Cerus Corporation

Welcome to the Sears Corporation First Quarter 2025 Earnings Conference Call. At this time, all participants are in a listen-only mode. After the speaker's presentation, there will be a question and answer session. To ask a question, please press star 1-1 on your telephone and wait for your name to be announced. To withdraw your question, please press star 1-1 again. Please be advised that today's conference is being recorded. I would now like to hand the conference over to Tim Lee, Sears Head of Investor Relations, Tim, you may begin.

Thank you, and good afternoon, everyone. I'd like to thank everyone for joining us today. As part of today's webcast, we are simultaneously displaying slides that you can follow. You can access the slides from the Investor Relations website at ir.cirrus.com. With me on the call are Obi Greenman, Cirrus's President and Chief Executive Officer, Vivek Jaraman, Cirrus' Chief Operating Officer, Kevin Green, Cirrus' Chief Financial Officer, and Carol Moore, Cirrus' Senior Vice President. Cirrus issued a press release today announcing our financial results for the first quarter and March 31, 2025, and describing the company's recent business highlights. You can access a copy of this announcement on the company's website at www.cirrus.com. I'd like to remind you that some of the statements we'll make on the call relate to future events and performance rather than historical facts and are forward-looking statements. Examples of forward-looking statements include those related to our future financial and operating results, including our 2025 product revenue guidance, our expectations for bottom line and non-GAAP adjusted EBITDA performance, our operating expense and gross margin expectations, And our expectations for positive operating cash flows for 2025. Expected future growth in our growth trajectory. Expectations with respect to our enhanced CE mark submission for intercept red blood cells. Expectations with respect to our new INT200 elimination device. Expectations with respect to patient enrollment in our phase three RETA study. And other statements that are not historical facts. These four linking statements involve risk and uncertainties that can cause actual events, performance, and results to differ materially. They are identified and described in today's press release, in our slide presentation, and under risk factors in our form 10Q for the quarter ended March 31st, 2025, which we will file shortly. We undertake no duty or obligation to update our four linking statements. On today's call, We will also be discussing our non-GAAP financial measures, including our non-GAAP adjusted EBITDA and non-GAAP constant currency metrics, which exclude the impact of foreign exchange rates. These non-GAAP measures should be considered a supplement to and not a replacement for measures presented in accordance with GAAP. For a reconciliation of non-GAAP financial measures to the most comparable GAAP financial measures, please refer to today's press release and the slide presentation available on our website. We'll begin today with opening remarks from Obie, followed by Vivek to discuss recent business highlights, then Kevin to review our financial highlights, expectations for the rest of 2025, and lastly, closing remarks from Obie. And now, it's my pleasure to introduce Obie Greenman, CIRS's President and Chief Executive Officer.

