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Table of Contents

 

 

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

 

Form 10-Q

 

 

(Mark one)

x QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the quarterly period ended March 31, 2013

OR

 

¨ 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 000-51623

 

 

Cynosure, Inc.

(Exact name of registrant as specified in its charter)

 

 

 

Delaware   04-3125110

(State or other jurisdiction of

incorporation or organization)

 

(I.R.S. Employer

Identification No.)

5 Carlisle Road

Westford, MA

  01886
(Address of principal executive offices)   (Zip code)

(978) 256-4200

(Registrant’s telephone number, including area code)

 

 

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.    x  Yes    ¨  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 (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit and post such files).    x  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   ¨  (Do not check if a smaller reporting company)    Smaller reporting company   ¨

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Act).    ¨  Yes    x  No

The number of shares outstanding of the registrant’s Class A common stock as of May 3, 2013:

 

                                     Class    Number of Shares

Class A Common Stock, $0.001 par value

   16,213,753

 

 

 


Table of Contents

Cynosure, Inc.

Table of Contents

 

          Page No.  

PART I

   Financial Information   

Item 1.

  

Financial Statements (Unaudited)

  
  

Consolidated Balance Sheets as of March 31, 2013 and December 31, 2012

     1   
  

Consolidated Statements of Operations for the Three Month Periods Ended March 31, 2013 and 2012

     2   
  

Consolidated Statements of Comprehensive Income for the Three Month Periods Ended March 31, 2013 and 2012

     3   
  

Consolidated Statements of Cash Flows for the Three Month Periods Ended March 31, 2013 and 2012

     4   
  

Notes to Consolidated Financial Statements (Unaudited)

     5   

Item 2.

  

Management’s Discussion and Analysis of Financial Condition and Results of Operations

     12   

Item 3.

  

Quantitative and Qualitative Disclosures About Market Risk

     18   

Item 4.

  

Controls and Procedures

     19   

PART II

  

Other Information

  

Item 1.

  

Legal Proceedings

     19   

Item 1A.

  

Risk Factors

     20   

Item 2.

  

Unregistered Sales of Equity Securities and Use of Proceeds

     34   

Item 4.

  

Mine Safety Disclosure

     34   

Item 6.

  

Exhibits

     35   

SIGNATURES

     36   

EXHIBIT INDEX

     37   

 

EX-2.1* Agreement and Plan of Merger

EX-10.1 Form of Company Stockholder Agreement

EX-10.2 Form of Buyer Stockholder Agreement

EX-10.3 Employment Agreement

EX-31.1 Section 302 Certification of Principal Executive Officer

EX-31.2 Section 302 Certification of Principal Financial Officer

EX-32.1 Section 906 Certification of Principal Executive Officer

EX-32.2 Section 906 Certification of Principal Financial Officer

EX-101** The following materials from the Cynosure, Inc. Quarterly Report on Form 10-Q for the quarter ended March 31, 2013, formatted in XBRL (eXtensible Business Reporting Language): (i) Consolidated Statements of Operations for the three months ended March 31, 2013 and 2012, (ii) Consolidated Balance Sheets at March 31, 2013 and December 31, 2012, (iii) Consolidated Statements of Comprehensive Income for the three months ended March 31, 2013 and 2012, (iv) Consolidated Statements of Cash Flows for the three months ended March 31, 2013 and 2012, and (v) Notes to Consolidated Financial Statements.

 

* Schedules to this Exhibit have been omitted in reliance on Item 601(b)(2) of Regulation S-K. Cynosure will furnish copies of any such schedules to the SEC upon request.
** Pursuant to Rule 406T of Regulation S-T, the Interactive Data Files on Exhibit 101 hereto are deemed not filed or part of a registration statement or prospectus for purposes of Sections 11 or 12 of the Securities Act of 1933, as amended, are deemed not filed for purposes of Section 18 of the Securities and Exchange Act of 1934, as amended, and otherwise are not subject to liability under those sections.


Table of Contents

Cynosure, Inc.

Consolidated Balance Sheets

(in thousands)

 

     (Unaudited)
March 31,
2013
    December 31,
2012
 
Assets     

Current assets:

    

Cash and cash equivalents

   $ 89,237      $ 86,057   

Short-term marketable securities

     43,770        40,617   

Accounts receivable, net

     20,945        17,970   

Inventories

     32,866        32,906   

Prepaid expenses and other current assets

     5,075        5,149   

Deferred income taxes

     779        783   
  

 

 

   

 

 

 

Total current assets

     192,672        183,482   

Property and equipment, net

     8,688        8,207   

Long-term marketable securities

     13,637        20,071   

Goodwill and intangibles, net

     21,376        21,748   

Other assets

     1,016        1,061   
  

 

 

   

 

 

 

Total assets

   $ 237,389      $ 234,569   
  

 

 

   

 

 

 
Liabilities and Stockholders’ Equity     

Current liabilities:

    

Accounts payable

   $ 10,127      $ 8,346   

Amounts due to related party

     1,701        1,896   

Accrued expenses

     17,637        17,201   

Deferred revenue

     5,112        6,319   

Capital lease obligation

     311        322   
  

 

 

   

 

 

 

Total current liabilities

     34,888        34,084   
  

 

 

   

 

 

 

Capital lease obligation, net of current portion

     349        432   

Deferred revenue, net of current portion

     343        281   

Other noncurrent liabilities

     2,227        2,265   

Commitments and contingencies

    

Stockholders’ equity:

    

Preferred stock, $0.001 par value

    

Authorized — 5,000 shares

    

Issued — none

     —         —    

Class A and Class B common stock, $0.001 par value

    

Authorized — 70,000 shares

    

Issued — 16,444 Class A shares and no Class B shares at March 31, 2013;

Issued — 16,402 Class A shares and no Class B shares at December 31, 2012

     17        17   

Additional paid-in capital

     192,384        190,979   

Retained earnings

     11,522        10,283   

Accumulated other comprehensive loss

     (2,168     (1,599

Treasury stock, 233 Class A shares, at cost

     (2,173     (2,173
  

 

 

   

 

 

 

Total stockholders’ equity

     199,582        197,507   
  

 

 

   

 

 

 

Total liabilities and stockholders’ equity

   $ 237,389      $ 234,569   
  

 

 

   

 

 

 

The accompanying notes are an integral part of these consolidated financial statements.

 

1


Table of Contents

Cynosure, Inc.

Consolidated Statements of Operations

(Unaudited, in thousands, except per share data)

 

     Three Months Ended
March 31,
 
     2013     2012  

Product revenues

   $ 34,117      $ 28,095   

Parts, accessories and service revenues

     6,573        6,073   
  

 

 

   

 

 

 

Total revenues

     40,690        34,168   

Cost of revenues

     17,003        14,660   
  

 

 

   

 

 

 

Gross profit

     23,687        19,508   

Operating expenses:

    

Sales and marketing

     12,603        11,551   

Research and development

     3,781        3,239   

Amortization of intangible assets acquired

     214        342   

General and administrative

     5,101        3,518   
  

 

 

   

 

 

 

Total operating expenses

     21,699        18,650   
  

 

 

   

 

 

 

Income from operations

     1,988        858   

Interest income, net

     32        10   

Other (expense) income, net

     (357     209   
  

 

 

   

 

 

 

Income before provision for income taxes

     1,663        1,077   

Provision for income taxes

     424        258   
  

 

 

   

 

 

 

Net income

   $ 1,239      $ 819   
  

 

 

   

 

 

 

Basic net income per share

   $ 0.08      $ 0.07   
  

 

 

   

 

 

 

Diluted net income per share

   $ 0.07      $ 0.06   
  

 

 

   

 

 

 

Basic weighted average common shares outstanding

     16,185        12,578   
  

 

 

   

 

 

 

Diluted weighted average common shares outstanding

     16,860        13,037   
  

 

 

   

 

 

 

The accompanying notes are an integral part of these consolidated financial statements.

 

2


Table of Contents

Cynosure, Inc.

Consolidated Statements of Comprehensive Income

(Unaudited, in thousands)

 

     Three Months Ended
March 31,
 
     2013     2012  

Net income

   $ 1,239      $ 819   
  

 

 

   

 

 

 

Other comprehensive (loss) income components:

    

Cumulative translation adjustment

     (594     322   

Unrealized gain on marketable securities, net of taxes

     25        9   
  

 

 

   

 

 

 

Total other comprehensive (loss) income

     (569     331   
  

 

 

   

 

 

 

Comprehensive income

   $ 670      $ 1,150   
  

 

 

   

 

 

 

The accompanying notes are an integral part of these consolidated financial statements.

 

3


Table of Contents

Cynosure, Inc.

Consolidated Statements of Cash Flows

(Unaudited, in thousands)

 

     Three Months Ended
March 31,
 
     2013     2012  

Operating activities:

    

Net income

   $ 1,239      $ 819   

Reconciliation of net income to net cash provided by operating activities:

    

Depreciation and amortization

     1,538        1,755   

Stock-based compensation expense

     839        665   

Gain on disposal of fixed assets

     —          (16

Deferred income taxes

     83        —     

Net accretion of marketable securities

     623        243   

Changes in operating assets and liabilities:

    

Accounts receivable

     (3,276     (1,675

Inventories

     (1,360     (1,291

Net book value of demonstration inventory sold

     114        177   

Prepaid expenses and other current assets

     96        (802

Accounts payable

     1,807        804   

Due to related party

     (195     (175

Tax benefit from the exercise of stock options

     (74     (25

Accrued expenses

     538        (93

Deferred revenue

     (1,078     3,359   

Other noncurrent liabilities

     (109     —    
  

 

 

   

 

 

 

Net cash provided by operating activities

     785        3,745   

Investing activities:

    

Purchases of property and equipment

     (806     (671

Proceeds from the sales and maturities of marketable securities

     12,415        13,171   

Purchases of marketable securities

     (9,709     (11,546

Decrease in other noncurrent assets

     10        107   
  

 

 

   

 

 

 

Net cash provided by investing activities

     1,910        1,061   

Financing activities:

    

Excess tax benefit on options exercised

     74        25   

Proceeds from stock option exercises

     492        200   

Payments on capital lease obligation

     (80     (69
  

 

 

   

 

 

 

Net cash provided by financing activities

     486        156   

Effect of exchange rate changes on cash and cash equivalents

     (1     (2
  

 

 

   

 

 

 

Net increase in cash and cash equivalents

     3,180        4,960   

Cash and cash equivalents, beginning of the period

     86,057        35,694   
  

 

 

   

 

 

 

Cash and cash equivalents, end of the period

   $ 89,237      $ 40,654   
  

 

 

   

 

 

 

Supplemental cash flow information

    

Cash paid for interest

   $ 7      $ 12   
  

 

 

   

 

 

 

Cash paid for income taxes

   $ 64      $ 228   
  

 

 

   

 

 

 

Supplemental noncash investing and financing activities

    

Transfer of demonstration equipment from inventory to fixed assets

   $ 1,048      $ 1,019   
  

 

 

   

 

 

 

Assets acquired under capital lease

   $ —        $ 276   
  

 

 

   

 

 

 

The accompanying notes are an integral part of these consolidated financial statements.

 

4


Table of Contents

Cynosure, Inc.

Notes to Consolidated Financial Statements (Unaudited)

Note 1 — Interim Consolidated Financial Statements

The accompanying unaudited interim consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States for interim information and pursuant to the rules and regulations of the Securities and Exchange Commission (SEC) for reporting on Form 10-Q. Accordingly, certain information and footnote disclosures required for complete financial statements are not included herein. It is recommended that these financial statements be read in conjunction with the consolidated financial statements and related notes that appear in the Annual Report on Form 10-K of Cynosure, Inc. (Cynosure) for the year ended December 31, 2012, as amended. In the opinion of management, all adjustments (consisting of normal recurring adjustments) considered necessary for a fair presentation of the financial position, results of operations, and cash flows as of the dates and for the periods presented have been included. The results of operations for the three months ended March 31, 2013 may not be indicative of the results that may be expected for the year ending December 31, 2013, or any other period.

Note 2 — Stock-Based Compensation

Cynosure recorded stock-based compensation expense of $0.8 million and $0.7 million for the three months ended March 31, 2013 and 2012, respectively. Cynosure capitalized $19,000 and $15,000 of stock-based compensation expense as part of inventory during the three months ended March 31, 2013 and 2012, respectively.

Total stock-based compensation expense was recorded to cost of revenues and operating expenses based upon the functional responsibilities of the individual holding the respective options, as follows:

 

     Three Months
Ended March 31,
 
       2013          2012    
     (In thousands)  

Cost of revenues

   $ 36       $ 29   

Sales and marketing

     240         208   

Research and development

     141         120   

General and administrative

     422         308   
  

 

 

    

 

 

 

Total stock-based compensation expense

   $ 839       $ 665   
  

 

 

    

 

 

 

Cash received from option exercises was $0.5 million and $0.2 million during the three months ended March 31, 2013 and 2012, respectively.

Cynosure granted 284,200 and 300,000 stock options during the three months ended March 31, 2013 and 2012, respectively. Cynosure utilizes the Black-Scholes model to determine the weighted average fair value of options. The weighted average fair value of the options granted during the three months ended March 31, 2013 and 2012 was $13.47 and $8.42, respectively, using the following assumptions:

 

     Three Months Ended
March 31,
     2013    2012

Risk-free interest rate

   0.79% - 0.92%    0.81% - 0.86%

Expected dividend yield

   —      —  

Expected term

   4.8 years    5.8 years

Expected volatility

   56%    57%

Estimated forfeiture rate

   5%    5%

Option-pricing models require the input of various subjective assumptions, including the option’s expected life and the price volatility of the underlying stock. Cynosure’s estimated expected stock price volatility is based on its own historical volatility. Cynosure’s expected term of options granted during the three months ended March 31, 2013 represents the weighted average period of time that options granted are expected to be outstanding giving consideration to vesting schedules and Cynosure’s historical exercise patterns. Cynosure’s expected term of options granted during the three months ended March 31, 2012 was derived from the simplified method described in ASC 718-10-S99. The risk-free rate for the expected term of the option is based on the U.S. Treasury yield curve in effect at the time of grant. The dividend yield of zero is based on the fact that Cynosure has never paid cash dividends and has no present intention to pay cash dividends.

 

5


Table of Contents

Note 3 — Inventories

Cynosure states all inventories at the lower of cost or market, determined on a first-in, first-out method. Inventory includes material, labor and overhead and consists of the following:

 

     March 31,
2013
     December 31,
2012
 
     (in thousands)  

Raw materials

   $ 9,185       $ 9,076   

Work in process

     1,576         1,134   

Finished goods

     22,105         22,696   
  

 

 

    

 

 

 
   $ 32,866       $ 32,906   
  

 

 

    

 

 

 

Note 4 — Fair Value

U.S. GAAP establishes a framework for measuring fair value under generally accepted accounting principles and enhances disclosures about fair value measurements. Fair value is defined as the exchange price that would be received for an asset or paid to transfer a liability (an exit price) in the principal or most advantageous market for the asset or liability in an orderly transaction between market participants on the measurement date. Valuation techniques used to measure fair value must maximize the use of observable inputs and minimize the use of unobservable inputs. The standard describes the following fair value hierarchy based on three levels of inputs, of which the first two are considered observable and the last unobservable, that may be used to measure fair value:

 

   

Level 1 — Quoted prices in active markets for identical assets or liabilities.

 

   

Level 2 — Inputs other than Level 1 that are observable, either directly or indirectly, such as quoted prices for similar assets or liabilities; quoted prices in markets that are not active; or other inputs that are observable or can be corroborated by observable markets data for substantially the full term of the assets or liabilities.

 

   

Level 3 — Unobservable inputs that are supported by little or no market activity and that are significant to the fair value of the assets or liabilities.

The following table represents Cynosure’s fair value hierarchy for its financial assets (cash equivalents and marketable securities) measured at fair value as of March 31, 2013 (in thousands):

 

     Level 1      Level 2      Level 3      Total  

Money market funds (1)

   $ 12,490       $ —        $  —        $ 12,490   

State and municipal bonds (2)

     —          54,348         —          54,348   

Treasuries and government agencies

     —          3,520         —          3,520   

Equity securities

     36         —          —          36   
  

 

 

    

 

 

    

 

 

    

 

 

 

Total

   $ 12,526       $ 57,868       $  —        $ 70,394   
  

 

 

    

 

 

    

 

 

    

 

 

 

 

(1) Included in cash and cash equivalents at March 31, 2013.
(2) $0.5 million included in cash and cash equivalents at March 31, 2013.

