Table of Contents



 

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

FORM

10-Q


 

FORM

10-Q


(Mark One)

QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

 

For the quarterly period ended September 30, 2022March 31, 2023

 

Or

 

TRANSITION REPORT PURSUANT TO SECTION13 OR 15(d)OF THE SECURITIES EXCHANGE ACT OF 1934

 

For the transition period from                     to                     .

 

Commission File Number 001-33092

 

LEMAITRE VASCULAR, INC.

(Exact name of registrant as specified in its charter)


LEMAITRE VASCULAR, INC.

(Exact name of registrant as specified in its charter)


 

Delaware

04-2825458

(State or other jurisdiction of

incorporation or organization)

(I.R.S. Employer

Identification No.)

 

63 Second Avenue, Burlington, Massachusetts

01803

(Address of principal executive offices)

(Zip Code)

 

(781) 221-2266

(Registrants telephone number, including area code)

(781) 221-2266

(Registrant’s telephone number, including area code)


 

Securities registered pursuant to Section 12(b) of the Exchange Act:

 

Title of each class

Trading Symbol(s)

Name of each exchange on which

registered

Common stock, $0.01 par value per share

LMAT

The Nasdaq Global Market

 

Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days.   Yes ☒   No ☐

1

 

Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files).   Yes ☒   No ☐

 

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company” and “emerging growth Company “in Rule 12b-2 of the Exchange Act.

 

Large accelerated filer

Accelerated filer

    

Non-accelerated filer

Smaller reporting company

    
  

Emerging growth company

 

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.   ☐

 

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act).   Yes ☐   No ☒

 

The registrant had 22,000,88022,156,519 shares of common stock, $.01 par value per share, outstanding as of October 31, 2022.April 28, 2023.

 

12

 

 

LEMAITRE VASCULAR

FORM 10-Q

TABLE OF CONTENTS

 

   

Page

Part I.

Financial Information:

4
    
 

Item 1.

Financial Statements

4
    
  

Consolidated Balance Sheets as of September 30, 2022March 31, 2023 (unaudited) and December 31, 20212022

34
    
  

Unaudited Consolidated Statements of Operations for the three-month and nine-month periods ended September 30,March 31, 2023 and 2022 and 2021

45
    
  

Unaudited Consolidated Statements of Comprehensive Income for the three-month and nine-month periods ended September 30,March 31, 2023 and 2022 and 2021

56
    
  

Unaudited Consolidated Statements of Stockholders’ Equity for the three-month and nine-month periods ended September 30,March 31, 2023 and 2022 and 2021

67
    
  

Unaudited Consolidated Statements of Cash Flows for the nine-monththree-month periods ended September 30,March 31, 2022 and 2021

78
    
  

Notes to Unaudited Consolidated Financial Statements

9
    
 

Item 2.

Management’s Discussion and Analysis of Financial Condition and Results of Operations

2522
    
 

Item 3.

Quantitative and Qualitative Disclosure about Market Risk

3530
    
 

Item 4.

Controls and Procedures

3530
   

Part II.

Other Information:

3732
    
 

Item 1.

Legal Proceedings

3732
    
 

Item 1A.

Risk Factors

3732
    
 

Item 2.

Unregistered Sales of Equity Securities and Use of Proceeds

3934
    
 

Item 6.

Exhibits

4035
   
 

Signatures

 36

 

23

 

Part I. Financial Information

Item 1. Financial Statements

 

LeMaitre Vascular, Inc.

Consolidated Balance Sheets

 

 

(unaudited)

     

(unaudited)

    
 

September 30,

 

December 31,

  

March 31,

 

December 31,

 
 

2022

 

2021

  

2023

  

2022

 
 

(in thousands, except share data)

  

(in thousands, except share data)

 

Assets

        

Current assets:

  

Cash and cash equivalents

 $16,913  $13,855  $16,677  $19,134 

Short-term marketable securities

 62,826  56,104  64,328  63,557 

Accounts receivable, net of allowances of $778 at September 30, 2022 and $679 at December 31, 2021

 20,094  19,631 

Accounts receivable, net of allowances of $820 at March 31, 2023 and $835 at December 31, 2022

 25,365  22,040 

Inventory and other deferred costs

 47,711  46,104  53,779  50,271 

Prepaid expenses and other current assets

 4,842  4,189   4,619   6,731 

Assets held for sale

  756   - 

Total current assets

 153,142  139,883  164,768  161,733 
  

Property and equipment, net

 15,351  17,059  19,242  17,901 

Right-of-use leased assets

 15,785  15,071  15,527  15,634 

Goodwill

 65,945  65,945  65,945  65,945 

Other intangibles, net

 48,063  52,710  45,508  46,527 

Deferred tax assets

 2,789  1,566  1,802  1,745 

Other assets

  973   568   2,074   991 

Total assets

 $302,048  $292,802  $314,866  $310,476 
 

Liabilities and stockholders equity

        

Current liabilities:

  

Accounts payable

 $2,848  $2,340  $3,371  $2,903 

Accrued expenses

 17,400  16,332  17,620  19,967 

Acquisition-related obligations

 1,363  1,271  856  573 

Lease liabilities - short-term

  1,828   1,870   2,057   1,886 

Total current liabilities

 23,439  21,813  23,904  25,329 
      

Lease liabilities - long-term

 14,897  14,067  14,448  14,710 

Deferred tax liabilities

 60  70  71  69 

Other long-term liabilities

  2,405   2,701   2,278   2,167 

Total liabilities

 40,801  38,651  40,701  42,275 
  

Stockholders’ equity:

  

Preferred stock, $0.01 par value; authorized 3,000,000 shares; none outstanding

 -  - 

Common stock, $0.01 par value; authorized 37,000,000 shares; issued 23,558,954 shares at September 30, 2022, and 23,477,784 shares at December 31, 2021

 236  235 

Preferred stock, $0.01 par value; authorized 3,000,000 shares; none outstanding

 -  - 

Common stock, $0.01 par value; authorized 37,000,000 shares; issued 23,714,913 shares at March 31, 2023, and 23,655,716 shares at December 31, 2022

 238  237 

Additional paid-in capital

 186,798  181,630  192,003  189,268 

Retained earnings

 94,896  88,125  100,714  97,773 

Accumulated other comprehensive loss

 (8,127) (3,435) (5,572) (6,031)

Treasury stock, at cost; 1,558,074 shares at September 30, 2022 and 1,554,905 shares at December 31, 2021

  (12,556)  (12,404)

Treasury stock, at cost; 1,572,197 shares at March 31, 2023 and 1,568,595 shares at December 31, 2022

  (13,218)  (13,046)

Total stockholders’ equity

  261,247   254,151   274,165   268,201 

Total liabilities and stockholders’ equity

 $302,048  $292,802  $314,866  $310,476 

 

See accompanying notes to consolidated financial statements. 

 

34

 

 

LeMaitre Vascular, Inc.

Consolidated Statements of Operations

(unaudited)

 

 

Three months ended

 

Nine months ended

  

Three months ended

 
 

September 30,

 

September 30,

  

March 31,

 
 

2022

 

2021

 

2022

 

2021

  

2023

  

2022

 
 

(in thousands, except per share data)

 

(in thousands, except per share data)

  

(in thousands, except per share data)

 
          

Net sales

 $39,028  $38,368  $120,697  $114,921  $47,075  $39,561 

Cost of sales

  13,958   13,502   41,855   39,495   16,192   13,599 
          

Gross profit

 25,070  24,866  78,842  75,426  30,883  25,962 
          

Sales and marketing

 8,229  6,941  24,321  20,210  10,897  7,850 

General and administrative

 7,229  6,004  21,812  18,748  7,932  7,252 

Research and development

 3,462  2,848  9,740  8,344  3,875  2,932 

Restructuring

 -  -  3,107  -   305   - 
              

Total operating expenses

  18,920   15,793   58,980   47,302   23,009   18,034 
          

Income from operations

 6,150  9,073  19,862  28,124  7,874  7,928 
          

Other income (expense):

          

Interest income

 264  54  539  56  568  108 

Interest expense

 -  (621) -  (1,693)

Foreign currency gain (loss)

  (266)  (72)  (709)  (105)

Foreign currency loss

  (425)  (40)
          

Income before income taxes

 6,148  8,434  19,692  26,382  8,017  7,996 

Provision for income taxes

  692   1,930   4,683   5,650   1,977   1,958 
          

Net income

 $5,456  $6,504  $15,009  $20,732  $6,040  $6,038 
          

Earnings per share of common stock:

Earnings per share of common stock:

        

Basic

 $0.25  $0.30  $0.68  $0.99  $0.27  $0.28 

Diluted

 $0.25  $0.30  $0.68  $0.98  $0.27  $0.27 
          

Weighted-average shares outstanding:

Weighted-average shares outstanding:

        

Basic

  21,984   21,592   21,959   20,920   22,111   21,935 

Diluted

  22,217   21,935   22,149   21,251   22,274   22,103 
          

Cash dividends declared per common share

 $0.125  $0.110  $0.375  $0.330  $0.140  $0.125 

 

See accompanying notes to consolidated financial statements. 

 

45

 

 

LeMaitre Vascular, Inc.

Consolidated Statements of Comprehensive Income

(unaudited) 

 

 

Three months ended

 

Nine months ended

  

Three months ended

 
 

September 30,

 

September 30,

  

March 31,

 
 

2022

 

2021

 

2022

 

2021

  

2023

  

2022

 
 

(in thousands)

 

(in thousands)

  

(in thousands)

 

Net income

 $5,456  $6,504  $15,009  $20,732  $6,040  $6,038 

Other comprehensive income (loss):

  

Foreign currency translation adjustment, net

 (1,350) (335) (2,876) (1,052) 252  (300)

Unrealized gain (loss) on short-term marketable securities

  (333)  (58)  (1,816)  (59)  207   (889)

Total other comprehensive income (loss)

  (1,683)  (393)  (4,692)  (1,111)  459   (1,189)
  

Comprehensive income

 $3,773  $6,111  $10,317  $19,621  $6,499  $4,849 

 

See accompanying notes to consolidated financial statements.

 

56

 

 

LeMaitre Vascular, Inc.

Consolidated Statements of Stockholders Equity

(unaudited)  

 

                 

Accumulated

                             

Accumulated

            
         

Additional

     

Other

         

Total

          

Additional

     

Other

         

Total

 
 

Common Stock

 

Paid-in

 

Retained

 

Comprehensive

 

Treasury Stock

 

Stockholders

  

Common Stock

 

Paid-in

 

Retained

 

Comprehensive

 

Treasury Stock

 

Stockholders

 
 

Shares

 

Amount

 

Capital

 

Earnings

 

Income (Loss)

 

Shares

 

Amount

 

Equity

  

Shares

  

Amount

  

Capital

  

Earnings

  

Income (Loss)

  

Shares

  

Amount

  

Equity

 
                  

Balance at December 31, 2021

 23,477,784  $235  $181,630  $88,125  $(3,435) 1,554,905  $(12,404) $254,151  23,477,784  $235  $181,630  $88,125  $(3,435) 1,554,905  $(12,404) $254,151 
                  

Net income

      6,038       6,038         6,038         6,038 

Other comprehensive income (loss)

       (1,189)     (1,189)          (1,189)      (1,189)

Issuance of common stock for stock options exercised

 24,917  -  508       508  24,917  -  508           508 

Vested restricted stock units

 7,158  -  -       -  7,158  -             - 

Repurchase of common stock for net settlement of equity awards

            3,016  (145) (145)

Stock-based compensation expense

     1,167        1,167       1,167           1,167 

Repurchase of common stock for net settlement of equity awards

       3,016  (145) (145)

Common stock dividend paid

       (2,743)      (2,743)        (2,743)        (2,743)

Balance at March 31, 2022

 23,509,859  $235  $183,305  $91,420  $(4,624) 1,557,921  $(12,549) $257,787   23,509,859  $235  $183,305  $91,420  $(4,624) 1,557,921  $(12,549) $257,787 
 

Net income

      3,515       3,515 

Other comprehensive income (loss)

       (1,820)     (1,820)

Issuance of common stock for stock options exercised

 10,808  -  164       164 

Vested restricted stock units

 221  -  -       - 

Stock-based compensation expense

     1,136        1,136 

Repurchase of common stock for net settlement of equity awards

       98  (4) (4)

Common stock dividend paid

       (2,745)      (2,745)

Balance at June 30, 2022

 23,520,888  $235  $184,605  $92,190  $(6,444) 1,558,019  $(12,553) $258,033 
 

Net income

      5,456       5,456 

Other comprehensive income (loss)

       (1,683)     (1,683)

Issuance of common stock for stock options exercised

 37,786  1  1,007       1,008 

Vested restricted stock units

 280  -  -       - 

Stock-based compensation expense

     1,186        1,186 

Repurchase of common stock for net settlement of equity awards

       55  (3) (3)

Common stock dividend paid

       (2,750)      (2,750)

Balance at September 30, 2022

  23,558,954  $236  $186,798  $94,896  $(8,127) 1,558,074  $(12,556) $261,247 

 

See accompanying notes to consolidated financial statements.

 

6

LeMaitre Vascular, Inc.

