OREXIGEN THERAPEUTICS, INC. (NASDAQ:OREX) Files An 8-K Regulation FD Disclosure
Item7.01.
| Regulation FD Disclosure. |
Beginning on March7, 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 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 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 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; 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 Companys ability
to
successfully complete the post-marketing requirement studies for
Contrave; the capabilities and performance of various third
parties on which Orexigen relies 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; the Companys 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. |
|
Exhibit No. |
Description |
|
| 99.1 | Slide Presentation, dated March 7, 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 +0.03 at 4.12 with 169,230 shares trading hands.