Fourth Quarter Highlights† Reported revenue of $355.2 million, up 9.4%Constant currency revenue* and constant currency revenue, organic* up 10.1% and up 6.1%, respectivelyGAAP operating margin of 10.3%, compared to 10.4% in prior year periodNon-GAAP operating margin* of 19.6%, compared to 16.6% in prior year periodGAAP EPS $0.46, down 2.6%,Non-GAAP EPS* $0.93, up 25.8%, andFree cash flow* generation of $65.3 million, up 18.4% Fiscal Year 2024 Highlights† Reported revenue of $1.357 billion, up 7.9%Constant currency revenue* and constant currency revenue, organic* up 8.5% and up 6.0%, respectivelyGAAP operating margin of 11.5 %, compared to 9.9% in prior yearNon-GAAP operating margin* of 19.0%, compared to 17.2% in prior yearGAAP EPS $2.03, up 25.3%,Non-GAAP EPS* $3.46, up 21.3%, andFree cash flow* generation of $185.7 million, up 67.5% Fourth Quarter Business Developments Completed the acquisition of lead management portfolio of medical devices and certain related assets from Cook Medical Holdings, LLCAnnounced FDA premarket approval of the Wrapsody® Cell-Impermeable Endoprosthesis device, which is intended to extend long-term vessel patency in dialysis patientsSubstantially completed integration of the production, distribution and sale of the EsophyX® Z+ device previously acquired from Endogastric Solutions, Inc. Fiscal Year 2025 Guidance Revenue of $1.470 billion to $1.490 billion, up 8% – 10% year-over-yearNon-GAAP EPS of $3.58 to $3.70, up 4% – 7% year-over-year † Comparisons noted in the bullet points are calculated for the current quarter compared with the fourth quarter of 2023 or for the current year compared with fiscal year 2023, as applicable, unless otherwise specified. Amounts in this release are rounded while percentages are calculated from the underlying amounts. * 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 EPS; and free cash flow figures (used here and below) are non-GAAP financial measures. A reconciliation of these financial measures to their most directly comparable GAAP financial measures is included under the heading “Non-GAAP Financial Measures” below. SOUTH JORDAN, Utah, Feb. 25, 2025 (GLOBE NEWSWIRE) — Merit Medical Systems, Inc. (NASDAQ: MMSI), a leading global manufacturer and marketer of healthcare technology, today announced revenue of $355.2 million for the quarter ended December 31, 2024, an increase of 9.4% compared to the quarter ended December 31, 2023. Constant currency revenue for the fourth quarter of 2024 increased 10.1% compared to the prior year period and increased 6.1% compared to the prior year period on a constant currency revenue, organic, basis. Revenue for the year ended December 31, 2024 was $1.357 billion, an increase of 7.9% compared to the year ended December 31, 2023. Constant currency revenue for 2024 increased 8.5% compared to the prior year and increased 6.0% compared to the prior year on a constant currency revenue, organic, basis. “We finished 2024 with strong momentum by delivering better-than-expected financial results in the fourth quarter, reflecting continued strong execution,” said Fred P. Lampropoulos, Merit’s Chairman and Chief Executive Officer. “Our constant currency revenue, organic, and our constant currency total revenue exceeded the high-end of our expectations in the fourth quarter. We delivered impressive year-over-year improvements in our non-GAAP operating margin and our non-GAAP earnings per share, which increased 305 basis points and 26%, respectively, year-over-year. We also delivered strong free cash flow generation in the fourth quarter and generated more than $185 million in fiscal year 2024, representing an increase of 67% year-over-year.” Mr. Lampropoulos continued: “We are introducing 2025 financial guidance which reflects confidence in our team’s ability to deliver continued strong execution, stable constant currency growth, improving profitability and solid free cash flow generation. We also remain focused on our Continued Growth Initiatives Program and on achieving the 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 twelve-month periods ended December 31, 2024 and 2023 was as follows (unaudited; in thousands, except for percentages): Three Months Ended Reported Constant Currency * December 31, Impact of foreign December 31, 2024 2023 % Change exchange 2024 % ChangeCardiovascular Peripheral Intervention$140,363 $134,143 4.6% $1,152 $141,515 5.5%Cardiac Intervention 95,673 90,242 6.0% 836 96,509 6.9%Custom Procedural Solutions 51,223 49,624 3.2% 150 51,373 3.5%OEM 50,441 41,216 22.4% 44 50,485 22.5%Total 337,700 315,225 7.1% 2,182 339,882 7.8% Endoscopy Endoscopy Devices 17,458 9,290 87.9% 19 17,477 88.1% Total$355,158 $324,515 9.4% $2,201 $357,359 10.1% Year Ended Reported Constant Currency * December 31, Impact of foreign December 31, 2024 2023 % Change exchange 2024 % ChangeCardiovascular Peripheral Intervention$552,168 $502,220 9.9% $2,852 $555,020 10.5%Cardiac Intervention 370,993 358,451 3.5% 3,022 374,015 4.3%Custom Procedural Solutions 201,201 195,333 3.0% 1,192 202,393 3.6%OEM 177,382 164,556 7.8% 46 177,428 7.8%Total 1,301,744 1,220,560 6.7% 7,112 1,308,856 7.2% Endoscopy Endoscopy Devices 54,770 36,806 48.8% 95 54,865 49.1% Total$1,356,514 $1,257,366 7.9% $7,207 $1,363,721 8.5% Merit’s GAAP gross margin for the fourth quarter of 2024 was 48.7%, compared