1138723--9/1/2010--ACCURAY_INC

related topics
{product, liability, claim}
{stock, price, operating}
{regulation, government, change}
{product, market, service}
{control, financial, internal}
{product, candidate, development}
{acquisition, growth, future}
{financial, litigation, operation}
{operation, international, foreign}
{property, intellectual, protect}
{personnel, key, retain}
{stock, price, share}
{regulation, change, law}
{provision, law, control}
{capital, credit, financial}
{operation, natural, condition}
{customer, product, revenue}
{condition, economic, financial}
Risks Related to Our Business If the CyberKnife system does not achieve widespread market acceptance, we will not be able to generate the revenue necessary to support our business. If we are unable to develop new products or enhance existing products, we may be unable to attract or retain customers. If we are unable to provide the significant education and training required for the healthcare market to accept our products, our business will suffer. We have a large accumulated deficit, may incur future losses and may be unable to maintain profitability. We face risks related to the current global economic environment, which could delay or prevent our customers from obtaining financing to purchase the CyberKnife system and implement the required facilities, which would adversely affect our business, financial condition and results of operations. The high unit price of the CyberKnife system, as well as other factors, may contribute to substantial fluctuations in our operating results, which could adversely affect our stock price. Because the majority of our revenue is derived from sales of the CyberKnife system, and because we experience a long and variable sales and installation cycle, our quarterly results may be inconsistent from period to period. These fluctuations in revenue may make it difficult to predict our revenue. Our ability to increase our profitability depends in part on maintaining or increasing our gross margins on product sales and service, which we may not be able to achieve. If third-party payors do not provide sufficient coverage and reimbursement to healthcare providers for use of the CyberKnife system, demand for our products and our revenue could be adversely affected. Our industry is subject to intense competition and rapid technological change, which may result in products or new tumor treatments that are superior to the CyberKnife system. If we are unable to anticipate or keep pace with changes in the marketplace and the direction of technological innovation and customer demands, our products may become less useful or obsolete and our operating results will suffer. If we fail to maintain an effective system of internal control over financial reporting, we may not be able to accurately report our financial results. As a result, current and potential stockholders could lose confidence in our financial reporting, which could have an adverse effect on our business and our stock price. We may have difficulties in determining the effectiveness of our internal control due to our complex financial model. Our reliance on single source suppliers for critical components of the CyberKnife system could harm our ability to meet demand for our products in a timely and cost effective manner. It is difficult and costly to protect our intellectual property and our proprietary technologies, and we may not be able to ensure their protection. Third parties may claim we are infringing their intellectual property, and we could suffer significant litigation or licensing expenses or be prevented from selling our product. We could become subject to product liability claims, product recalls, other field actions and warranty claims that could be expensive, divert management's attention and harm our business. The safety and efficacy of our products for certain uses is not yet supported by long-term clinical data and may therefore prove to be less safe and effective than initially thought. The CyberKnife system has been in use for a limited period of time for uses outside the brain, and the medical community has not yet developed a large quantity of peer-reviewed literature that supports safe and effective use in those locations in the body. International sales of the CyberKnife system account for a significant portion of our revenue, which exposes us to risks inherent in international operations. Our results may be impacted by changes in foreign currency exchange rates. We depend on third-party distributors to market and distribute the CyberKnife system in international markets. If our distributors fail to successfully market and distribute the CyberKnife system, our business will be materially harmed. We have limited experience and capability in manufacturing. If we encounter manufacturing problems, or if our manufacturing facilities do not continue to meet federal, state or foreign manufacturing standards, we may be required to temporarily cease all or part of our manufacturing operations, which would result in delays and lost revenue. We depend on key employees, the loss of whom would adversely affect our business. If we fail to attract and retain employees with the expertise required for our business, we may be unable to continue to grow our business. If we do not effectively manage our growth, our business may be significantly harmed. Any failure in our physician training efforts could result in lower than expected product sales and potential liabilities. Changes in interpretation or application of generally accepted accounting principles may adversely affect our operating results. As a strategy to assist our sales efforts, we may offer extended payment terms, which may potentially result in higher DSO and greater payment defaults. Our ability to raise capital in the future may be limited, and our failure to raise capital when needed could prevent us from executing our growth strategy. We may attempt to acquire new businesses, products or technologies, or enter into collaborations or strategic alliances, and if we are unable to successfully complete these acquisitions or to integrate acquired businesses, products, technologies or employees, we may fail to realize expected benefits or harm our existing business. We may face numerous risks in connection with our strategic alliance with Siemens AG. Our liquidity could be adversely impacted by adverse conditions in the financial markets. Our operations are vulnerable to interruption or loss due to natural disasters, epidemics, terrorist acts and other events beyond our control, which would adversely affect our business. Risks Related to the Regulation of our Products and Business Healthcare reform legislation could adversely affect demand for our products, our revenue and our financial condition. Modifications, upgrades and future products related to the CyberKnife system or new indications may require new FDA 510(k) clearances or premarket approvals, and such modifications, or any defects in design or manufacture may require us to recall or cease marketing the CyberKnife system until approvals or clearances are obtained. We must obtain and maintain regulatory approvals in international markets in which we sell, or seek to sell, our products. If we do not obtain and maintain the necessary international regulatory approvals, we will not be able to market and sell our products in foreign countries. Future legislative or regulatory changes to the healthcare system may affect our business. We are required to comply with federal and state "fraud and abuse" law, and if we are unable to comply with such laws, we could face substantial penalties and we could be excluded from government healthcare programs, which would adversely affect our business, financial condition and results of operations. If we are found to have violated laws protecting the confidentiality of patient health information, we could be subject to civil or criminal penalties, which could increase our liabilities and harm our reputation or our business. Risks Related to Our Common Stock The price of our common stock is volatile and may continue to fluctuate significantly, which could lead to losses for stockholders. Substantial sales of our common stock by our stockholders, including sales pursuant to 10b5-1 plans, could depress our stock price regardless of our operating results. Our directors, executive officers and major stockholders own approximately 42.6% of our outstanding common stock as of July 30, 2010, which could limit our ability to influence the outcome of key transactions, including changes of control. We have implemented anti-takeover provisions that could discourage or prevent a takeover, even if an acquisition would be beneficial in the opinion of our stockholders. We have not paid dividends in the past and do not expect to pay dividends in the future.