Consolidated Statements of Stockholders Equity

(unaudited)

                 

Accumulated

                             

Accumulated

            
         

Additional

     

Other

         

Total

          

Additional

     

Other

         

Total

 
 

Common Stock

 

Paid-in

 

Retained

 

Comprehensive

 

Treasury Stock

 

Stockholders

  

Common Stock

 

Paid-in

 

Retained

 

Comprehensive

 

Treasury Stock

 

Stockholders

 
 

Shares

 

Amount

 

Capital

 

Earnings

 

Income (Loss)

 

Shares

 

Amount

 

Equity

  

Shares

  

Amount

  

Capital

  

Earnings

  

Income (Loss)

  

Shares

  

Amount

  

Equity

 
                  

Balance at December 31, 2020

 22,061,554  $221  $114,924  $70,554  $(1,525) 1,538,572  $(11,602) $172,572 

Balance at December 31, 2022

 23,655,716  $237  $189,268  $97,773  $(6,031) 1,568,595  $(13,046) $268,201 
                  

Net income

      5,929       5,929         6,040         6,040 

Other comprehensive income (loss)

       (938)     (938)          459       459 

Issuance of common stock for stock options exercised

 63,895  -  1,385       1,385  50,424  1  1,445           1,446 

Vested restricted stock units

 5,974  -  -       -  8,773  -             - 

Repurchase of common stock for net settlement of equity awards

            3,602  (172) (172)

Stock-based compensation expense

     927        927       1,290           1,290 

Repurchase of common stock for net settlement of equity awards

       2,241  (88) (88)

Common stock dividend paid

       (2,262)      (2,262)

Balance at March 31, 2021

 22,131,423  $221  $117,236  $74,221  $(2,463) 1,540,813  $(11,690) $177,525 
 

Net income

      8,299       8,299 

Other comprehensive income (loss)

       220      220 

Issuance of common stock for stock options exercised

 70,355  1  1,186       1,187 

Stock-based compensation expense

     869        869 

Common stock dividend paid

       (2,267)      (2,267)

Balance at June 30, 2021

 22,201,778  $222  $119,291  $80,253  $(2,243) 1,540,813  $(11,690) $185,833 
 

Net income

      6,504       6,504 

Other comprehensive income (loss)

       (393)     (393)

Issuance of common stock

 1,150,000  12  58,683       58,695 

Issuance of common stock for stock options exercised

 17,410  -  299       299 

Vested restricted stock units

 14,941  -  -       - 

Stock-based compensation expense

     797        797 

Repurchase of common stock for net settlement of equity awards

       5,223  (286) (286)

Common stock dividend paid

       (2,401)      (2,401)

Balance at September 30, 2021

  23,384,129  $234  $179,070  $84,356  $(2,636) 1,546,036  $(11,976) $249,048 

Common stock cash dividend paid

        (3,099)        (3,099)

Balance at March 31, 2023

  23,714,913  $238  $192,003  $100,714  $(5,572) 1,572,197  $(13,218) $274,165 

 

See accompanying notes to consolidated financial statements.

 

7

 

 

LeMaitre Vascular, Inc.

Consolidated Statements of Cash Flows

(unaudited)

 

 

For the nine months ended

  

For the three months ended

 
 

September 30,

  

March 31,

 
 

2022

 

2021

  

2023

  

2022

 
 

(in thousands)

  

(in thousands)

 

Operating activities

        

Net income

 $15,009  $20,732  $6,040  $6,038 

Adjustments to reconcile net income to net cash provided by operating activities:

Adjustments to reconcile net income to net cash provided by operating activities:

  

Depreciation and amortization

 7,145  8,186  2,351  2,373 

Stock-based compensation

 3,489  2,593  1,290  1,167 

Provision for inventory write-downs

 334  498 

Loss on divestitures

 305  - 

Foreign currency effect on net income

 54  (428)

Fair value adjustment to contingent consideration obligations

 (81) (454) 25  (32)

Provision for doubtful accounts

 214  136  (7) 60 

Provision for inventory write-downs

 2,060  3,016 

Loss on disposal of property and equipment

 95  - 

Loss on divestitures

 1,406  - 

Foreign currency transaction (gain) loss

 (90) 322 

Changes in operating assets and liabilities:

  

Accounts receivable

 (1,737) (425) (3,242) (1,951)

Inventory and other deferred costs

 (5,041) (2,752) (3,755) (1,267)

Prepaid expenses and other assets

 (1,344) (741) 1,224  1,692 

Accounts payable and other liabilities

  176   (567)  (2,340)  (3,439)

Net cash provided by operating activities

 21,301  30,046  2,279  4,711 
      

Investing activities

        

Purchases of property and equipment and other assets

 (1,969) (4,276) (2,130) (536)

Purchases of short-term marketable securities

  (8,000)  (49,554) (564) - 

Payments related to acquisitions

  (270)  - 

Net cash used in investing activities

 (9,969) (53,830) (2,964) (536)
      

Financing activities

        

Payments of deferred acquisition consideration

 (401) (401)

Payment of long-term debt

 -  (39,000)

Proceeds from issuance of common stock

 1,679  61,566 

Proceeds from stock option exercises

 1,446  508 

Purchase of treasury stock for net settlement of equity awards

 (152) (374) (172) (145)

Common stock cash dividend paid

  (8,238)  (6,930)  (3,099)  (2,743)

Net cash provided by (used in) financing activities

 (7,112) 14,861 

Net cash used in financing activities

 (1,825) (2,380)
 

Effect of exchange rate changes on cash and cash equivalents

  (1,162)  (472)  53   (90)

Net increase (decrease) in cash and cash equivalents

 3,058  (9,395) (2,457) 1,705 

Cash and cash equivalents at beginning of period

  13,855   26,764   19,134   13,855 

Cash and cash equivalents at end of period

 $16,913  $17,369  $16,677  $15,560 

 

See accompanying notes to consolidated financial statements.

 

8

 

LeMaitre Vascular, Inc.

Notes to Consolidated Financial Statements

September 30, 2022March 31, 2023

(unaudited)

 

 

1. Organization and Basis for Presentation

 

Description of Business

 

Unless the context requires otherwise, references to LeMaitre, LeMaitre Vascular, we, our, and us refer to LeMaitre Vascular, Inc. and our subsidiaries. We develop, manufacture, and market medical devices and implants used primarily in the field of vascular surgery. We also derive revenues from the processing and cryopreservation of human tissues for implantation in patients. We operate in a single segment in which our principal product lines include the following: anastomotic clips, angioscopes, biologic vascular and dialysis grafts, biologic vascular and cardiac patches, carotid shunts, embolectomy catheters, occlusion catheters, radiopaque marking tape, synthetic vascular grafts, and valvulotomes. Our offices and production facilities are located in Burlington, Massachusetts; Fox River Grove, Illinois; North Brunswick, New Jersey; Chandler, Arizona; Vaughan, Canada; Sulzbach, Germany; Milan, Italy; Madrid, Spain; Hereford, England; Kensington, Australia; Tokyo, Japan; Shanghai, China; Singapore; and Seoul, Korea.

 

Basis of Presentation

 

The accompanying unaudited consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States (GAAP) for interim financial information and with the instructions to Form 10-Q10-Q and Article 10 of Regulation S-X.S-X. Accordingly, they do not include all of the information and footnotes required by GAAP for complete financial statements. In the opinion of management, all adjustments, consisting only of normal, recurring adjustments considered necessary for a fair presentation of the results of these interim periods have been included. Preparing financial statements requires management to make estimates and assumptions that affect the reported amounts of assets, liabilities, revenues and expenses. Actual results may differ from these estimates. Our estimates and assumptions, including those related to bad debts, inventories, intangible assets, sales returns and discounts, share-based compensation, and income taxes are updated as appropriate. The results for the ninethree months ended September 30, 2022 March 31, 2023 are not necessarily indicative of results to be expected for the entire year. The information contained in these interim financial statements should be read in conjunction with our audited consolidated financial statements as of and for the year ended December 31,2021, 2022, including the notes thereto, included in our Form 10-K10-K filed with the Securities and Exchange Commission (SEC) on February 28, 2022.March 1, 2023.

 

The preparation of financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the amounts reported in the unaudited consolidated financial statements and accompanying notes. The Company is not aware of any specific event or circumstance that would require an update to its accounting estimates or adjustments to the carrying value of its assets and liabilities as of November 8, 2022, May 9, 2023, the issuance date of this Quarterly Report on Form 10-Q.10-Q. Actual results could differ from those estimates.

Consolidation

 

Our consolidated financial statements include the accounts of LeMaitre Vascular and the accounts of our wholly-owned subsidiaries. All significant intercompany accounts and transactions have been eliminated in consolidation.

Revenue Recognition

 

Our revenue is derived primarily from the sale of disposable or implantable devices used during vascular surgery. We sell primarily directly to hospitals and to a lesser extent to distributors, as described below, and, during the periods presented in our consolidated financial statements, entered into consigned inventory arrangements with either hospitals or distributors on a limited basis. We also derive revenues from the processing and cryopreservation of human tissues for implantation in patients. These revenues are recognized when services have been provided and the tissue has been shipped to the customer, provided all other revenue recognition criteria discussed in the succeeding paragraph have been met.

 

9

We record revenue under the provisions of ASU 2014-09,2014-09, Revenue from Contracts with Customers (Topic 606)606). The core principle of Topic 606 is that an entity should recognize revenue to depict the transfer of goods or services to customers in an amount that reflects the consideration to which the entity expects to be entitled in exchange for those goods or services. The standard explains that to achieve the core principle, an entity should take the following actions:

 

Step 1: Identify the contract with a customer

 

Step 2: Identify the performance obligations in the contract

 

9

Step 3: Determine the transaction price

 

Step 4: Allocate the transaction price to the performance obligations

 

Step 5: Recognize revenue when or as the entity satisfies a performance obligation

 

Revenue is recognized when or as a company satisfies a performance obligation by transferring a promised good or service to a customer (which is when the customer obtains control of that good or service). In instances in which shipping and handling activities are performed after a customer takes control of the goods (such as when title passes upon shipment from our dock), we have made the policy election allowed under Topic 606 to account for these activities as fulfillment costs and not as performance obligations.

 

We generally reference customer purchase orders to determine the existence of a contract. Orders that are not accompanied by a purchase order are confirmed with the customer either in writing or verbally. The purchase orders or similar correspondence, once accepted, identify the performance obligations as well as the transaction price, and otherwise outline the rights and obligations of each party. We allocate the transaction price of each contract among the performance obligations in accordance with the pricing of each item specified on the purchase order, which is in turn based on standalone selling prices per our published price lists. In cases where we discount products or provide certain items free of charge, we allocate the discount proportionately to all performance obligations, unless it can be demonstrated that the discount should be allocated entirely to one or more, but not all, of the performance obligations.

 

We record revenue, net of allowances for returns and discounts, fees paid to group purchasing organizations, and any sales and value added taxes required to be invoiced, which we have elected to exclude from the measurement of the transaction price as allowed by the standard, at the time of shipment (taking into consideration contractual shipping terms), or in the case of consigned inventory, when it is consumed. Shipment is the point at which control of the product and title passes to our customers, and at which LeMaitre has a present right to receive payment for the goods.

 

Below is a disaggregation of our revenue by major geographic area, which is among the primary categorizations used by management in evaluating financial performance, for the periods indicated (in thousands):

 

  

Three months ended September 30,

  

Nine months ended September 30,

 
                 
  

2022

  

2021

  

2022

  

2021

 
  

($ in thousands)

  

($ in thousands)

 
                 

Americas

 $26,627  $25,299  $82,024  $76,327 

Europe, Middle East and Africa

  9,922   10,535   31,165   31,200 

Asia Pacific

  2,479   2,534   7,508   7,394 

Total

 $39,028  $38,368  $120,697  $114,921 

  

Three months ended March 31,

 
  

2023

 

2022

 
  

($ in thousands)

 
        

Americas

 $32,126 $26,543 

Europe, Middle East and Africa

  12,277  10,494 

Asia Pacific

  2,672  2,524 

Total

 $47,075 $39,561 

 

We do not carry any contract assets or contract liabilities, as there are generally no unbilled amounts due from customers under contracts for which we have partially satisfied performance obligations, or amounts received from customers for which we have not satisfied performance obligations. We satisfy our performance obligations under revenue contracts within a very short time period from receipt of the orders, and payments from customers are typically received within 30 to 60 days of fulfillment of the orders, except in certain geographies such as Spain and France where the payment cycle is customarily longer. Accordingly, there is no significant financing component to our revenue contracts. Additionally, we have elected as a policy that incremental costs (such as commissions) incurred to obtain contracts are expensed as incurred, due to the short-term nature of the contracts.

 

Customers returning products may be entitled to full or partial credit based on the condition and timing of the return. To be accepted, a returned product must be unopened (if sterile), unadulterated, and undamaged, must have at least 18 months remaining prior to its expiration date, or twelve months for our hospital customers in Europe, and generally be returned within 30 days of shipment. These return policies apply to sales to both hospitals and distributors. The amount of products returned to us, either for exchange or credit, has not been material. Nevertheless, we provide for an allowance for future sales returns based on historical returns experience, which requires judgment. Our cost of replacing defective products has not been material and is accounted for at the time of replacement.

10

Recent Accounting Pronouncements

 

From time to time, new accounting pronouncements are issued by the Financial Accounting Standards Board (FASB) or other standard setting bodies and are general adopted by the Company as of the specified effective date. Unless otherwise discussed, the Company believes that the impact of recently issued standards that are not yet effective will not have a material impact on its financial position or results of operations upon adoption.

10

 

 

2. Income Tax Expense

 

As part of the process of preparing our consolidated financial statements we are required to determine our income taxes in each of the jurisdictions in which we operate. This process involves estimating our 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 our consolidated balance sheet. We must then assess the likelihood that our deferred tax assets will be recovered from taxable income during the carryback period or in the future; and to the extent we believe that recovery is not more likely than not, we must establish a valuation allowance. To the extent we establish a valuation allowance or increase this allowance in a period, we must reflect this increase as an expense within the tax provision in the statement of operations. We do not provide for income taxes on undistributed earnings of certain foreign subsidiaries, as our intention is to permanently reinvest these earnings.

 

We recognize, measure, present and disclose in our financial statements any uncertain tax positions that we have taken, or expect to take on a tax return. We operate 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 our provision for income taxes, our deferred tax assets and liabilities, liabilities for uncertain tax positions, and any valuation allowance recorded against our net deferred tax assets. We will monitor the realizability of our deferred tax assets and adjust the valuation allowance accordingly.

 

Our policy is to classify interest and penalties related to unrecognized tax benefits as income tax expense. Our 20222023 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 our foreign subsidiaries, and discrete stock option exercises. Our 20212022 income tax expense varied from the statutory rate mainly due to the generation of federal and state tax credits, permanent items, and different statutory rates from our foreign subsidiaries, and discrete stock option exercises.subsidiaries.

