As filed with the Securities and Exchange Commission on April 9, 2010
Registration No. 333-164089
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
AMENDMENT NO. 6
THE SECURITIES ACT OF 1933
(Exact name of registrant as specified in its charter)
147 Keystone Drive
Montgomeryville, Pennsylvania 18936
(Address, including zip code and telephone number, including area code, of registrants principal executive offices)
Dennis M. McGrath
President and Chief Executive Officer
147 Keystone Drive
Montgomeryville, Pennsylvania 18936
(Name, address, including zip code and telephone number, including area code, of agent for service)
With copies to:
Approximate date of commencement of proposed sale to the public: As soon as practicable after this registration statement becomes effective.
If any of the securities being registered on this Form are to be offered on a delayed or continuous basis pursuant to Rule 415 under the Securities Act of 1933, check the following box. ¨
If this Form is filed to register additional securities for an offering pursuant to Rule 462(b) under the Securities Act, check the following box and list the Securities Act registration statement number of the earlier effective registration statement for the same offering. ¨
If this Form is a post-effective amendment filed pursuant to Rule 462(c) under the Securities Act, check the following box and list the Securities Act registration statement number of the earlier effective registration statement for the same offering. ¨
If this Form is a post-effective amendment filed pursuant to Rule 462(d) under the Securities Act, check the following box and list the Securities Act registration statement number of the earlier effective registration statement for the same offering. ¨
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, or a smaller reporting company. See the definitions of large accelerated filer, accelerated filer and smaller reporting company in Rule 12b-2 of the Exchange Act. (Check one):
The registrant hereby amends this registration statement on such date or dates as may be necessary to delay its effective date until the registrant shall file a further amendment which specifically states that this registration statement shall thereafter become effective in accordance with Section 8(a) of the Securities Act of 1933 or until the registration statement shall become effective on such date as the Commission, acting pursuant to said Section 8(a), may determine.
The information in this prospectus is not complete and may be changed. We may not sell these securities until the Securities and Exchange Commission declares our registration statement effective. This prospectus is not an offer to sell these securities and is not soliciting an offer to buy these securities in any state where the offer or sale is not permitted.
1,000,000 Common Shares
This prospectus relates to the offer and sale of 1,000,000 shares of our common stock, par value $0.01 per share.
Our common stock is traded on the Nasdaq Global Market under the symbol PHMD.
On April 8, 2010, the last reported sale price of our common stock was $10.20 per share, giving effect to the 1-for-6 reverse stock split, which was effective on February 3, 2010 ($1.70 on a pre-split basis). Our common stock began to trade on a split-effective basis on February 4, 2010.
INVESTING IN OUR COMMON STOCK INVOLVES A HIGH DEGREE OF RISK. YOU SHOULD READ THIS ENTIRE PROSPECTUS CAREFULLY, INCLUDING THE SECTION ENTITLED RISK FACTORS BEGINNING ON PAGE 6.
We have granted the underwriters an option, exercisable within 45 days after the date of this prospectus, to purchase up to 150,000 additional shares of common stock upon the same terms and conditions as the shares offered by this prospectus to cover over-allotments, if any.
In connection with this offering, we have also agreed to issue to the underwriters warrants to purchase, in the aggregate, up to 50,000 shares of our common stock.
NEITHER THE SECURITIES AND EXCHANGE COMMISSION NOR ANY STATE SECURITIES COMMISSION HAS APPROVED OR DISAPPROVED THESE SECURITIES OR DETERMINED IF THIS PROSPECTUS IS TRUTHFUL OR COMPLETE. ANY REPRESENTATION TO THE CONTRARY IS A CRIMINAL OFFENSE.
The underwriters expect to deliver the shares of common stock to purchasers on or about , 2010.
The date of this prospectus is , 2010.
You should rely only on the information contained in this prospectus. Neither we nor the underwriters have authorized any other person to provide you with additional or different information. If anyone provides you with different or inconsistent information, you should not rely on it. Neither we nor the underwriters are making an offer to sell these securities in any jurisdiction where an offer or sale is not permitted. You should assume that the information in this prospectus is accurate only as of the date on the front cover of this prospectus, regardless of the time of delivery of this prospectus or any sale of our common stock. Our business, financial condition, results of operations and prospects may have changed since that date.
For investors outside the U.S.: We have not, and the underwriters have not, done anything that would permit this offering or possession or distribution of this prospectus in any jurisdiction where action for that purpose is required, other than in the U.S. Persons outside the U.S. who come into possession of this prospectus must inform themselves about, and observe any restrictions relating to, the offering of the shares of our common stock and the distribution of this prospectus outside the U.S.
TRADEMARKS, TRADE NAMES AND SERVICE MARKS
PhotoMedex®, XTRAC®, XTRAC Velocity®, VTRAC®, SLT®, Laserpro®, Sinu-Clear®, Omnilux Blue®, Omnilux Revive®, Neova®, ProCyte®, Complex CU3®, GHK Copper Peptide Complex®, Z-Silc®, Ti-Silc®, Vital Copper®, Graftcyte® and Lumiére®, are registered trademarks of PhotoMedex, Inc. or its subsidiaries. Some of these marks are registered in certain foreign jurisdictions and some marks are registered in the U.S. Other service marks, trademarks and trade names of PhotoMedex, Inc. or its subsidiaries may be used in this prospectus. All other service marks, trademarks and trade names referred to in this prospectus are the property of their respective owners. Solely for convenience, any trademarks referred to in this prospectus may appear without the ® symbol, but such references are not intended to indicate, in any way, that we or the owner of such trademark, as
applicable, will not assert, to the fullest extent under applicable law, our or its rights, or the right of the applicable licensor, to these trademarks.
INDUSTRY AND MARKET DATA
The market data and other statistical information used throughout this prospectus are based on independent industry publications, government publications, reports by market research firms and other published independent sources. Some data is also based on our good faith estimates, which are derived from other relevant statistical information, as well as the independent sources listed above. Although we believe these sources are reliable, we have not independently verified the information.
This summary highlights certain information described in more detail later in this prospectus. This summary is not complete and does not contain all the information you should consider before investing in our common stock. You should carefully read the more detailed information set out in this prospectus, especially the risks related to our business and investing in our common stock that we discuss under the heading Risk Factors, as well as the consolidated financial statements and related notes appearing elsewhere in this prospectus. References in this prospectus to we, us, our, the Company, our Company and PhotoMedex refer to PhotoMedex, Inc. and its consolidated subsidiaries, unless the context requires otherwise.
PhotoMedex is a global skin health medical technology company that provides integrated disease management and aesthetic solutions through complementary laser and light-based devices, pharmaceuticals and cosmeceuticals. Through our historical relationships with dermatologists and plastic surgeons, we provide products and services that address skin diseases and skin conditions. These diseases and conditions include psoriasis, vitiligo, acne, actinic keratosis (a precursor to certain types of skin cancer) and sun damage. Our experience in addressing these diseases and conditions in the physician market has allowed us to expand our products and services to provide skin health solutions to the indoor tanning and spa markets and the in-store, on-line and television retail consumer markets for home use.
Our Current Strategy
Our strategic focus is built upon four key componentsestablishment of a unified sales force focused on superior skincare expertise, expanded international capabilities, the development of alternate channels for our varied product lines and a renewed commitment to innovation of our technologies.
Galderma Co-Promotion Agreement
On January 11, 2010, we entered into a co-promotion agreement with Galderma, pursuant to which our sales force will sell Galdermas Metvixia drug and Aktilite LED light for the photodynamic therapy treatment of actinic keratosis. Under the three year co-promotion agreement, which was effective as of January 1, 2010, Galderma will provide all marketing support for these products and we will provide the direct sales effort through our existing domestic sales organization.
Increase in Authorized Shares and Reverse Stock Split
On February 3, 2010, we held a Special Meeting of our Stockholders to consider and vote upon an increase in the number of our authorized shares of common stock to 35,000,000 (which number of shares would not be
adjusted in the reverse stock split) and a reverse stock split of our issued and outstanding common stock at an exchange ratio of not less than 1-for-6 and not more than 1-for-10 at the discretion of our Board of Directors. Our stockholders approved both of these proposals and our Board of Directors authorized a reverse stock split at an exchange ratio of 1-for-6. Immediately following the Special Meeting of our Stockholders on February 3, 2010, we filed an amendment to our Restated Certificate of Incorporation, as amended, with the Secretary of State of the State of Delaware to effect both the increase of our authorized shares to 35,000,000 and the reverse stock split at an exchange ratio of 1-for-6.
On March 19, 2010, we entered into a Term Loan and Security Agreement, or the Clutterbuck Agreement, and a related secured term note with Clutterbuck Funds LLC, or Clutterbuck Funds. We received net proceeds of approximately $2.37 million in the transaction. The secured term note, or the Clutterbuck Note, matures in September 2011 and has a principal amount of $2.5 million, which accrues interest at a rate of 12% per annum. The note is secured by XTRAC lasers (and the related usage agreements and payments received thereunder) that we have consigned to physician customers and that are not otherwise pledged to CIT Healthcare LLC and Life Sciences Capital LLC pursuant to our outstanding term notes with such lenders. In connection with the issuance of the Clutterbuck Note, we issued Clutterbuck Funds a warrant to purchase 102,180 shares of our common stock for an initial exercise price of $7.34 per share.
We were incorporated in Delaware on November 30, 1987 under our former name, Laser Photonics, Inc. Our headquarters are located at 147 Keystone Drive, Montgomeryville, Pennsylvania 18936. Our telephone number is (215) 619-3600. Our website address is www.photomedex.com. The information on our website is not and should not be considered part of this prospectus and is intended to be an inactive textual reference only.
You should read the discussion in this prospectus under the heading Use of Proceeds for more information.
Unless we indicate otherwise, all information in this prospectus assumes:
Summary Consolidated Financial Data
The following table sets forth our summary consolidated financial data as of and for the periods presented. The summary consolidated financial data as of December 31, 2008 and 2009 and for each of the years ended December 31, 2007, 2008 and 2009 have been derived from our audited annual consolidated financial statements, which are included elsewhere in this prospectus. The summary historical consolidated balance sheet data as of December 31, 2007 has been derived from our audited annual consolidated financial statements, which have not been included in this prospectus. You should read this data together with the consolidated financial statements and related notes appearing elsewhere in this prospectus, as well as Managements Discussion and Analysis of Financial Condition and Results of Operations and the other financial information included elsewhere in this prospectus. Historical results are not necessarily indicative of future performance.
Investing in our common stock involves a high degree of risk. Before you invest in our common stock, you should carefully consider the various risks of the investment, including those described below, together with all of the other information included in this prospectus. Additional risks may also impair our business operations and adversely affect our prospects. If any of the following risks actually occur, our business, financial condition or operating results could be adversely affected. In that case, the trading price of our common stock could decline and you could lose all or part of your investment.
Risks Related to Our Business
We have a history of losses, entertain the possibility of future losses and cannot assure you that we will become or remain profitable.
Historically, we have incurred significant losses and have had negative cash flows from our dermatological operations. Our surgical products business also has generated losses in recent years. To date, we have dedicated most of our financial resources to research and development and selling, general and administrative expenses. As of December 31, 2009, our accumulated deficit was approximately $115,841,000.
Our future revenues and success depend significantly upon acceptance and adoption of our excimer laser systems for the treatment principally of psoriasis. Our XTRAC system for the treatment of this condition generates revenues, but those revenues were insufficient under our consignment model to generate consistent, positive cash flows from our operations in the domestic XTRAC business segment. Our future revenues and success depend on revenue growth from our revamped sales strategies in our dermatological business. Our ability to market our products and services successfully under our revamped strategies and the expected benefits to be obtained from our products may be adversely affected by a number of factors, such as unforeseen costs and expenses, technological changes, economic downturns, competitive factors or other events beyond our control.
There can be no assurance that we will be able to maintain adequate liquidity to allow us to continue to operate our business or prevent the possible impairment of our assets. We cannot assure you that we will market any products successfully, operate profitably in the future, or that we will not require significant additional financing in order to accomplish our business plan. Any failure to achieve and maintain profitability would continue to have an adverse effect on our stockholders equity and working capital and could result in a decline in our stock price or cause us to cease operations.
Recent adverse developments with respect to our industry and the global macro-economy generally have adversely affected our business and our liquidity, the effect of which has resulted in our need to obtain additional financing.
The national and global economic downturn has resulted in a decline in overall consumer spending, a decline in access to credit and increased liquidity risks, all of which have, and could continue to, impact our business, financial condition and results of operations for the foreseeable future. Given our significant operating losses, negative cash flows, current forecasts and financial position as of September 30, 2009, we required significant additional funds in order to fund operations through and beyond the first quarter of 2010.
To address these liquidity concerns, in October 2009, we launched a private placement in which we received proceeds of approximately $2.85 million. On March 19, 2010, we entered into the Clutterbuck Agreement and the Clutterbuck Note with Clutterbuck Funds. We received net proceeds of approximately $2.37 million in the transaction. The Clutterbuck Note has a principal amount of $2.5 million, which accrues interest at a rate of 12% per annum. The Clutterbuck Note requires us to make monthly payments of interest only. The principal matures in September 2011 and may be prepaid without penalty at any time. The note is secured by XTRAC lasers (and the related usage agreements and payments received thereunder) that we have consigned to physician customers and that are not otherwise pledged to CIT Healthcare LLC and Life Sciences Capital LLC pursuant to our outstanding term notes with such lenders.
These proceeds and the continued implementation of our revised sales and marketing strategies are expected to fund our operations through the first quarter of 2011.
There are no assurances that we will obtain additional equity or debt financing in the future on favorable terms, or at all. In addition, there are no assurances that our new sales strategies will result in growth in our revenues. In the event that we are unsuccessful in raising requisite additional capital and in the event that we are also unsuccessful in spurring revenue growth, we may not be able to timely satisfy our working capital, debt repayment or capital equipment needs or execute our business plan. These adverse outcomes, should they both materialize, would raise substantial doubt about our ability to continue as a going concern.
To maintain and expand our business, we may need additional financing and such financing may not be available on favorable terms, if at all.
We have historically financed our activities through working capital provided from operations, the private placement of equity and debt securities and from lines of credit. We believe that our cash balance and other existing financial resources, and revenues from sales, distribution, licensing and manufacturing relationships, should be sufficient to meet our operating and capital requirements through the first quarter of 2011 and, assuming that we receive the maximum net proceeds under this offering at the assumed offering price, through the fourth quarter of 2011.
However, our operating plan or debt repayment obligations may change and we may need additional funds sooner than anticipated to meet our operational needs and repayment obligations or to answer our capital requirements for expansion, including in the event that:
If we need funds and cannot raise them on acceptable terms, we may not be able to:
We must secure the consent of the holder of the Convertible Notes to incur debt financing. This investor is not obligated to give consent and could prohibit us from issuing debt to raise capital. To raise additional equity financing, we must first offer our terms to the investor and, if this investor declines, or fails to accept, such terms, then we have 30 days in which to pursue subscriptions and another 30 days in which to consummate the subscriptions. Such delay may inhibit our ability to raise additional equity financing in a timely matter or at all. In connection with giving its consent to the Clutterbuck financing, the investor waived its right to purchase shares in this offering.
Our laser treatments of psoriasis, vitiligo, atopic dermatitis and leukoderma, our skincare products and our PTL products and any of our future products or services may fail to gain market acceptance, which could adversely affect our competitive position.
No independent studies with regard to the feasibility of our proposed business plan, including integration of the PTL products into our corporate operations or the reorganization of our sales strategies and sales force, have been conducted by third parties with respect to our present and future business prospects and capital requirements. We have generated limited commercial distribution for our XTRAC system and other products. Skincare products sales are dependent on existing strategic partners for distribution and marketing of our products. It is still not established that the PTL devices targeted for the consumer market will be widely accepted in that market. We may be unsuccessful in continuing our existing, or developing new, strategic selling affiliates and alternate channels in order to maintain or expand the markets for the existing or future products of the skincare and PTL businesses. In addition, our infrastructure to enable such expansion, though stronger than in the past, is still limited.
Even if adequate financing is available and our products are ready for market, we cannot assure you that our products and services will find sufficient acceptance in the marketplace under our new sales strategies. Our efforts through our clinical specialists to help physicians increase patient awareness and interest in, and improve and increase physicians effective utilization of, the XTRAC system may fail.
We also face a risk that other companies in the market for dermatological products and services may be able to provide dermatologists a higher overall yield on investment and therefore compromise our ability to increase our base of users and ensure they engage in optimal usage of our products. If, for example, such other companies have products (such as Botox or topical creams for disease management) that require less time commitment from the dermatologist and yield an attractive return on a dermatologists time and investment, we may find that our efforts to increase our base of users is hindered.
While we have engaged in clinical studies for our psoriasis treatment and, based on these studies, we have gained U.S. Food and Drug Administration, or FDA, clearance, appropriate Current Procedural Terminology, or CPT, reimbursement codes for treatment and suitable reimbursement rates from Centers for Medicare & Medicaid Services, or CMS, for those codes, we may face other hurdles to market acceptance. For example, practitioners in significant numbers may wait to see longer-term studies; or it may become necessary to conduct studies corroborating the role of the XTRAC system as a first-line or second-line therapy for treating psoriasis; or patients simply may not elect to undergo psoriasis treatment using the XTRAC system.
We have designed the XTRAC system so that a properly trained medical technician in a physicians office may, under the physicians supervision, safely and effectively administer treatments to a patient. In fact, the CMS reimbursement rates at the lower labor rates are achieved through delegation to medical technicians. Nevertheless, whether a treatment may be delegated and, if so, to whom and to what extent, are matters that may vary state by state, as these matters are within the province of the state medical boards. In states that may be more restrictive in such delegation, a physician may decline to adopt the XTRAC system into his or her practice, deeming it to be fraught with too many constraints and finding other outlets for the physicians time and staff time to be more remunerative. There can be no assurance that we will be successful in persuading such medical
boards that a liberal standard for delegation is appropriate for the XTRAC system, based on its design for ease and safety of use. If we are not successful, we may find that even if a geographic region has wide insurance reimbursement, the regions physicians may decline to adopt the XTRAC system into their practices.
We therefore cannot assure you that the marketplace will be receptive to our excimer laser technology or skincare products over competing products, services and therapies or that a cure will not be found for the underlying diseases we are focused on treating. Failure of our products to achieve market acceptance could have a material adverse effect on our business, financial condition and results of operations.
The markets for our products are highly competitive and we may not be able to compete effectively against the larger, well-established companies that dominate this market or emerging, and small, innovative companies that may seek to obtain or increase their share of the market.
The markets for our products are intensely competitive and many of our competitors are much larger and have substantially more financial and human resources than we do. Many have long histories and strong reputations within the industry and a relatively small number of companies dominate these markets. We face direct competition from large pharmaceutical companies, including for example Biogen, Inc., Centocor, Inc., and Abbott Laboratories, which are engaged in the research, development and commercialization of treatments for psoriasis, atopic dermatitis, vitiligo and leukoderma. In some cases, those companies have already received FDA approval or commenced clinical trials for such treatments. Many of these companies have significantly greater financial resources and expertise in research and development, manufacturing, conducting pre-clinical studies and clinical trials, and marketing than we do.
Competition in the wound care, skin health and hair care markets is intense. Our competitors include well-established pharmaceutical, cosmetic and healthcare companies such as Allergan, Inc., or Allergan, Obagi Medical Products, Inc., or Obagi, and Estee Lauder Inc., or Estee Lauder. These competitors have substantially more financial and other resources, larger research and development staffs, and more experience and capabilities in researching, developing and testing products in clinical trials, in obtaining FDA and other regulatory approvals, and in manufacturing, supply chain control, marketing and distribution than we do.
These companies enjoy significant competitive advantages over us, including:
Smaller or early-stage companies may also prove to be significant competitors, particularly through collaborative arrangements with large and established companies. Our commercial opportunity will be reduced or eliminated if we are unsuccessful in convincing physician and patient customers and consumers to use our products or if our competitors develop and commercialize products that are safer and more effective than any products that we may develop.
Our success is dependent on intellectual property rights held by us and our business may be adversely affected by direct competition if we are unable to protect these rights both domestically and internationally.
Our success will depend, in part, on our ability to maintain and defend our patents. However, we cannot guarantee that the patents covering certain of our technologies and processes will not be contested, found to be invalid or unenforceable or would not be circumventable. Moreover, as our patents expire, competitors may utilize the technology found in such patents to commercialize their own products. While we seek to offset the losses relating to important expiring patents by securing additional patents on commercially desirable improvements, there can be no assurance that we will be successful in securing such additional patents, or that such additional patents will adequately offset the effect of the expiring patents. Further, pending patent applications are not enforceable.
Of particular note is U.S. Patent No. 4,891,818, or the 818 Patent, which was directed to, among other things, the design of the gas chamber in the XTRAC laser. The 818 Patent has expired and therefore it no longer serves as a barrier to entry to the U.S. market. The additional patent rights we seek, if issued, may serve less to bar competitors from entry and may serve more, when aggregated with other clinical and competitive strengths, to differentiate and distinguish our products (e.g., the XTRAC Ultra and the XTRAC Velocity), in both utility and its range of applications, from those of competitors. If we are unable through our technological innovations to preserve our proprietary rights, our ability to market the XTRAC system could be materially and adversely affected.
We will rely on certain of our PTL patents to protect the home-use market for two of our PTL hand-held devices. If the patents prove unenforceable or circumventable, we may not attain growth and may lose market share from these PTL products.
Trade secrets and other proprietary information which are not protected by patents are also critical to our business. We attempt to protect our trade secrets by, among other steps, entering into confidentiality agreements with third parties, employees and consultants. However, such other steps may be ineffective and these agreements can be breached and, if they are and even if we are able to prove the breach or that our technology has been misappropriated under applicable state law, there may not be an adequate remedy available to us. In addition, costly and time-consuming litigation may be necessary to enforce and determine the scope of our proprietary rights; even should we prevail in such litigation, the party over which we prevail may have insufficient resources available to satisfy a judgment.
Furthermore, our skincare business seeks to establish customer loyalty, in part, by means of our use of trademarks. It can be difficult and costly to defend trademarks from encroachment, especially on the Internet, or misappropriation overseas. Third parties may also challenge the validity of our trademarks. In either eventuality, our customers may become confused and direct their purchases to competitors. Third parties may independently discover trade secrets and proprietary information that allow them to develop technologies and products that are substantially equivalent or superior to our own. Without the protection afforded by our patent, trade secret and proprietary information rights, we may face direct competition from others commercializing their products using our technology, which may have a material adverse effect on our business and our prospects.
From an international perspective, intellectual property law outside of the U.S. is uncertain to us. The laws of some countries may not protect our intellectual property rights to the same extent as laws in the U.S. The intellectual property rights we enjoy in one country or jurisdiction may be rejected in other countries or jurisdictions, or, if recognized there, the rights may be significantly diluted. It may be necessary or useful for us to participate in proceedings to determine the validity of our foreign intellectual property rights, or those of our competitors, which could result in substantial cost and divert our resources, efforts and attention from other aspects of our business.
In addition, we may be subject in the ordinary course of our business to legal proceedings and claims relating to the intellectual property or derivative rights of others. Defending against intellectual property infringement claims, both domestically and internationally, could be time-consuming and expensive and, if we are not successful, could cause substantial expenses and disrupt our business. If we are unable to defend our intellectual property rights internationally, we may face increased competition outside the U.S., which could materially and adversely affect our future business, prospects, operating results and financial results and financial condition.
Our success depends on third-party reimbursement of patients costs for our XTRAC system, which could result in potentially reduced prices or reduced demand.
Our ability to market the XTRAC system and other treatment products successfully will depend in large part on the extent to which various third parties are willing to reimburse patients or providers for the costs of medical procedures utilizing such products. These third parties include government authorities, private health insurers and other organizations, such as health maintenance organizations. Third-party payors are systematically challenging the prices charged for medical products and services. They may deny reimbursement if they determine that a prescribed device is not used in accordance with cost-effective treatment methods as determined by the payor, or is experimental, unnecessary or inappropriate. Further, although third parties may approve reimbursement, such approvals may be under terms and conditions that discourage use of the XTRAC system. Accordingly, if less costly drugs or other treatments are available, third-party payors may not authorize or may limit reimbursement for the use of our products, even if our products are safer or more effective than the alternatives.
Although we have received reimbursement approvals from an increasing number of private healthcare plans, we cannot give assurance that private plans will continue to adopt or maintain favorable reimbursement policies or to accept the XTRAC system in its clinical role as a second-line therapy in the treatment of psoriasis. Additionally, third-party payors may require further clinical studies or changes to our pricing structure and revenue model before authorizing reimbursement.
As of December 31, 2009, we estimate, based on published coverage policies and on payment practices of private and Medicare insurance plans, that more than 90% of the insured population in the U.S. is covered by insurance coverage or payment policies that reimburse physicians for using the XTRAC system for treatment of psoriasis. Based on these reports and estimates, we are continuing the implementation of a roll-out strategy under revised user models for the XTRAC system in the U.S. in selected areas of the country where reimbursement is widely available. The success of the roll-out depends on increasing physician and patient demand for the treatment. We can give no assurance that health insurers will not adversely modify their reimbursement policies for the use of the XTRAC system in the future.
