Welcome!

News Feed Item

Acura Pharmaceuticals Announces First Quarter 2014 Financial Results

PALATINE, IL -- (Marketwired) -- 05/05/14 -- Acura Pharmaceuticals, Inc. (NASDAQ: ACUR), a specialty pharmaceutical company developing products intended to address medication abuse and misuse, announced today financial results for the first quarter ended March 31, 2014.

The Company reported a net loss of $4.1 million for the first quarter 2014 or $0.08 per diluted share, compared to net loss of $4.2 million or $0.09 per diluted share for the same period in 2013.

Research and development expenses associated with product candidates utilizing the Company's AVERSION® and IMPEDE® Technologies were $1.4 million in the first quarter 2014, compared to $2.0 million for the same period in 2013. Selling, marketing, general and administrative expenses were $2.3 million in the first quarter 2014, versus $2.2 million in the same period last year. Selling expenses primarily consisted of advertising and marketing activities for NEXAFED®.

As of April 30, 2014, the Company had cash, cash equivalents and marketable securities of $20.3 million and $10.0 million in term debt financing.

We launched NEXAFED® commercially in mid-December 2012. Given the limited sales history of NEXAFED®, we could not reliably estimate expected returns of the product at the time of shipment. Accordingly, we have deferred recognition of revenue and the related cost of sales on product shipments of NEXAFED® since its launch until the right of return no longer exists or adequate history and information is available to estimate product returns. At March 31, 2014 we have deferred $290 thousand of revenue. During the 1st quarter 2014 we recognized revenue of $39 thousand for shipments to customers where the right of return no longer existed either because a pricing allowance was accepted in exchange for forfeiting the right of return or because information became available on pharmacy's reorder activity with their drug wholesaler. During the first quarter 2014 we shipped $42 thousand of NEXAFED®. We will continue to analyze information to assess the recognition of our revenue but also expect to continue the deferral of some revenue in the foreseeable future.

On April 10, 2014 we announced the signing of a letter agreement with Pfizer Inc. providing for termination of Pfizer's license to Acura's AVERSION® Technology and the return to Acura of the FDA approved AVERSION® oxycodone product, previously marketed by Pfizer under its brand name Oxecta®. The letter agreement provides that Acura will make a one-time payment of $2.0 million to Pfizer. The license termination is effective April 9, 2014. The AVERSION® Technology utilizes a proprietary mixture of inactive ingredients to discourage tampering of a product for abusive purposes.

Conference Call Information
Acura Pharmaceuticals, Inc. will host a conference call on Tuesday, May 6, 2014 at 8:30 a.m. ET to discuss the results.

To participate in the live conference call, please dial 1-888-428-9473 (U.S. and Canada) five to ten minutes prior to the start of the call. The participant passcode is 9678956.A replay of the call will be available beginning May 6, 2014 at 11:30 a.m. ET and ending on May 26, 2014 on the company's website, and by dialing 1-888-203-1112 (U.S. and Canada). The replay participant code is 9678956.

About Acura Pharmaceuticals
Acura Pharmaceuticals is a specialty pharmaceutical company engaged in the research, development and commercialization of product candidates intended to address medication abuse and misuse, utilizing its proprietary AVERSION® and IMPEDE® Technologies. AVERSION® contains polymers that cause the drug to gel when dissolved; it also contains compounds that irritate the nasal passages. IMPEDE® which is a combination of inactive ingredients that prevent the extraction of pseudoephedrine from tablets and disrupt the direct conversion of pseudoephedrine from tablets into methamphetamine. In mid-December 2012 we launched in the United States NEXAFED® (pseudoephedrine HC1) tablets formulated with our IMPEDE® Technology.

