Part I. Financial Information

 

Item 1. Financial Statements

 

LeMaitre Vascular, Inc.

 

Consolidated Balance Sheets

 

 

See accompanying notes to consolidated financial statements.  

 

 

LeMaitre Vascular, Inc.

 

Consolidated Statements of Operations

(unaudited)

 

 

See accompanying notes to consolidated financial statements. 

 

 

LeMaitre Vascular, Inc.

 

Consolidated Statements of Comprehensive Income

(unaudited) 

 

 

See accompanying notes to consolidated financial statements.

 

 

LeMaitre Vascular, Inc.

 

Consolidated Statements of Stockholders’ Equity

(unaudited)  

(dollars in thousands)

 

 

 

See accompanying notes to consolidated financial statements.

 

 

LeMaitre Vascular, Inc.

 

Consolidated Statements of Cash Flows

(unaudited)

 

 

See accompanying notes to consolidated financial statements.

 

 

LeMaitre Vascular, Inc.

 

Notes to Consolidated Financial Statements

June 30, 2025

(unaudited)

 

1. Nature of the Business and Basis of Presentation

 

Unless the context requires otherwise, references to LeMaitre, LeMaitre Vascular, and the Company refer to LeMaitre Vascular, Inc. and its subsidiaries. The Company develops, manufactures, and markets medical devices and implants used primarily in the field of vascular surgery. The Company also derives revenues from the processing and cryopreservation of human tissues for implantation in patients. The Company operates in a single segment in which its principal product lines include the following: anastomotic clips, biologic vascular and dialysis grafts, biologic vascular and cardiac patches, carotid shunts, embolectomy catheters, occlusion catheters, radiopaque marking tape, synthetic vascular and dialysis grafts, and valvulotomes. The Company’s offices and production facilities are located in Burlington, Massachusetts; Fox River Grove, Illinois; North Brunswick, New Jersey; Vaughan, Canada; Sulzbach, Germany; Milan, Italy; Madrid, Spain; Hereford, England; Dublin, Ireland; Maisons-Alfort, France; Zurich, Switzerland; Docklands, Australia; Tokyo, Japan; Shanghai, China; Singapore; Seoul, Korea; and Bangkok, Thailand.

 

The Company’s consolidated financial statements have been prepared in conformity with accounting principles generally accepted in the United States of America (“GAAP”). Any reference in these notes to applicable guidance is meant to refer to the authoritative GAAP as found in the Accounting Standards Codification (“ASC”) and Accounting Standards Update (“ASU”) of the Financial Accounting Standards Board (“FASB”). The accompanying unaudited consolidated financial statements have been prepared on the basis of continuity of operations, realization of assets and the satisfaction of liabilities and commitments in the ordinary course of business. The consolidated financial statements include the accounts of the Company and its wholly-owned subsidiaries. All intercompany accounts and transactions have been eliminated in consolidation.

 

2. Summary of Significant Accounting Policies

 

Unaudited Interim Financial Information

 

The accompanying unaudited interim financial statements and related notes have been prepared by the Company pursuant to the rules and regulations of the Securities and Exchange Commission (“SEC”) for interim financial statements. Certain information and footnote disclosures normally included in the financial statements prepared in accordance with GAAP have been condensed or omitted pursuant to such rules and regulations. These consolidated financial statements should be read in conjunction with the Company’s audited consolidated financial statements and the notes thereto for the year ended December 31, 2024, included in the Company’s Annual Report on Form 10-K filed with the SEC. In the opinion of management, all adjustments, consisting only of normal recurring adjustments necessary for a fair statement of the Company’s financial position as of June 30, 2025, and results of operations for the three- and six-months ended June 30, 2025 and 2024, and cash flows for the six months ended June 30, 2025 and 2024, have been made. The Company’s results of operations for the three- and six-months ended June 30, 2025, are not necessarily indicative of the results of operations that may be expected for the year ending December 31, 2025.

 

Use of Estimates

 

The preparation of financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities, the disclosure of contingent assets and liabilities at the date of the financial statements, and the reported amounts of revenue and expenses during the reporting periods. Significant estimates and assumptions reflected in these unaudited consolidated financial statements include, but are not limited to, credit losses, inventories, intangible assets, sales returns and discounts, share-based compensation, and income taxes. The Company bases its estimates on historical experience, known trends and other market-specific or relevant factors that it believes to be reasonable under the circumstances. On an ongoing basis, management evaluates its estimates as there are changes in circumstances, facts, and experience. Changes in estimates are recorded in the period in which they become known. As of the date of issuance of these unaudited consolidated financial statements, the Company is not aware of any specific event or circumstance that would require the Company to update estimates or judgments or to revise the carrying value of any assets or liabilities. Actual results may differ from those estimates or assumptions.

 

Fair Value Measurements

 

Certain assets and liabilities are carried at fair value under GAAP. Fair value is defined as the exchange price that would be received for an asset or paid to transfer a liability (an exit price) in the principal or most advantageous market for the asset or liability in an orderly transaction between market participants on the measurement date. Valuation techniques used to measure fair value must maximize the use of observable inputs and minimize the use of unobservable inputs. Financial assets and liabilities carried at fair value are to be classified and disclosed in one of the following three levels of the fair value hierarchy, of which the first two are considered observable and the last is considered unobservable:

 

• Level 1-Quoted prices in active markets for identical assets or liabilities.

 

 

• Level 2-Observable inputs (other than Level 1 quoted prices), such as quoted prices in active markets for similar assets or liabilities, quoted prices in markets that are not active for identical or similar assets or liabilities, or other inputs that are observable or can be corroborated by observable market data.

 

• Level 3-Unobservable inputs that are supported by little or no market activity and that are significant to determining the fair value of the assets or liabilities, including pricing models, discounted cash flow methodologies, and similar techniques.

 

The carrying values of the Company’s cash and cash equivalents, short-term marketable securities, accounts receivable, accounts payable, and accrued expenses approximate their fair values due to the short-term nature of these assets and liabilities. The Company’s 2.50% convertible senior notes due 2030 (the “Convertible Notes”) are carried at the face value less unamortized debt discount and issuance costs (a level 2 measurement) on the accompanying consolidated balance sheets, and the fair value of the Convertible Notes is presented at each reporting period for disclosure purposes only.

 

Employee Retention Credit

 

On March 27, 2020, the U.S. government enacted the Coronavirus Aid, Relief, and Economic Security Act (“CARES Act”). One provision within the CARES Act provided an Employee Retention Credit (“ERC”), which allows for employers to claim a refundable tax credit against the employer share of Social Security tax equal to 50% of the qualified wages paid to employees from March 13, 2020 through December 31, 2020. The ERC was subsequently expanded in 2021 for employers to claim a refundable tax credit for 70% of the qualified wages paid to employees from January 1, 2021 through September 30, 2021.

 

The Company accounted for the ERC by analogy to International Accounting Standard (“IAS”) 20, Accounting for Government Grants and Disclosure of Government Assistance. During the quarter ended June 30, 2025, the Company filed a claim for the ERC for qualified wages paid in 2021 and has yet to receive any refunds or receive any correspondence from the IRS regarding the ERC filing. The Company believes that there is not reasonable assurance that any receipt of credits will be obtained and therefore has not recognized any amounts related to the ERC in the accompanying consolidated financial statements. In the event the Company obtains a refund in future periods, such refunds would be subject to IRS audit under the applicable statute of limitations. Additionally, the Company has accounted for the contingent fee arrangement with its service provider in connection with the filing of the ERC under ASC 450-20, Contingencies, and believes it is not probable that it will receive the credits and therefore has not recognized any amounts related to the fee arrangement.

 

Recently Adopted Accounting Pronouncements

 

In November 2023, the FASB issued ASU 2023-07, Segment Reporting (Topic 280): Improvements to Reportable Segment Disclosures (ASU 2023-07), which requires all public entities, including public entities with a single reportable segment, to provide in interim and annual periods one or more measures of segment profit or loss used by the chief operating decision maker to allocate resources and assess performance. Additionally, the standard requires disclosures of significant segment expenses and other segment items as well as incremental qualitative disclosures. The Company adopted ASU 2023-07 effective December 31, 2024, on a retrospective basis. The adoption of 2023-07 did not change the way that the Company identifies its reportable segments and, as a result, did not have a material impact on the Company’s segment-related disclosures.

 

Recently Issued Accounting Pronouncements

 

In December 2023, the FASB issued ASU 2023-09, Income Taxes (Topic 740): Improvements to Income Tax Disclosures (ASU 2023-09), which requires enhanced income tax disclosures, including specific categories and disaggregation of information in the effective tax rate reconciliation, disaggregated information related to income taxes paid, income or loss from continuing operations before income tax expense or benefit, and income tax expense or benefit from continuing operations. The requirements of the ASU are effective for annual periods beginning after December 15, 2024, with early adoption permitted. The Company is currently in the process of evaluating the impact of this pronouncement on its related disclosures.

 

In November 2024, the FASB issued ASU 2024-03, Income Statement-Reporting Comprehensive Income-Expense Disaggregation Disclosures (Subtopic 220-40): Disaggregation of Income Statement Expenses (ASU 2024-03), which requires disclosure about the types of costs and expenses included in certain expense captions presented on the income statement. The new disclosure requirements are effective for the Company’s annual periods beginning after December 15, 2026, and interim periods beginning after December 15, 2027, with early adoption permitted. The Company is currently in the process of evaluating the impact of this pronouncement on its consolidated financial statements.

 

In November 2024, the FASB issued ASU 2024-04, Induced Conversions of Convertible Debt Instruments. The new guidance clarifies the assessment of whether a transaction should be accounted for as an induced conversion or extinguishment of convertible debt when changes are made to conversion features as part of an offer to settle the instrument. The guidance is effective for fiscal years beginning after December 15, 2025, with early adoption permitted, and it can be adopted either on a prospective or retrospective basis. The Company is currently in the process of evaluating the impact of this pronouncement on its consolidated financial statements and related disclosures.

 

  

3. Inventory and Other Deferred Costs

 

Inventory and other deferred costs consisted of the following:

 

		June 30, 2025				December 31, 2024
		(in thousands)
Raw materials		$	21,721			$	19,109
Work-in-process			2,251				2,157
Finished products			33,488				34,676
Other deferred costs			10,925				8,985
Total inventory and other deferred costs		$	68,385			$	64,927

 

The Company had inventory on consignment at customer sites of $2.3 million and $1.8 million as of June 30, 2025, and December 31, 2024, respectively.