We intend to seek coverage and reimbursement for the use of the XTRAC system to treat other inflammatory skin disorders after additional clinical studies are initiated. There can be no assurances that we will be in a position to expand coverage for vitiligo or to seek reimbursement for the use of the XTRAC system to treat atopic dermatitis or leukoderma, or, if we do, that any health insurers will agree to any reimbursement policies.
Any failure in our customer education efforts could significantly reduce product marketing.
It is important to the success of our marketing efforts to educate physicians and technicians how to properly use the XTRAC system. We rely on physicians to spend their time and money to attend our pre-sale educational sessions. Positive results using the XTRAC system are highly dependent upon proper use by physicians and technicians. If physicians and technicians use the XTRAC system improperly, they may have unsatisfactory patient outcomes or cause patient injury, which may give rise to negative publicity or lawsuits against us, any of which could have a material adverse effect on our reputation, revenues and profitability.
If revenue from a significant customer declines, we may have difficulty replacing the lost revenue, which would negatively affect our results and operations.
Excluding niche marketing efforts, the Skin Care business segment targets its sales in the U.S. market to physicians, who then mark the products up for sale to their patients. No single physician practice in itself is generally responsible for a significant proportion of our sales. However, a number of physician practices specializing in hair transplants are united under the management of a single group and this group accounts for a disproportionate share of our hair care products. Revenues from this group were approximately $1,056,000 in 2009, $990,455 in 2008 and $1,218,698 in 2007. We find as well that a few physicians re-sell our products not just to their own patients, but also at discounted prices on the internet. These practices undercut the sales of other physicians and violate our internet sales policy, but this policy can be difficult to enforce.
In our International Dermatology Equipment business segment (as well as in our Surgical Products business segment), we depend for a material portion of our sales in the international arena on several key sub-distributors, especially GlobalMed, which is our master distributor over much of the international arena. If we lose GlobalMed or one of these sub-distributors, our sales of phototherapy and surgical lasers are likely to suffer in the short term, which could have a negative effect on our revenues and profitability.
Our PTL products will likely be targeted to the consumer market significantly through mass retailers. It may be unfeasible to obtain long-term purchase commitments from such retailers. Loss of such a retailer could adversely impact revenues from the consumer market. Additionally, OEM arrangements or license arrangements will carry reduced profits.
The international nature of our business exposes us to certain business risks that could limit the effectiveness of our growth strategy and cause our results of operations to suffer.
Continued expansion into international markets is an element of our growth strategy. Introducing and marketing our services internationally, developing direct and indirect international sales and support channels and managing foreign personnel and operations will require significant management attention and financial resources. We face a number of risks associated with expanding our business internationally that could negatively impact our results of operations, including:
We may not succeed in our efforts to expand our international presence as a result of the factors described above or other factors that may have an adverse impact on our overall financial condition and results of operations. In addition, we have a relationship with GlobalMed, whereby they provide us with certain non-U.S. regulatory support. To the extent that we discontinue our relationship with GlobalMed, or if GlobalMed is otherwise unable to provide us with the resources and assistance that we need, we may have a difficult time expanding into international markets in an effective manner.
If we fail to integrate, build and manage our sales and marketing force or to market and distribute our products effectively, we may experience diminished revenues and profits.
There are significant risks involved in integrating, building and managing our sales and marketing force and marketing our products, including our ability:
To increase acceptance and utilization of our XTRAC system, we may have to expand our sales and marketing programs in the U.S. While we may be able to draw on currently available personnel within our organization to meet this need, we also expect that we will have to increase the number of representatives devoted to the sales and marketing programs and to broaden, through such representatives, the talents we have at our disposal. In some cases, we may look outside our organization for assistance in marketing our products.
In similar fashion, we cannot predict how successful we may be in marketing our skincare and Omnilux products in the U.S., nor can we predict the success of any new skincare or Omnilux products that we may introduce. Despite an increased focus on developing alternate channels for many of our skincare and Omnilux products, we may find that channels that are attractive to us are unavailable because they already carry competitive products. No assurance can be given that we will be successful in marketing and selling our skin health and hair care products or our Omnilux products.
The home-use consumer market is new to us. We may be unsuccessful in accessing this market with our PTL products or with our skincare products. Distribution through the consumer market will be principally through mass-retail chains in the near term, but will also include e-commerce and electronic media. While we expect the volumes will be higher, the margins may be lower. It may also prove difficult to obtain long-term commitments from the retailers. If we are unable to obtain favorable pricing or long-term commitments, our efforts in the home-use consumer market may be unsuccessful.
We may encounter difficulties manufacturing our products in commercial quantities, which could adversely impact the rate at which we grow.
We may encounter difficulties manufacturing our products because we have limited experience manufacturing our products in significant commercial quantities and because we will, in order to increase our manufacturing output significantly, have to attract and retain qualified employees for assembly and testing operations.
Some of the components necessary for the assembly of our products, including our PTL products, are currently provided to us by third-party suppliers. While alternative suppliers exist and could be identified, the disruption or termination of the supply of components could cause a significant increase in the costs of these components, which could affect our operating results. Our dependence on a limited number of third-party suppliers and the challenges we may face in obtaining adequate supplies involve several risks, including limited control over pricing, availability, quality and delivery schedules. A disruption or termination in the supply of components could also result in our inability to meet demand for our products, which could harm our ability to generate revenues, lead to customer dissatisfaction and damage our reputation. Furthermore, if we are required to change the manufacturer of a key component of our products, we may be required to verify that the new manufacturer maintains facilities and procedures that comply with quality standards and with all applicable regulations and guidelines. The delays associated with the verification of a new manufacturer could delay our ability to manufacture our products in a timely manner or within budget. We face the risk that there will be supply chain problems if the volumes do not match to the margins, as our consumer market products are intended to be high-volume, lower-margined products.
Although we believe that our current manufacturing facilities are adequate to support our commercial manufacturing activities for the foreseeable future, we may be required to expand or restructure our manufacturing facilities to increase capacity substantially. If we are unable to provide customers with high-quality products in a timely manner, we may not be able to achieve market acceptance for our XTRAC system or achieve market acceptance and growth for our skincare products. Our inability to manufacture or commercialize our devices successfully could have a material adverse effect on our revenue.
We may have difficulty managing our growth.
If private carriers continue to approve favorable reimbursement policies for psoriasis and our marketing programs are successful in increasing utilization of the XTRAC system, we expect to experience growth in the number of our employees and customers, and the scope of our operations. We also intend to enter the home-use market with our PTL products. Such growth may place a strain on our management and operations. Our ability to manage this growth will depend upon, among other factors, our ability to broaden our management team; our ability to attract, hire and retain skilled employees; and the ability of our officers and key employees to continue to implement and improve our operational, financial and other systems, to manage multiple, concurrent customer relationships and different products and to respond to increasing compliance requirements. Our future success is heavily dependent upon achieving such growth and acceptance of our products. If we cannot manage this growth, it could have a material adverse effect on our business and we may not become profitable.
We are reliant on a limited number of suppliers for production of key products.
Production of our XTRAC system requires specific component parts obtained from our suppliers. Production of our surgical laser systems requires some component parts that may become harder to procure as the design of a system ages. Similarly, our skincare products may require compounds that can be efficiently produced only by a limited number of suppliers. Our PTL business segment has one primary supplier of LEDs and relies on contract manufacturers. While we believe that we could find alternative suppliers, in the event that our suppliers fail to meet our needs, a change in suppliers or any significant delay in our ability to have access to such resources would have a material adverse effect on our delivery schedules, business, operating results and financial condition.
Our failure to respond to rapid changes in technology and its applications in the medical devices industry or the development of a cure for skin conditions treated by our products could make our treatment system obsolete.
The medical device industry is subject to rapid and substantial technological development and product innovations. To be successful, we must respond to new developments in technology, new applications of existing technology and new treatment methods. We may also encounter greater pressure for innovation in order to satisfy a demand for novelty in the consumer market. Our financial condition and operating results could be adversely affected if we fail to be responsive on a timely and effective basis to competitors new devices, applications, treatments or price strategies. For example, the development of a cure for psoriasis, vitiligo, atopic dermatitis or leukoderma would eliminate the need for our XTRAC system for these diseases and would require us to focus on other uses of our technology, which would have a material adverse effect on our business and prospects.
As we develop new products or improve our existing products, we may accelerate the economic obsolescence of the existing, unimproved products and their components. The obsolete products and related components may have little to no resale value, leading to an increase in the reserves we have against our inventory. Likewise, there is a risk that the new products or improved existing products may not achieve market acceptance and therefore may also lead to an increase in the reserves against our inventory.
Our products may be found defective or physicians and technicians may misuse our products and damages imposed on us may exceed our insurance coverage, or we may be subject to claims that are not covered by insurance.
Product returns and the potential need to remedy defects or provide replacement products or parts for items shipped in volume could result in substantial costs and have a material adverse effect on our business and results of operations. The clinical testing, manufacturing, marketing and use of our products and procedures may also expose us to product liability claims. Certain indications for use for our PTL light-based devices, though approved outside the U.S., are not approved in the U.S. If a physician elects to apply an off-label use and the use leads to injury, we may be involved in costly litigation. In addition, the fact that we train technicians whom we do not supervise in the use of our XTRAC system during patient treatment may expose us to third-party claims if those doing the training are accused of providing inadequate training. We presently maintain liability insurance with coverage limits of at least $5,000,000 per occurrence. However, continuing insurance coverage may not be available at an acceptable cost, if at all. We thus may not be able to obtain insurance coverage that will be adequate to satisfy a liability that may arise. Regardless of merit or eventual outcome, product liability claims may result in decreased demand for a product, injury to its reputation, withdrawal of clinical trial volunteers and loss of revenues. As a result, regardless of whether we are insured, a product liability claim or product recall may result in losses that could have a material adverse effect upon our business, financial condition and results of operations.
We depend on our executive officers and key personnel to implement our business strategy and could be harmed by the loss of their services.
We believe that our growth and future success will depend in large part upon the skills of our management and technical team. In particular, our success depends in part upon the continued service and performance of our named executive officers and of our chief financial officer:
We have fixed-term employment agreements with Mr. McGrath and Mr. Stewart and an at-will employment agreement with Ms. Allgeier; however, there are no assurances that the services of these individuals will be available to us for any specified period of time. The loss of the services of one or more of these officers could adversely affect our ability to develop and introduce our new products.
The competition for qualified personnel in the laser and skincare industries is intense, and we cannot assure you that we will be able to retain our existing key personnel or to attract additional qualified personnel. In addition, we do not have key-person life insurance on any of our employees. The loss of our key personnel or an inability to continue to attract, retain and motivate key personnel could adversely affect our business.
We may be unsuccessful in attaining our goals from the acquisition of PTL.
We acquired PTL in the first quarter of 2009 with the following goals in mind:
We are still in the process of realizing some of these goals, and we are adopting new sales strategies to enhance our ability to fully realize these goals. If we fail to attain some of the goals noted above, the benefits of the acquisition could be limited and our overall business and financial health could be materially and adversely affected.
Our indebtedness and debt service obligations may adversely affect our cash flows and operating flexibility.
If we are unable to generate sufficient cash to meet our interest and principal payment obligations under the Convertible Notes and our other debt obligations (including the Clutterbuck Note), we may have to restructure or limit our operations. The Convertible Notes mature on February 27, 2014. Except with respect to the portion of the interest of Note #1 described under Use of Proceeds, interest is payable on a bi-annual basis either in cash or in kind through the issuance of additional notes with the same terms. We have paid all interest in kind to date. Our Convertible Notes and other indebtedness could have significant additional negative consequences, including, but not limited to:
Our Convertible Notes provide that upon the occurrence of various events of default, one of our investors would be entitled to require us to prepay the Convertible Notes for cash, which could leave us with little or no working capital for operations or capital expenditures.
The terms of our Convertible Notes require us to prepay the Convertible Notes upon the occurrence of various events of default, such as the failure to pay any principal payments due and for the breach of any representations and warranties under the Convertible Notes, the Securities Purchase Agreement, or SPA, or the related transaction documents with the investor. The Convertible Notes also contain a cross-acceleration provision, which means that an acceleration of payment under other instruments (including the Clutterbuck Note) would give the investor the right to accelerate repayment under the Convertible Notes. If we are unable to comply with the covenants under the Convertible Notes, the investor may declare us in default and may declare all amounts due under the notes, including any accrued interest and penalties. As of December 31, 2009, we were in compliance with the covenants under the Convertible Notes and our other indebtedness. We expect to remain in compliance with the covenants of the Convertible Notes and our other indebtedness. We can make no assurances that we will remain in compliance with all of the covenants under the Convertible Notes and our other indebtedness.
As a result of the security interest and lien granted in connection with the Convertible Notes and the Clutterbuck Note, if we fail to meet our payment or other obligations under the Convertible Notes, the Clutterbuck Note or our other indebtedness, the investor or Clutterbuck Funds, as the case may be, would be entitled to foreclose on the assets subject to those encumbrances. Under those circumstances, we may not have sufficient funds to service our day-to-day operational needs. Any foreclosure by a lender on the collateral pledged to it would have a material adverse effect on our financial condition.
In addition, if an event of default occurs, we may be unable to prepay the entire amount due under the Convertible Notes in cash as required by their terms. Even if we are able to prepay the entire amount in cash, any such prepayment could leave us with little or no working capital for our business. We have not established a sinking fund for payment of our obligations under the Convertible Notes, nor do we anticipate doing so.
The terms of the SPA and the Clutterbuck Agreement prohibit us from taking certain actions without their prior consent.
Pursuant to the terms of the SPA and the Clutterbuck Agreement, we are prohibited from taking certain corporate actions without the prior consent of the lenders thereunder.
The SPA provides that, until such time as no Convertible Notes are outstanding and the investor no longer holds at least 66% of the aggregate number of shares of common stock issuable upon conversion of the Convertible Notes and the warrants, we may not take certain corporate actions without the prior consent of the investor. These actions include, among others:
These restrictive covenants are in addition to the investors right of first refusal and preemptive right with respect to future equity issuances and approval right with respect to future debt financings.
The Clutterbuck Agreement provides Clutterbuck Funds with some of the same approval rights that the investor has under the SPA.
If our management and Board of Directors desire to take any of such actions, there can be no assurance that the investor or Clutterbuck Funds will provide its consent as required, despite the fact that such actions may be in the best interests of us and our other stockholders. Any failure of the investor or Clutterbuck Funds, as the case may be, to provide its consent could have a material adverse effect on our business, financial condition and results of operation.
We are affected by the markets currency conditions.
Substantially all of our operations are conducted in U.S. dollars. Our PTL business, however, is exposed on a minimal basis to currency fluctuations. The majority of sales invoicing for our PTL business is done in either Euros or U.S. dollars, while product costs and the overhead of the offices in the United Kingdom are denominated in Pounds Sterling. Our U.S. operations, with U.S. dollar operating costs, serve to reduce the exposure to fluctuations in the value of the Pound Sterling or the Euro. To the extent that we adjust our invoicing practices for our PTL business, or if the remainder of our business (or any portion thereof) ceases to be conducted primarily in U.S. dollars, our exposure to the markets currency conditions could present a greater risk to us.
Risks Related to Regulatory Matters
Healthcare policy changes, including pending proposals to reform the U.S. healthcare system, may have a material adverse effect on us.
Healthcare costs have risen significantly over the past decade. There have been and continue to be proposals by legislators, regulators and third-party payors to keep these costs down. Certain proposals, if passed, would impose limitations on the prices we will be able to charge for our products, or the amounts of reimbursement available for our products from governmental agencies or third-party payors. These limitations could have a material adverse effect on our financial position and results of operations.
Changes in the healthcare industry in the U.S. and elsewhere could adversely affect the demand for our products as well as the way in which we conduct our business. On March 23, 2010, health reform legislation was
approved by Congress and has been signed into law. The reform legislation provides that most individuals must have health insurance, will establish new regulations on health plans, and create insurance pooling mechanisms and other expanded public health care measures. There is a risk that one of the results of the healthcare legislation is a reduction in Medicare spending on services provided by hospitals and other providers and a form of sales or excise tax on the medical device manufacturing sector.
Various healthcare reform proposals have also emerged at the state level. We cannot predict what healthcare initiatives, if any, will be implemented at the federal or state level, or the effect any future legislation or regulation will have on us. However, an expansion in governments role in the U.S. healthcare industry may lower reimbursements for our products, reduce medical procedure volumes and adversely affect our business, possibly materially. In addition, if the excise taxes contained in the House or Senate health reform bills are enacted into law, our operating expenses resulting from such an excise tax and results of operations would be materially and adversely affected.
If the effectiveness and safety of our products are not supported by long-term data, our revenues could decline.
Our products may not be accepted in the market if we do not produce clinical data supported by the independent efforts of clinicians. We received clearance from the FDA for the use of the XTRAC system to treat psoriasis based upon our study of a limited number of patients. Safety and efficacy data presented to the FDA for the XTRAC system was based on studies on these patients. For the treatment of vitiligo, atopic dermatitis, and leukoderma, we have received clearance from the FDA for the use of the XTRAC system based primarily on a showing of substantial equivalence to other previously cleared predicate devices. However, we may discover that physicians will expect clinical data on such treatments with the XTRAC system. We also may find that data from longer-term psoriasis patient follow-up studies may be inconsistent with those indicated by our relatively short-term data. If longer-term patient studies or clinical experience indicate that treatment with the XTRAC system does not provide patients with sustained benefits or that treatment with our product is less effective or less safe than our current data suggests, our revenues could decline. We can give no assurance that we will find that our data is substantiated in studies involving more patients. In such a case, we may never achieve significant revenues or profitability.
Certain indications for use for the PTL light-based products are permitted in Europe and elsewhere in the world, but are not approved or cleared for marketing in the U.S. Such approvals/clearances in the U.S. could be costly and take significant time to obtain. If we are ultimately not approved or cleared to market the devices for these additional indications for use in the U.S., it is uncertain whether the products will be successful in the U.S.
If we are found to be promoting the use of our products for unapproved or off-label uses or engaging in other noncompliant activities, we may be subject to recalls, fines, penalties, injunctions, prosecution, or other adverse actions, resulting in damage to our reputation and business.
Our labeling, advertising, promotional materials, and user training materials must comply with the FDA and other applicable laws and regulations, including the prohibition of the promotion of a medical device for a use that has not been cleared or approved by the FDA. Use of a device outside its cleared or approved indications is known as off-label use. If the FDA determines that our labeling, advertising, promotional materials, or user training materials include the promotion of an off-label use for the device, the agency could take the position that these materials have misbranded our devices and request that we modify our labeling, advertising, or user training or promotional materials and/or subject us to regulatory or legal enforcement actions, including the issuance of an Untitled Letter or a Warning Letter, injunction, seizure, recall, civil penalties, criminal penalties, or other adverse actions. It is also possible that other federal, state, or foreign enforcement authorities might take action if they consider our labeling, advertising, promotional, or user training materials to constitute promotion of an unapproved use, which could result in significant fines, penalties, or other adverse actions under other
statutory authorities, such as laws prohibiting false claims for reimbursement. In that event, our reputation could be damaged and adoption of the products would be impaired. Although we intend to refrain from statements that could be considered off-label promotion of our products, the FDA or another regulatory agency could disagree and conclude that we have engaged in off-label promotion. In addition, the off-label use of our products may increase the risk of injury to patients, and, in turn, the risk of product liability claims. Product liability claims are expensive to defend and could divert our managements attention and result in substantial damage awards against us.
We may be subject, directly or indirectly, to federal and state healthcare fraud and abuse laws and regulations and could face substantial penalties if we are unable to fully comply with such laws.
While we do not control referrals of healthcare services or bill directly to Medicare, Medicaid or other third-party payors, many healthcare laws and regulations apply to our business. For example, we could be subject to healthcare fraud and abuse and patient privacy regulation and enforcement by both the federal government and the states in which we conduct our business. The healthcare laws and regulations that may affect our ability to operate include:
Recently, the medical device industry has been under heightened scrutiny as the subject of government investigations and enforcement actions involving manufacturers who allegedly offered unlawful inducements to potential or existing customers in an attempt to procure their business, including arrangements with physician consultants. If our operations or arrangements are found to be in violation of any of the laws described above or any other governmental regulations that apply to us, we may be subject to penalties, including civil and criminal penalties, damages, fines, exclusion from the Medicare and Medicaid programs and the curtailment or restructuring of our operations. Any penalties, damages, fines, exclusions, curtailment or restructuring of our operations could adversely affect our ability to operate our business and our financial results. The risk of our being found in violation of these laws is increased by the fact that many of these laws are broad and their provisions are open to a variety of interpretations. Any action against us for violation of these laws, even if we successfully defend against it, could cause us to incur significant legal expenses and divert our managements attention from the operation of our business. If the physicians or other providers or entities with whom we do business are found to be non-compliant with applicable laws, they may be subject to sanctions, which could also have a negative impact on our business.
Our failure to obtain or maintain necessary FDA clearances or approvals, or equivalents thereof in relevant foreign markets, could hurt our ability to distribute and market our products.
Our laser products are considered medical devices and are subject to extensive regulation in the U.S. and in foreign countries where we intend to do business. In addition, certain of our skincare products and product candidates may fall under the regulatory purview of various centers at the FDA and in other countries by similar health and regulatory authorities. As we seek to expand sales of our skincare products outside the U.S., we may encounter requirements that we did not anticipate or that we may not be able to satisfy.
Each medical device that we wish to market in the U.S. must first receive either 510(k) clearance or premarket approval from the FDA unless an exemption applies. Either process can be lengthy and expensive. The FDAs 510(k) clearance process may take from three to twelve months, or longer and may or may not require human clinical data. The premarket approval process is much more costly and lengthy. It may take from eleven months to three years, or even longer, and will likely require significant supporting human clinical data. Delays in obtaining regulatory clearance or approval could adversely affect our revenues and profitability. Although we have obtained 510(k) clearances for our XTRAC system for use in treating psoriasis, vitiligo, atopic dermatitis and leukoderma, and extensive 510(k) clearances for our surgical products, our clearances may be subject to revocation if post-marketing data demonstrates safety issues or lack of effectiveness. Similar clearance processes may apply in foreign countries. Further, more stringent regulatory requirements or safety and quality standards may be issued in the future with an adverse effect on our business.
Although cosmetic products are not subject to any FDA premarket approval or clearance process, they must, nonetheless, comply with the FDAs formulation and labeling requirements or such products may be considered adulterated or misbranded by the agency which could subject us to potential regulatory enforcement actions. Similar, or more stringent, requirements may apply in foreign jurisdictions as well. We may also find that if our cosmetic products compete with a third-partys drug product, competitive and regulatory pressure may be applied against the cosmetic products.
Certain indications for use for our PTL light-based products are permitted in Europe and elsewhere in the world, but are not cleared or approved for marketing in the U.S. Such clearances/approvals could be costly and take significant time to obtain. If we are not approved or cleared to market the indications for use in the U.S., it is uncertain whether the products will be successful in the U.S.
Our market acceptance in international markets requires regulatory approvals from foreign governments and may depend on third party reimbursement of participants cost.
We have introduced our XTRAC system into markets in more than 30 countries in Europe, the Middle East, the Far East Asia, Southeast Asia, Australia, South Africa, and parts of Central and South America. We intend to expand the number of countries in these markets where we distribute our products through the network of distributors which PTL and GlobalMed have built. We cannot be certain that our distributors will be successful in marketing XTRAC systems in these or other countries or that our distributors will purchase XTRAC systems beyond their current contractual obligations or in accordance with our expectations.
We are regularly audited on the compliance of our quality systems with applicable requirements, which can be extensive and complex and subject to change due to evolving interpretations and changing requirements. Adverse audit findings could negatively affect our ability to market our products.
Even if we obtain and maintain the necessary foreign regulatory registrations or approvals, market acceptance of our products in international markets may be dependent, in part, upon the availability of reimbursement within applicable healthcare payment systems. Reimbursement and healthcare payment systems in international markets vary significantly by country, and include both government-sponsored healthcare and private insurance. We may seek international reimbursement approvals for our products, but we cannot assure
you that any such approvals will be obtained in a timely manner, if at all. Failure to receive international reimbursement approvals in any given market could have a material adverse effect on the acceptance or growth of our products in that market or others.
If we or our third-party manufacturers or suppliers fail to comply with the FDAs Quality System Regulation or any applicable state equivalent, our manufacturing operations could be interrupted and our potential product sales and operating results could suffer.
We and some of our third-party manufacturers and suppliers are required to comply with some or all of the FDAs Quality System Regulation, or QSR, that delineates the design controls, document controls, purchasing controls, identification and traceability, production and process controls, acceptance activities, nonconforming product requirements, corrective and preventive action requirements, labeling and packaging controls, handling, storage, distribution, and installation requirements, records requirements, servicing requirements, and statistical techniques potentially applicable to the production of our medical devices. We and our manufacturers and suppliers are also subject to the regulations of foreign jurisdictions regarding the manufacturing process if we market our products overseas. The FDA enforces the QSR through periodic and announced or unannounced inspections of manufacturing facilities. Our facilities have been inspected by the FDA and other regulatory authorities, and we anticipate that we and certain of our third-party manufacturers and suppliers will be subject to additional future inspections. If our facilities or those of our manufacturers or suppliers are found to be in significant non-compliance or fail to take satisfactory corrective action in response to adverse QSR inspectional findings, FDA could take enforcement actions against us and/or our products, which could impair our ability to produce our products in a cost-effective and timely manner in order to meet our customers demands. We may also be required to bear other costs or take other actions that may have a negative impact on our future sales and our ability to generate profits.