 

We have reviewed the tax positions taken, or to be taken, in our tax returns for all tax years currently open to examination by a taxing authority. As of September 30, 2022, March 31, 2023, the gross amount of unrecognized tax benefits exclusive of interest and penalties was $579,000. We recognized a reduction of unrecognized tax benefits in 2022 due to the lapse of the applicable statute of limitations in Australia.$608,000. We remain 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 2030. A reconciliation of beginning and ending amount of our unrecognized tax benefits is as follows:

 

 

Nine months ended September 30, 2022

  

Three months ended March 31, 2023

 
 

(in thousands)

  

(in thousands)

 

Unrecognized tax benefits as of December 31, 2021

 $768 

Unrecognized tax benefits as of December 31, 2022

 $612 

Additions/adjustments for tax positions of current year

 -  - 

Additions/adjustments for tax positions of prior years

 (95) (4)

Reductions for settlements with taxing authorities

 -  - 

Reductions for lapses of the applicable statutes of limitations

  (94)  - 

Unrecognized tax benefits as of September 30, 2022

 $579 

Unrecognized tax benefits as of March 31, 2023

 $608 

 

As of September 30, 2022, March 31, 2023, a summary of the tax years that remain subject to examination in our taxing jurisdictions is as follows:

 

United States

20182019 and forward

Foreign

20142015 and forward

 

11

 

 

3. Inventories and Other Deferred Costs

 

Inventories and other deferred costs consist of the following:

 

 

September 30, 2022

 

December 31, 2021

  

March 31, 2023

  

December 31, 2022

 
 

(in thousands)

  

(in thousands)

 

Raw materials and subassemblies

 $13,425  $5,945 

Raw materials

 $17,695  $14,929 

Work-in-process

 3,600  9,416  3,940  3,662 

Finished products

 25,409  25,286  27,233  26,688 

Other deferred costs

 5,277  5,457  4,911  4,992 
          

Total inventory and other deferred costs

 $47,711  $46,104  $53,779  $50,271 

 

We had inventory on consignment at customer sites of $1.7 million and $2.1$1.5 million at September 30,March 31, 2023 and December 31, 2022,and December 31,2021, respectively.

 

In connection with our 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 U.S. federal law, human tissues cannot be bought or sold. Therefore, the tissues we preserve are not held as inventory, and the costs we incur 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. General and administrative expenses and selling expenses associated with the provision of these services are expensed as incurred.

 

 

4. Acquisitions

Our acquisitions are accounted for using the acquisition method, and the acquired businesses’ results have been included in the accompanying consolidated financial statements from their respective dates of acquisition. In each case for the acquisitions disclosed below, pro forma information assuming the acquisition had occurred at the beginning of the earliest period presented is not included, as the impact is immaterial.

Our acquisitions have historically been made at prices above the fair value of the acquired identifiable assets, resulting in goodwill, due to expectations of synergies that will be realized by combining businesses. These synergies include the use of our existing sales channel to expand sales of the acquired businesses’ products, consolidation of manufacturing facilities, and the leveraging of our existing administrative infrastructure.

The fair market valuations associated with these transactions fall within Level 3 (see Note 15) of the fair value hierarchy, due to the use of significant unobservable inputs to determine fair value. The fair value measurements were calculated using unobservable inputs, primarily using the income approach, specifically the discounted cash flow method. The amount and timing of future cash flows within our analysis was based on our due diligence models, most recent operational budgets, long-range strategic plans and other estimates.

Artegraft Biologic Grafts Divestitures

 

On June 22, 2020, we entered into an Asset Purchase Agreement (Artegraft APA) to acquire the biologic graft business from Artegraft, Inc., which subsequent to the closing changed their name to Accidentals, Inc., (Artegraft, Inc.). Under the terms of the Artegraft APA, we agreed to pay Artegraft, Inc. a total of up to $90.0 million for the purchase of substantially all of the assets related to its business of manufacturing, marketing, sale and distribution of bovine grafts (Products) other than specifically identified excluded assets. The acquired assets included inventory, accounts receivable, machinery and equipment, intellectual property, permits and approvals, data and records, and customer and supplier information. At closing, $72.5 million of the purchase price was paid to Artegraft, Inc. and other parties as specified in the Artegraft APA, including $7.5 million into an escrow account. The escrow amount was held until December 31, 2021 to cover any potential claims against LeMaitre or Artegraft, Inc. and subsequently was released to Artegraft, Inc. by mutual consent of the parties.

Three earn-out payments of $5,833,333 each are potentially due to Artegraft, Inc. under the Artegraft APA depending on the achievement of specified revenue targets, as follows:

$5.8 million upon final determination that 20,000 units of the Product have been sold to third parties from January 1, 2021 to December 31, 2021 (this milestone was not met and accordingly no payment was made);

$5.8 million upon final determination that 24,000 units of the Product have been sold to third parties from January 1, 2022 to December 31, 2022; and

$5.8 million upon final determination that 28,800 units of the Product have been sold to third parties from January 1, 2023 to December 31, 2023.

12

The Artegraft APA includes a catch-up feature on the earn-outs such that, at the end of the three-year period, if the sum of the unit sales for all three years is greater than or equal to 58,240 unit sales (80% of the combined individual-year targets), Artegraft, Inc. will receive a “catch-up payment” in an amount equal to (a) $17,500,000 times a fraction, the numerator of which is the aggregate number of unit sales for the three-year period, and the denominator of which is 72,800 less (b) any individual-year earn-out previously paid. We recorded this liability at a fair value of $0.4 million to reflect management’s estimate of the likelihood of achieving these targets at the time of the closing of the acquisition, as well as the time value of money until payment. This amount will be remeasured each quarter during the earn-out period, with any adjustments recorded in income from operations. As of September 30, 2022 the fair value of the liability is $0.2 million.

On the date of acquisition, the Company allocated the consideration given to the individual assets acquired and the liabilities assumed based on a preliminary estimate of their fair values. During the three months ended September 30, 2020, the Company obtained and considered additional information related to the assets acquired and liabilities assumed, and recorded measurement period adjustments to the allocation of the purchase price. The following table summarizes the purchase price allocation:

  

Allocated

 
  

Fair Value

 
  

(in thousands)

 

Inventory

 $3,859 

Accounts receivable

  1,789 

Equipment and supplies

  1,140 

Accounts payable and other

  (53

)

Intangible assets

  39,056 

Goodwill

  27,115 
     

Purchase price

 $72,906 

The goodwill results from expected synergies of combining the acquired products and customer information to our existing operations, and is deductible for tax purposes over 15 years.

The following table reflects the allocation of purchase consideration to the acquired intangible assets and related estimated useful lives: 

  

Allocated

  

Estimated

 
  

Fair Value

  

Useful Life (years)

 
  

(in thousands)

     

Customer relationships

 $20,310   15.0 

Intellectual property

  16,449   10.0 

Non-compete agreement

  104   5.0 

Tradenames

  2,193   10.0 
         

Total intangible assets

 $39,056     

The weighted-average amortization period of the acquired intangible assets was 12.6 years.

13

5. Divestitures

On April 26, 2022, we committed to a plan to close our St. Etienne, France factory, which supported our LeMaitre Cardial SAS (Cardial) business, in order to streamline manufacturing operations and reduce expenses. The Cardial business consisted of the manufacture of polyester vascular grafts, valvulotomes, surgical glue and selected OEM devices. We acquired the Cardial business in 2018.

 

On June 30, 2022 we ceased operations at the St. Etienne, France factory and terminated most of the personnel at the site.factory. The closure resulted in a restructuring charge of $3.1 million for the three and six monthsyear ended June 30,December 31, 2022. Charges primarily consisted of employment termination costs, impairment of fixed assets and inventory, and third-partythird-party costs. We did not record additional expenses related to the closure for the three months ended September 30, 2022.

As of September 30, 2022, there were assets associated with Cardial classified as held for sale. The net assets held for sale represent the St. Etienne, France factory building, building improvements, and land that have met the criteria of “held for sale” accounting, as specified by Accounting Standards Codification (“ASC”) 360, “Property, Plant, and Equipment.”

 

On October 10, 2022 we sold the St. Etienne, France building, building improvements, and land for $0.9 million less closing costs of $0.1 million, resulting in a gain of approximately $0.1 million.million recorded for the three months ended December 31, 2022.

During the three-months ended March 31, 2023 we recorded an additional restructuring charge of $0.3 million in conjunction with the St. Etienne, France factory closure. The additional charge consisted primarily of employment termination settlement costs, legal costs and other third-party costs.

 

1412

 

 

6.5. Goodwill and Other Intangible Assets

 

There was no change to goodwill during the ninethree months ended September 30, 2022. March 31, 2023. Other intangible assets consist of the following:

 

 

September 30, 2022

 

December 31, 2021

  

March 31, 2023

  

December 31, 2022

 
 

Gross

     

Net

 

Gross

     

Net

  

Gross

     

Net

 

Gross

     

Net

 
 

Carrying

 

Accumulated

 

Carrying

 

Carrying

 

Accumulated

 

Carrying

  

Carrying

 

Accumulated

 

Carrying

 

Carrying

 

Accumulated

 

Carrying

 
 

Value

 

Amortization

 

Value

 

Value

 

Amortization

 

Value

  

Value

  

Amortization

  

Value

  

Value

  

Amortization

  

Value

 
 

(in thousands)

  

(in thousands)

 

Product technology and intellectual property

 $29,549  $12,616  $16,933  $29,549  $10,473  $19,076  $29,549  $14,021  $15,528  $29,549  $13,319  $16,230 

Trademarks, tradenames and licenses

 3,647  1,436  2,211  3,647  1,139  2,508  3,767  1,635  2,132  3,647  1,533  2,114 

Customer relationships

 36,197  7,686  28,511  36,197  5,674  30,523  36,542  9,042  27,500  36,197  8,359  27,838 

Other intangible assets

  1,461   1,053   408   1,461   858   603   1,536   1,188   348   1,461   1,116   345 
  

Total identifiable intangible assets

 $70,854  $22,791  $48,063  $70,854  $18,144  $52,710  $71,394  $25,886  $45,508  $70,854  $24,327  $46,527 

 

These assets are being amortized over useful lives ranging from 2 to 16 years. The weighted-average amortization period for these intangibles as of September 30, 2022 March 31, 2023 is 11.210.2 years. Amortization expense is included in general and administrative expense and was as follows for the periods indicated.

 

  

Three months ended September 30,

  

Nine months ended September 30,

 
  

2022

  

2021

  

2022

  

2021

 
  

(in thousands)

  

(in thousands)

 
                 

Amortization expense

 $1,535  $1,547  $4,647  $4,675 
  

Three months ended March 31,

 
  

2023

  

2022

 
  

(in thousands)

 
         

Amortization expense

 $1,559  $1,516 

 

We estimate that amortization expense for the remainder of 20222023 and for each of the five succeeding fiscal years will be as follows:

 

   

Year ended December 31,

 
  

2022

  

2023

  

2024

  

2025

  

2026

  

2027

 
  

(in thousands)

     
                         

Amortization expense

 $1,535  $5,952  $5,629  $5,429  $4,983  $4,706 

  Year ended December 31, 
  

2023

  

2024

  

2025

  

2026

  

2027

  

2028

 
  

(in thousands)

 
                         

Amortization expense

 $4,489  $5,772  $5,440  $5,041  $4,764  $4,378 

 

15
13

 

 

7. Revolving Line of Credit and Long-term Debt

In connection with the acquisition of the Artegraft biologic graft business, we incurred debt in the amount of $65.0 million under a senior secured credit facility with a group of banks. This credit arrangement included a $25.0 million revolving credit line that was fully drawn at inception, as well as a $40.0 million five-year term loan. During the year ended December 31, 2020, we made scheduled principal payments on the term loan of $1.0 million and repaid the revolving line of credit in full. During the nine months ended September 30, 2021, we made scheduled principal payments on the term loan of $1.0 million, and repaid the loan in full. Cash paid for interest during the nine months ended September 30, 2021 was $0.9 million.

Under the terms of the agreement, the loans bore interest at a rate per annum of, at our option, either (i) the Base Rate plus an applicable margin of from 1.25% to 1.75% depending on our consolidated leverage ratio, or (ii) the Eurodollar Rate plus an applicable margin of from 2.25% to 2.75% depending on our consolidated leverage ratio. Base Rate was defined in the credit agreement as a fluctuating rate per annum of the Federal Funds rate plus 0.5% or the prime rate of interest established from time to time by KeyBank National Association.

We incurred debt issuance costs in connection with this credit arrangement of approximately $1.8 million. These costs were allocated between the revolving line of credit and the term loans, with the portion related to the revolving line of credit of $0.7 million recorded in other assets on our balance sheet, and the portion allocated to the term loan recorded as a deduction from the amount of the debt. All of these transaction costs were being amortized into interest expense on a straight-line basis as the result would not be materially different from using the interest method, over the five-year term of the arrangement. This resulted in an effective interest rate of approximately 4.2%. During the three months ended September 30, 2021, in connection with prepaying the term loan in full, we expensed the remaining unamortized transaction costs allocated to the term loan of $0.6 million.

In November 2021, we terminated the credit agreement, including the revolving line of credit, as permitted under the original agreement.

16

8.6. Leases

 

We conduct the majority of our operations in leased facilities, all of which are accounted for as operating leases, as they do not meet the criteria for finance leases. Our principal worldwide executive, distribution, and manufacturing operations are located in five leased facilities with square footage totaling 109,354 in Burlington, Massachusetts. All five Burlington leases expire in December 2030.

 

Our European operations are headquartered at a 21,410 square foot leased facility located in Sulzbach, Germany. In June 2022, we increased our square footage by 4,940 (from 16,470) square feet and extended the lease through June 2031. This lease contains a fivefive-year-year renewal option. Additionally, in May 2022, we signed a new sales office/warehouse lease in the Seoul, Korea, which includes 2,300 square feet of office and warehouse space, and expires in April 2027. Finally, in In June 2022, we extended our Singapore lease by oneone-year-year and it will to expire in June 2023.

 

Similar to prior quarters, weWe also lease a facility in Hereford, England which houses our United Kingdom sales and distribution business. During the quarter ended June 30, 2021, we executed an expansion of the Hereford lease under terms substantially similar to the original lease. In connection with our acquisition of the Artegraft biologic graft business, we assumed a 16,732 square foot lease in North Brunswick, New Jersey, which expires in October 2029. In June 2021, we entered into a sixsix-year-year lease in Milan Italy which houses a customer serviceour Italian office and warehouse facility.warehouse. This lease contains a sixsix-year-year renewal option.