to GAAP gross margin of 46.4% for the fourth quarter of 2023. Merit’s non-GAAP gross margin* for the fourth quarter of 2024 was 53.5%, compared to non-GAAP gross margin* of 50.4% for the fourth quarter of 2023. GAAP gross margin for fiscal year 2024 was 47.4%, compared to GAAP gross margin of 46.4% for fiscal year 2023. Non-GAAP gross margin* for fiscal year 2024 was 51.7%, compared to non-GAAP gross margin* of 50.4% for fiscal year 2023. Merit’s GAAP net income for the fourth quarter of 2024 was $27.9 million, or $0.46 per share, compared to GAAP net income of $27.6 million, or $0.47 per share, for the fourth quarter of 2023. Merit’s non-GAAP net income* for the fourth quarter of 2024 was $56.3 million, or $0.93 per share, compared to non-GAAP net income* of $43.1 million, or $0.74 per share, for the fourth quarter of 2023. GAAP net income for fiscal year 2024 was $120.4 million, or $2.03 per share, compared to GAAP net income of $94.4 million, or $1.62 per share, for fiscal year 2023. Non-GAAP net income* for fiscal year 2024 was $205.4 million, or $3.46 per share, compared to non-GAAP net income* of $166.5 million, or $2.85 per share, for fiscal year 2023. As of December 31, 2024, Merit had cash and cash equivalents of $376.7 million, total debt obligations of $747.5 million, and outstanding letter of credit guarantees of $2.9 million, compared to cash and cash equivalents of $587 million, total debt obligations of $846.6 million, and outstanding letter of credit guarantees of $2.7 million as of December 31, 2023. Merit had additional available borrowing capacity of approximately $697 million as of December 31, 2024. Fiscal Year 2025 Financial Guidance Based upon the information currently available to Merit’s management, for the year ending December 31, 2025, absent material acquisitions, non-recurring transactions or other factors beyond Merit’s current expectations, Merit anticipates the following financial results: Revenue and Earnings Guidance* Prior Year(As Reported)GuidanceFinancial MeasureYear EndedYear Ending% Change December 31, 2024December 31, 2025Y/Y Net Sales$1.357 billion$1.470 – $1.490 billion8% – 10%Cardiovascular Segment$1.302 billion$1.395 – $1.413 billion7% – 9%Endoscopy Segment$54.8 million$74.6 – $76.7 million36% – 40% Non-GAAP Earnings Per Share**$3.46$3.58 – $3.704% – 7% *Percentage figures approximated; dollar figures may not foot due to rounding**Merit’s non-GAAP earnings per share reflect the dilutive impact of its 3.00% Convertible Senior Notes due 2029 (the “Convertible Notes”) calculated using the if-converted method of approximately $.02 and $0.11 for the years ending December 31, 2024 and 2025 respectively. Any offsetting impacts of the capped call associated with the Convertible Notes are not considered. 2025 Net Sales Guidance – % Change from Prior Year (Constant Currency) Reconciliation* Guidance Low High2025 Net Sales Guidance – % Change from Prior Year (GAAP)8.4% 9.8%Estimated impact of foreign currency exchange rate fluctuations0.2% 0.2%2025 Net Sales Guidance – % Change from Prior Year (Constant Currency)8.6% 10.1% *Percentage figures approximated and may not foot due to rounding 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, 2025 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, Tuesday, February 25, 2025, 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. CONSOLIDATED BALANCE SHEETS(in thousands) December 31, 2024 December 31, (Unaudited) 2023ASSETS Current Assets Cash and cash equivalents$376,715 $587,036 Trade receivables, net 190,243 177,885 Other receivables 16,588 10,517 Inventories 306,063 303,871 Prepaid expenses and other assets 28,544 24,286 Prepaid income taxes 3,286 4,016 Income tax refund receivables 2,335 859 Total current assets 923,774 1,108,470 Property and equipment, net 386,165 383,523 Intangible assets, net 498,265 325,883 Goodwill 463,511 382,240 Deferred income tax assets 16,044 7,288 Operating lease right-of-use assets 65,508 63,047 Other assets 65,336 54,793 Total Assets$2,418,603 $2,325,244 LIABILITIES AND STOCKHOLDERS’ EQUITY Current Liabilities Trade payables$68,502 $65,944 Accrued expenses 134,077 120,447 Current operating lease liabilities 10,331 12,087 Income taxes payable 3,492 5,086 Total current liabilities 216,402 203,564 Long-term debt 729,551 823,013 Deferred income tax liabilities 240 5,547 Long-term income taxes payable — 347 Liabilities related to unrecognized tax benefits 2,118 1,912 Deferred compensation payable 19,197 17,167 Deferred credits 1,502 1,605 Long-term operating lease liabilities 54,783 56,259 Other long-term obligations 15,451 13,830 Total liabilities 1,039,244 1,123,244 Stockholders’ Equity Common stock 703,219 638,150 Retained earnings 695,541 575,184 Accumulated other comprehensive loss (19,401) (11,334)Total stockholders’ equity 1,379,359 1,202,000 Total Liabilities and Stockholders’ Equity$2,418,603 $2,325,244 CONSOLIDATED STATEMENTS OF INCOME(Unaudited, in thousands except per share amounts) Three Months Ended Year Ended December 31, December 31, 2024 2023 2024 2023 Net sales$355,158 $324,515 $1,356,514 $1,257,366 Cost of sales 182,175 173,986 713,181 673,494 Gross profit 172,983 150,529 643,333 583,872 Operating expenses: Selling, general and administrative 111,074 95,751 399,731 373,676 Research and development 25,194 21,639 87,466 82,728 