Exhibit 99.1
CytoSorbents Provides Corporate Update and Reports Financial Results for the Period Ended June 30, 2013
MONMOUTH JUNCTION, N.J., August 14, 2013 - CytoSorbents Corporation (OTCBB:CTSO),a critical care focused company commercializing its European Union approved CytoSorb® blood filter to treat life-threatening illnesses in the intensive care unit, provides a corporate update and reports its financial results for the three and six month period ending June 30, 2013.
Operational Highlights:
- Publication of ourfirst CytoSorb® case report study in the medical journal, Blood Purification, reporting the successful reduction in cytokines and vasopressor support in a case of Staphylococcus aureus septic shock in a patient who survived at the University of Rostock, Germany
- Submission for publication of another successful case report study in the treatment of rhabdomyolysis from Vienna General Hospital (AKH), Austria – one of the largest hospitals in Europe. A number of other case reports are in preparation from other hospitals
- Registration of two new investigator initiated clinical studies: One at University of Greifswald, Germany for the treatment of septic shock and one for the use ofCytoSorb® in cardiac surgery at theMedical University of Vienna, Austria. These are the first of 18 investigator studies being planned, an increase from 10 studies earlier this year
- Acceptance of two abstracts at the German Sepsis Society meeting in Weimar, Germany (September 4-6, 2013). One is from the University of Ulm, Germany, concerning the first successful fungal sepsis case treated. The other is from Trauma Hospital in Linz, Austria for the treatment of a septic shock patient with liver cirrhosis. Both treated patients survived.
- An increase in our key opinion leader network to approximately 100 leaders in the field of critical care
- Announcement that the FDA has approved a US Air Force funded 30-patient randomized controlled pilot study for the treatment of trauma and rhabdomyolysis to start this year - our first United States based critical care trial
- Expansion of sales distribution to the United Kingdom/Ireland and Turkey, with exclusive distributorships with L.IN.C Medical and Hitit Medical, and ongoing discussions with other partners for distribution in other countries
- Appointment of Dr. Rainer Kosanke as our European Scientific Director, formerly responsible for helping to introduce the procalcitonin (PCT) assay into the German speaking markets, which is now the current gold standard for diagnosing bacterial infection and sepsis in Europe
- Presentation by Dr. Chan to an audience of approximately 200 people, including leaders in military blood research, after being selected to speak on our HemoDefendTM blood transfusion platform at the largest military healthcare conference in the United States, the Military Health System Research Symposium
Financial Highlights:
- Started our Year 2 technology development with DARPA in the Dialysis-Like Therapeutics program to treat sepsis, with second year milestones worth more than $1.5 million. We are working closely with Battelle Laboratories, the newly designated systems integrator, and its subcontractor NxStage Medical, to incorporate our cytokine and toxin removal technologies into the design of the final device prototype
- Successfully completed our $1 million US Army Phase II SBIR contract negotiations and commenced our Phase II work with research leaders at theUS Army Institute of Surgical Research (USAISR) in San Antonio usingCytoSorb®in porcine burn injury and trauma models. USAISR is one of the nation’s premier military joint research organizations, performing advanced research in burn injury, trauma, and other combat casualty care
- Revenue for the first six months of 2013 totaled $663,000, with an increase in CytoSorb®product sales to $304,000 as compared to $50,000 for the same period the prior year
- Revenue for the 2013 second quarter totaled $291,000, with an increase inCytoSorb®sales to $128,000 versus $33,000 for the same period the prior year
- Gross profit margins for the 2013 second quarter was 61.3%
Dr. Phillip Chan, Chief Executive Officer, stated “We are beginning to see the fruits of our labor, with robust activity across many fronts. Our sales and marketing team has done an outstanding job in introducingCytoSorb® into our direct target markets of Germany, Austria and Switzerland. Looking at a map of Germany, our team of four salespeople have created a broad foothold with product sales, new clinical studies, case reports, and ongoing discussions in the university and public hospitals across most of the major cities in Germany and a growing number of hospitals in Austria. This is a tremendous accomplishment in a relatively short period of time since ourCytoSorb® launch in the second half of last year. Now that we have established this broad exposure and key opinion leader support in this past phase, our focus now is to drive sales growth by drilling down into these accounts with an expanded sales force, and spurring usage and end user demand amongst daily treating physicians in these departments.”
