UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

 

Form 10-Q

 

 

(Mark one)

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

For the quarterly period ended March 31,June 30, 2015

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 Exchange Act).    ¨  Yes    x  No

The number of shares outstanding of the registrant’s Class A common stock as of May 1,July 29, 2015:

 

Class

 

Number of Shares

Class A Common Stock, $0.001 par value 22,160,72422,702,247

 

 

 


Cynosure, Inc.

Table of Contents

 

     Page
No.
 

PART I

 

Financial Information

  

Item 1.

 

Financial Statements (Unaudited)

  
 

Consolidated Balance Sheets as of March 31,June 30, 2015 and December 31, 2014

1

Consolidated Statements of Operations for the Three and Six Months Ended June 30, 2015 and 2014

2

Consolidated Statements of Comprehensive Income for the Three and Six Months Ended June 30, 2015 and 2014

   3  
 

Consolidated Statements of OperationsCash Flows for the ThreeSix Months Ended March 31,June 30, 2015 and 2014

   4  
 

Notes to Consolidated Financial Statements of Comprehensive (Loss) Income for the Three Months Ended March 31, 2015 and 2014

   5

Consolidated Statements of Cash Flows for the Three Months Ended March 31, 2015 and 2014

6

Notes to Consolidated Financial Statements (Unaudited)

7  

Item 2.

 

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

   1513  

Item 3.

 

Quantitative and Qualitative Disclosures About Market Risk

   2224  

Item 4.

 

Controls and Procedures

   2224  

PART II

 

Other Information

  

Item 1.

 

Legal Proceedings

   2425  

Item 1A.

 

Risk Factors

   2526  

Item 2.

 

Unregistered Sales of Equity Securities and Use of Proceeds

   3638  

Item 6.

 

Exhibits

   3638  

SIGNATURES

   3739  

EXHIBIT INDEX

   3839  

EX-10.1 Sixth Amendment to the Lease, dated April 16, 2015, between the Company and Glenborough Westford Center, LLC (incorporated by reference to Exhibit 10.1 to the Company’s Quarterly Report on Form 10-Q filed May 7, 2015)

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,June 30, 2015, formatted in XBRL (eXtensible Business Reporting Language): (i) Consolidated Statements of Operations for the three and six months ended March 31,June 30, 2015 and 2014, (ii) Consolidated Balance Sheets at March 31,June 30, 2015 and December 31, 2014, (iii) Consolidated Statements of Comprehensive (Loss) Income for the three and six months ended March 31,June 30, 2015 and 2014, (iv) Consolidated Statements of Cash Flows for the threesix months ended March 31,June 30, 2015 and 2014, and (v) Notes to Consolidated Financial Statements.


PART I — Financial Information

 

Item 1.Financial Statements (Unaudited)

Cynosure, Inc.

Consolidated Balance Sheets

(in thousands, except par value data)

 

  (Unaudited)
March 31,
2015
 December 31,
2014
   (Unaudited)
June 30,
2015
 December 31,
2014
 
Assets      

Current assets:

      

Cash and cash equivalents

  $71,914   $75,131    $93,073   $75,131  

Short-term marketable securities

   24,585   32,055     29,727   32,055  

Accounts receivable, net

   45,311   42,524     47,658   42,524  

Inventories

   68,209   59,318     73,352   59,318  

Prepaid expenses and other current assets

   10,580   9,629     13,702   9,629  

Deferred income taxes

   17,144   17,228     17,134   17,228  
  

 

  

 

   

 

  

 

 

Total current assets

 237,743   235,885     274,646   235,885  

Property and equipment, net

 35,523   34,256     35,348   34,256  

Long-term marketable securities

 30,082   26,189     22,405   26,189  

Goodwill

 105,877   105,764     105,860   105,764  

Intangibles, net

 51,272   53,583     48,971   53,583  

Other assets

 1,966   2,047     2,340   2,047  
  

 

  

 

   

 

  

 

 

Total assets

$462,463  $457,724    $489,570   $457,724  
  

 

  

 

   

 

  

 

 
Liabilities and Stockholders’ Equity   

Current liabilities:

   

Accounts payable

$27,062  $20,856    $26,651   $20,856  

Accrued expenses

 38,875   42,426     38,533   42,426  

Deferred revenue

 11,575   10,971     12,121   10,971  

Capital lease obligation

 135   137     324   137  
  

 

  

 

   

 

  

 

 

Total current liabilities

 77,647   74,390     77,629   74,390  
  

 

  

 

 

Capital lease obligation, net of current portion

 16,563   16,088     16,763   16,088  

Deferred revenue, net of current portion

 839   809     815   809  

Other noncurrent liabilities

 7,924   8,325     10,669   8,325  

Commitments and contingencies

Commitments and contingencies (Note 13)

   

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 — 23,335 Class A shares and no Class B shares at March 31, 2015; Issued — 23,253 Class A shares and no Class B shares at December 31, 2014

 23   23  

Issued — 24,197 Class A shares and no Class B shares at June 30, 2015;

   

Issued — 23,253 Class A shares and no Class B shares at December 31, 2014

   24   23  

Additional paid-in capital

 357,834   355,082     376,396   355,082  

Retained earnings

 39,966   39,974     45,324   39,974  

Accumulated other comprehensive loss

 (5,229 (3,863   (4,946 (3,863

Treasury stock, 1,628 Class A shares, at cost

 (33,104 (33,104   (33,104 (33,104
  

 

  

 

   

 

  

 

 

Total stockholders’ equity

 359,490   358,112     383,694   358,112  
  

 

  

 

   

 

  

 

 

Total liabilities and stockholders’ equity

$462,463  $457,724    $489,570   $457,724  
  

 

  

 

   

 

  

 

 

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

Cynosure, Inc.

Consolidated Statements of Operations

(Unaudited, in thousands, except per share data)

 

  Three Months Ended
March 31,
   Three Months Ended
June 30,
 Six Months Ended
June 30,
 
  2015 2014   2015 2014 2015 2014 

Product revenues

  $56,502   $49,701    $69,429   $59,596   $125,931   $109,297  

Parts, accessories, service and royalty revenues

   18,410   12,303     14,265   12,977   32,675   25,280  
  

 

  

 

   

 

  

 

  

 

  

 

 

Total revenues

 74,912   62,004     83,694   72,573   158,606   134,577  

Cost of revenues

 32,139   26,609     36,338   31,880   68,477   58,489  
  

 

  

 

   

 

  

 

  

 

  

 

 

Gross profit

 42,773   35,395     47,356   40,693   90,129   76,088  

Operating expenses:

     

Sales and marketing

 25,696   20,122     26,426   20,867   52,122   40,989  

Research and development

 5,958   5,574     5,251   4,999   11,209   10,573  

Amortization of intangible assets acquired

 736   713     736   713   1,472   1,426  

General and administrative

 8,330   7,640     7,302   7,716   15,632   15,356  
  

 

  

 

   

 

  

 

  

 

  

 

 

Total operating expenses

 40,720   34,049     39,715   34,295   80,435   68,344  
  

 

  

 

   

 

  

 

  

 

  

 

 

Income from operations

 2,053   1,346     7,641   6,398   9,694   7,744  

Interest expense, net

 (402 (349   (430 (343 (832 (692

Other (expense) income, net

 (1,663 66  

Other income (expense), net

   484   213   (1,179 279  
  

 

  

 

   

 

  

 

  

 

  

 

 

(Loss) income before provision for income taxes

 (12 1,063  

(Benefit) provision for income taxes

 (4 374  

Income before provision for income taxes

   7,695   6,268   7,683   7,331  

Provision for income taxes

   2,337   1,693   2,333   2,067  
  

 

  

 

   

 

  

 

  

 

  

 

 

Net (loss) income

$(8$689  

Net income

  $5,358   $4,575   $5,350   $5,264  
  

 

  

 

   

 

  

 

  

 

  

 

 

Basic net (loss) income per share

$(0.00$0.03  

Basic net income per share

  $0.24   $0.21   $0.24   $0.24  
  

 

  

 

   

 

  

 

  

 

  

 

 

Diluted net (loss) income per share

$(0.00$0.03  

Diluted net income per share

  $0.24   $0.20   $0.24   $0.23  
  

 

  

 

   

 

  

 

  

 

  

 

 

Basic weighted average common shares outstanding

 21,664   21,978     22,246   22,088   21,957   22,033  
  

 

  

 

   

 

  

 

  

 

  

 

 

Diluted weighted average common shares outstanding

 21,664   22,568     22,615   22,373   22,369   22,470  
  

 

  

 

   

 

  

 

  

 

  

 

 

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

Cynosure, Inc.

Consolidated Statements of Comprehensive (Loss) Income

(Unaudited, in thousands)

 

   Three Months Ended
March 31,
 
   2015  2014 

Net (loss) income

  $(8 $689  
  

 

 

  

 

 

 

Other comprehensive loss components:

Cumulative translation adjustment

 (1,379 (49

Unrealized gain (loss) on marketable securities, net of taxes

 13   (6
  

 

 

  

 

 

 

Total other comprehensive loss

 (1,366 (55
  

 

 

  

 

 

 

Comprehensive (loss) income

$(1,374$634  
  

 

 

  

 

 

 
   Three Months Ended
June 30,
   Six Months Ended
June 30,
 
   2015  2014   2015  2014 

Net income

  $5,358   $4,575    $5,350   $5,264  
  

 

 

  

 

 

   

 

 

  

 

 

 

Other comprehensive income (loss) components:

      

Cumulative translation adjustment

   290    229     (1,089  180  

Unrealized (loss) gain on marketable securities, net of taxes

   (7  2     6    (4
  

 

 

  

 

 

   

 

 

  

 

 

 

Total other comprehensive income (loss)

   283    231     (1,083  176  
  

 

 

  

 

 

   

 

 

  

 

 

 

Comprehensive income

  $5,641   $4,806    $4,267   $5,440  
  

 

 

  

 

 

   

 

 

  

 

 

 

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

Cynosure, Inc.

Consolidated Statements of Cash Flows

(Unaudited, in thousands)

 

  Three Months Ended
March 31,
 
  2015 2014   Six Months Ended
June 30,
 
  2015 2014 

Operating activities:

      

Net (loss) income

  $(8 $689  

Reconciliation of net (loss) income to net cash used in operating activities:

   

Net income

  $5,350   $5,264  

Reconciliation of net income to net cash (used in) provided by operating activities:

   

Depreciation and amortization

   4,686   4,241     9,424   8,435  

Stock-based compensation expense

   1,820   1,466     3,734   3,344  

Loss on disposal of fixed assets

   5   32     16   30  

Noncash interest expense on capital lease obligations

   395   366     827   734  

Noncash interest expense on license transfer agreement

   51    —       100    —    

Deferred income taxes

   21   44     2,250   (154

Net accretion of marketable securities

   514   240     1,034   625  

Changes in operating assets and liabilities:

      

Accounts receivable

   (3,698 (3,617   (5,798 (10,941

Inventories

   (10,963 (2,732   (17,051 (2,626

Net book value of demonstration inventory sold

   94   126     252   293  

Prepaid expenses and other current assets

   (1,290 260     (4,089 1,974  

Accounts payable

   6,321   3,103     5,873   5,519  

Tax benefit from the exercise of stock options

   (27 (382

Tax benefit from stock option exercises

   (248 (2,468

Accrued expenses

   (3,056 (4,748   (3,603 (6,651

Deferred revenue

   779   (8   1,269   498  

Other noncurrent liabilities

   (402  —      (234  —   
  

 

  

 

   

 

  

 

 

Net cash used in operating activities

 (4,758 (920

Net cash (used in) provided by operating activities

   (894 3,876  

Investing activities:

   

Purchases of property and equipment

 (2,814 (4,394   (4,049 (9,661

Proceeds from the sales and maturities of marketable securities

 13,150   3,565     22,420   12,940  

Purchases of marketable securities

 (10,081 (17,083   (17,346 (35,146

Decrease in other noncurrent assets

 (19 (127

Increase in other noncurrent assets

   (21 (70
  

 

  

 

   

 

  

 

 

Net cash provided by (used in) investing activities

 236   (18,039   1,004   (31,937

Financing activities:

   

Excess tax benefit on options exercised

 27   382     248   2,468  

Repurchases of common stock

   —     (8,971

Proceeds from stock option exercises

 901   7,340     17,330   7,486  

Payments on capital lease obligation

 (73 (311   (117 (516
  

 

  

 

   

 

  

 

 

Net cash provided by financing activities

 855   7,411     17,461   467  

Effect of exchange rate changes on cash and cash equivalents

 450   (77   371   (122
  

 

  

 

   

 

  

 

 

Net decrease in cash and cash equivalents

 (3,217 (11,625

Net increase (decrease) in cash and cash equivalents

   17,942   (27,716

Cash and cash equivalents, beginning of the period

 75,131   93,655     75,131   93,655  
  

 

  

 

   

 

  

 

 

Cash and cash equivalents, end of the period

$71,914  $82,030    $93,073   $65,939  
  

 

  

 

   

 

  

 

 

Supplemental cash flow information:

Supplemental cash flow information

   

Cash paid for interest

$5  $5    $9   $9  
  

 

  

 

   

 

  

 

 

Cash paid for income taxes

$515  $810    $2,444   $1,359  
  

 

  

 

   

 

  

 

 

Supplemental noncash investing and financing activities:

Supplemental noncash investing and financing activities

   

Transfer of demonstration equipment from inventory to fixed assets

$2,108  $556    $3,296   $1,045  
  

 

  

 

   

 

  

 

 

Assets acquired under capital lease

$151  $—      $151   $58  
  

 

  

 

   

 

  

 

 

Net effect of acquisition-related opening balance sheet adjustments

$140  $115    $143   $—    
  

 

  

 

   

 

  

 

 

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

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 (U.S. GAAP) for interim information and pursuant to the rules and regulations of the Securities and Exchange Commission 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, 2014. 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 threesix months ended March 31,June 30, 2015 may not be indicative of the results that may be expected for the year ending December 31, 2015, or any other period.

