Item 7.01.
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Regulation FD Disclosure.
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Beginning on September 26, 2017, representatives of
Orexigen Therapeutics, Inc. (the Company or Orexigen) will begin presenting to and conducting meetings with investors, analysts and others. During these presentations and meetings, the Company will present the slides that are
attached as Exhibit 99.1 to the Current Report on Form
8-K,
which are incorporated herein by reference.
The information in this Item 7.01 of this Current Report on Form
8-K,
including Exhibit 99.1, is
being furnished pursuant to Item 7.01 and shall not be deemed filed for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the Exchange Act), or otherwise subject to the liabilities of that
section, and it shall not be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or under the Exchange Act, whether made before or after the date hereof, except as expressly set forth by specific reference in
such filing to this item of this report.
* * *
By filing this Current Report on Form
8-K,
including Exhibit 99.1, and furnishing this information,
the Company makes no admission as to the materiality of any information in this report. The information contained in this report is intended to be considered in the context of the Companys filings with the Securities and Exchange Commission
(SEC) and other public announcements that the Company makes, by press release or otherwise, from time to time. The Company undertakes no duty or obligation to publicly update or revise the information contained in this report, although
it may do so from time to time as its management believes is appropriate. Any such updating may be made through the filing of other reports or documents with the SEC, through press releases or through other public disclosure.
Orexigen cautions you that statements included in this report that are not a description of historical facts are forward-looking statements.
Words such as believes, anticipates, plans, expects, indicates, will, should, intends, potential, suggests, assuming,
designed and similar expressions are intended to identify
forward-looking
statements. These statements are based on the Companys current beliefs and expectations. These
forward-looking
statements include statements regarding: the potential success of marketing and commercialization efforts for Contrave
®
in the United States;
the potential for Contrave and Mysimba
TM
to achieve commercial success globally, including through potential partnership arrangements outside the United States, and the potential timing of related
regulatory filings; the Companys future financial and sales projections, including future expectations regarding net sales, cash operating expense and market share, its expectation for profitable operations by 2019 and its sales growth
projections through 2019; and the status of various strategic plans and initiatives. The inclusion of financial modeling,
forward-looking
statements and potential financing and transaction plans and terms
should not be regarded as a representation by Orexigen that any of its plans will be achieved. Actual results may differ materially from those expressed or implied in this report due to the risk and uncertainties inherent in the Orexigen business,
including, without limitation: the potential that the marketing and commercialization of Contrave/Mysimba will not be successful; the Companys ability to obtain and maintain partnerships and the ability of it or its partners to maintain
marketing authorization globally; the Companys ability to adequately inform consumers about Contrave; the Companys ability to successfully commercialize Contrave with a specialty sales force in the United States; the capabilities and
performance of various third parties on which it relies for a number of activities related to the manufacture, development and commercialization of Contrave/Mysimba; the estimates of the capacity of manufacturing and the Companys ability to
secure additional manufacturing capabilities; the Companys ability to successfully complete the post-marketing requirement studies for Contrave; the therapeutic and commercial value of Contrave/Mysimba; competition in the global obesity
market, particularly from existing therapies; the Companys failure to successfully acquire, develop and market additional product candidates or approved products; the Companys ability to obtain and maintain global intellectual property
protection for Contrave and Mysimba; the potential for a Delaware court to determine that one or more of the Companys patents is not valid or that Actavis proposed generic product is not infringing each of the patents at issue; other
legal or regulatory proceedings
against Orexigen, as well as potential reputational harm, as a result of misleading public claims about Orexigen; the Companys ability to maintain sufficient capital to fund its operations
for the foreseeable future; the Companys ability to satisfy covenants in the indentures for its outstanding indebtedness, including one requirement that the Company generate consolidated net product sales of least $100 million for fiscal
2017; the Companys ability to satisfy the applicable listing standards of the NASDAQ Global Market; and other risks described in Orexigens filings with the Securities and Exchange Commission. You are cautioned not to place undue reliance
on these
forward-looking
statements, which speak only as of the date hereof, and Orexigen undertakes no obligation to revise or update this report to reflect events or circumstances after the date hereof.
Further information regarding these and other risks is included under the heading Risk Factors in Orexigens Quarterly Report on Form
10-Q,
which was filed with the Securities and Exchange
Commission on August 9, 2017 and its other reports, which are available from the SECs website (www.sec.gov) and on Orexigens website (www.orexigen.com) under the heading Investors. All
forward-looking
statements are qualified in their entirety by this cautionary statement. This caution is made under the safe harbor provisions of Section 21E of the Private Securities Litigation Reform
Act of 1995.