Although we believe that we are in substantial compliance with all applicable FDA regulations, current regulations depend heavily on administrative interpretation. We are also subject to periodic inspections by the FDA, other governmental regulatory agencies, as well as certain third party regulatory groups. Future interpretations made by the FDA or other regulatory bodies made during the course of these inspections may vary from current interpretations and may adversely affect our business and prospects. The FDAs and foreign regulatory agencies statutes, regulations, or policies may change, and additional government regulation or statutes may be enacted, which could increase post-approval regulatory requirements, or delay, suspend, or prevent marketing of any cleared/approved products. We cannot predict the likelihood, nature or extent of adverse governmental regulation that might arise from future legislative or administrative action, either in the U.S. or abroad.
Risks Relating to an Investment in Our Common Stock
Delaware law and our charter documents, as well as the SPA, contain provisions that could delay or prevent actual and potential changes in control, even if they would benefit stockholders.
We are subject to Section 203 of the Delaware General Corporation Law, which prohibits a business combination between a corporation and an interested stockholder within three years of the stockholder becoming an interested stockholder, except in limited circumstances. In addition, our bylaws contain certain provisions which require stockholders actions to be taken at meetings and not by written consent, and supermajority votes of stockholders to notice of special meetings of stockholders. Finally, pursuant to the SPA, the holder of our Convertible Notes must consent to any change of control transaction, subject to certain exceptions. These provisions could delay or prevent actual and potential changes in control, even if they would benefit our stockholders.
Potential fluctuations in our operating results could lead to fluctuations in the market price for our common stock.
Our results of operations are expected to fluctuate significantly from quarter-to-quarter, depending upon numerous factors, including:
Variations in the above operating factors could lead to significant fluctuations in the market price of our stock. Our quarter-to-quarter operating results could also be affected by the timing and usage of individual laser units in the treatment of patients, since our revenue model for the XTRAC system is generally based on a payment-per-usage plan.
Our stock price has been and continues to be volatile.
The market price for our common stock could fluctuate due to various factors. These factors include, among others:
In the event the Convertible Notes were to be converted to common stock, such common stock would represent 1,028,762 shares, or 31.5%, of our outstanding common stock, as of April 8, 2010. Such conversion could impact the price of our common stock by virtue of the overall dilution to our stockholders. Currently, $2,800,406 of the principal amount of the Convertible Notes has a conversion price of $11.25850 per share of common stock and $16,746,270 of the principal amount of the Convertible Notes has a conversion price of $21.46890 per share of Common Stock. In addition, the stock markets have, in recent years, experienced significant price fluctuations. These fluctuations often have been unrelated to the operating performance of the specific companies whose stock is traded. Market fluctuations, as well as economic conditions, have adversely affected, and may continue to adversely affect, the market price of our common stock.
Securities analysts may not initiate coverage for our common stock or may issue negative reports and this may have a negative impact on the market price of our common stock.
Securities analysts currently do not provide research coverage of our common stock and may not initiate coverage after the completion of this offering. The lack of research coverage may adversely affect the market price of our common stock. The trading market for our common stock may be affected in part by the research and reports that industry or financial analysts publish about us or our business. It may be difficult for companies such as ours, with smaller market capitalizations, to attract securities analysts that will cover our common stock. If one or more of the analysts who elect to cover us downgrades our stock, our stock price would likely decline rapidly. If one or more of these analysts ceases coverage of our company, we could lose visibility in the market, which in turn could cause our stock price to decline. This could have a negative effect on the market price of our stock.
Shares eligible for future sale by our current or future stockholders may cause our stock price to decline.
If our stockholders or holders of our other securities sell substantial amounts of our common stock in the public market, including shares issued in completed acquisitions or upon the exercise of outstanding Convertible Notes, options and warrants, then the market price of our common stock could fall. As of April 8, 2010, the holder of the Convertible Notes had the right to convert the Convertible Notes into an aggregate of 1,028,762 shares of our common stock and holds a warrant to purchase 251,527 shares of our common stock.
Issuance of shares of our common stock upon conversion of our Convertible Notes and exercise of warrants, or payment of interest in kind, will dilute the ownership interest of our existing stockholders and could adversely affect the market price of our common stock.
As of April 8, 2010, we had outstanding stock options to purchase an aggregate of 157,957 shares of common stock, warrants to purchase an aggregate of 433,419 shares of common stock and Convertible Notes convertible into 1,028,762 shares of common stock. In addition, we also have 60,874 shares of common stock reserved for issuance under our 2005 Equity Plan and our Non-Employee Director Plan. Upon completion of this offering, we will issue to the underwriters for nominal consideration warrants to purchase, in the aggregate, up to 50,000 shares of common stock.
The exercise of the stock options, warrants and Convertible Notes and the sales of stock issuable pursuant to them, would further reduce a stockholders percentage voting and ownership interest. Further, the stock options, warrants and Convertible Notes are likely to be exercised when our common stock is trading at a price that is higher than the exercise price of these options and warrants and we would be able to obtain a higher price for our common stock than we would receive under such options and warrants. The exercise, or potential exercise, of these options, warrants and Convertible Notes could adversely affect the market price of our common stock and the terms on which we could obtain additional financing.
In addition, we may issue additional convertible promissory notes as payment of interest in kind. Any of these issuances will further dilute the ownership interests of our existing stockholders. Any sales in the public market of this common stock could adversely affect prevailing market prices of our common stock. In addition, the existence of our note and our warrants may encourage short selling by market participants.
The terms of the Convertible Notes issued to one of our investors provides that, if on any date that is at least 31 trading days after the date of issuance, the market price for our common stock, as determined in accordance with the terms and conditions of the SPA, exceeds 300% of the then-effective conversion price of the Convertible Notes, then the entire principal amount and all accrued but unpaid interest under the Convertible Notes will automatically convert into shares of our common stock at the then-effective conversion price. Such a mandatory conversion of the Convertible Notes will dilute the ownership interests of our existing stockholders.
This offering will trigger anti-dilution adjustments in one of the Convertible Notes and in the related warrant, which will further dilute the ownership interest of our existing stockholders.
The ownership interests of our existing stockholders will be further diluted through adjustments to one of the Convertible Notes and related warrant under the terms of the anti-dilution provisions contained in those securities. The investor holds two Convertible Notes in an aggregate principal amount of $19,546,676. One of the
Convertible Notes, or Note #1, has a principal amount of $16,746,270 and is currently convertible into 780,025 shares of our common stock at a conversion price of $21.46890 per share. The other convertible note, or Note #2, has a principal amount of $2,800,406 and is convertible into 248,737 shares of our common stock at a fixed conversion price of $11.25850 per share. The investor also holds a warrant to purchase 251,527 shares of our common stock at an exercise price of $21.46890 per share. Note #1 and the related warrant continue to be subject to weighted-average anti-dilution adjustments in the event of an issuance of our common stock below their current conversion and exercise prices. Upon the conclusion of this offering at the assumed offering price and assuming (1) the exercise in full by the underwriters of their over-allotment option, (2) the issuance of the underwriters warrant and (3) that 47,410 shares are deemed outstanding after application of the treasury stock method to options and warrants on our common stock that have exercise prices less than the assumed offering price, the conversion price of the Note #1 will be subject to adjustment, resulting in such Note becoming convertible into an aggregate of 950,068 shares of common stock at a conversion price of $17.62639 per share. The warrant will also be subject to adjustment, resulting in such warrant becoming exercisable for an aggregate of 306,360 shares of common stock at an exercise price of $17.62639 per share. These adjustments will result in an additional 224,876 shares of common stock being reserved for issuance and will, upon conversion of the Convertible Notes or the warrant by the investor, further dilute the ownership interests of our existing stockholders.
We have not paid dividends in the past and do not expect to pay dividends in the future.
We have never declared or paid cash dividends on our capital stock. We currently intend to retain all future earnings for the operation and expansion of our business and, therefore, do not anticipate declaring or paying cash dividends in the foreseeable future. The payment of dividends will be at the discretion of our Board of Directors and will depend on our results of operations, capital requirements, financial condition, prospects, contractual arrangements, any limitations on payments of dividends present in any of our future debt agreements and other factors our Board of Directors may deem relevant. If we do not pay dividends, a return on your investment will only occur if our stock price appreciates.
We will have broad discretion in applying the net proceeds of this offering and may not use those proceeds in ways that will enhance the market value of our common stock.
We have significant flexibility in applying the net proceeds we will receive in this offering. We will use the proceeds that we receive from the sale of common stock in this offering for working capital and general corporate purposes. In addition, we may use a portion of the net proceeds from this offering to repay all or a portion of the outstanding principal amount of the Convertible Notes. As part of your investment decision, you will not be able to assess or direct how we apply these net proceeds. If we do not apply these funds effectively, we may lose significant business opportunities. Furthermore, our stock price could decline if the market does not view our use of the net proceeds from this offering favorably.
New investors in our common stock will experience immediate and substantial dilution after this offering.
If you purchase shares of our common stock in this offering, you will experience immediate dilution of $9.56 per share based on the assumed offering price because the price that you pay will be substantially greater than the adjusted pro forma net tangible book value per share of common stock that you acquire. This dilution is due in large part to the fact that a substantial portion of our net book value relates to intangible assets, which are excluded from our calculations of net tangible book value per share and the pro forma adjustments related thereto. If outstanding options to purchase our common stock are exercised, you will experience additional dilution. See the section entitled Dilution in this prospectus for a more detailed description of this dilution.
Our future capital needs could result in dilution of your investment.
Our Board of Directors may determine from time to time that there is a need to obtain additional capital through the issuance of additional shares of our common stock or other securities. These issuances would likely dilute the ownership interests of the investors in this offering and may dilute the net tangible book value per share of our common stock. Investors in subsequent offerings may also have rights, preferences and privileges senior to our current stockholders which may adversely impact our current stockholders.
The information included in this prospectus contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, or the Securities Act, and Section 21E of the Securities Exchange Act of 1934, as amended, or the Exchange Act, the attainment of which involves various risks and uncertainties. All statements other than statements of historical fact included in this prospectus are forward-looking statements. Forward-looking statements may be identified by the use of forward-looking terminology, such as may, will, expect, believe, estimate, anticipate, continue or similar terms, variations of those terms or the negative of those terms.
These forward-looking statements are based on assumptions that we have made in light of our experience in the industry in which we operate, as well as our perceptions of historical trends, current conditions, expected future developments and other factors we believe are appropriate under the circumstances. As you read and consider this prospectus, you should understand that these statements are not guarantees of performance or results. They involve risks, uncertainties (some of which are beyond our control) and assumptions. Although we believe that these forward-looking statements are based on reasonable assumptions, you should be aware that many factors could affect our actual financial condition or results of operations and cause actual results to differ materially from those in the forward-looking statements. These factors include, among other things:
Because of these factors, we caution that you should not place undue reliance on any of our forward-looking statements. Further, any forward-looking statement speaks only as of the date on which it is made. New risks and uncertainties arise from time to time and it is impossible for us to predict these events or how they may affect us. We are under no obligation to update or alter any forward-looking statements, whether as a result of new information, future events or otherwise.
We estimate that the net proceeds to us from this offering will be approximately $8,388,000, or approximately $9,803,250 if the underwriters exercise their over-allotment option in full, based on the assumed offering price of $10.20 (the last reported sale price of our common stock on April 8, 2010, giving effect to the 1-for-6 reverse stock split effective on February 3, 2010) and after deducting the estimated underwriting discounts and commissions and offering expenses payable by us related to this offering.
We intend to use the net proceeds of this offering for general working capital and other corporate purposes. In addition, we may use a portion of the net proceeds from this offering to repay the Clutterbuck Note and all or a portion of the outstanding principal amount of the Convertible Notes.
On March 19, 2010, we entered into the Clutterbuck Agreement and the Clutterbuck Note with Clutterbuck Funds. We received net proceeds of approximately $2.37 million in the transaction. The Clutterbuck Note has a principal amount of $2.5 million, which accrues interest at a rate of 12% per annum. The Clutterbuck Note requires us to make monthly payments of interest only. The principal matures in September 2011 and may be prepaid without penalty at any time. The note is secured by XTRAC lasers (and the related usage agreements and payments received thereunder) that we have consigned to physician customers and that are not otherwise pledged to CIT Healthcare LLC and Life Sciences Capital LLC pursuant to our outstanding term notes with such lenders. In connection with the issuance of the Clutterbuck Note, we issued Clutterbuck Funds a warrant to purchase 102,180 shares of our common stock for an initial exercise price of $7.34 per share. The warrant is exercisable at any time on or prior to the fifth anniversary of its issue date. Pursuant to the terms of the warrant, the exercise price is subject to a one-time downward adjustment if we make certain issuances of our equity securities at a price per share less than $7.34 during the 18-month period following the issuance of the warrant or, during the 18-month period beginning after such 18-month period, in the event aggregate proceeds of dilutive issuances during such second 18-month period exceed $2.5 million.
In order to consummate the bridge financing, it was necessary to secure the consent of the investor that holds the Convertible Notes. As of March 19, 2010, the outstanding principal and accrued interest under the Convertible Notes was $19,546,676. In order to obtain the investors consent, we agreed to the following modifications to the Convertible Notes:
The collateral securing the Convertible Notes was expanded by adding a first-priority lien against all of our assets other than the assets pledged with first-priority liens to CIT Healthcare and to Clutterbuck Funds. When assets are released from the lien of CIT Healthcare, such assets will become subject to the first-priority lien of Clutterbuck Funds and a second-priority lien of the investor. Finally, when assets are released from the lien of Clutterbuck Funds, such assets will become subject to the first-priority lien of the investor.
Three of our subsidiaries (ProCyte Corporation, Photo Therapeutics, Inc. and SLT Technology, Inc.) have guaranteed our obligations under the Convertible Notes.
Except as described above with respect to Note #1, the Convertible Notes accrue interest at a rate of 10% per annum, payable in cash or through the issuance of additional Convertible Notes, and mature on February 27, 2014. The terms of the Convertible Notes do not currently allow us to prepay any amount of outstanding principal. However, we have reached an agreement in principle with the holder of the Convertible Notes to permit us to prepay all of the outstanding principal amount of, and accrued but unpaid interest on, the Convertible Notes. In connection with a full repayment, all related warrants would be surrendered and all liens securing the Convertible Notes will be released. Any such prepayment would be subject to the determination of our Board of Directors that it is in our best interests, as well as in the best interests of our stockholders, to prepay the Convertible Notes with a portion of the offering proceeds and to the negotiation of the related definitive documentation. We have not concluded negotiations with respect to our ability to prepay less than all of the Convertible Notes.
If our Board of Directors determines that it is not in our best interests and in the best interests of our stockholders to prepay the Clutterbuck Note or all or a portion of the Convertible Notes with a portion of the offering proceeds, we will use all of the net proceeds from this offering for working capital and general corporate purposes. In addition, there is no guarantee that we will be able to reach final agreement with the holder of the Convertible Notes with respect to the definitive documentation relating to any prepayment.
Our common stock is listed on the Nasdaq Global Market under the symbol PHMD. The following table sets forth, for the periods indicated, the high and low sale prices of our common stock, as adjusted for the reverse stock split of 1-for-7 effective January 26, 2009 and the reverse stock split of our issued and outstanding shares of common stock at a ratio of 1-for-6 effective February 3, 2010:
On April 8, 2010, the closing market price for our common stock on the Nasdaq Global Market was $10.20 per share (as adjusted for the reverse stock split of our issued and outstanding shares of common stock at a ratio of 1-for-6, which was effective on February 3, 2010). As of April 8, 2010, we had 850 stockholders of record, without determining the number of stockholders who held shares in street name or other nominee accounts.
We have not declared or paid any dividend since inception on our common stock. We do not anticipate that we will declare or pay dividends in the foreseeable future on our common stock.
The following table describes our capitalization, cash and cash equivalents as of December 31, 2009 on an actual basis and on an as adjusted basis to reflect our sale of shares of common stock in this offering at the assumed offering price, after deducting estimated underwriting discounts and commissions and offering expenses payable by us related to this offering. The numbers presented in this table reflect the consummation of the reverse stock split of our issued and outstanding common stock at a ratio of 1-for-6, which was effective on February 3, 2010.
You should read this capitalization table together with the consolidated financial statements and related notes appearing elsewhere in this prospectus, as well as Use of Proceeds, Managements Discussion and Analysis of Financial Condition and Results of Operations and the other financial information included elsewhere in this prospectus.
Dilution is the amount by which the portion of the offering price paid by the purchasers of the common stock to be sold in this offering exceeds the net tangible book value or deficiency per share of our common stock after the offering. Net tangible book value or deficiency per share of our common stock is determined at any date by subtracting our total liabilities from our total assets less our intangible assets and dividing the difference by the number of shares of common stock deemed to be outstanding at that date.
Our net tangible book deficit as of December 31, 2009 was approximately $6,323,000, or $2.82 per share of common stock based on 2,238,637 shares then outstanding. After giving effect to our receipt of approximately $8,388,000 of estimated net proceeds (after deducting underwriting discounts and commissions and estimated offering expenses payable by us) from our sale of common stock in this offering based on the assumed offering price and the application of the estimated net proceeds as described under Use of Proceeds, our adjusted net tangible book value as of December 31, 2009 would have been approximately $2,065,000, or $0.64 per share of common stock based on a total of 3,238,637 shares of our common stock outstanding on December 31, 2009 on a pro-forma basis. This amount represents an immediate decrease in net tangible book deficit of $3.46 per share of our common stock to existing stockholders and an immediate dilution of $9.56 per share of our common stock to new investors purchasing shares of common stock in this offering at the assumed offering price.
The following table illustrates this dilution on a per share basis:
If the underwriters exercise their over-allotment option in full, the adjusted net tangible book value per share after giving effect to the offering would be $1.03 per share. This represents a decrease in net tangible book deficit of $3.85 per share to existing stockholders and an immediate dilution in adjusted net tangible book deficit of $9.17 per share to new investors.
The dilution calculation, including the above discussion and table, reflects the reverse stock split of our issued and outstanding shares of common stock at a ratio of 1-for-6, which was effective on February 3, 2010.
You should read the following selected historical consolidated financial data in conjunction with our consolidated financial statements included elsewhere in this prospectus and Managements Discussion and Analysis of Financial Condition and Results of Operations, beginning on page 31 of this prospectus. The selected historical consolidated statements of operations data for the years ended December 31, 2009, December 31, 2008 and December 31, 2007, and the selected historical consolidated balance sheet data as of December 31, 2009 and December 31, 2008, are derived from our audited consolidated financial statements included in this prospectus. The selected historical consolidated balance sheet data as of December 31, 2007 has been derived from our audited annual consolidated financial statements, which have not been included in this prospectus. The selected historical consolidated statements of operations data for the years ended December 31, 2006 and December 31, 2005 and the selected historical consolidated balance sheet data as of December 31, 2007, December 31, 2006 and December 31, 2005 are derived from our audited consolidated financial statements not included in this prospectus. The historical results presented here are not necessarily indicative of future results.
FINANCIAL CONDITION AND RESULTS OF OPERATIONS
The following discussion and analysis of our financial condition and results of operations should be read in conjunction with Selected Consolidated Financial Data, and the audited and unaudited historical consolidated financial statements and notes thereto included elsewhere in this prospectus. The following discussion contains forward-looking statements and involves numerous risks and uncertainties including, but not limited to, those discussed in Risk Factors. Actual results may differ materially from those contained in any forward-looking statements. You should read Cautionary Statement Regarding Forward-Looking Statements and Risk Factors included elsewhere in this prospectus.
Introduction, Outlook and Overview of Business Operations
We view our current business as comprised of the following five business segments:
Our Domestic XTRAC business segment is a U.S. based business with revenues generally derived from procedures performed by dermatologists. We are engaged in the development, manufacturing and marketing of our proprietary XTRAC® excimer laser and delivery systems and techniques used in the treatment of inflammatory skin disorders, including psoriasis, vitiligo, atopic dermatitis and leukoderma.
As part of our commercialization strategy in the U.S., we generally offer the XTRAC laser system to targeted dermatologists at no initial capital cost. Under this contractual arrangement, we maintain ownership of the laser and generally earn revenue each time a physician treats a patient with the equipment. We believe this arrangement will increase market penetration. We also may sell the laser directly to the customer for certain reasons, including the cost of logistical support, customer preference and as a means of addressing under-performing accounts while still preserving a vendor-customer relationship. Thus, we believe that we are able to reach, at reasonable margins, a sector of the laser market that is better suited to a sale model than a per-procedure model.
For the last several years we have sought to obtain health insurance coverage for XTRAC laser therapy to treat inflammatory skin disease, particularly psoriasis. We now benefit from the fact that, by our estimates, more than 90% of the insured U.S. population has policies that provide nearly full reimbursement for the treatment of psoriasis by means of an excimer laser.
We are currently restructuring sales and marketing efforts in business segments that have previously been dependent upon external infusions of debt capital to fund growth.
International Dermatology Equipment
In the international market, we derive revenues by selling our dermatology laser and lamp systems and replacement parts to distributors and directly to physicians. In this market, we have benefited from both our clinical studies and from the improved reliability and functionality of the XTRAC laser system. Compared to the domestic business segment, the sales of laser and lamp systems in the international business segment are
influenced to a greater degree by competition from similar laser technologies as well as non-laser lamp alternatives. Over time, this competition has reduced the prices we are able to charge to international distributors for our XTRAC products. To compete with other non-laser UVB products, we offer a lower-priced, lamp-based system called the VTRAC. We have expanded the international marketing of the VTRAC since its introduction in 2006. The VTRAC is used to treat psoriasis and vitiligo.
Beginning in the third quarter of 2009, we began realigning the management of this business segment. GlobalMed, an international distributor, is now generally responsible for managing our international device sales.
Skin Care (ProCyte)
Our Skin Care business segment generates revenues primarily from the sale of skin health, hair care and wound care products.
Our focus has been to provide unique products, primarily based upon proprietary technologies for selected applications in the dermatology, plastic and cosmetic surgery and medical spa markets. We have also expanded the use of our copper peptide technologies into the mass retail market for skin and hair care through targeted technology licensing and supply agreements.
Our skincare products are aimed at the growing demand for skin health and hair care products, including products to enhance appearance and address the effects of aging on skin and hair. Our skincare products are formulated, branded and targeted at specific markets. Our initial products addressed the dermatology, plastic and cosmetic surgery markets for use after various procedures. Anti-aging skincare products were added to offer a comprehensive approach for a patients skincare regimen. In 2009, we introduced DNA topical products, which include DNA Nourishing Lotion and DNA Total Repair and utilize innovative technology to address DNA damage. We also introduced Neova® Skin Care Systems, which are kits of Neova products that target specific conditions with complete treatment programs. These programs are named the Intense Age Defense, Extremely Clear, and Essential Eye Recovery. These kits are designed to make it simpler for physicians to dispense the products and to ensure patient compliance and satisfaction.
Photo Therapeutics (PTL)
Our PTL business segment is a developer and provider of non-laser light aesthetic devices for the treatment of a range of clinical and non-clinical dermatological conditions. Our PTL business segment has a portfolio of independent, experimental research that supports the efficacy and safety of our Omnilux technology system. Based on a patented technology platform comprised of a unique light-emitting diode, or LED, array, this technology delivers narrow-band, spectrally pure light of specific intensity, wavelength and dose to achieve clinically proven results via a process called photo bio-modulation. Since this technology generates no heat, a patient feels no pain or discomfort which results in improved regime compliance and a higher likelihood of repeat procedures. The lack of heat generation is in direct contrast to the current laser light-based technologies serving the aesthetics market today.
Our PTL LED products compete in the professional aesthetics device market for LED aesthetic medical procedures. In addition, we have recently developed a line of consumer devices to address the home-use market opportunity. The FDA has issued over-the-counter, or OTC, clearances for our two hand-held consumer devices.
To date, we have incorporated our PTL technology offering into a range of products targeting both the professional-based sector and the larger home-use market. Therefore, our PTL business segments current portfolio of products is divided into three types: professional products comprising the Omnilux systems for the medical market; the Lumiere® systems to address the non-medical professional market; and home-use products to address the consumer market.
The consolidated financial statements contained in this prospectus include the results of our PTL business segment from February 27, 2009, the date we acquired the PTL business through December 31, 2009.
Our Surgical Products business segment generates revenues by selling laser products and disposables to hospitals and surgery centers both within and outside of the U.S. Also included in this business segment are various non-laser surgical products (e.g. the ClearEss® II suction-irrigation system). We believe that sales of surgical laser systems and the related disposable base will decline as hospitals continue to seek outsourcing solutions instead of purchasing lasers and related disposables for their operating rooms. We are working to offset such decline by increasing sales from our Diode surgical laser, which includes entering into additional original equipment manufacturer, or OEM, arrangements.
