IRVINE, Calif.–(BUSINESS WIRE)–Edwards Lifesciences (NYSE: EW) today reported financial results for the quarter ended September 30, 2025. Recent Highlights Q3 sales grew 14.7% to $1.55 billion, or 12.6% adjusted1, with strength across all product groups Q3 TAVR sales grew 12.4%; constant currency1 sales grew 10.6% Q3 TMTT sales of $145.2 million, […]
Financial
Merit Medical Reports Third Quarter 2025 Results and Updates Full-Year Guidance
Highlights† Reported revenue of $384.2 million, up 13.0%Constant currency revenue* and constant currency revenue, organic* up 12.5% and up 7.8%, respectivelyGAAP operating margin of 11.1%, compared to 11.0% in prior year periodNon-GAAP operating margin* of 19.7%, compared to 19.2% in prior year periodGAAP EPS $0.46, down 3.0%Non-GAAP EPS* $0.92, up 6.7%Free cash flow* generation of $141.6 million over first nine months of 2025, up 17.6% year-over-year † Comparisons above are calculated for the current quarter compared with the third quarter of 2024, unless otherwise specified. Amounts stated 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, Oct. 30, 2025 (GLOBE NEWSWIRE) — Merit Medical Systems, Inc. (NASDAQ: MMSI), a leading global manufacturer and marketer of healthcare technology, today announced revenue of $384.2 million for the quarter ended September 30, 2025, an increase of 13.0% compared to the quarter ended September 30, 2024. Constant currency revenue for the third quarter of 2025 increased 12.5% compared to the prior year period and constant currency revenue, organic, for the third quarter of 2025 increased 7.8% compared to the prior year period. “Merit delivered better-than-expected financial performance in the third quarter, with top and bottom-line results exceeding the high-end of the company’s expectations,” said Martha G. Aronson, Merit’s President and CEO. “We have increased our 2025 revenue and non-GAAP earnings per share guidance to reflect the stronger-than-expected third quarter results and remain confident in our team’s ability to deliver strong execution, stable constant currency growth, improving profitability and solid cash flow generation this year.” Ms. Aronson continued: “I am proud to join the Merit Medical team and am committed to working closely with the executive leadership team, Fred and the rest of Merit’s Board of Directors to achieve a smooth transition and continued strong execution towards our Continued Growth Initiatives Program and related financial targets for the three-year period ending December 31, 2026.” Merit’s revenue by operating segment and product category for the three and nine-month periods ended September 30, 2025 and 2024 was as follows (unaudited; in thousands, except for percentages): Three Months Ended Reported Constant Currency* September 30, Impact of foreign September 30, 2025 2024(1) % Change exchange 2025 % ChangeCardiovascular Peripheral Intervention$144,781 $133,083 8.8% $(602) $144,179 8.3%Cardiac Intervention 116,682 90,240 29.3% (719) 115,963 28.5%Custom Procedural Solutions 54,136 50,455 7.3% (441) 53,695 6.4%OEM 50,826 49,077 3.6% (150) 50,676 3.3%Total 366,425 322,855 13.5% (1,912) 364,513 12.9% Endoscopy Endoscopy Devices 17,732 16,990 4.4% (14) 17,718 4.3% Total$384,157 $339,845 13.0% $(1,926) $382,231 12.5% Nine Months Ended Reported Constant Currency * September 30, Impact of foreign September 30, 2025 2024(1) % Change exchange 2025 % ChangeCardiovascular Peripheral Intervention$424,907 $397,535 6.9% $444 $425,351 7.0%Cardiac Intervention 331,674 273,723 21.2% (330) 331,344 21.1%Custom Procedural Solutions 155,712 149,110 4.4% (666) 155,046 4.0%OEM 156,870 143,676 9.2% (221) 156,649 9.0%Total 1,069,163 964,044 10.9% (773) 1,068,390 10.8% Endoscopy Endoscopy Devices 52,807 37,312 41.5% (5) 52,802 41.5% Total$1,121,970 $1,001,356 12.0% $(778) $1,121,192 12.0% (1)Commencing January 1, 2025, we reorganized our sales teams and product categories to include revenues from the sale of our spine devices under our OEM product category. Revenue figures for 2024 have been recast to reflect this realignment of our portfolio of spine products, representing approximately $5.7 million and $16.7 million in revenue for the three and nine-month periods ended September 30, 2024, within the OEM product category to provide comparability between the reported periods. Merit’s GAAP gross margin for the third quarter of 2025 was 48.5%, compared to GAAP gross margin of 46.4% for the third quarter of 2024. Merit’s non-GAAP gross margin* for the third quarter of 2025 was 53.6%, compared to non-GAAP gross margin* of 50.9% for the third quarter of 2024. Merit’s GAAP net income for the third quarter of 2025 was $27.8 million, or $0.46 per share, compared to GAAP net income of $28.4 million, or $0.48 per share, for the third quarter of 2024. Merit’s non-GAAP net income* for the third quarter of 2025 was $54.9 million, or $0.92 per share, compared to non-GAAP net income* of $51.2 million, or $0.86 per share, for the third quarter of 2024. As of September 30, 2025, Merit had cash and cash equivalents of $392.5 million and total debt obligations of $747.5 million, compared to cash and cash equivalents of $376.7 million and total debt obligations of $747.5 million as of December 31, 2024. Merit had available borrowing capacity of approximately $697 million as of September 30, 2025. Fiscal Year 2025 Financial Guidance Based upon the information currently available to Merit’s management, for the year ending December 31, 2025, absent the potential impact of trade policies and related actions implemented by the U.S. and other countries subsequent to today’s date, material acquisitions, non-recurring transactions or other factors beyond Merit’s current expectations, Merit anticipates the following financial results: Revenue and Earnings Guidance* Updated GuidancePrior Guidance(2)Financial MeasureYear Ending% ChangeYear Ending% Change December 31, 2025Y/YDecember 31, 2025Y/Y Net Sales$1.502 – $1.515 billion11% – 12%$1.495 – $1.507 billion10% – 11%Cardiovascular Segment$1.430 – $1.441 billion10% – 11%$1.423 – $1.434 billion9% – 10%Endoscopy Segment$72.0 – $74.0 million32% – 34%$72.0 – $73.0 million32% – 34% Non-GAAP Earnings Per Share(1)$3.66 – $3.796% – 10%$3.52 – $3.722% – 8% *Percentage figures approximated; dollar figures may not foot due to rounding(1)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 $0.04 per share for the year ending December 31, 2025. Any offsetting impacts of the capped call associated with the Convertible Notes are not considered.(2)“Prior Guidance” reflects Merit’s full-year 2025 financial guidance, previously introduced on July 30, 2025. 