Orexigen Therapeutics Reports Financial Results for the Fourth Quarter and Year Ended December 31, 2012

  Orexigen Therapeutics Reports Financial Results for the Fourth Quarter and
                         Year Ended December 31, 2012

PR Newswire

SAN DIEGO, March 13, 2013

SAN DIEGO, March 13, 2013 /PRNewswire/ -- Orexigen^® Therapeutics, Inc.
(Nasdaq: OREX), a biopharmaceutical company focused on the treatment of
obesity, today announced financial results for the fourth quarter and year
ended December 31, 2012.

Three months ended December 31, 2012
For the three months ended December 31, 2012, Orexigen reported a net loss of
$32.5 million, or $0.41 per share, as compared to a net loss of $4.3 million,
or $0.09 per share, for the fourth quarter of 2011.

Total operating expenses for the fourth quarter of 2012 were $33.3 million
compared to $5.2 million for the fourth 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.

Year ended December 31, 2012
For the year ended December 31, 2012, Orexigen reported a net loss of $90.1
million, or $1.27 per share, as compared to a net loss of $28.1 million, or
$0.58 per share, for 2011.

Total operating expenses for 2012 were $93.7 million compared to $32.3 million
for 2011. This overall increase in operating expenses reflects an increase in
research and development expenses associated with the conduct of the Light
Study.

As of December 31, 2012, Orexigen had $78.3 million in cash and cash
equivalents and an additional $59.1 million in marketable securities, for a
total of $137.4 million. Cash burn for 2013 is projected to be between $70
million and $85 million with total burn dependent on the timing of the Light
Study interim analysis and associated pre-launch expenses.

"I am extremely proud of the work our team accomplished in 2012 to expedite
enrollment of the Light Study, and our focus is now on 2013 which has the
potential to be a pivotal year for Orexigen," said Michael Narachi, CEO of
Orexigen. "A successful primary care launch is a large and complex
undertaking, and as such we are working with our partner Takeda on detailed
commercialization plans for Contrave while simultaneously conducting the Light
Study according to very high standards."

Product candidates update:

  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 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.

  In January, the Division of Metabolism and Endocrinology Products (DMEP) at
  the FDA proposed an NDA resubmission procedure that would allow the
  independent Data Monitoring Committee's summary report of the Light Study
  interim analysis to form the basis of the resubmission of the Contrave NDA.
  The complete clinical study report (CSR) for the interim analysis, which
  would ordinarily form the basis for the NDA resubmission filing, would be
  supplied to the FDA during the review within 60 days of the NDA
  resubmission.

  In February, Orexigen initiated enrollment and randomized 242 patients into
  the Ignite Study. The Ignite Study is an open-label clinical trial designed
  to provide additional information regarding the real world weight loss
  potential of Contrave in combination with a commercially available
  comprehensive lifestyle intervention program, compared to patients who
  receive usual care of diet and exercise advice from the study site staff but
  who do not receive Contrave. The primary endpoint for this trial is change
  in body weight after 26 weeks. Orexigen anticipates receiving results from
  the Ignite Study by year-end 2013.

  oEmpatic™, 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 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 fourth quarter and full year 2012 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 34404715. 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 timing of the
interim analysis and resubmission of the Contrave NDA, the rate of MACE in
the Light Study, the timing of approval for Contrave, the submission of a
Contrave 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 usage for the year 2013, 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 or analyses (such as the interim analysis) may
not be predictive of future results in the Light Study or Phase 3 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 November 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 BrewLIfe
(858) 875-8629                                        (510) 703-9491



Orexigen Therapeutics, Inc.
Balance Sheets
(In thousands, except share and par value amounts)
                                        December 31,         December 31,
                                        2012                 2011
Assets
Current assets:
Cash and cash equivalents              $            $      
                                        78,332               101,749
Investment securities,                  59,071               45,844
available-for-sale
Prepaid expenses and other current      1,491                1,126
assets
Total current assets                   138,894              148,719
Property and equipment, net            83                   439
Restricted cash                        177                  542
Total assets                           $             $      
                                        139,154              149,700
Liabilities and stockholders' equity
Current liabilities:
Accounts payable and accrued expenses  $           $        
                                        8,156                4,122
Clinical trial accrual                  13,529               155
Deferred revenue, current portion      3,429                3,429
Total current liabilities              25,114               7,706
Deferred revenue, less current portion 38,571               42,000
Other long-term liabilities            -                    288
Commitments and contingencies
Stockholders' equity:
Preferred stock, $.001 par value,
10,000,000 shares
 authorized at December 31, 2012 and
2011; no
 shares issued and outstanding at
 December 31, 2012 and 2011                    -                   -
Common stock, $.001 par value,
300,000,000
 shares authorized at December 31,
2012 and
 2011;
 84,413,670 and 61,285,514 shares
issued and outstanding
 at December 31, 2012 and 2011,      84                   61
respectively
Additional paid-in capital             512,174              446,357
Accumulated other comprehensive income  15                   (2)
(loss)
Accumulated deficit                     (436,804)            (346,710)
Total stockholders' equity             75,469               99,706
Total liabilities and stockholders'     $             $      
equity                                 139,154              149,700



Orexigen Therapeutics, Inc.
Statements of Operations
(In thousands, except per share amounts)
(Unaudited)
                                 Three Months Ended    Twelve Months Ended
                                 December 31,          December 31,
                                 2012        2011       2012        2011
Revenues:
Collaborative agreement         $ 857       $ 857      $ 3,428     $ 3,428
License revenue                   0           0        0           971
Total revenues                  857         857        3,428       4,399
Operating expenses:
Research and development        28,252      1,543      73,680      12,780
General and administrative      5,082       3,632      19,987      19,502
Total operating expenses        33,334      5,175      93,667      32,282
Loss from operations            (32,477)    (4,318)    (90,239)    (27,883)
Other income (expense):
Interest income                 22          11         147         46
Interest expense                -           -          (2)         (221)
Total other income (expense)    22          11         145         (175)
Net loss                        $ (32,455)  $ (4,307)  $ (90,094)  $ (28,058)
Net loss per share - basic and   $ (0.41)    $ (0.09)   $ (1.27)    $ (0.58)
diluted
Shares used in computing net
loss per share – basic and       78,952      49,048     70,739      48,273
diluted

SOURCE Orexigen Therapeutics, Inc.

Website: http://www.orexigen.com
 
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