Full 10-K form ▸

related documents
1138723--9/9/2009--ACCURAY_INC
919015--3/20/2009--BIOSPHERE_MEDICAL_INC
919015--3/26/2008--BIOSPHERE_MEDICAL_INC
1138723--9/10/2008--ACCURAY_INC
919015--3/26/2010--BIOSPHERE_MEDICAL_INC
919015--3/27/2007--BIOSPHERE_MEDICAL_INC
919015--3/21/2006--BIOSPHERE_MEDICAL_INC
1097136--3/21/2008--SENORX_INC
1040666--3/30/2007--VNUS_MEDICAL_TECHNOLOGIES_INC
1158895--3/29/2010--LEMAITRE_VASCULAR_INC
1040666--3/14/2008--VNUS_MEDICAL_TECHNOLOGIES_INC
1142596--3/15/2007--NUVASIVE_INC
1166463--3/13/2007--VISICU_INC
881464--2/26/2010--AMYLIN_PHARMACEUTICALS_INC
1142596--3/15/2006--NUVASIVE_INC
1275187--8/11/2006--ANGIODYNAMICS_INC
1383183--3/18/2010--CombiMatrix_Corp
784199--2/19/2010--CRYOLIFE_INC
1142596--3/2/2009--NUVASIVE_INC
31347--3/14/2006--ECHELON_CORP
1230355--3/13/2009--TRANS1_INC
1127393--12/27/2006--HEMOSENSE_INC
1137861--3/1/2006--WRIGHT_MEDICAL_GROUP_INC
885306--3/12/2007--CYNOSURE_INC
883697--3/28/2006--REGEN_BIOLOGICS_INC
1230355--3/25/2008--TRANS1_INC
1275187--8/14/2007--ANGIODYNAMICS_INC
1114365--3/30/2006--CURON_MEDICAL_INC
1048477--2/27/2009--BIOMARIN_PHARMACEUTICAL_INC
892025--12/29/2009--MARTEK_BIOSCIENCES_CORP