- Management to host call and webcast today at 5:00 p.m. Eastern to discuss
financial results and recent business highlights -
SAN DIEGO, Nov. 4 /PRNewswire-FirstCall/ -- Orexigen® Therapeutics, Inc.
(Nasdaq: OREX), a biopharmaceutical company focused on the treatment of
obesity, today announced unaudited financial results for the three months
ended September 30, 2009.
Three Months Ended September 30, 2009
As of September 30, 2009, Orexigen held $56.9 million in cash and cash
equivalents and an additional $50.9 million in investment securities,
available-for-sale. Together, these amounts total $107.8 million.
For the three months ended September 30, 2009, Orexigen reported a net loss of
$14.4 million, or $0.33 per share attributable to common stockholders,
compared to a net loss of $24.8 million, or $0.72 per share attributable to
common stockholders, for the comparable period in 2008.
Total operating expenses for the three months ended September 30, 2009, were
$14.2 million compared to $25.1 million for the comparable period in 2008.
The decreased operating expenses were due primarily to a decrease in research
and development expenses in connection with the completion of the Company's
Contrave® Phase 3 clinical trials, related proprietary product formulation
work and consulting activities totaling approximately $12.9 million. The
decrease was partly offset by an increase in costs incurred in connection with
the preparation of the Contrave NDA and an increase in salaries and personnel
related costs. In addition, general and administrative expenses increased
approximately $1.0 million due primarily to an increase in salaries and
personnel related costs, legal and accounting fees, recruiting expense and
facilities costs.
"The recent completion of the COR Phase 3 program and the Phase 2b trial of
Empatic(TM) were major milestones for Orexigen," said Mike Narachi, President
and CEO of Orexigen. "The results demonstrate the potential of these two
product candidates to help fill the current gap in obesity treatment by
providing physicians with useful pharmacologic options to address the varying
needs of this diverse patient population. We believe that Contrave, if
approved, has the potential to serve as the first-line treatment of obesity
for the majority of patients, while Empatic can be developed and positioned in
a highly complementary way."
Recent Highlights
Contrave
Orexigen announced new data from the COR-I, COR-II and COR-Diabetes trials at
Annual Scientific Meeting of The Obesity Society in late October. These new
data show that after completing 56 weeks of therapy with Contrave32 (bupropion
SR 360 mg/naltrexone SR 32 mg):
-- Approximately 34-48% of patients lost at least 10% of their baseline
body weight and approximately 17-23% lost at least 15%;
-- Significant improvements in markers of cardiometabolic risk, including
waist circumference, HDL and triglycerides were observed in Contrave
treated patients. Patients at higher risk for developing
cardiovascular
disease and diabetes demonstrated additional improvement in markers of
cardiometabolic risk such as waist circumference, HDL and
triglycerides;
-- In addition to the statistically significant improvements observed in
hemoglobin A1c (HbA1c) in obese patients with type 2 diabetes,
patients
who began the trial with a HbA1c level greater than 8% saw a mean
reduction of 1.1%, compared to 0.5% for the placebo group;
-- Patients reported an increased ability to control their eating and
resist food cravings; and
-- There was no evidence of increased abuse liability.
The most frequently observed treatment-emergent adverse events were nausea,
constipation and headache. Nausea was the leading adverse event resulting in
discontinuation; however, for the majority of patients experiencing nausea, it
was mild to moderate, transient and manageable.
The results from the successfully completed COR program of more than 4,500
patients exceed the FDA categorical efficacy benchmark for clinically
significant weight loss, supporting the Company's plan to file a New Drug
Application with the FDA in the first half of 2010.
Empatic
Orexigen recently announced the data from the Phase 2b clinical trial of
Empatic. The results of this trial demonstrated that patients completing 24
weeks of Empatic360 (bupropion SR 360mg/zonisamide SR 360 mg) therapy lost
9.9% of their baseline body weight, or 22 pounds, compared to 1.7% for placebo
patients (p<0.001). Importantly, Empatic patients continued to lose weight
through the end of the trial, with no evidence of a weight loss plateau.
Improvements were observed in key markers of cardiometabolic risk such as
waist circumference, triglycerides, fasting insulin and blood pressure. The
most commonly reported adverse events for all Empatic patients were headache,
insomnia and nausea, and the most common adverse events leading to
discontinuation were insomnia, headache and urticaria (hives). Adverse events
and laboratory findings appeared to be consistent with the individual
components of Empatic. There were no serious adverse events attributed by
investigators to study drug. There were no statistically or clinically
meaningful differences between Empatic and placebo on measures of cognitive
function, depression, suicidality or anxiety.
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 third quarter 2009 financial results and recent business highlights. The
live call may be accessed by phone by calling (866) 783-2138 (domestic) or
(857) 350-1597 (international), participant code 88599521. 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.
The archive may be accessed by calling (888) 286-8010 (domestic) or (617)
801-6888 (international), participant code 25068077.
