Click here to close now.

Welcome!

.NET Authors: Carmen Gonzalez, Elizabeth White, Liz McMillan, Greg O'Connor, Jason Bloomberg

News Feed Item

Avanir Pharmaceuticals Reports Fiscal 2012 Fourth Quarter And Year-End Financial And Business Results

ALISO VIEJO, Calif., Dec. 12, 2012 /PRNewswire/ -- Avanir Pharmaceuticals, Inc. (NASDAQ: AVNR) today reported financial results for the three and twelve months ended September 30, 2012.

Quarterly Financial Highlights

  • Gross and net NUEDEXTA® sales of $15.4 million and $12.4 million, respectively, an increase of 26% and 23% versus the previous quarter
  • Total company net revenue of $13.5 million
  • Cash, cash equivalents, and restricted investments of $72.1 million as of September 30, 2012

"Our business has very good momentum as we are executing our strategy to grow revenues and deliver much needed therapies to patients. In addition to growing the PBA franchise, we are investing in our pipeline to develop several breakthrough therapies for the future, which are important steps to becoming a leading mid-cap CNS company. The clinical trials are continuing to enroll, and investments in R&D should, if successful, result in value generating inflection points in the coming years," said Keith A. Katkin, president and CEO of Avanir.

Fiscal 2012 Fourth Quarter Results

  • Total net revenue for the quarter ended September 30, 2012 were $13.5 million, compared with $4.8 million for the comparable quarter in 2011; total net revenues consist of NUEDEXTA net revenue and royalty revenue from Abreva®
  • Total operating expenses were $24.2 million in the fourth quarter of fiscal 2012, compared with $22.7 million in the comparable period in fiscal 2011
  • Cash used in operations was $12.1 million in the fourth quarter of fiscal 2012
  • Net loss for the fiscal 2012 fourth quarter was $11.7 million, or $0.09 per share, compared with a net loss of $18.0 million, or $0.14 per share, for the same period in fiscal 2011

Twelve-Month Results

  • Total revenues for fiscal 2012 were $41.3 million, compared with $10.5 million for fiscal 2011
  • Total operating expenses for fiscal 2012, excluding cost of sales and share-based compensation, were $92.7 million; total operating expenses were $99.7 million for fiscal 2012
  • Cash used in operations was $57.7 million in fiscal 2012
  • Net loss for fiscal 2012 was $59.7 million, or $0.45 net loss per share, compared with a net loss of $60.6 million, or $0.51 net loss per share for fiscal 2011

Cash, Cash Equivalents & Marketable Securities
As of September 30, 2012 Avanir had cash, cash equivalents and investments in securities totaling $72.1 million, including cash and cash equivalents of $69.8 million and restricted investments in securities of $2.3 million.

Business Highlights
Recent highlights for the company include:

  • Achieved record NUEDEXTA prescriptions of 31,018 for the quarter ended September 30, 2012.
  • On September 4, 2012, the company announced the enrollment of the first patient in study AVR-131. The study is a Phase II clinical trial investigating the use of AVP-923 for the treatment of agitation in patients with Alzheimer's disease.
  • In the fourth quarter of fiscal 2012 the company completed a sales force expansion and realignment bringing the total number of sales representatives to 130.
  • On October 23, 2012, the company announced that The Michael J. Fox Foundation had awarded the company a grant to evaluate the safety and efficacy of AVP-923 (dextromethorphan hydrobromide and quinidine sulfate) for the treatment of levodopa-induced-dyskinesia (LID) in Parkinson's disease (PD).
  • In November 2012, we initiated the first-in-human Phase I clinical trial of AVP-786 (formerly known as deuterated dextromethorphan). The trial is designed to assess the single and multiple dose pharmacokinetics, safety and tolerability of AVP-786 administered to healthy subjects.

Note to Investors: As previously announced, Avanir will hold a conference call to discuss fiscal 2012 fourth quarter and year-end financial results today, December 12, 2012, beginning at 1:30 p.m. Pacific Time. You can listen to this call by dialing 1 (866) 314-5050 for domestic callers or +1 (617) 213-8051 for international callers, and entering passcode 16033129. Those interested in listening to the conference call live via the Internet may do so by visiting http://ir.avanir.com.