 

We also have smaller long-term leased sales, marketing and other facilities located in Arizona, Canada, Australia, Singapore and China, and short-term leases in Japan, Spain and Illinois. TheIn August 2022, the lease in Arizona was extended for an additional three years through August 2025, effective as of August 24, 2022. 2025. The lease in China was extended for an additional two years through August 2024, effective September 1, 2022. OurThe lease in Canada contains awas extended an additional fivethree-year renewal years through February 2026, effective March 1, 2023, with an additional three year option exercisable in February 2023. thereafter. Our leases in Germany and Italy are subject to periodic rent increases based on increases in the consumer price index as measured on an annual basis, with such increases applicable to the subsequent twelve months of lease payments. None of our noncancelable lease payments include non-lease components such as maintenance contracts; we generally reimburse the landlord for direct operating costs associated with the leased space. We have no subleases, and there are no residual value guarantees associated with, or restrictive covenants imposed by, any of our leases. There were no assets held under capital leases at September 30, 2022.March 31, 2023.

 

We also lease automobiles under operating leases in the United States as well as certain of our international subsidiaries. The terms of these leases are generally three years, with older vehicles replaced by newer vehicles from time to time. During the fiscal year 2021, we entered into a fivefive-year-year lease for printing equipment.

 

We account for leases under the provisions of ASU No.2016-02, 2016-02, Leases (Topic 842)842), subsequently amended by ASU 2018-11,2018-11, Leases (Topic 842)842): Targeted Improvements. Under this guidance, we are required to recognize the following for all leases (with the exception of short-term leases) at the commencement date: a lease liability, which is a lessee’s obligation to make lease payments arising from a lease, measured on a discounted basis; and a right-of-use asset, which is an asset that represents the lessee’s right to use, or control the use of, a specified asset for the lease term.

 

Our most significant judgement involved in determining the amounts to initially record as lease liabilities and right-of-use assets upon initial adoption of this standard, and for leases entered into subsequently, was the selection of a discount rate; because we had no debt as of the adoption of this standard, we had no incremental borrowing rate to reference. We therefore derived an incremental borrowing rate using quotes from potential lenders as the primary inputs, augmented by other available information. The resulting rate selected was 5.25%. We determined that it was appropriate to apply this single rate to our portfolio of leases worldwide, as the lease terms and conditions are substantially similar, and because we believe our subsidiaries would be unable to obtain borrowings on their own without a commitment of parent company support. In connection with the assumption of the Artegraft North Brunswick, New Jersey lease, we used LeMaitre’s borrowing rate of 3.5% as of the acquisition date associated with debt incurred to finance the acquisition to value the lease. Subsequently, we have adjusted the selection of a discount rate for any new or renewed lease agreements based upon a derived incremental borrowing rate using quotes from potential lenders as the primary inputs as of the effective date of the new or renewed lease.

 

17
14

Additional information with respect to our leases is as follows:

 

 

Three months ended September 30,

 

Nine months ended September 30,

 
 

2022

 

2021

 

2022

 

2021

  

Three Months Ended

 
 

(in thousands)

 

(in thousands)

 

(in thousands)

 

(in thousands)

   

March 31,

 
  

2023

  

2022

 

Lease cost

      

Operating lease cost

 $792  $588  $1,955  $1,682  580  525 

Short-term lease cost

  154   123   478   313   162   163 

Total lease cost

 $946  $711  $2,433  $1,995  $742  $688 
      

Other information

                

Cash paid for amounts included in the measurement of operating lease liabilities

 $977  $725  $2,461  $2,106  $737  $674 
                

Right-of-use assets obtained in exchange for new operating lease liabilities

 $287  $-  $2,669  $1,277  $472  $141 
      

 

Weighted average remaining lease term - operating leases (in years)

      8.2  8.4 

Weighted average remaining lease term in years - operating leases

 7.2 7.6 
      

Weighted average discount rate - operating leases

      4.93% 4.86% 4.95% 4.90%

 

At September 30, 2022, March 31, 2023, the minimum non-cancelable operating lease rental commitments with initial or remaining terms of more than one year are as follows:

 

Remainder of 2022

 $714 

Year ending December 31,

    

2023

  2,683 

2024

  2,600 

2025

  2,520 

2026

  2,471 

2027

  2,388 

Thereafter

  6,889 

Adjustment to net present value as of September 30, 2022

  (3,540)
     

Minimum noncancelable lease liability

 $16,725 

Remainder of 2023

 $2,184 

Year ending December 31,

    

2024

  2,860 

2025

  2,753 

2026

  2,532 

2027

  2,423 

2028

  2,390 

Thereafter

  4,585 

Adjustment to net present value as of March 31, 2023

  (3,222)
     

Minimum noncancelable lease liability

 $16,505 

 

1815

 

 

9.7. Accrued Expenses and Other Long-term Liabilities

 

Accrued expenses consist of the following:

 

  

September 30, 2022

  

December 31, 2021

 
  

(in thousands)

 

Compensation and related taxes

 $10,228  $10,236 
Accrued expenses  3,400   2,719 
Accrued purchases  3,202   2,545 

Income and other taxes

  408   551 

Professional fees

  43   129 

Other

  119   152 
         

Total

 $17,400  $16,332 

  

March 31, 2023

  

December 31, 2022

 
  

(in thousands)

 

Compensation and related taxes

 $7,713  $10,770 
Accrued purchases  5,222   3,748 
Accrued expenses  3,839   4,640 

Income and other taxes

  380   449 

Professional fees

  164   108 

Other

  302   252 
         

Total

 $17,620  $19,967 

 

Other long-term liabilities consist of the following:

 

  

September 30, 2022

  

December 31, 2021

 
  

(in thousands)

 

Aquisition-related liabilities

 $1,609  $1,761 

Income taxes

  646   799 

Other

  150   141 
         

Total

 $2,405  $2,701 

  

March 31, 2023

  

December 31, 2022

 
  

(in thousands)

 

Aquisition-related liabilities

 $1,463  $1,354 

Income taxes

  628   636 

Other

  187   177 
         

Total

 $2,278  $2,167 

 

 

10.8. Segment and Enterprise-Wide Disclosures

 

The FASB establishes standards for reporting information regarding operating segments in financial statements. Operating segments are identified as components of an enterprise that engage in business activities for which separate, discrete financial information is available and is regularly reviewed by the chief operating decision-maker in making decisions on how to allocate resources and assess performance. We view our operations and manage our business as one operating segment. No discrete operating information is prepared by us except for sales by product line and operations by legal entity for local purposes.

 

Most of our revenues are generated in the United States, Germany and other European countries, Canada, the United Kingdom and Japan, and substantially all of our assets are located in the United States and Germany. Net sales to unaffiliated customers by country were as follows:

 

  

Three months ended

  

Nine months ended

 
  

September 30,

  

September 30,

 
  

2022

  

2021

  

2022

  

2021

 
  

(in thousands)

  

(in thousands)

 

United States

 $24,242  $23,313  $74,734  $70,453 

Germany

  2,814   3,369   8,675   9,586 

Canada

  1,962   1,672   6,141   5,052 

United Kingdom

  1,269   1,204   4,150   3,497 

Other countries

  8,741   8,810   26,997   26,333 
                 

Net Sales

 $39,028  $38,368  $120,697  $114,921 

  

Three months ended

 
   

March 31,

 
  

2023

   

2022

 
  

(in thousands)

 

United States

 $29,015   $24,264 

Germany

  3,346    2,991 

Canada

  2,762    1,909 

Other countries

  11,952    10,397 
          

Net Sales

 $47,075   $39,561 

 

19
16

 

 

11.9. Share-based Compensation

 

Our Third 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 our officers, employees, directors and consultants. The components of share-based compensation expense were as follows:

 

 

Three months ended

 

Nine months ended

  

Three months ended

 
 

September 30,

 

September 30,

   

March 31,

 
 

2022

 

2021

 

2022

 

2021

  

2023

  

2022

 
 

(in thousands)

 

(in thousands)

  

(in thousands)

 

Stock option awards

 $614  $504  $1,840  $1,660  $662  $619 

Restricted stock units

 432  293  1,231  933  477  408 

Performance-based restricted stock units

  140   -   418   -   151   140 
      

Total share-based compensation

 $1,186  $797  $3,489  $2,593  $1,290  $1,167 

 

Stock-based compensation is included in our statements of operations as follows:

 

 

Three months ended

 

Nine months ended

  

Three months ended

 
 

September 30,

 

September 30,

   

March 31,

 
 

2022

 

2021

 

2022

 

2021

  

2023

  

2022

 
 

(in thousands)

 

(in thousands)

  

(in thousands)

 

Cost of sales

 $142  $91  $415  $291  $170  $138 

Sales and marketing

 205  124  607  412  214  209 

General and administrative

 720  499  2,127  1,617  777  712 

Research and development

  119   83   340   273   129   108 
      

Total stock-based compensation

 $1,186  $797  $3,489  $2,593  $1,290  $1,167 

 

During the nine-month period ended September 30, 2022, we granted options for the purchase of 2,052 shares of our common stock. We did not grant any options during the nine-month periodthree months ended September 30, 2021. March 31, 2023 or 2022. During the ninethree months ended September 30,March 31, 2023, and 2022,and 2021, we awarded restricted stock units of 728200 and 1,157,112, respectively. We awarded performance-based restricted stock units of 250 during the nine months ended September 30, 2022. We did not award any performance-based restricted stock units during the nine-month periodthree months ended September 30, 2021. March 31, 2023 or 2022. We issued approximately 81,00059,000 and 173,00032,000 shares of common stock following the exercise or vesting of underlying stock options or restricted stock units during the ninethree months ended September 30,March 31, 2023 and 2022,and 2021, respectively.

 

20
17

 

 

12.10. Net Income per Share

 

The computation of basic and diluted net income per share was as follows:

 

  

Three months ended

  

Nine months ended

 
  

September 30,

  

September 30,

 
  

2022

  

2021

  

2022

  

2021

 
  

(in thousands, except per share data)

  

(in thousands, except per share data)

 

Basic:

                

Net income available for common stockholders

 $5,456  $6,504  $15,009  $20,732 
                 

Weighted average shares outstanding

  21,984   21,592   21,959   20,920 
                 

Basic earnings per share

 $0.25  $0.30  $0.68  $0.99 
                 

Diluted:

                

Net income available for common stockholders

 $5,456  $6,504  $15,009  $20,732 
                 

Weighted-average shares outstanding

  21,984   21,592   21,959   20,920 

Common stock equivalents, if dilutive

  233   343   190   331 
                 

Shares used in computing diluted earnings per common share

  22,217   21,935   22,149   21,251 
                 

Diluted earnings per share

 $0.25  $0.30  $0.68  $0.98 
                 

Shares excluded in computing diluted earnings per share as those shares would be anti-dilutive

  159   -   286   1 

  

Three months ended

 
  

March 31,

 
  

2023

  

2022

 
  

(in thousands, except per share data)

 

Basic:

        

Net income available for common stockholders

 $6,040  $6,038 
         

Weighted average shares outstanding

  22,111   21,935 
         

Basic earnings per share

 $0.27  $0.28 
         

Diluted:

        

Net income available for common stockholders

 $6,040  $6,038 
         

Weighted-average shares outstanding

  22,111   21,935 

Common stock equivalents, if dilutive

  163   168 

Shares used in computing diluted earnings per common share

  22,274   22,103 
         

Diluted earnings per share

 $0.27  $0.27 
         

Shares excluded in computing diluted earnings per share as those shares would be anti-dilutive

  320   430 

 

21
18

 

 

13.11. Stockholders Equity

 

Share Repurchase Program

 

On February 22, 2022, 21, 2023, our Board of Directors authorized the repurchase of up to $20.0$25.0 million of the Company’s common stock through transactions on the open market, in privately negotiated purchases or otherwise until February 22, 2023. 21, 2024. The repurchase program may be suspended or discontinued at any time. To date we have not made any repurchases under this program.

 

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

  

Payment Date

  

Per Share Amount

  

Dividend Payment

 
     

(in thousands)

 
Fiscal Year 2023       

March 9, 2023

 March 23, 2023  $0.140  $3,099 
     

(in thousands)

        

Fiscal Year 2022

              

March 8, 2022

 

March 24, 2022

 $0.125  $2,743  March 24, 2022  $0.125  $2,743 

May 17, 2022

 

June 2, 2022

 $0.125  $2,745  June 2, 2022  $0.125  $2,745 

August 25, 2022

 

September 8, 2022

 $0.125  $2,750  

September 8, 2022

  $0.125  $2,750 
       

Fiscal Year 2021

       

March 9, 2021

 

March 25, 2021

 $0.110  $2,262 

May 19, 2021

 

June 3, 2021

 $0.110  $2,267 

August 26, 2021

 

September 9, 2021

 $0.110  $2,401 

November 19, 2021

 

December 2, 2021

 $0.110  $2,405 

November 17, 2022

 December 1, 2022  $0.125  $2,750 

 

On October 25, 2022, April 24, 2023, our Board of Directors approved a quarterly cash dividend on our common stock of $0.125$0.14 per share payable on DecemberJune 1, 2022, 2023, to stockholders of record at the close of business on NovemberMay 17, 2022.2023.

 

 

14.12. Supplemental Cash Flow Information

 

  

For the nine months ended

 
  

September 30,

 
  

2022

  

2021

 
  

(in thousands)

 

Cash paid for income taxes, net

 $6,822  $7,485 

  

For the three months ended

 
   

March 31,

 
  

2023

   

2022

 
  

(in thousands)

 

Cash paid for income taxes, net

 $271   $731 

 

2219

 

 

15.13. Fair Value Measurements

 

The fair value accounting guidance requires that assets and liabilities carried at fair value be classified and disclosed in one of the following three categories:

 

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

 

Level 2 — Observable inputs other than quoted prices included in Level 1, such as quoted prices for similar assets and liabilities in active markets; quoted prices for identical or similar assets and liabilities in markets that are not active; 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 the fair value of the assets or liabilities. This includes certain pricing models, discounted cash flow methodologies and similar techniques that use significant unobservable inputs.

 

Level 1 assets being measured at fair value on a recurring basis as of September 30, 2022 March 31, 2023 included our short-term investment and short-duration bond mutual fund accounts.

 

We had no Level 2 assets being measured at fair value on a recurring basis as of September 30, 2022. March 31, 2023.