Note 2 — Stock-Based Compensation

Cynosure recorded stock-based compensation expense of $1.8$1.9 million and $1.5 million for each of the three months ended March 31,June 30, 2015 and 2014. Cynosure recorded stock-based compensation expense of $3.7 million and $3.3 million for the six months ended June 30, 2015 and 2014, respectively. As of March 31,June 30, 2015 and 2014, respectively, Cynosure had $26,000 and $25,000 of stock-based compensation expense capitalized as a part of inventory.

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 share-based payments, as follows:

 

  Three Months
Ended March 31,
   Three Months
Ended

June 30,
   Six Months
Ended
June 30,
 
  2015   2014   2015   2014   2015   2014 
  (In thousands)   (In thousands) 

Cost of revenues

  $68    $65    $80    $75    $148    $140  

Sales and marketing

   475     443     495     519     970     962  

Research and development

   257     228     292     259     549     487  

General and administrative

   1,020     730     1,047     1,025     2,067     1,755  
  

 

   

 

   

 

   

 

   

 

   

 

 

Total stock-based compensation expense

$1,820  $1,466    $1,914    $1,878    $3,734    $3,344  
  

 

   

 

   

 

   

 

   

 

   

 

 

Cash received from option exercises was $0.9$17.3 million and $7.3$7.5 million during the threesix months ended March 31,June 30, 2015 and 2014, respectively.

Cynosure granted 319,509options to purchase 346,029 and 657,240719,230 shares of common stock options during the threesix months ended March 31,June 30, 2015 and 2014, respectively. Cynosure utilizeshas elected to use the Black-Scholes model to determine the weighted average fair value of options. The weighted average fair value of the options granted during the threesix months ended March 31,June 30, 2015 and 2014 was $11.78$11.90 and $11.23,$10.99, respectively, using the following assumptions:

 

  Three Months Ended
March 31,
  Six Months Ended
June 30,
  2015 2014  2015  2014

Risk-free interest rate

  1.39% - 1.53% 1.44% - 1.76%  1.39% - 1.55%  1.56% - 1.80%

Expected dividend yield

     —    —  

Expected term

  4.8 years 4.6 years  4.8 years  4.6 years

Expected volatility

  43% 43% - 44%  42% - 43%  43%

Estimated forfeiture rate

  5% 5%  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 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. The risk-free interest 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.

Cynosure granted 86,618 and 44,840 restricted stock units during the threesix months ended March 31,June 30, 2015 and 2014, respectively, to employees at a fair market value of its common stock on the date of grant and which vest annually over a three-year period. Cynosure is recognizing the related compensation expense on a straight-line basis over the three-year period.

Cynosure granted 16,685 and 43,500 restricted stock units during the six months ended June 30, 2015 and 2014, respectively, to non-employee directors at a fair market value of its common stock on the date of grant and which vest quarterly over a one-year period. Cynosure is recognizing related compensation expense on a straight-line basis over the one-year period.

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,
2015
   December 31,
2014
   June 30,
2015
   December 31,
2014
 
  (in thousands)   (in thousands) 

Raw materials

  $18,415    $16,875    $19,739    $16,875  

Work in process

   4,344     3,526     3,336     3,526  

Finished goods

   45,450     38,917     50,277     38,917  
  

 

   

 

   

 

   

 

 
$68,209  $59,318    $73,352    $59,318  
  

 

   

 

   

 

   

 

 

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,June 30, 2015 (in thousands):

 

  Level 1   Level 2   Level 3   Total   Level 1   Level 2   Level 3   Total 

Money market funds(1)

  $5,531    $—     $—     $5,531    $7,953    $—     $—     $7,953  

State and municipal bonds

   —      46,359     —      46,359     —      49,120     —      49,120  

Treasuries and government agencies

   —      8,299     —      8,299     —      3,002     —      3,002  

Equity securities

   9     —      —      9     10     —      —      10  
  

 

   

 

   

 

   

 

   

 

   

 

   

 

   

 

 

Total

$5,540  $54,658  $—   $60,198    $7,963    $52,122    $—     $60,085  
  

 

   

 

   

 

   

 

   

 

   

 

   

 

   

 

 

The following table represents Cynosure’s fair value hierarchy for its financial assets (cash equivalents and marketable securities) measured at fair value as of December 31, 2014 (in thousands):

 

  Level 1   Level 2   Level 3   Total   Level 1   Level 2   Level 3   Total 

Money market funds(1)

  $1,753    $—     $—     $1,753    $1,753    $—     $—     $1,753  

State and municipal bonds

   —      47,744     —      47,744     —      47,744     —      47,744  

Treasuries and government agencies

   —      8,486     —      8,486     —      8,486     —      8,486  

Corporate obligations and commercial paper

   —      2,001     —      2,001     —      2,001     —      2,001  

Equity securities

   13     —      —      13     13     —      —      13  
  

 

   

 

   

 

   

 

   

 

   

 

   

 

   

 

 

Total

$1,766  $58,231  $—   $59,997    $1,766    $58,231    $—     $59,997  
  

 

   

 

   

 

   

 

   

 

   

 

   

 

   

 

 

 

(1)Included in cash and cash equivalents at March 31,June 30, 2015 and December 31, 2014.

During the threesix months ended March 31,June 30, 2015, there were no significant transfers in and out of Level 1 and Level 2. Cynosure did not have any Level 3 financial assets or liabilities at March 31,June 30, 2015 or December 31, 2014.

Note 5 — Short and Long-Term Marketable Securities

Cynosure’s available-for-sale securities at March 31,June 30, 2015 consist of approximately $54.7$52.1 million of investments in debt securities consisting of state and municipal bonds, treasuries and government agencies and approximately $9,000$10,000 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,June 30, 2015, Cynosure’s marketable securities consist of the following (in thousands):

 

  Market
Value
   Amortized
Cost
   Unrealized
Gains
   Unrealized
Losses
   Market
Value
   Amortized
Cost
   Unrealized
Gains
   Unrealized
Losses
 

Available-for-Sale Securities:

                

Short-term marketable securities:

                

State and municipal bonds

  $23,576    $23,571    $5    $—     $28,717    $28,714    $5    $(2

Treasuries and government agencies

   1,000     1,000     —      —      1,000     1,000     —       —    

Equity securities

   9     13     —      (4   10     10     —       —    
  

 

   

 

   

 

   

 

   

 

   

 

   

 

   

 

 

Total short-term marketable securities

$24,585  $24,584  $5  $(4  $29,727    $29,724    $5    $(2
  

 

   

 

   

 

   

 

   

 

   

 

   

 

   

 

 

Long-term marketable securities:

        

State and municipal bonds

$22,783  $22,786  $6  $(9  $20,403    $20,417    $2    $(16

Treasuries and government agencies

 7,299   7,299   3   (3   2,002     2,000     2     —    
  

 

   

 

   

 

   

 

   

 

   

 

   

 

   

 

 

Total long-term marketable securities

$30,082  $30,085  $9  $(12  $22,405    $22,417    $4    $(16
  

 

   

 

   

 

   

 

   

 

   

 

   

 

   

 

 

Total available-for-sale securities

$54,667  $54,669  $14  $(16  $52,132    $52,141    $9    $(18
  

 

   

 

   

 

   

 

   

 

   

 

   

 

   

 

 

Total marketable securities

$54,667    $52,132        
  

 

         

 

       

As of December 31, 2014, Cynosure’s marketable securities consist of the following (in thousands):

 

  Market
Value
   Amortized
Cost
   Unrealized
Gains
   Unrealized
Losses
   Market
Value
   Amortized
Cost
   Unrealized
Gains
   Unrealized
Losses
 

Available-for-Sale Securities:

                

Short-term marketable securities:

                

State and municipal bonds

  $26,041    $26,033    $8    $—     $26,041    $26,033    $8    $—   

Treasuries and government agencies

   4,000     4,000     —      —      4,000     4,000     —      —   

Corporate obligations and commercial paper

   2,001     2,001     —      —      2,001     2,001     —      —   

Equity securities

   13     18     —      (5   13     18     —      (5
  

 

   

 

   

 

   

 

   

 

   

 

   

 

   

 

 

Total short-term marketable securities

$32,055  $32,052  $8  $(5  $32,055    $32,052    $8    $(5
  

 

   

 

   

 

   

 

   

 

   

 

   

 

   

 

 

Long-term marketable securities:

State and municipal bonds

$21,703  $21,721  $2  $(20

Treasuries and government agencies

 4,486   4,500   —    (14
  

 

   

 

   

 

   

 

 

Total long-term marketable securities

$26,189  $26,221  $2  $(34
  

 

   

 

   

 

   

 

 

Total available-for-sale securities

$58,244  $58,273  $10  $(39
  

 

   

 

   

 

   

 

 

Total marketable securities

$58,244  
  

 

       

   Market
Value
   Amortized
Cost
   Unrealized
Gains
   Unrealized
Losses
 

Long-term marketable securities:

        

State and municipal bonds

  $21,703    $21,721    $2    $(20

Treasuries and government agencies

   4,486     4,500     —      (14
  

 

 

   

 

 

   

 

 

   

 

 

 

Total long-term marketable securities

  $26,189    $26,221    $2    $(34
  

 

 

   

 

 

   

 

 

   

 

 

 

Total available-for-sale securities

  $58,244    $58,273    $10    $(39
  

 

 

   

 

 

   

 

 

   

 

 

 

Total marketable securities

  $58,244        
  

 

 

       

As of March 31,June 30, 2015, Cynosure’s available-for-sale debt securities mature as follows (in thousands):

 

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

State and municipal bonds

  $46,359    $23,576    $22,783    $—     $49,120    $28,717    $20,403    $—   

Treasuries and government agencies

   8,299     1,000     7,299     —      3,002     1,000     2,002     —   
  

 

   

 

   

 

   

 

   

 

   

 

   

 

   

 

 

Total available-for-sale debt securities

$54,658  $24,576  $30,082  $—     $52,122    $29,717    $22,405    $—   
  

 

   

 

   

 

   

 

   

 

   

 

   

 

   

 

 

Note 6 — Acquisition

Ellman International, Inc.

On September 5, 2014, Cynosure acquired substantially all of the assets of Ellman International, Inc. (Ellman) for $13.2 million in cash. In addition, Cynosure assumed current liabilities associated with normal working capital and certain contractual liabilities. The purchase price was based primarily on the net working capital on the date of purchase plus an amount to retire all of Ellman’s long term debt on the date of sale. Cynosure also assumed a license transfer agreement as part of the purchase valued at $4.2 million, which is classified as a liability. The acquisition complements Cynosure’s aesthetic treatment platform with radiofrequency energy sources and accessory products. The acquisition of substantially all of the assets of Ellman was considered a business acquisition for accounting purposes.

