SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 10-K
ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(D)
OF THE SECURITIES EXCHANGE ACT OF 1934
For the Fiscal Year Ended December 31, 2004
Commission File Number 0-32601
ESSENTIAL GROUP, INC.
(Exact name of registrant as specified in its charter)
| Delaware | 33-0597050 | |
| (State or other jurisdiction of incorporation or organization) |
(IRS Employer Identification No.) |
1325 Tri-State Parkway, Suite 300
Gurnee, Illinois 60031
(Address of Principal Executive Offices, Including Zip Code)
(847) 855-7500
(Registrants Telephone Number, Including Area Code)
AmericasDoctor, Inc.
(Former Name or former address, if changed since last report)
Securities registered pursuant to Section 12(b):
None
Securities to be registered pursuant to Section 12(g) of the Act:
Class A Common Stock, par value $.001
Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes x No ¨
Indicate by check mark if disclosure of delinquent filers pursuant to Item 405 of Regulation S-K is not contained herein, and will not be contained, to the best of registrants knowledge, in definitive proxy or information statements incorporated by reference in Part III of this Form 10-K or any amendment to this Form 10-K. ¨
Indicate by check mark whether the registrant is an accelerated filer (as defined in Rule 12b-2 of the Act). Yes ¨ No x
There is no public market for the common stock of Essential Group, Inc. At March 1, 2005, there were 3,430,043 shares of Class A common stock, par value $.001 per share, and 685,324 shares of Class B common stock, par value $.001 per share, of Essential Group, Inc. outstanding.
DOCUMENTS INCORPORATED BY REFERENCE
Part III of this Form 10-K incorporates by reference certain information from the information statement on Schedule 14C to be filed in connection with the taking of corporate action by the stockholders of Essential Group, Inc. to elect directors without a meeting, which information statement will be filed with the Securities and Exchange Commission on or prior to April 30, 2005.
FORWARD-LOOKING STATEMENTS
Statements in this annual report on Form 10-K that are not strictly historical, including statements as to plans, objectives and future performance, are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, or the Exchange Act. These forward-looking statements can be identified by the use of terminology such as believe, hope, may, anticipate, should, intend, plan, will, expect, estimate, project, positioned, strategy and similar expressions. In addition, the statements relating to our liquidity needs and expectations are forward-looking. We have based these forward-looking statements on our current expectations and projections about future events. You should be aware that these forward-looking statements are subject to risks and uncertainties that are beyond our control. These risks and uncertainties include unanticipated trends in the clinical research industry, changes in healthcare regulations and economic, competitive, legal, governmental, and technological factors affecting operations, markets, products, services and prices. These forward-looking statements included in this annual report on Form 10-K are not guarantees of future performances, and actual results could differ from those contemplated by these forward-looking statements. In the light of these risks and uncertainties, there can be no assurance that the results and events contemplated by the forward-looking information contained in this annual report on Form 10-K will in fact transpire. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of their dates.
PART I
ITEM 1. BUSINESS
Unless otherwise indicated, references to Essential Group, the Company, we, our and us in this annual report on Form 10-K refer to Essential Group, Inc. (formerly known as AmericasDoctor, Inc.) and its consolidated subsidiary.
Company Overview
We were founded in 1994 by several physicians as an affiliated site management network. We provide pharmaceutical, biotechnology, nutritional and device companies a single source for managing the conduct of Phase I-IV clinical research in the United States. In March 2004 we expanded our services into three separate operating units under the corporate entity of Essential Group, Inc. The three units are Essential CRO, Essential Patient Recruitment, and AmericasDoctor. We are considered a pharmaceutical services company providing services across the majority of functions for clinical development including experienced clinical investigative sites. We offer our complete services across all three business units to clients in the pharmaceutical, biotech, nutritional, device, and governmental research industries.
