Cytosorbents (CTSO) Reports Q4 Revenues Beat
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Cytosorbents (NASDAQ: CTSO) reported Q4 revenue for the quarter came in at $12 million versus the consensus estimate of $10.95 million.
Q4 2020 Results
- Q4 2020 total revenue was approximately $12.0 million versus $7.4 million a year ago
- Product sales growth accelerated in Q4 2020, with record quarterly product sales of approximately $11.5 million, a 74% increase from $6.6 million in Q4 2019
- Product gross margins were a record high of 82% in Q4 2020 versus 80% in Q4 2019
Dr. Phillip Chan, MD, PhD, Chief Executive Officer of CytoSorbents stated, "In our recent stockholder letter, I discussed how the company successfully navigated a challenging 2020 and outlined our expectation for continued growth this year as we eventually transition from COVID-19 to the 'new normal.' I would encourage you to read the letter if you have not already done so."
"In addition to our business objectives, we are focused on executing our clinical plan to support regulatory approvals, inclusion into standard treatment guidelines, and reimbursement. Our emphasis is to conduct rigorous, adequately powered, multi-center, company sponsored clinical trials. To this end, we have significantly expanded our clinical trial operational capabilities and will continue to do so in 2021."
"Our first priority is to leverage our Breakthrough Designation to remove ticagrelor (Brilinta®; AstraZeneca) during urgent or emergent cardiothoracic surgery, and to implement our clinical and regulatory strategy to gain U.S. approval. We believe this is the most expeditious, lowest risk, and least burdensome path to U.S. regulatory approval that leverages our extensive cardiac surgery experience, good clinical outcomes, and regulatory approvals in Europe in this application, from which we can then build our critical care and cardiac surgery franchises in the future. Following productive prior discussions with the FDA, we expect to imminently file an investigational device exemption (IDE) application to conduct a well-designed and powered clinical trial in the U.S. to demonstrate the clinical benefit of our therapy. This STAR-T Trial (Safe and Timely Antithrombotic Removal of Ticagrelor) will be led by two world-renowned Principal Co-investigators, with support from a distinguished Executive Committee. We have already screened and obtained the commitment from the majority of needed U.S. centers to participate in the study. In addition, the trial has been designed to obtain the clinical and health economics data needed to support a U.S. regulatory filing for this application, and also reimbursement. As previously noted, the Centers for Medicare & Medicaid Services announced the Medicare Coverage of Innovative Technology pathway that will provide national Medicare coverage for approved Breakthrough Medical Devices for 4 years. We plan to work closely with the FDA to expedite the review and approval of the IDE, and will have more detail on the final trial design at that time."
"Meanwhile, we are forging ahead with our efforts to open the U.S. market to our therapy for the removal of the direct oral anticoagulants (DOACs) in emergent or urgent cardiothoracic surgery. These include blockbuster anticoagulant medications such as the Factor Xa inhibitors - Eliquis® (apixaban; Pfizer, Bristol Myers Squibb), Xarelto® (rivaroxaban; Janssen, Bayer), and Lixiana® and Savaysa® (edoxaban; Daiichi Sankyo, Daewoong Pharmaceutical), as well as the direct thrombin inhibitors such as Pradaxa (dabigatran; Boehringer Ingelheim). As with ticagrelor, these blood thinners are also often associated with severe to life-threatening perioperative bleeding after cardiothoracic surgery. We anticipate that the clinical and regulatory pathway will be similar to that for ticagrelor. Our technology has shown the ability to remove all of these agents in vitro, and in the case of rivaroxaban and apixaban, in humans during cardiac surgery. This application would target an additional total addressable market in the U.S. alone of approximately $500M."
"In addition to the above, the company-sponsored CyTation trial in Germany for ticagrelor removal is open for enrollment, though the U.K. TISORB study has been impacted by COVID-19 restrictions in that country. We have also developed the STAR registry, that will collect real world data on the removal of antithrombotics with our blood purification technology."
"We are currently prioritizing the STAR-T trial. However, we plan to resume the U.S. REFRESH 2-AKI trial as soon as possible, pending COVID-19 restrictions. In addition to the studies above, we plan to initiate multiple other company-sponsored studies this year, including the multi-center, randomized, controlled PROCYSS (Prospective, Randomized, COntrolled Trial To Evaluate CYtoSorb For Shock Reversal in Septic Shock) trial in refractory septic shock in Germany anticipated to start in the third quarter, and the HepOnFire single arm pilot study in liver disease expected to start in the fourth quarter. The results of the REMOVE endocarditis study are expected soon. Finally, we plan to submit a publication on the results from ECMO and CytoSorb from the multi-center U.S. CTC registry and a review article summarizing the international experience in COVID-19 patients treated with CytoSorb and CRRT or hemoperfusion."
For earnings history and earnings-related data on Cytosorbents (CTSO) click here.
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