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LMAT > SEC Filings for LMAT > Form 10-Q on 13-Nov-2008All Recent SEC Filings

Show all filings for LEMAITRE VASCULAR INC | Request a Trial to NEW EDGAR Online Pro

Form 10-Q for LEMAITRE VASCULAR INC


13-Nov-2008

Quarterly Report


Item 2. Management's 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 federal securities law) that involve substantial risks and uncertainties. All statements, other than statements of historical facts, included in this Quarterly Report on Form 10-Q regarding our strategy, future operations, future financial position, future net sales, 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, actual results, performance, or financial condition may vary materially and adversely from those anticipated, estimated, or expected. We have identified below some important factors that could cause our forward-looking statements to differ materially from actual results, performance, or financial conditions:

• the unpredictability of our quarterly net sales and results of operations;

• the ability to keep pace with a rapidly evolving marketplace and to develop or acquire and then successfully market new and enhanced products;

• our ability to successfully identify, acquire, and integrate new products, businesses, and technologies and realize expected benefits;

• a highly competitive market for medical devices;

• the effect of a disaster at any of our manufacturing facilities;

• the loss of any significant suppliers, especially sole-source suppliers;

• the loss of any distributor or any significant customer, especially in regard to any product that has a limited distributor or customer base;

• our ability to adequately grow our operations and attain sufficient operating scale;

• our ability to obtain adequate profit margins;

• our ability to effectively protect our intellectual property and not infringe on the intellectual property of others;

• possible product liability lawsuits and product recalls;

• inadequate levels of third-party reimbursement to healthcare providers;

• our ability to initiate, complete, or achieve favorable results from clinical studies of our products;

• our ability to obtain and maintain U.S. and foreign regulatory clearance for our products and our manufacturing operations;

• our ability to raise sufficient capital when necessary or at satisfactory valuations;

• loss of key personnel; and

• other factors discussed elsewhere in this Quarterly Report on Form 10-Q.

For more information regarding these and other uncertainties and factors that could cause our actual results to differ materially from what we have anticipated in our forward-looking statements, or that otherwise could materially adversely affect our business, financial condition, or operating results, see our annual report on Form 10-K for the fiscal year ended December 31, 2007, under the heading "Part I - Item 1A. Risk Factors" and those risk factors included under the heading "Part II - Item 1A. Risk Factors" in this quarterly report.


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All forward-looking statements included in this report are expressly qualified in their entirety by the foregoing cautionary statements. We wish to caution readers not to place undue reliance on any forward-looking statement that speaks only as of the date made and to recognize that forward-looking statements are predictions of future results, which may not occur as anticipated. Actual results could differ materially from those anticipated in the forward-looking statements and from historical results, due to the uncertainties and factors described above, as well as others that we may consider immaterial or do not anticipate at this time. Although we believe that the expectations reflected in our forward-looking statements are reasonable, we do not know whether our expectations will prove correct. Our expectations reflected in our forward-looking statements can be affected by inaccurate assumptions we might make or by known or unknown uncertainties and factors, including those described above. The risks and uncertainties described above are not exclusive, and further information concerning us and our business, including factors that potentially could materially affect our financial results or condition, may emerge from time to time. We assume no obligation to update, amend, or clarify forward-looking statements to reflect actual results or changes in factors or assumptions affecting such forward-looking statements. We advise you, however, to consult any further disclosures we make on related subjects in our annual reports on Form 10-K, quarterly reports on Form 10-Q, and current reports on Form 8-K we file with or furnish to the Securities and Exchange Commission.

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 audited consolidated financial statements and the related notes contained in our Annual Report on Form 10-K for the year ended December 31, 2007, as filed with the Securities and Exchange Commission.

