SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-K Annual Report pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 For the fiscal year ended July 1, 2000 Commission file number 0-14742 CANDELA CORPORATION (Exact name of registrant as specified in its charter) DELAWARE 04-2477008 (State or other jurisdiction of (I.R.S. Employer incorporation or organization) Identification No.) 530 Boston Post Road, Wayland, Massachusetts 01778 (Address of principal executive offices) (Zip Code) Registrant's telephone number, including area code: (508) 358-7400 Securities registered pursuant to Section 12(b) of the Act: None Securities registered pursuant to Section 12(g) of the Act: Common Stock, $.01 par value Common Stock Purchase Warrants (Title of Class) Indicate by a check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports) and (2) has been subject to such filing requirements for the past 90 days. Yes [ X ] No [ ] Indicate by a check mark if the disclosure of delinquent filers, pursuant to Item 405 of Regulation S-K, is not contained herein and will not be contained in the definitive proxy or information statements incorporated by reference in Part III of this Form 10-K or any amendment to this Form 10-K. [ ] As of September 22, 2000, 11,435,788 shares of the registrant's Common Stock, $.01 par value, were issued and outstanding. The aggregate market value of the registrant's voting stock, held by non-affiliates of the registrant as of September 22, 2000, based upon the closing price of such stock on The NASDAQ Stock Market on that date, was approximately $118,561,230. DOCUMENTS INCORPORATED BY REFERENCE The registrant intends to file a Definitive Proxy Statement pursuant to Regulation 14A within 120 days of the end of the fiscal year ended July 1, 2000. Portions of such Proxy Statement are incorporated by reference in Part III of this report. PART I ITEM 1. BUSINESS Candela Corporation is a pioneer in the development and commercialization of advanced aesthetic laser systems that allow physicians and personal care practitioners to treat a wide variety of cosmetic and medical conditions including: - vascular lesion treatment of facial spider veins, leg veins, rosacea, scars, stretch marks, warts, port wine stains and hemangiomas - hair removal - removal of benign pigmented lesions such as age spots and tattoos - microdermabrasion for skin exfoliation Since our founding 30 years ago, we have continuously developed and enhanced applications of laser technology. In the mid-1980's we began developing laser technology for medical applications, and since that time have shipped approximately 4,000 lasers to 50 countries. Since the early 1990's we have focused our organizational resources on developing laser technology for use solely in the aesthetic and cosmetic laser industry. Our introduction of new dermatology/plastic surgery laser systems during the mid-1990's allowed us to expand rapidly in this area. Candela's product line of today offers comprehensive and technologically sophisticated aesthetic laser systems - used by dermatologists, plastic surgeons and electrologists, including the following: - GentleLASE-Registered Trademark- Plus with DCD-TM- Cool Comfort for permanent hair reduction and the treatment of large leg veins, - Vbeam-TM- with DCD Cool Comfort for treating all vascular lesions, - ALEXLAZR-TM- and YAGLAZR-TM-, for treating pigmented lesions and tattoos, and - GentlePeel-TM- microdermabrasion system for skin exfoliation. The discretionary income of aging baby boomers continues to rise and create new opportunities for Candela. This market places a premium on good health and personal appearance, and has demonstrated a willingness to pay for health and cosmetic products and services. The growing popularity of laser treatments among the general population is also spurring demand for Candela's products. Today, American women spend an estimated $2 billion a year on hair removal products and services. Increasingly, lasers are proving an attractive alternative for women, as well as many men, in eliminating unwanted hair. Still in the early stages of development, the laser hair removal market is expected to experience rapid growth over the next five years. The company is dedicated to developing safe and effective products. Its aesthetic laser systems are further distinguished by being among the fastest, smallest and most affordable in their respective markets. Candela believes that it has increasingly captured significant market share because of these product attributes and is committed to continual innovation to meet the needs of its markets. INDUSTRY OVERVIEW Medical lasers use the unique characteristics of laser light to achieve precise and efficacious therapeutic effects, often in a non-invasive manner. The precise color, concentration, and controllability of different types of laser light provide for the 1 delivery of a wide range of specialized treatments. First introduced in the 1960's, the use of lasers for medical applications grew rapidly in the 1990's as technical advances made medical lasers more effective and reliable. Medical lasers today are used for numerous types of procedures falling into four broad categories: ophthalmic surgery, aesthetic and cosmetic procedures, general surgery, and dental procedures. Candela competes solely within the growing market for lasers performing aesthetic and cosmetic procedures including: - removal of unwanted hair from the face, legs, back, and other body areas - treatment of facial veins and leg veins, rosacea, red birthmarks, scars, stretch marks, warts - removal of pigmented lesions and tattoos. Lasers produce intense bursts of highly focused light to treat skin tissues. A laser's wavelength (color), energy level, spot size and pulse width (exposure time) are optimized for the specific treatment. Hair removal and the treatment of various leg vein malformations require the deepest laser penetration for successful treatment while scars, stretch marks, and red birthmarks (port wine stains and hemangiomas) require less laser penetration. Pigmented lesions such as sunspots, liver spots and tattoos are typically surface conditions that require the least amount of penetration. Different conditions may require the use of different types of lasers, and an active aesthetic and cosmetic practice addressing a broad range of laser procedures requires multiple lasers. In the pioneering years of the cosmetic and aesthetic laser industry from the late 1980's to the mid 1990's, the market for laser procedures was focused on vascular conditions such as port wine stains and hemangiomas and the development of treatments for pigmented lesions, such as tattoos. Equipment available in this period tended to be expensive, slow, and bulky. In addition, laser applications addressed the needs of relatively small patient populations, served by a narrow group of specialists. In the last half of the 1990's, the development of computer driven beam delivery systems called scanners increased the interest of a growing number of physicians by providing procedures to new, larger market segments, such as wrinkle removal. During this period, the complexity and cost of equipment from many vendors still inhibited sales. However, clinical experience was broadening, leading to better development efforts for new applications, which are now resulting in the next generation of aesthetic and cosmetic lasers. The aesthetic and cosmetic laser industry appears to be entering an era of broader based growth. The major factors converging to drive this growth are: - the economics of practitioners in a tough medical reimbursement environment, - the rising discretionary income of aging baby boomers, and - the development of technology that allows for new, effective procedures for conditions that have large patient populations. Aesthetic and cosmetic laser vendors, who are able to deliver lasers that are cost effective, reliable, and easy to use, will be well positioned to take advantage of such broader-based industry growth. Managed care and reimbursement restrictions in the U.S. and similar constraints, such as socialized medicine, outside the U.S., are motivating practitioners to emphasize aesthetic and cosmetic procedures that are delivered on a private, fee-for-service basis. While cosmetic procedures were once the domain of plastic surgeons and dermatologists, reimbursement reductions coupled with the reliable revenue stream from private-pay procedures have piqued the interest of other specialties, including general practice physicians. Key technical developments required for the broader cosmetic laser markets relate to ease-of-use, speed, lower costs, safety, and effective elimination of undesirable side effects. These factors are critical for broader segments of practitioners who wish to build aesthetic and cosmetic laser practices. These factors are also 2 important for minimizing the disruption of a patient's normal routine and for building demand for procedures addressing very large patient populations. BUSINESS STRATEGY Candela believes that a convergence of price and performance is occurring in the aesthetic and cosmetic laser industry, driving the expansion of the market. We believe we have the necessary infrastructure in place to capitalize on this expansion. Candela's objective is to establish itself as the leading provider of aesthetic and cosmetic lasers by using its proprietary technology and expertise in light and tissue interaction, as well as by developing market-oriented products that utilize related technologies. Our business strategy is focused on the following goals: - reduce product costs, - increase penetration of our traditional customer base, - expand sales beyond our traditional customer base, - expand our domestic marketing and distribution channels, - expand our international marketing and distribution channels, - continue investing in research and development, and - broaden additional applications for our Dynamic Cooling Device ("DCD"). REDUCE PRODUCT COSTS. We apply bottom-up engineering, focusing on each component to improve the performance of each device while reducing its size, complexity, and cost. We believe our approach leads to lasers with fewer parts and greater manufacturing efficiency, resulting in lower production costs that enable us to offer more reliable products at more affordable prices. INCREASE PENETRATION OF OUR TRADITIONAL CUSTOMER BASE. Our traditional customer base consists of dermatologists and plastic and cosmetic surgeons. We believe that the affordability of our products will enable us to penetrate further into the dermatologist and plastic and cosmetic surgeon markets. We have conducted surveys that indicate that only approximately one-third of the 17,000 dermatologists and plastic and cosmetic surgeons in the U.S. presently have lasers. We believe that affordability has been a major obstacle preventing the remaining practitioners from purchasing a laser. As competition for patients among practitioners increases, those practitioners with aesthetic and cosmetic lasers will be able to differentiate themselves. EXPAND SALES BEYOND OUR TRADITIONAL CUSTOMER BASE. We seek collaborative relationships that expand upon our traditional customer base, such as our relationship with Physicians Sales & Services ("PSS"). We believe those specialist practitioners outside our traditional customer base are a market with a large growth potential. In December 1998, we entered into a three year distribution arrangement with PSS that gives PSS the exclusive right to distribute the GentleLASE-Registered Trademark- and ScleroPLUS-TM- to specific office-based specialists. The agreement with PSS specifies that our products will be the exclusive aesthetic and cosmetic lasers sold by PSS. In addition, we have begun an innovative leasing program to target electrologists in the U.S. as potential customers of the GentleLASE-Registered Trademark- for hair removal. EXPAND OUR DOMESTIC MARKETING AND DISTRIBUTION CHANNELS. The U.S. presently represents almost 50% of our sales and is the largest single geographic market for our products. We have increased the size of our U.S. direct sales force to better address the needs of our traditional core markets. EXPAND OUR INTERNATIONAL MARKETING AND DISTRIBUTION CHANNELS. Outside of the U.S. we continue to strengthen our long-standing positions in Europe and Japan and are seeking to expand our markets in Asia and Latin America. We currently have direct sales offices in Madrid, Frankfurt, and Tokyo and are anticipating opening an 3 additional sales office in Hong Kong. An office was opened in Osaka, Japan on June 1, 1999. Over the past year we increased the number and improved the quality of our international independent distributor channel. We currently utilize 34 independent distributors in 46 countries. CONTINUE INVESTING IN R&D. We believe that investment in research and development is necessary to remain a leader in the aesthetic and cosmetic laser market. Our research and development approach is to develop high-quality, reliable, and affordable products that continue to address existing markets and allow us to enter into and expand new markets. Our research and development staff works closely with our marketing and operations groups to ensure our goals are met. Our strategy has been to drive technology that is market applicable and addresses voids in the marketplace. To that end, Candela will continue to apply technologies to reduce the size and complexity of its technology and products, increase the speed and ease with which therapeutic applications can be delivered, improve its ability to build and deliver lasers at affordable prices, and address expanding therapeutic applications and markets. Candela has numerous research and development arrangements with leading hospitals and medical laboratories in the U.S. BROADEN ADDITIONAL APPLICATIONS FOR OUR DYNAMIC COOLING DEVICE ("DCD"). Recently, the aesthetic and cosmetic laser market has begun to recognize the importance of effective cooling delivery systems for laser treatment, especially in such large market segments as hair removal and treatment of leg veins. Currently, DCD is an integral component of our GentleLASE-Registered Trademark- and is sold as an attachment to our ScleroPLUS-TM-. We intend to broaden the incorporation of DCD into all of our lasers and believe by doing so we can address major new market opportunities. THE MARKET FOR AESTHETIC AND COSMETIC LASERS Our traditional customer base for aesthetic and cosmetic lasers consists of dermatologists and plastic and cosmetic surgeons. In addition, other practitioner groups are emerging as potential customers, including general practitioners, obstetricians, gynecologists, and general and vascular surgeons. In the U.S., according to the American Medical Association and various societies, there are approximately 10,000 dermatologists, and 7,000 plastic and cosmetic surgeons. Practitioners in other specialties that are beginning to buy aesthetic and cosmetic lasers include 70,000 general and family practitioners, 35,000 obstetricians and gynecologists, and 28,000 general and vascular surgeons. In addition, the aesthetic and cosmetic laser market includes non-medical practitioners, notably electrologists, of which there are an estimated 6,000 in the U.S. The end markets for cosmetic laser procedures encompass broad and growing patient groups, including aging "baby boomers" as well as younger age groups. According to the U.S. Census Bureau, at the end of 1998 the number of "baby boomers" in the 35 to 54 age range was approximately 80 million, representing more than 29% of the total U.S. population. This large population group generally has a high level of disposable income and has exhibited a strong demand for aesthetic and cosmetic procedures. We believe that as the cost of treatments decreases and the popularity of laser cosmetic procedures such as hair removal increases, the target market for these procedures will expand beyond the baby boomers to include a broad range of women and men aged 17 to 65. Demographic factors similar to the U.S. underlie the growth of the aesthetic and cosmetic laser market outside of the U.S. HAIR REMOVAL. We believe that the great majority of the 108 million women over the age of 16 in the U.S. employ one or more techniques for temporary hair removal from various parts of the body. Also, a growing number of men are removing hair by means other than their daily shaving routine. A number of techniques are used to pull hair from the follicle including waxing, depilatories, and tweezing. In the waxing process, a lotion, generally beeswax-based, is spread on the area to be treated and is then rapidly peeled off, pulling out the entrapped hairs. Depilatories employ rotating spring coils or slotted rubber rolls to trap and pull out the hairs. Tweezing involves removing individual hairs with a pair of tweezers. Pulling hair from the follicle produces temporary results, but is often painful and may cause skin irritation. Depilatory creams, which contain chemicals to dissolve hair, frequently leave a temporary unpleasant odor and may also cause skin irritation. Shaving is the 4 most widely used method of hair removal, especially for legs and underarms, but produces the shortest-term results. Hair bleaches do not remove hair, but instead lighten the color of hair so that it is less visible. A principal drawback of all of these methods is that they require frequent treatment. Before the advent of laser hair removal, electrolysis was the only method available for the long-term removal of body hair. Electrolysis is a process in which an electrologist inserts a needle directly into a hair follicle and activates an electric current in the needle, which disables the hair follicle. The tiny blood vessels in each hair follicle are heated and coagulated, presumably cutting off the blood supply to the hair matrix, or are destroyed by chemical action depending upon modality used. The success rate for electrolysis is variable depending upon the skill of the electrologist and always requires a series of treatments. Electrolysis is time-consuming, expensive and sometimes painful. There is also some risk of skin blemishes and a rising concern relating to needle infection. Because electrolysis requires that each hair follicle be treated separately and can only treat visible hair follicles, the treatment of an area as small as an upper lip may require numerous visits at an aggregate cost of up to $1,000. The American Electrology Association estimates that approximately one million people per year undergo electrology procedures. Although we believe the large majority of all electrolysis treatments are for facial hair, the neck, breasts and bikini line are also treated. Because hair follicles are disabled one at a time, electrolysis is rarely used to remove hair from large areas such as the back, chest, abdomen, and legs. We believe lasers enable the practitioner to address a potentially larger market than electrolysis by treating a larger area of the body more quickly and with better results. We believe the market for laser-based hair removal is in its early stages and that this market will grow as the customer compares laser treatments to other hair removal methods that are currently available. The benefits include: - significant longer term cosmetic improvement, - treatment of larger areas in each treatment session, - less discomfort during and immediately after procedures, - reduced procedure time and number of treatments, - reduced risk of scarring and infection, - non-invasive procedures, and - no risk of cross-contamination. VASCULAR LESIONS. Benign vascular lesions are generally enlarged and proliferating blood vessels that appear on the surface of the skin as splotches, dots, bulges, and spider shapes in a variety of colors ranging from red to purple. Different types of benign vascular lesions include the following: - varicose veins, which are large veins greater than 1mm in diameter and often bulge above the skin surface, - leg telangiectasias, which are smaller spider veins up to 1mm in diameter in size appearing as single strands, - facial and truncal telangiectasias, which are spider veins and other dilated veins that appear on the face and other parts of the body, - port wine stains, which are vascular birthmarks characterized by a red or purple discoloration of the skin, - hemangiomas, which are protuberances that consist of dilated vessels, which often appear on newborns within one month of birth, and - stretch marks and scars. 