Full Press Release Details
CytoSorbents Provides Preliminary Third Quarter
Business Update and Revised 2021 Product Revenue Guidance
Preliminary third quarter 2021 total revenue
was $9.7 million, including product sales of $8.9 million. Preliminary core non-COVID-19 product sales increased 4% Y-Y to approximately
MONMOUTH JUNCTION, N.J.,
October 12, 2021 - CytoSorbents Corporation (NASDAQ: CTSO), a leader in the treatment of life-threatening conditions
in intensive care and cardiac surgery using blood purification via its proprietary polymer adsorption technology, announces preliminary
third quarter financial results and revised second half and full year 2021 product revenue guidance, primarily reflecting pandemic-driven
adverse market conditions in Germany.
Quarter 2021 Financial Information
The third largest wave
in new COVID-19 cases in Germany, driven by the Delta variant, accelerated through August and, after peaking in mid-September,
has continued to date. This prompted many hospitals throughout Germany to reduce elective surgical procedures, to reserve ICU
beds, and to either maintain or reinstitute restrictions such as visitation rights to non-essential visitors, in preparation of
COVID-19 hospitalizations. However, unlike prior waves in Germany, the rates of severe COVID-19 illness requiring ICU care, and
death have been disproportionately very low. This is being partly attributed to high rates of vaccinations that are
associated with reduced severity of illness, reduced need for hospitalization, and risk of death.
These macro factors negatively
impacted our critical care and cardiac surgery markets in Germany, resulting in lower-than-expected sales of CytoSorb during the third
quarter. Specifically, there were:
Quarterly results were
further exacerbated by a greater-than-normal seasonal third quarter impact of European summer vacations.
A recent survey conducted
by BVMed (Association of German Medtech Companies) of 110 Medtech companies in Germany published this month highlights that our experience
is not unique. Based on the most cited reasons presented in the chart entitled, "Biggest Sales Hurdles in Germany in the Second
Coronavirus Year," 62% of Medtech companies cite postponed elective interventions, 59% cite declines in patient numbers in hospitals,
and 55% cite reduced contact to customers and/or patients.
Dr. Christian Steiner,
Executive Vice President of Sales and Marketing of CytoSorbents, stated, "At the time of our prior guidance in the first week of
August, new COVID-19 infections from the Delta variant in Germany were still low. Following strong results from the first half of this
year, we believed our core non-COVID-19 sales would continue to increase, encouraged that German hospitals were continuing to lift restrictions
and elective surgeries were increasing. However, within the span of weeks, rates of new COVID-19 cases accelerated in Germany, and changed
the macro business outlook significantly. The convergence of the multiple challenges outlined above during a traditionally seasonal third
quarter unexpectedly amplified the negative aspects of the pandemic on our business. We believe many of these roadblocks are outside of
our control, driven by the COVID-19 pandemic. And while it is difficult to predict how fast the business environment will improve, we
are diligently working in the background to improve the things we can control, to position our business for a return to sales growth.
Some examples include continuing to diversify our sources of revenue, maximizing existing clinical applications while launching new ones,
executing on our clinical trial strategy, investing in and expanding our direct sales territories, and optimizing our sales force and
access to physicians and hospitals."
Chief Executive Officer of CytoSorbents stated, "At the beginning of 2021, we highlighted that our challenge for the year was to
replace COVID-19 revenue with core non-COVID-19 revenue. We predicted that as vaccinations rose, the rates of COVID-19 and usage of CytoSorb
to treat COVID-19 would drop, but this would allow us to resume our core non-COVID-19 business. In the first half of 2021, we made good
progress towards this goal, despite previously discussed challenges of this transition. As we begin the traditionally strong fourth quarter
and busy winter season for ICU admissions, we believe these macro factors will likely take some time to resolve, particularly ICU capacity
issues, hospital restrictions, and the direction and impact of the COVID-19 pandemic, hence our revised guidance for the remainder of
2021. We are fortunate to have a solid cash balance to weather the near-term uncertainty and are working to keep tight control of our
expenses, while prioritizing generation of the next level of clinical data with seven Company-sponsored clinical studies, including four
randomized controlled trials, expected to be active by the end of this year. Meanwhile, we plan to make the most of our opportunities
in Germany, while diversifying and augmenting our efforts in new and existing direct sales countries and distributor/partner channels."
