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Tuesday, 02/10/2015 9:37:13 AM

Tuesday, February 10, 2015 9:37:13 AM

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Cynosure Reports Record Quarterly Revenue of $86.3 Million for the Fourth Quarter of 2014
1 hours 35 minutes ago - DJNF
WESTFORD, Mass., Feb. 10, 2015 /PRNewswire/ -- 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(TM) in North America."

Management's Comments on 2014

"Demand for our flagship picosecond laser, PicoSure(R) , 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 multicenter 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

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February 10, 2015 08:00 ET (13:00 GMT)