Cynosure is assessing the fair value of the assets acquired and liabilities assumed. Pro forma financial information was filed with the Securities and Exchange Commission within the applicable time period. Cynosure has allocated the purchase price to the net tangible and intangible assets based on their estimated fair values as of September 5, 2014. During the fourth quarter ofIn 2014, Cynosure completed its fair value procedures on the intangible assets, fixed assets and the license transfer agreement acquired in the Ellman acquisition. As such, the fair value of the accounts receivable, inventory, prepaid and other assets acquired, along with the accounts payable, accrued expenses and deferred revenue assumed presented in the table below are provisional and will be finalized in a later period once the fair value procedures are completed. Goodwill represents the excess of purchase price over the fair value of the net assets acquired. During the first quarter ofsix months ended June 30, 2015, Cynosure revised its estimates of the assets acquired and liabilities assumed in the Ellman acquisition, and as a result, increased goodwill from $6.6 million at December 31, 2014 to $6.7 million at March 31,June 30, 2015, with the offsetting decrease to inventory. The following table summarizes the estimated fair value as of September 5, 2014 of the net assets acquired (in thousands):

 

Purchase price:

  

Cash paid

$13,235    $13,235  
  

 

   

 

 

Total

$13,235    $13,235  
  

 

   

 

 

Assets (liabilities) acquired:

  

Accounts receivable

 2,147     2,144  

Inventory

 3,542     3,542  

Prepaid and other assets

 488     488  

Fixed assets

 612     612  

Intangible assets

 6,800     6,800  

Goodwill

 6,738  

Accounts payable

 (9

Accrued expenses

 (2,469

Deferred revenue

 (454

License transfer agreement

 (4,160
  

 

 

Total

$13,235  
  

 

 

Goodwill

   6,741  

Accounts payable

   (9

Accrued expenses

   (2,469

Deferred revenue

   (454

License transfer agreement

   (4,160
  

 

 

 

Total

  $13,235  
  

 

 

 

Note 7 — Goodwill and Other Intangible Assets

Changes to goodwill during the threesix months ended March 31,June 30, 2015 were as follows (in thousands):

 

Balance — December 31, 2014

$105,764  

Ellman acquisition

 140  

Translation adjustment

 (27
  

 

 

 

Balance — March 31, 2015

$105,877  
  

 

 

 

Balance – December 31, 2014

  $105,764  

Ellman acquisition

   143  

Translation adjustment

   (47
  

 

 

 

Balance – June 30, 2015

  $105,860  
  

 

 

 

Other intangible assets consisted of the following at March 31,June 30, 2015 and December 31, 2014 (in thousands):

 

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

March 31, 2015

       

June 30, 2015

       

Cost

  $29,240   $384   $19,718   $18,390   $1,353   $69,085    $29,240   $384   $19,718   $18,390   $1,353   $69,085  

Translation adjustment

   —     —     (45  —      —     (45   —     —     (42  —     —     (42

Accumulated amortization

   (9,394 (221 (6,294 (1,834 (25 (17,768   (10,947 (225 (6,797 (2,062 (41 (20,072
  

 

  

 

  

 

  

 

  

 

  

 

   

 

  

 

  

 

  

 

  

 

  

 

 

Balance, March 31, 2015

$19,846  $163  $13,379  $16,556  $1,328  $51,272  

Balance, June 30, 2015

  $18,293   $159   $12,879   $16,328   $1,312   $48,971  
  

 

  

 

  

 

  

 

  

 

  

 

   

 

  

 

  

 

  

 

  

 

  

 

 

December 31, 2014

       

Cost

$29,240  $384  $19,718  $18,390  $1,338  $69,070    $29,240   $384   $19,718   $18,390   $1,338   $69,070  

Translation adjustment

 —    34   2   —    2   38     —    34   2    —    2   38  

Accumulated amortization

 (7,840 (252 (5,818 (1,607 (8 (15,525   (7,840 (252 (5,818 (1,607 (8 (15,525
  

 

  

 

  

 

  

 

  

 

  

 

   

 

  

 

  

 

  

 

  

 

  

 

 

Balance, December 31, 2014

$21,400  $166  $13,902  $16,783  $1,332  $53,583    $21,400   $166   $13,902   $16,783   $1,332   $53,583  
  

 

  

 

  

 

  

 

  

 

  

 

   

 

  

 

  

 

  

 

  

 

  

 

 

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

Amortization expense for the three months ended March 31,June 30, 2015 and 2014 was $2.2$2.3 million and $2.1 million, respectively. Amortization expense for the six months ended June 30, 2015 and 2014 was $4.5 million and $4.2 million, respectively. Cynosure has approximately $1.0 million of indefinite-life intangible assets that are included in other intangible assets in the table above. As of March 31,June 30, 2015, amortization expense on existing intangible assets for the next five years and beyond is as follows (in thousands):

 

Remainder of 2015

$6,916    $4,608  

2016

 8,428     8,430  

2017

 6,439     6,441  

2018

 4,923     4,925  

2019

 3,188     3,189  

2020 and thereafter

 20,402     20,402  
  

 

   

 

 

Total

$50,296    $47,995  
  

 

   

 

 

Note 8 — Warranty Costs

Cynosure typically provides a one-year parts and labor warranty on end-user sales of lasers. Distributor sales generally include a one-year warranty on parts only. Estimated future costs for initial product warranties are provided for at the time of revenue recognition. The following table sets forth activity in the accrued warranty account, which is a component of accrued expenses in the consolidated balance sheets (in thousands):

 

Balance — December 31, 2014

$8,118  

Balance – December 31, 2014

  $8,118  

Warranty provision related to new sales

 2,997     6,439  

Costs incurred

 (3,311   (6,589
  

 

   

 

 

Balance — March 31, 2015

$7,804  

Balance – June 30, 2015

  $7,968  
  

 

   

 

 

Note 9 — Segment Information

In accordance with Accounting Standards Codification (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 revenuerevenues by geographic area:

 

  Three Months Ended
March 31,
   Three Months Ended
June 30,
   Six Months Ended
June 30,
 
  2015   2014   2015   2014   2015   2014 
  (in thousands)   (in thousands) 

United States

  $41,451    $27,948    $48,196    $32,722    $89,647    $60,670  

Europe

   10,657     12,133     10,445     13,490     21,102     25,623  

Asia / Pacific

   16,814     15,527     18,143     17,199     34,958     32,726  

Other

   5,990     6,396     6,910     9,162     12,899     15,558  
  

 

   

 

   

 

   

 

   

 

   

 

 

Total

$74,912  $62,004    $83,694    $72,573    $158,606    $134,577  
  

 

   

 

   

 

   

 

   

 

   

 

 

Total assets by geographic area are as follows:

 

  March 31,
2015
   December 31,
2014
   June 30,
2015
   December 31,
2014
 
  (in thousands)   (in thousands) 

United States

  $427,998    $420,513    $451,937    $420,513  

Europe

   20,796     23,235     22,657     23,235  

Asia / Pacific

   19,269     19,182     20,440     19,182  

Eliminations

   (5,600   (5,206   (5,464   (5,206
  

 

   

 

   

 

   

 

 

Total

$462,463  $457,724    $489,570    $457,724  
  

 

   

 

   

 

   

 

 

Long-lived assets (property and equipment only) by geographic area are as follows:

 

  March 31,
2015
   December 31,
2014
   June 30,
2015
   December 31,
2014
 
  (in thousands)   (in thousands) 

United States

  $31,339    $30,912    $31,331    $30,912  

Europe

   1,453     1,656     1,468     1,656  

Asia / Pacific

   2,731     1,688     2,549     1,688  
  

 

   

 

   

 

   

 

 

Total

$35,523  $34,256    $35,348    $34,256  
  

 

   

 

   

 

   

 

 

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

Note 10 — Net (Loss) Income Per Common Share

Basic net (loss) income per share is determined by dividing net (loss) income by the weighted average common shares outstanding during the period. Diluted net (loss) income per share is determined by dividing net (loss) 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 and restricted stock units based on the treasury stock method.

A reconciliation of basic and diluted shares is as follows (in thousands, except per share data):

 

  Three Months Ended
March 31,
   Three Months Ended
June 30,
   Six Months Ended
June 30,
 
  2015   2014   2015   2014   2015   2014 

Net (loss) income

  $(8  $689  

Net income

  $5,358    $4,575    $5,350    $5,264  
  

 

   

 

   

 

   

 

   

 

   

 

 

Basic weighted average common shares outstanding

 21,664   21,978     22,246     22,088     21,957     22,033  

Weighted average common equivalent shares

 —     590     369     285     412     437  
  

 

   

 

   

 

   

 

   

 

   

 

 

Diluted weighted average common shares outstanding

 21,664   22,568     22,615     22,373     22,369     22,470  
  

 

   

 

   

 

   

 

   

 

   

 

 

Basic net (loss) income per share

$(0.00$0.03  

Basic net income per share

  $0.24    $0.21    $0.24    $0.24  
  

 

   

 

   

 

   

 

   

 

   

 

 

Diluted net (loss) income per share

$(0.00$0.03  

Diluted net income per share

  $0.24    $0.20    $0.24    $0.23  
  

 

   

 

   

 

   

 

   

 

   

 

 

For the three and six months ended March 31,June 30, 2015, the number of basicapproximately 0.9 million and diluted1.0 million weighted average shares outstanding was the same, as any increase in the number of shares of common stock equivalents for the three months ended March 31, 2015 would be antidilutive based on the net loss for the period. For the three months ended March 31, 2015, outstanding options and restricted stock unitssubject to purchase 1.7 million shares were excluded from the computation of diluted earnings per share because their inclusion would have been antidilutive.

For the three months ended March 31, 2014, approximately 1.1 million weighted average stock options and restricted stock units, respectively, were excluded from the calculation of diluted weighted average common shares outstanding as their effect was antidilutive.

For the three and six months ended June 30, 2014, approximately 1.5 million and 1.3 million weighted average shares subject to purchase shares of the Company’s Class A common stock options and restricted stock units, respectively, were excluded from the calculation of diluted weighted average common shares outstanding as their effect was antidilutive.

Note 11 — Accumulated Other Comprehensive Loss

Changes to accumulated other comprehensive loss during the threesix months ended March 31,June 30, 2015 were as follows (in thousands):

 

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

Balance — December 31, 2014

  $(10  $(3,853  $(3,863

Current period other comprehensive loss

   13     (1,379   (1,366
  

 

 

   

 

 

   

 

 

 

Balance — March 31, 2015

$3  $(5,232$(5,229
  

 

 

   

 

 

   

 

 

 
   Unrealized
Loss on
Marketable
Securities, net

of taxes
   Translation
Adjustment
   Accumulated
Other
Comprehensive
Loss
 

Balance — December 31, 2014

  $(10  $(3,853  $(3,863

Current period other comprehensive income (loss)

   6     (1,089   (1,083
  

 

 

   

 

 

   

 

 

 

Balance — June 30, 2015

  $(4  $(4,942  $(4,946
  

 

 

   

 

 

   

 

 

 

Note 12 — Income Taxes

During each of the three and six months ended March 31,June 30, 2015, and 2014, Cynosure recorded an income tax benefitprovision of $4,000 and$2.3 million, representing an effective tax rate of 30%. The income tax provision of $374,000, respectively. The income tax benefit for the three and six months ended March 31,June 30, 2015 iswas primarily attributable to applying the Company’s estimated annual effective tax rate to its year-to-date consolidated income before provision for income taxes, and includes a $0.5 million discrete tax benefit for the release of the valuation allowance previously maintained against the net deferred tax assets of Palomar Japan KK. The difference between the U.S. federal statutory tax rate and the effective tax rate was primarily attributable to the discrete tax benefit of $0.5 million for the release of valuation allowance previously maintained against the net deferred tax assets of Palomar Japan KK. Other factors resulting in differences between the U.S. federal statutory tax rate and the effective tax rate are the jurisdictional mix of worldwide loss.earnings, non-deductible expenses and the domestic manufacturing deduction.

During the three and six months ended June 30, 2014, Cynosure recorded an income tax provision of $1.7 million and $2.1 million, respectively, representing an effective tax rate of 27% and 28%, respectively. The income tax provision for the three and six months ended June 30, 2014 was primarily attributable to applying the Company’s estimated annual effective tax rate to its year-to-date consolidated income before provision for income taxes, and includes a $0.3 million discrete tax benefit for the release of the valuation allowance previously maintained against the net deferred tax assets of Cynosure Spain S.L. The difference between the U.S. federal statutory tax rate and the effective tax rate was primarily attributable to the discrete tax benefit of $0.3 million for the release of the valuation allowance previously maintained against the net deferred tax assets of Cynosure Spain S.L. Other factors resulting in differences between the U.S. federal statutory tax rate and the effective tax rate are the jurisdictional mix of worldwide earnings, non-deductible expenses and the domestic manufacturing deduction.

