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SEC Filings

10-Q
OREXIGEN THERAPEUTICS, INC. filed this Form 10-Q on 05/12/2017
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into such an agreement, which would force us to delay, reduce or eliminate research, development, and commercialization activities.

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, cash equivalents and short-term investments will be sufficient to meet our projected operating requirements through at least the next 12 months.  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 may need additional capital to:

 

fund our operations and to conduct post-marketing requirements for Contrave;

 

develop and commercialize Contrave/Mysimba; and

 

qualify and outsource the commercial-scale of Contrave under cGMP.

The amount and timing of our future funding requirements will depend on many factors, including, but not limited to:

 

the successful commercialization of Contrave/Mysimba;

 

the rate of progress and cost of clinical activity, including the new CVOT for Contrave, and the scope and cost of the additional post-marketing requirements for Contrave, including expenses to support the trials and milestone payments that may become payable;

 

the terms and timing of any collaborative, licensing, co-promotion, distribution or other arrangements that we may establish with respect to Contrave/Mysimba;

 

the costs of establishing sales, marketing and distribution capabilities in order to commercialize Contrave/Mysimba in the United States and geographies outside the United States, should we elect to do so;

 

the costs involved in enforcing or defending patent claims or other intellectual property rights;

 

the costs and timing of additional regulatory approvals for Contrave/Mysimba; and

 

the extent to which we in-license, acquire or invest in other indications, products, technologies and businesses.

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.

Unless and 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, milestone payments, debt, receivables or royalty financings, or corporate collaboration and licensing arrangements, as well as through interest income earned on cash and investment 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.

Our quarterly and annual operating results may fluctuate significantly.

We expect our operating results to be subject to quarterly and annual fluctuations. Our net loss and other operating results may be affected by numerous factors, including:

 

the level of underlying demand for Contrave, wholesalers’ buying patterns with respect to Contrave, discounts given to certain Contrave customers, and our ability to successfully market Contrave following the transition from Takeda;

 

variations in the level of expenses, including, but not limited to, variation based on foreign currency exchange rates, related to our product or future development programs;

 

regulatory developments affecting our product or those of our competitors;

 

the timing of future payments, if any, we may receive under partnership, distributorship or similar agreements;

 

our execution of any additional collaborative, licensing, distribution or similar arrangements, and the timing of payments we may make or receive under these arrangements;

 

addition or termination of clinical trials or funding support; and

 

any intellectual property infringement lawsuit in which we may become involved.

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