 

In connection with the Company’s RestoreFlow allograft business, other deferred costs include costs incurred for the preservation of human tissues available for shipment, tissues currently in active processing, and tissues held in quarantine pending release to implantable status. By federal law, human tissues cannot be bought or sold. Therefore, the tissues the Company preserves are not held as inventory, and the costs the Company incurs to procure and process vascular tissues are instead accumulated and deferred. These costs include fixed and variable overhead costs associated with the cryopreservation process, including primarily direct labor costs, tissue recovery fees, inbound freight charges, indirect materials, and facilities costs. The Company expenses general and administrative expenses and selling expenses associated with the provision of these services as incurred.

 

4. Goodwill and Other Intangible Assets

 

There was no change to goodwill during the six months ended June 30, 2025. Other intangible assets consisted of the following:

 

		June 30, 2025												December 31, 2024
		Gross								Net				Gross								Net
		Carrying				Accumulated				Carrying				Carrying				Accumulated				Carrying
		Value				Amortization				Value				Value				Amortization				Value
		(in thousands)
Product technology and intellectual property		$	29,549			$	20,038			$	9,511			$	29,549			$	18,709			$	10,840
Trademarks, tradenames and licenses			3,767				2,437				1,330				3,767				2,261				1,506
Customer relationships			37,266				15,034				22,232				37,171				13,709				23,462
Other intangible assets			1,631				1,552				79				1,536				1,525				11
Total identifiable intangible assets		$	72,213			$	39,061			$	33,152			$	72,023			$	36,204			$	35,819

 

The Company is amortizing these assets over useful lives ranging from 2 to 16 years. The weighted-average amortization period for these intangibles as of June 30, 2025, is 8.6 years. The Company includes amortization expense in general and administrative expense as follows:

 

		Three months ended June 30,								Six months ended June 30,
		2025				2024				2025				2024
		(in thousands)								(in thousands)
Amortization expense		$	1,437			$	1,472			$	2,857			$	2,944

 

 

Estimated amortization expense for the remainder of 2025 and for each of the next five fiscal years is as follows:

 

 

		Year ended December 31,
		2025				2026				2027				2028				2029				2030
		(in thousands)
Amortization expense		$	2,780			$	5,163			$	4,854			$	4,468			$	4,435			$	3,396

 

5. Accrued Expenses and Other Long-term Liabilities

 

Accrued expenses consisted of the following:

 

		June 30, 2025				December 31, 2024
		(in thousands)
Compensation and related taxes		$	12,176			$	15,117
Accrued purchases			4,525				4,463
Accrued expenses			2,429				3,852
Accrued interest			2,300				86
Income and other taxes			1,094				639
Professional fees			74				144
Other			380				431
Total		$	22,978			$	24,732

 

Other long-term liabilities consisted of the following:

 

		June 30, 2025				December 31, 2024
		(in thousands)
Income taxes			623				572
Other			311				259
Total		$	934			$	831

 

6. Income Taxes

 

As part of the process of preparing its consolidated financial statements, the Company is required to determine its income taxes in each of the jurisdictions in which it operates. This process involves the Company estimating its actual current tax expense together with assessing temporary differences resulting from recognition of items for income tax and accounting purposes. These differences result in deferred tax assets and liabilities, which are included within the Company’s consolidated balance sheet. The Company must then assess the likelihood that its deferred tax assets will be recovered from taxable income during the carryback period or in the future; and to the extent the Company believes that recovery is not more likely than not, the Company must establish a valuation allowance. To the extent the Company establishes a valuation allowance or increases its allowance in a period, the Company must reflect this increase as an expense within the tax provision in the statement of operations. The Company does not provide for income taxes on undistributed earnings of certain foreign subsidiaries, as its intention is to permanently reinvest these earnings.

 

The Company recognizes, measures, presents, and discloses in its consolidated financial statements any uncertain tax positions that it has taken, or expects to take on a tax return. The Company operates in multiple taxing jurisdictions, both inside and outside the United States, and may be subject to audits from various tax authorities. Management’s judgment is required in determining the Company’s provision for income taxes, deferred tax assets and liabilities, liabilities for uncertain tax positions, and any valuation allowance recorded against the Company’s net deferred tax assets. The Company monitors the realizability of its deferred tax assets and will adjust the valuation allowance accordingly.

 

The Company’s policy is to classify interest and penalties related to unrecognized tax benefits as income tax expense. The Company’s 2025 income tax expense varies from the statutory rate mainly due to the generation of federal and state tax credits, permanent items, different statutory rates from its foreign subsidiaries, and discrete stock option exercises. The Company’s 2024 income tax expense varied from the statutory rate mainly due to the generation of federal and state tax credits, permanent items, different statutory rates from its foreign subsidiaries, and discrete stock option exercises.

 

 

The Company has reviewed the tax positions taken, or to be taken, in its tax returns for all tax years currently open to examination by a taxing authority. As of June 30, 2025, the gross amount of unrecognized tax benefits exclusive of interest and penalties was $0.4 million. The Company remains subject to examination until the statute of limitations expires for each remaining respective tax jurisdiction. The statute of limitations will be open with respect to these tax positions until 2031. A reconciliation of beginning and ending amount of the Company’s unrecognized tax benefits is as follows:

 

		Six months ended June 30, 2025
		(in thousands)
Unrecognized tax benefits as of December 31, 2024		$	515
Additions/adjustments for tax positions of current year			-
Additions/adjustments for tax positions of prior years			22
Reductions for settlements with taxing authorities			-
Reductions for lapses of the applicable statutes of limitations			(114	)
Unrecognized tax benefits as of June 30, 2025		$	423

 

As of June 30, 2025, a summary of the tax years that remain subject to examination in the Company’s taxing jurisdictions is as follows:

 

United States	2021 and forward
Foreign	2016 and forward

 

7. Convertible Senior Notes

 

Convertible senior notes consisted of the following:

 

		June 30, 2025				December 31, 2024
		(in thousands)
Principal amount of convertible senior notes		$	172,500			$	172,500
Less: Current portion of convertible senior notes			-				-
Convertible senior notes, net of current portion			172,500				172,500
Debt discount, net of accretion			(4,295	)			(4,728	)
Convertible senior notes, net of discount and current portion		$	168,205			$	167,772

 

On December 19, 2024, the Company issued $172.5 million aggregate principal amount of convertible senior notes due 2030, in a Rule 144A private placement to qualified institutional buyers pursuant to an indenture dated December 19, 2024, by and between the Company and U.S. Bank Trust Company, National Association (the “Indenture”). 

 

The Convertible Notes will mature on February 1, 2030, unless earlier repurchased, redeemed, or converted. The proceeds from the issuance of the Convertible Notes were approximately $167.7 million, net of initial purchaser discounts and other debt issuance costs totaling $4.8 million.

 

The Convertible Notes bear interest at a rate of 2.50% per year and interest is payable semiannually in arrears on August 1 and February 1 of each year. The initial conversion rate is 8.3521 shares of common stock per $1,000 principal amount of the Convertible Notes, which represents an initial conversion price of approximately $119.73 per share of common stock and a premium of approximately 30% over the closing price of the Company’s common stock on December 16, 2024. In connection with the payment by the Company on May 29, 2025 of a quarterly cash dividend of $0.20 per share (an increase from the quarterly dividend amount of $0.16 per share as of the time of issuance of the Convertible Notes), the conversion rate of the Convertible Notes was increased to 8.3602 shares of common stock per $1,000 principal amount of the Convertible Notes, which represents a conversion price of approximately $119.61 per share of common stock. A similar adjustment to the conversion rate will be made upon payment of the quarterly cash dividend of $0.20 on September 4, 2025, and upon payment of subsequent quarterly dividends in excess of $0.16 per share. The conversion rate and conversion price are subject to customary adjustments upon the occurrence of certain events as described in the Indenture.

 

Noteholders may convert all or a portion of their Convertible Notes at their option only in the following circumstances: (1) during any calendar quarter commencing after the calendar quarter ending on June 30, 2025, if the last reported sale price per share of the Company’s common stock exceeds 130% of the conversion price for each of at least 20 trading days during the 30 consecutive trading days ending on, and including, the last trading day of the immediately preceding calendar quarter; (2) during the five consecutive business days immediately after any five consecutive trading day period in which the trading price per $1,000 principal amount of Convertible Notes for each trading day of the measurement period was less than 98% of the product of the last reported sale price per share of the Company’s common stock on such trading day and the conversion rate on such trading day; (3) upon the occurrence of certain corporate events or distributions on the Company’s common stock, as described in the Indenture; (4) if the Company calls (or is deemed to have called) any Convertible Notes for redemption; and (5) at any time from, and including, August 1, 2029, until the close of business on the second scheduled trading day immediately before the maturity date. The Company has the right to elect to settle conversions either in cash, shares of its common stock, or in a combination of cash and shares of its common stock.

 

 

Additional interest of up to 0.5% per annum is payable if the Company fails to timely file required documents or reports with the SEC or the Convertible Notes become not freely tradable (as defined in the Indenture). The Company determined that the higher interest payments required in certain circumstances were embedded derivatives that should be bifurcated and accounted for at fair value. The Company assessed the value of the embedded derivatives at each balance sheet date and determined they had de minimis value.

 

Prior to February 5, 2028, the Convertible Notes will not be redeemable. On or after February 5, 2028, until the 40th trading day immediately before the maturity date, the Company may redeem for cash all or any portion of the Convertible Notes (subject to the partial redemption limitation set forth in the Indenture), at its option, if the last reported sale price of the Company’s common stock has been at least 130% of the conversion price then in effect for at least 20 trading days (whether or not consecutive) during any 30-consecutive-trading-day period (including the last trading day of such period) ending on, and including, the trading day immediately preceding the date on which the Company provides notice of redemption. In addition, calling any Convertible Note for redemption will constitute a “Make-Whole Fundamental Change” (as defined in the Indenture) with respect to that Convertible Note, in which case the conversion rate applicable to the conversion of that Convertible Note will be increased in certain circumstances if it is converted after it is called for redemption. 

 

During the six months ended June 30, 2025, the Company recognized $2.2 million in interest expense related to the 2.50% cash coupon of the Convertible Notes and $0.4 million of amortization expense of the debt issuance costs. The Company did not recognize interest expense during the six months ended June 30, 2024. As of June 30, 2025, the estimated fair value of the Convertible Notes was $172.7 million compared to $178.6 million as of December 31, 2024. The fair value was determined based on the quoted price of the last trade of the Convertible Notes prior to the end of the reporting period in an inactive market, which is considered as Level 2 in the fair value hierarchy.

