Form 8-K

 

 

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

 

Form 8-K

 

 

Current Report

Pursuant to Section 13 or 15(d) of the

Securities Exchange Act of 1934

Date of Report (Date of earliest event reported): 5/2/2012

 

 

LeMaitre Vascular, Inc.

(Exact name of registrant as specified in its charter)

 

 

Commission File Number: 001-33092

 

Delaware   04-2825458

(State or other jurisdiction

of incorporation)

 

(IRS Employer

Identification No.)

63 Second Avenue

Burlington, MA 01803

(Address of principal executive offices, including zip code)

781-221-2266

(Registrant’s telephone number, including area code)

 

(Former name or former address, if changed since last report)

 

 

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

 

¨ Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

 

¨ Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

 

¨ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

 

¨ Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

 

 

 


Information to be included in the report

Item 2.02. Results of Operations and Financial Condition

On May 2, 2012, LeMaitre Vascular, Inc. issued a press release regarding its financial and operational results for the first quarter ended March 31, 2012. A copy of the press release is furnished as Exhibit 99.1 to this report.

The information in this report, including the Exhibit attached hereto, is intended to be furnished and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934 (the “Exchange Act”) or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933 or the Exchange Act, except as expressly set forth by specific reference in such filing.

Item 9.01. Financial Statements and Exhibits

The following exhibit is furnished as part of this report, where indicated:

 

  (d) Exhibits.

 

Exhibit

No.

  

Description

99.1    Press release issued by LeMaitre Vascular, Inc. on May 2, 2012, announcing its financial and operational results for the first quarter ended March 31, 2012, furnished herewith.


Signature(s)

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

 

    LeMaitre Vascular, Inc.
Date: May 2, 2012   By:   Joseph P. Pellegrino, Jr.
   

/s/ JOSEPH P. PELLEGRINO, JR.

    Joseph P. Pellegrino, Jr.
    Chief Financial Officer


Exhibit Index

 

Exhibit No.

  

Description

EX-99.1    Press Release
Press Release

Exhibit 99.1

 

LOGO

For information contact:

J.J. Pellegrino

Chief Financial Officer

LeMaitre Vascular Inc.

781- 425-1691

jpellegrino@lemaitre.com

LeMaitre Vascular Q1 2012 Sales $13.9mm (+8% Organic), Op. Profit $0.9mm

BURLINGTON, MA, May 2, 2012 — LeMaitre Vascular, Inc. (NASDAQ: LMAT), a provider of peripheral vascular devices and implants, today reported Q1 2012 financial results. The Company posted Q1 2012 sales of $13.9mm and operating income of $0.9mm. The Company also approved a quarterly cash dividend of $0.025 per share, and provided Q2 2012 and full-year 2012 updated guidance.

Q1 2012 sales increased 8% organically vs. Q1 2011. Sales in the Americas grew 6% organically, while International increased 14%. International organic sales increases in the quarter were driven by the Company’s subsidiaries in Japan (+19%), Italy (+12%) and Germany (+9%), as well as newly direct efforts in Spain and Denmark. On a reported basis, Q1 2012 sales declined 5% due to the Company’s mid-2011 stent graft exit. In Q1 2012 the Company’s worldwide unit sales increased 15% year-over-year.

Gross margin was 70.9% in Q1 2012, versus 69.5% in the prior year quarter. This gross margin increase was largely the result of the Italian manufacturing facility closure, higher average selling prices, and improved product mix, and was partially offset by AlboGraft inventory write-offs.

Q1 2012 operating income was $0.9mm vs. an operating loss of $30,000 in the prior year quarter. Net income in Q1 2012 was $0.4mm, or $0.02 per diluted share, vs. $0.1mm or $0.00 per diluted share in Q1 2011.

George W. LeMaitre, Chairman and CEO said, “In addition to posting another ‘clean’ quarter, I am pleased to report that we are currently benefiting from a number of growth drivers. International sales continue to improve as our sales force is no longer distracted by stent-grafts, while our direct-to-hospital efforts in Spain and Denmark are bearing fruit. In addition, sales of XenoSure in Europe and the U.S. are ramping impressively, while our Over-the-Wire LeMaitre Valvulotome and UnBalloon launches continue to gain traction.”

Total operating expenses in Q1 2012 were $9.0mm, down from $10.2mm in the previous year. Q1 2011 operating expenses included $1.1mm of restructuring and impairment costs. Q1 2012


selling and marketing expenses increased 5% to $5.2mm, driven by additional sales representatives, as well as an increase in direct mail efforts. General and administrative expenses decreased 6% to $2.7mm in the quarter, mainly the result of the closure of the Italian facility and a reduction in compensation costs. Research and development expenses in Q1 2012 decreased 11% to $1.1mm, largely the result of the absence of stent graft clinical trials.