Financial Results for the First Six Months Ended June 30, 2013
For the six months ended June 30, 2013, the Company generated revenue of approximately $663,000 as compared to revenues of approximately $133,000 for the six months ended 2012, an increase of 497%. Revenue from product sales was approximately $304,000 in the first half of 2013, as compared to approximately $50,000 in the first half of 2012, an increase of 609%. This increase in product sales is a result of our direct sales force as well as sales to distributors in other parts of Europe and the Middle East. Product gross margins were approximately 60% for the six months ended June 30, 2013. Revenue from grants was approximately $359,000 in the first half of 2013, as compared to approximately $83,000 in the first half of 2012.
Our net loss for the six months ended June 30, 2013 was approximately $3,044,000 as compared to a net loss of approximately $2,474,000 for the six months ended June 30, 2012.
Financial Results for the Second Quarter Ended June 30, 2013
CytoSorbents generated revenues of approximately $291,000 and $83,000 for the three months ending June 30, 2013 and June 30, 2012, respectively. Product revenues were approximately $128,000 for the quarter ended June 30, 2013, as compared to product revenues of $33,000 for the three months ended June 30, 2012. Product gross margins were 61.3% for the quarter ended June 30, 2013. Additionally, grant revenue and other income approximated $164,000 and $50,000 for the three month periods ended June 30, 2013 and 2012, respectively.
Our net loss for the three months ending June 30, 2013 was approximately $1,415,000 as compared to a net loss of approximately $1,047,000 for the three months ended June 30, 2012.
On June 30, 2013 our cash balances were approximately $1,871,000 as compared to cash balances of approximately $1,729,000 as of December 31, 2012.
For additional information please see the Company’s 10-Q report for the period ended June 30, 2013 filed on August 14, 2013 onhttp://www.sec.gov.
About CytoSorbents Corporation
CytoSorbents is a critical care focused therapeutic device company using blood purification to modulate inflammation - with the goal of preventing or treating multiple organ failure in life-threatening illnesses. Organ failure is the cause of nearly half of all deaths in the intensive care unit, with little to improve clinical outcome. 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. CytoSorbents’ purification technologies are based on biocompatible, highly porous polymer beads that can actively remove toxic substances from blood and other bodily fluids by pore capture and surface adsorption. CytoSorbents has numerous products under development based upon this unique blood purification technology, protected by 32 issued US patents and multiple applications pending, including HemoDefend™, ContrastSorb, DrugSorb, and others. 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. Risk factors are detailed in the Company's Form 10-K filed with the SEC on April 3, 2013, which is available at http://www.sec.gov.
Company Contact:
CytoSorbents Corporation
Dr. Phillip Chan
Chief Executive Officer
(732) 329-8885 ext. *823
pchan@cytosorbents.com
Investor Contact:
Alliance Advisors, LLC
Alan Sheinwald
(914) 669-0222
asheinwald@allianceadvisors.net
Valter Pinto
(914) 669-0222 x201
valter@allianceadvisors.net
Media Contact:
JQA Partners
Jules Abraham
(917) 885-7378
jabraham@jqapartners.com
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Source: CytoSorbents Corporation
CYTOSORBENTS CORPORATION
(a development stage company)
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
(amounts in thousands, except per share data)
| | | Six months ended June 30, | | | Three months ended June 30, | |
