Financial

InspireMD to Announce Fourth Quarter and Full Year 2024 Financial Results

MIAMI, Feb. 26, 2025 (GLOBE NEWSWIRE) — InspireMD, Inc. (Nasdaq: NSPR), developer of the CGuard™ Prime carotid stent system for the treatment of carotid artery disease (CAD) and prevention of stroke, today announced that it will release its fourth quarter and full year 2024 financial results on Wednesday, March 12, 2025. In conjunction with the release, InspireMD will host a conference call and webcast at 8:30 a.m. Eastern Time to discuss its financial results and recent highlights.

Merit Medical Reports Fourth Quarter and Full Year 2024 Results and Issues Fiscal Year 2025 Guidance

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

BridgeBio Pharma Reports Fourth Quarter and Full Year 2024 Financial Results and Commercial Update

– As of February 17, 2025, 1,028 unique patient prescriptions for Attruby™ have been written by 516 unique prescribers since FDA approval – Attruby (acoramidis), the first and only near-complete TTR stabilizer (≥90%) was approved by the FDA to reduce cardiovascular death and cardiovascular-related hospitalization in ATTR-CM patients on November 22, 2024 – Acoramidis was approved as BEYONTTRA™ in the EU on February 10, 2025, achieving a $75 million milestone payment and ongoing royalties in a tiered structure beginning in the low-thirties percent on sales in the EU – Acoramidis demonstrated a 59% hazard reduction on the composite endpoint of all-cause mortality and first cardiovascular-related hospitalization in the variant ATTR-CM population by month 30; to the Company’s knowledge, this benefit is the largest and the only statistically significant result in this patient population, which has an aggressive phenotype and poor prognosis – Fully enrolled three global registrational studies – FORTIFY (BBP-418 for LGMD2I/R9), CALIBRATE (encaleret for ADH1), and PROPEL 3 (infigratinib for achondroplasia) – with last participant – last visit expected for each study before the end of 2025 – The Company ended the fourth quarter with $681 million in cash, cash equivalents, and short-term restricted cash. Further, the Company expects to receive $105 million in regulatory milestones in 1H 2025 from acoramidis Europe and Japan approvals PALO ALTO, Calif., Feb. 20, 2025 (GLOBE NEWSWIRE) — BridgeBio Pharma, Inc. (Nasdaq: BBIO) (“BridgeBio” or the “Company”), a new type of biopharmaceutical company focused on genetic diseases announced today its financial results for the fourth quarter and full year ended December 31, 2024, and provided an update on Attruby’s commercial progress. Commercial Progress: As of February 17, 2025, 1,028 unique patient prescriptions for Attruby have been written by 516 unique healthcare providers since FDA approval. ”I am very encouraged by the strength of the Attruby launch, with prescriptions being successfully filled across all patient types,” said Matt Outten, Chief Commercial Officer of BridgeBio. “In conversations with healthcare providers and patients, we have repeatedly heard that Attruby’s category-leading results – time to separation of just three months, along with a 42% reduction in all-cause mortality and recurrent hospitalizations and a 50% reduction in cardiovascular hospitalizations at 30 months – set it apart as a clinically meaningful advancement for ATTR-CM. Combined with our industry-leading patient support programs, we believe Attruby is delivering a much-needed change in the treatment landscape.” Pipeline Overview: ProgramStatusNext expected milestone Acoramidis for ATTR-CMApproved in U.S. and EUJapan approval in 1H 2025BBP-418 for LGMD2I/R9 FORTIFY, Phase 3 study enrollment completed Last Participant – Last Visit and Topline results in 2H 2025Encaleret for ADH1CALIBRATE, Phase 3 study enrollment completed Last Participant – Last Visit and Topline results in 2H 2025Infigratinib for achondroplasiaPROPEL 3, Phase 3 study enrollment completed Last Participant – Last Visit in 2H 2025Infigratinib for hypochondroplasiaACCEL, run-in for Phase 2 study ongoingEnrollment completion date to be announcedBBP-812 for Canavan diseaseCANaspire Phase 1/2 study ongoingEnrollment completion date to be announced Key Program Updates: “It is exciting to see patients, physicians, and payers resonate with our message that the greater levels of TTR stabilization that Attruby delivers can be of benefit to the patients we serve and that the TTR protein is clinically important, not toxic.” said Neil Kumar, Ph.D., Founder and CEO of BridgeBio. “We look forward to continuing to partner with the community to ensure that we find all patients that can be helped and ease their path to getting on therapy, when appropriate, as much as possible.” Attruby (acoramidis) – the first approved, near-complete (≥90%) TTR stabilizer for treatment of transthyretin amyloid cardiomyopathy (ATTR-CM): On November 22, 2024, the U.S. Food and Drug Administration (FDA) approved Attruby (acoramidis), a near-complete TTR stabilizer (≥90%), to reduce cardiovascular death and cardiovascular-related hospitalization (CVH) in adult patients with ATTR-CM.On February 10, 2025, the European Commission approved BEYONTTRA (acoramidis) for use in adult patients with ATTR-CM in the EU.Preliminary results from the ongoing ATTRibute-CM open-label extension (OLE) study of Attruby in ATTR-CM were simultaneously published in Circulation and presented at the American Heart Association Scientific Sessions, showing that Attruby demonstrated statistically significant risk reduction of 36% on All-Cause Mortality (ACM) alone at month 36 within the OLE, and 46% (p

