Full Press Release Details
CytoSorbents Achieves Record Total Revenue
and CytoSorb Sales in the Second Quarter 2018
Quarterly CytoSorb Sales Reach $5.2 Million,
With Trailing 12-month CytoSorb Sales of $17.4 Million
N.J., August 2, 2018 - CytoSorbents Corporation
CTSO) a critical care immunotherapy leader commercializing its CytoSorb
blood purification technology to treat deadly inflammation in critically-ill and cardiac surgery patients around the
world, reports financial and operational results for the quarter ending June 30, 2018.
2018 Financial Highlights:
Second Quarter 2018 Operational Highlights:
Dr. Phillip Chan, Chief Executive Officer
of CytoSorbents stated, "Quarterly sales of CytoSorb exceeded $5 million for the first time, marking the 24th consecutive
quarter of year-over-year quarterly growth, with trailing 12-month sales of $17.4 million, and an annualized revenue run rate of
nearly $21 million. Meanwhile, our blended product gross margins for the quarter were a healthy 74%, which did not yet reflect
the benefit of larger scale manufacturing from our new plant that came online at the end of the quarter."
"We are now very close to achieving
our stated objective this year of operating profitability on a quarterly basis, that excludes non-cash expenses and clinical trial
costs. With a solid cash balance, we expect to drive continued rapid sales growth and product gross margin expansion that can put
us in the upper echelon of medical device companies. We believe we are at the beginning of a compelling long-term growth story,
targeting a $20 billion opportunity in critical care and cardiac surgery worldwide."
"On the clinical front, we anticipate
the recently added indications of bilirubin and myoglobin reduction to the CytoSorb label will be significant catalysts for growth.
There are 50 million people who suffer from chronic liver disease due to chronic hepatitis, alcoholism, and non-alcoholic fatty
liver (NASH), leading to one million deaths from chronic liver disease, and another one million deaths from hepatic cancer each
year. Many of these patients are admitted to the hospital annually due to acute exacerbations of their existing chronic liver disease,
such as acute-on-chronic liver failure (ACLF), alcoholic hepatitis, and viral hepatitis flares. Also, many other patients are admitted
with new onset liver injury as in drug or alcohol overdose, or mushroom poisoning, for example. Patients often develop worsened
liver function, organ failure, severe confusion and coma, fluid overload, bleeding, jaundice and excessive levels of bilirubin
and cytokines, with a high short-term risk of death. CytoSorb has been used as a liver support therapy in many of these cases showing
both bilirubin and cytokine reduction, and significant clinical benefits including hemodynamic stabilization and the reversal of
hepatic encephalopathy or coma."
"Similarly, there are 56 million
hospitalizations due to trauma around the world with approximately 5 million deaths annually. A major contributor to poor outcomes
and death in those who survive the initial trauma is uncontrolled inflammation and the release of toxic myoglobin from damaged
muscle, which can lead to kidney failure and a significantly higher risk of death. CytoSorb is used regularly in a number of major
hospitals in Europe to broadly reduce cytokines and myoglobin in severe trauma patients."
"We have also been very excited by
the breadth of basic and clinical research on CytoSorb, in government funded studies like the REMOVE trial, in many investigator-initiated
studies, and in company-sponsored trials. To elaborate a little more on our REFRESH 2-AKI trial, the preference of our clinical
sites and study team was to have the protocol amendment approved before aggressively enrolling the trial. Taking advantage of the
fact that patient enrollment is typically slow at the beginning of a trial and to compensate for this delay, we are actively managing
to have as many sites as possible ready to enroll when the amendment is approved by the FDA and site ethics committees, driving
a step-function in enrollment, rather than the typical gradual increase."
"Please join us on our previously
announced earnings call today at 4:45PM EST where we will review our progress. We will also respond to questions from the audience
during our live Q&A session. The investor presentation and a written transcript of the conference call will be available within
a week of the webcast."
