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SEC Filings

OREXIGEN THERAPEUTICS, INC. filed this Form S-1/A on 02/16/2007
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not yet demonstrated an ability to obtain regulatory approval for or commercialize a product candidate. Consequently, any predictions about our future performance may not be as accurate as they could be if we had a history of successfully developing and commercializing pharmaceutical products.
We will need additional funding and may be unable to raise capital when needed, which would force us to delay, reduce or eliminate our product development programs or commercialization efforts.
Developing products for the obesity market, conducting clinical trials, establishing outsourced manufacturing relationships and successfully manufacturing and marketing drugs that we may develop is expensive. We believe that our existing cash and cash equivalents, together with the borrowing capacity under our $17.0 million credit and security agreement with Merrill Lynch Capital, will be sufficient to meet our projected operating requirements through at least March 31, 2008 and that the addition of the net proceeds from this offering will allow us to complete our planned Phase III clinical trials for Contrave and complete our ongoing Phase IIb clinical trial for Excalia. However, we have based these estimates on assumptions that may prove to be wrong, and we could spend our available financial resources much faster than we currently expect. Further, we will need to raise additional capital following this offering to:
  •      fund our operations and continue to conduct clinical trials to support potential regulatory approval of marketing applications;
  •      qualify and outsource the commercial-scale manufacturing of our products under cGMPs; and
  •      commercialize Contrave, Excalia or any other product candidates that we may develop, in-license or acquire, if any of these product candidates receive regulatory approval.
The amount and timing of our future funding requirements will depend on many factors, including, but not limited to:
  •      the rate of progress and cost of our clinical trials and other product development programs for Contrave, Excalia and any other product candidates that we may develop, in-license or acquire;
  •      the costs of filing, prosecuting, defending and enforcing any patent claims and other intellectual property rights associated with our product candidates;
  •      the costs and timing of completion of outsourced commercial manufacturing supply arrangements for each product candidate;
  •      the timing of regulatory approval of our product candidates, if at all;
  •      the costs of establishing sales, marketing and distribution capabilities, should we elect to do so;
  •      the effect of competing technological and market developments; and
  •      the terms and timing of any collaborative, licensing, co-promotion or other arrangements that we may establish.
Future capital requirements will also depend on the extent to which we acquire or invest in additional complementary businesses, products and technologies. We currently have no commitments or agreements relating to any of these types of transactions.
Until we can generate a sufficient amount of product revenue and achieve profitability, we expect to finance future cash needs through public or private equity offerings, debt financings or corporate collaboration and licensing arrangements, as well as through interest income earned on cash balances. We cannot be certain that additional funding will be available on acceptable terms, or at all. If adequate funds are not available, we may be required to delay, reduce the scope of or eliminate one or more of our development programs or our commercialization efforts.