
|
|
|
|
|
|
|
|
|
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 employee termination
benefits, 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 $0.3
million and $5.0 million to reported revenue for the three and
nine-month periods ended September 30, 2024,
respectively, were calculated using the applicable average foreign
exchange rates for the three and nine-month periods ended
September 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-month period ended September 30, 2024, Merit’s constant
currency revenue, organic, excludes revenues attributable to assets
acquired from EndoGastric Solutions, Inc. (“EGS”) in July 2024. For
the nine-month period ended September 30, 2024, Merit’s
constant currency revenue, organic, excludes revenues attributable
to assets acquired from EGS in July 2024 as well as 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 employee termination
benefits, 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
nine-month periods ended September 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 $3.1 million and $3.4 million for the three-month
periods ended September 30, 2024 and 2023, respectively
and $9.6 million and $9.2 million for the nine-month periods ended
September 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 |
|
September 30, 2024 |
|
Pre-Tax |
|
Tax Impact |
|
After-Tax |
|
Per Share Impact |
GAAP net income |
$ |
36,657 |
|
$ |
(8,213 |
) |
|
$ |
28,444 |
|
$ |
0.48 |
|
|
|
|
|
|
|
|
|
|
|
|
Non-GAAP adjustments: |
|
|
|
|
|
|
|
|
|
|
|
Cost of Sales |
|
|
|
|
|
|
|
|
|
|
|
Amortization of intangibles |
|
14,896 |
|
|
(3,522 |
) |
|
|
11,374 |
|
|
0.19 |
Inventory mark-up related to acquisitions |
|
559 |
|
|
(132 |
) |
|
|
427 |
|
|
0.01 |
Operating Expenses |
|
|
|
|
|
|
|
|
|
|
|
Contingent consideration expense |
|
103 |
|
|
(6 |
) |
|
|
97 |
|
|
0.00 |
Amortization of intangibles |
|
2,038 |
|
|
(482 |
) |
|
|
1,556 |
|
|
0.03 |
Performance-based share-based compensation (b) |
|
3,736 |
|
|
(609 |
) |
|
|
3,127 |
|
|
0.05 |
Corporate restructuring (c) |
|
2,084 |
|
|
(492 |
) |
|
|
1,592 |
|
|
0.03 |
Acquisition-related |
|
2,351 |
|
|
(555 |
) |
|
|
1,796 |
|
|
0.03 |
Medical Device Regulation expenses (d) |
|
1,983 |
|
|
(468 |
) |
|
|
1,515 |
|
|
0.03 |
Other (e) |
|
125 |
|
|
(30 |
) |
|
|
95 |
|
|
0.00 |
Other (Income) Expense |
|
|
|
|
|
|
|
|
|
|
|
Amortization of long-term debt issuance costs |
|
1,477 |
|
|
(349 |
) |
|
|
1,128 |
|
|
0.02 |
|
|
|
|
|
|
|
|
|
|
|
|
Non-GAAP net income |
$ |
66,009 |
|
$ |
(14,858 |
) |
|
$ |
51,151 |
|
$ |
0.86 |
|
|
|
|
|
|
|
|
|
|
|
|
Diluted shares |
|
|
|
|
|
|
|
|
|
|
59,537 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
September 30, 2023 (a) |
|
Pre-Tax |
|
Tax Impact |
|
After-Tax |
|
Per Share Impact |
GAAP net income |
$ |
30,222 |
|
|
$ |
(4,388 |
) |
|
$ |
25,834 |
|
|
$ |
0.44 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Non-GAAP adjustments: |
|
|
|
|
|
|
|
|
|
|
|
Cost of Sales |
|
|
|
|
|
|
|
|
|
|
|
Amortization of intangibles |
|
13,120 |
|
|
|
(3,154 |
) |
|
|
9,966 |
|
|
|
0.17 |
|
Inventory mark-up related to acquisitions |
|
1,741 |
|
|
|
(418 |
) |
|
|
1,323 |
|
|
|
0.02 |
|
Operating Expenses |
|
|
|
|
|
|
|
|
|
|
|
Contingent consideration expense |
|
562 |
|
|
|
(123 |
) |
|
|
439 |
|
|
|
0.01 |
|
Amortization of intangibles |
|
2,329 |
|
|
|
(560 |
) |
|
|
1,769 |
|
|
|
0.03 |
|
Performance-based share-based compensation (b) |
|
2,403 |
|
|
|
(344 |
) |
|
|
2,059 |
|
|
|
0.04 |
|
Acquisition-related |
|
107 |
|
|
|
(26 |
) |
|
|
81 |
|
|
|
0.00 |
|
Medical Device Regulation expenses (d) |
|
2,444 |
|
|
|
(587 |
