Good afternoon, ladies and gentlemen, and welcome to the CytoSorbents First Quarter 2025 Earnings Conference Call. At this time, all lines are in listen-only mode. Following the presentation, we will conduct a question-and-answer session. [Operator Instructions] This call is being recorded on [Thursday, May 8, 2025] (ph). I would now like to turn the conference over to Mr. Adanna Alexander. Please go ahead.

Thank you, Constantine, and good afternoon, everyone. Welcome to CytoSorbents' first quarter 2025 financial results and recent business highlights conference call. Joining me today from the company for prepared remarks are Dr. Phillip Chan, Chief Executive Officer; Dr. Makis Deliargyris, Chief Medical Officer; and Pete Mariani, Chief Financial Officer. Before I turn the call over to Dr. Chan, I'd like to remind listeners that during the call, management's prepared remarks may contain forward-looking statements, which are subject to risks and uncertainties. Management may make additional forward-looking statements in response to your questions today. Therefore, the company claims protection under the safe harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995. Actual results may differ from results discussed today. The forward-looking statements we make reflect our views and estimates as of today, May 14, 2025, and we assume no obligation to update these projections in the future as market conditions change. During today's call, we will have an overview presentation covering the operating and financial highlights for the first quarter 2025. Following the presentation, we will open the line to analysts for their questions. And now, it is my pleasure to turn the call over to Dr. Phillip Chan. Phil?

Thank you very much, Adanna. Good afternoon, and welcome, everyone, to our first quarter 2025 earnings call. As a quick summary for those who are new to the company, CytoSorbents is a leader in the treatment of life-threatening conditions in the intensive care unit in cardiac surgery through blood purification and the removal of harmful substances from blood with our proprietary sorbent bead technology. Cartridges filled with these beads are high-margin single-use disposables that are plug-and-play compatible with existing blood pump machines in the hospital, such as dialysis, ECMO and heart-lung machines. Our technologies are used in a broad number of blood purification applications, specifically CytoSorb, our flagship product, which is approved in the European Union, is used primarily to treat life-threatening conditions in the ICU and cardiac surgery such as sepsis, acute respiratory distress syndrome, liver failure, blood thinner removal and infective endocarditis. CytoSorb is the anchor of our core international business with over 270,000 devices utilized to-date in more than 70 countries worldwide and drove $35.6 million in core product sales in 2024. Our second product, DrugSorb-ATR is an investigational FDA breakthrough designated medical device intended to reduce the severity of perioperative bleeding in patients undergoing cardiac surgery due to blood thinning drugs. We are focused initially on the blood thinner Brilinta in patients undergoing coronary artery bypass grafting, or CABG, surgery. And in September and November of 2024, we submitted marketing applications to both FDA and Health Canada, respectively. Makis will have some updates on the status of these applications later. Given that we just had a broader update on the company in our end-of-year earnings call a month-and-a-half ago, today's agenda will just focus on the three main areas where we are concentrating our efforts. I will discuss our core CytoSorb business and highlight key catalysts…

Thank you, Phil, and good afternoon to everyone on the call. As most of you know, in the second half of last year, we submitted a de novo application to FDA and a medical device license application to Health Canada, supported by the STAR-T randomized clinical trial data and real-world evidence from the STAR registry. The FDA review process has been interactive with many issues discussed and resolved. However, on April 25, 2025, the FDA issued a denial letter citing remaining open issues. Following the issuance of the letter, we met with the FDA and had the opportunity to discuss these remaining issues and gain better clarity. We continue to believe that our submission package and data are strong and that the remaining issues can be resolved. After consulting with our regulatory counsel, we concluded that the most direct path forward is the filing of a formal appeal, which needs to happen within 60 days of receipt of the FDA letter. Once the appeal is filed, the process is prescribed and includes a formal hearing that will be attended by the company and our regulatory counsel, DuVal & Associates, the FDA review team, additional FDA senior officials and external clinical experts, such as cardiac surgeons, to provide expert testimony. The appeal decision is estimated approximately 60 days after the filing date, and there are three potential outcomes: first, the original decision is upheld and the de novo authorization is denied; second, the original decision is reversed and the de novo authorization is granted; and finally, a third option, where the original decision is reversed and the de novo authorization is granted, but under certain conditions that will need to be satisfied. Switching now to Canada, our medical device license application remains in advanced review. Health Canada recently indicated that they're…