2025 Net Sales Guidance – % Change from Prior Year (Constant Currency) Reconciliation* Updated Guidance Prior Guidance(1) Low High Low High2025 Net Sales Guidance – % Change from Prior Year (GAAP)10.7% 11.7% 10.2% 11.1%Estimated impact of foreign currency exchange rate fluctuations(0.5%) (0.5%) (0.5%) (0.5%)2025 Net Sales Guidance – % Change from Prior Year (Constant Currency)10.3% 11.2% 9.7% 10.6% *Percentage figures approximated and may not foot due to rounding(1)“Prior Guidance” reflects Merit’s full-year 2025 financial guidance, previously introduced on July 30, 2025. 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 attributable 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”). This guidance is based on information and estimates available to Merit as of October 30, 2025. Should known or unknown risks or uncertainties materialize or should underlying assumptions prove inaccurate, actual results will likely vary, and could vary materially, from past results and those anticipated, estimated or projected. CONFERENCE CALL Merit will hold its investor conference call today, Thursday, October 30, 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) September 30, 2025 December 31, (Unaudited) 2024ASSETS Current Assets Cash and cash equivalents$ 392,457 $ 376,715 Trade receivables, net 210,292 190,243 Other receivables 19,062 16,588 Inventories 326,550 306,063 Prepaid expenses and other assets 31,369 28,544 Prepaid income taxes 3,651 3,286 Income tax refund receivables 2,152 2,335 Total current assets 985,533 923,774 Property and equipment, net 418,004 386,165 Intangible assets, net 538,400 498,265 Goodwill 507,427 463,511 Deferred income tax assets 16,284 16,044 Operating lease right-of-use assets 88,496 65,508 Other assets 76,854 65,336 Total Assets$ 2,630,998 $ 2,418,603 LIABILITIES AND STOCKHOLDERS’ EQUITY Current Liabilities Trade payables$ 64,746 $ 68,502 Accrued expenses 147,377 134,077 Current operating lease liabilities 10,612 10,331 Income taxes payable 7,740 3,492 Total current liabilities 230,475 216,402 Long-term debt 732,916 729,551 Deferred income tax liabilities 26,707 240 Liabilities related to unrecognized tax benefits 2,169 2,118 Deferred compensation payable 17,083 19,197 Deferred credits 1,424 1,502 Long-term operating lease liabilities 77,624 54,783 Other long-term obligations 13,192 15,451 Total liabilities 1,101,590 1,039,244 Stockholders’ Equity Common stock 747,103 703,219 Retained earnings 786,024 695,541 Accumulated other comprehensive loss (3,719) (19,401)Total stockholders’ equity 1,529,408 1,379,359 Total Liabilities and Stockholders’ Equity$ 2,630,998 $ 2,418,603 CONSOLIDATED STATEMENTS OF INCOME(Unaudited, in thousands except per share amounts) Three Months Ended Nine Months Ended September 30, September 30, 2025 2024 2025 2024Net sales$384,157 $339,845 $1,121,970 $1,001,356 Cost of sales 197,746 182,310 579,052 531,006 Gross profit 186,411 157,535 542,918 470,350 Operating expenses: Selling, general and administrative 119,801 99,644 340,384 288,657 Research and development 23,966 20,527 70,811 62,272 Contingent consideration expense 32 103 1,198 292 Total operating expenses 143,799 120,274 412,393 351,221 Income from operations 42,612 37,261 130,525 119,129 Other income (expense): Interest income 3,615 6,652 11,166 21,489 Interest expense (6,754) (7,501) (20,097) (23,226)Other income (expense) — net (933) 245 (1,717) (544)Total other expense — net (4,072) (604) (10,648) (2,281) Income before income taxes 38,540 36,657 119,877 116,848 Income tax expense 10,785 8,213 29,394 24,438 Net income$27,755 $28,444 $90,483 $92,410 Earnings per common share Basic$0.47 $0.49 $1.53 $1.59 Diluted$0.46 $0.48 $1.49 $1.57 Weighted average shares outstanding Basic 59,245 58,231 59,095 58,110 Diluted 59,919 59,537 60,604 58,948 CONSOLIDATED STATEMENTS OF CASH FLOWS(Unaudited, in thousands) Nine Months Ended September 30, 2025 2024 CASH FLOWS FROM OPERATING ACTIVITIES: Net income$ 90,483 $ 92,410 Adjustments to reconcile net income to net cash provided by operating activities: Depreciation and amortization 91,629 74,093 Gain on disposition of a business (249) — Write-off of certain intangible assets and other long-term assets 152 401 Amortization of right-of-use operating lease assets 8,693 9,043 Fair value adjustments related to contingent consideration liabilities 1,198 292 Stock-based compensation expense 33,563 18,958 Other adjustments 4,711 4,569 Changes in operating assets and liabilities, net of acquisitions (31,319) (47,711)Total adjustments 108,378 59,645 Net cash, cash equivalents, and restricted cash provided by operating activities 198,861 152,055 CASH FLOWS FROM INVESTING ACTIVITIES: Capital expenditures for property and equipment (57,252) (31,668)Cash paid for notes receivable and other investments (14,936) (10,223)Cash paid in acquisitions, net of cash acquired (122,834) (110,182)Other investing, net (2,029) (2,133)Net cash, cash equivalents, and restricted cash used in investing activities (197,051) (154,206) CASH FLOWS FROM FINANCING ACTIVITIES: Proceeds from issuance of common stock 22,179 15,424 Proceeds from (payments on) long-term debt — (76,063)Contingent payments related to acquisitions (2,645) (209)Payment of taxes related to an exchange of common stock (8,597) (1,592)Net cash, cash equivalents, and restricted cash provided by (used in) financing activities 10,937 (62,440)Effect of exchange rates on cash 3,047 724 Net increase (decrease) in cash, cash equivalents and restricted cash 15,794 (63,867) CASH, CASH EQUIVALENTS AND RESTRICTED CASH: Beginning of period 378,767 589,144 End of period$ 394,561 $ 525,277 RECONCILIATION OF CASH, CASH EQUIVALENTS AND RESTRICTED CASH TO THE CONSOLIDATED BALANCE SHEETS: Cash and cash equivalents 392,457 523,128 Restricted cash reported in prepaid expenses and other current assets 2,104 2,149 Total cash, cash equivalents and restricted cash$ 394,561 $ 525,277 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, equity method investment loss (income) from equity investees, 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 ($1.9) million and $ (0.8) million to reported revenue for the three and nine-month periods ended September 30, 2025, respectively, were calculated using the applicable average foreign exchange rates for the three and nine-month periods ended September 30, 2024. Constant Currency Revenue, Organic Merit’s constant currency revenue, organic, is defined, with respect to prior fiscal year periods, as GAAP revenue. With respect to current fiscal year periods, constant currency revenue, organic, is defined as constant currency revenue (as defined above), less revenue from certain acquisitions. For the three-month period ended September 30, 2025, Merit’s constant currency revenue, organic, excludes revenues attributable to products acquired in connection with (i) Merit’s merger transaction with Biolife Delaware, L.L.C. (“Biolife”) in May 2025 (the “Biolife Merger”) and (ii) the assets acquired from Cook Medical