) |
|
|
1,857 |
|
|
|
0.03 |
|
Other (e) |
|
(2,946 |
) |
|
|
707 |
|
|
|
(2,239 |
) |
|
|
(0.04 |
) |
Other (Income) Expense |
|
|
|
|
|
|
|
|
|
|
|
Amortization of long-term debt issuance costs |
|
425 |
|
|
|
(102 |
) |
|
|
323 |
|
|
|
0.01 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Non-GAAP net income |
$ |
50,407 |
|
|
$ |
(8,995 |
) |
|
$ |
41,412 |
|
|
$ |
0.71 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Diluted shares |
|
|
|
|
|
|
|
|
|
|
58,375 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
___________________________
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)
|
|
|
|
|
|
|
|
|
|
|
|
|
Nine Months Ended |
|
September 30, 2024 (a) |
|
Pre-Tax |
|
Tax Impact |
|
After-Tax |
|
Per Share Impact |
GAAP net income |
$ |
116,848 |
|
$ |
(24,438 |
) |
|
$ |
92,410 |
|
$ |
1.57 |
|
|
|
|
|
|
|
|
|
|
|
|
Non-GAAP adjustments: |
|
|
|
|
|
|
|
|
|
|
|
Cost of Sales |
|
|
|
|
|
|
|
|
|
|
|
Amortization of intangibles |
|
40,827 |
|
|
(9,654 |
) |
|
|
31,173 |
|
|
0.53 |
Inventory mark-up related to acquisitions |
|
559 |
|
|
(132 |
) |
|
|
427 |
|
|
0.01 |
Operating Expenses |
|
|
|
|
|
|
|
|
|
|
|
Contingent consideration expense |
|
292 |
|
|
(31 |
) |
|
|
261 |
|
|
0.00 |
Amortization of intangibles |
|
5,546 |
|
|
(1,312 |
) |
|
|
4,234 |
|
|
0.07 |
Performance-based share-based compensation (b) |
|
9,396 |
|
|
(1,466 |
) |
|
|
7,930 |
|
|
0.13 |
Corporate restructuring (c) |
|
2,030 |
|
|
(479 |
) |
|
|
1,551 |
|
|
0.03 |
Acquisition-related |
|
3,610 |
|
|
(852 |
) |
|
|
2,758 |
|
|
0.05 |
Medical Device Regulation expenses (d) |
|
6,120 |
|
|
(1,445 |
) |
|
|
4,675 |
|
|
0.08 |
Other (e) |
|
302 |
|
|
(72 |
) |
|
|
230 |
|
|
0.00 |
Other (Income) Expense |
|
|
|
|
|
|
|
|
|
|
|
Amortization of long-term debt issuance costs |
|
4,431 |
|
|
(1,046 |
) |
|
|
3,385 |
|
|
0.06 |
|
|
|
|
|
|
|
|
|
|
|
|
Non-GAAP net income |
$ |
189,961 |
|
$ |
(40,927 |
) |
|
$ |
149,034 |
|
$ |
2.53 |
|
|
|
|
|
|
|
|
|
|
|
|
Diluted shares |
|
|
|
|
|
|
|
|
|
|
58,948 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Nine Months Ended |
|
September 30, 2023 (a) |
|
Pre-Tax |
|
Tax Impact |
|
After-Tax |
|
Per Share Impact |
GAAP net income |
$ |
80,622 |
|
|
$ |
(13,840 |
) |
|
$ |
66,782 |
|
|
$ |
1.14 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Non-GAAP adjustments: |
|
|
|
|
|
|
|
|
|
|
|
Cost of Sales |
|
|
|
|
|
|
|
|
|
|
|
Amortization of intangibles |
|
35,184 |
|
|
|
(8,460 |
) |
|
|
26,724 |
|
|
|
0.46 |
|
Inventory mark-up related to acquisitions |
|
2,001 |
|
|
|
(480 |
) |
|
|
1,521 |
|
|
|
0.03 |
|
Operating Expenses |
|
|
|
|
|
|
|
|
|
|
|
Contingent consideration expense |
|
2,177 |
|
|
|
(121 |
) |
|
|
2,056 |
|
|
|
0.04 |
|
Impairment charges |
|
270 |
|
|
|
— |
|
|
|
270 |
|
|
|
0.00 |
|
Amortization of intangibles |
|
5,959 |
|
|
|
(1,436 |
) |
|
|
4,523 |
|
|
|
0.08 |
|
Performance-based share-based compensation (b) |
|
6,067 |
|
|
|
(771 |
) |
|
|
5,296 |
|
|
|
0.09 |
|
Corporate restructuring (c) |
|
7,203 |
|
|
|
(1,729 |
) |
|
|
5,474 |
|
|
|
0.09 |
|
Acquisition-related |
|
5,218 |
|
|
|
(1,253 |
) |
|
|
3,965 |
|
|
|
0.07 |
|
Medical Device Regulation expenses (d) |
|
9,112 |
|
|
|
(2,187 |
) |
|
|
6,925 |
|
|
|
0.12 |
|
Other (e) |
|
(1,309 |
) |
|
|
314 |
|
|
|
(995 |
) |
|
|
(0.02 |
) |
Other (Income) Expense |
|
|
|
|
|
|
|
|
|
|
|
Amortization of long-term debt issuance costs |
|
1,054 |
|
|
|
(253 |
) |
|
|
801 |
|
|
|
0.01 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Non-GAAP net income |
$ |
153,558 |
|
|
$ |
(30,216 |
) |
|
$ |
123,342 |
|
|
$ |
2.11 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Diluted shares |
