Click here to close now.




















Welcome!

Microsoft Cloud Authors: Greg O'Connor, Liz McMillan, Aleksei Gavrilenko, Elizabeth White, Pat Romanski

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
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...
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...
It is one thing to build single industrial IoT applications, but what will it take to build the Smart Cities and truly society-changing applications of the future? The technology won’t be the problem, it will be the number of parties that need to work together and be aligned in their motivation to succeed. In his session at @ThingsExpo, Jason Mondanaro, Director, Product Management at Metanga, discussed how you can plan to cooperate, partner, and form lasting all-star teams to change the world and it starts with business models and monetization strategies.
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.
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.
Discussions about cloud computing are evolving into discussions about enterprise IT in general. As enterprises increasingly migrate toward their own unique clouds, new issues such as the use of containers and microservices emerge to keep things interesting. In this Power Panel at 16th Cloud Expo, moderated by Conference Chair Roger Strukhoff, panelists addressed the state of cloud computing today, and what enterprise IT professionals need to know about how the latest topics and trends affect their organization.
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.
Converging digital disruptions is creating a major sea change - Cisco calls this the Internet of Everything (IoE). IoE is the network connection of People, Process, Data and Things, fueled by Cloud, Mobile, Social, Analytics and Security, and it represents a $19Trillion value-at-stake over the next 10 years. In her keynote at @ThingsExpo, Manjula Talreja, VP of Cisco Consulting Services, discussed IoE and the enormous opportunities it provides to public and private firms alike. She will share what businesses must do to thrive in the IoE economy, citing examples from several industry sectors.
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...
There will be 150 billion connected devices by 2020. New digital businesses have already disrupted value chains across every industry. APIs are at the center of the digital business. You need to understand what assets you have that can be exposed digitally, what their digital value chain is, and how to create an effective business model around that value chain to compete in this economy. No enterprise can be complacent and not engage in the digital economy. Learn how to be the disruptor and not the disruptee.
Akana has released Envision, an enhanced API analytics platform that helps enterprises mine critical insights across their digital eco-systems, understand their customers and partners and offer value-added personalized services. “In today’s digital economy, data-driven insights are proving to be a key differentiator for businesses. Understanding the data that is being tunneled through their APIs and how it can be used to optimize their business and operations is of paramount importance,” said Alistair Farquharson, CTO of Akana.
Business as usual for IT is evolving into a "Make or Buy" decision on a service-by-service conversation with input from the LOBs. How does your organization move forward with cloud? In his general session at 16th Cloud Expo, Paul Maravei, Regional Sales Manager, Hybrid Cloud and Managed Services at Cisco, discusses how Cisco and its partners offer a market-leading portfolio and ecosystem of cloud infrastructure and application services that allow you to uniquely and securely combine cloud business applications and services across multiple cloud delivery models.
The enterprise market will drive IoT device adoption over the next five years. In his session at @ThingsExpo, John Greenough, an analyst at BI Intelligence, division of Business Insider, analyzed how companies will adopt IoT products and the associated cost of adopting those products. John Greenough is the lead analyst covering the Internet of Things for BI Intelligence- Business Insider’s paid research service. Numerous IoT companies have cited his analysis of the IoT. Prior to joining BI Intelligence, he worked analyzing bank technology for Corporate Insight and The Clearing House Payment...
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.
"Optimal Design is a technology integration and product development firm that specializes in connecting devices to the cloud," stated Joe Wascow, Co-Founder & CMO of Optimal Design, in this SYS-CON.tv interview at @ThingsExpo, held June 9-11, 2015, at the Javits Center in New York City.
SYS-CON Events announced today that CommVault has been named “Bronze Sponsor” of SYS-CON's 17th International Cloud Expo®, which will take place on November 3–5, 2015, at the Santa Clara Convention Center in Santa Clara, CA. A singular vision – a belief in a better way to address current and future data management needs – guides CommVault in the development of Singular Information Management® solutions for high-performance data protection, universal availability and simplified management of data on complex storage networks. CommVault's exclusive single-platform architecture gives companies unp...
Electric Cloud and Arynga have announced a product integration partnership that will bring Continuous Delivery solutions to the automotive Internet-of-Things (IoT) market. The joint solution will help automotive manufacturers, OEMs and system integrators adopt DevOps automation and Continuous Delivery practices that reduce software build and release cycle times within the complex and specific parameters of embedded and IoT software systems.
"ciqada is a combined platform of hardware modules and server products that lets people take their existing devices or new devices and lets them be accessible over the Internet for their users," noted Geoff Engelstein of ciqada, a division of Mars International, in this SYS-CON.tv interview at @ThingsExpo, held June 9-11, 2015, at the Javits Center in New York City.
Internet of Things is moving from being a hype to a reality. Experts estimate that internet connected cars will grow to 152 million, while over 100 million internet connected wireless light bulbs and lamps will be operational by 2020. These and many other intriguing statistics highlight the importance of Internet powered devices and how market penetration is going to multiply many times over in the next few years.
SYS-CON Events announced today that Dyn, the worldwide leader in Internet Performance, will exhibit at SYS-CON's 17th International Cloud Expo®, which will take place on November 3-5, 2015, at the Santa Clara Convention Center in Santa Clara, CA. Dyn is a cloud-based Internet Performance company. Dyn helps companies monitor, control, and optimize online infrastructure for an exceptional end-user experience. Through a world-class network and unrivaled, objective intelligence into Internet conditions, Dyn ensures traffic gets delivered faster, safer, and more reliably than ever.