Cerus Corp (CERS) 2025 Q1 法說會逐字稿

Good day, ladies and gentlemen. Thank you for standing by, and welcome to the Cerus Corporation first-quarter 2025 earnings conference call. (Operator Instructions)

Please be advised that today's conference is being recorded. I would now like to hand the conference over to Timothy Lee, Cerus 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.cerus.com. With me on the call are Obi Greenman, Cerus' President and Chief Executive Officer; Vivek Jayaraman, Cerus' Chief Operating Officer; Kevin Green, Cerus' Chief Financial Officer; and Carol Moore, Cerus' Senior Vice President.

Cerus issued a press release today announcing our financial results for the first quarter ended 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.cerus.com. I'd like to remind you that some of the statements we will 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 expenses and gross margin expectations, and our expectations for positive operating cash flows for 2025.

Expected future growth and our growth trajectory, expectations with respect to our enhanced CE Mark submission for INTERCEPT red blood cells, expectations with respect to our new INT-200 illumination device, expectations with respect to patient enrollment in our Phase III RedeS study, and other statements that are not historical facts.

These forward-looking statements involve risks and uncertainties that can cause actual events, performance, and results to differ materially. They are identified and described in today's press release and our slide presentation, and under Risk Factors in our Form 10-Q for the quarter ended March 31, 2025, which we will file shortly. We undertake no duty or obligation to update our forward-looking 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 Obi, followed by Vivek to discuss recent business highlights, and Kevin to review our financial highlights and expectations for the rest of 2025, and lastly, closing remarks from Obi.

And now, it's my pleasure to introduce Obi Greenman, Cerus' 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 Cerus 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 Cerus 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 INT-200, 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 INT-200 device to the FDA in 2026 for the planned launch in the US in 2027.

We expect that the phased global launch of the new INT-200 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 INT-200 will pay dividends for years to come.

In the US, 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 million to $200 million. Vivek will provide additional color on our commercial performance in his 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 Mark 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 III ReCePI 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 for ReCePI 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 Cerus 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 US red cell development program. The second Phase III study, called RedeS, is gating the US 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 to now turn the call over to Vivek 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 Q1 '25. Our double-digit year-over-year growth was the result of strength across our global franchise. Building off a strong 2024, we continue to see an uptick in our US ISV franchise and solid performance in our US and global platelet markets.

The earlier-than-expected approval of the INT-200 device provided another tailwind and allowed us to substantively demonstrate our commitment to innovation in this market. As mentioned, the INT-200 was a product designed with feedback from our blood center customers and is intended to improve their operations and enhance their experience.

Our design with your 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 shocks is that the value proposition for INTERCEPT remains as compelling as ever. As a reminder, platelets treated with INTERCEPT blood systems offer multiple advantages over conventional platelets, including: one, INTERCEPT platelets reduce the risk of transfusion-transmitted infection with pathogen reduction of a broad spectrum of bacteria, viruses, proteasomes, 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 pressure 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 condition. 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 US and Canada. Switching to international markets, the earlier-than-expected receipt of the CE Mark for INT-200 gives our field organization another great reason to reengage current customers and reach out to new ones. We anticipate that the next-generation LED-based illumination device may enhance Cerus' brand and reputation for delivering a reliable, innovative technology platform.

Moving beyond our current customer base, we continue to have active discussions with blood 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 IFC. Customer demand continues to grow. The five-day post-sta shelf life of IFC allows for transfusion services at hospitals to keep prepared units on hand to streamline stat orders. The potential for shorter turnaround times from physician request to patient transfusion appears to be hitting a responsive cord with clinicians.

Furthermore, the reduction in wastage and potential for faster OR turnaround times are attributes that really resonate with nonclinical decision-makers in the hospital. We are actively working with our blood bank partners to improve availability to IFC, 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 Cerus. 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 on 2024 solid momentum.

For the first quarter of 2025, we reported product revenue of $43.2 million, a 13% increase, and at the midpoint of the 10% to 15% guidance we provided in January. Higher North American platelet sales, along with increasing US demand for IFC, were the principal drivers of growth this quarter.

First-quarter North American product revenues increased 22% compared to the same period from the prior year. In EMEA, first-quarter product revenue declined 4% 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 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 million to $200 million, which includes expected IFC revenue contribution of $12 million 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 RedeS 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%. Product gross margins for the first quarter were 58.8% compared to 55.4% 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 inventorable charges and the nonrecurring 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 that 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, the 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 noncash 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 INT-200, 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 reflects 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 Cerus was $7.7 million or $0.04 per share compared to a net loss of $9.7 million or $0.05 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 of 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 US 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.

Furthermore, we expect to have increasing access to our revolving line of 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 Cerus business and mission have benefited and will continue to benefit from the solid technology and customer-focused foundation that we have built. With the early feedback from our European launch of our new LED INT-200 device being so positive, we are increasingly excited about the expected broader geographic expansion that that enables and ultimately launching the device in the US subsequent to expected PMA approval.

