Attached files

file filename
EX-31.1 - PALOMAR MEDICAL TECHNOLOGIES INCex31.htm
EX-32 - PALOMAR MEDICAL TECHNOLOGIES INCex32.htm
EX-31.2 - PALOMAR MEDICAL TECHNOLOGIES INCex312.htm

 
 

 


UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
 
FORM 10-Q

x
 
Quarterly Report pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
For the Quarter Ended September 30, 2010
 
¨
 
Transition Report pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
For the transition period from              to             

Commission file number:  0-22340
 
 
 
 
PALOMAR MEDICAL TECHNOLOGIES, INC.

A Delaware Corporation                                                                            I.R.S. Employer Identification No. 04-3128178

15 Network Drive, Burlington, Massachusetts  01803
Registrant’s telephone number, including area code:  (781) 993-2300

Securities registered pursuant to Section 12(b) of the Act:
Title of each class
Common Stock, $0.01 par value
Preferred Stock Purchase Rights
Name of each exchange on which registered
NASDAQ – Global Select Market
 
Securities registered pursuant to Section 12(g) of the Act:
None.

Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days.    Yes   x       No    ¨    

Indicate by check mark whether the registrant has submitted electronically and posted on its corporate Web site, if any, every Interactive Data File required to be submitted and posted pursuant to Rule 405 of Regulation S-T during the preceding 12 months (or for such shorter period that the registrant was required to submit and post such files).
Yes   ¨    No    ¨    

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, or a smaller reporting company. See the definitions of “large accelerated filer,” “accelerated filer,” and “smaller reporting company” in Rule 12b(2) of the Exchange Act. (Check one).

Large accelerated filer  ¨ Accelerated filer  x Non-accelerated filer  ¨  Smaller reporting company ¨
            (Do not check if a smaller
               reporting company)

Indicate by check mark if the registrant is a shell company, in Rule 12b(2) of the Exchange Act.    Yes  ¨    No  x

The number of shares outstanding of the registrant’s common stock as of the close of business on November 3, 2010 was 18,573,445.


 
 

 

 
Palomar Medical Technologies, Inc. and Subsidiaries


Table of Contents
 
     Page No.
PART I – Financial Information  
 Item 1. Financial Statements  
  Unaudited Condensed Consolidated Balance Sheets as of  September 30, 2010 and December 31, 2009   3
  Unaudited Condensed Consolidated Statements of Operations for the periods ended September 30, 2010 and September 30, 2009   4
  Unaudited Condensed Consolidated Statements of Cash Flows for the periods ended  September 30, 2010 and September 30, 2009  5
  Notes to Unaudited Condensed Consolidated Financial Statements  6
Item 2.  Management’s Discussion and Analysis of Financial Condition and the Results of Operations  14
Item 3. Quantitative and Qualitative Disclosures About Market Risk   20
Item 4.  Controls and Procedures   21
PART II – Other Information  
Item 1.  Legal Proceedings  21
Item 1A.  Risk Factors 24
Item 2.  Changes in Securities, Use of Proceeds and Issuer Purchases of Securities 26
Item 3.  Defaults Upon Senior Securities 26
Item 4.   (Removed and Reserved)  26
Item 5. Other Information 26
Item 6.   Exhibits  26
SIGNATURES   27
    
 



 
 

 

Palomar Medical Technologies, Inc. and Subsidiaries
Condensed Consolidated Balance Sheets
(Unaudited)
 


   
September 30,
   
December 31,
 
   
2010
   
2009
 
             
Assets
 
Current assets
           
Cash and cash equivalents
  $ 76,623,685     $ 81,948,482  
Short-term investments
    1,999,675       25,000,000  
Total cash, cash equivalents and short-term investments
    78,623,360       106,948,482  
Accounts receivable, net
    5,035,232       4,436,219  
Inventories
    12,218,475       11,126,352  
Other current assets
    1,783,674       2,179,233  
Total current assets
    97,660,741       124,690,286  
                 
Marketable securities, at estimated fair value
    24,129,348       4,024,313  
                 
Property and equipment, net
    37,271,766       34,629,410  
                 
Other assets
    218,716       126,087  
                 
Total assets
  $ 159,280,571     $ 163,470,096  
                 
Liabilities and Stockholders' Equity
 
                 
Current liabilities
               
Accounts payable
  $ 3,326,847     $ 2,696,217  
Accrued liabilities
    9,245,816       8,959,679  
Deferred revenue
    3,793,124       5,221,924  
Total current liabilities
    16,365,787       16,877,820  
                 
Accrued income taxes
    2,788,802       2,965,077  
                 
Total liabilities
  $ 19,154,589     $ 19,842,897  
                 
Commitments and contingencies (Note 9)
               
                 
Stockholders' equity
               
Preferred stock, $0.01 par value-
               
Authorized - 1,500,000 shares
               
Issued -  none
    -       -  
Common stock, $0.01 par value-
               
Authorized - 45,000,000 shares
               
Issued - 18,573,262 and 18,521,045 shares, respectively
    185,733       185,211  
Additional paid-in capital
    209,629,876       206,740,492  
Accumulated other comprehensive loss
    (460,540 )     (292,297 )
Accumulated deficit
    (69,229,087 )     (63,006,207 )
Total stockholders' equity
  $ 140,125,982     $ 143,627,199  
                 
Total liabilities and stockholders’ equity
  $ 159,280,571     $ 163,470,096  
                 
                 

See accompanying notes to condensed consolidated financial statements.

  3
 

 

Palomar Medical Technologies, Inc. and Subsidiaries
Condensed Consolidated Statements of Operations
(Unaudited)


 
   
Three Months Ended
   
Nine Months Ended
 
   
September 30,
   
September 30,
 
   
2010
   
2009
   
2010
   
2009
 
 Revenues
                       
 Product revenues
  $ 9,273,158     $ 7,528,645     $ 27,655,391     $ 23,939,493  
 Service revenues
    3,749,164       3,700,511       11,512,299       10,884,073  
 Royalty revenues
    1,499,182       1,264,022       4,444,327       4,032,039  
 Funded product development revenues
    -       806,482       -       1,636,082  
 Other revenues
    1,250,000       1,250,000       3,750,000       3,750,000  
 Total revenues
    15,771,504       14,549,660       47,362,017       44,241,687  
                                 
 Costs and expenses
                               
 Cost of product revenues
    3,781,473       2,873,956       10,583,241       9,849,383  
 Cost of service revenues
    1,367,316       1,901,303       4,320,439       5,417,280  
 Cost of royalty revenues
    599,673       505,609       1,777,731       1,612,816  
 Research and development
    3,545,622       3,305,311       11,320,691       10,125,279  
 Selling and marketing
    4,663,632       4,062,930       14,408,442       13,464,732  
 General and administrative
    4,267,535       2,451,496       11,579,566       7,566,053  
 Total costs and expenses
    18,225,251       15,100,605       53,990,110       48,035,543  
                                 
 Loss from operations
    (2,453,747 )     (550,945 )     (6,628,093 )     (3,793,856 )
                                 
 Interest income
    108,630       218,169       309,747       551,817  
 Other income
    390,784       156,941       212,922       506,761  
                                 
 Loss before income taxes
    (1,954,333 )     (175,835 )     (6,105,424 )     (2,735,278 )
                                 
 Provision for (benefit from) income taxes
    69,454       120,752       117,456       (780,319 )
                                 
 Net loss
  $ (2,023,787 )   $ (296,587 )   $ (6,222,880 )   $ (1,954,959 )
                                 
 Net loss per share
                               
 Basic
  $ (0.11 )   $ (0.02 )   $ (0.34 )   $ (0.11 )
 Diluted
  $ (0.11 )   $ (0.02 )   $ (0.34 )   $ (0.11 )
                                 
Weighted average number of shares outstanding
                         
 Basic
    18,561,877       18,065,655       18,539,847       18,058,246  
 Diluted
    18,561,877       18,065,655       18,539,847       18,058,246  
                                 
 Comprehensive loss:
                               
 Net loss
  $ (2,023,787 )   $ (296,587 )   $ (6,222,880 )   $ (1,954,959 )
     Unrealized gain (loss) on marketable securities, net of taxes     5,256       (24,138 )     (56,657 )     142,645  
 Foreign currency translation adjustment
    (122,434 )     (24,690 )     (111,586 )     (115,680 )
 Comprehensive loss
  $ (2,140,965 )   $ (345,415 )   $ (6,391,123 )   $ (1,927,994 )
                                 
                                 
 
See accompanying notes to condensed consolidated financial statements.

  4
 

 

Palomar Medical Technologies, Inc. and Subsidiaries
Condensed Consolidated Statements of Cash Flows
(Unaudited)
 
                 
Nine Months Ended
 
                 
September 30,
 
                 
2010
 
2009
 
Operating activities
           
 
Net loss
       
 $      (6,222,880
)
 $      (1,954,959
                         
 
Adjustments to reconcile net loss to net cash (used in) from operating activities:
 
   
Depreciation and amortization
 
              956,602
 
             469,167
 
   
Stock-based compensation expense
 
           2,794,761
 
          2,573,483
 
   
Provision for bad debt
 
                70,694
 
             139,810
 
   
Inventory write-off
 
              207,443
 
             151,274
 
   
Change in deferred tax asset
 
                  5,176
 
         (1,179,411
   
Tax benefit from the exercise of stock options
 
              (46,437
            (264,100
   
Other non-cash items
 
              (44,781
             178,000
 
   
Changes in assets and liabilities:
         
