1338648--2/29/2008--Oracle_Healthcare_Acquisition_Corp.

related topics
{product, liability, claim}
{interest, director, officer}
{product, candidate, development}
{stock, price, share}
{cost, regulation, environmental}
{property, intellectual, protect}
{provision, law, control}
{control, financial, internal}
{stock, price, operating}
{acquisition, growth, future}
{financial, litigation, operation}
{investment, property, distribution}
{regulation, government, change}
{customer, product, revenue}
{product, market, service}
{tax, income, asset}
{personnel, key, retain}
Risks Associated with our Business If we are unable to complete the business combination with PTI, we will not have enough time to negotiate and consummate another business combination and will be required to liquidate. You will not be entitled to protections normally afforded to investors of blank check companies under federal securities laws. Under Delaware law, the requirements and restrictions relating to our initial public offering contained in our amended and restated certificate of incorporation may be amended, which could reduce or eliminate the protection afforded to our stockholders by such requirements and restrictions. If our stockholders fail to vote or abstain from voting on the adoption of the proposed merger with PTI, they will not be able to exercise their conversion rights. If we do not complete the merger and are therefore required to dissolve and liquidate, payments from the trust account to our public stockholders may be delayed and may be reduced by claims of third parties. Our stockholders may be held liable for claims by third parties against us to the extent of distributions received by them. Risks Related to the Proposed Merger with PTI The combined company's inability to raise additional capital on acceptable terms in the future may limit its ability to develop and commercialize new tests and technologies. We may not be able to qualify for, or might fail to maintain, a listing for its common stock on The NASDAQ Stock Market making it more difficult for stockholders to dispose of or to obtain accurate quotations as to the value of their shares of our common stock. The combined company's working capital could be reduced, and our stockholders could own less than 45.8% of the combined company's outstanding common stock, if our stockholders exercise their right to convert their shares into cash. The combined company's operating results may fluctuate, which could cause its stock price to be volatile, and the value of your investment could decline significantly. Pursuant to the terms of the Merger Agreement, a substantial number of shares will be issued upon, and will be potentially issuable after, the consummation of the merger, which will result in significant dilution to the holders of our outstanding common stock immediately prior to the proposed merger. A substantial number of our shares will become eligible for future resale in the public market after the proposed merger which could result in dilution and have an adverse effect on the market price of those shares. Our directors and executive officers have interests in the merger that are different from yours because if the merger is not approved then the shares held by them may become worthless. The amount of stock held by executive officers, directors and other affiliates following the merger may limit your ability to influence the outcome of director elections and other matters requiring stockholder approval. The lack of diversification in the business of the combined company following the merger affects the combined company's ability to mitigate the risks that it may face or to offset possible losses that it may incur as a result of competing in the life sciences industry. The combined company may acquire other businesses or form joint ventures that could harm its operating results, dilute your ownership of the combined company, increase its debt or cause it to incur significant expense. The combined company will incur significant increased costs, and its financial controls and procedures may not be sufficient to ensure timely and reliable reporting of financial information, which, as a public company, could materially harm the combined company's stock price and listing on the NASDAQ Global Market. The combined company's management will have broad discretion to use our available cash following the merger, and the combined company's investment of these resources may not yield a favorable return. We may invest the available cash in ways you disagree with. Some provisions of the combined company's charter documents and Delaware law may have anti-takeover effects that could discourage an acquisition of the combined company by others, even if an acquisition would be beneficial to stockholders, and may prevent attempts by stockholders to replace or remove the combined company's management. Neither PTI nor Oracle has ever declared or paid dividends on its capital stock, and we do not anticipate paying dividends in the foreseeable future. As a result, you must rely on stock appreciation for any return on your investment. The combined company's ability to utilize PTI's historical federal and state net operating loss carryforwards may currently be limited or may become limited. PTI's financial results depend on sales of one test, ChemoFx, and it will need to generate sufficient revenues from this and other tests to run its business. If third-party payors, including managed care organizations and Medicare, do not provide adequate coverage and reimbursement for ChemoFx, its commercial success and PTI's revenue stream could be harmed. PTI has a history of losses, and it expects to incur net losses for the foreseeable future. The ability of ChemoFx to predict tumor responsiveness to selected types of chemotherapy has not yet been demonstrated in clinical outcome studies in cancer types other than ovarian cancer and may, therefore, prove to be less accurate than PTI currently believes. PTI may experience limits on its revenues or future sales growth if only a small number of physicians and patients decide to use its test, which is not currently recommended for use as a standard of care by existing clinical guideline organizations. If PTI fails to attract and retain highly skilled scientists, clinicians, salespeople and members of management, or to retain its current executive management team, it may be unable to manage its growth or successfully develop or further commercialize its products and technologies. If PTI is unable to support demand for its products, its business may suffer. Clinical studies using ChemoFx may not be completed successfully, in a timely manner, or at all. If PTI is unable to compete successfully, it may be unable to increase or sustain its revenues or achieve profitability. New product development involves a lengthy and complex process, and PTI may be unable to commercialize any of the tests it is currently developing or introduce new products in a timely manner, which could cause its test to become obsolete and its revenues to decline. PTI's research and development efforts will be hindered if it is not able to obtain access to tissue samples. If PTI's research collaborators or scientific advisors terminate their relationships with PTI or develop relationships with a competitor, its ability to develop and to commercialize ChemoFx or any future products could be adversely affected. PTI relies on single suppliers for some of its laboratory instruments and materials and may not be able to find replacements in the event the supplier no longer supplies that equipment. If PTI's sole laboratory facility becomes inoperable, it will be unable to perform its ChemoFx test, and its business will be harmed. If PTI uses chemical, biological or other hazardous materials in a manner that causes injury, it could be liable for damages. If PTI is sued for product liability, it could face substantial liabilities that exceed its resources. Risks Concerning the Regulation of PTI's Business Complying with numerous regulations pertaining to PTI's business is an expensive and time-consuming process, and any failure to comply could result in substantial penalties or loss of PTI's ability to conduct its business. If the FDA subjects PTI's laboratory-developed tests to regulation as medical devices, PTI could incur substantial costs for ChemoFx to meet requirements for premarket clearance or approval and experience significant delays in commercializing ChemoFx and any future products that it may develop. If PTI is required to conduct clinical studies to obtain FDA clearance or approval of its test, those studies could lead to delays or failure to obtain such approvals and harm its ability to become profitable. The FDA could regulate PTI as a device manufacturer, and its non-compliance with regulatory requirements could result in an adverse FDA enforcement action against it. Congress could create additional regulatory burdens for PTI's test, which could cause it to incur additional costs or experience delays in the commercialization of ChemoFx. PTI could face significant monetary damages and penalties and/or exclusion from the Medicare and Medicaid programs if it violates health care anti-fraud and abuse laws. Compliance with the HIPAA security regulations and privacy regulations may increase PTI's costs. Risks Related to PTI's Intellectual Property PTI's competitive position depends on maintaining intellectual property protection, which is difficult and costly, and it may not be able to ensure the protection of proprietary rights. PTI may incur substantial costs as a result of litigation or other proceedings relating to patent and other intellectual property rights, and it may be unable to protect its rights to, or commercialize, its products.

