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CytoSorbents Reports Second Quarter 2023 Financial and Operational Results Q2 2023 Total Revenue was $9.4 million, an 11% increase from $8.5 million in Q2 2022. Product sales rose 10% to $8.1 million vs $7.3 million in Q

Key Takeaway: CytoSorbents Corporation reported an 11% increase in total revenue for Q2 2023, reaching $9.4 million compared to $8.5 million in the same quarter last year. The company highlighted a growth in product sales by 10%, indicating effective commercial strategies amidst a recovering market. CytoSorbents is nearing completion of its pivotal STAR-T randomized trial, with topline data expected before the end of the year. The firm is also preparing for regulatory submissions in the U.S. and Canada, anticipating a solid future for its DrugSorb-ATR product addressing critical cardiac needs.

Market Sentiment Analysis

POSITIVE FACTORS

  • Total revenue increased by 11% in Q2 2023 compared to Q2 2022
  • Product gross margins rose significantly by 700 basis points to 74%
  • Positive momentum expected with upcoming pivotal STAR-T trial results
  • New growth initiatives and leadership are driving business momentum

Full Press Release Details

CytoSorbents Reports Second Quarter 2023 Financial
and Operational Results
Q2 2023 Total Revenue was $9.4 million, an
11% increase from $8.5 million in Q2 2022. Product sales rose 10% to $8.1 million vs $7.3 million in Q2 2022. Product gross margins grew
700 basis points to 74%
PRINCETON, N.J., August
1, 2023 - CytoSorbents Corporation (NASDAQ: CTSO), a leader in the treatment of life-threatening
conditions in the intensive care unit and cardiac surgery using blood purification via its proprietary polymer adsorption technology,
today reported unaudited financial and operating results for the quarter ended June 30, 2023.
Second Quarter 2023 Financial Results
Recent Operating Highlights:
Dr. Phillip Chan, Chief Executive Officer of CytoSorbents
stated, "We are pleased to report another successful quarter of executing on our three key business objectives for 2023. Most importantly,
we expect to complete the pivotal STAR-T randomized, controlled trial imminently, following the 30-day follow-up of the last patient,
which we believe puts us on target for topline data before the end of the year.
We continue to march towards our goal of opening
the U.S. and Canadian markets with DrugSorb-ATR through the STAR-T (Safe and Timely Antithromobotic Removal
of Ticagrelor) and pending STAR-D programs. We thank our U.S. and Canadian STAR-T clinical trial investigators and centers, study
Principal Investigators, contract research organizations, and the clinical team at CytoSorbents, for an outstanding performance in the
study and for completing enrollment well ahead of schedule. We are also pleased the independent DSMB, following two scheduled reviews
of unblinded safety data on the first 80 patients, recommended completion of the study without modifications in June.
We have been working with centers in parallel
during the STAR-T study to ensure timely entry and monitoring of data, and despite enrolling the final 60 patients in the last 2.5 months
of the study with a lot of work ongoing, we expect to formally complete the study shortly and drive data cleaning and database lock in
the next several months. This will be followed by statistical analysis of the data, which we believe will enable us to achieve our goal
of announcing topline data before year-end. Meanwhile, our regulatory personnel have been coordinating the resources of the company to
assemble the regulatory dossier needed to submit for marketing approval to U.S. FDA and Health Canada, which we plan to do as soon as
possible assuming positive clinical study data. We plan to follow this with a formal presention of the data at a major U.S. cardiovascular
conference. With improved visibility on future approval, we expect to execute our pre-commercialization strategy and begin building our
sales and marketing infrastructure next year.
DrugSorb-ATR targets a large and growing market
opportunity that exists today and we expect it to further accelerate as low-cost generic versions of ticagrelor become available starting
in 2024. For example, the need to remove Brilinta (ticagrelor, AstraZeneca) in patients with acute coronary syndrome who have received
dual anti-platelet therapy (aspirin and a P2Y12 platelet inhibitor), but now require coronary artery bypass graft (CABG) surgery, is highlighted
by the rapid speed of patient enrollment in the U.S. and Canadian STAR-T trial. Today, physicians have the choice of using different P2Y12
anti-platelet drugs, including Brilinta , Plavix (clopidogrel, BMS/Sanofi), and Effient (prasugrel, Eli Lilly, Daiichi Sankyo,
UBE). Although Brilinta has superior antithrombotic efficacy to Plavix, Plavix is still widely used because it is generic and less expensive.
However, since Brilinta is expected to become generic ticagrelor in 2024, we believe it will take market share from both Plavix and Effient
as the price of ticagrelor drops. In addition, if DrugSorb-ATR is approved to remove Brilinta, Brilinta will become the only P2Y12 platelet
inhibitor with a solution available to allow timely surgery in patients on the drug - a powerful marketing message to prescribing
cardiologists and emergency room physicians who know that 5-10% of patients with acute coronary syndrome treated with a P2Y12 inhibitor
will not be candidates for stent placement and will require surgery and be at high risk of potentially fatal perioperative bleeding.
The preference for Brilinta (ticagrelor) by U.S.
cardiologists has been highlighted recently in the prestigious JAMA Network Open publication, entitled, "Assessing the Clinical
Treatment Dynamics of Antiplatelet Therapy Following Acute Coronary Syndrome and Percutaneous Coronary Intervention in the US" where
in a cohort study of more than 62,000 patients from 2010-2019 demonstrated that "ticagrelor has emerged as the most commonly prescribed
P2Y12 inhibitor" following acute coronary syndrome and percutaneous coronary intervention. The rise of ticagrelor usage in this
setting can be easily seen in Figure 1, where in 2019, ticagrelor was the drug of choice in 60.4% of cases, while clopidogrel (Plavix )
dropped to 29.6%, and prasugrel (Effient ) dropped to 10.0% of cases. We believe this trend bodes well for DrugSorb-ATR and supports
our contention that the U.S. and Canadian ticagrelor market will expand over time.
With STAR-T enrollment complete, our clinical
