MONMOUTH JUNCTION, N.J.,
Oct. 12, 2021 /PRNewswire/
-- 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.
Preliminary Third Quarter 2021 Financial Information
- Total revenue, including product sales and grant income, for Q3
2021 was $9.7 million, down 8%
compared to $10.5 million in Q3
2020.
- Q3 2021 CytoSorb product sales were $8.9
million, down 13% compared to $10.2
million in Q3 2020.
- Q3 2021 product sales in Germany are estimated to be $3.7 million, a decrease of $1.1 million or 24%, from product sales of
$4.8 million in Germany in Q3 2020.
- Core non-COVID-19 product sales for Q3 2021 were approximately
$7.8 million, up 4% from
approximately $7.5 million in Q3
2020.
- Estimated product sales related to COVID-19 were $1.1 million in Q3 2021 versus approximately
$2.7 million in Q3 2020.
- The Company has a strong cash balance of $61.0 million at September
30, 2021 and no debt.
CytoSorbents Provides Preliminary Third Quarter Business Update and
Revised 2021 Product Revenue Guidance
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:
- Fewer critically ill COVID-19 patients on mechanical
ventilation and ECMO, and fewer core non-COVID-19 patients
undergoing elective surgeries with complications such as sepsis
where CytoSorb is often used.
- Increased hospital restrictions resulting in decreased access
of sales representatives to hospitals and fewer sales meetings with
physicians.
- Continued reduced ICU capacity that impacted the numbers of ICU
patients, compounded by staffing shortages as fatigued healthcare
workers (particularly ICU nurses) left to pursue other
opportunities, and as patient safety laws decreased the number of
ICU patients a nurse is allowed to manage.
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."
Dr. Phillip Chan, 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."
Dr. Chan concluded, "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 Revenue Guidance
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:
- Q4 2021 product revenue similar to Q3 2021 product revenue of
$8.9 million, suggesting
approximately $17.8 million in second
half product sales, down 17% from first half 2021 products sales,
as compared to previous expectations of higher second half 2021
product sales compared to first half 2021 product sales.
- Full year 2021 product revenue of at least $39.3 million, roughly flat compared to 2020
product revenue of $39.5 million.
While difficult to predict, 2021 core non-COVID-19 product sales
are expected to be approximately $33
to $34 million for the year versus
$30.1 million in 2020.
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 feed:
https://viavid.webcasts.com/starthere.jsp?ei=1505348&tp_key=fc4e9855a2
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 of
DrugSorb-ATR. The first is the 120-patient, 20 center STAR-T
(Safe and Timely Antithrombotic Removal of Ticagrelor) randomized,
controlled trial evaluating the ability of intraoperative
DrugSorb-ATR use to reduce perioperative bleeding risk in patients
on ticagrelor undergoing cardiothoracic surgery. The second
is the 120-patient, 25 center STAR-D (Safe and Timely
Antithrombotic Removal of Direct Oral Anticoagulants) randomized,
controlled trial, evaluating the intraoperative use of DrugSorb-ATR
to reduce perioperative bleeding risk in patients undergoing
cardiothoracic surgery on direct oral anticoagulants, including
apixaban and rivaroxaban.
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. Its technologies have received
non-dilutive grant, contract, and other funding of more than
$39.5 million from DARPA, the U.S.
Department of Health and Human Services (HHS), the National
Institutes of Health (NIH), National Heart, Lung, and Blood
Institute (NHLBI), the U.S. Army, the U.S. Air Force, U.S. Special
Operations Command (SOCOM), Air Force Material Command (USAF/AFMC),
and others. The Company has numerous marketed products and
products under development based upon this unique blood
purification technology protected by many issued U.S. and
international patents and registered trademarks, and multiple
patent applications pending, including ECOS-300CY®, CytoSorb-XL™,
HemoDefend-RBC™, HemoDefend-BGA™, VetResQ®, K+ontrol™,
DrugSorb™, DrugSorb-ATR™, ContrastSorb, and others. For
more information, please visit the Company's websites at
www.cytosorbents.com and www.cytosorb.com or follow us on
Facebook and Twitter.
Financial Disclosure Advisory
The Company reports its financial results in accordance with
U.S. generally accepted accounting principles. The expected
financial results discussed in this press release are preliminary,
unaudited, and represent the most current information available to
the Company's management, as financial closing procedures for the
quarter ended September 30, 2021 are
not yet complete. These estimates are not a comprehensive statement
of the Company's financial results for the quarter ended
September 30, 2021 and actual results
may differ materially from these estimates as a result of the
completion of normal quarter-end accounting procedures and
adjustments, including the execution of the Company's internal
control over financial reporting, the completion of the preparation
and review of the Company's financial statements for the quarter
ended September 30, 2021 and the
subsequent occurrence or identification of events prior to the
formal issuance of the third quarter financial results.
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. These
forward-looking statements include, but are not limited to,
statements about our plans, objectives, anticipated future results
and performance, representations and contentions and are not
historical facts and typically are identified by use of terms such
as "may," "should," "could," "expect," "plan," "anticipate,"
"believe," "estimate," "predict," "potential," "continue" and
similar words, although some forward-looking statements are
expressed differently. You should be aware that the
forward-looking statements in this press release represent
management's current judgment and expectations, but our actual
results, events and performance could differ materially from those
in the forward-looking statements. Factors which could cause
or contribute to such differences include, but are not limited to,
the risks discussed in our Annual Report on Form 10-K, filed with
the SEC on March 9, 2021, as updated
by the risks reported in our Quarterly Reports on Form 10-Q, and in
the press releases and other communications to shareholders issued
by us from time to time which attempt to advise interested parties
of the risks and factors which may affect our business. We
caution you not to place undue reliance upon any such
forward-looking statements. We undertake no obligation to
publicly update or revise any forward-looking statements, whether
as a result of new information, future events, or otherwise, other
than as required under the Federal securities laws.
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Investor Relations Contact:
Terri Anne Powers
Vice President, Investor Relations
and Corporate Communications
(732) 482-9984
tpowers@cytosorbents.com
U.S. Public Relations Contact:
Eric Kim
Rubenstein Public Relations
212-805-3052
ekim@rubensteinpr.com
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SOURCE CytoSorbents Corporation