The Company ended Q1 2012 with 79 sales representatives, up from 66 at the end of Q1 2011.

Cash and marketable securities were $19.6mm at March 31, 2012, a decrease of $0.5mm during the quarter. The decrease was driven by annual bonus and sales commissions of $1.5mm, share repurchases of $0.6mm and equipment purchases of $0.3mm, which were largely offset by cash generated from operations.

Quarterly Dividend

The Company’s Board of Directors approved the payment of a quarterly cash dividend of $0.025 per share of common stock. The dividend will be paid on June 4, 2012 to shareholders of record on May 18, 2012. Future declarations of quarterly dividends and the establishment of future record and payment dates are subject to the final determination of the Company’s Board of Directors.

FDA Routine Audit

In February 2012, the U.S. Food and Drug Administration conducted a routine audit of the Company’s Burlington facilities, including its AlboGraft manufacturing. In April 2012, the Company received written notice from the FDA indicating zero inspectional observations.

AlboGraft Prohibition in the U.K. and France

In response to product complaints, in April 2012, the regulatory agencies in the U.K. and France issued Prohibition Notices preventing AlboGraft sales in these two countries until their concerns are satisfied. The notices did not result in a recall and AlboGrafts already sold remain available for use. As a result of these notices, the Company recognized $0.1 million of inventory write-offs in Q1 2012. These are the first two such notices received in the Company’s 29 year history. Apart from the U.K. and France, the Company continues to sell AlboGraft in all geographies where it has regulatory approval, including the United States, Germany and the rest of the European Community.

The Company is appealing the rulings while seeking to satisfy the agencies’ concerns. In the Company’s initial face-to-face meeting with the U.K. agency on May 1st, the agency indicated that it may inspect the Company’s Burlington facilities in Q2 2012 as part of the resolution process. The Company hopes to satisfy all such concerns in three to six months, but there can be no assurances that this will occur.

 

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Business Outlook

The Company expects Q2 2012 sales of $14.2mm (+6% organic versus Q2 2011), and reported operating income of $1.0mm. The Company also expects 2012 full-year sales of $57.0mm (+8% organic vs. 2011), and reported operating income of $5.0mm.

The Company’s full-year 2012 top-line guidance has been revised downwards by $0.5mm to reflect the likely temporary loss of AlboGraft sales in the U.K and France. AlboGraft accounted for $1.0mm of sales in 2011 in these two countries.

Conference Call Reminder

Management will conduct a conference call at 5:00 p.m. EDT today to review the Company’s financial results and discuss its business outlook for the remainder of the year. The conference call will be broadcast live over the Internet. Individuals who are interested in listening to the webcast should log on to the Company’s website at www.lemaitre.com/investor. The conference call may also be accessed by dialing 866-356-3093 (+1 617-597-5381 for international callers), using pass-code 19578892. For individuals unable to join the live conference call, a replay will be available on the Company’s website.

About LeMaitre Vascular

LeMaitre Vascular is a provider of devices for the treatment of peripheral vascular disease, a condition that affects more than 20 million people worldwide. The Company develops, manufactures and markets disposable and implantable vascular devices to address the needs of its core customer, the vascular surgeon.

LeMaitre and the LeMaitre Vascular logo are registered trademarks of LeMaitre Vascular, Inc. This press release contains other trademarks and trade names of the Company.

For more information about the Company, please visit http://www.lemaitre.com.

Use of Non-GAAP Financial Measures

LeMaitre Vascular management believes that in order to better understand the Company’s short-term and long-term financial trends, investors may wish to consider certain non-GAAP financial measures as a supplement to financial performance measures prepared in accordance with GAAP. These non-GAAP measures result from facts and circumstances that vary in frequency and/or impact on continuing operations. Investors should consider these non-GAAP measures in addition to, and not as a substitute for, financial performance measures in accordance with GAAP. In addition to the description provided below, reconciliation of GAAP to non-GAAP results is provided in the financial statement tables included in this press release.

