MONMOUTH JUNCTION, N.J.,
March 31, 2014 /PRNewswire/
-- CytoSorbents Corporation (OTCQB: CTSO), a critical care
immunotherapy company using blood purification to treat
life-threatening illnesses in the intensive care unit, provides an
operational summary and financial results for the fiscal year
ending December 31, 2013.
Q1 2014 CytoSorb® product revenue guidance in the range of
$530,000 - $570,000 represents more
than 60% of total 2013 CytoSorb® revenues
Highlights for the Year Ending December 31, 2013
- Total revenue for the year was $2.4
million, as compared to total revenue for 2013 of
$1.3 million
- Achieved ~$822,000 in CytoSorb®
cytokine filter sales in the first full year of commercialization,
an increase of 442% over 2012 CytoSorb® product revenue.
- Product gross margins were approximately 61% for the year ended
December 31, 2013
- CytoSorb® sales have been accelerating; sales for the fourth
quarter of 2013 were approximately $314,000, an increase of 54 percent over the
third quarter of 2013. An additional $37,000 in CytoSorb® orders were invoiced in Q4
2013, but due to common freight carrier pick-up delays, could not
be recognized as revenue during the quarter
- Grant revenue for 2013 was approximately $1.6 million, up from $1.2
million in 2012
- Announced a strategic partnership with BioCon, India's largest biotechnology company,
initially for exclusive distributorship of CytoSorb® in
India and select emerging
countries
- Established agreements with distributors in the United Kingdom, Ireland, the
Netherlands, Russia, and
Turkey
- Ended the year with more than 100 key opinion leaders in
critical care medicine and other specialties who are either
currently using or planning to use CytoSorb®, with more than 30 new
investigator-initiated studies being planned, many of which are
enrolling patients
- Held the first CytoSorb® Users Meeting at the DIVI 2013
Conference in Leipzig, Germany in
December 2013. A short video summary of the meeting can be
found here:
https://www.youtube.com/watch?v=98FuPhIvF0Y&feature=youtu.be
- The U.S. Air Force announced funding of a 30 patient,
randomized controlled human pilot study in the United States amongst trauma patients with
rhabdomyolysis. The FDA and institutional ethics committees
have approved the trial, which has now commenced
- Established a world-class Trauma Advisory Board to assist with
international trauma and burn studies
- The National Heart, Lung, and Blood Institute (NHLBI), a
division of the National Institutes of Health ("NIH"), awarded the
Company a Phase I SBIR (Small Business Innovation Research)
contract to further advance its HemoDefend™ blood purification
technology for packed red blood cell (pRBC) transfusions
- Continued steady progress on our DARPA and U.S. Army programs
in sepsis, burn injury and trauma
- Reported interim data from the first arm of the Sepsis Dosing
study demonstrating that continuous treatment (replacing the
CytoSorb® cartridge every 24 hours) over 7 days was safe, with
cytokine reduction occurring throughout the 24 hour period.
Overall 28-day mortality was similar to that seen in the treatment
arm of the European Sepsis Trial in a preliminary analysis.
Dr. Phillip Chan, CEO of
CytoSorbents, stated, "We are an emerging leader in critical care
immunotherapy where we are working to reduce deadly inflammation to
prevent or treat organ failure. This is a $20 billion worldwide total addressable market
and with CytoSorb®, we are one of the few companies with an
approved product in the European Union targeting this
opportunity."
"2013 was an outstanding year for the Company, as outlined in
our 2013 Shareholder Letter. I would encourage shareholders
to read this letter if they have not already done so," Dr. Chan
continued. "During our first full year of product
commercialization, we experienced strong support for the CytoSorb®
therapy and continue to see solid momentum in 2014, as evidenced by
our Q1 2014 guidance. We believe our recent fundraise of
$10.2 million will help to further
catalyze the growth of our business, with proceeds focused on
CytoSorb® sales and clinical studies."
"Please join us on the earnings call today at 4:15PM EDT where we will cover our progress in
greater detail. The investor presentation and a written
transcript of the conference call will be available within a week
of the webcast."
Conference Call Details:
Date: Monday,
March 31, 2014
Time: 4:15 PM Eastern
Participant Dial-In: (480) 629-9760
Live Presentation Webcast:
http://public.viavid.com/index.php?id=108451
An archived recording of the conference call will be available
under the Investor Relations section of the Company's website at
http://www.cytosorbents.com/invest.htm
Fiscal Year 2013 Financial Results
For the year ended December 31,
2013, the Company generated revenue of approximately
$2,423,000 as compared to revenues of
approximately $1,343,000 for the year
ended December 31, 2012, an increase
of more than 80%.
Revenue from product sales was approximately $822,000 for the year ended December 31, 2013, as compared to approximately
$152,000 in the year ended
December 31, 2012, an increase of
442%. Fourth quarter 2013 product sales of CytoSorb® were
approximately $314,000, an increase
of 54% over third quarter 2013 product sales. This increase
in sales is the direct result of the efforts of our direct sales
force covering Germany,
Austria, and Switzerland, as well as sales to distributors
in other parts of Europe,
India, and the Middle
East.