 

8. Stock-Based Compensation

 

The Company’s Fourth Amended and Restated 2006 Stock Option and Incentive Plan allows for granting of incentive stock options, non-qualified stock options, stock appreciation rights, restricted stock units, performance-based restricted stock units, unrestricted stock awards, and deferred stock awards to its officers, employees, directors, and consultants. The components of stock-based compensation expense included in the consolidated statements of operations are as follows:

 

		Three months ended								Six months ended
		June 30,								June 30,
		2025				2024				2025				2024
		(in thousands)								(in thousands)
Stock option awards		$	910			$	732			$	1,810			$	1,473
Restricted stock units			634				573				1,320				1,134
Performance-based restricted stock units			400				304				860				612
Total stock-based compensation		$	1,944			$	1,609			$	3,990			$	3,219

 

 

Stock-based compensation is included in the Company’s consolidated statements of operations as follows:

 

		Three months ended								Six months ended
		June 30,								June 30,
		2025				2024				2025				2024
		(in thousands)								(in thousands)
Cost of sales		$	266			$	228			$	552			$	439
Sales and marketing			349				274				725				545
General and administrative			1,140				943				2,316				1,908
Research and development			189				164				397				327
Total stock-based compensation		$	1,944			$	1,609			$	3,990			$	3,219

 

During the six months ended June 30, 2025, the Company granted 741 options. The Company did not grant any options during the six months ended June 30, 2024. During the six months ended June 30, 2025 and 2024, the Company granted 1,521 and 222 restricted stock units, respectively. During the six months ended June 30, 2025, the Company granted 129 performance-based restricted stock units. The Company did not grant any performance-based restricted stock units during the six months ended June 30, 2024. The Company issued 93,658 and 147,540 shares of common stock following the exercise or vesting of underlying stock options, restricted stock units, and performance-based restricted stock units during the six months ended June 30, 2025 and 2024, respectively.

 

9. Net Income per Share

 

The Company computes basic net income per common share by dividing the net income by the weighted average number of shares of common stock outstanding for the period. Diluted net income per common share is computed by dividing net income by the weighted average number of shares of common stock outstanding for the period, including potential dilutive common shares assuming the dilutive effect of outstanding stock awards, using the treasury stock method, and outstanding convertible notes, using the if-converted method.

 

A reconciliation of the numerators and the denominators of the basic and dilutive net income per common share computations are as follows:

 

		Three months ended								Six months ended
		June 30,								June 30,
		2025				2024				2025				2024
		(in thousands, except per share data)								(in thousands, except per share data)
Numerator:
Net income		$	13,779			$	11,826			$	24,790			$	21,713
Denominator:
Weighted average basic common shares outstanding			22,614				22,458				22,592				22,412
Effect of dilutive securities:
Options to purchase common stock			210				184				235				173
Resticted stock units			40				57				39				47
Performance-based restricted stock units			28				26				30				25
Weighted average dilutive common shares outstanding			22,892				22,725				22,896				22,657
Net income per share:
Basic		$	0.61			$	0.53			$	1.10			$	0.97
Diluted		$	0.60			$	0.52			$	1.08			$	0.96

 

 

The Company excluded the following common shares, presented based on weighted average shares outstanding, from the computation of diluted net income per share because including them would have had an anti-dilutive effect:

 

		Three months ended								Six months ended
		June 30,								June 30,
		2025				2024				2025				2024
		(in thousands)								(in thousands)
Convertible senior notes			1,442				-				1,442				-
Options to purchase common stock			126				26				126				147
Restricted stock units			32				-				32				-
Performance-based restricted stock units			10				-				10				-
			1,610				26				1,610				147

 

10. Stockholders’ Equity

 

Share Repurchase Program

 

On February 18, 2025, the Company’s Board of Directors authorized the repurchase of up to $75.0 million of the Company’s common stock through transactions on the open market, in privately negotiated purchases, or otherwise until February 17, 2026. The repurchase program may be suspended or discontinued at any time. To date the Company has not made any repurchases under this program.

 

Dividends

 

In February 2011, the Company’s Board of Directors approved a policy for the payment of quarterly cash dividends on its common stock. Future declarations of quarterly dividends and the establishment of future record and payment dates are subject to approval by the Board of Directors on a quarterly basis. The dividend activity for the periods presented is as follows:

 

Record Date		Payment Date		Per Share Amount				Dividend Payment
								(in thousands)
Fiscal Year 2025
March 13, 2025		March 27, 2025		$	0.20			$	4,517
May 15, 2025		May 29, 2025		$	0.20			$	4,520
Fiscal Year 2024
March 14, 2024		March 28, 2024		$	0.16			$	3,589
May 16, 2024		May 30, 2024		$	0.16			$	3,593
August 15, 2024		August 29, 2024		$	0.16			$	3,596
November 21, 2024		December 5, 2024		$	0.16			$	3,600

 

On July 30, 2025, the Company’s Board of Directors approved a quarterly cash dividend on its common stock of $0.20 per share payable on September 4, 2025, to stockholders of record at the close of business on August 21, 2025.

 

  

11. Commitments and Contingencies

 

Operating Leases

 

The Company determines if an arrangement is a lease at inception of the contract. The Company has operating leases for buildings, primarily for office space, manufacturing, and distribution, as well as automobiles and printing equipment. As of June 30, 2025, the Company had the following building and facility leases capitalized on the balance sheet:

 

Location (leases)		Purpose		Approx. Sq. Ft.			Expiration
Americas
Burlington, MA (4)		Corporate headquarters and manufacturing			96,476		December 2034
North Brunswick, NJ		Artegraft biologic business			16,732		October 2029
Burlington, MA		US distribution			12,878		December 2030
Fox River Grove, IL		RestoreFlow allografts business			9,754		December 2026
Fox River Grove, IL		RestoreFlow allografts business			4,878		November 2025
Vaughn, Canada		Canada sales office and distribution			3,192		February 2026
Europe, Middle East and Africa
Sulzbach, Germany		European headquarters and distribution			21,410		June 2031
Milan, Italy		Italy sales office and distribution			5,705		September 2027
Hereford, England		United Kingdom sales office and distribution			3,575		October 2029
Maisons-Alfort, France		France sales office			3,492		February 2030
Zurich, Switzerland		Switzerland sales office and distribution			2,935		February 2030
Madrid, Spain		Spain sales office and distribution			2,260		June 2029
Asia Pacific
Tokyo, Japan		Japan sales office and distribution			4,236		July 2027
Shanghai, China		China sales office and distribution			3,432		October 2027
Docklands, Australia		Australia sales office and distribution			2,863		April 2030
Bangkok, Thailand		Thailand sales office and distribution			2,810		August 2026
Seoul, Korea		Korea sales office and distribution			2,300		April 2027
Singapore		Asia Pacific headquarters and distribution			1,270		June 2026
Ballarat, Australia		Supply facility		Up to 350 acres			December 2030

 

Operating lease right-of-use (ROU) assets and operating lease liabilities are recognized based on the present value of the future lease minimum payments over the lease term at commencement date. Many of the lease agreements contain renewal or termination clauses that are factored into the determination of the lease term if it is reasonably certain that these options would be exercised. The Company recognizes lease expense for these leases on a straight-line basis over the lease term.

 

None of the Company’s noncancelable lease payments include non-lease components such as maintenance contracts. The Company generally reimburses the landlord for direct operating costs associated with the leased space. The Company has no subleases, and there are no residual value guarantees associated with, or restrictive covenants imposed by, any of its leases. The Company held no assets under capital leases as of June 30, 2025. The Company elected the package of practical expedients that allow it to omit leases with initial terms of 12 months or less from its balance sheet, which the Company expenses on a straight-line basis over the life of the lease.

 

The interest rate implicit in lease agreements is typically not readily determinable, and as such the Company used the incremental borrowing rate based on the information available at commencement date in determining the present value of future payments. The incremental borrowing rate is defined as the interest the Company would pay to borrow on a collateralized basis.

 

Additional information with respect to the Company’s leases is as follows:

 

		Three months ended June 30,								Six months ended June 30,
		2025				2024				2025				2024
		(in thousands)								(in thousands)
Lease cost
Operating lease cost		$	447			$	709			$	1,041			$	1,149
Short-term lease cost			20				17				46				46
Total lease cost		$	467			$	726			$	1,087			$	1,195
Weighted average remaining lease term - operating leases (in years)											6.9				7.8
Weighted average discount rate - operating leases											6.62	%			6.60	%

 

 

As of June 30, 2025, the minimum noncancelable operating lease rental commitments with initial or remaining terms of more than one year are as follows:

 

Remainder of 2025		$	2,035
Year ending December 31,
2026			3,612
2027			3,030
2028			2,759
2029			2,695
2030			2,186
Thereafter			6,420
Adjustment to net present value as of June 30, 2025			(5,053	)
Minimum noncancelable lease liability		$	17,684

 

In June 2025, the Company executed a new building lease agreement in Billerica, Massachusetts for U.S. distribution. The 34,400 square foot building lease will commence on January 1, 2026, with a primary term through December 31, 2032. The Company has the option to renew the primary term of the lease for one additional 24-month period.

 

12. Segment and Geographic Information

 

The Company regularly reviews its segment financial information and the approach used by the chief operating decision maker (“CODM”), the Chief Executive Officer, to evaluate performance and allocate resources. The Company considers the business to be a single operating segment engaged in the development, manufacturing, and marketing of medical devices and implants, as well as the processing and cryopreservation of human tissues for implantation in patients, all used primarily in the field of vascular surgery.

 

The CODM assesses performance for its single operating segment and decides how to allocate resources based on net income that also is reported on the consolidated statements of operations. The measure of segment assets is reported on the consolidated balance sheets as total consolidated assets.

 

The CODM uses net income to evaluate income generated from segment assets (return on assets) in deciding whether to reinvest profits into the single operating segment or into other parts of the entity, such as for acquisitions, dividend payments, and/or short-term marketable security investments. Net income is also used to monitor budget versus actual results, which is used in assessing performance of the segment and in establishing management’s compensation.

