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8-K - FORM 8-K - CYNOSURE INCd868812d8k.htm

Exhibit 99.1

 

LOGO

 

Contact:   
Timothy Baker    Scott Solomon
President and Chief Financial Officer    Vice President
Cynosure, Inc.    Sharon Merrill Associates
(978) 256-4200    (617) 542-5300
TBaker@cynosure.com    CYNO@investorrelations.com

Cynosure Reports Record Quarterly Revenue of $86.3 Million for the Fourth Quarter of 2014

Westford, MA – February 10, 2015 – Cynosure, Inc. (Nasdaq: CYNO), which designs, manufactures and markets medical devices for aesthetic procedures and precision surgical applications worldwide, today reported financial results for the three and 12 months ended December 31, 2014.

Financial Highlights

 

    Q4 revenue up 16 percent year-over-year to $86.3 million

 

    Q4 GAAP net income of $23.0 million, or $1.05 per diluted share, reflecting the release of income tax valuation allowance

 

    Q4 non-GAAP net income of $7.9 million, or $0.36 per diluted share, excluding the release of income tax valuation allowance, acquisition costs and amortization expenses

 

    Q4 cash from operations of $22.2 million; $133.4 million in cash and investments at December 31, 2014

 

    Full-year 2014 revenue of $292.4 million, up 29 percent

“We capped an outstanding year in 2014 with a solid fourth quarter, driven by record revenues and continued profitability,” said Cynosure Chairman and Chief Executive Officer Michael Davin. “Equally important, we continue to generate strong operating cash flow and strengthen our balance sheet, while at the same time stepping up R&D and marketing investments as we focus on accelerating the pace at which our products are coming to market.”


“For example, we recently submitted, two months ahead of our original schedule, the 510(k) premarket notification to the U.S. Food and Drug Administration for our newest flagship technology, a 1060 nm laser for the non-invasive reduction of fat, with a goal of introducing the product in the second half of 2015,” Davin said. “We have expanded our engineering team and are investing in other product development initiatives. To address growing demand and new markets, we continue to broaden our distribution network, entering 2015 with the largest North American direct field sales force in the Company’s history. To serve physicians in the women’s health market, we are adding a 13-person specialty sales force to market MonaLisa Touch™ in North America.”

Management’s Comments on 2014

“Demand for our flagship picosecond laser, PicoSure®, remains a key driver of our North American laser business, which was up 29 percent in the fourth quarter of 2014 from the fourth quarter of 2013,” Davin said. “PicoSure has become the gold standard for tattoo removal and benign pigmented lesions since its U.S. introduction less than two years ago. Over the past two quarters we have seen increasing orders for PicoSure’s disposable FOCUS lens array, spurred by recent regulatory clearances for the treatment of wrinkles and acne scarring. We expect to introduce a 532 nm wavelength laser delivery system for PicoSure at the annual meeting of the American Academy of Dermatology in March which will be upgradable to the installed base. We also expect to introduce a third wavelength delivery system for PicoSure in the second half of the year. Internationally, our Asian subsidiaries and third-party distributors contributed to our top-line growth in the quarter, partly reflecting the addition of the new radiofrequency surgical assets we acquired from Ellman International in the third quarter.”

“The Ellman transaction is just one of several major accomplishments for Cynosure in 2014, a year of growth, expansion and diversification,” Davin said. “We completed the integration of Palomar Medical Technologies, an acquisition that helped us become one of the world’s premier energy-based aesthetic companies. We secured new international regulatory clearances for certain of our products, including PicoSure and Smartlipo Triplex. We introduced MonaLisa Touch, a carbon dioxide (CO2) laser for the treatment of vaginal atrophy, a condition that affects primarily postmenopausal women, breast cancer survivors and women who have undergone hysterectomies. In addition, we demonstrated continued scientific leadership with 35 clinical research presentations at the American Society for Laser Medicine and Surgery Annual Conference.”


Results for the Three Months Ended December 31, 2014

Total revenues for the fourth quarter of 2014 were $86.3 million, an increase of 16 percent compared with $74.5 million for the fourth quarter of 2013.

Net income for the fourth quarter of 2014 was $23.0 million, or $1.05 per diluted share, compared with net income of $7.3 million, or $0.33 per diluted share, for the fourth quarter of 2013. Net income for the fourth quarter of 2014 included an income tax benefit of $19.6 million, or $0.89 per diluted share, resulting from the release of the income tax valuation allowance relating to net deferred tax assets.