Holdings LLC in November 2024 (the “Cook Transaction”). For the nine-month period ended September 30, 2025, Merit’s constant currency revenue, organic, excludes revenues attributable to products acquired in connection with (i) the Biolife Merger, (ii) the Cook Transaction and (iii) the assets acquired from EndoGastric Solutions, Inc. in July 2024. Non-GAAP Gross Profit and Margin Non-GAAP gross profit is calculated by reducing GAAP cost of sales by amounts recorded for amortization of intangible assets and inventory mark-up related to acquisitions. Non-GAAP gross margin is calculated by dividing non-GAAP gross profit by reported net sales. Non-GAAP Operating Income and Margin Non-GAAP operating income is calculated by adjusting GAAP operating income for certain items which are deemed by Merit’s management to be outside of core operations and vary in amount and frequency among periods, such as expenses related to acquisitions or other extraordinary transactions, non-cash expenses related to amortization or write-off of previously acquired tangible and intangible assets, certain employee termination benefits, performance-based stock compensation expenses, expenses resulting from non-ordinary course litigation or administrative proceedings and resulting settlements, governmental proceedings, and changes in governmental or industry regulations, as well as other items referenced in the tables below. Non-GAAP operating margin is calculated by dividing non-GAAP operating income by reported net sales. Non-GAAP Net Income Non-GAAP net income is calculated by adjusting GAAP net income for the items set forth in the definition of non-GAAP operating income above, as well as for expenses related to debt issuance costs, gains or losses on disposal of certain assets, equity method investment loss (income) from equity investees, 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. Other Non-GAAP Financial Measure Reconciliations The following tables set forth supplemental financial data and corresponding reconciliations of non-GAAP financial measures to Merit’s corresponding financial measures prepared in accordance with GAAP, in each case, for the three and nine-month periods ended September 30, 2025 and 2024. The non-GAAP income adjustments referenced in the following tables do not reflect non-performance-based stock compensation expense of $4.6 million and $3.1 million for the three-month periods ended September 30, 2025 and 2024, respectively and $13.9 million and $9.6 million for the nine-month periods ended September 30, 2025 and 2024, respectively. Reconciliation of GAAP Net Income to Non-GAAP Net Income(Unaudited, in thousands except per share amounts) Three Months Ended September 30, 2025 Pre-Tax Tax Impact After-Tax Per Share ImpactGAAP net income$38,540 $(10,785) $27,755 $0.46 Non-GAAP adjustments: Cost of Sales Amortization of intangibles 19,212 (4,539) 14,673 0.24 Inventory mark-up related to acquisitions 183 (43) 140 0.00 Operating Expenses Contingent consideration expense 32 (5) 27 0.00 Amortization of intangibles 2,560 (604) 1,956 0.03 Performance-based share-based compensation (a) 9,028 (1,413) 7,615 0.13 Corporate restructuring (b) 286 (67) 219 0.00 Acquisition-related (68) 16 (52) (0.00)Medical Device Regulation expenses (c) 1,655 (391) 1,264 0.02 Other (d) 74 (17) 57 0.00 Other (Income) Expense Amortization of long-term debt issuance costs 1,414 (334) 1,080 0.02 Other non-operating loss (e) 260 (61) 199 0.00 Non-GAAP net income$73,176 $(18,243) $54,933 $0.92 Diluted shares 59,919 Three Months Ended September 30, 2024 Pre-Tax Tax Impact After-Tax Per Share ImpactGAAP net income$36,657 $(8,213) $28,444 $0.48 Non-GAAP adjustments: Cost of Sales Amortization of intangibles 14,896 (3,522) 11,374 0.19Inventory mark-up related to acquisitions 559 (132) 427 0.01Operating Expenses Contingent consideration expense 103 (6) 97 0.00Amortization of intangibles 2,038 (482) 1,556 0.03Performance-based share-based compensation (a) 3,736 (609) 3,127 0.05Corporate restructuring (b) 2,084 (492) 1,592 0.03Acquisition-related 2,351 (555) 1,796 0.03Medical Device Regulation expenses (c) 1,983 (468) 1,515 0.03Other (d) 125 (30) 95 0.00Other (Income) Expense Amortization of long-term debt issuance costs 1,477 (349) 1,128 0.02 Non-GAAP net income$66,009 $(14,858) $51,151 $0.86 Diluted shares 59,537 ___________________ Note: Certain per-share impacts may not sum to totals due to rounding. Reconciliation of GAAP Net Income to Non-GAAP Net Income(Unaudited, in thousands except per share amounts) Nine Months Ended September 30, 2025 Pre-Tax Tax Impact After-Tax Per Share ImpactGAAP net income$119,877 $(29,394) $90,483 $1.49 Non-GAAP adjustments: Cost of Sales Amortization of intangibles 55,798 (13,184) 42,614 0.70 Inventory mark-up related to acquisitions 250 (59) 191 0.00 Operating Expenses Contingent consideration expense 1,198 29 1,227 0.02 Amortization of intangibles 7,497 (1,771) 5,726 0.09 Performance-based share-based compensation (a) 19,681 (2,344) 17,337 0.29 Corporate restructuring (b) 2,873 (678) 2,195 0.04 Acquisition-related 2,088 (2) 2,086 0.03 Medical Device Regulation expenses (c) 4,883 (1,153) 3,730 0.06 Other (d) 103 (24) 79 0.00 Other (Income) Expense Amortization of long-term debt issuance costs 4,242 (1,002) 3,240 0.05 Other non-operating loss (gain) (e) 11 (61) (50) (0.00) Non-GAAP net income$218,501 $(49,643) $168,858 $2.79 Diluted shares 60,604 Nine Months Ended September 30, 2024 Pre-Tax Tax Impact After-Tax Per Share ImpactGAAP net income$116,848 $(24,438) $92,410 $1.57 Non-GAAP adjustments: Cost of Sales Amortization of intangibles 40,827 (9,654) 31,173 0.53Inventory mark-up related to acquisitions 559 (132) 427 0.01Operating Expenses Contingent consideration expense 292 (31) 261 0.00Amortization of intangibles 5,546 (1,312) 4,234 0.07Performance-based share-based compensation (a) 9,396 (1,466) 7,930 0.13Corporate restructuring (b) 2,030 (479) 1,551 0.03Acquisition-related 3,610 (852) 2,758 0.05Medical Device Regulation expenses (c) 6,120 (1,445) 4,675 0.08Other (d) 302 (72) 230 0.00Other (Income) Expense Amortization of long-term debt issuance costs 4,431 (1,046) 3,385 0.06 Non-GAAP net income$189,961 $(40,927) $149,034 $2.53 Diluted shares 58,948 ___________________ Note: Certain per-share impacts may not sum to totals due to rounding. Reconciliation of Reported Operating Income to Non-GAAP Operating Income(Unaudited, in thousands except percentages) Three Months Ended Three Months Ended Nine Months Ended Nine Months Ended September 30, 2025 September 30, 2024 September 30, 2025 September 30, 2024 Amounts % Sales Amounts % Sales Amounts % Sales Amounts % SalesNet Sales as Reported$384,157 $339,845 $1,121,970 $1,001,356 GAAP Operating Income 42,612 11.1 % 37,261 11.0% 130,525 11.6% 119,129 11.9%Cost of Sales Amortization of intangibles 19,212 5.0 % 14,896 4.4% 55,798 5.0% 40,827 4.1%Inventory mark-up related to acquisitions 183 0.0 % 559 0.2% 250 0.0% 559 0.1%Operating Expenses Contingent consideration expense 32 0.0 % 103 0.0% 1,198 0.1% 292 0.0%Amortization of intangibles 2,560 0.7 % 2,038 0.6% 7,497 0.7% 5,546 0.6%Performance-based share-based compensation (a) 9,028 2.4 % 3,736 1.1% 19,681 1.8% 9,396 0.9%Corporate restructuring (b) 286 0.1 % 2,084 0.6% 2,873 0.3% 2,030 0.2%Acquisition-related (68) (0.0)% 2,351 0.7% 2,088 0.2% 3,610 0.4%Medical Device Regulation expenses (c) 1,655 0.4 % 1,983 0.6% 4,883 0.4% 6,120 0.6%Other (d) 74 0.0 % 125 0.0% 103 0.0% 302 0.0% Non-GAAP Operating Income$75,574 19.7 % $65,136 19.2% $224,896 20.0% $187,811 18.8% ___________________ Note: Certain percentages may not sum to totals due to rounding. (a)Represents performance-based share-based compensation expense, including stock-settled and cash-settled awards.