Thanks, Makis. As we await regulatory decisions from both the FDA and Health Canada, we're proactively preparing for the potential commercial launch of DrugSorb-ATR in the U.S. and Canada. With the FDA's breakthrough device designation, DrugSorb-ATR is uniquely positioned to help address the critical challenge of perioperative bleeding in patients on blood thinners like Brilinta undergoing CABG surgery. Upon potential approval or authorization, our initial focus will be a controlled market introduction at select clinical trial centers. This phased approach will enable us to gather real-world data and valuable insights, confirm key assumptions and optimize our commercialization strategy ahead of a broader national rollout. We remain deeply committed to bringing DrugSorb-ATR to the North American market, where it represents a meaningful advance in the care of CABG patients facing life-threatening bleeding while on Brilinta. Momentum continues to build on the technology with growing awareness of DrugSorb-ATR's potential and compelling new European data emerging in 2025. As Makis has highlighted, these real-world findings consistently demonstrate reduced bleeding and highlight the device's promise in helping surgeons address a significant and persistent clinical challenge. We are thrilled to welcome Tom Shannon to the CytoSorbents team as Vice President of Marketing for North America, a big move as the company gears up for the potential launch of DrugSorb-ATR in the United States and Canada, pending market authorization. Tom is a global strategic marketing executive with over 25 years of experience bringing cutting-edge cardiovascular and critical care technologies to market and knows how to build momentum around major product launches. Tom has held leadership roles at multinational corporations like Medtronic, Fresenius and Getinge as well as Genesee BioMedical, where he helped launch dozens of products and drove consistent growth. For example, he helped launch the market-leading CardioHelp ECMO platform used around the world at Getinge in patients with refractory lung failure that was also used routinely with CytoSorb during the pandemic to salvage patients who otherwise would have died of COVID-19. Tom also brings hands-on clinical experience, having worked for over a decade as a cardiovascular perfusionist. Tom will be leading the marketing strategy for DrugSorb-ATR, which is designed to help reduce serious bleeding risks in heart surgery patients taking Brilinta. In the very short time he has been with the company, we have already been impressed with his deep expertise and operational efficiency that we believe makes him the right person to help CytoSorbents successfully enter the North American market with this important new therapy when the time comes. Now, I'll turn it over to Pete to give a financial update. Pete?

Thank you, Phil, and good afternoon, everyone. Today I will be reviewing our Q1 financial performance, including the strengthening of our balance sheet and our outlook for 2025. Revenue was $8.7 million, a decrease of 3% and flat on a constant currency basis compared to $9 million in Q1 of 2024. As Phil noted, we had strong revenue growth in our distributor and other direct European markets, and that growth was offset by declines in our largest market in Germany. The realignment of our German commercial team and approach is a key strategic initiative, and we are pleased with the progress we're making and expect these actions will drive improved execution and results in the second half of the year. Gross margin for the quarter was 71%, which is consistent with our full year '24 and lower than the 76% in Q1 of 2024. The year-over-year decrease was primarily due to a 23% reduction in the number of units produced in Q1 of this year compared to 2024 and partially offset by an 11% reduction in production costs year-over-year. We expect that production volumes to increase across the year to support growth in our core business and to prepare for the anticipated launch of DrugSorb-ATR in the U.S. and Canada later this year. Q1 operating loss improved by 17% to $3.9 million in the current year compared to $4.7 million in 2024, driven primarily by a 12% reduction in operating expenses to $10.1 million in Q1 of this year compared to $11.5 million last year. The decrease was driven by a 26% reduction in R&D expenses following the completion of our STAR-T trial, as well as lower spend in other clinical projects and the impact of cost-cutting efforts implemented over the previous year, including a 15% reduction in headcount. Net…

