News Feed Item

IsoRay, Inc. Reports Third Quarter Results

Sales Continue to All Study Sites Beyond Planned Enrollment Levels as Data Matures for Presentation and Peer Review

RICHLAND, WA -- (Marketwired) -- 05/16/14 -- IsoRay, Inc. (NYSE MKT: ISR), a medical technology company and innovator in seed brachytherapy and medical radioisotope applications for brain cancer, lung cancer, head and neck cancer, prostate cancer and gynecologic ("gyn") cancer, announced its financial results for the quarter and nine months ended March 31, 2014.

While substantially all of our outstanding warrants were exercised in the quarter ended March 31, 2014, generating cash proceeds in excess of $5,961,000, we still have over 400,000 warrants outstanding that result in derivative liability. The loss per share increase of 3¢ per share for the quarter and 5¢ per share for the nine month period are attributable to the non-cash derivative liability increase caused by the increase in our common stock price for the quarter.

Prostate treatment revenues constituting approximately 83% of all revenue were unchanged in the nine month period and slightly lower in the quarter, but in line with the continued national market weakness for all prostate treatment modalities. Low risk prostate patients increasingly are engaging in "watchful waiting" before making a final decision as to what modality to choose. Management believes these patients often wait too long when a simple solution like IsoRay's Cesium-131 (Cs-131) can be an effective option when the cancer hasn't metastasized. With multiple institutions now reporting 5 year and 6 year study data showing unequaled biochemical control utilizing IsoRay's Cesium-131 in the treatment of prostate cancer, management believes Cs-131 can provide a solution for these patients.

IsoRay Chairman and CEO Dwight Babcock commented, "The recent publication of the first peer reviewed article showing positive results using Cs-131 in the treatment of gynecologic cancer reinforces our strategy to focus on expanding the use of Cs-131 and its unique isotope qualities to treat cancers in the prostate and other body sites, such as brain cancer, head and neck cancer, lung cancer and gyn cancers, while providing patients with a better quality of life than many competing treatments. As the Company continues to accumulate peer reviewed articles reporting the success of Cs-131, we expect to see increasing acceptance of Cs-131 in the medical community that should lead to revenue growth. The marketing of new radioactive medical devices is a process that has numerous steps and is a long term process requiring patient study data to mature before submission of peer reviewed articles."

Babcock further said, "IsoRay's customers are continuing to use our products with new patients even though they have successfully reached their required patient enrollments to produce statistically relevant results. These early adopters are seeing successful outcomes from the application of Cs-131 in treating their patients and we are encouraged that they continue to order products for their new patients."

IsoRay's management continues to seek to maintain the highest manufacturing standards and quality assurance processes, which are reviewed periodically by U.S. and international regulatory agencies. IsoRay has never had any negative findings reported by such reviews. Presently IsoRay has no debt and sufficient cash and cash equivalents to meet its anticipated needs for the next several years. Management continues to invest in research and development such as the liquid form of the Cs-131 isotope. The Company continues to focus on Cs-131's efficacy for various cancers located throughout the body and we expect this to have a direct impact on our overall revenue growth with an expanding array of non-prostate cancer treatments.

IsoRay, Inc. and Subsidiaries
Consolidated Statements of Operations

                            Three months ended         Nine months ended
                                 March 31,                 March 31,
                             2014         2013         2014         2013
                         -----------  -----------  -----------  -----------

Product sales            $ 1,134,319  $ 1,275,478  $ 3,269,642  $ 3,283,167
Cost of product sales      1,083,413    1,065,574    3,329,950    3,276,314
                         -----------  -----------  -----------  -----------

  Gross profit                50,906      185,904      (60,308)       6,853
                         -----------  -----------  -----------  -----------

Operating expenses:
  Research and
   development expenses      153,611      155,137      470,631      445,785
  Sales and marketing
   expenses                  245,558      290,812      931,210      928,962
  General and
   expenses                  640,732      564,075    1,805,732    1,678,487
                         -----------  -----------  -----------  -----------

    Total operating
     expenses              1,039,901    1,010,024    3,207,573    3,053,234
                         -----------  -----------  -----------  -----------

    Operating loss          (988,995)    (824,120)  (3,267,881)  (3,046,381)
                         -----------  -----------  -----------  -----------

Non-operating income
  Interest income                556           83        1,391          355
  Change in fair value
   of warrant derivative
   liability              (1,095,000)     109,000   (1,014,000)     183,000
  Financing and interest
   expense                         -            -         (827)          (6)
                         -----------  -----------  -----------  -----------