Thank you, Tim, and good afternoon, everyone. I'm very happy to report to you all today the solid position Sears is in as we continue to grow our global business upon the strong foundation that we have built in establishing a new standard of care in transfusion medicine. During these times of uncertainty in the global financial markets, we are confident in our ability to continue to execute against our important mission as a company. Our mission at Cirrus has always been to fundamentally transform the safety and availability of transfused blood components and to provide unwavering customer support to deliver safe and effective blood products to patients. Our perseverance continues unabatedly. Our products have treated approximately 20 million intercept units globally based on the cumulative number of platelet and plasma kits sold. Intercept is now used in over 40 countries, and is the standard of care in approximately a third of those countries. In mid-Q1, we received CE Mark for the INT200, our next-generation LED-based illumination device, earlier than expected. This foundational device platform was designed with input and feedback from our global customer base to enhance the usability and efficiency of the system. Initial feedback from our customers has been very positive, and we now look forward to submitting the PMA for the INT200 device to the FDA in 2026 for the planned launch in the U.S. in 2027. We expect that the phased global launch of the new INT200 over the course of the next few years will provide our blood center customers with a reliable platform which will also enable the future geographic expansion of Intercept through the end of the decade. We expect that the effort and expense that went into the development of the IIT 200 will pay dividends for years to come. In the U.S., our core platelet customers continue to be an important driver of top line growth as we look to further expand our platelet market share in line with the hospital demand for 100% pathogen inactivated platelet inventory. In addition, we continue to improve IFC supply to meet growing customer demand, which has been exceeding our ability to supply. These activities, combined with another quarter of solid cross-functional execution, resulted in double-digit revenue growth, and we are reiterating our full-year product revenue guidance range of $194 to $200 million. The bank will provide additional color on our commercial performance in its prepared remarks. Regarding the Intercept Red Blood Cell Program, we continue to work closely with TUV SUD, our notified body, I'm happy to report that in mid-April, we submitted our updated CE-MARC application for the intercept red blood cell system to TUV, and the review has begun. The enhanced submission includes updated documentation from our positive phase three recipe study and additional data accumulated since our original filing. Leveraging the feedback from both the notified body and competent authority review from the initial submission, And integrating the new clinical data from Recipe into a new submission over less than a couple of quarters was a coordinated team effort. And I want to thank the cross-functional team at Cirrus for all of their hard work. As CUV completes its review of the various modules of this submission over the coming months, including the updated and more comprehensive clinical module, we look forward to updating you on our application on our Q2 earnings call. Turning to our U.S. red cell development program, the second phase three study called REDIS is gating the U.S. PMA submission pathway. Since commencing the study in 2019 on the back of the Zika virus epidemic and navigating the challenges of study enrollment during the COVID pandemic, we have enrolled more than 500 patients in the study to date. Enrollment continues, and we expect to enroll the last patient in the second half of this year. Switching to our financials, we are off to a strong start and are building upon last year's achievement of positive non-GAAP adjusted EBITDA for the full year. With the financial markets consumed by concerns about the impact of global tariffs on company operating plans, we believe we are in a unique and enviable position to continue to selectively invest in many key initiatives during 2025, while maintaining our goal to once again achieve positive non-GAAP adjusted EBITDA. Kevin will provide additional details in his prepared remarks. I would like now to turn the call over to the bank to discuss our first quarter commercial results along with color on our outlook for 2025.