Conference Call Details:
Date: Thursday, August 2, 2018
Time: 4:45 PM Eastern Time
Participant Dial-In: 646-828-8143
Conference ID: 7562383
Live Presentation Webcast: http://public.viavid.com/index.php?id=130364
It is recommended that participants dial
in approximately 10 minutes prior to the start of the call. There will also be a simultaneous live webcast of the conference
call that can be accessed through the following audio feed link: http://public.viavid.com/index.php?id=130364
An archived recording and written transcript
of the conference call will be available under the Investor Relations section of the Company's website at http://cytosorbents.com/investor-relations/financial-results/
Results of Operations
Comparison for the three months ended
June 30, 2018 and 2017:
Revenue from product sales was approximately
$5,246,000 in the three months ended June 30, 2018, as compared to approximately $3,041,000 in the three months ended June 30,
2017, an increase of approximately $2,205,000, or 73%. This increase was primarily driven by an increase in direct sales from both
new customers and repeat orders from existing customers and an increase in distributor sales. Approximately $371,000 of this increase
was due to the increase in the Euro to U.S. dollar exchange rate for the three months ended June 30, 2018 as compared to the three
months ended June 30, 2017.
Grant income was approximately $510,000
for the three months ended June 30, 2018 as compared to approximately $525,000 for the three months ended June 30, 2017, a decrease
of approximately $15,000. This decrease was a result of timing of certain grant revenue.
Total revenues were approximately $5,755,000
for the three months ended June 30, 2018, as compared to total revenues of approximately $3,566,000 for the three months ended
June 30, 2017, an increase of approximately $2,189,000 or 61%.
For the three months ended June 30, 2018
and 2017, cost of revenue was approximately $1,786,000 and $1,482,000, respectively, an increase of approximately $304,000. Product
cost of revenues increased approximately $323,000 during the three months ended June 30, 2018 as compared to the three months ended
June 30, 2017 due to increased sales. Product gross margins were approximately 74% for the three months ended June 30, 2018, as
compared to approximately 65% for the three months ended June 30, 2017. This increase in gross margin of 9% was due to a
reduction in the cost of devices manufactured as a result of production efficiencies achieved, as well as a favorable mix of sales
between direct customers and distributors and the impact of the increase in the exchange rate of the Euro.
Research and Development Expenses:
For the three months ended June 30, 2018,
research and development expenses were approximately $1,576,000 as compared to research and development expenses of approximately
$458,000 for the three months ended June 30, 2017. The increase of approximately $1,118,000 was due to increase in costs related
to our clinical studies and trials of approximately $587,000, an increase in our clinical related salaries of approximately $153,000,
an increase in non-clinical research and development salaries of approximately $92,000, an increase in new product development
costs of approximately $64,000, a decrease in direct labor and other costs being deployed toward grant-funded activities of approximately
$84,000, which had the effect of increasing the amount of our non-reimbursable research and development costs, and an increase
in lab supplies of approximately $26,000 and an increase in non-grant related research and development costs of approximately $112,000.
Legal, Financial and Other Consulting
Legal, financial and other consulting expenses
were approximately $458,000 for the three months ended June 30, 2018, as compared to approximately $443,000 for the three months
ended June 30, 2017. The increase of approximately $15,000 was due to an increase in legal fees of approximately $81,000 related
to certain corporate initiatives. This increase was offset by a decrease in accounting and auditing fees of approximately $49,000,
a reduction of employment agency fees of approximately $12,000 and a reduction of consulting fees of approximately $5,000.
Selling, General and Administrative
Selling, general and administrative expenses
were approximately $6,124,000 for the three months ended June 30, 2018, as compared to approximately $3,514,000 for the three months
ending June 30, 2017. The increase of $2,610,000 was due to an increase in salaries, commissions and related costs of approximately
$352,000 related to headcount additions and increased sales, an increase in non-cash stock based compensation expense of approximately