CTSO - NASDAQ

Good afternoon, ladies and gentleman and welcome to the CytoSorbents' Corporation Fourth Quarter and Full Year 2024 Financial Results and Recent Business Highlight Conference Call. AT his time all lines are in listen-only mode. [Operator Instructions]. This call is being recorded on Monday, March 31, 2024. I would now like to turn the call over to Adanna Alexander. Please go ahead.

Thank you, John, and good afternoon, everyone. Welcome to CytoSorbents' Fourth Quarter and Full Year 2024 Financial Results and Business Highlights Conference Call. Joining me today from the company for the prepared remarks are Dr. Phillip Chan, Chief Executive 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. And therefore, we refer you to a more detailed discussion of our performance represented by management include estimates today as of March 31 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 fourth quarter and full year 2024. Following the presentation, we will open the line to your questions during the live Q&A session with the rest of the management team. And now it is my pleasure to turn the call over to Dr. Phillip Chan. Phil?

Thank you very much, Adanna, and good afternoon, and welcome, everyone, to our fourth quarter and full year 2024 earnings call. CytoSorbents is a leader in the treatment of life-threatening conditions in the intensive care unit and 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 a 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 intensive care unit and cardiac surgery such as sepsis, acute respiratory distress syndrome or ARDS and liver failure. 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, graft or CABG surgery. In September and November of 2024, we submitted marketing applications to both FDA and Health Canada respectively for this application and expect regulatory decisions from both agencies this year. We'll talk more about this opportunity in just a moment. 2024 was a strong year of progress. We closed out 2024 on a high note delivering a 25% increase in fourth quarter product revenue compared to the prior year reaching $9.2 million and notched a total of $35.6 million in product revenue for the full year representing 15% year-over-year growth driven by 28% growth in direct sales outside of Germany and 22% growth in distributor and partner sales which was partially offset by flat growth in direct sales in Germany for the year. These results were obtained through disciplined execution of our growth strategy in international markets. Our product gross margin remained healthy at 71% reflecting the strength of our underlying razor blade and someone else's razor business model and as a vertically integrated U.S. manufacturer of our therapies. On the regulatory front, we continue to make significant progress in bringing our DrugSorb-ATR therapy to market. The FDA has accepted our de novo application and we are now in interactive review an important step towards potential U.S. marketing approval. Additionally, we submitted our medical device license application to Health Canada following MD SAP Certification and this is now an advanced review. We remain on track to receive regulatory decisions from both FDA and Health Canada in 2025. Meanwhile, our financial position was further strengthened last year through our $20 million debt facility with Avenue Capital Group that we consummated in June of 2024 and more recently our successful shareholder rights offering which has raised total net proceeds of $7.3 million to date including the exercise of the Series A Right Warrant. This offering also enabled the release of $5 million in restricted cash resulting in a total liquidity increase of $12.3 million. We're thankful to our dedicated shareholders for their support in this offering. As of December 31, 2024, our total cash and cash equivalents were $9.8 million and on a pro forma basis including the benefit of the Rights offering, our total cash position was approximately $17 million. Peter will go over our operating metrics in greater detail, but overall, we were pleased that in 2024 we significantly improved our financial performance and moved closer to our goal of getting our core business to near cash flow breakeven by the end of 2025 through a combination of sales performance, product gross margins, effective cost controls, improved operating efficiencies and focused cash management. Now we'll turn to a CytoSorb update. As I mentioned, our core business grew 15% in 2024 with more than $35 million in high-margin CytoSorb sales. One of the main reasons that CytoSorb usage continues to grow is because it targets massive inflammation which is at the heart of most critical illnesses. Inflammation is the body's normal response to injury and infection, but in life-threatening illnesses severe inflammation driven by cytokine storm can cause a chain reaction of problems that can end in organ failure and death. This deadly inflammatory response can rapidly lead to a host of problems such as life-threatening low blood pressure called shock, leakiness of blood vessels essentially drowning a patient from the inside out called capillary leak syndrome, the death of cells of the immune system causing immune dysfunction, direct tissue damage, hypercoagulability, cell mediated injury, microvascular dysfunction and other problems, ultimately leading to a system crash and the failure of vital organs like the heart, lungs, kidneys and liver. The worse the inflammation, the worse the disease and the worse the outcome. CytoSorb works to control this deadly inflammation and has demonstrated the reversal or prevention of many of these complications. CytoSorb is expanding the dimension of blood purification by helping to treat critical illnesses where massive inflammation plays a deadly role, which occurs in an estimated 40% to 60% of patients in the intensive care unit. These are diseases like septic shock, acute respiratory distress syndrome, trauma, burn injury, severe pancreatitis, acute liver failure, COVID and the flu. This is a much larger market than the 10% to 15% of patients in the intensive care unit that have kidney failure, which is what the main blood purification players like Fresenius, Baxter that is now Vantiv, B. Braun and others currently target. Because of this, we have the potential to significantly increase our leadership in critical care. Treating critically ill patients is very challenging and so many factors play into why these patients live or die. However, one thing is clear, the fire of severe inflammation spreads rapidly in the body via cytokine storm and other mechanisms and if you don't treat it early or aggressively enough just like a real fire, it can get out of hand and become impossible to control leading to organ failure and death. This is why we have been pushing our message of treating the right patient at the right time with the right dose of CytoSorb. This means treating the patients with severe inflammation early and aggressively with CytoSorb and in doing so the therapy helps to break the vicious cycle of deadly inflammation, reverse the instability like shock and helps to restore or preserve organ function while removing other harmful substances. This message is helping to drive optimized treatment strategies, improve patient outcomes and accelerate adoption of CytoSorb. For example, at this month's International Symposium of Intensive Care and Emergency Medicine Congress in Brussels, Professor Giorgio Berlot and colleagues from Italy presented compelling new data from 175 patient retrospective study on septic shock and multi organ failure. They concluded that early and intensive treatment with CytoSorb led to a statistically significant doubling of survival compared to predicted mortality. These results now accepted for publication in the Journal of Intensive Care Medicine reinforce previously published findings from our CytoSorb Therapy and COVID-19 Registry, also called our CTC Registry, in the journal Critical Care that early and intensive treatment is associated with high survival and shorter time on mechanical support. In training users how best to treat patients, we believe this will yield better outcomes which drives greater usage and ultimately more sales. Looking forward, we're encouraged by our commercial progress, but are prioritizing a return to sales growth in Germany, our largest market, which was flat for the second year in a row. Entering 2025, we initiated a reorganization of our direct sales team and strategy in Germany, including a rebalancing of territories and hospital accounts with the goal of restoring sales growth through deeper customer engagement, more effective market development and improved sales representative productivity. Because of the effect of these changes, we expect the short-term disruption in Germany sales that will result in a modestly lower product sales overall for the first quarter of 2025 compared to a year ago. However, we expect these actions will result in growth in Germany ultimately and improve results in the second half of this year with the intent to manage our total core business towards near breakeven. Now let's turn to DrugSorb-ATR. The DrugSorb-ATR opportunity with regulatory approvals has the potential to drive strong near-term growth opportunities in the United States and Canada to address perioperative bleeding caused by blood thinners like Brilinta also called ticagrelor generically from Astra