Unless the context requires 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, AnastoClip, EndoFit, Expandable LeMaitre Valvulotome, Flexcel, Glow 'N Tell, Grice, Inahara-Pruitt, InvisiGrip, LeverEdge, MollRing Cutter, NovaSil, OptiLock, Periscope, Pruitt, Pruitt-Inahara, Reddick, TT, UniFit, VascuTape, and the LeMaitre Vascular logo are registered trademarks of LeMaitre Vascular, and Albograft, aSpire, Biomateriali, EndoHelix, EndoRE, F3, Martin, TAArget, and VCS are unregistered trademarks of LeMaitre Vascular. This Quarterly Report on Form 10-Q also includes the registered and unregistered trademarks of other persons.

Overview

We are a medical device company that develops, manufactures, and markets medical devices and implants for the treatment of peripheral vascular disease. Our principal product offerings are sold throughout the world, primarily in the United States, the European Union, and, to a lesser extent, Japan. We estimate that the annual worldwide market addressed by our 14 current product lines exceeds $1 billion and that the annual worldwide market for all peripheral vascular devices exceeds $3 billion and is growing at 8 percent per year. We have used acquisitions as a primary means of further accessing the peripheral vascular device market, and we expect to continue to pursue this strategy in the future. We currently manufacture our product lines in our Burlington, Massachusetts, headquarters with the exception of the LeverEdge Contrast Injector (acquired in April 2007) and the Vascular Architects products (acquired in September 2007), for which a portion of the manufacturing is currently outsourced. In addition, our Albograft vascular grafts (acquired in December 2007) are manufactured at our facility in Brindisi, Italy.

Our products are used by vascular surgeons who treat peripheral vascular disease through both open surgical methods and more recently adopted endovascular techniques. Unlike interventional cardiologists and interventional radiologists, who are not typically certified to perform open surgical procedures, vascular surgeons can perform both open surgical and minimally invasive endovascular procedures, and are therefore uniquely positioned to provide patients with a wider range of treatment options.

We believe that the purchasing volume of the vascular surgeon will increase and that the changing product needs of the vascular surgeon present us with attractive opportunities to sell new devices. As a result, we have sought out and acquired new products and businesses that address these needs, such as our acquisition of the contrast injector in April 2007, the remote endarterectomy suite of products in September 2007, our four-year exclusive agreement to distribute the Endologix Powerlink System in 11 European countries, which commenced January 1, 2007, and the acquisition of a line of polyester vascular grafts in December 2007.


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Below is a listing of our product lines and product categories:

• Our Endovascular & Dialysis Access product category includes our TAArget Thoracic Stent Graft, UniFit Abdominal Stent Graft, VascuTape Radiopaque Tape, AnastoClip Vessel Closure System, LeverEdge Contrast Injector, and aSpire Covered Stent. We also report our distribution sales of the Endologix Powerlink System within this product category.

• Our Vascular product category includes our Expandable LeMaitre Valvulotome; Flexcel, Pruitt-Inahara, and Pruitt F3 Carotid Shunts; InvisiGrip Vein Stripper; LeMaitre Balloon Catheters; five remote endarterectomy products, which include our Martin Dissector, Periscope Dissector, EndoHelix Retrieval Device, MollRing Cutter Transection Device, and Ring Dissector; and our Albograft line of polyester prosthetic grafts.

• Our General Surgery product category includes our Reddick Cholangiogram Catheter and its accessories and our OptiLock Implantable Port.

• Our OEM category includes sales of a dacron product to a cardiac device manufacturer.

We evaluate the sales performance of our various product lines utilizing criteria that vary based upon the position of each product line in its expected life cycle. For established products, we typically review unit sales and selling prices. For faster growing products, we typically also focus on new account generation and customer retention.

Our business strategies include the following:

• the addition of complementary products through further acquisitions;

• the updating of existing products and the introduction of new products through research and development;

• the maintenance or expansion of our sales teams in North America, Europe, and Japan; and

• the introduction of our products in new markets via regulatory approvals.

We are currently pursuing all of these strategies.

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.

We sell our products primarily through a direct sales force. Our sales force was comprised of 49 sales representatives in North America, the European Union, and Japan as of September 30, 2008. We also sell our products through a network of distributors in various countries outside of the United States and Canada. In 2007, approximately 90% of our net sales were direct-to-hospital. For the nine-months ended September 30, 2008, approximately 88% of our net sales were direct-to-hospital.

