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{provision, law, control} |
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{loan, real, estate} |
{operation, international, foreign} |
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Risks Related to Our Business
We face significant and increasing competition, which could adversely affect our operating results.
We may not be able to enforce or protect our intellectual property rights, which may harm our ability to compete and adversely affect our business. If we are unsuccessful in protecting and maintaining our intellectual property, particularly our rights under the Wake Forest patents, our competitive position would be harmed.
We may be subject to claims of infringement of third-party intellectual property rights, which could adversely affect our business.
If we are unable to develop new generations of V.A.C. Therapy and therapeutic surface products and enhancements to existing products, we may lose market share as our existing patent rights begin to expire over time.
Changes in reimbursement regulations, policies and rules, or their interpretation, could reduce the reimbursement we receive for and adversely affect the demand for our products.
Medicare approval of, and assignment of billing codes to, products that compete with our V.A.C. products could reduce the reimbursement we receive for and adversely affect the demand for our products.
Reimbursement changes applicable to facilities, such as hospitals and skilled nursing facilities, that purchase our products could reduce the reimbursement we receive for and adversely affect the demand for our products.
The initiation by government agencies of periodic inspections, assessments or studies of the products, services and billing practices we provide with respect to Medicare and Medicaid patients could lead to reduced reimbursement for our products or result in material refunds, recoupments or penalties for past billings.
The focus on DME in certain governmental work plans for 2007 and beyond could lead to reduced reimbursement for our products or result in material refunds, recoupments or penalties for past billings.
We may be subject to claims audits that could harm our business and financial results.
We could be subject to governmental investigations regarding the submission of claims for payment for items and services furnished to federal and state health care program beneficiaries.
We could be subject to governmental investigations under the Anti-Kickback Statute, the Stark Law, the federal False Claims Act or similar state laws with respect to our business arrangements with prescribing physicians and other health care professionals.
We could be subject to increased scrutiny in states where we furnish items and services to Medicaid beneficiaries that result in refunds or penalties.
Failure of any of our randomized and controlled studies or a third-party study or assessment to demonstrate V.A.C. Therapy's clinical efficacy may reduce physician usage or put pricing pressures on V.A.C. and cause our V.A.C. Therapy revenue to decline.
Because we depend upon a limited group of suppliers and, in some cases, exclusive suppliers for products essential to our business, we may incur significant product development costs and experience material delivery delays if we lose any significant supplier, which could materially impact our rental and sales of V.A.C. Therapy systems and disposables.
We are exposed to fluctuations in currency exchange rates that could negatively affect our operating results.
Changes in effective tax rates or tax audits could adversely affect our results.
If we fail to comply with the extensive array of laws and regulations that apply to our business, we could suffer civil or criminal penalties or be required to make significant changes to our operations that could reduce our revenue and profitability.
We are subject to regulation by the FDA and its foreign counterparts that could materially reduce the demand for and limit our ability to distribute our products and could cause us to incur significant compliance costs.
If our future operating results do not meet our expectations or those of the equity research analysts covering us, the trading price of our common stock could fall dramatically.
Risks Related to Our Capital Structure
Our indebtedness could adversely affect our financial condition.
Our obligations under our senior credit facility are secured by substantially all of our assets.
Our articles of incorporation, our by-laws and Texas law contain provisions that could discourage, delay or prevent a change in control or management.
Full 10-K form ▸
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