Impairment charges — — — 270 Contingent consideration expense (benefit) 151 (473) 443 1,704 Acquired in-process research and development — — — 1,550 Total operating expenses 136,419 116,917 487,640 459,928 Income from operations 36,564 33,612 155,693 123,944 Other income (expense): Interest income 4,741 1,923 26,230 2,456 Interest expense (7,993) (4,977) (31,219) (15,511)Other income (expense) — net (167) 909 (711) 1,200 Total other expense — net (3,419) (2,145) (5,700) (11,855) Income before income taxes 33,145 31,467 149,993 112,089 Income tax expense 5,198 3,838 29,636 17,678 Net income$27,947 $27,629 $120,357 $94,411 Earnings per common share Basic$0.48 $0.48 $2.07 $1.64 Diluted$0.46 $0.47 $2.03 $1.62 Weighted average shares outstanding Basic 58,541 57,793 58,218 57,593 Diluted 60,613 58,385 59,365 58,356 CONSOLIDATED STATEMENTS OF CASH FLOWS(Unaudited, in thousands) Year Ended December 31, 2024 2023 CASH FLOWS FROM OPERATING ACTIVITIES: Net income$120,357 $94,411 Adjustments to reconcile net income to net cash provided by operating activities: Depreciation and amortization 102,709 89,985 Gain on disposition of a business — (431)Write-off of certain intangible assets and other long-term assets 456 506 Amortization of right-of-use operating lease assets 12,023 11,307 Fair value adjustments related to contingent consideration liabilities 443 1,704 Acquired in-process research and development — 1,550 Deferred income taxes (14,873) (12,643)Stock-based compensation expense 28,473 21,333 Other adjustments 8,156 7,451 Changes in operating assets and liabilities, net of acquisitions and divestitures (36,945) (70,022)Total adjustments 100,442 50,740 Net cash, cash equivalents, and restricted cash provided by operating activities 220,799 145,151 CASH FLOWS FROM INVESTING ACTIVITIES: Capital expenditures for property and equipment (35,140) (34,290)Cash paid for notes receivable and other investments (10,433) (4,755)Cash paid in acquisitions, net of cash acquired (320,182) (134,523)Other investing, net (2,898) (1,779)Net cash, cash equivalents, and restricted cash used in investing activities (368,653) (175,347) CASH FLOWS FROM FINANCING ACTIVITIES: Proceeds from issuance of common stock 40,908 15,584 Proceeds from (payments on) long-term debt (99,063) 619,579 Purchase of capped call option — (66,528)Long-term debt issuance costs — (677)Contingent payments related to acquisitions (261) (3,569)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 (60,008) 559,266 Effect of exchange rates on cash (2,515) (484)Net increase (decrease) in cash, cash equivalents and restricted cash (210,377) 528,586 CASH, CASH EQUIVALENTS AND RESTRICTED CASH: Beginning of period 589,144 60,558 End of period$378,767 $589,144 RECONCILIATION OF CASH, CASH EQUIVALENTS AND RESTRICTED CASH TO THE CONSOLIDATED BALANCE SHEETS: Cash and cash equivalents 376,715 587,036 Restricted cash reported in prepaid expenses and other current assets 2,052 2,108 Total cash, cash equivalents and restricted cash$378,767 $589,144 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; andfree 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 $2.2 million and $7.2 million to reported revenue for the three and twelve-month periods ended December 31, 2024, respectively, were calculated using the applicable average foreign exchange rates for the three and twelve-month periods ended December 31, 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 December 31, 2024, Merit’s constant currency revenue, organic, excludes revenues attributable to (i) the assets acquired from Cook Medical Holdings, LLC (“Cook Medical”) in November 2024 and (ii) the assets acquired from EndoGastric Solutions, Inc. (“EGS”) in July 2024. For the twelve-month period ended December 31, 2024, Merit’s constant currency revenue, organic, excludes revenues attributable to (a) the assets acquired from EGS in July 2024, (b) the assets acquired from Cook Medical in November 2024 and (c) the assets acquired from AngioDynamics, Inc. 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, corporate restructuring charges, 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, gains or losses on disposal of certain assets 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, 2024 and 2023. The non-GAAP income adjustments referenced in the following tables do not reflect non-performance-based stock compensation expense of approximately $3.7 million and $3.5 million for the three-month periods ended December 31, 2024 and 2023, respectively and $13.2 million and $12.7 million for the twelve-month periods ended December 31, 2024 and 2023, respectively. Reconciliation of GAAP Net Income to Non-GAAP Net Income(Unaudited, in thousands except per share amounts) Three Months Ended December 31, 2024 Pre-Tax Tax Impact After-Tax Per Share ImpactGAAP net income$33,145 $(5,198) $27,947 $0.46 Non-GAAP adjustments: Cost of Sales Amortization of intangibles 16,832 (3,978) 12,854 0.21 Inventory mark-up related to acquisitions 75 (17) 58 0.00 Operating Expenses Contingent consideration expense 151 48 199 0.00 Amortization of intangibles 2,385 (564) 1,821 0.03 Performance-based share-based compensation (b) 5,841 (141) 5,700 0.09 Corporate restructuring (c) 1,098 (260) 838 0.01 Acquisition-related 5,239 (1,237) 4,002 0.07 Medical Device Regulation expenses (d) 1,395 (329) 