    Non-operating income
     / (expense), net     (1,094,444)     109,083   (1,013,436)     183,349
                         -----------  -----------  -----------  -----------

    Net loss              (2,083,439)    (715,037)  (4,281,317)  (2,863,032)
    Preferred stock
     deemed dividend
     (Note 9)                      -            -     (726,378)           -
    Preferred stock
     dividends                (2,658)      (2,658)      (7,974)      (7,974)
                         -----------  -----------  -----------  -----------

    Net loss applicable
     to common
     shareholders        $(2,086,097) $  (717,695) $(5,015,669) $(2,871,006)
                         ===========  ===========  ===========  ===========

Basic and diluted loss
 per share               $     (0.05) $     (0.02) $     (0.13) $     (0.08)
                         ===========  ===========  ===========  ===========

Weighted average shares
 used in computing net
 loss per share:
Basic and diluted         42,506,077   34,611,517   38,852,980   34,359,567
                         ===========  ===========  ===========  ===========

About IsoRay
IsoRay, Inc., through its subsidiary, IsoRay Medical, Inc. is the sole producer of Cesium-131 brachytherapy seeds, which
is expanding brachytherapy options throughout the body. Learn more about this innovative Richland, Washington
company and explore the many benefits and uses of GliaSite® and Cesium-131 by visiting www.isoray.com. Join
us on Facebook/Isoray. Follow us on [email protected]

Safe Harbor Statement
Statements in this news release about IsoRay's future expectations, including: the advantages of our products and their delivery systems, whether IsoRay will be able to continue to expand its base beyond prostate cancer, whether sales of our products will continue at historic levels, decrease or increase, whether the use of our products will increase or continue, whether future studies of treatment of various cancers using our products will have favorable results, whether awareness of our products in the medical community will continue or increase, future demand for IsoRay's existing and planned products, whether revenue and other financial metrics will improve in future periods, whether we will maintain required manufacturing standards and quality assurance processes, and all other statements in this release, other than historical facts, are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995 ("PSLRA"). This statement is included for the express purpose of availing IsoRay, Inc. of the protections of the safe harbor provisions of the PSLRA. It is important to note that actual results and ultimate corporate actions could differ materially from those in such forward-looking statements based on such factors as physician acceptance, training and use of IsoRay's products, changing levels of demand for IsoRay's current and proposed future products, IsoRay's ability to reduce or maintain expenses while increasing sales, whether additional studies are released and support the conclusions of past studies, patient results achieved with our products, successful completion of future research and development activities, our ability of our distributors and customers to receive and maintain all required regulatory approvals in the U.S. and internationally, continued compliance with ISO standards as audited by BSI, the success of our sales and marketing efforts, IsoRay's ability to successfully manufacture, market and sell its products, IsoRay's ability to manufacture its products in sufficient quantities to meet demand within required delivery time periods while meeting its quality control standards, IsoRay's ability to enforce its intellectual property rights, changes in reimbursement rates, changes in laws and regulations applicable to our products, and other risks detailed from time to time in IsoRay's reports filed with the SEC.