Thank you, Obi, and good afternoon, everyone.

As Obi stated, we delivered another solid quarter of operating performance in Q125. Our double-digit year-over-year growth was the result of strength across our global franchise. Building off a strong 2024, we continued to see uptick in our U.S. ISV franchise and solid performance in our U.S. and global playland markets. The earlier than expected approval of the INT200 device provided another tailwind and allowed us to substantively demonstrate our commitment to innovation in this market. As mentioned, the INT200 was a product designed with feedback from our blood center customers and is intended to improve their operations and enhance their experience. Our designed with you, for you tagline is really resonating, and the initial feedback on the device is very positive. While there is a lot of geopolitical and macroeconomic uncertainty, it is worth noting that our business is in a very solid position. I feel confident that our experienced team is capable of navigating through any challenges and positioning us to deliver on our mission and expand access to safe blood products. The main reason I am confident in our ability to drive continued growth despite potential exogenous shock is that the value proposition for Intercept remains as compelling as ever. As a reminder, platelets treated with Intercept blood systems offers multiple advantages over conventional platelets, including, one, Intercept platelets reduce the risk of transfusion transmitted infection with patchy reduction of a broad spectrum of bacteria, viruses, protozoans, and leukocytes. Two, intercept platelets allow for extended shelf life in select international countries to seven-day storage compared to five days for untreated platelets, thereby reducing wastage. Three, intercept platelets also allow blood components to be available sooner, resulting in fresher platelets that may be transfused to patients. And four, Intercept platelets confer economic and operational efficiencies and flexibility through streamlined inventory management. Intercept treated platelets can be transfused to any patient, while conventional platelets may require additional measures depending on the underlying conditions. Intercept platelets are now the standard of care in many countries around the world, and we see continued growth in this franchise globally. Returning to our first quarter 2025 results, product revenue growth was led by robust North American platelet kit sales, where we saw increasing demand both in the U.S. and Canada. Switching to international markets, the earlier than expected receipt of the CE mark for INT200 gives our field organization another great reason to re-engage current customers and reach out to new ones. We anticipate that the next generation LED-based illumination device may enhance Cirrus' brand and reputation for delivering a reliable, innovative technology platform. Moving beyond our current customer base, we continue to have active discussions with flood centers and new and largely unpenetrated geographies. Collectively, these geographies represent nearly 5 million platelet units annually. While it's premature to predict when these discussions may materialize into sales, we are more encouraged than ever, especially considering the number of countries that have now adopted Intercept as a frontline strategy to improve platelet safety. Switching gears to ISV, customer demand continues to grow. The five-day post-saw shelf life of ISV allows for transfusion services at hospitals to keep prepared units on hand to streamline STAT orders. The potential for shorter turnaround times from physician requests to patient transfusion appears to be hitting a responsive chord with clinicians. Furthermore, the reduction in wastage and potential for faster OR turnaround times are attributes that really resonate with non-clinical decision-makers in the hospital. We are actively working with our blood bank partners to improve availability to ISV, and we expect supply to ramp up monthly through the balance of 2025. With that, I will turn it over to Kevin to discuss our financial results and outlook in more detail.