At March 31,June 30, 2015 and December 31, 2014, Cynosure had gross tax-effected unrecognized tax benefits of $0.8 million of which the entire amount, if recognized, would favorably impact the effective tax rate. Cynosure classifies interest and penalties related to income taxes as a component of its provision for income taxes. Cynosure does not expect any material changes in the amounts of unrecognized tax benefits over the next 12 months.

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 2011. With few exceptions, Cynosure is no longer subject to U.S. state tax examinations for years before 2010. Additionally, certain non-U.S. jurisdictions are no longer subject to income tax examinations by tax authorities for years before 2010.

Note 13 — Commitments and Contingencies

Lease Commitments

Cynosure leases the land portion of its U.S. operating facility and certain foreign facilities under non-cancellable operating lease agreements expiring through May 2027. These leases are non-cancellable and typically contain renewal options. Certain leases contain

rent escalation clauses for which Cynosure recognizes the expense on a straight-line basis. Rent expense for the three and six months ended March 31,June 30, 2015 and 2014 was approximately $0.5 million and $1.0 million, respectively. Rent expense for the three and six months ended June 30, 2014 was approximately $1.0 million and $1.9 million, respectively. The 2014 period rent expense includes approximately $0.5 millionrent expense incurred on the former Palomar Medical Technologies, Inc. (Palomar) headquarters, which Cynosure occupied through July 2014.

Cynosure leases the buildings portion of its U.S. operating facility and certain equipment and vehicles under capital lease agreements with payments due through May 2027. Commitments under Cynosure’s lease arrangements are as follows as of March 31,June 30, 2015 and reflect the impact of an April 2015 amendment on Cynosure’s U.S. operating facility lease (in thousands):

 

  Operating
Leases
   Capital
Leases
   Operating
Leases
   Capital
Leases
 

Remainder of 2015

  $1,428    $145    $945    $86  

2016

   1,850     2,327     1,839     2,328  

2017

   1,845     2,719     1,833     2,719  

2018

   1,800     2,626     1,790     2,626  

2019

   1,389     2,611     1,387     2,611  

Thereafter

   2,842     20,947  

2020 and thereafter

   2,842     20,948  
  

 

   

 

   

 

   

 

 

Total minimum lease payments

$11,154  $31,375    $10,636    $31,318  
  

 

   

 

   

 

   

 

 

Less amount representing interest

 (14,677     (14,231
    

 

     

 

 

Present value of obligations under capital leases

$16,698      $17,087  

Current portion of capital lease obligations

 135       324  
    

 

     

 

 

Capital lease obligations, net of current portion

$16,563      $16,763  
    

 

     

 

 

Contractual Obligations

Cynosure’s significant outstanding contractual obligations relate to its capital leases from its facilities leases, including the buildings portion of its U.S. operating facility, and equipment financings. Cynosure’s leases are non-cancellable and typically contain renewal options. Certain leases contain rent escalation clauses for which Cynosure recognizes the expense on a straight-line basis. Cynosure has summarized in the table below its fixed contractual cash obligations as of March 31,June 30, 2015. The table below reflects the impact of the April 2015 amendment on Cynosure’s U.S. operating facility lease.

 

  Total   Less Than
One Year
   One to
Three Years
   Three to
Five Years
   More than
Five Years
   Total   Less Than
One Year
   One to
Three Years
   Three to
Five Years
   More than
Five Years
 
  (in thousands)   (in thousands) 

Capital lease obligations, including interest

  $31,375    $727    $5,121    $5,209    $20,318    $31,318    $1,251    $5,197    $5,228    $19,642  

Operating leases

   11,154     1,890     3,682     2,953     2,629     10,636     1,864     3,647     2,717     2,408  
  

 

   

 

   

 

   

 

   

 

   

 

   

 

   

 

   

 

   

 

 

Total contractual obligations

$42,529  $2,617  $8,803  $8,162  $22,947    $41,954    $3,115    $8,844    $7,945    $22,050  
  

 

   

 

   

 

   

 

   

 

   

 

   

 

   

 

   

 

   

 

 

Contingencies

Cynosure continually assesses litigation to determine if an unfavorable outcome would lead to a probable loss or reasonably possible loss, which could be estimated. In accordance with the Financial Accounting Standards Board’s guidance on accounting for contingencies, Cynosure accrues for all direct costs associated with the estimated resolution of contingencies at the earliest date at which it is deemed probable that a liability has been incurred and the amount of such liability can be reasonably estimated. If the estimate of a probable loss is a range and no amount within the range is more likely, Cynosure accrues the minimum amount of the range. In cases where Cynosure believes that a reasonably possible loss exists, Cynosure discloses the facts and circumstances of the litigation, including an estimable range, if possible. In management’s opinion, Cynosure is not currently involved in any legal proceedings, which, individually or in the aggregate, could have a material effect on Cynosure’s financial statements. Cynosure believes that contingent losses associated with any current litigation were remote as of March 31,June 30, 2015 and at the time of the filing of this Quarterly Report on Form 10-Q, and as such, Cynosure has not recorded or disclosed any material loss contingencies.

Note 14 — Recent Accounting Pronouncements

In May 2014, the Financial Accounting Standards Board issued guidance codified in ASC 606,Revenue Recognition — Revenue from Contracts with Customers, which amends the guidance in ASC 605,Revenue Recognition. This new revenue standard creates a

single source of revenue guidance for all companies in all industries and is more principles-based than the current revenue guidance. The new guidance must be adopted using either a full retrospective approach for all periods presented in the period of adoption or a modified retrospective approach. ASC 606 was originally scheduled to be effective for interim and annual periods beginning after December 15, 2016. In AprilJuly 2015, the Financial Accounting Standards Board proposed a one-year deferral ofdeferred the effective date for ASC 606. Under the proposal, theThe standard wouldwill be effective for public entities for interim and annual reporting periods beginning after December 15, 2017. Cynosure is currently evaluating the impact of the provisions of ASC 606.

 

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

Forward-Looking Statements

This Quarterly Report on Form 10-Q, which we refer to as this Quarterly Report, 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 in the cautionary statements included in this Quarterly Report, particularly in Part II, Item 1A of this Quarterly Report, 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 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 Part I, 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 on March 13, 2015. 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.

Company Overview

We develop, manufacture, and market aesthetic treatment systems that enable plastic surgeons, dermatologists and other medical practitioners to perform non-invasive and minimally invasive procedures to remove hair, treat vascular and benign pigmented lesions, remove multi-colored tattoos, revitalize the skin, liquefy and remove unwanted fat through laser lipolysis, reduce cellulite, clear nails infected by toe fungus, ablate sweat glands and improve vaginal health. We also market radiofrequency, energy sourcedor RF, energy-sourced medical devices for precision surgical applications such as facial plastic and general surgery, gynecology, ear, nose, and throat procedures, ophthalmology, oral and maxillofacial surgery, podiatry and proctology. We sell our products through a direct sales force in the United States, Canada, Mexico, France, Morocco, Germany, Spain, the United Kingdom, Australia, China, Japan and Korea and through international distributors in approximately 120 other countries.

Our product portfolio is composed of a broad range of energy sources including Alexandrite, diode, Nd: YAG, picosecond, pulse dye, Q-switched lasers, intense pulsed light and radiofrequencyRF technology. 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 provide 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 LaserBodySculptingS for the removal of unwanted fat;

 

  our Cellulaze product line for the treatment of cellulite;

 

  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 andRevLite product lines for the removal of benign pigmented lesions, as well as multi-colored tattoos;

 

  our PicoSure product line for the treatment of tattoos, benign pigmented lesions, acne scars, fine lines and wrinkles;

 

  our Icon Aesthetic System for hair removal, wrinkle reduction and scar and stretch mark treatment;

  our Vectus diode laser for high volume hair removal; and

 

  our MonaLisa Touch laser for the treatment of vaginal atrophy.health.

On September 5, 2014, we acquired substantially all of the assets of Ellman International, Inc., or Ellman, for $13.2 million in cash. In addition, we assumed certain of its contractual and current liabilities.

The Ellman acquisition complements our platform with RF energy sources and accessory products for aesthetic and surgical indications. Ellman’s product line encompasses multiple RF generators and single-use electrodes for aesthetic and multi-specialty surgical indications such as facial plastic and general surgery, gynecology, ear, nose and throat procedures, ophthalmology, oral and maxillofacial surgery, podiatry and proctology. Ellman’s proprietary high frequency, low-temperature RF technology is optimized for achieving surgical precision and controlled hemostasis. The main products which have been added to our portfolio as a result of the acquisition include:

 

  the Surgitron® radiowave platform technology line of RF surgical generators;

 

  the Pelleve® wrinkle reduction system for skin tightening and non-ablative skin rejuvenation; and

 

  the PelleFirm™ RF body treatment system for skin tightening and reduction in the appearance of cellulite.

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, light-based technologies and other energies 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.

We are developingSculpSure, a hyperthermic laser treatment for non-invasive lipolysis of the flanks and abdomen. SculpSure is designed to reduce fat non-invasively by disrupting subcutaneous fat cells. In May 2015, we received U.S. Food and Drug Administration, or FDA, clearance to marketSculpSure for non-invasive lipolysis of the flanks. In July 2015, we received an expanded FDA clearance to marketSculpSure for non-invasive lipolysis of the abdomen. We plan to introduceSculpSure through a U.S. direct sales force in the second half of 2015.

In November 2014, we signed an exclusive agreement with El.En. S.p.A., or El.En., to market and distribute in North America theMonaLisa Touch, a carbon dioxide laser for the treatment of vaginal atrophy,health, a condition that affects primarily postmenopausal women, breast cancer survivors and women who have undergone hysterectomies. We launched the product in the United States in the first quarter of 2015 through a specialty surgical sales force.2015.

In March 2013, we commenced commercialization of ourPicoSure® system, our picosecond laser technology platform for the treatment of tattoos and benign pigmented lesions. ThePicoSure system 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 ourMedLite® andRevLite™ products, which deliver pulses in billionths of a second. U.S. Food and Drug Administration, or FDA clearance to market thePicoSure laser was received in November 2012. In October 2013, we launched thePicoSure FOCUS Lens Array which microscopically concentrates thePicoSure laser pulse to a precise depth and exposes less than 10% of the skin to areas of high fluence while the surrounding skin is exposed to a low background fluence. We received marketing authorization for ourPicoSure system in Canada in July 2013, in Australia in November 2013, and in Korea and Taiwan in January 2014. In July 2014, we received FDA clearance to marketPicoSure for the treatment of acne scars. In September 2014, we received FDA clearance to marketPicoSure withPicoSure FOCUS Lens Arrayfor the treatment of wrinkles. In February 2015, we received FDA clearance to market the 532 nm wavelength forPicoSure designed to more effectively treat red, yellow and orange tattoo ink colors, which we offer as an upgrade to our currentPicoSure customer base. Subject to receiving FDA clearance, which we anticipate by the end of this year, we plan to introduce a third upgradable wavelength forPicoSure: a 1064 nm laser delivery system for skin rejuvenation with theFOCUS Lens Array.

Revenues

We generate revenues primarily from sales of our products and parts and accessories and from services, including product warranty revenues, and royalty payments received from our licensees. During the threesix months ended March 31,June 30, 2015, we derived approximately 75%79% of our revenues from sales of our products and 25%21% of our revenues from parts, accessories, service and royalty revenues. During the threesix months ended March 31,June 30, 2014, we derived approximately 80%81% of our revenues from sales of our products and 20%19% of our revenues from parts, accessories, service and royalty 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 recognize royalty revenues when we can reliably estimate such amounts and collectability is reasonably assured. As such, we recognize royalty revenues in the quarter reported to us by our licensees, which is generally one quarter following the quarter in which sales by our licensees occurred. Royalty revenues also include amounts due from settlements with licensees for back-owed royalties from prior periods. These settlement amounts are considered revenue, when collectability is reasonably assured, because they constitute our ongoing major or central operations.

In December 2013, we completed a comprehensive settlement agreement with Tria Beauty, Inc., or Tria, which ended the patent infringement litigation between Tria and Palomar Medical Technologies Inc., or Palomar. Under the agreement, we arewere entitled to receive $10.0 million plus future royalty payments. We will paypaid approximately $2.0 million of this revenue to Massachusetts General Hospital, or MGH, under an exclusive license agreement between Palomar and MGH, which will bewas recorded as cost of revenues within our consolidated statement of operations. We recognized the final $3.0 million of this revenue in the three months ended March 31, 2015, which is recorded as royalty revenues within our consolidated statement of operations.

