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
Other News
Nanox to Present New Clinical Data on Nanox.ARC Advanced 3D Digital Tomosynthesis Imaging System at ECR 2025
PETACH TIKVA, Israel, Feb. 25, 2025 (GLOBE NEWSWIRE) — NANO-X IMAGING LTD (“Nanox” or the “Company”, Nasdaq: NNOX), an innovative medical imaging technology company, today announced that it will present data supporting the Nanox.ARC performance at the 2025 European Congress of Radiology (ECR), taking place February 26 – March 2 in Vienna, Austria.
Heartflow Unveils Bold New Vision for Management of Coronary Artery Disease
New Brand Identity Reaffirms Commitment to Transforming the World’s Leading Cause of Death Into a Manageable Condition
We’ve entered a new era at Heartflow – reaffirming our commitment to transforming coronary artery disease into a manageable condition. Discover what it means to see CAD clearly and manage it for life.
MOUNTAIN VIEW, Calif., Feb. 25, 2025 (GLOBE NEWSWIRE) — Heartflow, Inc., the global leader in AI technology for coronary artery disease (CAD) management, today introduced its new brand identity reflecting its focus on delivering clarity, precision, and confidence in the prevention, diagnosis, and treatment of CAD. This updated identity represents a new era for Heartflow, reinforcing the company’s leadership in providing clinicians with decisive insights to manage CAD throughout patients’ lives. Heartflow has helped clinicians manage over 400,000 patients worldwide and is striving to make a difference for the millions of patients whose lives are impacted by CAD every year. “At Heartflow, we are working toward a new vision to transform coronary artery disease from the leading cause of death to a disease that can be managed for life,” said John Farquhar, president and CEO of Heartflow. “With our AI-driven technology, we’re doing more than diagnosing CAD – we’re equipping clinicians with the insights needed to develop personalized treatment plans to provide the best possible care to each patient. We’re excited about the future, where Heartflow is positioned to help physicians identify CAD earlier and guide patients toward a lifetime of better health.” Heartflow’s new branding will be rolled out across all company materials, product interfaces, social media channels, and the Heartflow.com website beginning today. Importantly, the new brand identity and materials reflect input collected from Heartflow customers and cardiovascular community stakeholders. A key element of Heartflow’s approach is close collaboration with clinical teams to improve patient experiences, create efficient care pathways, and reach more patients with personalized insights, ensuring the best possible outcomes. In the U.S., CAD is estimated to be responsible for one heart attack every 40 seconds and one out of every five deaths.1 Many of the estimated 18 million adults in the U.S. and 315 million people globally living with CAD either have no symptoms or symptoms that go unrecognized.2, 3 Heartflow is working to ensure that its technology not only helps clinicians see CAD earlier but also transforms how they understand and manage the disease. Coronary computed tomography angiography (CCTA) was a major advancement in CAD diagnostics, helping physicians estimate if a stenosis was significant and requiring intervention. Technologies like Heartflow fractional flow reserve computed tomography (FFRCT) provide lesion-specific physiology, which enhances CCTA’s diagnostic accuracy. Now Heartflow Plaque Analysis leverages AI to quantify and characterize the amount and type of plaque present in the arteries from a single CCTA scan. These advancements provide physicians with more precise, personalized insights into heart health, aiding in treatment planning and identifying individuals at high risk of major adverse cardiovascular events (MACE), such as heart attacks, which can occur in patients with and without symptoms of CAD. Heartflow is dedicated to defeating CAD by partnering with physicians to generate robust, high-quality clinical evidence. Heartflow has been adopted by more than 1,400 institutions globally and continues to strengthen its commercial presence to make its cutting-edge solutions more widely available to an increasingly diverse patient population worldwide. About Heartflow, Inc.Heartflow is advancing coronary care by transforming coronary artery disease into a screenable, diagnosable, and manageable condition. Heartflow One is the only complete, non-invasive, precision coronary care platform providing patient insights throughout the guideline-directed CCTA pathway. The AI-driven platform – including Roadmap™ Analysis, FFRCT Analysis and Plaque Analysis – is supported by the ACC/AHA Chest Pain Guideline and backed by more than 600 peer-reviewed publications. Heartflow has helped clinicians manage over 400,000 patients worldwide. Discover how we’re shaping the future of cardiovascular care at www.heartflow.com. References Centers for Disease Control and Prevention. Heart Disease Facts. https://www.cdc.gov/heart-disease/data-research/facts-stats. Accessed Feb. 18, 2025.Cleveland Clinic. Coronary Artery Disease. https://my.clevelandclinic.org/health/diseases/16898-coronary-artery-disease. Accessed Feb. 21, 2025.Stark, B, Johnson, C, Roth, G. Global Prevalence of Coronary Artery Disease: An Update From The Global Burden of Disease Study. JACC. 2024 Apr, 83 (13_Supplement) 2320. https://doi.org/10.1016/S0735-1097(24)04310-9 Media ContactElliot Levyelevy@heartflow.com Investor ContactNick Laudiconlaudico@heartflow.com A video accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/bcb78bab-c373-4d0e-98f6-de83872371f6
