Cytosorbents Corporation (NASDAQ:CTSO) Q4 2022 Earnings Call Transcript

Efthymios Deliargyris: Sure. Let me just, first of all the guidelines you heard from multiple people on the call today. We see that as a major development. Getting in the guidelines, it’s really a milestone for any intervention, any therapy, any drug, any device. So we think that’s definitely a tailwind. It gives a different stature to the therapy. And of course it gives the credibility from the review of tens of experts who formed this guideline committee. So there’s no question. I think that’s a positive. The STAR registry will have serial data readouts. We’re hoping this year, as I mentioned, one presentation is already locked in this May in Paris in a massive meeting, the EuroPCR meeting. But we think we’re going to have more.

And the reason we’re going to have sequential analysis is because we’re seeing this robust enrollment, the numbers keep going up, and therefore statistical power increases, we’re able to look at subgroups, different drugs, different types of patients, different types of surgery. So we think the body of evidence will continue to grow and will support what we already seeing, which is an increasing adoption. And increasingly as a standard of care in many heart centers. The STAR-T trial will open up the U.S., the North American market, U.S. and Canada, hopefully, if positive, of course. And once that’s in play, we think then the story around ATR will be complete in addition with some health economic analysis that have already begun to be making their way from different healthcare systems showing that there’s a lot of cost savings associated with that procedure.

So I hope that helps.

Josh Jennings: Definitely. Thanks for that download. Wanted to ask about the gross margin expansion and the return to that 75% to 80% range on product gross margins. Is there any way to break out just the reliance on that expansion to volume growth versus some of the cost reduction issues or recovery in costs? And also just on top of that is, any pricing dynamics for CytoSorb that we should understand?

Phillip Chan: Vince, do you want to take the first part of that or Kathy?

Vincent Capponi: Sure.

Phillip Chan: And then Christian, maybe you can talk about the pricing stability. Thanks.

Vincent Capponi: Okay. Sure. I’ll take the first part about the gross margin. I mean it’s €“ there have been a €“ there will be efficiencies associated with this new facility and actually just the reduction in cost just out of efficiencies because we’re under one roof as opposed to two sites we were in previously. But the second thing is the volume in the business is starting to come back. And the fact that we’ve scaled so much now, the overhead absorption will be much better as we drive more volume out of here. So continued gross margin reduction will be a factor of both, obviously, improvements in efficiency because of the new location, but also increases demand from the market, and that will continue to drive the price. And obviously as most businesses that are volume driven such as this the higher the volume, it drops relatively quickly with increasing volume. Christian?

Christian Steiner: Thank you Josh for the question. I have to say the price stability for sizes of is very high. So we have very stable and customer prices and even could slightly increased prices in different markets. So this is mainly backed up by a continuous expansion of the value of the therapy. So as you have heard from Makis there’s a continuous stream of new clinical data, which really is supporting the price and supporting the supporting value proposition. And I think we are not yet finished with this development and can show on the next two quarters and years in increased body of evidence and much more support for the therapy. So very stable pricing, I have to say, all over the world.

Josh Jennings: Great, thanks. Maybe just one last question. Phil, we’re going to just hear sometimes hard for us to track some of these international markets, but how is the competitive landscape for heme purification technology shaping up anything we should have on our radar? Thanks so much.

Phillip Chan: Hi, Josh. Thanks for the questions. I think that from a competitive standpoint, you can look at the level of competitiveness of our technology based on others just by looking at the volume of publications that have been put out by users over the years. We have some Chinese competitors that are trying to break into the acute care marketplace. But if you do a search on their technology, or if you do a search on really our, probably our major competitor, which is Baxter and their offerings you can see that the volume of those publications are very low, considering the amount of time they’ve been in the marketplace compared to our publication list, which continues to grow significantly every single year to, again, hundreds and hundreds of published articles now.

So I think that we are continuing to remain the leader in the blood purification space to treat life-threatening inflammation, acute care diseases. We are the leader in fact the only player approved specifically to reduce anti-thrombotic agents in the European Union under our CE marks certificate and continue to drive that leadership through new innovation and some of the studies that you’ve seen in staph aureus endocarditis and acute respiratory distress syndrome and in liver €“ treatment of acute liver disease and many others.

Josh Jennings: Excellent. Thanks, Phil.

Phillip Chan: Great. Thanks, Josh.

Operator: The next question comes from Sean Lee with H.C. Wainwright. Please go ahead.

Sean Lee: Good afternoon guys, and thanks for taking my questions. My first question is previously you mentioned that the revenue reduction in 2022 was mostly due to several headwinds, including the prevalence of mild COVID cases that limited access to hospitals. So I was wondering, have those headwinds cleared up so far this year, and what’s your outlook for 2023?

Phillip Chan: Yes, thanks, Sean. Maybe Christian, you can comment on that, and if I needed, I can comment as well.