 

As discussed in Note 4, severalSeveral of our acquisition-related assets and liabilities have been measured using Level 3 techniques. During 2020 we recorded a contingent liability associated with our acquisition of the bovine carotid graft business from Artegraft. The agreement requiresrequired us to make potential additional payments to Artegraft of up to $17.5 million depending on the achievement of certain unit sales milestones during the firstthree calendar years following the acquisition. We recorded this liability at a fair value of $0.4 million to reflect management’s estimate of the likelihood of achieving these targets at the time of the Closing, as well as the time value of money until payment. This amount is being remeasured each quarter during the earn-out period, with any adjustments recorded in income from operations. During the quarter ended December 31, 2022 we recorded a reduction to the liability to reflect a change in our estimate of the likelihood of achieving the unit sales milestones. There was no change in the estimated liability during the quarter ended March 31, 2023.

 

During 2019, we recorded contingent liabilities associated with our acquisition of the Admedus biologic patch business from Admedus Ltd (Admedus).business. The agreement includes the potential for us to pay up to $7.8 million of additional consideration beyond payments made prior to that date, with $0.3 million contingent upon the delivery of audited financial statementsstatement of the acquired business to us; $2.0 million contingent on LeMaitre’s success in obtaining CE marks under the European Union (EU) Medical Device Regulation (MDR)MDR regulations on the acquired products, $0.5 million contingent upon Admedus’ success in extending the shelf life of the acquired products as specified in the agreement, and another $5.0 million contingent on the achievement of specified levels of revenues in the first12 and 24 months following the acquisition date. This additional contingent consideration was initially valued in total at $2.3 million and is being re-measured each reporting period until the payment requirement ends, with any adjustments reported in income from operations. The contingent payment related to the delivery of audited financial statements of the business was paid in November 2019 upon satisfaction of the deliverable. The contingent payments related to Admedus’ extending the shelf life of the acquired products and achieving the revenue targets during the first12 and 24 month periods following the acquisition were not met, and the portion of the liabilities related to these items was adjusted through income from operations. The agreement was amended in August 2021 such that the contingent payment of $2.0 million potentially due upon LeMaitre’sLeMaitre Vascular’s success in obtaining CE marks under MDR regulations on the acquired products may be reduced for certain costs incurred by LeMaitre in achieving the CE marks. During the quarter ended September 30, 2021 we recorded a reduction to the liability of $0.5 million, with the offset recorded in income from operations, to reflect our estimate of costs to be deducted from the contingent payment in connection with this amendment. Additionally, during the quarter ended December 31, 2022 we recorded a reduction to the liability of approximately $0.1 million, with the offset recorded in income from operations. There was no change in the estimated liability during the quarter ended March 31, 2023.

20

 

The following table provides a rollforwardroll-forward of the fair value of these liabilities, as determined by Level 3 unobservable inputs including management’s forecast of future revenues for the acquired businesses, as well as, management’s estimates of the likelihood of achieving the other specified criteria:

 

  

Nine months ended September 30,

 
  

2022

  

2021

 
  

(in thousands)

 

Beginning balance

 $1,492  $2,240 

Additions

  -   - 

Payments

  -   - 

Change in fair value included in earnings

  41   (508)
         

Ending balance

 $1,533  $1,732 

23

  

Three months ended

 
   

March 31,

 
  

2023

  

2022

 
  

(in thousands)

 

Beginning balance

 $1,339  $1,492 

Additions

  -   - 

Payments

  -   - 

Change in fair value included in earnings

  20   14 

Ending balance

 $1,359  $1,506 

 

 

16.14. Accumulated Other Comprehensive Loss

 

Changes to our accumulated other comprehensive loss for the ninethree months ended September 30,March 31, 2023 and 2022and 2021 consisted primarily of foreign currency translation and unrealized losses on short-term marketable securities:

 

  

Three months ended

 
   

March 31,

 
  

2023

  

2022

 
  

(in thousands)

 

Beginning balance

 $(6,031) $(3,435)

Other comprehensive income (loss) before reclassifications

  459   (1,189)

Ending Balance

 $(5,572) $(4,624)

 

  

Nine months ended

 
  

September 30,

 
  

2022

  

2021

 
  

(in thousands)

 

Beginning balance

 $(3,435) $(1,525)
         

Other comprehensive income (loss) before reclassifications

  (4,692)  (1,111)
         

Ending Balance

 $(8,127) $(2,636)

15. Subsequent Events

 

On April 20, 2023, we entered into an agreement with Aziyo Biologics, Inc. (Aziyo) to become the exclusive distributor of Aziyo’s cardiovascular patches in the United States. Under the terms of the agreement, LeMaitre will distribute the products for three years with an option to acquire Aziyo’s worldwide cardiovascular patch business during the second and third year of the terms of the agreement.

 

2421

 

Item 2. Managements Discussion and Analysis of Financial Condition and Results of Operations

 

This Quarterly Report on Form 10-Q contains forward-looking statements (within the meaning of the U.S. Private Securities Litigation Reform Act of 1995) that involve substantial risks and uncertainties, particularly risks related to the regulatory environment, our common stock, fluctuations in our quarterly and annual results, our ability to successfully integrate acquisitions into our business, and risks related to our business and industry generally, such as risks inherent in the process of developing and commercializing products and services that are safe and effective for use in the peripheral vascular disease market. All statements, other than statements of historical facts, included in this report regarding our strategy, future operations, future financial position, future net sales, gross margin expectations, projected costs, projected expenses, prospects and plans and objectives of management are forward-looking statements. The words anticipates, believes, estimates, expects, intends, may, plans, projects, will, would, and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. We have based these forward-looking statements on our current expectations and projections about future events. Although we believe that the expectations underlying any of our forward-looking statements are reasonable, these expectations may prove to be incorrect, and all of these statements are subject to risks and uncertainties. Should one or more of these risks and uncertainties materialize, or should underlying assumptions, projections, or expectations prove incorrect, our actual results, performance, or financial condition may vary materially and adversely from those anticipated, estimated, or expected. No forward-looking statement can be guaranteed and actual results may vary materially from those projected in the forward-looking statements. We intend to take advantage of the Safe Harbor provisions of the Private Securities Litigation Reform Act of 1995 regarding our forward-looking statements, and are including this sentence for the express purpose of enabling us to use the protections of the safe harbor with respect to all forward-looking statements. These risks and uncertainties include, but are not limited to: the risk of significant fluctuations in our quarterly and annual results due to numerous factors; the risk that assumptions about the market for the Companys products and the productivity of the Companys direct sales force and distributors may not be correct; the risk that we may not be able to maintain our recent levels of profitability; the status of our global regulatory approvals and compliance with regulatory requirements to market and sell our products both in the US and outside of the US; the duration and severity of the impact of COVID-19 on the global economy, our customers, our suppliers and our company; the risk that the Company may not realize the anticipated benefits of its strategic activities; risks related to the integration of acquisition targets; the acceleration or deceleration of product growth rates; risks related to product demand and market acceptance of the Companys products and pricing; the risk that a recall of our products could result in significant costs or negative publicity; the risk that the Company is not successful in transitioning to a direct-selling model in new territories.

 

Forward-looking statements reflect managements analysis as of the date of this quarterly report. Further information on potential risk factors that could affect our business and financial results is detailed in Part II, Item 1A, Risk Factors in this Quarterly Report on Form 10-Q and in our other filings with the Securities and Exchange Commission, including under the section headed Risk Factors in our most recent Annual Report on Form 10-K. Given these risks, uncertainties and other factors, you should not place undue reliance on these forward-looking statements. The following discussion and analysis should be read in conjunction with our consolidated financial statements and the related notes included in this report and our other SEC filings, including our audited consolidated financial statements and the related notes contained in our Annual Report on Form 10-K for the year ended December 31, 2021,2022, as filed with the SEC on February 28, 2022.March 1, 2023. We do not assume any obligation to update any forward-looking statements, whether as a result of new information, future events, or otherwise, except as required by law. Unless the context indicates otherwise, references to LeMaitre Vascular, we, our, and us in this Quarterly Report on Form 10-Q refer to LeMaitre Vascular, Inc. and its subsidiaries.

 

LeMaitre, AlboGraft, AnastoClip, AnastoClip GC, Artegraft, Cardial, CardioCel, Dialine, Eze-Sit, Glow ‘N Tell, LeverEdge, LifeSpan, Omniflow, ProCol, Pruitt, Pruitt F3, Pruitt-Inahara, RestoreFlow, Syntel, TufTex, VascuCel, VascuTape, Wovex and XenoSure are registered trademarks of LeMaitre Vascular or one of its subsidiaries.subsidiaries, and AlboSure, Chevalier, DuraSure, Flexcel, and PeriVu are unregistered trademarks of LeMaitre Vascular. This Quarterly Report on Form 10-Q also includes the registered and unregistered trademarks of other persons, which are the property of their respective owners. 

 

Overview

 

LeMaitre Vascular is 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 to a lesser extent 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. 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 $750 million. We have grown our business using a simple 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 and, to a lesser extent, developing complementary devices. We have used acquisitions as a primary means of further penetrating the peripheral vascular device market, and we expect to continue to pursue this strategy in the future. We currently manufacture most of our products in our Burlington, Massachusetts headquarters.

 

2522

 

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. More recently, however, we have begun to explore adjacent market customers, or non-vascular surgeon customers, who can be served by our vascular device technologies, such as cardiac surgeons and neurosurgeons.

 

Since March 2020, the COVID-19 pandemic has significantly impacted the markets for our products as well as our business. In response to COVID-19, many hospitals limited elective procedures in response to the onset of the pandemic and then periodically when infection rates have increased. Many of our devices are used in elective procedures. Additionally, our sales representatives’ access to hospitals and surgeons has periodically been restricted by hospitals or local governments. More recently, however, in many geographies we have seen restrictions eased. Since 2020, these dynamics resulted in, and we expect will continue to result in, variable and unpredictable sales.

Our 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. Through our RestoreFlow allografts business, we also provide services related to the processing and cryopreservation of human vascular and cardiac tissue.

 

Our principal biologic offerings include vascular and cardiac patches as well as vascular and dialysis grafts. In Q3 2022,Q1 2023, biologics represented 50%49% of worldwide sales. We view the biologic device offerings favorably, as we believe they represent differentiated and in somemany cases growing product segments.

 

To assist us in evaluating our business strategies, we regularly 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:

 

 

adding complementary products through acquisitions;

growing our direct sales force in the United States, Europe, the United Kingdom, Canada and Asia Pacific, including replacing a distributordistributors with our direct sales personnel;

adding complementary products through acquisitions;

 

 

introducing our products into new territories upon receipt of regulatory approvals or registrations in these territories;registrations;

  

 

 

increasing the average selling prices of our devices;

  

 

 

consolidating and automating product manufacturing at our Burlington, Massachusetts facilities; and

  

 

 

updating existing products and introducing new products through research and development.

 

Our ability to execute on these opportunities on a timely basis, or at all, may be impacted by the COVID-19 pandemic, the duration and severity of which are uncertain.

We sell our products and services primarily through a direct sales force. As of September 30, 2022,March 31, 2023, our sales force was comprised of 118128 sales representatives in North America, Europe and Asia Pacific, including two export managers. Our worldwide headquarters is located in Burlington, Massachusetts, and we also have North American sales offices in Chandler, Arizona and Vaughan, Canada. Our European headquarters is located in Sulzbach, Germany, and we also have sales offices in Milan, Italy; Madrid, Spain; and Hereford, England. Our Asia Pacific headquarters is located in Singapore, and we also have sales offices in Tokyo, Japan; Shanghai, China; Kensington, Australia; and Seoul, Korea. During the current quarter, approximately 94%97% of our net sales were generated in territories in which we employ direct sales representatives. We also sell our products in other countries through distributors.

 

Historically we have experienced success in lower-rivalry niche segments. In the valvulotome market, for example, our highly differentiated devices have historically allowed us to increase our selling prices while maintaining unit share. In contrast, we have experienced less success in highly competitive markets such as the polyester vascular graft market, where we face competition from larger companies with greater resources and lower per unit costs. While we believe these challenging market dynamics can be mitigated by our relationships with vascular surgeons, there can be no assurance that we will succeed in highly competitive markets.

 

26
23

 

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

 

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

 

 

In July 2019, we entered into an agreement with UreSil, LLC to purchase the remaining assets of their Eze-Sit valve cutter business, including U.S. distribution rights, for $8.0 million.

  

 

 

In October 2019, we entered into an agreement with Admedus to purchase the assets of their CardioCel biologic patch business for $15.5 million plus additional payments of up to $7.8 million, depending upon the satisfaction of certain contingencies.

  

 

 

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, depending upon 2021 – 2023 unit sales.

 

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

 

 

During 2021, we made decisions to wind down or discontinue 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 $1.0 million in 2021 revenues.

 

From time to time we may undertake SKU reductions andor transition sales to other SKUs or products with similar features. For example, in 2022, we decided to initiateinitiated 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 our distributors to transition their sales of our medical devices into our direct sales organization:

 

 

During 2020, we entered into definitive agreements with, or participated with Admedus in concluding agreements with, several former Admedus distributors in Europe and Canada, in order to terminate their distribution of ourthe acquired bovine cardiac and vascular patch products, and we began selling direct-to-hospital in those geographies. The distribution termination fees totaled approximately $0.1 million.

 

 

During 2020, we participated with Artegraft in concluding agreements with several of their former U.S. distributors in order to terminate their distribution of our bovine graft products. We now sell Artegraft products direct-to-hospital throughout the United States.U.S.

 

 

In May 2022, we entered into a distribution transition agreement with our Korean distributor in order to sell products directly in Korea and dissolve the existing distribution arrangement. We expect to beginhave 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 Thailand distributor in January 2023.order to sell products directly in Thailand and dissolve the existing distribution arrangement. The distribution termination fees will total approximately $0.5$0.7 million.

 

We also rely, to a much lesser extent, on internal product development efforts to bring differentiated technology and next-generation products to market:

 

 

In 2020, we launched RestoreFlow cardiac allografts for use in cardiac repair and restoration.

  

 

 

In March 2022, we received U.S. FDA clearance to market PhasTIPP, a portable powered phlebotomy device used to remove varicose veins in the leg. We expect to launch this product in 2023.

 

2724

 

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

 

 

In June 2014, we acquired the Omniflow II ovine graft business from BioNova, International. In June 2019, we initiated a project to transfer the production of these devices to our Burlington facilities. We received approval to sell these devices in Europe in June 2022. This transfer will be substantially completed in 2023.