 

 

In addition to total segment net income, the CODM’s quarterly reporting package includes several highlighted expense categories that the CODM considers key strategic drivers of the Company’s long-term profitability. The following is the Company’s operating segment reconciliation of net income, including significant segment expenses:

 

		Three months ended June 30,								Six months ended June 30,
		2025				2024				2025				2024
		(in thousands)								(in thousands)
Net sales		$	64,232			$	55,849			$	124,103			$	109,327
Cost of sales			19,258				17,381				37,709				34,194
Gross profit			44,974				38,468				86,394				75,133
Less:
Selling expense			13,579				9,796				26,403				20,348
Marketing expense			1,316				1,188				2,704				2,322
Administrative expense			7,177				5,972				14,000				11,868
Finance expense			2,481				2,276				5,449				4,814
Management information systems expense			738				572				1,434				1,151
Research and development expense			1,113				830				2,214				1,662
Process engineering expense			543				735				1,282				1,540
Regulatory and clinical expense			1,885				2,719				4,140				5,174
Other (income) expense, net*			2,363				2,554				3,978				4,541
Net income		$	13,779			$	11,826			$	24,790			$	21,713

 

*Refer to the consolidated statement of operations for the components of other income and expense and related amounts.

 

Most of the Company’s revenues are generated in the United States, Germany, the United Kingdom, other European countries, and Canada. Substantially all of the Company’s assets are located in the United States and Germany. Net sales to unaffiliated customers based on customer location by country were as follows:

 

		Three months ended June 30,								Six months ended June 30,
		2025				2024				2025				2024
		(in thousands)								(in thousands)
United States		$	36,656			$	32,798			$	71,284			$	63,923
Germany			4,458				3,509				8,435				7,027
Canada			3,955				3,618				7,676				7,230
United Kingdom			3,296				2,718				6,445				5,246
Other countries			15,867				13,206				30,263				25,901
Net sales		$	64,232			$	55,849			$	124,103			$	109,327

 

13. Subsequent Event

 

On July 4, 2025, President Donald Trump signed the One Big Beautiful Bill Act (“OBBBA”) into law, which is considered the enactment date under U.S. GAAP. Key corporate tax provisions include the restoration of 100% bonus depreciation, immediate expensing for domestic research and experimental expenditures, changes to Section 163(j) interest limitations, and updates to GILTI and FDII rules. In accordance with ASC 740, the effects of the new tax law will be recognized in the period of enactment. The Company is currently evaluating the impact of the OBBBA, and we currently do not believe there will be a material impact to the Company’s financial statements.

 

Additionally, in April 2025, the Company filed amended Forms 941-X to claim the expanded ERC totaling $6.3 million of credits for filing periods beginning January 1, 2021, through September 30, 2021. The OBBBA removed the claims filed by any taxpayer after January 31, 2024, for the period July 1, 2021, through September 30, 2021. The Company’s amended Forms 941-X for the period July 1, 2021, through September 30, 2021, were filed in April 2025 with a credit of $2.2 million.

 

  

Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations

 

The following discussion and analysis of our financial condition and results of operations should be read in conjunction with our consolidated financial statements and related notes appearing elsewhere in this Quarterly Report on Form 10-Q and our Annual Report on Form 10-K for the year ended December 31, 2024, as filed with the SEC on February 28, 2025, or the 2024 Form 10-K. Some of the information contained in this discussion and analysis or set forth elsewhere in this Quarterly Report on Form 10-Q, including information with respect to our plans and strategy for our business, includes forward-looking statements that involve risks and uncertainties. As a result of many factors, including those factors set forth in the “Item 1A. Risk Factors” section of this Quarterly Report on Form 10-Q and the “Item 1A. Risk Factors” section of our 2024 Form 10-K, our actual results could differ materially from the results described in or implied by the forward-looking statements contained in the following discussion and analysis.

 

Overview

 

We are a global provider of medical devices and human tissue cryopreservation services largely used in the treatment of peripheral vascular disease, end-stage renal disease, and cardiovascular disease. We develop, manufacture, and market vascular devices to address the needs of vascular surgeons and, to a lesser degree, other specialties such as cardiac surgeons, general surgeons, and neurosurgeons. Our diversified portfolio of devices consists of brand name products that are used in arteries and veins and are well known to vascular surgeons. Our principal product offerings are sold globally, primarily in the United States, Europe, Canada, and Asia Pacific, or APAC. We estimate that the annual worldwide market for peripheral vascular devices exceeds $5 billion, within which we estimate that the market for our products is approximately $1 billion. We have grown our business using a three-pronged strategy: 1) pursuing a focused call point, 2) competing for sales of low-rivalry, niche products, and 3) expanding our worldwide direct sales force while acquiring complementary devices. We have used acquisitions as a primary means of further penetrating the peripheral vascular device market, and we expect to continue this strategy in the future. We currently manufacture most of our products in our Burlington, Massachusetts headquarters.

 

Our products and services are used primarily by vascular surgeons who treat peripheral vascular disease through both open surgical methods and endovascular techniques. In contrast to interventional cardiologists and interventional radiologists, vascular surgeons can perform both open surgical and minimally invasive endovascular procedures, and therefore can provide a wider range of treatment options to their patients. Recently we have also begun to explore adjacent market customers, such as cardiac surgeons and interventional cardiologists.

 

Our principal product lines include the following: anastomotic clips, biologic vascular and dialysis grafts, biologic vascular and cardiac patches, carotid shunts, embolectomy and occlusion catheters, radiopaque marking tape, synthetic vascular and dialysis grafts, and valvulotomes. Through our RestoreFlow allografts business, we also process and cryopreserve human vascular and cardiac tissue.

 

Our principal biologic offerings include vascular and cardiac patches as well as vascular and dialysis grafts. In Q2 2025, biologics represented 51% of our worldwide sales. We believe our biologic devices represent differentiated and, in many cases, growing product segments.

 

To assist us in evaluating our business strategies, we monitor long-term technology trends in the peripheral vascular device market. Additionally, we consider the information obtained from discussions with the medical community in connection with the demand for our products, including potential new product launches. We also use this information to help determine our competitive position in the peripheral vascular device market and our manufacturing capacity requirements.

 

Our business opportunities include the following:

 

	•	growing our direct sales force in North America, Europe, and APAC, including replacing distributors with our direct sales personnel;
	•	increasing the average selling prices of our devices;
	•	introducing our products into new territories upon receipt of regulatory approvals or registrations;
	•	acquiring complementary products and the transition of distributor sales to LeMaitre;
	•	updating existing products and introducing new products through research and development; and
	•	consolidating product manufacturing into our Burlington, Massachusetts facilities.

 

 

We sell our products and services primarily through a direct sales force. Our worldwide headquarters is located in Burlington, Massachusetts, and we also have a North American sales office in Vaughan, Canada. Our European headquarters is located in Sulzbach, Germany, and we also have European sales offices in Milan, Italy; Madrid, Spain; Hereford, England; Dublin, Ireland; Maisons-Alfort, France; and Zurich, Switzerland. Our APAC headquarters is located in Singapore, and we also have APAC sales offices in Tokyo, Japan; Shanghai, China; Docklands, Australia; Seoul, Korea; and Bangkok, Thailand. During the quarter ended June 30, 2025, approximately 95% of our net sales were generated in territories in which we employ direct sales representatives. We sell our products in other countries through distributors. As of June 30, 2025, our sales force comprised 163 sales representatives and export managers in North America, Europe, and APAC.

 

Historically we have experienced success in lower-rivalry niche segments. In the valvulotome market, for example, our differentiated devices have historically allowed us to increase average selling prices without incurring significant unit share loss. In contrast, we have experienced less success in competitive markets such as the polyester vascular graft market, where we face competition from larger companies with greater resources and lower per unit costs.

 

We have also experienced success in international markets, such as Europe, where we have a significant sales force, and sometimes offer lower average selling prices than in North America. If we continue to seek growth opportunities outside of North America, we may experience downward pressure on our gross margin.

 

We obtain regulatory approvals for our devices and services in new product categories and geographies to further access the broader peripheral device market and select other markets, thus extending our geographic reach. We received approvals to sell the XenoSure patch for carotid indication in Japan in May 2023, and the Pruitt Irrigation Occlusion Catheter in China in October 2023. We received approvals to sell the Artegraft bovine graft in Thailand and Malaysia in August 2024 and South Africa in October 2024, and the XenoSure patch for cardiac indications in China in December 2024. We received approvals to sell the Artegraft bovine graft in the European Union (EU) in April 2025 and Australia in June 2025, the Pruitt Aortic Occlusion Catheter in the EU in May 2025, and the Pruitt Occlusion Catheter in China in June 2025.

 

Separately, our regulatory efforts to maintain approvals in the EU and the United Kingdom (UK) have shown steady progress and success as the EU transitions from the Medical Device Directive (MDD) to the Medical Device Regulation (MDR) and the UK transitions to the United Kingdom Conformity Assessed (UKCA) marks.  In 2024, we received MDR CE and UKCA marks allowing for the continued sale of 11 devices into the EU and UK. In January 2025, we received MDR CE and UKCA marks to market Burlington-manufactured CardioCel and VascuCel devices in the EU and UK. As of June 30, 2025, we have 19 MDR CE marks and UKCA approvals, and expect to hold 22 approvals by the end of 2025. Those 22 CE and UKCA marks will represent substantially all of our product offerings in the EU and UK. The European Commission has designated the end of 2028 as the final MDR CE mark transition deadline.

 

Our strategy for growing our business includes acquisitions of complementary product lines and companies, which can be difficult to identify, negotiate, and purchase. There can be no assurance that we will be able to do so in the future.

 

•

In June 2020, we entered into an agreement with Artegraft to purchase the assets of their bovine graft business for $72.5 million plus additional payments of up to $17.5 million, contingent upon future unit sales.

 

Occasionally we discontinue or divest products that are no longer complementary to our business or not commercially viable.

 

	•	During 2021, we made decisions to wind down the TRIVEX powered phlebectomy systems, remote endarterectomy devices, and surgical glue. These product lines totaled approximately $2.2 million in 2021 revenues.
	•	During 2022, we made the decision to wind down the ProCol graft, AlboSure polyester patch, LeverEdge, and Latis graft cleaning catheter product lines. These products totaled approximately $0.7 million in 2022 revenues.
	•	During 2024, we made the decision to wind down the PeriVu Angioscope product line. This product totaled approximately $0.9 million in 2024 revenues.
	•	During 2025, we made the decision to end our cardiovascular porcine patch distribution agreement with Elutia. Previously, in April 2023, we had entered into an agreement with Elutia to become the exclusive U.S. distributor of their cardiovascular porcine patches. Under the agreement, we could distribute the products for three years with an option to acquire Elutia’s worldwide cardiovascular porcine patch business during the second and third years of the agreement. This product totaled approximately $1.8 million in 2025 revenues.