On a non-GAAP basis, excluding the income tax benefit relating to the release of the income tax valuation allowance, acquisition costs and amortization, fourth-quarter 2014 net income was $7.9 million, or $0.36 per diluted share, compared with non-GAAP net income of $9.2 million, or $0.41 per diluted share, in the same period of 2013.

Cynosure had $133.4 million in cash and investments at December 31, 2014, compared with $113 million at the end of the third quarter of 2014 and $129 million at year-end 2013.

Recent Highlights

 

    Submission of 510(k) for Non-Invasive Fat Reduction: Cynosure has submitted to the U.S. Food and Drug Administration a 510(k) application to market its newest flagship product, a 1060 nm laser for the non-invasive reduction of fat. The application is supported by clinical data from approximately 100 patients treated with the device at two U.S. sites.

 

    Exclusive Agreement to Market MonaLisa Touch: Cynosure signed an exclusive agreement with El.En. S.p.A. to market and distribute in North America the MonaLisa Touch, a carbon dioxide (CO2) laser for the treatment of vaginal atrophy, a condition that affects primarily postmenopausal women, breast cancer survivors and women who have undergone hysterectomies. Cynosure launched the MonaLisa Touch in January.

 

    Favorable Clinical Data: A multi-center trial showed a statistically significant improvement in the vaginal health of women treated with the MonaLisa Touch. The multi-center trial assessed the use of CO2 fractional laser therapy on 30 women with menopause-related symptoms such as dryness, pain, itching, painful urination and painful intercourse. Preliminary trial data was presented in December at the 2014 Pelvic Anatomy and Gynecologic Surgery Symposium.


Business Outlook

“We achieved 29 percent revenue growth and solid profitability in 2014 by successfully executing on our strategy of organic growth, complementary acquisitions and prudent balance sheet management,” Davin said. “Today, we are financially and operationally stronger than at any point in our history. With the rollout of MonaLisa Touch and the planned introduction of our new non-invasive technology for fat removal in the second half of this year, we believe we are well positioned for momentum in 2015 and beyond.”

Fourth-Quarter Financial Results Conference Call

In conjunction with the announcement of its fourth-quarter and year-end 2014 financial results, Cynosure will host a conference call for investors and analysts at 9:00 a.m. ET today. On the call, Chairman and CEO Michael Davin and Timothy Baker, the Company’s President and Chief Financial Officer, will discuss Cynosure’s financial results and provide a business overview. Those who wish to listen to the conference call webcast should visit the “Investors” section of the Company’s website at www.cynosure.com. The live call can also be accessed by dialing (877) 709-8155 or (201) 689-8881. If you are unable to listen to the live call, the webcast will be archived for one year on the Company’s website.

About Cynosure, Inc.

Cynosure develops, manufactures, and markets 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. Cynosure also markets radiofrequency 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. Cynosure’s 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 radiofrequency technology. Cynosure sells its products globally under the Cynosure, Palomar, ConBio and Ellman brand names through a direct sales force in the United States, Canada, Mexico, France, Germany, Spain, the United Kingdom, Australia, China, Japan and Korea, and through international distributors in approximately 120 other countries. For corporate or product information, visit Cynosure’s website at www.cynosure.com.


Forward-Looking Statements

Any statements in this press release about future expectations, plans and prospects for Cynosure, Inc., including Cynosure’s expectations with respect to timing of product launches, as well as other statements containing the words “believes,” “anticipates,” “plans,” “expects,” “will” and similar expressions, constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including the market price of Cynosure’s stock prevailing from time to time, the nature of other investment opportunities presented to the Company from time to time, the Company’s cash flows from operations, levels of demand for procedures performed with Cynosure products and for Cynosure products themselves, competition in the aesthetic laser industry, general business and economic conditions, effects of acquisitions that Cynosure has made or may make, Cynosure’s ability to develop and commercialize new products, Cynosure’s reliance on sole source suppliers, the inability to accurately predict the timing or outcome of regulatory decisions, and economic, market, technological and other factors discussed in Cynosure’s most recent Annual Report on Form 10-K and subsequently filed Quarterly Reports on Form 10-Q for the first, second and third quarters of 2014, which are filed with the Securities and Exchange Commission. In addition, the forward-looking statements included in this press release represent Cynosure’s views as of the date of this press release. Cynosure anticipates that subsequent events and developments will cause its views to change. However, although Cynosure may elect to update these forward-looking statements at some point in the future, it specifically disclaims any obligation to do so. These forward-looking statements should not be relied upon as representing Cynosure’s views as of any date subsequent to the date of this press release.


