Ladies and gentlemen, good afternoon, and welcome to the CytoSorbents Second Quarter 2024 Financial and Operating Results Conference Call. At this time, all participants are in a listen-only mode. Following the formal remarks, we will open the call for your questions. Please be advised that the call will be recorded at the company's request. At this time, I'd like to turn the call over to our moderator, Eric Ribner. Please go ahead, Mr. Ribner.

Thank you, and good afternoon. Welcome to CytoSorbents' second quarter 2024 financial and operating results conference call. Joining me today from the company are Dr. Phil Chan, Chief Executive Officer; Vincent Capponi, President and Chief Operating Officer; Kathleen Bloch, Chief Financial Officer; Dr. Makis Deliargyris, Chief Medical Officer; Dr. Christian Steiner, Executive Vice President of Sales and Marketing and Managing Director of CytoSorbents Europe; and Christopher Cramer, Senior Vice President of Business Development. 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 these risks and uncertainties in the company's filings with the SEC. Any projections as to the company's future performance represented by management include estimates today as of August 13, 2024, 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 of 2024 by Dr. Chan, Ms. Bloch. Mr. Capponi and Dr. Deliargyris. 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's my pleasure to turn the call over to Dr. Phillip Chan.

Well, thank you very much, Eric, and good afternoon, everyone to the Q2 2024 earnings call. First I'd like to go over our operating highlights for the quarter. First, more than 0.25 million CytoSorb devices have been cumulatively delivered to date, helping us save many lives around the world. Second, in the second quarter, total revenue increased 5% to $9.9 million while product sales increased by 10% to $8.8 million and gross product margins were solid at 75%. Importantly, our second quarter operating loss decreased 48% to $3.4 million from $6.6 million a year ago. Following our $10.3 million equity raise in December 2023, we secured an additional $20 million credit facility with Avenue Capital Group, strengthening our balance sheet. And following the quarter, we completed additional cutbacks expected to save an additional annualized $5 million in expenses going forward. Over the past five months, we have decreased our workforce by 17%. Finally, our cash balance at the end of the second quarter was $14.9 million, including $8.5 million in unrestricted cash and $6.5 million in restricted cash. Today, we are pleased to announce the start of our new Chief Financial Officer, Peter J. Mariani, starting tomorrow. And unfortunately, the retirement of our existing CFO, Kathy Bloch, as of the end of business today. You'll hear more from both people at the end of this meeting. We're also on track to set marketing applications in parallel for the investigational DrugSorb-ATR system to the FDA as a De Novo application and Health Canada in this third quarter of this year. You'll hear more about that from both Makis Deliargyris as well as Vince Capponi. In addition, we completed our MDSAP audit, which is a key requisite to Canadian commercialization. Data from our STAR registry was presented at the EuroPCR 2024 Conference and was selected as a top five finalist in the best scientific abstract competition. And importantly, we launched a new redesigned modern consolidated corporate and product website. Lastly, we also launched our CytoSorb, our PuriFi -- MDR certified PuriFi hemoperfusion pump, placing in fact, all 30 pumps from our original order with our OEM and are expecting delivery on the next order from our OEM very shortly. Importantly that the pump itself has received extremely well good reviews from users citing it as very easy to use and easy to set up and easy to implement our therapies. With that, let me turn it over to Kathy Bloch, our current Chief Financial Officer, Kathy?