Thanks, Pete. We believe our value proposition is both strong and highly differentiated. With CytoSorb, we have built a robust high-margin international business in critical care and cardiac surgery, markets with vast unmet needs and enormous potential for growth. Our foundation is solid, and we are now focused on generating new clinical data to help guide physicians in optimizing CytoSorb use, treating the right patient at the right time with the right dose. We believe that improving clinical outcomes will drive broader adoption across a range of indications, ultimately accelerating product utilization and revenue growth. Last year, we saw encouraging momentum, particularly from strong direct sales outside of Germany and solid performance by our distributor and partner network. We are also taking proactive steps to reignite growth in Germany. If successful, this could significantly strengthen our overall financial performance. Importantly, continued growth in product sales brings us closer to our goal of near breakeven by the end of 2025 and sets the stage for long-term financial independence. What is not yet fully reflected in our growth story is the exciting potential of DrugSorb-ATR. We are working diligently on driving positive regulatory decisions from both FDA and Health Canada this year. In the meantime, we are actively preparing for launch, building awareness with positive real-world clinical data, corroborating the significant reduction in serious bleeding events in CABG patients on Brilinta seen in our pivotal trial and presenting at major cardiovascular conferences. While we await regulatory decisions from FDA and Health Canada, a positive outcome could unlock our first commercial access to the United States and Canadian markets. We expect to begin with a controlled market release and scale up from there. The initial addressable market, again, is estimated at $300 million for Brilinta in CABG surgery that could eventually exceed $1 billion with broader indications for use. With that, on behalf of the team at CytoSorbents, we thank you for your attention and continued support. That concludes our prepared remarks. Operator, please open the line for questions. Thank you.

[Operator Instructions] Your first question comes from the line of Mr. Michael Sarcone from Jefferies. Please go ahead.

Good afternoon, and thanks for taking our questions, and thanks for all the detail you provided.

Hi, Mike.

Just to start -- hey, Phil, understanding you're going to submit for an appeal of the FDA letter, I guess, can you talk about your level of confidence that we can get this over the finish line and get clearance? And then, as my follow-up to that, just when you think about the various scenarios, in the worst case, if you appeal and it gets denied, where do we go from there? Thank you.

Sure. Makis, why don't you take that question?

Yeah. Thanks, Michael. So, as we stated in our prepared remarks, we feel very strongly about the strength of our submission. We feel that the data in CABG from the STAR-T trial are compelling. And as I showed you and discussed previously, our real-world performance of the device has been excellent so far and very well-received by practicing clinicians. We, therefore, believe that our chances during this appeal process are good, and we discussed this with our regulatory council who agree with us, and therefore, we're taking this path as the most expedited way to resolve this. Now, on your second part of your question, what we can tell you is that there's always an opportunity should the appeal process not be successful to continue with a new de novo submission utilizing a very large portion of the original submission, and therefore, resulting in a much more truncated review time and review items that are remaining since many of the items were resolved during the initial submission.

Got it. That's very helpful. Thank you. And I guess in that latter scenario, Makis, would you have to run another trial and generate more data or would you not have to do that?

Although in general, we have not discussed the details of the remaining deficiencies outlined on the letter we received from FDA, I think we can announce that we have not received a request for an additional trial. So, we believe that the remaining issues can be resolved with the existing data at hand.

Got it. Very helpful. Thank you.

Your next question is from the line of Sean Lee from H.C. Wainwright. Please go ahead.

Hey. Good afternoon, guys, and thanks for taking the questions.

Hi, Sean.

Hi. My first one is on the various -- registry as well as the data that you've been presenting. Will these results help in any way with your marketing or reimbursement in Europe?

The clinical data is always the core of the discussion around the value of any introduced medical technology, the drugs or devices. So, the strongest your clinical proposition, the more powerful your value proposition. So absolutely, we plan to leverage this clinical data to support reimbursement and health technology assessment decisions over in the EU.