(b)Includes employee termination benefits associated with activities related to corporate restructuring initiatives and costs to terminate certain distribution contracts from our Biolife Merger.(c)Represents incremental expenses incurred to comply with the E.U. Medical Device Regulation.(d)Represents costs to comply with Merit’s corporate integrity agreement with the U.S. Department of Justice (the “DOJ”).(e)Includes gains and losses associated with the disposal of business units and equity method investment loss (income) from equity investees. Reconciliation of Reported Revenue to Constant Currency Revenue (Non-GAAP), and Constant Currency Revenue, Organic (Non-GAAP)(Unaudited, in thousands except percentages) Three Months Ended Nine Months Ended September30, September30, % Change 2025 2024 % Change 2025 2024Reported Revenue13.0%$384,157 $339,845 12.0%$1,121,970 $1,001,356 Add: Impact of foreign exchange (1,926) — (778) — Constant Currency Revenue (a)12.5%$382,231 $339,845 12.0%$1,121,192 $1,001,356 Less: Revenue from certain acquisitions (16,031) — (51,445) — Constant Currency Revenue, Organic (a)7.8%$366,200 $339,845 6.8%$1,069,747 $1,001,356 ___________________ (a)A non-GAAP financial measure. For a definition of this and other non-GAAP financial measures, see the section of this release entitled “Non-GAAP Financial Measures.” Reconciliation of Reported Gross Margin to Non-GAAP Gross Margin (Non-GAAP)(Unaudited, as a percentage of reported revenue) Three Months Ended Nine Months Ended September30, September30, 2025 2024 2025 2024Reported Gross Margin48.5% 46.4% 48.4% 47.0% Add back impact of: Amortization of intangibles5.0% 4.4% 5.0% 4.1%Inventory mark-up related to acquisitions0.0% 0.2% 0.0% 0.1% Non-GAAP Gross Margin53.6% 50.9% 53.4% 51.1% ___________________ Note: Certain percentages may not sum to totals due to rounding. ABOUT MERIT Founded in 1987, Merit is engaged in the development, manufacture, and distribution of proprietary medical devices used in interventional, diagnostic, and therapeutic procedures, particularly in cardiology, radiology, oncology, critical care, and endoscopy. Merit serves customers worldwide with a domestic and international sales force and clinical support team totaling more than 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 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 preceded 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. The forward-looking statements contained in this release are based on Merit management’s current expectations and assumptions regarding future events or outcomes. If underlying expectations or assumptions prove inaccurate, or risks or uncertainties materialize, actual results will likely differ, and could differ materially, from Merit’s expectations reflected in any forward-looking statements. Financial estimates are subject to change and are not intended to be relied upon as predictions of future operating results. Investors are cautioned not to unduly rely on any such forward-looking statements. The following are some of the important risks and uncertainties that could cause Merit’s actual results to differ from management’s expectations in any forward-looking statements: risks and uncertainties associated with consequences of Merit’s executive succession planning activities and leadership transition; risks and uncertainties regarding trade policies or related actions implemented by the U.S. or other countries, including existing, proposed or prospective tariffs, duties or other measures; risks and uncertainties associated with Merit’s proposed acquisition of the C2 CryoBalloon device and related assets from Pentax of America, Inc., the possibility that Merit may not complete the proposed acquisition and, if the acquisition is completed, Merit’s integration of the acquired products and Merit’s ability to achieve projected financial results, product development and other projected benefits of the proposed acquisition; risks and uncertainties associated with Merit’s integration of the Biolife business and operations and its ability to achieve financial results, product development and other anticipated benefits of such acquisition; risks and uncertainties associated with Merit’s integration of products acquired in the Cook Transaction and Merit’s ability to achieve anticipated financial results, product development and other anticipated benefits of such acquisition; 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; U.S. and global political, economic, competitive, reimbursement and regulatory conditions, including the ongoing “shutdown” of the United States government; modification or limitation of, or policies and procedures associated with, governmental or private insurance reimbursement policies; reduced availability of, and price increases associated with, components and other raw materials; increases in transportation expenses; 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; fluctuations in interest or foreign currency exchange rates and inflation; cybersecurity events; government scrutiny and regulation of the medical device industry; difficulties relating to development, testing and regulatory approval, clearance and maintenance of Merit’s products; the safety, efficacy and patient and physician adoption of Merit’s products; the ability to fully enroll and the outcomes of ongoing and future clinical trials and market studies relating to Merit’s products; litigation and other judicial proceedings affecting Merit; consequences associated with a Corporate Integrity Agreement executed between Merit and the U.S. Department of Justice; failure to comply with U.S. and foreign laws and 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; potential for significant adverse changes in governing regulations; 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; failure to comply with applicable environmental