Galdermas Metvixia and Aktilite Products
On January 11, 2010, we entered into a co-promotion agreement with Galderma, pursuant to which our sales force will promote Galdermas Metvixia drug and Aktilite LED light for the photodynamic therapy treatment of actinic keratosis. Metvixia is a topical porphyrin precursor used in photodynamic therapy. When applied to actinic keratosis lesions, Metvixia is selectively absorbed into precancerous cells causing a build-up of endogenous porphyrins. These endogenous porphyrins are illuminated with the Aktilite CL128 lamp emitting a narrow output spectrum of red light with a peak wavelength at 630 nm. Subsequently, a reaction occurs that results in the destruction of the precancerous cells. Clinical trials in various countries with the Metvixia PDT system have shown comparable or better response rates than conventional treatments, such as cryotherapy or surgery. Metvixia PDT selectively targets precancerous cells so the surrounding healthy cells are less subjected to the treatment, therein minimizing scarring and ensuring more acceptable cosmetic outcomes for patients.
On March 19, 2010, we entered into the Clutterbuck Agreement and the Clutterbuck Note with Clutterbuck Funds LLC. Clutterbuck Funds LLC, a registered investment advisor based in Cleveland, Ohio. We received net proceeds of approximately $2.37 million in the transaction. The Clutterbuck Note has a principal amount of $2.5 million, which accrues interest at a rate of 12% per annum. The Clutterbuck Note requires us to make monthly payments of interest only. The principal matures in September 2011 and may be prepaid without penalty at any time. The note is secured by XTRAC lasers (and the related usage agreements and payments received thereunder) that we have consigned to physician customers and that are not otherwise pledged to CIT Healthcare LLC and Life Sciences Capital LLC pursuant to our outstanding term notes with such lenders. In connection with the issuance of the Term Note to Clutterbuck, we issued Clutterbuck Funds a warrant to purchase 102,180 shares of our common stock for an initial exercise price of $7.34 per share. The warrant is exercisable at any time on or prior to the fifth anniversary of its issue date. Pursuant to the terms of the warrant, the exercise price is subject to a one-time downward adjustment if we make certain issuances of our equity securities at a price per share less than $7.34 during the 18-month period following the issuance of the warrant or, during the 18-month period after such 18-month period, in the event aggregate proceeds of dilutive issuances during such second 18-month period exceed $2.5 million.
Sales and Marketing
As of December 31, 2009, our sales and marketing personnel consisted of 56 full-time positions. Of the 56 sales personnel, they are directed to sales as follows: 53 in Domestic XTRAC, Skin Care and PTL and three in International Dermatology Equipment, international skincare and Surgical Products.
Sale of Surgical Services Business
Our Surgical Services business segment was a fee-based procedures business using mobile surgical laser equipment operated by our technicians at hospitals and surgery centers in the U.S. We decided to sell certain
assets of this division in August 2008 because the growth rates and operating margins of the division had decreased as the business changed to rely more heavily upon procedures performed using equipment from third-party suppliers, thereby limiting the profit potential of these services. On August 8, 2008, we sold certain assets of the business, including accounts receivable, inventory and equipment, for $3,149,737.
Reverse Stock Split
On January 26, 2009, we completed the reverse split of our issued and outstanding shares of common stock at a ratio of 1-for-7. Our common stock began trading on a reverse split-adjusted basis at the market opening on January 27, 2009. As a result of the stock split, we had 9,005,175 shares of common stock outstanding, taking into account the rounding up of fractional shares (but not adjusted for the 1-for-6 reverse stock split described below).
On February 3, 2010, we completed a reverse split of our issued and outstanding shares of common stock at a ratio of 1-for-6. Our common stock began trading on Nasdaq on a reverse stock split-adjusted basis at the market opening on February 4, 2010. As a result of the stock split, we had 2,238,637 shares of common stock outstanding on a post-split basis, taking into account the rounding up of fractional shares.
Critical Accounting Policies
The discussion and analysis of our financial condition and results of operations in this prospectus is based upon our consolidated financial statements, which have been prepared in accordance with accounting principles generally accepted in the U.S. The preparation of financial statements requires management to make estimates and judgments that affect the reported amounts of assets and liabilities, revenues and expenses and disclosures at the date of the financial statements. On an on-going basis, we evaluate our estimates, including, but not limited to, those related to revenue recognition, accounts receivable, inventories, impairment of property and equipment and of intangibles, and accruals for warranty claims. We use authoritative pronouncements, historical experience and other assumptions as the basis for making estimates. Actual results could differ from those estimates. Management believes that the following critical accounting policies affect our more significant judgments and estimates in the preparation of our Consolidated Financial Statements. These critical accounting policies and the significant estimates made in accordance with these policies have been discussed with our Audit Committee.
We have two distribution channels for our phototherapy treatment equipment. We either (x) sell the laser through a distributor or directly to a physician or (y) place the laser in a physicians office (at no charge to the physician) and generally charge the physician a fee for an agreed-upon number of treatments. In some cases, we and the customer stipulate to a quarterly or other periodic target of procedures to be performed, and accordingly revenue is recognized ratably over the period. When we sell an XTRAC laser to a distributor or directly to a foreign or domestic physician, revenue is recognized when the following four criteria have been met: (i) the product has been shipped and we have no significant remaining obligations; (ii) persuasive evidence of an arrangement exists; (iii) the price to the buyer is fixed or determinable; and (iv) collection is probable. The criteria described in the clauses (i) through (iv) are collectively referred to as the Criteria. At times, units are shipped, but revenue is not recognized until all of the Criteria have been met, and until that time, the unit is carried on our books as inventory.
We ship most of our products freight on board, or FOB, shipping point, although from time to time certain customers, for example governmental customers, will insist upon FOB destination. Among the factors we take
into account in determining the proper time at which to recognize revenue are when title to the goods transfers and when the risk of loss transfers. Shipments to distributors or physicians that do not fully satisfy the collection criteria are recognized when invoiced amounts are fully paid or assured.
Under the terms of our distributor agreements, distributors do not have a unilateral right to return any unit that they have purchased. However, we do allow products to be returned, under warranty, by our distributors for product defects or other claims.
When we place a laser in a physicians office, we generally recognize service revenue based on the number of patient treatments performed, or purchased under a periodic commitment, by the physician. Treatments to be performed through random laser-access codes that are sold to physicians free of a periodic commitment, but not yet used, are deferred and recognized as a liability until the physician performs the treatment. Unused treatments remain an obligation of ours because the treatments can only be performed on our equipment. Once the treatments are delivered to a patient, this obligation has been satisfied.
We defer substantially all sales of treatment codes ordered by and delivered to our customers within the last two weeks of the period in determining the amount of procedures performed by our physician-customers. Our management believes this approach closely approximates the actual number of unused treatments that existed at the end of a period. For the years ended December 31, 2009 and 2008, we deferred $303,868 and $670,546, respectively, under this approach.
Skin Care Operations
We generate revenues from our Skin Care business primarily through product sales for skin health, hair care and wound care. We recognize revenues on the products and copper peptide compound when they are shipped, net of returns and allowances. We ship the products FOB shipping point.
Photo Therapeutics Operations
We generate revenues from our Photo Therapeutics business primarily from two channels. The first is through product sales of LEDs and skincare products. The second is through milestone payments and potential royalty payments from a licensing agreement. We recognize revenues from the product sales, including sales to distributors and other customers, when the Criteria have been met. We recognize the milestone payments when the milestones have been achieved and potential royalty revenues as they are earned from the licensee.
Surgical Products and Service Operations
We generate revenues from our surgical products business primarily from product sales of laser systems, related maintenance service agreements, recurring laser delivery systems and laser accessories. Domestic sales generally are direct to the end-user, though we have some sales to a small number of domestic distributors; foreign sales are to distributors. We recognize revenues from surgical laser and other product sales, including sales to distributors and other customers, when the Criteria have been met.
Revenue from maintenance service agreements is deferred and recognized on a straight-line basis over the term of the agreements. Revenue from billable services, including repair activity, is recognized when the service is provided.
Inventory. We account for inventory at the lower of cost (first-in, first-out) or market. Cost is determined to be purchased cost for raw materials and the production cost (materials, labor and indirect manufacturing cost) for work-in-process and finished goods. Throughout the laser manufacturing process, the related production costs are recorded within inventory. Work-in-process is immaterial, given the typically short manufacturing cycle, and therefore is disclosed in conjunction with raw materials. We perform full physical inventory counts for XTRAC and cycle counts on the other inventory to maintain controls and obtain accurate data.
Our XTRAC laser is either (i) sold to distributors or physicians directly or (ii) placed in a physicians office and remains our property. The cost to build a laser, whether for sale or for placement, is accumulated in inventory. When a laser is placed in a physicians office, the cost is transferred from inventory to lasers in service within property and equipment. At times, units are shipped to distributors, but revenue is not recognized until all of the Criteria have been met, and until that time, the unit is carried on our books as inventory. Revenue is not recognized from these distributors until payment is either assured or paid in full.
Reserves for slow-moving and obsolete inventories are provided based on historical experience and product demand. Management evaluates the adequacy of these reserves periodically based on forecasted sales and market trends.
Allowance for Doubtful Accounts. Accounts receivable are reduced by an allowance for amounts that may become uncollectible in the future. The majority of receivables related to phototherapy sales are due from various distributors located outside of the U.S. and from physicians located inside the U.S. The majority of receivables related to skincare products and surgical products are due from various customers and distributors located inside the U.S. From time to time, our customers dispute the amounts due to us, and, in other cases, our customers experience financial difficulties and cannot pay on a timely basis. In certain instances, these factors ultimately result in uncollectible accounts. The determination of the appropriate reserve needed for uncollectible accounts involves significant judgment. Such factors include changes in the financial condition of our customers as a result of industry, economic or customer-specific factors. A change in the factors used to evaluate collectability could result in a significant change in the reserve needed.
Property and Equipment. As of December 31, 2009 and 2008, we had net property and equipment of $9,293,482 and $10,388,406, respectively. The most significant component of these amounts relates to the XTRAC lasers placed by us in physicians offices. We own the equipment and charge the physician on a per-treatment basis for use of the equipment. The recoverability of the net carrying value of the lasers is predicated on continuing revenues from the physicians use of the lasers. If the physician does not generate sufficient treatments, then we may remove the laser from the physicians office and redeploy elsewhere. XTRAC lasers placed in service are depreciated on a straight-line basis over the estimated useful life of five-years. For other property and equipment, including property and equipment acquired from ProCyte, depreciation is calculated on a straight-line basis over the estimated useful lives of the assets, primarily three to seven years for computer hardware and software, furniture and fixtures, automobiles, and machinery and equipment. Leasehold improvements are amortized over the lesser of the useful lives or lease terms. Useful lives are determined based upon an estimate of either physical or economic obsolescence, or both.
Goodwill and Intangibles Assets. Our balance sheet includes goodwill and other intangible assets which affect the amount of future period amortization expense and possible impairment expense that we will incur. Managements judgments regarding the existence of impairment indicators are based on various factors, including market conditions and operational performance of our business. As of December 31, 2009 and 2008, we had $29,244,974 and $19,155,895, respectively, of goodwill and other intangibles, accounting for 55% and 41% of our total assets at the respective dates. We do not amortize our goodwill, but do amortize our other intangibles. The determination of the value of such intangible assets requires management to make estimates and assumptions that affect our consolidated financial statements. We test our goodwill for impairment at least annually. This test is usually conducted in December of each year in connection with our annual budgeting and forecast process. Also, on a quarterly basis, we evaluate whether events have occurred that would negatively impact the realizable value of our intangibles or goodwill.
For the purposes of goodwill impairment testing, our reporting units are defined as Domestic XTRAC, International Dermatology Equipment and Skin Care. We completed our annual goodwill impairment analysis as of December 31, 2009. Our assessment did not result in good will impairment. Our analysis employed the use of both a market and income approach, with each method given equal weighting. Significant assumptions used in the income approach include growth and discount rates, margins and our weighted average cost of capital. We
used historical performance and management estimates of future performance to determine margins and growth rates. Discount rates selected for each reporting unit varied. Our weighted average cost of capital included a review and assessment of market and capital structure assumptions. The balance of our goodwill for each of our business segments as of December 31, 2009 is as follows: Domestic XTRAC $2,061,096, International Dermatology Equipment $883,327, and Skin Care $13,973,385. Of the three reporting units with goodwill, International Dermatology Equipment has a fair value that is significantly in excess of its carrying value by approximately 187%, while Skin Care has a fair value that is approximately 22% in excess of its carrying value. The third reporting unit, Domestic XTRAC has a fair value that is approximately 11% in excess of its carrying value. Considerable management judgment is necessary to evaluate the impact of operating changes and to estimate future cash flows. Changes in our actual results and/or estimates or any of our other assumptions used in our analysis could result in a different conclusion.
In connection with the acquisition of Photo Therapeutics on February 27, 2009, we acquired certain intangibles recorded at fair value as of the date of acquisition and allocated them fully to the PTL business segment.
The balances of these acquired intangibles, net of amortization, were:
Derivative Financial Instruments. We recognize all derivative financial instruments as assets or liabilities in the financial statements and measures them at fair value with changes in fair value reflected as current period income or loss unless the derivatives qualify as hedges. As a result, certain warrants are now accounted for as derivatives. As of December 31, 2009, we had $741,525 in derivative financial instruments.
Fair Value Measurements. We measure fair value in accordance with Financial Accounting Standards Board Accounting Standards Codification 820, Fair Value Measurements and Disclosures, or ASC Topic 820. ASC Topic 820 defines fair value, establishes a framework and gives guidance regarding the methods used for measuring fair value, and expands disclosures about fair value measurements. Fair value is an exit price, representing the amount that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants. As such, fair value is a market-based measurement that should be determined based on assumptions that market participants would use in pricing an asset or liability. As a basis for considering such assumptions there exists a three-tier fair-value hierarchy, which prioritizes the inputs used in measuring fair value. Our derivative financial instruments are considered to be significant unobservable inputs (level 3).
Deferred Income Taxes. We have a deferred tax asset that is fully reserved by a valuation allowance. We have not recognized the deferred tax asset, given our historical losses and the lack of certainty of future taxable income. However, if and when we become profitable and can reasonably foresee continuing profitability, then under FASB ASC 740, Income Taxes, or ASC Topic 740, we may recognize some of the deferred tax asset. The recognized portion may variously reduce acquired goodwill, increase stockholders equity directly and/or benefit the statement of operations.
Warranty Accruals. We establish a liability for warranty repairs based on estimated future claims for XTRAC systems and based on historical analysis of the cost of the repairs for surgical laser systems. However, future returns of defective laser systems and related warranty liability could differ significantly from estimates, and historical patterns, which would adversely affect our operating results.
Results of Operations
The following table illustrates revenues from our five business segments for the periods listed below:
Revenues from our Surgical Services business segment, in the amount of $4,398,047 through August 8, 2008, the date of sale, have been accounted for in 2008 as a discontinued operation. Revenues from our Surgical Services business segment were $7,667,174 for the year ended December 31, 2007 were reclassified to discontinued operations.
Domestic XTRAC Business Segment
Recognized treatment revenue for the years ended December 31, 2009, 2008, and 2007 was $9,736,800, $8,500,452 and $6,981,223, respectively, reflecting billed procedures of 145,521, 133,594 and 109,139, respectively. In addition, 6,567, 6,899 and 4,157 procedures were performed for the years ended December 31, 2009, 2008 and 2007, respectively, without billing from us, in connection with clinical research and customer evaluations of the XTRAC laser. The increase in procedures in the year ended December 31, 2009 compared to the same periods in 2008 and 2007 was largely related to our increased marketing programs. Increases in procedures are dependent upon building market acceptance through marketing programs with our physician partners and their patients that the XTRAC procedures will be of clinical benefit and be generally reimbursed.
We have a program to support certain physicians who may be denied reimbursement by private insurance carriers for XTRAC treatments. We recognize service revenue during this program from the sale of XTRAC procedures or equivalent treatments to physicians participating in this program only to the extent the physician has been reimbursed for the treatments. For the year ended December 31, 2009, we recognized revenues of $18,132 (279 procedures) net, under this program, compared to deferred revenues of $109,777 (1,682 procedures) net, under this program for the year ended December 31, 2008. For the year ended December 31, 2007, we deferred revenues of $103,851 (1,587 procedures) net, under this program. The change in deferred revenue under this program is presented in the table below.
We defer substantially all sales of treatment codes ordered by and delivered to the customer within the last two weeks of the period in determining the amount of procedures performed by our physician-customers. Management believes this approach closely approximates the actual amount of unused treatments that existed at the end of a period. For the year ended December 31, 2009, we recognized net revenues of $260,211 (4,003 procedures) and for the year ended December 31, 2008, we deferred net revenues of $107,210 (1,643 procedures), respectively, under this approach. For the year ended December 31, 2007, we deferred net revenues of $56,896 (869 procedures) under this approach.
For the years ended December 31, 2009 and 2008, domestic XTRAC laser sales were $3,054,148 and $3,919,520, respectively. There were 84 and 78 lasers sold, respectively. Included in the year ended December 31, 2008 laser sales was a sale of one Omnilux product from PTL for which we had been acting as a distributor in the U.S. There were 43 XTRAC lasers sold for the year ended December 31, 2007 for a total of $2,160,634. We sell the laser directly to the customer for certain reasons, including the costs of logistical support and customer preference as well as a means of addressing under-performing accounts while preserving the vendor-customer relationship. We believe that we are able to reach, at reasonable margins, a sector of the laser market that is better suited to a sale model than a per-procedure, or consignment, model.
The following table illustrates the above analysis for the Domestic XTRAC business segment for the periods reflected below:
The average price for a treatment may be reduced in some instances based on the volume of treatments performed. The average price for a treatment also varies based upon the mix of mild and moderate psoriasis patients treated by our physician partners. We charge a higher price per treatment for moderate psoriasis patients due to the increased body surface area required to be treated, although there are fewer patients with moderate psoriasis than there are with mild psoriasis.
International Dermatology Equipment Business Segment
International sales of our XTRAC and VTRAC systems and related parts were $3,996,067 for the year ended December 31, 2009 compared to $3,782,456 and $3,256,505 for the years ended December 31, 2008 and 2007, respectively. We sold 94 systems in the year ended December 31, 2009 which compared to 86 and 65 systems in the years ended December 31, 2008 and 2007, respectively. The average price of dermatology equipment sold internationally varies due to the quantity mix of refurbished domestic XTRAC systems and VTRACs sold. Both of these products have lower average selling prices than new XTRAC laser systems. However, by adding these to our product offerings along with expanding into new geographic territories where the products are sold, we have been able to increase overall international dermatology equipment revenues.
The following table illustrates the key changes in the International Dermatology Equipment business segment for the periods reflected below:
Skin Care Business Segment
For the year ended December 31, 2009, Skin Care revenues were $7,895,473 compared to $12,829,816 for the year ended December 31, 2008 and $13,471,973 for the year ended December 31, 2007. These revenues are generated from the sale of various skin, hair care and wound products and from the sale of copper peptide compound.
The following table illustrates the key changes in the Skin Care business segment for the periods reflected below:
Photo Therapeutics (PTL) Business Segment
For the year ended December 31, 2009, our PTL business segments revenues were $4,383,016. Since PTL was acquired on February 27, 2009, there were no corresponding revenues for the years ended December 30, 2008 and 2007. PTL revenues are primarily generated from the sale of LED devices and milestone payments on a licensing agreement targeting the mass consumer acne market.
The following table illustrates the key changes in our PTL business segment for the periods reflected below:
We are actively seeking distribution channels to reach the home-use consumer market with our New-U® hand-held LED device. Licensing revenues are from a license of the Clear-U, which the licensee intends to use as a platform to attempt to address the mass consumer acne market. We expect that the platform product may be released in early 2011.
Surgical Products Business Segment
Revenues from our Surgical Products business segment include revenues derived from the sales of surgical laser systems together with sales of related laser fibers and laser disposables. Laser fibers and laser disposables are more profitable than laser systems, but the sales of laser systems generate subsequent recurring sales of fibers and disposables.
For the year ended December 31, 2009, surgical products revenues were $3,622,580 compared to $5,738,048 in the year ended December 31, 2008. The decrease in the year was mainly related to the termination of an OEM contract in 2008 with AngioDynamics. In the second half of 2008, AngioDynamics elected not to continue with the OEM contract. There were no sales to Angio-Dynamics for the year ended December 31, 2009. Sales to AngioDynamics were $1.4 million for the year ended December 31, 2008 compared to $480,000 for the year ended December 31, 2007.
The change in average price per laser between the periods, as set forth in the table below, was largely due to the mix of lasers sold and partly due to the trade level at which the lasers were sold (i.e. wholesale versus retail). Our diode laser has replaced our Nd:YAG laser, which had a substantially higher sales price. Included in laser sales during the years ended December 31, 2009, 2008 and 2007 were sales of 26, 141 and 78 diode lasers, respectively. The diode lasers have lower sales prices than our other types of lasers. We are phasing out our holmium and CO2 laser systems.
Fiber and other disposables sales decreased 14% with the comparable years ended December 31, 2008 and 2007. We expect that our disposables base will continue to erode over time as hospitals continue to seek outsourcing solutions instead of purchasing lasers and related disposables for their operating rooms.
The following table illustrates the key changes in our Surgical Products business segment for the periods reflected below:
Cost of Revenues
Our cost of revenues are comprised of product cost of revenues and service cost of revenues. Within product cost of revenues are the costs of products sold in our International Dermatology Equipment business segment, the Skin Care business segment (with royalties included in the services side of the segment), our PTL business segment (with licensing revenues included in the services side of the segment) and our Surgical Products business segment (with laser maintenance fees included in the services side of this segment). Product costs also include XTRAC domestic laser sales. Within services cost of revenues are the costs associated with the Domestic XTRAC business segment, excluding the laser sales, as well as costs associated with the above-referenced royalties, licensing and maintenance revenues.
Product cost of revenues during the year ended December 31, 2009 were $11,675,233, compared to $11,968,222 for the year ended December 31, 2008. The $292,989 decrease is due to decreases in product cost of sales for surgical products of $1,216,902 related to the decrease in laser sales, a decrease in skincare products of $1,792,332 resulting from the switch to our internally produced Neova product and a decrease in domestic XTRAC laser sales of $338,810. These decreases were partly offset, by an increase in international dermatology equipment sales in the amount of $716,725. In addition, there was an increase due to the inclusion of $2,338,330 in product costs for our PTL business.
Product cost of revenues during the year ended December 31, 2008 were $11,968,222, compared to $9,582,715 for the year ended December 31, 2007. The increase of $2,385,507 is due to product cost increases from the following business segments: domestic XTRAC of $978,664; international dermatology equipment of $170,368; surgical products of $1,013,217; and skin care of $223,258. The increases are primarily a result of the increased number of laser sales which have a higher cost percentage than non-laser products. The skin care increase is the result of third-party licensed products which have a higher cost. There were also increases to the excess and obsolete inventory reserves mainly in the surgical product segment, $374,000, and skin care segment, $162,000. Warranty expense, which is included in cost of goods sold, amounted to $238,662 and $95,314 for the year ended December 31, 2008 and 2007, respectively.
Services cost of revenues was $5,750,733 in the year ended December 31, 2009 compared to $5,027,095 in the year ended December 31, 2008, representing an increase of $723,638. The increase is directly related to the increase in our Domestic XTRAC business segment costs of $706,393.
Services cost of revenues was $5,027,095 in the year ended December 31, 2008 compared to $3,998,911 in the year ended December 31, 2007, representing an increase of $1,028,184. The increase is directly related to the increase in our Domestic XTRAC business segment costs of $1,029,175.
Certain allocable XTRAC manufacturing overhead costs are charged against the XTRAC service revenues. Our manufacturing facility in Carlsbad, California is used exclusively for the production of the XTRAC lasers. The unabsorbed costs are allocated to the domestic XTRAC and the international dermatology equipment business segments based on actual production of lasers for each segment. Included in these allocated manufacturing costs are unabsorbed labor and direct plant costs.
The following table illustrates the key changes in cost of revenues for the periods reflected below:
Gross Profit Analysis
Gross profit decreased to $15,262,118 during the year ended December 31, 2009 from $17,774,975 during the same period in 2008. As a percentage of revenues, the gross margin decreased to 46.7% for the year ended December 31, 2009 from 51.1% for the same period in 2008.
Gross profit increased to $17,774,975 during the year ended December 31, 2008 from $17,464,817 during the same period in 2007. As a percentage of revenues, the gross margin decreased to 51.1% for the year ended December 31, 2008 from 56.3% for the same period in 2007.