VitalConnect, Inc. Secures $100 Million in Financing

SAN JOSE, Calif.–(BUSINESS WIRE)–VitalConnect®, Inc., a leader in biosensor technology, specializing in ambulatory cardiac monitoring, today announced the closing of $100 million in financing through a combination of equity and debt capital. The equity financing was led by new investor Ally Bridge Group, with significant participation from the Company’s existing […]

BIOTRONIK and Egg Medical Form Strategic Alliance to Improve Radiation Protection for Interventional Healthcare Workers

BIOTRONIK, a global leader in cardiovascular, endovascular, and neuromodulation solutions, today announced it is partnering with Egg Medical, Inc., a global leader in radiation protection technology, to co-sell Egg Medical’s EggNest™ Radiation Protection Systems for healthcare workers in the United States. The EggNest Systems (EggNest XR, EggNest Protect & EggNest Complete) are […]

OrphAI Therapeutics Announces Appointment of Dr. Aaron Waxman to Board of Directors

Leading clinician and researcher in Pulmonary Disease TherapeuticsNEW HAVEN, Conn., Feb. 19, 2025 (GLOBE NEWSWIRE) — OrphAI Therapeutics Inc. (“OrphAI”), a clinical-stage biopharmaceutical company developing novel therapeutics for diseases with unmet needs, announced today the appointment of Aaron B. Waxman, M.D., Ph.D. to its Board of Directors. Waxman is a distinguished clinician and researcher specializing in pulmonary disease, with a particular focus on pulmonary hypertension (PH). He has authored over 150 peer-reviewed publications, including more than 70 in the field of PH. Dr. Waxman has served as a principal investigator for numerous clinical trials evaluating investigational treatments for PH, including Sotatercept and Treprostinil. His research contributions span key areas including inflammatory mediators driving vascular remodeling, early disease phenotyping, and the application of invasive cardiopulmonary exercise testing for diagnosis and disease monitoring. In addition to his research, Dr. Waxman is the Executive Director of the Center for Pulmonary Heart Disease, and the Director of the Pulmonary Vascular Disease Program at Brigham and Women’s Hospital and an Associate Professor of Medicine at Harvard Medical School. He has a dual appointment at Mass General Brigham in Cardiovascular Medicine and Pulmonary and Critical Care. His work has significantly advanced understanding of the pathophysiology of pulmonary vascular diseases and has led to innovative approaches in both clinical care and therapeutic development. Dr. Aaron Waxman holds a Ph.D. in Anatomy and Neuroscience from Albany Medical College and an M.D. from Yale University School of Medicine. He completed his residency in internal medicine at Yale New Haven Hospital, followed by two fellowships: one at the Howard Hughes Medical Institute and another in pulmonary and critical care medicine at Yale University school of Medicine and Yale New Haven Hospital. Dr. Waxman is board certified in internal medicine, pulmonary disease, and critical care medicine. “Dr. Aaron Waxman provides a wealth of expertise and leadership in the study and development of new and approved agents in the pulmonary vascular disease armamentarium. His guidance and insights will be invaluable as we progress LAM-001 in pulmonary hypertension and other indications. After working with Aaron on our clinical trial of LAM-001 in pulmonary hypertension, it is an honor to now have him join our Board of Directors,” said Dr. Brigette Roberts, CEO and Director of OrphAI. “I am delighted to join the OrphAI Therapeutics’ Board of Directors,” said Dr. Waxman. “I look forward to working with their team to develop new, innovative therapies for pulmonary vascular diseases.” ”We are excited to welcome Dr. Aaron Waxman to our Board of Directors,” said David Scheer, Chairman of the Board of Directors at OrphAI. “His clinical leadership will be an important contribution to the company as we advance our programs through clinical development towards commercialization.” About OrphAI Therapeutics OrphAI Therapeutics’ mission is to transform the lives of patients in need of safe and effective disease modifying therapeutics. The company is currently developing two investigational therapies across multiple indications: LAM-001, a proprietary inhaled form of rapamycin, currently in Phase 2 for Groups 1 and 3 pulmonary hypertension and bronchiolitis obliterans syndrome (BOS); and AIT-102, a proprietary analogue of mithramycin, in preclinical development, for the treatment of transcriptionally dysregulated tumors. To learn more, please visit: OrphAI-Therapeutics.com CONTACT: MEDIA CONTACT:
info@orphai-therapeutics.com

