Welcome!

Microsoft Cloud Authors: Kevin Benedict, Pat Romanski, Liz McMillan, Lori MacVittie, Elizabeth White

News Feed Item

Orexigen Therapeutics Reports Financial Results for the Third Quarter Ended September 30, 2012

SAN DIEGO, Nov. 7, 2012 /PRNewswire/ -- Orexigen® Therapeutics, Inc. (Nasdaq: OREX), a biopharmaceutical company focused on the treatment of obesity, today announced financial results for the third quarter of 2012. For the three months ended September 30, 2012, Orexigen reported a net loss of $30.6 million, or $0.44 per share, as compared to a net loss of $4.6 million, or $0.10 per share, for the third quarter of 2011. As of September 30, 2012, Orexigen had $56.1 million in cash and cash equivalents and an additional $52.2 million in marketable securities, for a total of $108.3 million. In October 2012, Orexigen completed a follow-on public offering of common stock raising net proceeds of approximately $56.5 million.

Total operating expenses for the third quarter of 2012 were $31.5 million compared to $5.4 million for the third 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.

Given the accelerated and higher enrollment in the Light Study, Orexigen expects some clinical trial costs originally projected for 2013 to now be incurred in 2012 and a commensurate reduction in anticipated clinical trial costs for 2013. The Company projects the use of $70 million to $75 million in cash this year, resulting in a year end balance of cash, cash equivalents and marketable securities of between $130 million to $135 million.

"We expect 2013 to be a pivotal year for our company," said Michael Narachi, CEO of Orexigen. "U.S. approval of Contrave could come as early as late 2013, and we are working closely with our North American partner, Takeda, to prepare for commercialization.  Outside the U.S., we expect to submit an application for marketing authorization in Europe and to negotiate a partnership for the rest-of-world rights to Contrave and Empatic™. The additional capital we raised last month better positions us to execute on our corporate goals."

Product candidate update:
Contrave (32 mg naltrexone sustained-release (SR)/360 mg bupropion SR) for the treatment of obesity: Orexigen has enrolled more than 8,000 patients in the Light Study. 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. Orexigen now expects to randomize approximately 9,000 patients into the study. An interim analysis and New Drug Application resubmission is planned once at least 87 major adverse cardiovascular events (MACE) have occurred, which is anticipated in the second or third quarter of 2013.

In late October, Orexigen announced that it had received a response to a formal dispute resolution request (FDRR) from the United States FDA's Center for Drug Evaluation and Research (CDER). The response indicated that CDER highly supports further discussions regarding a faster path to resubmission of the Contrave New Drug Application (NDA). Orexigen plans to explore with the FDA the possibility of resubmitting the Contrave NDA in advance of the interim data from the Light Study. Under this scenario data from the planned interim analysis would be provided during the anticipated review period. Although procedural details need to be addressed, the Company is optimistic that these discussions could result in a faster path to resubmission of the Contrave NDA.

Empatic, a fixed dose combination of bupropion SR and zonisamide SR, for the treatment of obesity: The Company is communicating with the FDA regarding Empatic Phase III clinical development plans and to reconfirm with the Agency that reassuring results from the Light Study may sufficiently characterize the cardiovascular risk of Empatic, so long as the weight loss and blood pressure and heart rate data for Empatic are similar to or more favorable than those of Contrave.  Orexigen owns worldwide rights to Empatic.

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 third quarter 2012 financial results and recent business highlights. The live call may be accessed by phone by calling 888-895-5479 (US) or 847-619-6250 (International), participant code 33664518. 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 III 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 II 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 enrollment and rate of MACE in the Light Study, the ability to gain agreement with FDA on the procedural details for a Contrave NDA resubmission in advance of the Light Study interim data, the timing of the subsequent resubmission of the NDA for Contrave, the timing of approval for Contrave, the submission of an 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 balance at the end of 2012, the expected cash usage for the year 2012, 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 may not be predictive of future results in the Light Study or Phase III 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 August 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

WCG

(858) 875-8629

(510) 703-9491

 

                                                                          Orexigen Therapeutics, Inc.

                                                                                    Balance Sheets

                                                        (In thousands, except share and par value amounts)








September 30,


December 31,


2012


2011


(Unaudited)



Assets




Current assets:




Cash and cash equivalents 

$   56,057


$  101,749

Investment securities, available-for-sale 

52,227


45,844

Prepaid expenses and other current assets 

1,507


1,126

Total current assets 

109,791


148,719

Property and equipment, net 

166


439

Restricted cash 

177


542

Total assets 

$  110,134


$  149,700





Liabilities and stockholders' equity 




Current liabilities:




Accounts payable and accrued expenses 

$   17,775


$    4,277

Deferred revenue, current portion 

3,429


3,429

Total current liabilities 

21,204


7,706

Deferred revenue, less current portion 

39,429


42,000

Other long-term liabilities 

140


288

Commitments and contingencies




Stockholders' equity:




Preferred stock, $.001 par value, 10,000,000 shares 




    authorized at September 30, 2012 and December 31, 2011; no




    shares issued and outstanding at  




    at September 30, 2012 and December 31, 2011

-


-

Common stock, $.001 par value, 300,000,000 shares




    authorized at September 30, 2012 and December 31, 2011;




    70,727,827 and 61,285,514 shares issued and outstanding 




    at September 30, 2012 and December 31, 2011, respectively

71


61

Additional paid-in capital 

453,624


446,357

Accumulated other comprehensive income (loss)

15


(2)

Accumulated deficit

(404,349)


(346,710)

Total stockholders' equity 

49,361


99,706

Total liabilities and stockholders' equity 

$  110,134


$  149,700





 



























Orexigen Therapeutics, Inc.