Forward-Looking Statements
Certain statements in this press release constitute "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements involve known and unknown risks, uncertainties and other factors which may cause our actual results, performance or achievements to be materially different from any future results, performance, or achievements expressed or implied by such forward-looking statements. Forward-looking statements may include, but are not limited to:

  • our ability to enter into a license agreement for our FDA approved AVERSION® oxycodone product;
  • our and our licensee's ability to successfully launch and commercialize our products and technologies including AVERSION® oxycodone and NEXAFED® Tablets;
  • our and our licensee's ability to obtain necessary regulatory approvals and commercialize products utilizing our technologies;
  • the market acceptance of and competitive environment for any of our products;
  • the willingness of wholesalers and pharmacies to stock NEXAFED® Tablets;
  • expectations regarding potential market share for our products and the timing of first sales;
  • our ability to enter into additional license agreements for our AVERSION® Technology product candidates;
  • our exposure to product liability and other lawsuits in connection with the commercialization of our products;
  • the increasing cost of insurance and the availability of product liability insurance coverage;
  • the ability to avoid infringement of patents, trademarks and other proprietary rights of third parties;
  • the ability of our patents to protect our products from generic competition and our ability to protect and enforce our patent rights in any paragraph IV patent infringement litigation;
  • the ability to fulfill the FDA requirements for approving our product candidates for commercial manufacturing and distribution in the United States, including, without limitation, the adequacy of the results of the laboratory and clinical studies completed to date, the results of laboratory and clinical studies we may complete in the future to support FDA approval of our product candidates and the sufficiency of our development process to meet OTC Monograph standards as applicable;
  • the adequacy of the development program for our product candidates, including whether additional clinical studies will be required to support FDA approval of our product candidates;
  • changes in regulatory requirements;
  • adverse safety findings relating to our product candidates;
  • whether the FDA will agree with our analysis of our clinical and laboratory studies;
  • whether further studies of our product candidates will be required to support FDA approval;
  • whether or when we are able to obtain FDA approval of labeling for our product candidates for the proposed indications and will be able to promote the features of our abuse discouraging technologies; and
  • whether our AVERSION® product candidates will ultimately deter abuse in commercial settings and whether our IMPEDE® technology will disrupt the processing of pseudoephedrine into methamphetamine.

In some cases, you can identify forward-looking statements by terms such as "may," "will," "should," "could," "would," "expects," "plans," "anticipates," "believes," "indicates," "estimates," "projects," "predicts," "potential" and similar expressions intended to identify forward-looking statements. These statements reflect our current views with respect to future events and are based on assumptions and subject to risks and uncertainties. Given these uncertainties, you should not place undue reliance on these forward-looking statements. We discuss many of these risks in greater detail in our filings with the Securities and Exchange Commission. Unless required by law, we undertake no obligation to update or revise any forward-looking statements to reflect new information or future events or developments. Thus, you should not assume that our silence over time means that actual events are bearing out as expressed or implied in such forward-looking statements. In light of these risks, uncertainties and assumptions, the forward-looking events and circumstances discussed in this press release may not occur and actual results could differ materially and adversely from those anticipated or implied in the forward-looking statements.


                         ACURA PHARMACEUTICALS, INC.
                    CONDENSED CONSOLIDATED BALANCE SHEETS
                               (in thousands)

                                                  (unaudited)    (audited)
                                                   March 31,    December 31,
                                                      2014          2013
                                                 ------------- -------------
Current assets                                   $      23,692 $      27,453
Property, plant and equipment, net                         947           941
Other assets                                               221           236
                                                 ------------- -------------
  Total assets                                   $      24,860 $      28,630
                                                 ------------- -------------

Current liabilities                              $       1,352 $         820
Deferred revenue                                           290           287
Other liabilities                                           46             -
Long-term debt, net of debt discount of $370 and
 $400                                                    9,630         9,600
Stockholders' equity                                    13,542        17,923
                                                 ------------- -------------
  Total liabilities and stockholders' equity     $      24,860 $      28,630
                                                 ------------- -------------



                        ACURA PHARMACEUTICALS, INC.
           CONSOLIDATED STATEMENTS OF COMPREHENSIVE INCOME (LOSS)
                   (in thousands, except per share data)

