MONMOUTH JUNCTION, N.J., April 3, 2013 (GLOBE NEWSWIRE) -- CytoSorbents Corporation (OTCBB:CTSO), a critical care focused company using blood purification to treat life-threatening illnesses in the intensive care unit, provides a shareholder update and reports its financial results for the fiscal year ending December 31, 2012.
Highlights for the Year Ending December 31, 2012
- Officially launched the CytoSorb® cytokine filter in the second half of 2012 in Germany, Austria and Switzerland with a direct sales force led by our Vice President of Sales and Marketing, Dr. Christian Steiner. Reimbursement was established in Germany and Austria.
- Total revenue for the year was $1.34 million, including grant income from DARPA and the U.S. Army, and initial CytoSorb® sales, with product gross margins greater than 50%.
- CytoSorb® sales have been accelerating, with sales of CytoSorb® in the first quarter of 2013 exceeding CytoSorb® sales for all of 2012, and doubling from the previous quarter.
- Experienced a strong market reception from more than 60 key opinion leaders in critical care medicine and other specialties who are either currently using or planning to use CytoSorb®, with at least six new investigator-initiated studies being planned.
- Witnessing orders from a broad base of new customers, as well as re-orders from existing customers who have had success with CytoSorb® across a wide range of critical care applications including sepsis, burn injury, trauma, lung injury, liver failure, pancreatitis, influenza and other life-threatening conditions.
- Was awarded $5 million in milestone-based R&D contracts from DARPA for sepsis, and the U.S. Army for trauma and burn injury, of which $1.1 million was recognized in 2012.
- Advanced our product pipeline with solid progress on the HemoDefend platform that targets the improved safety of blood transfusion products, and introduction of ContrastSorb, a development stage polymer designed to efficiently remove IV contrast from blood following certain imaging or interventional radiology procedures to prevent kidney failure.
"While we are just at the ground floor of commercialization of CytoSorb®, one only needs to visit an intensive care unit or speak to a physician or nurse to understand the vast market and tremendous need for new therapies that can actively help critically-ill patients. As a novel therapy targeting the prevention or treatment of organ failure, the leading cause of death in the ICU from any cause, CytoSorb® has the unique potential opportunity to save lives while reducing massive healthcare costs," stated Dr. Phillip Chan, CEO of CytoSorbents. "This revolutionary approach is fundamentally different from the current standard of care 'life support' therapies that help keep patients alive but don't actually help them get better. With CytoSorb® targeting one of the largest unmet medical needs in modern medicine, we believe that CytoSorbents has the same or greater potential than many biotechnology companies, but with the benefit of having an approved product on the market generating revenue."
Fiscal Year 2012 Financial Results
For the year ended December 31, 2012, CytoSorbents reported $1.34 million in revenue, consisting of $1.19 million in grant income from DARPA and the U.S. Army, and $152K in CytoSorb® product sales. This compares to total revenue of $36K in fiscal 2011. Overall, 2012 blended gross margins were 76%, with product gross margins in excess of 50%.
The Company narrowed its operating loss to $3.5 million for the year ended December 31, 2012, compared to an operating loss of $4.4 million in the year ago period. Fiscal year 2012 results benefited from increased revenue from grant income and product sales. The Company reported a net loss of $6.2 million for 2012 compared to a net loss of $8.6 million for the year ended December 31, 2011. Results include a non-cash charge for preferred stock dividends of $2.5 million in 2012 compared to $3.1 million in 2011. Cash used by operating activities in 2012 was $3.6 million compared to $3.8 million in 2011. Cash and cash equivalents was $1.7 million as of December 31, 2012 compared with $1.2 million at December 31, 2011.
2013 First Quarter Revenue
CytoSorbents expects to report 2013 first quarter CytoSorb® product revenue in the range of $170-180K (unaudited) with product gross margins in excess of 50%.
About CytoSorbents
CytoSorbents Corporation is a critical care focused therapeutic device company using blood purification to modulate the immune system and fight multi-organ failure in life-threatening illnesses. Its purification technology is based on biocompatible, highly porous polymer beads that can actively remove toxic substances from blood and other bodily fluids by pore capture and adsorption. CytoSorb®, the Company's flagship product, is approved in the European Union as a safe and effective extracorporeal cytokine filter, designed to reduce the "cytokine storm" that could otherwise cause massive inflammation, organ failure and death in common critical illnesses such as sepsis, burn injury, trauma, lung injury, and pancreatitis. These are conditions where the mortality is extremely high, yet no effective treatments exist. Additional information is available for download on the Company's website: http://www.cytosorbents.com.