5 Varicose leg veins typically result when damaged valves cause blood to stagnate rather than be pumped back to the heart, causing the vein walls to stretch and bulge. Varicose veins affect a significant portion of the U.S. adult population and increase in prevalence with age. To date, treatment for varicose veins has been predominantly performed on women. Other benign vascular lesions include port wine stains, hemangiomas, and facial and truncal telangiectasias or spider veins. It is estimated that in 1997 there were approximately 661,000 procedures performed in the U.S. to remove vascular lesions and the number of procedures is expected to increase to an estimated 2.6 million in 2002. PIGMENTED LESIONS/TATTOOS: Benign pigmented lesions can be both epidermal and dermal, natural or man-made (tattoos), and can constitute a significant cosmetic problem to those who have them. MICRODERMABRASION: A significant percentage of the population suffers from fine lines and wrinkles or older looking skin as a result of the normal aging process, which is often exacerbated by the effects of sun damage and smoking. This is the primary group of candidates for microdermabrasion procedures. While there are a variety of techniques used for smoothing skin including botox and collagen injections, chemical peels and laser skin resurfacing, microdermabrasion has become an accepted alternative for efficacious treatment of fine lines on the skin, blending of scars, acne scars and other imperfections. Developed in the mid 1990's, microdermabrasion experienced explosive growth fueled by improved technology and patient acceptance of the procedure. CANDELA'S PRODUCTS We develop, manufacture, market, and service lasers used to perform procedures addressing patients' aesthetic and cosmetic concerns. We offer a comprehensive range of products based on proprietary technologies. Our products focus on the major aesthetic and cosmetic laser applications including: - hair removal, - non-invasive treatment of facial and leg veins and other benign vascular lesions, - removal of benign pigmented lesions such as age spots and tattoos, - treatment of scars and stretch marks, and - microdermabrasion. Intense light technology forms the basis for most of our products. Our patented technology uses thermal energy generated by an intense pulsed laser light source to selectively eliminate unwanted skin blemishes without damaging the surrounding healthy tissue, and to remove facial or other unwanted hair throughout the body. Candela's objective is to establish itself as the leading provider of aesthetic and cosmetic lasers by continually striving to develop smaller, faster, and less expensive devices. Candela has been a pioneer in the laser industry. From the start, our mission has been to lead the way in the development of innovative laser products. Significant innovations include: - a pulsed dye laser system with integrated DCD to treat vascular lesions while minimizing the problematic side effects of postoperative bruising, commonly referred to as purpura, - a hair removal laser with integrated DCD. GENTLELASEPLUS. The GentleLASEPlus, integrated with DCD, is a high-energy, long-pulse solid-state laser that generates laser light in the near infrared wavelength range. It is used for both hair removal and the treatment of large (1mm or larger) leg veins. The technology incorporated in the GentleLASEPlus uses high energy 6 directed through an Alexandrite rod, which achieves selective heating while keeping the temperature of the skin below its damage threshold. The longer Alexandrite laser wavelength enables GentleLASEPlus to penetrate skin surfaces deeper than traditional Ruby lasers, and the large spot size (15mm) allows the practitioner to treat a larger area more quickly. The DCD is integrated into the design of GentleLASEPlus and delivers a short burst of cryogen coolant onto targeted areas of the skin undergoing treatment. DCD selectively cools only the top layer of the skin, while leaving the targeted underlying hair follicle, vein or other structure at normal temperature. As a result, higher levels of laser energy can be delivered during treatment, while minimizing thermal injury, pain, and the inconvenience associated with anesthetics. The design of the hand-held DCD enables the practitioner to clearly see the area being treated, and the combined efficiency of GentleLASEPlus and DCD reduces the risks of over treatment, which can result in white spots on the skin, or under treatment which can result in brown spots. GentleLASEPlus was initially cleared for marketing by the FDA in December 1997 for treating facial veins and vascular lesions and we commenced sales in March 1998. Candela began selling GentleLASE-Registered Trademark- for hair removal in the U.S. in July 1998, when it received FDA marketing clearance for hair removal. In August 1998, we were issued a CE Mark on GentleLASE-Registered Trademark-, clearing it for sale in 15 European A countries. We introduced an enhanced version of the GentleLASE-Registered Trademark-, the GentleLASE PLUS-Registered Trademark-, on September 22, 1999. The GentleLASE PLUS-Registered Trademark- features a larger spot size for faster treatment times, an elliptical spot option for improved alignment when treating large leg veins, and a foot pedal for greater physician convenience in operating the system. Hair removal typically requires three to five treatments to achieve efficacious results due to the growth cycle of hair follicles. A typical treatment can range from approximately $200 for an upper lip and chin procedure to as much as $1,000 per treatment for the back or chest. VBEAM-TM-. The Vbeam delvers the safety and efficacy of the clinically proven pulsed dye laser (PDL) while minimizing the problematic side effects of postoperative bruising, commonly referred to as purpura. It features Candela's patented Dynamic Cooling Device (DCD) to protect the epidermis. The system comes in a choice of four colors, an industry first, and is priced very competitively. Vbeam provides treatment of facial spider veins, port wine stains, leg telangiectasias, hemangiomas, poikiloderma, rosacea, scars, warts, stretch marks, vulvodynia, and other vascular abnormalities in adults, children and infants. The Vbeam's user-adjustable laser pulse duration (1.5-40msec) features Candela's innovative ultra-long pulse duration, the longest offered in a dye laser. Most treatments of vascular lesions cost between $300 and $800, depending on the length and type of procedure. The combination of Vbeam(TM) and GentleLASE-Registered Trademark- offers the capability to treat a majority of leg veins in patients seeking treatment. A predecessor product to Vbeam, the SPTL-1b, is currently marketed in Japan, pending Ministry of Health approval of Vbeam. The Vbeam was cleared for marketing by the FDA in the U.S. in January 2000, and it supplements our earlier ScleroPlus laser originally approved in 1995. ALEXLAZR-TM- AND YAGLAzr-TM-. We offer two types of lasers to address removal of a broad range of pigmented lesions and most tattoos. The ALEXlazr-TM- is a short-pulsed solid-state laser, which emits near-infrared light for the non-invasive removal of tattoo pigments and pigmented lesions such as freckles and Nevus of Ota, a bluish colored, non-vascular, pigmented lesion, generally found among persons of Asian descent. The ALEXlazr-TM- was cleared by the FDA for marketing for these uses in the U.S. in 1994. The ALEXlazr-TM- has a fiber optic delivery system that produces an even beam distribution without hot spots. Its wavelength maximizes beam penetration, providing positive results with deeper pigments and is effective in the removal of most tattoo pigments except red. 7 The YAGlazr-TM- is a short-pulsed Nd/YAG laser, which is able to emit both near infrared and green light, for the non-invasive removal of red tattoos and the treatment of brown benign pigmented lesions, such as age spots and sunspots. The YAGlazr-TM- was cleared for marketing by the FDA for these uses in the U.S. in 1994. The YAGlazr-TM- has variable pulse repetition frequency to optimize treatment time, and dual wavelengths that broaden treatment options, allowing for removal of tattoos which have red pigments as well as tattoos in darker skin types. GENTLEPEEL-TM- The GentlePeel microdermabrasion system provides skin exfoliation of the face, hands, neck and eye areas. The GentlePeel is designed for practioners with patients who care about their appearance but have concerns about the recovery time from more invasive procedures. GentlePeel treatments are generally performed in less than 20 minutes. Clients look healthy and vibrant immediately - no discomfort, no healing time, and no need for dressings or camouflage make up. GentlePeel clinical indications include general dermabrasion, blending of scars and other imperfections, acne scar revision and skin exfoliation. DYNAMIC COOLING DEVICE. Currently, DCD is integrated into GentleLASEPlus and Vbeam systems, as described above. SALES AND DISTRIBUTION We pursue a global marketing, sales and distribution strategy which is centrally managed out of our Wayland, Massachusetts headquarters. Separate regional managers for the Americas, Europe and the Middle East, and Asia ensure that the differing needs of each region are identified and satisfied. International sales are an important contributor to our revenue. During our 2000 fiscal year, the U.S. and Canada comprised 48% of our revenue, Japan and the Far East 32%, Europe 19%, and the rest of the world 1%. We sell our products through our direct sales force and a network of independent distributors. The particular mix of direct sales and distributors varies by region. Generally, our distributors enter into a two to three year exclusive agreement during which they typically agree not to sell our competitors' products. Our sales strategy is to choose the most productive and practicable distribution channel within each of our geographic markets. We sell products in the U.S. primarily through our direct sales force to our traditional customer base of dermatologists and plastic and cosmetic surgeons. In addition, several independent distributors enhance our coverage of this traditional customer base. In order to expand outside our traditional customer base in the U.S., we entered into a three-year distribution arrangement with PSS in December 1998 that gives PSS the exclusive right to distribute the GentleLASE-Registered Trademark- and ScleroPLUS-TM- to specific office-based specialists. The PSS agreement has been amended to include our new Vbeam-TM- laser and any new products that are developed during the term of the agreement. PSS is a division of PSS World Medical, Inc., and is the largest distributor of medical supplies, equipment, and pharmaceuticals to office-based physicians in the U.S. Through its nationwide sales force of 700 representatives, PSS offers our products to approximately 100,000 office sites containing family practice and general practice physicians, ob/gyn specialists and/or general and vascular surgeons. The agreement with PSS specifies that our products will be the only aesthetic and cosmetic lasers sold by PSS. Outside the U.S. we sell our products in Western Europe, Japan, Central and South America, including Brazil, the Middle East, and the Pacific Rim through direct sales offices and distribution relationships. We have 35 employees in our direct sales offices in Madrid, Frankfurt, Bangkok, Paris, Tokyo, and Osaka. We plan to open an additional direct sales office in northern Japan. We have established distribution relationships throughout Europe, Japan, Africa, Central and South America, including Brazil, and the Middle East. Outside the U.S. we currently utilize 37 distributors in 46 countries. The following chart shows data relating to Candela's international activities during each of the last two fiscal years by geographic region. Revenue generated from 8 regions other than the U.S. includes sales from Candela's German, Spanish, French, and Japanese subsidiaries, as well as sales shipped directly to international locations from the U.S. Candela does not record or report, either internally or externally, operating profit or assets in the same manner it aggregates revenues. YEAR ENDED --------------------------------- July 1, 2000 July 3, 1999 ----------------- --------------- REVENUE: (in 000's) United States and Canada ............................... $ 36,353 $ 28,135 Japan and Far East ..................................... 24,005 18,175 Europe ................................................. 14,608 11,837 United States shipments to other regions of the world .. 424 391 SERVICE AND SUPPORT We believe that quick and effective delivery of service is important to our customers. We strive to respond to service calls within 24 hours and to complete the call within 48 hours to minimize practitioner disruption. Our principal service center and parts depot is located at our Wayland, Massachusetts headquarters. Parts depots are also located at our sales offices in Japan, Spain, Germany and France. Independent distributors maintain parts depots and service representatives adequate to cover their installed systems and have primary responsibility to service such systems. In addition, we have service representatives in each of our markets worldwide. Product maintenance and repair following the warranty period provides an additional recurring source of revenue. Customers may elect to purchase a service contract or to purchase service on a time-and-materials basis. Our service contracts vary by the type of systems and the level of services desired by the customer and are typically for a 12 to 24 month period after the initial warranty period expires. Initial warranties on all laser products cover parts and service for twelve months. Customers may elect to purchase an additional 2 years of warranty on GentleLASE-Registered Trademark-. Our newest product, the V-Beam-Registered Trademark- laser system, comes with a 3-year, full-service warranty that includes maintenance and consumables. Candela emphasizes education and support of its customers. Our recommended preventative maintenance, coupled with continuing technical education for service representatives, helps to ensure product reliability. After a sale, the system is installed and supported by a Candela qualified service engineer. After installation of a system at the customer's location, a nurse clinician provides the practitioner with training and clinical support. MANUFACTURING We design, manufacture, assemble, and test our branded products other than the GentlePeel system at our Wayland, Massachusetts facility. Ensuring adequate and flexible production capacity, continuous cost reduction, and superior product quality are top priorities of our manufacturing organization. We achieve our goals by: - working closely with the research and development organization, including significant early involvement in product design; - continually improving our just-in-time manufacturing and inventory processes; and - effectively managing a limited number of the most qualified suppliers. Our facility has ISO 9001 certification and EN 46001 registration. ISO 9001 certification provides guidelines for the quality of company systems associated with the design, manufacturing, installation, and servicing of company products. EN 46001 9 standards are European quality requirements specifically relating to the design of medical devices. Our products are manufactured with standard components and subassemblies supplied by subcontractors to our specifications. We purchase certain components and subassemblies from a limited number of suppliers. If our suppliers are unable to meet our requirements on a timely basis, our production could be interrupted until we obtain an alternative source of supply. To date, we have not experienced significant delays in obtaining dyes, optical and electro-optical components, electronic components, and raw materials for our products. RESEARCH AND DEVELOPMENT We believe that our advanced research and engineering activities are crucial to maintaining and enhancing our business, and we are currently conducting research on a number of applications. We believe that our in-house research and development staff has demonstrated its ability to develop innovative new products that meet evolving market needs. Our core competencies include: - applied laser physics and technology, - new imaging methods, - tissue optics, - photochemistry, - laser-tissue interaction, - clinical research, and - engineering and design of medical laser devices. As we discover new technologies or applications with commercial potential, we assemble a team to develop the new product or application in cooperation with leading physicians and medical and research institutions. In most instances, we must receive FDA clearance before marketing new products or applications. Our research and development team works with our operations group to design our products for ease of manufacturing and assembly and with our marketing group to respond to market opportunities. We believe that this interaction between functional groups facilitates the introduction of new products with the right balance of features, performance, quality, and cost. To date our research and development effort has relied primarily on internal development building on our core technologies, rather than through acquisition. In addition, Candela conducts joint research with physicians affiliated with various medical and research institutions. One example of technology developed through joint research is our DCD that was developed in conjunction with the Beckman Laser Institute at the University of California, Irvine. We anticipate continuing joint research and licensing arrangements with medical research institutions. As of July 1, 2000, our research and development staff consisted of 32 people, eight of whom have advanced degrees including four Ph.Ds. The core members of our research and development team have been with us for an average of ten years. CUSTOMERS We currently sell our products primarily to physicians. The majority of our sales in the U.S. are financed through leasing companies. Although our sales are not dependent on any single customer or distributor, our sales to PSS have increased and we expect sales to PSS to continue to represent a significant portion of sales. Our customers are located in more than 40 countries. We have recently begun an 10 innovative program to target the estimated 6,000 electrologists in the U.S. as potential customers for GentleLASEPlus for hair removal, positioning GentleLASEPlus as an adjunct to traditional electrolysis methods. COMPETITION Competition in the aesthetic and cosmetic laser industry is intense and technological developments are expected to continue at a rapid pace. Although there are over 20 manufacturers of aesthetic and cosmetic lasers, we believe that only Candela and a few others offer a broad range of products able to address multiple applications. Unlike Candela, few, if any, of our competitors focus exclusively on the cosmetic and aesthetic laser market. We believe that our principal competitors are currently Coherent and ESC Medical Systems. We compete on the basis of proprietary technology, product features, performance, service, price, and reputation. Some of our competitors have greater financial, marketing, and technical resources than we do. In addition, some competitors have developed, and others may attempt to develop, products with applications similar to ours. We believe that many factors will affect our competitive position in the future, including our ability to: - develop and manufacture new products that meet the needs of our markets, - respond to competitive developments and technological changes, - manufacture our products at lower cost, - retain a highly qualified research and engineering staff, and - provide sales and service to a worldwide customer base. PROPRIETARY RIGHTS We own several U.S. and foreign patents and have four U.S. and one foreign patent applications pending to protect our rights in certain technical aspects of our hair removal, benign vascular lesion, pigmented lesion, and other laser systems. The expiration dates for our issued U.S. patents range from December 8, 2006 to February 5, 2017. In addition to our portfolio of patents issued and pending, we license patented technology from third parties. We use DCD under a license agreement to patent rights owned by the Regents of the University of California. In August, 2000, we entered into an agreement to amend the license agreement whereby in exchange for an annual exclusivity fee, which will be prepaid in full in the amount of approximately $1.5 million by Candela, Candela will obtain exclusive license rights to the DCD (subject to certain limited license rights of Cool Touch) in the following fields of use: procedures that involve skin resurfacing and rejuvenation, vascular skin lesions, and laser hair removal. Cool Touch, Inc. ("Cool Touch"), a subsidiary of New Star, will obtain a license to the DCD on a co-exclusive basis with Candela, in certain narrower fields of use. Cool Touch is restricted in its