Endovascular Engineering Raises $42 Million in Series B Financing to Advance the Treatment of Pulmonary Embolism

MENLO PARK, Calif., Feb. 18, 2025 /PRNewswire/ — Endovascular Engineering, Inc. (“E2”) has secured $42 million in an oversubscribed Series B financing to advance its next generation clot removal technology platform for venous thromboembolism (VTE). The round was co-led by 415 Capital and…

Kestra Medical Technologies, Ltd. Appoints Al Ford as Chief Commercial Officer

KIRKLAND, Wash., Feb. 18, 2025 (GLOBE NEWSWIRE) — Kestra Medical Technologies Ltd. (“Kestra”), a wearable medical device and digital healthcare company, announced today that Al Ford is joining the company as Chief Commercial Officer (CCO). Mr. Ford will be responsible for advancing sales strategies and leading the Kestra commercial team. “We are pleased to welcome Al to the team,” said Brian Webster, President and Chief Executive Officer at Kestra. “With significant experience managing strategic sales and commercial operations, he brings valuable knowledge, perspective, and leadership to our organization. Al also has deep experience in the underlying defibrillation technologies that are central to the ASSURE® system. We are confident that he will be an impactful addition as we continue to drive adoption of our lifesaving system.” Mr. Ford brings 20 years of experience in MedTech organizations to his new role at Kestra. Most recently, he served as Chief Commercial Officer at Axonics where he led the development and execution of their commercialization strategy. Prior to that, he was Chief Commercial Officer at Cardiac Science Corporation. “I am honored to join Kestra in a commercial leadership role that aligns seamlessly with my experience,” said Mr. Ford. “The innovative Cardiac Recovery System® portfolio, and its ability to positively impact the lives of a meaningfully underserved patient population, were significant factors in my decision to join Kestra. I look forward to working with the team to execute on our commitment to patients and their prescribers.” About KestraKestra Medical Technologies, Ltd. is a commercial-stage wearable medical device and digital healthcare company focused on transforming patient outcomes in cardiovascular disease using diagnostic monitoring and therapeutic technologies that are intuitive, intelligent, and connected. Kestra was founded in 2014 by leaders from the external (AED) and implantable (ICD) defibrillation industries. For more information, visit www.kestramedical.com. INVESTOR CONTACTMarissa Bych or Webb CampbellGilmartin Groupinvestor.relations@kestramedical.com MEDIA CONTACTRhiannon PickusKestra Medical Technologies, Inc.Rhiannon.Pickus@kestramedical.com