We sell our products globally under the Cynosure, Palomar, ConBio and Ellman brand names through a direct sales force in the United States, Canada, Mexico, France, Morocco, Germany, Spain, the United Kingdom, Australia, China, Japan and Korea, and use distributors to sell our products in other countries where we do not have a direct presence. During the threesix months ended March 31,June 30, 2015 and 2014, we derived 43%41% and 53%52% of our total revenues, respectively, from sales outside North America. As of March 31,June 30, 2015, we had 110139 sales employees covering North America and 6465 sales employees in France, Morocco, Germany, Spain, the United Kingdom, Australia, China, Japan and Korea. We utilize a global distribution network covering approximately 120 countries.

The following table provides revenue data by geographical region for the threesix months ended March 31,June 30, 2015 and 2014:

 

  Percentage of Revenues   Percentage of Revenues 
  Three Months
Ended March 31,
   Six Months Ended
June 30,
 

Region

  2015 2014   2015 2014 

North America

   57 47   59 48

Europe

   14   20     13   19  

Asia/Pacific

   22   25     22   24  

Other

   7   8     6   9  
  

 

  

 

   

 

  

 

 

Total

 100 100   100 100
  

 

  

 

   

 

  

 

 

See Note 9 to our consolidated financial statements included in this Quarterly Report for revenues and asset data by geographic region.

Results of Operations

THREE MONTHS ENDED MARCH 31,JUNE 30, 2015 AND 2014

The following table contains selected statement of operations data, which serve as the basis of the discussion of our results of operations for the three months ended March 31,June 30, 2015 and 2014, respectively (in thousands, except for percentages):

 

   Three Months Ended March 31,       
   2015  2014       
   Amount  As a % of
Total
Revenues
  Amount  As a % of
Total
Revenues
  $
Change
  %
Change
 

Product revenues

  $56,502    75 $49,701    80 $6,801    14

Parts, accessories, service and royalty revenues

   18,410    25    12,303    20    6,107    50  
  

 

 

  

 

 

  

 

 

  

 

 

  

 

 

  

 

 

 

Total revenues

 74,912   100   62,004   100   12,908   21  

Cost of revenues

 32,139   43   26,609   43   5,530   21  
  

 

 

  

 

 

  

 

 

  

 

 

  

 

 

  

 

 

 

Gross profit

 42,773   57   35,395   57   7,378   21  

Operating expenses

Sales and marketing

 25,696   34   20,122   32   5,574   28  

Research and development

 5,958   8   5,574   9   384   7  

Amortization of intangible assets acquired

 736   1   713   1   23   3  

General and administrative

 8,330   11   7,640   13   690   9  
  

 

 

  

 

 

  

 

 

  

 

 

  

 

 

  

 

 

 

Total operating expenses

 40,720   54   34,049   55   6,671   20  
  

 

 

  

 

 

  

 

 

  

 

 

  

 

 

  

 

 

 

Income from operations

 2,053   3   1,346   2   707   53  

Interest expense, net

 (402 (1 (349 —    (53 (15

Other (expense) income, net

 (1,663 (2 66   —    (1,729 (2,620
  

 

 

  

 

 

  

 

 

  

 

 

  

 

 

  

 

 

 

(Loss) income before (benefit) provision for income taxes

 (12 —     1,063   2   (1,075 (101

(Benefit) provision for income taxes

 (4 —     374   1   (378 (101
  

 

 

  

 

 

  

 

 

  

 

 

  

 

 

  

 

 

 

Net (loss) income

$(8 —  $689   1$(697 (101)% 
  

 

 

  

 

 

  

 

 

  

 

 

  

 

 

  

 

 

 
   Three Months Ended
June 30,
  $
Change
   %
Change
 
  2015  2014    
  Amount   As a % of
Total
Revenues
  Amount   As a % of
Total
Revenues
    

Product revenues

  $69,429     83 $59,596     82 $9,833     16

Parts, accessories, service and royalty revenues

   14,265     17    12,977     18    1,288     10  
  

 

 

   

 

 

  

 

 

   

 

 

  

 

 

   

 

 

 

Total revenues

   83,694     100    72,573     100    11,121     15  

Cost of revenues

   36,338     43    31,880     44    4,458     14  
  

 

 

   

 

 

  

 

 

   

 

 

  

 

 

   

 

 

 

Gross profit

   47,356     57    40,693     56    6,663     16  

Operating expenses

          

Sales and marketing

   26,426     32    20,867     29    5,559     27  

   Three Months Ended
June 30,
  $
Change
  %
Change
 
  2015  2014   
  Amount  As a % of
Total
Revenues
  Amount  As a % of
Total
Revenues
   

Research and development

   5,251    6    4,999    7    252    5  

Amortization of intangible assets acquired

   736    1    713    1    23    3  

General and administrative

   7,302    9    7,716    10    (414  (5
  

 

 

  

 

 

  

 

 

  

 

 

  

 

 

  

 

 

 

Total operating expenses

   39,715    48    34,295    47    5,420    16  
  

 

 

  

 

 

  

 

 

  

 

 

  

 

 

  

 

 

 

Income from operations

   7,641    9    6,398    9    1,243    19  

Interest expense, net

   (430  (1  (343  —     (87  (25

Other income, net

   484    1    213    —     271    127  
  

 

 

  

 

 

  

 

 

  

 

 

  

 

 

  

 

 

 

Income before provision for income taxes

   7,695    9    6,268    9    1,427    23  

Provision for income taxes

   2,337    3    1,693    2    644    38  
  

 

 

  

 

 

  

 

 

  

 

 

  

 

 

  

 

 

 

Net Income

  $5,358    6 $4,575    7 $783    17
  

 

 

  

 

 

  

 

 

  

 

 

  

 

 

  

 

 

 

Revenues

Total revenues for the three months ended March 31,June 30, 2015 increased by $12.9$11.1 million, or 21%15%, to $74.9$83.7 million, as compared to revenues of $72.6 million for the three months ended March 31,June 30, 2014 revenues of $62.0 million (in thousands, except for percentages):

 

  Three Months Ended
March 31,
   $   %   Three Months Ended
June 30,
   $
Change
   %
Change
 
  2015   2014   Change   Change   2015   2014   

Product sales in North America

  $31,278    $21,609    $9,669     45  $40,727    $27,635    $13,092     47

Product sales outside North America

   25,224     28,092     (2,868   (10   28,702     31,961     (3,259   (10

Global parts, accessories, service and royalty sales

   18,410     12,303     6,107     50     14,265     12,977     1,288     10  
  

 

   

 

   

 

   

 

   

 

   

 

   

 

   

 

 

Total revenues

$74,912  $62,004  $12,908   21  $83,694    $72,573    $11,121     15
  

 

   

 

   

 

   

 

   

 

   

 

   

 

   

 

 

The increase in total revenues was attributable to a number of factors:

 

  Revenues from the sale of products in North America increased by approximately $9.7$13.1 million, or 45%47%, from the 2014 period primarily due to an increase in the number of units sold, including sales attributable to the launch ofMonaLisa Touch and the products acquired from Ellman in 2014 and the launch ofMonaLisa Touch..

 

Revenues from the sale of products outside of North America decreased by approximately $2.9$3.3 million, or 10%, from the 2014 period primarily due to unfavorable exchange rates impactingaffecting our European and Asia Pacific subsidiaries and units sold to our European and Middle Eastern distributors.

 

Revenues from the sale of parts, accessories, services and royalties increased by approximately $6.1$1.3 million, or 50%10%, from the 2014 period primarily due to the $3.0 million settlement received from Tria pursuant to our December 2013 patent license agreement and accessories revenues attributable to products acquired from Ellman.

Cost of Revenues

 

  Three Months Ended
March 31,
 $   %   Three Months Ended
June 30,
 $
Change
   %
Change
 
  2015 2014 Change   Change   2015 2014   

Cost of revenues (dollars in thousands)

  $32,139   $26,609   $5,530     21  $36,338   $31,880   $4,458     14

Cost of revenues (as a percentage of total revenues)

   43 43      43 44   

Total cost of revenues increased $5.5$4.5 million, or 21%14%, to $32.1$36.3 million for the 2015 period, as compared to $26.6$31.9 million in the 2014 period. The increase was primarily associated with our 21%15% increase in total revenues in the 2015 period compared to 2014.the 2014 period. Our total cost of revenues for the 2015 period decreased as a percentage of total revenues remained consistent foras compared to the 2015 and 2014 periods.period primarily due to a higher percentage of laser revenue from our North American distribution, where average selling prices tend to be higher.

Sales and Marketing

 

  Three Months Ended
March 31,
 $   %   Three Months Ended
June 30,
 $
Change
   %
Change
 
  2015 2014 Change   Change   2015 2014   

Sales and marketing (dollars in thousands)

  $25,696   $20,122   $5,574     28  $26,426   $20,867   $5,559     27

Sales and marketing (as a percentage of total revenues)

   34 32      32 29   

Sales and marketing expenses increased $5.6 million, or 28%27%, to $25.7$26.4 million for the 2015 period, as compared to $20.1$20.9 million in the 2014 period. The increase was primarily due to increases in the number of our sales employees as well asand an increase in commission expense due to increased product revenues. Our total sales and marketing expenses for the 2015 period increased as a percentage of total revenues as compared to the 2014 period due primarily to the additional costs of incorporating the acquired Ellman organization, as well as marketing costs associated withMonaLisa TouchSculpSure.

Research and Development

 

  Three Months Ended
March 31,
 $   %   Three Months Ended
June 30,
 $
Change
   %
Change
 
  2015 2014 Change   Change   2015 2014   

Research and development (dollars in thousands)

  $5,958   $5,574   $384     7  $5,251   $4,999   $252     5

Research and development (as a percentage of total revenues)

   8 9      6 7   

Research and development expenses increased $0.4$0.3 million, or 7%5%, to $6.0$5.3 million for the 2015 period, as compared to $5.6$5.0 million for the 2014 period. The increase was primarily due to the inclusion of Ellman’s research and development expenses of $0.6 million forwithin the 2015 period offset by a reduction in project materials expenses.period. Our total research and development expenses for the 2015 period decreased as a percentage of total revenues as compared to the 2014 period.period due to improved operating leverage.

Amortization of Intangible Assets Acquired

 

  Three Months Ended
March 31,
 $   %   Three Months Ended
June 30,
 $
Change
   %
Change
 
  2015 2014 Change   Change   2015 2014   

Amortization of intangible assets acquired (dollars in thousands)

  $736   $713   $23     3  $736   $713   $23     3

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

   1 1      1 1   

Amortization of intangible assets acquired increased $23,000, or 3%, for the 2015 period as compared to the 2014 period. The increase resulted from the addition of the identifiable intangible assets from the Ellman acquisition included in the 2015 period. Amortization of intangible assets acquired as a percentage of total revenues remained consistent for the 2015 and 2014 periods.

General and Administrative

 

  Three Months Ended
March 31,
 $   %   Three Months Ended
June 30,
 $
Change
   %
Change
 
  2015 2014 Change   Change   2015 2014   

General and administrative (dollars in thousands)

  $8,330   $7,640   $690     9  $7,302   $7,716   $(414   (5)% 

General and administrative (as a percentage of total revenues)

   11 13      9 10   

General and administrative expenses increased $0.7decreased $0.4 million, or 9%5%, to $8.3$7.3 million for the 2015 period, as compared to $7.6$7.7 million for the 2014 period. The decrease is primarily due to $1.8 million less in costs associated with acquisitions during the 2015 period as compared to the 2014 period, partially offset by increased headcount, legal expenses and Ellman administration expenses. Excluding acquisition costs, our total general and administrative expenses as a percentage of total revenues remained consistent for the 2015 and 2014 periods.

Interest Expense, net

   Three Months Ended
June 30,
   $
Change
   %
Change
 
   2015   2014     

Interest expense, net (dollars in thousands)

  $(430  $(343  $(87   (25)% 

The increase in interest expense, net was primarily due to interest charges on the license transfer agreement acquired in the 2014 Ellman acquisition, which are included in the 2015 period.

Other Income, net

   Three Months Ended
June 30,
   $
Change
   %
Change
 
   2015   2014     

Other income, net (dollars in thousands)

  $484    $213    $271     127

The change in other income, net was primarily a result of increased net foreign currency remeasurement gains in the 2015 period, compared to the 2014 period, primarily due to the weakening of the U.S. dollar against the euro, British pound, Korean won and Australian dollar.