ability to assign its license rights to certain existing competitors of Candela. Candela will receive one-half of all royalty income payable to the Regents from Cool Touch. Under the amended agreement, Candela no longer is required by the Regents to negotiate sublicenses to third parties. However, Candela will receive one-half of all royalties due from any other entity that licenses the DCD technology from the Regents in other fields of use. We rely primarily on a combination of patent, copyright, and trademark laws to establish and protect our proprietary rights. We also rely on trade secret laws, confidentiality procedures, and licensing arrangements to establish and protect our technology rights. In addition, we seek to protect our proprietary 11 rights by using confidentiality agreements with employees, consultants, advisors, and others. We cannot be certain that these agreements will adequately protect our proprietary rights in the event of any unauthorized use or disclosure, that our employees, consultants, advisors, or others will maintain the confidentiality of such proprietary information, or that our competitors will not otherwise learn about or independently develop such proprietary information. Despite our efforts to protect our intellectual property, unauthorized third parties may attempt to copy aspects of our products, to violate our patents, or to obtain and use our proprietary information. In addition, the laws of some foreign countries do not protect our intellectual property to the same extent as do the laws of the U.S. The loss of any material trademark, trade name, trade secret, or copyright could hurt our business, results of operations, and financial condition. We believe that our products do not infringe from the rights of third parties. However, we cannot be certain that third parties will not assert infringement claims against us in the future or that any such assertion will not result in costly litigation or require us to obtain a license to third party intellectual property. In addition, we cannot be certain that such licenses will be available on reasonable terms or at all, which could hurt our business, results of operations, and financial condition. We have received correspondence from Palomar Medical Technologies, the exclusive licensee from Star Medical Technologies of certain United States patents, and also from Star Medical, offering to grant us a nonexclusive license to such patents. We have engaged in discussions with Palomar relative to these patents, but have not yet decided on a specific course of action. GOVERNMENT REGULATION FDA'S PREMARKET CLEARANCE AND APPROVAL REQUIREMENTS. Unless an exemption applies, each medical device that we wish to market in the U.S. must receive either "510(k) clearance" or "PMA approval" in advance from the U.S. Food and Drug Administration pursuant to the Federal Food, Drug, and Cosmetic Act. The FDA's 510(k) clearance process usually takes from four to twelve months, but it can last longer. The process of obtaining PMA approval is much more costly, lengthy, and uncertain and generally takes from one to three years or even longer. We cannot be sure that 510(k) clearance or PMA approval will ever be obtained for any product we propose to market. The FDA decides whether a device must undergo either the 510(k) clearance or PMA approval process based upon statutory criteria. These criteria include the level of risk that the agency perceives is associated with the device and a determination whether the product is a type of device that is similar to devices that are already legally marketed. Devices deemed to pose relatively less risk are placed in either class I or II, which requires the manufacturer to submit a pre-market notification requesting 510(k) clearance, unless an exemption applies. The pre-market notification must demonstrate that the proposed device is "substantially equivalent" in intended use and in safety and effectiveness to a legally marketed "predicate device" that is either in class I, class II, or is a "pre-amendment" class III device (i.e., one that was in commercial distribution before May 28, 1976) for which the FDA has not yet decided to require PMA approval. After a device receives 510(k) clearance, any modification 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. The FDA requires each manufacturer to make this determination in the first instance, but the FDA can review any such decision. If the FDA disagrees with a manufacturer's decision not to seek a new 510(k) clearance, the agency may retroactively require the manufacturer to submit a pre-market notification requiring 510(k) clearance. The FDA also can require the manufacturer to cease marketing and/or recall the modified device until 510(k) clearance is obtained. We have modified some of our 510(k) cleared devices, but have determined that, in our view, new 510(k) clearances are not required. We cannot be certain that the FDA would agree with any of our decisions not to seek 510(k) clearance. If the FDA requires us to seek 510(k) clearance for any modification, we also may be required to cease marketing and/or recall the modified device until we obtain a new 510(k) clearance. 12 Devices deemed by the FDA to pose the greatest risk such as life-sustaining, life-supporting, or implantable devices, or deemed not substantially equivalent to a legally marketed predicate device, are placed in class III. Such devices are required to undergo the PMA approval process in which the manufacturer must prove the safety and effectiveness of the device to the FDA's satisfaction. A PMA application must provide extensive pre-clinical and clinical trial data and also information about the device and its components regarding, among other things, manufacturing, labeling, and promotion. After approval of a PMA, a new PMA or PMA supplement is required in the event of a modification to the device, its labeling, or its manufacturing process. A clinical trial may be required in support of a 510(k) submission or PMA application. Such trials generally require an Investigational Device Exemption ("IDE") application approved in advance by the FDA for a limited number of patients, unless the product is deemed a nonsignificant risk device eligible for more abbreviated IDE requirements. The IDE application must be supported by appropriate data, such as animal and laboratory testing results. Clinical trials may begin if the IDE application is approved by the FDA and the appropriate institutional review boards at the clinical trial sites. To date, the FDA has deemed our products to be class II devices eligible for the 510(k) clearance process. We believe that most of our products in development will receive similar treatment. However, we cannot be certain that FDA will not deem one or more of our future products to be a class III device and impose the more burdensome PMA approval process. PERVASIVE AND CONTINUING FDA REGULATION. A host of regulatory requirements apply to marketed devices such as our laser products, including labeling regulations, the Quality System Regulation (which requires manufacturers to follow elaborate design, testing, control, documentation, and other quality assurance procedures), the Medical Device Reporting regulation (which requires that manufacturers report to the FDA certain types of adverse events involving their products), and the FDA's general prohibition against promoting products for unapproved or "off label" uses. Class II devices such as ours also can have special controls such as performance standards, post-market surveillance, patient registries, and FDA guidelines that do not apply to class I devices. Unanticipated changes in existing regulatory requirements or adoption of new requirements could hurt our business, financial condition, and results of operations. We are subject to inspection and market surveillance by the FDA for compliance with regulatory requirements. If the FDA finds that we have failed to comply with applicable requirements, the agency can institute a wide variety of enforcement actions. The FDA sometimes issues a public warning letter, but also may pursue more drastic remedies, such as refusing our requests for 510(k) clearance or PMA approval of new products, withdrawing product approvals already granted to us, requiring us to recall products, or asking a court to require us to pay civil penalties or criminal fines, adhere to operating restrictions, or close down our operations. Ultimately, criminal prosecution is available to FDA as punishment for egregious offenses. Any FDA enforcement action against us could hurt our business, financial condition, and results of operation. OTHER U.S. REGULATION. We also must comply with numerous federal, state, and local laws relating to such matters as safe working conditions, manufacturing practices, environmental protection, fire hazard control, and hazardous substance disposal. We cannot be sure that we will not be required to incur significant costs to comply with such laws and regulations in the future or that such laws or regulations will not hurt our business, financial condition, and results of operations. FOREIGN REGULATION. International sales are subject to foreign government regulation, the requirements of which vary substantially from country to country. The time required to obtain approval by a foreign country may be longer or shorter than that required for FDA approval, and the requirements may differ. Companies are now required to obtain the CE Mark prior to sale of certain medical devices within the EU. During this process, the sponsor must demonstrate compliance with ISO manufacturing and quality requirements. In addition, Candela is currently awaiting 13 Ministry of Health approval in Japan to market the ScleroPLUS-TM- and the Vbeam-TM-, and in Korea to market the Vbeam-TM-. Candela and its products may also be subject to other federal, state, local, or foreign regulations relating to health and safety, environmental matters, quality assurance, and the like. Candela's compliance with laws that regulate the discharge of materials into the environment or otherwise relate to the protection of the environment does not have a material effect on its ongoing operations. Candela has not made any material expenditures for environmental control facilities. PRODUCT LIABILITY AND WARRANTIES Our products are generally covered by a one-year warranty, while our Vbeam(TM) has a three-year warranty. We set aside a reserve based on anticipated warranty claims. We believe such reserves to be adequate, but in the event of a major product problem or recall, such reserves may be inadequate to cover all costs, and such an event could have a material adverse effect on our business, financial condition, and results of operations. Our business involves the inherent risk of product liability claims. We maintain appropriate product liability insurance with respect to our products with a coverage limit of $13 million in the aggregate. We cannot be certain that with respect to our current or future products, such insurance coverage will continue to be available on terms acceptable to us or that such coverage will be adequate for liabilities that may actually be incurred. THE SKIN CARE CENTERS In June 1996, we began an effort to own and operate skin care centers offering cosmetic laser treatments utilizing our equipment along with other cosmetic services traditionally offered by high-end spas. We pursued this strategy by purchasing an operating spa in Boston in 1996. In March 1997, we opened a new facility in Scottsdale, Arizona, with no pre-existing customer base. We subsequently decided to reduce our focus on our skin care center efforts. We closed our Scottsdale, Arizona facility in the quarter ended December 27, 1997, and in January of 1999 ceased to offer aesthetic laser procedures at our Boston skin care center, although we continue to offer health and beauty services from this location. We are actively seeking buyers to assume the leases and purchase the assets of both the Scottsdale and Boston facilities in order to concentrate on our core business of manufacturing and servicing advanced aesthetic laser systems. EMPLOYEES As of July 1, 2000, we employed 311 people in the following areas of our organization: - 32 in research, development, and engineering, - 42 in manufacturing and quality assurance, - 25 in service positions, - 31 in sales and marketing, - 29 in finance and administrative positions and all others, - 117 in our clinic and health spa subsidiary, including both full and part-time employees, and - 35 in our international sales and service subsidiaries. 14 NEW ACCOUNTING PRONOUNCEMENTS In June 1999, the Financial Accounting Standards Board ("FASB") issued Statement of Financial Accounting Standard ("SFAS") No. 137, "Accounting for Derivative Instruments and Hedging Activities - Deferral of the Effective Date of FASB Statement 133," which postponed the adoption date of SFAS No. 133. As such, the Company is not required to adopt the statement until fiscal 2001. Had the Company implemented SFAS No. 133 for the current reporting period, there would have been no material effect on operational results. In December 1999, The Securities and Exchange Commission issued Staff Accounting Bulletin No. 101 ("SAB 101"), Revenue Recognition in Financial Statements. SAB 101 provides guidance on applying generally accepted accounting principles to revenue recognition issues in financial statements. The Company has not assessed the effect that such adoption may have on its consolidated results of operations and financial position. EXECUTIVE OFFICERS The current executive officers of the Company are as follows: NAME AGE POSITION ------ ----- --------- Gerard E. Puorro 53 President, Chief Executive Officer and Director F. Paul Broyer 51 Senior Vice President of Finance and Administration, Chief Financial Officer, and Treasurer William B. Kelley 45 Vice President, North American and Latin American Sales William McGrail 39 Vice President, Operations Toshio Mori 48 Vice President, President of Candela KK Robert J. Wilber 42 Vice President, European Sales Executive officers of the Company are elected by the Board of Directors on an annual basis and serve until their successors are duly elected and qualified, subject to earlier removal by the Board of Directors. There are no family relationships among any of the executive officers or directors of the Company. Mr. Puorro was appointed a Director of the Company in September 1991. Mr. Puorro has been President and Chief Executive Officer of the Company since April 1993. From April 1989 until April 1993, he was Senior Vice President and Chief Financial Officer of the Company. He was elected Chief Operating Officer in December 1992. Prior to joining the Company, and since 1982, he was Vice President and Controller at Massachusetts Computer Corporation. Mr. Broyer was appointed Senior Vice President of Finance and Administration, Chief Financial Officer, and Treasurer in July 1998. Mr. Broyer joined the Company in October 1996 as Vice President and Chief Financial Officer. Prior to joining the Company, Mr. Broyer held the position of Vice President Finance at Integrated Genetics from 1994 to 1996. From 1987 until 1994, Mr. Broyer was Corporate Controller for Laserdata, Inc. and held earlier positions with Avatar Technologies and Data General Corporation. Mr. Kelley was named Vice President of North American and Latin American Sales in July 1998. Mr. Kelley was previously Vice President, North American Sales and Service, from April 1993 through June 1998. From January 1993 until April 15 1993 he was Vice President, Domestic Sales. He has been with the Company since 1987 and previously held the positions of National Sales Manager and Eastern Regional Sales Manager. Prior to joining the Company, Mr. Kelley held a number of sales and sales management positions in the medical industry. Mr. McGrail was named Vice President of Operations in May 2000. Previously, Mr. McGrail served in the positions of Vice President of Development Engineering since July 1998. Mr. McGrail also served in the position of Director of Engineering since August 1994. From 1987 to 1992, he held the positions of Senior Software Engineer and Software Design Engineer. Prior to joining Candela, Mr. McGrail was employed with Raytheon Corporation. Mr. Mori was named Vice President, President of Candela K.K. in July 1998, after serving as President and Representative Director of Candela K.K. since September 1996. Previously, Mr. Mori held the positions of Director of Candela K.K. from September 1992 to September 1996, and General Manager from September 1989 to September 1992. From 1976 to 1989, he was employed by Sansui Electric Co. Ltd. in Tokyo. Mr. Wilber was appointed Vice President of European Sales in February 1999, after serving as Vice President, Worldwide Service since August 1997. Previously, Mr. Wilber held the position of Director of Worldwide Service from October 1993 to August 1997. He has been with the Company since September of 1989 and was previously a Finance Group Director. From 1989 to 1992 Mr. Wilber held the positions of International Accounting Manager, Customer Service Manager, and Director of Financial Planning and Analysis. Prior to joining the Company, Mr. Wilber held positions at Sony Corporation of America, Massachusetts Computer Corporation, and National Semiconductor/Data Terminal Systems. ITEM 2. PROPERTIES We lease a facility totaling approximately 35,000 square feet for our operations in Wayland, Massachusetts, which is located approximately 20 miles west of Boston. The lease on this facility was amended in April 1998 to extend the expiration date to March 2003. Candela's management believes that its current facilities are suitable and adequate for our near-term needs. Candela's subsidiary, Candela Skin Care Centers, Inc, currently leases the following facilities: 1) Candela Skin Care Center of Scottsdale, Inc., 7,555 square feet located at 6939 E. Main Street, Scottsdale, AZ. The lease on this facility is for a period of ten years, expiring on June 30, 2006, with a provision for two five-year extensions; and 2) Candela Skin Care Center of Boston, Inc., 20,728 square feet located at 28 Arlington Street, Boston, MA. The lease on this facility is for a period of 15 years, and commenced on June 1, 1994. ITEM 3. LEGAL PROCEEDINGS On August 11, 2000, Candela reached a settlement of legal disputes with the Regents of the University of California ("Regents") and New Star Technology, Inc. (`New Star"), relating to the Dynamic Cooling Device ("DCD") licensed by Candela from the Regents. Candela had commenced an arbitration against the Regents seeking a declaration that it was in compliance with its amended license agreement with the Regents. New Star had commenced litigation against Candela and the Regents arising from its unsuccessful efforts to obtain a license to the DCD technology from the Regents. Pursuant to the settlement, all three parties agreed to dismiss with prejudice all pending proceedings in the U.S. District Court for the Eastern District of California and the District of Massachusetts, and before the American Arbitration Association, and to exchange full releases. In addition, Candela and the Regents agreed to a further amendment of the 16 DCD license agreement between Candela and the Regents to provide that, in exchange for an annual exclusivity fee, which will be prepaid in full in the amount of approximately $1.5 million by Candela, Candela will obtain exclusive license rights to the DCD (subject to certain limited license rights of Cool Touch) in the following fields of use: procedures that involve skin resurfacing and rejuvenation, vascular skin lesions, and laser hair removal. Cool Touch, Inc. ("Cool Touch"), a subsidiary of New Star, will obtain a license to the DCD, on a co-exclusive basis with Candela, in certain narrower fields of use. The settlement agreement also contains restrictions on Cool Touch's ability to assign its license rights to certain existing competitors of Candela. Candela will receive one-half of all royalty income payable to the Regents from Cool Touch. Under the amended agreement, Candela will no longer be required by the Regents to negotiate sublicenses to third parties. However, Candela will receive one-half of all royalties due from any other entity that licenses the DCD technology from the Regents in other fields of use. The annual exclusivity fee is payable upon closing with the Regents and Cool Touch in one payment, and will be amortized over the remaining life of the Regents' DCD patent. The amended license agreement specifies that, from the date of settlement, Candela's royalty obligation to the Regents will be computed based upon the list price (or price to distributors) on the DCD component of the laser system. While this modification retains the historical percentage royalty rate previously payable to the Regents, it will prospectively apply to more components sold and as a result will increase Candela's royalty payments compared to the method of computing royalties prior to the modification. Finally, Candela has agreed to provide a non-assignable contract not to sue Cool Touch relating to a patent owned by Candela. The parties' August 11, 2000 settlement is binding. The parties are currently negotiating a definitive settlement agreement and amended license agreement. The parties' August 11, 2000 settlement agreement provides that any dispute concerning these documents will be promptly and conclusively resolved by the mediator who facilitated the settlement. From time to time, we are a party to various legal proceedings incidental to our business. We believe that none of the other presently pending legal proceedings will have a material adverse effect upon our financial position, results of operations, or liquidity. ITEM 4. SUBMISSION OF MATTERS TO A VOTE OF SECURITY HOLDERS No matter was submitted to a vote of our security holders during the fourth quarter of the fiscal year covered by this report. 