RadNet’s Wholly-Owned Subsidiary, DeepHealth, and ConcertAI’s TeraRecon Announce Strategic Collaboration Around Integrated AI and Advanced Visualization
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Initiation of ReDS-SAFE HF II Trial for Advancing Heart Failure Management
BOSTON, Feb. 24, 2025 /PRNewswire/ — At the THT conference, Dr. Jesus Alvarez-Garcia, MD, PhD, head of Advanced Heart Failure Unit at Ramón y Cajal Hospital in Madrid, announced the launch of ReDS-SAFE HF II, a large-scale investigator-initiated trial designed to validate the benefits of…
BioStem Receives Institutional Review Board (IRB) Approval to Advance Clinical Trial Demonstrating the Therapeutic Benefits of BioREtain® Technology in Treating Venous Leg Ulcers
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Enhancing radiology workflows: Sectra and Siemens Healthineers enable seamless integration across systems for better patient care
LINKÖPING, Sweden, Feb. 24, 2025 /PRNewswire/ — International medical imaging IT and cybersecurity company Sectra (STO: SECT B) and Siemens Healthineers AG are collaborating to improve radiologists’ diagnostic capabilities and, as such, patient care through a seamless integration. The…
Inozyme Pharma to Present Recently Announced Interim Data for INZ-701 in Infants and Young Children with ENPP1 Deficiency at CHOP Cardiology 2025
BOSTON, Feb. 21, 2025 (GLOBE NEWSWIRE) — Inozyme Pharma, Inc. (Nasdaq: INZY) (“the Company” or “Inozyme”), a clinical-stage biopharmaceutical company developing innovative therapeutics for rare diseases that affect bone health and blood vessel function, today announced that Kurt Gunter, M.D., Senior Vice President and Chief Medical Officer, will present recently announced data from the company’s Expanded Access Program (EAP) evaluating INZ-701 in infants and children with ENPP1 Deficiency at the CHOP Cardiology Annual Meeting, held February 19-23, 2025, in Orlando, Florida. Presentation Details: Title: Impact of the Enzyme Replacement Therapy, INZ-701, in Children with ENPP1 Deficiency: Experience from an Expanded Access ProgramPresentation Number: 10 – Poster SessionDate: Saturday, February 22, 2025Time: 10:00 – 11:00am ETPresenter: Kurt Gunter, M.D., Senior Vice President and Chief Medical Officer About ENPP1 Deficiency ENPP1 Deficiency is a serious and progressive rare disease that affects blood vessels, soft tissues, and bones. Individuals who present in utero or in infancy are typically diagnosed with generalized arterial calcification of infancy (GACI Type 1), with about 50% of these infants not surviving beyond six months. Children with this condition typically develop autosomal-recessive hypophosphatemic rickets type 2 (ARHR2), while adolescents and adults may develop osteomalacia, or softened bones. ARHR2 and osteomalacia cause pain and difficulty with movement. Additionally, patients may experience hearing loss, calcification in arteries and joints, and heart problems. ENPP1 Deficiency is an autosomal recessive disease and biallelic mutations are estimated to occur in approximately 1 in 64,000 pregnancies worldwide. Many individuals with just one copy of the mutated gene (monoallelic ENPP1 Deficiency) exhibit severe symptoms, suggesting that the worldwide prevalence of ENPP1 Deficiency is much higher than current estimates. Currently, there are no approved therapies for ENPP1 Deficiency. About Inozyme Pharma Inozyme Pharma is a pioneering clinical-stage biopharmaceutical company dedicated to developing innovative therapeutics for rare diseases that affect bone health and blood vessel function. We are experts in the PPi-Adenosine Pathway, where the ENPP1 enzyme generates inorganic pyrophosphate (PPi), which regulates mineralization, and adenosine, which controls intimal proliferation (the overgrowth of smooth muscle cells inside blood vessels). Disruptions in this pathway impact the levels of these molecules, leading to severe musculoskeletal, cardiovascular, and neurological conditions, including ENPP1 Deficiency, ABCC6 Deficiency, calciphylaxis, and ossification of the posterior longitudinal ligament (OPLL). Our lead candidate, INZ-701, is an ENPP1 Fc fusion protein enzyme replacement therapy (ERT) designed to increase PPi and adenosine, enabling the potential treatment of multiple diseases caused by deficiencies in these molecules. It is currently in clinical development for the treatment of ENPP1 Deficiency, ABCC6 Deficiency, and calciphylaxis. By targeting the PPi-Adenosine Pathway, INZ-701 aims to correct pathological mineralization and intimal proliferation, addressing the significant morbidity and mortality in these devastating diseases. For more information, please visit https://www.inozyme.com/ or follow Inozyme on LinkedIn, X, and Facebook. Contacts Investors:Inozyme PharmaStefan Riley, Senior Director of IR and Corporate Communications(617) 461-2442stefan.riley@inozyme.com Media:Biongage CommunicationsTodd Cooper(617) 840-1637todd@biongage.com
Bracco and the European Society of Radiology build on long-standing partnership at ECR 2025 through new campaign to advance innovative and sustainable approaches in radiology
Bracco will present an immersive experience at its booth to educate congress attendees on the importance of corporate commitment to sustainability and how its MR imaging portfolio contributes to the progress of sustainable radiology. Bracco will reinforce its commitment to deepening…
Shape Memory Medical Announces European Enrollment in the AAA-SHAPE Randomized Controlled Pivotal Trial
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