The following table analyzes changes in our gross margin for the periods reflected below:
The primary reasons for changes in gross profit and the gross margin percentage for the year ended December 31, 2009 compared to the same period in 2008 were as follows:
The primary reasons for changes in our gross profit for the year ended December 31, 2008, compared to the same period in 2007 were as follows:
The following table analyzes the gross profit for our Domestic XTRAC business segment for the periods reflected below:
Gross profit increased for this business segment for the year ended December 31, 2009 from the comparable periods in 2008 by $3,393. The key factors for this increase were as follows:
Gross profit increased for this business segment for the year ended December 31, 2008 from the comparable periods in 2007 by $1,270,276. The key factors for this increase were as follows:
The following table analyzes the gross profit for our International Dermatology Equipment business segment for the periods reflected below:
Gross profit for the year ended December 31, 2009 decreased by $503,114 from the comparable prior year period. The key factors for the decrease were as follows:
Gross profit for the year ended December 31, 2008 increased by $355,583 from the comparable prior year period. The key factors for the increase were as follows:
The following table analyzes our gross margin for our Skin Care (ProCyte) business segment for the periods presented below:
Gross profit for the year ended December 31, 2009 decreased by $3,142,011 over the comparable period in 2008. The key factors for the decrease in this business segment were as follows:
Gross profit for the year ended December 31, 2008 decreased by $865,415 over the comparable period in 2007. The key factors for the decrease in this business segment were as follows:
The following table analyzes the gross profit for our PTL business segment for the periods presented below:
The key factors in this business segment were as follows:
The following table analyzes our gross profit for our Surgical Products business segment for the periods presented below:
Gross profit for the year ended December 31, 2009 decreased by $915,811 from the comparable prior year period. The key factors impacting gross profit were as follows:
Gross profit for the year ended December 31, 2008 decreased by $450,286 from the comparable prior year period. The key factors in this business segment were as follows:
Selling, General and Administrative Expenses
For the year ended December 31, 2009, selling, general and administrative expenses decreased to $23,083,347 from $26,797,107 for the year ended December 31, 2008 for the following reasons:
For the year ended December 31, 2008, selling, general and administrative expenses increased to $26,797,107 from $22,279,534 for the year ended December 31, 2007 for the following reasons:
Engineering and Product Development
Engineering and product development expenses for the year ended December 31, 2009 increased to $1,137,725 from $1,073,215 for the year ended December 31, 2008. The increase for the year ended December 31, 2009 was due to the engineering and product development expenses of our PTL business segment of $286,806 for the year ended December 31, 2009. Offsetting this increase was meeting our financial sponsorship obligations of $189,000 in March 2008 for the severe psoriasis study by John Koo, MD, of the University of California San Francisco Medical Center.
Engineering and product development expenses for the year ended December 31, 2008 increased to $1,073,215 from $799,108 for the year ended December 31, 2007. The increase for the year ended December 31, 2008 was due to meeting our financial sponsorship obligations, of $189,000 in March 2008 for the severe psoriasis study by John Koo, MD, of the University of California San Francisco Medical Center.
Refinancing charge for the year ended December 31, 2007 was due to the termination of the lending arrangements with both GE Capital Corporation and Leaf Financial. This included $108,876 for prepayment penalties; $178,699 buyback of previously issued warrants to GE; and $154,381 of unamortized costs for previous draws on the line of credit. These costs were incurred in order to obtain a new credit facility with CIT on terms more favorable to us.
Interest Expense, Net
Net interest expense for the year ended December 31, 2009 increased to $2,370,676, as compared to $1,032,597 for the year ended December 31, 2008. The change in net interest expense was the result of the interest expense on the convertible debt which was issued on February 27, 2009. The following table illustrates the change in net interest expense:
Net interest expense for the year ended December 31, 2008 increased to $1,032,597, as compared to $529,489 for the year ended December 31, 2007. The change in net interest expense was the result of the interest earned on cash reserves in the year ended December 31, 2007 due to the equity financing in November 2006, which offset interest expense in those periods from the draws on the line of credit. The draws, on average, were for larger amounts at higher rates in 2008 as compared to 2007. The following table illustrates the change in interest expense, net:
Change in fair value of warrants
In accordance with FASB ASC 470, Debt Debt with Conversion and Other Options, or ASC Topic 470, warrants issued in connection with the financing to acquire PTL were recorded at fair value and recognized as liabilities. In accordance with the provisions of FASB ASC 820, Fair Value Measurements and Disclosures, or ASC Topic 820, we measured the fair value of these warrants as of December 31, 2009, and recognized $808,786 for the year ended December 31, 2009 in other income in recording the liabilities associated with these warrants at their fair value as of December 31, 2009.
The factors discussed above resulted in a net loss of $10,520,775 during the year ended December 31, 2009, as compared to a net loss of $11,290,907 during the year ended December 31, 2008, a decrease of 6.8%. The year ended December 31, 2008 included a loss on sale of discontinued operations of $448,675.
The following table illustrates the impact of major expenses, namely depreciation, amortization, interest and stock option expense between the periods:
The aforementioned factors resulted in a net loss of $11,290,907 during the year ended December 31, 2008, as compared to a net loss of $6,354,246 for the year ended December 31, 2007, an increase of 77.7%. The year ended December 31, 2008 included a loss on sale of discontinued operations of $448,675.
The following table illustrates the impact of major expenses, namely depreciation, amortization, interest and stock option expense between the periods:
Income taxes were immaterial, given our current period losses and operating loss carryforwards.
Liquidity and Capital Resources
We have historically financed our operations with cash provided by equity financing and from lines of credit.
At December 31, 2009, our current ratio was 1.20 compared to 1.26 at December 31, 2008. As of December 31, 2009 we had $2,214,505 of working capital compared to $3,408,187 as of December 31, 2008. Cash and cash equivalents were $2,194,788 as of December 31, 2009, as compared to $3,736,607 as of December 31, 2008. We had $78,000 of cash that was classified as restricted as of both December 31, 2009 and December 31, 2008.
Based on our presently available resources, including the private placement of our securities described below, the substantial reduction in the use of cash in the last six months of 2009 compared to the first six months of 2009 and the last six months of 2008 and the continuation of our restructuring efforts, we believe that we can fund operations through and beyond the first quarter of 2011. However, given the uncertainty in the general economic conditions and the impact on our business and industry, and in light of our historical operating losses and negative cash flows, there is no assurance that we will not require additional funds in order to continue as a going concern through and beyond the first quarter of 2011.
Starting in August 2009, we began to restructure our operations and redirect our efforts in a manner that management expects will result in improved results of operations. As part of such redirected efforts, management continues to minimize our operational costs and capital expenditures. In addition, we are developing strategies to increase ongoing revenue streams and have also refocused our sales efforts to convert customer relationships within the Domestic XTRAC business segment which are underperforming under the consignment model, to a sale of the currently consigned equipment in order to accelerate cash receipts. In the year ended December 31, 2009, we sold 40 of these underperforming lasers, for approximately $1,138,000 in proceeds. In addition, in an effort to preserve cash resources, we have secured from certain vendors extended payment arrangements.
On October 22, 2009, we closed a private placement of our common shares with several accredited investors, which yielded gross proceeds of approximately $2.7 million and which improved our available cash.
On November 10, 2009, we issued to an affiliate of one of the accredited investors participating in the October 22, 2009 private placement an additional 230,000 shares, which yielded additional gross proceeds of $149,500. Although this financing, together with our other resources and arrangements with creditors, satisfied our immediate liquidity constraints at such time, we continue to explore additional opportunities to secure capital which might be used to continue to develop new business opportunities or, if necessary, to fund operations.
On March 19, 2010, we entered into the Clutterbuck Agreement and the Clutterbuck Note with Clutterbuck Funds. We received net proceeds of approximately $2.37 million in the transaction. The Clutterbuck Note has a principal amount of $2.5 million, which accrues interest at a rate of 12% per annum. The Clutterbuck Note requires us to make monthly payments of interest only. The principal matures in September 2011 and may be prepaid without penalty at any time. The note is secured by XTRAC lasers (and the related usage agreements and payments received thereunder) that we have consigned to physician customers and that are not otherwise pledged to CIT Healthcare LLC and Life Sciences Capital LLC pursuant to our outstanding term notes with such lenders. In connection with the issuance of the Term Note to Clutterbuck, we issued Clutterbuck Funds a warrant to purchase 102,180 shares of our common stock for an initial exercise price of $7.34 per share. The warrant is exercisable at any time on or prior to the fifth anniversary of its issue date. Pursuant to the terms of the warrant, the exercise price is subject to a one-time downward adjustment if we make certain issuances of our equity securities at a price per share less than $7.34 during the 18-month period following the issuance of the warrant or, during the 18-month period after such 18-month period, in the event aggregate proceeds of dilutive issuances during such second 18-month period exceed $2.5 million.
These proceeds and the continued implementation of our revised sales and marketing strategies are expected to ensure our liquidity through the first quarter of 2011.
In order to consummate the bridge financing, it was necessary to secure the consent of the investor that holds the Convertible Notes. As of March 19, 2010, the outstanding principal and accrued interest under the Convertible Notes was $19,546,676. In order to obtain the investors consent, we agreed to the following modifications to the Convertible Notes:
On December 31, 2007, we entered into a term-note credit facility from CIT Healthcare and Life Sciences Capital, or CIT. The credit facility had a commitment term of one year, which expired on December 31, 2008. We accounted for each draw as funded indebtedness, with ownership in the lasers remaining with us. CIT holds a
security interest in the lasers and in their revenue streams. Each draw against the credit facility has a repayment period of three years, except for legacy components refinanced from previous borrowings. On September 30, 2008, the facility was amended to permit us to make a fourth draw of $1.9 million in the third quarter of 2008; Life Sciences Capital did not participate in the fourth draw. We have used our entire availability under the CIT credit facility. A summary of the terms and activity under the CIT credit facility is presented in Note 10, Long-term Debt, of the Financial Statements included in this Report.
On February 27, 2009, as part of the first tranche of the convertible debt financing in connection with our acquisition of our Photo Therapeutics business, the holder of the convertible debt funded approximately $2 million to be used to pay for costs related to the acquisition and its financing, and approximately $3 million to be used as working capital. A summary of the terms and activity under the convertible debt is presented in Note 11, Convertible Debt, of the Financial Statements included in this Report.
Net cash and cash equivalents used in operating activitiescontinuing operations was $2,254,247 for the year ended December 31, 2009 compared to cash used of $1,294,070 for the year ended December 31, 2008. The change in cash used between the years was mostly due to the decreases in accounts receivable and inventories.
Net cash and cash equivalents used in operating activitiescontinuing operations was $1,294,070 for the year ended December 31, 2008 compared to cash used of $1,739,728 for the year ended December 31, 2007. The change in cash used between the years was mostly due to the increases in accounts payable and other accrued liabilities and decreases in accounts receivable and prepaid expenses and other assets.
Net cash and cash equivalents used in investing activitiescontinuing operations was $14,656,266 for the year ended December 31, 2009 compared to $2,766,153 for the year ended December 31, 2008. This was primarily due to acquisition costs, net of cash received, of $12,578,022 in connection with the Photo Therapeutics acquisition. The balance of the increase was mainly for the placement of lasers into service.
Net cash and cash equivalents used in investing activitiescontinuing operations was $2,766,153 for the year ended December 31, 2008 compared to $4,301,624 for the year ended December 31, 2007. This was primarily for the placement of lasers into service. The year ended December 31, 2008 was net of proceeds received from the sale of discontinued operations of $3,149,736.
The placement of lasers into service is shown net of the remaining net book value of the lasers that we sold during the period presented. When we retire a laser from service, we transfer the laser into inventory and then write off the net book value of the laser, which is typically negligible. Over the last few years the retirement of lasers from service have been minor or immaterial and, therefore, they are reported with placements on a net basis.
Net cash and cash equivalents used in financing activities was $15,263,633 for the year ended December 31, 2009 compared to cash provided by financing activities of $2,634,849 for the year ended December 31, 2008. In the year ended December 31, 2009 we received $18 million in proceeds in the convertible debt financing and $2,857,250 from private placement equity financing, both of which were partially offset by repayment of $4,717,381 on the line of credit, $415,905 for certain notes payable and registration costs of $460,614.
Net cash and cash equivalents used in financing activities was $2,634,849 for the year ended December 31, 2008 compared to cash provided by financing activities of $2,659,036 for the year ended December 31, 2007. In the year ended December 31, 2008 we repaid $1,655,123 on the lease and term-note lines of credit, net of advances and $1,018,726 for the payment of certain notes payable and capital lease obligations.
Set forth below is a summary of our current obligations as of December 31, 2009 to make future payments due by the period indicated below, excluding payables and accruals. We expect to be able to meet our obligations in the ordinary course. The obligations under the credit facility from CIT are term notes. Operating lease and rental obligations are respectively for personal and real property which we use in our business. The obligations relating to the Convertible Notes are stated at the principal amount due and are not discounted for related warrants or origination costs.
Our ability to expand our business operations is currently dependent in significant part on financing from external sources. There can be no assurance that changes in our manufacturing and marketing, research and development plans or other changes affecting our operating expenses and business strategy will not require financing from external sources before we will be able to develop profitable operations. Under the terms of the SPA, we must secure the approval of the holder of the convertible notes for the incurrence of debt. Equity securities must first be offered to the holder of the Convertible Notes. There can be no assurance that additional capital will be available on terms favorable to us, if at all. To the extent that additional capital is raised through the sale of additional equity or convertible debt securities, the issuance of such securities could result in additional dilution to our common stockholders. Moreover, our cash requirements may vary materially from those now planned because of marketing results, product testing, changes in the focus and direction of our marketing programs, competitive and technological advances, the level of working capital required to sustain our planned growth, litigation, operating results, including the extent and duration of operating losses, and other factors. In the event that we experience the need for additional capital, and are not able to generate capital from financing sources or from future operations, management may be required to modify, suspend or discontinue our business plan.
Off-Balance Sheet Arrangements
At December 31, 2009, we had no off-balance sheet arrangements.
Impact of Inflation
We have not operated in a highly inflationary period, and we do not believe that inflation has had a material effect on our sales or expenses.
PhotoMedex is a global skin health medical technology company that provides integrated disease management and aesthetic solutions through complementary laser and light-based devices, pharmaceuticals and cosmeceuticals. Through our historical relationships with dermatologists and plastic surgeons, we provide products and services that address skin diseases and skin conditions. These diseases and conditions include psoriasis, vitiligo, acne, actinic keratosis (a precursor to certain types of skin cancer) and sun damage. Our experience in addressing these diseases and conditions in the physician market has allowed us to expand our products and services to provide skin health solutions to the indoor tanning and spa markets and the in-store, on-line and television retail consumer markets for home use.
We were organized in 1987 and through 1999 were principally a research and development company with insignificant end-user revenue. In January 2000, the FDA issued a 510(k) clearance for the XTRAC laser system, an important milestone in our history. The XTRAC was a new breakthrough technology designed to treat psoriasis using targeted narrow band UVB light. Despite receiving FDA clearance, our ability to commercialize the XTRAC was limited due to the lack of insurance reimbursement available for the treatment, a key driver in the acceptance by dermatologists and their psoriasis patients. A prolonged effort was undertaken to establish insurance reimbursement, an effort that would ultimately take until 2007 for the Blue Cross Blue Shield Association to include the XTRAC in its National Reference Policy and until 2008 for all of the Blue Cross and Blue Shield Plans to issue policies covering the system.
During this period, we augmented our business through a series of acquisitions which expanded our product suite to include skincare and LED product lines. While these acquisitions, along with the development and growth of the XTRAC business, have significantly increased our revenues over this time, the limited integration of the sales and marketing teams which were previously product focused, coupled with an emphasis on short term goals over long term strategy, has resulted in a history of losses.
Our Key Strategies
Our current strategic focus is built upon four key components establishment of a unified sales force focused on superior skin health expertise, expanded international capabilities, the development of alternate channels for our varied product lines and a renewed commitment to innovation of our technologies.
Establishment of a Unified Sales Force
In the fourth quarter of 2009, we began implementing a strategy to develop a single, skin health solutions-based sales force with expertise in our three primary skin health brands: XTRAC, Neova and Omnilux. The goal of this strategy is to gain sales and financial leverage out of our current sales force while providing solutions across our complete product suite to our customers. In furtherance of this strategy, we have reduced the size of our sales force by approximately 25%, which resulted in an increase in the amount of time each salesperson spends with physicians and their staff in their respective geographic territories. These steps have reduced the cost of our sales force and increased productivity.
Along with reducing the size of our sales force, we have refocused the way that we sell our products to our customers. Rather than selling discrete products, we have shifted the way we sell our skin health solutions from an individual product focus to educating our customers in the various ways they might utilize multiple products from our varied line to address their patients needs. This approach requires each member of our sales force to be an expert with respect to each one of our products. We have implemented a continual training program for our sales representatives to expertly position all of our products through comprehensive protocols demonstrating how our skin health solutions are best used in combination rather than simply as stand-alone offerings. We believe this approach increases our ability to sell multiple products into a single physician practice.
This new unified sales approach has created a platform for co-marketing partnership opportunities. Our sales force is now a scalable organization that is able to take products manufactured by others and add them to the skin health solutions that are presented to our customers. For example, on January 11 2010, we entered into a co-promotion agreement with Galderma, pursuant to which our sales force will promote Galdermas Metvixia drug and Aktilite LED light for the photodynamic therapy treatment of actinic keratosis. Under the three year co-promotion agreement, which was effective on January 1, 2010, Galderma will provide all marketing support for these products and we will provide the direct sales effort through our existing domestic sales organization. Co-marketing partnerships, such as our partnership with Galderma, which couple our sales force and products with complementary third-party products, provide us additional opportunities to increase revenue while leveraging our existing infrastructure.
Expanded International Capabilities
In the third quarter of 2009, we realigned our international operations and selling approach, and the once limited capabilities of the international organization have been dramatically enhanced through two initiatives.
First, we have entered into an expanded management relationship with GlobalMed with respect to our laser and light based devices. GlobalMed is an international distribution and management company focused on creating increased market opportunity through the engagement and management of local in-country distributors and providing assistance in expediting regulatory approvals. Historically, GlobalMed managed our distribution relationships in the Pacific Rim for the XTRAC and VTRAC product lines, which represented a majority of our total international device sales. As a result of their success in managing our Pacific Rim distribution relationships, we have now expanded their responsibilities to include all of our laser and light based devices in substantially all markets outside of the U.S. For purposes of our business and the discussion in this prospectus, we consider the Pacific Rim to include the following countries: the Philippines, China, Taiwan, Korea, Japan, Singapore, Malaysia, Indonesia, Thailand, Australia, New Zealand, Cambodia and Vietnam. GlobalMeds efforts are supported by our internal organization and by GlobalMed employees in each major region of the world.
Second, we have begun to undertake significant efforts to expand the international reach of our skincare business in both the physician and consumer channels. We have reformulated our clinical skincare products by eliminating certain preservatives and other ingredients in order to comply with international regulations. All of our skincare product packaging has been redesigned to meet international regulations and we are currently in the process of making required filings in order to register our products in certain foreign jurisdictions. We intend to submit applications for product marketing approval in Canada, China, the European Union, Japan, Korea, Mexico and certain countries in South and Central America in the first half of 2010 and anticipate that we may obtain one or more approvals by the end of 2010. Our sales approach in these countries will incorporate procedure specific protocols for in-office treatments coupled with outpatient product kits designed for patients to continue to use the products at home. The protocols combine the use of several of our skincare products and Omnilux professional and hand-held LED light systems in a regimen designed to address skin rejuvenation, acne clearance, skin brightening, eye treatment and recovery and photoaging repair. In these unique protocols, our copper peptide complexes, DNA repair enzymes and LED technology combine to provide patients with optimized treatment outcomes.
In addition, we have put in place an international organization of employees comprised of seven professionals, including five employees and two consultants, capable of driving the sales, marketing, regulatory and operational requirements of international sales for our clinical skincare and handheld Omnilux products throughout the world. This organization effectively interfaces with GlobalMed and our other direct distribution partners. We have distribution capability through approximately 65 distribution partners worldwide.
Development of Alternate Channels
We are currently focused on expanding sales of our professional products through channels beyond the physician markets that we serve. Our products are adaptable to alternative channels of distribution, enabling us to expand our sales opportunities through industry leading distributors and directly to end consumers.
We believe that there are opportunities to sell our products through non-physician related markets in which our customers can sell or distribute our products to consumers. We are accessing these markets either through direct relationships with multi-location organizations or through relationships with distributors. In the indoor tanning market, which today services approximately 30 million people in the U.S. on an annual basis, we sell Omnilux LED devices and certain skincare products directly to Planet Beach, Planet Beach International, LLC and Planet Beach Franchising Corporation for use and sale within their tanning/spa franchises. ETS, LLC, the leading distributor in the indoor tanning industry, purchases Omnilux and skincare products for sale in their substantial network of stores. In addition, we are working with a leading tanning bed manufacturer on what we believe will be significant enhancements to their products through incorporation of our skin rejuvenation light technology. In the spa market, we have developed a relationship with Four Seasons Sales & Service, Inc., a Nashville, Tennessee-based company that specializes in indoor tanning equipment and supplies, to carry our Omnilux products. We intend to expand this relationship and enter into new relationships with several other spa groups both domestically and internationally to sell our other products.
To further expand our retail channels, we are working with GlobalBeauty to develop new sales channels in the direct to consumer skincare markets, including the in-store, on-line and television retail channels. GlobalBeauty is experienced in identifying and pursuing, through long-standing relationships, distribution of retail and home use products and technologies through the appropriate specialty, prestige and mass retail channels and electronic media. As a result of this new relationship, the Omnilux New-U handheld unit for the reduction of wrinkles is scheduled to be aired for the first time on the Home Shopping Network in January 2010. Our strategy in working with GlobalBeauty is to maximize the distribution of our skincare and home use Omnilux products into appropriate channels and to develop new lines of skincare products specifically to take advantage of the retail opportunity that we believe our technologies present.
Other retail opportunities have led us to enter into an agreement with a leader in household health and personal care products for the worldwide distribution of our Omnilux handheld acne product. Our partner in this relationship had approximately $10 billion in worldwide revenue in 2008. Omnilux incorporates clinically efficacious doses of LED light into a home use device capable of treating skin rejuvenation or wrinkle reduction and providing an effective regimen for the clearance of acne. We believe future indications may also include applications for alleviating pain and accelerating the healing of certain wounds.
Renewed Commitment to Innovation
We believe that our innovative products have been crucial to our ability to succeed in the extremely competitive skin health market. Under the guidance of our Scientific Advisory Board, future indications for our products are being explored as well as potential combinations of our products with other dermatological treatments. We have recently launched, or are working on, innovative new uses for our technologies that we believe will allow us to leverage the success of our current products in the marketplace.
XTRAC Velocity. Prior to June 2009, we offered the XTRAC Ultra as our only solution for the treatment of psoriasis. The XTRAC Ultra is most appropriate for use on patients with mild to moderate psoriasis. We did not have a device which we marketed to physicians to use to treat patients with severe psoriasis. Over $1 billion is spent annually in the U.S. on device and drug treatments of severe psoriasis, many of which have side effects or FDA warning labels. To deliver a safe and more cost-effective treatment for psoriasis, we launched the XTRAC Velocity, an innovation of the XTRAC Ultra. The XTRAC Velocity is three times faster and more powerful than the XTRAC Ultra, making it ideal for practices having a greater mix of severe patients or having a significantly larger volume of psoriasis patients overall. With the innovation of the XTRAC Ultra into the XTRAC Velocity, we now have a psoriasis solution for physician practices of all sizes and patient demographics.
In addition, beginning in early 2010, we are co-sponsoring a clinical trial with Dr. John Y. M. Koo, the Director of the Psoriasis Treatment Center at the University of California San Francisco Medical Center, to demonstrate the effectiveness of the XTRAC Velocity in combination with the drug Clobex from Galderma Pharma S.A. for patients with severe psoriasis. Dr. Koo has published numerous articles and book chapters in the field of
psoriasis. The goal is to achieve better patient results in fewer treatments than either the drug or the XTRAC Velocity can achieve as a stand-alone treatment. If successful, the end result will be greater efficacy and convenience for the patient, which we believe will result in an increase in the use and applicability of the XTRAC Velocity.
DNA Repair. UV-induced stresses to the skin can cause damage to skin cells and their DNA. The first natural line of defense against the damaging effects of the sun is melanin which reflects or absorbs UV light and prevents damaging UV rays from striking the DNA in the cell nucleus. During this process, UV photons produce a chemical in the DNA bases, which alters the genetic code. Alterations to those genes can interrupt or destroy the repair process. The consequences of unrepaired DNA damage for skin cells can be severe and include discolorations, wrinkles and other signs of photodamage.
We have identified certain types of damage that, if not repaired quickly, become permanent. Our new DNA Repair topical products, which include DNA Nourishing Lotion and DNA Total Repair, use innovative technology to address DNA damage by activating the skins natural recovery process after damage has occurred but before the secondary result, such as erythema or skin cancer, appears. Modern sunscreen products frequently combine UV filters with one or more antioxidants, which provide a degree of secondary photoprotection against oxygen radicals. Our DNA Repair products activate the DNA repair process. The liposome system used in our DNA Repair products has been specifically engineered for the transference of DNA repair enzymes into epidermal cells and to enhance DNA repair of UV-irradiated skin.
Our DNA Repair products help skin continuously repair its appearance in three advanced ways. First, the products heighten the skins natural repair process, which, over time, results in a reduction in the visible signs of aging, including fine lines, wrinkles and discolorations. Second, the products help skin continuously repair the appearance of past damage caused by UV exposure before they become permanent. Finally, the products, which contain a blend of an anti-inflammatory and a powerful antioxidant, block the activation of the two enzymes, elastase and matrix metalloproteinase, which degrade collagen and elastin and destroy the skins supporting structure, leading to wrinkle formation.