17 PART II ITEM 5. MARKET FOR THE REGISTRANT'S COMMON STOCK AND RELATED STOCKHOLDER MATTERS Candela's common stock trades on The NASDAQ Stock Market under the symbol "CLZR." At September 22, 2000, there were 375 holders of record of the Company's common stock and the closing sales price of the Company's common stock was $11.25. The following table sets forth quarterly high and low closing sales prices of the common stock for the indicated fiscal periods: HIGH LOW ------- ------ FISCAL 2000 First Quarter.................................. $11.7500 $ 6.7087 Second Quarter................................. 12.7500 6.7087 Third Quarter.................................. 18.1250 11.5420 Fourth Quarter................................. 14.0000 9.0000 FISCAL 1999 First Quarter.................................. $ 3.1667 $ 1.7920 Second Quarter................................. 4.0207 2.0000 Third Quarter.................................. 6.6667 3.7500 Fourth Quarter................................. 13.6253 5.4167 DIVIDEND POLICY The Company has never paid a cash dividend and has no present intention to pay cash dividends in the foreseeable future. The Board of Directors currently intends to retain any future earnings for use in the Company's business. 18 ITEM 6. SELECTED CONSOLIDATED FINANCIAL DATA The table set forth below contains certain consolidated financial data for each of the last five fiscal years of the Company. This data should be read in conjunction with the detailed information, financial statements and related notes, as well as Management's Discussion and Analysis of Financial Condition and Results of Operations included elsewhere herein. (IN THOUSANDS, EXCEPT PER SHARE DATA) FOR THE YEAR ENDED ----------------------------------------------------------------- JULY 1, JULY 3, JUNE 27, JUNE 28, JUNE 29, CONSOLIDATED STATEMENT OF OPERATIONS DATA: 2000 1999 1998 1997 1996 - ----------------------------------------- ---- ---- ---- ---- ---- REVENUE: Lasers and other products.................... $60,340 $46,708 $25,917 $25,601 $20,403 Product related service...................... 11,320 8,801 8,405 7,660 7,861 Skin care centers............................ 3,730 3,079 2,703 2,244 2,149 ------- ------- ------- ------- ------- Total revenue........................... 75,390 58,588 37,025 35,505 30,413 COST OF SALES: Lasers and other products.................... 22,703 18,623 11,272 11,195 9,159 Product related service...................... 6,802 5,715 6,954 5,563 6,560 Skin care centers............................ 2,377 2,125 2,481 1,892 1,114 ------- ------- ------- ------- ------ Total cost of sales .................... 31,882 26,463 20,707 18,650 16,833 GROSS PROFIT: Lasers and other products.................... 37,637 28,085 14,645 14,406 11,244 Product related service...................... 4,518 3,086 1,451 2,097 1,301 Skin care centers............................ 1,353 954 222 352 1,035 ------- ------- ------- ------- -------- Total gross profit...................... 43,508 32,125 16,318 16,855 13,580 OPERATING EXPENSES: Research and development .................... 4,822 3,998 2,399 2,488 1,818 Selling, general & administrative............ 21,669 17,891 15,271 13,680 9,873 Restructuring charge (1).................... 0 0 2,609 0 0 ------- ------- ------- ------- ------- Total operating expenses................ 26,491 21,889 20,279 16,168 11,691 ------- ------- ------- ------- ------- Income (loss) from operations ................. 17,017 10,236 (3,961) 687 1,889 OTHER INCOME (EXPENSE): Interest income.............................. 1,427 115 42 84 93 Interest expense............................. (482) (492) (235) (107) (49) Other (income) expense....................... 242 (3) (123) (26) (207) ------- -------- -------- -------- -------- Total other income (expense)............ 1,187 (380) (316) (49) (163) ------- -------- -------- -------- -------- INCOME (LOSS) BEFORE INCOME TAXES............. 18,204 9,856 (4,277) 638 1,726 Provision for income taxes.................... 3,641 2,365 175 400 481 ------- ------- ------- ------- ------- NET INCOME (LOSS)............................. $14,563 $ 7,491 $(4,452) $ 238 $ 1,245 ======= ======= ======== ======= ======= Basic earnings(loss)per share................ $ 1.33 $ .91 $ (.54) $ .03 $ .16 Diluted earnings(loss)per share.............. $ 1.19 $ .82 $ (.54) $ .03 $ .15 Weighted average shares outstanding.......... 10,932 8,250 8,219 8,097 7,982 Adjusted weighted average shares outstanding. 12,190 9,179 8,219 8,510 8,478 JULY 1, JULY 3, JUNE 27, JUNE 28, JUNE 29 CONSOLIDATED BALANCE SHEET DATA: 2000 1999 1998 1997 1996 - ------------------------------- ---- ---- ---- ---- ---- Cash and cash equivalents.................... $34,863 $10,055 $ 1,615 $ 2,674 $ 3,041 Working capital.............................. 44,255 13,186 2,639 7,032 8,608 Total assets................................. 73,164 36,451 22,604 24,837 19,334 Long-term debt............................... 3,034 3,181 887 1,519 557 Total stockholders' equity................... 48,563 14,023 5,395 10,246 9,965 Total liabilities and stockholders' equity... 73,164 36,451 22,604 24,837 19,334 (1) During the quarter ended December 27, 1997, a restructuring charge was recorded and a reserve established in the amount of $2.6 million resulting from the closure of the skin care center located in Scottsdale, Arizona. 19 ITEM 7. MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS ALL STATEMENTS, TREND ANALYSIS AND OTHER INFORMATION CONTAINED IN THE FOLLOWING DISCUSSION RELATIVE TO MARKETS FOR OUR PRODUCTS AND TRENDS IN REVENUE, GROSS MARGINS AND ANTICIPATED EXPENSE LEVELS, AS WELL AS OTHER STATEMENTS INCLUDING WORDS SUCH AS "ANTICIPATE", "BELIEVE", "PLAN", "ESTIMATE", "EXPECT", AND "INTEND" AND OTHER SIMILAR EXPRESSIONS CONSTITUTE FORWARD-LOOKING STATEMENTS. THESE FORWARD-LOOKING STATEMENTS ARE SUBJECT TO BUSINESS AND ECONOMIC RISKS AND UNCERTAINTIES, AND OUR ACTUAL RESULTS OF OPERATIONS MAY DIFFER MATERIALLY FROM THOSE CONTAINED IN THE FORWARD-LOOKING STATEMENTS. FACTORS THAT COULD CAUSE OR CONTRIBUTE TO SUCH DIFFERENCES INCLUDE, BUT ARE NOT LIMITED TO THOSE DISCUSSED IN "CAUTIONARY STATEMENTS" AS WELL AS OTHER RISKS AND UNCERTAINTIES REFERENCED IN THIS PROSPECTUS. OVERVIEW We research, develop, manufacture, market, and service lasers used to perform aesthetic and cosmetic procedures. We sell our lasers principally to medical practitioners. Candela markets its products directly and through a network of distributors to end users. Our traditional customer base includes plastic and cosmetic surgeons and dermatologists. More recently, we have expanded our sales to a broader group of practitioners consisting of general practitioners and certain specialists including obstetricians, gynecologists, and general and vascular surgeons. Over 50% of our revenue in fiscal 2000 came from international sales. We derive our revenue from: - the sale of lasers and other products; - the provision of product related services; and - the operations of our remaining skin care center. Domestic and international product sales are generated principally through our direct sales force based in the U.S. and five international offices. Prior to fiscal 1999, a relatively small portion of our sales have come through our network of independent distributors. In December 1998, we entered into an exclusive distributorship arrangement with Physician Sales and Service (PSS) whose 700 representatives target general practice physicians and certain specialists in the U.S. Sales to distributors for the years ended July 1, 2000 and July 3, 1999, increased as a result of this arrangement. We typically assemble products in our Wayland, Massachusetts, facility in the quarter in which they are shipped, and backlog has not been significant. We experience some seasonal reduction of our product sales in the quarter ending in September due to the summer holiday schedule of physicians and their patients. All product shipments include a 12-month parts and service warranty. The anticipated cost associated with the warranty coverage is accrued at the time of shipment and amortized over the warranty period as a cost of sales charged to service revenue. Costs associated with product installation are also recognized as costs of product-related service revenue. Both such anticipated and actual costs have no associated revenue and therefore reduce the gross profit from product related service revenue. Product related service revenue consists of revenue from maintenance and repair services and the sale of spare parts and consumables. We derive revenue from extended warranty contracts, which are typically for a 12 to 24 month period. An extended 24 month warranty contract is standard with the purchase of our V-Beam-TM- system. In addition, we provide on- site service worldwide on a time-and-materials basis directly or through our distributors. In June 1996, we began an effort to own and operate skin care centers offering cosmetic laser treatments utilizing our equipment, along with providing other cosmetic services traditionally offered by high-end spas. We pursued this strategy 20 by purchasing an existing spa in Boston in 1996. In March 1997, we opened a new skin care center in Scottsdale, Arizona, with no pre-existing client base. We subsequently decided to reduce our focus on our skin care center efforts and to renew our commitment to our core aesthetic and cosmetic laser business. In the quarter ending December 27, 1997, we closed our Scottsdale facility because it had failed to generate any material revenue from its inception, recorded a restructuring charge, and established a reserve in the amount of $2.6 million which represented the anticipated cost associated with this closure. In January 1999, we ceased to offer aesthetic laser procedures at our Boston skin care center because the rate of performance was insufficient to justify the associated costs, but we continue to provide personal care and health and beauty services from this location. We are actively seeking buyers to assume the leases and purchase the assets of both the Scottsdale and Boston facilities. International revenue, consisting of sales from our subsidiaries in Germany, France, Spain, and Japan, and sales shipped directly to international locations from the U.S., during the fiscal years ended July 1, 2000, and July 3, 1999, represented 52% of total sales, and 53% for the year ended June 27, 1998. Our fiscal year consists of the 52 or 53-week period ending on the Saturday closest to June 30 of each year. The years ended July 1, 2000, July 3, 1999, and June 27, 1998, contained 52, 53 and 52 weeks, respectively. RESULTS OF OPERATIONS The following tables set forth selected financial data for the periods indicated, expressed as percentages. FOR THE YEAR ENDED ---------------------------------------- JULY 1, JULY 3, JUNE 27, 2000 1999 1998 ---- ---- ---- REVENUE MIX: (PERCENTAGE OF TOTAL REVENUE) Lasers and other products 80.0% 79.7% 70.0% Product related service 15.0 15.0 22.7 Skin care centers 5.0 5.3 7.3 ----- ----- ----- Total 100.0% 100.0% 100.0% OPERATING RATIOS: GROSS PROFIT (PERCENTAGE OF EACH REVENUE CATEGORY) Lasers and other products 62.4% 60.1% 56.5% Product related service 39.9 35.1 17.3 Skin care centers 36.3 31.0 8.2 ----- ----- ----- Total 57.7% 54.8% 44.1% OPERATING EXPENSE (PERCENTAGE OF TOTAL REVENUE) Research and development 6.4% 6.8% 6.5% Selling, general and administrative 28.7 30.5 41.2 Restructuring charge 0.0 0.0 7.1 ----- ----- ----- Total 35.1 37.3 54.8 ----- ----- ----- Income (loss) from operations 22.6 17.5 (10.7) Other income (expense) 1.5 (0.6) (0.9) ----- ----- ----- Net income (loss) before income taxes 24.1 16.9 (11.6) Provision for income taxes 4.8 4.0 0.4 ----- ----- ----- Net income (loss) 19.3% 12.8% (12.0)% ===== ===== ===== 21 FISCAL YEAR ENDED JULY 1, 2000 COMPARED TO FISCAL YEAR ENDED JULY 3, 1999 REVENUE. Total revenue increased 29% to $75.4 million in fiscal 2000 from $58.6 million in fiscal 1999. International revenue, consisting of sales from our subsidiaries in Germany, Spain, and Japan, and sales shipped directly to international locations from the U.S., was 52% of total revenue for both fiscal 2000 and fiscal 1999. Laser and product revenue increased 29% to $60.3 million in fiscal 2000 from $46.7 million in fiscal 1999. This was due to our initial shipments of our new Vbeam-TM- laser system for the treatment of vascular lesions and continued strong sales of our GentleLASE-Registered Trademark- hair removal system. Product-related service revenue increased 29% to $11.3 million in fiscal 2000 from $8.8 million in fiscal 1999. This increase was attributable to increased shipments of consumables used with our Vbeam-TM-, GentleLASE-Registered Trademark-, and Sclero products as well as an increase in the sale of service contracts. Skin care center revenue increased 21% to $3.7 million in fiscal 2000 compared to $3.1 million in 1999, due to increased marketing and promotional activities for our Boston Spa. GROSS PROFIT. Gross profit increased to $43.5 million or 58% of revenue in fiscal 2000 from $32.1 million or 55% of revenue in fiscal 1999 mainly as a result of increased sales of higher margin GentleLASE-Registered Trademark- and Vbeam-Registered Trademark- systems. Gross profit on lasers and other products increased to $37.6 million or 62% in fiscal 2000 compared to $28.1 million or 60% in fiscal 1999. Gross profit for service revenue in fiscal 2000 increased to $4.5 million or 40% of revenue compared to $3.1 million or 35% of revenue for fiscal 1999 resulting from the increase in the number of units in service. Skin care center gross profit for fiscal year 2000 increased to $1.35 million or 36% of revenue in comparison to $0.95 million or 31% of revenue for fiscal year 1999 resulting from a combination of increased number of services and emphasis placed on cost control within the center. RESEARCH AND DEVELOPMENT EXPENSE. Research and development spending for fiscal 2000 increased 21% to $4.8 million, from $4.0 million for fiscal 1999. The increase in research and development expense reflects efforts to develop new products and product improvements designed to enhance, augment, and expand our existing product lines. SELLING, GENERAL AND ADMINISTRATIVE EXPENSE. Selling, general and administrative expense increased 21% to $21.7 million in fiscal 2000, from $17.9 million in fiscal 1999. This reflects additional expenditures incurred to support our increased sales volume. This includes increased commission and travel costs as well as expenditures relating to our offices in Frankfurt, Paris, and Osaka. These offices were opened during the course of fiscal 1999 and 2000 and did not have a full year of expenses in fiscal 1999. Selling, general and administrative expenses were 29% of revenue in fiscal 2000 compared to 31% for fiscal 1999. RESTRUCTURING CHARGE. During the quarter ended December 27, 1997, a restructuring charge was recorded and a reserve established in the amount of $2.6 million resulting from the closure of the skin care center located in Scottsdale, Arizona. During fiscal 2000, a total of $476,000 was charged against this reserve, representing costs associated with the closure of the Scottsdale facility leaving a reserve balance of $1.0 million. Candela continues to pursue a sublease of the Scottsdale facility, but if this effort is not successful, we could incur additional costs in excess of our existing reserve. Management believes that the reserve established to date will be sufficiently adequate so that no additional material charges will need to be recorded for at least the next 18 months. OPERATING INCOME. Income from operations for the year ended July 1, 2000, increased by $6.8 million to $17.0 million, up from $10.2 million a year earlier. The improved performance was a result of increased revenue from product sales. OTHER INCOME/EXPENSE. For the fiscal year ended July 1, 2000, total other income was $1.2 million in comparison to other expense of $0.4 million for the same period a year earlier. This increase was a result of increased interest income due to our substantially higher cash balances in fiscal 2000 in comparison to fiscal 1999. Operating margins for future periods will be impacted by a modified royalty formulation with respect to our DCD license from the Regents negotiated in August of 2000, since the same royalty rate will mow apply to more components sold. 22 INCOME TAXES. The provision for income taxes results from a combination of activities of both the domestic and foreign subsidiaries. The provision for income taxes for the year ended July 1, 2000, reflects the utilization of tax credits generated in the current and tax provisions calculated in Japan and Spain at a rate in excess of the U.S. statutory tax rate. As of July 3, 1999, there were no federal net operating loss carryforwards and the federal tax credit carryforwards. We also released $3.1 million of the valuation allowance against our deferred tax asset in fiscal 2000. The effective tax rate for fiscal 2000 and 1999 are approximately 20% and 24%, respectively. During fiscal 2000, Candela believed it was more likely than not that a portion of the deferred tax asset would be utilized during the current year. Therefore, the Company, in accordance with the Statement of Financial Accounting Standards Board No. 109 "Accounting for Income Taxes", decreased in valuation allowance against current year taxable income, resulting in a decrease to its effective rate. FISCAL YEAR ENDED JULY 3, 1999 COMPARED TO FISCAL YEAR ENDED JUNE 27, 1998 REVENUE. Total revenue increased 58% to $58.6 million in fiscal 1999 from $37.0 million in fiscal 1998. International product revenue, consisting of sales from our subsidiaries in Germany, Spain, and Japan, and sales shipped directly to international locations from the U.S., was 52% of total revenue for fiscal 1999 compared to 53% for the same period in 1998. Laser and product revenue increased 80% to $46.7 million in fiscal 1999 from $25.9 million in fiscal 1998. This was due mainly to a significant increase in the volume of both domestic and international shipments of the GentleLASE-Registered Trademark-, which we began shipping in March 1998. Product-related service revenue increased 5% to $8.8 million in fiscal 1999 from $8.4 million in fiscal 1998. This increase was attributable to shipments of consumables used with the GentleLASE-Registered Trademark- and Sclero products. Skin care center revenue increased 14% to $3.1 million in 1999 compared to $2.7 million in 1998, due to increased marketing and promotional activities for our Boston Spa. GROSS PROFIT. Gross profit increased to $32.1 million or 55% of revenue in fiscal 1999 from $16.3 million or 44% of revenue in fiscal 1998 as a result of increased sales of higher margin GentleLASE-Registered Trademark- and higher absorption of fixed portions of manufacturing overhead. Gross profit on lasers and other products increased to $28.0 million or 60% in fiscal 1999 compared to $14.6 million or 57% in fiscal 1998. Gross profit for service revenue in fiscal 1999 increased to $3.1 million or 35% of revenue compared to $1.5 million or 17% of revenue for fiscal 1998. Skin care center gross profit for the year ended July 3, 1999 was positively impacted, in comparison to 1998, by the closure of the Scottsdale facility in the second quarter of fiscal 1998. RESEARCH AND DEVELOPMENT EXPENSE. Research and development spending for fiscal 1999 increased 67% to $4.0 million, from $2.4 million for fiscal 1998. The increase in research and development expense reflects efforts to develop products and product improvements designed to enhance, augment, and expand existing product lines. Research and development