During the three months ended March 31, 2013, there were no significant transfers in and out of Level 1 and Level 2. Cynosure did not have any Level 3 financial assets at March 31, 2013 or December 31, 2012.

 

6


Table of Contents

Note 5 — Short and Long-Term Marketable Securities

Cynosure’s available-for-sale securities at March 31, 2013 consist of approximately $57.9 million of investments in debt securities consisting of state and municipal bonds, treasuries and government agencies and approximately $36,000 in equity securities. All investments in available-for-sale securities are recorded at fair market value, with any unrealized gains and losses reported as a separate component of accumulated other comprehensive loss. As of March 31, 2013, Cynosure’s marketable securities consist of the following (in thousands):

 

     Market
Value
     Amortized
Cost
     Unrealized
Gains
     Unrealized
Losses
 

Available-for-sale Securities:

           

Cash equivalents:

           

State and municipal bonds

   $ 497       $ 497       $  —         $  —     
  

 

 

    

 

 

    

 

 

    

 

 

 

Total cash equivalents

   $ 497       $ 497       $ —         $ —    
  

 

 

    

 

 

    

 

 

    

 

 

 

Short-term marketable securities:

           

State and municipal bonds

   $ 40,214       $ 40,196       $ 21       $ (3

Treasuries and government agencies

     3,520         3,516         4         —    

Equity securities

     36         6         30         —    
  

 

 

    

 

 

    

 

 

    

 

 

 

Total short-term marketable securities

   $ 43,770       $ 43,718       $ 55       $ (3
  

 

 

    

 

 

    

 

 

    

 

 

 

Long-term marketable securities:

           

State and municipal bonds

   $ 13,637       $ 13,629       $ 8       $ —     
  

 

 

    

 

 

    

 

 

    

 

 

 

Total long-term marketable securities

   $ 13,637       $ 13,629       $ 8       $ —     
  

 

 

    

 

 

    

 

 

    

 

 

 

Total available-for-sale securities

   $ 57,904       $ 57,844       $ 63       $ (3
  

 

 

    

 

 

    

 

 

    

 

 

 

Total marketable securities

   $ 57,407            
  

 

 

          

As of December 31, 2012, Cynosure’s marketable securities consist of the following (in thousands):

 

     Market
Value
     Amortized
Cost
     Unrealized
Gains
     Unrealized
Losses
 

Available-for-Sale Securities:

           

Cash equivalents:

           

State and municipal bonds

   $ 4,417       $ 4,417       $  —        $  —    

Government agencies

     1,000         1,000         —          —    
  

 

 

    

 

 

    

 

 

    

 

 

 

Total cash equivalents

   $ 5,417       $ 5,417       $  —        $  —    
  

 

 

    

 

 

    

 

 

    

 

 

 

Short-term marketable securities:

           

State and municipal bonds

   $ 33,250       $ 33,251       $ 6       $ (7

Treasuries and government agencies

     7,346         7,345         1         —    

Equity securities

     21         6         15         —    
  

 

 

    

 

 

    

 

 

    

 

 

 

Total short-term marketable securities

   $ 40,617       $ 40,602       $ 22       $ (7
  

 

 

    

 

 

    

 

 

    

 

 

 

Long-term marketable securities:

           

State and municipal bonds

   $ 18,046       $ 18,052       $ 2       $ (8

Treasuries and government agencies

     2,025         2,021         4         —    
  

 

 

    

 

 

    

 

 

    

 

 

 

Total long-term marketable securities

   $ 20,071       $ 20,073       $ 6       $ (8
  

 

 

    

 

 

    

 

 

    

 

 

 

Total available-for-sale securities

   $ 66,105       $ 66,092       $ 28       $ (15
  

 

 

    

 

 

    

 

 

    

 

 

 

Total marketable securities

   $  60,688            
  

 

 

          

As of March 31, 2013, Cynosure’s available-for-sale debt securities mature as follows (in thousands):

 

     Total      Maturities  
      Less
Than
One
Year
     One to
Five
Years
     More
than
five
years
 

State and municipal bonds

   $ 54,348       $ 40,711       $ 13,637       $  —    

Treasuries and government agencies

     3,520         3,520         —           —    
  

 

 

    

 

 

    

 

 

    

 

 

 

Total available-for-sale debt securities

   $ 57,868       $ 44,231       $ 13,637       $  —    
  

 

 

    

 

 

    

 

 

    

 

 

 

 

7


Table of Contents

Note 6 — Goodwill and Other Intangible Assets

Changes to goodwill during the three months ended March 31, 2013 were as follows (in thousands):

 

     Total  

Balance – December 31, 2012

   $ 15,811   

Translation adjustment

     (45
  

 

 

 

Balance – March 31, 2013

   $ 15,766   
  

 

 

 

Other intangible assets consist of the following at March 31, 2013 and December 31, 2012 (in thousands):

 

     Developed
Technology
& Patents
    Business
Licenses
    Customer
Relationships
    Trade
Names
    Other     Total  

March 31, 2013

            

Cost

   $ 3,250      $ 384      $ 3,323      $ 2,650      $ 48      $ 9,655   

Translation adjustment

     —         33        21        —         3        57   

Accumulated amortization

     (1,389     (202     (2,189     (316     (6     (4,102
  

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Balance, March 31, 2013

   $ 1,861      $ 215      $ 1,155      $ 2,334      $ 45      $ 5,610   
  

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

December 31, 2012

            

Cost

   $ 3,250      $ 384      $ 3,323      $ 2,650      $ 48      $ 9,655   

Translation adjustment

     —         38        24        —         3        65   

Accumulated amortization

     (1,292     (195     (2,019     (272     (5     (3,783
  

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Balance, December 31, 2012

   $ 1,958      $ 227      $ 1,328      $ 2,378      $ 46      $ 5,937   
  

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Amortization expense related to developed technology and patents is classified as a component of cost of revenues in the Consolidated Statements of Operations. Amortization expense related to customer relationships and trade names is classified as a component of amortization of intangible assets acquired in the Consolidated Statements of Operations. Amortization expense related to business licenses and other is classified as a component of general and administrative expenses in the Consolidated Statements of Operations.

Amortization expense for the three months ended March 31, 2013 and 2012 was $0.3 million and $0.5 million, respectively. Cynosure has approximately $41,000 of indefinite-life intangible assets that are included in other intangible assets in the table above. As of March 31, 2013, amortization expense on existing intangible assets for the next five years and beyond is as follows (table in thousands):

 

Remainder of 2013

   $ 976   

2014

     950   

2015

     765   

2016

     380   

2017

     344   

2018 and thereafter

     2,154   
  

 

 

 

Total

   $ 5,569   
  

 

 

 

The table above includes $0.6 million for the remainder of 2013, $0.6 million for 2014, $0.4 million for 2015, $0.2 million for 2016, $0.2 million for 2017 and $1.5 million for 2018 and thereafter, to be recognized within operating expenses related to intangible assets acquired through the Elemé Medical and ConBio acquisitions.

Note 7 — Warranty Costs

Cynosure typically provides a one-year parts and labor warranty on end-user sales of laser systems. Distributor sales generally include a warranty on parts only. Estimated future costs for initial product warranties are provided at the time of revenue recognition. The following table provides the detail of the change in Cynosure’s product warranty accrual during the three months ended March 31, 2013, which is a component of accrued expenses in the consolidated balance sheets:

 

     Total  
     (in thousands)  

Warranty accrual, beginning of period

   $ 3,415   

Warranty provision related to new sales

     1,585   

Costs incurred

     (1,053
  

 

 

 

Warranty accrual, end of period

   $ 3,947   
  

 

 

 

 

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Note 8 — Segment Information

In accordance with ASC 280, Segment Reporting Topic, operating segments are identified as components of an enterprise about which separate discrete financial information is available for evaluation by the chief operating decision maker, or decision-making group, in making decisions how to allocate resources and assess performance. Cynosure’s chief decision-maker, as defined under ASC 280, is a combination of the Chief Executive Officer and the Chief Financial Officer. Cynosure views its operations and manages its business as one segment, aesthetic treatment products and services.

The following table represents total revenue by geographic destination:

 

     Three Months Ended
March 31,
 
     2013      2012  
     (in thousands)  

United States

   $ 17,740       $ 15,160   

Europe

     7,768         7,019   

Asia / Pacific

     10,937         9,277   

Other

     4,245         2,712   
  

 

 

    

 

 

 

Total

   $ 40,690       $ 34,168   
  

 

 

    

 

 

 

Total assets by geographic area are as follows:

 

     March 31,
2013
    December 31,
2012
 
     (in thousands)  

United States

   $ 213,749      $ 210,596   

Europe

     14,776        15,623   

Asia / Pacific

     11,656        11,038   

Eliminations

     (2,792     (2,688
  

 

 

   

 

 

 

Total

   $ 237,389      $ 234,569   
  

 

 

   

 

 

 

Long-lived assets by geographic area are as follows:

 

     March 31,
2013
     December 31,
2012
 
     (in thousands)  

United States

   $ 7,457       $ 7,266   

Europe

     1,503         1,570   

Asia / Pacific

     744         432   
  

 

 

    

 

 

 

Total

   $ 9,704       $ 9,268   
  

 

 

    

 

 

 

No individual country within Europe or Asia/Pacific represented greater than 10% of total revenue, total assets or total long-lived assets for any period presented.

Note 9 — Net Income Per Common Share

Basic net income per share is determined by dividing net income by the weighted average common shares outstanding during the period. Diluted net income per share is determined by dividing net income by the diluted weighted average shares outstanding during the period. Diluted weighted average shares reflect the dilutive effect, if any, of common stock options based on the treasury stock method. For the three months ended March 31, 2013, there are no outstanding Class B shares, and Cynosure may not issue Class B shares in the future. For the three months ended March 31, 2012, common shares outstanding include both Class A and Class B as each share participated equally in earnings. Class B shares were convertible at any time into shares of Class A on a one-for-one basis at the option of the holder.

 

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A reconciliation of basic and diluted shares is as follows:

 

     Three Months Ended
March 31,
 
     2013      2012  

Net income

   $ 1,239       $ 819   
  

 

 

    

 

 

 

Basic weighted average common shares outstanding

     16,185         12,578   

Weighted average common equivalent shares

     675         459   
  

 

 

    

 

 

 

Diluted weighted average common shares outstanding

     16,860         13,037   
  

 

 

    

 

 

 

Basic net income per share

   $ 0.08       $ 0.07   
  

 

 

    

 

 

 

Diluted net income per share

   $ 0.07       $ 0.06   
  

 

 

    

 

 

 

For the three months ended March 31, 2013 and 2012 options to purchase approximately 0.4 million and 1.5 million shares of the Company’s Class A common stock were excluded from the calculation of diluted weighted average common shares outstanding as their effect was antidilutive.

Note 10 — Accumulated Other Comprehensive Loss

Changes to accumulated other comprehensive loss during the three months ended March 31, 2013 were as follows (in thousands):

 

     Unrealized
Gain on
Marketable
Securities, net
of taxes
     Translation
Adjustment
    Accumulated
Other
Comprehensive
Loss
 

Balance — December 31, 2012

   $ 13       $ (1,612   $ (1,599

Current period other comprehensive loss

     25         (594     (569
  

 

 

    

 

 

   

 

 

 

Balance — March 31, 2013

   $ 38       $ (2,206   $ (2,168

Note 11 — Agreement to Acquire Palomar Medical Technologies, Inc.

In March 2013, Cynosure signed a definitive agreement to acquire Palomar Medical Technologies, Inc. (Palomar) in a cash and stock transaction valued at approximately $294 million. Under the terms of the transaction, Palomar stockholders will receive $13.65 per share of Palomar common stock: $6.825 per share in cash and $6.825 per share in Cynosure common stock (subject to adjustment and collar provisions). Cynosure will issue approximately 5.2 million shares in the transaction and fund the approximately $147 million in cash consideration through existing cash balances. The transaction has been unanimously approved by the board of directors of each company and, subject to approval by the stockholders of each company, is expected to close by the end of June 2013. During the three months ended March 31, 2013, Cynosure incurred $1.1 million in costs associated with the acquisition of Palomar.

Note 12 — Litigation

In 2005, a plaintiff, individually and as putative representative of a purported class, filed a complaint against Cynosure under the federal Telephone Consumer Protection Act (the TCPA) in Massachusetts Superior Court in Middlesex County, captioned Weitzner v. Cynosure, Inc., No. MICV2005-01778 (Superior Court, Middlesex County), seeking monetary damages, injunctive relief, costs and attorneys’ fees. The complaint alleges that Cynosure violated the TCPA by sending unsolicited advertisements by facsimile to the plaintiff and other recipients without the prior express invitation or permission of the recipients. Under TCPA, recipients of unsolicited facsimile advertisements are entitled to damages of up to $500 per facsimile for inadvertent violations and up to $1,500 per facsimile for knowing or willful violations. Based on discovery in this matter, the plaintiff alleges that approximately three million facsimiles were sent on Cynosure’s behalf by a third party to approximately 100,000 individuals. In January 2012, the Court denied the class certification motion. In November 2012, the Court issued the final judgment and awarded the plaintiff $6,000 in damages and awarded Cynosure $3,495 in costs. The plaintiff has appealed this decision. In addition, in July 2012, the plaintiff filed a new purported class action, based on the same operative facts and asserting the same claims as in the Massachusetts action, in federal court in the Eastern District of New York, captioned Weitzner, et al. v. Cynosure, Inc., No. 1:12-cv-03668-MKB-RLM (U.S District Court, Eastern District of New York). In February 2013, that court granted Cynosure’s motion to dismiss the plaintiff’s claims. In March 2013, the plaintiff filed a motion seeking reconsideration of the court’s judgment and vacation of the court’s order of dismissal. In April 2013, Cynosure filed a response opposing the plaintiff’s motion.

On March 21, 2013, a putative stockholder class action complaint, captioned Edgar Calin v. Palomar Medical Technologies, Inc., et al., No. 13-1051 BLS1 (Superior Court, Suffolk County), was filed against Palomar, its board of directors, Cynosure and Commander Acquisition Corp., Cynosure’s wholly-owned subsidiary (Commander), in Massachusetts Superior Court in Suffolk County. On April 9, 2013, a second putative stockholder class action complaint, captioned Vladimir Gusinsky Living Trust v. Palomar

 

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Medical Technologies, Inc., et al., No. 13-1328 BLS1 (Superior Court, Suffolk County), was filed against Palomar, its board of directors and Cynosure in Massachusetts Superior Court in Suffolk County. On April 12, 2013, a third putative stockholder class action complaint, captioned Albert Saffer v. Palomar Medical Technologies, Inc. et al., No. 13-1385 BLS1 (Superior Court, Suffolk County), was filed against Palomar, its board of directors, Cynosure and Commander in Massachusetts Superior Court in Suffolk County. On April 23, 2013, each of the plaintiffs in the foregoing suits filed an amended complaint. Each amended complaint alleges that members of the Palomar board of directors breached their fiduciary duties in connection with the approval of the merger contemplated by the agreement and plan of merger, dated as of March 17, 2013, by and among Palomar, Cynosure and Commander, and that Cynosure and, with respect to the Calin and Saffer suits, Commander, aided and abetted the alleged breach of fiduciary duties. Each amended complaint alleges that the Palomar directors breached their fiduciary duties in connection with the proposed transaction by, among other things, conducting a flawed sale process and failing to maximize stockholder value and obtain the best financial and other terms, and that the registration statement filed by Cynosure is materially deficient. Each of these plaintiffs seeks injunctive and other equitable relief, including enjoining the defendants from consummating the merger, in addition to other unspecified damages, fees and costs. The plaintiffs in the three Massachusetts actions moved to expedite the proceedings on May 1, 2013 and moved to consolidate the actions on May 1, 2013. Cynosure, Palomar and their respective boards of directors believe that the Massachusetts lawsuits are without merit and intend to defend them vigorously.

