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| OMCM.OB > SEC Filings for OMCM.OB > Form 10-Q on 14-Aug-2009 | All Recent SEC Filings |
14-Aug-2009
Quarterly Report
General
The following information should be read in conjunction with the information contained in our unaudited consolidated financial statements and notes thereto appearing elsewhere herein and conjunction with the Management's Discussion and Analysis set forth in our Annual Report on Form 10-K for the year ended December 31, 2008 and other information set forth in this report.
Forward-Looking Statements
Statements contained in this Form 10-Q that are not historical fact are "forward looking statements". These statements can often be identified by the use of forward-looking terminology such as "estimate", "project", "believe", "expect", "may", "will", "should", "intends", or "anticipates" or the negative thereof or other variations thereon or comparable terminology, or by discussions of strategy that involve risks and uncertainties. We wish to caution the reader that these forward-looking statements, contained in this Form 10-Q regarding matters that are not historical facts, are only predictions. No assurance can be given that plans for the future will be consummated or that the future results indicated, whether expressed or implied, will be achieved. While sometimes presented with numerical specificity, these plans and projections and other forward-looking statements are based upon a variety of assumptions, which we consider reasonable, but which nevertheless may not be realized. Because of the number and range of the assumptions underlying our projections and forward-looking statements, many of which are subject to significant uncertainties and contingencies that are beyond our reasonable control, some of the assumptions inevitably will not materialize, and unanticipated events and circumstances may occur subsequent to the date of this Form 10-Q. Therefore, our actual experience and results achieved during the period covered by any particular projections or forward-looking statements may differ substantially from those projected. Consequently, the inclusion of projections and other forward- looking statements should not be regarded as a representation by us or any other person that these plans will be consummated or that estimates and projections will be realized, and actual results may vary materially. There can be no assurance that any of these expectations will be realized or that any of the forward-looking statements contained herein will prove to be accurate. The Company does not undertake any obligation to update or revise any forward-looking statement made by it or on its behalf, whether as a result of new information, future events or otherwise.
Overview
We are a healthcare technology company that provides Electronic Data Capture ("EDC") solutions and related value-added services to pharmaceutical and biotechnology companies, Clinical Research Organizations ("CRO"), and other clinical trial sponsors via our Web-based software applications, TrialMaster and the EDC software and applications acquired from eResearch Technology in June 2009. Our EDC software applications allow clinical trial sponsors and investigative sites to securely collect, validate, transmit, and analyze clinical study data including patient histories, patient dosing, adverse events, and other clinical trial information.
During fiscal 2009 we will seek to build and expand on our strategic efforts. The primary focus of our strategy includes:
• Stimulating demand by providing clinical trial Sponsors with high value eClinical applications and services;
• Emphasizing low operating costs;
• Continued emphasis on expanding our business model by offering our software solution, TrialMaster, on a licensed basis in addition to our existing hosted-services solutions;
• Broadening our eClinical suite of services and software applications on an organic R & D basis, and on a selective basis via the acquisition or licensing of complementary solutions;
• Expanding our business development efforts in Europe to capitalize on our operational and clinical capabilities vis-à-vis our competition in that geographic market;
• Providing EDC services to small and midsize Pharma, Bio-Tech, Medical Device Companies and CROs (Clinical Research Organizations); and
• Differentiation through service.
According to a 2008 EvaluatePharma report, global R & D expenditures by the pharmaceutical and BioTech industries were approximately $120 billion in 2008, with approximately 50% of that amount spent by North American-based pharmaceutical, biotechnology and medical device companies. A 2007 report by Health Industry Insights states that by the end of 2007, approximately 45% of all new Phase I-III studies were initiated using EDC. The report also states that the total addressable market for EDC and eClinical services is expected to grow from approximately $600MM currently to $1.8B in 2010. Our operating focus is first to increase our sales and marketing capabilities and penetration rate and secondly, to continue developing and improving TrialMaster to ensure our services and products remain an attractive, high-value EDC choice. During early 2009 we have increased our marketing and sales personnel both in the U.S. and European markets and will look to aggressively expand the scope of our CRO Preferred Program in order to increase our penetration of the domestic CRO market. Additionally, we believe we have established an effective presence in the European clinical trial market and will seek to aggressively expand the scope of our sales and marketing operations there.
Our ability to compete within the EDC industry is predicated on our ability to continue enhancing and broadening the scope of solutions offered through TrialMaster. Our R & D efforts are focused on developing new, complementary software solutions, as well as enhancing our existing software solutions through the addition of increased functionality. During fiscal 2008, we spent approximately $897,000, on R & D activities and have spent approximately $512,000 during the six months ended June 20, 2009. We spent approximately $449,000 on R &D activities during six months ended June 30, 2008. The majority of these expenses represent salaries to our developers which include costs associated with customization of the TrialMaster software for our clients' projects.
The Six-Month period-ended June 30, 2009 Compared With the Six-Month period ended June 30, 2008
Results of Operations
A summarized version of our results of operations for the six months ended June 30, 2009 and June 30, 2008 is included in the table below.
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