|
|
|
|
|
|
|
|
|
|
58,345 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
___________________________
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 |
|
Nine Months Ended |
|
Nine Months Ended |
|
September 30, 2024 |
|
September 30, 2023 (a) |
|
September 30, 2024 (a) |
|
September 30, 2023 (a) |
|
Amounts |
|
% Sales |
|
Amounts |
|
% Sales |
|
Amounts |
|
% Sales |
|
Amounts |
|
% Sales |
Net Sales as Reported |
$ |
339,845 |
|
|
|
|
$ |
315,230 |
|
|
|
|
|
$ |
1,001,356 |
|
|
|
|
$ |
932,851 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
GAAP Operating Income |
|
37,261 |
|
11.0 |
% |
|
|
35,137 |
|
|
11.1 |
|
% |
|
|
119,129 |
|
11.9 |
% |
|
|
90,332 |
|
|
9.7 |
|
% |
Cost of Sales |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Amortization of intangibles |
|
14,896 |
|
4.4 |
% |
|
|
13,120 |
|
|
4.2 |
|
% |
|
|
40,827 |
|
4.1 |
% |
|
|
35,184 |
|
|
3.8 |
|
% |
Inventory mark-up related to acquisitions |
|
559 |
|
0.2 |
% |
|
|
1,741 |
|
|
0.6 |
|
% |
|
|
559 |
|
0.1 |
% |
|
|
2,001 |
|
|
0.2 |
|
% |
Operating Expenses |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Contingent consideration expense |
|
103 |
|
0.0 |
% |
|
|
562 |
|
|
0.2 |
|
% |
|
|
292 |
|
0.0 |
% |
|
|
2,177 |
|
|
0.2 |
|
% |
Impairment charges |
|
— |
|
— |
|
|
|
— |
|
|
— |
|
|
|
|
— |
|
— |
|
|
|
270 |
|
|
0.0 |
|
% |
Amortization of intangibles |
|
2,038 |
|
0.6 |
% |
|
|
2,329 |
|
|
0.7 |
|
% |
|
|
5,546 |
|
0.6 |
% |
|
|
5,959 |
|
|
0.6 |
|
% |
Performance-based share-based compensation (b) |
|
3,736 |
|
1.1 |
% |
|
|
2,403 |
|
|
0.8 |
|
% |
|
|
9,396 |
|
0.9 |
% |
|
|
6,067 |
|
|
0.7 |
|
% |
Corporate restructuring (c) |
|
2,084 |
|
0.6 |
% |
|
|
— |
|
|
— |
|
|
|
|
2,030 |
|
0.2 |
% |
|
|
7,203 |
|
|
0.8 |
|
% |
Acquisition-related |
|
2,351 |
|
0.7 |
% |
|
|
107 |
|
|
0.0 |
|
% |
|
|
3,610 |
|
0.4 |
% |
|
|
5,218 |
|
|
0.6 |
|
% |
Medical Device Regulation expenses (d) |
|
1,983 |
|
0.6 |
% |
|
|
2,444 |
|
|
0.8 |
|
% |
|
|
6,120 |
|
0.6 |
% |
|
|
9,112 |
|
|
1.0 |
|
% |
Other (e) |
|
125 |
|
0.0 |
% |
|
|
(2,946 |
) |
|
(0.9 |
) |
% |
|
|
302 |
|
0.0 |
% |
|
|
(1,309 |
) |
|
(0.1 |
) |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Non-GAAP Operating Income |
$ |
65,136 |
|
19.2 |
% |
|
$ |
54,897 |
|
|
17.4 |
|
% |
|
$ |
187,811 |
|
18.8 |
% |
|
$ |
162,214 |
|
|
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 Foundations for
Growth Program (“FFG Program”) are not adjusted as part of our
non-GAAP financial measures. As a result, our non-GAAP financial
measures for prior periods have been recast for comparability. For
the three-month period ended September 30, 2023, our non-GAAP
financial measures have been updated to no longer adjust $2.8
million for consulting fees under our FFG Program and the related
income tax effect. For the nine-month periods ended September 30,
2024 and 2023, our non-GAAP financial measures have been updated to
no longer adjust $1.0 million and $7.0 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
$2.1 million and $2.0 million for the three and nine-month periods
ended September 30, 2024, respectively, for employee termination
benefits associated with activities related to corporate
restructuring initiatives primarily for the integration of our
acquisition of EGS. For the nine-month period ended September 30,
2023, includes employee termination benefits associated with
restructuring activities related to corporate initiatives of $2.9
million 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. |
|
|
(d) |
Represents incremental expenses incurred to comply with the E.U.
