Orexigen(R) Therapeutics Announces Fourth Quarter and Year Ended December 31, 2009 Financial Results
SAN DIEGO, March 9 /PRNewswire-FirstCall/ -- Orexigen® Therapeutics, Inc. (Nasdaq: OREX), a biopharmaceutical company focused on the treatment of obesity, today announced financial results for the three months and year ended December 31, 2009.
Three months ended December 31, 2009
As of December 31, 2009, Orexigen held $37.7 million in cash and cash equivalents and an additional $54.5 million in investment securities, available-for-sale. Together, these amounts total $92.2 million.
For the three months ended December 31, 2009, Orexigen reported a net loss of $15.0 million, or $0.32 per share attributable to common stockholders, as compared to a net loss of $22.1 million, or $0.64 per share attributable to common stockholders, for the same period in 2008.
Total operating expenses for the three months ended December 31, 2009 were $14.8 million compared to $22.1 million for the same period in 2008. The decreased operating expenses were due primarily to a decrease in research and development expenses of $8.7 million related to the completion of our Contrave® Phase 3 clinical trials and completion of our Phase 2 clinical trial for Empatic™, offset partly by an increase in general and administrative costs of $1.3 million due principally to increases in salaries and personnel related costs, marketing and consulting expenses and medical affairs expense.
Year ended December 31, 2009
For the year ended December 31, 2009, Orexigen reported a net loss of $66.6 million, or $1.67 per share attributable to common stockholders, as compared to a net loss of $93.2 million, or $2.76 per share attributable to common stockholders, for 2008.
Total operating expenses for the year ended December 31, 2009 were $65.6 million compared to $94.9 million for 2008. The decreased operating expenses were due primarily to a decrease in research and development expenses of $31.8 million related to the completion of our Contrave Phase 3 clinical trials and completion of our Phase 2 clinical trial for Empatic, offset partly by an increase in general and administrative costs of $2.5 million due principally to increases in salaries and personnel related costs, medical affairs expense, recruiting expense and public relations costs.
"Orexigen has made significant progress in the past year that positions us for our transformation to a commercial enterprise," said Michael Narachi, President and CEO of Orexigen. "We completed our Contrave Phase 3 Program and our Empatic Phase 2 program, both with very positive results, and have nearly completed all sections of our New Drug Application for Contrave, which we expect to file with the FDA by the end of April. In addition, we raised additional capital which has allowed us to advance our preparations for a targeted commercial launch, and to outline the value proposition for potential partners that would enable access to the broader primary care markets."
2009 Highlights
- Orexigen made a number of key additions to its management team and staff, which will help position the Company for long term regulatory and commercial success. In April, Orexigen announced that it appointed Michael Narachi, a 20 year veteran of Amgen, as President and Chief Executive Officer. Later in the year, the Company announced a number of other strategic hires: Jay Hagan as Head of Corporate Development and Strategy, Mark Booth as Chief Commercial Officer, Dawn Viveash M.D. as Head of Global Regulatory Affairs, Suzanne McDonald as Head of Managed Markets and Government Affairs, Preston Klassen, M.D., MHS as Head of the Global Contrave Program and Whedy Wang, Ph.D., MPH as Head of Global Biomedical Information.
Contrave
Orexigen announced the results of all four of its Phase 3 trials in the Contrave Obesity Research, or COR, program in 2009. Each trial met its co-primary endpoints. Data from these trials demonstrated the following:
- In the COR-I and COR-II trials, approximately 48% and 56% of patients on Contrave32 lost at least 5% of their body weight after 56 weeks on an intent-to-treat basis, as compared to placebo patients who lost approximately 16% and 17% (p<0.001). Additionally, approximately 34% to 48% of patients who completed one year of therapy on Contrave32 in these two trials lost at least 10% of their baseline body weight.
- In the COR-BMOD trial, which incorporated an intensive diet and exercise behavior modification regimen, approximately 55% of patients who completed one year of therapy on Contrave32 lost at least 10% of their baseline body weight.
- In the COR-Diabetes trial, patients with type 2 diabetes taking Contrave lost significantly more weight than patients on placebo, and they also achieved substantial improvements in glycemic control. Specifically, Contrave patients showed a 0.6% reduction in hemoglobin A1c (HbA1c) from baseline, compared to a 0.1% reduction in placebo.
- Key secondary endpoints met across the entire COR Phase 3 program included significant improvements in markers of cardiometabolic risk such as waist circumference, HDL cholesterol and triglycerides. Additional analyses indicate that Contrave patients experienced an increased ability to control their eating compared to placebo.
- Contrave was generally well tolerated by patients across the COR Phase 3 program. 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 by the end of April
Empatic
In September, Orexigen announced the data from the Phase 2b clinical trial of Empatic. The results of this trial demonstrated the following:
- Patients completing 24 weeks of Empatic360 (bupropion SR 360mg/zonisamide SR 360 mg) therapy lost 9.9% of their baseline body weight compared to 1.7% for placebo patients (p<0.001). Importantly, mean weight loss for patients on Empatic continued to decline through the endpoint 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, compared to placebo.