Cerus 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 Cerus team for their unwavering focus on securing 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.

(Operator Instructions)

Josh Jennings, TD Cowen.

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 breakdown between Canada and US, and really wanted to hear about the US INTERCEPT some more details on the US INTERCEPT platelet 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. As we had indicated exiting last year, we saw a lot of underlying demand and growth in our US franchise, both on the platelet and ISC side, and that continued as reflected in our Q1 results. While we are already standard of care in the US, there continue to be 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 now that CVS is fully implemented with IFC, and we're obviously starting to continue the validation process with Hema Quebec. And so the growth was predominantly in the US, but we certainly had a 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 US, 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, and Josh, just a point of clarification. When Vivek was talking about CVS and 100% adoption, that was for platelets, just to be clear.

That's correct. Thank you.

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

Yeah, thanks a lot, Josh. And Carol is 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 the notified body.

But as far as next steps and how this proceeds with the 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 file. So TUV initiates the review.

That's the notified body, and they conduct a clinical review first, and 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.

Ross Osborn, Cantor Fitzgerald

Hey guys, this is Matt Park on for Ross today. I guess I 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. Vivek, again, would 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 EFS. 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 borne out by the hemovigilance data 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, we really view that business is strengthening over the course of the year. It will be a driver in terms of our overall forecasted double-digit growth on the top line. And at least at this point, we have not heard anything about a decrease in donations, and frankly, the clinical value of Safeblood and our technology continues to be validated. So we're encouraged about our international prospects.

Got it. That's helpful. 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?

Sure. Yeah, happy to highlight that. We indicated exiting last year, a few of our blood center production partners and ISV 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 expressed demand for IFC but didn't have an in-state manufacturer could start to get a product.

And upon securing those BLAs, it was their intention to ramp up manufacturing. 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 in terms of their manufacturing volume. So with each passing week this calendar year, we see an increased 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 BLAs, the other has one in application.

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 really starting to see momentum in this business start to take shape.

Mark Massaro with BTIG.

This is Vidyun on for Mark. To start off, could you just talk through some of the assumptions in your guidance? It seems like on the ISC front, there's just a little bit of a ramp up required in the back half. And then more broadly, does the guide also contemplate any revenue from the next-gen Illuminator launch?

Thanks for the question, Vidyun. I think the questions are all yours today apparently. You want to handle that?

Sure. Yes, 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. I just want to say thank you to my colleagues in our regulatory, clinical quality groups, all of whom developed, of course, all of them 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 validation of 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 reengage 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, 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 ISC side, it does assume a ramp-up over the course of the year. As noted when we exited last year, we said that we had built up quite a bit of demand, that we're 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 satisfy 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, as we are on this call here on May 1, those trend lines appear to be materializing. So we're still early days in terms of penetrating this market. So we anticipate continued growth in IFC.

Okay, perfect. Thanks for the color there. 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. Just wondering if you're expecting any material investments in the back half of this year, and just some of your assumptions there.

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

Yeah, happy to. We really don't -- what we said in our prepared remarks, especially for SG&A, is that it might tick up slightly as we realize a full quarter of cost-of-living adjustments. But we don't anticipate making any significant 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 BARDA contract really kicks off and the activities under that agreement begin beyond just the nascent levels that we described.

So other than that, I think we feel pretty confident that Q1, as implied by our revenue guidance, is typically the lowest revenue quarter for us. And we think that with the growth coupled with stable margins and control of OpEx, it is going to bode well for our ability to hit that adjusted EBITDA goal.

Great, thanks so much for taking the questions.

Thank you very much, Vidyun.

Bill Bonello, Craig-Hallum.

Hi guys, this is John on for Bill. So you guys talked earlier on the call about some new geographies in the pipeline. I know you've also talked before about the next-gen Illuminator being a potential catalyst in those conversations with new geographies. Any additional color you're able to give on where talks are at there, and 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. The ASA started, and it was just great to get the approval earlier than we expected. And then, there have been subsequent in-country approvals that have come through as well. But I can give you a much better perspective on what the customer reaction has been and the ongoing efforts to deploy the instrument at multiple sites.

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 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 in the Middle East, in particular, the Kingdom of Saudi Arabia, 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 US, that really has a positive influence on that market. In parallel, the government is making a concerted investment in health care. 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 is a bit more like the US 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 who have become advocates for pathogen reduction.

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 where we have a very strong partner there. We believe that the clinical value and utility for INTERCEPT in the Chinese market is significant, and we're marching towards approval there from the NMPA.

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. It's always a bit of a gamble to speculate as to exactly when some of these things will materialize.

But one of the things that we have now and continue 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 Obi noted earlier in the call, we're north of 20 million transfusable 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 was 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 Sul, 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 Cerus 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 the early part of August. Thanks very much.

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