In October 2019, we acquired the biologic patch business assets from Admedus. In July 2020, we initiated a project to transfer the production of these devices to our Burlington facilities. We expect this transfer to be substantially complete in 2023.

  

 

 

In June 2018, we acquired the Cardial business from Becton Dickenson. Cardial manufactured polyester vascular grafts, valvulotomes and surgical glue at its St. Etienne, France, facility. In June 2022, we closed ourthe St. Etienne France factory in order to streamline manufacturing operations and to reduce expenses. The Cardial business consisted of the manufacturing of polyester vascular grafts, valvulotomes, surgical glue and select OEM devices. We expect to transition Cardial graft sales to our Burlington-manufactured AlboGraftpolyester vascular graft product (AlboGraft) for additional cost savings and improved margins. We acquired the Cardial businessThe valvulotome manufacturing transfer to Burlington was substantially completed in 2018.2022.

 

Our execution of these initiatives may affect the comparability of our financial results and may cause fluctuations from period to period as we incur related process engineering and other charges.

 

Fluctuations in the exchange rates between the U.S. dollar and foreign currencies, primarily the Euro, affect our financial results. For the ninethree months ended September 30, 2022March 31, 2023, approximately 38% of our sales took place outside of the U.S., 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. However, if there is an increase in the rate at which a foreign currency is exchanged for U.S. dollars, it will require more of the foreign currency to equal a specified amount of U.S. dollars than before the rate increase. In such cases we will record less revenue in U.S. dollars than we did before the exchange rate changed. For the ninethree months ended September 30, 2022,March 31, 2023, we estimate that the effects of changes in foreign exchange rates decreased our reported sales by approximately $4.4$1.1 million, as compared to rates in effect for the ninethree months ended September 30, 2021.March 31, 2022.

 

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 freight expense we pay to ship products to customers.

 

Sales and marketing. Our 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).

 

25

Income tax expense. We are subject to federal and state income taxes for earnings generated in the U.S., 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 U.S. and foreign subsidiaries, permanent items, discrete items, unrecognized tax benefits, and amortization of goodwill for U.S. tax reporting purposes.

 

28

Results of Operations

Since March 2020, the COVID-19 pandemic has significantly impacted the markets for our products as well as our business. In response to COVID-19, many hospitals limited elective procedures at the onset of the pandemic and then periodically over the last two years when infection rates have increased. Many of our devices are used in elective procedures. Additionally, our sales representatives’ access to hospitals and surgeons has periodically been restricted by hospitals or local governments. More recently, in many geographies we have seen restrictions eased. During 2020 and into 2022, these dynamics resulted in, and we expect will continue to result in, variable and unpredictable sales.

As described above, our results could be materially impacted in the near term. These financial statements and management’s discussion and analysis of financial condition and results of operations should be read in that context.

 

Comparison of the three- and nine-month periodsthree-month period ended September 30, 2022March 31, 2023 to the three- and nine-month periodsthree-month period ended September 30, 2021:March 31, 2022:

 

The following tables set 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 September 30,

 

Nine months ended September 30,

  

Three months ended March 31,

 

(unaudited)

         

Percent

         

Percent

          

Percent

 
 

2022

 

2021

 

change

 

2022

 

2021

 

change

  

2023

  

2022

  

change

 
 

($ in thousands)

 

($ in thousands)

  

($ in thousands)

 

Net sales

 $39,028  $38,368  2% $120,697  $114,921  5% $47,075  $39,561  19%
              

Net sales by geography:

              

Americas

 $26,627  $25,299  5% $82,024  $76,327  7% $32,126  $26,543  21%

Europe, Middle East and Africa

 9,922  10,535  (6%) 31,165  31,200  (0%) 12,277  10,494  17%

Asia Pacific

  2,479  2,534  (2%)  7,508  7,394  2%  2,672  2,524  6%

Total

 $39,028  $38,368  2% $120,697  $114,921  5% $47,075  $39,561  19%

 

Net sales. Net sales increased by $0.7$7.5 million, or 2%19%, to $39.0$47.1 million for the three months ended September 30, 2022,March 31, 2023, compared to $38.4$39.6 million for the three months ended September 30, 2021.March 31, 2022. The increase was driven primarily by elevated hospital procedure volumes, higher average selling prices, and additional sales representatives, which resulted in increased shunt sales of $0.7 million, bovine graft sales of $0.6 million, and allograft preservation services of $0.3 million. The increased sales were partially offset by decreased valvulotomes sales of $0.4 million, ovine graft sales of $0.2 million, clips sales of $0.2 million, and increased ovine graft backorders. We estimate that the stronger U.S. dollar decreased net sales by $1.9 million during the three months ended September 30, 2022 as compared to the three months ended September 30, 2021.

Net sales increased by $5.8 million, or 5%, to $120.7 million for the nine months ended September 30, 2022, compared to $114.9 million for the nine months ended September 30, 2021. The increase was driven primarily by increased bovine graft sales of $2.2 million, carotid patch salesbovine grafts of $1.8$1.5 million, allograft preservation services of $1.7$1.2 million, and shunt salescarotid patches of $1.6 million. The increased sales were partially offset by decreased ovine graft sales of $0.8 million and cardiac patch sales of $0.4$1.1 million. We estimate that the stronger U.S. dollar decreased net sales by $4.4$1.1 million during the ninethree months ended September 30, 2022March 31, 2023 as compared to the ninethree months ended September 30, 2021.March 31, 2022.

 

Direct-to-hospital net sales were 94%97% of our total net sales for the ninethree months ended September 30, 2022March 31, 2023, and September 30, 2021.95% for the three months ended March 31, 2022.

29

 

Net sales by geography. Net sales in the Americas increased $1.3$5.6 million, or 5%21%, for the three months ended September 30, 2022March 31, 2023 as compared to the three months ended September 30, 2021.March 31, 2022. The increase was driven primarily by increased bovine graft sales of $0.6valvulotomes of $1.9 million, shunt salesbovine grafts of $0.3$1.5 million, and allograft preservation services of $0.3$0.9 million.

 

NetEMEA net sales in the Americas increased $5.7$1.8 million, or 7%17%, for the ninethree months ended September 30, 2022March 31, 2023 as compared to the ninethree months ended September 30, 2021.March 31, 2022. The increase was driven primarily by increased bovine graftcarotid shunt sales of $2.2$0.5 million, carotid patches of $0.4 million, and allograft preservation services of $1.4 million, and shunt sales of $0.8 million.

EMEA net sales decreased $0.6 million, or 6%, for the three months ended September 30, 2022 as compared to the three months ended September 30, 2021. The decrease was driven primarily by decreased valvulotomes sales of $0.4 million, ovine graft sales of $0.2 million, and cardiac patch sales of $0.1 million. The decreased sales were partially offset by increased shunt sales of $0.4 million.

EMEA net sales decreased less than $0.1 million, or 0.1%, for the nine months ended September 30, 2022 as compared to the nine months ended September 30, 2021. The decrease was driven primarily by decreased ovine graft sales of $0.8 million largely due to the lack of CE mark for Burlington-produced devices through June 30, 2022, surgical glue sales of $0.4 million, and cardiac patch sales of $0.3 million. The decreased sales were partially offset by increased shunt sales of $0.9 million and carotid patch sales of $0.8 million.

Asia Pacific net sales decreased $0.1 million, or 2%, for the three months ended September 30, 2022 as compared to the three months ended September 30, 2021. The decrease was driven primarily by decreased powered phlebectomy and clip sales of $0.1 million each. The decreased sales were partially offset by increased carotid patch sales of $0.1 million.

 

Asia Pacific net sales increased $0.1 million, or 2%6%, for the ninethree months ended September 30, 2022March 31, 2023 as compared to the ninethree months ended September 30, 2021.March 31, 2022. The increase was driven primarily by increased carotid patch sales of $0.5 million and embolectomy catheters salescarotid patches of $0.1$0.2 million. The increased sales wereincrease was partially offset by decreased shunt sales of $0.1 million, clip sales of $0.1 million, and valvulotomes salespowered phlebectomy devices of $0.1 million.

 

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

 

  

Three months ended March 31,

 

(unaudited)

             

Percent

 
  

2023

  

2022

  

Change

  

change

 
  

($ in thousands)

 

Gross profit

 $30,883  $25,962  $4,921   19%
                 

Gross margin

  65.6%  65.6%  (0.0%)  * 
                 
*Not applicable                

 

  

Three months ended September 30,

  

Nine months ended September 30,

 

(unaudited)

             

Percent

              

Percent

 
  

2022

  

2021

  

Change

  

change

  

2022

  

2021

  

Change

  

change

 
  

($ in thousands)

  

($ in thousands)

 

Gross profit

 $25,070  $24,866  $204   1% $78,842  $75,426  $3,416   5%
                                 

Gross margin

  64.2%  64.8%  (0.6%)  *   65.3%  65.6%  (0.3%)  * 

*Not applicable

26

 

Gross Profit. Gross profit increased $0.2$4.9 million, or 1%19%, to $25.1$30.9 million for the three months ended September 30, 2022,March 31, 2023, and gross margin decreased 60 basis points to 64.2% in the period.was unchanged at 65.6%. The increase in gross profit was driven primarily by increased sales, particularly from shunts,valvulotomes and bovine grafts, and allografts.grafts. The decrease in the gross margin, which remained unchanged, was driven primarily by an increaseincreases in labor costs, unfavorable product mix, including higher sales of comparatively lowlower margin embolectomy cathetersallograft preservation services, and lower sales of comparatively high margin valvulotomes, unfavorable changes in foreign currency exchange rates, andall of which were offset by improved manufacturing inefficiencies including higher inventory write-offs.efficiencies.

 

Gross profit increased $3.4 million, or 5%, to $78.8 million for the nine months ended September 30, 2022, and gross margin decreased 30 basis points to 65.3% in the period. The increase in gross profit was driven primarily by increased sales from bovine grafts, carotid patches, and allografts. The decrease in the gross margin was driven primarily by an increase in labor costs, unfavorable product mix, including higher sales of comparatively low margin embolectomy catheters and polyester grafts, unfavorable changes in foreign currency exchange rates, and manufacturing inefficiencies including higher inventory write-offs.

30

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 March 31,

 

(unaudited)

             

Percent

 
  

2023

  

2022

  

$ Change

  

change

 

Sales and marketing

 $10,897  $7,850  $3,047   39%

General and administrative

  7,932   7,252   680   9%

Research and development

  3,875   2,932   943   32%

Restructuring

  305   -   305   * 

Total

 $23,009  $18,034  $4,975   28%

 

  

Three months ended September 30,

  

Nine months ended September 30,

 

(unaudited)

             

Percent

              

Percent

 
  

2022

  

2021

  

$ Change

  

change

  

2022

  

2021

  

$ Change

  

change

 
                                 

Sales and marketing

 $8,229  $6,941  $1,288   19% $24,321  $20,210  $4,111   20%

General and administrative

  7,229   6,004   1,225   20%  21,812   18,748   3,064   16%

Research and development

  3,462   2,848   614   22%  9,740   8,344   1,396   17%

Restructuring

  -   -   -   *   3,107   -   3,107   * 

Total

 $18,920  $15,793  $3,127   20% $58,980  $47,302  $11,678   25%

  

Three months ended September 30,

  

Nine months ended September 30,

 
  

2022

  

2021

      

2022

  

2021

     
  

% of Net

Sales

  

% of Net

Sales

  

Change

  

% of Net

Sales

  

% of Net

Sales

  

Change

 
                         

Sales and marketing

  21%  18%  3%  20%  18%  2%

General and administrative

  19%  16%  3%  18%  16%  2%

Research and development

  9%  7%  2%  8%  7%  1%

Restructuring

  0%  0%  0%  3%  0%  3%

* Not a meaningful percentage relationship.

  

Three months ended March 31,

 
  

2023

  

2022

     
  % of Net  % of Net     
  

 Sales

  

Sales

  

Change

 
             

Sales and marketing

  23%  20%  3%

General and administrative

  17%  18%  (1%)

Research and development

  8%  7%  1%

Restructuring

  1%  0%  1%
             
* Not a meaningful percentage relationship.            

 

Sales and marketing. For the three months ended September 30, 2022,March 31, 2023, sales and marketing expenseexpenses increased 19%39% to $8.2$10.9 million. The increase was driven primarily by higher sales rep headcount and sales performance, resulting in higher salaries and related expenses of $0.9$2.4 million, including higher salesselling commissions of approximately $0.3$1.1 million. From September 30, 2021 to September 30, 2022, we increased our sales representatives from 92 to 118. We also added two additional regional sales managers in the period. Travel and related expenses were also higher by $0.3 million. Expense reduction programs implemented during the second quarterSales rep headcount was 128 as of 2020 through the fourth quarter of 2021 in response to the COVID-19 global pandemic, includingMarch 31, 2023, a reduction in force, lowered expenses for the three months ended September 30, 2021. We have since rehired in many areas, including our sales force.14% increase from March 31, 2022. As a percentage of net sales, sales and marketing expense increased to 21%23% for the three months ended September 30, 2022,March 31, 2023, up from 18% in the prior period.

For the nine months ended September 30, 2022, sales and marketing expense increased 20% to $24.3 million. The increase was driven by higher salaries and related expenses of $3.1 million, including higher commissions of approximately $0.9 million. Travel and related expenses were also higher by $0.7 million. As a percentage of net sales, sales and marketing expense increased to 20% for the nine months ended September 30, 2022, up from 18% in the prior period.

 

General and administrative. For the three months ended September 30, 2022,March 31, 2023, general and administrative expenses increased 20%9% to $7.2$7.9 million. The increase was driven primarily by higher salaries and related expenses of $1.1$0.7 million, as well as an increase in personnel. Additionally, in the prior year we recognized a gain of $0.5 million related to the amendment of a contingent purchase obligation associated with our 2019 Admedus biologic patch acquisition which lowered our general and administrative expenses. The increased expenses were partially offset by lower outside services expenses. As a percentage of sales, general and administrative expense increaseddecreased to 19%17% for the three months ended September 30, 2022, upMarch 31, 2023, down from 16% in the prior period.

For the nine months ended September 30, 2022, general and administrative expenses increased 16% to $21.8 million. The increase was driven primarily by higher salaries and related expenses of $2.3 million, as well as an increase in personnel. Travel, general supplies, and office facility costs each increased $0.2 million in the period. As a percentage of net sales, general and administrative expense increased to 18% for the nine months ended September 30, 2022, up from 16% in the prior period.