                                                        (unaudited)
                                               Three Months Ended March 31,
                                                    2014           2013
                                               -------------  -------------
Revenues:
  Royalty revenue                              $           3  $           4
  Product sales, net                                      39              -
                                               -------------  -------------
    Total revenues, net                                   42              4
                                               -------------  -------------
Operating expenses:
  Cost of sales (excluding write-down)                    38              -
  Inventory write-down                                   133              -
  Research and development                             1,438          2,026
  Selling, marketing, general and
   administrative                                      2,259          2,222
                                               -------------  -------------
    Total operating expenses                           3,868          4,248
                                               -------------  -------------
    Operating loss                                    (3,826)        (4,244)
Non-operating income (expense):
  Investment income                                       44             10
  (Loss) gain on sales of marketable
   securities                                             (5)            16
  Interest expense                                      (301)             -
                                               -------------  -------------
    Total other income (expense)                        (262)            26
                                               -------------  -------------
    Loss before income taxes                          (4,088)        (4,218)
Provision for income taxes                                 -              -
                                               -------------  -------------
    Net loss                                   $      (4,088) $      (4,218)
                                               -------------  -------------
Other comprehensive income (loss):
  Unrealized gains (losses) on securities                 29             52
                                               -------------  -------------
    Total other comprehensive income (loss)               29             52
                                               -------------  -------------
    Comprehensive income (loss)                $      (4,059) $      (4,166)
                                               -------------  -------------


                                               -------------  -------------
Loss per share:
  Basic                                        $       (0.08) $       (0.09)
  Diluted                                      $       (0.08) $       (0.09)
                                               -------------  -------------
Weighted average shares outstanding:
  Basic                                               48,842         46,685
  Diluted                                             48,842         46,685
                                               -------------  -------------

Contact:
for Acura Investor Relations
Email Contact
847-705-7709

for Acura Media Relations
Email Contact
847-705-7709

More Stories By Marketwired .

Copyright © 2009 Marketwired. All rights reserved. All the news releases provided by Marketwired are copyrighted. Any forms of copying other than an individual user's personal reference without express written permission is prohibited. Further distribution of these materials is strictly forbidden, including but not limited to, posting, emailing, faxing, archiving in a public database, redistributing via a computer network or in a printed form.

