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
Existing Big Data solutions are mainly focused on the discovery and analysis of data. The solutions are scalable and highly available but tedious when swapping in and swapping out occurs in disarray and thrashing takes place. The resolution for thrashing through machine learning algorithms and support nomenclature is through simple techniques. Organizations that have been collecting large customer data are increasingly seeing the need to use the data for swapping in and out and thrashing occurs ...
SYS-CON Events announced today that Enzu will exhibit at 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, and the 21st International Cloud Expo®, which will take place October 31-November 2, 2017, at the Santa Clara Convention Center in Santa Clara, CA. Enzu’s mission is to be the leading provider of enterprise cloud solutions worldwide. Enzu enables online businesses to use its IT infrastructure to their competitive ad...
SYS-CON Events announced today that delaPlex will exhibit at SYS-CON's @CloudExpo, which will take place on June 6-8, 2017, at the Javits Center in New York City, NY. delaPlex pioneered Software Development as a Service (SDaaS), which provides scalable resources to build, test, and deploy software. It’s a fast and more reliable way to develop a new product or expand your in-house team.
DevOps is often described as a combination of technology and culture. Without both, DevOps isn't complete. However, applying the culture to outdated technology is a recipe for disaster; as response times grow and connections between teams are delayed by technology, the culture will die. A Nutanix Enterprise Cloud has many benefits that provide the needed base for a true DevOps paradigm.
SYS-CON Events announced today that Interoute 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. Interoute is the owner operator of Europe's largest network and a global cloud services platform, which encompasses over 70,000 km of lit fiber, 15 data centers, 17 virtual data centers and 33 colocation centers, with connections to 195 additional partner data centers. Our full-service Unifie...
SYS-CON Events announced today that Progress, a global leader in application development, 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. Enterprises today are rapidly adopting the cloud, while continuing to retain business-critical/sensitive data inside the firewall. This is creating two separate data silos – one inside the firewall and the other outside the firewall. Cloud ISVs oft...
SYS-CON Events announced today that Carbonite will exhibit at 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. Carbonite protects your entire IT footprint with the right level of protection for each workload, ensuring lower costs and dependable solutions with DoubleTake and Evault.
SYS-CON Events announced today that WineSOFT will exhibit at 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. Based in Seoul and Irvine, WineSOFT is an innovative software house focusing on internet infrastructure solutions. The venture started as a bootstrap start-up in 2010 by focusing on making the internet faster and more powerful. WineSOFT’s knowledge is based on the expertise of TCP/IP, VPN, SSL, peer-to-peer, mob...
When NSA's digital armory was leaked, it was only a matter of time before the code was morphed into a ransom seeking worm. This talk, designed for C-level attendees, demonstrates a Live Hack of a virtual environment to show the ease in which any average user can leverage these tools and infiltrate their network environment. This session will include an overview of the Shadbrokers NSA leak situation.
Cloud-based disaster recovery is critical to any production environment and is a high priority for many enterprise organizations today. Nearly 40% of organizations have had to execute their BCDR plan due to a service disruption in the past two years. Zerto on IBM Cloud offer VMware and Microsoft customers simple, automated recovery of on-premise VMware and Microsoft workloads to IBM Cloud data centers.
SYS-CON Events announced today that Ocean9will exhibit at 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. Ocean9 provides cloud services for Backup, Disaster Recovery (DRaaS) and instant Innovation, and redefines enterprise infrastructure with its cloud native subscription offerings for mission critical SAP workloads.
SYS-CON Events announced today that Progress, a global leader in application development, 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. Enterprises today are rapidly adopting the cloud, while continuing to retain business-critical/sensitive data inside the firewall. This is creating two separate data silos – one inside the firewall and the other outside the firewall. Cloud ISVs ofte...
Most DevOps journeys involve several phases of maturity. Research shows that the inflection point where organizations begin to see maximum value is when they implement tight integration deploying their code to their infrastructure. Success at this level is the last barrier to at-will deployment. Storage, for instance, is more capable than where we read and write data. In his session at @DevOpsSummit at 20th Cloud Expo, Josh Atwell, a Developer Advocate for NetApp, will discuss the role and valu...
SYS-CON Events announced today that Cloud Academy will exhibit at 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. Cloud Academy is the industry’s most innovative, vendor-neutral cloud technology training platform. Cloud Academy provides continuous learning solutions for individuals and enterprise teams for Amazon Web Services, Microsoft Azure, Google Cloud Platform, and the most popular cloud computing technologies. Ge...
As cloud adoption continues to transform business, today's global enterprises are challenged with managing a growing amount of information living outside of the data center. The rapid adoption of IoT and increasingly mobile workforce are exacerbating the problem. Ensuring secure data sharing and efficient backup poses capacity and bandwidth considerations as well as policy and regulatory compliance issues.