Thank you, Phil, and hello to everyone on the call. Today, I will discuss our second quarter 2024 financial results, including revenues and gross margins. And additionally, I will provide an update on our working capital and cash runway. CytoSorb product revenue was approximately $8.8 million in the second quarter of 2024 compared to $8.1 million in the second quarter of 2023, an increase of approximately $800,000 or 10%. Second quarter 2024 grant revenue was approximately $1.1 million compared to approximately $1.3 million in 2023, and this decrease was due to the conclusion of several brands during 2023. Total second quarter 2024 revenue, which includes both product sales and grant revenue, was approximately $9.9 million as compared to $9.4 million in 2023. And product gross margins on devices and device accessories with 75% in the second quarter of 2024 compared to product gross margins of 74% in 2023. Next slide, please. For the first half of 2024, CytoSorb product revenue was approximately $17.8 million compared to approximately $16 million for the first half of 2023, which is an increase of approximately $1.8 million or 12%. First half 2024 grant revenue was $1.8 million as compared to $2.9 million, again, due to the conclusion of several grants in 2023. And product gross margins on devices and accessories were 74% in the first half of 2024 compared to 71% in the first half of 2023 as we continue to realize more operating efficiencies at our new manufacturing plant in Princeton, New Jersey. Next slide, please. The blue bars on this chart represent our annual product sales for the trailing 12-month period ending June 30 for each year 2018 to 2024. We know that for the years 2020, 2021 and 2022, sales were very favorably impacted because CytoSorb is used to treat COVID-19…

Thank you, Kathy. So for the -- I'd like to cover the clinical...

Yes. I think Makis is on the call. Makis, would you like to take the first part of this?

Sure. Thanks, Bill. Thanks, Vince. As you heard -- and welcome to everybody on our call this afternoon. As you heard from Phil previously, the regulatory submissions for our investigational DrugSorb-ATR system is a top priority for the company. And we are happy to report that we're on track according to previously stated time lines. The STAR-T clinical data were presented earlier this year, the top line results and the filing data analysis has been completed. And in fact, the clinical study report that contains all this information is in the final stages of development and publishing. This will represent the main source for the probable benefit to risk allowances that will be at the crux of our De Novo submission to the FDA. We also intend to include in the submission supportive supplementary data with the real-world evidence of ticagrelor removal during CABG that was presented from the STAR European Conference, and I'm going to spend the next slide, giving you a little bit more visibility on that data. The completion of the technical files is leveraging the electronic eSTAR platform. And as already stated, we are on track for the FDA de novo submission in September, with Health Canada submission leveraging the same platform to follow sooner after. Just as a reminder to our listeners, DrugSorb-ATR is an FDA breakthrough designated device, which means that its submission will be associated with a priority review. A recent analysis suggested that de novo applications of breakthrough designated devices have an estimated 25% faster review time lines compared to regular applications. And as such, pending the FDA agreement of the de novo pathway submissions and the associated priority review of the breakthrough status of the DrugSorb-ATR device, this means that we could have a potential FDA decision within six months to…

Thank you, Makis. This is Vince Capponi, and good day to everybody. As Mike has mentioned, the de novo time line, we're in the final stages of assembling the technical file that will be submitted through the eSTAR program. At this point, we're -- I'm happy to say we're 75% complete with that file. We've concluded most of the engineering documentation and now starting to complete the clinical documentation for that submission. Along with the submission in parallel, we are also working on preparing the Canadian submission, which we hope to have filed shortly after the eSTAR for FDA. It's very similar, so we believe we can do it in a relatively timely manner. Hopefully, also through the Canadian submission, generally speaking, Canadian approvals have generally in the past been a bit faster than U.S. FDA approvals. But of course, we can't protect with 100% certainty, but we're hopeful that we will be able to be -- able to get a quick approval through Canada. Next slide, please. Global from a regulatory standpoint as part of the preparation for the Canadian submission, we have completed the MDSAP audit, which is required for a Canadian submission. I'm happy to say that the audit went very well. It's currently under review by but we feel very confident that it will be approved for a submission to Canada through the MDSAP program. With respect to MDR, which affects obviously our European operations and Rest of World, we are targeting a December 2024 submission to our notified body and have already requested the MDR audit for June of 2025. We're very confident based on our continued successful audits throughout the product life cycle of CytoSorb that we will be able to achieve the MDR audit, again, meeting all the requirements which are more extensive than the MDD, but we are very confident that we'll be able to achieve approval. As Phil mentioned, the PuriFi pump registration was received in June, working with our partner, Medica. We were able to get that completed and able to receive the first 30 pumps. And we have the second order that will be coming in shortly here, and we are looking forward to, again, expanding that into the market. And as Phil mentioned, has received very, very good reception in the marketplace. On top of that, we've also received after over 1.5 years’ worth of effort registration in Taiwan, and we're looking forward to now opening up with that market. With that, I'll turn it back to you, Phil.