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Consolidated Statements of Income (Unaudited)

 

(In thousands, except per share data)

 

     Three Months Ended December 31,     Twelve Months Ended December 31,  
     2014     2013     2014     2013  

Revenues

   $ 86,262      $ 74,537      $ 292,369      $ 226,010   

Cost of revenues

     37,410        29,865        127,131        95,730   
  

 

 

   

 

 

   

 

 

   

 

 

 

Gross profit

     48,852        44,672        165,238        130,280   

Operating expenses

        

Selling and marketing

     25,854        20,149        88,564        64,347   

Research and development

     5,714        5,123        22,033        17,473   

Amortization of intangible assets acquired

     795        1,166        2,961        2,114   

General and administrative

     8,223        9,984        30,420        52,173   
  

 

 

   

 

 

   

 

 

   

 

 

 

Total operating expenses

     40,586        36,422        143,978        136,107   

Income (loss) from operations

     8,266        8,250        21,260        (5,827
  

 

 

   

 

 

   

 

 

   

 

 

 

Interest (expense) income, net

     (412     (103     (1,446     (23

Other (expense) income, net

     (928     (5     (1,476     313   
  

 

 

   

 

 

   

 

 

   

 

 

 

Income (loss) before income taxes

     6,926        8,142        18,338        (5,537

Income tax (benefit) provision

     (16,074     793        (13,000     (3,890
  

 

 

   

 

 

   

 

 

   

 

 

 

Net income (loss)

   $ 23,000      $ 7,349      $ 31,338      $ (1,647
  

 

 

   

 

 

   

 

 

   

 

 

 

Diluted net income (loss) per share

   $ 1.05      $ 0.33      $ 1.41      $ (0.09
  

 

 

   

 

 

   

 

 

   

 

 

 

Diluted weighted average shares outstanding

     21,938        22,565        22,195        19,325   
  

 

 

   

 

 

   

 

 

   

 

 

 

Basic net income (loss) per share

   $ 1.06      $ 0.33      $ 1.44      $ (0.09
  

 

 

   

 

 

   

 

 

   

 

 

 

Basic weighted average shares outstanding

     21,599        22,052        21,824        19,325   
  

 

 

   

 

 

   

 

 

   

 

 

 


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Condensed Consolidated Balance Sheet

 

(In thousands)

 

     December 31,
2014
     December 31,
2013
 
     (Unaudited)         

Assets:

     

Cash, cash equivalents and marketable securities

   $ 75,131       $ 93,655   

Short-term investments and related financial instruments

     32,055         26,633   

Accounts receivable, net

     42,524         36,587   

Inventories

     59,318         50,251   

Deferred tax asset, current portion

     17,228         9,341   

Prepaid expenses and other current assets

     9,629         6,891   
  

 

 

    

 

 

 

Total current assets

     235,885         223,358   

Property and equipment, net

     34,256         26,445   

Long-term marketable securities

     26,189         8,804   

Goodwill and intangibles, net

     159,347         154,416   

Other noncurrent assets

     2,047         1,678   
  

 

 

    

 

 

 

Total assets

   $ 457,724       $ 414,701   
  

 

 

    

 

 

 

Liabilities and stockholders’ equity:

     

Accounts payable and accrued expenses

   $ 63,282       $ 50,939   

Amounts due to related parties

     —           1,268   

Deferred revenue

     10,971         9,163   

Capital lease obligations

     137         286   
  

 

 

    

 

 

 

Total current liabilities

     74,390         61,656   

Capital lease obligations, net of current portion

     16,088         14,957   

Deferred revenue, net of current portion

     809         1,010   

Other long-term liabilities

     8,325         8,726   

Total stockholders’ equity

     358,112         328,352   
  

 

 

    

 

 

 

Total liabilities and stockholders’ equity

   $ 457,724       $ 414,701   
  

 

 

    

 

 

 


LOGO

 

To supplement our consolidated financial statements presented in accordance with GAAP, Cynosure uses non-GAAP gross profit, non-GAAP income from operations, non-GAAP net income and non-GAAP diluted net income per share. The presentation of this financial information is not intended to be considered in isolation or as a substitute for the financial information prepared and presented in accordance with GAAP. The non-GAAP financial measures included in this press release exclude costs associated with the acquisitions and amortization of intangible assets acquired, as well as unrealized foreign exchange gains or losses for the three and twelve months ended December 31, 2014 and 2013. This exclusion may be different from, and therefore not comparable to, similar measures used by other companies.