expense also includes approximately $481,000 of management bonuses, which are tied to pre-tax profits. SELLING, GENERAL AND ADMINISTRATIVE EXPENSE. Selling, general and administrative expense increased 17% to $17.9 million in fiscal 1999, from $15.3 million in fiscal 1998. This reflects increased staffing levels in the sales and marketing departments incurred to support revenue growth, partially offset by savings realized from operating one skin care center rather than two during the first six months of the fiscal year. Also affecting selling, general and administrative expense for fiscal 1999 was an expense of approximately $1.3 million for the payment of management bonuses that are tied to pre-tax profits derived from product and service revenue. In fiscal 1998, the management bonus accrued amounted to approximately $325,000. In relation to revenue, selling, general and administrative expenses were 31% of revenue in fiscal 1999 compared to 41% for fiscal 1998. RESTRUCTURING CHARGE. During the quarter ended December 27, 1997, a restructuring charge was recorded and a reserve established in the amount of $2.6 million resulting 23 from the closure of the skin care center located in Scottsdale, Arizona. During fiscal 1999, a total of $476,000 was charged against this reserve, representing costs associated with the closure of the Scottsdale facility leaving a reserve balance of $1.5 million. OPERATING INCOME. Income from operations for the year ended July 3, 1999, increased by $14.2 million, from a loss of $4.0 million in fiscal 1998 to a profit of $10.2 million, in fiscal 1999. The improved performance was a result of both increased revenue from product sales and reduced expenses in connection with operations of the skin care centers. OTHER INCOME/EXPENSE. For the fiscal year ended July 3, 1999, total other expense was $380,000 in comparison to $316,000 for the same period a year earlier. The increase resulted from an increase in interest expenses from the debt issued in October, 1998, partially offset by a decrease in exchange losses from our foreign operations and an increase in interest income resulting from higher cash balances. INCOME TAXES. The provision for income taxes results from a combination of activities of both the domestic and foreign subsidiaries. The provision for income taxes for the year ended July 3, 1999, reflects the utilization of the domestic net operating loss and tax credit carryforwards and tax provisions calculated in Japan and Spain at a rate in excess of the U.S. statutory tax rate. We had a net operating loss carryforward of approximately $2.2 million and tax credit carryforwards of approximately $1.6 million at June 28, 1998, the beginning of the current fiscal year. Based on current year operating results, we utilized all of the federal net operating loss carryforwards and the federal tax credit carryforwards. We also released $1.1 million of the valuation allowance against our deferred tax asset in fiscal 1999. The effective tax rate for fiscal 1999 is approximately 24%. During the second quarter of fiscal 1999, Candela believed that it was more likely than not that a portion of the deferred tax asset would be utilized during 2000. Therefore, the Company, in accordance with the Statement of Financial Accounting Standard No. 109 "Accounting for Income Taxes", decreased its valuation allowance for the portion related to the utilization of the net operating loss and tax credit carryforwards against current year taxable income, resulting in a decrease to its effective rate. LIQUIDITY AND CAPITAL RESOURCES Cash provided by operating activities amounted to $8.5 million for fiscal 2000 compared to $8.8 million in fiscal 1999, reflecting increased operating profit offset by an increase in account receivables and other assets. Cash used in investing activities totaled $554,000 for fiscal 2000 compared to $161,000 for the same period a year earlier resulting from a reduction in the amount of assets sold in fiscal 2000. Cash provided by financing activities amounted to $18.1 million in 2000 in comparison to $15,000 for 1999. This was a result of completing our secondary offering in July, 1999, with the proceeds offset by the cost of Candela shares repurchased in the open market during the fourth quarter of fiscal 2000. Cash and cash equivalents at July 1,2000, increased by $24.8 million to $34.9 million from $10.1 million at July 3, 1999, primarily due to the cash proceeds received from our July, 1999 secondary offering. We completed a public offering in July 1999, for 3,645,000 shares of common stock, of which 2,249,781 shares were sold by Candela and 1,395,219 shares were sold by certain selling shareholders. We received approximately $19.1 million in net proceeds from the sale of our shares. On October 15, 1998, we issued eight-year, 9.75% subordinated term notes to three investors in the aggregate amount of $3.7 million, secured by the Company's assets. The notes become due in October, 2006, and require quarterly interest payments. In addition, we issued warrants to purchase 555,000 shares of common stock to the note holders that have an exercise price of $2.67 per share. The relative fair value ascribed to the warrants is $836,000 and has been recorded as a component of Additional Paid-In Capital in Stockholders Equity. The relative fair value of the debt was recorded as $2,864,000. The debt will be accreted to face value using the 24 interest method over eight years, which will result in interest expense of $836,000 over the eight-year period in addition to the 9.75% face interest. The Company also maintains a renewable $5,000,000 revolving credit agreement with a major bank with interest at the bank's base rate. Any borrowings outstanding under the line of credit are due on demand or according to a payment schedule established at the time funds are borrowed. The line of credit is unsecured. The agreement contains restrictive covenants limiting the establishment of new liens, and the purchase of margin stock. No amounts were outstanding under the line of credit as of July 1, 2000. Our remaining short-term and long-term debt is comprised of capital lease obligations in the amount of $15,000 and $9,000, respectively, at July 1, 2000, compared to $310,000 and $252,000, respectively, at July 3, 1999. We believe that cash balances will be sufficient to meet anticipated cash requirements through the first quarter of fiscal 2002. However, we cannot be sure that we will not require additional capital beyond the amounts currently forecasted by us, nor that any such required additional capital will be available on reasonable terms, if at all, at such as it becomes required. YEAR 2000 READINESS DISCLOSURE STATEMENT We have executed a plan designed to make our products, information technology systems and equipment Year 2000 ready. To date, we have experienced no significant problems in our products, business interruptions or material adverse effects from the Year 2000 issue. However, we could still experience material unanticipated problems and costs caused by undetected errors or defects from the Year 2000 issue. We cannot guarantee that our Year 2000 readiness plan has been successfully implemented, and actual results could still differ materially from our plan CAUTIONARY STATEMENTS This Annual Report on Form 10-K contains forward-looking statements including, without limitation, statements concerning the future of the industry, product development, business strategy (including the possibility of future acquisitions), anticipated operational and capital expenditure levels, continued acceptance and growth of our products, and dependence on significant customers and suppliers. This Annual Report on Form 10-K contains forward-looking statements that we have made based on our current expectations, estimates and projections about our industry, operations, and prospects, not historical facts. We have made these forward-looking statements pursuant to the provisions of the Private Securities Litigation Reform Act of 1995. These statements can be identified by the use of forward-looking terminology such as "may," "will," "believe," "expect," "anticipate," "estimate," "continue" or other similar words. These statements discuss future expectations, and may contain projections of results of operations or of financial condition or state other forward-looking information. When considering forward-looking statements, you should keep in mind the cautionary statements in this Annual Report on Form 10-K. The cautionary statements noted below and other factors noted throughout this Annual Report on Form 10-K could cause our actual results to differ significantly from those contained in any forward-looking statement. We may not update or publicly release the results of these forward-looking statements to reflect events or circumstances after the date hereof. BECAUSE WE DERIVE MORE THAN HALF OF OUR REVENUE FROM INTERNATIONAL SALES, INCLUDING APPROXIMATELY ONE-THIRD OF OUR REVENUE FROM JAPAN AND THE ASIA-PACIFIC MARKETPLACE IN FISCAL 2000, WE ARE SUSCEPTIBLE TO CURRENCY FLUCTUATIONS, NEGATIVE ECONOMIC CHANGES TAKING PLACE IN JAPAN AND THE ASIA-PACIFIC MARKETPLACE, AND OTHER RISKS ASSOCIATED WITH CONDUCTING BUSINESS OVERSEAS. 25 We sell a significant portion of our products and services outside the U.S. and Canada. International sales, consisting of sales from our subsidiaries in Germany, Spain, and Japan, and sales shipped directly to international locations from the U.S., accounted for 52% of our revenue for fiscal year 2000, and we expect that they will continue to be significant. As a result, a major part of our revenues and operating results could be adversely affected by risks associated with international sales. In particular, significant fluctuations in the exchange rates between the U.S. dollar and foreign currencies could cause us to lower our prices and thus reduce our profitability, or could cause prospective customers to push out orders because of the increased relative cost of our products in the aftermath of a currency devaluation or currency fluctuation. Other risks associated with international sales which we have faced in the past include: - longer payment cycles common in foreign markets, - failure to obtain or significant delays in obtaining necessary import or foreign regulatory approvals for our products, and - difficulties in staffing and managing our foreign operations. THE FAILURE TO OBTAIN ALEXANDRITE RODS FOR THE GENTLELASE-Registered Trademark- AND ALEXLAZR-TM-FROM OUR SOLE SUPPLIER WOULD IMPAIR OUR ABILIty to MANUFACTURE AND SELL GENTLELASE-Registered Trademark-. We use Alexandrite rods to manufacture the GentleLASE-Registered Trademark- and the ALEXlazr-TM-, which account for a significant portion of Our total revenues. We depend exclusively on Litton Airtron Synoptics to supply these rods, for which no alternative supplier meeting our quality standards exists. We cannot be certain that Litton will be able to meet our future requirements at current prices or at all. To date, we have been able to obtain adequate supplies of Alexandrite rods in a timely manner, but any extended interruption in our supplies could hurt our results. DISAPPOINTING QUARTERLY REVENUE OR OPERATING RESULTS COULD CAUSE THE PRICE OF OUR COMMON STOCK TO FALL. Our quarterly revenue and operating results are difficult to predict and may swing sharply from quarter to quarter. Historically, our first fiscal quarter has had the least amount of revenue in any quarter of our fiscal year. The results of the first quarter are directly impacted by the seasonality of the purchasing cycle. In the last three fiscal years, first quarter revenue has been below the previous quarter's revenue in the range of 11.0% to 19.1%. If our quarterly revenue or operating results fall below the expectations of investors or public market analysts, the price of our common stock could fall substantially. Our quarterly revenue is difficult to forecast for many reasons, some of which are outside of our control, including the following: MARKET SUPPLY AND DEMAND - potential increases in the level and intensity of price competition between us and our competitors, - potential decrease in demand for our products, and - possible delays in market acceptance of our new products. CUSTOMER BEHAVIOR - changes in or extensions of our customers' budgeting and purchasing cycles, and - changes in the timing of product sales in anticipation of new product introductions or enhancements by us or our competitors. 26 COMPANY OPERATIONS - absence of significant product backlogs, - our effectiveness in our manufacturing process, - unsatisfactory performance of our distribution channels, service providers, or customer support organizations, and - timing of any acquisitions and related costs. THE COST OF CLOSING OUR SKIN CARE CENTERS MAY BE HIGHER THAN MANAGEMENT HAS ESTIMATED TO DATE, AND HIGHER ACTUAL COSTS WOULD NEGATIVELY IMPACT OUR OPERATING RESULTS. We have renewed our commitment to expand and diversify our core cosmetic and surgical laser equipment business. As part of this refocus, we decided to reduce our focus on our efforts to own and operate centers which would offer cosmetic laser treatments utilizing our equipment, along with providing other cosmetic services traditionally offered by high-end spas. Although we are actively seeking buyers for the two skin care centers we opened which are located in Scottsdale, Arizona, and Boston, Massachusetts, we cannot be certain that a sale or sublease of either facility will be completed on favorable terms or at all. We have established a reserve to accrue for the anticipated costs of terminating the Scottsdale facility, but we can't be sure that such a reserve will be adequate. To date, we have not established a reserve in connection with the Boston facility, which we are continuing to operate as a spa without providing cosmetic laser services. OUR FAILURE TO RESPOND TO RAPID CHANGES IN TECHNOLOGY AND INTENSE COMPETITION IN THE LASER INDUSTRY COULD MAKE OUR LASERS OBSOLETE. The aesthetic and cosmetic laser equipment industry is subject to rapid and substantial technological development and product innovations. To be successful, we must be responsive to new developments in laser technology and new applications of existing technology. Our financial condition and operating results could be hurt if our products fail to compete favorably in response to such technological developments, or we are not agile in responding to competitors' new product introductions or product price reductions. In addition, we compete against numerous companies offering products similar to ours, some of which have greater financial, marketing, and technical resources than we do. We cannot be sure that we will be able to compete successfully with these companies and our failure to do so could hurt our business, financial condition, and results of operations. LIKE OTHER COMPANIES IN OUR INDUSTRY, WE ARE SUBJECT TO A REGULATORY REVIEW PROCESS AND OUR FAILURE TO RECEIVE NECESSARY GOVERNMENT CLEARANCES OR APPROVALS COULD AFFECT OUR ABILITY TO SELL OUR PRODUCTS AND REMAIN COMPETITIVE. The types of medical devices that we seek to market in the U.S. generally must receive either "510(k) clearance" or "PMA approval" in advance from the U.S. Food and Drug Administration (FDA) pursuant to the Federal Food, Drug, and Cosmetic Act. The FDA's 510(k) clearance process usually takes from four to twelve months, but it can last longer. The process of obtaining PMA approval is much more costly and uncertain and generally takes from one to three years or even longer. To date, the FDA has deemed our products eligible for the 510(k) clearance process. We believe that most of our products in development will receive similar treatment. However, we cannot be sure that the FDA will not impose the more burdensome PMA approval process upon one or more of our future products, nor can we be sure that 510(k) clearance or PMA approval will ever be obtained for any product we propose to market. Many foreign countries in which we market or may market our products have regulatory bodies and restrictions similar to those of the FDA. Particularly, for example, we are awaiting Ministry of Health approval in Japan for the sale of ScleroPLUS-TM- and the Vbeam-TM-. We cannot be certain that we will be able to obtain (or continue to obtain) 27 any such government approvals or successfully comply with any such foreign regulations in a timely and cost-effective manner, if at all, and our failure to do so could adversely affect our ability to sell our products. WE HAVE MODIFIED SOME OF OUR PRODUCTS WITHOUT FDA CLEARANCE. THE FDA COULD RETROACTIVELY DECIDE THE MODIFICATIONS WERE IMPROPER AND REQUIRE US TO CEASE MARKETING AND/OR RECALL THE MODIFIED PRODUCTS. Any modification to one of our 510(k) 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. The FDA requires every manufacturer to make this determination in the first instance, but the FDA can review any such decision. We have modified some of our marketed devices, but we believe that new 510(k) clearances are not required. We cannot be certain that the FDA would agree with any of our decisions not to seek 510(k) clearance. If the FDA requires us to seek 510(k) clearance for any modification, we also may be required to cease marketing and/or recall the modified device until we obtain a new 510(k) clearance. ACHIEVING COMPLETE COMPLIANCE WITH FDA REGULATIONS IS DIFFICULT, AND IF WE FAIL TO COMPLY, WE COULD BE SUBJECT TO FDA ENFORCEMENT ACTION. We are subject to inspection and market surveillance by the FDA to determine compliance with regulatory requirements. The FDA's regulatory scheme is complex, especially the Quality System Regulation, which requires manufacturers to follow elaborate design, testing, control, documentation, and other quality assurance procedures. This complexity makes complete compliance difficult to achieve. Also, the determination as to whether a QSR violation has occurred is often subjective. If the FDA finds that we have failed to comply with the QSR or other applicable requirements, the agency can institute a wide variety of enforcement actions, including a public warning letter or other stronger remedies, such as: - fines, injunctions, and civil penalties against us, - recall or seizure of our products, - operating restrictions, partial suspension, or total shutdown of our production, - refusing our requests for 510(k) clearance or PMA approval of new products, - withdrawing product approvals already granted, and - criminal prosecution. CLAIMS BY OTHERS THAT OUR PRODUCTS INFRINGE THEIR PATENTS OR OTHER INTELLECTUAL PROPERTY RIGHTS COULD PREVENT US FROM MANUFACTURING AND SELLING SOME OF OUR PRODUCTS OR REQUIRE US TO INCUR SUBSTANTIAL COSTS FROM LITIGATION OR DEVELOPMENT OF NON-INFRINGING TECHNOLOGY. Our industry has been characterized by frequent litigation regarding patent and other intellectual property rights. Patent applications are maintained in secrecy in the U.S. until such patents are issued and are maintained in secrecy for a period of time outside the U.S. Accordingly, we can conduct only limited searches to determine whether our technology infringes any patents or patent applications of others. Any claims of patent infringement would be time-consuming and could: - result in costly litigation, - divert our technical and management personnel, - cause product shipment delays, - require us to develop non-infringing technology, or 28 - require us to enter into royalty or licensing agreements. Although patent and intellectual property disputes in the laser industry have often been settled through licensing or similar arrangements, costs associated with such arrangements may be substantial and often require the payment of ongoing royalties, which could hurt our gross margins. In addition, we cannot be sure that the necessary licenses would be available to us on satisfactory terms, or that we could redesign our products or processes to avoid infringement, if necessary. Accordingly, an adverse determination in a judicial or administrative proceeding, or the failure to obtain necessary licenses, could prevent us from manufacturing and selling some of our products, which could hurt our business, results of operations, and financial condition. On the other hand, we may have to start costly and time consuming litigation in order to enforce our patents, to protect trade secrets, and know-how owned by us or to determine the enforceability, scope, and validity of the proprietary rights of others. We have received correspondence from Palomar Medical Technologies, the exclusive licensee from Star Medical Technologies of certain United States patents, and also from Star Medical, offering to grant us a nonexclusive license to such patents. We have engaged in discussions with Palomar relative to these patents, but have not yet decided on a specific course of action. WE COULD INCUR SUBSTANTIAL COSTS AS A RESULT OF PRODUCT LIABILITY CLAIMS. There are various risks of physical injury to the patient when using our lasers for aesthetic and cosmetic treatments. Injuries often result in product liability or other claims being brought against the practitioner utilizing the device and us. The costs and management time we would have to spend in defending or settling any such claims, or the payment of any award in connection with such claims, could hurt our business, results of operations, and financial condition. Although we maintain product liability insurance, we cannot be certain that our policy will provide sufficient coverage for any claim or claims that may arise, or that we will be able to maintain such insurance coverage on favorable economic terms. WE MAY BE UNABLE TO ATTRACT AND RETAIN MANAGEMENT AND OTHER PERSONNEL WE NEED TO SUCCEED. The loss of any of our senior management or other key research, development, sales, and marketing personnel, particularly if lost to competitors, could hurt our future operating results. 