OREXIGEN THERAPEUTICS, INC. (NASDAQ:OREX) Files An 8-K Regulation FD Disclosure
Item7.01. Regulation FD Disclosure.
Beginning on February14, 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 hereto as Exhibit 99.1
to this Current Report on Form 8-K, which are incorporated herein
by reference.
The information in this Item7.01 of this Current Report on Form
8-K, including Exhibit 99.1, is being furnished to Item7.01 and
shall not be deemed filed for purposes of Section18 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 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; and
Orexigens preclinical development plans and ability to perform
IND-enabling studies successfully. 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; 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 November7,
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 Section21E of
the Private Securities Litigation Reform Act of 1995.
Item9.01 Financial Statements and Exhibits.
(d) Exhibits.
|
ExhibitNo. |
Description |
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| 99.1 | Slide Presentation, dated February 9, 2017 |
About OREXIGEN THERAPEUTICS, INC. (NASDAQ:OREX)
Orexigen Therapeutics, Inc. is a biopharmaceutical company. The Company is focused on the treatment of obesity. The Company’s product, Contrave, is approved in the United States by the United States Food and Drug Administration as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in adults with an initial body mass index (BMI) of 30 kilograms per square meter or greater (obese) or 27 kilograms per square meter or greater (overweight) in the presence of a weight-related comorbid condition. Contrave is a combination of generic drug components, each of which has received regulatory approval for other indications and has been commercialized in the United States and in a range of member countries of the European Union. Contrave regulates appetite and energy expenditure through central nervous system (CNS) activity. Contrave is a fixed dose combination of bupropion hydrochloride (HCl) extended release (ER) and naltrexone HCl ER. OREXIGEN THERAPEUTICS, INC. (NASDAQ:OREX) Recent Trading Information
OREXIGEN THERAPEUTICS, INC. (NASDAQ:OREX) closed its last trading session up +0.24 at 4.82 with 775,401 shares trading hands.