Latest Stories
In his session at 18th Cloud Expo, Sagi Brody, Chief Technology Officer at Webair Internet Development Inc., and Logan Best, Infrastructure & Network Engineer at Webair, focused on real world deployments of DDoS mitigation strategies in every layer of the network. He gave an overview of methods to prevent these attacks and best practices on how to provide protection in complex cloud platforms. He also outlined what we have found in our experience managing and running thousands of Linux and Unix ...
"LinearHub provides smart video conferencing, which is the Roundee service, and we archive all the video conferences and we also provide the transcript," stated Sunghyuk Kim, CEO of LinearHub, in this SYS-CON.tv interview at @ThingsExpo, held November 1-3, 2016, at the Santa Clara Convention Center in Santa Clara, CA.
When you focus on a journey from up-close, you look at your own technical and cultural history and how you changed it for the benefit of the customer. This was our starting point: too many integration issues, 13 SWP days and very long cycles. It was evident that in this fast-paced industry we could no longer afford this reality. We needed something that would take us beyond reducing the development lifecycles, CI and Agile methodologies. We made a fundamental difference, even changed our culture...
Internet of @ThingsExpo, taking place June 6-8, 2017 at the Javits Center in New York City, New York, is co-located with the 20th International Cloud Expo and will feature technical sessions from a rock star conference faculty and the leading industry players in the world. @ThingsExpo New York Call for Papers is now open.
SYS-CON Events announced today that Dataloop.IO, an innovator in cloud IT-monitoring whose products help organizations save time and money, has been named “Bronze Sponsor” of SYS-CON's 20th International Cloud Expo®, which will take place on June 6-8, 2017, at the Javits Center in New York City, NY. Dataloop.IO is an emerging software company on the cutting edge of major IT-infrastructure trends including cloud computing and microservices. The company, founded in the UK but now based in San Fran...
"There's a growing demand from users for things to be faster. When you think about all the transactions or interactions users will have with your product and everything that is between those transactions and interactions - what drives us at Catchpoint Systems is the idea to measure that and to analyze it," explained Leo Vasiliou, Director of Web Performance Engineering at Catchpoint Systems, in this SYS-CON.tv interview at 18th Cloud Expo, held June 7-9, 2016, at the Javits Center in New York Ci...
The 20th International Cloud Expo has announced that its Call for Papers is open. Cloud Expo, to be held June 6-8, 2017, at the Javits Center in New York City, brings together Cloud Computing, Big Data, Internet of Things, DevOps, Containers, Microservices and WebRTC to one location. With cloud computing driving a higher percentage of enterprise IT budgets every year, it becomes increasingly important to plant your flag in this fast-expanding business opportunity. Submit your speaking proposal ...
WebRTC is the future of browser-to-browser communications, and continues to make inroads into the traditional, difficult, plug-in web communications world. The 6th WebRTC Summit continues our tradition of delivering the latest and greatest presentations within the world of WebRTC. Topics include voice calling, video chat, P2P file sharing, and use cases that have already leveraged the power and convenience of WebRTC.
In a recent research, analyst firm IDC found that the average cost of a critical application failure is $500,000 to $1 million per hour and the average total cost of unplanned application downtime is $1.25 billion to $2.5 billion per year for Fortune 1000 companies. In addition to the findings on the cost of the downtime, the research also highlighted best practices for development, testing, application support, infrastructure, and operations teams.
20th Cloud Expo, taking place June 6-8, 2017, at the Javits Center in New York City, NY, will feature technical sessions from a rock star conference faculty and the leading industry players in the world. Cloud computing is now being embraced by a majority of enterprises of all sizes. Yesterday's debate about public vs. private has transformed into the reality of hybrid cloud: a recent survey shows that 74% of enterprises have a hybrid cloud strategy.
Discover top technologies and tools all under one roof at April 24–28, 2017, at the Westin San Diego in San Diego, CA. Explore the Mobile Dev + Test and IoT Dev + Test Expo and enjoy all of these unique opportunities: The latest solutions, technologies, and tools in mobile or IoT software development and testing. Meet one-on-one with representatives from some of today's most innovative organizations
@DevOpsSummit taking place June 6-8, 2017 at Javits Center, New York City, is co-located with the 20th International Cloud Expo and will feature technical sessions from a rock star conference faculty and the leading industry players in the world. @DevOpsSummit at Cloud Expo New York Call for Papers is now open.
Providing the needed data for application development and testing is a huge headache for most organizations. The problems are often the same across companies - speed, quality, cost, and control. Provisioning data can take days or weeks, every time a refresh is required. Using dummy data leads to quality problems. Creating physical copies of large data sets and sending them to distributed teams of developers eats up expensive storage and bandwidth resources. And, all of these copies proliferating...
SYS-CON Events announced today that Catchpoint Systems, Inc., a provider of innovative web and infrastructure monitoring solutions, has been named “Silver Sponsor” of SYS-CON's DevOps Summit at 18th Cloud Expo New York, which will take place June 7-9, 2016, at the Javits Center in New York City, NY. Catchpoint is a leading Digital Performance Analytics company that provides unparalleled insight into customer-critical services to help consistently deliver an amazing customer experience. Designed ...
DevOps is being widely accepted (if not fully adopted) as essential in enterprise IT. But as Enterprise DevOps gains maturity, expands scope, and increases velocity, the need for data-driven decisions across teams becomes more acute. DevOps teams in any modern business must wrangle the ‘digital exhaust’ from the delivery toolchain, "pervasive" and "cognitive" computing, APIs and services, mobile devices and applications, the Internet of Things, and now even blockchain. In this power panel at @...