On April 19, 2013, a fourth putative stockholder class action complaint, captioned Gary Drabek v. Palomar Medical Technologies, Inc. et al., No. 8491, (Del. Ch.) was filed against Palomar, its board of directors, Cynosure and Commander in Delaware Chancery Court. On May 1, 2013, a fifth putative stockholder class action complaint, captioned Daniel Moore v. Palomar Medical Technologies, Inc. et al., No. 8516, (Del. Ch.) was filed against Palomar, its board of directors, Cynosure and Commander in Delaware Chancery Court. Each of the foregoing lawsuits alleges that members of the Palomar board of directors breached their fiduciary duties in connection with the approval of the merger and that Cynosure and Commander aided and abetted the alleged breach of fiduciary duties. Each complaint alleges that the Palomar directors breached their fiduciary duties in connection with the proposed transaction by, among other things, conducting a flawed sale process and failing to maximize stockholder value and obtain the best financial and other terms, and that the registration statement filed by Cynosure is materially deficient. Each of these plaintiffs seeks injunctive and other equitable relief, including enjoining the defendants from consummating the merger, in addition to other unspecified damages, fees and costs. The plaintiff in the Drabek action moved to expedite the proceedings on April 29, 2013, and the plaintiff in the Moore action moved to expedite and moved for a preliminary injunction on May 3, 2013. The court has scheduled a preliminary injunction hearing for June 17, 2013 in the Drabek action. Cynosure, Palomar and their respective boards of directors believe that the Delaware lawsuits are without merit and intend to defend them vigorously.

In addition to the matters discussed above, from time to time, Cynosure is subject to various claims, lawsuits, disputes with third parties, investigations and pending actions involving various allegations against Cynosure incident to the operation of its business, principally product liability. Each of these other matters is subject to various uncertainties, and it is possible that some of these other matters may be resolved unfavorably to Cynosure. Cynosure establishes accruals for losses that management deems to be probable and subject to reasonable estimate. Cynosure believes that the ultimate outcome of these matters will not have a material adverse impact on its consolidated financial position, results of operations or cash flows.

Note 13 — Related Party Transactions

As of March 31, 2013, El. En. S.p.A. (El.En.) owned approximately 13% of Cynosure’s outstanding common stock. Purchases of inventory from El.En. during the three months ended March 31, 2013 and 2012 were approximately $1.6 million and $1.1 million, respectively. As of March 31, 2013 and December 31, 2012, amounts due to related party for these purchases were approximately $1.7 million and $1.9 million, respectively. There were no amounts due from El.En. as of March 31, 2013 or December 31, 2012.

Note 14 — Income Taxes

At December 31, 2012, Cynosure had gross tax-effected unrecognized tax benefits of $0.6 million, of which $0.3 million, if recognized, would favorably impact the effective tax rate. During the quarter ended March 31, 2013, due to the completion of a tax examination, Cynosure released gross tax-effected unrecognized tax benefits of $0.2 million, of which $0.1 million impacted the effective tax rate. Cynosure classifies interest and penalties related to income taxes as a component of its provision for income taxes, and the amount of interest and penalties recorded as of March 31, 2013 and December 31, 2012 in the statements of operations and balance sheet was immaterial.

Cynosure files income tax returns in the U.S. federal jurisdiction, and in various state and foreign jurisdictions. Cynosure is no longer subject to U.S. federal income tax examinations by tax authorities for years before 2010. With few exceptions, Cynosure is no longer subject to U.S. state tax examinations for years before 2008. Additionally, certain non-U.S. jurisdictions are no longer subject to income tax examinations by tax authorities for years before 2008.

 

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Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations

Forward-Looking Statements

This Quarterly Report on Form 10-Q contains forward-looking statements that involve substantial risks and uncertainties. All statements, other than statements of historical facts, included in this Quarterly Report regarding our strategy, future operations, future financial position, future revenues, projected costs, prospects, plans, objectives of management and expected market growth are forward-looking statements. The words “anticipate,” “believe,” “estimate,” “expect,” “intend,” “may,” “plan,” “predict,” “project,” “will,” “would” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. These forward-looking statements include, among other things, statements about:

 

   

our ability to identify and penetrate new markets for our products and technology;

 

   

our strategy of growing through acquisitions;

 

   

our ability to innovate, develop and commercialize new products;

 

   

our ability to obtain and maintain regulatory clearances;

 

   

our sales and marketing capabilities and strategy in the United States and internationally;

 

   

our intellectual property portfolio; and

 

   

our estimates regarding expenses, future revenues, capital requirements and needs for additional financing.

We may not actually achieve the plans, intentions or expectations disclosed in our forward-looking statements, and you should not place undue reliance on our forward-looking statements. Actual results or events could differ materially from the plans, intentions and expectations disclosed in the forward-looking statements we make. We have included important factors below under the heading “Risk Factors” in Part II, Item 1A, and in our other public filings with the Securities and Exchange Commission that could cause actual results or events to differ materially from the forward-looking statements that we make.

You should read this Quarterly Report and the documents that we have filed as exhibits to the Quarterly Report completely and with the understanding that our actual future results may be materially different from what we expect. It is routine for internal projections and expectations to change as the year or each quarter in the year progresses, and therefore it should be clearly understood that the internal projections and beliefs upon which we base our expectations are made as of the date of this Quarterly Report on Form 10-Q and may change prior to the end of each quarter or the year. While we may elect to update forward-looking statements at some point in the future, we do not undertake any obligation to update any forward-looking statements whether as a result of new information, future events or otherwise, except as required by law.

The following discussion should be read in conjunction with, and is qualified in its entirety by, the consolidated financial statements and notes thereto included in Item 1 of this Quarterly Report and the consolidated financial statements and notes thereto and Management’s Discussion and Analysis of Financial Condition and Results of Operations in our Form 10-K filed with the Securities and Exchange Commission (the “SEC”) on March 8, 2013, as amended on Form 10-K/A filed with the SEC on April 29, 2013. Historical results and percentage relationships among any amounts in the financial statements are not necessarily indicative of trends in operating results for any future periods.

Forward-Looking Statements about the Proposed Transaction

This Quarterly Report on Form 10-Q contains forward-looking statements about the merger transaction between us and Palomar Medical Technologies, Inc. (Palomar) and the expected closing of the merger. These forward-looking statements are neither promises nor guarantees, but involve risks and uncertainties that may individually or mutually impact the matters herein, and cause actual results, events and performance to differ materially from such forward-looking statement. These risk factors include, but are not limited to, failure to receive approval from the stockholders of Cynosure or Palomar or to satisfy other conditions to the parties’ obligations to complete the merger, the risk that competing offers for Palomar will be made and/or other factors, which are detailed from time to time in reports that we or Palomar file with the SEC, including our Registration Statement on Form S-4 (File No. 333-187895). Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. Neither we nor Palomar undertakes any obligation to release publicly the result of any revisions to the forward-looking statements that may be made to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events.

Additional Information about the Proposed Transaction and Where to Find it

In connection with the proposed transaction between us and Palomar, we filed a Registration Statement on Form S-4 (File No. 333-187895) with the SEC on April 12, 2013 (the “Registration Statement”). The Registration Statement includes a joint proxy statement of us and Palomar that also constitutes a prospectus of ours. We and Palomar also plan to file other relevant documents with

 

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the SEC regarding the proposed transaction. INVESTORS ARE URGED TO READ THE JOINT PROXY STATEMENT/PROSPECTUS AND OTHER RELEVANT DOCUMENTS FILED WITH THE SEC (IF AND WHEN THEY BECOME AVAILABLE) BECAUSE THEY CONTAIN OR WILL CONTAIN IMPORTANT INFORMATION. You may obtain a free copy of the joint proxy statement/prospectus and other relevant documents filed by us and Palomar with the SEC (if and when they become available) at the SEC’s website at www.sec.gov. You may also obtain these documents by contacting our Investor Relations Department at (617) 542-5300 or CYNO@investorrelations.com, or by contacting Palomar’s Investor Relations Department at (781) 993-2411 or ir@palomarmedical.com.

We and Palomar and our respective directors and executive officers and other members of management and employees may be deemed to be participants in the solicitation of proxies in respect of the proposed transaction. Information about our directors and executive officers is available in the joint proxy statement/prospectus under the heading “Information About Cynosure’s Directors, Officers and 5% Stockholders” and in our Annual Report on Form 10-K dated March 8, 2013, as amended on Form 10-K/A dated April 29, 2013, under Items 10, 11, 12 and 13. As of April 5, 2013, our directors and executive officers beneficially owned approximately 2.9 million shares, or 17.1%, of our Class A common stock. Information about Palomar’s directors and executive officers is available in its Annual Report on Form 10-K dated March 14, 2013, as amended on Form 10-K/A dated April 26, 2013, under Items 10, 11, 12 and 13. As of March 15, 2013, Palomar’s directors and executive officers beneficially owned approximately 2.7 million shares, or 13.1%, of Palomar’s common stock. Additional information regarding the interests of Palomar’s directors and executive officers in the proposed transaction, including information relating to the acceleration of Palomar equity awards; the election of Joseph P. Caruso, Palomar’s President, Chief Executive Officer and Chairman of the Board of Directors, as our President and Vice Chairman of our Board of Directors; amendments to existing Palomar employment agreements; a new employment agreement between us and Mr. Caruso; indemnification and insurance matters relating to Palomar directors and executive officers; and golden parachute compensation, can be found in the joint proxy statement/prospectus under the heading “Interests of Directors and Executive Officers of Palomar in the Merger.” Investors should read the joint proxy statement/prospectus carefully before making any voting or investment decisions. You may obtain free copies of any documents described above from us or Palomar using the sources indicated above.

This document shall not constitute an offer to sell or the solicitation of an offer to buy any securities, nor shall there be any sale of securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such jurisdiction. No offering of securities shall be made except by means of a prospectus meeting the requirements of Section 10 of the U.S. Securities Act of 1933, as amended.

Company Overview

We develop and market aesthetic treatment systems that are used by physicians and other practitioners to perform non-invasive and minimally invasive procedures to remove hair, treat vascular and benign pigmented lesions, treat multi-colored tattoos, rejuvenate the skin, liquefy and remove unwanted fat through laser lipolysis, reduce cellulite and treat onychomycosis. We are also developing in conjunction with our development agreement with Unilever a laser treatment system for the home use market.

In March 2013, we signed a definitive agreement to acquire Palomar in a cash and stock transaction valued at approximately $294 million. Under the terms of the transaction, Palomar stockholders will receive $13.65 per share of Palomar common stock: $6.825 per share in cash and $6.825 per share in our common stock (subject to adjustment and collar provisions). We will issue approximately 5.2 million shares in the transaction and fund the approximately $147 million in cash consideration through existing cash balances. The transaction has been unanimously approved by the board of directors of each company and, subject to approval by the stockholders of each company, is expected to close by the end of June 2013.

Our systems incorporate a broad range of laser and other light-based energy sources, including Alexandrite, pulse dye, Nd:Yag and diode lasers, as well as intense pulsed light. We believe that we are one of only a few companies that currently offer aesthetic treatment systems utilizing Alexandrite and pulse dye lasers, which are particularly well suited for some applications and skin types. We offer single energy source systems as well as workstations that incorporate two or more different types of lasers or pulsed light technologies. We offer multiple technologies and system alternatives at a variety of price points depending primarily on the number and type of energy sources included in the system. Our products are designed to be easily upgradeable to add additional energy sources and handpieces, which provides our customers with technological flexibility as they expand their practices.

We focus our development and marketing efforts on offering leading, or flagship, products for the following high volume applications:

 

   

our Elite product line for hair removal and treatment of facial and leg veins and pigmentations;

 

   

our Smartlipo product line for LaserBodySculptingSM for the removal of unwanted fat;

 

   

our Cellulaze product line for the treatment of cellulite;

 

   

our SmoothShapes XV product line for the temporary reduction in the appearance of cellulite;

 

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our Affirm/SmartSkin product line for anti-aging applications, including treatments for wrinkles, skin texture, skin discoloration and skin tightening;

 

   

our Cynergy product line for the treatment of vascular lesions;

 

   

our Accolade, MedLite C6 and RevLite product lines for the removal of benign pigmented lesions, as well as multi-colored tattoos; and

 

   

our PicoSure product line for the treatment of tattoos and benign pigmented lesions.

A key element of our business strategy is to launch innovative new products and technologies into high-growth aesthetic applications. Our research and development team builds on our existing broad range of laser and light-based technologies to develop new solutions and products to target unmet needs in significant aesthetic treatment markets. Innovation continues to be a strong contributor to our strength. For the three months ended March 31, 2013, 46% of our product revenues were attributable to the sale of systems that we have introduced to the market since the beginning of 2010.

In March 2013, we commenced commercialization of our PicoSure system, our picosecond laser technology platform for the treatment of tattoos and benign pigmented lesions. PicoSure is the first commercially available picosecond Alexandrite aesthetic laser platform. Picosecond lasers deliver pulses that are measured in trillionths of a second, in contrast with nanosecond technology, such as our MedLite and RevLite products, which deliver pulses in billionths of a second. FDA clearance to market PicoSure was received in November 2012.

In July 2012, we received FDA clearance in the United States to market an at home device for the treatment of wrinkles that we are developing in partnership with Unilever. Unilever has advised us that it expects to launch the product commercially near the end of 2013.

We generate revenues primarily from sales of our products, parts and accessories and from services, including product warranty revenues. During the three months ended March 31, 2013, we derived approximately 84% of our revenues from sales of our products and 16% of our revenues from parts, accessories and service revenues. During the three months ended March 31, 2012, we derived approximately 82% of our revenues from sales of products and 18% of our revenues from parts, accessories and service revenues. Generally, we recognize revenues from the sales of our products upon delivery to our customers, revenues from service contracts and extended product warranties ratably over the coverage period and revenues from service in the period in which the service occurs.

We sell our products through a direct sales force in North America, France, Spain, the United Kingdom, Germany, Korea, China, Japan and Mexico, and use distributors to sell our products in other countries where we do not have a direct presence. During each of the three months ended March 31, 2013 and 2012, we derived 54% of our revenues from sales outside North America. As of March 31, 2013, we had 44 sales employees covering North America, 43 sales employees in France, Spain, the United Kingdom, Germany, Korea, China and Japan and approximately 70 distributors covering approximately 100 countries.

The following table provides revenue data by geographical region for the three months ended March 31, 2013 and 2012:

 

     Percentage of Revenues  
     Three Months
Ended March 31,
 

Region

   2013     2012  

North America

     46     46

Europe

     19        21   

Asia/Pacific

     27        27   

Other

     8        6   
  

 

 

   

 

 

 

Total

     100     100
  

 

 

   

 

 

 

See Note 8 to our consolidated financial statements included in this Quarterly Report for revenues and asset data by geographic region.

 

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Results of Operations

The following table contains selected income statement information, which serves as the basis of the discussion of our results of operations for the three months ended March 31, 2013 and 2012, respectively (in thousands, except for percentages):

 

     Three Months Ended March 31,     $
Change
    %
Change
 
   2013     2012      
   Amount     As a % of
Total
Revenues
    Amount      As a % of
Total
Revenues
     

Product revenues

   $ 34,117        84   $ 28,095         82   $ 6,022        21

Parts, accessories and service revenues

     6,573        16        6,073         18        500        8   
  

 

 

   

 

 

   

 

 

    

 

 

   

 

 

   

 

 

 

Total revenues

     40,690        100        34,168         100        6,522        19   

Cost of revenues

     17,003        42        14,660         43        2,343        16   
  

 

 

   

 

 

   

 

 

    

 

 

   

 

 

   

 

 

 

Gross profit

     23,687        58        19,508         57        4,179        21   

Operating expenses

             

Sales and marketing

     12,603        31        11,551         34        1,052        9   

Research and development

     3,781        9        3,239         9        542        17   

Amortization of intangible assets acquired

     214        —          342         1        (128     (37

General and administrative

     5,101        13        3,518         10        1,583        45   
  

 

 

   

 

 

   

 

 

    

 

 

   

 

 

   

 

 

 

Total operating expenses

     21,699        53        18,650         55        3,049        16   
  

 

 

   

 

 

   

 

 

    

 

 

   

 

 

   

 

 

 

Income from operations

     1,988        5        858         3        1,130        132   

Interest income, net

     32        —          10         —         22        220   

Other (expense) income, net

     (357     (1     209         1        (566     (271
  

 

 

   

 

 

   

 

 

    

 

 

   

 

 

   

 

 

 

Income before provision for income taxes

     1,663        4        1,077         3        586        54   

Provision for income taxes

     424        1        258         1        166        64   
  

 

 

   

 

 

   

 

 

    

 

 

   

 

 

   

 

 

 

Net income

   $ 1,239        3   $ 819         2   $ 420        51
  

 

 

   

 

 

   

 

 

    

 

 

   

 

 

   

 

 

 

Revenues

 

     Three Months Ended
March 31,
     $
Change
     %
Change
 
     2013      2012        

Product sales in North America

   $ 16,337       $ 13,562       $ 2,775         20

Product sales outside North America

     17,780         14,533         3,247         22   

Global parts, accessories and service sales

     6,573         6,073         500         8   
  

 

 

    

 

 

    

 

 

    

 

 

 

Total Revenues

   $ 40,690       $ 34,168       $ 6,522         19
  

 

 

    

 

 

    

 

 

    

 

 

 

Revenues in the three months ended March 31, 2013 increased from the three months ended March 31, 2012 by $6.5 million, or 19%. The increase was attributable to a number of factors:

 

   

Revenues from the sale of products in North America increased by $2.8 million, or 20%, from the 2012 period primarily due to an increase in average selling prices attributable to the introduction of new products, including PicoSure and Elite Plus.

