Cytosorbents Corp.CTSO
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Cytosorbents Corp. H.C. Wainwright 28th Annual Global Investment Conference

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Sean LeeSenior Biotech Analyst

Okay. Hello and good morning, everyone. Thank you for joining us at the 28th Annual H.C. Wainwright Global Investment Conference. My name is Sean Lee, and I am a senior biotech analyst at the bank. Joining me today for this next fireside chat is Mr. Phillip Chan, who is the CEO of CytoSorbents, and Mr. Pete Mariani, who is the CFO. CytoSorbents is known for developing novel blood purifiers for critical care, cardiac surgery, and other indications. The company is currently commercializing CytoSorb in Europe and other international markets and plans to file a de novo application for DrugSorb-ATR in the U.S. early next year. Without further ado, please welcome Phil and Pete.

Pete MarianiCFO

Thanks, Sean. Thanks very much, Sean.

Sean LeeSenior Biotech Analyst

Okay, Phil, to start us off and for the benefit of our audience today, who may not be familiar with CytoSorbents, could you provide a high-level overview of the company?

Phillip ChanCEO

Sure. I am Dr. Phillip Chan. I am the CEO of CytoSorbents, been leading the company for about 18 years now. Our company is a NASDAQ-traded medical device company that specializes in blood purification to treat life-threatening illnesses in the intensive care unit, as well as in cardiac surgery. This is our flagship product here, CytoSorb. We manufacture this out of our ISO 13485 certified facility in New Jersey, and this is a product that we commercialize in 75 countries around the world based upon our EU approval. It has now accumulated more than 300,000 treatments to date. In the past trailing 12 months, it has generated $37.3 million in high margin sales of this product all over the world. In Q2, our gross margins were 73%. People call it a Brita filter for your blood.

Phillip ChanCEO

It kind of belies, I think, the sophistication of the technology, but in every cartridge, there's hundreds of thousands of tiny porous polymer beads, roughly the size of a grain of salt, that help to extract toxic materials from the bloodstream, helping to control deadly inflammation and a lot of other problems that happen in critically ill patients. You set it up just like dialysis. It, in fact, is plug and play compatible with the existing blood pump infrastructure in a hospital today, whether or not it's a dialysis machine in the intensive care unit or heart lung machine, for example, in the operating room. Because of the success that we've had with that product to date, we are now nearing cash flow break even, which we expect to achieve in the second half of this year.

Phillip ChanCEO

In the second quarter, we burned only about $200,000 in operating cash, if you subtract out restructuring charges, and we hope to get to that cash flow break even point second half of this year and then profitability, hopefully, in the near future. As Sean said, a third initiative of ours, value creating initiative, is to get a different product approved in the U.S. called DrugSorb-ATR. This is a device that is specifically designed to remove blood thinners during cardiothoracic surgery that can cause potentially serious or even fatal perioperative bleeding. There's currently no antidote for this today except to wait. We are currently in front of FDA looking to try to get this product approved, hopefully sometime mid-2027.

Phillip ChanCEO

A fourth and final value proposition that we have is a product called HemoDefend, which is a preclinical program entering human clinical trials that is designed. It's a filter that is designed to create universal blood products that can be given to anybody regardless of their blood type. So simplifying the blood transfusion industry, particularly for plasma and platelets, down to a single, instead of A, B, AB, and O type blood products, we can make a universal blood product that can be given to anyone, thereby helping, hopefully, to save future costs in the industry. But also, if you think about the pre-hospital situation, emergency vehicles and emergency first responders, we have the ability to potentially give life-saving blood products to people in the field if this product gets developed, which would be really the holy grail of pre-hospital emergency response. So that's us in a nutshell.

Sean LeeSenior Biotech Analyst

Thank you for that, Phil. For the first part of our fireside, I'd like to focus on your existing commercial business. For over the last two years or so, the company's revenues have been going up and down, primarily as a result of challenges in the Germany direct sales market. What is the situation there right now, and what do you need still to do to achieve a turnaround?

Phillip ChanCEO

Yeah, we have been actually working. We have a hybrid sales model where we sell direct in 10 countries in the European Union and then in 65 countries through distributors and partners like Fresenius Medical Care, one of the largest dialysis companies in the world, and other places in the world. Germany accounts for, in the last quarter, about 25% of our sales, and it has undergone a restructuring since early 2025, where we've really looked to revamp our entire sales approach in Germany to try to return Germany back to growth following the pandemic. During the pandemic, there was a lot of things that happened, including loss of a lot of healthcare workers, for example, ICU nurses, ICU healthcare workers, and because of that, the ICU markets have shrunk in Germany.

Phillip ChanCEO

But we felt that we had the ability to take this into our own hands and improve our own sales approach. We've undergone a fairly broad restructuring where we've revamped leadership, we've implemented new key sales processes that were all designed to try to improve the efficiency and efficacy of our sales force, including, for example, new training, better medical marketing and messaging, the institution of more key performance indicators so that we have better visibility on what our salespeople are actually doing, and a number of other changes where we've now seen significant improvement in sales rep productivity. But in that restructuring, we've had to shrink down the organization by a little bit more than 30%.

Phillip ChanCEO

We are now in the process of now rebuilding that organization, which we think is really now the key, now that the processes are all in place, the key to getting back to growth in Germany. We're well on our way to doing that. We're already seeing the benefits of that restructuring now.

Sean LeeSenior Biotech Analyst

Great to hear that. In contrast to Germany, we've seen pretty notable growth in the other direct sales in the international markets, especially over the last two quarters. Do you expect this growth to continue over the next couple of quarters? What are some of the pushes and pulls that will affect this trend?

Phillip ChanCEO

Yeah. One of the reasons why we are very optimistic about our future sales growth is that the other parts of our hybrid sales model, where we are selling through distributors or we are selling direct through our own sales force in countries outside of Germany, is that actually they have been doing very well. Distributors in the last quarter grew 16%. Direct sales outside of Germany grew 9%, which is one of the reasons why we are so focused on getting Germany back to growth. It is a very dynamic business. There is a lot happening all over the world. One of our key growth initiatives was actually opening up the Middle East. In January 2025, based upon a tremendous amount of support and interest in the Middle East and the North Africa region, the MENA region, we opened up a new subsidiary in Dubai, U.A.E.

Phillip ChanCEO

Unfortunately, as we all know, there was the Iran war that has happened that really destabilized, I think, the region and put a lot of uncertainty there, which made it difficult for us to really drive sales. But I think we have not lost focus there because we have been continuing to speak to clinicians. We have been continuing to drive support of our technology and also publicity of our technology in the area for these applications in critical care and cardiac surgery. We are cautiously optimistic about the second half year. We think that we will have some modest sales in the MENA region. But we think that we are well-situated for true growth in 2027.

Sean LeeSenior Biotech Analyst

I see. Also, finishing up on the existing commercialization, I have noticed that the company's gross margins have also improved steadily over the last couple of quarters. Can we expect this trend to continue? Also, do you have sufficient production capacity to support a future DrugSorb-ATR launch?

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