Omnilux Home Use Devices. Consumers have long sought products that would help them look their best conveniently and affordably. Since the prices of professional procedures performed in a salon, spa or medical office can be high, and traveling to these establishments for treatment typically entails an additional commitment of time for the consumer, products developed for home-use often best meet these needs. The Omnilux New-U for treating peri-orbital wrinkles was cleared by the FDA for over-the-counter sale directly to the consumer on March 3, 2008. The Omnilux Clear-U was cleared by the FDA for over-the-counter sale directly to the consumer on January 16, 2009. We are continuing to advance the technology by reducing the size of the products even further and thereby reducing their manufacturing costs. We intend to launch the Omnilux Nano and the Omnilux Micro in 2010. Both will have the same power as the larger Clear-U and New-U, but the Nano will treat fewer skin surface areas in a single treatment and the Micro will only have one wavelength rather than two. Both advancements will result in a lower selling price for the products as compared to the Clear-U and New-U, providing greater access to the technology by the consumer.
Our products have applications in two general areas: management of skin diseases and conditions and skincare. Some of our products, which are described in more detail below, address both the management of skin diseases and conditions and skincare areas, as illustrated in the following chart:
Our Ability to Treat Skin Diseases and Conditions
Our XTRAC System
In January 2000, we obtained FDA 510(k) clearance to market our XTRAC excimer laser system for the treatment of psoriasis, a chronic, autoimmune disease that appears on the skin. Indications for the XTRAC were later expanded to include the treatment of vitiligo, a medical condition that causes the skin to lose color; atopic dermatitis (eczema), an inflammation of the skin; and leukoderma, an acquired condition with localized loss of pigmentation of the skin that may occur after any number of inflammatory skin conditions, including burns and scars.
According to the National Psoriasis Foundation, psoriasis afflicts as many as 7.5 million Americans and 125 million people worldwide. While the exact cause of psoriasis is unknown, the immune system and genetics play major roles in the development of this disease. Most researchers agree that the immune system is mistakenly triggered, which causes the acceleration of skin cell growth. Normal skin cells mature and fall off the body in 28 to 30 days. In a patient with psoriasis, skin cells take only three to four days to mature and instead of falling off, build up on the surface of the skin, forming psoriatic lesions.
Our XTRAC system applies a concentrated dose of UVB radiation directly to the diseased skin at a high intensity, which temporarily stops this excess cell buildup and allows the diseased skin to return to a more normal state during a term of remission. Remission length varies from several months to in excess of one year. Our XTRAC system utilizes a 308-nm light wavelength, which studies have shown to be an optimal wavelength to treat psoriasis effectively.
Nearly one-quarter of people with psoriasis have cases that are considered moderate to severe. We offer two versions of our XTRAC system: the XTRAC Ultra, which has been established as one of the most clinically effective therapies for treating patients with mild to moderate psoriasis, and the XTRAC Velocity, launched in June 2009, which is three times faster than the XTRAC Ultra and enables physicians to safely treat severe psoriasis patients conveniently and effectively without the significant side effects of other more expensive modalities.
Vitiligo, which affects up to 2% of the world population, develops when cells called melanocytes die or are destroyed by the bodys immune system. As the cells die, an area of skin or hair turns white because the cells no longer make pigment. The XTRAC treatment of vitiligo, delivered in much the same way as when treating psoriasis but requiring more treatments, re-ignites the melanocytes causing pigment to return to the skin. We do not yet know how long the positive effects of our treatment for vitiligo will last on an individual, but based on anecdotal data we believe the re-pigmentation may last for several years. Vitiligo is genetically inherited and is thought to be triggered by certain unknown environmental factors. There is presently no known cure for vitiligo.
Our VTRAC System
Our VTRAC system is a lamp-based product line that is sold principally outside of the U.S. and is used to treat the same diseases and conditions as the XTRAC laser. This product offering provides an effective, non-laser option to compete against lower-priced UVB lamp-based international competitors.
Our Omnilux Products
We market a family of products under the brand name Omnilux that produce certain therapeutic wavelengths of light through LEDs. Our Omnilux technology is based on narrowband LEDs and the range of products include the Omnilux blue (blue light), Omnilux revive (red light), Omnilux plus (infrared light) and Omnilux PDT (red light-marketed only outside the U.S.). The professional products consist of a base unit upon which an interchangeable LED head is attached. Each detachable treatment head delivers pure, optimized, narrowband light via a matrix of LEDs carefully positioned to deliver a measured dosage of light to the treatment area. In addition, we have developed two hand-held home use devices, the Omnilux New-U for the treatment of peri-orbital wrinkles (skin rejuvenation) and the Omnilux Clear-U for the treatment of acne.
Our Omnilux products provide treatments for acne and actinic keratosis and also offer skin health solutions addressing skin rejuvenation, anti-aging, post-procedure care and wound healing. The Omnilux therapy stimulates the bodys own cellular mechanisms through a process known as photomodulation. The therapy produces no heat, is non-invasive and non-ablative and causes no damage to sub-dermal tissue.
Actinic keratosis is considered the earliest stage in the development of certain skin cancers. The treatment for actinic keratosis lesions ranks as one of the most frequent reasons that people consult a dermatologist.
Acne is the most common skin disorder in the U.S., affecting as many as 50 million Americans. The bacteria within acne produce chemicals, that when stimulated by the blue light of the Omnilux blue, neutralize the bacteria. With the bacteria eliminated, the inflammation of acne subsides. Red light is also used in the treatment of acne due to its anti-inflammatory properties. The handheld Omnilux Clear-U device allows the user to switch between red light and blue light in the same device.
Galdermas Metvixia and Aktilite Products
On January 11, 2010, we entered into a co-promotion agreement with Galderma, pursuant to which our sales force will promote Galdermas Metvixia drug and Aktilite LED light for the photodynamic therapy treatment of actinic keratosis. Metvixia is a topical porphyrin precursor used in photodynamic therapy. When applied to actinic keratosis lesions, Metvixia is selectively absorbed into precancerous cells causing a build-up of endogenous porphyrins. These endogenous porphyrins are illuminated with the Aktilite CL128 lamp emitting a narrow output spectrum of red light with a peak wavelength at 630 nm. Subsequently, a reaction occurs that results in the destruction of the precancerous cells. Clinical trials in various countries with the Metvixia PDT system have shown comparable or better response rates than conventional treatments, such as cryotherapy or surgery. Metvixia PDT selectively targets precancerous cells so the surrounding healthy cells are less subjected to the treatment, therein minimizing scarring and ensuring more acceptable cosmetic outcomes for patients.
Our Skin Health SolutionsNeova Therapy and Omnilux Products
Skin Rejuvenation and Anti-Aging
The highly competitive clinical skincare market has been dominated by anti-aging products. It continues to lead the skincare market with over $30 billion in estimated global sales. Over the last seven years, the skincare market has witnessed an increasing convergence of the personal care and pharmaceutical industries, which has led to the emergence of new hybrid markets where actives and ingredients have been leveraged from pharmaceuticals into cosmeceuticals. Our Neova Therapy product line consists of anti-aging and skin rejuvenation products that we specifically developed in response to the demand from physician customers for a comprehensive approach to medically directed skincare. The Neova Therapy line of copper peptide complex products include moisturizers and serums that are complemented by cleansers, toners and masks for an integrated approach to skincare. We also market a line of facial peel products and Neova Advanced Essential Lash, an eyelash conditioner. We have recently added products containing DNA repair enzymes to our line of Neova products. DNA repair enzymes are designed to help cellular components of skin recover from past damage. They help restore thymine dimers, which are pieces of DNA that have been broken by UV exposure. Our Omnilux revive and plus products deliver wavelengths of light in the red and infrared spectrums that have been proven to stimulate cellular mechanisms responsible for tissue repair and regeneration. The Omnilux products are used both as stand-alone treatment as well as in conjunction with our Neova line of products.
Post-Procedure Care and Wound Healing
The global market size for advanced/active wound care products is estimated to be $4.9 billion and growing at a 10% annual rate. Within our Neova line, our Complex Cu3 topical products provide a comprehensive approach to post-procedure care and allow us to differentiate our line of skincare products on the basis of our proprietary copper and manganese peptide technologies. Studies have indicated that the skin heals more rapidly with the use of copper peptide compounds than with a placebo treatment. Our Complex Cu3 Post Laser Lotion, Intensive Repair Crème, Cleanser and Hydrating Gel products containing copper peptide compounds are used to treat patients following chemical peels, microdermabrasion and laser treatments. Our Omnilux professional and handheld units also provide wound healing results. Trials have clearly displayed that 633 nm light not only enhances DNA synthesis, but also augments cellular tissue regeneration pathways, including collagen deposition. Light at 830nm is known to stimulate tissue, remodel cell lines and influence remodeling and restructuring of collagen. Study groups have shown that near infrared light (830nm, Omnilux plus) combined with red light (633nm, Omnilux revive) accelerates the wound healing response and therefore offers an effective treatment for the healing of compromised tissue. The Omnilux handheld New-U combines both wavelengths in a single device.
Ti-Silc and Z-Silc are our line of advanced sun protection products, which are recommended by dermatologists and plastic surgeons to assist in the prevention of sun exposure that can lead to a number of problems including age spots, hyperpigmentation, premature aging and melanoma.
The market in which our XTRAC system competes is highly competitive. We compete with other products and methodologies used to treat the symptoms of psoriasis, vitiligo, atopic dermatitis and leukoderma, including topical treatments, systemic medications and other phototherapies. We believe that our XTRAC system will favorably compete with alternative treatments for these disorders primarily on the basis of its effectiveness, as well as on the basis of its cost-effectiveness. Market acceptance of our XTRAC system treatment for these diseases is dependent on our ability to establish, with the medical and patient communities, the efficacy of our XTRAC system as a preferred treatment modality. In addition, all or a portion of patient costs for many of the alternative treatments are paid or are reimbursable by health insurance coverage or other third-party payors, such as Medicaid and Medicare. Patient costs for treatments utilizing our XTRAC system may not be initially eligible
for health care coverage or reimbursement by third-party payors until such payors approve reimbursement. This may cause some patients or physicians to choose alternative treatments offered by our competitors that are eligible for such coverage reimbursement.
We also face direct competition from other companies, including large pharmaceutical companies, engaged in the research, development and commercialization of treatments for psoriasis, atopic dermatitis, vitiligo and leukoderma. In some cases, those companies have already received FDA approval or commenced clinical trials for such treatments. Many of these companies have significantly greater financial resources and expertise in research and development, manufacturing, conducting pre-clinical studies and clinical trials and marketing than we do.
Various other companies are now marketing laser-based phototherapy treatment products. In addition to one company that has received FDA clearance to market an excimer laser for the treatment of psoriasis in the U.S., we are aware of foreign-based companies which market an excimer laser for the treatment of skin disorders outside of the U.S. Other devices include pulse-dye lasers, lamp-based systems, intense pulsed systems and standard UVB systems using fiber-optic delivery systems. We expect that other devices may enter the market in the future. All of these technologies will continue to evolve with time. We cannot say how much these technologies will impact us, but we anticipate that most competitors that enter the U.S. market will not use a fee-per-procedure model but will use an outright sales model and will likely sell not on claims of superior quality, but on claims of lower prices and possibly better economic returns. Non-laser systems are typically reimbursed at substantially lower rates.
Competition in the wound care, skin health and hair care markets is intense. Our competitors include well-established pharmaceutical, cosmetic and healthcare companies such as Obagi, La Roche Posay, Pavonia, Decleor, Murad and Allergan. These competitors have substantially more financial and other resources, larger research and development staffs and more experience and capabilities in researching, developing and testing products in clinical trials, in obtaining FDA and other regulatory approvals and in manufacturing, supply chain control, marketing and distribution than we do. A number of smaller companies are also developing or marketing competitive products. Our competitors may succeed in developing and commercializing products or obtaining patent protection or other regulatory approvals for products more rapidly than we can. In addition, competitive products may be manufactured and marketed more successfully than our potential products. Such developments could render our existing or potential products less competitive or obsolete and could have a material adverse effect on our business, financial condition and results of operations.
With regard to surgical lasers, we face substantial competition from other manufacturers of surgical laser systems, whose identity varies depending on the medical application for which the surgical system is being used and from traditional surgical methods. Other companies are developing competitive surgical systems and related technologies. Many of these companies are substantially larger and have substantially greater resources than we do.
Our LED products also face substantial competition. We compete based on quality of design, manufacturing and clinical research. In addition, we have a broad intellectual property position which will deter companies with LED products from entering the market.
Research and Development
As of April 8, 2010 our research and development team, including engineers, included 13 employees. We conduct research and development activities at four of our facilities. Our research and development expenditures were approximately $1.1 million in 2009, $1.1 million in 2008 and $0.8 million in 2007.
Our research and development activities are focused on:
Patents and Proprietary Technologies
We intend to protect our proprietary rights from unauthorized use by third parties to the extent that our proprietary rights are covered by valid and enforceable patents or are effectively maintained as trade secrets.
Our policy is to file patent applications and to protect certain technology, inventions and improvements that are commercially important to the development of our business. As patents expire and expose our inventions to public use, we seek to mitigate the impact of such expirations by seeking protection of improvements. The patents in our Skin Care business segment relate to use of our copper and manganese peptide-based technology for a variety of healthcare applications and to the composition of certain biologically active, synthesized compounds. Our strategy has been to apply for patent protection for certain compounds and their discovered uses that are believed to have potential commercial value in countries that offer significant market potential. As of December 31, 2009, we had 71 domestic and foreign issued patents, which serve to help protect the technology of our businesses in phototherapy, skin health and hair care and surgical products and services. As of December 31, 2009, we had 43 patent applications pending in the U.S. and abroad.
We have licensed certain of our proprietary technology to third parties. We seek licenses from third parties for technology that can broaden our product and service offerings. For example, we secured a license from the Mount Sinai School of Medicine, New York, New York, which granted us exclusive rights to a patent directed to the use of excimer lasers in the treatment of vitiligo.
We also rely on trade secrets, employee and third-party nondisclosure agreements and other protective measures to protect our intellectual property rights pertaining to our products and technology.
Many of our products and services are offered under trademarks and service marks, both registered and unregistered. We believe our trademarks encourage customer loyalty and aid in the differentiation of our products from competitors products, especially in our skincare products. Accordingly, we had federally registered 35 of our trademarks in the U.S. as of December 31, 2009. In addition, as of December 31, 2009, we had 121 trademark registrations for our products in foreign jurisdictions. Trademarks for products that are not commercially important may be allowed to lapse.
Regulations Relating to Products and Manufacturing
Our products and research and development activities are regulated by numerous governmental authorities, principally the FDA and corresponding state and foreign regulatory agencies. Any medical device we manufacture and/or distribute will be subject to pervasive and continuing regulation by the FDA. The U.S. Food, Drug and Cosmetics Act, or FDA Act, and other federal and state laws and regulations govern the pre-clinical and clinical testing, design, manufacture, use, labeling and promotion of medical devices, including our XTRAC system, surgical lasers and other products currently under development by us. Product development and approval within this regulatory framework takes a number of years and involves the expenditure of substantial resources.
In the U.S., medical devices are classified into three different classes, Class I, II, and III, on the basis of controls deemed necessary to provide a reasonable assurance of the safety and effectiveness of the device. Class I devices are subject to general controls, such as facility registration, medical device listing, labeling requirements, premarket notification (510(k)) (unless the medical device has been specifically exempted from this requirement), adherence to the FDAs Quality System Regulation, and requirements concerning the submission of device-related adverse event reports to the FDA. Class II devices are subject to general and special controls, such as performance standards, postmarket surveillance, patient registries and FDA guidelines. Some Class III devices are 510(k)-exempt. Generally, Class III devices are those that must receive premarket approval by the FDA to provide a reasonable assurance of their safety and effectiveness, such as life-sustaining, life-supporting and implantable devices, or new devices that have been found not to be substantially equivalent to existing legally marketed devices.
With limited exceptions, before a new medical device can be distributed in the U.S., marketing authorization typically must be obtained from the FDA through a premarket notification under Section 510(k) of the FDA Act, or through a premarket approval application under Section 515 of the FDA Act. The FDA will typically grant a 510(k) clearance if it can be established that the device is substantially equivalent to a predicate device that is a legally marketed Class I or II device (or to pre-amendments Class III devices for which the FDA has yet to call for premarket approvals). We have received FDA 510(k) clearance to market our XTRAC system for the treatment of psoriasis, vitiligo, atopic dermatitis and leukoderma and to market our PTL products for a variety of indications for use. Additionally, the FDA has issued clearances to commercially market our Contact Laser System (which includes the systems laser unit, laser probes, laser scalpels and fiberoptic delivery systems) in a variety of surgical specialties and procedures in gynecology, gastroenterology, urology, pulmonology, general and plastic surgery, cardiothoracic surgery, ENT surgery, ophthalmology, neurosurgery and head and neck surgery. The FDA granted these clearances under Section 510(k) on the basis of substantial equivalence to other laser or electrosurgical cutting devices that had received prior clearances. The range of clearances for our diode laser system is similar to the range of clearances for the CLMD Nd:YAG laser systems. In October 2008, we received 510(k) clearance for laser lipolysis to be performed with our 980 nm diode laser.
For any devices that are cleared through the 510(k) process, modifications or enhancements that could significantly affect the safety or effectiveness of the device, or that constitute a major change in the intended use of the device, will require a new 510(k) submission. In August 2003, the FDA granted 510(k) clearance for a significantly modified version of our XTRAC laser, which we have marketed as the XTRAC XL Plus Excimer Laser System. In October 2004, the FDA granted clearance for the XTRAC Ultra (AL 8000) Excimer Laser System and, in March 2008, we received 510(k) clearance for the XTRAC Velocity (AL 10000) Excimer Laser System.
A premarket approval application may be required for a Class II device if it is not substantially equivalent to an existing legally marketed Class I or II device (or a preamendments Class III device for which the FDA has yet to call for premarket approval) or if the device is a Class III premarket approval device by regulation. A premarket approval application must be supported by valid scientific evidence to demonstrate a reasonable assurance of safety and effectiveness of the device, typically including the results of clinical trials, bench tests and possibly animal studies. In addition, the submission must include, among other things, the proposed labeling. The premarket approval process can be expensive, uncertain and lengthy and a number of devices for which FDA approval has been sought by other companies have never been approved for marketing.
We are subject to routine inspection by the FDA and, as noted above, must comply with a number of regulatory requirements applicable to firms that manufacture medical devices and other FDA-regulated products for distribution within the U.S., including requirements related to device labeling (including prohibitions against promoting products for unapproved or off-label uses), facility registration, medical device listing, labeling requirements, adherence to the FDAs Quality System Regulation, good manufacturing processes and requirements for the submission of reports regarding certain device-related adverse events to the FDA.
We are also subject to the radiological health provisions of the FDA Act and the general and laser-specific radiation safety regulations administered by the Center for Devices and Radiological Health, or CDRH, of the FDA. These regulations require laser manufacturers to file initial, new product, supplemental and annual reports,
to maintain quality control, product testing and sales records, to incorporate certain design and operating features (depending on the class of product) in lasers sold to end users pursuant to a performance standard and to certify and appropriately label each laser sold as belonging to one of four classes, based on the level of radiation from the laser that is accessible to users. Moreover, we are obligated to repair, replace, or refund the cost of certain electronic products that are found to fail to comply with applicable federal standards or otherwise are found to be defective. The CDRH is empowered to seek fines and other remedies for violations of the regulatory requirements. To date, we have filed the documentation with the CDRH for our laser products requiring such filing and have not experienced any difficulties or incurred significant costs in complying with such regulations.
We have received ISO 13485/EN46001 certification for our XTRAC system and our Diode, holmium and CO2 laser systems. This certification authorizes us to affix a CE mark to these products as evidence that they meet all European Community, or EC, quality assurance standards and compliance with applicable European medical device directives for the production of medical devices. This will enable us to market our approved products in all of the member countries that accept the CE mark. We also will be required to comply with additional individual national requirements that are in addition to those required by these nations. Our products have also met the requirements for marketing in various other countries.
Failure to comply with applicable regulatory requirements can result in fines, injunctions, civil penalties, recalls or seizures of products, total or partial suspensions of production, refusals by the U.S and foreign governments to permit product sales and criminal prosecution.
As to our cosmetic products in the Skin Care business segment, the FDA Act and the regulations promulgated thereunder and other federal and state statutes govern the testing, manufacture, safety, labeling, storage, record-keeping, advertising and promotion of cosmetic products. Our cosmetic products and product candidates in the Skin Care business segment may be regulated by any of the various FDA Centers. Routinely, however, cosmetics are regulated by the FDAs Center for Food Safety and Applied Nutrition. In other countries, cosmetic products may also be regulated by similar health and regulatory authorities. The Skin Care business also has three devices (e.g. wound care dressings) subject to 510(k) clearance, seven products (e.g. sunscreen products) that contain drugs approved for use in over-the-counter products, and one prescription drug. The process of obtaining and maintaining regulatory approvals in the U.S. and abroad for the manufacturing or marketing of our existing and potential skincare products is potentially costly and time-consuming and is subject to unanticipated delays. Regulatory requirements ultimately imposed could also adversely affect our ability to clinically test, manufacture or market products.
Failure to obtain regulatory approvals where appropriate for our cosmetic, device or drug product candidates or to attain or maintain compliance with quality system regulations or other manufacturing requirements could have a material adverse effect on our business, financial condition and results of operations.
We are or may become subject to various other federal, state, local and foreign laws, regulations and policies relating to, among other things, safe working conditions, good laboratory practices and the use and disposal of hazardous or potentially hazardous substances used in connection with research and development.
Fraud and Abuse Laws
Because of the significant federal funding involved in Medicare and Medicaid, Congress and the states have enacted, and actively enforce, a number of laws whose purpose is to eliminate fraud and abuse in federal health care programs. Our business is subject to compliance with these laws.
In the U.S., there are federal and state anti-kickback laws that generally prohibit the payment or receipt of kickbacks, bribes or other remuneration in exchange for the referral of patients or other health-related business. The U.S. federal healthcare programs Anti-Kickback Statute makes it unlawful for individuals or entities knowingly and willfully to solicit, offer, receive or pay any kickback, bribe or other remuneration, directly or indirectly, in exchange for or to induce the purchase, lease or order, or arranging for or recommending purchasing, leasing, or ordering, any good, facility, service, or item for which payment may be made in whole or
in part under a federal healthcare program such as Medicare or Medicaid. The Anti-Kickback Statute covers any remuneration, which has been broadly interpreted to include anything of value, including for example gifts, certain discounts, the furnishing of free supplies, equipment or services, credit arrangements, payments of cash and waivers of payments. Several courts have interpreted the statutes intent requirement to mean that if any one purpose of an arrangement involving remuneration is to induce referrals of federal healthcare covered business, the arrangement can be found to violate the statute. Penalties for violations include criminal penalties and civil sanctions such as fines, imprisonment and possible exclusion from Medicare, Medicaid and other federal healthcare programs. In addition, several courts have permitted kickback cases brought under the Federal False Claims Act to proceed, as discussed in more detail below.
Because the Anti-Kickback Statute is broadly written and encompasses many harmless or efficient arrangements, Congress authorized the Office of Inspector General of the U.S. Department of Health and Human Services, or OIG, to issue a series of regulations, known as safe harbors. For example, there are regulatory safe harbors for payments to bona fide employees, properly reported discounts, and rebates, and for certain investment interests. Although an arrangement that fits into one or more of these exceptions or safe harbors is immune from prosecution, arrangements that do not fit squarely within an exception or safe harbor do not necessarily violate the statute. The failure of a transaction or arrangement to fit precisely within one or more of the exceptions or safe harbors does not necessarily mean that it is illegal or that prosecution will be pursued. However, conduct and business arrangements that arguably implicate the Anti-Kickback Statute but do not fully satisfy all the elements of an exception or safe harbor may be subject to increased scrutiny by government enforcement authorities such as the OIG.
Many states have laws that implicate anti-kickback restrictions similar to the Anti-Kickback Statute. Some of these state prohibitions apply, regardless of whether federal health care program business is involved, to arrangements such as for self-pay or private-pay patients.
Government officials have focused their enforcement efforts on marketing of healthcare services and products, among other activities, and recently have brought cases against companies, and certain sales, marketing and executive personnel, for allegedly offering unlawful inducements to potential or existing customers in an attempt to procure their business.
Federal Civil False Claims Act and State False Claims Laws
The federal civil False Claims Act imposes liability on any person or entity who, among other things, knowingly and willfully presents, or causes to be presented, a false or fraudulent claim for payment by a federal healthcare program, including Medicare and Medicaid. The qui tam, or whistleblower provisions of the False Claims Act allow a private individual to bring actions on behalf of the federal government alleging that the defendant has submitted a false claim to the federal government, and to share in any monetary recovery. In recent years, the number of suits brought against healthcare providers by private individuals has increased dramatically. Medical device companies, like us, can be held liable under false claims laws, even if they do not submit claims to the government where they are deemed to have caused submission of false claims by, among other things, providing incorrect coding or billing advice about their products to customers that file claims, or by engaging in kickback arrangements with customers that file claims.
The False Claims Act also has been used to assert liability on the basis of misrepresentations with respect to the services rendered and in connection with alleged off-label promotion of products. Our future activities relating to the manner in which we sell our products and document our prices such as the reporting of discount and rebate information and other information affecting federal, state and third-party reimbursement of our products, and the sale and marketing of our products, may be subject to scrutiny under these laws.
