Orexigen Therapeutics Reports Financial Results for the Third Quarter Ended September 30, 2012

 Orexigen Therapeutics Reports Financial Results for the Third Quarter Ended
                              September 30, 2012

PR Newswire

SAN DIEGO, Nov. 7, 2012

SAN DIEGO, Nov. 7, 2012 /PRNewswire/ --Orexigen^® Therapeutics, Inc. (Nasdaq:
OREX), a biopharmaceutical company focused on the treatment of obesity, today
announced financial results for the third quarter of 2012. For the three
months ended September 30, 2012, Orexigen reported a net loss of $30.6
million, or $0.44 per share, as compared to a net loss of $4.6 million, or
$0.10 per share, for the third quarter of 2011. As of September 30, 2012,
Orexigen had $56.1 million in cash and cash equivalents and an additional
$52.2 million in marketable securities, for a total of $108.3 million. In
October 2012, Orexigen completed a follow-on public offering of common stock
raising net proceeds of approximately $56.5 million.

Total operating expenses for the third quarter of 2012 were $31.5 million
compared to $5.4 million for the third quarter of 2011. This overall increase
in operating expenses reflects an increase in research and development
expenses associated with the conduct of the Light Study, the Contrave®
cardiovascular outcomes trial.

Given the accelerated and higher enrollment in the Light Study, Orexigen
expects some clinical trial costs originally projected for 2013 to now be
incurred in 2012 and a commensurate reduction in anticipated clinical trial
costs for 2013. The Company projects the use of $70 million to $75 million in
cash this year, resulting in a year end balance of cash, cash equivalents and
marketable securities of between $130 million to $135 million.

"We expect 2013 to be a pivotal year for our company," said Michael Narachi,
CEO of Orexigen. "U.S. approval of Contrave could come as early as late 2013,
and we are working closely with our North American partner, Takeda, to prepare
for commercialization. Outside the U.S., we expect to submit an application
for marketing authorization in Europe and to negotiate a partnership for the
rest-of-world rights to Contrave and Empatic™. The additional capital we
raised last month better positions us to execute on our corporate goals."

Product candidate update:
Contrave (32 mg naltrexone sustained-release (SR)/360 mg bupropion SR) for the
treatment of obesity: Orexigen has enrolled more than 8,000 patients in the
Light Study. The primary objective of the double blind, randomized, placebo
controlled Light Study, which Orexigen is conducting under a Special Protocol
Assessment with the FDA (United States Food and Drug Administration), is to
rule out excess cardiovascular risk in overweight and obese patients receiving
Contrave. Orexigen now expects to randomize approximately 9,000 patients into
the study. An interim analysis and New Drug Application resubmission is
planned once at least 87 major adverse cardiovascular events (MACE) have
occurred, which is anticipated in the second or third quarter of 2013.

In late October, Orexigen announced that it had received a response to a
formal dispute resolution request (FDRR) from the United States FDA's Center
for Drug Evaluation and Research (CDER). The response indicated that CDER
highly supports further discussions regarding a faster path to resubmission of
the Contrave New Drug Application (NDA). Orexigen plans to explore with the
FDA the possibility of resubmitting the Contrave NDA in advance of the interim
data from the Light Study. Under this scenario data from the planned interim
analysis would be provided during the anticipated review period. Although
procedural details need to be addressed, the Company is optimistic that these
discussions could result in a faster path to resubmission of the Contrave NDA.

Empatic, a fixed dose combination of bupropion SR and zonisamide SR, for the
treatment of obesity: The Company is communicating with the FDA regarding
Empatic Phase III clinical development plans and to reconfirm with the Agency
that reassuring results from the Light Study may sufficiently characterize the
cardiovascular risk of Empatic, so long as the weight loss and blood pressure
and heart rate data for Empatic are similar to or more favorable than those of
Contrave. Orexigen owns worldwide rights to Empatic.

Conference Call Today at 5 p.m. Eastern Time (2:00 p.m. Pacific Time)
The Orexigen management team will host a teleconference and webcast to discuss
the third quarter 2012 financial results and recent business highlights. The
live call may be accessed by phone by calling 888-895-5479 (US) or
847-619-6250 (International), participant code 33664518. The webcast can be
accessed live on the investor relations section of the Orexigen web site at
http://www.orexigen.com, and will be archived for 14 days following the call.

About Orexigen Therapeutics
Orexigen Therapeutics, Inc. is a biopharmaceutical company focused on the
treatment of obesity. The Company's lead product candidate is Contrave, which
has completed Phase III clinical trials and for which a New Drug Application
has been submitted and reviewed by the FDA. The Company has also reached
agreement with the FDA on a Special Protocol Assessment (SPA) for the Light
Study, the Contrave cardiovascular outcomes trial. The Company's other product
candidate, Empatic, has completed Phase II clinical trials. Further
information about the Company can be found at www.orexigen.com.