Are there any current discussions going on in countries outside of Germany?

In relation to?

Reimbursements, I mean. I know that your -- the reimbursement is mostly focused on Germany and surrounding countries. I was wondering for the broader reimbursement you use, especially during cardiac surgery, is there broader discussions on that?

Yeah. I think that cardiac surgery is where the data are simpler and clearer, and we absolutely have active discussions going on to try to obtain reimbursement in that area. In fact, in places like the United Kingdom, cardiac surgery is one of the top applications that's driving revenue in that territory, for example.

I see. Yeah, thanks for the additional color. That's all the questions we have.

Thank you, Sean.

[Operator Instructions] Your next question comes from the line of Mr. Tom Kerr from Zacks Small-Capital Research. Please go ahead.

Hey, everyone. This is Michael Kim filling in for Tom Kerr. Some of our questions have been asked and answered, but we did have a couple more. Just first, curious if there are any other European markets that might be showing promise for the CytoSorbent device besides Germany?

Yeah, I think that we're making good progress in the Big 5. We go direct in the U.K. We go direct in Germany. We work through distributors in Italy and Spain/Portugal. And in France, it's kind of a hybrid approach with partners and our own direct sales. So, from that standpoint, I think our progress is going actually quite well. And then, obviously, in the other European territories, I think that we're making good progress as well. We have decided to pull back in Scandinavia, favoring a distributor-focused approach in that territory, given the types of volumes in that part of the world. But that being said, we are seeing good momentum in other countries around the EU as well as outside of the EU.

Got it. That's helpful. And then, any updates on other products in development besides CytoSorbents and DrugSorb-ATR?

Well, right now, the big fish on the plate is DrugSorb-ATR. And so, we're uniquely and solely focused on driving that to the finish line. So, I think that when -- we obviously have other technologies like HemoDefend-BGA that we'll hopefully be talking about in the future, but for right now, we are uniquely and singularly focused on DrugSorb-ATR.

Got it. Thanks for taking our questions.

Sure. Absolutely.

Your last question is a follow-up from the line of Michael Sarcone from Jefferies. Please go ahead.

Hey, thanks again. Just had a follow-up on Germany. You talked about aiming to accelerate or get back to growth in the second half. I guess, what kind of visibility do you have into the conditions there? And again, we would just like to hear how you're thinking about your level of confidence in being able to reaccelerate growth in Germany.

Yeah. As I mentioned in my remarks, and I mentioned last time that Germany faces -- is the largest market -- medical device market in the European Union, but as such, faces some unique challenges. And so, there's been issues related to the pandemic and the pandemic hangover that we've talked about extensively in the past. There is the new issue of hospital reform that is happening. And this is being slowly rolled out throughout Europe, where they're going to be focused more on quality measures to drive reimbursement rather than pay for procedure measures to pay for reimbursement. And that, again, we believe, favors our technology given that our technology is designed to get patients -- to keep patients from getting so sick and getting them out of the hospital as quickly as possible, which I think is the major tenet of the hospital reform that's taking place in Germany. But that being said, we can always be doing better in our own execution of sales. And I think that is what our reorganization and new efforts at trying to drive operational efficiency at our German subsidiary. And I think that these changes are something that we can control that we have -- are actively implementing. And we believe that the results of these changes that started at the beginning of the first quarter will flow through, and ultimately, we'll see benefits in the second half of this year. Already in Q2, we're seeing promises -- promising developments that would suggest that we're making progress.

Great. Thanks, Phil.

Sure.

There are no further questions at this time. I'd like to turn the call over to Dr. Phil Chan for closing comments. Sir, please go ahead.

Well, thank you, everyone, for joining the call today. If you do have any other questions, please feel free to reach out to us at ir@cytosorbents.com. We look forward to updating you in the future. Have a good evening, everyone, and thank you very much. Have a great night.

This concludes today's conference call. Thank you very much for your participation. You may now disconnect.