We formally launched Essential Contract Research Organization (CRO) in May 2004 as a specialty full-service provider focused in three therapeutic areas of urology, womens health, gastroenterology, and the associated oncologies for each. The CRO services are comprehensive from study design, study initiation, project management, quality assurance, data management/statistical analysis, report writing, study closeout and regulatory support for filings. We conduct trials from phase I-IV in humans. We contract directly with the sponsor of the research trial and then execute on their behalf as a contractor.
In June 2003, we formally launched the brand of Essential Patient Recruitment as a full-service patient recruitment provider for clinical trials. Many recruitment firms identify patients for clinical trials, but struggle to get them enrolled. We had been providing patient recruitment services as a service under AmericasDoctor since 1996. This operating unit uses creative advertising and media in print, radio, and television to attract, screen and refer patients who may qualify to be enrolled in a clinical trial. The patients are referred directly to trained medical professionals at a study site who provide final assessment and qualification of the patient to be enrolled in a study. We provide patient recruitment services in over 60 different disease states. We contract directly with the sponsor of the research project and then execute on their behalf as a contractor.
Our AmericasDoctor operating unit provides clinical research investigative site services through approximately 107 independently owned investigative sites encompassing approximately 275 principal investigators, with over 900 total physicians, operating in 32 states in the United States and the District of
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Columbia. Through our network of investigative sites, we provide sponsors of clinical research with study management services, including access to experienced investigators and study coordinators and large numbers of patients and centralized management of clinical research studies. These capabilities are designed to facilitate study start-up and quality and accuracy of study data. Our network of investigative sites provides sponsors with the ability to complete clinical research trials quickly and efficiently. By integrating a leading community-based physician network and comprehensive site management expertise, we provide a broad range of services, including patient recruitment and project management, fundamental to executing well-controlled clinical trials expeditiously and economically.
We were originally incorporated in the State of California on November 23, 1993 and reincorporated on September 19, 1996 in the State of Delaware. On January 6, 2000, our wholly owned subsidiary merged with AmericasDoctor.com, Inc., an interactive Internet healthcare information site for consumers based in Maryland. In this annual report, the merger is sometimes referred to as the Merger and the Maryland-based AmericasDoctor.com, Inc. is sometimes referred to as Old AmDoc. Following the Merger, Old AmDoc became our wholly-owned subsidiary and changed its name to AmericasDoctor Internet Operations, Inc. and we changed our corporate name to AmericasDoctor.com, Inc. In November 2001, we changed our corporate name to AmericasDoctor, Inc. In December 2002, Old AmDoc was merged into us.
On September 17, 2003, our board of directors approved a business transition plan to position us for stronger growth as we enter our second decade of service to the pharmaceutical, biotechnology, nutritional, device and governmental research industries. The new strategy was announced on October 27, 2003 and requires us to tightly focus on more profitable growth through expanded project management services, expanded patient recruitment services and a more focused approach to site management. Through this business plan, we are focusing our resources in clinical trial site management in four therapeutic areas: urology, womens health, gastroenterology and central nervous system and have exited from four other therapeutic areas related to AmericasDoctor site management services. In accordance with our business plan, we changed our name to Essential Group, Inc. on March 24, 2004 and are offering expanded project management services and patient recruitment as a specialty contract research organization, or CRO, under a business unit named Essential and continue to offer site management services under a business unit named AmericasDoctor.
Research Services
General
We have built three operating units that operate across the general scope of services required to conduct phase I-IV clinical research in humans. The Essential CRO unit provides the overall project management for a clinical trial and is a replica of the clinical development organizations in the pharmaceutical industry. Our Essential Patient Recruitment unit provides the services now required in many clinical studies to identify and enroll patients into clinical trials. Our third operating unit of AmericasDoctor is a U.S. network of independently owned investigative sites to facilitate and coordinate independent clinical research trials on drugs and devices for pharmaceutical, biotechnology, nutritional and device companies and CROs located throughout the world; these entities are commonly referred to as sponsors. Each of the sites in our network is a party to an exclusive clinical research services agreement with us. Pursuant to the agreement, we perform various services for the site through our central office, including patient recruitment, source documentation, regulatory services, quality assurance and other consultation services. Although we provide various services to facilitate clinical research, the actual clinical trials are performed by the investigative sites. Through our network of investigative sites, we provide sponsors of clinical research with study management services, including access to experienced investigators and study coordinators and large numbers of patients and centralized management of clinical research studies. These capabilities are designed to facilitate study start-up and quality and accuracy of study data. Our collective operating units provide an array of services and a network of investigative sites to sponsors with the ability to complete clinical research trials quickly and efficiently. Our business is currently focused on the U.S. markets.
