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Three months ended December 31, 2008
As of December 31, 2008, Orexigen held $45.5 million in cash and cash equivalents and an additional $40.7 million in investment securities, available-for-sale.
For the three months ended December 31, 2008, Orexigen reported a net loss of $22.1 million, or $0.64 per share attributable to common stockholders, as compared to a net loss of $19.4 million, or $0.72 per share attributable to common stockholders, for the same period in 2007.
Total operating expenses for the three months ended December 31, 2008 were $22.1 million compared to $20.3 million for the same period in 2007. The increased operating expenses were due primarily to an increase in general and administrative expenses of $1.3 million due to increases in non-cash stock-based compensation expense, salaries and personnel related costs, facilities expenses and consulting activities.
Year ended December 31, 2008
For the year ended December 31, 2008, Orexigen reported a net loss of $93.2 million, or $2.76 per share attributable to common stockholders, as compared to a net loss of $57.8 million, or $3.08 per share attributable to common stockholders, for 2007.
Total operating expenses for the year ended December 31, 2008 were $94.9 million compared to $60.9 million for 2007. The increased operating expenses were due primarily to a $29.0 million increase in research and development expenses in connection with the Company's Contrave(R) Phase 3 clinical trials, related proprietary product formulation work and increased consulting activities. In addition, general and administrative expenses increased by $5.0 million due primarily to increases in non-cash stock-based compensation expense, salaries and personnel related costs, facilities expenses and consulting activities.
"Orexigen has made significant progress in the past year," said Eckard Weber, M.D., Interim President and CEO of Orexigen. "We executed a successful equity financing, completed enrollment in our four Phase 3 clinical trials for Contrave and recently disclosed what we believe are promising results in the first of our four Contrave Phase 3 clinical trials. In addition, we were issued two key patents by the U.S. Patent and Trademark Office, which we believe will extend protection for Contrave through at least 2024."
Recent Highlights
Contrave
-- The Company announced that NB-302, the first of four Phase 3 clinical
trials of Contrave, met its co-primary and key secondary endpoints,
showing a significant reduction in body weight, improvements in markers
of cardiovascular risk and reductions in selected food craving measures.
In this trial, which included an intensive diet and exercise behavior
modification regimen, obese patients treated with Contrave, based on
intent-to-treat and completer analyses, lost an average of 20.3 pounds
to 25.0 pounds, or 9.3% to 11.5% of their baseline body weight, versus
11.0 pounds to 16.0 pounds, or 5.1% to 7.3% of baseline body weight, for
patients treated with placebo. In addition, in the categorical weight
reduction analysis, the percentage of patients who lost greater than or
equal to 10% of their body weight was 41.5% in the Contrave group
compared to 20.2% in the placebo group. All of these findings were
highly statistically significant (p<0.001). Contrave was generally
well tolerated by patients, with an overall safety profile that was
consistent with its individual components, naltrexone and bupropion.
The most frequently observed treatment-emergent adverse events for
patients on study drug were nausea, headache, constipation and
dizziness. The overall discontinuation rate due to adverse events was
25.9% for patients taking Contrave versus 13.0% for those taking
placebo. Treatment with Contrave was not associated with increases in
symptoms of depression, suicidality or worsening of mean blood pressure.
-- The Company has continued to make progress in the three other Phase 3
clinical trials of Contrave. The results of these trials, each of which
is designed to measure change in body weight 56 weeks after the start of
treatment, are expected to be announced in the third quarter of 2009.
Empatic(TM)
-- The Company initiated the second Phase 2b clinical trial of Empatic,
ZB-202. The trial is designed to build on the results from the previous
Phase 2b trial of Empatic, ZB-201. In the current trial, which measures
weight loss after 24 weeks of treatment, two different dosages of the
Empatic combination are being studied along with the individual
constituents, zonisamide and bupropion. The Company expects the results
of this Phase 2b clinical trial to be announced in the third quarter of
2009.
Other
-- The Company was issued two key patents by the U.S. Patent and Trademark
Office. These include the Weber/Cowley composition patent, which
extends coverage for Contrave until March 2025, and its companion
patent, the Weber/Cowley methods patent, which covers methods of
treating obesity with combinations of bupropion and naltrexone, the two
active agents in Contrave, through mid 2024.
-- In addition, the European Patent Office issued a Decision to Grant a
Patent covering compositions and uses of bupropion and naltrexone for
affecting weight loss. This patent extends protection for Contrave in
Europe until 2024.
-- The Company made a number of presentations of data at the Annual
Scientific Meeting of The Obesity Society in October. These included the
improvement of markers of metabolic and cardiovascular risk associated
with Contrave therapy in the NB-201 Phase 2b trial.
