|By Marketwired .||
|May 16, 2014 09:42 AM EDT||
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 (Unaudited) 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 administrative 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 (expense): 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 =========== =========== =========== ===========
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 Twitter@Isoray.
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.
Puppet Labs has announced the next major update to its flagship product: Puppet Enterprise 2015.2. This release includes new features providing DevOps teams with clarity, simplicity and additional management capabilities, including an all-new user interface, an interactive graph for visualizing infrastructure code, a new unified agent and broader infrastructure support.
Sep. 3, 2015 01:30 PM EDT Reads: 567
Contrary to mainstream media attention, the multiple possibilities of how consumer IoT will transform our everyday lives aren’t the only angle of this headline-gaining trend. There’s a huge opportunity for “industrial IoT” and “Smart Cities” to impact the world in the same capacity – especially during critical situations. For example, a community water dam that needs to release water can leverage embedded critical communications logic to alert the appropriate individuals, on the right device, as...
Sep. 3, 2015 01:30 PM EDT
ElasticBox, the agile application delivery manager, announced freely available public boxes for the DevOps community. ElasticBox works with enterprises to help them deploy any application to any cloud. Public boxes are curated reference boxes that represent some of the most popular applications and tools for orchestrating deployments at scale. Boxes are an adaptive way to represent reusable infrastructure as components of code. Boxes contain scripts, variables, and metadata to automate proces...
Sep. 3, 2015 01:30 PM EDT
All major researchers estimate there will be tens of billions devices - computers, smartphones, tablets, and sensors - connected to the Internet by 2020. This number will continue to grow at a rapid pace for the next several decades. With major technology companies and startups seriously embracing IoT strategies, now is the perfect time to attend @ThingsExpo, November 3-5, 2015, at the Santa Clara Convention Center in Santa Clara, CA. Learn what is going on, contribute to the discussions, and e...
Sep. 3, 2015 01:15 PM EDT
WebRTC services have already permeated corporate communications in the form of videoconferencing solutions. However, WebRTC has the potential of going beyond and catalyzing a new class of services providing more than calls with capabilities such as mass-scale real-time media broadcasting, enriched and augmented video, person-to-machine and machine-to-machine communications. In his session at @ThingsExpo, Luis Lopez, CEO of Kurento, will introduce the technologies required for implementing thes...
Sep. 3, 2015 01:15 PM EDT
Amazon and Google have built software-defined data centers (SDDCs) that deliver massively scalable services with great efficiency. Yet, building SDDCs has proven to be a near impossibility for ‘normal’ companies without hyper-scale resources. In his session at 17th Cloud Expo, David Cauthron, founder and chief executive officer of Nimboxx, will discuss the evolution of virtualization (hardware, application, memory, storage) and how commodity / open source hyper converged infrastructure (HCI) so...
Sep. 3, 2015 01:15 PM EDT Reads: 133
SYS-CON Events announced today that Pythian, a global IT services company specializing in helping companies leverage disruptive technologies to optimize revenue-generating systems, has been named “Bronze Sponsor” of SYS-CON's 17th Cloud Expo, which will take place on November 3–5, 2015, at the Santa Clara Convention Center in Santa Clara, CA. Founded in 1997, Pythian is a global IT services company that helps companies compete by adopting disruptive technologies such as cloud, Big Data, advance...
Sep. 3, 2015 01:00 PM EDT Reads: 365
Puppet Labs is pleased to share the findings from our 2015 State of DevOps Survey. We have deepened our understanding of how DevOps enables IT performance and organizational performance, based on responses from more than 20,000 technical professionals we’ve surveyed over the past four years. The 2015 State of DevOps Report reveals high-performing IT organizations deploy 30x more frequently with 200x shorter lead times. They have 60x fewer failures and recover 168x faster
Sep. 3, 2015 12:59 PM EDT
In today's digital world, change is the one constant. Disruptive innovations like cloud, mobility, social media, and the Internet of Things have reshaped the market and set new standards in customer expectations. To remain competitive, businesses must tap the potential of emerging technologies and markets through the rapid release of new products and services. However, the rigid and siloed structures of traditional IT platforms and processes are slowing them down – resulting in lengthy delivery ...
Sep. 3, 2015 12:45 PM EDT Reads: 634
Consumer IoT applications provide data about the user that just doesn’t exist in traditional PC or mobile web applications. This rich data, or “context,” enables the highly personalized consumer experiences that characterize many consumer IoT apps. This same data is also providing brands with unprecedented insight into how their connected products are being used, while, at the same time, powering highly targeted engagement and marketing opportunities. In his session at @ThingsExpo, Nathan Trel...
Sep. 3, 2015 12:30 PM EDT Reads: 281
Containers are not new, but renewed commitments to performance, flexibility, and agility have propelled them to the top of the agenda today. By working without the need for virtualization and its overhead, containers are seen as the perfect way to deploy apps and services across multiple clouds. Containers can handle anything from file types to operating systems and services, including microservices. What are microservices? Unlike what the name implies, microservices are not necessarily small,...
Sep. 3, 2015 12:00 PM EDT Reads: 122
In his session at @ThingsExpo, Lee Williams, a producer of the first smartphones and tablets, will talk about how he is now applying his experience in mobile technology to the design and development of the next generation of Environmental and Sustainability Services at ETwater. He will explain how M2M controllers work through wirelessly connected remote controls; and specifically delve into a retrofit option that reverse-engineers control codes of existing conventional controller systems so the...
Sep. 3, 2015 12:00 PM EDT Reads: 245
The web app is agile. The REST API is agile. The testing and planning are agile. But alas, data infrastructures certainly are not. Once an application matures, changing the shape or indexing scheme of data often forces at best a top down planning exercise and at worst includes schema changes that force downtime. The time has come for a new approach that fundamentally advances the agility of distributed data infrastructures. Come learn about a new solution to the problems faced by software organ...
Sep. 3, 2015 11:00 AM EDT Reads: 131
U.S. companies are desperately trying to recruit and hire skilled software engineers and developers, but there is simply not enough quality talent to go around. Tiempo Development is a nearshore software development company. Our headquarters are in AZ, but we are a pioneer and leader in outsourcing to Mexico, based on our three software development centers there. We have a proven process and we are experts at providing our customers with powerful solutions. We transform ideas into reality.
Sep. 3, 2015 10:45 AM EDT Reads: 569
With the Apple Watch making its way onto wrists all over the world, it’s only a matter of time before it becomes a staple in the workplace. In fact, Forrester reported that 68 percent of technology and business decision-makers characterize wearables as a top priority for 2015. Recognizing their business value early on, FinancialForce.com was the first to bring ERP to wearables, helping streamline communication across front and back office functions. In his session at @ThingsExpo, Kevin Roberts...
Sep. 3, 2015 10:45 AM EDT