Medical Device Regulation (“MDR”). |
|
|
(e) |
Represents costs to comply with our corporate integrity
agreement with the U.S. Department of Justice (the “DOJ”). The
three and nine-month periods ended September 30, 2023 also include
an insurance reimbursement of approximately $(3.0) million for
costs incurred in responding to an inquiry by the DOJ which was
settled in 2020. The nine-month period ended September 30, 2023
also includes 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 |
|
|
|
Nine Months Ended |
|
|
|
September30, |
|
|
|
September30, |
|
% Change |
|
2024 |
|
2023 |
|
% Change |
|
2024 |
|
2023 |
Reported Revenue |
7.8 |
% |
$ |
339,845 |
|
|
$ |
315,230 |
|
7.3 |
% |
$ |
1,001,356 |
|
|
$ |
932,851 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Add: Impact of foreign
exchange |
|
|
|
281 |
|
|
|
— |
|
|
|
|
5,006 |
|
|
|
— |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Constant Currency Revenue
(a) |
7.9 |
% |
$ |
340,126 |
|
|
$ |
315,230 |
|
7.9 |
% |
$ |
1,006,362 |
|
|
$ |
932,851 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Less: Revenue from certain
acquisitions |
|
|
|
(6,805 |
) |
|
|
— |
|
|
|
|
(18,368 |
) |
|
|
— |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Constant Currency Revenue,
Organic (a) |
5.7 |
% |
$ |
333,321 |
|
|
$ |
315,230 |
|
5.9 |
% |
$ |
987,994 |
|
|
$ |
932,851 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
___________________________
(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 |
|
Nine Months Ended |
|
September30, |
|
September30, |
|
2024 |
|
2023 |
|
2024 |
|
2023 |
Reported Gross Margin |
46.4 |
% |
|
45.1 |
% |
|
47.0 |
% |
|
46.5 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
Add back impact of: |
|
|
|
|
|
|
|
|
|
|
|
Amortization of intangibles |
4.4 |
% |
|
4.2 |
% |
|
4.1 |
% |
|
3.8 |
% |
Inventory mark-up related to acquisitions |
0.2 |
% |
|
0.6 |
% |
|
0.1 |
% |
|
0.2 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
Non-GAAP Gross Margin |
50.9 |
% |
|
49.8 |
% |
|
51.1 |
% |
|
50.4 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
___________________________
Note: Certain percentages may not sum to totals due to
rounding.
ABOUT MERIT
Founded in 1987, Merit is engaged in the
development, manufacture, and distribution of proprietary medical
devices used in interventional, diagnostic, and therapeutic
procedures, particularly in cardiology, radiology, oncology,
critical care, and endoscopy. Merit serves customers worldwide with
a domestic and international sales force and clinical support team
totaling more than 700 individuals. Merit employs approximately
7,200 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 is not comprehensive, such risks and
uncertainties include inherent risks and uncertainties associated
with Merit’s proposed acquisition of Cook Medical’s lead management
portfolio, Merit’s integration of products acquired from EGS and
proposed to be acquired from Cook Medical, Merit’s ability to
achieve anticipated financial results, product development and
other anticipated benefits of the EGS acquisition and the proposed
acquisition of the lead management portfolio and associated
operations of Cook Medical; 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
those completed and proposed acquisitions; uncertainties as to
whether Merit will be successful in completing the proposed
acquisition of the lead management portfolio of Cook Medical;
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 or exposure
to additional tax liabilities which may adversely affect our
effective tax rate; 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:Sarah
Comstock Merit Medical |
Investor Inquiries:Mike
Piccinino, CFA, IRCWestwicke – ICR |
+1-801-432-2864 |
+1-443-213-0509 |
sarah.comstock@merit.com |
mike.piccinino@westwicke.com |
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