Thank you, Phil, and good afternoon, everyone. As we get started today, I wanted to note our 8-K filing this afternoon disclosing that we had identified misstatements in inventory and non-cash stock compensation for restricted stock units in our previously issued financial statements and that we are restating our 2023 annual and quarterly reports and our 2024 quarterly reports in today's 10-K filing. More specifically, we identified an overstatement of inventory as of December 31st of last year -- December 31, 2023 of $304,000 and an understatement of non-cash stock compensation expense of $435,000 for 2023, as well as incorrect accounting entries to the related balance sheet accounts. The misstatement of non-cash stock compensation also impacted earlier periods, but that impact was determined to be immaterial and did not require restatement of those earlier reports. The misstatements have now been corrected in today's 10-K filing and are more fully described in Note 12 of our audited financial statements. Additionally, the errors in accounting for restricted stock units have led to a determination of a material weakness in our internal controls over financial reporting, which we have also disclosed in item 9A of today's 10-K. We are committed to completing remediation of this material weakness as quickly as possible and expect enhancements to be fully implemented during this calendar year. And now turning to the quarter. Product revenue was $9.2 million an increase of 25% compared to $7.3 million in 2023. This growth was driven primarily by strength in our direct countries other direct countries and distributor sales and partially offset by flat growth in Germany. Grant income was approximately $1 million compared to $1.3 million in 2023. This decrease was due to the conclusion of several grants over the last 12 months. We have historically reported grant income as a component of total revenue and cost of revenue as well as a reduction of the related research and development expense. We are now adopting a standard accounting convention of reporting revenue to only include product sales and will now report grant income solely as a reduction of related research and development expense. We believe this is a more common standard across med tech companies and improves comparability of our financial results. If we had continued our historical reporting, total revenue, including product revenue and grant income in Q4 2024, would have been $10.1 million an increase of 17% compared to $8.7 million in Q4 of 2023. The financial tables in this press release include a reconciliation of previously reported amounts, including the impact of this and other reclassifications. Gross margins for the quarter was 71% compared to 61% in Q3 of 2024 and 68% percent in Q4 of 2023. This improvement reflects a return to more normalized production levels in our state-of-the-art manufacturing facility in Princeton, New Jersey, which, as a reminder, is designed to support commercial growth as we continue to support our international critical care business and the rollout of DrugSorb-ATR in the U.S. and Canada. Q4 operating expenses decreased 30% year-over-year to $10.2 million driven primarily by the completion of the STAR-T trial and the impact of cost cutting efforts implemented over the previous year, including a 22% reduction in headcount. As a result, operating loss improved 61% year-over-year to $3.7 million. Adjusted EBITDA loss for the quarter, which excludes the impact of non-cash stock compensation and changes in foreign currency, improved by 70% to $2.4 million compared to an adjusted EBITDA loss of $8.1 million in the prior year, driven by revenue growth and the reduction of operating expenses. Net loss for the quarter was $7.5 million or $0.14 per share compared to $6.1 million or $0.13 per share net loss in the prior year. And adjusted net loss for the quarter, which also excludes the impact of non-cash stock compensation and changes in foreign currency, improved to $1.7 million or $0.03 per share compared to an adjusted net loss of $7.8 million or $0.17 per share in the prior year. Our revenue growth and cost cutting efforts have resulted in lower cash burn with $2.5 million used in the quarter compared to $2.7 million in the previous quarter and well below the $6.5 million used in the fourth quarter of 2023. Effective cash management continues to remain a top priority as we drive revenue growth and further efficiencies, and that result in our core business approaching breakeven in the second half of this year, allowing for investment in our North American commercial launch of DrugSorb-ATR. We were also pleased to have successfully executed our shareholder rights offering, and we raised total net proceeds of $7.3 million to date from the offering and including the exercise of the Series A right warrant. This raise allowed for the release of $5 million of restricted cash on our balance sheet and combined increased our available liquidity by $12.3 million. The Series B right warrant remains outstanding through April 10, and we are evaluating the option of providing a 30-day extension to this warrant through May 10th of this year. As a result, our pro form a balance of cash, cash equivalents and restricted cash on December 31, 2024, after giving effect to the rights offering and the exercise of the Series A right warrants as if it had occurred on December 31, 2024, would have been approximately $17 million including unrestricted cash of approximately $15.5 million. This gives us a solid balance sheet to support the business through expected regulatory decisions and launch of the DrugSorb-ATR and into 2026. Additionally, our loan agreement provides for a second tranche of $5 million which may be drawn at the company's request in the second half of 2025 provided the company receives FDA marketing approval of its DrugSorb-ATR application. And turning to the full year of 2024 financial results, product revenue was $35.6 million an increase of 15% compared to $31.1 million in 2023. The growth was also driven by strength in our other direct countries and international distributors while being partially offset by flat growth in Germany. Grant income for the year was $3.6 million compared to $5.3 million in 2023. As I stated earlier, we are now reclassifying grant revenue or grant income out of revenue and reporting it solely as a reduction of R&D expense for 2023 and 2024, and we'll continue to do this going forward. However, if the company had continued its historical reporting, total revenue, including product revenue and grant income, would have been $39.2 million an increase of 8% compared to $36.4 million in 2023. Gross margin was 71% for the year and consistent with that of 2023. Operating loss for 2024 improved by 47% to $16.7 million compared to $31.9 million in 2023, reflecting higher revenue and a 22% reduction in operating expenses. 2024 adjusted EBITDA loss improved by 56% to $11.5 million and adjusted net loss improved to $12.7 million or $0.23 per share compared to an adjusted net loss of $27 million or $0.61 per share in 2023. We have entered 2025 with strong momentum and a clear strategy for sustainable growth. As Phil mentioned we are seeing strength in our developing clinical data and in driving optimized treatment strategies. We are making changes in Germany that we believe will return that market to growth, but will result in modestly lower product sales in the first quarter. And we remain committed to strengthening our core international business, which delivered double-digit growth in 2024 with over 70% gross margins as we approach breakeven in the second half of 2025. We are confident that we are well capitalized through DrugSorb-ATR North American regulatory decisions and launch and into 2026. Now let me turn the call back over to Phil.

