Orexigen Therapeutics Reports Financial Results for the First Quarter Ended March 31, 2013

 Orexigen Therapeutics Reports Financial Results for the First Quarter Ended
                                March 31, 2013

PR Newswire

SAN DIEGO, May 8, 2013

SAN DIEGO, May 8, 2013 /PRNewswire/ --Orexigen^® Therapeutics, Inc. (Nasdaq:
OREX), a biopharmaceutical company focused on the treatment of obesity, today
announced financial results for the first quarter ended March 31, 2013.

For the three months ended March 31, 2013, Orexigen reported a net loss of
$19.4 million, or $0.21 per share, as compared to a net loss of $10.4 million,
or $0.16 per share, for the first quarter of 2012.

Total operating expenses for the first quarter of 2013 were $20.3 million
compared to $11.3 million for the first quarter of 2012. 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. As of March 31, 2013, Orexigen had $67.1
million in cash and cash equivalents and an additional $47.5 million in
marketable securities, for a total of $114.6 million.

"In 2013 we are focused on strong execution of the Light Study, preparation
for the interim analysis, and the subsequent resubmission of the Contrave
NDA," said Michael Narachi, CEO of Orexigen.

Narachi continued: "It has been gratifying to see recent recognition of the
role weight loss should play in the management of diabetes. In April the
American Academy of Clinical Endocrinologists published the Comprehensive
Diabetes Management Algorithm, 2013 which positions management of obesity via
lifestyle modification or, as appropriate, anti-obesity drug therapies as an
integrated approach to the management of prediabetes, glycemic control, and
cardiovascular risk."

Product candidates:
Contrave (32 mg naltrexone sustained-release (SR)/360 mg bupropion SR) for the
treatment of obesity: In 2012, Orexigen screened more than 13,000 patients,
enrolled more than 10,400 and ultimately completed recruitment of the Light
Study with approximately 8,900 randomized patients. 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. An interim analysis and NDA
resubmission is planned once the independent Data Monitoring Committee (DMC)
has determined that sufficient information has been gathered for the analysis
that would include at least 87 adjudicated major adverse cardiovascular events
(MACE). Orexigen enrolled into the Light Study a patient population that the
company predicted would have an annualized MACE rate between 1% and 2%.
Orexigen is preparing to be ready to conduct the interim analysis and resubmit
the Contrave NDA in 2013. However, if the observed MACE rate is at or near
the low end of the range of 1% to 2%, the resubmission of the Contrave NDA may
not occur until early 2014.

Orexigen has licensed North American commercial rights to Takeda
Pharmaceuticals. Orexigen owns Contrave rights throughout the rest of the
world and intends to license commercial rights outside North America.

Empatic™, a fixed dose combination of bupropion SR and zonisamide SR, for the
treatment of obesity: In a series of discussions with the FDA on the continued
development of Empatic, the FDA stated that Phase 3 data for Empatic may be
sufficient to support submission of an NDA without data from a cardiovascular
outcomes trial. The FDA indicated that as long as the placebo-subtracted
changes in body weight, blood pressure and heart rate for Empatic are similar
to or more favorable than the placebo-subtracted changes observed with
Contrave, and there are no signals of cardiovascular concern in the Empatic
development program, reassuring results of a cardiovascular outcomes trial
with Contrave will be sufficient. In addition, while the FDA reiterated the
belief that the teratogenicity potential for zonisamide is very concerning,
the FDA will allow Phase 3 studies of Empatic to include women of childbearing
potential who have a Body Mass Index that meets the FDA definition of
overweight (>27kg/m^2) in the presence of at least one weight-related
comorbidity.

Orexigen owns worldwide rights to Empatic. Prior to initiating Phase 3 studies
of Empatic, the Company plans to seek a collaboration partner to help fund
further clinical development and, if approved, commercialization.

