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 status of our global regulatory approvals and compliance with foreign regulatory requirements to market and sell our products outside the United States; the duration and severity of the impact of COVID-19 on the global economy, our customers, our suppliers and our company; the risk of significant fluctuations in our quarterly and annual results due to numerous factors; the risk that assumptions about the market for the Company's products and the productivity of the Company's 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 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 Company's 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 management's 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, as filed with the SEC on February 28, 2022. 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, Artegraft, CardioCel, Omniflow, RestoreFlow, VascuCel and XenoSure are registered trademarks of LeMaitre Vascular or one of its subsidiaries. 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, the United Kingdom, Canada and Asia Pacific. We estimate that the annual worldwide market for peripheral vascular devices exceeds $5 billion, within which we estimate that the addressable 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.





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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, although the prevalence of COVID-19 variants has not always resulted in the re-opening of hospital access. During 2020 and into 2022, 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 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 Q1 2022, biologics represented 48% of worldwide sales. We view the biologic device offerings favorably, as we believe it contains differentiated and in some 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 North America, Europe, the United Kingdom,
    and Asia Pacific, including when replacing a distributor with our sales
    personnel;




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

  • 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 March 31, 2022, our sales force was comprised of 112 sales representatives in North America, Europe, the United Kingdom and Asia Pacific, including three 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; and Kensington, Australia. During the current quarter, approximately 95% 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.





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Historically we have experienced success in lower-rivalry niche segments, for example the markets for valvulotomes and carotid shunts. In the valvulotome market, 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. 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.

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 and occasionally the discontinuance or divestiture of products or activities that are no longer complementary:





  • 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 Anteris 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.

  • During 2021, we made decisions to wind down or discontinue TRIVEX powered
    phlebectomy systems, remote endarterectomy devices and surgical glue. These
    product lines combined to account for approximately $2.2 million in revenues
    in 2021.

  • In March 2022, we made the decision to wind down the ProCol graft product
    line, which totaled approximately $0.7 million in revenues in 2021.



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
    Anteris in concluding agreements with, several former Anteris distributors in
    Europe and Canada, in order to terminate their distribution of our acquired
    bovine cardiac and vascular patch products, and we began selling
    direct-to-hospital in those geographies. The 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.



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





  • In 2019, we launched DuraSure, a biologic patch indicated for closing or
    repairing dural defects during open neurosurgical procedures.

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

  • In March 2022, we received U.S. FDA approval to market PhasTIPP, a portable
    powered phlebotomy device used to remove larger varicose veins in the leg.



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 September 2018, we acquired the Syntel embolectomy catheter business assets
    from Applied Medical. We immediately initiated a project to transfer the
    production to our Burlington facilities. This transfer is now complete.




  • In 2018 and 2019, we expanded our Burlington biologic clean room in order to
    transfer the production of our Omniflow II vascular graft from our North
    Melbourne, Australia facility to Burlington. This transfer is substantially
    complete, and the North Melbourne facility has been sold.

  • 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 complete
    in 2023.




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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 three months ended March 31, 2022 approximately 39% of our sales took place outside 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 quarter ended March 31, 2022, we estimate that the effects of changes in foreign exchange rates decreased our reported sales by approximately $0.8 million, as compared to rates in effect for the quarter ended March 31, 2021.

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 congresses, training programs, advertising and product promotions, direct mail and other marketing costs.

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

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

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

Income tax expense. We are subject to federal and state income taxes for earnings generated in the 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.





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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 in response to 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, however, in many geographies we have seen restrictions eased, although the prevalence of COVID-19 variants has not always resulted in the re-opening of hospital access. During 2020 and into 2022, these dynamics resulted in, and we expect will continue to result in, variable and unpredictable sales.

For reasons 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-month period ended March 31, 2022 to the three-month month period ended March 31, 2021:

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 March 31,
(unaudited)                                                         Percent
                                    2022              2021          change
                                              ($ in thousands)
Net sales                        $    39,561       $    35,883            10 %

Net sales by geography:
Americas                         $    26,543       $    23,699            12 %
Europe, Middle East and Africa        10,494             9,862             6 %
Asia Pacific                           2,524             2,322             9 %
Total                            $    39,561       $    35,883            10 %



Net sales. Net sales increased $3.7 million, or 10%, to $39.6 million for the three months ended March 31, 2022, compared to $35.9 million for the three months ended March 31, 2021. The increase was driven primarily by an increase in bovine graft sales of $1.0 million, and carotid patch sales of $0.7 million, largely due to carotid patch CE mark issues in the prior year. Additionally, shunt, allograft, and valvulotome sales increased by $0.7 million, $0.6 million, and $0.5 million, respectively, for the three months ended March 31, 2022 compared to the three months ended March 31, 2021. We estimate that the stronger U.S. dollar decreased net sales by $0.8 million during the three months ended March 31, 2022 as compared to the three months ended March 31, 2021.

