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| LMAT > SEC Filings for LMAT > Form 10-Q on 13-Nov-2009 | All Recent SEC Filings |
13-Nov-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, Albograft, 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 aSpire, Biomateriali, EndoHelix, EndoRE, Martin, Pruitt F3, TAArget, UnBalloon, VCS, and XenoSure 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 15 current product lines exceeds $1 billion and that the annual worldwide market for all peripheral vascular devices exceeds $3 billion. We have used acquisitions as a primary means of further accessing the peripheral vascular device market. We expect to continue to pursue this strategy in the future, while also investing in our research and development efforts in order to gain market access. We currently manufacture the majority of our product lines in our Burlington, Massachusetts, headquarters. In addition, our AlboGraft Vascular Graft is manufactured at our facility in Brindisi, Italy.
Our products are primarily 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.
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, The UnBalloon Non-Occlusive Modeling Catheter, 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, Inahara-Pruitt, Pruitt F3 and Flexcel Carotid Shunts, InvisiGrip Vein Stripper, LeMaitre Balloon Catheters, and the five EndoRE 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 our distribution sales of the Neovasc XenoSure Biologic Patch (formerly called PeriPatch) 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 polyester 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 long-term growth of our sales force in North America, Europe and Japan; and
• 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 September 30, 2009 our sales force was comprised of 56 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 nine months ended September 30, 2009, approximately 92% 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, 2009, approximately 42% 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 or sale 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 exchange fluctuations and changes to our business activities for each of the quarters listed:
(amounts in thousands) 2009 2008 2007 (unaudited) Q3 Q2 Q1 Q4 Q3 Q2 Q1 Q4 Q3 Q2 Q1 Total net sales 13,346 12,630 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) (215 ) (699 ) (622 ) (448 ) 452 836 674 439 253 267 322 Net impact of acquisitions, distributed sales and discontinued products, excluding currency exchange rate fluctuations (2) 333 234 101 235 703 929 1,133 1,116 635 567 455 |
(1) Represents the impact of the change in foreign exchange rates compared to 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, for the current period only.
Results of Operations
Comparison of the three and nine months ended September 30, 2009, to the three and nine months ended September 30, 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 September 30 Nine months ended September 30
Percent Percent
(unaudited) 2009 2008 change 2009 2008 change
($ in thousands) ($ in thousands)
Net sales $ 13,346 $ 12,023 11 % $ 37,324 $ 36,609 2 %
Net sales by product category:
Endovascular $ 3,916 $ 3,966 (1 )% $ 11,080 $ 11,836 (6 )%
Vascular 8,321 6,987 19 % 23,105 21,600 7 %
General Surgery 973 1,000 (3 )% 2,829 2,926 (3 )%
Total Branded Products 13,210 11,953 11 % 37,014 36,362 2 %
OEM 136 70 94 % 310 247 26 %
Total $ 13,346 $ 12,023 11 % $ 37,324 $ 36,609 2 %
Net sales by geograghy:
Americas $ 7,766 $ 6,868 13 % $ 21,716 $ 20,228 7 %
International 5,580 5,155 8 % 15,608 16,381 (5 )%
Total $ 13,346 $ 12,023 11 % $ 37,324 $ 36,609 2 %
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Net sales. Net sales increased 11% to $13.3 million for the three months ended September 30, 2009, compared to $12.0 million for the three months ended September 30, 2008. New acquisitions and business development activities added 3% to year-over-year sales growth, while changes in foreign currency exchange rates subtracted 2%. Excluding these effects, net sales for the three months ended September 30, 2009 grew 10%. Net sales increased 2% to $37.3 million for the nine months ended September 30, 2009, compared to $36.6 million for the nine months ended September 30, 2008. New acquisitions and business development activities added 2% to year-over-year sales growth, while changes in foreign currency exchange rates subtracted 4%. Excluding these effects, net sales for the nine months ended September 30, 2009 grew 4%.
Sales increases for the three months ended September 30, 2009 were largely driven by higher average selling prices across nearly all product lines, as well as broad-based increases in our Vascular product category of $1.3 million which, included increased AlboGraft Vascular Graft sales of $0.3 million and additional XenoSure Biologic Patch sales of $0.3 million. These gains were partially offset by the effect of negative currency exchange rate fluctuations of $0.2 million, as well as a decrease of $0.1 million in our Endovascular product category, primarily due to AnastoClip Vessel Closure System and TAArget Thoracic Stent Graft results.
Sales increases for the nine months ended September 30, 2009 were largely driven by higher average selling prices across nearly all product lines, as well as an increase in our Vascular product category of $1.5 million which included additional XenoSure Biologic Patch sales of $0.7 million, and increased remote endarterectomy sales of $0.3 million. These gains were partially offset by the effect of negative currency exchange rate fluctuations of $1.5 million, as well as a $0.8 million decrease in our Endovascular product category, primarily due to Endologix Powerlink System, AnastoClip Vessel Closure System and the TAArget Thoracic Stent Graft results.
Direct-to-hospital net sales were 92% for the three and nine months ended September 30, 2009, up from 89% for the three months ended, and 87% for the nine months ended, September 30, 2008. The increase was largely due to strong results from our comparatively newer sales organizations in Italy and France and reduced sales to international distributors.
Net sales by geography. Net sales in the Americas increased $0.9 million for the three months ended September 30, 2009. The increase was largely the result of higher average selling prices across nearly all product lines and the addition of sales of XenoSure Biologic Patch of $0.3 million. International net sales increased $0.4 million for the three months ended September 30, 2009. The increase was primarily driven by increased sales of the AlboGraft Vascular Graft of $0.3 million, increased sales throughout Germany of $0.2 million, and increased sales at our Japanese sales office of $0.1 million. These gains were partially offset by the effect of negative currency exchange rate fluctuations of $0.2 million.