     
Accounts receivable
 
            (660,480
             738,195
 
     
Inventories
   
         (1,163,575
          3,690,047
 
     
Other current assets
 
              402,125
 
             894,688
 
     
Other assets
   
              (54,797
                 2,538
 
     
Accounts payable
 
              351,590
 
          2,947,087
 
     
Accrued liabilities
 
              476,106
 
          1,428,661
 
     
Accrued income taxes
 
            (176,275
)
               15,122
 
     
Deferred revenue
 
         (1,612,595
         (2,047,346
       
Net cash (used in) from operating activities
 
         (4,717,323
          7,782,256
 
                         
Investing activities
           
 
Purchases of property and equipment
 
         (3,592,144
       (15,775,678
 
Purchases of marketable securities
 
       (22,055,963
                         -
 
 
Purchases of short-term investments
 
         (1,999,675
)
                         -
 
 
Proceeds from sale of short-term investments
  25,000,000   -  
 
Proceeds from sale of marketable securities
 
           1,850,000
 
             625,000
 
       
Net cash used in investing activities
 
            (797,782
)
       (15,150,678
                         
Financing activities
           
 
Proceeds from the exercise of stock options and warrants
 
                48,708
 
             117,415
 
 
Tax benefit from the exercise of stock options
 
                46,437
 
             264,100
 
  Costs incurred related to purchase of stock for treasury   -   (258,491
 
Proceeds from borrowings on credit facility
 
                          -
 
        14,000,000
 
 
Payments on borrowings on credit facility
 
                          -
 
       (20,000,000
       
Net cash from (used in) financing activities
 
                95,145
 
         (5,876,976
           
Effect of exchange rate changes on cash and cash equivalents
    95,163     4,236  
   
Net decrease in cash and cash equivalents
 
         (5,324,797
)
       (13,241,162
Cash and cash equivalents, beginning of the period
 
         81,948,482
 
      122,601,139
 
Cash and cash equivalents, end of the period
 
 $      76,623,685
 
 $   109,359,977
 
                         
Supplemental disclosure of cash flow information
 
                         
 
 Cash paid for income taxes
 
 $             52,000
 
 $            36,493
 
                         
Supplemental noncash investing activities
         
 
Unrealized (loss) gain on marketable securities, net of taxes
 $           (56,657
)
 $          142,645
 
                         
                         
See accompanying notes to condensed consolidated financial statements.

 

 
Palomar Medical Technologies, Inc. and Subsidiaries
Notes to Condensed Consolidated Financial Statements
(Unaudited)

 
Note 1 –    Basis of presentation
 
The accompanying unaudited condensed consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States for interim information.  The consolidated balance sheet at December 31, 2009 has been derived from the audited balance sheet at that date; however, the accompanying financial statements do not include all of the information and footnotes required by accounting principles generally accepted in the United States for complete financial statements.  The results of operations for the interim periods shown in this report are not necessarily indicative of expected results for any future interim period or for the entire fiscal year.  We believe that the quarterly information presented includes all adjustments (consisting of normal, recurring adjustments) necessary for a fair presentation in accordance with accounting principles generally accepted in the United States.  The accompanying condensed consolidated financial statements and notes should be read in conjunction with our Form 10-K for the year ended December 31, 2009.

In 2010, we reclassified certain balances within revenues and costs and expenses.  To be consistent with the 2010 presentation, we reclassified certain 2009 balances within revenues and costs and expenses in the accompanying Condensed Consolidated Statements of Operations.  The reclassifications had no impact on previously reported results of operations or cash flow related to operating activities.

There have been no recent accounting pronouncements or changes in accounting pronouncements during the nine months ended September 30, 2010, as compared to the recent accounting pronouncements described in the Company’s Form 10-K, that are of significance, or potential significance to the Company.

Note 2 – Stock-based compensation
 
Stock-based compensation expense recorded was $0.9 million and $1.0 million for the three months ended September 30, 2010 and 2009, respectively and $2.8 million and $2.6 million for the nine months ended September 30, 2010 and 2009, respectively.  As of September 30, 2010, there was $4.1 million of unrecognized compensation expense related to non-vested share awards.  The expense is expected to be recognized over a weighted-average period of 1.6 years.

During the three months ended September 30, 2010, no equity awards, including options, warrants, stock-settled stock appreciation rights, or restricted stock were granted.  During the nine months ended September 30, 2010, 8,000 stock-settled stock appreciation rights were granted.

 
Note 3 – Inventories
 
Inventories are valued at the lower of cost (first-in, first-out method) or market, and include material, labor and manufacturing overhead. At September 30, 2010 and December 31, 2009, inventories consisted of the following:
 
       
 September 30,
December 31,       
 
       
  2010
2009               
    
 
Raw materials
 
 $         4,984,923
 $         4,365,150
 
 
Work in process
 
            1,397,387
               361,931
 
 
Finished goods
 
            5,836,165
            6,399,271
 
   
Total
 
 $       12,218,475
 $       11,126,352
 
             
 
 
 
6

 

 
Note 4 – Property and equipment
 

Property and equipment are recorded at cost.  Repairs and maintenance costs are expensed as incurred. Depreciation and amortization are provided using the straight-line method over the estimated useful lives of property and equipment.  Land and construction in progress assets are not depreciated.  At September 30, 2010 and December 31, 2009, property and equipment consisted of the following:

   
September 30,
   
December 31,
 
Estimated
   
2010
   
2009
 
useful life
               
Land
  $ 10,680,000     $ 10,680,000    
Building
    24,307,148       -  
39 years
Machinery and equipment
    2,698,464       2,100,331  
3-7 years
Furniture and fixtures
    5,405,189       3,364,989  
7 years
Leasehold improvements
    39,589       537,648  
Shorter of estimated useful life or term of lease
Construction in progress
    -       23,385,614    
      43,130,390       40,068,582    
Accumulated depreciation
    (5,858,624 )     (5,439,172 )  
          Total
  $ 37,271,766     $ 34,629,410    

On November 19, 2008, we purchased land for $10.7 million on which we built our new operational facility.  Construction of the building was completed and the building was placed into service during the first quarter of 2010.  We financed the project by using cash on hand.

Note 5 – Warranty costs

We typically offer a one year warranty on our base systems. Warranty coverage provided is for labor and parts necessary to repair the systems during the warranty period. We account for the estimated warranty cost of the standard warranty coverage as a charge to cost of revenue when revenue is recognized. The estimated warranty cost is based on units sold, historical product performance and the cost per repair. We assess the adequacy of the warranty provision and we may adjust this provision if necessary.

The following table provides the detail of the change in our product warranty accrual, which is a component of accrued liabilities on the Condensed Consolidated Balance Sheets as of September 30, 2010 and December 31, 2009:
 
     
   September 30,
   
   December 31,
 
     
  2010
   
   2009
 
 
Warranty accrual, beginning of period
  $ 596,210     $ 856,158  
 
Charges to cost and expenses relating to new sales
    1,097,107       1,280,301  
 
Costs of product warranty claims/change of estimate
    (1,173,832 )     (1,540,249 )
 
Warranty accrual, end of period
  $ 519,485     $ 596,210  

Note 6 – Fair Value of Financial Instruments

 In September 2006, the Financial Accounting Standards Board (FASB) issued new guidance on fair value measurements.  This guidance defines fair value, establishes a framework for measuring fair value and expands disclosure of fair value measurements.  The guidance applies under other accounting pronouncements that require or permit fair value measurements and accordingly, does not require any new fair value measurements.  This guidance was effective for financial statements issued for fiscal years beginning after November 15, 2007, and we adopted this guidance on January 1, 2008.  In February 2008, the FASB issued an update to the fair value measurement guidance.  This guidance permitted the delayed application of the fair value measurement guidance for all non-recurring fair value measurements of non-financial assets and non-financial liabilities until fiscal years beginning after November 15, 2008.  The adoption of this guidance had no impact on the Company’s consolidated financial statements.
 

 
7

 
 
We performed an analysis of our investments held at September 30, 2010 and December 31, 2009 to determine the significance and character of all inputs to their fair value determination.  The standard requires additional disclosures about the inputs used to develop the measurements and the effect of certain measurements on changes in fair value for each reporting period.

The FASB’s fair value measurement guidance establishes a fair value hierarchy that prioritizes the inputs to valuation techniques used to measure fair value into the following three broad categories.

·  
Level 1 - Inputs are unadjusted, quoted prices in active markets for identical assets or liabilities at the measurement date.
 
·  
Level 2 - Inputs (other than quoted prices included in Level 1) are either directly or indirectly observable for the asset or liability through correlation with market data at the measurement date and for the duration of the instrument’s anticipated life.
 
·  
Level 3 - Inputs reflect management’s best estimate of what market participants would use in pricing the asset or liability at the measurement date. Consideration is given to the risk inherent in the valuation technique and the risk inherent in the inputs to the model.

Fair Value on a Recurring Basis

Assets and liabilities measured at fair value on a recurring basis are categorized in the tables below based upon the lowest level of significant input to the valuations.  The following table presents our assets measured at fair value on a recurring basis as of September 30, 2010 and December 31, 2009.
 

Assets 
 
Fair Value as of September 30, 2010
 
(In thousands)
 
  Level 1
 
Level 2
 
Level 3
 
Total
 
Short-term investments
 
$
2,000
 
$
-
 
$
-
24
$
2,000
 
Marketable securities
   
22,042
   
-
   
-
   
22,042
 
Auction-rate preferred securities
   
-
   
-
   
1,006
   
1,006
 
Auction-rate municipal securities
   
-
   
-
   
1,081
   
1,081
 
Total
 
$
24,042
 
$
-
 
$
2,087
 
$
26,129
 
 
 
Assets 
 
Fair Value as of December 31, 2009
 
(In thousands)
 
  Level 1
 
Level 2
 
Level 3
 
Total
 
Short-term investments
 
$
25,000
 
$
-
 
$
-
24
$
25,000
 
Auction-rate preferred securities
   
-
   
-
   
2,622
   
2,622
 
Auction-rate municipal securities
   
-
   
-
   
1,402
   
1,402
 
Total
 
$
25,000
 
$
-
 
$
4,024
 
$
29,024
 
 
 


At September 30, 2010, the amortized cost basis of the auction-rate preferred securities and auction-rate municipal securities were $1.1 million and $1.4 million, respectively.  At December 31, 2009, the amortized cost basis of the auction-rate preferred securities and auction-rate municipal securities were $2.9 million and $1.5 million, respectively.  As described in more detail below, all of our auction-rate securities (ARS) have unrealized losses which have been recorded in accumulated other comprehensive loss.

There is no maturity date of the auction-rate preferred securities while the maturity date for our auction-rate municipal securities is in December 2045.

At September 30, 2010, we had $22.0 million of marketable securities classified as held-to-maturity securities which included commercial paper, U.S Treasuries, and corporate bonds.  The maturity dates range from 91 days to 2 years.