 

   

Revenues from the sale of products outside of North America increased by $3.2 million, or 22%, from the 2012 period primarily due to an increase in the number of units sold by our Asia Pacific subsidiaries and distributors.

 

   

Revenues from the sale of parts, accessories and services increased by $0.5 million, or 8%, from the 2012 period primarily due to an increase in revenues generated from performing service on laser systems.

Cost of Revenues

 

     Three Months Ended
March 31,
    $
Change
     %
Change
 
     2013     2012       

Cost of revenues (in thousands)

   $ 17,003      $ 14,660      $ 2,343         16

Cost of revenues (as a percentage of total revenues)

     42     43     

Total cost of revenues increased $2.3 million, or 16%, to $17.0 million for three months ended March 31, 2013, as compared to $14.7 million for the three months ended March 31, 2012. The increase was primarily associated with our 19% increase in total revenues. Total cost of revenues decreased slightly as a percentage of total revenues, to 42% for the three months ended March 31, 2013, from 43% for the three months ended March 31, 2012, primarily due to a higher volume of sales through our direct subsidiaries, which yield higher gross profit margins.

 

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Sales and Marketing

 

     Three Months Ended
March 31,
    $
Change
     %
Change
 
     2013     2012       

Sales and marketing (in thousands)

   $ 12,603      $ 11,551      $ 1,052         9

Sales and marketing (as a percentage of total revenues)

     31     34     

Sales and marketing expenses increased $1.1 million, or 9%, for the three months ended March 31, 2013, as compared with the three months ended March 31, 2012. The increase included $0.5 million in personnel costs due to an increase in the number of our sales employees. Commission expense increased $0.3 million due to increased product revenues. Sales and marketing costs increased $0.3 million due to an increased number of workshops, trade shows and other promotional efforts, including those related to the launch of PicoSure. Sales and marketing expenses for the three months ended March 31, 2013 decreased as a percentage of total revenues to 31%, due to favorable product mix and continued operating leverage.

Research and Development

 

     Three Months Ended
March 31,
    $
Change
     %
Change
 
     2013     2012       

Research and development (in thousands)

   $ 3,781      $ 3,239      $ 542         17

Research and development (as a percentage of total revenues)

     9     9     

Research and development expenses increased $0.5 million, or 17%, for the three months ended March 31, 2013 as compared with the three months ended March 31, 2012. This increase was primarily due to increases in personnel and professional services costs associated with the development of new products.

Amortization of Intangible Assets Acquired

 

     Three Months Ended
March 31,
    $
Change
    %
Change
 
     2013     2012      

Amortization of intangible assets acquired (in thousands)

   $ 214      $ 342      $ (128     (37 )% 

Amortization of intangible assets acquired (as a percentage of total revenues)

     1     1 %    

For the three months ending March 31, 2013, we recognized amortization expense of $0.2 million in our operating expenses relating to certain intangible assets acquired through our 2011 acquisitions of Elemé Medical and ConBio’s aesthetic business.

General and Administrative

 

     Three Months Ended
March 31,
    $
Change
     %
Change
 
     2013     2012       

General and administrative (in thousands)

   $ 5,101      $ 3,518      $ 1,583         45

General and administrative (as a percentage of total revenues)

     13     10     

General and administrative expenses increased $1.6 million, or 45%, for the three months ended March 31, 2013, as compared to the three months ended March 31, 2012. The increase was primarily due to $1.1 million in acquisition-related costs, with the remainder due to an increase in personnel and other administrative costs.

Interest Income, net

 

     Three Months Ended
March 31,
     $
Change
     %
Change
 
     2013      2012        

Interest income, net (in thousands)

   $ 32       $ 10       $ 22         220

The increase in interest income, net was primarily due to increased cash invested in interest-bearing securities in the first three months of 2013 as compared to the first three months of 2012.

 

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Other (Expense) Income, net

 

     Three Months Ended
March 31,
     $
Change
    %
Change
 
     2013     2012       

Other (expense) income, net (in thousands)

   $ (357   $ 209       $ (566     (271 )% 

The change in other (expense) income, net was primarily a result of net foreign currency remeasurement losses in the three months ended March 31, 2013, as compared to net foreign currency remeasurement gains in the three months ended March 31, 2012, primarily due to weakening of the euro and the pound against the U.S. dollar.

Provision for Income Taxes

 

     Three Months Ended
March 31,
    $
Change
     %
Change
 
     2013     2012       

Provision for income taxes (in thousands)

   $ 424      $ 258      $ 166         64

Provision as a % of income before provision for income taxes

     25     24     

The provision for income taxes results from a combination of the activities of our U.S. entities and foreign subsidiaries. During the three months ended March 31, 2013, we recorded an income tax provision of $0.4 million, representing an effective tax rate of 25%. The income tax provision in both the 2013 and 2012 periods was primarily attributable to the tax provision recorded on current domestic and foreign taxable earnings. We continue to maintain a valuation allowance against our net domestic deferred tax assets as well as the deferred tax assets of our Japanese and Mexican subsidiaries at March 31, 2013.

Liquidity and Capital Resources

We require cash to pay our operating expenses, make capital expenditures, fund acquisitions and pay our long-term liabilities. We have funded our operations through proceeds from public offerings of our Class A common stock and funds generated from our operations. In November 2012, we raised approximately $55.3 million through a public offering of shares of our Class A common stock.

At March 31, 2013, our cash, cash equivalents and short and long-term marketable securities were $146.6 million. Our cash and cash equivalents of $89.2 million are highly liquid investments with maturities of 90 days or less at date of purchase and consist of cash in operating accounts, investments in money market funds and various state and municipal governments. Our short-term marketable securities of $43.8 million consist of investments in various state and municipal governments, U.S. government agencies and treasuries, all of which mature by March 15, 2014. Our long-term marketable securities of $13.6 million consist of investments in various state and municipal governments, all of which mature by November 15, 2014.

We expect to close the acquisition of Palomar by the end of June 2013. At the closing we will pay approximately $147 million to Palomar stockholders. We will fund this payment from our existing cash balances.

Our future capital requirements depend on a number of factors, including the rate of market acceptance of our current and future products, the resources we devote to developing and supporting our products and continued progress of our research and development of new products. During the three months ended March 31, 2013 and 2012, we purchased $0.8 million and $0.7 million, respectively, of property and equipment. During each of the three months ended March 31, 2013 and 2012, we transferred $1.0 million of demonstration equipment to fixed assets. We expect that our capital expenditures during the remainder of 2013 will remain consistent with the 2012 period.

In July 2009, our board of directors authorized the repurchase of up to $10 million of our Class A common stock, from time to time, on the open market or in privately negotiated transactions under a stock repurchase program. The program will terminate upon the purchase of $10 million in common stock, unless our board of directors discontinues it sooner. During the three months ended March 31, 2013, we did not repurchase any shares of our common stock under this program. As of March 31, 2013, we have repurchased an aggregate of 196,970 shares under this program at an aggregate cost of $1.9 million.

We believe that our current cash, cash equivalents and short and long-term marketable securities, as well as cash generated from operations, will be sufficient to meet our anticipated cash needs for working capital and capital expenditures for the foreseeable future.

Cash Flows

Net cash provided by operating activities was $0.8 million for the three months ended March 31, 2013. This resulted primarily from net income for the period of $1.2 million, increased by approximately $2.4 million in depreciation, amortization and stock-based compensation expense and by approximately $0.6 million in net accretion of marketable securities. Net changes in working capital items decreased cash from operating activities by approximately $3.4 million principally related to increases in accounts receivable

 

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and inventory, as well as a decrease in deferred revenue, offset by an increase in accounts payable. Net cash provided by investing activities was $1.9 million for the three months ended March 31, 2013, which consisted of net proceeds from the sales and maturities of marketable securities of $2.7 million offset by purchases of property and equipment of $0.8 million. Net cash provided by financing activities during the three months ended March 31, 2013 was $0.5 million, primarily relating to proceeds from stock option exercises.

Net cash provided by operating activities was $3.7 million for the three months ended March 31, 2012. This resulted primarily from net income for the period of $0.8 million, increased by approximately $2.4 million in depreciation, amortization and stock-based compensation expense and increased by approximately $0.2 million in accretion of discounts on marketable securities. Net changes in working capital items increased cash from operating activities by approximately $0.3 million principally related to an increase in deferred revenue of $3.4 million offset by an increase in accounts receivable of $1.7 million and increased inventory of $1.3 million, net of demonstration equipment transfers, associated with increased purchases to meet the increased revenue requirements. Net cash provided by investing activities was $1.1 million for the three months ended March 31, 2012, which consisted of net proceeds from the sales and maturities of marketable securities of $1.7 million offset by purchases of property and equipment of $0.7 million. Net cash provided by financing activities during the three months ended March 31, 2012 was $0.2 million, primarily relating to proceeds from stock option exercises.

Critical Accounting Policies and Estimates

The discussion and analysis of our financial condition and results of operations set forth above are based on our financial statements, which have been prepared in accordance with U.S. generally accepted accounting principles. The preparation of these financial statements requires us to make estimates and judgments that affect the reported amounts of assets, liabilities, revenues and expenses. On an ongoing basis, we evaluate our estimates and judgments, including those described in our Annual Report on Form 10-K for the year ended December 31, 2012, as amended. We base our estimates on historical experience and on various assumptions that we believe to be reasonable under the circumstances. These estimates and assumptions form the basis for making judgments about the carrying values of assets and liabilities, and the reported amounts of revenues and expenses, 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 our Annual Report on Form 10-K for the fiscal year ended December 31, 2012, as amended. There have been no material changes to our critical accounting policies as of March 31, 2013.

 

Item 3. Quantitative and Qualitative Disclosures about Market Risk

The following discussion about our market risk disclosures involves forward-looking statements. Actual results could differ materially from those projected in the forward-looking statements. We are exposed to market risk related to changes in interest rates and foreign currency exchange rates. We do not use derivative financial instruments.

Interest Rate Sensitivity. We maintain an investment portfolio consisting mainly of money market funds, state and municipal government obligations, U.S. government agencies and treasuries. The securities, other than money market funds, are classified as available-for-sale and consequently are recorded on the balance sheet at fair value with unrealized gains and losses reported as a separate component of accumulated other comprehensive loss. All investments mature by November 15, 2014. These available-for-sale securities are subject to interest rate risk and will fall in value if market interest rates increase, which could result in a realized loss if we are forced to sell an investment before its scheduled maturity. We currently have the ability and intent to hold our fixed income investments until maturity. We do not utilize derivative financial instruments to manage our interest rate risks.

The following table provides information about our investment portfolio in available-for-sale debt securities. For investment securities, the table presents principal cash flows (in thousands) and weighted average interest rates by expected maturity dates.

 

     March 31, 2013     Future Maturities
in 2013
    Future Maturities
in 2014
 

Investments (at fair value)

   $ 57,868      $ 35,958      $ 21,910   

Weighted average interest rate

     0.27     0.26     0.29

Foreign Currency Exchange. A significant portion of our operations is conducted through operations in countries other than the United States. Revenues from our international operations that were recorded in U.S. dollars represented approximately 53% of our total international revenues during the three months ended March 31, 2013. Substantially all of the remaining 47% were sales in euros, British pounds, Japanese yen, Chinese yuan and South Korean won. Since we conduct our business in U.S. dollars, our main exposure, if any, results from changes in the exchange rate between these currencies and the U.S. dollar. Our functional currency is the U.S. dollar. Our policy is to reduce exposure to exchange rate fluctuations by having most of our assets and liabilities, as well as most of our revenues and expenditures, in U.S. dollars, or U.S. dollar linked. We have not historically engaged in hedging activities relating to our non-U.S. dollar operations. We sell inventory to our subsidiaries in U.S. dollars. These amounts are recorded at our local subsidiaries in local currency rates in effect on the transaction date. Therefore, we may be exposed to exchange rate fluctuations that

 

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occur while the payment is outstanding, which we recognize as unrealized gains and losses in our statements of operations. Upon settlement of these payments, we may record realized foreign exchange gains and losses. We may incur negative foreign currency translation charges as a result of changes in currency exchange rates.

 

Item 4. Controls and Procedures

Evaluation of Disclosure Controls and Procedures

Our management, with the participation of our principal executive officer and principal financial officer, evaluated the effectiveness of our disclosure controls and procedures as of March 31, 2013. The term “disclosure controls and procedures,” as defined in Rules 13a-15(e) and 15d-15(e) under the Securities Exchange Act of 1934, as amended, or the Exchange Act, means controls and other procedures of a company that are designed to ensure that information required to be disclosed by a company in the reports that it files or submits under the Exchange Act is recorded, processed, summarized and reported, within the time periods specified in the SEC’s rules and forms. Disclosure controls and procedures include, without limitation, controls and procedures designed to ensure that information required to be disclosed by a company in the reports that it files or submits under the Exchange Act is accumulated and communicated to the company’s management, including its principal executive and principal financial officers, as appropriate to allow timely decisions regarding required disclosure. Management recognizes that any controls and procedures, no matter how well designed and operated, can provide only reasonable assurance of achieving their objectives and management necessarily applies its judgment in evaluating the cost-benefit relationship of possible controls and procedures. Based on the evaluation of our disclosure controls and procedures as of March 31, 2013, our principal executive officer and principal financial officer have concluded that, as of such date, our disclosure controls and procedures were effective at the reasonable assurance level.

Changes in Internal Control over Financial Reporting

There was no change in our internal control over financial reporting (as defined in Rules 13a-15(f) and 15d-15(f) under the Exchange Act) that occurred during the quarter ended March 31, 2013 that has materially affected, or is reasonably likely to materially affect, our internal control over financial reporting.

PART II — Other Information

 

Item 1. Legal Proceedings

In 2005, a plaintiff, individually and as putative representative of a purported class, filed a complaint against us under the federal Telephone Consumer Protection Act, or the TCPA in Massachusetts Superior Court in Middlesex County, captioned Weitzner v. Cynosure, Inc., No. MICV2005-01778 (Superior Court, Middlesex County), seeking monetary damages, injunctive relief, costs and attorneys’ fees. The complaint alleges that we violated the TCPA by sending unsolicited advertisements by facsimile to the plaintiff and other recipients without the prior express invitation or permission of the recipients. Under the TCPA, recipients of unsolicited facsimile advertisements are entitled to damages of up to $500 per facsimile for inadvertent violations and up to $1,500 per facsimile for knowing or willful violations. Based on discovery in this matter, the plaintiff alleges that approximately three million facsimiles were sent on our behalf by a third party to approximately 100,000 individuals. In January 2012, the Court denied the class certification motion. In November 2012, the Court issued the final judgment and awarded the plaintiff $6,000 in damages and awarded us $3,495 in costs. The plaintiff has appealed this decision. In addition, in July 2012, the plaintiff filed a new purported class action, based on the same operative facts and asserting the same claims as in the Massachusetts action, in federal court in the Eastern District of New York, captioned Weitzner, et al. v. Cynosure, Inc., No. 1:12-cv-03668-MKB-RLM (U.S District Court, Eastern District of New York). In February 2013, that court granted our motion to dismiss the plaintiff’s claims. In March 2013, the plaintiff filed a motion seeking reconsideration of the court’s judgment and vacation of the court’s order of dismissal. In April 2013, we filed a response opposing the plaintiff’s motion.

