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| LMAT > SEC Filings for LMAT > Form 10-Q on 14-May-2009 | All Recent SEC Filings |
14-May-2009
Quarterly Report
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 recent adverse changes in U.S., global, or regional economic conditions;
• 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.
We may not actually achieve the plans, intentions, or expectations disclosed in our forward-looking statements and you should not place undue reliance on our forward-looking statements. 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, 2008, under the heading "Part I - Item 1A. Risk Factors" and those risk factors, if any, included elsewhere in this report.
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, 2008, 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 which we estimate had been growing at 8% per year prior to the recent economic downturn. 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 the majority of our product lines in our Burlington, Massachusetts, headquarters. 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. In contrast to interventional cardiologists and interventional radiologists, neither of whom are 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, and have pursued a strategy of selling directly to hospitals in our major markets.
In January 2007 we commenced distribution of the Endologix Powerlink System, an abdominal stent graft, in several European countries, including Germany, France and the United Kingdom. We believe that this product complements our UniFit and TAArget stent graft product lines, allowing our European sales force to offer a complete range of stent grafts for the entire aorta. In 2008 we extended this distribution agreement through December 31, 2010. In April 2007 we acquired our LeverEdge product line from Cardiovascular Innovations, LLC, and in September 2007 we acquired our EndoRE and aSpire product lines from Vascular Architects. In September 2007 we reached an agreement to launch a direct sales force in Italy effective January 2008. We and our exclusive distributor in Italy agreed to terminate its exclusive rights as of January 25, 2008, in exchange for a termination fee of approximately $1.1 million. In December 2007 we purchased certain patents and in-process research and development from Arizona Heart Innovative Technologies, LLC related to a pre-commercial endovascular device.
In December 2007 we also acquired Biomateriali, S.r.l., a privately held Italian company that manufactured the AlboGraft Vascular Graft for vessel replacement in the peripherals, abdomen, and thorax. Biomateriali's manufacturing operations are located in Brindisi, Italy, and at the time of the acquisition its primary product, the AlboGraft Vascular Graft, was sold in Europe under an exclusive distribution agreement with Edwards Lifesciences. In March 2009, we paid $3.5 million to Edward Lifesciences to terminate this distribution agreement and purchase their AlboGraft customer list, certain customer contracts, the remaining AlboGraft inventory, and certain sales and marketing services.
In December 2008 we entered into an agreement with Neovasc Inc. to distribute its biological patches for use in vascular surgery, including carotid endarterectomy, in the United States, the European Union, and select other European markets. This seven year agreement became effective January 26, 2009. We were also granted an option to acquire this product commencing in 2014.
Below is a listing of our product lines and product categories:
• Our Endovascular 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, Pruitt-Inahara, Pruitt F3 and Flexcell Carotid Shunts, InvisiGrip Vein Stripper, LeMaitre Balloon Catheters, and the five remote endarterectomy products which include our Martin Dissector, Periscope Dissector, EndoHelix Retrieval Device, MollRing Cutter Transection Device, and Ring Dissector, and the AlboGraft Vascular Graft. We also report the results of our distribution of the Neovasc Peripatch Biologic Vascular Patch within this category.
• 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 opportunities include the following:
• the addition of complementary products through acquisition;
• the updating of existing products and introduction of new products through research and development;
• the introduction of our products in new markets upon obtainment of regulatory approvals in these markets.
We are currently pursuing each of these opportunities.
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. As of March 31, 2009 our sales force was comprised of 52 sales representatives in North America, the European Union, and Japan. We also sell our products through a network of distributors in various countries outside of the United States and Canada. In 2008, approximately 88% of our net sales were direct-to-hospital. For the three months ended March 31, 2009, approximately 93% 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 three months ended March 31, 2009, approximately 41% of our net sales were denominated in currencies other than the U.S. dollar, primarily the euro and the yen. 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 each fiscal period.
Further, 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.