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 attract, retain, and motivate sufficient numbers of such personnel. OUR FAILURE TO MANAGE FUTURE ACQUISITIONS AND JOINT VENTURES EFFECTIVELY MAY DIVERT MANAGEMENT ATTENTION FROM OUR CORE BUSINESS AND CAUSE US TO INCUR ADDITIONAL DEBT, LIABILITIES OR COSTS. We may acquire businesses, products, and technologies that complement or expand our business. We may also consider joint ventures and other collaborative projects. We may not be able to: - identify appropriate acquisition or joint venture candidates, - successfully negotiate, finance, or integrate any businesses, products, or technologies that we acquire, or - successfully manage any joint ventures or collaborations. Furthermore, the integration of any acquisition or joint venture may divert management time and resources. If we fail to manage these acquisitions or joint ventures effectively we may incur debts or other liabilities or costs which could harm our operating results or financial condition. While we from time to time 29 evaluate potential acquisitions of businesses, products, and technologies, consider joint ventures and other collaborative projects, and anticipate continuing to make these evaluations, we have no present understandings, commitments, or agreements with respect to any acquisitions or joint ventures. ITEM 7a. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK At July 1, 2000, the Company held foreign currency forward contracts with notional values totaling approximately $4,621,515 for the deliverance of 239,789,349 Japanese Yen, 826,885 German Marks, 262,959,104 Spanish Pesetas, and 3,524,487 French Francs. These contracts have maturities prior to September 13, 2000.The Company held foreign currency forward contracts with notional values totaling approximately $5,307,086 for the deliverance of 631,844,877 Japanese Yen at July 3, 1999. The carrying and net fair value of these contracts at July 1, 2000, was $0 and ($65,591), respectively, compared to $0 and $86,090, respectively, at July 3, 1999. The net fair value is computed by subtracting the value of the contracts using the yearend exchange rate (the notional value) from the value of the forward contracts computed at the contracted exchange rates. We have cash equivalents and marketable securities that primarily consist of commercial paper, corporate bonds and overnight money market accounts. Interest rate return is fixed at the time of investment. ITEM 8. FINANCIAL STATEMENTS AND SUPPLEMENTARY DATA Financial statements and supplementary data are included herein and are indexed under item 14 (a) (1)-(2). ITEM 9. CHANGES IN AND DISAGREEMENTS WITH ACCOUNTANTS ON ACCOUNTING AND FINANCIAL DISCLOSURE The information required under this item is incorporated by reference to the Company's report on Form 8-K dated March 21, 2000 filed with the commission. PART III ITEM 10. DIRECTORS AND EXECUTIVE OFFICERS OF THE REGISTRANT The information concerning directors of the Company required under this item is incorporated herein by reference to the Company's definitive proxy statement pursuant to Regulation 14A to be filed with the Commission not later than 120 days after the close of the Company's fiscal year ended July 1, 2000 under the headings "Election of Directors" and "Section 16(a) Reporting Delinquencies." The information concerning executive officers of the Company set forth under the caption "Executive Officers" in Item 1 of this Form 10-K is incorporated herein by reference to the Company's definitive proxy statement pursuant to Regulation 14A, to be filed with the Commission not later than 120 days after the close of the Company's fiscal year ended July 1, 2000 under the heading "Section 16(a) Reporting Delinquencies." ITEM 11. EXECUTIVE COMPENSATION The information required under this item is incorporated herein by reference to the Company's definitive proxy statement pursuant to Regulation 14A, to be filed with the Commission nor later than 120 days after the close of the 30 Company's fiscal year ended July 1, 2000, under the heading "Compensation and Other Information Concerning Directors and Officers." ITEM 12. SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT The information required under this item is incorporated herein by reference to the Company's definitive proxy statement pursuant to Regulation 14A, to be filed with the Commission not later than 120 days after the close of the Company's fiscal year ended July 1, 2000, under the heading "Security Ownership of Certain Beneficial Owners and Management." ITEM 13. CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS The information, if any, required under this item is incorporated herein by reference to the Company's definitive proxy statement pursuant to Regulation 14A, to be filed with the Commission within 120 days after the close of the Company's fiscal year ended July 1, 2000, under the heading "Certain Transactions." PART IV ITEM 14. EXHIBITS, FINANCIAL STATEMENT SCHEDULES AND REPORTS ON FORM 8-K (a) The following items are filed as part of this report: (1) CONSOLIDATED FINANCIAL STATEMENTS: Report of Independent Auditors F-1 Report of Independent Accountants F-2 Consolidated Balance Sheets - July 1, 2000 and July 3, 1999 F-3 Consolidated Statements of Operations - Years ended July 1, 2000, July 3, 1999, and June 27, 1998 F-4 Consolidated Statements of Stockholders' Equity - Years Ended July 1, 2000, July 3, 1999, and June 27, 1998 F-5 Consolidated Statements of Cash Flows - Years Ended July 1, 2000, July 3, 1999, and June 27, 1998 F-6 Notes to Consolidated Financial Statements F-7 (2) CONSOLIDATED FINANCIAL STATEMENT SCHEDULES: Schedule II - Valuation and Qualifying Accounts F-21 The reports of the registrant's independent auditors with respect to the above-listed financial statements and financial statement schedule appears on page F-1 and F-2 of this report. All other financial statements and schedules not listed have been omitted since the required information is included in the consolidated financial statements or the notes thereto, or is not applicable, material, or required. (3) EXHIBITS: Except as otherwise noted, the following documents are incorporated by reference from the Company's Registration Statement on Form S-1 (File Number 333-78339): 3.1 Certificate of Incorporation, as amended 3.2 < FN9 > By-laws of the Company, as amended and restated 3.3 < FN1 > Agreement of Merger between Candela Corporation, Inc., a Massachusetts corporation, and Candela Laser Corporation, a Delaware corporation. 4.1 < FN6 > Form of Rights Agreement dated as of September 4, 1992, between the Company and The First National Bank of Boston, as Rights Agent, which includes as Exhibit A thereto the Form of Rights Certificate 10.1 < FN1 > 1985 Incentive Stock Option Plan 10.2 < FN2 > 1987 Stock Option Plan 10.2.1 < FN2 > 1989 Stock Plan 10.2.2 < FN3 > 1990 Employee Stock Purchase Plan 10.2.3 < FN3 > 1990 Non-Employee Director Stock Option Plan 10.2.4 < FN7 > 1993 Non-Employee Director Stock Option Plan 10.2.5 < FN13 > 1998 Stock Plan 10.3 < FN7 > Lease for premises at 526 Boston Post Road, Wayland, Massachusetts 10.4 < FN7 > Lease for premises at 530 Boston Post Road, Wayland, Massachusetts 10.5 < FN7 > Patent License Agreement between the Company and Patlex Corporation effective as of July 1, 1988 10.6 < FN4 > License Agreement among the Company, Technomed International, Inc. and Technomed International S.A. dated as of December 20, 1990 10.7 < FN5 > License Agreement between the Company and Pillco Limited Partnership effective as of October 1, 1991 31 10.8 < FN8 > Distribution Agreement between the Company and Cryogenic Technology Limited, dated October 15, 1993 10.9 < FN10 > Asset Purchase Agreement between the Company and Derma-Laser, Limited and Derma-Lase, Inc. dated June 23, 1994. 10.10 < FN13 > Letter Agreement between the Company and Fleet Bank dated February 13, 1997 10.10.1 < FN13 > Amendment to Letter Agreement between the Company and Fleet Bank dated December 15, 1998. 10.11* < FN11 > Exclusive Distribution Agreement dated as of December 21, 1999, by and among the Company and Physicians Sales and Service. 10.12* < FN11 > Exclusive License Agreement dated as of February 13,1995 and amended October 15, 1998, by and among the Company and the Regents of the University of California. 10.12.1* Settlement Agreement dated August 11, 2000 and among the Company, the Regents of the University of California, and Cool Touch, Inc. 10.13 < FN12 > Note and Warrant Purchase Agreement, dated as of October 15, 1998 by and among the Company, Massachusetts Capital Resource Company, William D. Witter and Michael D.Witter. 10.13.1 < FN12 > Form of Note delivered to the Company in the aggregate principal amount of $3,700,000 to Massachusetts Capital Resource Company, William D. Witter and Michael D. Witter. 10.13.2 < FN12 > Form of Common Stock Purchase Warrant to purchase an aggregate of 370,000 shares of the Company's Common Stock delivered to Massachusetts Capital Resource Company, William D. Witter and Michael D. Witter. 21.1 < FN11 > Subsidiaries of the Company 23.1 Consent of PricewaterhouseCoopers LLP (Independent Accountants) 23.2 Consent of Ernst & Young, LLP (Independent Auditors) 27.1 Financial Data Schedule _ * Confidential treatment as to certain portions has been requested pursuant to Rule 24b-2. < FN1 > Previously filed as an exhibit to Registration Statement No. 33-54448B and incorporated herein by reference. < FN2 > Previously filed as an exhibit to the Company's Amended and Restated Annual Report on Form 10-K for the fiscal year ended June 30, 1988, and incorporated herein by reference. < FN3 > Previously filed as an exhibit to the Company's Annual Report on Form 10-K for the fiscal year ended June 30, 1990, and incorporated herein by reference. < FN4 > Previously filed as an exhibit to Form 10-Q for the quarter ended December 29, 1990, and incorporated herein by reference. < FN5 > Previously filed as an exhibit to Form 10-Q for the quarter ended September 28, 1991, and incorporated herein by reference. < FN6 > Previously filed as an exhibit to Form 8-K, dated September 8, 1992, and incorporated herein by reference. < FN7 > Previously filed as an exhibit to the Company's Annual Report on Form 10-K for the fiscal year ended July 3, 1993, and incorporated herein by reference. < FN8 > Previously filed as an exhibit to Form 10-Q for the quarter ended January 1, 1994, and incorporated herein by reference. < FN9 > Previously filed as an exhibit to Form 10-Q for the quarter ended April 2, 1994, and incorporated herein by reference. < FN10 > Previously filed as an exhibit to the Company's Annual Report on Form 10-K for the fiscal year ended July 2, 1994, and incorporated herein by reference. < FN11 > Previously filed as an exhibit to Form 10-Q for the quarter ended March 27, 1999 and incorporated herein for reference. < FN12 > Previously filed as an exhibit to the Company's Amended and Restated Annual Report on Form 10-K for the fiscal year ended June 27, 1998, and incorporated herein by reference. < FN13 > Previously filed as an exhibit to Registration Statement No. 333-78339 and incorporated herein by reference. (b) Reports on Form 8-K. No reports on Form 8-K were filed by the Company during the fourth quarter of the fiscal year ended July 1, 2000. (c) The Company hereby files, as part of this Form 10-K, the exhibits listed in Item 14(a)(3) above. (d) The Company hereby files, as part of this Form 10-K, the consolidated financial Statement schedules listed in Item 14(a)(2) above. 32 SIGNATURES Pursuant to the requirements of Section 13 or 15(d) of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized, on September 28, 2000. CANDELA CORPORATION By: /s/ Gerard E. Puorro --------------------- Gerard E. Puorro, President, Chief Executive Officer and Director Pursuant to the requirements of the Securities Exchange Act of 1934, this report has been signed below by the following persons on behalf of the registrant and in the capacities and on the dates indicated. Signature Title Date --------- ----- ---- /s/ Gerard E. Puorro President, Chief Executive September 28, 2000 ------------------------- Officer, and Director Gerard E. Puorro (Principal Executive Officer) /s/ F. Paul Broyer Senior Vice President of September 28, 2000 ------------------------- Finance and Administration, F. Paul Broyer Treasurer and Chief Financial Officer /s/ Kenneth D. Roberts Chairman of the Board September 28, 2000 ------------------------- of Directors Kenneth D. Roberts /s/ Richard J. Cleveland Director September 28, 2000 ------------------------- Richard J. Cleveland /s/ Theodore G. Johnson Director September 28, 2000 ------------------------- Theodore G. Johnson /s/ Nancy Nager Director September 28, 2000 ------------------------- Nancy Nager /s/ Douglas W. Scott Director September 28, 2000 ------------------------- Douglas W. Scott 33 REPORT OF INDEPENDENT AUDITORS To the Stockholders and Board of Directors Candela Corporation We have audited the accompanying consolidated balance sheet of Candela Corporation and subsidiaries as of July 1, 2000 and the related statements of operations and comprehensive income, stockholders' equity and cash flows for the year ended July 1, 2000. Our audit also included the financial statement schedule listed in the Index at Item 14(a). These financial statements and schedule are the responsibility of the Company's management. Our responsibility is to express an opinion on these financial statements and schedule based on our audit. We conducted our audit in accordance with auditing standards generally accepted in the United States. Those standards require that we plan and perform the audit to obtain reasonable assurance as to whether the financial statements are free of material misstatement. An audit includes examining, on a test basis, evidence supporting the amounts and disclosures in the financial statements. An audit also includes assessing the accounting principles used and significant estimates made by management, as well as evaluating the overall financial statement presentation. We believe that our audit provides a reasonable basis for our opinion. In our opinion, the financial statements referred to above present fairly, in all material respects, the consolidated financial position of Candela Corporation and subsidiaries at July 1, 2000, and the results of its operations and its cash flows for the year ended July 1, 2000 in conformity with accounting principles generally accepted in the United States. Also, in our opinion, the related financial statement schedule, when considered in relation to the basic financial statements taken as a whole, presents fairly in all material respects the information set forth therein. /s/ERNST & YOUNG LLP Boston, Massachusetts August 11, 2000 F-1 REPORT OF INDEPENDENT ACCOUNTANTS To the Board of Directors and Stockholders of Candela Corporation: In our opinion, the accompanying consolidated balance sheet and the related consolidated statements of operations and comprehensive income, of stockholders' equity and cash flows, present fairly, in all material respects, the financial position of Candela Corporation and its Subsidiaries at July 3, 1999, and the results of their operations and their cash flows for each of the two years in the period ended July 3, 1999, in conformity with generally accepted accounting principles. In addition, in our opinion, the financial statement schedule for each of the two years in the period ended July 3, 1999, presents fairly, in all material respects, the information set forth therein when read in conjunction with the related consolidated financial statements. These financial statements and financial statement schedule are the responsibility of the Company's management; our responsibility is to express an opinion on these financial statements based on our audits. We conducted our audits of these statements in accordance with generally accepted auditing standards which require that we plan and perform the audit to obtain reasonable assurance about whether the financial statements are free of material misstatement. An audit includes examining, on a test basis, evidence supporting the amounts and disclosures in the financial statements, assessing the accounting principles used and significant estimates made by management, and evaluating the overall financial statement presentation. We believe that our audits provide a reasonable basis for the opinion expressed above. /s/PRICEWATERHOUSECOOPERS LLP Boston, Massachusetts August 23, 1999 F-2 CANDELA CORPORATION AND SUBSIDIARIES CONSOLIDATED BALANCE SHEETS JULY 1, 2000 AND JULY 3, 1999 (DOLLARS IN THOUSANDS) ASSETS 2000 1999 - ------ ---- ---- Current assets: Cash and cash equivalents (Note 1) $ 34,863 $ 10,055 Accounts receivable (net of allowance of $1,207 and $998 in 2000 and 1999, respectively)(Notes 1 & 8) 19,875 12,337 Notes receivable 1,813 2,186 Inventories (Notes 1 & 2) 8,386 6,927 Other current assets 885 928 -------- -------- Total current assets 65,822 32,433 Property and equipment, net (Note 3) 2,462 2,626 Deferred tax assets (Note 7) 4,643 1,100 Other assets 237 292 -------- -------- Total assets $ 73,164 $ 36,451 ======== ======== LIABILITIES AND STOCKHOLDERS' EQUITY - ------------------------------------ Current liabilities: Accounts payable $ 4,654 $ 4,846 Accrued payroll and related expenses 2,351 3,735 Accrued warranty costs 3,295 2,502 Income taxes payable 3,332 3,185 Restructuring reserve (Note 10) 1,043 1,519 Other accrued liabilities 1,467 1,132 Current portion of long-term debt(Note 5) 15 415 Deferred income (Note 4) 5,410 1,913 -------- -------- Total current liabilities 21,567 19,247 Long-term debt (Note 5) 3,034 3,181 Commitments and contingencies(Note 5) - - Stockholders' equity (Note 6): Common stock, $.01 par value: 30,000,000 shares authorized; 11,501,241 and 8,347,497 shares issued and outstanding in 2000 and 1999, respectively 115 83 Additional paid-in capital 41,924 18,535 Treasury stock, at cost; 280,000 shares (3,046) - Accumulated earnings (deficit) 10,717 (3,846) Accumulated other comprehensive income (1,147) (749) -------- -------- Total stockholders' equity 48,563 14,023 -------- -------- Total liabilities and stockholders' equity $ 73,164 $ 36,451 ======== ======== The accompanying notes are an integral part of the consolidated financial statements. F-3 CANDELA CORPORATION AND SUBSIDIARIES CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE INCOME FOR THE YEARS ENDED JULY 1, 2000, JULY 3, 1999, AND JUNE 27, 1998 (IN THOUSANDS, EXCEPT PER SHARE DATA) 2000 1999 1998 -------- -------- -------- Revenue: Lasers and other products $ 60,340 $ 46,708 $ 25,917 Product related service 11,320 8,801 8,405 Skin care centers 3,730 3,079 2,703 -------- -------- -------- Total revenue 75,390 58,588 37,025 Cost of sales: Lasers and other products 22,703 18,623 11,272 Product related service 6,802 5,715 6,954 Skin care centers 2,377 2,125 2,481 -------- -------- -------- Total cost of sales 31,882 26,463 20,707 -------- -------- -------- Gross profit 43,508 32,125 16,318 Operating expenses: Research and development 4,822 3,998 2,399 Selling, general and administrative 21,669 17,891 15,271 Restructuring charge - - 2,609 -------- -------- -------- Total operating expenses 26,491 21,889 20,279 -------- -------- -------- Income (loss) from operations 17,017 10,236 (3,961) Other income (expense) Interest income 1,427 115 42 Interest expense (482) (492) (235) Other income (expense) 242 (3) (123) -------- -------- -------- Total other income (expense) 1,187 (380) (316) -------- -------- -------- Income (loss) before income taxes 18,204 9,856 (4,277) Provision for income taxes 3,641 2,365 175 -------- -------- -------- Net income (loss) $ 14,563 $ 7,491 $ (4,452) ======== ======== ======== Basic earnings (loss) per share $ 1.33 $ 0.91 $ (0.54) Diluted earnings (loss) per share $ 1.19 $ 0.82 $ (0.54) ======== ======== ======== Weighted average shares outstanding 10,932 8,250 8,219 Adjusted weighted average shares outstanding 12,190 9,179 8,219 ======== ======== ======== Net income (loss) $ 14,563 $ 7,491 $ (4,452) Other comprehensive income (loss) net of tax: Foreign currency translation adjustment (318) (14) (607) -------- -------- -------- Comprehensive income (loss) $ 14,245 $ 7,477 $ (5,059) ======== ======== ======== The accompanying notes are an integral part of the consolidated financial statements. F-4 CANDELA CORPORATION AND SUBSIDIARIES CONSOLIDATED STATEMENTS OF STOCKHOLDERS' EQUITY FOR THE YEARS ENDED JULY 1, 2000, JULY 3, 1999, AND JUNE 27, 1998 (IN THOUSANDS) ACCUMULATED ADDITIONAL ACCUMULATED OTHER PAID-IN EARNINGS COMPREHENSIVE COMMON STOCK CAPITAL TREASURY STOCK (DEFICIT) INCOME TOTAL ------------- -------- -------------- ---------- -------- ------- SHARES AMOUNT SHARES AMOUNT - ------------------------------------------------------------------------------------------------------------------------------------ BALANCE JUNE 29, 1997 8,130 $81 $17,196 - $- $ (6,885) $(146) $10,246 Sale of common stock under stock plans 89 1 184 185 Net loss (4,452) (4,452) Currency translation adjustment (584) (584) - ----------------------------------------------------------------------------------------------------------------------------------- BALANCE JUNE 27, 1998 8,219 82 17,380 - - (11,337) (730) 5,395 Sale of common stock under stock plans 126 1 309 310 Exercise of stock warrants 3 10 10 Issuance of stock warrants 836 836 Net income 7,491 7,491 Currency translation adjustment (19) (19) - ----------------------------------------------------------------------------------------------------------------------------------- BALANCE JULY 3, 1999 8,348 83 18,535 - - (3,846) (749) 14,023 Sale of common stock under stock plans 693 7 1,856 1,863 Exercise of stock warrants 210 2 788 790 Secondary offering 2,250 23 19,101 19,124 Purchase of treasury stock (280) (3,046) (3,046) Disqualifying dispositions of stock options 1,644 1,644 Net income 14,563 14,563 Currency translation adjustment (398) (398) - ----------------------------------------------------------------------------------------------------------------------------------- BALANCE JULY 1, 2000 11,501 $115 $ 41,924 (280) $ (3,046) $ 10,717 $(1,147) $ 48,563 - ----------------------------------------------------------------------------------------------------------------------------------- The accompanying notes are an integral part of the consolidated financial statements. F-5 CANDELA CORPORATION AND SUBSIDIARIES CONSOLIDATED STATEMENTS OF CASH FLOWS FOR THE YEARS ENDED JULY 1, 2000, JULY 3, 1999, AND JUNE 27, 1998 (IN THOUSANDS) 2000 1999 1998 ------ ------ ------- Cash flows from operating activities: Net income (loss) $ 14,563 $ 7,491 $ (4,452) Adjustments to reconcile net income (loss) to net cash provided by (used for) operating activities: Depreciation and amortization 715 751 815 Provision for bad debts 312 268 844 Provision for restructuring charges - - 2,609 Accretion of interest on debt discount 96 66 - Increase (decrease) in cash from working capital: Accounts receivable (7,984) (3,905) (950) Notes receivable 629 (488) (434) Inventories (1,247) 362 (810) Other current assets 91 (762) 314 Other assets (3,542) (1,114) 664 Accounts payable 443 361 (1,046) Accrued payroll and related expenses (1,278) 2,415 491 Deferred income 3,499 78 (241) Accrued warranty costs 793 488 683 Income taxes payable 1,646 2,849 (154) Restructuring reserve (476) (289) (501) Other accrued liabilities 265 213 303 -------- -------- -------- Net cash provided by (used for) operating activities 8,525 8,784 (1,865) Cash flows from investing activities: Proceeds from sale of assets - 363 24 Purchases of property and equipment (554) (524) (317) -------- -------- -------- Net cash used for investing activities (554) (161) (293) Cash flows from financing activities: Net borrowings from (repayments of) lines of credit - (2,700) 1,700 Proceeds from issuance of debt and stock warrants - 3,700 396 Principal payments on debt (78) (668) (441) Payments of capital lease obligations (574) (638) (390) Proceeds from issuance of common stock 21,777 321 184 Purchases of treasury stock (3,046) - - -------- -------- -------- Net cash provided by financing activities 18,079 15 1,449 Effect of exchange rate changes on cash and cash equivalents (1,242) (198) (350) -------- -------- -------- Net increase (decrease) in cash and cash equivalents 24,808 8,440 (1,059) Cash and cash equivalents at beginning of period 10,055 1,615 2,674 -------- -------- -------- Cash and cash equivalents at end of period $ 34,863 $ 10,055 $ 1,615 ======== ======== ======== Cash paid during the year for: Interest $ 387 $ 366 $ 235 Income taxes 3,099 $ 615 $ 356 Non-cash activity: Capital lease financing $ - $ 42 $ 84 The accompanying notes are an integral part of the consolidated financial statements. F-6 NOTES TO CONSOLIDATED FINANCIAL STATEMENTS 1. SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES BUSINESS The Company researches, develops, manufactures, markets, and services lasers and other devices used to perform aesthetic and cosmetic procedures. BASIS OF PRESENTATION The consolidated financial statements include the accounts of Candela Corporation and its wholly-owned subsidiaries. All intercompany accounts and transactions have been eliminated. The Company's fiscal year ends on the Saturday nearest June 30. The years ended July 1, 2000, July 3, 1999, and June 27, 1998 contain 52, 53 and 52 weeks, respectively. USE OF ESTIMATES The presentation of financial statements in conformity with generally accepted accounting principles requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities, disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenues and expenses during the reporting period. It is the belief of the Company's management that all necessary adjustments have been made for an accurate presentation of results. Actual results could differ from those estimates and impact future results of operations and cash flows. CASH AND CASH EQUIVALENTS The Company classifies investments purchased with a maturity at the date of acquisition of three months or less as cash equivalents. These are valued at cash plus accrued interest, which approximates market value. At July 1, 2000, and July 3, 1999, substantially all cash equivalents were invested in overnight Repurchase Agreements, U.S. Treasury Bills with a major bank, or commercial paper issued by a major bank. The Company had letters of credit outstanding at July 1, 2000, amounting to $37,727 with expiration dates varying between August 15, and September 30, 2000. FINANCIAL INSTRUMENTS The Company operates internationally, with sales offices, customers, and vendors in several countries outside of the United States. The Company may reduce its exposure to fluctuations in foreign exchange rates by creating offsetting positions through the use of foreign currency forward contracts, a type of derivative financial instrument. Foreign currency exposures are accounted for on an accrual basis. The Company does not use derivative financial instruments for trading or speculative purposes, nor is the Company a party to leveraged derivatives. At July 1, 2000, the Company held foreign currency forward contracts with notional values totaling approximately $6,179,614 for the deliverance of 387,425,844 Japanese Yen, 826,885 German Marks, 262,959,104 Spanish Pesetas, and 3,524,487 French Francs. These contracts have maturities prior to September 13, 2000. The Company held foreign currency forward contracts with notional values totaling approximately $5,307,086 for the deliverance of F-7 631,844,877 Japanese Yen at July 3, 1999. The carrying and net fair value of these contracts at July 1, 2000, was $0 and ($52,921), respectively, compared to $0 and $86,090, respectively, at July 3, 1999. The net fair value is computed by subtracting the value of the contracts using the year-end exchange rate (the notional value) from the value of the forward contracts computed at the contracted exchange rates. ACCOUNTS RECEIVABLE AND NOTES RECEIVABLE The Company's trade accounts receivables and notes receivables are primarily from sales to end users and distributors servicing the dermatology market, and reflect a broad domestic and international customer base. The Company does not require collateral and has not historically experienced significant credit losses related to receivables from individual customers or groups of customers in any particular industry or geographic area. INVENTORY Inventory is stated at the lower of cost (first-in, first-out method) or market, using a standard costing system. PROPERTY AND EQUIPMENT Purchased property and equipment is recorded at cost. Property and equipment purchased under capital lease arrangements is recorded at the lesser of cost or the present value of the minimum lease payments required during the lease period. Laser systems used for testing are capitalized at cost. Depreciation and amortization are provided using the straight-line method over the estimated useful lives as follows: NUMBER OF YEARS --------------- Leasehold improvements and assets under capital lease 2 to 13 Office furniture and other equipment 3 to 5 Laser systems 3 REVENUE RECOGNITION PRODUCT SALES - Revenue from product sales, except sales to certain distributors, is recognized at the time of shipment. Shipments made to distributors, for which payment to the Company is dependent on resale of the system, are not recognized as revenue unless the distributor demonstrates that the system is sold. GRANTS - Revenue from U.S. government contracts is granted under the Small Business Innovation Research program. Government contracts limit reimbursement to 100% of allowable direct costs and a negotiated rate for indirect costs. The revenue is recognized as reimbursable costs are incurred. SERVICE - Revenue from the sale of service contracts is deferred and recognized on a straight-line basis over the contract period. Revenue from service administered by Candela is recognized as the services are provided. Amounts received from the sale of gift certificates by Candela Skin Care Centers ("CSCC") are deferred and recognized as revenue when the services are provided. F-8 ADVERTISING COSTS Advertising costs are expensed as incurred. Advertising costs were $782,000, $604,000 and $608,000 for the years ending July 1, 2000, July 3, 1999 and June 27, 1998, respectively. FOREIGN CURRENCY TRANSLATION The activity of the Company's foreign subsidiaries is translated into U.S. dollars in accordance with Statement of Financial Accounting Standards (SFAS) No. 52, "Foreign Currency Translation". Assets and liabilities are translated into U.S. dollars at current exchange rates, while income and expense items are translated at average rates of exchange prevailing during the year. Exchange gains and losses arising from translation of the Japanese, Spanish, German, and French subsidiary balance sheets are accumulated as a separate component of stockholders' equity. Net exchange gain or (loss) resulting from foreign currency transactions amounted to $190,000, ($20,000) and ($138,000) for fiscal 2000, 1999, and 1998, respectively, and are included in other expense. PRODUCT WARRANTY COSTS The length of the Company's warranty on end user sales of medical devices is generally one year on parts and labor except on our Vbeam-TM- system, which carries a standard three-year warranty. An extended warranty is also available for purchase for our GentleLASE-Registered Trademark- systems. Distributor sales generally include a parts warranty only. Estimated future costs for initial product warranties are provided for at the time of sale. STOCK SPLIT On January 19, 2000, the Board of Directors approved a three-for-two stock split, payable in the form of a 50% stock dividend, to all shareholders of record on January 28, 2000. Except for shares authorized, references to number of shares and to per share information in the consolidated financial statements have been adjusted to reflect the stock split. TREASURY STOCK The Board of Directors approved a share repurchase program whereby the Company has the option to repurchase up to 750,000 of its common shares between December 13, 1999 and December 12, 2001. The Company has implemented the plan through open market purchases, which are paid for with general corporate funds. As of July 1, 2000, the Company had repurchased 280,000 shares. EARNINGS (LOSS) PER SHARE (numbers in thousands, except FOR THE YEARS ENDED per share amounts) ------------------------------------------ JULY 1, JULY 3, JUNE 27, 2000 1999 1998 -------- -------- -------- NUMERATOR Net income (loss) $14,563 $ 7,491 $(4,452) ======= ======== ======== DENOMINATOR BASIC EARNINGS PER SHARE Weighted average shares outstanding 10,932 8,250 8,219 -------- -------- -------- Basic earnings (loss) per share $ 1.33 $ 0.91 $ (0.54) ======= ======== ======== F-9 DILUTED EARNINGS PER SHARE Weighted average shares outstanding 10,932 8,250 8,219 Effect of dilutive warrants 702 317 - Effect of dilutive options 556 612 - -------- -------- -------- Adjusted weighted average shares outstanding 12,190 9,179 8,219 -------- -------- -------- Diluted earnings (loss) per share $ 1.19 $ 0.82 $ (0.54) ======= ======== ======== During the years ended July 1, 2000, July 3, 1999, and June 27, 1998, options and warrants to purchase 157,500, 6,884 and 304,371 shares of common stock, respectively, were not included in the computation of diluted earnings (loss) per share because they would have had an anti-dilutive effect. DIVIDENDS The Company currently intends to retain future earnings for use in its business and, therefore, does not expect to pay dividends in the foreseeable future. ACCOUNTING FOR STOCK-BASED COMPENSATION The Company has elected the disclosure-only alternative permitted under SFAS No. 123, "Accounting for Stock-Based Compensation." The Company has disclosed herein pro forma net income and pro forma earnings per share in the footnotes using the fair value based method for fiscal 2000, 1999, and 1998. NEW ACCOUNTING PRONOUNCEMENTS In June 1999, the Financial Accounting Standards Board (FASB) issued SFAS No. 137, "Accounting for Derivative Instruments and Hedging Activities - Deferral of the Effective Date of FASB Statement 133," which postponed the adoption date of SFAS No. 133. As such, the Company is not required to adopt SFAS 133 until fiscal 2001. Had the Company implemented SFAS No. 133 for the current reporting period, there would have been no material effect on operational results. In December 1999, The Securities and Exchange Commission issued Staff Accounting Bulletin No. 101 ("SAB 101"), Revenue Recognition in Financial Statements. SAB 101 provides guidance on applying generally accepted accounting principles to revenue recognition issues in financial statements. The Company has not assessed the effect that such adoption may have on its consolidated results of operations and financial position. UNCERTAINTIES The Company is subject to risks common to companies in the aesthetic laser industry, including (i) the Company's ability to successfully complete preclinical and clinical development and obtain timely regulatory approval and adequate patent and other proprietary rights protection of its products and services, (ii) the content and timing of decisions made by the Food & Drug Administration and other agencies regarding the procedures for which the Company's products may be approved, (iii) the ability of the Company to manufacture adequate supplies of its products for development and commercialization activities, (iv) the accuracy of the Company's estimates of the size and characteristics of markets to be addressed by the Company's products and services, (v) market acceptance of the Company's product and services, (vi) the Company's ability to obtain reimbursement for its products from third-party payers, where appropriate, and (vii) the accuracy of the F-10 Company's information concerning the products and resources of competitors and potential competitors. 2. INVENTORIES Inventories consist of the following (in thousands): JULY 1, JULY 3, 2000 1999 ---- ---- Raw materials $2,750 $1,643 Work in process 602 1,395 Finished goods 5,034 3,889 ------ ------ $8,386 $6,927 ====== ====== 3. PROPERTY AND EQUIPMENT Property and equipment consists of the following (in thousands): JULY 1, JULY 3, 2000 1999 ---- ---- Leasehold improvements $2,268 $2,173 Office furniture 977 791 Laser systems 483 482 Computers and other equipment 4,486 4,265 ----- ----- 8,214 7,711 Less accumulated depreciation and amortization (5,752) (5,085) ----- ----- Property and equipment, net $2,462 $2,626 ====== ====== Depreciation expense was approximately $715,000, $751,000, and $684,000 for fiscal 2000, 1999, and 1998, respectively. Assets under capital lease obligations of $989,000 and $487,000 are included in property and equipment at July 1, 2000 and July 3, 1999, respectively. Accumulated depreciation on these assets was $811,000 and $413,000 at July 1, 2000 and July 3, 1999, respectively. 4. DEFERRED INCOME Deferred income consists of the following (in thousands): JULY 1, JULY 3, 2000 1999 ---- ---- Service contract revenue $ 2,041 $ 941 Extended service plans 2,228 - Gift certificate revenue 730 510 Customer deposits 270 - Other deferred sales revenue 141 462 ------- ------- $ 5,410 $ 1,913 ======= ======= F-11 5. DEBT AND LEASE OBLIGATIONS LINE OF CREDIT During fiscal 2000, the Company obtained a renewable $5,000,000 revolving credit agreement with a major bank with interest at the bank's base rate or LIBOR plus 225 basis points. Any borrowings outstanding under the line of credit are due on demand or according to a payment schedule established at the time funds are borrowed. The line of credit is unsecured. The agreement contains restrictive covenants limiting the establishment of new liens, and the purchase of margin stock. No amounts were outstanding under the line of credit as of July 1, 2000. During fiscal 1999, the Company maintained a renewable $3,500,000 revolving credit agreement with a major bank with interest at the bank's prime lending rate. No amounts were outstanding under the line of credit as of July 3, 1999. This line of credit expired on December 1, 1999. SUBORDINATED NOTES On October 15, 1998, the Company issued eight-year, 9.75%, subordinated term notes ("Note Agreement") to three investors in the aggregate amount of $3.7 million, secured by the assets of the Company. The notes become due in October 2006, and require quarterly interest payments. The Company is required to make mandatory quarterly principal payments of $185,000, along with any unpaid interest, beginning on January 31, 2002. In addition, the Company issued warrants to purchase 370,000 shares of common stock (555,000 shares post-split) to the note holders which have an exercise price of $4.00 per share and are exercisable through October 2006. The relative fair value ascribed to the warrants of $836,000 (measured as of the date of issuance) was estimated using a Black-Scholes model assuming a 4.5% risk free rate of return, an eight-year life of the warrant, a 72% volatility factor for an eight-year period and no dividend rate. The relative fair value of the warrants has been recorded as a component of Additional Paid-In Capital. The relative fair value of the debt was recorded as $2,864,000. In addition to the 9.75% stated interest rate, interest expense of an additional $836,000 will be accreted to debt using the interest method over the eight-year life of the debt to bring the value of that debt to its $3.7 million face value. The Note Agreement also contains clauses that prohibit the Company from redeeming the notes earlier than November 1, 2001, except in certain circumstances. The Company is also subject to an early redemption premium amounting to 10% if paid in the first year following November 1, 2001. This premium decreases by 2% per year for the next two years following November 1, 2001 and allows for the Company to redeem the notes without penalty after November 1, 2004. The agreement contains restrictive covenants establishing maximum leverage, certain minimum ratios, and minimum levels of net income. BANK LOAN In June 1997, the Company obtained an unsecured term bank loan denominated in 75,000,000 Japanese Yen bearing interest at 1.745% per annum with quarterly payments of principal and interest. This bank loan was paid in full September 1999. In June 1998, the Company obtained a term bank loan denominated in 50,000,000 Japanese Yen, collateralized by a customer note receivable, bearing interest at F-12 1.825% per annum with payment of interest in advance. The principal became due and was paid in August 1998. LONG-TERM DEBT The Company's long-term debt consists of the following (dollars in thousands): JULY 1, JULY 3, 2000 1999 -------- -------- Subordinated notes, eight-year term, 9.75% interest rate, quarterly interest payments due through October, 2006 quarterly principal payments commencing in January, 2002 $ 3,025 $ 2,929 Obligations under capital leases collateralized by the related equipment interest from 5.8% to 12.31% per annum; payments of principal and interest through March 2002 24 598 Unsecured term bank loan denominated in 75,000,000 Japanese yen; interest at 1.745% per annum; quarterly payments of principal and interest through September 1999 _ 69 ----- ----- 3,049 3,596 Less current portion 15 415 ------- ------- Total long-term debt $ 3,034 $ 3,181 ======= ======= As of July 1, 2000, the Company's scheduled maturities under debt and capital lease obligations are as follows (in thousands): Fiscal 2001 $ 15 2002 379 2003 740 2004 740 2005 and thereafter 1,850 ------ Total obligations 3,724 Less: future accretion (675) ------ Long-term obligations $3,049 ====== OPERATING LEASE COMMITMENTS The Company leases several facilities and automobiles under noncancellable lease arrangements. The facility leases may be adjusted for increases in maintenance and insurance costs above specified levels. In addition, certain facility leases contain escalation provisions based on certain specified criteria, and one lease calls for the payment of additional rent based on a percentage of gross revenues above a base gross sales level for that particular location. These operating leases expire in various years through 2009. These leases may be renewed for periods ranging from one to five years. Future minimum lease payments under noncancellable operating leases with initial terms of one year or more consisted of the following at July 3, 2000: (in thousands) 2001 $ 799 2002 673 2003 415 2004 208 2005 and thereafter 688 ----- Total minimum lease payments $2,783 ====== F-13 Total rent expense was approximately $912,000, $769,000, and $848,000 for fiscal 2000, 1999, and 1998, respectively. 