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
Without lifecycle traceability and visibility across the tool chain, stakeholders from Planning-to-Ops have limited insight and answers to who, what, when, why and how across the DevOps lifecycle. This impacts the ability to deliver high quality software at the needed velocity to drive positive business outcomes. In his general session at @DevOpsSummit at 19th Cloud Expo, Eric Robertson, General Manager at CollabNet, will discuss how customers are able to achieve a level of transparency that e...
Kubernetes, Docker and containers are changing the world, and how companies are deploying their software and running their infrastructure. With the shift in how applications are built and deployed, new challenges must be solved. In his session at @DevOpsSummit at19th Cloud Expo, Sebastian Scheele, co-founder of Loodse, will discuss the implications of containerized applications/infrastructures and their impact on the enterprise. In a real world example based on Kubernetes, he will show how to ...
@DevOpsSummit has been named the ‘Top DevOps Influencer' by iTrend. iTrend processes millions of conversations, tweets, interactions, news articles, press releases, blog posts - and extract meaning form them and analyzes mobile and desktop software platforms used to communicate, various metadata (such as geo location), and automation tools. In overall placement, @DevOpsSummit ranked as the number one ‘DevOps Influencer' followed by @CloudExpo at third, and @MicroservicesE at 24th.
Established in 1998, Calsoft is a leading software product engineering Services Company specializing in Storage, Networking, Virtualization and Cloud business verticals. Calsoft provides End-to-End Product Development, Quality Assurance Sustenance, Solution Engineering and Professional Services expertise to assist customers in achieving their product development and business goals. The company's deep domain knowledge of Storage, Virtualization, Networking and Cloud verticals helps in delivering ...
24Notion is full-service global creative digital marketing, technology and lifestyle agency that combines strategic ideas with customized tactical execution. With a broad understand of the art of traditional marketing, new media, communications and social influence, 24Notion uniquely understands how to connect your brand strategy with the right consumer. 24Notion ranked #12 on Corporate Social Responsibility - Book of List.
In his session at @DevOpsSummit at 19th Cloud Expo, Robert Doyle, lead architect at eCube Systems, will examine the issues and need for an agile infrastructure and show the advantages of capturing developer knowledge in an exportable file for migration into production. He will introduce the use of NXTmonitor, a next-generation DevOps tool that captures application environments, dependencies and start/stop procedures in a portable configuration file with an easy-to-use GUI. In addition to captu...
Most of us already know that adopting new cloud applications can boost a business’s productivity by enabling organizations to be more agile and ready to change course in our fast-moving and connected digital world. But the rapid adoption of cloud apps and services also brings with it profound security threats, including visibility and control challenges that aren’t present in traditional on-premises environments. At the same time, the cloud – because of its interconnected, flexible and adaptable...
SYS-CON Events announced today that SoftNet Solutions will exhibit at the 19th International Cloud Expo, which will take place on November 1–3, 2016, at the Santa Clara Convention Center in Santa Clara, CA. SoftNet Solutions specializes in Enterprise Solutions for Hadoop and Big Data. It offers customers the most open, robust, and value-conscious portfolio of solutions, services, and tools for the shortest route to success with Big Data. The unique differentiator is the ability to architect and...
In past @ThingsExpo presentations, Joseph di Paolantonio has explored how various Internet of Things (IoT) and data management and analytics (DMA) solution spaces will come together as sensor analytics ecosystems. This year, in his session at @ThingsExpo, Joseph di Paolantonio from DataArchon, will be adding the numerous Transportation areas, from autonomous vehicles to “Uber for containers.” While IoT data in any one area of Transportation will have a huge impact in that area, combining senso...
More and more brands have jumped on the IoT bandwagon. We have an excess of wearables – activity trackers, smartwatches, smart glasses and sneakers, and more that track seemingly endless datapoints. However, most consumers have no idea what “IoT” means. Creating more wearables that track data shouldn't be the aim of brands; delivering meaningful, tangible relevance to their users should be. We're in a period in which the IoT pendulum is still swinging. Initially, it swung toward "smart for smar...
Cognitive Computing is becoming the foundation for a new generation of solutions that have the potential to transform business. Unlike traditional approaches to building solutions, a cognitive computing approach allows the data to help determine the way applications are designed. This contrasts with conventional software development that begins with defining logic based on the current way a business operates. In her session at 18th Cloud Expo, Judith S. Hurwitz, President and CEO of Hurwitz & ...
@ThingsExpo has been named the Top 5 Most Influential M2M Brand by Onalytica in the ‘Machine to Machine: Top 100 Influencers and Brands.' Onalytica analyzed the online debate on M2M by looking at over 85,000 tweets to provide the most influential individuals and brands that drive the discussion. According to Onalytica the "analysis showed a very engaged community with a lot of interactive tweets. The M2M discussion seems to be more fragmented and driven by some of the major brands present in the...
In the next five to ten years, millions, if not billions of things will become smarter. This smartness goes beyond connected things in our homes like the fridge, thermostat and fancy lighting, and into heavily regulated industries including aerospace, pharmaceutical/medical devices and energy. “Smartness” will embed itself within individual products that are part of our daily lives. We will engage with smart products - learning from them, informing them, and communicating with them. Smart produc...
As ridesharing competitors and enhanced services increase, notable changes are occurring in the transportation model. Despite the cost-effective means and flexibility of ridesharing, both drivers and users will need to be aware of the connected environment and how it will impact the ridesharing experience. In his session at @ThingsExpo, Timothy Evavold, Executive Director Automotive at Covisint, will discuss key challenges and solutions to powering a ride sharing and/or multimodal model in the a...
In his keynote at 19th Cloud Expo, Sheng Liang, co-founder and CEO of Rancher Labs, will discuss the technological advances and new business opportunities created by the rapid adoption of containers. With the success of Amazon Web Services (AWS) and various open source technologies used to build private clouds, cloud computing has become an essential component of IT strategy. However, users continue to face challenges in implementing clouds, as older technologies evolve and newer ones like Docke...