About Orexigen Therapeutics
Orexigen Therapeutics, Inc. is a biopharmaceutical company focused on
developing therapies that offer multiple approaches to treating obesity. The
Company's lead investigational product, Contrave®, has completed the COR Phase
3 clinical development program and is on track for a regulatory submission
with the FDA in the first half of 2010. The Company's second obesity drug
candidate, Empatic(TM), has completed Phase 2 trials. 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, through combination therapeutic approaches. Further information about
the Company can be found at http://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 efficacy and
safety of Empatic(TM) and Contrave®, the potential for, and timing of,
proceeding to Phase 3 clinical trials for Empatic or filing an NDA for
Contrave, the commercial and therapeutic potential of Empatic and Contrave,
and the potential to obtain regulatory approval for, and effectively treat
obesity with, either product candidate. 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: additional analyses of data from the
Empatic Phase 2b trial or Contrave Phase 3 trials and any other clinical
trials of Empatic or Contrave may produce negative or inconclusive results, or
may be inconsistent with previously announced results or previously conducted
clinical trials; the FDA may not agree with the Company's interpretation of
efficacy and safety results; earlier clinical trials may not be predictive of
future results; Empatic or Contrave may not receive regulatory approval on a
timely basis or at all, and 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, including serious adverse events that are not characterized
by clinical investigators as possibly related to Empatic or Contrave and
adverse events associated with the individual components of these product
candidates; the third parties on whom Orexigen relies to assist with the
development programs for Empatic or Contrave, 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 its
product candidates; 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. Information
included herein is based on the Company's review and evaluation of the
clinical data. All conclusions and determinations contained herein are
subject to the Company's further analysis of the clinical data. The ultimate
determination of the safety and efficacy of Contrave and Empatic will be made
by the FDA and other relevant regulatory authorities.
Orexigen Therapeutics, Inc.
(a development stage company)
Balance Sheets
(In thousands, except share and par value amounts)
September 30, December 31,
2009 2008
---- ----
(Unaudited)
Assets
Current assets:
Cash and cash equivalents $56,936 $45,451
Investment securities, available-for-sale 50,859 40,716
Prepaid expenses and other current assets 1,980 1,184
----- -----
Total current assets 109,775 87,351
Property and equipment, net 1,441 2,059
Restricted cash 1,290 1,375
Other assets 689 1,123
--- -----
Total assets $113,195 $91,908
======== =======
Liabilities and stockholders' equity
Current liabilities:
Accounts payable and accrued expenses $10,562 $18,810
Deferred revenue, current portion 88 88
Long-term debt, current portion 7,184 7,591
----- -----
Total current liabilities 17,834 26,489
Deferred revenue, less current portion 993 1,058
Long-term debt, less current portion 3,741 8,800
Other long-term liabilities 1,775 1,767
Commitments and contingencies
Stockholders' equity:
Preferred stock, $.001 par value,
10,000,000 shares
authorized at September 30, 2009
and December 31, 2008; no
shares issued and outstanding at
September 30, 2009 and December 31, 2008 - -
Common stock, $.001 par value,
100,000,000 shares
authorized at September 30, 2009
and December 31, 2008;
47,039,720 and 34,433,322 shares issued
and outstanding
at September 30, 2009 and
December 31, 2008, respectively 47 34
Additional paid-in capital 340,495 253,782
Accumulated other comprehensive income 27 153
Deficit accumulated during the
development stage (251,717) (200,175)
-------- --------
Total stockholders' equity 88,852 53,794
------ ------
Total liabilities and stockholders' equity $113,195 $91,908
======== =======
Orexigen Therapeutics, Inc.
(a development stage company)
Statements of Operations
(In thousands, except per share amounts)
(Unaudited)
Period
from
Three Nine September
Months Months 12,
Ended Ended 2002
September September (Inception)
30, 30, to
--------- --------- September 30,
2009 2008 2009 2008 2009
---- ---- ---- ---- -----
Revenues:
Collaborative
agreement $- $- $- $- 174
License
revenue 22 22 66 66 419
-- -- -- -- ---
Total
revenues 22 22 66 66 593
Operating
expenses:
Research and
development 9,592 21,463 38,579 61,735 207,697
General and
administrative 4,592 3,638 12,254 11,049 50,076
----- ----- ------ ------ ------
Total operating
expenses 14,184 25,101 50,833 72,784 257,773
------ ------ ------ ------ -------
Loss from
operations (14,162) (25,079) (50,767) (72,718) (257,180)
Other income
(expense):
Interest
income 47 662 295 2,800 8,974
Interest
expense (318) (370) (1,070) (1,196) (3,511)
---- ---- ------ ------ ------
Total other
income
(expense) (271) 292 (775) 1,604 5,463
---- --- ---- ----- -----
Net loss (14,433) (24,787) (51,542) (71,114) (251,717)
Accretion to
redemption
value of
redeemable
convertible
preferred
stock - - - - (78)
Deemed
dividend of
beneficial
conversion
for Series C
preferred
stock - - - - (13,860)
-- -- -- -- -------
Net loss
attributable to
common
stockholders $(14,433) $(24,787) $(51,542) (71,114) $(265,655)
======== ======== ======== ======== =========
Net loss per
share
attributable
to common
stockholders
- basic and
diluted $(0.33) $(0.72) $(1.38) $(2.12)
====== ====== ====== ======
Shares used in
computing net loss
per share
attributable to
common stockholders
- basic and
diluted 43,087 34,355 37,484 33,539
====== ====== ====== ======
SOURCE Orexigen Therapeutics, Inc.
Graham Cooper, Chief Financial Officer of Orexigen, +1-858-875-8600; or Media,
Lori Rosen, +1-212-301-7173, or Liz Frank, +1-212-301-7216, both of WeissComm
Partners, for Orexigen