Another approximately $37,000 in
revenues related to orders invoiced during the fourth quarter of
2013 will be recognized in Q1 2014 due to common freight carrier
delays and pick-up of the products on January 2, 2014. Our revenue recognition
policies require that we recognize revenue on products at the time
when title and risk of loss passes to the customer, which occurs
when the products are picked up by the freight carrier.
Product gross margins were approximately 61% for the year ended
December 31, 2013.
Revenue from grants was approximately $1,601,000, as compared to approximately
$1,191,000 in the year ended
December 31, 2012.
The Company reported an operating loss of $4.7 million for the year ended December 31, 2012, compared to an operating loss
of $3.7 million in the previous
year. Cash used by operating activities in 2013 was
$3.5 million compared to $3.6 million in 2012. Cash and cash
equivalents was $2.2 million as of
December 31, 2013 compared with
$1.7 million at December 31, 2012.
On March 7, 2014, the Company
entered into subscription agreements with certain investors
providing for the issuance and sale by the Company (the "Offering")
of 40,800,000 units (the "Units") for an aggregate purchase
price of $10,200,000, or $0.25 per share. The Company received
net proceeds from the Offering of approximately $9,451,000 million. The net proceeds received by
the Company from the Offering will be used to build additional
sales and marketing infrastructure, clinical studies, working
capital and general corporate purposes.
2014 First Quarter Revenue Guidance
CytoSorbents expects to report 2014 first quarter CytoSorb®
product revenue in the range of $530,000 to
$570,000 (unaudited) with product gross margins in excess of
60%.
About CytoSorbents
CytoSorbents Corporation is a critical care focused
immunotherapy 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 risk of death 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 March 31, 2014, 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,
|
|
|
|
|
|
|
2013
|
2012
|
Revenues
|
|
|
|
Sales
|
$
822
|
$
152
|
|
Grant
income
|
1,601
|
1,191
|
|
Total
revenue
|
2,423
|
1,343
|
|
|
|
|
Cost of
revenue
|
1,912
|
319
|
|
|
|
Gross
profit
|
511
|
1,024
|
|
|
|
Expenses:
|
|
|
|
Research and
development
|
1,739
|
2,532
|
|
Legal, financial and
other consulting
|
908
|
627
|
|
Selling, general and
administrative
|
2,577
|
1,355
|
|
Total operating costs
and
expenses
|
5,224
|
4,514
|
|
|
|
|
Operating
loss
|
(4,713)
|
(3,490)
|
|
|
|
|
Other expenses,
net
|
423
|
565
|
|
|
|
|
Net loss before
benefit from income taxes
|
(5,136)
|
(4,055)
|
|
|
|
|
Benefit from income
taxes
|
(458)
|
(391)
|
|
|
|
|
Net
loss
|
(4,678)
|
(3,664)
|
|
|
|
|
Preferred stock
dividend
|
2,395
|
2,511
|
|
|
|
|
Net loss available to
common stockholders
|
$
(7,073)
|
$
(6,175)
|
|
|
|
|
Earnings per
share:
|
|
|
|
Basic and diluted
earnings per
share
|
$
(0.03)
|
$
(0.03)
|
|
Basic and diluted
weighted average shares outstanding
|
236,019,972
|
198,228,289
|
CYTOSORBENTS
CORPORATION
|
(a development stage
company)
|
CONDENSED
CONSOLIDATED BALANCE SHEETS
|
(amounts in
thousands)
|
|
|
|
|
|
|
December
31,
|
December
31,
|
|
|
2013
|
2012
|
|
|
|
|
ASSETS:
|
|
|
Cash and cash
equivalents
|
$
2,183
|
$
1,729
|
Grant and accounts
receivable, net
|
453
|
52
|
Inventories
|
246
|
682
|
Prepaid expenses and
other current assets
|
605
|
476
|
|
Total current
assets
|
3,487
|
2,939
|
|
|
|
|
Property and
equipment,
net
|
145
|
146
|
Other
assets
|
414
|
254
|
|
TOTAL
ASSETS
|
$
4,046
|
$
3,339
|
|
|
|
|
LIABILITIES AND
STOCKHOLDERS'EQUITY:
|
|
|
Accounts
payable
|
$
787
|
$
801
|
Accrued expenses and
other current
liabilities
|
362
|
350
|
Deferred
revenue
|
272
|
---
|
Convertible notes
payable,
net
|
1,644
|
926
|
|
Total current
liabilities
|
3,065
|
2,077
|
|
|
|
|
|
Total
liabilities
|
3,065
|
2,077
|
|
|
|
|
Redeemable Series B
Convertible Preferred
Stock
|
15,246
|
12,887
|
|
|
|
|
Total stockholders'
equity
|
(14,265)
|
(11,625)
|
|
TOTAL LIABILITIES AND
EQUITY
|
$
4,046
|
$
3,339
|
SOURCE CytoSorbents Corporation