1,066 0.02 Other (e) 71 (16) 55 0.00 Other (Income) Expense Amortization of long-term debt issuance costs 2,338 (552) 1,786 0.03 Non-GAAP net income$68,570 $(12,244) $56,326 $0.93 Diluted shares 60,613 Three Months Ended December 31, 2023 (a) Pre-Tax Tax Impact After-Tax Per Share ImpactGAAP net income$31,467 $(3,838) $27,629 $0.47 Non-GAAP adjustments: Cost of Sales Amortization of intangibles 12,611 (3,032) 9,579 0.16 Corporate restructuring (c) 448 (108) 340 0.01 Inventory mark-up related to acquisitions 68 (17) 51 0.00 Operating Expenses Contingent consideration benefit (473) 74 (399) (0.01)Amortization of intangibles 2,334 (562) 1,772 0.03 Performance-based share-based compensation (b) 2,459 (350) 2,109 0.04 Corporate restructuring (c) (137) 34 (103) (0.00)Acquisition-related 68 (16) 52 0.00 Medical Device Regulation expenses (d) 2,710 (651) 2,059 0.04 Other (e) 41 (10) 31 0.00 Other (Income) Expense Amortization of long-term debt issuance costs 585 (140) 445 0.01 Gain on disposal of business unit (431) — (431) (0.01) Non-GAAP net income$51,750 $(8,616) $43,134 $0.74 Diluted shares 58,385 _________________________ 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) Year Ended December 31, 2024 (a) Pre-Tax Tax Impact After-Tax Per Share ImpactGAAP net income$149,993 $(29,636) $120,357 $2.03 Non-GAAP adjustments: Cost of Sales Amortization of intangibles 57,659 (13,632) 44,027 0.74 Inventory mark-up related to acquisitions 634 (149) 485 0.01 Operating Expenses Contingent consideration expense 443 17 460 0.01 Amortization of intangibles 7,931 (1,876) 6,055 0.10 Performance-based share-based compensation (b) 15,237 (1,607) 13,630 0.23 Corporate restructuring (c) 3,128 (739) 2,389 0.04 Acquisition-related 8,849 (2,089) 6,760 0.11 Medical Device Regulation expenses (d) 7,515 (1,774) 5,741 0.10 Other (e) 373 (88) 285 0.00 Other (Income) Expense Amortization of long-term debt issuance costs 6,769 (1,598) 5,171 0.09 Non-GAAP net income$258,531 $(53,171) $205,360 $3.46 Diluted shares 59,365 Year Ended December 31, 2023 (a) Pre-Tax Tax Impact After-Tax Per Share ImpactGAAP net income$112,089 $(17,678) $94,411 $1.62 Non-GAAP adjustments: Cost of Sales Amortization of intangibles 47,795 (11,492) 36,303 0.62 Corporate restructuring (c) 448 (108) 340 0.01 Inventory mark-up related to acquisitions 2,069 (497) 1,572 0.03 Operating Expenses Contingent consideration expense 1,704 (47) 1,657 0.03 Impairment charges 270 — 270 0.00 Amortization of intangibles 8,293 (1,998) 6,295 0.11 Performance-based share-based compensation (b) 8,526 (1,121) 7,405 0.13 Corporate restructuring (c) 7,065 (1,695) 5,370 0.09 Acquisition-related 5,286 (1,269) 4,017 0.07 Medical Device Regulation expenses (d) 11,822 (2,838) 8,984 0.15 Other (e) (1,268) 304 (964) (0.02)Other (Income) Expense Amortization of long-term debt issuance costs 1,639 (393) 1,246 0.02 Gain on disposal of business unit (431) — (431) (0.01) Non-GAAP net income$205,307 $(38,832) $166,475 $2.85 Diluted shares 58,356 _________________________ 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 Year Ended Year Ended December 31, 2024 December 31, 2023 (a) December 31, 2024 (a) December 31, 2023 (a) Amounts % Sales Amounts % Sales Amounts % Sales Amounts % SalesNet Sales as Reported$355,158 $324,515 $1,356,514 $1,257,366 GAAP Operating Income 36,564 10.3% 33,612 10.4% 155,693 11.5% 123,944 9.9%Cost of Sales Amortization of intangibles 16,832 4.7% 12,611 3.9% 57,659 4.3% 47,795 3.8%Corporate restructuring (c) — — 448 0.1% — — 448 0.0%Inventory mark-up related to acquisitions 75 0.0% 68 0.0% 634 0.0% 2,069 0.2%Operating Expenses Contingent consideration expense (benefit) 151 0.0% (473) (0.1)% 443 0.0% 1,704 0.1%Impairment charges — — — — — — 270 0.0%Amortization of intangibles 2,385 0.7% 2,334 0.7% 7,931 0.6% 8,293 0.7%Performance-based share-based compensation (b) 5,841 1.6% 2,459 0.8% 15,237 1.1% 8,526 0.7%Corporate restructuring (c) 1,098 0.3% (137) (0.0)% 3,128 0.2% 7,065 0.6%Acquisition-related 5,239 1.5% 68 0.0% 8,849 0.7% 5,286 0.4%Medical Device Regulation expenses (d) 1,395 0.4% 2,710 0.8% 7,515 0.6% 11,822 0.9%Other (e) 71 0.0% 41 0.0% 373 0.0% (1,268) (0.1)% Non-GAAP Operating Income$69,651 19.6% $53,741 16.6% $257,462 19.0% $215,954 17.2% _________________________ 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 Merit’s Foundations for Growth Program (“FFG Program”) are not adjusted as part of its non-GAAP financial measures. As a result, Merit’s non-GAAP financial measures for prior periods have been recast for comparability. For the three-month period ended December 31, 2023, Merit’s non-GAAP financial measures have been updated to no longer adjust $5.3 million for consulting fees under its FFG Program and the related income tax effect. For the twelve-month periods ended December 31, 2024 and 2023, Merit’s non-GAAP financial measures have been updated to no longer adjust $1.0 million and $12.3 million, respectively, for consulting fees under our FFG Program and the related income tax effects. As of December 31, 2023, Merit completed the final year of its FFG Program. (b) Represents performance-based share-based compensation expense, including stock-settled and cash-settled awards. (c) Includes $1.1 million and $3.1 million for the three and twelve-month periods ended December 31, 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 