 

 

Level 3 Gains and Losses

The table presented below summarizes the change in balance sheet carrying values associated with Level 3 financial instruments for the nine months ended September 30, 2010.
 
 
   Auction-rate
       Auction-rate
   
(In thousands)
   preferred securities
         municipal securities
Total
Balance at December 31, 2009
$2,622
 
$1,402
 
$4,024
 
Net payments, purchases and sales
(1,750
(100
(1,850
Net transfers in/(out)
-
 
-
 
-
 
Gains/(losses)
           
    Realized
-
 
-
 
-
 
    Unrealized
134
        (221   (87
Balance at September 30, 2010
$1,006
 
$1,081
 
$2,087
 
             
             
 
 
All of the above ARS have been in a continuous unrealized loss position for 12 months or longer.  We continue to receive regular dividends from each of our ARS at current market rates.
 
Historically, the ARS market was an active and liquid market where we could purchase and sell our ARS on a regular basis through auctions.  As such, we classified our ARS as Level 1 investments in accordance with the FASB’s guidance at December 31, 2007.  Subsequent to December 31, 2007, several of our ARS failed at auction due to a decline in liquidity in the ARS and other capital markets.  We will not be able to access our investments in ARS until future auctions are successful, ARS are called for redemption by the issuers, or until sold in a secondary market.  As all of our investments in ARS currently lack short-term liquidity, we have classified these investments as non-current investments as of September 30, 2010 and December 31, 2009.

 The estimated fair value of our holdings of ARS at September 30, 2010 was $2.1 million.  To value our ARS, we determined the present value of the ARS at the balance sheet date by discounting the estimated future cash flows based on a fair value rate of interest and an expected time horizon to liquidity.  We also evaluated the credit rating of the issuer and found them all to be investment grade securities.  There was no change in our valuation method during the three and nine month periods ended September 30, 2010 as compared to prior reporting periods.  Our valuation analysis showed that our ARS have nominal credit risk.  The impairment is due to liquidity risk.  Additionally, as of September 30, 2010, we do not intend to sell the ARS, it is not more likely than not that we will be required to sell the ARS before recovery of their amortized cost bases, which may be at maturity, and we expect to recover the full amortized cost basis of these securities.  As a result of our valuation analysis, our investment strategy, recurring dividend stream from these investments, and our strong cash and cash equivalents position, we have determined that the fair value of our ARS was temporarily impaired as of September 30, 2010.

We continue to monitor the market for ARS and consider its impact, if any, on the fair value of our investments.  If current market conditions deteriorate further, we may be required to record additional unrealized losses in accumulated other comprehensive (loss) income.  If the credit rating of the security issuers deteriorates, the anticipated recovery in market values does not occur, or we stop receiving dividends, we may be required to adjust the carrying value of these investments through impairment charges in our Consolidated Statements of Operations.

Note 7 – Net loss per common share

Basic net loss per share was determined by dividing net loss by the weighted average common shares outstanding during the period.  Diluted net loss per share was determined by dividing net loss by the diluted weighted average shares outstanding. Diluted weighted average shares reflect the dilutive effect, if any, of stock options, stock appreciation rights, and warrants based on the treasury stock method.

 
9

 
A reconciliation of basic and diluted shares for the three and nine months ended September 30, 2010 and 2009 is as follows:

   
Three Months Ended
   
Nine Months Ended
 
   
September 30,
   
September 30,
 
   
2010
   
2009
   
2010
   
2009
 
Basic weighted average number of shares outstanding
    18,561,877       18,065,655       18,539,847       18,058,246  
Potential common shares pursuant to stock options, stock appreciation rights and warrants
    -       -       -       -  
Diluted weighted average number of shares outstanding
    18,561,877       18,065,655       18,539,847       18,058,246  

For the three months ended September 30, 2010 and 2009, approximately a net of 2.5 million and 2.3 million, respectively, weighted average options, stock-settled SARs, and warrants to purchase shares of our common stock were excluded from the computation of diluted earnings per share because the effect of including the options, stock-settled SARs, and warrants would have been antidilutive.

Note 8 – Income Taxes

We provide for income taxes under the liability method in accordance with the FASB’s guidance on accounting for income taxes.  Under this guidance, we can only recognize a deferred tax asset for future benefit of our tax loss, temporary differences and tax credit carry forwards to the extent that it is more likely than not that these assets will be realized.  We consider available evidence, both positive and negative, including historical levels of income, expectations and risks associated with estimates of future taxable income and ongoing prudent and feasible tax planning strategies in assessing the need for the valuation allowance.

In evaluating our ability to recover our US and foreign deferred tax assets, we considered all available positive and negative evidence, giving greater weight to the recent current losses, the absence of taxable income in the carry back periods and the uncertainty regarding our ability to project financial results in future periods. We believe that it is more likely than not that the associated deferred tax assets will not be utilized and have established a full valuation allowance.
 
We establish reserves for uncertain tax positions based on management’s assessment of exposure associated with tax deductions, permanent tax differences and tax credits. The tax reserves are analyzed periodically and adjustments are made, as events occur to warrant adjustment to the reserve. At September 30, 2010, we have $2.8 million of net unrecognized tax benefits, all of which would affect our effective tax rate, if recognized.
 
We recognize interest and penalties related to uncertain tax positions in income tax expense. As of September 30, 2010, we had approximately $113,000 of accrued interest and penalties related to uncertain tax positions.
 
The tax years 2007-2009 remain open to examination by the major taxing jurisdictions to which we are subject. We file income tax returns in the U.S. federal jurisdiction, and various state and foreign jurisdictions.
 
Note 9 – Contingencies

Candela Corporation, Massachusetts Litigation

On August 9, 2006, we commenced an action for patent infringement against Candela Corporation (now Syneron, Inc.) in the United States District Court for the District of Massachusetts seeking both monetary damages and injunctive relief. The complaint alleges Candela’s GentleYAG and GentleLASE systems, which use laser technology for hair removal willfully infringe U.S. Patent No. 5,735,844 (the “’844 patent”), which is exclusively licensed to us by MGH.  Candela answered the complaint denying that its products infringe valid claims of the asserted patent and filing a counterclaim seeking a declaratory judgment that the asserted patent and U.S. Patent No. 5,595,568 (the “’568 patent”) are invalid and not infringed.  We filed a reply denying the material allegations of the counterclaims.

 
10

 
We filed an amended complaint on February 16, 2007 to add MGH as a plaintiff.  In addition, we further alleged that Candela’s GentleMAX system willfully infringes the ‘844 patent and that Candela’s Light Station system willfully infringes both the ‘844 and ‘568 patents.  On February 16, 2007, Candela filed an amended answer to our complaint adding allegations of inequitable conduct, double patenting and violation of Massachusetts General Laws Chapter 93A.  On February 28, 2007, we filed a response to Candela’s amended complaint pointing out many weaknesses in Candela’s allegations.  A claim construction hearing, sometimes called a “Markman Hearing”, was held August 2, 2007, and we received what we consider to be a favorable Markman ruling on November 9, 2007.  

On November 17, 2008, the Judge stayed the lawsuit pending the outcome of reexamination procedures requested by a third party on both the ‘844 and ‘568 patents in the United States Patent and Trademark Office (the “Patent Office”).  On December 9, 2008, Candela also filed requests for reexamination of both patents.  Generally, a reexamination proceeding is one which re-opens patent prosecution to ensure that the claims in an issued patent are valid over prior art references.  On January 16, 2009, we filed a preliminary amendment to the ‘844 patent adding new claims 33-59 which depend from claim 32 and a preliminary amendment to the ‘568 patent adding new claims 23 and 24 which depend from claim 1. On June 9, 2009, the Patent Office issued an office action confirming the validity of all claims of the ‘844 patent except claims 12-14.  Rejecting Candela's and the other company's arguments to the contrary, the Patent Office confirmed that claims 1-3, 6-8, 11, 17-20, 27, 28, 30, 32 of the '844 patent are valid and patentable. The Patent Office also confirmed new claims 33-59 as valid and patentable.  The Patent Office rejected only independent claim 12 and related dependent claims 13-14 of the ‘844 patent as unpatentable.  We cancelled claims 12-14 from the '844 patent in order to expedite the reexamination proceeding. Claims 4, 5, 9, 10, 15, 16, 21-26, 29 and 31 were not under reexamination. Consequently, all currently pending claims were found valid by the Patent Office.  On November 18, 2009, the Patent Office issued a Reexamination Certificate for the ‘844 patent that closed the reexamination proceeding on the ‘844 patent.

On June 19, 2009, we filed a motion to lift the stay and reopen the lawsuit.  Because Candela has discontinued products which infringe the ‘568 patent, we dropped our claims of infringement of the ‘568 patent from the lawsuit and we agreed to a covenant not to sue Candela for past infringement under the ‘568 patent.  On July 13, 2009, Candela filed their opposition to our motion to lift the stay, and on July 17, 2009, we filed our response to their opposition.  On January 5, 2010 the Judge lifted the stay. Expert discovery is complete.   A hearing was held on September 14, 2010 on Candela's motion for summary judgment regarding both invalidity and non-infringement of certain claims of the '844 patent.  A trial date will not be set until the Judge rules on Candela's motion.

On August 10, 2006, Candela Corporation (now Syneron, Inc.) commenced an action for patent infringement against us in the United States District Court for the District of Massachusetts seeking both monetary damages and injunctive relief.  The complaint alleged that our StarLux System with the LuxV handpiece willfully infringes U.S. Patent No. 6,743,222 (the “’222 patent”) which is directed to acne treatment, that our QYAG5 System willfully infringes U.S. Patent No. 5,312,395 which is directed to treatment of pigmented lesions, and that our StarLux System with the LuxG handpiece willfully infringes U.S. Patent No. 6,659,999 which is directed to wrinkle treatment.  On October 25, 2006, Candela filed an amended complaint which did not include U.S. Patent No. 6,659,999.  Consequently, Candela no longer alleges in this lawsuit that the StarLux System with LuxG handpiece infringes its patents. With regard to the two remaining patents, Candela is seeking to enjoin us from selling these products in the United States if we are found to infringe the patents, and to obtain compensatory and treble damages, reasonable costs and attorney’s fees, and other relief as the court deems just and proper. On October 30, 2006, we answered the complaint denying that our products infringe the asserted patents and filing counterclaims seeking declaratory judgments that the asserted patents are invalid and not infringed.  In addition, with regard to U.S. Patent No. 5,312,395, we filed a counterclaim of inequitable conduct.