When an entity is determined to have violated the False Claims Act, it may be required to pay up to three times the actual damages sustained by the government, plus civil penalties of between $5,500 to $11,000 for each separate false claim. There are many potential bases for liability under the False Claims Act. A number of states
have enacted false claim laws analogous to the federal civil False Claims Act and many of these state laws apply where a claim is submitted to any state or private third-party payor. In this environment, our engagement of physician consultants in product development and product training and education could subject us to similar scrutiny. We are unable to predict whether we would be subject to actions under the False Claims Act or a similar state law, or the impact of such actions. However, the costs of defending such claims, as well as any sanctions imposed, could significantly affect our financial performance.
HIPAA Fraud and Other Regulations
The Health Insurance Portability and Accountability Act of 1996, or HIPAA, created a class of federal crimes known as the federal health care offenses, including healthcare fraud and false statements relating to healthcare matters. The HIPAA health care fraud statute prohibits, among other things, knowingly and willfully executing, or attempting to execute, a scheme or artifice to defraud any healthcare benefit program, or to obtain by means of false of fraudulent pretenses, any money under the control of any health care benefit program, including private payors. A violation of this statute is a felony and may result in fines, imprisonment and/or exclusion from government-sponsored programs. The HIPAA false statements statute prohibits, among other things, knowingly and willfully falsifying, concealing or covering up a material fact or making any materially false, fictitious or fraudulent statement or representation in connection with the delivery of or payment for healthcare benefits, items or services. A violation of this statute is a felony and may result in fines and/or imprisonment. Entities that are found to have aided or abetted in a violation of the HIPAA federal health care offenses are deemed by statute to have committed the offense and are punishable as a principal.
We are also subject to the U.S. Foreign Corrupt Practices Act and similar anti-bribery laws applicable in non-U.S. jurisdictions that generally prohibit companies and their intermediaries from making improper payments to non-U.S. government officials for the purpose of obtaining or retaining business. Because of the predominance of government sponsored healthcare systems around the world, most of our customer relationships outside of the U.S. will be with governmental entities and therefore subject to such anti-bribery laws.
HIPAA and Other Privacy Regulations
The regulations that implement HIPAA also establish uniform standards governing the conduct of certain electronic healthcare transactions and protecting the security and privacy of individually identifiable health information maintained or transmitted by healthcare providers, health plans and healthcare clearinghouses, which are referred to as covered entities. Several regulations have been promulgated under HIPAAs regulations including: the Standards for Privacy of Individually Identifiable Health Information, or the Privacy Rule, which restricts the use and disclosure of certain individually identifiable health information, the Standards for Electronic Transactions, or the Transactions Rule, which establishes standards for common healthcare transactions, such as claims information, plan eligibility, payment information and the use of electronic signatures, and the Security Standards for the Protection of Electronic Protected Health Information, or the Security Rule, which requires covered entities to implement and maintain certain security measures to safeguard certain electronic health information. Although we do not believe we are a covered entity and therefore are not currently directly subject to these standards, we expect that our customers generally will be covered entities and may ask us to contractually comply with certain aspects of these standards by entering into requisite business associate agreements. While the government intended this legislation to reduce administrative expenses and burdens for the healthcare industry, our compliance with certain provisions of these standards entails significant costs for us.
The Health Information Technology for Economic and Clinical Health Act, or the HITECH Act, which was enacted in February 2009, strengthens and expands the HIPAA Privacy and Security Rules and the restrictions on use and disclosure of patient identifiable health information. HITECH also fundamentally changed a business associates obligations by imposing a number of Privacy Rule requirements and a majority of Security Rule provisions directly on business associates that were previously only directly applicable to covered entities. HITECH includes, but is not limited to, prohibitions on exchanging patient identifiable health information for
remuneration, restrictions on marketing to individuals and obligations to agree to provide individuals an accounting of virtually all disclosures of their health information. Moreover, HITECH requires covered entities to report any unauthorized use or disclosure of patient identifiable health information, known as a breach, to the affected individuals, the United States Department of Health and Human Services, or HHS, and depending on the size of any such breach, the media for the affected market. Business associates are similarly required to notify covered entities of a breach. Most of the HITECH provisions will become effective in February 2010 and it is expected that the HHS will issue regulations to clarify many of the new provisions. HHS has already issued regulations governing breach notification which were effective in September 2009.
HITECH has increased civil penalty amounts for violations of HIPAA by either covered entities or business associates up to an annual maximum of $1.5 million for uncorrected violations based on willful neglect. Imposition of these penalties is more likely now because HITECH significantly strengthens enforcement. It requires HHS to conduct periodic audits to confirm compliance beginning in February 2010 and to investigate any violation that involves willful neglect which carries mandatory penalties beginning in February 2011. Additionally, state attorneys general are authorized to bring civil actions seeking either injunctions or damages in response to violations of HIPAA Privacy and Security Rules that threaten the privacy of state residents.
In addition to federal regulations issued under HIPAA, some states have enacted privacy and security statutes or regulations that, in some cases, are more stringent than those issued under HIPAA. In those cases, it may be necessary to modify our planned operations and procedures to comply with the more stringent state laws. If we fail to comply with applicable state laws and regulations, we could be subject to additional sanctions.
Federal and state consumer protection laws are being applied increasingly by the United States Federal Trade Commission, or FTC, and state attorneys general to regulate the collection, use, storage and disclosure of personal or patient information, through websites or otherwise, and to regulate the presentation of web site content. Courts may also adopt the standards for fair information practices promulgated by the FTC, which concern consumer notice, choice, security and access. Numerous other countries have or are developing laws governing the collection, use, disclosure and transmission of personal or patient information.
HIPAA as well as other federal and state laws apply to our receipt of patient identifiable health information in connection with research and clinical trials. We collaborate with other individuals and entities in conducting research and all involved parties must comply with applicable laws. Therefore, the compliance of the physicians, hospitals or other providers or entities with whom we collaborate also impacts our business.
Our ability to market our phototherapy products successfully depends in large part on the extent to which various third parties are willing to reimburse patients or providers for the cost of medical procedures utilizing our treatment products. These third parties include government authorities, private health insurers and other organizations, such as health maintenance organizations. Third-party payors are systematically challenging the prices charged for medical products and services. They may deny reimbursement if they determine that a prescribed device is not used in accordance with cost-effective treatment methods as determined by the payor, or is experimental, unnecessary or inappropriate. Accordingly, if less costly drugs or other treatments are available, third-party payors may not authorize or may limit reimbursement for the use of our products, even if our products are safer or more effective than the alternatives. Additionally, they may require changes to our pricing structure and revenue model before authorizing reimbursement.
Reimbursement systems in international markets vary significantly by country and by region within some countries and reimbursement approvals must be obtained on a country-by-country basis. Many international markets have government-managed healthcare systems that control reimbursement for new devices and procedures. In most markets, there are private insurance systems, as well as government-managed systems. Our XTRAC products remain substantially without approval for reimbursement in many international markets under either government or private reimbursement systems. Since our skincare products are primarily for cosmetic applications, reimbursement is not a critical factor in growing revenues for this product segment.
In 2008, we continued our efforts to secure private, third-party reimbursement in our Domestic XTRAC business segment. We secured favorable reviews by BlueCross or BlueShield affiliates in California, Arizona, Massachusetts and Tennessee, which now essentially provides comprehensive coverage throughout the U.S. Blue Cross/Blue Shield Plans. Many private plans key their reimbursement rates to rates set by the Centers for Medicare and Medicaid Services under three distinct CPT codes based on the total skin surface area being treated.
As of December 31, 2009, the national rates were as follows:
The national rates are adjusted by overhead factors applicable to each state.
In addition to Medicare and Medicaid, consistent domestic private healthcare reimbursement is critical for significant growth in XTRAC system procedures. There were more than 152,000 XTRAC procedures in 2009, 140,000 XTRAC procedures in 2008, 113,000 XTRAC procedures in 2007, 89,000 XTRAC procedures in 2006, 60,000 XTRAC procedures in 2005 and more than 50,000 XTRAC procedures in 2004 with the majority being covered by third-party reimbursement. Historically, it has been our belief that a rapid increase in widespread adoption of private healthcare reimbursement was being thwarted by a perception that the XTRAC therapy, although widely publicized as clinically safe and efficacious, was not economically cost-effective compared to other existing therapies. We sponsored the completion of an economic and clinical study to review the clinical and economic effectiveness of the XTRAC laser as a second-step therapy for the treatment of psoriasis. The conclusions of the study were: there is no additional direct cost of adding XTRAC as second-line therapy in a managed care plan; XTRAC is a cost-effective second-line treatment for mild-to-moderate plaque psoriasis; XTRAC requires fewer office visits than the majority of other treatments evaluated; XTRAC has a lower cost per treatment-free-day than the majority of other treatments evaluated; and XTRAC has a lower cost per remission day than the majority of other treatments evaluated. The results of this study were compiled in a data compendium and distributed to all the major health insurers; the results have also been published in a peer-review journal. From 2005 through 2008 substantive progress was made in connection with obtaining approvals for covering medically necessary targeted UVB therapy for mild to moderate psoriasis i.e. lesions over less than 5% of body surface area. We are now seeking approvals for severe psoriasis. In fact, Independence Blue Cross and Blue Shield have already approved the XTRAC for treatment up to 20% body surface area.
We lease a 42,000 sq. ft. facility in Montgomeryville, Pennsylvania that houses our executive offices and surgical laser manufacturing operations. This lease expires on July 31, 2011. The base rent is $20,475 per month.
We lease an 8,000 sq. ft. facility consisting of office, manufacturing and warehousing space in Carlsbad, California. The lease expires on June 15, 2012. We have the right to cancel the lease commencing in July 2010, provided that we pay off any remaining obligation for tenant improvements. The outstanding obligation for the tenant improvements was $77,239 as of December 31, 2009. The base rent is $6,640 per month. Our Carlsbad facility houses the manufacturing and development operations for our excimer laser business. We also lease a 6,643 sq. ft facility consisting of office and warehousing space in Carlsbad, California for use by our PTL business segment. The lease expires on June 14, 2012. The base rent is $6,577 per month.
We also lease a 12,209 sq. ft facility consisting of office and warehousing space in Redmond, Washington. The lease expires on June 30, 2010. The base rent is $12,403 per month. Our Redmond facility formerly housed the warehousing operations for our skincare business. We have relocated these operations to our headquarters.
Additionally, our PTL business segment leases two facilities in the United Kingdom. The first lease is a 2,389 sq. ft. facility consisting of office space in Tamworth, UK. The lease expires on April 1, 2011. The base rent is $3,896 per month. The second lease is a 1,500 sq. ft. facility consisting of office space in Altrincham, UK. The lease expires on April 2, 2011. The base rent is $2,856 per month.
We believe that our current facilities are sufficient to meet our needs for the foreseeable future.
Since January 2004, we have been involved in a dispute with Ra Medical Systems, Inc. and Dean Irwin, one of our former employees, arising out of a claim of misappropriation of certain of our proprietary information. We refer to Ra Medical Systems, Inc. and Dean Irwin, collectively, in this prospectus as Ra Medical. In November 2004, Ra Medical brought a malicious prosecution action against us, which was subsequently settled in May 2007. In June 2006, Ra Medical brought an action against us for unfair competition. In October 2008, Ra Medical brought a second malicious prosecution action against us and our outside counsel, alleging that the action we brought in January 2004 against Ra Medical was initiated and maintained with malice. Oral arguments have been heard on certain of these matters, and we await the decision of the appellate court.
St. Paul Fire and Marine Insurance Company
We have notified St. Paul Fire and Marine Insurance Company, or St. Paul, our general liability and umbrella liability insurer, of the second malicious prosecution suit brought by Ra Medical. St. Paul has claimed that it has no duty to defend us or indemnify us, asserting, among other things, that it had been released from such duties in the settlement of the previous malicious prosecution action brought by Ra Medical. Notwithstanding these claims, in March 2009, St. Paul informed us that they will pay for the cost of defense subject to a full reservation of rights.
Cowen and Company
We engaged Cowen and Company, or Cowen, to provide certain services in connection with our acquisition of PTL, including rendering a fairness opinion as to the consideration paid in the transaction. In July 2009, Cowen and Company brought an action against us seeking payment of the fees it had earned in the engagement. On November 10, 2009, we reached a settlement with Cowen, pursuant to which we made a payment of $300,000 to Cowen upon execution of the settlement agreement and will pay the remaining $599,380 in nine monthly installments, at no interest. The final payment will be made in August 2010.
We are involved in certain other legal actions and claims arising in the ordinary course of business. We believe, based on discussions with legal counsel, that these other litigation and claims will likely be resolved without a material effect on our consolidated financial position, results of operations or liquidity.
As of April 8, 2010, we had 129 full-time employees, which consisted of three executive officers, 11 senior managers, 47 sales and marketing staff, 28 people engaged in manufacturing of lasers, 11 customer-field service personnel, 13 engaged in research and development, including eight engineers, and 17 finance and administration staff. We intend to hire additional sales personnel as the development of our business makes such action appropriate. The loss of the services of key employees could have a material adverse effect on our business. Since there is intense competition for qualified personnel knowledgeable in our industry, no assurances can be given that we will be successful in retaining and recruiting needed personnel.
Our employees are not represented by a labor union nor covered by a collective bargaining agreement. We believe that we have good relations with our employees.
Our directors currently have terms which will end at our next annual meeting of the stockholders or until their successors are elected and qualify, subject to their prior death, resignation or removal. Officers serve at the discretion of the Board of Directors. There are no family relationships among any of our directors and executive officers. Members of our Board of Directors are encouraged to attend meetings of the Board of Directors and the Annual Meeting of Stockholders. The Board of Directors held 28 meetings and executed three unanimous written consents in lieu of a meeting in 2009.
The following sets forth certain biographical information concerning our current directors and our executive officers.
Directors and Executive Officers
Richard J. DePiano was appointed to our Board of Directors in May 2000 and was unanimously elected to serve as Non-Executive Chairman of the Board on January 31, 2003. Mr. DePiano has been a director of Escalon Medical Corp., a publicly traded healthcare business specializing in the development and marketing of ophthalmic devices and pharmaceutical and vascular access products, since February 1996 and has served as its Chairman and Chief Executive Officer since March 1997. Mr. DePiano has been the Chief Executive Officer of the Sandhurst Company, L.P. and Managing Director of the Sandhurst Venture Fund since 1986. Mr. DePiano was also the Chairman of the Board of Directors of SLT prior to our acquisition of SLT. Mr. DePiano serves on the Board of Trustees for Drexel University and Salus University. Mr. DePiano brings professional experience and executive management experience with a healthcare company to the Board.
Dennis M. McGrath was appointed as our President, Chief Executive Officer and a director in July 2009. Mr. McGrath also served as our Chief Financial Officer and Vice PresidentFinance and Administration from January 2000 through November 2009. Mr. McGrath has held several senior level positions including, from February 1999 to January 2000, serving as the Chief Operating Officer of Internet Practice, the largest division for AnswerThink Consulting Group, Inc., a public company specializing in business consulting and technology integration. Concurrently, from August 1999 until January 2000, Mr. McGrath served as Chief Financial Officer of Think New Ideas, Inc., a public company specializing in interactive marketing services and business solutions. In addition to the financial reporting responsibilities, Mr. McGrath was responsible for the merger integration of Think New Ideas, Inc. and AnswerThink Consulting Group, Inc. From September 1996 to February 1999, Mr. McGrath was the Chief Financial Officer and Executive Vice-PresidentOperations of TriSpan, Inc., an internet commerce solutions and technology consulting company, which was acquired by AnswerThink Consulting Group, Inc. in 1999. Mr. McGrath is currently a director of RICOMM Systems, Inc. and Noninvasive Medical Technologies, Inc. Mr. McGrath graduated with a B.S. in accounting from LaSalle University in 1979. Mr. McGrath holds a license from the states of Pennsylvania and New Jersey as a certified public accountant.
Christina L. Allgeier was appointed as our Vice President and Chief Financial Officer in October 2009. Prior to this time, Ms. Allgeier served as our corporate controller since December 2002. Ms. Allgeier graduated with a B.S. in accounting from Penn State University. Ms. Allgeier holds a license from the Commonwealth of Pennsylvania as a certified public accountant.
Michael R. Stewart was appointed as our Executive Vice President of Corporate Operations on December 27, 2002, immediately following the acquisition of SLT and, on July 19, 2005, he was appointed our Chief Operating Officer. From July 1999 to the acquisition of SLT, Mr. Stewart was the President and Chief Executive Officer of SLT and, from October 1990 to July 1999 he served as SLTs Vice President Finance and Chief Financial Officer. Mr. Stewart graduated from LaSalle University with a B.S. in accounting and received an M.B.A. from LaSalle University in 1986. Mr. Stewart passed the CPA examination in New York in 1986.
David W. Anderson was appointed to our Board of Directors on September 28, 2004. Mr. Anderson has been the President and Chief Executive Officer of Gentis, Inc. since November 2004. He has over twenty years of entrepreneurial management experience in the medical device, orthopedics and pharmaceutical field. He has served as President and CEO of Sterilox Technologies, Inc., the worlds leader in the development and marketing of non-toxic biocides; Bionx Implants, Inc., a publicly traded orthopedic sports medicine and trauma company, and Kensey Nash Corporation, a publicly traded cardiology and biomaterials company. In addition, Mr. Anderson was previously Vice President of LFC Financial Corp., a venture capital and leasing company, where he was responsible for LFCs entry into the healthcare market; and was a founder and Executive Vice President of Osteotech, Inc., a high-technology orthopedic start-up. Mr. Anderson is also on the Board of Directors of Vision Sciences, Inc. (Nasdaq: VSCI). Mr. Anderson has executive experience in variety of healthcare companies.
Stephen P. Connelly was appointed to our Board of Directors on May 3, 2007. Mr. Connelly has served as President and Chief Operating Officer of Viasys Healthcare, Inc., a medical technology and device company. In addition, Mr. Connelly was Senior Vice President and General Manager of the Americas as well as a member of the Executive Committee of Rhone Poulenc Rorer. Mr. Connellys broad background includes over twenty-five years of experience in the planning, development and management of rapid-growth marketing-driven businesses in the medical device and pharmaceutical fields. In addition, Mr. Connelly has a diverse and comprehensive business background, with expertise in such areas as strategic and tactical business development, joint ventures, mergers, acquisitions and corporate partnering, structuring and finance. Mr. Connelly is well-versed in every aspect of marketing, sales, general management, research and development of high-technology products and processes. Mr. Connelly possesses extensive international experience, having lived in Asia and having had operational P&L responsibility in many developed countries. Mr. Connelly has executive experience in seasoned healthcare companies, with particular expertise in international dealings.
Leonard L. Mazur was appointed to our Board of Directors on May 13, 2009. Mr. Mazur is the co-founder and Chief Operating Officer of Triax Pharmaceuticals, LLC, or Triax. Prior to joining Triax, he was the founder and, from 1995 to 2005, Chief Executive Officer of Genesis Pharmaceutical, Inc., a skincare company that dispenses products through dermatologists offices. In addition, Mr. Mazur has extensive sales, marketing and business development experience from his tenures at Medicis Pharmaceutical Corporation, ICN Pharmaceuticals, Inc. and Cooper Laboratories, Inc. Mr. Mazur is a member of the Board of Trustees of Manor College in Jenkintown, PA. Mr. Mazur has entrepreneurial experience in the healthcare industry.
Alan R. Novak was appointed to our Board of Directors in October 1997. Mr. Novak is Chairman of Infra Group, L.L.C., an international project finance and development company. He is also Chairman of Lano International, Inc., a real estate development company. Mr. Novak is a graduate of Yale University, Yale Law School and Oxford University as a Marshall Scholar. Mr. Novak practiced law at Cravath, Swaine & Moore and Swidler & Berlin, Chartered. His public service includes three years as an officer in the U.S. Marine Corps, a U.S. Supreme Court clerkship with Justice Potter Stewart, Senior Counsel to Senator Edward M. Kennedy, Senior Executive Assistant to Undersecretary of State, Eugene Rostow and the Executive Director of President Johnsons Telecommunications Task Force. Mr. Novak was appointed by President Carter and served for five years as Federal Fine Arts Commissioner. Mr. Novak brings professional experience to the Board and business experience from the vantage point of a non-healthcare company.
With respect to the incumbent members of the Board of Directors, none of the members has, in the past 10 years, been subject to a federal or state judicial or administrative order, judgment, decree or finding, not
subsequently reversed, suspended or vacated, relating to any legal proceedings, which include judicial or administrative proceedings resulting from involvement in mail or wire fraud or fraud in connection with any business entity or based on violations of federal or state securities, commodities, banking, or insurance laws and regulations, or any settlement to such actions, and any disciplinary sanction or order imposed by a stock, commodities or derivatives exchange or other self-regulatory organization.
Board Leadership Structure
In accordance with the provisions of our bylaws and the SPA, the total number of directors who serve on our Board of Directors is currently set at seven. Currently, six directors serve on our Board of Directors and we have one vacancy as a result of the resignation of Wayne M. Withrow from our Board. We choose to separate the position of our Chief Executive Officer from that of our Chairman of the Board of Directors. Our Board of Directors has made this decision based on their belief that an independent Chairman of the Board can act as a balance to the Chief Executive Officer, who also serves as a non-independent director.
Our Board of Directors administers its risk oversight function as a whole by making risk oversight a matter of collective consideration. While management is responsible for identifying risks, our Board of Directors has charged the Audit Committee of the Board of Directors with evaluating financial and accounting risk, the Compensation Committee of the Board of Directors with evaluating risks associated with employees and compensation. Investor-related risks are usually addressed by the Board as a whole. We believe an independent Chairman of the Board adds an additional layer of insight to our Board of Directors risk oversight process.
Compensation, Nominations and Corporate Governance and Audit Committees
General. Our Board of Directors maintains charters for select committees. In addition, our Board of Directors has adopted a written set of corporate governance guidelines and a code of business conduct and ethics and a code of conduct for our chief executive and senior financial officers that generally formalize practices that we already had in place. We have adopted a Code of Ethics on Interactions with Health Care Professionals and an Anti-Fraud Program. To view the charters of our Audit, Compensation and Nominations and Corporate Governance Committees, Code of Ethics, corporate governance guidelines, codes of conduct and whistle blower policy, please visit our website at www.photomedex.com (this website address is not intended to function as a hyperlink and the information contained on our website is not intended to be a part of this prospectus). The Board of Directors determined in 2009 that, except for Mr. McGrath, who is our Chief Executive Officer, all current members of the Board of Directors are independent under the revised listing standards of Nasdaq.
Compensation Committee. Our Compensation Committee discharges the Board of Directors responsibilities relating to compensation of our Chief Executive Officer and other executive officers, produces an annual report on executive compensation for inclusion in our annual proxy statement that is included in this prospectus and provides general oversight of compensation structure. Other specific duties and responsibilities of the Compensation Committee include:
Our Board of Directors has adopted a written charter for the Compensation Committee. The Compensation Committee is currently composed of Messrs. Novak, Connelly and Mazur. Mr. DePiano attends the
Compensation Committee meetings as a guest of the committee. Mr. Connelly serves as the Chairman of the Compensation Committee. Our Board of Directors determined in 2009 that each member of the Compensation Committee satisfies the independence requirements of the Commission and Nasdaq. The Compensation Committee held four meetings during 2009. Messrs. Dimun, Glazer and Withrow each served on the Compensation Committee during a portion of 2009 and resigned from the Compensation Committee and the Board of Directors effective March 17, 2009, August 5, 2009 and December 28, 2009, respectively.
The Compensation Committee reviews executive compensation from time to time and reports to the Board of Directors, which makes all final decisions with respect to executive compensation. The Compensation Committee adheres to several guidelines in carrying out its responsibilities, including performance by the employees, our performance, enhancement of stockholder value, growth of new businesses and new markets and competitive levels of fixed and variable compensation. The report of the Compensation Committee for 2009 is presented below.
Nominations and Corporate Governance Committee. Our Board of Directors has established a Nominations and Corporate Governance Committee for the purpose of reviewing all Board of Director-recommended and stockholder-recommended nominees, determining each nominees qualifications and making a recommendation to the full Board of Directors as to which persons should be our Board of Directors nominees. Our Board of Directors has adopted a written charter for the Nominations and Corporate Governance Committee. The Nominations and Corporate Governance Committee is composed of Messrs. Novak, DePiano, Anderson and Connelly. Mr. Anderson serves as the Chairman of the Nominations and Corporate Governance Committee. Our Board of Directors determined in 2009 that each member of the Nominations and Corporate Governance Committee satisfies the independence requirements of the Commission and Nasdaq. The Nominations and Corporate Governance Committee held one formal meeting during 2009 in conjunction with a meeting of the full Board of Directors.
The duties and responsibilities of the Nominations and Corporate Governance Committee include:
Our Board of Directors believes that it is necessary that the majority of our Board of Directors be comprised of independent directors and that it is desirable to have at least one financial expert serving on the Audit Committee. The Nominations and Corporate Governance Committee considers these requirements when recommending nominees to our Board of Directors. Our Nominations and Corporate Governance Committee utilizes a variety of methods for identifying and evaluating nominees for our directors. Our Nominations and
Corporate Governance Committee will regularly assess the appropriate size of our Board of Directors and whether any vacancies on the Board of Directors are expected due to retirement or other circumstances. When considering potential director nominees, the Nominations and Corporate Governance Committee also considers the candidates character, judgment, diversity, age, skills, including financial literacy and experience in the context of the needs of PhotoMedex and of the existing directors. The Nominations and Corporate Governance Committee also seeks director nominees who are from diverse backgrounds and who possess a range of experiences as well as a reputation for integrity. The Nominations and Corporate Governance Committee considers all of these factors to ensure that our Board of Directors as a whole possesses a broad range of skills, knowledge and experience useful to the effective oversight and leadership of the Company.
