Full Press Release Details
CytoSorbents Reports First Quarter 2020
Financial and Operational Results
2020 Total Revenue grew 68% to $8.7M and Product Sales grew 78% to $8.2M over Q1 2019
N.J., May 5, 2020 - CytoSorbents Corporation (NASDAQ: CTSO), a critical
care immunotherapy leader using its CytoSorb blood purification technology to
treat deadly inflammation in critically-ill and cardiac surgery patients around the world, reports record financial and operational
results for the quarter ending March 31, 2020.
First Quarter 2020 Financial Results:
First Quarter 2020 Operational Highlights:
Dr. Phillip Chan, MD, PhD, Chief Executive
Officer of CytoSorbents stated, "Before COVID-19 became a pandemic, Q1 2020, our strongest quarter to date, was already looking
robust, buoyed by momentum from the prior record quarter, and energized by our recently expanded commercialization team driving
sales across our everyday core markets of cardiac surgery and critical care."
Dr. Chan continued, "We began the
quarter with some great news: CE Mark approval for CytoSorb to remove ticagrelor during on-pump cardiothoracic surgery. This allowed
us to begin aggressively marketing the use of CytoSorb for this application on-label in all of the countries we serve, with the
goal of reducing costly and potentially life-threatening perioperative bleeding caused by this "blood thinner" in patients
who require urgent or emergent cardiac surgery. Because of its ease of use, its efficacy in removing ticagrelor, and an established
record of safety in low to high risk cardiac surgery patients, we believe CytoSorb has the potential to become the standard of
care for this application in the E.U., with the potential to significantly expand our current product revenue over time, and help
drive us to profitability. Ticagrelor has the potential to displace its rivals as the preferred anti-platelet therapy in acute
coronary syndrome in-part because our therapy makes it the only reversible P2Y12 platelet inhibitor - thereby vastly
improving its safety profile over the others in this patient population, we believe the market could be even greater. We followed
through with a hat trick of sorts. In April, we received U.S. FDA Breakthrough Designation for the use of CytoSorb to reduce ticagrelor
during cardiopulmonary bypass in urgent or emergent cardiac surgery. This was an acknowledgement of the major unmet medical need
that we could potentially serve, while enabling the FDA to work with us to speed the development, assessment, and regulatory review
of CytoSorb for this application. Then just recently, we announced the hiring of our new Chief Medical Officer, Dr. Ethymios "Makis"
Deliargyris, MD, an experienced cardiologist and interventional cardiologist, and an industry veteran whose prior experience includes
The Medicines Company. Makis is a subject matter expert in the clinical development, usage, and complications of anti-coagulants
and anti-thrombotics such as ticagrelor, cangrelor, bivalirudin, and aspirin, while being well-versed in the treatment and management
of critical illnesses, particularly shock - one of the hallmark effects of CytoSorb in critically-ill patients. These developments
give us much greater visibility on a potential U.S. regulatory path for approval that could be game-changing for the company."
"Meanwhile, as China instituted unprecedented
measures to try to control the spread of coronavirus, we could see the looming threat of COVID-19 coming. Early reports of cytokine
storm contributing to severity of illness and death in patients afflicted with SARS-CoV-2 infection were not a surprise. CytoSorbents,
with our flagship product CytoSorb - one of the leading therapies in Europe approved specifically to treat cytokine storm- has
been one of the most vocal advocates for years proselytizing the harms of cytokine storm and the fact that an out-of-control immune
response and organ failure is what really kills patients in a wide variety of life-threatening conditions seen in the intensive
care unit on a daily basis, such as sepsis, trauma, acute respiratory distress syndrome (ARDS), shock, liver failure, and many
others. That it took a literal pandemic to finally drive the term "cytokine storm" into the common vernacular of journalists,
government officials, investors, the lay public, and even many healthcare experts, underscores how prescient we have been and how
timely CytoSorb has become."