 
11

 
In February 2008, we filed a request for reexamination and then an amended request for reexamination of Candela's ‘222 patent with the Patent Office.  In our request, we argued that Candela's ‘222 patent is unpatentable over our own United States Patent No. 6,605,080 alone or in combination with other prior art.  About the same time, we filed a motion to stay all proceedings in this action related to the ‘222 patent pending resolution of the amended request for reexamination of the ‘222 patent.  In March 2008, the Patent Office granted our request for reexamination of the ‘222 patent.   On June 11, 2008, the Court ordered the parties to report back to the Court after the Patent Office made its decision in the reexamination of the ‘222 patent, after which a claim construction hearing (i.e., a Markman Hearing) would be scheduled for both the ‘222 and ‘395 patents. On June 12, 2008, the parties informed the Court that the total time the reexamination will remain pending is not known.  On January 19, 2010, the Patent Office issued a Notice of Intent to Issue Ex Parte Reexamination Certificate for the ‘222 patent which will close the reexamination proceeding on the ‘222 patent. If this lawsuit is re-started, we will continue to defend the action vigorously and believe that we have meritorious defenses of non-infringement, invalidity and inequitable conduct. However, litigation is unpredictable and we may not prevail in successfully defending or asserting our position. If we do not prevail, we may be ordered to pay substantial damages for past sales and an ongoing royalty for future sales of products found to infringe in the United States. We could also be ordered to stop selling any products in the United States that are found to infringe.

Alma Lasers, Inc., Delaware Litigation

On September 11, 2008, Alma Lasers, Inc. filed a complaint requesting a declaratory judgment that our fractional patent, U.S. Patent No. 6,997,923, is not infringed by Alma's products and is invalid over prior art.  Alma served this lawsuit on us on November 6, 2008, and on November 21, 2008, we filed an answer which denied Alma's allegations that the patent is invalid and not infringed.  We also filed a counterclaim accusing Alma's Pixel C02 Omnifit Fractional C02 Handpiece and Pixel C02 Fractional C02 Skin Resurfacing System of infringing the patent.  On December 16, 2008, upon the request of both parties, a mediation conference was scheduled for June 30, 2009 before Magistrate Judge Mary Pat Thynge.  On December 18, 2008, upon the request of both parties, the Judge presiding over the lawsuit, stayed the lawsuit and later closed the lawsuit pending the outcome of the mediation.  Due to unforeseen circumstances, the mediation scheduled for June 30, 2009 was postponed until October 13, 2009.  Following our request, Magistrate Judge Mary Pat Thynge cancelled the mediation on October 6, 2009.  By letter dated October 13, 2009, we asked presiding Judge Farnan to re-open the case.  On December 28, 2009, Alma filed a First Amended Complaint to add a claim that U.S. Patent No. 6,997,923 is unenforceable due to inequitable conduct.  On January 11, 2010, we filed our Amended Answer and Counterclaim to Alma’s First Amended Complaint denying Alma’s allegation of inequitable conduct. On March 4, 2010 the parties filed a joint stipulated order of dismissal requesting that the court dismiss this action, including all claims and counterclaims, in its entirety without prejudice, with the parties agreeing that any future litigation between them over U.S. Patent No. 6,997,923, any patent claiming priority (either directly or indirectly) thereto, and/or any patents relating to fractional technology, shall be commenced in this Court.

Syneron, Inc., Massachusetts Litigation

On November 14, 2008, we commenced an action for patent infringement against Syneron, Inc. in the United States District Court for the District of Massachusetts seeking both monetary damages and injunctive relief. The complaint alleges Syneron's eLight, eMax, eLaser, Aurora DS, Polaris DS, Comet and Galaxy Systems, which use light-based technology for hair removal, willfully infringe the ‘568 patent and the ‘844 patent, which are exclusively licensed to us by MGH.  In March 2009, we served Syneron with this suit. On April 30, 2009, the parties filed a stipulation to stay the lawsuit pending the outcome of the reexaminations of the ‘568 patent and the ‘844 patent.

On June 9, 2009, the Patent Office issued an office action confirming the validity of all claims of the ‘844 patent except claims 12-14.  The Patent Office confirmed that claims 1-3, 6-8, 11, 17-20, 27, 28, 30, 32 of the '844 patent are valid and patentable. The Patent Office also confirmed new claims 33-59 as valid and patentable.  The Patent Office rejected only independent claim 12 and related dependent claims 13-14 of the ‘844 patent as unpatentable.  We cancelled claims 12-14 from the '844 patent in order to expedite the reexamination proceeding. Claims 4, 5, 9, 10, 15, 16, 21-26, 29 and 31 were not under reexamination. Consequently, all currently pending claims were found valid by the Patent Office.  On November 18, 2009, the Patent Office issued a Reexamination Certificate for the ‘844 patent which closed the reexamination proceeding on the ‘844 patent.

 
12

 
On October 28, 2009, the Patent Office issued a Reexamination Certificate for the ‘568 patent which closed the reexamination proceeding on the ‘568 patent. The Patent Office confirmed the validity and patentability of all the claims of the ‘568 patent including new claims 23 and 24.

On September 23, 2009, we filed a motion to lift the stay and reopen the lawsuit.  On October 6, 2009, Syneron filed their opposition to our motion to lift the stay, and on October 9, 2009, we filed our response to their opposition.    On November 13, 2009, the Judge re-opened the case and a scheduling hearing took place on January 6, 2010.  The parties are in discovery.  A claim construction hearing (also known as a Markman hearing) is scheduled for November 17, 2010.  No trial date has yet been set.

Tria Beauty, Inc., Massachusetts Litigation

On June 24, 2009, we commenced an action for patent infringement against Tria Beauty, Inc. (previously named Spectragenics, Inc.), in the United States District Court for the District of Massachusetts seeking both monetary damages and injunctive relief. The complaint alleged that the Tria System, which uses light-based technology for hair removal, willfully infringes the ‘844 patent, which is exclusively licensed to us by MGH.  Tria answered the complaint denying that its products infringe valid claims of the asserted patent and filing a counterclaim seeking a declaratory judgment that the asserted patent is not infringed, is invalid and not enforceable.  We filed a reply denying the material allegations of the counterclaims.  On September 21, 2009, following successful re-examination of the ‘568 patent, we filed a motion to amend our complaint to add a claim for willful infringement of the ‘568 patent, which is also exclusively licensed to us by MGH.  Our motion also included adding MGH as a plaintiff in the lawsuit.  Tria did not oppose the motion and the Judge granted the motion on October 8, 2009.  A claim construction hearing (also known as a Markman hearing) was held on August 10, 2010, and we received what we consider to be a favorable ruling on October 13, 2010.  The parties are in discovery.  No trial date has yet been set.

Asclepion Laser Technologies GmbH, German Litigation

On October 13, 2010, we commenced an action for patent infringement against Asclepion Laser Technologies GmbH in the District Court of Düsseldorf, Germany seeking both monetary damages and injunctive relief.  The complaint alleged that Asclepion's MedioStar and RubyStar products infringe European Patent Number EP 0 806 913, which is the first issued European patent corresponding to U.S. Patent Numbers 5,595,568 and 5,735,844.

Asclepion Laser Technologies GmbH, Italian Litigation

On October 22, 2010, we were served with an International Summons for a lawsuit filed September 20, 2010 by Asclepion Laser Technologies GmbH in the Court of Rome in Italy.  In this suit, Asclepion asks the Italian court to declare that Asclepion's MedioStar and RubyStar products do not infringe either the Italian or German portions of EP 0 806 913 B1 or EP 1 230 900 B1, which are the first two issued European patents corresponding to U.S. Patent numbers 5,595,568 and 5,735,844. 

 


 
13 

 
 
Item 2.   Management’s Discussion and Analysis of Financial Condition and Results of Operations
 
The following discussion contains forward-looking statements, which involve risks and uncertainties. Our actual results could differ materially from those anticipated in these forward-looking statements as a result of various factors, including those set forth previously under the caption “Risk Factors” in our Annual Report on Form 10-K filed with the Securities and Exchange Commission on March 5, 2010 and those included in Item 1A below.  This Management’s Discussion and Analysis of Financial Condition and Results of Operations should be read in conjunction with our consolidated financial statements and related notes included elsewhere in this report.

Critical accounting policies
 
The discussion and analysis of our financial condition and results of operations are based upon our consolidated financial statements, which have been prepared in accordance with accounting principles generally accepted in the United States. The preparation of these financial statements requires us to make estimates and judgments that affect the reported amounts of assets, liabilities, revenues and expenses, and related disclosure of contingent assets and liabilities. On an on-going basis, we evaluate our estimates, including those related to revenue recognition, bad debts, inventories, investments, warranty obligations, contingencies and income taxes. We base our estimates on historical experience and on various other assumptions that we believe to be reasonable under the circumstances, the results of which form the basis for making judgments about the carrying value of assets and liabilities that are not readily apparent from other sources. Actual results may differ from these estimates under different assumptions or conditions. A discussion of our critical accounting policies and the related judgments and estimates affecting the preparation of our consolidated financial statements is included in the Annual Report on our Form 10-K fiscal year 2009.  There have been no material changes to our critical accounting policies as of September 30, 2010.

Recently issued accounting standards

There have been no recent accounting pronouncements or changes in accounting pronouncements during the nine months ended September 30, 2010, as compared to the recent accounting pronouncements described in the Company’s Form 10-K, that are of significance, or potential significance to the Company.

Overview
 
We are a global medical device company engaged in research, development, manufacturing and distribution of proprietary light-based systems for medical and cosmetic treatments. Since our inception, we have been able to develop a differentiated product mix of light-based systems for various treatments through our research and development as well as with our partnerships throughout the world. We are continually developing and testing new indications to further the advancement in light-based treatments.