 

Research and development. For the three months ended September 30, 2022,March 31, 2023, research and development expense increased 22%32% to $3.5$3.9 million. The increase was driven primarily by higher salaries and related expenses of $0.2$0.3 million, as well as an increase in personnel. Outside services and testing also increased by $0.5$0.4 million primarily due to higher consulting and third-party costs associated with European regulatory approvals. Our products are currently regulated in the European Union (EU) and the United Kingdom under the European Medical Devices Directive (MDD) and the EU Medical Device Regulation (MDR). In order to market our medical devices in the EU and the United Kingdom, we are required to obtain CE marks, which denote conformity to the essential requirements of the MDD or MDR. As a percentage of sales, total research and development expense increased to 9% for the three months ended September 30, 2022, from 7% in the prior period.

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For the nine months ended September 30, 2022, research and development expenses increased 17% to $9.7 million. The increase was driven primarily by higher salaries and related expenses of $0.8 million, as well as an increase in personnel. Outside services and testing also increased by $0.6 million. As a percentage of net sales, total research and development expense increased to 8% for the ninethree months ended September 30, 2022,March 31, 2023, up from 7% in the prior period.

 

Restructuring. For the ninethree months ended September 30, 2022,March 31, 2023, restructuring expense was $3.1$0.3 million. On June 30, 2022 we ceased operations at our St. Etienne, France factory and terminated most of the personnel at the site.factory. The closure resulted in a restructuring charge of $3.1 million for the three and six monthsyear ended June 30,December 31, 2022. ChargesThese charges consisted primarily consisted of employment termination costs, impairment of fixed assets and inventory, and third-party costs. Total costs associatedFor the three months ended March 31, 2023 we recorded an additional restructuring charge of $0.3 million in conjunction with the closure are expected to be approximately $3.5 million. We did not recordSt. Etienne, France factory closure. The additional expenses related to the closurecharges consist primarily of employment termination costs, legal costs, and other third-party costs. As a percentage of sales, restructuring expense was 1% for the three months ended September 30, 2022.March 31, 2023.

27

 

Income tax expense. We recorded a tax provision of $0.7$2.0 million on pre-tax income of $6.1$8.0 million for the three months ended September 30, 2022,March 31, 2023, compared to a $1.9$2.0 million tax provision on pre-tax income of $8.4$8.0 million for the three months ended September 30, 2021. We recorded a tax provision of $4.7 million on pre-tax income of $19.7 million for the nine months ended September 30, 2022, compared to a tax provision of $5.6 million on pre-tax income of $26.4 million for the nine months ended September 30, 2021.March 31, 2022. Our effective income tax rate was 11.3% and 23.8% for the three- and nine-month periods ended September 30, 2022. Our effective income tax rate24.5% for the three-month period ended September 30, 2022 was impacted by the realization of tax benefits for losses incurred in connection with the closure of the St. Etienne, France factory. Generally, income tax provisions for interim periods are based on an estimated annual income tax rate, adjusted for discrete tax items, with any changes affecting the estimated annual effective tax rate recorded in the interim period in which the change occurs.March 31, 2023. Our tax expense for the current period is based on an estimated annual effective tax rate of 25.1%25.5%, 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 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 22.6% and 21.3%24.5% for the three- and nine-monththree-month periods ended September 30, 2021.March 31, 2022. Our 20212022 provision was based on the estimated annual effective tax rate of 24.3%24.5%, adjusted in the applicable quarterly period for discrete stock option exercises and other discrete items. Our income tax expense for the nine-monththree-month period ended September 30, 2021March 31, 2022 varied from the statutory rate mainly due to federal and state tax credits, permanent items, and different statutory rates from our foreign entities, and a discrete item for stock option exercises.entities.

 

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 September 30, 2022,March 31, 2023, we have provided a valuation allowance of $1.6 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.

 

The Inflation Reduction Act ("IRA") was enacted into law on August 16, 2022. Included in the IRA was a provision to implement a 15% corporate alternative minimum tax on “adjusted financial statement income” for applicable corporations and a 1% excise tax on repurchases of stock. These provisions are effective for tax years beginning after December 31, 2022. We are in the process of evaluating the provisions of the IRA, but we do not currently believe the IRA will have a material impact on our reported results, cash flows or financial position when it becomes effective.position.

 

Liquidity and Capital Resources

 

At September 30, 2022,As of March 31, 2023, our cash and cash equivalents were $16.9$16.7 million as compared to $13.9$19.1 million atas of December 31, 2021.2022. We also had $62.8$64.3 million in short-term marketable securities as of September 30, 2022March 31, 2023 and $56.1$63.6 million as of December 31, 2021.2022. Our cash and cash equivalents are highly 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 managed income mutual fund investing mainly in short-term investment grade, U.S.-dollar denominated fixed and floating-rate debt, and a short-duration bond fund. As of September 30, 2022March 31, 2023 our short-term marketable securities reflected an unrealized loss of $2.1$1.6 million as a result of increasing market interest rates.

 

On July 16, 2021, we closed an offering of 1,000,0000 shares of our common stock, $0.01 par value per share, at a price to the public of $54.50 per share less underwriting discounts. The net proceeds, after deducting the underwriting discounts and other offering expenses, were approximately $51.0 million. We used a portion of the proceeds from the offering to repay our outstanding debt. We plan to use the remaining proceeds for general corporate purposes, including working capital needs and capital expenditures, dividend payments, deferred payments related to prior acquisitions, and the funding of future acquisitions. On August 4, 2021, the underwriters purchased an additional 150,000 shares pursuant to an option granted to them in connection with the offering described above. The net proceeds to the Company, after deducting underwriting discounts and other offering expenses, were approximately $7.6 million. We plan to use the proceeds for general corporate purposes.

32

On February 22, 2022,21, 2023, our Board of Directors authorized the repurchase of up to $20.0$25.0 million of the Company’s common stock through transactions on the open market, in privately negotiated purchases or otherwise until February 22, 2023.21, 2024. The repurchase program may be suspended or discontinued at any time. To date we have not made any repurchases under this program.

In June 2020, in connection with the Artegraft acquisition, we incurred debt of $65 million including a five-year revolving line of credit of $25 million and a five-year term loan of $40 million. The loans bore interest at either the Base Rate as defined in the agreement plus an applicable margin of 1.25% to 1.75% depending on our consolidated leverage ratio, or the Eurodollar Rate plus an applicable margin of 2.25% to 2.75% depending on our consolidated leverage ratio. In July 2021 we repaid the balance under the term loan, plus accrued interest, in full.

In November 2021, we terminated the credit agreement, including the revolving line of credit, as permitted under the original agreement.

 

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 $19.9$7.9 million for the ninethree months ended September 30, 2022.March 31, 2023. For the year ended December 31, 2021,2022, we had operating income of $36.4$26.8 million. 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:

 

 

the 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;

 

 

the costs associated with expanding our manufacturing, marketing, sales, and distribution efforts;

 

28

 

the costs associated with our initiatives to sell direct-to-hospital in new countries;

 

 

the costs of obtaining and maintaining U.S. FDA and other regulatory clearances for our existing and future products;

 

 

the costs associated with obtaining European MDR clearances for our existing and future products;

 

 

the number, timing, and nature of acquisitions, divestitures and other strategic transactions, and

 

 

potential future share repurchases.

 

Our cash balances may decrease as we continue to use cash to fund our operations, make acquisitions, pay dividends, repurchase shares of our common stock and make deferred payments related to prior acquisitions. We believe that our cash, cash equivalents, investments and the interest we earn on these balances will be sufficient to meet our anticipated cash requirements for at least the next twelve months. If these sources of cash are insufficient to satisfy our liquidity requirements beyond the next twelve months, we may seek to sell additional equity or debt securities or take out a loan. The sale of additional equity and debt securities may result in dilution to our stockholders, as was the case with our July 2021 equity offering. If we raise additional funds through the issuance of debt securities, such securities could have rights senior to those of our common stock and could contain covenants that would restrict our operations and possibly our ability to pay dividends. We may require additional capital beyond our currently forecasted amounts. Any such required additional capital may not be available on reasonable terms, if at all.

 

33

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 2022

          

March 8, 2022

 

March 24, 2022

 $0.125  $2,743 

May 17, 2022

 

June 2, 2022

 $0.125  $2,745 

August 25, 2022

 

September 8, 2022

 $0.125  $2,750 
           

Fiscal Year 2021

          

March 9, 2021

 

March 25, 2021

 $0.110  $2,262 

May 19, 2021

 

June 3, 2021

 $0.110  $2,267 

August 26, 2021

 

September 9, 2021

 $0.110  $2,401 

November 19, 2021

 

December 2, 2021

 $0.110  $2,405 

Record Date

 

Payment Date

  

Per Share Amount

  

Dividend Payment

 
         

(in thousands)

 

Fiscal Year 2023

           

March 9, 2023

 

March 23, 2023

  $0.140  $3,099 
            

Fiscal Year 2022

           

March 8, 2022

 

March 24, 2022

  $0.125  $2,743 

May 17, 2022

 

June 2, 2022

  $0.125  $2,745 

August 25, 2022

 

September 8, 2022

  $0.125  $2,750 

November 17, 2022

 

December 1, 2022

  $0.125  $2,750 

 

On October 25, 2022April 24, 2023, our Board of Directors approved a quarterly cash dividend on our common stock of $0.125$0.14 per share payable on DecemberJune 1, 2022,2023, to stockholders of record at the close of business on NovemberMay 17, 2022.2023.

 

Cash Flows

 

  

Nine months ended September 30,

 
  

(in thousands)

 
  

2022

  

2021

  

Net Change

 

Cash and cash equivalents

 $16,913  $17,369  $(456)
             

Cash flows provided by (used in):

         

Operating activities

 $21,301  $30,046  $(8,745)

Investing activities

  (9,969)  (53,830)  43,861 

Financing activities

  (7,112)  14,861   (21,973)

  

Three months ended March 31,

 
  

(in thousands)

 
  

2023

  

2022

  

Net Change

 

Cash and cash equivalents

 $16,677  $15,560  $1,117 
             

Cash flows provided by (used in):

            

Operating activities

 $2,279  $4,711  $(2,432)

Investing activities

  (2,964)  (536)  (2,428)

Financing activities

  (1,825)  (2,380)  555 

 

Net cash provided by operating activities. Net cash provided by operating activities was $21.3$2.8 million for the ninethree months ended September 30, 2022,March 31, 2023, consisting of $15.0$6.0 million in net income, adjustments for non-cash or non-operating items of $14.2$4.4 million (including primarily depreciation and amortization of $7.1$2.4 million, stock-based compensation of $3.5$1.3 million, provisions for inventory write-offs and doubtful accounts of $2.3$0.3 million, and loss on divestiture of $1.4$0.3 million), and also a net use of working capital of $7.9$8.1 million. The net cash used for working capital was driven by an increase in accounts receivable of $3.2 million, an increase in inventory and other deferred costs of $5.0 million, an increase in accounts receivable of $1.7$3.8 million, and an increasepayments of accounts payable and accrued liabilities of $2.3 million. These cash uses were offset by a decrease in prepaid expenses and other assets of $1.3$1.2 million. These cash uses were offset by an increase in accounts payable

29

 

Net cash provided by operating activities was $30.0$4.7 million for the ninethree months ended September 30, 2021,March 31, 2022, consisting of $20.7$6.0 million in net income, adjustments for non-cash or non-operating items of $13.8$3.6 million (including primarily depreciation and amortization of $8.2$2.4 million, stock-based compensation of $2.6$1.2 million, provisions for inventory write-offs and doubtful accounts of $3.2$0.6 million), and also a net use of working capital of $4.5$5.0 million. The net cash used for working capital was driven by an increase in accounts receivable of $2.0 million, an increase in inventory and other deferred costs of $2.8$1.3 million, an increase in prepaid expenses and other assets of $0.7 million, payments of accounts payable and accrued liabilities of $0.6 million,$3.4 million. These cash uses were offset by a decrease in prepaid expenses and an increase in accounts receivableother assets of $0.4$1.7 million.

 

Net cash used in investing activities. Net cash used in investing activities was $10.0$3.0 million for the ninethree months ended September 30, 2022,March 31, 2023, consisting of purchases of marketable securities of $8.0 million and expenditures on equipment and technology of $2.0$2.1 million, purchases of marketable securities of $0.6 million, and acquisition related payments of $0.3 million.

 

Net cash used in investing activities was $53.8$0.5 million for the ninethree months ended September 30, 2021,March 31, 2022, consisting of purchases of marketable securities of $49.6 million and expenditures on equipment and technology of $4.3 million.technology.

 

Net cash used in financing activities. Net cash used in financing activities was $7.1$1.8 million for the ninethree months ended September 30, 2022,March 31, 2023, consisting primarily of a dividend payment of $8.2 million and deferred payments for acquisitions of $0.4.$3.1 million. This use of cash was partly offset by proceeds from stock option exercises of $1.5$1.3 million, net of shares repurchased used to pay employee payroll taxes.

 

34

Net cash provided byused in financing activities was $14.9$2.4 million for the ninethree months ended September 30, 2021. SourcesMarch 31, 2022, consisting primarily of a dividend payment of $2.7 million. This use of cash included primarily net proceeds from an equity offering of $58.7 million andwas partly offset by proceeds from stock option exercises of $2.5$0.4 million, net of shares repurchased used to paycover employee payroll taxes. These sources of cash were offset by payments made on our long-term debt of $39.0 million, dividend payments of $6.9 million and deferred payments for acquisitions of $0.4 million.

 

Critical Accounting Policies and Estimates

 

We have adopted various accounting policies to prepare our consolidated financial statements in accordance with U.S. generally accepted accounting principles, or U.S. GAAP. Our most significant accounting policies are described in Note 1 to our consolidated financial statements included in our Annual Report on Form 10-K for the fiscal year ended December 31, 2021.2022. There have been no material changes in our critical accounting policies during the ninethree months ended September 30, 2022.March 31, 2023. The preparation of our consolidated financial statements in conformity with U.S. GAAP requires us to make estimates and assumptions that affect the amounts reported in our consolidated financial statements and accompanying notes. Our estimates and assumptions, including those related to revenue recognition, inventory valuation, valuation of intangible assets and goodwill, contingent consideration and income taxes are reviewed on an ongoing basis and updated as appropriate. Actual results may differ from those estimates.