Cynosure’s management believes that the non-GAAP financial measures provide meaningful supplemental information regarding our performance by excluding the acquisition-related costs, amortization and foreign exchange costs that may not be indicative of our core business operating results. Cynosure believes that both management and investors benefit from referring to the non-GAAP financial measures in assessing Cynosure’s performance and when planning, forecasting and analyzing future periods. The non-GAAP financial measures also facilitate management’s internal comparisons to Cynosure’s historical performance and our competitors’ operating results. Cynosure believes that the non-GAAP measures are useful to investors in allowing for greater transparency with respect to supplemental information used by management in our financial and operational decision making.

Reconciliation of GAAP Income Statement Measures to Non-GAAP Income Statement Measures (Unaudited)

 

(In thousands, except per share data)

 

     Three Months Ended December 31,     Twelve Months Ended December 31,  
     2014     2013     2014     2013  

Gross profit

   $ 48,852      $ 44,672      $ 165,238      $ 130,280   
  

 

 

   

 

 

   

 

 

   

 

 

 

Non-GAAP adjustments to gross profit:

        

Costs associated with acquisitions and amortization

     1,731        150        5,975        3,604   
  

 

 

   

 

 

   

 

 

   

 

 

 

Total Non-GAAP adjustments to gross profit

     1,731        150        5,975        3,604   
  

 

 

   

 

 

   

 

 

   

 

 

 

Non-GAAP Gross profit dollars

   $ 50,583      $ 44,822      $ 171,213      $ 133,884   
  

 

 

   

 

 

   

 

 

   

 

 

 

Non-GAAP Gross profit percentage

     58.6     60.1     58.6     59.2
     Three Months Ended December 31,     Twelve Months Ended December 31,  
     2014     2013     2014     2013  

Income (loss) from operations

   $ 8,266      $ 8,250      $ 21,260      $ (5,827
  

 

 

   

 

 

   

 

 

   

 

 

 

Non-GAAP adjustments to income (loss) from operations:

        

Costs associated with acquisitions and amortization

     3,364        4,995        13,682        38,070   
  

 

 

   

 

 

   

 

 

   

 

 

 

Total Non-GAAP adjustments to income (loss) from operations

     3,364        4,995        13,682        38,070   
  

 

 

   

 

 

   

 

 

   

 

 

 

Non-GAAP Income from operations

   $ 11,630      $ 13,245      $ 34,942      $ 32,243   
  

 

 

   

 

 

   

 

 

   

 

 

 
     Three Months Ended December 31,     Twelve Months Ended December 31,  
     2014     2013     2014     2013  

Net income (loss)

   $ 23,000      $ 7,349      $ 31,338      $ (1,647
  

 

 

   

 

 

   

 

 

   

 

 

 

Non-GAAP adjustments to net income (loss):

        

Costs associated with acquisitions and amortization

     3,364        4,995        13,682        38,070   

Unrealized foreign exchange loss (gain)

     941        (15     1,552        (334

Income tax effect of non-GAAP adjustments

     (19,443     (3,144     (22,083     (13,550
  

 

 

   

 

 

   

 

 

   

 

 

 

Total Non-GAAP adjustments to net income (loss)

     (15,138     1,836        (6,849     24,186   
  

 

 

   

 

 

   

 

 

   

 

 

 

Non-GAAP net income

   $ 7,862      $ 9,185      $ 24,489      $ 22,539   
  

 

 

   

 

 

   

 

 

   

 

 

 
     Three Months Ended December 31,     Twelve Months Ended December 31,  
     2014     2013     2014     2013  

Diluted net income (loss) per share

   $ 1.05      $ 0.33      $ 1.41      $ (0.09
  

 

 

   

 

 

   

 

 

   

 

 

 

Costs associated with acquisitions and amortization

     0.15        0.22        0.62        1.91   

Unrealized foreign exchange loss (gain)

     0.04        (0.00     0.07        (0.02

Income tax effect of Non-GAAP adjustments

     (0.88     (0.14     (1.00     (0.67
  

 

 

   

 

 

   

 

 

   

 

 

 

Total Non-GAAP adjustments to net income (loss)

     (0.69     0.08        (0.31     1.22   

Non-GAAP diluted net income per share

   $ 0.36      $ 0.41      $ 1.10      $ 1.13   
  

 

 

   

 

 

   

 

 

   

 

 

 

Weighted average shares used to compute GAAP diluted net income (loss) per share

     21,938        22,565        22,195        19,325   
  

 

 

   

 

 

   

 

 

   

 

 

 

Weighted average shares used to compute Non-GAAP diluted net income per share

     21,938        22,565        22,195        19,884