Item 7.01.
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Regulation FD Disclosure.
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Beginning on January 9, 2017, representatives of
Orexigen Therapeutics, Inc. (the Company or Orexigen) began presenting to and conducting meetings with investors, analysts and others. During these presentations and meetings, the Company presented the slides that were
attached as Exhibit 99.1 to the Current Report on Form
8-K
that was filed by the Company with the U.S. Securities and Exchange Commission on January 9, 2017 (the Slides). The Company revised
the Slides and, beginning on January 12, 2017, representatives of the Company will present the slides attached as Exhibit 99.1 to this Current Report on Form
8-K,
which is 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
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 Orexigens current beliefs and expectations. These
forward-looking
statements include statements regarding: the potential success of marketing and commercialization of Contrave in the United States, including the recently-launched patient-focused marketing campaign; the potential for Contrave and Mysimba
®
to achieve commercial success globally; the potential for Orexigen and its partners to obtain regulatory approvals for Contrave and Mysimba in additional markets outside the United States; the
ability of Orexigen to enter into successful partnership arrangements for Contrave/Mysimba in additional territories outside the United States; the potential for Orexigen to achieve commercial success for Contrave in the United States without a
partner; the sales force capacity, effectiveness and efficiency for commercialization of Contrave in the United States; the Companys strategic plans and initiatives; Orexigens ability to manage its expenses, including by implementing a
CVOT that achieves significant cost savings; the potential to acquire, develop and market additional product candidates or approved products; Orexigens preclinical development plans and ability to perform
IND-enabling
studies successfully; and
on-going
patent litigation related to Contrave. The inclusion of financial modeling,
forward-looking
statements and potential 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 presentation 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,
particularly, with respect to Contrave, in the U.S. following the launch of the patient-focused marketing campaign; the Companys ability to obtain and maintain partnerships and marketing authorization globally; our ability to adequately inform
consumers about
Contrave; our ability to successfully commercialize Contrave with a specialty sales force in the United States; our ability to successfully complete the post-marketing requirement studies for
Contrave; the capabilities and performance of various third parties on which we rely for a number of activities related to the manufacture, development and commercialization of Contrave/Mysimba; the therapeutic and commercial value of
Contrave/Mysimba; competition in the global obesity market, particularly from existing and generic therapies; the Companys failure to successfully acquire, develop and market additional product candidates or approved products; the estimates of
the capacity of manufacturing and the companys ability to secure additional manufacturing capabilities; our ability to obtain and maintain global intellectual property protection for Contrave and Mysimba; legal or regulatory proceedings
against Orexigen, as well as potential reputational harm, as a result of misleading public claims about Orexigen; our ability to maintain sufficient capital to fund our operations for the foreseeable future; the potential for a Delaware court to
determine that one or more of the patents are not valid or that Actavis proposed generic product is not infringing each of the patents at issue; 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 news release 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
filed
with the Securities and Exchange Commission on November 7, 2016 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