 

 

From time to time we may undertake SKU reductions and attempt to transition sales to other SKUs or products with similar features. For example, in 2022, we initiated the transition of sales of our Syntel spring tip catheter to our Syntel regular tip catheter. Any of these actions may result in inventory write-offs and temporary or permanent negative impacts to our sales, gross margin, and customer relationships.

 

Because we believe that direct-to-hospital sales engender closer customer relationships, and allow for higher selling prices and gross margins, we periodically enter into transactions with country-specific distributors to transition their sales of our medical devices into our direct sales organization:

 

•

In May 2022, we entered into a distribution transition agreement with our Korean distributor to sell products directly in Korea and dissolve the existing distribution arrangement. We have been selling direct-to-hospital in Korea since December 2022. The distribution termination fees totaled approximately $0.5 million.

 

	•	In March 2023, we entered into a distribution transition agreement with our Thai distributor to sell products directly in Thailand and dissolve the existing distribution arrangement. We have been selling direct-to-hospital in Thailand since August 2023. The distribution termination fees totaled approximately $0.7 million.
	•	In March 2025, we entered into a distribution transition agreement with our Portuguese distributor to sell products directly in Portugal and dissolve the existing distribution arrangement. We have been selling direct-to-hospitals in Portugal since May 2025. The distribution termination fees are expected to total approximately $0.2 million.
	•	In June 2025, we entered into a distribution transition agreement with our Czech distributor to sell products directly in Czechia and dissolve the existing distribution arrangement. We plan to be selling direct-to-hospitals in Czechia in Q3 2025. The distribution termination fees are expected to total approximately $0.1 million.

 

We also benefit, to a lesser extent, from internal product development efforts to bring differentiated technologies and next-generation products and services to market:

 

•

In March 2022, we received FDA clearance to market PhasTIPP, a portable powered phlebotomy device used to remove varicose veins in the leg. The device was launched in the United States in April 2024.

 

In addition to our sales growth strategies, we have also executed several operational initiatives designed to consolidate manufacturing into our Burlington facilities. We expect these plant consolidations and manufacturing transfers will result in improved control over production quality as well as reduced costs. Our most recent manufacturing transfer was:

 

•

In October 2019, we acquired the CardioCel and VascuCel biologic patch businesses from Anteris. The transfer to Burlington was substantially completed in 2023. In June 2023, the MDR CE mark application for these Burlington-produced devices was submitted, and we obtained approval in January 2025, allowing for distribution of these patches in the EU in 2025. We began distributing these Burlington-produced patches in the United States, Canada, and select APAC markets in 2024.

 

Our execution of these initiatives may affect the comparability of our financial results and may cause fluctuations from period to period.

 

In February 2024, we began implementing a new enterprise resource planning, or ERP, system to replace our financial reporting and planning system. We expect that the new ERP system will be beneficial in a number of areas, including inventory management, pricing programs, financial operations, and real-time reporting. We have been preparing for this transition since 2022 and hired an experienced consulting team to assist in this transition. In the United States, we transitioned from our legacy ERP system to our newly implemented Microsoft Dynamics D365 system in February 2024. In February 2025, we implemented this new system in the UK. As of June 30, 2025, we have capitalized costs on our balance sheet of $4.9 million associated with this ERP system.

 

Fluctuations in the exchange rates between the U.S. dollar and foreign currencies, primarily the Euro, affect our financial results. For the six months ended June 30, 2025, approximately 43% of our sales took place outside of the United States, largely in currencies other than the U.S. dollar. We expect foreign currencies will represent a significant percentage of future sales. Selling, marketing, and administrative costs related to these sales are also denominated in foreign currencies, thereby partially mitigating our bottom-line exposure to exchange rate fluctuations. If there is an increase in the rate at which a foreign currency is exchanged for U.S. dollars, it will require less of the foreign currency to equal a specified amount of U.S. dollars than before the rate increase. In such cases we will record more revenue in U.S. dollars than we would have if the exchange rate had not changed. For the six months ended June 30, 2025, we estimate that the effects of changes in foreign exchange rates increased our reported sales by approximately $0.3 million, as compared to rates in effect for the six months ended June 30, 2024.

 

 

Net Sales and Expense Components

 

The following is a description of the primary components of our net sales and expenses:

 

Net sales. We derive our net sales from the sale of our products and services, less discounts and returns. Net sales include the shipping and handling fees paid for by our customers. Most of our sales are generated by our direct sales force and are shipped and billed to hospitals or clinics throughout the world. In countries where we do not have a direct sales force, sales are primarily to distributors, who in turn sell to hospitals and clinics. In certain cases our products are held on consignment at a hospital or clinic prior to purchase; in those instances we recognize revenue at the time the product is used in surgery rather than at shipment.

 

Cost of sales. We manufacture the majority of the products that we sell. Our cost of sales consists primarily of manufacturing personnel, raw materials and components, depreciation of property and equipment, and other allocated manufacturing overhead, as well as the freight expense we pay to ship products to customers.

 

Sales and marketing. Sales and marketing expense consists primarily of salaries, commissions, stock-based compensation, travel and entertainment, sales meetings, attendance at vascular and cardiac congresses, training programs, advertising and product promotions, direct mail, and other marketing costs.

 

General and administrative. General and administrative expense consists primarily of executive, finance and human resource salaries, stock-based compensation, legal and accounting fees, information technology expense, intangible asset amortization expense, and insurance expense.

 

Research and development. Research and development expense primarily includes costs associated with obtaining and maintaining regulatory approval of our products, salaries, laboratory testing, and supply costs. It also includes costs associated with the design and execution of clinical studies, costs to register, maintain, and defend our intellectual property, and costs to transfer the manufacturing of acquired product lines to our Burlington facility. Also included are costs associated with the design, development, testing, and enhancement of new or existing products.

 

Other income (expense). Other income (expense) primarily includes interest income and expense, foreign currency gains (losses), and other miscellaneous gains (losses).

 

Income tax expense. We are subject to federal and state income taxes for earnings generated in the United States, which include operating losses or profits in certain foreign jurisdictions for certain years depending on tax elections made, and foreign taxes on earnings of our wholly-owned foreign subsidiaries. Our consolidated tax expense is affected by the mix of our taxable income (loss) in the United States and foreign subsidiaries, permanent items, discrete items, unrecognized tax benefits, and amortization of goodwill for U.S. tax reporting purposes. 

 

Results of Operations

 

Comparison of the three- and six-month periods ended June 30, 2025, to the three- and six-month periods ended June 30, 2024:

 

The following table sets forth for the periods indicated our net sales by geography and the change between the specified periods expressed as a percentage increase or decrease:

 

		Three months ended June 30,												Six months ended June 30,
(unaudited)										Percent												Percent
		2025				2024				change				2025				2024				change
		(in thousands)												(in thousands)
Net sales		$	64,232			$	55,849				15	%		$	124,103			$	109,327				14	%
Net sales by geography:
Americas		$	41,321			$	36,907				12	%		$	80,279			$	72,152				11	%
Europe, Middle East and Africa			18,840				15,298				23	%			35,799				29,693				21	%
Asia Pacific			4,071				3,644				12	%			8,025				7,482				7	%
Total		$	64,232			$	55,849				15	%		$	124,103			$	109,327				14	%

 

Net sales. Net sales increased by $8.4 million, or 15%, to $64.2 million for the three months ended June 30, 2025, compared to $55.8 million for the three months ended June 30, 2024. The increase was driven primarily by higher average selling prices, higher unit volumes shipped to customers, and additional sales representatives. Graft sales increased $3.6 million, catheter sales increased $1.6 million, valvulotome sales increased $1.3 million, and shunt sales increased $0.8 million. We estimate that the weaker U.S. dollar increased net sales by $1.0 million during the three months ended June 30, 2025, as compared to the three months ended June 30, 2024.

 

 

Direct-to-hospital net sales were 95% of our total net sales for both the three months ended June 30, 2025 and 2024.

 

Net sales increased by $14.8 million, or 14%, to $124.1 million for the six months ended June 30, 2025, compared to $109.3 million for the six months ended June 30, 2024. The increase was driven primarily by higher average selling prices, higher unit volumes shipped to customers, and additional sales representatives. Graft sales increased $6.7 million, valvulotome and catheter sales increased $2.0 million each, patch sales increased $1.7 million, and shunt sales increased $1.5 million. We estimate that the weaker U.S. dollar increased net sales by $0.3 million during the six months ended June 30, 2025, as compared to the six months ended June 30, 2024.

 

Direct-to-hospital net sales were 94% and 95% of our total net sales for the six months ended June 30, 2025 and 2024, respectively.

 

Net sales by geography. Net sales in the Americas increased $4.4 million, or 12%, for the three months ended June 30, 2025, as compared to the three months ended June 30, 2024. The increase was driven primarily by increased sales of grafts of $2.9 million, catheters of $0.7 million, and valvulotomes of $0.6 million.

 

Net sales in the Americas increased $8.1 million, or 11%, for the six months ended June 30, 2025, as compared to the six months ended June 30, 2024. The increase was driven primarily by increased sales of grafts of $4.6 million, valvulotomes of $1.3 million, catheters of $0.7 million, and patches and clips of $0.4 million each.

 

Europe, Middle East, and Africa, or EMEA, net sales increased $3.5 million, or 23%, for the three months ended June 30, 2025, as compared to the three months ended June 30, 2024. The increase was driven primarily by increased sales of catheters of $1.0 million, patches and shunts of $0.7 million each, and valvulotomes of $0.6 million.

 

EMEA net sales increased $6.1 million, or 21%, for the six months ended June 30, 2025, as compared to the six months ended June 30, 2024. The increase was driven primarily by increased sales of grafts of $1.9 million, catheters of $1.4 million, shunts of $1.2 million, and patches of $1.1 million.

 

APAC net sales increased $0.4 million, or 12%, for the three months ended June 30, 2025, as compared to the three months ended June 30, 2024. The increase was driven primarily by increased sales of grafts and patches of $0.2 million each.

 

APAC net sales increased $0.5 million, or 7%, for the six months ended June 30, 2025, as compared to the six months ended June 30, 2024. The increase was driven primarily by increased sales of grafts, patches, and valvulotomes of $0.2 million each, offset by decreased sales of catheters of $0.1 million.