Orchestra BioMed Appoints Vivek Reddy, M.D. as Executive Chairman of the BACKBEAT Study Steering Committee and Chairman of Bioelectronic Therapies Scientific Advisory Board

The BACKBEAT global pivotal study is currently enrolling patients to evaluate the efficacy and safety of atrioventricular interval modulation (“AVIM”) therapy for patients who have uncontrolled hypertension and a pacemaker indicationA globally recognized thought leader and innovator in cardiovascular technologies, including electrophysiology and cardiac rhythm management, Dr. Reddy currently serves as the Director of Cardiac Arrhythmia Services at The Mount Sinai Fuster Heart Hospital, the Director of Electrophysiology for the Mount Sinai Health System, and the Leona M. and Harry B. Helmsley Charitable Trust Professor of Medicine in Cardiac Electrophysiology at the Icahn School of Medicine at Mount Sinai NEW HOPE, Pa., Feb. 18, 2025 (GLOBE NEWSWIRE) — Orchestra BioMed Holdings, Inc. (Nasdaq: OBIO, “Orchestra BioMed” or the “Company”), a biomedical company accelerating high-impact technologies to patients through risk-reward sharing partnerships, today announced the appointment of Vivek Reddy, M.D., as Executive Chairman of the Company’s BACKBEAT Study Steering Committee and Chairman of its Bioelectronic Therapies Scientific Advisory Board. In these roles, Dr. Reddy will provide critical leadership in continuing to execute the BACKBEAT global pivotal study and further develop scientific evidence and clinical value for the Company’s bioelectronic therapies portfolio. Dr. Reddy commented, “I believe strongly in the transformative potential of AVIM therapy to help address uncontrolled hypertension in populations with increased cardiovascular risk such as the pacemaker-indicated patients we are focusing on in the BACKBEAT study. Hypertension is a critical global health challenge affecting hundreds of millions of patients worldwide. For patients with increased cardiovascular risk, the prospect of integrating an always-on, adjustable hypertension treatment that doesn’t rely on patient adherence is truly exciting. I am dedicated to driving the successful completion of the BACKBEAT study and synchronizing efforts among Orchestra BioMed’s clinical advisors to fully realize the potential of AVIM therapy for hypertension populations with increased cardiovascular risk. I’m also excited about exploring other therapeutic applications for which we believe there is potential utility for this novel technology.” “We are thrilled to have Dr. Vivek Reddy assume these key leadership roles to help drive successful completion of the BACKBEAT global pivotal study and maximize the clinical value AVIM therapy can potentially offer to patients with uncontrolled hypertension worldwide,” said David Hochman, Chairman, Chief Executive Officer, and Founder of Orchestra BioMed. “While Dr. Reddy has been a long-standing advisor to this exciting program, his expanded role will allow him to further engage in establishing awareness of AVIM therapy in the clinical community and drive effective communication across our distinguished team of clinical advisors. We believe his leadership will be instrumental in educating the clinical community about the BACKBEAT study and AVIM therapy, ultimately helping us and our colleagues at Medtronic deliver this exciting device-based treatment option to patients worldwide. We also look forward to collaborating closely with Dr. Reddy as we continue research and development of our proprietary bioelectronic therapies for additional indications such as heart failure.” Dr. Reddy currently serves as the Director of Cardiac Arrhythmia Services at The Mount Sinai Fuster Heart Hospital, the Director of Electrophysiology for the Mount Sinai Health System, and the Leona M. and Harry B. Helmsley Charitable Trust Professor of Medicine in Cardiac Electrophysiology at the Icahn School of Medicine at Mount Sinai. Dr. Reddy has led groundbreaking work in catheter ablation for atrial fibrillation and ventricular tachycardia, as well as leadless pacing and has been at the forefront of device therapies for stroke prevention, positioning him as one of the most respected experts in electrophysiology. Under his leadership, Mount Sinai has served as the lead investigational site for many pioneering clinical trials, and in 2014 implanted the world’s first leadless pacemaker. Dr. Reddy’s commitment to advancing medical innovation and his track record in clinical study leadership will play a pivotal role in the continued success of Orchestra BioMed’s efforts to revolutionize device-based cardiovascular solutions. About Orchestra BioMedOrchestra BioMed (Nasdaq: OBIO) is a biomedical innovation company accelerating high-impact technologies to patients