twelve-month period ended December 31, 2023, includes employee termination benefits associated with restructuring activities related to corporate initiatives of $2.7 million, 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, and within cost of sales included $0.4 million for the write-off of inventory related to 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 Merit’s corporate integrity agreement with the U.S. Department of Justice (the “DOJ”). The twelve-month period ended December 31, 2023 also includes an insurance reimbursement of approximately $(3.0) million for costs incurred in responding to an inquiry by the DOJ which was settled in 2020, and 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 Year Ended December31, December31, % Change 2024 2023 % Change 2024 2023Reported Revenue 9.4% $355,158 $324,515 7.9% $1,356,514 $1,257,366 Add: Impact of foreign exchange 2,201 — 7,207 — Constant Currency Revenue (a) 10.1% $357,359 $324,515 8.5% $1,363,721 $1,257,366 Less: Revenue from certain acquisitions (13,089) — (31,457) — Constant Currency Revenue, Organic (a) 6.1% $344,270 $324,515 6.0% $1,332,264 $1,257,366 _________________________ (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 Year Ended December31, December31, 2024 2023 2024 2023 Reported Gross Margin 48.7% 46.4% 47.4% 46.4% Add back impact of: Amortization of intangibles 4.7% 3.9% 4.3% 3.8%Corporate restructuring (a) — 0.1% —% 0.0%Inventory mark-up related to acquisitions 0.0% 0.0% 0.0% 0.2% Non-GAAP Gross Margin 53.5% 50.4% 51.7% 50.4% _________________________ Note: Certain percentages may not sum to totals due to rounding. (a) Represents corporate restructuring charges reflected within costs of sales including the write-off of inventory related to the divestiture or exit of certain businesses or product lines. 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 800 individuals. Merit employs approximately 7,400 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 Exchange Act of 1934, as amended. Forward-looking statements include, among others: statements proceeded or followed by, or that include the words, “may,” “will,” “should,” “expects,” “plans,” “anticipates,” “intends,” “seeks,” “believes,” “estimates,” “projects,” “forecasts,” “potential,” “target,” “continue,” “upcoming,” “optimistic” or other forms of these words or similar words or expressions, or the negative thereof or other comparable terminology;statements that address Merit’s future operating performance or events or developments that Merit’s management expects or anticipates will occur, including, without limitation, any statements regarding Merit’s projected revenues, earnings or other financial measures, Merit’s plans and objectives for future operations, Merit’s proposed new products or services, the integration, development or commercialization of the business or any assets acquired from other parties, future economic conditions or performance, the implementation of, and results which may be achieved through, Merit’s Continued Growth Initiatives Program or other business optimization initiatives, and any statements of assumptions underlying any of the foregoing; andstatements regarding Merit’s past performance, efforts, or results about which inferences or assumptions may be made, including statements proceeded or followed by the words “preliminary,” “initial,” “potential,” “possible,” “diligence,” “industry-leading,” “compliant,” “indications,” or “early feedback” 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, 2024 (the “2024 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 integration of products acquired from EGS and Cook Medical, Merit’s ability to achieve anticipated financial results, product development and other anticipated benefits of the EGS and Cook Medical acquisitions; 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; shifts in trade policies in the U.S. or other countries, including new or modified tariffs or other measures; effects of the Convertible Notes on Merit’s net income and earnings per share performance; 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; the safety, efficacy and patient and physician adoption of Merit’s products; 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 Merit’s 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 2024 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 MedicalInvestor Inquiries:Mike Piccinino, CFA, IRCICR Healthcare+1-801-432-2864+1-443-213-0509sarah.comstock@merit.commike.piccinino@icrhealthcare.com
Tag: Merit Medical
Merit Medical’s WRAPSODY WAVE Trial Exceeds Performance Goals for Arteriovenous Graft (AVG) Patients
WRAPSODY achieves 82% target lesion primary patency at six months in the single-arm cohort of the US pivotal trial WRAPSODY achieves 82% target lesion primary patency at six months in the single-arm cohort of the US pivotal trial
Merit Medical to Present at the 2024 Cardiovascular and Interventional Radiological Society of Europe (CIRSE) Annual Congress
SOUTH JORDAN, Utah, Sept. 11, 2024 (GLOBE NEWSWIRE) — Merit Medical Systems, Inc. (NASDAQ: MMSI), a leading global manufacturer and marketer of healthcare technology, announced today that clinicians will present updates on two of its pivotal studies during scientific sessions held on September 14 at CIRSE in Lisbon, Portugal.