Our corporate headquarters and United States operations are located in Burlington, Massachusetts, where we conduct our manufacturing, warehousing, research and development, regulatory, sales, customer service, marketing and administrative activities.  In the United States, Australia, Canada, and Japan, we market, sell and service our products primarily through our direct sales force and customer service employees.  In the rest of the world, sales are generally made through our worldwide distribution network in over 50 countries.

Recent Events

On September 21, 2010, we announced that we would move the launch of our patented, home-use laser for the treatment of periorbital wrinkles by a few months. This is the only laser with over-the-counter (OTC) clearance from the United States Food and Drug Administration (FDA) for the treatment of periorbital wrinkles.


 
14 

 

Results of operations

Revenues for the quarter ended September 30, 2010 increased to $15.8 million, as compared to $14.5 million reported in the third quarter of 2009.  Product and service revenues increased to $13.0 million, a 16 percent increase over the $11.2 million reported in the third quarter of 2009.  Third quarter gross margin from product and service revenues was 60 percent, an increase over the 57 percent reported in the third quarter of 2009.  Loss before income taxes for the third quarter ended September 30, 2010 was $2.0 million, which included a $1.5 million patent litigation expense and a $0.9 million non-cash stock-based compensation expense.

The following table contains selected income statement information, which serves as the basis of the discussion of our results of operations for the three and nine months ended September 30, 2010 and 2009, respectively (in thousands, except for percentages):

 
   
Three Months Ended September 30,
             
   
2010
   
2009
             
         
As a % of
         
As a % of
             
         
Total
         
Total
   
Change
   
Amount
   
Revenue
   
Amount
   
Revenue
     $       %
Revenues
                                     
Product revenues
  $ 9,273       59 %   $ 7,529       52 %   $ 1,744       23 %
Service revenues
    3,749       24 %     3,700       25 %     49       1 %
Royalty revenues
    1,499       10 %     1,264       9 %     235       19 %
Funded product development revenues
-       - %     806       6 %     (806 )     (100 %)
Other revenues
    1,250       8 %     1,250       9 %     -       - %
Total revenues
    15,771       100 %     14,549       100 %     1,222       8 %
                                                 
Costs and expenses
                                               
Cost of product revenues
    3,781       24 %     2,874       20 %     907       32 %
Cost of service revenues
    1,367       9 %     1,901       13 %     (534 )     (28 %)
Cost of royalty revenues
    600       4 %     506       3 %     94       19 %
Research and development
    3,546       22 %     3,305       23 %     241       7 %
Selling and marketing
    4,664       30 %     4,063       28 %     601       15 %
General and administrative
    4,267       27 %     2,451       17 %     1,816       74 %
Total costs and expenses
    18,225       116 %     15,100       104 %     3,125       21 %
                                                 
Loss from operations
    (2,454 )     (16 %)     (551 )     (4 %)     1,903       345 %
                                                 
Interest income
    109       1 %     218       1 %     (109 )     (50 %)
Other income
    391       2 %     157       1 %     234       149 %
                                                 
Loss before income taxes
    (1,954 )     (12 %)     (176 )     (1 %)     1,778       1010 %
                                                 
Provision for income taxes
69       - %     121       1 %     (52 )     (43 %)
                                                 
Net loss
  $ (2,023 )     (13 %)   $ (297 )     (2 %)   $ 1,726       581 %
                                                 
                                                 

 
15 

 

   
Nine Months Ended September 30,
             
   
2010
   
2009
             
         
As a % of
         
As a % of
             
         
Total
         
Total
   
Change
   
Amount
   
Revenue
   
Amount
   
Revenue
     $       %
Revenues
                                     
Product revenues
  $ 27,656       58 %   $ 23,940       54 %   $ 3,716       16 %
Service revenues
    11,512       24 %     10,884       25 %     628       6 %
Royalty revenues
    4,444       9 %     4,032       9 %     412       10 %
Funded product development revenues
-       - %     1,636       4 %     (1,636 )     (100 %)
Other revenues
    3,750       8 %     3,750       8 %     -       - %
Total revenues
    47,362       100 %     44,242       100 %     3,120       7 %
                                                 
Costs and expenses
                                               
Cost of product revenues
    10,584       22 %     9,850       22 %     734       7 %
Cost of service revenues
    4,320       9 %     5,417       12 %     (1,097 )     (20 %)
Cost of royalty revenues
    1,778       4 %     1,613       4 %     165       10 %
Research and development
    11,321       24 %     10,125       23 %     1,196       12 %
Selling and marketing
    14,408       30 %     13,465       30 %     943       7 %
General and administrative
    11,579       24 %     7,566       17 %     4,013       53 %
Total costs and expenses
    53,990       114 %     48,036       109 %     5,954       12 %
                                                 
Loss from operations
    (6,628 )     (14 %)     (3,794 )     (9 %)     2,834       75 %
                                                 
Interest income
    310       1 %     552       1 %     (242 )     (44 %)
Other income
    212       - %     507       1 %     (295 )     (58 %)
                                                 
Loss before income taxes
    (6,106 )     (13 %)     (2,735 )     (6 %)     (3,371 )     123 %
                                                 
Provision for (benefit from) income taxes    117       -     (780     (2 %)      897       115 %
                                                 
Net loss
  $ (6,223 )     (13 %)   $ (1,955 )     (4 %)   $ 4,268       218 %
                                                 
                                                 
 
 

Product revenues.  During the three and nine months ended September 30, 2010, our product revenues increased 23% and 16%, respectively, as compared to the corresponding periods in the prior year, primarily due to increases in revenues from sales of our StarLux Laser and Pulsed Light Systems, including a base unit and multiple, optional handpieces.
 
Service revenues.  Service revenues are primarily comprised of revenue generated from our service organization to provide ongoing service, sales of replacement handpieces, sales of consumables and accessories and repair of our products. During the three and nine months ended September 30, 2010, service revenues increased 1% and 6%, respectively,  as compared to the corresponding periods in the prior year, primarily in sales from replacement handpieces and sales of consumables and accessories.
 
The following table sets forth, for the periods indicated, information about our total product and service revenues, by geographic region:
 
     
Three Months Ended
   
Nine Months Ended
 
     
September 30,
   
September 30,
 
     
2010
   
2009
   
2010
   
2009
 
 
North America
    52 %     63 %     58 %     60 %
 
Europe
    22 %     17 %     20 %     18 %
 
South and Central America
    7 %     10 %     7 %     8 %
 
Australia
    6 %     4 %     6 %     5 %
 
Asia/Pacific Rim
    10 %     3 %     6 %     5 %
 
Other
    3 %     3 %     3 %     4 %
 
Total Product and Service Revenues
    100 %     100 %     100 %     100 %

 
16

 
Royalty revenues.  Royalty revenues increased for the three and nine months ended September 30, 2010 by 19% and 10%, respectively, as compared to the corresponding periods in the prior year.  The increase is attributed to an increase in on-going royalty payments from our licensees.

Funded product development revenues.  Funded product development revenues decreased during the three and nine months ended September 30, 2010 as compared to the same periods in 2009. This decrease in funded product development revenues is directly related to the termination of our Joint Development and License Agreement with Johnson & Johnson Consumer Companies, Inc. in the fourth quarter of 2009.

Other revenues.  For the three months ended September 30, 2010 and 2009, we recognized $1.25 million of other revenues, consisting of quarterly payments relating to a License Agreement with The Procter & Gamble Company.  For the nine months ended September 30, 2010 and 2009, we recognized $3.75 million of other revenues relating to the License Agreement.

 Cost of product revenues. For the three months ended September 30, 2010, our cost of product revenues as a percentage of total revenues was 24% as compared to 20% in the corresponding period in 2009.  The increase as a percentage of total revenues is due to a shift in product revenues away from North American sales where we sell our product through a direct sales force instead of through distributors at fixed transfer prices, offset by higher product sales volume which resulted in higher overhead absorption.  For both the nine months ended September 30, 2010 and 2009, our cost of product revenues as a percentage of total revenues was 22%.

Cost of service revenues.  For the three months ended September 30, 2010, our cost of service revenues as a percentage of total revenues was 9% as compared to 13% in the corresponding period in 2009.  For the nine months ended September 30, 2010 and 2009, our cost of service revenues as a percentage of total revenues was 9% and 12%, respectively.  The decrease is due in part to the improved absorption of fixed service costs and the continued growth of service contract revenue. We have been able to convert a high percentage of our domestic installed base to service contracts upon the expiration of the warranty periods. In addition, the failure rates in certain of our products have decreased.

Cost of royalty revenues.  The cost of royalty revenues increased for the three and nine months ended September 30, 2010 in comparison to the same periods in 2009.  This increase is attributed to higher on-going royalty payments from our licensees.  As a percentage of royalty revenues, the cost of royalty revenues was consistent at 40% in accordance with our license agreement with Massachusetts General Hospital in comparison to the same periods in 2009.

Research and development expense. For the three and nine months ended September 30, 2010, research and development expenses increased 7% and 12%, respectively, as compared to the corresponding periods in the prior year. Research and development expenses relating to our professional business decreased by 26% and 12%, respectively, for the three and nine months ended September 30, 2010, as compared to the same periods in the prior year. Research expenses relating to our professional business include internal research and development projects relating to the introduction of new professional products, enhancements to our current line of professional products as well as research and development overhead.  Research and development expense relating to our consumer business increased by 106% and 76%, respectively, for the three and nine months ended September 30, 2010 as compared to the same periods in 2009. This increase in research and development expense related to our consumer business includes increases in payroll and payroll related expense, materials, consultants, and other overhead expenses related directly to our consumer products as compared to the same periods in 2009.

Selling and marketing expense.  For the three and nine months ended September 30, 2010, selling and marketing expenses increased 15% and 7%, respectively, as compared to the corresponding periods in the prior year.  Selling and marketing expenses relating to our professional business for the three and nine months ended September 30, 2010 remained consistent with the same periods in 2009.  Contributing to our overall increase in selling and marketing expenses in 2010 were our expenses related to our consumer business.  We did not incur any sales and marketing expenses related to our consumer business in the first nine months of 2009.