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 first quarter 2013 financial results and recent business highlights. The
live call may be accessed by phone by calling (888) 895-5479 (domestic) or
(847) 619-6250 (international), participant code 34792506. 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 3 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 2 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 Special Protocol
Assessment, or SPA, and the protocol for the Contrave^® cardiovascular
outcomes trial, or Light Study; the potential for, and timing of, the accrual
and adjudication of MACE; the expected retention rate for patients in the
Light Study; the probability of success of the Light Study; the potential for,
and timing of, resubmission and approval of a NDA for Contrave based on
interim results of the Light Study; the possibility of resubmitting the
Contrave NDA with the independent DMC report on the interim analysis and
without the clinical study report for the interim analysis; the potential to
accelerate the timing of the review of the Contrave NDA; the safety and
effectiveness of Contrave; the potential for past Contrave clinical trials to
predict the outcome of future Contrave clinical trials; the potential to enter
into a collaborative partnership to fund Phase III development and, if
approved, commercialization of Empatic™; the potential for the FDA to approve
an NDA for Empatic without requiring data from a cardiovascular outcomes trial
in addition to the data obtained from the Light Study; and the use of
pharmacotherapy to treat obesity. 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 materially from those expressed or
implied in this release due to the risk and uncertainties inherent in the
Orexigen business, including, without limitation: the possibility that the FDA
determines not to initiate review of the Contrave NDA until it has received
the complete study report for the interim analysis; the 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; Orexigen's ability to conduct the Light Study and
the progress and timing thereof, including risks associated with enrolling and
retaining the appropriate patients in the Light Study; Orexigen's ability to
demonstrate in the Light Study that the risk of MACE in overweight and obese
patients treated with Contrave does not adversely affect Contrave's
benefit-risk profile; the potential that earlier clinical trials may not be
predictive of future results in the Light Study; the potential for the FDA to
not approve Contrave even after the resubmission with the MACE data; the
potential for the Light Study to cost more than what is projected; the
potential for early termination of Orexigen's North American collaboration
agreement with Takeda Pharmaceutical Company Limited; the costs and time
required to complete additional clinical, non-clinical or other requirements
prior to any resubmission of the Contrave NDA; the therapeutic and commercial
value of Contrave; Orexigen's ability to maintain sufficient capital to fund
our operations through potential approval of Contrave in 2014; the development
plan for Empatic; Orexigen's ability to enter into a collaborative partnership
for Empatic on acceptable terms, if at all; and other risks described in
Orexigen'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 Annual Report on Form
10-K filed with the Securities and Exchange Commission March 14, 2013 and its
other reports, which are 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 BrewLIfe
(858) 875-8629                                        (510) 703-9491



Orexigen Therapeutics, Inc.
Balance Sheets
(In thousands, except share and par value amounts)
                                        March 31,            December 31,
                                        2013                 2012
                                        (Unaudited)
Assets
Current assets:
Cash and cash equivalents              $            $       
                                        67,054               78,332
Investment securities,                  47,502               59,071
available-for-sale
Prepaid expenses and other current      1,998                1,491
assets
Total current assets                   116,554              138,894
Property and equipment, net            7                    83
Restricted cash                        177                  177
Total assets                           $             $      
                                        116,738              139,154
Liabilities and stockholders' equity
Current liabilities:
Accounts payable and accrued expenses  $           $        
                                        6,671                8,156
Accrued clinical trial expenses         10,312               13,529
Deferred revenue, current portion      3,429                3,429
Total current liabilities              20,412               25,114
Deferred revenue, less current portion 37,714               38,571
Other long-term liabilities            -                    -
Commitments and contingencies
Stockholders' equity:
Preferred stock, $.001 par value,
10,000,000 shares
 authorized at March 31, 2013 and
December 31, 2012; no
 shares issued and outstanding at
 March 31, 2013 and December 31,               -                   -
2012
Common stock, $.001 par value,
300,000,000
 shares authorized at March 31, 2013
and
 December 31, 2012 and;
 92,641,567 and 84,413,670 shares
issued and outstanding
 at March 31, 2013 and December 31,  93                   84
2012, respectively
Additional paid-in capital             514,678              512,174
Accumulated other comprehensive income  13                   15
(loss)
Accumulated deficit                     (456,172)            (436,804)
Total stockholders' equity             58,612               75,469
Total liabilities and stockholders'     $             $      
equity                                 116,738              139,154







Orexigen Therapeutics, Inc.
Statements of Operations
(In thousands, except per share amounts)
(Unaudited)
                                                        Three Months Ended
                                                        March 31,
                                                        2013        2012
Revenues:
Collaborative agreement                                $ 857       $ 857
License revenue                                          0           0
Total revenues                                         857         857
Operating expenses:
Research and development                               15,155      6,800
General and administrative                             5,100       4,512
Total operating expenses                               20,255      11,312
Loss from operations                                   (19,398)    (10,455)
Other income (expense):
Interest income                                        31          43
Interest expense and other                              (1)         (2)
Total other income (expense)                           30          41
Net loss                                               $ (19,368)  $ (10,414)
Net loss per share - basic and diluted                 $ (0.21)    $ (0.16)
Shares used in computing net loss per share – basic     90,336      65,989
and diluted





SOURCE Orexigen Therapeutics, Inc.

Website: http://www.orexigen.com
 
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