Welcome!

Microsoft Cloud Authors: Janakiram MSV, Yeshim Deniz, David H Deans, Andreas Grabner, Stackify Blog

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.

@ThingsExpo Stories
Widespread fragmentation is stalling the growth of the IIoT and making it difficult for partners to work together. The number of software platforms, apps, hardware and connectivity standards is creating paralysis among businesses that are afraid of being locked into a solution. EdgeX Foundry is unifying the community around a common IoT edge framework and an ecosystem of interoperable components.
As popularity of the smart home is growing and continues to go mainstream, technological factors play a greater role. The IoT protocol houses the interoperability battery consumption, security, and configuration of a smart home device, and it can be difficult for companies to choose the right kind for their product. For both DIY and professionally installed smart homes, developers need to consider each of these elements for their product to be successful in the market and current smart homes.
Infoblox delivers Actionable Network Intelligence to enterprise, government, and service provider customers around the world. They are the industry leader in DNS, DHCP, and IP address management, the category known as DDI. We empower thousands of organizations to control and secure their networks from the core-enabling them to increase efficiency and visibility, improve customer service, and meet compliance requirements.
With major technology companies and startups seriously embracing Cloud strategies, now is the perfect time to attend 21st Cloud Expo October 31 - November 2, 2017, at the Santa Clara Convention Center, CA, and June 12-14, 2018, at the Javits Center in New York City, NY, and learn what is going on, contribute to the discussions, and ensure that your enterprise is on the right path to Digital Transformation.
SYS-CON Events announced today that mruby Forum will exhibit at the Japan External Trade Organization (JETRO) Pavilion at SYS-CON's 21st International Cloud Expo®, which will take place on Oct 31 – Nov 2, 2017, at the Santa Clara Convention Center in Santa Clara, CA. mruby is the lightweight implementation of the Ruby language. We introduce mruby and the mruby IoT framework that enhances development productivity. For more information, visit http://forum.mruby.org/.
Digital transformation is changing the face of business. The IDC predicts that enterprises will commit to a massive new scale of digital transformation, to stake out leadership positions in the "digital transformation economy." Accordingly, attendees at the upcoming Cloud Expo | @ThingsExpo at the Santa Clara Convention Center in Santa Clara, CA, Oct 31-Nov 2, will find fresh new content in a new track called Enterprise Cloud & Digital Transformation.
Most technology leaders, contemporary and from the hardware era, are reshaping their businesses to do software. They hope to capture value from emerging technologies such as IoT, SDN, and AI. Ultimately, irrespective of the vertical, it is about deriving value from independent software applications participating in an ecosystem as one comprehensive solution. In his session at @ThingsExpo, Kausik Sridhar, founder and CTO of Pulzze Systems, will discuss how given the magnitude of today's applicati...
Smart cities have the potential to change our lives at so many levels for citizens: less pollution, reduced parking obstacles, better health, education and more energy savings. Real-time data streaming and the Internet of Things (IoT) possess the power to turn this vision into a reality. However, most organizations today are building their data infrastructure to focus solely on addressing immediate business needs vs. a platform capable of quickly adapting emerging technologies to address future ...
SYS-CON Events announced today that NetApp has been named “Bronze Sponsor” of SYS-CON's 21st International Cloud Expo®, which will take place on Oct 31 – Nov 2, 2017, at the Santa Clara Convention Center in Santa Clara, CA. NetApp is the data authority for hybrid cloud. NetApp provides a full range of hybrid cloud data services that simplify management of applications and data across cloud and on-premises environments to accelerate digital transformation. Together with their partners, NetApp emp...
In a recent survey, Sumo Logic surveyed 1,500 customers who employ cloud services such as Amazon Web Services (AWS), Microsoft Azure, and Google Cloud Platform (GCP). According to the survey, a quarter of the respondents have already deployed Docker containers and nearly as many (23 percent) are employing the AWS Lambda serverless computing framework. It’s clear: serverless is here to stay. The adoption does come with some needed changes, within both application development and operations. Tha...