Our worldwide headquarters are in Burlington, Massachusetts. Our international operations are headquartered in Sulzbach, Germany. We also have sales offices located in Tokyo, Japan, and Rome, Italy, and a manufacturing facility in Brindisi, Italy. For the nine months ended September 30, 2008, approximately 45% of our net sales were denominated in currencies other than the U.S. dollar. Accordingly, our results of operations are influenced by changes in currency exchange rates. Increases or decreases in the value of the U.S. dollar, as compared to other currencies in which our net sales are denominated, will directly affect our reported results as we translate those currencies into U.S. dollars for reporting purposes.

Our strategy for growing our business includes the acquisition of complementary product lines and companies and occasionally the discontinuance of products or activities that are no longer complementary. These actions may affect the comparability of our financial results from period to period and may cause substantial fluctuations period to period.


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The following table indicates the impact of foreign currency fluctuations and changes to our business activities for each of the quarters listed:

(amounts in thousands)                  2008                           2007                                2006
(unaudited)                     Q3       Q2       Q1       Q4       Q3       Q2      Q1      Q4        Q3        Q2        Q1
Total net sales               12,023   12,739   11,847   11,104   10,144   10,315   9,883   8,757     8,540     8,760     8,571
Impact of currency exchange
rate fluctuations (1)            452      836      674      439      253      267     322     232       135        (1 )    (287 )
Net impact of acquisitions,
distributed sales and
discontinued products,
excluding currency exchange
rate fluctuations (2)            703      929    1,133    1,116      635      567     455    (252 )    (383 )    (107 )      37

(1) Represents the impact of the change in foreign exchange rates over the corresponding quarter of the prior year based on the weighted averge exchange rate for each quarter.

(2) Represents the impact of sales of products of acquired businesses and distributed sales of other manufacturers' products, net of sales related to discontinued products and other activities, based on 12 months' sales following the date of the event or transaction, and shown in the current period only.

Results of Operations

Comparison of the three and nine months ended September 30, 2008, to the three and nine months ended September 30, 2007

The following tables set forth, for the periods indicated, our results of operations, net sales by product category, net sales by geography, and the change between the specified periods expressed as a percent increase or decrease:

                                                 Three months ended                 Nine months ended
                                                    September 30                      September 30
                                                                  Percent                           Percent
(unaudited)                                   2008       2007     change        2008       2007     change
                                                  ($ in thousands)                  ($ in thousands)
Net sales                                   $ 12,023   $ 10,144        19 %   $ 36,609   $ 30,342        21 %

Net sales by product category:
Endovascular & Dialysis Access              $  3,966   $  3,211        24 %   $ 11,836   $ 10,256        15 %
Vascular                                       6,987      5,982        17 %     21,600     17,216        25 %
General Surgery                                1,000        951         5 %      2,926      2,870         2 %

Total Branded Products                        11,953     10,144        18 %     36,362     30,342        20 %
OEM                                               70         -          *          247         -          *

Total                                       $ 12,023   $ 10,144        19 %   $ 36,609   $ 30,342        21 %

Net sales by geograghy:
United States and Canada                    $  6,805   $  6,236         9 %   $ 20,061   $ 18,232        10 %
Outside the United States and Canada           5,218      3,908        34 %     16,548     12,110        37 %

Total                                       $ 12,023   $ 10,144        19 %   $ 36,609   $ 30,342        21 %

* Not a meaningful percentage relationship.