Dr. Chan continued, "That said, our
positioning of CytoSorb as one of the leading therapies to treat cytokine storm has led to a host of new opportunities and now
more than an estimated 750 COVID-19 patients treated worldwide. The China Medical System Holdings Ltd partnership and the listing
of CytoSorb in the Italy and Panama COVID-19 treatment guidelines, were just several examples. In Germany, where the most COVID-19
patients have now been treated with CytoSorb, there is a groundswell of clinical study activity, including randomized controlled
trials, that will hopefully translate into published patient-level data that can be leveraged worldwide. And most recently, in
mid-April, CytoSorb was the first extracorporeal blood purification technology, that is compatible with the main blood pump machines
used to treat critically-ill patients around the world (e.g. CRRT, hemodialysis, and ECMO), to receive FDA Emergency Use Authorization
for use in critically-ill adult COVID-19 patients with imminent or confirmed respiratory failure. For the first time, we are able
to make CytoSorb commercially available to all U.S. hospitals, physicians, and patients, now with nearly 200 inquiries, 30 active
hospital accounts, with CytoSorb either shipped or in use at half of these, and multiple reorders. In the U.S., in a very short
period of time, there have been approximately 25 patients treated, quite a number who have been weaned off of extracorporeal membrane
oxygenation (ECMO) or mechanical ventilation."
"We were fortunate to have begun
planning and ramping production early in the quarter to meet this projected need. We strengthened our balance sheet significantly,
preparing for uncertain times, and making sure we had the financial resources to withstand the coming storm and aggressively fund
production expansion. And like other businesses, we took steps to protect our workforce while ramping production 24 hours a day,
7 days a week. Although we are nearing full capacity now, we have the flexibility to rapidly scale production up or down as the
global need requires based on whether projected second and third waves of COVID-19 infection materialize. We ended the quarter
with orders linked to the rapidly spreading COVID-19 pandemic in many of the countries we serve, and the existing physician user
base that has used CytoSorb successfully in their critically-ill and cardiac surgery patients for years. This demand was on top
of the already strong results from our existing business, resulting in an exceptional quarter with our first backlog ever."
"As one of a select group of companies
thriving in these uncertain times, we believe the growth story at CytoSorbents remains remarkably bright, with so many different
potential catalysts and shots on goal for our company. To be clear, we are not a COVID-19 company. What the pandemic has done,
however, is put a spotlight on our company, our CytoSorb technology, and our core message of treating cytokine storm. This message
transcends coronavirus infection and is the same message in sepsis that kills 1 in 5 people worldwide
every year; in seasonal influenza that according to the World Health Organization,
kills more people worldwide each year than COVID-19 has to date; in millions of hospitalized patients with acute exacerbations
of chronic liver disease, that afflicts 1 in 11 people worldwide; in infective endocarditis cases that plague cardiac surgery
programs throughout the U.S. some of which are often doing one of these surgeries a day with a patient
cost that can exceed $150,000 and a high risk of death due to an explosion of heart valve infections caused by the
opiate crisis and use of dirty needles with IV heroin use; and many, many others. Because of COVID-19, we have re-introduced CytoSorb
to the world, and are working to generate clinical data that will support its use in the same complications of COVID-19 infection
such as shock and acute respiratory failure that are seen in other critically-ill non-COVID-19 patients, that may keep COVID-19
as a potential long-term catalyst for our business."
Dr. Chan concluded, "I cannot begin
to express my pride and gratitude to the outstanding men and women of this company, who in the depths of the COVID-19 crisis, came
together, pitching in wherever needed, even when doing so put themselves and their families at risk, to ensure that we maintained
the production, delivery, and access of CytoSorb to help patients around the world. And finally, to all of the healthcare workers
globally, who worked tirelessly on the front lines during the COVID-19 pandemic, putting themselves directly into harm's
way to save lives, with many making the ultimate sacrifice - the thankfulness, thoughts and prayers of a grateful world community."
"Please join us on our earnings conference
call today, details for which are below."
Conference Call Details:
Date: Tuesday, May 5, 2020
Time: 4:45 PM Eastern Time
Participant Dial-In: 877-451-6152
Conference ID: 13701769
Live Presentation Webcast: http://public.viavid.com/index.php?id=139054
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=139054
An archived recording 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
March 31, 2020 and 2019: