Click here to close now.




















Welcome!

Microsoft Cloud Authors: Elizabeth White, the Editor, Michael Krems, Xenia von Wedel, Jayaram Krishnaswamy

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
SYS-CON Events announced today that IceWarp will exhibit at the 17th International Cloud Expo®, which will take place on November 3–5, 2015, at the Santa Clara Convention Center in Santa Clara, CA. IceWarp, the leader of cloud and on-premise messaging, delivers secured email, chat, documents, conferencing and collaboration to today's mobile workforce, all in one unified interface
The Internet of Things (IoT) is about the digitization of physical assets including sensors, devices, machines, gateways, and the network. It creates possibilities for significant value creation and new revenue generating business models via data democratization and ubiquitous analytics across IoT networks. The explosion of data in all forms in IoT requires a more robust and broader lens in order to enable smarter timely actions and better outcomes. Business operations become the key driver of IoT applications and projects. Business operations, IT, and data scientists need advanced analytics t...
With the proliferation of connected devices underpinning new Internet of Things systems, Brandon Schulz, Director of Luxoft IoT – Retail, will be looking at the transformation of the retail customer experience in brick and mortar stores in his session at @ThingsExpo. Questions he will address include: Will beacons drop to the wayside like QR codes, or be a proximity-based profit driver? How will the customer experience change in stores of all types when everything can be instrumented and analyzed? As an area of investment, how might a retail company move towards an innovation methodolo...
As more and more data is generated from a variety of connected devices, the need to get insights from this data and predict future behavior and trends is increasingly essential for businesses. Real-time stream processing is needed in a variety of different industries such as Manufacturing, Oil and Gas, Automobile, Finance, Online Retail, Smart Grids, and Healthcare. Azure Stream Analytics is a fully managed distributed stream computation service that provides low latency, scalable processing of streaming data in the cloud with an enterprise grade SLA. It features built-in integration with Azur...
WebRTC has had a real tough three or four years, and so have those working with it. Only a few short years ago, the development world were excited about WebRTC and proclaiming how awesome it was. You might have played with the technology a couple of years ago, only to find the extra infrastructure requirements were painful to implement and poorly documented. This probably left a bitter taste in your mouth, especially when things went wrong.
As more intelligent IoT applications shift into gear, they’re merging into the ever-increasing traffic flow of the Internet. It won’t be long before we experience bottlenecks, as IoT traffic peaks during rush hours. Organizations that are unprepared will find themselves by the side of the road unable to cross back into the fast lane. As billions of new devices begin to communicate and exchange data – will your infrastructure be scalable enough to handle this new interconnected world?
Too often with compelling new technologies market participants become overly enamored with that attractiveness of the technology and neglect underlying business drivers. This tendency, what some call the “newest shiny object syndrome,” is understandable given that virtually all of us are heavily engaged in technology. But it is also mistaken. Without concrete business cases driving its deployment, IoT, like many other technologies before it, will fade into obscurity.
Consumer IoT applications provide data about the user that just doesn’t exist in traditional PC or mobile web applications. This rich data, or “context,” enables the highly personalized consumer experiences that characterize many consumer IoT apps. This same data is also providing brands with unprecedented insight into how their connected products are being used, while, at the same time, powering highly targeted engagement and marketing opportunities. In his session at @ThingsExpo, Nathan Treloar, President and COO of Bebaio, will explore examples of brands transforming their businesses by t...
SYS-CON Events announced today that Micron Technology, Inc., a global leader in advanced semiconductor systems, will exhibit at the 17th International Cloud Expo®, which will take place on November 3–5, 2015, at the Santa Clara Convention Center in Santa Clara, CA. Micron’s broad portfolio of high-performance memory technologies – including DRAM, NAND and NOR Flash – is the basis for solid state drives, modules, multichip packages and other system solutions. Backed by more than 35 years of technology leadership, Micron's memory solutions enable the world's most innovative computing, consumer,...
Through WebRTC, audio and video communications are being embedded more easily than ever into applications, helping carriers, enterprises and independent software vendors deliver greater functionality to their end users. With today’s business world increasingly focused on outcomes, users’ growing calls for ease of use, and businesses craving smarter, tighter integration, what’s the next step in delivering a richer, more immersive experience? That richer, more fully integrated experience comes about through a Communications Platform as a Service which allows for messaging, screen sharing, video...
