Print Page  Close Window


SEC Filings

S-1/A
OREXIGEN THERAPEUTICS, INC. filed this Form S-1/A on 02/16/2007
Entire Document
 
Table of Contents

In addition, future acquisitions may entail numerous operational and financial risks, including:
 
  •      exposure to unknown liabilities;
 
  •      disruption of our business and diversion of our management’s time and attention to develop acquired products or technologies;
 
  •      incurrence of substantial debt or dilutive issuances of securities to pay for acquisitions;
 
  •      higher than expected acquisition and integration costs;
 
  •      increased amortization expenses;
 
  •      difficulty and cost in combining the operations and personnel of any acquired businesses with our operations and personnel;
 
  •      impairment of relationships with key suppliers or customers of any acquired businesses due to changes in management and ownership; and
 
  •      inability to retain key employees of any acquired businesses.
 
Further, any product candidate that we acquire may require additional development efforts prior to commercial sale, including extensive clinical testing and approval by the FDA and applicable foreign regulatory authorities. All product candidates are prone to risks of failure typical of pharmaceutical product development, including the possibility that a product candidate will not be shown to be sufficiently safe and effective for approval by regulatory authorities. In addition, we cannot provide assurance that any products that we develop or approved products that we acquire will be manufactured profitably or achieve market acceptance.
 
Healthcare reform measures could hinder or prevent our product candidates’ commercial success.
 
In the United States, there have been a number of legislative and regulatory changes to the healthcare system in ways that could affect our future revenues and profitability and the future revenues and profitability of our potential customers. For example, the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 established a new Part D prescription drug benefit, which became effective January 1, 2006. It remains difficult to predict the impact that the prescription drug program will have on us and our industry. Under the prescription drug benefit, Medicare beneficiaries can obtain prescription drug coverage from private sector plans that are permitted to limit the number of prescription drugs that are covered in each therapeutic category and class on their formularies. However, at this time, weight loss drugs are not covered under Part D. As a result, our products will not be placed on the formularies of the private sector providers participating in the Part D program unless the law is changed in the future to allow for coverage of obesity products or unless the drugs are offered as a separate supplemental benefit not funded by Medicare, and if our products are not placed on such formularies, this could negatively impact our ability to sell our products.
 
There also have been, and likely will continue to be, legislative and regulatory proposals at the federal and state levels directed at containing or lowering the cost of health care. We cannot predict the initiatives that may be adopted in the future. The continuing efforts of the government, insurance companies, managed care organizations and other payors of health care services to contain or reduce costs of health care may adversely affect:
 
  •      our ability to set a price we believe is fair for our products;
 
  •      our ability to generate revenues and achieve or maintain profitability; and
 
  •      the availability of capital.


21