 
17

 
General and administrative expense.  For the three and nine months ended September 30, 2010, general and administrative expenses increased 74% and 53%, respectively, as compared to the corresponding periods in the prior year primarily due to increases in legal expenses, incentive compensation, and general overhead expenses.  The nine months ended September 30, 2010 includes the remaining lease obligation at our old facility in addition to depreciation and other expenses related to our new facility.

Interest income. Interest income decreased for the three and nine months ended September 30, 2010 as compared to the corresponding periods in the prior year primarily from lower cash and cash equivalents, short-term investments, and marketable securities balances and lower interest rates.  The decline in our cash and cash equivalents, short-term investments, and marketable securities balance is primarily from costs associated with the construction of our new operational facility in 2009.

Other income.  Other income for the three and nine months ended September 30, 2010 and 2009 includes the foreign exchange gain resulting from transactions in currencies other than the U.S. dollar.

Provision for (benefit from) income taxes.  Our effective tax rate was 2% and (29%) for the nine months ended September 30, 2010 and 2009, respectively.  In 2010, our effective tax rate was less than the combined federal and state statutory rates primarily due to an increase in the valuation allowance.

Liquidity and capital resources
 
The following table sets forth, for the periods indicated, a year over year comparison of key components of our liquidity and capital resources (in thousands):
 
                       
   
Nine months ended
         
      September 30,  
Change
   
2010
 
2009
 
$
%
 
                       
Cash flows (used in) from operating activities
 
$
(4,717
)
$
7,782
 
(12,499
)
(161
%) 
Cash flows used in investing activities
   
(798
)  
(15,151
14,353
 
       95
Cash flows from (used in) financing activities
   
95
   
(5,877
5,972
 
102
                       
Capital expenditures
 
$
3,592
 
$
15,776
 
(12,184
(77
%) 

 
Additionally, our cash and cash equivalents, short-term investments, accounts receivable, inventories, working capital and marketable securities, at estimated fair value are shown below for the periods indicated (in thousands).
 
     September 30,      December 31,    Change  
     2010      2009    $    %  
                     
Cash and cash equivalents
$
76,624
 
$
81,948
$
   (5,324
)
   (6
%)
Short-term investments
 
2,000
   
25,000
 
(23,000
)
(92
%) 
Accounts receivable, net
 
5,035
   
4,436
 
599
 
14
%
Inventories, net
 
12,218
   
11,126
 
    1,092
 
    10
%
Working capital
 
81,295
   
107,812
 
(26,517
)
(25
%)
Marketable securities, at estimated fair value
 
24,129
   
4,024
 
  20,105
 
500
%

We believe that our current cash, cash equivalents, short-term investments, and marketable securities balances and expected future cash flows will be sufficient to meet our anticipated cash needs for working capital, capital expenditures and other activities for at least the next twelve months.
 
 
 
18

 
Cash flows (used in) from operating activities for the nine months ended September 30, 2010, decreased compared to the same period in 2009. This decrease in operating activity cash flows reflects an increase in working capital requirements, an increase in net loss, offset by an increase in depreciation and amortization and an increase in stock-based compensation expense in the first nine months of 2010, compared to the same period in 2009.  Cash flows used in investing activities decreased for the nine months ended September 30, 2010, compared to the same period in 2009. The decrease reflects lower purchases of property and equipment and higher purchases of short-term investments and marketable securities over the same period in 2009, offset by sales of marketable securities and short-term investments.  Cash flows from (used in) financing activities increased for the nine month period ended September 30, 2010, compared to the same period in 2009. This increase was primarily due to a decrease in borrowings.

We anticipate that capital expenditures relating to machinery and equipment, furniture and fixtures, and building improvements for the remainder of 2010 will total approximately $300,000. We expect to finance these expenditures with cash on hand.

 At September 30, 2010, we held $2.1 million in auction-rate securities (ARS). The ARS we invest in are high quality securities, none of which are mortgage-backed.  At December 31, 2007, because of the short-term nature of our investment in these securities, they were classified as available-for-sale and included in short-term investments on our consolidated balance sheets.  Subsequent to December 31, 2007, our securities failed at auction due to a decline in liquidity in the ARS and other capital markets.  We will not be able to access our investments in ARS until future auctions are successful, ARS are called for redemption by the issuers, or until sold in a secondary market.  As our investments in ARS currently lack short-term liquidity, we have reclassified these investments as non-current as of September 30, 2010.  In the nine months ended September 30, 2010, we sold $1.9 million of the ARS held at December 31, 2009.
 
We have determined that the fair value of our ARS was temporarily impaired as of September 30, 2010.  For the three and nine months ended September 30, 2010, we marked to market our ARS and recorded an unrealized gain of $5,000, and an unrealized loss of $57,000, respectively, net of taxes in accumulated other comprehensive (loss) income in stockholder’s equity to reflect the temporary impairment of our ARS.  The recovery of these investments is based upon market factors which are not within our control.  As of September 30, 2010, we do not intend to sell the ARS and it is not more likely than not that we will be required to sell the ARS before recovery of their amortized cost bases, which may be at maturity.
 
On August 13, 2007, our Board of Directors approved a stock repurchase program under which our management is authorized to repurchase up to one million shares of our common stock.  The timing and actual number of shares purchased will depend on a variety of factors such as price, corporate and regulatory requirements, alternative investment opportunities and other market conditions.  Stock repurchases under this program, if any, will be made using our cash resources, and may be commenced or suspended at any time or from time to time at management’s discretion without prior notice.

Off-balance sheet arrangements

We do not participate in transactions that generate relationships with unconsolidated entities or financial partnerships, such as entities often referred to as variable interest or special purpose entities, which would have been established for the purpose of facilitating off-balance sheet arrangements or other contractually narrow or limited purposes. As of September 30, 2010, we were not involved in any unconsolidated transactions.

Contractual obligations

We are a party to three patent license agreements with Massachusetts General Hospital whereby we are obligated to pay royalties to Massachusetts General Hospital for sales of certain products as well as a percentage of royalties received from third parties.  Royalty expense for the three and nine months ended September 30, 2010 totaled approximately $0.7 million and $2.2 million, respectively.
 
For more information, please see the Amended and Restated License Agreement (MGH Case Nos. 783, 912, 2100), the License Agreement (MGH Case No. 2057) and the License Agreement (MGH Case No. 1316) filed as Exhibits 10.1, 10.2, and 10.3 to our Current Report on Form 8-K filed on March 20, 2008.
 
 
19

 
We have obligations related to the adoption of ASC Topic 740, “Accounting for Income Taxes” (ASC 740). Further information about changes in these obligations can be found in Note 8.

We are obligated to make future payments under various contracts, including non-cancelable inventory purchase commitments.

On November 19, 2008, we purchased land for $10.7 million on which we built our new operational facility.  Construction of the building was completed and the building was placed in service during the first quarter of 2010.  We financed the project by using cash on hand.  We vacated our old facility during the first quarter of 2010 and incurred a charge of $1.2 million relating to the write-off of our remaining lease obligation.

The following table summarizes our estimated contractual cash obligations as of September 30, 2010, excluding royalty and employment obligations because they are variable and/or subject to uncertain timing (in thousands):

 
Payments due by period
   
 
Total
Less than
 1 year
1 - 3
Years
4 - 5
Years
After 5
Years
Operating leases
$
265
$
167
$
98
$
-
$
-
Purchase commitments
 
7,928
 
7,928
 
-
 
-
 
-
Total contractual cash obligations
$
8,193
$
8,095
$
98
$
-
$
-

Item 3.  Quantitative and qualitative disclosures about market risk

Market risk is the potential loss arising from adverse changes in market rates and prices, such as foreign currency exchange rates, interest rates and a decline in the stock market. The current turbulence in the U.S. and global financial markets has caused a decline in stock values across all industries. We are exposed to market risks related to changes in interest rates and foreign currency exchange rates.

Our investment portfolio of cash equivalents, corporate preferred securities, and municipal debt securities is subject to interest rate fluctuations, but we believe this risk is immaterial because of the historically short-term nature of these investments.  At September 30, 2010, we held $2.1 million in auction-rate securities (“ARS”). The ARS we invest in are high quality securities, none of which are mortgage-backed.  At December 31, 2007, because of the short-term nature of our investment in these securities, they were classified as available-for-sale and included in short-term investments on our consolidated balance sheets.  Subsequent to December 31, 2007, our securities failed at auction due to a decline in liquidity in the ARS and other capital markets.  We will not be able to access our investments in ARS until future auctions are successful, ARS are called for redemption by the issuers, or until sold in a secondary market.  As our investments in ARS currently lack short-term liquidity, we have reclassified these investments as non-current as of September 30, 2010.  In the nine months ended September 30, 2010, we sold $1.9 million of the ARS held at December 31, 2009. The recovery of the remaining $2.1 million ARS held is based upon market factors which are not within our control.

Our international subsidiaries in The Netherlands, Australia and Japan conduct business in both local and foreign currencies and therefore, we are exposed to foreign currency exchange risk resulting from fluctuations in foreign currencies. This risk could adversely impact our results and financial condition.  We have not entered into any foreign currency exchange and option contracts to reduce our exposure to foreign currency exchange risk and the corresponding variability in operating results as a result of fluctuations in foreign currency exchange rates.


  20
 

 

Item 4.  Controls and procedures

Under the direction of the principal executive officer and principal financial officer, we have evaluated the effectiveness of our disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) as of September 30, 2010. Based on that evaluation, we have concluded that our disclosure controls and procedures were effective.

The Company’s management, including the CEO and CFO, does not expect that our disclosure controls or internal controls over financial reporting will prevent all errors and all fraud.  A control system, no matter how well designed and operated, can provide only reasonable, not absolute, assurance that the control system’s objectives will be met.  Further, the design of a control system must reflect the fact that there are resource constraints, and the benefits of controls must be considered relative to their costs.  Because of the inherent limitations in all control systems, no evaluation of controls can provide absolute assurance that all control issues and instances of fraud, if any, within the Company have been detected.  These inherent limitations include the realities that judgments in decision making can be faulty and that individual acts of some persons, by collusion of two or more people, or by management override of the controls.  The design of any system of controls is based in part on certain assumptions about the likelihood of future events, and there can be no assurance that any design will succeed in achieving its stated goals under all potential future conditions.  Over time, controls may become inadequate because of changes in conditions or deterioration in the degree of compliance with policies or procedures.  Because of the inherent limitations in a cost-effective control system, misstatements due to error or fraud may occur and not be detected.