On March 21, 2013, a putative stockholder class action complaint, captioned Edgar Calin v. Palomar Medical Technologies, Inc., et al., No. 13-1051 BLS1 (Superior Court, Suffolk County), was filed against Palomar, its board of directors, us and Commander in Massachusetts Superior Court in Suffolk County. On April 9, 2013, a second putative stockholder class action complaint, captioned Vladimir Gusinsky Living Trust v. Palomar Medical Technologies, Inc., et al., No. 13-1328 BLS1 (Superior Court, Suffolk County), was filed against Palomar, its board of directors and us in Massachusetts Superior Court in Suffolk County. On April 12, 2013, a third putative stockholder class action complaint, captioned Albert Saffer v. Palomar Medical Technologies, Inc. et al., No. 13-1385 BLS1 (Superior Court, Suffolk County), was filed against Palomar, its board of directors, us and Commander in Massachusetts Superior Court in Suffolk County. On April 23, 2013, each of the plaintiffs in the foregoing suits filed an amended complaint. Each amended complaint alleges that members of the Palomar board of directors breached their fiduciary duties in connection with the approval of the merger contemplated by the agreement and plan of merger, dated as of March 17, 2013, by and among Palomar, us and Commander, and that we and, with respect to the Calin and Saffer suits, Commander, aided and abetted the alleged breach of fiduciary duties. Each amended complaint alleges that the Palomar directors breached their fiduciary duties in connection with the proposed transaction by, among other things, conducting a flawed sale process and failing to maximize stockholder value and obtain the best

 

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financial and other terms, and that the registration statement filed by us is materially deficient. Each of these plaintiffs seeks injunctive and other equitable relief, including enjoining the defendants from consummating the merger, in addition to other unspecified damages, fees and costs. The plaintiffs in the three Massachusetts actions moved to expedite the proceedings on May 1, 2013 and moved to consolidate the actions on May 1, 2013. We, Palomar and our respective boards of directors believe that the Massachusetts lawsuits are without merit and intend to defend them vigorously.

On April 19, 2013, a fourth putative stockholder class action complaint, captioned Gary Drabek v. Palomar Medical Technologies, Inc. et al., No. 8491, (Del. Ch.) was filed against Palomar, its board of directors, us and Commander in Delaware Chancery Court. On May 1, 2013, a fifth putative stockholder class action complaint, captioned Daniel Moore v. Palomar Medical Technologies, Inc. et al., No. 8516, (Del. Ch.) was filed against Palomar, its board of directors, us and Commander in Delaware Chancery Court. Each of the foregoing lawsuits alleges that members of the Palomar board of directors breached their fiduciary duties in connection with the approval of the merger and that we and Commander aided and abetted the alleged breach of fiduciary duties. Each complaint alleges that the Palomar directors breached their fiduciary duties in connection with the proposed transaction by, among other things, conducting a flawed sale process and failing to maximize stockholder value and obtain the best financial and other terms, and that the registration statement filed by us is materially deficient. Each of these plaintiffs seeks injunctive and other equitable relief, including enjoining the defendants from consummating the merger, in addition to other unspecified damages, fees and costs. The plaintiff in the Drabek action moved to expedite the proceedings on April 29, 2013, and the plaintiff in the Moore action moved to expedite and moved for a preliminary injunction on May 3, 2013. The court has scheduled a preliminary injunction hearing for June 17, 2013 in the Drabek action. We, Palomar and our respective boards of directors believe that the Delaware lawsuits are without merit and intend to defend them vigorously.

In addition to the matters discussed above, from time to time, we are subject to various claims, lawsuits, disputes with third parties, investigations and pending actions involving various allegations against us incident to the operation of its business, principally product liability. Each of these other matters is subject to various uncertainties, and it is possible that some of these other matters may be resolved unfavorably to us. We establish accruals for losses that management deems to be probable and subject to reasonable estimate. We believe that the ultimate outcome of these matters will not have a material adverse impact on our consolidated financial position, results of operations or cash flows.

 

Item 1A. Risk Factors

We have revised and re-ordered our discussion of the risk factors affecting our business since those presented in our Annual Report on Form 10-K, Part I, Item 1A, for the fiscal year ended December 31, 2012. For convenience, all of our risk factors are included below, and we have denoted with an asterisk (*) those risk factors that have been materially revised. If any of the following risks actually occurs, our business, financial condition, results of operations and cash flows could be materially adversely affected. This section contains forward-looking statements. You should refer to the explanation of the qualifications and limitations on forward-looking statements beginning on page 12.

Risks Related to Our Business and Industry

We have a history of net losses, and we may not be able to maintain our profitability.

We incurred net losses of approximately $2.9 million in 2011 and $5.5 million in 2010. Although we were profitable in 2012 and in the first quarter of 2013, we may not be able to maintain this profitability for the remainder of 2013, or thereafter. If we are unable to maintain profitability, the market value of our stock may decline, and an investor could lose all or a part of their investment.

If there is not sufficient consumer demand for the procedures performed with our products, practitioner demand for our products could decline, which would adversely affect our operating results.

The aesthetic laser and light-based treatment system industry in which we operate is particularly vulnerable to economic trends. Most procedures performed using our aesthetic treatment systems are elective procedures that are not reimbursable through government or private health insurance. The cost of these elective procedures must be borne by the patient. As a result, the decision to undergo a procedure that utilizes our products may be influenced by the cost.

Consumer demand, and therefore our business, is sensitive to a number of factors that affect consumer spending, including political and macroeconomic conditions, health of credit markets, disposable consumer income levels, consumer debt levels, interest rates and consumer confidence. If there is not sufficient consumer demand for the procedures performed with our products, practitioner demand for our products would decline, and our business would suffer.

Consumer demand for these procedures, and practitioner demand for our products, decreased dramatically during 2009, which contributed to a decrease in our total product revenues from $123.2 million in 2008 to $55.9 million in 2009. However, demand has increased from 2010 through the first quarter of 2013. We believe that consumer demand for discretionary aesthetic laser treatments remains uncertain and may continue to adversely affect our operating results.

 

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Our financial results may fluctuate from quarter to quarter, which makes our results difficult to predict and could cause our results to fall short of expectations.

Our financial results may fluctuate as a result of a number of factors, many of which are outside of our control. For these reasons, comparing our financial results on a period-to-period basis may not be meaningful, and you should not rely on our past results as an indication of our future performance. Our future quarterly and annual expenses as a percentage of our revenues may be significantly different from those we have recorded in the past or which we expect for the future. Our financial results in some quarters may fall below our expectations or the expectations of market analysts or investors. Any of these events could cause our stock price to fall. Each of the risk factors listed in this “Risk Factors” section, and the following factors, may adversely affect our financial results:

 

   

our inability to introduce new products to the market in a timely fashion, or at all;

 

   

continued availability of attractive equipment leasing terms for our customers, which may be negatively influenced by interest rate increases or lack of available credit;

 

   

increases in the length of our sales cycle; and

 

   

reductions in the efficiency of our manufacturing processes.

In addition, we may be subject to seasonal fluctuations in our results of operations, because our customers may be more likely to make equipment purchasing decisions near year-end, and because practitioners may be less likely to make purchasing decisions in the summer months.

Our competitors may prevent us from achieving further market penetration or improving operating results.

Competition in the aesthetic device industry is intense. Our products compete against products offered by public companies, such as Cutera, Solta Medical, Syneron Medical, ZELTIQ Aesthetics and Palomar, which we have agreed to acquire, as well as several smaller specialized private companies, such as Alma Lasers. Some of these competitors have greater financial and human resources than we do and have established reputations, as well as worldwide distribution channels and sales and marketing capabilities that are larger and more established than ours. Additional competitors may enter the market, and we are likely to compete with new companies in the future.

We also face competition against non-light-based medical products, such as BOTOX® and collagen injections, and surgical and non-surgical aesthetic procedures, such as face lifts, chemical peels, abdominoplasty, liposuction, microdermabrasion, sclerotherapy and electrolysis. We may also face competition from manufacturers of pharmaceutical and other products that have not yet been developed. As a result of competition with these companies, products and procedures, we could experience loss of market share and decreasing revenue as well as reduced prices and profit margins, any of which would harm our business and operating results.

As a result of competition with our competitor companies, products and procedures, we could experience loss of market share and decreasing revenue as well as reduced prices and profit margins, any of which would harm our business and operating results.

Our ability to compete effectively depends upon our ability to distinguish our company and our products from our competitors and their products. Factors affecting our competitive position include:

 

   

product performance and design;

 

   

ability to sell products tailored to meet the applications needs of clients and patients;

 

   

quality of customer support;

 

   

product pricing;

 

   

product safety;

 

   

sales, marketing and distribution capabilities;

 

   

success and timing of new product development and introductions; and

 

   

intellectual property protection.

We may be exposed to credit risk of customers that have been adversely affected by weakened markets.

In the event of deterioration of general business conditions or the availability of credit, the financial strength and stability of our customers and potential customers may deteriorate over time, which may cause them to cancel or delay their purchase of our products. In addition, we may be subject to increased risk of non-payment of our accounts receivables. We may also be adversely affected by bankruptcies or other business failures of our customers and potential customers. A significant delay in the collection of funds or a reduction of funds collected may impact our liquidity or result in bad debts.

 

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If we do not continue to develop and commercialize new products and identify new markets for our products and technology, we may not remain competitive, and our revenues and operating results could suffer.

The aesthetic laser and light-based treatment system industry is subject to continuous technological development and product innovation. For the three months ended March 31, 2013, 46% of our product revenues were attributable to the sale of systems that we have introduced to the market since the beginning of 2010. If we do not continue to innovate and develop new products and applications, our competitive position will likely deteriorate as other companies successfully design and commercialize new products and applications. Accordingly, our success depends in part on developing or acquiring new and innovative applications of laser and other light-based technology and identifying new markets for and applications of existing products and technology. If we are unable to develop and commercialize new products, identify and acquire complementary businesses, products or technologies, and identify new markets for our products and technology, our product and technology offerings could become obsolete and our revenues and operating results could be adversely affected.

To remain competitive, we must:

 

   

develop or acquire new technologies that either add to or significantly improve our current products;

 

   

convince our target practitioner customers that our new products or product upgrades would be attractive revenue-generating additions to their practices;

 

   

sell our products to non-traditional customers, including primary care physicians, gynecologists and other specialists;

 

   

identify new markets and emerging technological trends in our target markets and react effectively to technological changes; and

 

   

maintain effective sales and marketing strategies.

If our new products do not gain market acceptance, our revenues and operating results could suffer, and our newer generation product sales could cause earlier generation product sales to suffer.

The commercial success of the products and technology we develop will depend upon the acceptance of these products by providers of aesthetic procedures and their patients and clients, and in the case of our home-use system, consumers. It is difficult for us to predict how successful recently introduced products, or products we are currently developing, will be over the long term. If the products we develop do not gain market acceptance, our revenues and operating results could suffer.

We expect that many of the products we develop will be based upon new technologies or new applications of existing technologies. It may be difficult for us to achieve market acceptance of some of our products, particularly the first products that we introduce to the market based on new technologies or new applications of existing technologies.

For example, in the first quarter of 2013 we launched our PicoSure laser system for the removal of tattoos and benign pigmented lesions. The PicoSure system, which is based on several years of research and development effort and expense, is the first commercially available picosecond Alexandrite aesthetic laser system on the market. Acceptance of our PicoSure laser system by providers of aesthetic procedures and their patients and clients is important to our commercial success.

We are also developing in conjunction with Unilever a laser treatment system for the home-use market. This system has been cleared by the FDA for marketing in the United States for the treatment of wrinkles. Unilever holds exclusive rights to sell this product, and Unilever has advised us that it expects to launch this product commercially near the end of 2013. However, because competitors have already introduced home-use laser systems to the market, this home-use system may not gain anticipated levels of market acceptance. If these products or others that we introduce do not gain market acceptance, our business would suffer.

As we introduce new technologies to the market, our earlier generation product sales could suffer, which may result in write-offs of those earlier generation products. For example, in 2009, we recorded a $2.1 million charge to cost of product revenues related to the write-down of an earlier generation product. The write-down resulted, in part, from customers adopting our newer generation products more quickly than we anticipated, coupled with the downturn in the overall aesthetic laser market.

If demand for our aesthetic treatment systems by physician customers does not increase, or if our home-use product does not achieve market acceptance, our revenues will suffer and our business will be harmed.

We market our aesthetic treatment systems to physicians and other practitioners. In addition, through our development agreement with Unilever, we plan to begin to address the home-use aesthetic laser market near the end of 2013. We believe, and our growth expectations assume, that we and other companies selling lasers and other light-based aesthetic treatment systems have not fully penetrated these markets and that we will continue to receive a significant percentage of our revenues from selling to these markets. If our expectations as to the size of these markets and our ability to sell our products to participants in these markets are not correct, our revenues will suffer and our business will be harmed.

 

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We sell our products and services through subsidiaries and distributors in numerous international markets. Our operating results may suffer if we are unable to manage our international operations effectively.

We sell our products and services through subsidiaries and distributors in approximately 100 foreign countries, and we therefore are subject to risks associated with having international operations. We derived 49%, 56% and 55% of our product revenues from sales outside North America for the years ended December 31, 2012, 2011 and 2010, respectively. In the first quarter of 2013 we derived 52% of our product revenues from sales outside of North America. Our gross margin has decreased from periods prior to 2009 as a result of a higher percentage of laser revenue from our international markets, where our products tend to have lower average selling prices than in North America.

Our international sales are subject to a number of risks, including:

 

   

foreign certification and regulatory requirements;

 

   

difficulties in staffing and managing our foreign operations;

 

   

import and export controls; and

 

   

political and economic instability.

If we are unsuccessful at managing these risks, our results of operations may be adversely affected.

We may incur foreign currency translation charges as a result of changes in currency exchange rates, which could cause our operating results to suffer.

The U.S. dollar is our functional currency. Although we sell our products and services through subsidiaries and distributors in approximately 100 foreign countries, approximately 50% of our revenues outside of North America for the year ended December 31, 2012, and 44% of our revenues outside of North America for the year ended December 31, 2011, were denominated in or linked to the U.S. dollar. In the first quarter of 2013, 53% of our revenues outside of North America were denominated in or linked to the U.S. dollar. Substantially all of our remaining revenues and all of our operating costs outside of North America are recognized in euros, British pounds, Japanese yen, Chinese yuan and South Korean won. We have not historically engaged in hedging activities relating to our non-U.S. dollar operations. Fluctuations in exchange rates between the currencies in which such revenues are realized or costs are incurred and the dollar may have a material adverse effect on our results of operations and financial condition.

We may not receive revenues from our current research and development efforts for several years, if at all.

Investment in product development often involves a long payback cycle. For example, our PicoSure laser system, which we launched in the first quarter of 2013, has been in development by us for several years. We have made and expect to continue making significant investments in research and development and related product opportunities. Accelerated product introductions and short product life cycles require high levels of expenditures for research and development that could adversely affect our operating results if not offset by revenue increases. We believe that we must continue to dedicate a significant amount of resources to our research and development efforts to maintain our competitive position. However, we may not generate anticipated revenues from these investments for several years, if at all.

Because we do not require training for users of our non-invasive products, and we sell these products to non-physicians, there exists an increased potential for misuse of these products, which could harm our reputation and our business.

Federal regulations allow us to sell our products to or on the order of practitioners licensed by law to use or order the use of a prescription device. The definition of “licensed practitioners” varies from state to state. As a result, our products may be purchased or operated by physicians with varying levels of training and, in many states, by non-physicians, including nurse practitioners, chiropractors and technicians. Outside the United States, many jurisdictions do not require specific qualifications or training for purchasers or operators of our products. We do not supervise the procedures performed with our non-invasive products or require that direct medical supervision occur. We and our distributors offer product training sessions, but neither we nor our distributors require purchasers or operators of our non-invasive products to attend training sessions. The lack of required training and the purchase and use of our non-invasive products by non-physicians may result in product misuse and adverse treatment outcomes, which could harm our reputation and expose us to costly product liability litigation.

We may be unable to attract and retain management and other personnel we need to succeed.

Our success depends on the services of our senior management and other key research and development, manufacturing, sales and marketing employees. The loss of the services of one or more of these employees could have a material adverse effect on our business. We consider retaining Michael R. Davin, our president and chief executive officer, to be key to our efforts to develop, sell and market our products and remain competitive. We have entered into an employment agreement with Mr. Davin; however, the employment agreement is terminable by him on short notice and may not ensure his continued service with our company. Our future success will depend in large part upon our ability to attract, retain and motivate highly skilled employees. We cannot be certain that we will be able to do so.