Provision for Income Taxes

   Three Months Ended
June 30,
  $
Change
   %
Change
 
   2015  2014    

Provision for income taxes (dollars in thousands)

  $2,337   $1,693   $644     38

Provision as a percentage of income before provision for income taxes

   30  27   

The provision for income taxes results from a combination of the activities of our U.S. entities and foreign subsidiaries. In the three months ended June 30, 2015, we recorded an income tax provision of $2.3 million, representing an effective tax rate of 30%. The difference between the U.S. federal statutory tax rate and the effective tax rate was primarily attributable to a discrete tax benefit of $0.5 million for the release of the valuation allowance previously maintained against the net deferred tax assets of Palomar Japan KK. Other factors resulting in differences between the U.S. federal statutory tax rate and the effective tax rate are the jurisdictional mix of worldwide earnings, non-deductible expenses and the domestic manufacturing deduction. In the three months ended June 30, 2014, we recorded an income tax provision of $1.7 million, representing an effective tax rate of 27%. The difference between the U.S. federal statutory tax rate and the effective tax rate was primarily attributable to a discrete tax benefit of $0.3 million for the release of the valuation allowance previously maintained against the net deferred tax assets of Cynosure Spain S.L. Other factors resulting in differences between the U.S. federal statutory tax rate and the effective tax rate are the jurisdictional mix of worldwide earnings, non-deductible expenses and the domestic manufacturing deduction.

SIX MONTHS ENDED JUNE 30, 2015 AND 2014

The following table contains selected statement of operations data, which serves as the basis of the discussion of our results of operations for the six months ended June 30, 2015 and 2014, respectively (in thousands, except for percentages):

   Six Months Ended
June 30,
       
   2015  2014       
   Amount  As a % of
Total
Revenues
  Amount  As a % of
Total
Revenues
  $
Change
  %
Change
 

Product revenues

  $125,931    79 $109,297    81 $16,634    15

Parts, accessories, service and royalty revenues

   32,675    21    25,280    19    7,395    29  
  

 

 

  

 

 

  

 

 

  

 

 

  

 

 

  

 

 

 

Total revenues

   158,606    100    134,577    100    24,029    18  

Cost of revenues

   68,477    43    58,489    43    9,988    17  
  

 

 

  

 

 

  

 

 

  

 

 

  

 

 

  

 

 

 

Gross profit

   90,129    57    76,088    57    14,041    18  

Operating expenses

       

Sales and marketing

   52,122    33    40,989    30    11,133    27  

Research and development

   11,209    7    10,573    8    636    6  

Amortization of intangible assets acquired

   1,472    1    1,426    1    46    3  

General and administrative

   15,632    10    15,356    12    276    2  
  

 

 

  

 

 

  

 

 

  

 

 

  

 

 

  

 

 

 

Total operating expenses

   80,435    51    68,344    51    12,091    18  
  

 

 

  

 

 

  

 

 

  

 

 

  

 

 

  

 

 

 

Income from operations

   9,694    6    7,744    6    1,950    25  

Interest expense, net

   (832  —      (692  (1  (140  (20

Other (expense) income, net

   (1,179  (1  279    —     (1,458  (523
  

 

 

  

 

 

  

 

 

  

 

 

  

 

 

  

 

 

 

Income before provision for income taxes

   7,683    5    7,331    5    352    5  

Provision for income taxes

   2,333    2    2,067    1    266    13  
  

 

 

  

 

 

  

 

 

  

 

 

  

 

 

  

 

 

 

Net income

  $5,350    3 $5,264    4 $86    2
  

 

 

  

 

 

  

 

 

  

 

 

  

 

 

  

 

 

 

Revenues

Total revenues for the six months ended June 30, 2015 increased by $24.0 million, or 18%, to $158.6 million, as compared to revenues of $134.6 million for the six months ended June 30, 2014 (in thousands, except for percentages):

   Six Months Ended
June 30,
   $
Change
   %
Change
 
   2015   2014     

Product sales in North America

  $72,005    $49,244    $22,761     46

Product sales outside North America

   53,926     60,053     (6,127   (10

Global parts, accessories, service and royalty sales

   32,675     25,280     7,395     29  
  

 

 

   

 

 

   

 

 

   

 

 

 

Total revenues

  $158,606    $134,577    $24,029     18
  

 

 

   

 

 

   

 

 

   

 

 

 

The increase in total revenues was attributable to a number of factors:

Revenues from the sale of products in North America increased by approximately $22.8 million, or 46%, from the 2014 period primarily due to an increase in the number of units sold, including sales attributable to the launch ofMonaLisa Touch and the products acquired from Ellman in 2014.

Revenues from the sale of products outside of North America decreased by approximately $6.1 million, or 10%, from the 2014 period primarily due to unfavorable exchange rates affecting our European and Asia Pacific subsidiaries and units sold to our European and Middle Eastern distributors.

Revenues from the sale of parts, accessories, services and royalties increased by approximately $7.4 million, or 29%, from the 2014 period primarily due to accessories revenues attributable to products acquired from Ellman along with the $3.0 million settlement received from Tria during the 2015 period.

Cost of Revenues

   Six Months Ended
June 30,
  $
Change
   %
Change
 
   2015  2014    

Cost of revenues (dollars in thousands)

  $68,477   $58,489   $9,988     17

Cost of revenues (as a percentage of total revenues)

   43  43   

Total cost of revenues increased $10.0 million, or 17%, to $68.5 million for the 2015 period, as compared to $58.5 million in the 2014 period. The increase was primarily associated with our 18% increase in total revenues in the 2015 period compared to the 2014 period. Our total cost of revenues as a percentage of total revenues remained consistent for the 2015 and 2014 periods.

Sales and Marketing

   Six Months Ended
June 30,
  $
Change
   %
Change
 
   2015  2014    

Sales and marketing (dollars in thousands)

  $52,122   $40,989   $11,133     27

Sales and marketing (as a percentage of total revenues)

   33  30   

Sales and marketing expenses increased $11.1 million, or 27%, to $52.1 million for the 2015 period, as compared to $41.0 million in the 2014 period. The increase was primarily due to increases in the number of our sales employees and an increase in commission expense due to increased product revenues. Our total sales and marketing expenses for the 2015 period increased as a percentage of total revenues as compared to the 2014 period due primarily to the additional costs of incorporating the acquired Ellman organization, as well as marketing costs associated withMonaLisa Touch and SculpSure.

Research and Development

   Six Months Ended
June 30,
  $
Change
   %
Change
 
   2015  2014    

Research and development (dollars in thousands)

  $11,209   $10,573   $636     6

Research and development (as a percentage of total revenues)

   7  8   

Research and development expenses increased $0.6 million, or 6%, to $11.2 million for the 2015 period, as compared to $10.6 million for the 2014 period. The increase was primarily due to the inclusion of Ellman’s research and development expenses within the 2015 period along with an increase in professional services fees. Our total research and development expenses for the 2015 period decreased as a percentage of total revenues as compared to the 2014 period due to improved operating leverage.

Amortization of Intangible Assets Acquired

   Six Months Ended
June 30,
  $
Change
   %
Change
 
   2015  2014    

Amortization of intangible assets acquired (dollars in thousands)

  $1,472   $1,426   $46     3

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

   1  1   

Amortization of intangible assets acquired increased $46,000, or 3%, for the 2015 period as compared to the 2014 period. The increase resulted from the addition of the identifiable intangible assets from the Ellman acquisition included in the 2015 period. Amortization of intangible assets acquired as a percentage of total revenues remained consistent for the 2015 and 2014 periods.

General and Administrative

   Six Months Ended
June 30,
  $
Change
   %
Change
 
   2015  2014    

General and administrative (dollars in thousands)

  $15,632   $15,356   $276     2

General and administrative (as a percentage of total revenues)

   10  12   

General and administrative expenses increased $0.3 million, or 2%, to $15.6 million for the 2015 period, as compared to $15.4 million for the 2014 period. The increase is primarily due to increased headcount, legal expenses and Ellman administration expenses. These areexpenses, partially offset by $0.7$2.5 million less in severance and change in control costs associated with acquisitions during the 2015 period as compared to the 2014 period. Excluding acquisition costs, our total general and administrative expenses as a percentage of total revenues remained consistent for the 2015 and 2014 periods.

Interest Expense, net

 

   Three Months Ended
March 31,
   $   % 
   2015   2014   Change   Change 

Interest expense, net (dollars in thousands)

  $(402  $(349  $(53   (15)% 
   Six Months Ended
June 30,
   $
Change
   %
Change
 
   2015   2014     

Interest expense, net (dollars in thousands)

  $(832  $(692  $(140   (20)% 

The increase in interest expense, net was primarily due to interest charges on the license transfer agreement acquired in the 2014 Ellman acquisition, which are included in the 2015 period.

Other (Expense) Income, net

 

   Three Months Ended
March 31,
   $   % 
   2015   2014   Change   Change 

Other (expense) income, net (dollars in thousands)

  $(1,663  $66    $(1,729   (2,620)% 
   Six Months Ended
June 30,
   $
Change
   %
Change
 
   2015   2014     

Other (expense) income, net (dollars in thousands)

  $(1,179  $279    $(1,458   (523)% 

The change in other (expense) income, net was primarily a result of net foreign currency remeasurement losses in the 2015 period, as compared to net foreign currency remeasurement gains in the 2014 period, primarily due to the strengthening of the U.S. dollar against the euro, British pound, Japanese yen and Australian dollar.

(Benefit) Provision for Income Taxes

 

   Three Months Ended
March 31,
  $   % 
   2015  2014  Change   Change 

(Benefit) provision for income taxes (dollars in thousands)

  $(4 $374   $(378   (101)% 

Effective tax rate

   35  35   
   Six Months Ended
June 30,
  $
Change
   %
Change
 
   2015  2014    

Provision for income taxes (dollars in thousands)

  $2,333   $2,067   $266     13

Provision as a percentage of income before provision for income taxes

   30  28   

The benefitprovision for income taxes results from a combination of the activities of our U.S. entities and foreign subsidiaries. InDuring the first quarter ofsix months ended June 30, 2015, we recorded an income tax benefitprovision of $4,000,$2.3 million, representing an effective tax rate of 35%30%. The incomedifference between the U.S. federal statutory tax benefit forrate and the 2015 periodeffective tax rate was primarily attributable to applying our estimated annuala discrete tax benefit of $0.5 million for the release of the valuation allowance previously maintained against the net deferred tax assets of Palomar Japan KK. Other factors resulting in differences between the U.S. federal statutory tax rate and the effective tax rate to our year-to-dateare the jurisdictional mix of worldwide loss. Theearnings, non-deductible expenses and the domestic manufacturing deduction. During the six months ended June 30, 2014, we recorded an income tax provision forof $2.1 million, representing an effective tax rate of 28%. The difference between the 2014 periodU.S. federal statutory tax rate and the effective tax rate was primarily attributable to a discrete tax benefit of $0.3 million for the tax provision onrelease of the earnings of our foreign and domestic operations. We continue to maintain a valuation allowance onpreviously maintained against the net deferred tax assets of our subsidiariesCynosure Spain S.L. Other factors resulting in Mexico, Japan,differences between the U.S. federal statutory tax rate and Germany.the effective tax rate are the jurisdictional mix of worldwide earnings, non-deductible expenses and the domestic manufacturing deduction.

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 cash generated from our operations and proceeds from public offerings of our Class A common stock.

At March 31,June 30, 2015, our cash, cash equivalents and short and long-term marketable securities were $126.6$145.2 million. Our cash and cash equivalents of $71.9$93.1 million are highly liquid investments with maturities of 90 days or less at date of purchase and consist of cash in operating accounts and investments in money market funds. Our short-term marketable securities of $24.6$29.7 million consist of

investments in various state and municipal governments, U.S. government agencies and treasuries, all of which mature by March 15,June 1, 2016. Our long-term marketable securities of $30.1$22.4 million consist of investments in various state and municipal governments, U.S. government agencies and treasuries, all of which mature by MarchJune 1, 2017.

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 threesix months ended March 31,June 30, 2015, we purchased $2.8$4.0 million of property and equipment. During the threesix months ended March 31,June 30, 2014, we purchased $4.4$9.7 million of property and equipment, which included $2.9$5.8 million for the expansion and improvement of our corporate headquarters. During the threesix months ended March 31,June 30, 2015 and 2014, we transferred $2.1$3.3 million and $0.6$1.0 million, respectively, of demonstration equipment to fixed assets. We expect that our capital expenditures during the remainder of 2015 will decrease compared with the 2014 period, as we have completed the integration of Palomar and the expansion and improvement of our corporate headquarters.