Great. Well, thanks, Vince. This year, we have worked diligently to execute upon a broad turnaround strategy that is dependent on obtaining a number of key objectives. You've heard today that, one, our guidance that we continue to expect to submit to our marketing applications to U.S. FDA and Health Canada for DrugSorb-ATR this quarter and have made excellent progress in parallel programs like MDSAP that are critical to commercialization, for example, in Canada. Secondly, we have strengthened our balance sheet with the addition of a new debt facility from Avenue Capital and believe that if we can hit our milestones, the $20 million in capital will get us to both Health Canada and FDA regulatory decisions. Third, we remain extremely committed to cutting costs to drive efficiency and be self-sustaining. Importantly, you heard that we have made excellent progress in reducing our operating loss and expect to see additional benefit from our most recently completed cost cuts. Fourth, our gross margins continue to be strong and are expected to expand as we grow the markets in Europe and certainly are expected to expand further if we are able to drive U.S. FDA and Health Canada approval where the gross margins for DrugSorb-ATR are expected to be significantly higher than for CytoSorb. And lastly, we are -- have done a lot of work to try to increase our core CytoSorb sales growth beyond the 25 million devices that we've delivered to date. Finally, as you are aware, we have been positioning CytoSorbents for the next stage of growth, both our existing international franchise as well as the potential to open the U.S. and Canadian markets. This is why it has taken us so long to find the right CFO candidate to replace our esteemed retiring CFO, Kathy Bloch. Kathy has gone above and beyond the call of duty, selflessly coming back from retirement last August, resumed her former full-time CFO role and in the intervening 12 months, helping to secure the future of the company with two key financings and orchestrating our cash conservation strategy. With her retirement announced today to capture an outstanding CFO career and will continue as a consultant to help manage the smooth transition, our newly appointed CFO, Peter Mariani. On behalf of everyone at CytoSorbents, we thank Kathy for more than 11 years of dedication and leadership at the company as a trusted colleague and friend with so many contributions that have helped us achieve the success we have today and wish her an enjoyable relaxing and well-deserved retirement. With that, I'd like to turn the call over back to Kathy to have some final words. Kathy?

Thank you so much, Phil. I would like to take this opportunity to thank the Board of Directors, my colleagues on the management team and really all the employees of CytoSorbents for their support and collaboration, which have made my 11-year tenure as CFO still very enjoyable. I especially want to thank the finance and accounting team members who have supported me in the U.S. and in the EU, I'd like to thank you for your extraordinary dedication, talent and contributions to the company. And I wish everyone, including our new CFO, Pete Mariani, the best of success as we head towards the exciting upcoming job of commercialization of DrugSorb-ATR in the United States. So thank you all so much.

Thank you, Kathy. And with that, I'd like to welcome Pete Mariani to the CytoSorbents team. Pete is a seasoned and accomplished medical device CFO, who has many successes at high-growth publicly traded companies such as Axogen, Hansen Medical and Guidant Corporation speak for themselves. He has consistently demonstrated a disciplined and rigorous approach to financial management, operational excellence and strategic development, both domestically and internationally, that aligns perfectly with our next phase of expected rapid growth. Importantly, CytoSorbents today shares many similarities to Axogen when Pete joined as CFO in 2016, including with respect to its size, revenue base, U.S. market opportunity and high-margin business model. He has proven his ability to fund, scale and manage impressive growth. As we pursue U.S. and Canadian marketing approval for DrugSorb-ATR and drive our OUS business with CytoSorb, we believe Pete will be an outstanding fit where his deep global experience and insight is expected to be vital to our success. We are thrilled to have Pete joined CytoSorbents and be a key member of the management team. And in the coming months, we hope to reach out to many of you to introduce you firsthand to Pete. With that, let me have Pete stay a few words here as we wind up this call. Pete?