About NUEDEXTA
NUEDEXTA is an innovative combination of two well-characterized components; dextromethorphan hydrobromide (20 mg), the ingredient active in the central nervous system, and quinidine sulfate (10 mg), a metabolic inhibitor enabling therapeutic dextromethorphan concentrations. NUEDEXTA acts on sigma-1 and NMDA receptors in the brain, although the mechanism by which NUEDEXTA exerts therapeutic effects in patients with PBA is unknown.

NUEDEXTA Important Safety Information
NUEDEXTA is indicated for the treatment of pseudobulbar affect (PBA). PBA occurs secondary to a variety of otherwise unrelated neurological conditions, and is characterized by involuntary, sudden, and frequent episodes of laughing and/or crying. PBA episodes typically occur out of proportion or incongruent to the underlying emotional state.

Studies to support the effectiveness of NUEDEXTA were performed in patients with amyotrophic lateral sclerosis (ALS) and multiple sclerosis (MS). NUEDEXTA has not been shown to be safe and effective in other types of emotional lability that can commonly occur, for example, in Alzheimer's disease and other dementias.

NUEDEXTA (dextromethorphan hydrobromide and quinidine sulfate) 20/10 mg capsules can interact with other medications causing significant changes in blood levels of those medications and/or NUEDEXTA which may lead to serious side effects. Adjust dose or use alternate treatment of the other medication when clinically indicated.

NUEDEXTA is contraindicated in patients concomitantly taking: QT-prolonging drugs metabolized by CYP2D6 (e.g., thioridazine and pimozide); monoamine oxidase inhibitors (MAOIs) within the preceding or following 14 days; other drugs containing quinidine, quinine, or mefloquine and in patients with a known hypersensitivity to these drugs or any of NUEDEXTA's components. Discontinue use of NUEDEXTA if hepatitis, thrombocytopenia, serotonin syndrome or a hypersensitivity reaction occurs.

NUEDEXTA is contraindicated in patients with certain risk factors for arrhythmia: Prolonged QT interval; congenital long QT syndrome, history suggestive of torsades de pointes; heart failure; complete atrioventricular (AV) block or risk of AV block without an implanted pacemaker.

NUEDEXTA causes dose-dependent QTc prolongation. When initiating NUEDEXTA in patients at risk for QT prolongation and torsades de pointes, electrocardiographic (ECG) evaluation should be conducted at baseline and 3-4 hours after the first dose. Risk factors include left ventricular hypertrophy or dystrophy or concomitant use of drugs that prolong QT interval or certain CYP3A4 inhibitors.

The most common adverse reactions are diarrhea, dizziness, cough, vomiting, asthenia, peripheral edema, urinary tract infection, influenza, increased gamma-glutamyltransferase, and flatulence. NUEDEXTA may cause dizziness. Precautions to reduce the risk of falls should be taken, particularly for patients with motor impairment affecting gait or a history of falls.

These are not all the risks from use of NUEDEXTA. Please refer to the accompanying full Prescribing Information or visit www.NUEDEXTA.com.

About Avanir Pharmaceuticals, Inc.
Avanir Pharmaceuticals, Inc. is a biopharmaceutical company focused on bringing innovative medicines to patients with central nervous system disorders of high unmet medical need. As part of our commitment, we have extensively invested in our pipeline and are dedicated to advancing medicines that can substantially improve the lives of patients and their loved ones. For more information about Avanir, please visit www.avanir.com.

Avanir® and NUEDEXTA® are registered trademarks owned by Avanir Pharmaceuticals, Inc. All other trademarks are the property of their respective owners.

©2012 Avanir Pharmaceuticals, Inc. All Rights Reserved.

Forward Looking Statements
Except for the historical information contained herein, the matters set forth in this press release, including statements regarding Avanir's plans, potential opportunities, financial or other expectations, projections, goals objectives, milestones, strategies, market growth, timelines, legal matters, product pipeline, clinical studies, product development and the potential benefits of its commercialized products and products under development are forward-looking statements within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995. These forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially, including the risks and uncertainties associated with Avanir's operating performance and financial position, the market demand for and acceptance of Avanir's products domestically and internationally, research, development and commercialization of new products domestically and internationally, obtaining additional indications for commercially marketed products domestically and internationally, obtaining and maintaining regulatory approvals domestically and internationally, and other risks detailed from time to time in the Company's most recent Annual Report on Form 10-K and other documents subsequently filed with or furnished to the Securities and Exchange Commission. These forward-looking statements are based on current information that may change and you are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this press release. All forward-looking statements are qualified in their entirety by this cautionary statement, and the Company undertakes no obligation to revise or update any forward-looking statement to reflect events or circumstances after the issuance of this press release.