| | | 2013 | | | 2012 | | | 2013 | | | 2012 | |
| | | (Unaudited) | | | (Unaudited) | | | (Unaudited) | | | (Unaudited) | |
| Revenues | | | | | | | | | | | | |
| Sales | | $ | 304 | | | $ | 50 | | | $ | 128 | | | $ | 33 | |
| Grant income | | | 359 | | | | 83 | | | | 163 | | | | 50 | |
| Total revenues | | | 663 | | | | 133 | | | | 291 | | | | 83 | |
| | | | | | | | | | | | | | | | | |
| Cost of revenue | | | 453 | | | | 20 | | | | 199 | | | | 10 | |
| | | | | | | | | | | | | | | | | |
| Gross profit | | | 210 | | | | 113 | | | | 92 | | | | 73 | |
| | | | | | | | | | | | | | | | | |
| Expenses: | | | | | | | | | | | | | | | | |
| Research and development | | | 1,412 | | | | 1,392 | | | | 708 | | | | 716 | |
| Legal, financial and other | | | | | | | | | | | | | | | | |
| consulting | | | 413 | | | | 235 | | | | 190 | | | | 74 | |
| Selling, general and administrative | | | 1,214 | | | | 563 | | | | 601 | | | | 293 | |
| Total operating costs and | | | | | | | | | | | | | | | | |
| expenses | | | 3,039 | | | | 2,190 | | | | 1,499 | | | | 1,083 | |
| | | | | | | | | | | | | | | | | |
| Operating loss | | | (2,829 | ) | | | (2,077 | ) | | | (1,407 | ) | | | (1,010 | ) |
| Other expenses, net | | | 215 | | | | 397 | | | | 8 | | | | 37 | |
| Net loss before benefit from income taxes | | | (3,044 | ) | | | (2,474 | ) | | | (1,415 | ) | | | (1,047 | ) |
| Benefit from income taxes | | | -- | | | | -- | | | | -- | | | | -- | |
| Net loss | | | (3,044 | ) | | | (2,474 | ) | | | (1.415 | ) | | | (1,047 | ) |
| Preferred stock dividend | | | 1,203 | | | | 1,241 | | | | 616 | | | | 578 | |
| Net loss available to common shareholders | | $ | (4,247 | ) | | $ | (3,715 | ) | | $ | (2,031 | ) | | $ | 1,625 | ) |
| Earnings per share: | | | | | | | | | | | | | | | | |
| Basic and diluted earnings per | | | | | | | | | | | | | | | | |
| share | | $ | (0.02 | ) | | $ | (0.02 | ) | | $ | (0.01 | ) | | $ | (0.01 | ) |
| Basic and diluted weight average shares outstanding | | | 227,299,644 | | | | 187,795,284 | | | | 231,583,119 | | | | 194,439,923 | |
| | | | | | | | | | | | | | | | | |
| Net loss | | $ | (3,044 | ) | | $ | (2,474 | ) | | $ | (1,415 | ) | | $ | (1,047 | ) |
| Other comprehensive loss: | | | | | | | | | | | | | | | | |
| Currency translation adjustment | | | (3 | ) | | | -- | | | | (1 | ) | | | -- | |
| Comprehensive loss | | $ | (3,047 | ) | | $ | (2,474 | ) | | $ | (1,416 | ) | | $ | (1047 | ) |
CYTOSORBENTS CORPORATION
(a development stage company)
CONDENSED CONSOLIDATED BALANCE SHEETS
(amounts in thousands)
| | | June 30, 2013 (Unaudited) | | | December 31, 2012 | |
| ASSETS: | | | | | | |
| Cash and cash equivalents | | $ | 1,871 | | | $ | 1,729 | |
| Accounts receivable, net | | | 84 | | | | 52 | |
| Inventories | | | 476 | | | | 683 | |
| Prepaid expenses and other current assets | | | 156 | | | | 476 | |
| Total current assets | | | 2,587 | | | | 2,940 | |
| | | | | | | | | |
| Property and equipment, net | | | 143 | | | | 145 | |
| Other assets | | | 251 | | | | 254 | |
| TOTAL ASSETS | | $ | 2,981 | | | $ | 3,339 | |
| | | | | | | | | |
| LIABILITIES AND STOCKHOLDERS’ EQUITY | | | | | | | | |
| Accounts payable | | $ | 721 | | | $ | 801 | |
| Accrued expenses and other current liabilities | | | 471 | | | | 349 | |
| Convertible notes payable, net | | | 912 | | | | 926 | |
| Total current liabilities | | | 2,104 | | | | 2,076 | |
| TOTAL LIABILITIES | | | 2,104 | | | | 2,076 | |
| | | | | | | | | |
| Redeemable Series B Convertible Preferred Stock | | | 14,062 | | | | 12,888 | |
| | | | | | | | | |
| Total stockholders’ equity | | | (13,185 | ) | | | (11,625 | ) |
| | | | | | | | | |
| TOTAL LIABILITIES AND STOCKHOLDER’S EQUITY | | $ | 2,981 | | | $ | 3,339 | |