Thanks, Pete. Before we conclude, I want to say a few words about Jim Cason, our Vice President and Corporate Controller, who passed away unexpectedly from natural causes during the first quarter. For those of us who knew Jim professionally, he was an outstanding controller with tremendous knowledge and experience and a fierce dedication to our business, who contributed greatly to the growth and success of this company over his 10-year tenure. He was a great team player with a great sense of humor and a consummate professional who through his expertise and poise was the bedrock of our finance and accounting team for the past decade. We thank Jim for all that he has done for Cytosorbents. We believe we have a clear and compelling value proposition. With CytoSorb, we have established a substantial international high margin core business in critical care and cardiac surgery that has tremendous growth potential with a massive total addressable market and attacking major unmet medical needs. We are now amassing new data to be able to teach users how to teach the right patient at the right -- how to treat the right patient at the right time with the right dose of CytoSorb. With better clinical outcomes, we believe this will translate into greater usage and adoption in many different applications and ultimately help to accelerate sales. We saw good growth last year led by significant growth in direct sales outside Germany and in distributor and partner sales. And we are taking active measures to restore Germany back to growth and if successful has the potential to get us back to even better financial performance. The important part is that the growth in product sales moves our core business closer to our goal of near breakeven by the end of 2025 and ultimately greater financial independence. Not being yet factored into our story is the potential for DrugSorb-ATR. We are currently conducting a host of pre-launch activities and are actively sharing our positive data in reducing serious bleeding events in CABG patients on Brilinta at many important cardiovascular conferences. As we wait for FDA and Health Canada decisions, if positive, we plan to be in a position to open the U. S. and or Canadian markets for the first time and start with controlled market releases and accelerate from there into an initial estimated $300 market for Brilinta CABG surgery that could grow beyond $1 billion over time. We are excited about how our story may unfold in 2025 and are grateful for all of your support. This concludes our prepared remarks. Operator, please open the line for questions. Thank you.

Thank you. [Operator Instructions] Your first question comes from the line of Michael Sarcone from Jefferies. Your line is now open.

Good afternoon and thanks for taking the questions. I guess just to start, for DrugSorb and the regulatory process, have you seen any impacts from the new U.S. administration just on regulator staffing? And I guess what gives you confidence that you can continue to reiterate you'll see clearance by year end?

Yes. Hi, Mike. Thanks for the question. Although there's been a lot of uncertainty related to the cuts to HHS, which include the FDA, these cuts from what we understand are not targeting review personnel. This was specifically detailed in a number of reports.

Okay, got it. And then just when you do get clearance, you talked about a controlled launch before ramping to a full commercial launch. Can you just give us a sense of what are the key things you'll be looking for and how that may impact how you hone your commercial strategy?

Hi, Mike, it's Pete. We're getting we've got a great opportunity with these clinical sites. We've got surgeons who are used to the product and want the product. And what we're interested in learning is just some of the basics of how to get into the hospital, get onto their list and get ordered. We're interested in learning how quickly we can get through back committees. And then we want to see how these surgeons fit this into their normal pattern of usage. These are things we can evaluate very quickly with these clinical sites that have already started and allows us to learn quickly and then titrate the launch up as we see success in those sites.

Got it. That's helpful. Thanks, Pete. And I guess just last one for me. Can you give us the latest and greatest on your thoughts on what kind of or size commercial organization you might need to fully commercialize, particularly in the

Well, I think from our perspective, we see ourselves moving towards the sales force between 15% and 25% over time. But again, what's really important for us and it could go larger than that, obviously, longer term. But in the near term, we want to see effectively getting very sticky accounts early and seeing those accounts continue to use and grow that usage, not just one surgeon, but across multiple surgeons across the whole account. And so we can determine the rate at which we ramp those up, and we'll learn the effectiveness of each of these reps, and we'll learn the ability to add them over time. But I think over the near-term model, once we move into a more full commercial launch, we're looking at in the neighborhood of 15% to 25%.

I think, Mike, we're looking also to supplement that potentially with potential distributors throughout certain parts of the country where it doesn't make sense to necessarily have a direct sales rep. And during the COVID pandemic, we've actually created a number of very strong relationships with some of these distributors distributing our product for the COVID pandemic. And so I think it will be a bit of a hybrid approach.

Very helpful. Thanks, Phill. Thanks, Pete.

Yes. Thanks, Mike.

Your next question comes from the line of Sean Lee from H. C. Wainwright. Your line is now open.

Hi, good afternoon, guys, and thanks for taking my questions. My first question is just on the CytoSorb market. So could you give us a bit more color on what was the main growth drivers behind the high growth that we see in sales outside Germany as well as distributors? And why did that not apply to the German market?