Avanir Investor & Media Contact
Ian Clements, PhD
[email protected]
+1 (949) 389-6700

 

 

AVANIR PHARMACEUTICALS, INC.

CONDENSED CONSOLIDATED BALANCE SHEETS






September 30,


September 30,


2012


2011


(unaudited)


(audited)

ASSETS

Current assets:




     Cash and cash equivalents

$   69,778,406


$   79,542,564

     Trade receivables, net

7,231,759


2,011,165

     Inventories, net

415,475


252,244

     Prepaid expenses and other current assets

2,434,590


1,965,748

     Current portion of restricted investments in marketable securities 

1,054,463


618,314

          Total current assets

80,914,693


84,390,035

Restricted investments in marketable securities, net of current portion

1,302,136


1,634,625

Property and equipment, net

1,808,594


1,695,329

Non-current inventories, net

908,364


792,933

Other assets

1,078,009


1,136,072

       TOTAL ASSETS

$   86,011,796


$   89,648,994





LIABILITIES AND STOCKHOLDERS' EQUITY

Current liabilities:




    Accounts payable, accrued expenses and other liabilities

$   15,598,666


$   10,449,427

    Deferred product revenues, net

-


1,652,788

    Current portion of note payble

2,162,263


-

    Current portion of deferred royalty revenues

2,557,464


2,087,226

       Total current liabilities

20,318,393


14,189,441

Accrued expenses and other liabilities, net of current portion

666,179


68,487

Note Payable

26,698,263


-

Deferred royalty revenues, net of current portion

1,491,854


4,051,402

        Total liabilities

49,174,689


18,309,330

         Total stockholders' equity

36,837,107


71,339,664

TOTAL LIABILITIES AND STOCKHOLDERS'  EQUITY

$   86,011,796


$   89,648,994

 

 

AVANIR PHARMACEUTICALS, INC.

CONDENSED STATEMENT OF OPERATIONS










Three Months Ended September 30,


Twelve Months Ended September 30,


2012


2011


2012


2011

REVENUES AND COSTS FROM PRODUCT SALES








   Gross product sales

$  15,431,249


$    4,322,688


$  45,107,989


$    7,014,778

   Less: discounts and allowances

3,037,891


627,631


8,033,422


925,472

   Net product sales

12,393,358


3,695,057


37,074,567


6,089,306

   Revenues from royalties

1,138,448


1,065,713


4,200,506


4,406,589

           Total revenues

13,531,806


4,760,770


41,275,073


10,495,895









OPERATING EXPENSES








   Cost of product sales

712,546


212,445


2,120,221


445,980

   Research and development

6,095,161


5,631,610


23,066,037


15,253,739

   Selling, general and administrative

17,399,704


16,903,327


74,490,996


55,425,591

           Total operating expenses

24,207,411


22,747,382


99,677,254


71,125,310









Loss from operations

(10,675,605)


(17,986,612)


(58,402,181)


(60,629,415)









OTHER INCOME (EXPENSE)








   Interest income

12,752


10,754


42,815


38,785

   Interest expense

(1,059,244)




(1,385,342)



   Other, net

-


(9,438)


4,081


(37,733)









Loss before provision for income taxes

(11,722,097)


(17,985,296)


(59,740,627)


(60,628,363)









   Provision for income taxes

3,200


3,200


3,200


3,200









Net loss and comprehensive loss

$ (11,725,297)


$ (17,988,496)


$ (59,743,827)


$ (60,631,563)









Basic and diluted net loss per share

$            (0.09)


$            (0.14)


$            (0.45)


$            (0.51)