Direct-to-hospital net sales were 95% of our total net sales for the three months ended March 31, 2022, and 94% for the three-months ended March 31, 2021.





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Net sales by geography. Net sales in the Americas increased $2.8 million, or 12%, for the three months ended March 31, 2022 as compared to the three months ended March 31, 2021. The increase was driven mainly by increased bovine graft sales of $1.0 million, or 16%, increased allograft sales of $0.6 million, or 28%, and increased valvulotome sales of $0.5 million, or 10%.

EMEA net sales increased $0.6 million, or 6%, for the three months ended March 31, 2022 as compared to the three months ended March 31, 2021. Higher sales of carotid shunts and bovine carotid patches led the growth, with increased sales of $0.4 million each, offset by a $0.1 million decline in embolectomy catheter sales.

Asia Pacific net sales increased $0.2 million, or 9%, for the three months ended March 31, 2022 as compared to the three months ended March 31, 2021, with increased bovine carotid patch sales of $0.2 million. This and other product sales increases were offset, in part, by a $0.1 million decline in bovine cardiac patch sales.

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
                 2022         2021       Change       change
                              ($ in thousands)
Gross profit   $ 25,962     $ 23,799     $ 2,163             9 %

Gross margin       65.6 %       66.3 %     (0.7% )           *




*Not applicable



Gross Profit. Gross profit increased $2.2 million, or 9%, to $26.0 million for the three months ended March 31, 2022, and gross margin decreased 70 basis points to 65.6% in the period. The increase in gross profit was driven primarily by increased sales from bovine grafts and valvulotomes. 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 polyester grafts, unfavorable changes in foreign currency exchange rates and manufacturing inefficiencies largely related to bovine carotid patches.





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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
                               2022         2021        $ Change       change

Sales and marketing          $  7,850     $  6,466     $    1,384            21 %
General and administrative      7,252        6,544            708            11 %
Research and development        2,932        2,844             88             3 %
Total                        $ 18,034     $ 15,854     $    2,180            14 %




                                          Three months ended March 31,
                                   2022                     2021
                              % of Net Sales           % of Net Sales        Change

Sales and marketing                        20 %                     18 %           2 %
General and administrative                 18 %                     18 %           0 %
Research and development                    7 %                      8 %          (1 %)



Sales and marketing. For the three months ended March 31, 2022, sales and marketing expense increased 21% to $7.9 million. The increase was driven primarily by higher sales rep headcount, resulting in higher salaries and related expenses of $1.1 million, including higher selling commissions of approximately $0.3 million. Travel and related expenses were also higher by $0.2 million. Expense reduction programs implemented during the second quarter of 2020 through the fiscal year 2021 in response to the COVID-19 global pandemic, including a reduction in force, lowered expenses for the three months ended March 31, 2021. Since the pandemic has abated, we have hired in many areas, including our sales force. As a percentage of net sales, sales and marketing expense increased to 20% for the three months ended March 31, 2022, up from 18% in the prior period.

General and administrative. For the three months ended March 31, 2022, general and administrative expenses increased 11% to $7.3 million. Compensation and related expenses increased by $0.7 million, largely due to salary and stock-based compensation increases, as well as an increase in personnel. As a percentage of sales, general and administrative expenses were unchanged at 18% for each of the three month periods ended March 31, 2022 and 2021, respectively.

Research and development. For the three months ended March 31, 2022, research and development expense increased $0.1 million, or 3%, to $2.9 million. The increase was driven by higher salaries and related expenses of $0.4 million, as well as an increase in personnel. These increases were largely offset by a decrease in professional fees and outside services of $0.3 million. As a percentage of sales, total research and development expense decreased to 7% for the three months ended March 31, 2022, from 8% in the prior period.