 

Gross Profit. The following table sets forth the change in our gross profit and gross margin for the periods indicated:

 

 

		Three months ended June 30,																Six months ended June 30,
(unaudited)														Percent																Percent
		2025				2024				Change				change				2025				2024				Change				change
		(in thousands)																(in thousands)
Gross profit		$	44,974			$	38,468			$	6,506				17	%		$	86,394			$	75,133			$	11,261				15	%
Gross margin			70.0	%			68.9	%			1.1	%			*				69.6	%			68.7	%			0.9	%			*

 

*Not applicable

 

Gross profit increased $6.5 million, or 17%, to $45.0 million for the three months ended June 30, 2025, as compared to $38.5 million for the three months ended June 30, 2024, and gross margin increased by 110 basis points to 70.0% in the period, as compared to 68.9% for the three months ended June 30, 2024. The increase in gross profit was driven primarily by increased sales, particularly from grafts, catheters, and valvulotomes. The increase in gross margin was driven primarily by greater manufacturing efficiencies, sales price increases, and favorable product mix, including decreased sales of comparatively lower margin porcine patches due to the decision to end our distribution agreement with Elutia. The increase was partially offset by increased shipping and warehousing costs.

 

Gross profit increased $11.3 million, or 15%, to $86.4 million for the six months ended June 30, 2025, as compared to $75.1 million for the six months ended June 30, 2024, and gross margin increased by 90 basis points to 69.6% in the period, as compared to 68.7% for the six months ended June 30, 2024. The increase in gross profit was driven primarily by increased sales, particularly from grafts, catheters, and valvulotomes. The increase in gross margin was driven primarily by greater manufacturing efficiencies, sales price increases, and decreased scrap and excess and obsolescence charges, partially offset by increased shipping and warehousing costs and unfavorable product mix, including increased sales of our comparatively lower margin allograft preservation services.

 

 

Operating Expenses. The following tables set forth changes in our operating expenses for the periods indicated and the change between the specified periods expressed as a percentage increase or decrease:

 

		Three months ended June 30,																Six months ended June 30,
(unaudited)														Percent																Percent
		2025				2024				$ Change				change				2025				2024				$ Change				change
		(in thousands)																(in thousands)
Sales and marketing		$	14,895			$	10,984			$	3,911				36	%		$	29,107			$	22,670			$	6,437				28	%
General and administrative			10,396				8,820				1,576				18	%		$	20,883			$	17,833				3,050				17	%
Research and development			3,541				4,284				(743	)			(17	%)		$	7,636			$	8,376				(740	)			(9	%)
Total		$	28,832			$	24,088			$	4,744				20	%		$	57,626			$	48,879			$	8,747				18	%

 

		Three months ended June 30,												Six months ended June 30,
		2025				2024								2025				2024
		% of Net Sales				% of Net Sales				Change				% of Net Sales				% of Net Sales				Change
Sales and marketing			23	%			20	%			3	%			23	%			21	%			2	%
General and administrative			16	%			16	%			0	%			17	%			16	%			1	%
Research and development			6	%			8	%			(2	%)			6	%			8	%			(2	%)

 

Sales and marketing. For the three months ended June 30, 2025, sales and marketing expenses increased 36% to $14.9 million. The increase was driven primarily by higher sales representative headcount and wage increases, which resulted in increased compensation and related expenses of $2.8 million. Additionally, travel and training expenses increased $0.6 million and professional fees and outside services expenses increased $0.5 million. Sales force headcount was 163 as of June 30, 2025, a 10% increase from June 30, 2024. As a percentage of sales, sales and marketing expenses increased to 23% for the three months ended June 30, 2025, up from 20% for the three months ended June 30, 2024.

 

For the six months ended June 30, 2025, sales and marketing expenses increased 28% to $29.1 million. The increase was driven primarily by higher sales representative headcount and wage increases, which resulted in increased compensation and related expenses of $4.3 million. Additionally, professional fees and outside services expenses increased $1.0 million and travel and training expenses increased $0.9 million. As a percentage of sales, sales and marketing expenses increased to 23% for the six months ended June 30, 2025, up from 21% for the six months ended June 30, 2024.

 

General and administrative. For the three months ended June 30, 2025, general and administrative expenses increased 18% to $10.4 million. The increase was driven primarily by higher headcount and wage increases, which resulted in increased compensation and related expenses of $1.2 million. Additionally, travel and training expenses increased $0.2 million. As a percentage of sales, general and administrative expenses remained consistent at 16% for the three months ended June 30, 2025 and 2024, respectively.

 

For the six months ended June 30, 2025, general and administrative expenses increased 17% to $20.9 million. The increase was driven primarily by higher headcount and wage increases, which resulted in increased compensation and related expenses of $2.4 million. Additionally, facilities expenses increased $0.6 million and travel and training expenses increased $0.2 million. As a percentage of sales, general and administrative expenses increased to 17% for the six months ended June 30, 2025, up from 16% for the six months ended June 30, 2024.

 

Research and development. For the three months ended June 30, 2025, research and development expenses decreased 17% to $3.5 million. The decrease was driven primarily by lower third-party service fees, which resulted in decreased professional fees and outside services expenses related to MDR related activities of $0.9 million, partially offset by increased facilities expenses of $0.1 million. As a percentage of sales, research and development expenses decreased to 6% for the three months ended June 30, 2025, down from 8% for the three months ended June 30, 2024.

 

For the six months ended June 30, 2025, research and development expenses decreased 9% to $7.6 million. The decrease was driven primarily by lower third-party service fees, which resulted in decreased professional fees and outside services expenses related to MDR related activities of $1.3 million, partially offset by increased compensation and related expenses of $0.3 million and facilities expenses of $0.2 million. As a percentage of sales, research and development expenses decreased to 6% for the six months ended June 30, 2025, down from 8% for the six months ended June 30, 2024.

 

Income tax expense. We recorded a tax provision of $4.3 million on pre-tax income of $18.1 million for the three months ended June 30, 2025, compared to a $3.7 million tax provision on pre-tax income of $15.5 million for the three months ended June 30, 2024. We recorded a tax provision of $7.5 million on pre-tax income of $32.3 million for the six months ended June 30, 2025, compared to a tax provision of $6.6 million on pre-tax income of $28.3 million for the six months ended June 30, 2024. Our effective income tax rate was 23.7% and 23.3% for the three- and six-month periods ended June 30, 2025. Our tax expense for the current period is based on an estimated annual effective tax rate of 23.8%, adjusted in the applicable quarterly periods for discrete stock option exercises and other discrete items. Our income tax expense for the current period varies from the statutory rate mainly due to the generation of federal and state tax credits, permanent items, different statutory rates from our foreign entities, and a discrete item for stock option exercises.

 

 

Our effective income tax rate was 23.7% and 23.3% for the three- and six-month periods ended June 30, 2024. Our 2024 provision was based on the estimated annual effective tax rate of 24.3%, adjusted in the applicable quarterly period for discrete stock option exercises and other discrete items. Our income tax expense for the three- and six-month periods ended June 30, 2024 varied from the statutory rate mainly due to the generation of federal and state tax credits, permanent items, different statutory rates from our foreign entities, and a discrete item for stock option exercises.

 

We monitor the mix of profitability by tax jurisdiction and adjust our annual expected rate on a quarterly basis as needed. While it is often difficult to predict the final outcome or timing of the resolution for any particular tax matter, we believe our tax reserves reflect the probable outcome of known contingencies.

 

We assess the likelihood that our deferred tax assets will be realized through future taxable income and record a valuation allowance to reduce gross deferred tax assets to an amount that we believe is more likely than not to be realized. As of June 30, 2025, we have provided a valuation allowance of $1.7 million for deferred tax assets primarily related to Australian net operating loss and capital loss carry forwards and Massachusetts tax credit carry forwards that are not expected to be realized.

 

Liquidity and Capital Resources

 

As of June 30, 2025, our cash and cash equivalents were $27.2 million, as compared to $25.6 million as of December 31, 2024. We had $292.3 million in short-term marketable securities as of June 30, 2025, and $274.1 million as of December 31, 2024. Our cash and cash equivalents are liquid investments with maturities of 90 days or less at the date of purchase and consist primarily of operating bank accounts. Our short-term marketable securities consist of a U.S. government money market fund investing mainly in high-quality, short-term securities that are issued or guaranteed by the U.S. government or by U.S. government agencies and instrumentalities, and a short-duration bond fund. As of June 30, 2025, our short-term marketable securities reflected an unrealized loss of $0.7 million as a result of increasing market interest rates.

 

On February 18, 2025, our Board of Directors authorized the repurchase of up to $75.0 million of our common stock through transactions on the open market, in privately negotiated purchases, or otherwise until February 17, 2026. The repurchase program may be suspended or discontinued at any time. To date we have not made any repurchases under this or any prior program.

 

Convertible Senior Notes

 

On December 19, 2024, we issued $172.5 million aggregate principal amount of convertible senior notes due 2030, or the Convertible Notes, in a Rule 144A private placement to qualified institutional buyers pursuant to an indenture dated December 19, 2024, by and between us and U.S. Bank Trust Company, National Association, or the Indenture.

 

The Convertible Notes will mature on February 1, 2030, unless earlier repurchased, redeemed or converted. The proceeds from the issuance of the Convertible Notes were approximately $167.7 million, net of debt issuance costs totaling $4.8 million. The Convertible Notes bear interest at a rate of 2.50% per year, and interest is payable semiannually in arrears on August 1 and February 1 of each year. The initial conversion rate is 8.3521 shares of common stock per $1,000 principal amount of the Convertible Notes, which represents an initial conversion price of approximately $119.73 per share of common stock and a premium of approximately 30% over the closing price of our common stock on December 16, 2024. In connection with the payment by us on May 29, 2025 of a quarterly cash dividend of $0.20 per share (an increase from the quarterly dividend amount of $0.16 per share as of the time of issuance of the Convertible Notes), the conversion rate of the Convertible Notes was increased to 8.3602 shares of common stock per $1,000 principal amount of the Convertible Notes, which represents a conversion price of approximately $119.61 per share of common stock. A similar adjustment to the conversion rate will be made upon payment of the quarterly cash dividend of $0.20 on September 4, 2025, and upon payment of subsequent quarterly dividends in excess of $0.16 per share. The conversion rate and conversion price are subject to customary adjustments upon the occurrence of certain events as described in the Indenture.