 

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Our stock price has fluctuated substantially, and we expect it will continue to do so.

Our Class A common stock price has fluctuated substantially since our initial public offering in 2005. From January 1, 2011 through May 3, 2013, our Class A common stock has traded as high as $30.20 per share and as low as $8.84 per share. The stock market in general has experienced extreme volatility that has often been unrelated to the operating performance of particular companies. The market price for our Class A common stock may be influenced by many factors, including:

 

   

the success of competitive products or technologies;

 

   

regulatory developments in the United States and foreign countries;

 

   

developments or disputes concerning patents or other proprietary rights;

 

   

the recruitment or departure of key personnel;

 

   

variations in our financial results or those of companies that are perceived to be similar to us;

 

   

market conditions in our industry and issuance of new or changed securities analysts’ reports or recommendations; and

 

   

general economic, industry and market conditions.

In addition, if the stock market in general experiences a loss of investor confidence, the trading price of our Class A common stock could decline for reasons unrelated to our business, financial condition or results of operations. A decline in our stock price could result in the loss of all or a part of our stockholders’ investments.

Risks Related to Our Reliance on Third Parties

If we fail to obtain key components of our products from our sole source or limited source suppliers or service providers, our ability to manufacture and sell our products would be impaired and our business could be materially harmed.

We depend on sole or limited suppliers of certain components and systems that are critical to the products that we manufacture and sell, and to which the significant majority of our revenues are attributable. We depend on El.En. for the SmartLipo MPX system and the SLT II laser system that we integrate with our own proprietary software and delivery systems into our Smartlipo Triplex and Cellulaze systems. We use Alexandrite rods to manufacture the lasers for our Elite and PicoSure products and Nd:Yag rods to manufacture the lasers for our RevLite / MedLite C6 products. We depend exclusively on Northrop Grumman SYNOPTICS to supply both the Alexandrite and Nd:Yag rods to us, and we are aware of no alternative supplier of Alexandrite rods meeting our quality standards. We use gaussian mirrors and polarizers to manufacture our RevLite / MedLite C6 product lines, for which we depend exclusively on Channel Islands Opto-Mechanical Engineering and JDS Uniphase Corporation, respectively. We offer our SmartCool treatment cooling systems for use with our laser aesthetic treatment systems, and we depend exclusively on Zimmer Elektromedizin GmbH to supply SmartCool systems to us. In addition, one third party supplier assembles and tests many of the components and subassemblies for our Elite, Cynergy, SmoothShapes XV, Affirm and Accolade product families.

In October 2012, we entered into a new exclusive distribution agreement with El.En., which replaced our prior distribution agreements with El.En, and pursuant to which we purchase from it the SmartLipo MPX system and the SLT II laser system. We have exclusive worldwide rights under this agreement to sell the SmartLipo MPX systems and products containing the SLT II laser system. The price at which we purchase the SLT II laser system from El.En. is specified in the agreement; however, it may be changed by El.En. at its discretion upon 30 days’ notice. We are required to use commercially reasonable efforts to sell and promote our systems containing the SLT II laser system, and we are responsible for obtaining and maintaining regulatory approvals for systems containing the SLT II laser system. The new distribution agreement has an initial term that expires in October 2019, and it will automatically renew for additional one-year terms unless either party provides notice of termination at least six months prior to the expiration of the initial term or any subsequent renewal term. We or El.En. may terminate the agreement at any time based upon material uncured breaches by, or the insolvency of, the other party. In addition, El.En. may terminate the agreement if we do not meet annual minimum purchase obligations specified in the agreement and we may terminate if El.En. rejects a purchase order that is in line with our forecast.

Other than with El.En., we do not have long-term arrangements with any of our suppliers for the supply of these components or systems or with the assembly and test service provider referenced above, but instead purchase from them on a purchase order basis. Northrop Grumman SYNOPTICS, Channel Islands Opto-Mechanical Engineering, JDS Uniphase Corporation and Zimmer Elektromedizin are not required, and may not be able or willing, to meet our future requirements at current prices, or at all.

Under our agreement with El.En. and our purchase order arrangements with our other suppliers and service providers, we are vulnerable to supply shortages and cessations and price fluctuations with respect to these critical components and systems and services. Such shortages or cessations could occur either as a result of breach by El.En. or us of our new distribution agreement, or as a result of other types of business decisions made by El.En. or other suppliers and service providers. Any extended interruption in our supplies of these components or systems or in the assembly and test services could materially harm our business.

 

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We rely on third party distributors to market, sell and service a significant portion of our products. If these distributors do not commit the necessary resources to effectively market, sell and service our products or if our relationships with these distributors are disrupted, our business and operating results may be harmed.

In North America, France, Spain, the United Kingdom, Germany, Korea, China, Japan and Mexico, we sell our products through our internal sales organization. Outside of these markets, we sell our products through third party distributors. Our home-use laser system for the treatment of wrinkles, which we expect to be launched in the United States near the end of 2013, will be sold by Unilever. Our sales and marketing success in these other markets depends on these distributors, in particular their sales and service expertise and relationships with the customers in the marketplace. Sales of our aesthetic treatment systems by third party distributors represented 25%, 25% and 18% of our product revenue in 2012, 2011 and 2010, respectively. In the first quarter of 2013, sales of our aesthetic treatment systems by third party distributors represented 26% of our product revenue. The increases in 2012 and 2011 primarily related to sales of our ConBio products, which are generally sold through distributors.

We do not control our distributors or Unilever, and these parties may not be successful in marketing our products. These parties may terminate their relationships with us, or fail to commit the necessary resources to market and sell our products to the level of our expectations. Currently, we have written distributor agreements in place with most of our third party distributors. The third party distributors with which we do not have written distributor agreements may terminate their relationships with us and stop selling and servicing our products with little or no notice. If current or future third party distributors or other parties that sell our products do not perform adequately, or if we fail to maintain our existing relationships with these parties or fail to recruit and retain distributors in particular geographic areas, our revenue from international sales may be adversely affected and our operating results could suffer.

Risks Related to Our Relationship with El.En. and Our Corporate Structure

El.En. and its subsidiaries market and sell products that compete with our products, and any increased competition from El.En. could have a material adverse effect on our business.

El.En. is a leading laser manufacturer in Europe and a leading light-based medical device manufacturer worldwide. El.En. and its subsidiaries develop and produce laser systems with scientific, industrial, commercial and medical applications. In October 2012 we entered into a new seven-year exclusive distribution agreement with El.En., which replaced our prior distribution agreements with El.En. Under this new agreement, we purchase from El.En. its proprietary SmartLipo MPX system and its SLT II laser system. The SLT II laser system is an essential component of our SmartLipo Triplex and Cellulaze systems, which also incorporate our proprietary software and delivery systems.

El.En. markets, sells, promotes and licenses other products that compete with our products, both in North America and elsewhere throughout the world, and our agreement with El.En. does not prevent El.En. from competing with us by selling products that we purchased in the past from El.En., including earlier generation SmartLipo systems. In the event that our distribution agreement with El.En. terminates, El.En. would be able to compete with us worldwide with the SmartLipo MPX system and with products containing the SLT II laser system. Our business could be materially and adversely affected by increased competition from El.En.

Conflicts of interest may arise between us and El.En., and these conflicts might ultimately be resolved in a manner unfavorable to us.

Although his term will expire at our 2013 annual meeting of stockholders, one of our directors, Andrea Cangioli, is also an officer and or director of El.En., and certain of El.En.’s subsidiaries and affiliates compete with us in the worldwide market. Mr. Cangioli owns or has an interest in substantial amounts of El.En. stock. Ownership interests of our directors in El.En. stock, or service as a director of our company while at the same time serving as, or being the spouse of, a director or officer of El.En., could give rise to conflicts of interest when a director or officer is faced with a decision that could have different implications for the two companies.

Conflicts may arise with respect to possible future distribution and research and development arrangements with El.En. or another El.En. affiliated company in which the terms and conditions of the arrangements are subject to negotiation between us and El.En. or such other El.En. affiliated company. These potential conflicts could also arise, for example, over matters such as:

 

   

the nature, timing, marketing, distribution and price of our products and El.En.’s products that compete with each other;

 

   

intellectual property matters; and

 

   

business opportunities that may be attractive to both El.En. and us.

Conflicts between us and El.En. might ultimately be resolved in a manner unfavorable to us, which could harm our business.

In order to address potential conflicts of interest between us and El.En., our restated certificate of incorporation contains provisions regulating and defining the conduct of our affairs as they may involve El.En. and El.En. affiliated companies and El.En.’s officers and directors who serve as our directors. These provisions recognize that we and El.En. and El.En. affiliated companies have

 

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engaged and may continue to engage in the same or similar business activities and lines of business and will continue to have contractual and business relations with each other. These provisions expressly permit El.En. and its affiliated companies to compete against us and narrowly limit corporate opportunities that El.En. or its directors or officers who serve as our directors must make available to us. These provisions have the effect of limiting our ability, and the ability of our stockholders, to make claims against El. En. relating to conflicts of interest.

El.En. and our executive officers and directors have substantial control over us.

As of March 31, 2013, El.En. beneficially owned approximately 13% of our outstanding common stock, and our executive officers and directors who are not affiliates of El.En. in the aggregate beneficially owned 4.70% of our outstanding common stock. As a result, if these stockholders were to act together, they would be able to exercise substantial influence over matters submitted to our stockholders for approval. This concentration of voting power could delay or prevent an acquisition of our company on terms that other stockholders may desire.

Provisions in our corporate charter documents and under Delaware law may delay or prevent attempts by our stockholders to change our management and hinder efforts to acquire a controlling interest in us.

Provisions of our certificate of incorporation and bylaws may discourage, delay or prevent a merger, acquisition or other change in control that stockholders may consider favorable, including transactions in which you might otherwise receive a premium for your shares. These provisions may also prevent or frustrate attempts by our stockholders to replace or remove our management. These provisions include:

 

   

the classification of the members of our board of directors;

 

   

limitations on the removal of our directors;

 

   

advance notice requirements for stockholder proposals and nominations;

 

   

the inability of stockholders to act by written consent or to call special meetings; and

 

   

the ability of our board of directors to designate the terms of and issue new series of preferred stock without stockholder approval, which could be used to institute a “poison pill” that would work to dilute the stock ownership of a potential hostile acquirer, effectively preventing acquisitions that have not been approved by our board of directors.

The affirmative vote of the holders of at least 75% of our shares of capital stock entitled to vote is necessary to amend or repeal the above provisions of our certificate of incorporation. In addition, absent approval of our board of directors, our bylaws may only be amended or repealed by the affirmative vote of the holders of at least 75% of the voting power of our shares of capital stock entitled to vote. In addition, Section 203 of the Delaware General Corporation Law prohibits a publicly held Delaware corporation from engaging in a business combination with an interested stockholder, generally a person which together with its affiliates owns or within the last three years has owned 15% of our voting stock, for a period of three years after the date of the transaction in which the person became an interested stockholder, unless the business combination is approved in a prescribed manner. Accordingly, Section 203 may discourage, delay or prevent a change in control of our company.

The price of our common stock may decline because of future sales of our shares by El.En.

El.En. may sell all or part of the shares of our common stock that it owns. El.En. is not subject to any contractual obligation to maintain its ownership position in our shares, and, consequently, El.En. may not maintain its ownership of our common stock. Sales by El.En. of substantial amounts of our common stock in the public market could adversely affect prevailing market prices for our common stock. The shelf registration statement on Form S-3 that was declared effective on October 26, 2012, which we refer to as the shelf registration statement, permits us and El.En. to offer and sell shares of our common stock in one or more offerings.

If El.En. sells the shares of our stock held by it, our commercial relationship with El.En. may be adversely affected.

El.En. is not subject to any contractual obligation to maintain an ownership position in our shares. The shelf registration statement permits us and El.En. to offer and sell shares of our common stock in one or more offerings. If El.En. does not have a continuing interest or reduced interest in our financial success, it may be more inclined to compete with us in North America and in other markets, not to enter into future commercial agreements with us or to terminate or not renew our existing distribution agreement. If any of these events were to occur, it could harm our business.

 

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Risks Related to Intellectual Property

If we infringe or are alleged to infringe intellectual property rights of third parties, our business could be adversely affected.

Our products may infringe or be claimed to infringe patents or patent applications under which we do not hold licenses or other rights. Third parties may own or control these patents and patent applications in the United States and abroad. These third parties could bring claims against us that would cause us to incur substantial expenses and, if successfully asserted against us, could cause us to pay substantial damages. Further, if a patent infringement suit were brought against us, we could be forced to stop or delay manufacturing or sales of the product that is the subject of the suit.

As a result of patent infringement claims, or in order to avoid potential claims, we may choose or be required to seek a license from the third party and be required to pay license fees or royalties or both, as we did in a 2006 patent license agreement with Palomar. Such licenses may not be available on acceptable terms, or at all. Even if we were able to obtain a license, the rights may be nonexclusive, which could result in our competitors gaining access to the same intellectual property. Ultimately, we could be forced to cease some aspect of our business operations if, as a result of actual or threatened patent infringement claims, we are unable to enter into licenses on acceptable terms. This could harm our business significantly.

There has been substantial litigation and other proceedings regarding patent and other intellectual property rights in our industry. In addition to infringement claims against us, we may become a party to other types of patent litigation and other proceedings, including reexamination proceedings or interference proceedings declared by the U.S. Patent and Trademark Office and opposition proceedings in the European Patent Office, regarding intellectual property rights with respect to our products and technology. The cost to us of any patent litigation or other proceeding, even if resolved in our favor, could be substantial. Some of our competitors may be able to sustain the costs of such litigation or proceedings more effectively than we can because of their greater financial resources. Uncertainties resulting from the initiation and continuation of patent litigation or other proceedings could have a material adverse effect on our ability to compete in the marketplace. Patent litigation and other proceedings may also absorb significant management time.

If we are unable to obtain or maintain intellectual property rights relating to our technology and products, the commercial value of our technology and products will be adversely affected and our competitive position could be harmed.

Our success and ability to compete depends in part upon our ability to obtain protection in the United States and other countries for our products by establishing and maintaining intellectual property rights relating to or incorporated into our technology and products. We own numerous patents and patent applications in the United States and corresponding patents and patent applications in many foreign jurisdictions. We do not know how successful we would be in any instance in which we asserted our patents against suspected infringers. Our pending and future patent applications may not issue as patents or, if issued, may not issue in a form that would be advantageous to us. Even if issued, our 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.

If we are unable to protect the confidentiality of our proprietary information and know-how, the value of our technology and products could be adversely affected.

In addition to patented technology, we rely upon unpatented proprietary technology, processes and know-how, particularly with respect to our Alexandrite and pulse dye lasers. We generally seek to protect this information in part by confidentiality agreements with our employees, consultants and third parties. These agreements may be breached, and we may not have adequate remedies for any such breach. In addition, our trade secrets may otherwise become known or be independently developed by competitors.

Risks Related to Government Regulation

If we fail to obtain and maintain necessary U.S. Food and Drug Administration clearances for our products and indications or if clearances for future products and indications are delayed or not issued, our business would be harmed.

Our products are classified as medical devices and are subject to extensive regulation by the FDA and other federal, state and local authorities. These regulations relate to manufacturing, labeling, sale, promotion, distribution, importing and exporting and shipping of our products. In the United States, before we can market a new medical device, or a new use of, or claim for, an existing product, we must first receive either 510(k) clearance or premarket approval from the FDA, unless an exemption applies. Both of these processes can be expensive and lengthy and entail significant user fees, unless exempt. The FDA’s 510(k) clearance process usually takes from three to 12 months, but it can last longer. The process of obtaining premarket approval is much more costly and uncertain than the 510(k) clearance process. It generally takes from one to three years, or even longer, from the time the premarket approval application is submitted to the FDA until an approval is obtained.