Forward-Looking Statements
This press release includes forward-looking statements intended to qualify for the safe harbor from liability established by the Private Securities Litigation Reform Act of 1995. Forward-looking statements in this press release are not promises or guarantees and are subject to risks and uncertainties that could cause our actual results to differ materially from those anticipated. These statements are based on management's current expectations and assumptions and are naturally subject to uncertainty and changes in circumstances. We caution you not to place undue reliance upon any such forward-looking statements. Actual results may differ materially from those expressed or implied by the statements herein. CytoSorbents Corporation and CytoSorbents, Inc believe that its primary risk factors include, but are not limited to: obtaining government approvals including required FDA and additional CE Mark approvals; ability to successfully develop commercial operations; dependence on key personnel; acceptance of the Company's medical devices in the marketplace; the outcome of potential litigation; compliance with governmental regulations; reliance on research and testing facilities of various universities and institutions; the ability to obtain adequate and timely financing in the future when needed; product liability risks; limited manufacturing experience; limited marketing, sales and distribution experience; market acceptance of the Company's products; competition; unexpected changes in technologies and technological advances; and other factors detailed in the Company's Form 10-K filed with the SEC on April 3, 2013, which is available at http://www.sec.gov.
| CYTOSORBENTS CORPORATION | ||
| (a development stage company) | ||
| CONDENSED CONSOLIDATED STATEMENT OF OPERATIONS | ||
| (amounts in thousands, except per share data) | ||
|
Year Ended December 31, |
||
| 2012 | 2011 | |
| Revenues | ||
| Sales | $ 152 | $ 36 |
| Grant income | 1,191 | -- |
| Total revenues | 1,343 | 36 |
| Cost of revenue | 319 | 12 |
| Gross profit | 1,024 | 24 |
| Expenses: | ||
| Research and development | 2,532 | 2,888 |
| Legal, financial and other consulting | 627 | 343 |
| Selling, general and administrative | 1,355 | 1,230 |
| Total operating costs and expenses | 4,514 | 4,461 |
| Operating loss | (3,490) | (4,437) |
| Other expenses, net | 565 | 1,045 |
| Net loss before benefit from income taxes | (4,055) | (5,482) |
| Benefit from income taxes | (391) | -- |
| Net loss | (3,664) | (5,482) |
| Preferred stock dividend | 2,511 | 3,087 |
| Net loss available to common stockholders | $ (6,175) | $ (8,569) |
| Earnings per share: | ||
| Basic and diluted earnings per share | $ (0.03) | $ (0.05) |
| Basic and diluted weighted average shares outstanding | 198,228,289 | 160,235,291 |
| CYTOSORBENTS CORPORATION | ||
| (a development stage company) | ||
| CONDENSED CONSOLIDATED BALANCE SHEETS | ||
| (amounts in thousands) | ||
| December 31, 2012 | December 31, 2011 | |
| ASSETS: | ||
| Cash and cash equivalents | $ 1,729 | $ 1,186 |
| Accounts receivable, net | 52 | 36 |
| Inventories | 682 | 431 |
| Prepaid expenses and other current assets | 476 | 44 |
| Total current assets | 2,939 | 1,697 |
| Property and equipment, net | 146 | 155 |
| Other assets | 254 | 271 |
| TOTAL ASSETS | $ 3,339 | $ 2,123 |
| LIABILITIES AND STOCKHOLDERS' EQUITY: | ||
| Accounts payable | $ 801 | $ 676 |
| Accrued expenses and other current liabilities | 350 | 558 |
| Convertible notes payable, net | 926 | 294 |
| Total current liabilities | 2,077 | 1,528 |
| Convertible notes payable, net | -- | 276 |
| Total liabilities | 2,077 | 1,804 |
| Redeemable Series B Convertible Preferred Stock | 12,887 | 10,408 |
| Total stockholders' equity | (11,625) | (10,089) |
| TOTAL LIABILITIES AND EQUITY | $ 3,339 | $ 2,123 |