By facilitating business development and study start-up activities and providing management support and patient recruitment, we assist the investigative sites in growing their research practices.
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The Pharmaceutical Industry
Before a new pharmaceutical or biotechnology product can be marketed in the U.S., it must undergo extensive testing and regulatory review to determine its relative safety and effectiveness. This process involves preclinical testing, which typically lasts for up to three years and involves animal testing and laboratory analysis to determine the basic biological activity and safety of the product. Upon successful completion of the preclinical phase, the product undergoes a series of clinical tests in humans, including healthy volunteers as well as patients with the targeted disease. The clinical trial phase is generally longer than preclinical testing, typically lasting five to seven years. In the U.S., preclinical and clinical testing must comply with the requirements of Good Clinical Practices and other standards promulgated by the Food and Drug Administration, or the FDA, and other federal and state governmental authorities.
The need of pharmaceutical, biotechnology and device companies to both produce new products at low costs and comply with governmental regulations drives the clinical research industry. Competition and the increasing pressure to control costs are forcing these companies to more efficiently develop new drugs and to seek ways to save time in the clinical development process in order to bring products to market faster. In an effort to save time and cut costs, sponsors often outsource certain aspects of the clinical research process to third parties, including research networks. In addition, sponsors have found that investigator-prescribers, physicians who conduct clinical trials, help decrease the time it takes to bring products to market. The physicians familiarity with the product, which results from them conducting the clinical trials, may accelerate the clinical investigators use of the medicine when it is marketed and assists with the success of the market launch of the product.
CRO Industry
The CRO industry is global with over 600 public and private companies providing an array of services to the pharmaceutical, biotech, nutritional, device, and governmental research industries. These CRO services range from pre-clinical animal testing to post-marketing product support. The industry is dominated by companies who provide the full array of services across all therapeutic areas. The remainder of the CRO industry is specialized or niche in some manner. These niches can be by study phase, by therapeutic area, or by functional service provided. Global capability is achieved either through global owned assets or through partnerships/joint ventures. CROs range in size from six to eight figure annual revenue. Many are publicly owned such as PPD, ICON, PRA, Parexel and Covance. Most CROs are privately held.
Patient Recruitment Industry
The patient recruitment industry has emerged since the late 1990s led by major advertising and communication companies who have seen the move into the R&D market as a natural extension of their product marketing expertise. These ad agencies have pursued clinical trial patient recruitment as a market segmentation strategy that provides them earlier access to products and clients for building relationships while applying their experience in building consumer awareness and response. The segmentation strategy of the major ad agencies into the clinical trial patient recruitment domain has had questionable results. Accordingly, a growing number of pure-play patient recruitment firms, such as ours at Essential, have emerged with a distinct focus on expanding awareness, opportunity and access to all patients for enrollment into clinical trials. This opportunity provides patients with controlled and early access to products and devices that may assist their medical condition years before the product or device is available in the market. The service can provide the sponsor with accelerated or timely enrollment that can help them meet critical timelines with an associated potential reduction in the overall cost of clinical research from timely study completion.