laws; changes in key personnel; labor shortages and increases in labor costs; price and product competition; extreme weather events; and geopolitical events. For a further discussion of the risks and uncertainties which may affect Merit’s business, operations and financial condition, see Part I, Item 1A. “Risk Factors” in Merit’s Annual Report on Form 10-K for the year ended December 31, 2024 filed with the SEC, which Merit updated in Part II, Item 1A. “Risk Factors” in Merit’s Quarterly Reports on Form 10-Q for each of the quarters ended March 31, 2025, June 30, 2025 and September 30, 2025, which Merit filed with the SEC. All subsequent forward-looking statements attributable to Merit or persons acting on its behalf are expressly qualified in their entirety by these cautionary statements. Actual results will likely differ, and may differ materially, from anticipated results. Financial estimates are subject to change and are not intended to be relied upon as predictions of future operating results. Those estimates and all other forward-looking statements included in this release are made only as of the date of this release, and except as otherwise required by applicable law, Merit assumes no obligation to update or disclose revisions to estimates and all other forward-looking statements. TRADEMARKS Unless noted otherwise, trademarks and registered trademarks used in this release are the property of Merit Medical Systems, Inc., its subsidiaries, or its licensors. 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
CytoSorbents to Report Third Quarter 2025 Financial Results and Recent Business Highlights
PRINCETON, N.J., Oct. 30, 2025 /PRNewswire/ — CytoSorbents Corporation (NASDAQ: CTSO), a leader in the treatment of life-threatening conditions in the intensive care unit and cardiac surgery using blood purification, will report third quarter 2025 financial results and recent business…
BridgeBio Reports Third Quarter 2025 Financial Results and Business Updates
-$120.7 million in total third quarter revenue, comprised of $108.1 million of U.S. Attruby® net product revenue, $4.3 million from royalty revenue, and $8.3 million in license and services revenue -As of October 25, 2025, 5,259 unique patient prescriptions have been written by 1,355 unique prescribers, representing an accelerating launch driven by strong month over month growth in the crucial treatment naïve patient segment -Attruby continues to differentiate clinically by proving its unique profile in new subpopulations and holistic analyses: -JACC publication demonstrated the effect of Attruby on cumulative cardiovascular outcomes within the first month of treatment -Positive topline interim analysis results from FORTIFY, the registrational Phase 3 study of BBP-418, a small molecule in development for LGMD2I/R9 -Primary interim analysis endpoint, glycosylated αDG, significantly increased by 1.8x change from baseline at 3 months (p
Sparrow BioAcoustics Secures $10 Million to Support Expanding U.S. Deployment of Smartphone-Based Cardiac AI
Sparrow BioAcoustics today announced the closing of a $10 million financing round led by Killick Capital and Klister Credit, with participation from Pelorus VC, 98827 Newfoundland & Labrador Inc., and Brinex Capital. ST. JOHN’S, NL, Oct. 29, 2025 /PRNewswire/ – The new investment supports…
VentureMed Group Closes $28M Series C Funding to Accelerate Commercial Adoption and Expand Indications for the FLEX VPTM System
MINNEAPOLIS, Oct. 29, 2025 /PRNewswire/ — VentureMed Group, Inc., a leading medical device company specializing in vessel preparation and access management technologies for the treatment of peripheral arterial disease (PAD) and arteriovenous fistulas and grafts (AVF, AVG), today…
Conavi Medical announces agreement with the Province of Ontario as part of the Life Sciences Scale-Up Fund
Agreement to provide up to $2.5 million CAD to Conavi Medical to support the commercial launch of the next-generation Novasight Hybrid systemTORONTO, Oct. 29, 2025 (GLOBE NEWSWIRE) — Conavi Medical Corp. (TSXV: CNVI) (OTCQB: CNVIF) (“Conavi” or the “Company”), a commercial-stage medical device company focused on designing, manufacturing, and marketing imaging technologies to guide minimally invasive cardiovascular procedures, is pleased to announce that it has entered into an agreement with the Province of Ontario as part of the Life Sciences Scale-Up Fund (LSSUF). LSSUF provides financial support to help small-to-medium sized enterprises based in Ontario to scale up the life sciences sector. As part of the agreement, Conavi is eligible to receive up to $2.5 million CAD over the course of the project to cover up to one-third of eligible project costs related to the commercial launch of the next-generation Novasight Hybrid™ system, subject to certain requirements. Additional details regarding LSSUF can be found at https://www.ontario.ca/page/life-sciences-scale-fund. “We are incredibly grateful to the Province of Ontario, the Ministry of Economic Development, Job Creation, and Trade, and Minister Victor Fedeli for the ongoing support of Conavi and our vision,” said Tom Looby, Chief Executive Officer of Conavi Medical. “Heart disease remains a leading cause of death in Canada and globally, and intravascular imaging has been shown to significantly improve outcomes for patients undergoing coronary procedures. We believe the next-generation Novasight Hybrid™ system is well positioned to become a category leader and help propel the Ontario ecosystem.” “Ontario’s Life Sciences Scale-Up Fund is accelerating the development of next-generation health technologies and reinforcing our province’s position as a global leader in life science innovation,” said Vic Fedeli, Minister of Economic Development, Job Creation and Trade. “Through this partnership, Conavi Medical will advance the design and manufacturing of their cardiovascular imaging technology, ensuring more medical breakthroughs are developed right here, in Ontario.” Conavi’s proprietary Novasight Hybrid™ system uniquely combines both intravascular ultrasound (IVUS) and optical coherence tomography (OCT) into a single integrated system. This dual-modality approach is designed to provide cardiologists with a comprehensive view of coronary arteries, potentially enabling more precise diagnosis and treatment of cardiovascular disease. About Conavi Medical Conavi Medical is focused on designing, manufacturing, and marketing imaging technologies to guide common minimally invasive cardiovascular procedures. Its patented Novasight Hybrid™ System is the first to combine intravascular ultrasound (IVUS) and optical coherence tomography (OCT) into a single device, enabling simultaneous and co-registered imaging of coronary arteries. The first-generation Novasight Hybrid™ System has regulatory clearance in the