Statements of Operations

(In thousands, except per share amounts)

(Unaudited)





























Three Months Ended 

Nine Months Ended 


September 30, 

September 30, 


2012


2011


2012


2011

Revenues:








Collaborative agreement 

$     857


$     857


$    2,571


$    2,571

License revenue 

-


-


-


971

Total revenues 

857


857


2,571


3,542

Operating expenses:








Research and development 

25,806


1,539


45,428


11,237

General and administrative 

5,651


3,907


14,905


15,870

Total operating expenses 

31,457


5,446


60,333


27,107

Loss from operations 

(30,600)


(4,589)


(57,762)


(23,565)

Other income (expense):








Interest income 

36


9


125


35

Interest expense 

-


-


(2)


(221)

Total other income (expense) 

36


9


123


(186)

Net loss 

$ (30,564)


$  (4,580)


$ (57,639)


$ (23,751)








Net loss per share - basic and diluted 

$    (0.44)


$   (0.10)


$     (0.85)


$     (0.49)

Shares used in computing net loss per share – basic and diluted 

70,152


48,085


67,982


48,012























 

SOURCE Orexigen Therapeutics, Inc.

More Stories By PR Newswire

Copyright © 2007 PR Newswire. All rights reserved. Republication or redistribution of PRNewswire content is expressly prohibited without the prior written consent of PRNewswire. PRNewswire shall not be liable for any errors or delays in the content, or for any actions taken in reliance thereon.

IoT & Smart Cities Stories
DXWorldEXPO LLC announced today that ICOHOLDER named "Media Sponsor" of Miami Blockchain Event by FinTechEXPO. ICOHOLDER gives detailed information and help the community to invest in the trusty projects. Miami Blockchain Event by FinTechEXPO has opened its Call for Papers. The two-day event will present 20 top Blockchain experts. All speaking inquiries which covers the following information can be submitted by email to [email protected] Miami Blockchain Event by FinTechEXPOalso offers sp...
Digital Transformation is much more than a buzzword. The radical shift to digital mechanisms for almost every process is evident across all industries and verticals. This is often especially true in financial services, where the legacy environment is many times unable to keep up with the rapidly shifting demands of the consumer. The constant pressure to provide complete, omnichannel delivery of customer-facing solutions to meet both regulatory and customer demands is putting enormous pressure on...
SYS-CON Events announced today that IoT Global Network has been named “Media Sponsor” of SYS-CON's @ThingsExpo, which will take place on June 6–8, 2017, at the Javits Center in New York City, NY. The IoT Global Network is a platform where you can connect with industry experts and network across the IoT community to build the successful IoT business of the future.
The best way to leverage your Cloud Expo presence as a sponsor and exhibitor is to plan your news announcements around our events. The press covering Cloud Expo and @ThingsExpo will have access to these releases and will amplify your news announcements. More than two dozen Cloud companies either set deals at our shows or have announced their mergers and acquisitions at Cloud Expo. Product announcements during our show provide your company with the most reach through our targeted audiences.
Machine learning has taken residence at our cities' cores and now we can finally have "smart cities." Cities are a collection of buildings made to provide the structure and safety necessary for people to function, create and survive. Buildings are a pool of ever-changing performance data from large automated systems such as heating and cooling to the people that live and work within them. Through machine learning, buildings can optimize performance, reduce costs, and improve occupant comfort by ...
@DevOpsSummit at Cloud Expo, taking place November 12-13 in New York City, NY, is co-located with 22nd international CloudEXPO | first international DXWorldEXPO and will feature technical sessions from a rock star conference faculty and the leading industry players in the world. The widespread success of cloud computing is driving the DevOps revolution in enterprise IT. Now as never before, development teams must communicate and collaborate in a dynamic, 24/7/365 environment. There is no time t...
CloudEXPO New York 2018, colocated with DXWorldEXPO New York 2018 will be held November 11-13, 2018, in New York City and will bring together Cloud Computing, FinTech and Blockchain, Digital Transformation, Big Data, Internet of Things, DevOps, AI, Machine Learning and WebRTC to one location.
DXWorldEXPO | CloudEXPO are the world's most influential, independent events where Cloud Computing was coined and where technology buyers and vendors meet to experience and discuss the big picture of Digital Transformation and all of the strategies, tactics, and tools they need to realize their goals. Sponsors of DXWorldEXPO | CloudEXPO benefit from unmatched branding, profile building and lead generation opportunities.
The deluge of IoT sensor data collected from connected devices and the powerful AI required to make that data actionable are giving rise to a hybrid ecosystem in which cloud, on-prem and edge processes become interweaved. Attendees will learn how emerging composable infrastructure solutions deliver the adaptive architecture needed to manage this new data reality. Machine learning algorithms can better anticipate data storms and automate resources to support surges, including fully scalable GPU-c...
Disruption, Innovation, Artificial Intelligence and Machine Learning, Leadership and Management hear these words all day every day... lofty goals but how do we make it real? Add to that, that simply put, people don't like change. But what if we could implement and utilize these enterprise tools in a fast and "Non-Disruptive" way, enabling us to glean insights about our business, identify and reduce exposure, risk and liability, and secure business continuity?