Thank you, Phil. I appreciate the warm welcome, I appreciate the trust of Board in creating this opportunity for me. It is great to be with all of you as investors today as well. I am excited to join CytoSorbents at this pivotal time in its history. I've had the great privilege to be part of some of the most significant advancements in medical technology over the years, including advancements in cardiac stents, cardiac rhythm management, medical robotics, laser cataract therapies and, of course, nerve repair. CytoSorbents blood purification therapy is a natural extension of this equipment (ph), and I am looking forward to partner to further develop execute and scale our long-term growth strategy and bring improved [Technical Difficulty] hospitals. And of course, I look forward to meeting with many of you in the near future. (ph) Thanks again, Phil.

Thanks very much, Pete. That concludes our prepared remarks. Operator, please open the call up for the Q&A session. Just let me remind you, as Pete has not officially started until tomorrow, he will not be participating in the Q&A session. Operator?

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

Hey, good afternoon and thanks for taking the questions. Just to start, congrats to both Kathy and Pete. Kathy has been great working with you. I hope you have a great retirement, and Pete, looking forward to working with you again. So -- all right. So I guess the first one for, I guess, for either Phil or Makis, you're on track with the FDA and Health Canada submission for DrugSorb. Can you just give us an update on how you're feeling about approval? Maybe can you give us an update on any conversations you've had with the regulators, particularly the FDA more recently?

Thanks very much, Michael. Makis, would you like to take that?

Sure. And thanks, Michael, for the question. As we have discussed previously, we feel that the STAR-T pivotal trial does provide the necessary information to be able to execute the necessary benefit to risk analysis. And I think as we have highlighted in previous calls and stated during our own corporate webinars is that the STAR-T data has helped us identify more specifically, they intend to target population. And as we discussed before, we have identified that to be those patients undergoing a coronary artery bypass operation and also the intended potential benefit associated with the use of device. So in that regard, we believe that can -- as a standalone, can support a robust benefit/risk analysis. In addition, as I've shared today on the call, the accumulating evidence that is now captured systematically in the high-quality registry such as the STAR registry, we believe it will be an important supplement in our permutations with the agency. Having said that, the -- anytime you submit an application, you have to wait for the review and the comments from the agency. We have not had any additional discussions with the agency since our last call. So there's no update on that front. But we do believe that the application will provide the necessary information for a very productive and collaborative interaction with the agency and to allow them to proceed with the necessary benefit to risk analysis.

Got it. Thanks, Makis. So then maybe one or two for Kathy. Just on the gross margins. The press release today mentioned the line of sight to 80%. Can you talk about what gets us to 80% and what level of sales might get you there? And then just kind of the second part of that is more in the near term, how are you thinking about gross margins in the second half of '24?

Yeah. I think, actually, Michael -- okay, Kathy, go ahead, please.

Yeah. So Michael, obviously, volume is going to -- any amount of volume growth is going to increase our product gross margins, and they should grow up very rapidly. I expect that at 15% to 20% year-over-year growth, we should see approaching 80% or at 80%. So it should be relatively straightforward. Of course, once we get approval in the U.S., the margins will be even higher. And then we would see like exceptional growth rates in our overall gross margins.

Got it. [Multiple Speakers] Sorry, go ahead.

I’m sorry, Michael. One of the people responsible for helping to drive our gross margins higher as Vince Capponi, our President and Chief Operating Officer. Maybe, Vince, you wanted to give a little commentary on how our manufacturing processes have improved and our confidence that we can get to that 80% on a blended basis.