Investigative Sites
The investigative site industry includes all of the clinical investigators who enroll patients in clinical trials and collect information at the patient level for pharmaceutical, biotechnology and device companies and CROs. All of the investigative sites in our network are owned by private practice physicians, and a few of these sites conduct only clinical research trials. The size of the private physician practices in our network range from one physician to approximately twenty physicians. Typically, the investigative sites in our network consist of two to four physician partners in a private practice medical office. We require the investigative sites to enter into a clinical research services agreement with us, which we believe creates significant stability for our business and our clients. These
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agreements govern the terms and conditions upon which the investigative site performs studies and outlines the scope of services we provide to the sites. Pursuant to the terms of the clinical research services agreement, all clinical research services performed by the site are required to be conducted exclusively through us, except for studies in which we elect not to participate. In addition, these agreements contain non-competition and non-solicitation covenants that limit or prohibit these sites from competing with us or hiring our personnel for a period of time after the termination of the agreement. The clinical research services agreement provides that a percentage of the contract amount paid to us by study sponsors will be paid to the sites as investigator fees. The percentage of fees paid to investigative sites varies by contract depending upon the level of services provided to these sites. The term of the clinical research services agreement is typically two years and automatically renews for additional terms of two years, unless either party terminates with 120 days prior written notice. The agreement may also be terminated immediately if the investigative site loses its license, fails to comply with Good Clinical Practices or maintain standards of quality and scientific integrity, or is debarred from clinical research participation by local, state or federal authorities.
Services to Sponsors
CRO: We assist the sponsors through our Essential CRO unit by providing people and infrastructure they do not have to adequately execute on the portfolio of clinical trials. Our services can be used comprehensively, or on a functional need basis by the sponsor thus giving the sponsor flexibility in execution and resource deployment. The CRO oversees all aspects of the clinical trial in close oversight and control by the sponsor central management team.
As a specialty CRO, we offer focused full service CRO expertise in three key therapeutic areas: urology, gastroenterology and womens health. These services include project management, patient recruitment, study start-up, therapeutic consulting, clinical and medical monitoring, clinical labs and packaging, data management, biostatistics, quality assurance, regulatory affairs, training and medical writing, either directly or through our partners, to the pharmaceutical and biotechnology industries. Our experience and expertise in project management of clinical trials, combined with our therapeutic focus, enable us to offer valuable services to the industry.
Overall Essential CRO Services Provided to Sponsors
| | Protocol design and therapeutic consultation |
| | Project management |
| | Rapid study startup |
| | Clinical monitoring |
| | Patient recruitment |
| | Medical monitoring and drug safety |
| | Clinical labs and packaging |
| | Data management and statistical analysis |
| | Quality assurance |
| | Regulatory affairs |
| | Training |
| | Medical writing |
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Patient Recruitment: We assist sponsors through our Essential Patient Recruitment unit by providing strategy and execution of advertising, media procurement and placement to achieve timely recruitment of prospective patients for clinical trials. We refer the patients to the study site where medical professionals screen, enroll and manage each patient while on the clinical trial. We work directly with each study site to optimize the flow, screen and enrollment of potential interested patients. Our historical knowledge and experience from running the AmericasDoctor investigative site network is significant in helping our collaboration on patient recruitment with all study sites.
The recruitment of patients for clinical studies has been a major obstacle to the timely completion of clinical trials for over forty years. The pharmaceutical industrys member organization, Pharmaceutical Research Manufacturers of America, estimates that over 85% of clinical studies fail to meet their patient recruitment timelines costing the industry billions of dollars a year in lost revenue, shortened patent life, and increased research and development expense. The delays to recruiting patients are often caused by stringent protocol requirements and other restrictions. In addition, many patient recruitment business models do not effectively deal with delays because they only identify potential patients; they do not actually enroll patients into clinical study treatments. Since 1998, we have conducted patient recruitment for clinical studies being conducted by the investigative sites in our network and for sites that are not in our network but are part of a multi-center trial. We intend to further focus our efforts to expand opportunities in patient recruitment.