- The most commonly reported adverse events, as well as those leading to discontinuation, for all Empatic patients were headache, nausea and insomnia. Adverse events and laboratory findings appeared to be consistent with the individual components of Empatic. There were no statistically or clinically meaningful differences between Empatic and placebo on measures of cognitive function, depression, suicidality or anxiety.
Corporate
- In July, the Company completed a public offering of 11.5 million shares of common stock at $7.50 per share, which resulted in net proceeds to the Company of approximately $81.6 million.
Conference Call Today at 8:00 a.m. Eastern Time (5:00 a.m. Pacific Time)
The Orexigen management team will host a teleconference and webcast to discuss the three months and year ended December 31, 2009 financial results and recent business highlights. The live call may be accessed by phone by calling (866) 730-5769 (domestic) or (857) 350-1593 (international), participant code 19470590. 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 investigational product, Contrave®, has completed Phase 3 clinical trials. The Company's second product, Empatic™, has completed Phase 2 clinical development. 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 and in the teleconference/webcast 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 potential for, and timing of, filing an NDA for Contrave. 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: risks inherent in the continued analyses of clinical trial results, including Contrave Phase 3 trials; the uncertainty of the FDA approval process and other regulatory requirements; the therapeutic and commercial value of Contrave and Empatic; reliance on third parties to assist with the development of Contrave and Empatic and the regulatory submissions related thereto; the potential for adverse safety findings relating to Contrave or Empatic; the potential to enter into and the terms of any commercial partnership or other strategic transaction relating to Contrave or 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)
Statements of Operations
(In thousands, except per share amounts)
(Unaudited)
Period from
September 12,
Three Months Ended Year Ended 2002
December 31, December 31, (Inception)
------------- ------------- to
December 31,
2009 2008 2009 2008 2009
---- ---- ---- ---- ----
Revenues:
Collaborative
agreement $- $- $- $- $174
License revenue 22 22 88 88 441
--- --- --- --- ---
Total revenues 22 22 88 88 615
Operating
expenses:
Research and
development 8,862 17,526 47,441 79,261 216,559
General and
administrative 5,923 4,602 18,177 15,651 55,999
----- ----- ------ ------ ------
Total operating
expenses 14,785 22,128 65,618 94,912 272,558
------ ------ ------ ------ -------
Loss from
operations (14,763) (22,106) (65,530) (94,824) (271,943)
Other income
(expense):
Interest
income 38 315 333 3,115 9,012
Interest
expense (295) (335) (1,365) (1,531) (3,806)
---- ---- ------ ------ ------
Total other
income
(expense) (257) (20) (1,032) 1,584 5,206
---- --- ------ ----- -----
Net loss (15,020) (22,126) (66,562) (93,240) (266,737)
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 $(15,020) $(22,126) $(66,562) $(93,240) $(280,675)
======== ======== ======== ======== =========
Net loss per
share
attributable
to
common
stockholders -
basic and
diluted $(0.32) $(0.64) $(1.67) $(2.76)
====== ====== ====== ======
Shares used in
computing net
loss per share
attributable to
common
stockholders –
basic and
diluted 47,088 34,429 39,905 33,762
====== ====== ====== ======
Orexigen Therapeutics, Inc.
(a development stage company)
Balance Sheets
(In thousands, except share and par value amounts)
December 31, December 31,
2009 2008
---- ----
(Unaudited)
Assets
Current assets:
Cash and cash equivalents $37,658 $45,451
Investment securities, available-
for-sale 54,500 40,716
Prepaid expenses and other current
assets 1,529 1,184
----- -----
Total current assets 93,687 87,351
Property and equipment, net 1,324 2,059
Restricted cash 1,290 1,375
Other assets 547 1,123
--- -----
Total assets $96,848 $91,908
======= =======
Liabilities and stockholders' equity
Current liabilities:
Accounts payable and accrued expenses $9,828 $18,810
Deferred revenue, current portion 88 88
Long-term debt, current portion 6,384 7,591
----- -----
Total current liabilities 16,300 26,489
Deferred revenue, less current portion 971 1,058
Long-term debt, less current portion 2,416 8,800
Other long-term liabilities 1,258 1,767
Commitments and contingencies
Stockholders’ equity:
Preferred stock, $.001 par value,
10,000,000 shares
authorized at December 31, 2009
and 2008; no shares issued and outstanding
at December 31, 2009 and 2008 - -
Common stock, $.001 par value,
100,000,000 shares
authorized at December 31, 2009
and 2008; 47,215,479 and 34,433,322
shares issued and outstanding
at December 31, 2009 and 2008,
respectively 47 34
Additional paid-in capital 342,599 253,782
Accumulated other comprehensive income
(loss) (6) 153
Deficit accumulated during the
development stage (266,737) (200,175)
-------- --------
Total stockholders’ equity 75,903 53,794
------ ------
Total liabilities and stockholders’
equity $96,848 $91,908
======= =======
SOURCE Orexigen Therapeutics, Inc.
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