U.S., Canada, China, and Japan. For more information, visit conavi.com. Cautionary Statement Regarding Forward-Looking Information This news release contains “forward-looking statements” within the meaning of applicable Canadian and U.S. securities laws, which reflect the current expectations of management of Conavi’s future growth, results of operations, performance and business prospects and opportunities. Forward-looking statements are frequently, but not always, identified by words such as “may”, “would”, “could”, “will”, “anticipate”, “believe”, “plan”, “expect”, “intend”, “estimate”, “potential for” and similar expressions, although these words may not be present in all forward-looking statements. Forward-looking statements that appear in this release may include, without limitation, references to Conavi’s actual receipt of funds from the Province of Ontario under the LSSUF program and satisfaction of the conditions thereto, Conavi’s plans for the commercialization of its Novasight Hybrid™ System and expected FDA clearance and the commercial launch of next generation Novasight in the U.S. These forward-looking statements reflect management’s current beliefs with respect to future events, and are based on information currently available to management that, while considered reasonable by management as of the date on which the statements are made, are inherently subject to significant business, economic and competitive uncertainties and contingencies which could result in actions, events, conditions, results, performance or achievements to be materially different from those projected in the forward-looking statements. Forward-looking statements involve significant risks, uncertainties and assumptions and many factors could cause Conavi’s actual results, performance or achievements to be materially different from any future results, performance or achievements that may be expressed or implied by such forward-looking statements. Such factors and assumptions include, but are not limited to, Conavi’s ability to retain key personnel; its ability to execute on its business plans and strategies; and other factors listed in the “Risk Factors” sections of the joint information circular of Conavi dated August 30, 2024 and in the final short form prospectus of Conavi dated April 15, 2025 (each of which may be viewed at www.sedarplus.com). Should one or more of these risks or uncertainties materialize, or should assumptions underlying the forward-looking statements prove incorrect, actual results, performance, or achievements may vary materially from those expressed or implied by the forward-looking statements contained in this news release. These factors should be considered carefully, and prospective investors should not place undue reliance on the forward-looking statements. Although the forward-looking statements contained in the news release are based upon what management currently believes to be reasonable assumptions and Conavi has attempted to identify important factors that could cause actual actions, events, conditions, results, performance or achievements to differ materially from those described in forward-looking statements, Conavi cannot assure prospective investors that actual results, performance or achievements will be consistent with these forward-looking statements. Except as required by law, Conavi expressly disclaims any intention or obligation to update or revise any forward-looking statements whether as a result of new information, future events or otherwise. Accordingly, investors should not place undue reliance on forward-looking statements. All the forward-looking statements are expressly qualified by the foregoing cautionary statements. Neither the TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this press release. Contact:Stefano PiconeChief Financial Officer(416) 483-0100
FARAPULSE™ PFA PLATFORM Team Wins Inaugural Thomas J. Fogarty Innovation Prize
MOUNTAIN VIEW, Calif.–(BUSINESS WIRE)–Allan Zingeler, Raju Viswanathan, PhD, and Michael Mahoney of Boston Scientific have been awarded the inaugural Thomas J. Fogarty Prize (Fogarty Prize) for the FARAPULSE™ PFA Platform. The award, which includes an unrestricted $100,000 cash prize and a custom-cast bronze medallion, was announced on October 24 at a sold-out black-tie […]
Novartis completes acquisition of Tourmaline Bio
Basel, October 28, 2025 – Novartis today announced that it has successfully completed its acquisition of Tourmaline Bio, Inc. (“Tourmaline”). With the completion of the acquisition, shares of common stock, par value $0.0001 per share (the “Shares”), of Tourmaline, have ceased trading on the Nasdaq Stock Market LLC and Tourmaline is now an indirect wholly owned subsidiary of Novartis. “The acquisition of Tourmaline Bio aligns with our strategy to deepen expertise in areas where Novartis can lead and add value in cardiovascular innovation,” said Shreeram Aradhye, M.D., President of Development and Chief Medical Officer at Novartis. “Pacibekitug’s differentiated anti-IL-6 mechanism offers a scientifically compelling approach to residual inflammation – a key driver of atherosclerotic cardiovascular disease. We look forward to collaborating with Tourmaline’s team to further advance this promising asset and continue strengthening our ability to deliver potentially transformative therapies for diseases with high unmet need.” Novartis’ previously announced tender offer to acquire all of the outstanding Shares at a price of $48.00 per Share, in cash, without interest and subject to any applicable withholding, expired at one minute following 11:59 p.m., Eastern Time, on October 27, 2025. Approximately 24,030,382 Shares were validly tendered, and not validly withdrawn from the tender offer, representing approximately 92.94% of the issued and outstanding Shares. In accordance with the terms of the tender offer, all Shares that were validly tendered and not validly withdrawn have been accepted for payment and paid for. Following completion of the tender offer, Novartis completed the acquisition of Tourmaline through the merger of its indirect wholly owned subsidiary, Torino Merger Sub Inc., with and into Tourmaline, without a vote of Tourmaline’s stockholders pursuant to Section 251(h) of the General Corporation Law of the State of Delaware. As a result of the merger, each Share issued and outstanding and not tendered in the tender offer was canceled and extinguished and automatically converted into the right to receive the same consideration per Share payable in the tender offer. Disclaimer This press release contains statements that are not statements of historical fact, or “forward-looking statements,” including with respect to Novartis’s acquisition of Tourmaline. Forward-looking statements can generally be identified by words such as “potential,” “can,” “will,” “plan,” “may,” “could,” “would,” “expect,” “anticipate,” “look forward,” “believe,” “committed,” “investigational,” “pipeline,” “launch,” or similar terms, or by express or implied discussions regarding potential marketing approvals, new indications or labeling for Tourmaline’s product candidates, Tourmaline’s platform, the acquisition of Tourmaline, the benefits sought to be achieved in the acquisition, or potential future revenues from Tourmaline’s product candidates. You should not place undue reliance on these statements. Such forward-looking statements are based on Novartis’s current beliefs and expectations regarding future events and are subject to significant known and unknown risks and uncertainties. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those set forth in the forward-looking statements. There can be no guarantee that clinical trials for any of Tourmaline’s product candidates will be successful, that Tourmaline’s approach to the discovery and development of product candidates based on its AOC™ platform will produce any products of commercial value, that any of Tourmaline’s product candidates will be submitted for marketing approval or approved for sale or, if approved, receive approval for any additional indications or labeling, in any market, or at any particular time, nor can there be any guarantee that, if approved, any of Tourmaline’s product candidates will be commercially successful in the future. Neither can there be any guarantee that the expected benefits or synergies from this transaction will be achieved in the expected timeframe, or at all. In particular, expectations regarding Tourmaline or the transaction described in this press release could be affected by, among other things; the effects of disruption from the transactions contemplated by the Merger Agreement and the impact of the announcement of the transactions on Novartis and/or Tourmaline’s businesses, including their relationships with employees, business partners or governmental entities; the risk that stockholder litigation in connection with the offer or the merger may result in significant costs of defense, indemnification and liability; a diversion of management’s attention from ongoing business operations and opportunities as a result of the offer, the merger or otherwise; general industry conditions and competition; general political, economic and business conditions, including interest rate and currency exchange rate fluctuations; the uncertainties inherent in research and development, including clinical trial results and additional analysis of existing clinical data; regulatory actions or delays or government regulation generally; global trends toward health care cost containment, including government, payor and general public pricing and reimbursement pressures and requirements for increased pricing transparency; our ability to obtain or maintain proprietary intellectual property protection; the particular prescribing preferences of physicians and patients; general political, economic and business conditions; safety, quality, data integrity or manufacturing issues; potential or actual data security and data privacy breaches, or disruptions of our information technology systems, and other risks and factors referred to in Novartis AG’s and Tourmaline’s filings and reports with the SEC, including Novartis AG’s Annual Report on Form 20-F for the year ended December 31, 2024, Tourmaline’s Annual Report on Form 10-K for the year ended December 31, 2024, Quarterly Reports on Form 10-Q for the quarters ended March 31, 2025 and June 30, 2025, and any subsequent filings made by either party with the SEC, available on the SEC’s website at www.sec.gov. Novartis is providing the information in this press release as of this date, and Novartis does not undertake any obligation to update any forward-looking statements contained in this press release as a result of new information, future events or otherwise, except to the extent required by law. About Novartis Novartis is an innovative medicines company. Every day, we work to reimagine medicine to improve and extend people’s lives so that patients, healthcare professionals and societies are empowered in the face of serious disease. Our medicines reach more than 300 million people worldwide. Reimagine medicine with us: Visit us at https://www.novartis.com and connect with us on LinkedIn, Facebook, X/Twitter and Instagram. # # # Novartis Media Relations E-mail: media.relations@novartis.com Novartis Investor Relations Central investor relations line: +41 61 324 7944 E-mail: investor.relations@novartis.com
Orchestra BioMed and Terumo Enter into New $30 Million Virtue SAB Strategic Agreements
New agreement grants Terumo Virtue SAB coronary indication right of first refusal and supersedes prior distribution agreementTerumo to pay a total of $30 million to Orchestra BioMedOrchestra BioMed retains all development and distribution rights to Virtue SAB in all indicationsOrchestra BioMed recently initiated patient enrollment for the Virtue Trial, its U.S. pivotal IDE trial of Virtue SAB in the treatment of coronary in-stent restenosis (“ISR”) NEW HOPE, Pa., Oct. 28, 2025 (GLOBE NEWSWIRE) — Orchestra BioMed Holdings, Inc. (Nasdaq: OBIO, “Orchestra BioMed” or the “Company”), a biomedical company accelerating high-impact technologies to patients through strategic partnerships with market-leading global medical device companies, today announced that it has entered into a termination and right of first refusal agreement (the “ROFR Agreement”) with Terumo Corporation (TYO:4543) and Terumo Medical Corporation (collectively, “Terumo”) with respect to Virtue® Sirolimus AngioInfusion™ Balloon (“SAB”) for the treatment of coronary artery disease worldwide. The ROFR Agreement, which supersedes and terminates the prior Virtue SAB distribution agreement between Orchestra BioMed and Terumo (the “Prior Agreement”), grants Terumo a right of first refusal (“ROFR”) to acquire the rights, or enter a distribution arrangement, with respect to Virtue SAB for the treatment of coronary artery disease, in exchange for an upfront payment of $10 million. Terumo and Orchestra BioMed have also entered into a securities purchase agreement, pursuant to which Terumo has agreed to invest an additional $20 million in Orchestra BioMed through a new series of non-voting preferred stock, which is convertible into common stock in the future, subject to certain conditions, at a minimum of $12 per share (the “Securities Purchase Agreement”). Terumo previously made a $30 million non-refundable payment and $5 million common stock investment in Orchestra BioMed upon execution of the Prior Agreement. David Hochman, Chairman and Chief Executive Officer of Orchestra Biomed stated: “Our new agreements with Terumo reflect the