Merit Medical Announces Asset Purchase Agreement with EndoGastric Solutions, Inc.®
Asset acquisition expands Merit’s endoscopy portfolio with a minimally invasive solution for patients suffering from chronic gastroesophageal reflux disease (GERD). Asset acquisition projected to add approximately $30 million of revenue, on an annualized basis, in key gastrointestinal endoscopy market that leverages existing commercial footprint. Merit reaffirms full-year 2024 financial guidance on standalone basis and updates full-year 2024 financial guidance to include projected partial-year impact from this acquisition. SOUTH JORDAN, Utah, July 01, 2024 (GLOBE NEWSWIRE) — Merit Medical Systems, Inc. (NASDAQ: MMSI), a global leader of healthcare technology, today announced it has executed an asset purchase agreement with EndoGastric Solutions, Inc. for a total cash consideration of approximately $105 million. EndoGastric Solutions’ EsophyX® Z+ device delivers a durable, minimally invasive non-pharmacological treatment option for patients suffering from GERD. GERD is a digestive disorder that occurs when the lower esophageal sphincter doesn’t tighten correctly, allowing acid from the stomach to enter the esophagus. When this occurs chronically, it can result in serious health conditions, such as esophageal damage and cancer. The EsophyX Z+ device treats GERD by restoring the body’s reflux barrier. “This acquisition is consistent with our Continued Growth Initiatives. It enhances our product portfolio in existing clinical specialties while expanding our global footprint in the multi-billion-dollar gastrointestinal market,” said Fred P. Lampropoulos, Merit’s Chairman and Chief Executive Officer. “We look forward to helping more patients by providing clinicians with a sustained and minimally invasive treatment option for chronic GERD.” Mr. Lampropoulos continued: “In addition to the strong strategic rationale, we believe the financial profile of this acquisition is compelling. While modestly dilutive to our full year 2024 non-GAAP profitability given the partial-year contribution, we expect the acquisition to be accretive to our non-GAAP gross and operating margins*, non-GAAP net income* and non-GAAP EPS* in the first full year post-closing. Importantly, we reaffirmed our full-year 2024 financial guidance on a stand-alone basis and we look forward to discussing this acquisition and our updated outlook for 2024 on our second quarter earnings report on August 1, 2024.” * Non-GAAP net income; non-GAAP earnings per share; non-GAAP gross margin; non-GAAP operating margin and constant currency revenue are non-GAAP financial measures. A description of these financial measures is included under the heading “Non-GAAP Financial Measures” below. A quantitative reconciliation of such financial measures to comparable GAAP financial measures is not available without unreasonable effort. About EsophyX Z+ Treatment By restoring the body’s reflux barrier, the acquired EsophyX Z+ device is designed to provide relief of GERD symptoms and reduce acid reflux that can cause long-term complications and risk. This is accomplished under endoscopic visualization during a minimally invasive procedure called Transoral Incisionless Fundoplication (TIF 2.0). Recently, the American Gastroenterology Association released a clinical practice update on the evaluation and management of GERD and listed TIF 2.0 as an effective endoscopic option in carefully selected patients.2 TIF 2.0 can also be combined with a surgical hiatal hernia repair, in a procedure referred to as Concomitant Transoral Incisionless Fundoplication (cTIF). During cTIF, an interventional gastroenterologist and a surgeon collaborate to bridge the treatment gap between medication and more invasive-surgical fundoplication. Financial Summary: The assets acquired from EndoGastric Solutions generated approximately $26 million of revenue over the twelve-month period ended December 31, 2023. The acquired assets are expected to contribute revenue, from closing date through December 31, 2024, in the range of $13 to $15 million and are expected to dilute Merit’s previously forecasted non-GAAP operating margin, non-GAAP net income and non-GAAP earnings per share, inclusive of approximately $2.7 million of lower interest income on cash balances used for the total purchase consideration and excluding approximately $6.5 million of non-cash and non-recurring transaction-related expenses, and to be dilutive to Merit’s full-year 2024 GAAP net income and GAAP earnings per share. The acquisition is expected to be accretive to non-GAAP gross margin, non-GAAP operating margin, non-GAAP net income and non-GAAP earnings per share in the first full-year post close, but dilutive to Merit’s GAAP net income and earnings per share for that period. Updated Fiscal Year 2024 Financial Guidance Merit’s updated full-year 2024 financial guidance now reflects the forecasted impacts of the acquisition of EndoGastric Solutions from the closing date through December 31, 2024. Merit is reaffirming prior full-year 2024 financial guidance ranges for the stand-alone Merit business previously announced on April 30, 2024. 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 acquired from EndoGastric Solutions, but absent material acquisitions, non-recurring transactions or other factors beyond Merit’s current expectations, Merit now expects the following financial results: Revenue and Earnings Guidance* Updated Guidance(1)Prior Guidance(2) Year Ending% Change Year Ending% Change Financial Measure December 31, 2024Y/YDecember 31, 2024Y/Y Net Sales $1.324 – $1.340 billion5% – 7%$1.312 – $1.325 billion4% – 5% Cardiovascular Segment $1.272 – $1.285 billion4% – 5%$1.272 – $1.285 billion4% – 5% Endoscopy Segment $53.3 – $55.7 million45% – 51%$39.7 – $40.1 million8% – 9% Non-GAAP Earnings Per Share $3.22 – $3.317% – 10%$3.28 – $3.359% – 11% *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) LowHighLow High 2024 Net Sales Guidance – % Change from Prior Year (GAAP) 5.3%6.6%4.3% 5.4% Estimated impact of foreign currency exchange rate fluctuations 0.5%0.5%0.5% 0.5% 2024 Net Sales Guidance – % Change from Prior Year (Constant Currency) 5.8%7.1%4.8% 5.9% *Percentage figures approximated and may not foot due to rounding (1) “Updated Guidance” reflects Merit’s full-year 2024 financial guidance on standalone basis, plus the forecasted impacts of the acquisition of EndoGastric Solutions, Inc. from closing date 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, excluding the acquisition of the assets of EndoGastric Solutions. 