Conference Call Today at 5:00 p.m. Eastern Time (2:00 p.m. Pacific Time)
The Orexigen management team will host a teleconference and webcast to discuss the three months and year ended December 31, 2008 financial results and recent business highlights. The live call may be accessed by phone by calling (800) 860-2442 (domestic) or (412) 858-4600 (international). 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 development of pharmaceutical product candidates for the treatment of obesity. The Company's lead combination product candidates targeted for obesity are Contrave, which is in Phase 3 clinical trials, and Empatic, which is in the later stages of Phase 2 clinical development. Both product candidates take advantage of the Company's understanding of how the brain appears to regulate appetite and energy expenditure, as well as the mechanisms that come into play to limit weight loss over time. Each product candidate is designed to act on a specific group of neurons in the central nervous system with the goal of achieving appetite suppression and sustained weight loss. 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," "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 enrollment, timing and completion of clinical trials of Contrave and Empatic, the potential to obtain regulatory approval for, and effectively treat obesity with, Contrave and Empatic, and the scope and duration of protection of issued patents relating to 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: the final analyses of data from the NB-302 trial and other clinical trials of Contrave may produce negative or inconclusive results, or may be inconsistent with previously conducted clinical trials, and the FDA may not agree with the Company's interpretation of efficacy and safety results; the potential that earlier clinical trials may not be predictive of future results; Contrave or Empatic may not receive regulatory approval on a timely basis or at all; the FDA may require Orexigen to complete additional clinical, non-clinical or other requirements prior to the submission or the approval of NDAs for either product candidate; the potential for adverse safety findings relating to Empatic or Contrave to delay or prevent regulatory approval or commercialization, or result in product liability claims; the third parties on whom Orexigen relies to assist with the development programs for Contrave or Empatic, including clinical investigators, contract laboratories, clinical research organizations and manufacturing organizations, may not successfully carry out their contractual duties or obligations or meet expected deadlines, and the quality or accuracy of the data or materials generated by such third parties may be of insufficient quality to include in the Company's regulatory submissions; the ability of Orexigen and its licensors to obtain, maintain and successfully enforce adequate patent and other intellectual property protection of Contrave and Empatic; 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. 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 Therapeutics, Inc.
(a development stage company)
Balance Sheets
(In thousands, except share and par value amounts)
December 31, December 31,
2008 2007
---- ----
(Unaudited)
Assets
Current assets:
Cash and cash equivalents $45,451 $28,967
Investment securities,
available-for-sale 40,716 56,487
Prepaid expenses and
other current assets 1,184 2,471
----- -----
Total current assets 87,351 87,925
Property and equipment, net 2,059 924
Restricted cash 1,375 1,125
Other assets 1,123 1,346
----- -----
Total assets $91,908 $91,320
======= =======
Liabilities and stockholders' equity
Current liabilities:
Accounts payable $5,644 $4,114
Accrued expenses 13,166 4,340
Deferred revenue, current portion 88 88
Long-term debt, current portion 7,591 4,735
----- -----
Total current liabilities 26,489 13,277
Deferred revenue,
less current portion 1,058 1,147
Long-term debt,
less current portion 8,800 11,072
Other long-term liabilities 1,767 941
Commitments and contingencies
Stockholders' equity:
Preferred stock, $.001 par value,
10,000,000 shares authorized at
December 31, 2008 and 2007; no
shares issued and outstanding at
December 31, 2008 and 2007 - -
Common stock, $.001 par value,
100,000,000 shares authorized at
December 31,2008 and 2007;
34,433,322 and 26,982,601 shares
issued and outstanding at
December 31, 2008 and 2007,
respectively 34 27
Additional paid-in capital 253,782 171,571
Accumulated other
comprehensive income 153 220
Deficit accumulated during the
development stage (200,175) (106,935)
-------- --------
Total stockholders' equity 53,794 64,883
------ ------
Total liabilities and
stockholders' equity $91,908 $91,320
======= =======
Orexigen Therapeutics, Inc.
(a development stage company)
Statements of Operations
(In thousands, except per share amounts)
(Unaudited)
Period
from
September
12, 2002
Three Months Ended Year ended (Inception)
December December to
31, 31, December
------------- ------------- 31,
2008 2007 2008 2007 2008
---- ---- ---- ---- ----
Revenues:
Collaborative
agreement $- $- $- $- $174
License revenue 22 22 88 88 353
-- -- -- -- ---
Total revenues 22 22 88 88 527
Operating expenses:
Research and
development 17,526 17,038 79,261 50,253 169,118
General and
administrative 4,602 3,255 15,651 10,657 37,822
----- ----- ------ ------ ------
Total operating
expenses 22,128 20,293 94,912 60,910 206,940
------ ------ ------ ------ -------
Loss from
operations (22,106) (20,271) (94,824) (60,822) (206,413)
Other income
(expense):
Interest income 315 1,101 3,115 3,901 8,679
Interest expense (335) (250) (1,531) (846) (2,441)
---- ---- ------ ---- ------
Total other income
(expense) (20) 851 1,584 3,055 6,238
--- --- ----- ----- -----
Net loss (22,126) (19,420) (93,240) (57,767) (200,175)
Accretion to
redemption value
of redeemable
convertible
preferred stock - 1 - (10) (78)
Deemed dividend
of beneficial
conversion for
Series C
preferred
stock - - - - (13,860)
----- ----- ----- ----- -------
Net loss
attributable to
common
stockholders $(22,126) $(19,419) $(93,240) $(57,777)$(214,113)
======== ======== ======== ======== =========
Net loss per share
attributable to
common
stockholders -
basic and diluted $(0.64) $(0.72) $(2.76) $(3.08)
====== ====== ====== ======
Shares used in
computing net
loss per share
attributable to
common
stockholders -
basic and diluted 34,429 26,930 33,762 18,757
====== ====== ====== ======
SOURCE Orexigen Therapeutics, Inc.
http://www.orexigen.com
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