Overall Essential Patient Recruitment Services Provided to Sponsors
| | Situation analysis |
| | Strategy development |
| | Tactical planning |
| | Media acquisition and placement |
| | Site integration |
| | Implementation and enrollment |
| | Metrics and reporting |
AmericasDoctor: We assist the investigative sites in our AmericasDoctor network with planning and coordinating of independent clinical trials on drugs and devices for pharmaceutical, biotechnology and device companies and CROs located throughout the world. Through our network of investigative sites, we provide sponsors with access to experienced investigators and study coordinators, facilitate quick study start-up and ensure efficient production of quality study data. We provide patient recruitment to sponsors through investigative sites within and outside our network. We provide services designed to enable sponsors of clinical trials to complete the clinical research process efficiently, cost effectively and in a high quality manner.
The clinical research portion of the drug development process involves selection of investigative sites to conduct the trials, the actual conduct of the trials and the gathering and completion of the data generated during the trials. We facilitate the clinical trial process for sponsors by providing a single point of contact to identify the appropriate investigative sites within our network to conduct the trials. The investigative sites in our network perform the clinical trials, focusing on Phases II through IV of the drug development process, and we provide those sites with various services designed for each clinical trial, including sales, marketing, administrative support, patient recruitment, Good Clinical Practices training, source documentation, quality assurance and coordinator services.
Overall AmericasDoctor Services Provided to Sponsors
| | Access to experienced investigators |
| | Access to large patient populations |
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| | Centralized management |
| | Protocol consultation |
| | Protocol approval |
| | Accelerated product acceptance |
Services to Investigative Sites
Our success is dependent upon our ability to attract and retain high quality investigative sites. We provide the following services to these independently owned sites:
| | Sales and marketing |
| | Contract/budget negotiation |
| | Training and education |
| | Administrative and regulatory service |
| | Source documentation |
| | Funds management |
| | Patient recruitment |
Competition
CRO
The CRO service industry is highly fragmented. We compete with a number of CRO firms varying greatly in size, global reach, and service offerings. Some of our competitors have greater financial resources and name recognition, greater experience in specific diseases and offer a full range of services internal to their company. While many of these competitors are broadly focused, we are focused specifically in targeted therapeutic areas with expertise and experience in project management as an outsourced CRO service firm in assisting our customers in managing their clinical trials. While we believe that we compete favorably as a CRO service firm, there can be no assurance that we will be able to respond to pressures or changes from competitors.
Patient Recruitment
We compete with major global communications firms, niche or pure-play patient recruitment firms, and a few CROs, some of which may be our sponsors. Although these companies primarily focus on Phase IV trials, to a growing extent, they also perform Phase II and Phase III trials.
AmericasDoctor
The clinical research industry is highly fragmented. We primarily compete with private practice research sites. The majority of these private practice research sites are single sites dispersed throughout the country. We also compete with hospitals, academic medical centers and site management organizations, or SMOs. No single competitor or group of competitors has a substantial presence in the clinical research industry. Some of our competitors have greater financial resources and name recognition, greater experience in specific diseases and conditions and larger non-exclusive medical specialist networks than we do. Research sites generally compete on the basis of previous experience, medical and scientific expertise in specific therapeutic areas, quality of clinical research, ability to manage clinical studies involving multiple sites, ability to provide administrative and regulatory services, ability to respond rapidly to requests for proposals, ability to rapidly recruit patients and geographic location. While we believe that we compete favorably in most of these areas, there can be no assurance that we will be able to respond to these pressures or changes.
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Regulatory Matters
We are subject to substantial governmental regulation. The clinical investigation of new drugs is highly regulated by the FDA. The purpose of these regulations is to ensure that only those products that have been proven to be safe and effective are made available to the public. Sponsors are obligated to comply with FDA regulations governing such activities as:
| | IRB oversight; |
| | qualifications of investigators; |
| | obtaining patient informed consents; |
| | reporting patients adverse reactions to drugs; and |
| | maintaining thorough and accurate records. |
FDA regulations require the principal investigator to maintain adequate and accurate records of each patient in a clinical trial, including source documents such as medical records, eligibility screening logs, patient consent forms and drug dispensing records. Sponsors are required to maintain source documents for each study for specified periods and to make such documents available for review by the study sponsor and the FDA during audits.