SYS-CON Events announced today that Pythian, a global IT services company specializing in helping companies leverage disruptive technologies to optimize revenue-generating systems, has been named “Bronze Sponsor” of SYS-CON's 17th Cloud Expo, which will take place on November 3–5, 2015, at the Santa Clara Convention Center in Santa Clara, CA. Founded in 1997, Pythian is a global IT services company that helps companies compete by adopting disruptive technologies such as cloud, Big Data, advanced analytics, and DevOps to advance innovation and increase agility. Specializing in designing, imple...
Akana has announced the availability of the new Akana Healthcare Solution. The API-driven solution helps healthcare organizations accelerate their transition to being secure, digitally interoperable businesses. It leverages the Health Level Seven International Fast Healthcare Interoperability Resources (HL7 FHIR) standard to enable broader business use of medical data. Akana developed the Healthcare Solution in response to healthcare businesses that want to increase electronic, multi-device access to health records while reducing operating costs and complying with government regulations.
SYS-CON Events announced today that HPM Networks will exhibit at the 17th International Cloud Expo®, which will take place on November 3–5, 2015, at the Santa Clara Convention Center in Santa Clara, CA. For 20 years, HPM Networks has been integrating technology solutions that solve complex business challenges. HPM Networks has designed solutions for both SMB and enterprise customers throughout the San Francisco Bay Area.
For IoT to grow as quickly as analyst firms’ project, a lot is going to fall on developers to quickly bring applications to market. But the lack of a standard development platform threatens to slow growth and make application development more time consuming and costly, much like we’ve seen in the mobile space. In his session at @ThingsExpo, Mike Weiner, Product Manager of the Omega DevCloud with KORE Telematics Inc., discussed the evolving requirements for developers as IoT matures and conducted a live demonstration of how quickly application development can happen when the need to comply wit...
The Internet of Everything (IoE) brings together people, process, data and things to make networked connections more relevant and valuable than ever before – transforming information into knowledge and knowledge into wisdom. IoE creates new capabilities, richer experiences, and unprecedented opportunities to improve business and government operations, decision making and mission support capabilities.
Explosive growth in connected devices. Enormous amounts of data for collection and analysis. Critical use of data for split-second decision making and actionable information. All three are factors in making the Internet of Things a reality. Yet, any one factor would have an IT organization pondering its infrastructure strategy. How should your organization enhance its IT framework to enable an Internet of Things implementation? In his session at @ThingsExpo, James Kirkland, Red Hat's Chief Architect for the Internet of Things and Intelligent Systems, described how to revolutionize your archit...
MuleSoft has announced the findings of its 2015 Connectivity Benchmark Report on the adoption and business impact of APIs. The findings suggest traditional businesses are quickly evolving into "composable enterprises" built out of hundreds of connected software services, applications and devices. Most are embracing the Internet of Things (IoT) and microservices technologies like Docker. A majority are integrating wearables, like smart watches, and more than half plan to generate revenue with APIs within the next year.
Growth hacking is common for startups to make unheard-of progress in building their business. Career Hacks can help Geek Girls and those who support them (yes, that's you too, Dad!) to excel in this typically male-dominated world. Get ready to learn the facts: Is there a bias against women in the tech / developer communities? Why are women 50% of the workforce, but hold only 24% of the STEM or IT positions? Some beginnings of what to do about it! In her Opening Keynote at 16th Cloud Expo, Sandy Carter, IBM General Manager Cloud Ecosystem and Developers, and a Social Business Evangelist, d...
In his keynote at 16th Cloud Expo, Rodney Rogers, CEO of Virtustream, discussed the evolution of the company from inception to its recent acquisition by EMC – including personal insights, lessons learned (and some WTF moments) along the way. Learn how Virtustream’s unique approach of combining the economics and elasticity of the consumer cloud model with proper performance, application automation and security into a platform became a breakout success with enterprise customers and a natural fit for the EMC Federation.
The Internet of Things is not only adding billions of sensors and billions of terabytes to the Internet. It is also forcing a fundamental change in the way we envision Information Technology. For the first time, more data is being created by devices at the edge of the Internet rather than from centralized systems. What does this mean for today's IT professional? In this Power Panel at @ThingsExpo, moderated by Conference Chair Roger Strukhoff, panelists addressed this very serious issue of profound change in the industry.