Thanks, Vivek, and hello to everyone listening today. Thank you for your time and your interest in CIRAS. On today's call, I'll be discussing our financial results for the first quarter of 2025, as well as our product revenue guidance for the year. Finally, I'll highlight some of the key success factors that we are focused on as we move forward, building off of 2024's solid momentum. For the first quarter of 2025, we reported product revenue of $43.2 million, a 13 percent increase and at the midpoint of the 10 to 15 percent guidance we provided in January. Higher North American platelet sales, along with increasing U.S. demand for IFC, were the principal drivers of growth this quarter. First quarter North American product revenues increased 22 percent compared to the same period from the prior year. In EMEA, first quarter product revenue declined 4 percent on an as-reported basis, compared to the same period last year. Excluding the impact of foreign currency exchange rates, EMEA product sales declined 1% on a non-GAAP basis year over year. Moving beyond our Platelet and Plasma franchise, for the first quarter of 2025, US IFC sales totaled $3 million, compared to $1.9 million during the first quarter of 2024. IFC sales growth was driven by continued strong customer demand from both our direct hospital channel and as blood centers satisfied demand for their own hospital customers. Looking ahead to the balance of this year, based on the robust first quarter performance, coupled with the growing demand for both our platelet and IFC product lines, we are reiterating our full year 2025 product revenue guidance range of 194 to $200 million, which includes expected IFC revenue contribution of $12 to $15 million. Beyond product revenue, and not included in our guidance, government contract revenue for the first quarter of 2025 was $5.6 million, compared to $5 million for the prior year period. Increasing enrollment in REDIS contributed to the year-over-year increase in government contract revenue As did certain nascent activities under the recently awarded 2024 BARDA contract, we remain actively engaged with BARDA and expect to continue successfully delivering on our contracts with the federal government, advancing patient access to safe blood components. First quarter, product gross profit was $25.4 million, up from $21.3 million for the same period of the prior year. an increase of 20 percent. Product gross margins for the first quarter were 58.8 percent compared to 55.4 percent for the first quarter of 2024. Much of the year-over-year increase in gross margin was due to the combined effects of the capitalization of inventoryable charges and the non-recurring release of previously accounted for favorable variances during the first quarter of 2025. Without the impact of these accounting adjustments, for the balance of 2025, we expect product gross margins to generally remain in the mid-50s, with potential variability in any given quarter. Factors that could drive quarterly variability include, but are not limited to, FX rates, product mix, production costs of IFC to meet increasing demand, economies of scale and production volumes, and the timing of COGS reduction initiatives coming online. Beyond these normal variables, I'd like to take a moment to address the potential impact of the current tariffs without trying to anticipate what future tariffs will ultimately be in place. At the current enacted global tariff landscape, and without any potential offset which we may pursue, we expect that our consolidated gross margins would be modestly impacted but remain north of 50%. Let's move below gross profit on the P&L. Operating expenses for the first quarter totaled $36.9 million compared to $34.3 million for Q1 of 2024. This increase reflects the elevated activities driving government contract revenue, advancement of our LED illumination device globally, and cost of living adjustments for our employee base. First quarter 2025 operating expenses included $6.6 million in non-cash stock-based compensation. R&D expenses for the first quarter totaled $16.6 million, compared to $14.5 million during the prior year. The year-over-year increase in R&D expenses was primarily related to higher development costs of INT200, higher government contract costs, which in turn drove the increased government contract revenue, and modestly higher employee-related expenses due to cost of living adjustments, which we had contemplated going into the year. SG&A expenses for the first quarter were $20.3 million, compared to $19.8 million in Q1 2024. The year-over-year increase in SG&A expenses reflect modestly higher employee-related expenses, which we had also anticipated. As we look ahead to the balance of 2025, by and large, we expect that SG&A expenses will resemble Q1 levels, but may be slightly higher due to the realization of full quarter impact from the cost of living adjustments enacted during Q1. With that said, we expect to continue delivering compelling leverage from our SG&A spend. relative to the anticipated revenue growth implied by our product revenue guidance. Shifting our focus to the bottom line and non-GAAP adjusted EBITDA results. On the bottom line, for Q1 2025, net loss attributable to Cirrus was $7.7 million, or 4 cents per share, compared to a net loss of $9.7 million, or 5 cents per share for the prior year period. These results represent a 20% improvement from Q1 of last year. Furthermore, expanding on the financial foundation we established in 2024, we are pleased to announce our fourth straight quarter of positive adjusted EBITDA, totaling $157,000 for the first quarter of 2025, compared to a negative $2.7 million for the prior year period. To elaborate on my earlier comments regarding the potential impact from the currently imposed tariffs, I want to be clear. We remain resolute in our goal of achieving full-year positive adjusted EBITDA results, assuming existing tariffs remain in place, and the U.S. or any other government does not introduce new or increased tariffs. Focusing in on the balance sheet and associated cash flows, We ended the first quarter of 2025 with $80.9 million of cash, cash equivalents, and short-term investments on hand compared to $80.5 million at the end of 2024. Cash used from operations was minimal at $800,000 compared to cash generated of $2 million during the same period of the prior year. Cash used during the first quarter of 2025 was primarily tied to investment in working capital, namely inventory, in anticipation of expected commercial growth. Looking ahead, based on the revenue growth implied by our guidance, our commitment to achieving positive adjusted EBITDA results, and investments in working capital, we believe we are in a position to deliver annual positive operating cash flow to fuel our growth going forward. We expect to have increasing access to our revolving lender credit should we choose to further use that facility and offset receivable or inventory-related working capital investments. With that, let me turn it back over to Obi for some closing remarks.