 

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In this press release, the Company has reported non-GAAP financial measures relating to sales growth after adjusting for foreign exchange, business development transactions, and other events. The Company refers to this as “organic” sales growth, and it differs from the manner in which the Company calculated the “organic” sales growth prior to the fourth quarter of 2011 in that previously, divestitures were adjusted from the current year reported sales, but are now adjusted from the prior year reported sales. The Company analyzes net sales on a constant currency basis net of acquisitions and other non-recurring events to better measure the comparability of results between periods. Because changes in foreign currency exchange rates have a non-operating impact on net sales, and acquisitions, product discontinuations, and other strategic transactions are episodic in nature and highly variable in sales impact, the Company believes that evaluating growth in sales on a constant currency basis net of such transactions provides an additional and meaningful assessment of sales to both management and the Company’s investors. During Q3 2011, the Company completed its divestiture of the TAArget and UniFit product lines and ceased distributing the Endologix Powerlink stent graft.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the U.S. Private Securities Litigation Reform Act of 1995. Statements in this press release regarding the Company’s business that are not historical facts may be “forward-looking statements” that involve risks and uncertainties. Specifically, statements regarding the financial and operational guidance, our AlboGraft product complaints and recalls and our related remediation efforts; our AlboGraft U.K. and French Prohibition Notices and our expectations regarding the success of appeals for rescission of such sales prohibitions, future sales growth, commercial success of the launch of the Over-the-Wire LeMaitre Valvulotome or The UnBalloon or other products, commercial success of the XenoSure product, manufacturing consolidations, effectiveness of the expanded sales force, acceptance of the product portfolio mix, and the addition of direct-sales territories are forward-looking, involving risks and uncertainties. The Company’s current quarterly financial results, as discussed in this release, are preliminary and unaudited, and subject to adjustment. Forward-looking statements are based on management’s current, preliminary expectations and are subject to risks and uncertainties that could cause actual results to differ from the results predicted. These risks and uncertainties include, but are not limited to, the risk that sales prohibitions against our AlboGraft product in the United Kingdom and France may not be rescinded in a timely manner or at all; the risk that the sales prohibitions against our AlboGraft product will expand to countries beyond the United Kingdom and France; the risk that the Company experiences significant fluctuations in its quarterly and annual results; the risk that assumptions about the market for the Company’s products may not be correct; the productivity of our direct sales force and distributors; risks related to product demand and market acceptance of the Company’s products; risks that the Company’s products may fail to provide the desired safety and efficacy; risks related to attracting, training and retaining sales representatives and other employees; risks related to government mandated or voluntary recalls that could occur as a result of component failures, manufacturing errors or design defects, the significant competition the Company faces from other companies, technologies, and alternative medical procedures; the risk that the Company may fail to expand its product offerings through internal development or acquisition; the risk that the Company is not successful in transitioning to a direct-selling model in new territories; the risk that the Company experiences production delays or quality difficulties

 

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in the consolidation of its manufacturing operations; the general uncertainty related to seeking regulatory approvals for the Company’s products; adverse conditions in the general domestic and global economic markets and other risks and uncertainties included under the heading “Risk Factors” in our most recent Annual Report on Form 10-K, as updated by our subsequent filings with the SEC, all of which are available on the Company’s investor relations website at http://www.lemaitre.com and on the SEC’s website at http://www.sec.gov. Undue reliance should not be placed on forward-looking statements, which speak only as of the date they are made. The Company undertakes no obligation to update publicly any forward-looking statements to reflect new information, events, or circumstances after the date they were made, or to reflect the occurrence of unanticipated events.

Financial Statements

 

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LEMAITRE VASCULAR, INC (NASDAQ: LMAT)

CONDENSED CONSOLIDATED BALANCE SHEETS

(amounts in thousands)

 

     March 31,
2012
    December 31,
2011
 
     (unaudited)        

Assets

    

Current assets:

    

Cash and cash equivalents

   $ 19,622      $ 20,132   

Accounts receivable, net

     8,690        8,541   

Inventories

     8,297        8,003   

Other current assets

     3,009        3,011   
  

 

 

   

 

 

 

Total current assets

     39,618        39,687   

Property and equipment, net

     4,631        4,661   

Goodwill

     11,917        11,917   

Other intangibles, net

     2,800        2,985   

Deferred tax assets

     7        6   

Other assets

     416        431   
  

 

 

   

 

 

 

Total assets

   $ 59,389      $ 59,687   
  

 

 

   

 

 

 

Liabilities and stockholders’ equity

    

Current liabilities:

    

Accounts payable

   $ 825      $ 981   

Accrued expenses

     5,442        5,539   

Acquisition-related obligations

     19        19   
  

 

 

   

 

 

 

Total current liabilities

     6,286        6,539   

Deferred tax liabilities

     989        989   

Other long-term liabilities

     68        71   
  

 

 

   

 

 

 

Total liabilities

     7,343        7,599   

Stockholders’ equity

    