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Net sales. Net sales increased 19% to $12.0 million and 21% to $36.6 million, for the three and nine months ended September 30, 2008, respectively, compared to $10.1 million and $30.3 million for the three and nine months ended September 30, 2007, respectively. Sales growth for the three months ended September 30, was driven by the inclusion of the sales of Biomateriali acquired in December 2007 and the EndoRE suite of products acquired in September of 2007. Sales growth was also driven by the positive effects of currency exchange rate fluctuations, higher average selling prices across nearly all product lines, and greater sales of the recently improved TAArget and UniFit stent grafts, Powerlink System, and embolectomy balloon catheters. Strong performance in our endovascular and dialysis access category for the three months ended September 30, 2008 was driven primarily by our newly redesigned TAArget and UniFit stent grafts. Sales growth for the nine months ended September 30, 2008 was driven by the inclusion of Biomateriali and the EndoRE suite of products, as well as the LeverEdge contrast injector acquired in April 2007. Sales growth for the nine months was driven by the positive effects of currency exchange rate fluctuations, higher average selling prices across nearly all product lines, and greater sales of the Powerlink System, valvulotomes and embolectomy balloon catheters. Strong performance in our vascular category for the nine months ended September 30, 2008 reflected in part the addition of our recently acquired prosthetic vascular grafts and suite of remote endarterectomy products.

Direct-to- hospital net sales were 89% during the three months ended September 30, 2008 and 2007. Direct to hospital total net sales decreased to 87% of total net sales during the nine months ended September 30, 2008, from 89% in the year earlier period. In 2008, direct-to-hospital sales growth was increased by our recent direct sales initiatives in France, Italy, Sweden and Ireland, and offset by the inclusion of our sales of prosthetic vascular grafts to a distributor in Europe.

The impact of foreign currency fluctuations and changes in business activities are presented in the table in the "Overview" section above.

Net sales by geography. Net sales in the United States and Canada increased 9% to $6.8 million and 10% to $20.1 million, for the three and nine months ended September 30, 2008, respectively. Increases were largely a result of the inclusion of the EndoRE suite of products, higher average selling prices across nearly all product lines, strong valvulotome and embolectomy balloon catheter sales, and increased sales representative efficiency. Net sales outside of the United States and Canada increased 34% to $5.2 million and 37% to $16.5 million, for the three and nine months ended September 30, 2008, respectively. Increases were attributable to the positive effects of currency exchange rate fluctuations, the inclusion of the prosthetic vascular graft product line, and increased sales of the recently improved TAArget and UniFit stent grafts as well as the Powerlink system.

Direct-to-hospital net sales outside of the United States and Canada increased to 76% during the three months ended September 30, 2008, from 74% of net sales in the year earlier period. Direct to hospital net sales outside of the United States and Canada were 72% during the nine months ended September 30, 2008 and 2007. Direct-to-hospital sales growth was increased of our recent direct sales initiatives in France, Italy, Sweden and Ireland, and offset by the inclusion of our sales of prosthetic vascular grafts to a distributor in Europe.

Gross profit:

                                               Three months ended                                 Nine months ended
                                                  September 30                                       September 30
                                                                       Percent                                             Percent
(unaudited)                         2008        2007       $ Change    change         2008         2007        $ Change    change
                                                ($ in thousands)                                   ($ in thousands)
Gross profit                       $ 8,103     $ 7,581     $     522       6.9 %    $ 25,478     $ 22,564     $    2,914      12.9 %

Gross margin                          67.4 %      74.7 %           *      (7.3 )%       69.6 %       74.4 %            *      (4.8 )%

Gross profit increased 7% to $8.1 million and 13% to $25.5 million, for the three and nine months ended September 30, 2008, respectively. Our gross margin decreased 7% to 67.4% and 5% to 69.6%, for the three and nine months ended September 30, 2008, respectively. Increased gross profit was driven by higher sales versus prior


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periods. Gross margin decreases were driven by the inclusion of the comparatively lower margin sales of our Biomateriali subsidiary, inventory write-offs of approximately $0.4 million largely associated with product improvements, and continued strength in the company's international business, which generally carries a lower gross margin.