Thanks, Kevin. The Cirrus business and mission has benefited and will continue to benefit from the solid technology and customer-focused foundation that we have built. With early feedback from our European launch, of our new LED INT200 device being so positive, we are increasingly excited about the expected broader geographic expansion that that enables and ultimately launching the device in the U.S. subsequent to expected PMA approval. Cirrus remains singularly focused on helping blood centers around the world to improve the safety and availability of the blood supply and to innovate with their blood product offering so as to improve their economics, operational efficiencies, and sustainability. To this end, we believe our continued investments in both our supply chain and in securing global regulatory approvals for our complete Intercept product portfolio will yield value for the long term. We remain resolute in this mission to transform the field of transfusion medicine in partnership with our blood center customers so that there is increased resiliency in getting safe blood to patients timely. In summary, I'd like to thank the Sears team for their unwavering focus to secure blood safety around the globe, as well as their continued dedication and determination. As such, we started 2025 with double-digit product revenue growth. Our development program milestones were realized earlier than expected, and our financials are stronger than ever. With that, operator, we'll open up the call for questions.

Thank you. As a reminder, to ask a question, please press star 1-1 on your telephone and wait for your name to be announced. To withdraw your question, please press star 1-1 again. One moment for questions. Our first question comes from Josh Jennings with TD Cowan. You may proceed.

Hi, good afternoon. Thanks for taking the questions, and congratulations on a strong start to the year. I was hoping to just dig a little bit deeper into the 22% growth in the North American product revenue in Q1, and maybe just help us highlight the drivers there, maybe break down between Canada, the U.S., and really wanted to hear about the U.S. intercept plate, some more details on the U.S. intercept plate, but revenue growth.

Yeah, thanks for the question, Josh. And Vivek, I think you're best placed to answer that question.

Yeah, I'd be happy to, Josh. Thanks for the call and the kind words about the quarter. You know, as we had indicated exiting last year, we saw a lot of underlying demand and growth in our U.S. franchise, both on the Platelet and ISD side, and that continued as reflected in our Q1 results. While we are already standard of care in the U.S., there are continuing opportunities to capture share, and we saw a nice progress there that's certainly buffeted by the continued validation in terms of real world experience with Intercept. In Canada, we benefited, you know, now CBS is fully implemented with IFC and we're obviously starting the, we're continuing the validation process with Hema Quebec. And so the growth was predominantly in the U.S., but we certainly had the benefit from Canada. And then on the IFC side, as we transition to the kit model, we see continued demand from hospitals, continued positive experience when clinicians are using it in their practice. And we were really focused as we talked about exiting last year in terms of ramping supply and production volume from our supply partners continues to grow. So we feel good about how we started the year in the U.S. and we feel confident about our ability to continue to see growth across both of our franchises in North America here on a going forward basis.

Yeah, just Josh, as a point of clarification, when Vivek was talking about CVS and 100% adoption, that was for platelets, just to be clear. That's correct, yeah.

Thank you.

Great. Well, thanks for that. And I know there's hard to make calls on regulators' timelines, but just it's great to see the CMARC application for intercepted blood cell system in. And I was just wondering, I mean, maybe you could just, outline in a little bit more detail just the next steps in terms of interactions with the notified body and what would you expect, what should investors be looking out for in terms of milestones as we move forward during the European regulatory process from here? Thanks for taking the questions.

Yeah, thanks a lot, Josh. And Carol's on the call, so she can address this in a little bit more detail. But just to start, we were really excited to get that back in. We do believe that there's a lot of leverage that can be gained from the previous submission review, both with the competent authority and notified body. But as far as next steps and how this proceeds with TUV, Carol, do you mind elaborating a little bit?

Sure. Thanks for the question. We're delighted to have refiled and the TUV is working very closely with us as they always have been. And we've been working on a very appropriate schedule for the fact that they were very familiar with the files. So TUV initiates the review, that's the notified body and they conduct the clinical review first and then they then they will be ready to move it on to the competent authorities. So it's the dual arrangement of review as we had before. And I think we feel very good about the communications we're having with TUV and the application itself. It's very strong as it was before, and I think we're in a good position to keep it moving.

Great. Thanks so much.

Thank you. Our next question comes from Ross Osborne with Cantor Fitzgerald. You may proceed.

Hey, guys. This is Matt Park on for Ross today. Thanks for taking the question. I guess you just wanted to start on the EMEA business. Can you give us an update on the France platelet business specifically? Are you seeing continued stability in the region, and how does it compare to other EMEA markets where FX appears to be a headwind?

Yeah, thanks for the question, Matt. Again, do you mind covering this?

yeah no problem so as you know in france we enjoy 100 of the platelet market with our partnership with the ess we have seen donations stabilize in the region and so that business continues to be a strong contributor and their experience with intercept is quite positive and that's worn out by the individual and data that they that they track so things in france are going well we are initiating activity on the plasma side there as well and then across EMEA you know we really view that business as strengthening over the course of the year it'll be a driver in terms of our overall forecasted double digit growth on the top line and uh you know at least at this point we have uh not heard anything about a decrease in donations. And frankly, the clinical value of safe blood in our technology continues to be validated. So we're encouraged about our international prospects.