Basic and diluted weighted average number of common shares outstanding 

136,239,668


124,325,299


133,358,571


119,405,230

SOURCE Avanir Pharmaceuticals, 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 Media announced today that @ThingsExpo Blog launched with 7,788 original stories. @ThingsExpo Blog offers top articles, news stories, and blog posts from the world's well-known experts and guarantees better exposure for its authors than any other publication. @ThingsExpo Blog can be bookmarked. The Internet of Things (IoT) is the most profound change in personal and enterprise IT since the creation of the Worldwide Web more than 20 years ago.
The world's leading Cloud event, Cloud Expo has launched Microservices Journal on the SYS-CON.com portal, featuring over 19,000 original articles, news stories, features, and blog entries. DevOps Journal is focused on this critical enterprise IT topic in the world of cloud computing. Microservices Journal offers top articles, news stories, and blog posts from the world's well-known experts and guarantees better exposure for its authors than any other publication. Follow new article posts on Twitter at @MicroservicesE
SYS-CON Events announced today that robomq.io will exhibit at SYS-CON's @ThingsExpo, which will take place on June 9-11, 2015, at the Javits Center in New York City, NY. robomq.io is an interoperable and composable platform that connects any device to any application. It helps systems integrators and the solution providers build new and innovative products and service for industries requiring monitoring or intelligence from devices and sensors.
Wearable technology was dominant at this year’s International Consumer Electronics Show (CES) , and MWC was no exception to this trend. New versions of favorites, such as the Samsung Gear (three new products were released: the Gear 2, the Gear 2 Neo and the Gear Fit), shared the limelight with new wearables like Pebble Time Steel (the new premium version of the company’s previously released smartwatch) and the LG Watch Urbane. The most dramatic difference at MWC was an emphasis on presenting wearables as fashion accessories and moving away from the original clunky technology associated with t...
SYS-CON Events announced today that Litmus Automation will exhibit at SYS-CON's 16th International Cloud Expo®, which will take place on June 9-11, 2015, at the Javits Center in New York City, NY. Litmus Automation’s vision is to provide a solution for companies that are in a rush to embrace the disruptive Internet of Things technology and leverage it for real business challenges. Litmus Automation simplifies the complexity of connected devices applications with Loop, a secure and scalable cloud platform.
In 2015, 4.9 billion connected "things" will be in use. By 2020, Gartner forecasts this amount to be 25 billion, a 410 percent increase in just five years. How will businesses handle this rapid growth of data? Hadoop will continue to improve its technology to meet business demands, by enabling businesses to access/analyze data in real time, when and where they need it. Cloudera's Chief Technologist, Eli Collins, will discuss how Big Data is keeping up with today's data demands and how in the future, data and analytics will be pervasive, embedded into every workflow, application and infra...
As Marc Andreessen says software is eating the world. Everything is rapidly moving toward being software-defined – from our phones and cars through our washing machines to the datacenter. However, there are larger challenges when implementing software defined on a larger scale - when building software defined infrastructure. In his session at 16th Cloud Expo, Boyan Ivanov, CEO of StorPool, will provide some practical insights on what, how and why when implementing "software-defined" in the datacenter.
So I guess we’ve officially entered a new era of lean and mean. I say this with the announcement of Ubuntu Snappy Core, “designed for lightweight cloud container hosts running Docker and for smart devices,” according to Canonical. “Snappy Ubuntu Core is the smallest Ubuntu available, designed for security and efficiency in devices or on the cloud.” This first version of Snappy Ubuntu Core features secure app containment and Docker 1.6 (1.5 in main release), is available on public clouds, and for ARM and x86 devices on several IoT boards. It’s a Trend! This announcement comes just as...
SYS-CON Events announced today that Vicom Computer Services, Inc., a provider of technology and service solutions, will exhibit at SYS-CON's 16th International Cloud Expo®, which will take place on June 9-11, 2015, at the Javits Center in New York City, NY. They are located at booth #427. Vicom Computer Services, Inc. is a progressive leader in the technology industry for over 30 years. Headquartered in the NY Metropolitan area. Vicom provides products and services based on today’s requirements around Unified Networks, Cloud Computing strategies, Virtualization around Software defined Data Ce...
SYS-CON Events announced today the IoT Bootcamp – Jumpstart Your IoT Strategy, being held June 9–10, 2015, in conjunction with 16th Cloud Expo and Internet of @ThingsExpo at the Javits Center in New York City. This is your chance to jumpstart your IoT strategy. Combined with real-world scenarios and use cases, the IoT Bootcamp is not just based on presentations but includes hands-on demos and walkthroughs. We will introduce you to a variety of Do-It-Yourself IoT platforms including Arduino, Raspberry Pi, BeagleBone, Spark and Intel Edison. You will also get an overview of cloud technologies s...