 

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In order to obtain premarket approval and, in some cases, a 510(k) clearance, a product sponsor must conduct well controlled clinical trials designed to test the safety and effectiveness of the product. Conducting clinical trials generally entails a long, expensive and uncertain process that is subject to delays and failure at any stage. The data obtained from clinical trials may be inadequate to support approval or clearance of a submission. In addition, the occurrence of unexpected findings in connection with clinical trials may prevent or delay obtaining approval or clearance. If we conduct clinical trials, they may be delayed or halted, or be inadequate to support approval or clearance, for numerous reasons, including:

 

   

the FDA, other regulatory authorities or an institutional review board may place a clinical trial on hold;

 

   

patients may not enroll in clinical trials, or patient follow-up may not occur, at the rate we expect;

 

   

patients may not comply with trial protocols;

 

   

institutional review boards and third party clinical investigators may delay or reject our trial protocol;

 

   

third party clinical investigators may decline to participate in a trial or may not perform a trial on our anticipated schedule or consistent with the clinical trial protocol, good clinical practices, or other FDA requirements;

 

   

third party organizations may not perform data collection and analysis in a timely or accurate manner;

 

   

regulatory inspections of our clinical trials or manufacturing facilities may, among other things, require us to undertake corrective action or suspend or terminate our clinical trials, or invalidate our clinical trials;

 

   

changes in governmental regulations or administrative actions; and

 

   

the interim or final results of the clinical trials may be inconclusive or unfavorable as to safety or effectiveness.

Medical devices may be marketed only for the indications for which they are approved or cleared. The FDA may not approve or clear indications that are necessary or desirable for successful commercialization. Indeed, the FDA may refuse our requests for 510(k) clearance or premarket approval of new products, new intended uses or modifications to existing products. Our clearances can be revoked if safety or effectiveness problems develop.

After clearance or approval of our products, we are subject to continuing regulation by the FDA, and if we fail to comply with FDA regulations, our business could suffer.

Even after clearance or approval of a product, we are subject to continuing regulation by the FDA, including the requirements that our facility be registered and our devices listed with the agency. We are subject to Medical Device Reporting regulations, which require us to report to the FDA if our products may have caused or contributed to a death or serious injury or malfunction in a way that would likely cause or contribute to a death or serious injury if the malfunction were to recur. We must report corrections and removals to the FDA where the correction or removal was initiated to reduce a risk to health posed by the device or to remedy a violation of the Federal Food, Drug, and Cosmetic Act caused by the device that may present a risk to health, and maintain records of other corrections or removals. The FDA closely regulates promotion and advertising and our promotional and advertising activities could come under scrutiny. If the FDA objects to our promotional and advertising activities or finds that we failed to submit reports under the Medical Device Reporting regulations, for example, the FDA may allege our activities resulted in violations.

The FDA and state authorities have broad enforcement powers. Our failure to comply with applicable regulatory requirements could result in enforcement action by the FDA or state agencies, which may include any of the following sanctions:

 

   

untitled letters, warning letters, fines, injunctions, consent decrees and civil penalties;

 

   

repair, replacement, refunds, recall or seizure of our products;

 

   

operating restrictions or partial suspension or total shutdown of production;

 

   

refusing or delaying our requests for 510(k) clearance or premarket approval of new products or new intended uses;

 

   

withdrawing 510(k) clearance or premarket approvals that have already been granted; and

 

   

criminal prosecution.

If any of these events were to occur, they could harm our business.

Federal regulatory reforms may adversely affect our ability to sell our products profitably.

From time to time, legislation is drafted and introduced in Congress that could significantly change the statutory provisions governing the clearance or approval, manufacture and marketing of a device. In addition, FDA regulations and guidance are often revised or reinterpreted by the agency in ways that may significantly affect our business and our products. For example, the FDA recently proposed changing its standards for determining when a medical device modification must receive premarket clearance or approval. Although Congress objected to these revised standards, it is possible that the FDA will seek to implement these or similar changes in the future.

 

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In addition, beginning in 2013, most of the products and systems that we sell became subject to a new excise tax on sales of certain medical devices in the United States after December 31, 2012 by the manufacturer, producer or importer in an amount equal to 2.3% of the sale price. Under the law, additional charges, including warranties, may be deemed to be included in the sale price for purposes of determining the amount of the excise tax. We believe this excise tax could harm our sales and reduce our profitability.

In August 2012, the SEC adopted a final rule that will require public companies to make disclosures about the use of certain “conflict minerals” in the products that they manufacture. The rule requires annual disclosures by public companies for which conflict minerals (regardless of the place of origin of such minerals) are necessary to the functionality or production of products that they manufacture. Such companies must conduct inquiries into the country of origin of their necessary conflict minerals and disclose the results of such inquiries. If, based on its country of origin, a company determines that its conflict minerals originated in the Democratic Republic of Congo, or adjacent nations, and did not come from recycled or scrap sources, or has reason to believe that such conflict minerals may have originated in the covered countries and may not have come from recycled or scrap sources, then it must (i) exercise due diligence on the source and chain of custody of such conflict minerals and (ii) prepare an independently audited Conflict Minerals Report that, among other things, describes its due diligence efforts and identifies products containing conflict minerals that directly or indirectly finance or benefit designated armed groups perpetrating serious human rights abuses in the covered countries. The rules include an exception from the audit requirement for two years where the company is unable to determine if the minerals are “DRC conflict free.” All companies providing disclosures under the final rule must do so on a new Form SD, to be filed annually with the SEC on or before May 31 of each year. Information on Form SD will cover a company’s conflict minerals disclosure for the prior calendar year, regardless of the company’s fiscal year end. The first Form SDs will be due on or before May 31, 2014 and will cover conflict minerals disclosures for calendar year 2013. Because certain materials used in the manufacturing of our products are considered conflict minerals, we anticipate that we will file a Form SD before May 31, 2014 for conflict minerals disclosures for calendar year 2013. We believe our efforts to comply with these requirements will be costly and time consuming.

It is impossible to predict whether other legislative changes will be enacted or government regulations, guidance or interpretations changed, and what the impact of such changes, if any, may be.

We have modified some of our products without FDA clearance. The FDA could retroactively determine that the modifications were improper and require us to stop marketing and recall the modified products.

Any modifications to one of our FDA-cleared devices that could significantly affect its safety or effectiveness, or that would constitute a major change in its intended use, requires a new 510(k) clearance or a premarket approval. We may be required to submit extensive pre-clinical and clinical data depending on the nature of the changes. We may not be able to obtain additional 510(k) clearances or premarket approvals for modifications to, or additional indications for, our existing products in a timely fashion, or at all. Delays in obtaining future clearances or approvals would adversely affect our ability to introduce new or enhanced products in a timely manner, which in turn would harm our revenue and operating results. We have made modifications to our devices in the past and may make additional modifications in the future that we believe do not or will not require additional clearances or approvals. If the FDA disagrees, and requires new clearances or approvals for the modifications, we may be required to recall and to stop marketing the modified devices, which could harm our operating results and require us to redesign, among other things, our products.

If we fail to comply with the FDA’s Quality System Regulation and laser performance standards, our manufacturing operations could be halted, and our business would suffer.

We are currently required to demonstrate and maintain compliance with the FDA’s QSR. The QSR is a complex regulatory scheme that covers the methods and documentation of the design, testing, control, manufacturing, labeling, quality assurance, packaging, storage and shipping of our products. Because our products involve the use of lasers, our products also are covered by a performance standard for lasers set forth in FDA regulations. The laser performance standard imposes specific record keeping, reporting, product testing and product labeling requirements. These requirements include affixing warning labels to laser products as well as incorporating certain safety features in the design of laser products. The FDA enforces the QSR and laser performance standards through periodic unannounced inspections. We have been, and anticipate in the future being, subject to such inspections. Our failure to comply with the QSR or to take satisfactory corrective action in response to an adverse QSR inspection or our failure to comply with applicable laser performance standards could result in enforcement actions, including a public warning letter, a shutdown of or restrictions on our manufacturing operations, delays in approving or clearing a product, refusal to permit the import or export of our products, a recall or seizure of our products, fines, injunctions, civil or criminal penalties, or other sanctions, such as those described in the preceding paragraphs, any of which could cause our business and operating results to suffer.

If we fail to comply with state laws and regulations, or if state laws or regulations change, our business could suffer.

In addition to FDA regulations, most of our products are also subject to state regulations relating to their sale and use. These regulations are complex and vary from state to state, which complicates monitoring compliance. In addition, these regulations are in many instances in flux. For example, federal regulations allow our prescription products to be sold to or on the order of “licensed practitioners,” that is, practitioners licensed by law to use or order the use of a prescription device. Licensed practitioners are defined

 

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on a state-by-state basis. As a result, some states permit non-physicians to purchase and operate our products, while other states do not. Additionally, a state could change its regulations at any time to prohibit sales to particular types of customers. We believe that, to date, we have sold our prescription products only to licensed practitioners. However, our failure to comply with state laws or regulations and changes in state laws or regulations may adversely affect our business.

We, or our distributors, may be unable to obtain or maintain international regulatory qualifications or approvals for our current or future products and indications, which could harm our business.

Sales of our products outside the United States are subject to foreign regulatory requirements that vary widely from country to country. In many countries, our third party distributors are responsible for obtaining and maintaining regulatory approvals for our products. We do not control our third party distributors, and they may not be successful in obtaining or maintaining these regulatory approvals. In addition, the FDA regulates exports of medical devices from the United States.

Complying with international regulatory requirements can be an expensive and time consuming process, and approval is not certain. The time required to obtain foreign clearances or approvals may be longer than that required for FDA clearance or approval, and requirements for such clearances or approvals may differ significantly from FDA requirements. Foreign regulatory authorities may not clear or approve our products for the same indications cleared or approved by the FDA. The foreign regulatory approval process may include all of the risks associated with obtaining FDA clearance or approval in addition to other risks. Although we or our distributors have obtained regulatory approvals in the European Union and other countries outside the United States for many of our products, we or our distributors may be unable to maintain regulatory qualifications, clearances or approvals in these countries or obtain qualifications, clearances or approvals in other countries. For example, we are in the process of seeking regulatory approvals from the Japanese Ministry of Health, Labour and Welfare for the direct sale of our products into that country. If we are not successful in doing so, our business will be harmed. We may also incur significant costs in attempting to obtain and in maintaining foreign regulatory clearances, approvals or qualifications. Foreign regulatory agencies, as well as the FDA, periodically inspect manufacturing facilities both in the United States and abroad. If we experience delays in receiving necessary qualifications, clearances or approvals to market our products outside the United States, or if we fail to receive those qualifications, clearances or approvals, or if we fail to comply with other foreign regulatory requirements, we and our distributors may be unable to market our products or enhancements in international markets effectively, or at all. Additionally, the imposition of new requirements may significantly affect our business and our products. We may not be able to adjust to such new requirements.

New regulations may limit our ability to sell to non-physicians, which could harm our business.

Currently, we sell our products primarily to physicians and, outside the United States, to aestheticians. In addition, we also market our products to the growing aesthetic spa market, where non-physicians under physician supervision perform aesthetic procedures at dedicated facilities. However, federal, state and international regulations could change at any time, disallowing sales of our products to aestheticians, and limiting the ability of aestheticians and non-physicians to operate our products. Any limitations on our ability to sell our products to non-physicians or on the ability of aestheticians and non-physicians to operate our products could cause our business and operating results to suffer.

Risks Related to Litigation

Product liability suits could be brought against us due to defective design, material or workmanship or due to misuse of our products. These lawsuits could be expensive and time consuming and result in substantial damages to us and increases in our insurance rates.

If our products are defectively designed, manufactured or labeled, contain defective components or are misused, we may become subject to substantial and costly litigation by our customers or their patients or clients. Misusing our products or failing to adhere to operating guidelines for our products can cause severe burns or other damage to the eyes, skin or other tissue. We are routinely involved in claims related to the use of our products. Product liability claims could divert management’s attention from our core business, be expensive to defend and result in sizable damage awards against us. Our current insurance coverage may not be sufficient to cover these claims, and the coverage we have is subject to deductibles for which we are responsible. Moreover, in the future, we may not be able to obtain insurance in amount or scope sufficient to provide us with adequate coverage against potential liabilities. Any product liability claims brought against us, with or without merit, could increase our product liability insurance rates or prevent us from securing continuing coverage, could harm our reputation in the industry and reduce product sales. We would need to pay any product losses in excess of our insurance coverage out of cash reserves, harming our financial condition and adversely affecting our operating results.

We may incur substantial expenses if our past practices are shown to have violated the Telephone Consumer Protection Act.

We previously used facsimiles to disseminate information about our clinical workshops to large numbers of customers and potential customers. These facsimiles were transmitted by third parties retained by us, and were sent to recipients whose facsimile numbers were supplied by us as well as other recipients whose facsimile numbers we purchased from other sources. In May 2005, we stopped sending unsolicited facsimiles to customers and potential customers.

 

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Under the federal Telephone Consumer Protection Act, or TCPA, recipients of unsolicited facsimile “advertisements” may be entitled to damages of up to $500 per facsimile for inadvertent violations and up to $1,500 per facsimile for knowing or willful violations. Recipients of unsolicited facsimile advertisements may seek enforcement of the TCPA in state courts. The TCPA also permits states to initiate a civil action in a federal district court to enforce the TCPA against a party who engages in a pattern or practice of violations of the TCPA. In addition, complaints may be filed with the Federal Communications Commission, which has the power to assess penalties against parties for violations of the TCPA.

In 2005, a plaintiff, individually and as putative representative of a purported class, filed a complaint against us under the TCPA in Massachusetts Superior Court in Middlesex County seeking monetary damages, injunctive relief, costs and attorneys’ fees. The complaint alleged that we violated the TCPA by sending unsolicited advertisements by facsimile to the plaintiff and other recipients without the prior express invitation or permission of the recipients. Based on discovery in this matter, the plaintiff alleges that approximately three million facsimiles were sent on our behalf by a third party to approximately 100,000 individuals. In January 2012, the Court denied the class certification motion. In November 2012, the Court issued the final judgment and awarded the plaintiff $6,000 in damages and awarded us $3,495 in costs. The plaintiff has appealed this decision. In addition, in July 2012, the plaintiff filed a new purported class action, based on the same operative facts and asserting the same claims as in the Massachusetts action, in federal court in the Eastern District of New York. In February 2013 that court granted our motion to dismiss the plaintiff’s claims. In March 2013, the plaintiff filed a motion seeking reconsideration of the court’s judgment and vacation of the court’s order of dismissal. In April 2013, we filed a response opposing the plaintiff’s motion.

We are vigorously defending these lawsuits. However, litigation is subject to numerous uncertainties and we are unable to predict the ultimate outcome of this or any other matter. Moreover, the amount of any potential liability in connection with this lawsuit will depend, to a large extent, on whether a class in a class action lawsuit is certified and, if one is certified, on the scope of the class, neither of which we can predict at this time.

These and any future lawsuits that we may face regarding these issues could materially and adversely affect our results of operations, cash flows and financial condition, cause us to incur significant expenses and divert the attention of our management and key personnel from our business operations.

Risks Related to the Proposed Merger

* Uncertainty about the merger may adversely affect the relationships of us, Palomar or the combined company with our respective customers, suppliers and employees, whether or not the merger is completed.

In response to the announcement of the merger, our existing or prospective customers or suppliers or existing or prospective customers of Palomar or the combined company may:

 

   

delay, defer or cease purchasing goods or services from or providing goods or services to us, Palomar or the combined company;

 

   

delay or defer other decisions concerning us, Palomar or the combined company, or refuse to extend credit to us, Palomar or the combined company; or

 

   

otherwise seek to change the terms on which they do business with us, Palomar or the combined company.

Any such delays or changes to terms could seriously harm our business or Palomar’s business or, if the merger is completed, the business of the combined company.

In addition, as a result of the announcement of the merger, current and prospective employees could experience uncertainty about their future with us, Palomar or the combined company. These uncertainties may impair our ability or Palomar’s or the combined company’s ability to retain, recruit or motivate key personnel.

* Any delay in the completion of the merger may significantly reduce the benefits expected to be obtained from the merger or could adversely affect the market price of our Class A common stock or our future business and financial results.

The merger is subject to a number of conditions, including approvals of our stockholders and Palomar stockholders, which are beyond our control and Palomar’s control and which may prevent, delay or otherwise materially and adversely affect completion of the merger.

Failure to complete the merger would prevent us from realizing the anticipated benefits of the merger. We and Palomar would each remain liable for significant transaction costs, including legal, accounting and financial advisory fees. Any delay in completing the merger may significantly reduce the synergies and other benefits that we and Palomar expect to achieve if we successfully complete the merger within the expected timeframe and integrate our respective businesses.