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 items 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, 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”). Second Quarter of Fiscal Year 2024 Financial Results Conference Call: Merit will release its financial results for the quarter ended June 30, 2024, after the close of the stock market on Thursday, August 1, 2024 and will host a conference call at 5:00 p.m. Eastern that day (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. Advisors: Oppenheimer & Co. acted as a financial advisor to Merit. Parr Brown Gee & Loveless P.C. served as legal advisor to Merit. Cooley LLP served as legal advisor to EndoGastric Solutions, Inc. Non-GAAP Financial Measures Although Merit’s financial statements are prepared in accordance with accounting principles generally accepted in the United States of America, 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 referenced in this release include: constant currency revenue; non-GAAP gross profit and margin; non-GAAP operating income and margin; non-GAAP net income; and non-GAAP earnings per share. Merit’s management team uses these non-GAAP financial measures to evaluate Merit’s profitability and efficiency, to compare operating 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 referenced 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 profit and margin, non-GAAP operating income and margin, and non-GAAP net income 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 referenced 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 referenced 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 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 US 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 US dollar. 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, corporate transformation expenses, expenses resulting from non-ordinary course litigation or administrative proceedings and resulting settlements, governmental proceedings, and changes in governmental or industry regulations. 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, gains or losses on disposal of certain assets, changes in tax regulations, and other items. Non-GAAP EPS Non-GAAP EPS is defined as non-GAAP net income divided by the diluted shares outstanding for the corresponding period. 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 Statements contained in this release which are not purely historical, including, without limitation, statements regarding Merit’s forecasted plans, revenues, net sales, net income (GAAP and non-GAAP), operating income and margin (GAAP and non-GAAP), gross profit and margin (GAAP and non-GAAP), earnings per share (GAAP and non-GAAP), 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, 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, 2023 (the “2023 Annual Report”) and other filings with the SEC. Such risks and uncertainties include inherent risks and uncertainties associated with Merit’s integration of the assets and operations acquired from EndoGastric Solutions and its ability to achieve anticipated financial results, product development and other anticipated benefits of the EndoGastric Solutions 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 U.S. Office of Inspector General – Department of Health and Human Services; difficulties, delays and expenditures relating to development, testing and regulatory approval or clearance of Merit’s products, including the pursuit of approvals under the European Union Medical Device Regulation, and risks that such products may not be developed successfully or approved for commercial use; 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; 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; 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; 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 release are made only as of the date of this release, 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. REFERENCES 1. Sharma et al. 2023. “Healthcare Resource Utilization and Costs Among Patients With Gastroesophageal Reflux Disease, Barrett’s Esophagus, and Barrett’s Esophagus–Related Neoplasia in the United States.” Journal of Health Economics and Outcomes Research 10, no. 1 (March): 51 ̶ 58. Accessed June 11, 2024. doi: 10.36469/001c.68191. (PMID: 58829388)2. 2. Yadlapati, Gyawali, and Pandolfino. 2022. “AGA Clinical Practice Update on the Personalized Approach to the Evaluation and Management of GERD: Expert Review.” Clinical Gastroenterology and Hepatology 20, no. 5 (May): 984 ̶ 94.e1. Accessed June 11, 2024. doi: 10.1016/j.cgh.2022.01.025. (PMID: 35123084)
Merit Medical Systems to Announce Second Quarter 2024 Results on August 1, 2024
SOUTH JORDAN, Utah, June 18, 2024 (GLOBE NEWSWIRE) — Merit Medical Systems, Inc. (NASDAQ: MMSI), a leading global manufacturer and marketer of healthcare technology, announced today that it will release its financial results for the quarter ended June 30, 2024, after the close of the stock market on Thursday, August 1, 2024. Merit will hold its investor conference call on the same day (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 can be accessed using this link. A link to both register for the conference call and view the webcast will be made available at merit.com. 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.