On October 29, 2013, we announced that our board of directors authorized the repurchase of up to $25 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. On April 30, 2014, our board of directors approved an increase of $10 million to the stock repurchase program. The program will terminate upon the purchase of $35 million in common stock or expiration of the program on November 1, 2015. During the threesix months ended March 31,June 30, 2015, we did not repurchase any shares of our common stock under this program. As of March 31,June 30, 2015, approximately $4.1 million remains available to repurchase shares under the program. As of March 31,June 30, 2015, we have repurchased an aggregate of 1,395,480 shares under this program at an aggregate cost of $30.9 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 used in operating activities was $4.8$0.9 million for the threesix months ended March 31,June 30, 2015. This resulted primarily from net changes in working capital items decreasing cash from operating activities by approximately $12.2$23.6 million driven by increases in inventory, and accounts receivable and prepaid expenses and decreases in accrued expenses. This was partially offset by approximately $6.5$5.4 million in net income for the period and $13.2 million in depreciation, amortization and stock-based compensation expense.expense for the period. Net cash provided by investing activities was $0.2$1.0 million for the threesix months ended March 31,June 30, 2015, which consisted primarily of net proceeds from the sales and maturities of marketable securities of $13.2$22.4 million partially offset by purchases of marketable securities of $10.1$17.3 million and purchases of property and equipment of $2.8$4.0 million. Net cash provided by financing activities during the threesix months ended March 31,June 30, 2015 was $0.9$17.5 million, primarily relating to proceeds from stock option exercises.

Net cash used inprovided by operating activities was $0.9$3.9 million for the threesix months ended March 31, 2014. ThisJune 30, 2014, and resulted primarily from the net income for the period of $5.3 million and $11.8 million in depreciation and amortization and stock-based compensation expense for the period. Net changes in working capital items decreasingdecreased cash from operating activities by approximately $8.0$14.4 million primarily driven by increases in inventory and accounts receivable and decreases in accrued expenses. This was partially offset by approximately $6.1 million in depreciation, amortization, stock-based compensation and interest expense and by approximately $0.7 million in net income for the period. Net cash used in investing activities was $18.0$31.9 million for the threesix months ended March 31,June 30, 2014, which consisted primarily of purchases of marketable securities of $17.1$35.1 million and purchases of property and equipment of $4.4$9.7 million, partially offset by net proceeds from the sales and maturities of marketable securities of $3.6$12.9 million. Net cash provided by financing activities during the threesix months ended March 31,June 30, 2014 was $7.4$0.5 million, primarilyprincipally relating to proceeds fromof stock option exercises.exercises and the excess tax benefit from the exercise of stock options offset by repurchases of common stock.

Off-Balance Sheet Arrangements

Since inception, we have not engaged in any off-balance sheet financing activities.

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, 2014. 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, 2014. There have been no material changes to our critical accounting policies as of March 31,June 30, 2015.

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 MarchJune 1, 2017. 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, 2015 Future Maturities
in 2015
 Future Maturities
in 2016
 Future Maturities
in 2017
   June 30, 2015 Future Maturities
in 2015
 Future Maturities
in 2016
 Future Maturities
in 2017
 

Investments (at fair value)

  $54,658   $19,636   $30,048   $4,974    $52,122   $15,471   $27,426   $9,225  

Weighted average interest rate

   0.35 0.23 0.37 0.68   0.36 0.24 0.34 0.62

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 47%48% of our total international revenues during the threesix months ended March 31,June 30, 2015. Substantially all of the remaining 53%52% were sales in euros, British pounds, Moroccan dirham, Japanese yen, Chinese yuan, South Korean won and Australian dollars. 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 occur while the debt is outstanding which we recognize as unrealized gains and losses in our statements of operations. Upon settlement of these debts, we may record realized foreign exchange gains and losses in our statements of operations. 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 chief executive officer and chief financial officer (our principal executive and principal financial officers, respectively), evaluated the effectiveness of our disclosure controls and procedures as of March 31,June 30, 2015. 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 Securities and Exchange Commission’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,June 30, 2015, our chief executive officer and chief financial officer 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

We acquired substantially all of the assets of Ellman on September 5, 2014. We are in the process of integrating the acquired operations into our overall internal control over financial reporting process and have extended our oversight and monitoring processes that support our internal control over financial reporting to include the acquired operations. 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 firstsecond quarter of the year ending December 31, 2015 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

Telephone Consumer Protection Act Litigation

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 TCPA, in Massachusetts Superior Court in Middlesex County, captionedWeitzner 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 appealed this decision, and oral argument on the appeal was held in October 2013 before the Commonwealth of Massachusetts Appeals Court. In March 2014, the appeals court affirmed the lower court’s ruling, and in April 2014 the plaintiff filed a request for further appellate review by the Supreme Judicial Court. On May 6, 2014, the Supreme Judicial Court issued a Notice of Denial of Application for Further Appellate Review. No further appeals are possible in Massachusetts. 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, captionedWeitzner, 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 drafted a motion seeking reconsideration of the court’s judgment and vacation of the court’s order of dismissal. In April 2013, we drafted a response opposing the plaintiff’s motion. In August 2013, plaintiff filed its motion with the court, although the deadline had been April 2013. We filed a letter with the court objecting to this untimely motion and requesting sanctions. In February 2014, the court denied plaintiff’s motion and denied our request for sanctions. On March 6, 2014, plaintiff filed an appeal of the court’s judgment entered on March 5, 2013. On July 23, 2014, the Second Circuit notified the parties that it will not hear oral arguments and will decide the case based on the briefs.

Asclepion Laser Technologies GmbH, Italian Litigation

In October 2010, Palomar was served with an International Summons for a lawsuit filed in September 2010 by Asclepion Laser Technologies GmbH, or Asclepion, in the Court of Rome in Italy. In this suit, Asclepion asked the Italian court to declare that Asclepion’s MeDioStar and RubyStar products do not infringe either the Italian or German portions of EP 0 806 913 B1 or EP 1 230 900 B1, which are the first two issued European patents corresponding to U.S. Patent Nos. 5,595,568 and 5,735,844, which are exclusively licensed to Palomar by Massachusetts General Hospital, or MGH. We filed a request with the Italian Supreme Court challenging the international jurisdiction of the Italian courts for deciding infringement of the non-Italian parts of the European patents. A hearing was held in May 2013, and in a development contrary to settled Italian case law, the Italian Supreme Court ruled that the Italian courts have jurisdiction over the Italian as well as the German portions of the European patent. Asclepion has resumed its case before the Court of Rome. In March 2014, we, Palomar and MGH entered into a comprehensive settlement agreement with Asclepion which ended the patent disputes between the companies, including this patent dispute, which terminated on April 24, 2014, theAsclepion Laser Technologies GmbH, German Litigation described below, which terminated on March 21, 2014, and pending opposition proceedings before the European Patent Office. This settlement agreement includes a Non-exclusive Patent License Agreement under which Asclepion is granted a non-exclusive, worldwide, fully paid-up license to U.S. Patent Nos. 5,735,844 and 5,595,568 and foreign counterparts, for professional hair removal products and we and Palomar are granted a non-exclusive, worldwide, royalty-free license to certain Asclepion patents. As part of the agreement, Asclepion made two payments to us for the paid-up license. The first payment was made in March 2014 and the second payment was made in March 2015. MGH received 40% of the first and second payments from Asclepion, after deducting our related outside legal costs.

Asclepion Laser Technologies GmbH, German Litigation

In October 2010, prior to being served the International Summons for the above described lawsuit in Italy (seeAsclepion Laser Technologies GmbH, Italian Litigation), Palomar commenced an action for patent infringement against Asclepion in the District Court of Düsseldorf, Germany seeking both monetary damages and injunctive relief. The complaint alleged that Asclepion’s MeDioStar and RubyStar products infringe European Patent Number EP 0 806 913, which is the first issued European patent corresponding to U.S. Patent Nos. 5,595,568 and 5,735,844, which are exclusively licensed to Palomar by MGH. This proceeding was stayed by mutual agreement of the parties in January 2011 pending the outcome ofAsclepion Laser Technologies GmbH, Italian Litigation and a final decision in opposition proceedings rendered by the European Patent Office, in which Asclepion filed an intervention in December 2010. In March 2014, we, Palomar and MGH entered into a comprehensive settlement agreement with Asclepion which ended the patent disputes between the companies, including this patent dispute, which terminated on March 21, 2014, theAsclepion Laser Technologies GmbH, Italian Litigation described above, which terminated on April 24, 2014, and the pending opposition proceedings

before the European Patent Office. This settlement agreement includes a Non-exclusive Patent License Agreement under which Asclepion is granted a non-exclusive, worldwide, fully paid-up license to U.S. Patent Nos. 5,735,844 and 5,595,568 and foreign counterparts, for professional hair removal products and we and Palomar are granted a non-exclusive, worldwide, royalty-free license to certain Asclepion patents. As part of the agreement, Asclepion made two payments to us for the paid-up license. The first payment was made in March 2014 and the second payment was made in March 2015. MGH received 40% of the first and second payments from Asclepion, after deducting our related outside legal costs.

Cirrex Systems LLC

In May 2014, Cirrex Systems LLC, or Cirrex, commenced an action for alleged patent infringement against us in the U.S. District Court for the District of Delaware seeking both monetary damages and injunctive relief. The complaint alleges that our SideLaze800 and SideLaze3D fibers used with ourCellulaze™ laser workstation andPrecisionTx™ laser infringe U.S. Patent Nos. 5,953,477 and 6,144,791. Cirrex is seeking to enjoin us from manufacturing, using or selling these products in the United States if we are found to infringe the patents and to obtain compensatory damages, interest and other relief. On July 21, 2014, we answered the complaint, denying that our products infringe the asserted patents and asserting that the patents are invalid and unenforceable. In April 2015, we entered into a comprehensive settlement agreement with Cirrex for nominal consideration, which ended the patent dispute between the companies.

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 other 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 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, 2014. 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 15.13.

Risks Related to Our Business and Industry

We have incurred net losses in prior periods.

Although we were profitable in the second quarter of 2015 and in 2014 and 2012, we incurred losses in the first quarter of 2015 and in 2013, 2011 and 2010. 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, consumer confidence and other factors. For example, consumer demand for the procedures performed with our products, and practitioner demand for our products, decreased dramatically during 2009 as a result of turmoil in the financial markets, which contributed to a significant decrease in our total product revenues during that year. 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.

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;

 

our inability to quickly address and resolve reliability issues in our products and/or meet warranty and service obligations to our customers;

 

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, Lumenis, Syneron Medical, and ZELTIQ Aesthetics, as well as several smaller specialized private companies, such as Alma Lasers (acquired in May 2013 by Shanghai Fosun Pharmaceutical (Group) Ltd.). 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, reliability 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 face exposure to credit risk of customers.

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.

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. 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;

 

preserve goodwill and brand value with customers; 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 or meet customer expectations, 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.

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, 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 began to address the home-use aesthetic laser market in the second half of 2014. 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.

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 120 foreign countries, and we therefore are subject to risks associated with having international operations. We derived 45%41% of our product revenues from sales outside North America for the threesix months ended March 31,June 30, 2015. We derived 48%, 48%, and 49% of our product revenues from sales outside North America for the years ended December 31, 2014, 2013, and 2012, respectively.

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 120 foreign countries, approximately 47%48% of our revenues outside of North America for the threesix months ended March 31,June 30, 2015, and 47% of our revenues outside of North America for the year ended December 31, 2014, 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, Moroccan dirham, Japanese yen, Chinese yuan, South Korean won and Australian dollars. 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 U.S. dollar may have a material adverse effect on our results of operations and financial condition. For the threesix months ended March 31,June 30, 2015 we incurred a loss on foreign currency of $1.7$1.2 million, which is recorded as other expense (income)income (expense), net within our consolidated statement of operations. This was primarily due to the weakeningstrengthening of the U.S. dollar against the euro, British pound, Japanese yen and Australian dollar against the U.S. dollar. Unfavorable foreign exchange rates also had a negative impact on our European and Asia Pacific subsidiaries’ revenues for the threesix months ended March 31,June 30, 2015.

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 and risks associated with new technology. For example, ourPicoSure laser system, which we launched in 2013, was in development for several years. OurSculpSure laser system, which we plan to launch in the second half of 2015, has been in development for five 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 products, nor can we 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 chief executive officer, 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.

We may seek to acquire companies or technologies that could disrupt our ongoing business, divert the attention of our management and employees and adversely affect our results of operations.

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. We may not be able to identify suitable future acquisition candidates, consummate acquisitions on favorable terms or complete otherwise favorable acquisitions because of antitrust or other regulatory concerns. We cannot assure you that the acquisitions we have completed, including our September 2014 acquisition of substantially all of the assets of Ellman, 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.