Net sales in the Americas increased $1.5 million for the nine months ended September 30, 2009. The increase was largely the result of higher average selling prices across nearly all product lines as well as the addition of sales of XenoSure Biologic Patch of $0.7 million. International net sales decreased $0.8 million for the nine months ended September 30, 2009. The decrease was primarily driven by the effect of negative currency exchange rate fluctuations of $1.5 million, and a $0.1 million decrease in AlboGraft sales. These decreases were partially offset by increased sales of $0.6 million at our Italian sales office and increased sales of $0.2 million at our Japanese sales office.
International direct-to-hospital net sales increased to 81% for the three months ended, and 82% for the nine months ended, September 30, 2009, up from 76% for the three months ended, and 72% for the nine months ended, September, 30, 2008. The increase was largely due to strong results from our comparatively newer sales organizations in Italy and France and reduced sales to international distributors.
Three months ended September 30 Nine months ended September 30
Percent Percent
(unaudited) 2009 2008 $ change change 2009 2008 $ change change
($ in thousands) ($ in thousands)
Gross profit $ 9,743 $ 8,103 $ 1,640 20.2 % $ 27,131 $ 25,478 $ 1,653 6.5 %
Gross margin 73.0 % 67.4 % * 5.6 % 72.7 % 69.6 % * 3.1 %
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Gross Profit. Gross profit increased 20.2% to $9.7 million for the three months ended September 30, 2009, while our gross margin increased 5.6% to 73.0% in the same period. The gross margin increase was largely the result of a reduction in inventory write-downs related to the redesign of our TAArget Thoracic Stent Graft product line in 2008, improved manufacturing efficiencies, higher average selling prices across nearly all product lines and our direct-to-hospital AlboGraft Vascular Graft transition in Europe which commenced on March 27, 2009. The increase was partially offset by negative currency exchange rate fluctuations.
Gross profit increased 6.5% to $27.1 million for the nine months ended September 30, 2009, while our gross margin increased 3.1% to 72.7% in the same period. The gross margin increase was largely the result of higher average selling prices across nearly all product lines, our direct-to-hospital AlboGraft Vascular Graft transition in Europe which commenced on March 27, 2009, improved manufacturing efficiencies, and a reduction in inventory write-downs related to the redesign of our TAArget Thoracic Stent Graft product line in 2008. The increase was partially offset by negative currency exchange rate fluctuations.
Three months ended September 30 Nine months ended September 30
Percent Percent
(unaudited) 2009 2008 $ change change 2009 2008 $ change change
($ in thousands) ($ in thousands)
Sales and marketing $ 4,508 $ 4,373 $ 135 3 % $ 12,903 $ 15,353 $ (2,450 ) (16 )%
General and administrative 2,494 2,164 330 15 % 7,431 7,726 (295 ) (4 )%
Research and development 1,448 1,203 245 20 % 4,194 4,027 167 4 %
Restructuring charges 0 163 (163 ) * 1,777 1,143 634 55 %
Impairment charge - 30 (30 ) * 106 514 (408 ) (79 )%
Total $ 8,450 $ 7,933 $ 517 7 % $ 26,411 $ 28,763 $ (2,352 ) (8 )%
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Three months ended September 30 Nine months ended September 30
2009 as a % 2008 as a % 2009 as a % 2008 as a %
of Revenue of Revenue Change of Revenue of Revenue Change
Sales and marketing 34 % 36 % (2 )% 35 % 42 % (7 )%
General and administrative 19 % 18 % 1 % 20 % 21 % (1 )%
Research and development 11 % 10 % 1 % 11 % 11 % 0 %
Restructuring charges 0 % 1 % (1 )% 5 % 3 % 2 %
Impairment charge 0 % 0 % (0 )% 0 % 1 % (1 )%
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Sales and marketing. For the three months ended September 30, 2009 sales and marketing expenses increased 3% to $4.5 million. Selling expenses increased $0.1 million while marketing expenses increased $0.1 million. For the three months ended September 30, 2009, foreign currency exchange rate fluctuations reduced sales and marketing expenses by $0.1 million compared to the same period in the prior year. Selling expense increases were driven by additional sales personnel and related costs of $0.1 million. As a percentage of revenues, sales and marketing expenses decreased to 34% in the three months ended September 30, 2009, from 36% in the prior year quarter.
For the nine months ended September 30, 2009 sales and marketing expenses decreased 16% to $12.9 million. Selling expenses decreased $1.9 million while marketing expenses decreased $0.6 million. For the nine months ended September 30, 2009, foreign currency exchange rate fluctuations reduced sales and marketing expenses by $0.6 million compared to the same period in the prior year. Selling expense decreases were driven largely by reduced sales commissions and payroll costs of $1.0 million and decreased travel and entertainment expenses of $0.4 million. Marketing expense decreases were largely the result of reduced direct marketing and trade show expenses of $0.3 million, reduced advisory board expenses of $0.1 million and the effects of currency exchange rate fluctuations, and were partially offset by additional headcount costs of $0.1 million. As a percentage of revenues, sales and marketing expenses decreased to 35% in the nine months ended September 30, 2009 from 42% in the prior year. As of September 30, 2009 we employed 56 sales representatives and 12 sales managers worldwide.
General and administrative. For the three months ended September 30, 2009, general and administrative expenses increased 15% to $2.5 million. The increase was due to our management team's 2008 voluntary bonus reduction program, increased amortization of $0.1 million related to termination of our AlboGraft Vascular Graft distribution agreement, and increased professional service fees of $0.1 million. General and administrative expenses decreased 4% to $7.4 . . .
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