Study sponsors monitor their research activities and compliance with study protocols by performing periodic audits at each investigative site. In addition, the FDA has the authority to investigate clinical research facilities and audit drug testing studies both during the course of the study and after completion. If repeated or deliberate failure to comply with regulations or submission of false information is discovered, the individual investigator may be disqualified by the FDA from participating in current or future clinical trials. The FDA may also disqualify data from previous trials conducted by the investigator.
Some other federal agencies, such as the Department of Health and Human Services, and some state and local governments may have additional regulations regarding the use of human subjects in clinical trials. In addition, regulatory initiatives, such as the Health Insurance Portability and Accountability Act, relating to the use and retention of patient medical information may have an impact on our storage and use of patient information in our databases. The information we currently use in connection with our study management services is de-identified and randomized in accordance with current regulations and we do not expect currently proposed regulatory initiatives to have a significant impact on our operations. Depending on the scope of any new regulations restricting the use and retention of patient records, however, we may be obligated to incur additional costs to implement additional systems to comply with these regulations. Although we do not expect these regulations to have a material impact on our operations, there can be no assurance that this will be the case.
As part of our clinical research trial management responsibilities, our study coordinators engage from time to time in patient-screening activities that include physical contact with patients, such as taking blood. Accordingly, these study coordinators are subject to the requirements of the Occupational Heath and Safety Act and similar state regulations. The Occupational Health and Safety Act and similar state laws require that our study coordinators satisfy annual training and certification requirements, which may vary significantly from state to state. The failure of our study coordinators to satisfy these requirements may result in their disqualification from participating in clinical research studies or the imposition of fines and penalties upon us.
Several regulations have been passed that may restrict the ability of principal investigators to perform clinical research services for sponsors with whom they have certain defined financial relationships or require additional administrative disclosure and paperwork regarding the existence of these relationships. Compliance with the financial relationship disclosure regulations has had little economic effect on our business.
The delivery of healthcare services and products is heavily regulated under federal and state law. For example, federal and state agencies regulate the practice of medicine and establish licensing and reimbursement requirements. In addition, through fraud and abuse laws, federal and some state agencies prohibit payments for the referral of patients to a person participating in, or for the order, purchase or recommendation of items or services
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that are subject to reimbursement by, Medicare, Medicaid and other federal or state healthcare programs or third-party payors. While we have attempted to structure our business activities in a manner that will not constitute the practice of medicine or involve prohibited referrals, federal and/or state healthcare regulatory authorities may determine that, in a particular case or generally, we are engaged in the practice of medicine through the activities of our doctors or other healthcare professionals. We do not research the laws of each of the states in which we operate or obtain opinions or rulings from federal and state agencies with authority to enforce these laws. A finding that our business activities violate any of these laws or statutes may have a material adverse effect on our business, financial condition and results of operations.
Intellectual Property
We rely primarily on a combination of copyrights, trademarks, trade secret laws, our user policy and restrictions on disclosure to protect our intellectual property and our content, trademarks, trade names and trade secrets. We have filed several trademark applications and registrations for AmericasDoctor, Essential, Essential Group, Inc. and other related trademarks. We license information and technology from third parties.
Employees
As of February 1, 2005, we had approximately 114 full-time employees. None of our employees is represented by a labor union. We believe that relations with our employees are good.
ITEM 2. PROPERTIES
We lease approximately 31,153 square feet of space in Gurnee, Illinois where our headquarters are located. Our lease expires in December 2009, and may be extended at our option, for two additional five-year terms. We also lease approximately 700 square feet in Tacoma, Washington for a coordinator site. The lease is month to month and may be terminated at any time. We believe that our properties are generally suited for the purposes for which they are presently being used.
ITEM 3. LEGAL PROCEEDINGS
We are not aware of any material litigation against us. In the ordinary course of our business, from time to time, we are a party to routine litigation.