Merit Medical Launches basixSKY™ Inflation Device
SOUTH JORDAN, Utah, May 21, 2024 (GLOBE NEWSWIRE) — Merit Medical Systems, Inc. (NASDAQ: MMSI), a global leader of healthcare technology, today announced the US commercial release of the basixSKY Inflation Device. BasixSKY is the latest addition to Merit’s comprehensive inflation device portfolio, which includes both digital and analog devices. The basixSKY is available as a standalone solution and in kits with Merit Angioplasty Packs, configured to offer complementing AccessPLUS™, Honor®, and PhD™ hemostasis valves. Designed with ease of use in mind, the new device is simple and highly responsive, creating an efficient approach to inflation. Rotational torque and handle revolutions to reach pressure are minimized, and a comfort-grip feature enables one-handed preparation. Learn more about the basixSKY Inflation Device. Endovascular interventions, such as balloon angioplasty and stent placement procedures used to widen narrowed or blocked coronary and peripheral arteries, utilize an inflation device. These are minimally invasive techniques that can restore blood flow through diseased vessels and minimize damage to surrounding tissue. In 2024, it is estimated that 1.79 million coronary balloon and stent placement procedures will be performed in the United States.1 “We are pleased to broaden our portfolio of inflation devices,” said Fred P. Lampropoulos, Merit’s Chairman and Chief Executive Officer. “With high-quality digital and analog solutions and custom kit options, we remain a leader in the inflation device market. We’re proud of that. We look forward to continuing to serve our healthcare partners, helping them to provide the best patient care.” ABOUT MERIT MEDICAL 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. 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 +1-801-432-2864 | sarah.comstock@merit.com INVESTOR INQUIRIES Mike Piccinino, CFA, IRC Westwicke – ICR +1-443-213-0509 | mike.piccinino@westwicke.com 1. Clarivate DRG, Market Insights ǀ Interventional Cardiology Devices ǀ United States ǀ 2023, December 29, 2022 (Clarivate, 2022).
Merit Medical Expands Embolics Portfolio with New Siege™ Vascular Plug and Bearing nsPVA Express™ Prefilled Syringe
SOUTH JORDAN, Utah, May 14, 2024 (GLOBE NEWSWIRE) — Merit Medical Systems, Inc. (NASDAQ: MMSI), a global leader of healthcare technology, today announced US Food and Drug Administration (FDA) 510(k) clearance for its Siege Vascular Plug. Merit also announced the launch of its Bearing nsPVA Express Prefilled Syringe in the United States and Australia.
Merit Medical Launches the Micro ACE™ Advanced Micro-Access System
Micro ACE combines a unique balance of stiffness and resiliency to achieve successful micro-access in challenging casesSOUTH JORDAN, Utah, March 19, 2024 (GLOBE NEWSWIRE) — Merit Medical Systems, Inc. (NASDAQ: MMSI), a global leader of healthcare technology, today announced commercial release of its US Food and Drug Administration (FDA)-cleared Micro ACE Advanced Micro-Access System. Merit also intends to file Micro ACE for CE mark designation. The Micro ACE system is the latest innovation in the Merit Vascular portfolio. The comprehensive portfolio includes a full range of percutaneous access and closure devices. Combining a balance of stiffness and resiliency, Micro ACE is designed to achieve micro-access in a wide range of vascular anatomies. Interventional procedures utilizing micro-access are commonly performed to diagnose and open narrowed (i.e., atherosclerotic) blood vessels. Atherosclerosis is an inflammatory condition that develops when there is a buildup of plaque inside the arteries. Diseases linked to atherosclerosis, such as coronary and peripheral artery disease, are the leading cause of death in the United States.1 To facilitate such interventional procedures, the Micro ACE balances stiffness and flexibility to offer twice the resistance to kink and compression over the leading competitor. 2 It is also 9% stiffer than the leading standard micro-introducer. 2 In addition, a unique marker tip design allows for nine times greater visibility under fluoroscopy for accurate positioning needed at the start of a procedure.2 Merit is pursuing patents on Micro ACE technology in the United States and internationally. Learn more about the Micro ACE. “Merit has always looked for opportunities to improve patient care. Micro ACE leverages our experience with reinforced sheath design to improve a procedure that is done over and over each day,” said Fred P. Lampropoulos, Merit’s Chairman and CEO. “We are excited to partner with interventional physicians to advance vascular access.” ABOUT MERIT MEDICAL 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 in excess of 700 individuals. Merit employs approximately 7,000 people worldwide. TRADEMARKSUnless 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 +1-801-432-2864 | sarah.comstock@merit.com INVESTOR INQUIRIES Mike Piccinino, CFA, IRC Westwicke – ICR +1-443-213-0509 | mike.piccinino@westwicke.com 1. National Heart, Lung, and Blood Institute (NIH). 2022. “Atherosclerosis.” Last modified March 24, 2022. Accessed March 18, 2024. https://www.nhlbi.nih.gov/health/atherosclerosis 2. Data on File.
Merit Medical Systems to Announce First Quarter 2024 Results on April 30, 2024
SOUTH JORDAN, Utah, March 18, 2024 (GLOBE NEWSWIRE) — Merit Medical Systems, Inc. (NASDAQ: MMSI), a leading global manufacturer and marketer of healthcare technology, announced today that it will release its financial results for the quarter ended March 31, 2024, after the close of the stock market on Tuesday, April 30, 2024. Merit will hold its investor conference call on the same day (Tuesday, April 30, 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 can be accessed using this link. A link to both register for the conference call and view the webcast will be made available at merit.com. 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. Contacts: PR/Media Inquiries:Teresa Johnson Merit MedicalInvestor Inquiries:Mike Piccinino, CFA, IRCWestwicke – ICR+1-801-208-4295+1-443-213-0509tjohnson@merit.commike.piccinino@westwicke.com
Merit Medical to Host Evening of Innovation during the 2024 Society of Interventional Radiology (SIR) Annual Scientific Meeting
SOUTH JORDAN, Utah, March 05, 2024 (GLOBE NEWSWIRE) — Merit Medical Systems, Inc. (NASDAQ: MMSI), a global leader of healthcare technology, announced today a series of events for clinicians attending the 2024 SIR Annual Meeting. These educational events will take place at Merit’s headquarters and at SIR booth 320. On […]