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Special Note Regarding Forward-Looking Statements
Risks Relating to Our Business
If generic products that compete with any of our branded pharmaceutical products are approved, sales of our products may be adversely affected.
Our trademarks, patents and other intellectual property are valuable assets and if we are unable to protect them from infringement or challenges, our business prospects may be harmed.
Delays in production could have a material adverse impact on our business.
Pricing pressures from third-party payors, including managed care organizations, government sponsored health systems and regulations relating to Medicare and Medicaid, healthcare reform, pharmaceutical reimbursement and pricing in general could decrease our revenues.
Changes in laws and regulations could adversely affect our results of operations, financial position or cash flows.
Taxing authorities could reallocate our taxable income among our subsidiaries, which could increase our consolidated tax liability.
Changes in market conditions, including lower than expected cash flows or revenues for our branded pharmaceutical products, may result in our inability to realize the value of these products, in which case we may have to record an impairment charge.
The loss of the services of members of our senior management team or scientific staff or the inability to attract and retain other highly qualified employees could impede our ability to meet our strategic objectives and adversely affect our business.
Product liability claims and product recalls could harm our business.
Sales of our products may be adversely affected by the consolidation among wholesale drug distributors and the growth of large retail drug store chains.
If we fail to comply with government regulations we could be subject to fines, sanctions and penalties that could adversely affect our ability to operate our business.
New legal and regulatory requirements could make it more difficult for us to obtain new or expanded approvals for our products, and could limit or make more burdensome our ability to commercialize our approved products.
Delays and uncertainties in clinical trials or the government approval process for new products could result in lost market opportunities and hamper our ability to recoup costs associated with product development.
We may not be able to successfully identify, develop, acquire, license or market new products as part of growing our business.
Prescription drug importation from Canada and other countries could increase pricing pressure on certain of our products and could decrease our revenues and profit margins.
The perceived health effects of estrogen and combined estrogen-progestogen hormone therapy products may affect the acceptability and commercial success of our HT products.
We have a significant amount of intangible assets, which may never generate the returns we expect.
If we fail to comply with our reporting and payment obligations under the Medicaid rebate program or other governmental pricing programs, we could be subject to additional reimbursements, penalties, sanctions and fines which could have a material adverse effect on our business.
Adverse outcomes in our outstanding litigation matters could negatively impact our business, results of operations, financial condition and cash flows.
Risks Related to our Indebtedness
We have a substantial amount of indebtedness, which may adversely affect our cash flow and our ability to operate our business, remain in compliance with debt covenants and make payments on our indebtedness.
To service our indebtedness, we will require a significant amount of cash. Our ability to generate cash depends on many factors beyond our control, and any failure to meet our debt service obligations could harm our business, financial condition and results of operations.
The terms of our senior secured credit facility and the indenture governing our outstanding Notes restrict our current and future operations, particularly our ability to respond to changes in our business or to take certain actions.
Risks Relating to Our Common Stock
Future sales of our shares could depress the market price of our common stock.
The market price of our common stock may be volatile, which could cause the value of your investment to decline significantly.
Provisions of our bye-laws could delay or prevent a takeover of us by a third party.
Because our Sponsors own a majority of our outstanding common stock, if they act collectively, the influence of our public shareholders over significant corporate actions may be limited, and conflicts of interest between our Sponsors and us or you could arise in the future.
Full 10-K form ▸
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