 

Recent Accounting Pronouncements

 

A summary of recent accounting pronouncements that may impact our financial statements upon adoption in future periods can be found in Note 1 to our financial statements included under Part 1, Item 1 of this Quarterly Report on Form 10-Q.

 

Item 3. Quantitative and Qualitative Disclosures About Market Risk

 

In the ordinary course of conducting business, we are exposed to certain risks associated with potential changes in market conditions. These market risks include changes in currency exchange rates and interest rates which could affect operating results, financial position and cash flows. We manage our exposure to these market risks through our regular operating and financing activities and, if considered appropriate, we may enter into derivative financial instruments such as forward currency exchange contracts, although we have not done so in 20222023 or in recent years. There have been no material changes in our quantitative and qualitative market risks since the disclosure in our Annual Report on Form 10-K for the year ended December 31, 2021.2022.

 

Item 4. Controls and Procedures

 

Evaluation of Disclosure Controls and Procedures

 

Our management, with the participation and supervision of our Chief Executive Officer and Chief Financial Officer, is responsible for our disclosure controls and procedures pursuant to Rules 13a-15(e) and 15d-15(e) under the Exchange Act. Disclosure controls and procedures are controls and other procedures that are designed to ensure that information required to be disclosed in our reports filed or submitted under the Exchange Act is recorded, processed, summarized and reported, within the time periods specified under SEC rules and forms. Disclosure controls and procedures include controls and procedures designed to ensure that information required to be disclosed in our reports filed under the Exchange Act is accumulated and communicated to our principal executive officer and our principal financial officer, as appropriate, to allow timely decisions regarding required disclosure. We design our disclosure controls and procedures to ensure, at reasonable assurance levels, that such information is timely recorded, processed, summarized and reported, and then accumulated and communicated appropriately.

 

30

Based on an evaluation of our disclosure controls and procedures as of September 30, 2022March 31, 2023 our Chief Executive Officer and Chief Financial Officer concluded that, as of such date, our disclosure controls and procedures were effective at reasonable assurance levels.

 

Changes in Internal Control

 

There have been no changes in our internal control over financial reporting for the ninethree months ended September 30, 2022March 31, 2023 that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.

35

 

Inherent Limitations of Internal Controls

 

Notwithstanding the foregoing, our management, including our Chief Executive Officer and Chief Financial Officer, does not expect that our disclosure controls and procedures or our internal controls will prevent all error and all fraud. A control system, no matter how well conceived and operated, can provide only reasonable, not absolute, assurance that the objectives of the control system are met. Because of the inherent limitations in all control systems, no evaluation of controls can provide absolute assurance that all control issues and instances of fraud, if any, within the company have been detected. These inherent limitations include the realities that judgments in decision-making can be faulty, and that breakdowns can occur because of a simple error or mistake. Additionally, controls can be circumvented by the individual acts of some persons, by collusion of two or more people, or by management override of the control. The design of any system of controls is based in part upon certain assumptions about the likelihood of future events, and there can be no assurance that any system will succeed in achieving its stated goals under all potential future conditions. Over time, control may become inadequate because of changes in conditions, or the degree of compliance with the policies or procedures may deteriorate. Because of the inherent limitations in a cost-effective control system, misstatements due to error or fraud may occur and not be detected.

 

3631

 

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, as of November 8, 2022,May 9, 2023, 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, 2021,2022, 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, 2021.2022.

 

If we do not comply with international regulatory requirements to market our products outside the United States or are required to modify our operations or products as a result of such requirements, our business will be harmed.

 

Sales of medical devices outside the United StatesU.S. are subject to international regulatory requirements that vary from country to country. These requirements and the amount of time required for approval may differ from our experiences with the U.S. FDA. In some countries, we rely on our international distributors to obtain premarket approvals, complete product registrations, comply with clinical trial requirements, and complete those steps that are customarily taken in the applicable jurisdictions to comply with governmental and quasi-governmental regulation. In the future, we expect to continue to rely on distributors in this manner in those countries where we continue to market and sell our products through them. Failure to satisfy these foreign regulations would impact our ability to sell our products in these countries and could cause our business to suffer. There can be no assurance that we will be able to obtain or maintain the required regulatory approvals in these countries.

 

Our products are currently regulated in the European Union (EU) and the United Kingdom under the European Medical Devices Directive (93/42/EC as amended by 2007/47/EC) (MDD)MDD and the European Medical Device Regulation (2017/745) (MDR).MDR. In order to market our medical devices in the EU, we are required to obtain CE marks, which denote conformity to the essential requirements of the MDD or MDR, and manufacturers of higher-risk devices generally must use a “Notified Body”—an appointed independent third party to assess conformity. We currently use three Notified Bodies for our various products. We have received CE marks under the MDD to sell most of our products after managing a reinstatement processand have recently received our first CE mark under the MDR for those CE marks in 2020 and 2021.our Pruitt F3 Carotid Shunt.

 

In April 2017, the EU adopted new regulations for medical devices, the MDR, which replace the MDD and which tookstarted to take effect as of May 26, 2021. The final deadline for compliance with MDR was initially set to May 26, 2024, and subsequently revised to December 31, 2027 and December 31, 2028 for certain classifications of medical devices. Our products will eventually be fully subject to the MDR, which requires all of our products, regardless of classification, to obtain a new CE mark in accordance with the new, more stringent standards under the MDR. As a condition to CE mark approval, higher levels of clinical evidence will be required for Class III and implantable devices. As our Notified Bodies transition from MDD to MDR, they have begun to impose more rigorous requirements on us. Until recently,Nearly all of our preparation of filingsproducts have been submitted to our Notified Bodies for review under the MDR had been delayed due to our work on the MDD CE mark reinstatement referred to above. As a result, we may not receive CE marks under MDR on a timely basis, which could lead to backorders if we have not placed sufficient inventory on the EU market before our CE mark under MDD expires in order to bridge any gap between such CE mark and a new CE mark under MDR. For example, the arrangement under which Admedus agreed to manufacture and supply us with CardioCel and VascuCel inventory expires on July 11, 2023 and we may not receive a CE mark under MDR for such products until Q2 2024. If we are unable to procure sufficient inventory to cover such gap period, then we could encounter backorders in CardioCel and VascuCel until receipt of CE marks under MDR for such products in 2024. If we fail to obtain new CE marks on these products or our other products under the MDR in a timely manner, or at all, future sales of our products in the EU could be adversely impacted.

 

There can be no assurance that we will be able to obtain or maintain MDR CE marks for our existing products, and obtaining CE marks may involve a significant amount of time and expense, stringent clinical and preclinical testing, or modification of our products and could result in limitations being placed on the use of our products in order to obtain approval. These types of more stringent restrictions on our products as they transition to MDR could impact sales of our products and/or their gross margins could be adversely impacted. For example, under the MDR CE mark issued in January 2023 for our Pruitt F3 Carotid Shunt, we were unable to secure the new CE marking for the polyurethane balloon models (F3-S). While the MDD CE mark issuedremains valid for XenoSurethe F3-S, we will be required to incur more expenses to gain MDR CE marking for those models. The F3-S models accounted for roughly $53,000 of annual sales in 2021,Europe and the indications for its use no longer include neuro or cardiac applications, indications for which the product was previously approved. Additionally, only XenoSure made from bovine pericardium sourced from certain of our suppliers is permitted to be sold under the new CE mark. While our existing suppliers are meeting our demand for tissue supply, there can be no assurance that they will meet or sustain higher levels of demandU.K. in the future. If they cannot meet our demand for tissue supply, our ability to supply conforming XenoSure devices to our EMEA customers may be impacted and our sales may suffer. Additionally, the tissue from the two approved tissue suppliers is significantly more expensive than that sourced from the third supplier. As a result, our EMEA gross margin for XenoSure has been negatively impacted. The Company is pursuing a path to reinstate the third supplier, although no assurances can be given.

37

2022. Additionally, significant changes to our devices may trigger a requirement to file foror obtain an MDR CE mark earlier than expected, which could result in backorders. For example, in March 2020, we learned that a chemical used in our latex formulation was obsoleted. As a result, we submitted our new latex formulation to one of our Notified Bodies for review and acceptance under our Class III Pruitt F3 shunt MDD CE mark. Our Notified Body determined that the change is significant under the rules of the Class III MDD and as such we cannot implement that change under the Class III MDD rules. We filed for an MDR CE mark on that device in Q4 2021, and we currently await the results of our MDR review. We anticipate approval for that device in Q4 2022, though no assurance can be given as to timing or result. We believe inventory for our Pruitt F3 shunt will likely only be sufficient to supply customers until the end of Q4 2022, based on historical sales, and as a result, we may begin to experience backorders for the Pruitt F3 shunt while we await approval by our Notified Body. If we fail to obtain a new CE mark under MDR on this product in a timely manner, or at all, future sales of this product in the EU could be adversely impacted, though we could pursue mitigation strategies, including country-by-country derogations.chain delays.

 

As a result of the United Kingdom’s exit from the EU, the U.K. Medicines and Healthcare Products Regulatory Agency (MHRA) has announced that devices marketed in the U.K. will require U.K. Conformity Assessed (UKCA) marks certified by a U.K. approved Notified Body following the expiration of a transition period. During the transition period, CE marking will continue to be recognized in the U.K. and certificates issued by EU-recognized Notified Bodies will continue to be valid in the U.K. market. For all of our CE marked products except CardioCel and VascuCel, the transition period will expire May 25, 2024. Following such date (and in the case of CardioCel and VascuCel, following August 13, 2023), our devices marketed in the U.K. will require U.K. Conformity Assessed (UKCA) marks certified by a U.K. approved Notified Body. We intend to seek such marks for our products currently sold on the U.K. market. If we fail to obtain UKCA marks in a timely manner, or at all, future sales of our products in the U.K. could be adversely impacted.

Failure to receive or maintain CE mark approval would prohibit us from selling these products in the EU or the U.K., and would require significant delays in obtaining individual country approvals. If we do not receive or maintain these approvals, our business could be harmed. Maintaining a CE mark is contingent upon our continued compliance with applicable European medical device requirements, including limitations on advertising and promotion of medical devices and requirements governing the handling of adverse events. As highlighted above, there can be no assurance that we will be successful in obtaining, retaining or maintaining the CE mark for any of our current products. In particular, adverse event reporting requirements in the EU and the U.K. mandate that we report incidents which led or could have led to death or serious deterioration in health. Under certain circumstances, we could be required to or could voluntarily initiate a recall or removal of our product from the market in order to address product deficiencies or malfunctions. Any recall of our products may harm our reputation with customers and divert managerial and financial resources.

 

32

As a result of the United Kingdom’s exit from the EU, the U.K. Medicines and Healthcare Products Regulatory Agency (“MHRA”) announced that CE marking will continue to be recognized in the U.K. and certificates issued by EU-recognized Notified Bodies will continue to be valid in the U.K. market until July 1, 2024. This deadline was subsequently revised by MHRA to coincide with the EU extensions ending in December 31, 2027 and December 31, 2028. Following such dates, all devices marketed in the U.K. will require U.K. Conformity Assessed (“UKCA”) marks certified by a U.K. Approved Body. If we fail to obtain UKCA marks by these deadlines, or at all, our sales in the U.K. could be negatively affected.

Our facilities are subject to periodic inspection by numerous regulatory authorities, including governmental agencies and Notified Bodies, and we must demonstrate compliance with the applicable medical devices regulations. Any failure by us to comply with regulatory requirements may entail our taking corrective action, such as modification of our policies and procedures or recall of products.procedures. In addition, we may be required to cease all or part of our operations for some period of time until we can demonstrate that appropriate steps have been taken. There can be no assurance that we will be found in compliance with such standards in future audits.

 

We also pursue registrations in other jurisdictions in which we sell our devices directly, such as Japan and China. In 2015, the China Food and Drug Administration (NMPA) significantly increased the application fees for product registrations and imposed additional requirements for obtaining product approval, which includes requirements for conducting clinical trials to support the registration application process on newly introduced products in China. As a result, we may not seek registration for certain products where the cost is not justified. Any delay in product registrations could have a negative impact on our results of operations.

 

3833

 

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

 

July 1, 2022 through July 31, 2022

  -  $-   N/A   N/A 

August 1, 2022 through August 31, 2022

  55  $53.24   N/A   N/A 

September 1, 2022 through September 30, 2022

  -  $-   N/A   N/A 

Total

  55  $53.24   N/A   N/A 
  

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

 

January 1, 2023 through January 31, 2023

  3,345  $47.53   N/A   N/A 

February 1, 2023 through February 28, 2023

  159  $48.91   N/A   N/A 

March 1, 2023 through March 31, 2023

  98  $50.06   N/A   N/A 

Total

  3,602  $47.66   N/A   N/A 

 

(1) For the three months ended September 30, 2022,March 31, 2023, we repurchased 553,602 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.

 

3934

 

Item 6. Exhibits

 

  

Incorporated by Reference

 

Exhibit

Number

Exhibit Description

Form

Date

Number

Filed

Herewith

      

3.1

Amended and Restated By-laws of the Registrant

S-1/A

5/26/06

001-33092

3.2

Second Amended and Restated Certificate of Incorporation of the Registrant

10-K

3/29/10

001-33092

3.3

Amendment to Second Amended and Restated Certificate of Incorporation of the Registrant

8-K

6/5/12

001-33092

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

 


 

Indicates a management contract or any compensatory plan, contract, or arrangement.

*

The certifications attached as Exhibit 32.1 and Exhibit 32.2 that accompany this Quarterly Report on Form 10-Q, are not deemed filed with the SEC and are not to be incorporated by reference into any filing of LeMaitre Vascular, Inc. under the Securities Act of 1933, as amended, or the Securities Exchange Act of 1934, as amended, whether made before or after the date of this Quarterly Report on Form 10-Q, irrespective of any general incorporation language contained in such filing.

 

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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 November 8, 2022.May 9, 2023.

 

LEMAITRE VASCULAR, INC.

 
  

/s/ George W. LeMaitre

 

George W. LeMaitre

 

Chairman and Chief Executive Officer

 
  

/s/ Joseph P. Pellegrino, Jr.

 

Joseph P. Pellegrino, Jr.

 

Chief Financial Officer and Director

 

 

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