Common stock

     163        163   

Additional paid-in capital

     64,500        64,619   

Accumulated deficit

     (6,054     (6,440

Accumulated other comprehensive loss

     (313     (606

Less: treasury stock

     (6,250     (5,648
  

 

 

   

 

 

 

Total stockholders’ equity

     52,046        52,088   
  

 

 

   

 

 

 

Total liabilities and stockholders’ equity

   $ 59,389      $ 59,687   
  

 

 

   

 

 

 

 

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LEMAITRE VASCULAR, INC (NASDAQ: LMAT)

CONDENSED CONSOLIDATED STATEMENT OF OPERATIONS

(amounts in thousands, except per share amounts)

(unaudited)

 

     For the three months ended  
     March 31,
2012
    March 31,
2011
 

Net sales

   $ 13,928      $ 14,598   

Cost of sales

     4,058        4,447   
  

 

 

   

 

 

 

Gross profit

     9,870        10,151   

Operating expenses:

    

Sales and marketing

     5,213        4,973   

General and administrative

     2,668        2,848   

Research and development

     1,135        1,272   

Restructuring charges

     —          1,005   

Impairment charge

     —          83   
  

 

 

   

 

 

 

Total operating expenses

     9,016        10,181   
  

 

 

   

 

 

 

Income (loss) from operations

     854        (30

Other income (loss):

    

Interest income, net

     7        1   

Other income (loss), net

     (198     147   
  

 

 

   

 

 

 

Total other income (loss), net

     (191     148   
  

 

 

   

 

 

 

Income before income taxes

     663        118   

Provision for income taxes

     277        54   
  

 

 

   

 

 

 

Net income

   $ 386      $ 64   
  

 

 

   

 

 

 

Net income per share of common stock:

    

Basic

   $ 0.03      $ —     
  

 

 

   

 

 

 

Diluted

   $ 0.02      $ —     
  

 

 

   

 

 

 

Weighted average shares outstanding:

    

Basic

     15,294        15,465   
  

 

 

   

 

 

 

Diluted

     15,726        16,038   
  

 

 

   

 

 

 

Cash dividends declared per common share

   $ 0.025      $ 0.020   
  

 

 

   

 

 

 

 

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LEMAITRE VASCULAR, INC (NASDAQ: LMAT)

SELECTED NET SALES INFORMATION

(amounts in thousands)

(unaudited)

 

     For the three months ended  
     March 31, 2012     March 31, 2011  
     $      %     $      %  

Net Sales by Product Category:

          

Open Vascular

   $ 11,405         82   $ 10,760         74

Endovascular and other

     2,523         18     3,838         26
  

 

 

    

 

 

   

 

 

    

 

 

 

Total Net Sales

   $ 13,928         100   $ 14,598         100
  

 

 

    

 

 

   

 

 

    

 

 

 

Net Sales by Geography

          

Americas

   $ 9,474         68   $ 9,002         62

International

     4,454         32     5,596         38
  

 

 

    

 

 

   

 

 

    

 

 

 

Total Net Sales

   $ 13,928         100   $ 14,598         100
  

 

 

    

 

 

   

 

 

    

 

 

 

LEMAITRE VASCULAR, INC (NASDAQ: LMAT)

IMPACT OF FOREIGN CURRENCY AND BUSINESS ACTIVITIES

(amounts in thousands)

(unaudited)

 

     2012     2011     2010  
     Q1     Q4     Q3     Q2     Q1     Q4     Q3     Q2     Q1  

Total net sales

     13,928        13,411        14,564        15,112        14,598        14,431        13,656        14,158        13,815   

Impact of currency exchange rate fluctuations (1)

     (146     15        431        669        10        (420     (418     (336     314   

Net impact of acquisitions and distributed sales, excluding currency exchange rate fluctuations (2)

     —          260        319        335        328        156        —          —          95   

Net impact of discontinued products, excluding excluding currency rate fluctuations (3)

     (1,584     (1,904     (370     (76     (45     (100     (105     (65     —     
  

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

 

(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 new sales of acquired products or businesses and newly distributed sales of other manufacturers’ during the current year period, measured for 12 months following the date of the event or transaction.
(3) Represents the impact of sales related to discontinued and divested products, and discontinued distributed sales of other manufacturers’ products, during the comparable prior period, measured for 12 months following the date of the event or transaction.