There were no significant changes in our internal controls over financial reporting or in other factors that could significantly affect these controls during the quarter ended September 30, 2010, including any corrective actions with regard to significant deficiencies and material weaknesses.

PART II – Other information

Item 1.    Legal proceedings

Candela Corporation, Massachusetts Litigation

On August 9, 2006, we commenced an action for patent infringement against Candela Corporation (now Syneron, Inc.) in the United States District Court for the District of Massachusetts seeking both monetary damages and injunctive relief. The complaint alleges Candela’s GentleYAG and GentleLASE systems, which use laser technology for hair removal willfully infringe U.S. Patent No. 5,735,844 (the “’844 patent”), which is exclusively licensed to us by MGH.  Candela answered the complaint denying that its products infringe valid claims of the asserted patent and filing a counterclaim seeking a declaratory judgment that the asserted patent and U.S. Patent No. 5,595,568 (the “’568 patent”) are invalid and not infringed.  We filed a reply denying the material allegations of the counterclaims.

We filed an amended complaint on February 16, 2007 to add MGH as a plaintiff.  In addition, we further alleged that Candela’s GentleMAX system willfully infringes the ‘844 patent and that Candela’s Light Station system willfully infringes both the ‘844 and ‘568 patents.  On February 16, 2007, Candela filed an amended answer to our complaint adding allegations of inequitable conduct, double patenting and violation of Massachusetts General Laws Chapter 93A.  On February 28, 2007, we filed a response to Candela’s amended complaint pointing out many weaknesses in Candela’s allegations.  A claim construction hearing, sometimes called a “Markman Hearing”, was held August 2, 2007, and we received what we consider to be a favorable Markman ruling on November 9, 2007.  

On November 17, 2008, the Judge stayed the lawsuit pending the outcome of reexamination procedures requested by a third party on both the ‘844 and ‘568 patents in the United States Patent and Trademark Office (the “Patent Office”).  On December 9, 2008, Candela also filed requests for reexamination of both patents.  Generally, a reexamination proceeding is one which re-opens patent prosecution to ensure that the claims in an issued patent are valid over prior art references.  On January 16, 2009, we filed a preliminary amendment to the ‘844 patent adding new claims 33-59 which depend from claim 32 and a preliminary amendment to the ‘568 patent adding new claims 23 and 24 which depend from claim 1. On June 9, 2009, the Patent Office issued an office action confirming the validity of all claims of the ‘844 patent except claims 12-14.  Rejecting Candela's and the other company's arguments to the contrary, the Patent Office confirmed that claims 1-3, 6-8, 11, 17-20, 27, 28, 30, 32 of the '844 patent are valid and patentable. The Patent Office also confirmed new claims 33-59 as valid and patentable.  The Patent Office rejected only independent claim 12 and related dependent claims 13-14 of the ‘844 patent as unpatentable.  We cancelled claims 12-14 from the '844 patent in order to expedite the reexamination proceeding. Claims 4, 5, 9, 10, 15, 16, 21-26, 29 and 31 were not under reexamination. Consequently, all currently pending claims were found valid by the Patent Office.  On November 18, 2009, the Patent Office issued a Reexamination Certificate for the ‘844 patent that closed the reexamination proceeding on the ‘844 patent.

 
21

 
On June 19, 2009, we filed a motion to lift the stay and reopen the lawsuit.  Because Candela has discontinued products which infringe the ‘568 patent, we dropped our claims of infringement of the ‘568 patent from the lawsuit and we agreed to a covenant not to sue Candela for past infringement under the ‘568 patent.  On July 13, 2009, Candela filed their opposition to our motion to lift the stay, and on July 17, 2009, we filed our response to their opposition.  On January 5, 2010 the Judge lifted the stay. Expert discovery is complete.   A hearing was held on September 14, 2010 on Candela's motion for summary judgment regarding both invalidity and non-infringement of certain claims of the '844 patent.  A trial date will not be set until the Judge rules on Candela's motion.

On August 10, 2006, Candela Corporation (now Syneron, Inc.) commenced an action for patent infringement against us in the United States District Court for the District of Massachusetts seeking both monetary damages and injunctive relief.  The complaint alleged that our StarLux System with the LuxV handpiece willfully infringes U.S. Patent No. 6,743,222 (the “’222 patent”) which is directed to acne treatment, that our QYAG5 System willfully infringes U.S. Patent No. 5,312,395 which is directed to treatment of pigmented lesions, and that our StarLux System with the LuxG handpiece willfully infringes U.S. Patent No. 6,659,999 which is directed to wrinkle treatment.  On October 25, 2006, Candela filed an amended complaint which did not include U.S. Patent No. 6,659,999.  Consequently, Candela no longer alleges in this lawsuit that the StarLux System with LuxG handpiece infringes its patents. With regard to the two remaining patents, Candela is seeking to enjoin us from selling these products in the United States if we are found to infringe the patents, and to obtain compensatory and treble damages, reasonable costs and attorney’s fees, and other relief as the court deems just and proper. On October 30, 2006, we answered the complaint denying that our products infringe the asserted patents and filing counterclaims seeking declaratory judgments that the asserted patents are invalid and not infringed.  In addition, with regard to U.S. Patent No. 5,312,395, we filed a counterclaim of inequitable conduct.

In February 2008, we filed a request for reexamination and then an amended request for reexamination of Candela's ‘222 patent with the Patent Office.  In our request, we argued that Candela's ‘222 patent is unpatentable over our own United States Patent No. 6,605,080 alone or in combination with other prior art.  About the same time, we filed a motion to stay all proceedings in this action related to the ‘222 patent pending resolution of the amended request for reexamination of the ‘222 patent.  In March 2008, the Patent Office granted our request for reexamination of the ‘222 patent.   On June 11, 2008, the Court ordered the parties to report back to the Court after the Patent Office made its decision in the reexamination of the ‘222 patent, after which a claim construction hearing (i.e., a Markman Hearing) would be scheduled for both the ‘222 and ‘395 patents. On June 12, 2008, the parties informed the Court that the total time the reexamination will remain pending is not known.  On January 19, 2010, the Patent Office issued a Notice of Intent to Issue Ex Parte Reexamination Certificate for the ‘222 patent which will close the reexamination proceeding on the ‘222 patent. If this lawsuit is re-started, we will continue to defend the action vigorously and believe that we have meritorious defenses of non-infringement, invalidity and inequitable conduct. However, litigation is unpredictable and we may not prevail in successfully defending or asserting our position. If we do not prevail, we may be ordered to pay substantial damages for past sales and an ongoing royalty for future sales of products found to infringe in the United States. We could also be ordered to stop selling any products in the United States that are found to infringe.


 
22 

 

Alma Lasers, Inc., Delaware Litigation

On September 11, 2008, Alma Lasers, Inc. filed a complaint requesting a declaratory judgment that our fractional patent, U.S. Patent No. 6,997,923, is not infringed by Alma's products and is invalid over prior art.  Alma served this lawsuit on us on November 6, 2008, and on November 21, 2008, we filed an answer which denied Alma's allegations that the patent is invalid and not infringed.  We also filed a counterclaim accusing Alma's Pixel C02 Omnifit Fractional C02 Handpiece and Pixel C02 Fractional C02 Skin Resurfacing System of infringing the patent.  On December 16, 2008, upon the request of both parties, a mediation conference was scheduled for June 30, 2009 before Magistrate Judge Mary Pat Thynge.  On December 18, 2008, upon the request of both parties, the Judge presiding over the lawsuit, stayed the lawsuit and later closed the lawsuit pending the outcome of the mediation.  Due to unforeseen circumstances, the mediation scheduled for June 30, 2009 was postponed until October 13, 2009.  Following our request, Magistrate Judge Mary Pat Thynge cancelled the mediation on October 6, 2009.  By letter dated October 13, 2009, we asked presiding Judge Farnan to re-open the case.  On December 28, 2009, Alma filed a First Amended Complaint to add a claim that U.S. Patent No. 6,997,923 is unenforceable due to inequitable conduct.  On January 11, 2010, we filed our Amended Answer and Counterclaim to Alma’s First Amended Complaint denying Alma’s allegation of inequitable conduct. On March 4, 2010 the parties filed a joint stipulated order of dismissal requesting that the court dismiss this action, including all claims and counterclaims, in its entirety without prejudice, with the parties agreeing that any future litigation between them over U.S. Patent No. 6,997,923, any patent claiming priority (either directly or indirectly) thereto, and/or any patents relating to fractional technology, shall be commenced in this Court.

Syneron, Inc., Massachusetts Litigation

On November 14, 2008, we commenced an action for patent infringement against Syneron, Inc. in the United States District Court for the District of Massachusetts seeking both monetary damages and injunctive relief. The complaint alleges Syneron's eLight, eMax, eLaser, Aurora DS, Polaris DS, Comet and Galaxy Systems, which use light-based technology for hair removal, willfully infringe the ‘568 patent and the ‘844 patent, which are exclusively licensed to us by MGH.  In March 2009, we served Syneron with this suit. On April 30, 2009, the parties filed a stipulation to stay the lawsuit pending the outcome of the reexaminations of the ‘568 patent and the ‘844 patent.

On June 9, 2009, the Patent Office issued an office action confirming the validity of all claims of the ‘844 patent except claims 12-14.  The Patent Office confirmed that claims 1-3, 6-8, 11, 17-20, 27, 28, 30, 32 of the '844 patent are valid and patentable. The Patent Office also confirmed new claims 33-59 as valid and patentable.  The Patent Office rejected only independent claim 12 and related dependent claims 13-14 of the ‘844 patent as unpatentable.  We cancelled claims 12-14 from the '844 patent in order to expedite the reexamination proceeding. Claims 4, 5, 9, 10, 15, 16, 21-26, 29 and 31 were not under reexamination. Consequently, all currently pending claims were found valid by the Patent Office.  On November 18, 2009, the Patent Office issued a Reexamination Certificate for the ‘844 patent which closed the reexamination proceeding on the ‘844 patent.