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)
(unaudited)
2009 2008 2007
Q1 Q4 Q3 Q2 Q1 Q4 Q3 Q2 Q1
Total net sales 11,348 12,111 12,023 12,739 11,847 11,104 10,144 10,315 9,883
Impact of currency exchange
rate fluctuations (1) (622 ) (448 ) 452 836 674 439 253 267 322
Net impact of acquisitions,
distributed sales and
discontinued products,
excluding currency exchange
rate fluctuations (2) 101 235 703 929 1,133 1,116 635 567 455
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(1) Represents the impact of the change in foreign exchange rates over the corresponding quarter of the prior year based on the weighted average 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 months ended March 31, 2009, to the three and ended March 31, 2008
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 March 31
Percent
(unaudited) 2009 2008 change
($ in thousands)
Net sales $ 11,348 $ 11,847 (4 )%
Net sales by product category:
Endovascular $ 3,501 $ 3,542 (1 )%
Vascular 6,915 7,323 (6 )%
General Surgery 880 904 (3 )%
Total Branded Products 11,296 11,769 (4 )%
OEM 52 78 (33 )%
Total $ 11,348 $ 11,847 (4 )%
Net sales by geograghy:
United States and Canada $ 6,681 $ 6,454 4 %
Outside the United States and Canada 4,667 5,393 (13 )%
Total $ 11,348 $ 11,847 (4 )%
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Net sales. Net sales decreased 4% to $11.3 million for the three months ended March 31, 2009, compared to $11.8 million for the three months ended March 31, 2008. New acquisitions and business development activities added 1% to year-over-year sales growth, while changes in foreign currency exchange rates subtracted 5%.
Sales decreases for the three months ended March 31, 2009 were largely driven by the effect of currency exchange rate fluctuations of $0.6 million, a $0.4 million decrease in sales to international distributors of our non-AlboGraft products, and a $0.4 million decrease in AlboGraft Vascular Graft sales to Edwards Lifesciences during the wind-down phase of their distribution. Sales decreases were partially offset by higher average selling prices across nearly all product lines, as well as increased year-over-year sales in Italy of $0.3 million, reflecting the results of our recent Italian direct-sales initiative, and increased year-over-year sales in the United States of $0.2 million. For the three months ended March 31, 2009, the decrease in our endovascular category was driven primarily by reduced sales of our AnastoClip and aSpire product lines of $0.2 million, as well as the negative effects of currency exchange rate fluctuations. The decrease in our vascular category was mainly the result of reduced AlboGraft sales in the quarter of $0.4 million, as well as the negative effects of currency exchange rate fluctuations, and was partially offset by increased shunt and catheter sales of $0.3 million.
Direct-to-hospital net sales were 93% of total net sales during the three months ended March 31, 2009, as compared to 86% during the three months ended March 31, 2008. The increase was largely due to reduced sales to international distributors, as well as strong results from our comparatively newer sales organizations in Italy and France.
The impact of foreign currency fluctuations and changes in business activities are presented in the table in the "Overview" section above. The negative impact of foreign currency fluctuations during the three months ended March 31, 2009 was significant and this trend may continue into the quarter ended June 30, 2009.
Net sales by geography. Net sales in the United States and Canada increased 4% to $6.7 million for the three months ended March 31, 2009. The increase was largely a result of higher average selling prices across nearly all product lines, increased shunt and catheter sales of $0.3 million and sales gains in our remote endarterectomy and radiopaque tape products. Net sales outside of the United States and Canada decreased 13% to $4.7 million for the three months ended March 31, 2009. The decrease was driven by the effect of currency exchange rate fluctuations of $0.6 million, a $0.4 million decrease in sales to international distributors of our non-AlboGraft products, largely in Greece and Spain, and a $0.4 million decrease in AlboGraft Vascular Graft sales to Edwards Lifesciences during the wind-down phase of their distribution, partially offset by an increase in direct-to-hospital net sales of $0.7 million in Europe.
Direct-to-hospital net sales outside of the United States and Canada increased to 82% of total net sales during the three months ended March 31, 2009, up from 67% of net sales in the year earlier period. The increase was largely due to decreased sales to international distributors, as well as strong results from our comparatively newer sales organizations in Italy and France.