 

Noteholders may convert all or a portion of their Convertible Notes at their option only in the following circumstances: (1) during any calendar quarter commencing after the calendar quarter ending on June 30, 2025, if the last reported sale price per share of our common stock exceeds 130% of the conversion price for each of at least 20 trading days during the 30 consecutive trading days ending on, and including, the last trading day of the immediately preceding calendar quarter; (2) during the five consecutive business days immediately after any five consecutive trading day period in which the trading price per $1,000 principal amount of Convertible Notes for each trading day of the measurement period was less than 98% of the product of the last reported sale price per share of our common stock on such trading day and the conversion rate on such trading day; (3) upon the occurrence of certain corporate events or distributions on the our common stock, as described in the Indenture; (4) if we call (or are deemed to have called) any Convertible Notes for redemption; and (5) at any time from, and including, August 1, 2029, until the close of business on the second scheduled trading day immediately before the maturity date. We have the right to elect to settle conversions either in cash, shares of common stock, or in a combination of cash and shares of our common stock.

 

 

Prior to February 5, 2028, the Convertible Notes will not be redeemable. On or after February 5, 2028, until the 40th scheduled trading day immediately before the maturity date, we may redeem for cash all or any portion of the Convertible Notes (subject to the partial redemption limitation set forth in the Indenture), at our option, if the last reported sale price of our common stock has been at least 130% of the conversion price then in effect for at least 20 trading days (whether or not consecutive) during any 30 consecutive trading day period (including the last trading day of such period) ending on, and including, the trading day immediately preceding the date on which we provide notice of redemption. In addition, calling any Convertible Note for redemption will constitute a “Make-Whole Fundamental Change” (as defined in the Indenture) with respect to that Convertible Note, in which case the conversion rate applicable to the conversion of that Convertible Note will be increased in certain circumstances if it is converted after it is called for redemption. 

 

Operating and Capital Expenditure Requirements 

 

We require cash to pay our operating expenses, make capital expenditures, and pay our long-term liabilities. Since our inception, we have funded our operations through public offerings and private placements of equity securities, short-term and long-term borrowings, and funds generated from our operations.

 

We recognized operating income of $28.8 million for the six months ended June 30, 2025, compared to $26.3 million for the six months ended June 30, 2024. We expect to fund any increased costs and expenditures from our existing cash and cash equivalents, though our future capital requirements depend on numerous factors. These factors include, but are not limited to, the following:

 

	•	revenues generated by sales of our products and services;
	•	payments associated with potential future quarterly cash dividends to our common stockholders;
	•	future acquisition-related payments;
	•	payments associated with income and other taxes;
	•	costs associated with expanding our manufacturing, marketing, sales, and distribution efforts;
	•	costs associated with our initiatives to sell direct-to-hospital in new countries;
	•	costs of obtaining and maintaining FDA and other regulatory clearances;
	•	costs associated with obtaining European MDR CE mark approvals;

 

	•	the number, timing, and nature of acquisitions, divestitures, and other strategic transactions; and
	•	potential future share repurchases.

 

We believe that our cash, cash equivalents, investments, and the interest we earn on these balances will enable us to fund our operating expenses, capital expenditures requirements, and Convertible Note payments for at least twelve months following the filing of this Form 10-Q and, together with our anticipated future cash, cash equivalents, and investments, to meet our known long-term cash requirements.

 

We may need to raise additional funding, which might not be available on desirable terms or at all. See “Item 1A. Risk Factors” in our Annual Report on Form 10-K for the year ended December 31, 2024. 

 

 

Cash Flows

 

		Six months ended June 30,
		2025				2024				Net Change
		(in thousands)
Cash and cash equivalents		$	27,177			$	22,268			$	4,909
Cash flows provided by (used in):
Operating activities		$	29,330			$	14,696			$	14,634
Investing activities			(20,669	)			(13,364	)			(7,305	)
Financing activities			(8,003	)			(2,831	)			(5,172	)

 

Net cash provided by operating activities. Net cash provided by operating activities was $29.3 million for the six months ended June 30, 2025, consisting of $24.8 million in net income, adjustments for non-cash or non-operating items of $12.9 million (including primarily depreciation and amortization of $5.2 million, stock-based compensation of $4.0 million, interest and debt offering expense of $2.6 million, and provision for inventory write-offs and credit losses of $1.4 million), and a net use of working capital of $8.3 million. The net cash used for working capital was driven by an increase in accounts receivable of $5.3 million, an increase in inventory and other deferred costs of $3.5 million, and payments of accounts payable and other liabilities of $1.3 million. These cash uses were offset by a decrease in prepaid expenses and other assets of $1.7 million.

 

Net cash provided by operating activities was $14.7 million for the six months ended June 30, 2024, consisting of $21.7 million in net income, adjustments for non-cash or non-operating items of $10.4 million (including primarily depreciation and amortization of $4.8 million, stock-based compensation of $3.2 million, provisions for inventory write-offs and credit losses of $1.7 million, and foreign currency effect on net income of $0.7 million), and a net use of working capital of $17.4 million. The net cash used for working capital was driven by an increase in accounts receivable of $6.5 million, an increase in inventory and other deferred costs of $7.3 million, and payments of accounts payable and other liabilities of $4.3 million. These cash uses were offset by a decrease in prepaid expenses and other assets of $0.7 million.

 

Net cash used in investing activities. Net cash used in investing activities was $20.7 million for the six months ended June 30, 2025, consisting of purchases of marketable securities of $17.8 million, expenditures on property and equipment of $2.7 million, and payments related to acquisitions of $0.1 million.

 

Net cash used in investing activities was $13.4 million for the six months ended June 30, 2024, consisting of purchases of marketable securities of $10.1 million and expenditures on property and equipment of $3.2 million.

 

Net cash used in financing activities. Net cash used in financing activities was $8.0 million for the six months ended June 30, 2025, consisting primarily of dividend payments of $9.0 million and deferred payments for acquisitions of $1.4 million. This use of cash was offset by stock option exercises of $2.5 million, net of shares repurchased used to pay employee payroll taxes.

 

Net cash used in financing activities was $2.8 million for the six months ended June 30, 2024, consisting of proceeds from stock option exercises of $4.4 million, net of shares repurchased used to pay employee payroll taxes. This proceed of cash was offset by dividend payments of $7.2 million.

 

Dividends 

 

In February 2011, our Board of Directors approved a policy for the payment of quarterly cash dividends on our common stock. Future declarations of quarterly dividends and the establishment of future record and payment dates are subject to approval by our Board of Directors on a quarterly basis. The dividend activity for the periods presented is as follows:

 

Record Date		Payment Date		Per Share Amount				Dividend Payment
								(in thousands)
Fiscal Year 2025
March 13, 2025		March 27, 2025		$	0.20			$	4,517
May 15, 2025		May 29, 2025		$	0.20			$	4,520
Fiscal Year 2024
March 14, 2024		March 28, 2024		$	0.16			$	3,589
May 16, 2024		May 30, 2024		$	0.16			$	3,593
August 15, 2024		August 29, 2024		$	0.16			$	3,596
November 21, 2024		December 5, 2024		$	0.16			$	3,600

 

 

On July 30, 2025, our Board of Directors approved a quarterly cash dividend on our common stock of $0.20 per share payable on September 4, 2025, to stockholders of record at the close of business on August 21, 2025.

 

Critical Accounting Policies and Significant Judgments and Estimates

 

Our consolidated financial statements are prepared in accordance with generally accepted accounting principles in the United States. The preparation of our consolidated financial statements and related disclosures requires us to make estimates, assumptions and judgments that affect the reported amounts of assets, liabilities, revenue, costs and expenses, and related disclosures. We evaluate our estimates on an ongoing basis. Our actual results may differ from these estimates under different assumptions or conditions.

 

There have been no material changes to our critical accounting policies and estimates from those disclosed in our consolidated financial statements and the related notes and other financial information included in our 2024 Form 10-K.

 

Recent Accounting Pronouncements

 

A description of recently issued accounting pronouncements that may potentially impact our financial position, results of operations, or cash flows is disclosed in Note 2 to our consolidated financial statements included elsewhere in this Quarterly Report on Form 10-Q.

 

Item 3. Quantitative and Qualitative Disclosures About Market Risk

 

We are exposed to changes in interest rates and foreign currency exchange rates because we denominate our transactions in a variety of foreign currencies. Changes in these rates may have an impact on future cash flow and earnings. We manage these risks through normal operating and financing activities. There has been no material change in the foreign currency risk or interest rate risk discussed in “Management’s Discussion and Analysis of Financial Condition and Results of Operations” and in “Quantitative and Qualitative Disclosure About Market Risk” included in our 2024 Form 10-K.

 

Item 4. Controls and Procedures

 

Evaluation of Disclosure Controls and Procedures

 

Our management, with the participation of our Chief Executive Officer and our Chief Financial Officer (our principal executive officer and principal financial and accounting officer, respectively), evaluated the effectiveness of our disclosure controls and procedures as of June 30, 2025. The term “disclosure controls and procedures,” as defined in Rules 13a-15(e) and 15d-15(e) under the Securities Exchange Act of 1934, as amended, or the Exchange Act, means controls and other procedures of a company that are designed to ensure that information required to be disclosed by a company in the reports that it files or submits under the Exchange Act is recorded, processed, summarized and reported within the time periods specified in the SEC’s rules and forms. Disclosure controls and procedures include, without limitation, controls and procedures designed to ensure that information required to be disclosed by a company in the reports that it files or submits under the Exchange Act is accumulated and communicated to the company’s management, including its principal executive and principal financial officers, or persons performing similar functions, as appropriate to allow timely decisions regarding required disclosure.

 

Management recognizes that any controls and procedures, no matter how well designed and operated, can provide only reasonable assurance of achieving their objectives and management necessarily applies its judgment in evaluating the cost-benefit relationship of possible controls and procedures. Based on the evaluation of our disclosure controls and procedures as of June 30, 2025, our Chief Executive Officer and our Chief Financial Officer concluded that, as of such date, our disclosure controls and procedures were effective at the reasonable assurance level.

 

Changes in Internal Control over Financial Reporting

 

As previously disclosed, in February 2024 we began implementing a new ERP system. The ERP implementation requires the integration of new ERP software with multiple new data flows and business processes. The new ERP is designed to accurately maintain our books and records and provide information to our management teams which is important to the operations of the business. As the phased implementation of the new ERP system progresses, we expect to continue to change certain processes and procedures which, in turn, are expected to result in changes to our internal control over financial reporting. As such changes occur, we will evaluate quarterly whether such changes materially affect our internal control over financial reporting.

 

Other than the new ERP system implementation, there have been no changes to our internal control over financial reporting during the quarter ended June 30, 2025, that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.