Thanks, Phil. So we did a lot of improvements in the last year in the operation. We've actually reduced the labor requirement by almost 30% in part of the operation filling processes to help offset some of the lower volumes that we've had. So with the improvements that we're continually making here, we expect that we're going to continue to see improving margins. But as Kathy said, it's really dependent upon the volume as well. I think the other thing we need to keep in mind is that as part of our controlling cost, we're actually lowering our inventories. We're doing that by slowing down the production so that we can conserve the cash as we go through the FDA approval. So to Kathy's point, and when we get to the 15% to 20% growth rate, we certainly have line of sight to that 80-plus percent plus an approval, obviously, for DrugSorb-ATR with much higher ASPs than the current CytoSorb certainly contribute to that. And it's also based on the mix the direct sales. The higher, if you will, gross margin direct sales versus distributor which are lower margins than direct. So Again, there's a lot of factors in that. But what we're doing is we are continuing to improve the operation. And again, it's going -- as Kathy mentioned, going to be very dependent upon volume, but we do have a number of cost improvements that we're slowly implementing in the process here to hopefully get us back to that 80% soon.

Great. Very helpful. Thanks for all the color.

Thanks very much, Michael.

And your next question comes from the line of Yuan Zhi with B. Riley. Your line is open.

Congrats on a good quarter and thank you for taking our question. Kathy, congrats on the retirement, and Pete, welcome on board, exciting time for you to join here at CytoSorbents. Maybe Phil, start with you, can you provide more color what factors pushed the revenue to grow in second quarter? And do you see similar trends in 3Q and comment on the volume versus the price change will be helpful?

Yeah. I think that in the second quarter, what we saw was strength in the distributor and partner channel. I think that it coincided a little bit with the launch of our PuriFi pump. And as we told you previously, the PuriFi pump is intended to help establish an infrastructure of blood purification capabilities in countries where they don't have well-established dialysis infrastructures. And so -- this typically is found in our distributor territories that are necessarily in Western Europe, for example, as with Germany and Italy and France and the U.K. and Spain, for example. So I think that particular channel was good. And our hope is that our third quarter, which is typically a seasonal quarter for us because of holidays in Europe, will be a respectable quarter.

Any comments on the volume versus the price change year-over-year?

As Vince mentioned, the transfer prices to distributors are typically lower than our ASPs to -- for direct sales. But on the other hand, we benefit from having a lower cost of distributor sales because we don't incur those direct costs of the sales force ourselves. That being said, our pricing has been fairly stable across the board, both in transfer pricing as well as in direct sale pricing as well. But what you'll see from Q2 results is that the distributor channel was stronger for this quarter.

Got it. And the following question is how will the delivery of PuriFi pump contributed to the revenue growth in 3Q, either itself or helping the sales of CytoSorbents territories without the infrastructure. Can you provide more color on that?

Yes. We have a different model for rolling out the PuriFi pump in different parts of the world. And I think, though, the thing to keep in mind is that we’re not looking to necessarily make money on the PuriFi pump, right? This is very much the printer – printer cartridge model, where the printers provided at relatively low cost with the goal of driving disposable revenues of the printer cartridge. This is very similar to our approach to the PuriFi pump. Again, the PuriFi pump is there to establish this infrastructure of the purification capabilities so that they can use more of our CytoSorb devices. And so I think moving forward, the goal is to really drive CytoSorb volume rather than a typical hardware company trying to drive sales from hardware, if that makes sense.

Yeah. Got it. That’s very helpful. Thank you.

And your next question comes from the line of Tom Kerr with Zacks Small-Cap Research. Your line is open.

Good afternoon, guys and congratulations to Kathy, and thanks for all your detailed explanations and quick response to questions, so I appreciate it. Can you clarify -- I'm unclear on the Canadian submission because originally, I thought it was going to be jointly. Now it's going to happen after the FDA submission. So it's a fourth quarter event. I'm sorry, I don't have the slides in front of me, but can you clarify when that is expected to be submitted to the Canadian authorities?

Yeah. I think that what you heard us say today is that we expect to post of those submissions in the third quarter with the prioritization, of course, for the U.S. FDA application. So I think that we remain on track to try to achieve that, but we certainly will be prioritizing the FDA submission first.

Okay. So it's possible the Canadian submission could roll in the fourth quarter, but that's not your goal, correct?

Yes. That's not the goal. And I think that we're reiterating our guidance of third quarter submission for both.

Okay. All right. Sorry, I misunderstood that. Couple of financial questions. The R&D down to $1.5 million. Is that just the comparison against the STAR-T trials a year ago or is there anything else in there?