 

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In addition, the market price of our Class A common stock may reflect various market assumptions as to whether and when the merger will be completed. Consequently, the completion of, the failure to complete, or any delay in the completion of the merger could result in a significant change in the market price of our Class A common stock.

* The issuance of shares of our Class A common stock to Palomar stockholders in the merger will substantially reduce the percentage interests of our stockholders.

If the merger is completed, we will issue approximately 5.2 million shares of our Class A common stock, which would result in Palomar stockholders owning approximately 23% of the outstanding Class A common stock of the combined company immediately following the closing of the merger, based on an assumed exchange ratio of 0.240, which is the exchange ratio calculated as if March 15, 2013 were the third trading day prior to the effective time of the merger.

The issuance of shares of our Class A common stock to Palomar stockholders in the merger will cause a significant reduction in the relative percentage interest of our current stockholders in our earnings, liquidation value and book and market value.

* Sales of substantial amounts of our Class A common stock in the open market by former Palomar stockholders could depress the market price of our Class A common stock.

Shares of our Class A common stock that are issued to stockholders of Palomar in the merger will be freely tradable by such stockholders without restrictions or further registration under the Securities Act, provided, however, that any stockholders who are affiliates of Cynosure will be subject to the resale restrictions of Rule 144 under the Securities Act.

We currently expect that we will issue approximately 5.2 million shares of our Class A common stock in the merger, based on an assumed exchange ratio of 0.240, which is the exchange ratio calculated as if March 15, 2013 were the third trading day prior to the effective time of the merger.

If the merger is completed and if Palomar’s former stockholders sell substantial amounts of our Class A common stock in the public market following the completion of the merger, the market price of our Class A common stock may decrease. These sales might also make it more difficult for us to raise capital by selling equity or equity-related securities at a time and price that we otherwise would deem appropriate.

* Diversion of management’s attention could harm us, Palomar or the combined company, whether or not the merger is completed.

Completion of the merger will require a significant amount of time and attention from our management and Palomar’s management. The diversion of management’s attention away from ongoing operations could adversely affect our ongoing operations and business relationships and Palomar’s ongoing operations and business relationships and, if the merger is completed, the combined company.

* We may be unable to integrate successfully the businesses of Palomar and realize the anticipated benefits of the merger.

The merger involves the combination of two organizations that currently operate as independent public companies. Due to legal restrictions, we and Palomar have conducted only limited planning regarding the integration of the two companies, and we will continue to operate as independent public companies until the completion of the merger. The combined company will be required to devote significant management attention and resources to integrating the two companies. Delays in this process could adversely affect the combined company’s business, financial results, financial condition and stock price.

Achieving the anticipated benefits of the merger will depend, in part, on the integration of operations, personnel and technology of us and Palomar. If we are unable to successfully integrate Palomar’s business into our business in a manner that permits the combined company to achieve the cost savings and operating synergies anticipated to result from the merger, the anticipated benefits of the merger may not be realized fully or at all or may take longer to realize than expected.

Potential difficulties the combined company may encounter in the integration process include the following:

 

   

lost sales and customers as a result of certain of our customers or Palomar’s customers deciding not to do business with the combined company;

 

   

the inability to procure goods and services on favorable terms as a result of our suppliers or Palomar’s suppliers deciding not to do business with the combined company;

 

   

the inability to retain, recruit or motivate key personnel;

 

   

complexities associated with managing the combined businesses;

 

   

difficulties associated with integrating personnel from diverse corporate cultures while maintaining focus on providing consistent, high quality products and customer service;

 

   

potential unknown liabilities and unforeseen increased expenses or delays associated with the merger;

 

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performance shortfalls as a result of the diversion of management’s attention to the merger;

 

   

disruption or interruption of, or loss of momentum in, our ongoing business and Palomar’s ongoing business; and

 

   

inconsistencies in standards, controls, procedures and policies.

Any of these difficulties could adversely affect our ability to maintain relationships with suppliers, customers and employees or our ability to achieve the anticipated benefits of the merger, or could reduce our earnings or otherwise adversely affect the business and financial results of the combined company.

Even if we are able to integrate Palomar’s business operations successfully, this integration may not result in the realization of the full benefits of synergies, cost savings, innovation and operational efficiencies that may be possible from this integration and these benefits may not be achieved within a reasonable period of time.

Additionally, we may, from time to time, evaluate potential strategic acquisitions of other complementary businesses, products or technologies, as well as consider joint ventures and other collaborative projects. However, we cannot assure you that these completed acquisitions, or any future acquisitions that we may make, will enhance our products or strengthen our competitive position. In particular, we may encounter difficulties assimilating or integrating the acquired businesses, technologies, products, personnel or operations of the acquired companies, and in retaining and motivating key personnel from these businesses. The integration of these businesses may not result in the realization of the full benefits of synergies, cost savings, innovation and operational efficiencies that may be possible from this integration and these benefits may not be achieved within a reasonable period of time.

* We will incur significant costs in connection with the merger.

We will incur substantial expenses related to the merger, whether or not the merger is completed. We estimate that we will incur direct transaction costs of approximately $2.9 million in connection with the merger, approximately $1.9 million of which is not contingent on the completion of the merger. In addition, we expect that we will incur costs of approximately $14.5 million in “golden parachute” compensation that each named executive officer of Palomar could receive in connection with the merger.

In the event the merger is completed, we expect to incur significant additional expenses. There are a large number of systems that must be integrated, including management information, purchasing, accounting and finance, sales, billing, payroll and benefits, fixed assets and lease administration systems, and regulatory compliance. While we have assumed that a certain level of expenses would be incurred from the integration of the two companies, there are a number of factors beyond our control that could affect the total amount or the timing of all the expected integration expenses, including, among other things, constraints arising under U.S. federal or state antitrust laws (such as limitations on sharing information) that may prevent or hinder us from fully developing integration plans. Moreover, many of the expenses that will be incurred, by their nature, are impracticable to estimate at the present time. These expenses could, particularly in the near term, exceed the savings that we expect to achieve from the elimination of duplicative expenses, the realization of economies of scale, and cost savings and revenue synergies related to the integration of the two companies following the completion of the merger. The amount and timing of any these charges are uncertain at the present time. In addition, the combined company may incur additional material charges in subsequent fiscal quarters to reflect additional costs in connection with the merger.

* The market price of our Class A common stock after the merger may be affected by factors different from those affecting the market price of our Class A common stock before the merger.

When we complete the merger, Palomar stockholders will become our stockholders. The results of our operations, as well as the market price of our Class A common stock, after the merger may be affected by factors different from those currently affecting our results of operations or Palomar’s results of operations and the market price of our Class A common stock.

* Loss of key personnel could have a material adverse effect on the business and results of operations of the combined company.

The success of the combined company, if the merger is completed, will depend in part upon the ability of the combined company to retain key employees of both companies. Competition for qualified personnel can be intense. In addition, key employees may depart because of issues relating to the uncertainty or difficulty of integration or a desire not to remain with the combined company. Accordingly, the combined company may not be able to retain key employees. Loss of key personnel could have a material adverse effect on the business and operations of the combined company.

* The combined company will face uncertainties related to the effectiveness of internal controls.

Public companies in the United States are required to review their internal control over financial reporting under Section 404 of the Sarbanes-Oxley Act of 2002. Any system of control, however well designed and operated, can provide only reasonable, and not absolute, assurance that the objectives of the system are met. In addition, the design of any control system is based in part upon certain assumptions about the likelihood of future events. Because of these and other inherent limitations of control systems, any design may not achieve its stated goal under all potential future conditions, regardless of how remote.

 

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Our integration with Palomar, and our respective internal control systems and procedures, may result in or lead to a future material weakness in the combined company’s internal controls, or the combined company or its independent registered public accounting firm may identify a material weakness in the combined company’s internal controls in the future. A material weakness in internal control over financial reporting would require management and the combined company’s independent public accounting firm to evaluate the combined company’s internal controls as ineffective. If the combined company’s internal control over financial reporting is not considered adequate, the combined company may experience a loss of public confidence, which could have an adverse effect on its business and stock price.

* Internal control deficiencies or weaknesses that are not yet identified could emerge.

Over time the combined company may identify deficiencies or weaknesses in its internal controls and, where and when appropriate, report on these deficiencies or weaknesses. However, the internal control procedures can provide only reasonable, and not absolute, assurance that deficiencies or weaknesses are identified. Deficiencies or weaknesses that have not been identified by Cynosure or Palomar could emerge and these deficiencies or weaknesses could have a material impact on the results of operations for the combined company.

* Charges to earnings resulting from the application of the acquisition method of accounting may adversely affect the market value of our Class A common stock following the completion of the merger.

In accordance with generally accepted accounting principles in the United States, the merger will be accounted for using the acquisition method of accounting, which will result in charges to earnings that could have an adverse impact on the market value of our Class A common stock following the completion of the merger. Under the acquisition method of accounting, the total estimated purchase price will be allocated to Palomar’s net tangible assets, identifiable intangible assets based on their respective fair values as of the date of completion of the merger. Any excess of the purchase price over those fair values will be recorded as goodwill. The combined company will incur additional amortization expense based on the identifiable amortizable intangible assets acquired pursuant to the merger agreement and their relative useful lives. Additionally, to the extent the value of goodwill or identifiable intangible assets or other long-lived assets may become impaired, the combined company will be required to incur material charges relating to the impairment. These amortization and potential impairment charges could have a material impact on the combined company’s results of operations.

We currently estimate that we will incur approximately $40.3 million of incremental amortization expense after completion of the merger, based on the closing price of our Class A common stock on The NASDAQ Stock Market LLC on March 15, 2013, the last trading day before the public announcement of the merger. The actual amount of the incremental amortization expense will be based on the aggregate value of the merger consideration to be paid to Palomar stockholders in the merger, less the fair value of all net assets acquired and goodwill assumed. Changes in earnings per share, including as a result of this incremental expense, could adversely affect the market price of our Class A common stock.

* Stockholder class-action lawsuits have been brought against Palomar, its directors and us in connection with the merger. These lawsuits could be expensive and time consuming and result in the delay of the consummation of the merger and cause Palomar, its directors and us to pay substantial damages and incur additional costs and expenses.

Since we announced the merger on March 18, 2013, five putative stockholder class action complaints have been filed against Palomar, its directors and us. The complaints allege that the Palomar board of directors breached their fiduciary duties to the Palomar stockholders in connection with the approval of the merger and that we and, in four of the five lawsuits, our wholly-owned subsidiary, Commander Acquisition Corp., aided and abetted the alleged breach of fiduciary duties. The complaints allege that the Palomar board of directors breached their fiduciary duties in connection with the proposed transaction by, among other things, conducting a flawed sale process, failing to maximize stockholder value and to obtain the best financial and other terms, and that the registration statement we filed is materially deficient. We are vigorously defending these lawsuits. However, litigation is subject to numerous uncertainties and we are unable to predict the ultimate outcome of this or any other matter. If one or more of the lawsuits is successful, it could delay the consummation of the merger, result in substantial damages to Palomar, its directors and us and cause us to incur additional costs and expenses in connection with the merger.

 

Item 2. Unregistered Sales of Equity Securities and Use of Proceeds

In July 2009, our Board of Directors authorized the repurchase of up to $10 million of our Class A common stock, from time to time, on the open market or in privately negotiated transactions under a stock repurchase program. The program will terminate upon the purchase of $10 million in common stock, unless our Board of Directors discontinues it sooner. During the three months ended March 31, 2013, we did not repurchase any shares of our common stock under this program. As of March 31, 2013, we have repurchased an aggregate of 196,970 shares under this program at an aggregate cost of $1.9 million.

 

Item 4. Mine Safety Disclosure

None.

 

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Item 6. Exhibits

 

  (a) Exhibits

 

Exhibit

No.

 

Description

2.1*   Agreement and Plan of Merger by and among Cynosure, Inc., Commander Acquisition Corp. and Palomar Medical Technologies, Inc., dated as of March 17, 2013 (Incorporated by reference to the exhibits to the Company’s Current Report on Form 8-K filed March 18, 2013)
10.1   Form of Company Stockholder Agreement (filed as Exhibit A to Exhibit 2.1 and incorporated herein by reference)
10.2   Form of Buyer Stockholder Agreement (filed as Exhibit B to Exhibit 2.1 and incorporated herein by reference)
10.3   Employment Agreement by and between Cynosure, Inc. and Joseph P. Caruso, dated March 17, 2013 (Incorporated by reference to the exhibits to the Company’s Current Report on Form 8-K filed March 18, 2013)
31.1   Certification of the Principal Executive Officer
31.2   Certification of the Principal Financial Officer
32.1   Certification of the Principal Executive Officer Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002
32.2   Certification of the Principal Financial Officer Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002
101**   The following materials from the Cynosure, Inc. Quarterly Report on Form 10-Q for the quarter ended March 31, 2013, formatted in XBRL (eXtensible Business Reporting Language): (i) Consolidated Statements of Operations for the three months ended March 31, 2013 and 2012, (ii) Consolidated Balance Sheets at March 31, 2013 and December 31, 2012, (iii) Consolidated Statements of Comprehensive Income for the three months ended March 31, 2013 and 2012, (iv) Consolidated Statements of Cash Flows for the three months ended March 31, 2013 and 2012, and (v) Notes to Consolidated Financial Statements.

 

* Schedules to this Exhibit have been omitted in reliance on Item 601(b)(2) of Regulation S-K. Cynosure will furnish copies of any such schedules to the SEC upon request.
** Pursuant to Rule 406T of Regulation S-T, the Interactive Data Files on Exhibit 101 hereto are deemed not filed or part of a registration statement or prospectus for purposes of Sections 11 or 12 of the Securities Act of 1933, as amended, are deemed not filed for purposes of Section 18 of the Securities and Exchange Act of 1934, as amended, and otherwise are not subject to liability under those sections.

 

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Signatures

Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant certifies that it has caused this Report to be signed on its behalf by the undersigned, thereunto duly authorized.

 

   

Cynosure, Inc.

(Registrant)

Date: May 8, 2013     By:  

/S/    MICHAEL R. DAVIN

      Michael R. Davin
      Chairman, President, Chief Executive Officer
Date: May 8, 2013     By:  

/S/    TIMOTHY W. BAKER

      Timothy W. Baker
      Executive Vice President, Chief Financial Officer and Treasurer

 

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EXHIBIT INDEX

 

Exhibit

No.

 

Description

2.1*   Agreement and Plan of Merger by and among Cynosure, Inc., Commander Acquisition Corp. and Palomar Medical Technologies, Inc., dated as of March 17, 2013 (Incorporated by reference to the exhibits to the Company’s Current Report on Form 8-K filed March 18, 2013)
10.1   Form of Company Stockholder Agreement (filed as Exhibit A to Exhibit 2.1 and incorporated herein by reference)
10.2   Form of Buyer Stockholder Agreement (filed as Exhibit B to Exhibit 2.1 and incorporated herein by reference)
10.3   Employment Agreement by and between Cynosure, Inc. and Joseph P. Caruso, dated March 17, 2013 (Incorporated by reference to the exhibits to the Company’s Current Report on Form 8-K filed March 18, 2013)
31.1   Certification of the Principal Executive Officer
31.2   Certification of the Principal Financial Officer
32.1   Certification of the Principal Executive Officer Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002
32.2   Certification of the Principal Financial Officer Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002
101**   The following materials from the Cynosure, Inc. Quarterly Report on Form 10-Q for the quarter ended March 31, 2013, formatted in XBRL (eXtensible Business Reporting Language): (i) Consolidated Statements of Operations for the three months ended March 31, 2013 and 2012, (ii) Consolidated Balance Sheets at March 31, 2013 and December 31, 2012, (iii) Consolidated Statements of Comprehensive Income for the three months ended March 31, 2013 and 2012, (iv) Consolidated Statements of Cash Flows for the three months ended March 31, 2013 and 2012, and (v) Notes to Consolidated Financial Statements.

 

* Schedules to this Exhibit have been omitted in reliance on Item 601(b)(2) of Regulation S-K. Cynosure will furnish copies of any such schedules to the SEC upon request.
** Pursuant to Rule 406T of Regulation S-T, the Interactive Data Files on Exhibit 101 hereto are deemed not filed or part of a registration statement or prospectus for purposes of Sections 11 or 12 of the Securities Act of 1933, as amended, are deemed not filed for purposes of Section 18 of the Securities and Exchange Act of 1934, as amended, and otherwise are not subject to liability under those sections.

 

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