Got it. That's helpful. And then just one more on IFC. You guys talked about how you expect supply to ramp up in the balance of 25. Can you just walk us through your plans to increase production capacity to meet growing demand? Thanks for taking the questions.

Yeah, thanks, Matt.

Sure. Yeah, happy to highlight that. You know, as we indicated exiting last year, a few of our blood center production partners and manufacturers had received their biologic license application approval, so that enabled them to transfer products across state lines. And that way, hospitals in states that express demand for ISD but didn't have an in-state manufacturer could start to get product. And upon securing those DLAs, it was their intention to ramp manufacturing. And so we really saw that ramp up in manufacturing start to come to fruition in the first quarter of this year. And those blood centers are not anywhere near capacity yet in terms of their manufacturing volume. So with each passing week, this calendar year, we see an increase. amount of volume in terms of produced product. And the great thing about that is we've queued up quite a bit of clinical demand to consume that product. So we anticipate that evolving over the course of this calendar year. Seven of the eight production partners we have now have been issued BLA as the other has one in application. And in parallel, we've received de novo interest from a number of blood centers to initiate IFC production because they're getting queries from their hospital customers requesting IFC. So, we're really starting to see momentum in this business start to take shape.

Thank you. Our next question comes from Mark Massaro with BTIG. You may proceed.

Hey, Chris. This is Vivian. I'm for Mark. Thanks for taking the questions. To start off, could you just talk through some of the assumptions in your guidance? It seems like on the ISD front, there's just a little bit of a ramp required in the back half. And then more broadly, does the guide also contemplate any revenue from the NextGen Illuminator launch?

Thanks. Yeah, thanks for the question, Vivian. I think the questions are all yours today, apparently. You mind handling that?

Sure. Yeah. Happy to weigh in. So I'll start with the second half of your question first. So we had initially anticipated the INP 200 CE mark clearance in the middle of the year. So securing it in Q1 was fantastic news. And I just want to say thank you to my colleagues in our regulatory clinical quality groups, all of whom, development, of course, all of whom who really did the heavy lifting to get that approval and that product across the finish line. Initial customer feedback has been excellent, and it's sort of validation to our customers that we're committed to continuing to innovate in this space. So it gives us a chance to engage new customers and also re-engage existing customers with new technology, which always excites them. So getting that a bit earlier certainly does improve our ability to deliver against our revenue guidance and some of the intended sales in the back half of the year. You know, once we get future registrations and the rest, we can look to realize those earlier in the period. So it was contemplated in our overall guidance just with a slightly later approval than what was realized. So again, thanks to my colleagues for making that a reality. On the IFC side, it does assume a ramp up over the course of the year. As noted in When we exited last year, we said that we had built up quite a bit of demand that was getting slightly ahead of our manufacturing volumes, and that with the BLA secured by our manufacturing partners, as they ramped volumes, we could start to pacify that demand that was building up. So, we anticipate that will be reflected in revenue growth throughout the course of the year, and as things are playing out now through the first third of the year, you know, as we On this call here on May 1st, those trend lines appear to be materializing. So we anticipate we're still early days in terms of penetrating this market. So we anticipate continued growth in IFC.

Okay, perfect. Thanks for the call there. And then just turning to the bottom line, you beat us on adjusted EBITDA. I think you guys have discussed being modestly positive for the balance of 25%. I'm just wondering if you're expecting any material investments in the back half of this year, just some of your assumptions there. Thanks.

Yeah, thanks, Vivian. Kevin, do you mind covering that?