6. STOCKHOLDERS' EQUITY STOCK PLANS 1990 CANDELA CORPORATION EMPLOYEE STOCK PURCHASE PLAN The 1990 Employee Stock Purchase Plan (the "Purchase Plan") provides for the sale of up to 750,000 shares of common stock to eligible employees. The shares are issued at the lesser of 85% of the average market price on the first or last day of semiannual periods. Substantially all full-time employees are eligible to participate in the Purchase Plan. At July 1, 2000 there were 484,504 shares available for grant. The following is a summary of shares issued under the Purchase Plan: RANGE OF SHARES PRICE PER SHARE ------ --------------- 1998 22,824 $1.67 - $2.50 1999 31,802 $1.67 - $3.33 2000 25,382 $7.75 - $8.33 1985, 1987, 1989 AND 1998 CANDELA CORPORATION STOCK OPTION PLANS The 1985, 1987, 1989 and 1998 Stock Option Plans (the "Stock Option Plans") provide for the granting of incentive stock options to employees for the purchase of common stock at an exercise price not less than the fair market value of the stock on the date of grant. The Stock Option Plans also provide for the granting of non-qualified stock options. The Board of Directors has terminated the granting of options under the 1985 and 1987 Stock Option Plans. Options granted under the 1989 Stock Option Plan become exercisable ratably over two or four years from the date of grant and expire ten years from the date of the grant. Options granted under the 1998 Stock Option Plan become exercisable on the date of grant or in installments, as specified by a Committee established by the Board of Directors, and expire ten years from the date of the grant. The maximum number of shares for which options may be granted under the 1989 Stock Option Plan is 1,500,000 shares. The maximum number of shares for which options may be granted under the 1998 Stock Option Plan is 750,000 shares. On April 28, 1998, the Board of Directors approved the repricing of certain outstanding stock options granted under the 1989 Stock Option Plan priced at $5.83 and $5.42. The exercise price of these options was amended to $2.17, the fair market value of the stock on that date. F-14 1990 AND 1993 CANDELA CORPORATION NON-EMPLOYEE DIRECTOR STOCK OPTION PLANS The 1990 and 1993 Non-Employee Director Stock Option Plans (the "Non-Employee Director Plans," collectively with the Stock Option Plans, the "Plans") provide for the issuance of options for the purchase of up to 90,000 and 120,000 shares of common stock, respectively. Under the Non-Employee Director Plans, each director who is neither an employee nor an officer receives a one-time grant of an option to purchase 10,000 shares of common stock at an exercise price equal to the fair market value of the common stock on the date of grant. Under the Non-Employee Director Plans, options become exercisable in equal amounts over a period of four and two years, respectively. Shares under the Non-Employee Director Plans expire four and ten years, respectively, after the date of grant and are nontransferable. The following is a summary of stock option activity under the Plans: WEIGHTED AVERAGE NUMBER OF EXERCISE PRICE SHARES OPTION PRICE PER SHARE Balance at June 28, 1997 1,291,886 $ 3.2533 Granted 365,801 $2.17 -$ 3.17 $ 2.7352 Exercised (65,837) $1.83 -$ 2.25 $ 2.0801 Canceled (404,960) $1.83 -$ 6.58 $ 4.7011 ------- Balance at June 27, 1998 1,186,890 $ 2.4800 Granted 571,500 $2.29 -$ 5.63 $ 3.6533 Exercised (94,940) $1.33 -$ 5.00 $ 2.4352 Canceled (189,843) $2.13 -$ 5.17 $ 2.7977 ------- Balance at July 3, 1999 1,473,607 $ 3.0470 Granted 172,500 $8.33 -$12.04 $10.1875 Exercised (635,294) $1.00 -$ 5.63 $ 3.3127 Canceled (165,375) $2.17 -$ 9.67 $ 5.9191 -------- Balance at July 1, 2000 845,438 $ 5.0869 -------- Options available for grant at July 1, 2000 478,875 ======= The following table summarizes information about stock options under the Plans outstanding at July 1, 2000: OPTIONS OUTSTANDING OPTIONS EXERCISABLE ------------------------------------------------------------------------------ ---------------------------------- WEIGHTED AVERAGE WEIGHTED WEIGHTED RANGE OF NUMBER REMAINING AVERAGE NUMBER AVERAGE EXERCISE OUTSTANDING CONTRACTUAL EXERCISE EXERCISABLE EXERCISE PRICES AT 7/1/00 LIFE (YEARS) PRICE AT 7/1/00 PRICE -------------------------------------------------------------------------- ---------------------------------- $ 1.8333-$ 2.2500 211,848 3.72 $ 2.1802 177,728 $ 2.1802 $ 2.2917-$ 3.8333 223,317 7.09 $ 3.0366 150,840 $ 3.1258 $ 4.1250-$ 4.6667 176,337 8.15 $ 4.5515 75,087 $ 4.3962 $ 5.0000-$ 8.3333 76,436 8.55 $ 6.0371 18,564 $ 6.0544 $12.0420-$12.0420 157,500 9.54 $12.0420 0 $ 0.0000 ------- - $ 1.8333-$12.0420 845,438 7.06 $ 5.0869 422,219 $ 3.0824 ======= ======= F-15 The Company applies Accounting Principles Board Opinion No. 25, "Accounting for Stock Issued to Employees", and related interpretations in accounting for its option plans. Accordingly, no compensation expense has been recognized for options granted to employees and directors of the Company. Had compensation expense for the Plans been determined based on the fair value at the grant date for awards under the Plans consistent with the methodology prescribed under SFAS No. 123, the Company's net income and net income per share would have been reduced by $579,000, or $.05 per share in 2000, $479,000 or $.08 per share in 1999, and $45,000 or $.01 per share in 1998. The weighted average fair value of the options granted under the Plans in 2000, 1999 and 1998, calculated using the Black-Scholes pricing model, was $7.54, $2.16, and $1.66 per share, respectively. The weighted average fair value of shares issued under the Purchase Plan for 2000, 1999, and 1998 calculated using the Black-Scholes pricing model, were $4.87, $.92, and $3.29 per share. The following assumptions were used in the Black-Scholes pricing model for options granted in 2000, 1999, and 1998, respectively: 2000 1999 1998 ---- ---- ---- risk-free interest rate 6.61% 4.84% 5.95% estimated volatility 82% 77% 83% expected life for stock options (yrs) 4.06 3.8 6 expected life for stock purchase plan (yrs) .5 .5 .5 expected dividends none none none The effects of applying SFAS No. 123 in this pro-forma disclosure are not indicative of the pro-forma effect on net income in future years because SFAS No. 123 does not take into consideration pro-forma expenses related to options granted prior to 1996. CANDELA CORPORATION COMMON STOCK WARRANTS In connection with a litigation settlement in January 1991, the Company authorized warrants to purchase 300,000 shares of common stock (450,000 shares post-split) in March 1992. The exercise price for the warrants is $6.875 per share, which was not affected by the stock split. These warrants will expire in November 2000. There were 300,833 warrants outstanding at July 1, 2000. (See Note 5) The Company also issued warrants to purchase 370,000 shares of common stock (555,000 shares post-split) to the note holders of the Company's $3.7 million debt issuance in October, 1998, at a price of $4.00 per warrant, which was not affected by the stock split. At July 1, 2000, 465,000 warrants were outstanding. (See Note 5) RESERVED SHARES The Company has reserved 4,151,523 shares of common stock for issuance under its Purchase, Stock Option, Non-Employee Director Plans and Warrants. CANDELA CORPORATION STOCKHOLDER RIGHTS PLAN On September 4, 1992, the Company adopted a Stockholder Rights Plan under which it declared a dividend of one common stock purchase right (the Right) for each share of the Company's common stock outstanding on September 22, 1992. The Rights are not currently exercisable, but would become exercisable if certain triggering events occur, such as the initiation of certain tender offers for the Company's common stock. If such an event occurs, each Right would initially F-16 entitle shareholders to purchase one share of the Company's common stock at an exercise price of $48 per share, subject to adjustment. In the event that the Rights are exercised after further triggering events, each Right would entitle holders to purchase, for the exercise price then in effect, shares of the Company's common stock (or other property, under certain circumstances) having a value of twice the exercise price. Such Rights do not extend to any shareholders whose action triggered the Rights. The Company can in certain circumstances redeem the Rights at .005 per Right. The Rights expire on September 22, 2002, unless redeemed earlier by the Company. 7. INCOME TAXES The components of income before income taxes and the related provision for income taxes consists of the following periods (in thousands): FOR YEARS ENDED -------------------------------------------- JULY 1, JULY 3, JUNE 27, 2000 1999 1998 -------- ------- --------- Income (loss) before income taxes: Domestic $16,559 $ 8,063 $(4,686) Foreign 1,645 1,793 409 ------- ------- ------- $18,204 $ 9,856 $(4,277) ======= ======= ======= Provision for income taxes: Current provision: Federal $ 5,341 $ 1,890 $ - State 707 635 26 Foreign 1,136 940 149 ------- ------- ------- Total current provision for income taxes 7,184 3,465 175 Deferred provision: Federal (3,543) (1,100) - ------- -------- ------- Total provision for income taxes $ 3,641 $ 2,365 $ 175 ======= ======= ======= The components of the Company's deferred tax assets consist of the following (in thousands): JULY 1, JULY 3, 2000 1999 ---- ---- State net operating loss carryforwards $ - $ 108 State tax credit carryforwards 321 315 Inventory valuation reserves 599 1,022 Warranty reserve 2,237 1,001 Deferred revenue 344 368 Bad debt reserve 391 360 Restructuring reserve 412 608 Pre-opening expense 256 260 Other 83 172 ------ ------ Gross deferred tax asset 4,643 4,214 Valuation allowance - (3,114) ------ ------ Net deferred tax assets $4,643 $1,100 ====== ====== F-17 A reconciliation from the federal statutory tax rate to the effective tax rate is as follows: JULY 1, JULY 3, JUNE 27, 2000 1999 1998 ---- ---- ----- Statutory rate 35% 34% 34% State taxes 4 4 - Differences between foreign and U.S. tax rates 2 3 - Utilization of deferred tax assets (17) (14) - Unbenefitted losses - (6) (35) Other (4) 3 (3) ---- --- ---- Effective tax rate 20 % 24 % (4)% === === === As of July 3, 1999 the Company had approximately $3.1 million of valuation allowance relating to a deferred tax asset resulting principally from U.S. tax losses, research and development tax credits, and timing differences relating to U.S. assets and liabilities. Income tax expense for the year ended July 1, 2000, has been reduced by approximately $3.1 million through a reduction in the valuation allowance. As of July 1, 2000, the Company has no valuation allowance against the deferred tax asset. In accounting for the deferred tax asset, the Company has relied on historic data to determine the necessity of providing a valuation allowance for this asset. Under the requirements of SFAS No. 109, "Accounting for Income Taxes", Candela believed it more likely than not that the deferred tax asset would be fully utilized against future income taxes. 8. SEGMENT, GEOGRAPHIC AND MAJOR CUSTOMER INFORMATION The Company operates principally in two industry segments; the design, manufacture, sale, and service of medical devices and related equipment, and the performance of services in the skin care/health spa industry. GEOGRAPHIC DATA Geographic information for fiscal 2000 and fiscal 1999 is as follows (in thousands): 2000 1999 ---- ---- Revenue: United States $ 47,482 $ 39,403 Intercompany 17,690 14,374 -------- -------- 65,172 53,777 Europe 8,010 6,059 Japan 19,898 13,126 -------- -------- 93,080 72,962 Elimination (17,690) (14,374) -------- -------- Consolidated total $ 75,390 $ 58,588 ======== ======== Income from operations: United States $ 16,034 $ 9,381 Europe (782) 404 Japan 1,709 1,411 Elimination 56 (960) -------- -------- Consolidated total $ 17,017 $ 10,236 ======== ======== F-18 Geographic identification of long-term assets: United States $ 7,291 $ 3,975 Europe 51 43 Japan - - -------- -------- Consolidated total $ 7,342 $ 4,018 ======== ======== LINE OF BUSINESS DATA Revenue: Product sales and service $ 71,660 $ 55,509 Skin care/health spa services 3,730 3,079 -------- -------- Total revenue $ 75,390 $ 58,588 ======== ======== Income (loss) from operations: Product sales and service $ 17,647 $ 11,321 Skin care/health spa services (630) (1,085) -------- -------- Total income (loss) from operations $ 17,017 $ 10,236 ======== ======== Depreciation and amortization: Product sales and service $ 331 $ 520 Skin care/health spa services 384 221 -------- -------- Total depreciation and amortization $ 715 $ 741 ======== ======== Capital expenditures: Product sales and service $ 336 $ 566 Skin care/health spa services 218 0 -------- -------- Total capital expenditures $ 554 $ 566 ======== ======== Total assets: (net of intercompany accounts) Product sales and service $ 71,151 $ 34,250 Skin care/health spa services 2,013 2,201 -------- -------- Total assets $ 73,164 $ 36,451 ======== ======== United States revenue includes export sales to unaffiliated companies located principally in Western Europe, the Middle East, and in the Asia-Pacific region, which approximated $11,781,000, $11,218,000, and $7,695,000 for fiscal 2000, 1999, and 1998, respectively. One customer, a domestic distributor, accounted for 13% of net revenue and 22.2% of gross receivables as of July 1, 2000 in comparison to 8% of net revenue and 16.6% of gross receivables as of July 3, 1999. In addition, two foreign distributors accounted for 7.8% and 9.6% of gross receivables at July 3, 1999. The Company depends on a single vendor for Alexandrite rods used to manufacture the GentleLASE-Registered Trademark- and the ALEXlazr-TM-. These products account for a significant portion of our total revenues. 9. EMPLOYEE BENEFIT PLANS The Company offers a savings plan which allows eligible U.S. employees to make tax-deferred contributions, a portion of which are matched by the Company. Company contributions vest ratably with three years of employment and amounted to $168,000, $102,000, and $58,000 in fiscal 2000, 1999, and 1998, respectively. 10. RESTRUCTURING COSTS AND OTHER CHARGES During the second quarter ended December 27, 1997, the Company recorded a restructuring charge against income in the amount of $2,609,000. This charge F-19 represents the anticipated costs associated with closing the Scottsdale, Arizona, LaserSpa-TM-, including costs of maintaining the facility, reserve for leasehold improvements and fixed assets (carrying value before reserve of $1,123,000), and a reserve against loss upon liquidation of the equipment at the site. Charges against the reserve for the years ended July 1, 2000 and July 3, 1999 total $476,000 and $476,000, respectively, leaving a reserve balance of $1,043,000 at July 1, 2000. Candela continues to pursue a sublease of the Scottsdale facility, but if this effort is not successful, the Company could incur additional costs in excess of our existing reserve. LEASEHOLD IMPROVEMENTS PAYROLL AND AND FIXED FACILITY CAPITALIZED SEVERANCE ASSETS COSTS START UP COSTS TOTAL ----------- ----------- --------- -------------- ------- Balance at December 27, 1997 $ 419 $ 1,123 $ 887 $ 180 $ 2,609 Cash Charges (134) - (161) - (295) Non-Cash Charges - (139) - (180) (319) ---------- -------- -------- ------- ------- Balance at June 27, 1998 285 984 726 - 1,995 Cash Charges (75) - (214) - (289) Non-Cash Charges - (187) - - (187) --------- ------- ------- ------- ------- Balance at July 3, 1999 210 797 512 - 1,519 Cash Charges (65) - (206) - (271) Non-Cash Charges - (205) - - (205) --------- ------- ------- ------- ------- Balance at July 1, 2000 $ 145 $ 592 $ 306 $ - $ 1,043 ========= ======= ======= ======== ======= As of July 1, 2000, the payroll and severance costs will be paid through December, 2003 and the facility lease expires in 2006. 11. LEGAL PROCEEDINGS On August 11, 2000, Candela reached a settlement of legal disputes with the Regents of the University of California and New Star Technology, Inc., relating to the Dynamic Cooling Device ("DCD") licensed by Candela from the Regents. Pursuant to the settlement, all three parties agreed to dismiss with prejudice all pending proceedings in the U.S. District Court for the Eastern District of California and the District of Massachusetts, and before the American Arbitration Association, and to exchange full releases. In addition, Candela pre-paid a fee of $1,500,000 in exchange for exclusive rights to DCD in certain fields of use. From time to time, the Company is a party to various legal proceedings incidental to our business. The Company believes that none of the other presently pending legal proceedings will have a material adverse effect upon our financial position, results of operations, or liquidity. 12. QUARTERLY RESULTS OF OPERATIONS (UNAUDITED) QUARTER 1999 FIRST SECOND THIRD FOURTH - ------------------------------------------------------------------------------ Revenues $10,738 $13,299 $15,844 $18,707 Gross profit 5,064 6,800 9,024 11,237 Net income 910 1,393 1,907 3,281 Earnings per common share Basic earnings per share $ 0.11 $ 0.17 $ 0.23 $ 0.39 Diluted earnings per share $ 0.11 $ 0.16 $ 0.21 $ 0.33 F-20 QUARTER 2000 FIRST SECOND THIRD FOURTH - ------------------------------------------------------------------------------ Revenues $16,040 $17,779 $19,207 $22,364 Gross profit 9,141 10,107 11,422 12,837 Net Income 2,714 3,246 3,657 4,946 Earning per common share Basic earnings per share $ 0.26 $ 0.30 $ 0.33 $ 0.44 Diluted earnings per share $ 0.23 $ 0.27 $ 0.30 $ 0.40 F-21 SCHEDULE II CANDELA CORPORATION VALUATION AND QUALIFYING ACCOUNTS FOR THE YEARS ENDED JULY 1, 2000, JULY 3, 1999, AND JUNE 27, 1998 COLUMN A COLUMN B COLUMN C COLUMN D Balance at Additions Deductions Balance at Beginning Charged to from End of Description of Period Income Reserves Period - ---------------------------------------------------------------------------------------------------------------------- Reserves deducted from assets to which they apply (in thousands): Allowance for doubtful accounts: Year ended July 1, 2000 $ 998 $ 312 $ 103 $1,207 ====== ====== ====== ====== Year ended July 3, 1999 $1,038 $ 268 $ 308 $ 998 ====== ====== ====== ====== Year ended June 27, 1998 $ 197 $ 866 $ 25 $1,038 ====== ====== ====== ====== Restructuring reserve: Year ended July 1, 2000 $1,519 $ 0 $ 476 $1,043 ====== ====== ====== ====== Year ended July 3, 1999 $1,995 $ 0 $ 476 $1,519 ====== ====== ====== ====== Year ended June 27, 1998 $ 0 $2,609 $ 614 $1,995 ====== ====== ====== ====== F-22 EXHIBIT INDEX Page ---- G10.12.1 Settlement Agreement 38 21 Subsidiaries of the Company 39 23.1 Consent of PricewaterhouseCoopers LLP, 40 Independent Accountants 23.2 Consent of Ernst & Young LLP, 41 Independent Auditors