Operating Expenses:



                                          Three months ended September 30                  Nine months ended September 30
                                                                        Percent                                         Percent
                                       2008      2007     $ change      change         2008       2007      $ change    change
(unaudited)                                       ($ in thousands)                                ($ in thousands)
Sales and marketing                  $  4,373   $ 4,583   $    (210 )        (5 )%   $ 15,353   $ 14,131   $    1,222         9 %
General and administrative              2,164     2,341        (177 )        (8 )%      7,726      6,917          809        12 %
Research and development                1,203     1,144          59           5 %       4,027      3,416          611        18 %
Restructuring charges                     163     1,054        (891 )         *         1,143      1,059           84         *
Impairment charge                          30        -           30           *           514          7          507         *

                                     $  7,933   $ 9,122   $  (1,189 )       (13 )%   $ 28,763   $ 25,530   $    3,233        13 %

                                      Three months ended September 30                 Nine months ended September 30
                                  2008 as a %      2007 as a %                   2008 as a %      2007 as a %
                                  of Revenue       of Revenue       Change       of Revenue       of Revenue       Change
Sales and marketing                        36 %             45 %        (9 )%             42 %             47 %        (5 )%
General and administrative                 18 %             23 %        (5 )%             21 %             23 %        (2 )%
Research and development                   10 %             11 %        (1 )%             11 %             11 %        (0 )%
Restructuring charges                       1 %             10 %        (9 )%              3 %              3 %        (0 )%
Impairment charge                           0 %              0 %         0 %               1 %              0 %         1 %

Sales and marketing. Sales and marketing expenses decreased from the previous year by $0.2 million to $4.4 million and increased over the previous year by $1.2 million to $15.4 million, for the three and nine months ended September 30, 2008, respectively. The three month decrease was driven primarily by fewer sales managers as a result of our 2008 reduction in force, as well as reduced direct marketing efforts of $0.1 million. These reductions were partially offset by the start-up of our French and Italian direct sales efforts, as well as foreign currency exchange rate fluctuations of $0.2 million. The nine month year-over-year expense increase was driven largely by higher sales representative and sales manager expenses, as well as foreign currency exchange rate fluctuations of $0.6 million. As of September 30, 2008, we employed 49 sales representatives and 10 sales managers worldwide, as compared to 53 sales representatives and 16 sales managers worldwide as of September 30, 2007. Total sales and marketing expenses as a percentage of sales decreased versus the prior year from 45% to 36% and from 47% to 42% for the three and nine months ended September 30, 2008, respectively.

General and administrative. General and administrative expenses decreased from the previous year by $0.2 million to $2.2 million and increased over the previous year by $0.8 million to $7.7 million, for the three and nine months ended September 30, 2008, respectively. The three month decrease was driven primarily by reduced consulting, outside services, insurance and other expenses , which we refer to as the 2008 Expense Shave cost cutting effort. The nine month year over year increase was driven largely by higher general expenses, as well as the inclusion of our Biomateriali, France direct and Italy direct efforts which totaled $0.5 million. The increase was also negatively affected by currency exchange rate fluctuation of $0.2 million. Total general and administrative expenses as a percentage of sales decreased versus the prior year from 23% to 18% and from 23% to 21% for the three and nine months ended September 30, 2008, respectively.


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Research and development. Research and development expenses increased over the previous year by $0.1 million to $1.2 million and by $0.6 million to $4.0 million, for the three and nine months ended September 30, 2008, respectively. Increases were largely a result of the UNITE Trial, which did not commence patient enrollment until June 2007, as well as other increased clinical and regulatory spending as we seek to obtain clearances to sell new products or existing products in new markets. We launched our 9 French Pruitt F3 Carotid Shunt and our 5 French Plus Over-the-Wire Embolectomy Catheter during the quarter ended September 30, 2008. We anticipate that research and development expenses will continue to increase as more UNITE Trial patients are enrolled, as new products follow the regulatory pathways, and as more product development is undertaken.

Restructuring. Restructuring charges incurred in 2008 were a result of payments related to non-compete and consulting agreements made with our recently terminated Italian distributor of approximately $0.7 million, as well as, severance costs of $0.4 million resulting from the reduction in force of eight and 32 employees in the third and first quarters, respectively. In September 2007, we entered into termination agreements with our former Italian and Irish distributors resulting in $1.1 million of restructuring expenses.

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