"Meanwhile, we remain laser-focused on our U.S. regulatory program for the removal of antithrombotic drugs, or blood thinners,
during cardiothoracic surgery. We have already initiated our U.S. STAR-T pivotal randomized controlled trial (RCT) to remove ticagrelor
during open heart surgery, and today have announced, that just two months after receiving FDA Breakthrough Device Designation for
DrugSorb-ATR to remove apixaban (Eliquis , Bristol-Myers Squibb/Pfizer), and rivaroxaban (Xarelto ,
Janssen/Bayer) during urgent cardiothoracic surgery, the FDA has now fully approved the start of our STAR-D pivotal RCT to do the same.
These accomplishments highlight the sense of urgency and priority we have placed on these programs. If both studies are successful, we
believe they can be major catalysts for potential revenue growth as we seek FDA marketing approval for this approximately $1 billion
total addressable U.S. market opportunity."
Revised 2021 Product
The macro environment of the global COVID-19 pandemic
continues to add uncertainty to the Company's sales outlook, especially since we are unable to predict the course of the pandemic
or predict what impact, if any, the COVID-19 pandemic may have on global sales for the remainder of the year.
We believe the revised
guidance below is achievable, as in deriving the revised fourth quarter and full year product revenue outlook, we have assumed no improvement
in the COVID-19 pandemic-related environment observed during the third quarter of 2021. In addition, we do not have full visibility into
the potential impact of the recently released data from the REMOVE study, as full study results are not yet available. Though we believe
that CytoSorb will continue to be used in selected infective endocarditis populations, we have included a potential negative impact to
sales in our guidance. As a result, the Company now expects:
Third Quarter 2021 Results Call Information
CytoSorbents will report third quarter 2021 operating
and financial results after the market close on November 4, 2021. CytoSorbents' management will host a live conference call
and presentation webcast at 4:30 p.m. Eastern the same day.
Conference call details:
Date: Thursday, November 4, 2021
Time: 4:30 p.m. Eastern
Toll free: 1-877-521-4127
International: 1-212-231-2930
Conference ID: 21998483
Live presentation webcast: https://viavid.webcasts.com/starthere.jsp?ei=1505348&tp_key=fc4e9855a2
It is recommended that participants dial in approximately 10 minutes
prior to the start of the call.
A simultaneous live webcast can be accessed via the following audio
An archived recording of the conference call will be available under
the Investor Relations portion of the company's website at https://cytosorbents.com/investor-relations/financial-results/
About CytoSorbents Corporation (NASDAQ: CTSO)
CytoSorbents Corporation is a leader in
the treatment of life-threatening conditions in intensive care and cardiac surgery using blood purification. Its flagship product,
CytoSorb , is approved in the European Union with distribution in 68 countries around the world as an extracorporeal
cytokine adsorber designed to reduce the "cytokine storm" or "cytokine release syndrome" seen in common critical
illnesses that may result in massive inflammation, organ failure and patient death. These are conditions where the risk of death can
be extremely high, yet few to no effective treatments exist. CytoSorb is also being used during and after cardiothoracic surgery
to remove inflammatory mediators that can lead to post-operative complications, including multiple organ failure. More than 152,000
CytoSorb devices have been delivered to date. CytoSorb was originally introduced into the European Union under CE-Mark as a first-in-kind
cytokine adsorber. Additional CE-Mark label expansions were received for the removal of bilirubin and myoglobin in clinical conditions
such as liver disease and trauma, respectively, and both ticagrelor and rivaroxaban during cardiothoracic surgery. CytoSorb
has also received FDA Emergency Use Authorization in the United States for use in adult critically ill COVID-19 patients with
imminent or confirmed respiratory failure. The DrugSorb-ATR Antithrombotic Removal System, which is based on the same polymer
technology as CytoSorb, has also been granted FDA Breakthrough Designation for the removal of ticagrelor, as well as FDA Breakthrough
Designation for the removal of the direct oral anticoagulant (DOAC) drugs, apixaban and rivaroxaban, in a cardiopulmonary bypass
circuit during urgent cardiothoracic surgery. The Company is initiating two pivotal trials designed to support U.S. FDA marketing approval