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

Our Class A common stock price has fluctuated substantially in recent years. From January 1, 2012 through May 1,July 29, 2015, our Class A common stock has traded as high as $35.21$42.97 per share and as low as $11.64 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.

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, which could adversely affect our stock price. A decline in our stock price could result in the loss of all or a part of our stockholders’ investments.

Our common stock could be further diluted by the conversion of outstanding options and restricted stock units.

In the past, we have issued and still have outstanding convertible securities in the form of options and restricted stock units. We may continue to issue options, restricted stock units, and other equity rights as compensation for services and incentive compensation for our employees, directors and consultants or others who provide services to us. We have a substantial number of shares of common stock reserved for issuance upon the conversion and exercise of these securities. Such a conversion would dilute our stockholders and could adversely affect the market price of our common stock.

We may not be able to successfully collect licensing royalties.

Portions of our revenues consist of royalties from sub-licensing patents, including patents licensed to us on an exclusive basis by MGH. These patents expired in the United States on February 1, 2015 and their foreign counterparts will expire in several foreign jurisdictions on January 31, 2016. If we are unable to collect our licensing royalties, our revenues will decline. In addition, though we receive royalty revenues on other patents, our revenues will decline as a result of the expiration of the MGH patents because we will no longer receive any royalties from such patents.

We face risks associated with product warranties.

We could incur substantial costs as a result of product failures for which we are responsible under warranty obligations.

If we are unable to protect our information technology infrastructure against service interruptions, data corruption, cyber-based attacks or network security breaches, our reputation, business and operating results may suffer.

We rely on information technology networks and systems, including the Internet, to process and transmit sensitive electronic information and to manage or support a variety of business processes and activities, including procurement and supply chain, manufacturing, distribution, and invoicing and collection of payments for our products. We use enterprise information technology systems to record, process, and summarize financial information and results of operations for internal reporting purposes and to comply with regulatory financial reporting, legal, and tax requirements. Our information technology systems, some of which are

managed by third parties, are susceptible to damage, disruptions or shutdowns due to failures during the process of upgrading or replacing software, databases or components thereof, power outages, hardware failures, computer viruses, attacks by computer hackers, telecommunication failures, user errors or catastrophic events. If our information technology systems suffer severe damage, disruption or shutdown and we are unable to effectively resolve the issues in a timely manner, our reputation, business and operating results may suffer.

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 a single contract manufacturer in the United States for the subassembly of certain products that we manufacture and sell, and for the manufacturing of certain products that we sell, and to which a significant portion of our revenues are attributable to these products. We depend on El.En. for theSLT II laser system that we integrate with our own proprietary software and delivery systems into ourSmartLipo Triplex, Cellulaze systems andPrecisionTx. We also depend on El.En. for theMonaLisa Touch laser system (for further information regarding our distribution agreements with El.En. please see the discussion on page 19 of our Annual Report on Form 10-K for the year ended December 31, 2014). We use Alexandrite rods to manufacture the lasers for ourEliteandPicoSure products and Nd:YAG rods to manufacture the lasers for ourRevLite /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 ourRevLite /MedLite C6 product lines, for which we depend exclusively on Channel Islands Opto-Mechanical Engineering and JDS Uniphase Corporation, respectively. We offer ourSmartCool treatment cooling systems for use with our laser aesthetic treatment systems, and we depend exclusively on Zimmer Elektromedizin GmbH to supplySmartCool systems to us. In addition, one third party supplier assembles and tests many of the components and subassemblies for ourElite, Cynergy, SmoothShapes XVandAccolade product families. We use diode laser subassemblies from IPG Photonics to manufacture our Aspire® body sculpting system withSlimLipo handpiece, and we use diode laser bars from Coherent to manufacture ourVectus Laser. Although alternative suppliers exist for the diode laser subassemblies and diode laser bars, they could take months to qualify and implement.

Other than with El.En., we do not have long-term arrangements with any of our suppliers or our contract manufacturer 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, Zimmer Elektromedizin, IPG Photonics and Coherent are not required, and may not be able or willing, to meet our future requirements at current prices, or at all.

Under our agreements 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 distribution agreements, 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.

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 the United States, Canada, Mexico, France, Morocco, Germany, Spain, the United Kingdom, Australia, China, Japan and Korea, 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 launched in the United States in the second quarter of 2014, is 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 19% of our product revenue for the threesix months ended March 31,June 30, 2015. Sales of our aesthetic treatment systems by third party distributors represented 21%, 25% and 25% of our product revenue for the years ended December 31, 2014, 2013, and 2012, respectively.

We do not control our distributors or Unilever, and these parties may not be successful in marketing our products. These parties may 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 and a distribution and licensing agreement in place with

Unilever. We cannot be sure that our distributors or Unilever will agree with our interpretation of the terms of the agreements or that we will receive payments under the agreements. The third party distributors with which we do not have written distributor agreements may also disagree with the terms of our relationship. Our distributors and Unilever 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. If Unilever fails to successfully sell the home-use product or we fail to maintain our relationship with Unilever, this could have an adverse effect on our business, results of operations and financial condition.

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. Under exclusive distribution agreements with El.En., we purchase from El.En. its proprietarySmartLipo MPX system and itsSLT II laser system. TheSLT II laser system is an essential component of ourSmartLipo Triplex andCellulaze systems, which also incorporate our proprietary software and delivery systems. We also depend on El.En. for theMonaLisa Touch laser system (for further information regarding our distribution agreements with El.En. please see the discussion on page 19 of our Annual Report on Form 10-K for the year ended December 31, 2014).

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 agreements with El.En. do not prevent El.En. from competing with us by selling products that we purchased in the past from El.En., including earlier generationSmartLipo systems. In the event that the applicable agreement terminates, El.En. would be able to compete with us worldwide with theSmartLipo MPX system, with products containing theSLT II laser system and with theMonaLisa Touch product line. Our business could be materially and adversely affected by increased competition from El.En.

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 our stockholders might otherwise receive a premium for their 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.

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, inter partes or post-grant review 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. 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 FDA 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 often takes from three to 12 months. The FDA may require us to withdraw an application if they cannot make a determination that the

device is substantially equivalent according to the regulations. In such situations, we may re-submit the 510(k) application with additional data for reconsideration or we may determine not to commercialize the device or the new indication for use. 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.

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;
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 other regulators, 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. We may also be subject to various state or other regulations.

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 had 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.

In addition, most of the products and systems that we sell became subject in 2013 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.

The Patient Protection and Affordable Care Act includes reporting and disclosure requirements, commonly referred to as the “Sunshine Act”, for manufacturers of drugs, biological, medical devices and medical supplies with regard to payments or other transfers of value made to certain physicians and teaching hospitals. The final rules implementing the Sunshine Act are complex, ambiguous, and broad in scope. Sales related to the Ellman surgical product line are subject to the reporting requirements under the Sunshine Act. We believe that sales related to our aesthetic product lines fall under a reporting exception under this law and, accordingly, reporting related to those sales is not required.

Our compliance with applicable legal and regulatory requirements is, and will continue to 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. If we are found to be in violation of any of this or any other law, we may be subject to penalties, including fines.

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 Quality Systems Regulation, or the 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 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. 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.

Risks Related to Litigation

Product liability and business 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 significant damage to the eyes, skin or other tissue. If our products fail to function properly, we may be required to conduct product recalls and our customers may lose the ability to treat their patients or clients resulting in a loss of business for our customers. We are routinely involved in claims related to the use of our products. Product liability and business 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 apply or 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 or other 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 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.

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 appealed this decision and oral argument on the appeal was heard in October 2013 before the Commonwealth of Massachusetts Appeals Court. In March 2014, the appeals court affirmed the lower court’s ruling, and in April 2014 plaintiff filed a request for further appellate review by the Supreme Judicial Court. On May 6, 2014, the Supreme Judicial Court issued a Notice of Denial of Application for Further Appellate Review. No further appeals are possible in Massachusetts. 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 drafted a motion seeking reconsideration of the court’s judgment and vacation of the court’s order of dismissal. In April 2013, we drafted a response opposing the plaintiff’s motion. On August 14, 2013, plaintiff filed its motion with the court, although the deadline had been April 26, 2013. We filed a letter with the court objecting to this untimely motion and requesting sanctions. On February 6, 2014, the court denied plaintiff’s motion and denied our request for sanctions. On March 6, 2014, plaintiff filed an appeal of the court’s judgment entered on March 5, 2013. On July 23, 2014, the Second Circuit notified the parties that it will not hear oral arguments and will decide the case based on the briefs.

We are vigorously defending these lawsuits.this lawsuit. 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.

TheseThis 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.

Employment related lawsuits could be brought against us for improper termination of employment, sexual harassment, hostile work environment and other claims. These lawsuits could be expensive and time consuming and result in substantial damages to us and increases in our insurance rates.

If we terminate employment for improper reasons or fail to provide an appropriate work environment or it is alleged that we did so, we may become subject to substantial and costly litigation by our former and current employees. We are routinely involved in claims related to improper termination and other claims. Such 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 apply or 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 employment related claims brought against us, with or without merit, could increase our employment law 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 losses in excess of our insurance coverage out of cash reserves, harming our financial condition and adversely affecting our operating results.

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

On October 29, 2013, we announced that our board of directors authorized the repurchase of up to $25 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. On April 30, 2014, our board of directors approved an increase of $10 million to the stock repurchase program. The program will terminate upon the purchase of $35 million in common stock or expiration of the program on November 1, 2015. During the three months ended March 31,June 30, 2015, we did not repurchase any shares of our common stock under this program. As of March 31,June 30, 2015, approximately $4.1 million remains available to repurchase shares under the program. As of March 31,June 30, 2015, we have repurchased an aggregate of 1,395,480 shares under this program at an aggregate cost of $30.9 million.

 

Item 6.Exhibits

 

Exhibit

No.

  

Description

  10.1  Sixth Amendment to the Lease, dated April 16, 2015, between the Company and Glenborough Westford Center, LLC (incorporated by reference to Exhibit 10.1 to the Company’s Quarterly Report on Form 10-Q filed May 7, 2015)
  31.1  Certification of the Principal Executive Officer pursuant to Rule 13a-14(a) or Rule 15d-14(a) of the Securities Exchange Act of 1934, as amended
  31.2  Certification of the Principal Financial Officer pursuant to Rule 13a-14(a) or Rule 15d-14(a) of the Securities Exchange Act of 1934, as amended
  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,June 30, 2015, formatted in XBRL (eXtensible Business Reporting Language): (i) Consolidated Statements of Operations for the three and six months ended March 31,June 30, 2015 and 2014, (ii) Consolidated Balance Sheets at March 31,June 30, 2015 and December 31, 2014, (iii) Consolidated Statements of Comprehensive (Loss) Income for the three and six months ended March 31,June 30, 2015 and 2014, (iv) Consolidated Statements of Cash Flows for the threesix months ended March 31,June 30, 2015 and 2014, and (v) Notes to Consolidated Financial Statements.

Signatures

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

 

 

Cynosure, Inc.

(Registrant)

Date: May 7,August 5, 2015  By: 

/Ss/    MICHAEL R. DAVIN        

   Michael R. Davin
   Chairman and Chief Executive Officer
Date: May 7,August 5, 2015  By: 

/Ss/     TIMOTHY W. BAKER        

   Timothy W. Baker
   President, Chief Operating Officer and Chief Financial Officer

EXHIBIT INDEX

 

Exhibit

No.

  

Description

  10.1  Sixth Amendment to the Lease, dated April 16, 2015, between the Company and Glenborough Westford Center, LLC (incorporated by reference to Exhibit 10.1 to the Company’s Quarterly Report on Form 10-Q filed May 7, 2015)
  31.1  

Certification of the Principal Executive Officer pursuant to Rule 13a-14(a) or Rule 15d-14(a) of the Securities Exchange Act of 1934, as amended

  31.2  Certification of the Principal Financial Officer pursuant to Rule 13a-14(a) or Rule 15d-14(a) of the Securities Exchange Act of 1934, as amended
  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,June 30, 2015, formatted in XBRL (eXtensible Business Reporting Language): (i) Consolidated Statements of Operations for the three and six months ended March 31,June 30, 2015 and 2014, (ii) Consolidated Balance Sheets at March 31,June 30, 2015 and December 31, 2014, (iii) Consolidated Statements of Comprehensive (Loss) Income for the three and six months ended March 31,June 30, 2015 and 2014, (iv) Consolidated Statements of Cash Flows for the threesix months ended March 31,June 30, 2015 and 2014, and (v) Notes to Consolidated Financial Statements.

 

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