ITEM 4. SUBMISSION OF MATTERS TO A VOTE OF SECURITY HOLDERS
We submitted no matters to a vote of our stockholders during the fourth quarter of 2004.
PART II
ITEM 5. MARKET FOR THE REGISTRANTS COMMON EQUITY, RELATED STOCKHOLDER MATTERS AND ISSUER PURCHASERS OF EQUITY SECURITIES
There is no established public trading market for our Class A common stock. As of March 1, 2005, there were approximately 590 holders of record of our Class A common stock and one holder of record of our Class B common stock.
We have never paid a dividend on shares of our equity securities. We do not intend to pay any dividends on our Class A common stock during the foreseeable future. It is anticipated that earnings, if any, from operations will be used to finance growth. Any future dividends on our Class A common stock will depend upon our results of operations, financial condition, working capital requirements and other factors deemed relevant by our board of directors. In addition, our ability to declare and pay dividends on shares of our Class A common stock is restricted by the preferential rights of the holders of our Series A preferred stock to receive specified dividends.
On February 10, 2003, we issued options to purchase an aggregate of 23,000 shares of Class A common stock to Galen Advisors LLC and options to purchase an aggregate of 17,000 shares of Class A common stock to LHC Corporation. The options were exercisable 100% on the date of grant and terminate on the tenth anniversary of the date of grant. These options were issued in consideration for services rendered by our directors, Zubeen Shroff and Claudie Williams, respectively, in 2002. The aggregate amount of consideration for these options was $80,000.
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On December 16, 2003, we issued a Class A common stock warrant exercisable to purchase up to an aggregate of 46,250 shares of our Class A common stock at $2.00 per share to Tatum CFO Partners, LLP pursuant to an employment agreement between us and our Chief Financial Officer, Dennis N. Cavender. The warrant was issued in lieu of stock options to be granted to Mr. Cavender in consideration for his employment with us. The warrant was exercisable 25% on the first anniversary of the date of grant with the remaining portion becoming exercisable quarterly in equal installments for twelve quarters thereafter, and terminates on the tenth anniversary of the date of grant or earlier if Dennis N. Cavender ceases to be employed by us in specified circumstances. In addition, on that date, we issued a Class A common stock warrant exercisable to purchase up to an aggregate of 25,000 shares of our Class A common stock at $2.00 per share to AVOS LifeSciences, LLC in consideration for services rendered by an affiliate of AVOS LifeSciences, LLC to us in the aggregate amount of $50,000. The warrant was exercisable 100% on the date of grant and terminates on the fifth anniversary of the date of grant.
On February 5, 2004, we issued a Class A common stock warrant exercisable to purchase up to an aggregate of 12,000 shares of our Class A common stock at $2.00 per share to Galen Advisors LLC. The warrant was issued in consideration for services rendered by our director, Zubeen Shroff, in 2003. The warrant was exercisable 100% on the date of grant and terminates on the tenth anniversary of the date of grant.
The above-described transactions were made in reliance upon an exemption from registration under the Securities Act of 1933 pursuant to Section 4(2) of the Securities Act and/or Rule 506 of Regulation D promulgated thereunder for transactions not involving a public offering. No underwriters were engaged in connection with the sales of securities, and these sales were made without general solicitation or advertising.
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ITEM 6. SELECTED FINANCIAL DATA
The following table sets forth selected historical consolidated financial information of the Essential Group as of and for each of the five years ended December 31, 2004, 2003, 2002, 2001 and 2000. The financial information for 2000 reflects the combined results of operations of Essential Group and Old AmDoc since January 6, 2000, the date of the Merger. Pro forma financial statements to reflect the acquisition of Old AmDoc have not been presented as the financial statements as of and for the year ended December 31, 2000 reflect the Merger for the entire period (the results of operations of Old AmDoc for the period from January 1 to January 5, 2000 were not significant).