On October 28, 2009, the Patent Office issued a Reexamination Certificate for the ‘568 patent which closed the reexamination proceeding on the ‘568 patent. The Patent Office confirmed the validity and patentability of all the claims of the ‘568 patent including new claims 23 and 24.

On September 23, 2009, we filed a motion to lift the stay and reopen the lawsuit.  On October 6, 2009, Syneron filed their opposition to our motion to lift the stay, and on October 9, 2009, we filed our response to their opposition.    On November 13, 2009, the Judge re-opened the case and a scheduling hearing took place on January 6, 2010.  The parties are in discovery.  A claim construction hearing (also known as a Markman hearing) is scheduled for November 17, 2010.  No trial date has yet been set.

Tria Beauty, Inc., Massachusetts Litigation

On June 24, 2009, we commenced an action for patent infringement against Tria Beauty, Inc. (previously named Spectragenics, Inc.), in the United States District Court for the District of Massachusetts seeking both monetary damages and injunctive relief. The complaint alleged that the Tria System, which uses light-based technology for hair removal, willfully infringes the ‘844 patent, which is exclusively licensed to us by MGH.  Tria answered the complaint denying that its products infringe valid claims of the asserted patent and filing a counterclaim seeking a declaratory judgment that the asserted patent is not infringed, is invalid and not enforceable.  We filed a reply denying the material allegations of the counterclaims.  On September 21, 2009, following successful re-examination of the ‘568 patent, we filed a motion to amend our complaint to add a claim for willful infringement of the ‘568 patent, which is also exclusively licensed to us by MGH.  Our motion also included adding MGH as a plaintiff in the lawsuit.  Tria did not oppose the motion and the Judge granted the motion on October 8, 2009.  A claim construction hearing (also known as a Markman hearing) was held on August 10, 2010, and we received what we consider to be a favorable ruling on October 13, 2010.  The parties are in discovery.  No trial date has yet been set.

 
23

 
Asclepion Laser Technologies GmbH, German Litigation

On October 13, 2010, we commenced an action for patent infringement against Asclepion Laser Technologies GmbH in the District Court of Düsseldorf, Germany seeking both monetary damages and injunctive relief.  The complaint alleged that Asclepion's MedioStar and RubyStar products infringe European Patent Number EP 0 806 913, which is the first issued European patent corresponding to U.S. Patent Numbers 5,595,568 and 5,735,844.

Asclepion Laser Technologies GmbH, Italian Litigation

On October 22, 2010, we were served with an International Summons for a lawsuit filed September 20, 2010 by Asclepion Laser Technologies GmbH in the Court of Rome in Italy.  In this suit, Asclepion asks the Italian court to declare that Asclepion's MedioStar and RubyStar products do not infringe either the Italian or German portions of EP 0 806 913 B1 or EP 1 230 900 B1, which are the first two issued European patents corresponding to U.S. Patent numbers 5,595,568 and 5,735,844. 

Item 1A.    Risk Factors
 
Investing in our common stock involves a high degree of risk. You should carefully consider the risks and uncertainties described in our Annual Report on Form 10-K for the year ended December 31, 2009 in addition to the other information included in this quarterly report, including the additional risk factors below. If any of the risks actually occur, our business, financial condition or results of operations would likely suffer. In that case, the trading price of our common stock could fall.
 
Our proprietary technology has only limited protections which may not prevent competitors from copying our new developments.  This may impair our ability to compete effectively.  We may expend significant resources enforcing our intellectual property rights to prevent such copying, or our intellectual property could be determined to be not infringed, invalid or unenforceable.
 
        Our business could be materially and adversely affected if we are not able to adequately protect our intellectual property rights. We rely on a combination of patent, copyright, trademark and trade secret laws, licenses and confidentiality agreements to protect our proprietary rights. We own and license a variety of patents and patent applications in the United States and corresponding patents and patent applications in many foreign jurisdictions. Our pending and future patent applications may not issue as patents or, if issued, may not issue in a form that will be advantageous to us. Even if issued, patents may be challenged, narrowed, invalidated or circumvented, which could limit our ability to stop competitors from marketing similar products or limit the length of term of patent protection we may have for our products. Changes in either patent laws or in interpretations of patent laws in the United States and other countries may diminish the value of our intellectual property or narrow the scope of our patent protection. 
 
        We have granted certain patent licenses to several competitors, and in return for those license grants, we receive a significant ongoing royalty revenue stream.  A few of these competitors entered into license agreements only after we sued them for patent infringement.  We are currently enforcing certain of our patents against Candela Corporation, Syneron, Inc., Tria Beauty, Inc. and Asclepion Laser Technologies GmbH and intend to enforce against other competitors in the future.  We do not know how successful we will be in asserting our patents against Candela, Syneron, Tria, Asclepion or other suspected infringers.  Whether or not we are successful in the pending lawsuits, litigation consumes substantial amounts of our financial resources and diverts management's attention away from our core business. Public announcements concerning these lawsuits that are unfavorable to us may in the future result in significant declines in our stock price. An adverse ruling or judgment in these lawsuits could result in a loss of our significant ongoing royalty revenue stream and could also have a material adverse effect on license agreements with other companies both of which could have a material adverse effect on our business and results of operation and cause our stock price to decline significantly.  (For more information about our patent litigation, see Part II, Item 1 Legal Proceedings.)
 
 
24

 
         In addition to patented technology, we rely upon unpatented proprietary technology, processes and know-how. We generally enter into agreements with our employees and third parties with whom we work, including but not limited to consultants and vendors, to restrict access to, and distribution of, our proprietary information and define our intellectual property ownership rights. Despite our efforts to protect our proprietary rights, unauthorized parties may attempt to copy or otherwise obtain and use our proprietary technology, proprietary information and know-how and we may not have adequate remedies for any such breach. Monitoring unauthorized use of our technology is difficult and we cannot be certain that the steps we have taken will prevent unauthorized use of our technology, particularly in foreign countries where the laws may not protect our proprietary rights as fully as in the United States. If competitors are able to use our proprietary technology, our ability to compete effectively could be harmed and the value of our technology and products could be adversely affected.  Costly and time consuming lawsuits may be necessary to enforce and defend patents issued or licensed exclusively to us, to protect our trade secrets and/or know-how or to determine the enforceability, scope and validity of others' intellectual property rights. Such lawsuits may result in patents issued or licensed exclusively to us to be found invalid and unenforceable.  In addition, our trade secrets may otherwise become known or our competitors also may independently develop technologies that are substantially equivalent or superior to our technology and which do not infringe our patents.
 
To successfully grow our international presence, we must address many issues with which we have little or no experience. We may not be able to properly manage our foreign subsidiaries which may have an adverse effect on our business and operating results.
 
        We have three international subsidiaries which are located in The Netherlands, Australia, and Japan. In managing foreign operations, we must address many issues with which we have little or no experience which exposes our business to additional risk. Our foreign operations redirect management's time from other operating issues. We may not be successful in operating our foreign subsidiaries. If we are unsuccessful in managing our foreign subsidiaries, the foreign subsidiaries could be unprofitable and negatively impact our resources and financial position.
 
The liquidity and market value of our investments may decrease.
 
        As of September 30, 2010, we held approximately $2.1 million of auction-rate securities. Recently, there have been disruptions in the market for auction-rate securities related to liquidity which has caused substantially all auctions to fail. All of our securities held as of September 30, 2010 failed in their last auction. We will not be able to access our investments in ARS until future auctions are successful, ARS are called for redemption by the issuers, or until we sell the securities in a secondary market. In the event that we are unable to sell the underlying securities at or above par, these securities may not provide us a liquid source of cash in the future. At September 30, 2010, due to the uncertainty and illiquidity in this market, we have classified our auction-rate securities as non-current assets and have recorded a cumulative unrealized loss of $0.4 million, net of taxes in accumulated other comprehensive (loss) income. The recovery of these investments is based upon market factors which are not within our control. As of September 30, 2010, we do not intend to sell the ARS and it is not more likely than not that we will be required to sell the ARS before recovery of their amortized cost bases, which may be at maturity.


 
25 

 

Item 2.  Changes in securities, use of proceeds and issuer purchases of securities

Period
Total number of shares purchased
Average price paid per share
Total number of shares purchased as part of publicly announced program *
Maximum number of shares that may yet be purchased under program *
July 1, 2010 through July 31, 2010
-
-
-
324,500
August 1, 2010 through August 31, 2010
-
-
-
324,500
September 1, 2010 through September 30, 2010
-
-
-
324,500
Total
-
-
-
324,500

* On August 13, 2007, our Board of Directors approved a stock repurchase program under which our management is authorized to repurchase up to one million shares of our common stock.  The timing and actual number of shares purchased will depend on a variety of factors such as price, corporate and regulatory requirements, alternative investment opportunities and other market conditions.  Stock repurchases under this program, if any, will be made using our cash resources, and may be commenced or suspended at any time or from time to time at management’s discretion without prior notice.

Item 3.  Defaults upon senior securities

None.

Item 4.  (Removed and Reserved)

None.

Item 5.  Other information

None.

Item 6.  Exhibits
 
 
31.1
Certification of Joseph P. Caruso, President and Chief Executive Officer of the Company, as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.
 
31.2
Certification of Paul S. Weiner, Vice President and Chief Financial Officer of the Company, as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.
 
32
Certification of Joseph P. Caruso, President and Chief Executive Officer of the Company, pursuant to 18 United States Code Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.
 
32
Certification of Paul S. Weiner, Vice President and Chief Financial Officer of the Company, pursuant to 18 United States Code Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.


 
26 

 


Pursuant to the requirements of Section 13 or 15(d) of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.

 
Palomar Medical Technologies, Inc.
(Registrant)
 
 
 
 
Date:  November 5, 2010
 
 
 
/s/  Joseph P. Caruso     
Joseph P. Caruso
President, Chief Executive Officer and Director
   
 
 
 
 
Date: November 5, 2010
 
 
 
 
/s/  Paul S. Weiner      
Paul S. Weiner
Vice President and Chief Financial Officer
   





 
27