SYS-CON Events announced today that AIC, a leading provider of OEM/ODM server and storage solutions, will exhibit at SYS-CON's 16th International Cloud Expo®, which will take place on June 9-11, 2015, at the Javits Center in New York City, NY. AIC is a leading provider of both standard OTS, off-the-shelf, and OEM/ODM server and storage solutions. With expert in-house design capabilities, validation, manufacturing and production, AIC's broad selection of products are highly flexible and are configurable to any form factor or custom configuration. AIC leads the industry with nearly 20 years of ...
Containers and microservices have become topics of intense interest throughout the cloud developer and enterprise IT communities. Accordingly, attendees at the upcoming 16th Cloud Expo at the Javits Center in New York June 9-11 will find fresh new content in a new track called PaaS | Containers & Microservices Containers are not being considered for the first time by the cloud community, but a current era of re-consideration has pushed them to the top of the cloud agenda. With the launch of Docker's initial release in March of 2013, interest was revved up several notches. Then late last...
The only place to be June 9-11 is Cloud Expo & @ThingsExpo 2015 East at the Javits Center in New York City. Join us there as delegates from all over the world come to listen to and engage with speakers & sponsors from the leading Cloud Computing, IoT & Big Data companies. Cloud Expo & @ThingsExpo are the leading events covering the booming market of Cloud Computing, IoT & Big Data for the enterprise. Speakers from all over the world will be hand-picked for their ability to explore the economic strategies that utility/cloud computing provides. Whether public, private, or in a hybrid form, clo...
WebRTC is an up-and-coming standard that enables real-time voice and video to be directly embedded into browsers making the browser a primary user interface for communications and collaboration. WebRTC runs in a number of browsers today and is currently supported in over a billion installed browsers globally, across a range of platform OS and devices. Today, organizations that choose to deploy WebRTC applications and use a host machine that supports audio through USB or Bluetooth can use Plantronics products to connect and transit or receive the audio associated with the WebRTC session.
Internet of Things (IoT) will be a hybrid ecosystem of diverse devices and sensors collaborating with operational and enterprise systems to create the next big application. In their session at @ThingsExpo, Bramh Gupta, founder and CEO of robomq.io, and Fred Yatzeck, principal architect leading product development at robomq.io, will discuss how choosing the right middleware and integration strategy from the get-go will enable IoT solution developers to adapt and grow with the industry, while at the same time reduce Time to Market (TTM) by using plug and play capabilities offered by a robust I...
IoT is still a vague buzzword for many people. In his session at @ThingsExpo, Mike Kavis, Vice President & Principal Cloud Architect at Cloud Technology Partners, discussed the business value of IoT that goes far beyond the general public's perception that IoT is all about wearables and home consumer services. He also discussed how IoT is perceived by investors and how venture capitalist access this space. Other topics discussed were barriers to success, what is new, what is old, and what the future may hold. Mike Kavis is Vice President & Principal Cloud Architect at Cloud Technology Pa...
@ThingsExpo has been named the Top 5 Most Influential Internet of Things Brand by Onalytica in the ‘The Internet of Things Landscape 2015: Top 100 Individuals and Brands.' Onalytica analyzed Twitter conversations around the #IoT debate to uncover the most influential brands and individuals driving the conversation. Onalytica captured data from 56,224 users. The PageRank based methodology they use to extract influencers on a particular topic (tweets mentioning #InternetofThings or #IoT in this case) takes into account the number and quality of contextual references that a user receives.
Buzzword alert: Microservices and IoT at a DevOps conference? What could possibly go wrong? Join this panel of experts as they peel away the buzz and discuss the important architectural principles behind implementing IoT solutions for the enterprise. As remote IoT devices and sensors become increasingly intelligent, they become part of our distributed cloud environment, and we must architect and code accordingly. At the very least, you’ll have no problem filling in your buzzword bingo cards.
As enterprises move to all-IP networks and cloud-based applications, communications service providers (CSPs) – facing increased competition from over-the-top providers delivering content via the Internet and independently of CSPs – must be able to offer seamless cloud-based communication and collaboration solutions that can scale for small, midsize, and large enterprises, as well as public sector organizations, in order to keep and grow market share. The latest version of Oracle Communications Unified Communications Suite gives CSPs the capability to do just that. In addition, its integration ...
SYS-CON Events announced today that Creative Business Solutions will exhibit at SYS-CON's 16th International Cloud Expo®, which will take place on June 9-11, 2015, at the Javits Center in New York City, NY. Creative Business Solutions is the top stocking authorized HP Renew Distributor in the U.S. Based out of Long Island, NY, Creative Business Solutions offers a one-stop shop for a diverse range of products including Proliant, Blade and Industry Standard Servers, Networking, Server Options and Care Packs. As a trusted supplier, CBS guarantees quality controlled stock levels thanks to an Auto...