Three months ended March 31
Percent
(unaudited) 2009 2008 $ Change change
($ in thousands)
Gross profit $ 8,266 $ 8,489 $ (223 ) (2.6 )%
Gross margin 72.8 % 71.7 % * 1.1 %
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Gross Profit. Gross profit decreased 3% to $8.3 million for the three months ended March 31, 2009. Our gross margin increased 1.1% to 72.8% in the same period. Decreased gross profit was driven by lower sales versus the prior period. The gross margin increase was the result of higher average selling prices across nearly all product lines, increased gross margin contribution from both the Powerlink product line and our Biomateriali subsidiary, and reduced sales to European distributors, which usually carry a lower gross margin. Gross margin was reduced 1.4% by the negative effect of currency exchange rate fluctuations.
Three months ended March 31
Percent
(unaudited) 2009 2008 $ change change
($ in thousands)
Sales and marketing $ 4,146 $ 5,829 $ (1,683 ) (29 )%
General and administrative 2,525 2,828 (303 ) (11 )%
Research and development 1,311 1,350 (39 ) (3 )%
Restructuring charges 1,777 633 1,144 *
Impairment charge 73 435 (362 ) *
Total $ 9,832 $ 11,075 $ (1,243 ) (11 )%
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Three months ended March 31
2009 as a % 2008 as a %
of Revenue of Revenue Change
Sales and marketing 37 % 49 % (12 )%
General and administrative 22 % 24 % (2 )%
Research and development 12 % 11 % 1 %
Restructuring charges 16 % 5 % 11 %
Impairment charge 1 % 4 % (3 )%
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Sales and marketing. For the three months ending March 31, 2009 sales and marketing expenses decreased 29% to $4.1 million. The decrease included a reduction in selling expenses of $1.4 million and a reduction in marketing expenses of $0.3 million. Foreign currency exchange rate fluctuations decreased sales and marketing expenses by $0.3 million in the period. Selling expense decreases were driven largely by reduced sales commissions and contests of $0.4 million, decreased travel and entertainment expenses of $0.3 million, the effects of currency exchange rate fluctuations and three fewer sales managers. Marketing expense decreases were largely the result of reduced advertising, direct marketing and trade show expenses of $0.1 million, as well as reduced advisory board expenses of $0.1 million. As a percentage of revenues, sales and marketing expenses decreased to 37% from 49% in the prior year quarter. As of March 31, 2009 we employed 52 sales representatives and 11 sales managers worldwide.
General and administrative. For the three months ending March 31, 2009 general and administrative expenses decreased 11% to $2.5 million. The reduction was driven primarily by lower wages in the United States of $0.2 million, foreign currency exchange rate fluctuations of $0.1 million and general expense reduction throughout the organization. As a percentage of revenues, general and administrative expenses decreased by 2% to 22%.
Research and development. For the period ending March 31, 2009 research and development expenses decreased 3% to $1.3 million. The decrease was the result of lower process engineering headcount and royalty expenses of $0.1 million, and was partially offset by increased product development, regulatory and clinical headcount expenses of $0.1 million. We increased enrollment in our UNITE clinical trial by 8 patients from December 31, 2008. We anticipate that research and development expenses will increase over time as more UNITE Trial patients are enrolled, new products follow the regulatory pathways, and more product development is undertaken. As a percentage of revenues, research and development expenses increased by 1% to 12%.
Restructuring. During the three months ended March 31, 2009 we incurred a $1.8 million restructuring charge related to the March 27, 2009 termination of our AlboGraft distribution agreement with Edwards Lifesciences. The transaction included the payment of $3.5 million in exchange for the termination of the distribution agreement, and the acquisition of detailed customer information, transition services, and remaining product inventory. Restructuring charges recorded for the three months ended March 31, 2008 included $0.4 million related to a reduction in force, and $0.3 million related to the termination of our former distributors in Italy and Ireland.
Impairment charge. During the period ending March 31, 2009 we determined that we were likely to fail to meet a product development milestone relating to certain patents within our endovascular product category portfolio in the United States and Europe, and subsequently determined that the patents had no value based value based upon an analysis of expected economic benefits. As a result, we recorded an impairment charge of $0.1 million for the write-down of these . . .
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