SYS-CON Events announced today that Avere Systems, a leading provider of enterprise storage for the hybrid cloud, will exhibit at SYS-CON's 21st International Cloud Expo®, which will take place on Oct 31 - Nov 2, 2017, at the Santa Clara Convention Center in Santa Clara, CA. Avere delivers a more modern architectural approach to storage that doesn't require the overprovisioning of storage capacity to achieve performance, overspending on expensive storage media for inactive data or the overbui...
SYS-CON Events announced today that Avere Systems, a leading provider of hybrid cloud enablement solutions, will exhibit at SYS-CON's 21st International Cloud Expo®, which will take place on Oct 31 – Nov 2, 2017, at the Santa Clara Convention Center in Santa Clara, CA. Avere Systems was created by file systems experts determined to reinvent storage by changing the way enterprises thought about and bought storage resources. With decades of experience behind the company’s founders, Avere got its ...
Amazon is pursuing new markets and disrupting industries at an incredible pace. Almost every industry seems to be in its crosshairs. Companies and industries that once thought they were safe are now worried about being “Amazoned.”. The new watch word should be “Be afraid. Be very afraid.” In his session 21st Cloud Expo, Chris Kocher, a co-founder of Grey Heron, will address questions such as: What new areas is Amazon disrupting? How are they doing this? Where are they likely to go? What are th...
As hybrid cloud becomes the de-facto standard mode of operation for most enterprises, new challenges arise on how to efficiently and economically share data across environments. In his session at 21st Cloud Expo, Dr. Allon Cohen, VP of Product at Elastifile, will explore new techniques and best practices that help enterprise IT benefit from the advantages of hybrid cloud environments by enabling data availability for both legacy enterprise and cloud-native mission critical applications. By rev...
Recently, REAN Cloud built a digital concierge for a North Carolina hospital that had observed that most patient call button questions were repetitive. In addition, the paper-based process used to measure patient health metrics was laborious, not in real-time and sometimes error-prone. In their session at 21st Cloud Expo, Sean Finnerty, Executive Director, Practice Lead, Health Care & Life Science at REAN Cloud, and Dr. S.P.T. Krishnan, Principal Architect at REAN Cloud, will discuss how they b...
SYS-CON Events announced today that SkyScale will exhibit at SYS-CON's 21st International Cloud Expo®, which will take place on Oct 31 – Nov 2, 2017, at the Santa Clara Convention Center in Santa Clara, CA. SkyScale is a world-class provider of cloud-based, ultra-fast multi-GPU hardware platforms for lease to customers desiring the fastest performance available as a service anywhere in the world. SkyScale builds, configures, and manages dedicated systems strategically located in maximum-security...
High-velocity engineering teams are applying not only continuous delivery processes, but also lessons in experimentation from established leaders like Amazon, Netflix, and Facebook. These companies have made experimentation a foundation for their release processes, allowing them to try out major feature releases and redesigns within smaller groups before making them broadly available. In his session at 21st Cloud Expo, Brian Lucas, Senior Staff Engineer at Optimizely, will discuss how by using...
In this strange new world where more and more power is drawn from business technology, companies are effectively straddling two paths on the road to innovation and transformation into digital enterprises. The first path is the heritage trail – with “legacy” technology forming the background. Here, extant technologies are transformed by core IT teams to provide more API-driven approaches. Legacy systems can restrict companies that are transitioning into digital enterprises. To truly become a lead...
SYS-CON Events announced today that Daiya Industry will exhibit at the Japanese Pavilion at SYS-CON's 21st International Cloud Expo®, which will take place on Oct 31 – Nov 2, 2017, at the Santa Clara Convention Center in Santa Clara, CA. Ruby Development Inc. builds new services in short period of time and provides a continuous support of those services based on Ruby on Rails. For more information, please visit https://github.com/RubyDevInc.
As businesses evolve, they need technology that is simple to help them succeed today and flexible enough to help them build for tomorrow. Chrome is fit for the workplace of the future — providing a secure, consistent user experience across a range of devices that can be used anywhere. In her session at 21st Cloud Expo, Vidya Nagarajan, a Senior Product Manager at Google, will take a look at various options as to how ChromeOS can be leveraged to interact with people on the devices, and formats th...