There a number of [Multiple Speakers] go ahead, Kathy. Kathy, you may be on mute, please go ahead.

Thanks, Phil. The largest impact is coming from the STAR-T trial completion. So we're not incurring those hospital costs and patient costs that are associated with the trial. There have also been -- there's also been a strong focus of our R&D efforts on exclusively grant-related activities where the costs of those personnel are funded through the grant. So we have been prioritizing that making sure that, that is the focus of the team to try to cut down in any non-grant R&D costs, so both of those are contributing. But the highest impact is coming from the STAR-T trial being completed.

Okay. The comparisons, right. So is that a good number to use for the second half of the year, $1.5 million per quarter?

Yes.

Okay. One last big picture question for Phil or anybody. The Taiwan thing seems interesting. Can you talk about that and what the size of that business could be or could it be the next Germany? Is it that big enough of a market?

Yeah. I think it remains to be seen. I mean, Taiwan is, as you may have read from the press release, a very large market and a big believer in blood purification. So from an opportunity standpoint, it's very exciting. We're working through a distributor in Taiwan currently. And they, in fact, were helpful in getting the Taiwanese approval and registration. So time will tell to see how this will develop. And we are -- we have a lot of hopes for Taiwan, but it's just one of many countries where we're working to drive CytoSorb sales.

Got it. Last financial question for me. You did receive the $15 million loan, right? It wasn't a subsequent event at the end of the quarter?

We closed the financing at the last day of the quarter. So it was a Q2 event on the financing

[Multiple Speakers]

In the second quarter, yes, that's correct.

Thank you. That’s all I have for today.

Thanks, Tom.

[Operator Instructions] And your next question comes from the line of Sean Lee with H.C. Wainwright. Your line is open.

Hey. Good afternoon, guys. Congrats to Kathy and hope wish you a happy retirement. And welcome, Pete. I look forward to working with you. Most of my key questions have been answered, but I'm just wondering, you were mentioning the doing R&D mostly on the grant. So I was wondering what are the major projects that you are working on in terms of the grant supported ones? I know previously you had worked on HemoDefend with I was wondering whether that's still going on and whether there are other projects or products that we can look forward to? Thanks.

Sure. Thanks, Sean. Yes, the programs that -- R&D programs -- preclinical R&D programs that are being funded right now really are focused on HemoDefend-BGA and the use of HemoDefend-BGA in different form factors for either military, civilian or industrial usage. And I think that we're making excellent progress in that program. We continue to seek additional funding opportunities for that program. And we're getting very close, I believe, to human testing. So Vince, would you like to comment about the HemoDefend program?

Sure, Phil. Thanks. So Sean nice to hear from me. We’ve made quite a bit of progress on the HemoDefend-BGA, as Phil mentioned. Just a couple of different form factors that we’re focused on to really get to what we think will be the most accessible markets, which would be the military and then ultimately, the civilian. So those programs are – there’s two key programs that are funding that right now. We have a couple of other grants that are in preparation right now to extend that funding further into commercialization through funding of a clinical trial and ultimately scaling for commercialization. But as Phil mentioned, there are a number of different form factors, but really the two key form factors that we’re pushing forward very aggressively are related to the military application and then also what would be at the point of collection, which, by the way, will feed into potentially the freeze-dried, if you will, plasma market, and we’re working closely with a couple of people in that area as well, where we think we can provide some value. Thanks, Sean.

Thanks, Vince.

Great. Thanks for taking the questions.

Thanks, Sean.

[Operator Instructions] And with no further questions at this time, I would like to turn the call back over to Dr. Phillip Chan for any additional or closing remarks.

Well, thank you, everyone, for joining the call today. If you do have any other questions, please feel free to reach out to me directly at cytosorbents.com while we manage this transition, and I'll hopefully be able to reply to your questions where possible. Have a great evening, everyone, and thank you very much. Good night.

And ladies and gentlemen, that concludes our conference for today. We thank you for your participation, and you may now disconnect.