differentiated value of Virtue SAB for the treatment of atherosclerotic disease in the coronary arteries and provide strategic optionality for both companies. This new arrangement highlights the strong clinical and commercial potential of Virtue SAB to become a best-in-class therapy in the global coronary market. The $30 million in proceeds from Terumo provides meaningful additional capital resources to advance both of our pivotal stage programs to key clinical and regulatory milestones. We are glad to be aligned with our colleagues at Terumo and are thrilled to have initiated the Virtue Trial evaluating our fundamentally different approach to treating coronary in-stent restenosis.” Ghada Farah, President of Terumo Interventional Systems commented: “We are very pleased to enter into a new strategic agreement with Orchestra BioMed that reflects the significant potential for Virtue SAB in the treatment of coronary artery disease. We believe it aligns the objectives of both companies, and we wish Orchestra BioMed great success as they enroll patients in the Virtue Trial.” The ROFR Agreement Under the ROFR Agreement, Orchestra BioMed will have the opportunity to seek development and commercialization partnerships for Virtue SAB in any therapeutic indication, including coronary artery disease treatment. Terumo will have the first right to review and respond to any potential third party offers presented to Orchestra BioMed related to the global coronary market. The ROFR period expires ninety (90) days after Orchestra BioMed discloses primary endpoint data from the Virtue Trial to Terumo or the public, whichever is earlier (the “ROFR period”). The transactions contemplated by the ROFR Agreement and the Securities Purchase Agreement are subject to customary closing conditions and are expected to close no later than November 7, 2025. About Orchestra BioMed Orchestra BioMed is a biomedical innovation company accelerating high-impact technologies to patients through strategic collaborations with market- leading global medical device companies. The Company’s two flagship product candidates – Atrioventricular Interval Modulation (AVIM) Therapy and Virtue® Sirolimus AngioInfusion™ Balloon (Virtue SAB) – are currently undergoing pivotal clinical trials for their lead indications which both represent multi-billion-dollar annual global market opportunities. AVIM Therapy is a bioelectronic treatment for hypertension, the leading risk factor for death worldwide, and is designed to be delivered as a firmware upgrade to a pacemaker and achieve immediate, substantial and sustained reductions in blood pressure in patients with hypertensive heart disease. The Company has a strategic collaboration with Medtronic for the development and commercialization of AVIM Therapy for the treatment of uncontrolled hypertension in pacemaker-indicated patients. AVIM Therapy has FDA Breakthrough Device Designation for these patients as well as an estimated 7.7 million total patients in the U.S. with uncontrolled hypertension despite medical therapy and increased cardiovascular risk. Virtue SAB is a highly differentiated, first-of-its-kind drug delivery angioplasty balloon system designed to deliver a proprietary extended-release formulation of sirolimus, SirolimusEFR™, for the treatment of atherosclerotic artery disease, the leading cause of mortality worldwide. Virtue SAB has been granted Breakthrough Device Designation by the FDA for the treatment of coronary ISR, coronary small vessel disease and below-the-knee peripheral artery disease. The Company has a right of first refusal agreement with Terumo Corporation and Terumo Medical Corporation, a leading global medical device company, for a potential transaction related to Virtue SAB for the treatment of coronary artery disease. For further information about Orchestra BioMed, please visit www.orchestrabiomed.com, and follow us on LinkedIn. About Virtue SABVirtue SAB is a highly differentiated, first-of-its-kind drug delivery angioplasty balloon system designed to deliver a proprietary extended-release formulation of sirolimus, SirolimusEFR™. It uses a non-coated microporous AngioInfusion™ Balloon to protect the drug in transit and consistently deliver a large liquid dose, overcoming certain limitations of drug-coated balloons. SirolimusEFR delivered by Virtue SAB has been shown in published preclinical series involving hundreds of arterial deliveries to achieve sustained tissue levels well above the known required therapeutic tissue concentration for inhibiting restenosis (1 ng/mg tissue) for the entire critical healing period of approximately 30 days. Virtue SAB demonstrated positive three-year clinical data in coronary ISR in the SABRE study, a multi-center prospective, independent core lab-adjudicated clinical study of 50 patients conducted in Europe. Virtue SAB has been granted Breakthrough Device Designation by the FDA for the treatment of coronary ISR, coronary small vessel disease and peripheral artery disease below-the-knee. About Coronary In-Stent Restenosis (ISR)Coronary ISR is a serious complication of coronary stenting, which can increase the risk of life-threatening heart problems. It is characterized by a re-narrowing of a coronary artery segment that was previously treated with a stent. According to the National Cardiovascular Data Registry, coronary ISR occurs in up to 10% of stented patients during the first year and continues at a rate of up to 3% per year thereafter, resulting in an estimated over 325,000 coronary ISR lesions annually worldwide that may require treatment. The only device treatments currently approved by the FDA for use in coronary ISR lesions are balloon angioplasty and intravascular radiation therapy known as brachytherapy. Traditional balloon angioplasty has high retreatment rates and brachytherapy is considered a last resort treatment due to radiation burden, expense, limited availability, and long-term requirement for dual antiplatelet therapy. If left untreated, coronary ISR may lead to stable angina, unstable angina, acute coronary syndrome, acute myocardial infarction, or death. 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 StatementsCertain 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 closing of the transactions contemplated by the ROFR Agreement and the Securities Purchase Agreement, the timing of the initiation of the Virtue Trial, and the potential safety and efficacy of the Company’s product candidates. 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; 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 filed with the U.S. Securities and Exchange Commission on March 31, 2025, 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 BioMedSnewcomb@orchestrabiomed.com Media ContactKelsey Kirk-EllisOrchestra BioMedkkirkellis@orchestrabiomed.com