Yes, I think that in international direct sales outside of Germany, we've seen continued momentum. A number of our countries have demonstrated strong growth and adoption for specific applications that seem to be driving this growth. And they've been able to get reimbursement for some of these applications and/or tender order payments for these applications and they've been very successful at that in certain countries. For distributors and partners, I think it's a matter of incubation time. What we've seen is that, as you know, we have a broad number of distributors around the world. But these markets have been incubating over time with greater and greater numbers of physicians using our product and much more activity on a local level in terms of marketing and conferences and peer-to-peer support. And so, I think that's been the story there. But I think importantly, coming back to this messaging of right patient, right time, right dose, this is something that users understand, right? And by shifting the concept of treating these patients from a therapy of last resort to really a proactive therapy, treating them upfront and aggressively is making a big difference. And I think that is flowing through those particular verticals. In Germany, I think that we -- Germany is the largest medical device market in Europe and a very important country for our company. As we've detailed many times, has had its share of its own issues, particularly post COVID hangover issues and the loss of ICU nurses and decreased ICU beds resulting in decreased patient throughput and other things. And so, although that has been improving, that still remains an issue. And there's also other things like hospital reform and other things that are making its way through the system that, is causing some level of uncertainty. But that being said, we can control the things that we can control.

Oh, my apologies.

I'm sorry, Sean?

My apologies. I thought I was -- I might have been cut off for it. I thought you've finished answering already.

Oh, no. I'm sorry, Sean. Not yet. But I think that what we see is an opportunity to optimize our sales approach and that was really the basis of the reorganization. This is something that we can control directly and we think that this is going to have significant benefits in this reorganization particularly in the second half of the year which is really where it's going to count. And so I think taking a little bit of short-term pain for long term gain is really our goal.

Great. Thank you for that. My last question is on the operational side. I think you mentioned that the company is targeting near cash breakeven in the core business by the end of this year. So I was wondering if you can provide a bit of color on what metrics do you need to hit to reach that breakeven in terms of revenues and gross margins and such?

Yes, Sean, we as you know, we're not giving specific guidance, but I can tell you, to hit that number, we see continued revenue growth from here, not a lot of revenue growth is needed. But if we have just good solid revenue growth and continue to drive 70% plus gross margins, we'll continue to drive efficiencies through the rest of the business and begin to see cash burn continuing to come down to lower levels than we have right now. But again, moving it towards -- moving the core business towards cash flow breakeven in the back half of the year is an important goal for us as it allows us to free up investment for the DrugSorb launch.

Great. Thanks a lot, Pete. That's all I have.

Your next question comes from the line of Thomas Kerr from

Good afternoon, everyone. Just a quick clarification on that last question on the breakeven. That assumes no DrugSorb-ATR revenues domestically or Canada. Is that correct?

Assumes no, that's correct. When we talk about core business, we're saying core business exclusive of DrugSorb at all. We want the core business to be able to run towards breakeven, So new investment can go towards DrugSorb.

To be hypothetical, the second part of the question is, if you get early FDA clearance, the commercialization takes a relatively quick time and you could get DrugSorb revenues in the fourth quarter. I mean, does that change the probability level or is it possible? You know what I'm getting at?

Yes. Well, what I would expect is in the early quarters of the DrugSorb launch, the DrugSorb business would not be immediately profitable, right, because we're going to be investing in commercial capabilities. So what I'm saying is, if we get DrugSorb revenue going in those quarters, we'll be able to leverage the expense we need to continue to drive that growth, but we'll have the cash available to do that because we've run the core business towards breakeven.

Got it. So 2026 could be a very nice year going forward in terms of margins. If everything gets approved.

Yes. Yes, it could.

Just going back to FDA real quick. Can they I forget -- Can they ask for anything else at this point, more data, clarifications, or is the only thing left to clearance?

No. You know, as I mentioned, as an FDA breakthrough device, we're currently in an interactive review of our de novo application for drug absorbed with FDA, which highlights that back and forth more informal nature of the interaction. And we continue to work collaboratively with FDA to respond to their questions. And we're also in advanced review with Health Canada for the same and we expect to continue to have regulatory decisions this year.

Oh, so you have interactive discussions with them. It's not just like a one-time AAR or anything like that. Okay.

With FDA, that's correct. As a breakthrough designated device.

Got it. Got it. Alright. One last quick financial one. The pro forma cash of $17 million does not include the Q1 2025 burn. So we can assume that maybe cash as of today and you obviously don't have to say exactly it's $14 million, $15 million in that range.

Yeah. It's less than $17 million.

Okay. Alright. Just want to make sure that wasn't included in there. Alright. That's all I have that's all I have for right now. Thanks.

Okay. Thanks, Tom.

There are no further questions at this time. I will now turn the call over to Dr. Phillip Chan. Please continue.

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