The selected consolidated financial data as of and for each of the three years ended December 31, 2004 has been derived from our consolidated financial statements, which were audited by Grant Thornton LLP, our independent public accountants. The selected consolidated financial data as of and for each of the two years ended December 31, 2001 has been derived from our unaudited consolidated financial statements. You should read the information in this table in conjunction with our consolidated financial statements and the notes to those statements and Managements Discussion and Analysis of Financial Condition and Results of Operations, included in Item 7 below.
The consolidated statements of operations for each of the four years ended December 31, 2003 are being restated as discussed in Managements Discussion and Analysis of Financial Condition and Results of Operations, included in Item 7 below. The consolidated balance sheets, consolidated statements of stockholders deficit and consolidated statements of cash flows for each of these periods were not impacted by the restatement. You should read the information in this table in conjunction with our consolidated financial statements and the notes to those statements and Managements Discussion and Analysis of Financial Condition and Results of Operations, included in Item 7 below.
| For the Year Ended December 31, |
||||||||||||||||||||
| 2004 |
2003 |
2002 |
2001 |
2000 |
||||||||||||||||
| (in thousands, except per share data) | ||||||||||||||||||||
| (as restated) | (as restated) | (as restated, unaudited) |
(as restated, unaudited) |
|||||||||||||||||
| STATEMENT OF OPERATIONS DATA: |
||||||||||||||||||||
| Revenue |
$ | 47,985 | $ | 59,465 | $ | 66,587 | $ | 56,011 | $ | 57,462 | ||||||||||
| Expenses |
||||||||||||||||||||
| Direct study costs |
36,220 | 44,101 | 48,504 | 38,751 | 38,242 | |||||||||||||||
| Selling, general and administrative |
13,892 | 17,751 | 18,590 | 22,415 | 41,164 | |||||||||||||||
| Class B common stock (depreciation) appreciation |
(117 | ) | (178 | ) | | (1,919 | ) | (1,028 | ) | |||||||||||
| Depreciation and amortization |
407 | 567 | 1,006 | 1,560 | 12,990 | |||||||||||||||
| Impairment of goodwill |
| | | 7,208 | 22,964 | |||||||||||||||
| Total expenses |
50,230 | 62,241 | 68,100 | 68,045 | 114,332 | |||||||||||||||
| Operating loss |
(2,417 | ) | (2,776 | ) | (1,513 | ) | (12,034 | ) | (56,870 | ) | ||||||||||
| Other (expenses) income, net |
(51 | ) | (9 | ) | 95 | 305 | 304 | |||||||||||||
| Net loss |
$ | (2,468 | ) | $ | (2,785 | ) | $ | (1,418 | ) | $ | (11,729 | ) | $ | (56,566 | ) | |||||
| Basic and diluted net loss per common share |
||||||||||||||||||||
| Class A |
$ | (2.24 | ) | $ | (2.19 | ) | $ | (1.68 | ) | $ | (4.11 | ) | $ | (15.62 | ) | |||||
| Class B |
(2.24 | ) | (2.19 | ) | (1.68 | ) | (4.11 | ) | (15.62 | ) | ||||||||||
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| As of December 31, |
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| 2004 |
2003 |
2002 |
2001 |
2000 |
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| (in thousands) | ||||||||||||||||||||
| BALANCE SHEET DATA: |
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| ASSETS |
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| Current assets |
||||||||||||||||||||
| Cash and cash equivalents |
$ | 1,252 | $ | 1,984 | $ | 2,774 | $ | 5,601 | $ | 9,389 | ||||||||||
| Other current assets |
10,958 | 14,988 | 17,283 | 18,245 | 21,016 | |||||||||||||||
| Total current assets |
12,210 | 16,972 | 20,057 | 23,846 | 30,405 | |||||||||||||||
| Fixed assets, net |
519 | 774 | 1,260 | 1,997 | 3,029 | |||||||||||||||
| Goodwill and other assets |
24 | 27 | 24 | 24 | 7,578 | |||||||||||||||
| $ | 12,753 | $ | 17,773 | $ | 21,341 | $ | 25,867 | $ | 41,012 | |||||||||||