Full 10-K form ▸

related documents
1047188--3/16/2010--PENWEST_PHARMACEUTICALS_CO
1047188--3/16/2009--PENWEST_PHARMACEUTICALS_CO
1047188--3/17/2008--PENWEST_PHARMACEUTICALS_CO
1383183--3/27/2009--CombiMatrix_Corp
1180145--9/29/2009--Cardiovascular_Systems_Inc
887708--6/15/2009--CARACO_PHARMACEUTICAL_LABORATORIES_LTD
1230355--3/13/2009--TRANS1_INC
1230355--3/25/2008--TRANS1_INC
1172480--3/4/2008--SANTARUS_INC
792977--2/27/2009--AMAG_PHARMACEUTICALS_INC.
1230355--3/12/2010--TRANS1_INC
704328--2/3/2010--SOMANETICS_CORP
1276591--2/28/2008--HANSEN_MEDICAL_INC
1057377--4/14/2008--SAMARITAN_PHARMACEUTICALS_INC
919015--3/20/2009--BIOSPHERE_MEDICAL_INC
704328--2/6/2008--SOMANETICS_CORP
1098972--3/16/2009--ANTIGENICS_INC_/DE/
1159036--3/13/2009--HALOZYME_THERAPEUTICS_INC
704328--2/11/2009--SOMANETICS_CORP
859737--11/24/2010--HOLOGIC_INC
863680--3/31/2009--CARDIOGENESIS_CORP_/CA
881464--2/26/2010--AMYLIN_PHARMACEUTICALS_INC
1383183--3/18/2010--CombiMatrix_Corp
918112--9/16/2008--NEUROBIOLOGICAL_TECHNOLOGIES_INC_/CA/
881464--2/27/2009--AMYLIN_PHARMACEUTICALS_INC
1364326--1/5/2010--Pure_Pharmaceuticals_CORP
919015--3/26/2010--BIOSPHERE_MEDICAL_INC
1317872--3/11/2010--TomoTherapy_Inc
789132--3/17/2008--SPECTRANETICS_CORP
856984--4/8/2009--AMERICAN_BIOGENETIC_SCIENCES_INC