team is now focused on the activities leading up to the analysis of the results, and if positive, preparation of the documentation needed
for our planned U.S. and Health Canada regulatory submissions for DrugSorb-ATR. When appropriate, we plan to continue our STAR (Safe and
Timely Antithrombotic Removal) program with the resumption of the STAR-D trial, that will evaluate the use of DrugSorb-ATR to remove the
direct oral anticoagulant (DOAC) Factor Xa inhibitors, Eliquis and Xarelto (among the highest revenue generating pharmaceuticals in the
world), and to reduce bleeding risk in cardiothoracic surgery patients on these agents. We plan to leverage the same site network as in
STAR-T and based on their feedback that they routinely encounter patients on DOACs needing cardiac surgery and their proven track record
of trial execution, we believe the STAR-D trial can be run quickly and cost-effectively.
Finally, CMS recently announced details surrounding
the Transitional Coverage for Emerging Technologies (TCET) program and are currently in the public comment period. The current proposed
program falls short of what was widely anticipated by the medical device community and its trade organization, Advamed, providing a transparent
pathway for securing dedicated CMS national coverage of FDA Breakthrough Designated Devices within 6 months of FDA clearance or approval,
but departing from the automatic four-year national coverage upon FDA approval of qualified Breakthrough Devices that was discussed by
CMS previously. We expect there to be ongoing discussion and possible modification of the program. We believe DrugSorb-ATR, as a Breakthrough
Designated Device whose core target population falls squarely in the age group covered by Medicare, would still be an excellent candidate
for this TCET program and we will continue to follow the story as it develops. Meanwhile, the STAR-T trial is expected to provide significant
health economics data to support reimbursement through traditional private and public insurance pathways.
CytoSorb targets the massive critical care and
cadiac surgery markets outside the U.S., helping to control deadly inflammation and other life-threatening conditions such as sepsis,
lung injury, trauma, burn injury, liver failure, complications of surgery, cytokine release syndrome in cancer immunotherapy, and many
others. Following a post-COVID slowdown in hospital-based markets globally in 2022, we are pleased to report our third consecutive quarter
of sequential product sales growth and a 10% increase in Q2 2023, year-over-year. With many new growth initiatives, and importantly new
leadership in key positions in our therapy area verticals and our overall commercialization organization, we anticipate further momentum
of our business over time. Importantly, product gross margins have rebounded 700 basis points to 74%, a trend consistent with our guidance
of returning to 75-80% product gross margins on a quarterly basis this year. Our new manufacturing facility is fully online and producing
CytoSorb devices in volume.
We believe there is now no question of what we
have known for years - that CytoSorb is a powerful treatment of cytokine storm, particularly following the landmark publication in the
journal Critical Care, describing the excellent effect of CytoSorb on reducing systemic cytokine levels in a well-controlled human endotoxin
challenge model. We have learned a lot over the past 11 years of CytoSorb commercialization and the more than 200,000 human treatments
administered to date in patients that are literally battling between life and death. Every study that has been published - positive, neutral,
or negative - has taught us more about how to best treat patients with CytoSorb. We have distilled it down to the very simple message
of "Right Patient, Right Timing, Right Dose."
The concept of treating the right patient at the
right time with the right dose to have good clinical outcomes is, in fact, relevant to most therapies. For example, antibiotics are some
of the most commonly used drugs in the intensive care unit and are a perfect analogy for CytoSorb. Certainly you need antibiotics to kill
the pathogen and to survive a life-threatening infection, just as you need to control the deadly massive inflammatory response in sepsis
with CytoSorb. But despite antibiotics and the best standard of care (excluding CytoSorb), approximately 20-25% of patients with sepsis
and organ dysfunction will die, and 35-50% of patients with septic shock will still die. A lot of these failures can be traced back to
not following the "Right Patient, Right Timing, Right Dose" mantra. For example, if a patient with an infection is misdiagnosed
and treated with the wrong antibiotic, it will not work (e.g. treating COVID-19 with penicillin instead of Paxlovid ). Or if an infection
is not treated with antibiotics until the infection has spiraled out of control and the patient develops sepsis - then this is too
little too late.' Or if the dose of the antibiotic is not adjusted for the severity of illness, the antibiotic may not work optimally.
This is why for the past several years, thanks
to the observations of many dedicated CytoSorb users around the world, we have been emphasizing the "Right patient, right timing,
and right dose" with the early and aggressive treatment of patients with clear evidence of hyperinflammation. Many of the older
studies, for example, used CytoSorb relatively late in patients that had already developed kidney failure and were on dialysis, a generally
later stage complication in critical illness that itself increases the risk of death, making it more difficult to demonstrate a benefit.
Other studies did not evaluate the inflammatory status of patients. But when CytoSorb is used early and aggressively in documented hyperinflamed
patients, we have seen some outstanding results. This includes the recently published final CTC (CytoSorb Therapy in COVID-19) Registry

Frequently Asked Questions

What was CytoSorbents' revenue for Q2 2023?

CytoSorbents reported a revenue of $9.4 million for Q2 2023.

How much did product sales increase in Q2 2023?

Product sales increased by 10% to $8.1 million compared to Q2 2022.

What is DrugSorb-ATR targeting?

DrugSorb-ATR targets the removal of ticagrelor in specific surgical patients.

When is topline data for STAR-T expected?

Topline data for the STAR-T trial is anticipated before the end of 2023.

What gross margin did CytoSorbents achieve?

CytoSorbents achieved product gross margins of 74% in Q2 2023.

Last updated: Aug 1, 2023