through risk-reward sharing partnerships with leading medical device companies. Orchestra BioMed’s partnership-enabled business model focuses on forging strategic collaborations with leading medical device companies to drive successful global commercialization of products it develops. Orchestra BioMed’s lead product candidate is atrioventricular interval modulation (“AVIM”) therapy for the treatment of hypertension, a significant risk factor for death worldwide. Orchestra BioMed is also developing Virtue® Sirolimus AngioInfusion™ Balloon (SAB) for the treatment of atherosclerotic artery disease, the leading cause of mortality worldwide. Orchestra BioMed has a strategic collaboration with Medtronic, one of the largest medical device companies in the world, for development and commercialization of AVIM therapy for the treatment of hypertension in pacemaker-indicated patients, and a strategic partnership with Terumo, a global leader in medical technology, for development and commercialization of Virtue SAB for the treatment of artery disease. For further information about Orchestra BioMed, please visit www.orchestrabiomed.com, and follow us on LinkedIn. References to Websites and Social Media Platforms References to information included on, or accessible through, websites and social media platforms do not constitute incorporation by reference of the information contained at or available through such websites or social media platforms, and you should not consider such information to be part of this press release. Forward-Looking Statements Certain statements included in this press release that are not historical facts are forward-looking statements for purposes of the safe harbor provisions under the United States Private Securities Litigation Reform Act of 1995. Forward-looking statements generally are accompanied by words such as “believe,” “may,” “will,” “estimate,” “continue,” “anticipate,” “intend,” “expect,” “should,” “would,” “plan,” “predict,” “potential,” “seem,” “seek,” “future,” “outlook” and similar expressions that predict or indicate future events or trends or that are not statements of historical matters. These forward-looking statements include, but are not limited to, statements relating to the potential efficacy and safety of the Company’s commercial product candidates, additional indications of the Company’s proprietary bioelectronic therapies, implementation of the Company’s ongoing BACKBEAT global pivotal study, the ability of the Company’s partnerships to accelerate clinical development, and the Company’s late-stage development programs, strategic partnerships and plans to expand its product pipeline. These statements are based on various assumptions, whether or not identified in this press release, and on the current expectations of the Company’s management and are not predictions of actual performance. These forward-looking statements are provided for illustrative purposes only and are not intended to serve as and must not be relied on as a guarantee, an assurance, a prediction, or a definitive statement of fact or probability. Actual events and circumstances are difficult or impossible to predict and may differ from assumptions. Many actual events and circumstances are beyond the control of the Company. These forward-looking statements are subject to a number of risks and uncertainties, including changes in domestic and foreign business, market, financial, political, and legal conditions; risks related to regulatory approval of the Company’s product candidates and ongoing regulation of the Company’s product candidates, if approved; the timing of, and the Company’s ability to achieve, expected regulatory and business milestones; the impact of competitive products and product candidates; and the risk factors discussed under the heading “Item 1A. Risk Factors” in the Company’s annual report on Form 10-K for the year ended December 31, 2023, which was filed with the U.S. Securities and Exchange Commission on March 27, 2024, as updated by any risk factors disclosed under the heading “Item 1A. Risk Factors” in the Company’s subsequently filed quarterly reports on Form 10-Q. The Company operates in a very competitive and rapidly changing environment. New risks emerge from time to time. Given these risks and uncertainties, the Company cautions against placing undue reliance on these forward-looking statements, which only speak as of the date of this press release. The Company does not plan and undertakes no obligation to update any of the forward-looking statements made herein, except as required by law. Investor ContactSilas NewcombOrchestra BioMed (908) 723-4489 Snewcomb@orchestrabiomed.com Media ContactKelsey Kirk-EllisOrchestra BioMed(484) 682-4892Kkirkellis@orchestrabiomed.com