Audit Committee. Our Board of Directors has established an Audit Committee to assist it in fulfilling its responsibilities for general oversight of the integrity of our consolidated financial statements, compliance with legal and regulatory requirements, the independent auditors qualifications and independence, the performance of our independent auditors and an internal audit function and risk assessment and risk management. The duties of our Audit Committee include:
The Audit Committee works closely with management as well as our independent auditors. The Audit Committee has the authority to obtain advice and assistance from, and receive appropriate funding from us for, outside legal, accounting or other advisors as the Audit Committee deems necessary to carry out its duties.
Our Board of Directors has adopted a written charter for the Audit Committee, which charter meets the applicable standards of the Commission and Nasdaq. The members of the Audit Committee are Messrs. DePiano, Anderson and Connelly. Mr. DePiano serves as Chairman of the Audit Committee. The Audit Committee meets regularly and held 10 meetings during 2009. Messrs. Dimun and Withrow each served on the Audit Committee for a portion of 2009 and resigned from the Board of Directors and the Audit Committee on March 17, 2009 and December 28, 2009, respectively.
The Board of Directors determined in 2009 that each member of the Audit Committee satisfies the independence and other composition requirements of the Commission and Nasdaq. Our Board has determined that each member of the Audit Committee qualifies as an audit committee financial expert under Item 401(h) of Regulation S-K under the Exchange Act and has the requisite accounting or related financial expertise required by applicable Nasdaq rules.
Compensation Committee Interlocks and Insider Participation
No interlocking relationship exists between any member of our Board of Directors or Compensation Committee and any member of the board of directors or compensation committee of any other companies, nor has such interlocking relationship existed in the past.
Stockholder Communications with the Board of Directors
Our Board of Directors has established a process for stockholders to communicate with our Board of Directors or with individual directors. Stockholders who wish to communicate with our Board of Directors or with individual directors should direct written correspondence to Davis Woodward, Corporate Counsel at firstname.lastname@example.org or to the following address (our principal executive offices): Board of Directors, c/o Corporate Secretary, 147 Keystone Drive, Montgomeryville, Pennsylvania 18936. Any such communication must contain:
Mr. Woodward or the Corporate Secretary, as the case may be, will forward such communications to our Board of Directors or the specified individual director to whom the communication is directed unless such communication is unduly hostile, threatening, illegal or similarly inappropriate, in which case Mr. Woodward or the Corporate Secretary, as the case may be, has the authority to discard the communication or to take appropriate legal action regarding such communication.
Compliance with Section 16 of the Securities Exchange Act of 1934
Section 16(a) of the Exchange Act requires our directors and executive officers and beneficial holders of more than 10% of our common stock to file with the Commission initial reports of ownership and reports of changes in ownership of our equity securities. As of April 8, 2010, we believe, based solely on a review of the copies of such reports furnished to us and representations of these persons that no other reports were filed and that all reports needed to be filed have been filed for the year ended December 31, 2009.
Compensation Discussion and Analysis
The Compensation Committee of our Board of Directors is responsible for reviewing and approving the annual compensation of our executive officers. The Nominations and Corporate Governance Committee of our Board of Directors is responsible for reviewing and approving the compensation of our non-employee directors.
The Compensation Committee is composed solely of directors who are not our current or former employees, and each is independent under the revised listing standards of Nasdaq. Our Board of Directors has delegated to the Compensation Committee the responsibility to review and approve our compensation and benefits plans, programs and policies, including the compensation of our President and Chief Executive Officer and our other executive officers as well as middle-level management and other key employees. The Compensation Committee administers all of our executive compensation programs, incentive compensation plans and equity-based plans and provides oversight for all of our other compensation and benefit programs.
The key components of the compensation program for executive officers are base salary and bonus, and long-term incentives in the form of stock options and now, under our 2005 Equity Plan in the form of restricted shares of our common stock. These components are administered with the goal of providing total compensation that is competitive in the marketplace, recognizes meaningful differences in individual performance and offers the opportunity to earn superior rewards when merited by individual and corporate performance.
All share numbers and per share amounts in the following discussion and the tables contained herein take into account the reverse stock split, at a ratio of 1-for-6, which was effective on February 3, 2010.
Objectives of Our Compensation Program
The Compensation Committee intends to govern and administer compensation plans to support the achievement of our long-term strategic objectives, to enhance stockholder value, to attract, motivate and retain highly qualified employees by paying them competitively and rewarding them for their own and our success.
We have no retirement plans or deferred compensation programs in effect for our non-employee directors and our executive officers, except for our 401(k) plan in which our executive officers are eligible to participate. Compensation is generally paid as earned. We do not have a specific formula for allocating between cash and non-cash compensation, which has been in the form of stock options and awards of stock.
In order to assess whether the compensation program we had been providing to our executive officers was competitive and effective, the Compensation Committee engaged a third-party consulting firm specializing in executive compensation in 2008 but did not do so in 2009. As an ongoing matter, the Compensation Committee does not engage third-party consultants to advise on our compensation policies. Furthermore, our Compensation Committee does not delegate its responsibilities for reviewing and approving executive compensation.
To the extent consistent with the foregoing objectives, the Compensation Committee also intends to maximize the deductibility of compensation for tax purposes. The Compensation Committee may, however, decide to exceed the tax deductible limits established under Section 162(m) of the Internal Revenue Code of 1986, as amended, the Code, when such a decision appears to be warranted based upon competitive and other factors.
What Our Compensation Program is Designed to Reward
The key components of the compensation program for our executive officers are base salary, bonus and long-term incentives under the 2005 Equity Plan. These components are administered with the goal of providing
total compensation that is competitive in the marketplace, recognizes meaningful differences in individual performance and offers the opportunity to earn superior rewards when merited by individual and corporate performance.
Stock price performance has not been a factor in determining annual compensation insofar as the price of our common stock is subject to a number of factors outside of our control. We have endeavored through grants of stock options to our executive officers to incentivize individual and team performance by providing a meaningful stake in us that links their compensation to our overall success. Through awards of restricted stock, we have attempted to forge a closer link by tying the vesting of the restricted stock to certain milestone prices of our common stock.
Elements of Our Compensation Plan and How Each Element Relates to Objectives
There are three primary elements in the compensation package of our executive officers: base salary, bonus and long-term incentives. Compensation payable in the event of the termination of an executives employment with the Company is a secondary but material element in the package.
Base Salaries. Base salaries for our executive officers are designed to provide a base pay opportunity that is appropriately competitive within the marketplace. As an officers level of responsibility increases, a greater proportion of his or her total compensation will be dependent on our financial performance and stock price appreciation rather than base salary. Adjustments to each individuals base salary are made in connection with annual performance reviews and an assessment of market competitiveness.
Bonus. At the outset of a fiscal year, the Compensation Committee establishes a bonus program for executive officers and other managers and key employees eligible to participate in the program. The program is based on a financial plan for the fiscal year and other business factors. The amount of bonus, if any, hinges on corporate performance and financial condition and on the performance of the participant in the program. A program will typically allow some partial or discretionary awards based on an evaluation of the relevant factors. Provision for bonus expense is typically made over the course of a fiscal year. The provision becomes fixed, based on the final review of the Compensation Committee, which is usually made after the financial results of the fiscal year have been reviewed by our independent accountants.
The Compensation Committee made portions of the bonuses established for our named executive officers for the 2008 calendar year contingent upon the completion of an ordinary-course capital equipment financing related to the XTRAC business on terms acceptable to our Board of Directors but in the aggregate amount of not less than $5,000,000 and consummated not later than December 31, 2009. The amounts contingent upon the completion of such a financing were $44,888, $32,813 and $68,217 for Messrs. McGrath, Stewart and ODonnell, respectively, and, if earned, would have been paid within 30 days following completion of any such financing. This contingency was not met as of December 31, 2009 and therefore this portion of the bonus will not be paid.
For 2009, Messrs. McGrath and Stewart, are eligible to earn a bonus based on the amount of earnings before interest and taxes, or EBIT, for the year ended December 31, 2009, subject to completion of an audit of the financial results for the year. In the event the Companys EBIT is $950,000 or more, these executives bonus opportunity would be 100%. In the event of a negative EBIT (i.e., a loss) of $950,000 or more, the bonus opportunity would be zero. In the event of a break-even EBIT, the bonus opportunity would be 40%. Each $95,000 reduction of the negative EBIT from negative $950,000 earns four percentage point increments in the bonus opportunity, while each $95,000 increase in earnings above the break-even point earns six percentage point increments in the bonus opportunity. Given the losses incurred as of December 31, 2009, no bonus has been accrued for 2009 based upon the achievement of these metrics.
Long-Term Incentives. Grants of stock options under our stock option plans are designed to provide our executive officers and other managers and key employees with an opportunity to share, along with stockholders, in
our long-term performance. Stock option grants are generally made annually to all executive officers, with additional grants being made following a significant change in job responsibility, scope or title or a significant achievement. The size of the option grant to each executive officer is set by the Compensation Committee at a level that is intended to create a meaningful opportunity for stock ownership based upon the individuals current position with us, the individuals personal performance in recent periods and his or her potential for future responsibility and promotion over the option term. The Compensation Committee also takes into account the number of unvested options held by the executive officer in order to maintain an appropriate level of equity incentive for that individual. The relevant weight given to each of these factors varies from individual to individual.
Prior to 2006, stock options granted under the various stock option plans generally had a four-year vesting schedule depending upon the size of the grant, and generally were set to expire five years from the date of grant. In 2006, the Compensation Committee determined that such grants would be for 10 years and vest over five years. The exercise price of options granted under the stock option plans is at no less than 100% of the fair market value of the underlying stock on the date of grant. The number of stock options granted to each executive officer is determined by the Compensation Committee based upon several factors, including the executive officers salary grade, performance and the estimated value of the stock at the time of grant, but the Compensation Committee has the flexibility to make adjustments to those factors at its discretion. The options granted to executives as a rule have provisions by which vesting and exercisability are accelerated in the event of a change of control or a termination of employment initiated by the Company other than for cause.
Similar criteria are applied in making awards of restricted shares of our common stock under the 2005 Equity Plan, but in the case of restricted stock, we can make a direct link between the price performance of our common stock with the vesting schedule of the restricted stock.
To encourage our executive officers to have a greater stake in the equity of the Company, the Compensation Committee recommended, and the Board of Directors and the Company stockholders approved, the 2005 Investment Plan at the 2005 annual stockholders meeting. On December 22, 2009, our Board of Directors terminated the 2005 Investment Plan. No additional awards will be made under such plan, however, our executive officers will continue to be eligible to receive equity awards under our 2005 Equity Plan.
The vast majority of the stock options outstanding under the Companys equity plans have exercise prices which are well above the current market price of our common stock. The decline in the Companys stock price over recent years has made our goal of attracting, retaining and motivating employees more challenging.
Compensation on Termination of Employment or Change of Control. We have employment agreements with Messrs. McGrath and Stewart. The employment agreement with Mr. ODonnell terminated on July 31, 2009 as a result of his separation. Each of these agreements provides for severance upon termination of employment, whether in context of a change of control or not.
In the event of an involuntary termination not in connection with a change in control of the Company, an executive will be vested in those options that were unvested as of the termination but that would have vested in the 12 months following termination. In the event of a change of control, all of an executives unvested options will vest. Any unvested shares of restricted stock will vest upon a change of control to the extent that the acquisition price exceeds a milestone price or if an acquirer elects not to continue to employ the services of the executive.
How Amounts Were Selected for Each Element of an Executives Compensation
Each executives current and prior compensation is considered in setting future compensation. In addition, the Compensation Committee reviews from time to time the compensation practices of other companies, particularly our peer companies. To some extent, our compensation plan is based on the market and the companies we compete against for executives. Base salary and the long-term incentives are not set with reference to a formula.
An executives target bonus amount is set by an executives employment agreement, which was negotiated at arms length. A target bonus, or a portion thereof, is earned, based on fulfillment of conditions, which are set by the Compensation Committee at the outset of a fiscal year.
As a general rule, options and restricted stock awards are made in the first or second fiscal quarter of a year and after the financial results for the prior year have been audited and reported to our Board of Directors. Grants and awards are valued, and exercise prices are set, as of the date the grant or award is made. Exceptions to the general rule may arise for grants made to recognize a promotion or to address the effect of expiring options. The Compensation Committee may elect to defer a grant until after the Company has made public disclosure of its financial results, typically in a conference call on earnings. In such a case, the exercise price is set at the higher of the closing price on the approval date or the fixed grant date. In these deliberations, the Compensation Committee does not delegate any related function, unless to the Board of Directors as a whole, and the grants or awards made to executives are valued under the same measurement standards as grants made to other grantees.
Accounting and Tax Considerations
On January 1, 2006, we adopted FASB ASC Topic 718. Under this accounting standard, we are required to value stock options granted, and restricted stock awarded, in 2006 and beyond under the fair value method and expense those amounts in our income statement over the vesting period of the stock option or restricted stock. We were also required to value unvested stock options granted prior to our adoption of FASB ASC Topic 718 under the fair value method and amortize such expense in our income statement over the stock options remaining vesting period. A material portion of such amortizing expense relates to stock option grants made to our executive officers and future option grants and stock awards made in 2006 and beyond to our executive officers will also have a material impact on such expense.
Our compensation program has been structured to comply with Sections 409A and 162(m) of the Code. If an executive is entitled to nonqualified deferred compensation benefits that are subject to Section 409A, and such benefits do not comply with Section 409A, then the benefits are taxable in the first year they are not subject to a substantial risk of forfeiture. In such case, the executive service-provider is subject to regular federal income tax, interest and an additional federal income tax of 20% of the benefit includible in income.
Under Section 162(m) of the Code, a limitation was placed on tax deductions of any publicly-held corporation for individual compensation to certain executives of such corporation exceeding $1,000,000 in any taxable year, unless the compensation is performance-based. The Compensation Committee has been advised that based upon prior stockholder approval on January 26, 2009 of the material terms of our 2005 Equity Plan, compensation under our 2005 Equity Plan is excluded from this limitation, provided that the other requirements of Section 162(m) are met. However, when warranted based upon competitive and other factors, the Compensation Committee may decide to exceed the tax deductible limits established under Section 162(m). The base salary provided to each of our executives in 2007, 2008 and 2009 did not exceed the limits under Section 162(m) for tax deductibility. None of our executives exercised any options in 2007, 2008 or 2009.
Overview of Executive Employment Agreements and Option Awards
Employment Agreement with Jeffrey F. ODonnell. The employment agreement with Mr. ODonnell is no longer in force as Mr. ODonnell separated from us effective July 31, 2009. Mr. ODonnell has received, and will continue to receive, severance in accordance with the terms of his employment agreement.
Employment Agreement with Dennis M. McGrath. In November 1999, we entered into an employment agreement with Dennis M. McGrath to serve as our Chief Financial Officer and Vice President-Finance and Administration. We amended and restated that agreement in August 2002, September 2007 and May 6, 2008. On July 2, 2009, Mr. McGrath became our President and Chief Executive Officer following Mr. ODonnells separation. Mr. McGraths employment agreement was renewed in accordance with its terms through December 31, 2010. Mr. McGraths annual base salary was approximately $300,000 in 2008 and 2009. Mr. McGraths 2010
annual base salary will be $325,000. The severance arrangements contained in Mr. McGraths employment agreement are summarized in the section below entitled Potential Payments upon Termination of Employment or Change in Control.
On February 1, 2008, Mr. McGrath was awarded under the 2005 Equity Plan 3,886 options to purchase shares of our common stock at an exercise price of $37.38 per share. These options vest over five years and will expire on February 1, 2018.
On June 15, 2009, Mr. McGrath was awarded under the 2005 Equity Plan 2,917 restricted shares of common stock at a purchase price of $0.06 per share. We have the right to repurchase the shares at $0.06 per share if we do not have positive adjusted net income in the year 2010. Adjusted net income is defined as net income after income taxes, excluding expense from options and warrants. Mr. McGrath was also granted 8,750 options to purchase shares of our common stock at an exercise price of $6.24 per share. The options vest over five years and will expire on June 15, 2019.
Employment Agreement with Michael R. Stewart. Effective August 1, 2002, Michael R. Stewart became our Executive Vice President of Corporate Operations, pursuant to an employment agreement. The employment agreement was amended and restated in September 2007. Mr. Stewart became our Chief Operating Officer on July 19, 2005, at which time he was granted 5,000 options. Mr. Stewarts annual base salary was $262,500 in 2008 and 2009. Mr. Stewarts 2010 annual base salary will be $300,000. Mr. Stewarts employment agreement was renewed in accordance with its terms through December 31, 2010. The severance arrangements contained in Mr. Stewarts employment agreement are summarized in the section below entitled Potential Payments upon Termination of Employment or Change in Control.
On February 1, 2008, Mr. Stewart was awarded 3,110 options to purchase shares of our common stock under the 2005 Equity Plan at an exercise price of $37.38 per share. The options vest over five years and will expire on February 1, 2018.
On June 15, 2009, Mr. Stewart was awarded 1,750 restricted shares of common stock under the 2005 Equity Plan at a purchase price of $0.06 per share. We have the right to repurchase the shares at $0.06 per share if we do not have positive adjusted net income in the year 2010. Mr. Stewart was also granted 5,250 options to purchase shares of our common stock at an exercise price of $6.24 per share. The options vest over five years and will expire on June 15, 2019.
Summary Compensation Table
The following table includes information for the years ended December 31, 2009 and 2008 concerning compensation for our named executive officers. Mr. ODonnell was Chief Executive Officer and President until July 2, 2009, at which time the Board of Directors appointed Mr. McGrath to serve as our Chief Executive Officer and President. Ms. Allgeier was appointed to serve as our Chief Financial Officer on November 4, 2009.
Non-Equity Incentive Plan; Non-Qualified Deferred Compensation
We do not have a non-equity incentive plan, nor do we have a plan or program of non-qualified deferred compensation.
Potential Payments on Termination of Employment or Change of Control
Potential payments to our named executive officers upon termination of employment or a change of control of the Company are governed by their respective employment agreements and by the terms of their option agreements and restricted stock agreements.
Pursuant to the terms of their employment agreements, should (1) the Company terminate Mr. McGraths or Mr. Stewarts employment without cause, (2) Mr. McGrath or Mr. Stewart resign for good reason or (3) the Company fail to renew the applicable employment agreement, then the affected individual will become entitled to the following benefits upon his delivery of an effective release to the Company:
(i) a cash payment equal to his annual base salary in effect at the time of such termination, payable in installments in accordance with the Companys payroll practices based on the terms of the agreement;
(ii) a pro-rated bonus for the year in which such termination occurs;
(iii) continued medical and dental coverage for himself and his eligible dependents for the 12-month period following such termination;
(iv) continued coverage under the Companys long-term and short-term disability plans for the 12-month period following such termination;
(v) a monthly cash payment for a period of 12 months equal to the premium cost to maintain the individuals life insurance coverage at the level of coverage in effect at the time of such termination;
(vi) a tax gross-up to the extent to which the amounts in subparagraphs (iv) or (v) above are taxable to the individual; and
(vii) full acceleration of all outstanding equity awards held by the individual at the time of such termination. Each outstanding option will remain exercisable until the earlier of the 12-month anniversary of his termination date and the options expiration date.
In connection with his separation, Mr. ODonnell became entitled, pursuant to his Employment Agreement, to the benefits described above for Messrs. McGrath and Stewart.
If, during the one-year period immediately following a change in control of the Company, Mr. McGraths or Mr. Stewarts employment is terminated (1) by the Company without cause, (2) by the individual for good reason or (3) due to non-renewal of the applicable employment agreement, and the individual delivers an effective release to the Company, the affected individual will become entitled to receive the following benefits:
(i) a cash payment equal to two times his annual base salary in effect at the time of such termination, payable in installments in accordance with the Companys payroll practices based on the terms of the agreement;
(ii) a pro-rated bonus for the year in which such termination occurs;
(iii) continued medical and dental coverage for himself and his eligible dependents for the 24-month period following such termination;
(iv) continued coverage under the Companys long-term and short-term disability plans for the 24-month period following such termination;
(v) a monthly cash payment for a period of 24 months equal to the premium cost to maintain the individuals life insurance coverage at the level of coverage in effect at the time of such termination;
(vi) a full tax gross-up to the extent to which the amounts in subparagraphs (iv) or (v) above are taxable to the individual;
(vii) full acceleration of all outstanding equity awards held by the individual at the time of such termination, and each outstanding option will remain exercisable until the earlier of the 12-month anniversary of his termination date and the options expiration date; and
(viii) a full tax gross-up with respect to any excise tax imposed under Section 4999 of the Code on any payments or benefits received in connection with such change in control (including any accelerated vesting of his equity awards) that are deemed to constitute parachute payments under Section 280G of the Code.
If, following a change in Control of the Company, Ms. Allgeiers employment is terminated (a) by the Company without cause or (b) by Ms. Allgeier for good reason, she shall be entitled to six months salary continuation.
If any of the events set forth in the table below had occurred by December 31, 2009, then we estimate the value of the benefits that would have been triggered and thus accrued to Messrs. McGrath and Stewart and Ms. Allgeier had the triggering event occurred on December 31, 2009. Mr. ODonnell has received, and will receive, severance benefits in accordance with the terms of his employment agreement. Such amounts are reflected in the table below.
Potential Payments Upon Termination or Change in Control Table
All unvested options generally become exercisable by reason of a change of control. However, none of the executives unvested options were in the money as of December 31, 2009, and therefore there would have been no benefit as of December 31, 2009. Similarly, in the event of an involuntary termination without cause, the executive optionee becomes vested in those options that would otherwise have vested in twelve months following the date of termination. As in the hypothetical change of control, so in this case of hypothetical involuntary termination, there would have been no benefit to the optionee inasmuch as no option was in the money at December 31, 2009.
Our 2005 Equity Plan is the vehicle by which restricted stock awards and option grants are made to the executives and other service-providers. At the 2009 annual meeting of stockholders, the number of shares reserved for issuance under the 2005 Equity Plan was increased to 194,286 shares of our common stock. Participation in the 2005 Investment Plan was limited to the executives; the 2005 Investment Plan was authorized by our stockholders for up to 9,524 shares of our common stock. Our Board of Directors terminated the 2005 Investment Plan effective December 22, 2009.
Grants of Plan-Based Awards Table
The following table sets forth certain information with respect to the options granted and restricted stock awarded during or for the year ended December 31, 2009 to our named executive officers listed in the Summary Compensation Table as shown under the caption Executive Compensation. The stock awards and option grants reflected below were awarded under the 2005 Equity Plan. Mr. ODonnell served as our President and Chief Executive Officer through July 2, 2009, but received no stock awards or option grants in 2009.
Grants of Plan-Based Awards Table
Outstanding Equity Awards Value at Fiscal Year-End Table
The following table includes certain information with respect to the value of all unexercised options previously awarded to the executive officers named above at December 31, 2009.
Outstanding Equity Awards at Fiscal Year-end Table, As Adjusted to Reflect the Reverse Stock Split of 1-for-7 Effective January 26, 2009 and the Reverse Stock Split of 1-for-6 Effective February 3, 2010
Compensation Committee Report on Executive Compensation
The Compensation Committee has reviewed and discussed with management certain Compensation Discussion and Analysis provisions to be included herein. Based on the review and discussion referred to above, the Compensation Committee recommended to our Board of Directors that the Compensation Discussion and Analysis referred to above be included herein.
Mr. Dimun was a member of the Compensation Committee before he resigned from our Board of Directors effective as of March 17, 2009. Mr. Mazur was appointed to the Compensation Committee on January 13, 2010. Neither of these individuals took part in the above-referenced reviews and discussions. Mr. Withrow resigned from the Compensation Committee effective December 28, 2009.
Stephen P. Connelly Alan R. Novak Leonard L. Mazur
Directors who are also our employees receive no separate compensation for serving as directors or as members of committees of our Board of Directors. Directors who are not our employees are compensated under the Non-Employee Director Plan. Each director receives non-qualified options to purchase up to 834 shares of our common stock on an annual basis. The options vest quarterly in the year of grant, vesting on the last day of service within a quarter. Each outside director receives an annual cash retainer of $20,000 and is also paid $1,000 for personal attendance at each meeting of the Board of Directors and for personal attendance for each committee meeting held not in conjunction with meetings of the Board of Directors itself, and in 2009, for personal attendance at a committee meeting held in conjunction with meetings of the Board of Directors. In addition, each outside director is paid $500 for telephonic attendance at each Board of Directors or committee meeting, excluding meetings of limited scope and duration. The chairmen of each Committee of our Board of Directors will receive additional annual compensation as follows: (1) Audit Committee $10,000, (2) Compensation Committee $5,000, and (3) Nominations and Corporate Governance Committee $5,000. We pro-rate the retainer for a director serving less than a full year. The table below sets forth our non-employee directors compensation through December 31, 2009.
Director Compensation Table