 

 

Part II. Other Information

 

Item 1. Legal Proceedings

 

In the ordinary course of business, we are from time to time involved in lawsuits, claims, investigations, proceedings, and threats of litigation relating to employment, product liability, commercial arrangements, contracts, intellectual property and other matters. While the outcome of these proceedings and claims cannot be predicted with certainty, there are no matters that management believes would have a material adverse effect on our financial position, results of operations, or cash flows.

 

Item 1A. Risk Factors

 

In addition to the information set forth in this report, you should consider the risks and uncertainties discussed in “Part I, Item 1A. Risk Factors” in our Annual Report on Form 10-K for the year ended December 31, 2024, which could materially affect our business, financial condition, or future results. The risk factors below supplement and update the risk factors and information discussed in our Annual Report on Form 10-K for the year ended December 31, 2024.

 

Adverse global economic conditions could have a negative effect on our business, results of operations and financial condition and liquidity.

 

Sustained uncertainty about, or worsening of, current global economic conditions and further tariffs and escalations of tensions between the United States and its trading partners could result in a global economic slowdown and long-term changes to global trade. Such events may also cause customers to reduce, delay or forego spending on our products, which could negatively affect demand for our products and our business, financial condition and results of operations. In addition, these conditions could increase the cost for our goods imported in markets outside the United States, further pressuring sales growth and margins and adversely impacting our operating performance. However, we believe our U.S. domestic business is unlikely to be materially affected by tariffs as we manufacture our products in the United States.

 

Even after our products have received marketing approval or clearance, our products and the tissue we process may be subject to recall. Licenses, registrations, approvals, and clearances could be withdrawn or suspended due to failure to comply with regulatory standards or the occurrence of unforeseen problems following initial approval.

 

Our products, services, marketing, sales, development activities, and manufacturing processes are subject to extensive and rigorous regulation by the FDA, by comparable agencies in foreign countries, and by other regulatory agencies and governing bodies. If those regulatory bodies feel that we have failed to comply with regulatory standards, there can be no assurance that any approval, licensure, or registration will not be subsequently withdrawn, suspended or conditioned upon extensive post-market study requirements, even after having received marketing approval or clearance or licenses and registrations. Further, due to the interconnectedness of the various regulatory agencies, particularly within the EU, there is also no assurance that withdrawal or suspension of any of our approvals, licenses, or registrations by any single regulatory agency will not precipitate one or more additional regulatory agencies from also withdrawing or suspending their approval, license, or registration.

 

In the event that any of our products prove to be defective, we can voluntarily recall, or the FDA or foreign equivalent could require us to recall, any of our products. In the EU and UK, adverse event reporting requirements mandate that we report incidents which led or could have led to death or serious deterioration in health. Recalls, whether voluntary or required, could result in significant costs to us and significant adverse publicity. In severe instances, the FDA may also issue a warning letter, destruction of defective product, and/or order the suspension or cessation of manufacturing of defective product. Additionally, if someone is harmed by a malfunction or a product defect, we may experience product liability claims for such defects. Any corrective action, whether voluntary or involuntary, as well as defending ourselves in a lawsuit, will require the dedication of our time and capital and may harm our financial results. Future recalls or claims could also result in significant costs to us and significant adverse publicity, which could harm our ability to market our products in the future. For example, in April 2025, we voluntarily notified our regulatory bodies of an inadequate seal on the packaging of our TufTex Over-the-Wire, Pruitt Occlusion, and Pruitt Irrigation catheters, which may result in a compromised sterile barrier. Notice was provided to each of our customers of the inadequate seal and customers may request a product replacement for any existing inventory currently on hand. The financial impact of the voluntary notification is not expected to be material to our business.

 

Item 2. Unregistered Sales of Equity Securities and Use of Proceeds

 

Recent Sales of Unregistered Securities

 

None.

 

 

Issuer Purchases of Equity Securities

 

Issuer Purchases of Equity Securities

Maximum Number

(or Approximate

Total Number of

Dollar Value) of

Shares (or Units)

Shares (or Units)

Total

Average

Purchased as

that may yet be

Number of

Price

Part of Publicly

Purchased under

Shares (or Units)

Paid Per

Announced Plans

the Plans or

Period

Purchased (1)

Share (or Unit)

or Program

Program (2)

April 1, 2025 through April 30, 2025

33

$

85.16

N/A

$

75,000,000

May 1, 2025 through May 31, 2025

19

$

80.26

N/A

$

75,000,000

June 1, 2025 through June 30, 2025

-

$

-

N/A

$

75,000,000

Total

52

$

83.37

N/A

 

(1)

For the three months ended June 30, 2025, we repurchased 52 shares of our common stock to satisfy employees’ obligations with respect to minimum statutory withholding taxes in connection with the vesting of restricted stock units and performance-based restricted stock units.

(2)

On February 18, 2025, our Board of Directors authorized the repurchase of up to $75.0 million of our common stock through transactions on the open market, in privately negotiated transactions, or otherwise until February 17, 2026. To date, we have not made any repurchases under this program.

 

Item 5. Other Information

 

Amendments to By-laws

 

The information set forth below is included herewith for the purpose of providing the disclosure required under “Item 5.03 – Amendments to Articles of Incorporation or Bylaws; Change in Fiscal Year” of Form 8-K.

 

On August 4, 2025, following a review of corporate law developments and market practice, the Company’s Board of Directors (the “Board”) approved the Company’s Second Amended and Restated By-laws (the “By-laws”), which became effective the same day. Among other things, the By-laws:

 

●

update the advance notice provisions that apply where a stockholder intends to propose a director nomination or other business at a stockholder meeting, including to address Rule 14a-19 of the Exchange Act (“Rule 14a-19”), by requiring:

 

o

any stockholder submitting a nomination notice to make a representation as to whether such stockholder intends to solicit proxies in support of director nominees other than the Company’s nominees in accordance with Rule 14a-19 and to provide reasonable evidence that certain requirements of such rule have been satisfied;

o

the nomination of the proposed director nominee be disregarded if, after a stockholder provides notice pursuant to Rule 14a-19, such stockholder subsequently fails to comply with the requirements of Rule 14a-19, and no other person has provided notice pursuant to, and in compliance with, Rule 14a-19 with respect to such proposed director nominee;

o

that the number of nominees a stockholder may nominate for election at a stockholder meeting may not exceed the number of directors to be elected at such meeting;

o

certain representations with respect to a proposed nominee regarding the absence of certain voting commitments, disclosure of compensation for service and compliance with the Company’s corporate governance and other policies, and intent to serve the entire term; and

o

additional background information and disclosures regarding proposing stockholders, proposed nominees and business, and other persons related to a stockholder’s solicitation of proxies.

 

●

clarifying the situations in which either nominations of persons for election to the Board or stockholder proposals may be brought at a special meeting of stockholders;

 

 

●

requiring that any stockholder directly or indirectly soliciting proxies from other stockholders must use a proxy card color other than white, with the white proxy card being reserved for exclusive use by the Board;

 

●

designating, unless consented to by the Company, the Court of Chancery of the State of Delaware as the sole and exclusive forum for (i) any derivative action or proceeding brought on behalf of the Company; (ii) any action asserting a claim based on a breach of any fiduciary duty owed by any director, officer, or other employee or stockholder of the Company to the Company or to the stockholders of the Company; (iii) any action asserting a claim arising pursuant to any provision of the Delaware General Corporation Law (“DGCL”), the Company’s charter or the By-laws, or as to which the DGCL confers jurisdiction to the Court of Chancery; or (iv) any action asserting a claim governed by the internal affairs doctrine;

 

●

designating, unless consented to by the Company, the U.S. federal district courts as the sole and exclusive forum for claims under the Securities Act of 1933, as amended, and the Securities Exchange Act of 1934, as amended; and

 

●

make certain other technical, modernizing and clarifying changes.

 

The foregoing description is a summary and is qualified in its entirety by reference to the full text of the By-laws.  A copy of the By-laws marked to show the changes approved by the Board is filed as Exhibit 3.1 to this Quarterly Report on Form 10-Q and an unmarked copy of the By-laws incorporating the changes approved by our Board is filed as Exhibit 3.2 to this Quarterly Report on Form 10-Q.  Both exhibits are hereby incorporated by reference. 

 

Rule 10b5-1 and non-Rule 10b5-1 trading arrangements

 

None.

 

  

Item 6. Exhibits

 

			Incorporated by Reference
Exhibit Number	Exhibit Description		Form	Date	Number	Filed Herewith
3.1	Amendments to Second Amended and Restated By-laws of the Registrant Effective August 4, 2025					X
3.2	Second Amended and Restated By-laws of the Registrant					X
31.1	Certification of Chief Executive Officer, as required by Rule 13a-14(a) or Rule 15 d-14(a).					X
31.2	Certification of Chief Financial Officer, as required by Rule 13a-14(a) or Rule 15d-14(a).					X
32.1†	Certification by the Chief Executive Officer, as required by Rule 13a-14(b) or Rule 15d-14(b) and Section  1350 of Chapter 63 of Title 18 of the United States Code (18 U.S.C. §1350).*					X
32.2†	Certification by the Chief Financial Officer, as required by Rule 13a-14(b) or Rule 15d-14(b) and Section  1350 of Chapter 63 of Title 18 of the United States Code (18 U.S.C. §1350).*					X
101.INS	Inline XBRL Instance Document.					X
101.SCH	Inline XBRL Taxonomy Extension Schema Document.					X
101.CAL	Inline XBRL Taxonomy Extension Calculation Linkbase Document.					X
101.DEF	Inline XBRL Taxonomy Extension Definition Linkbase Document.					X
101.LAB	Inline XBRL Taxonomy Extension Label Linkbase Document.					X
101.PRE	Inline XBRL Taxonomy Extension Presentation Linkbase Document.					X
104	Cover Page Interactive Data File (formatted as Inline XBRL and contained in Exhibit 101).					X

 

 

---

 

†

This certification will not be deemed “filed” for purposes of Section 18 of the Exchange Act, or otherwise subject to the liability of that section. Such certification will not be deemed to be incorporated by reference into any filing under the Securities Act of 1933, as amended, or the Exchange Act, except to the extent specifically incorporated by reference into such filing.

 

 

SIGNATURES

 

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized on August 6, 2025.

 

LEMAITRE VASCULAR, INC.
/s/ George W. LeMaitre
George W. LeMaitre
Chairman and Chief Executive Officer
/s/ Dorian P. LeBlanc
Dorian P. LeBlanc
Chief Financial Officer