Forward-Looking Statements
Orexigen cautions you that statements included in this press release 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 Company's current beliefs and expectations. These
forward-looking statements include statements regarding the timing of
enrollment and rate of MACE in the Light Study, the ability to gain agreement
with FDA on the procedural details for a Contrave NDA resubmission in advance
of the Light Study interim data, the timing of the subsequent resubmission of
the NDA for Contrave, the timing of approval for Contrave, the submission of
an application for marketing authorization in Europe and the negotiation of a
partnership for the rest-of-world rights to Contrave and Empatic, the expected
cash balance at the end of 2012, the expected cash usage for the year 2012,
the development of Empatic and the communication with the FDA, the possibility
that a cardiovascular outcomes trial will be needed for Empatic, and the
commercial potential of Contrave and Empatic. The inclusion of forward-looking
statements should not be regarded as a representation by Orexigen that any of
its plans will be achieved. Actual results may differ from those set forth in
this release due to the risk and uncertainties inherent in the Orexigen
business, including, without limitation: Orexigen's ability to conduct the
Light Study and the progress and timing thereof; Orexigen's ability to
demonstrate in the Light Study that the risk of MACE in overweight and obese
subjects treated with Contrave does not adversely affect the product
candidate's benefit-risk profile; the potential that earlier clinical trials
may not be predictive of future results in the Light Study or Phase III trials
for Empatic; the Special Protocol Assessment (SPA) is not binding on the FDA
if public health concerns unrecognized at the time the SPA agreement was
entered into become evident, other new scientific concerns regarding product
safety or efficacy arise, or if Orexigen fails to comply with the agreed upon
trial protocol; the potential for the FDA to not approve Contrave or Empatic;
the potential for early termination of the collaboration agreement between
Orexigen and Takeda; the costs and time required to complete additional
clinical, non-clinical or other requirements prior to any resubmission of an
NDA for Contrave or an NDA for Empatic; the therapeutic and commercial value
of Contrave or Empatic; Orexigen's ability to maintain sufficient capital; and
other risks described in the Company's 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 Orexigen's Quarterly Report on Form 10-Q filed with the Securities and
Exchange Commission August 9, 2012 and which is available from the SEC's
website (www.sec.gov) and on Orexigen's website (www.orexigen.com) under the
heading "Investor Relations." 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.



Orexigen Contact:                                     Media Contact:
McDavid Stilwell                                      Denise Powell
VP, Corporate Communications and Business Development WCG
(858) 875-8629                                        (510) 703-9491



 Orexigen
Therapeutics, Inc.

Balance Sheets
 (In thousands, except share
and par value amounts)
                                       September 30,             December 31,
                                       2012                      2011
                                       (Unaudited)
Assets
Current assets:
Cash and cash equivalents             $  56,057                $ 101,749
Investment securities,                 52,227                    45,844
available-for-sale
Prepaid expenses and other current     1,507                     1,126
assets
Total current assets                  109,791                   148,719
Property and equipment, net           166                       439
Restricted cash                       177                       542
Total assets                          $ 110,134                $ 149,700
Liabilities and stockholders' equity
Current liabilities:
Accounts payable and accrued expenses $  17,775                $  4,277
Deferred revenue, current portion     3,429                     3,429
Total current liabilities             21,204                    7,706
Deferred revenue, less current         39,429                    42,000
portion
Other long-term liabilities           140                       288
Commitments and contingencies
Stockholders' equity:
Preferred stock, $.001 par value,
10,000,000 shares
 authorized at September 30, 2012
and December 31, 2011; no
 shares issued and outstanding at
 at September 30, 2012 and December -                         -
31, 2011
Common stock, $.001 par value,
300,000,000 shares
 authorized at September 30, 2012
and December 31, 2011;
 70,727,827 and 61,285,514 shares
issued and outstanding
 at September 30, 2012 and December 71                        61
31, 2011, respectively
Additional paid-in capital            453,624                   446,357
Accumulated other comprehensive income 15                        (2)
(loss)
Accumulated deficit                    (404,349)                 (346,710)
Total stockholders' equity            49,361                    99,706
Total liabilities and stockholders'    $ 110,134                $ 149,700
equity



Orexigen Therapeutics, Inc.
Statements of Operations
(In thousands, except per share amounts)
(Unaudited)
                           Three Months Ended      Nine Months Ended
                           September 30,           September 30,
                           2012         2011        2012          2011
Revenues:
Collaborative agreement   $   857    $   857   $  2,571    $  2,571
License revenue           -            -           -             971
Total revenues            857          857         2,571         3,542
Operating expenses:
Research and development  25,806       1,539       45,428        11,237
General and                5,651        3,907       14,905        15,870
administrative
Total operating expenses  31,457       5,446       60,333        27,107
Loss from operations      (30,600)     (4,589)     (57,762)      (23,565)
Other income (expense):
Interest income           36           9           125           35
Interest expense          -            -           (2)           (221)
Total other income         36           9           123           (186)
(expense)
Net loss                  $ (30,564)   $ (4,580)  $ (57,639)    $ (23,751)
Net loss per share - basic $  (0.44)  $  (0.10)  $   (0.85)  $   (0.49)
and diluted
Shares used in computing
net loss per share – basic 70,152       48,085      67,982        48,012
and diluted



SOURCE Orexigen Therapeutics, Inc.

Website: http://www.orexigen.com
 
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