Key Developments For Medidata Solutions, Inc.
Medidata Solutions, Inc. (MDSO.O) (Consolidated Issue listed on NASDAQ Global Market)
Medidata Solutions, Inc. Files Registration Statement For Public Offering Of Common Stock
Medidata Solutions, Inc. announced that it filed a registration statement with the Securities and Exchange Commission for a proposed public offering of 4.5 million shares of common stock of the Company. The shares are being offered by certain stockholders of the Company, including funds affiliated with Insight Venture Partners. Medidata Solutions will not receive any of the proceeds from the intended offering. To the extent that the underwriters sell more than 4.5 million shares of common stock, the selling stockholders intend to grant the underwriters an option for a period of 30 days to purchase up to 675,000 additional shares of common stock. Citigroup Global Markets, Inc. and Credit Suisse Securities (USA) LLC are acting as joint bookrunning managers for the proposed offering. Jefferies & Company, Inc. and Needham & Company, LLC are acting as co-managers.
Medidata Solutions, Inc. Issues Q4 2009 Guidance Above Analysts' Estimates; Raises FY 2009 Guidance
Medidata Solutions, Inc. announced that for fourth quarter 2009 it expects revenues to be between $35.2 and $36.2 million and non-GAAP operating income to be between $5.1 and $6.1 million. Based on current estimates, this would equate to a GAAP operating income of $0.6 and $1.6 million. Non-GAAP net income is expected to be between $2.3 and $3.3 million. Based on current estimates, this would equate to a GAAP net income of between $0.4 and $1.4 million. For fiscal 2009, it has increased its previous guidance and now expects revenues to be between $138 and $139 million. Non-GAAP operating income is expected to be between $22.0 and $23.0 million. Based on current estimates, this would equate to GAAP operating income between $6.3 and $7.3 million. Non-GAAP net income is expected to be between $10.5 and $11.5 million. Based on current estimates, this would equate to GAAP net income between $3.8 and $4.8 million. According to Reuters Estimates, analysts are expecting the Company to report revenue of 434.6 million, EBIT of $1.1 million and net income of $1.4 million for fourth quarter 2009; revenue of $136 million, EBIT of $4.9 million and net income of $5.0 million for fiscal 2009.
Shire Extends Agreement With Medidata Solutions, Inc. For Trial Planning Products
Medidata Solutions, Inc. announced a multi year contract extension with Shire plc for use of Medidata Grants Manager and CRO Contractor benchmarking and analysis tools for investigator site and contract research organization (CRO) trial budget planning and forecasting. Under this new contract, Shire will also implement three Analysis modules that will enable the company to gain greater insight into clinical research costs and further enhance the management and success of its clinical development processes. As a result of this most recent collaboration with Medidata, Shire's study teams will continue to provide high-level cost forecasting and address budget issues. In addition, in order to fully optimize the use of Grants Manager, CRO Contractor and the Analysis tools, Shire added a full time position dedicated to providing quality assurance of the planning and budgeting process, conducting analyses of overall clinical spending and ensuring compliance to Fair Market Value (FMV) payment practices.
Medidata Solutions, Inc. Announces Extension of Contract With Bristol-Myers Squibb Co.
Medidata Solutions, Inc. announced a multi-year contract extension with Bristol-Myers Squibb Co. for use of Medidata Grants Manager, an investigator site benchmarking tool that helps sponsors ensure fair and consistent investigator payments, mitigate compliance risks and reduce trial start-up time. Under this new contract, Bristol-Myers Squibb will also be expanding its use of Grants Manager to include analysis and contracting modules. Bristol-Myers Squibb has used Grants Manager for 15 years. Powered by the PICAS clinical cost database of negotiated agreements between sponsors and investigators, Grants Manager provides access to key fair market value data of investigator costs and payments. The Grants Manager solution enables clinical teams to facilitate clinical cost planning and budgeting processes and create consensus in the budget review and approval process. The analysis tool offers access to reporting on trial financial data, while the contracting module enables collaborative review of budgets via the Internet to further streamline the company's processes.
NovImmune Selects Medidata Solutions, Inc.'s Trial Planning Products To Support Growing Pipeline Of Biologics
Medidata Solutions, Inc. announced Switzerland-based NovImmune has selected Medidata`s Trial Planning product suite to support the development of its diverse pipeline of biologics for immune-related disorders. NovImmune has already utilized Medidata Grants Manager and CRO Contractor for a Phase II type I diabetes trial involving 160 patients and 75 sites in 12 countries, and is also incorporating Medidata Designer into its clinical development process. NovImmune is also implementing Medidata Designer, which enables the standardized development of study protocols and simultaneous capture of all protocol metadata in a structured, CDISC ODM certified XML file that can be reused to rapidly set-up downstream systems, such as electronic data capture (EDC).