 

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LEMAITRE VASCULAR, INC (NASDAQ: LMAT)

NON-GAAP FINANCIAL MEASURES

(amounts in thousands)

(unaudited)

 

Reconciliation between GAAP and Non-GAAP sales growth:

       

For the three months ending March 31, 2012

       

Net sales as reported

   $ 13,928        

Impact of currency exchange rate fluctuations

     146        
  

 

 

      

Adjusted net sales

     $ 14,074      

For the three months ending March 31, 2011

       

Net Sales as reported

   $ 14,598        

Net impact of discontinued products sales excluding currency

     (1,584     
  

 

 

      

Adjusted net sales

     $ 13,014      
    

 

 

    

Adjusted net sales increase for the three months ending March 31, 2012

     $ 1,060         8
    

 

 

    

 

 

 

Reconciliation between GAAP and Non-GAAP Americas sales growth:

       

For the three months ending March 31, 2012

     $ 9,474      

For the three months ending March 31, 2011

       

Net Sales as reported

   $ 9,002        

Net impact of discontinued products sales excluding currency

     (30     
  

 

 

      

Adjusted net sales

     $ 8,972      
    

 

 

    

Adjusted net sales increase for the three months ending March 31, 2012

     $ 502         6
    

 

 

    

 

 

 

Reconciliation between GAAP and Non-GAAP International sales growth:

       

For the three months ending March 31, 2012

       

Net sales as reported

   $ 4,454        

Impact of currency exchange rate fluctuations

     146        
  

 

 

      

Adjusted net sales

     $ 4,600      

For the three months ending March 31, 2011

       

Net Sales as reported

   $ 5,596        

Net impact of discontinued products sales excluding currency

     (1,554     
  

 

 

      

Adjusted net sales

     $ 4,042      
    

 

 

    

Adjusted net sales increase for the three months ending March 31, 2012

     $ 558         14
    

 

 

    

 

 

 

Reconciliation between GAAP and Non-GAAP Japan growth:

       

For the three months ending March 31, 2012

       

Net sales as reported

   $ 616        

Impact of currency exchange rate fluctuations

     (22     
  

 

 

      

Adjusted net sales

     $ 594      

For the three months ending March 31, 2011

       

Net Sales as reported

     $ 500      
    

 

 

    

Adjusted net sales increase for the three months ending March 31, 2012

     $ 94         19
    

 

 

    

 

 

 

 

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Reconciliation between GAAP and Non-GAAP Italy sales growth:

       

For the three months ending March 31, 2012

       

Net sales as reported

   $ 493        

Impact of currency exchange rate fluctuations

     21        
  

 

 

      

Adjusted net sales

     $ 514      

For the three months ending March 31, 2011

       

Net Sales as reported

   $ 584        

Net impact of discontinued products sales excluding currency

     (126     
  

 

 

      

Adjusted net sales

     $ 458      
    

 

 

    

Adjusted net sales increase for the three months ending March 31, 2012

     $ 56         12
    

 

 

    

 

 

 

Reconciliation between GAAP and Non-GAAP Germany sales growth:

       

For the three months ending March 31, 2012

       

Net sales as reported

   $ 2,732        

Impact of currency exchange rate fluctuations

     120        
  

 

 

      

Adjusted net sales

     $ 2,852      

For the three months ending March 31, 2011

       

Net Sales as reported

   $ 3,735        

Net impact of discontinued products sales excluding currency

     (1,128     
  

 

 

      

Adjusted net sales

     $ 2,607      
    

 

 

    

Adjusted net sales increase for the three months ending March 31, 2012

     $ 245         9
    

 

 

    

 

 

 

Reconciliation between GAAP and Non-GAAP sales growth for Quarterly Guidance:

       

For the three months ending June 30, 2012

       

Net sales per guidance

   $ 14,200        

Impact of currency exchange rate fluctuations

     348        
  

 

 

      

Adjusted net sales

     $ 14,548      

For the three months ending June 30, 2011

     15,112        

Net impact of discontinued products sales excluding currency

     (1,343     
  

 

 

      

Adjusted net sales

     $ 13,769      
    

 

 

    

Adjusted net sales increase for the three months ending June 30, 2012

     $ 779         6
    

 

 

    

 

 

 

Reconciliation between GAAP and Non-GAAP sales growth for Annual Guidance:

       

For the year ending December 31, 2012

       

Net sales per guidance

   $ 57,000        

Impact of currency exchange rate fluctuations

     834        
  

 

 

      

Adjusted net sales

     $ 57,834      

For the year ending December 31, 2011

     57,685        

Net impact of discontinued products sales excluding currency

     (4,068     
  

 

 

      

Adjusted net sales

     $ 53,617      
    

 

 

    

Adjusted net sales increase for the year ending December 31, 2012

     $ 4,217         8
    

 

 

    

 

 

 

 

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