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Income tax expense. We recorded a tax provision of $2.0 million on pre-tax income of $8.0 million for the three months ended March 31, 2022, compared to a $1.6 million tax provision on pre-tax income of $7.5 million for the three months ended March 31, 2021. Our effective income tax rate was 24.5% for the three month period ended March 31, 2022. Our tax expense for the current period is based on an estimated annual effective tax rate of 24.5%, 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, and different statutory rates from our foreign entities.

Our effective income tax rate was 20.8% for the three month period ended March 31, 2021. Our 2021 provision was based on the estimated annual effective tax rate of 24.0%, adjusted in the applicable quarterly period for discrete stock option exercises and other discrete items. Our income tax expense for the three month period ended March 31, 2021 varied 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.

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 March 31, 2022, we have provided a valuation allowance of $1.7 million for deferred tax assets primarily related to Australian net operating loss and capital loss carry forwards and Massachusetts tax credit carry forwards that are not expected to be realized.

Liquidity and Capital Resources

At March 31, 2022, our cash and cash equivalents were $15.6 million as compared to $13.9 million at December 31, 2021. We also had $55.3 million in short-term marketable securities as of March 31, 2022 and $56.1 million as of December 31, 2021. 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.

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.





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On February 22, 2022, our Board of Directors authorized the repurchase of up to $20.0 million of the Company's common stock through transactions on the open market, in privately negotiated purchases or otherwise until February 22, 2023. 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 allowed for in 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 $7.9 million for the three months ended March 31, 2022. For the year ended December 31, 2021, we had operating income of $36.4 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;




  • 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, repay outstanding debt, 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.





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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

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



On April 26, 2022 our Board of Directors approved a quarterly cash dividend on our common stock of $0.125 per share payable on June 2, 2022, to stockholders of record at the close of business on May 17, 2022.





Cash Flows



                                          Three months ended March 31,
                                                 (in thousands)
                                       2022           2021        Net Change
Cash and cash equivalents           $   15,560      $ 23,525     $     (7,965 )

Cash flows provided by (used in):
Operating activities                $    4,711      $  6,074     $     (1,363 )
Investing activities                      (536 )      (1,060 )            524
Financing activities                    (2,380 )      (7,965 )          5,585



Net cash provided by operating activities. Net cash provided by operating activities was $4.7 million for the three months ended March 31, 2022, consisting of $6.0 million in net income, adjustments for non-cash or non-operating items of $3.6 million (including primarily depreciation and amortization of $2.4 million, stock-based compensation of $1.2 million, provisions for inventory write-offs and doubtful accounts of $0.6 million), and also a net use of working capital of $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 $1.3 million, and payments of accounts payable and accrued liabilities of $3.4 million. These cash uses were offset by a decrease in prepaid expenses and other assets of $1.7 million.

Net cash provided by operating activities was $6.1 million for the three months ended March 31, 2021, consisting of $5.9 million in net income, adjustments for non-cash or non-operating items of $4.7 million (including depreciation and amortization of $2.6 million, stock-based compensation of $0.9 million, provisions for inventory write-offs and doubtful accounts of $1.1 million), and also a net use of working capital of $4.6 million. The net cash used for working capital was driven by payments of accounts payable and accrued liabilities of $3.0 million, an increase in inventory and other deferred costs of $1.3 million and an increase in receivable of $0.9 million. These cash uses were offset by a decrease in prepaid expenses and other assets of $0.6 million.





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Net cash used in investing activities. Net cash used in investing activities was $0.5 million for the three months March 31, 2022, consisting of expenditures on equipment and technology.

Net cash used in investing activities was $1.1 million for the three months ended March 31, 2021, consisting of expenditures on equipment and technology.

Net cash used in financing activities. Net cash used in financing activities was $2.4 million for the three months ended March 31, 2022, consisting primarily of a dividend payment of $2.7 million. This use of cash was partly offset by proceeds from stock option exercises of $0.4 million, net of shares repurchased to cover employee payroll taxes.

Net cash used in financing activities was $8.0 million for the three months ended March 31, 2021, consisting primarily of payments made on our long-term debt of $7.0 million and a dividend payment of $2.3 million. These uses of cash were partly offset by proceeds from stock option exercise of $1.3 million, net of shares repurchased to cover employee payroll taxes.

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. There have been no material changes in our critical accounting policies during the three months ended March 31, 2022. 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.

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