Yeah, happy to. We really don't. You know, what we said in our prepared remarks, especially for SG&A, is that they might tick up slightly as we realize a full quarter of cost of living adjustments. But we don't anticipate making any significant changes investments at least as it pertains to our adjusted ebitda metric we do expect that government contract expenses and the corresponding revenue may tick up as the 2024 barter contract really kicks off and the activities under that agreement um begin you know beyond just the nascent levels that that we described so other than that i you know i think we feel pretty confident q1 as implied by our revenue guidance, is typically the lowest revenue quarter for us. And we think that, you know, the growth coupled with stable margins and control of OPEX is going to bode well for our ability to hit that adjusted EBITDA goal.

Great. Thanks so much for taking the question.

Thank you very much, Vivian.

Thank you. And as a reminder, to ask a question, please press star 1-1 on your telephone. Our next question comes from Bill Bonello with Craig Hallam. You may proceed.

Hi, guys. This is John. I'm for Bill. So you guys, you talked earlier on the call about some new geographies in the pipeline. I know you've talked before also about the next-gen illuminator being a potential catalyst in those conversations with new geographies. So if you could, any additional color you're able to give on where talks are at there and kind of the pace you see those potentially progressing at and then any color you can add on whether you've seen like early interest and uptake with the next-gen illuminator.

Yeah, thanks very much for the question, John. You know, the ACE to start, it was just great to get the approval earlier than we expected, and then there's actually been subsequent in-country approvals that have come through as well. But they can give you a much better perspective on sort of what the customer reaction has been and the ongoing efforts to deploy or deploy the instrument at multiple sites.

Yeah, thanks, Obi. As Obi noted, getting that approval was critical because it's a catalyst, especially as we enter into new geographies. That is going to be the sort of foundational illumination device for new markets that we enter into. I think we've spoken in the past about rough geographic areas where we're targeting growth, the Middle East, in particular the Kingdom of Saudi Arabia, that we've seen solid growth there. There's a tremendous amount of potential in that marketplace. they tend to follow AABB and FDA standards. So with the strength of our business in the U.S., that really has positive influence on that market. And in parallel, the government is making a concerted investment in healthcare. So we are seeing meaningful growth there. In Germany, we've initiated commercial activity in Germany. That's the single largest market in Western Europe. That market's a bit more like the U.S., as opposed to France, where in France there's one decision maker, but in Germany there are multiple. But the conversations are really positive there, and there are a number of clinicians that have become advocates for pathogen reduction. And then expanding outside of our EMEA geography, I think we've noted our joint venture with China in the past that continues to be an area of – we have a very strong partner there. We believe that the clinical value and utility – for intercepting the Chinese market is significant. We're marching towards approval there from the NMPA. And so those are just a few of the examples of international markets that we believe are receptive to our technology, should be able to drive growth through the balance of the decade and where we've continued to make meaningful progress over the course of the past few quarters. And it's always a bit of... gamble to speculate as to exactly when some of these things will materialize but one of the things that we have now and continues to strengthen over the course of each quarter that we go through is the volume of real world experience clinical validation and customer advocacy supporting the technology as ob noted earlier in the call you know we're north of 20 million transfuseful doses that we've distributed, and so it really does speak to the value and the clinical demand for our technology.

Awesome. Thank you.

That is very helpful, and I'm sure it feels good to have a CE mark approval ahead of schedule. I guess one follow-up. Do you guys know yet, or are you able to say who the competent authority is that will be reviewing the new red blood cell submission?

Yeah, in discussions with the TUV, we've identified SUCL, which is the Czech Competent Authority. It's not a done deal until the file gets transferred to the Competent Authority by TUV. So it's still a possibility it could change, but unlikely.

Awesome. Thanks a lot, guys.

Thanks a lot, John.

Thank you. I would now like to turn the call back over to Obi Greenman for any closing remarks.

Well, thank you all for joining us today and for your continued support of CIRIS and our enduring mission. Looking forward to updating you on all the progress we're going to make throughout the remainder of Q2 on the next earnings call, which will likely be at the end of July or early part of August. Thanks very much.

Thank you. This concludes the conference. Thank you for your participation. You may now disconnect.