Cerus Corporation (NASDAQ:CERS) has announced positive outcomes from its Phase 3 ReCePI clinical trial for INTERCEPT red blood cells (RBCs), which are used in complex cardiovascular surgeries. The trial achieved its primary efficacy endpoint, demonstrating non-inferiority to conventional RBCs.
The company, which specializes in blood transfusion products, reported a 24% increase in product revenue to $38.4 million in Q1 2024, driven by robust sales in the United States and Canada. Looking ahead, Cerus reiterated its 2024 product revenue guidance of $172 million to $175 million and expects to reach adjusted EBITDA breakeven by year-end. Additionally, the company anticipates positive operating cash flows for the full year.
Key Takeaways
- Cerus Corporation reported a successful Phase 3 ReCePI clinical trial for INTERCEPT RBCs.
- Q1 2024 product revenue increased by 24% year-over-year to $38.4 million.
- The company maintains its 2024 revenue guidance of $172 million to $175 million.
- Adjusted EBITDA breakeven is anticipated for the full year 2024.
- Positive operating cash flows are expected for the full year.
Company Outlook
- Cerus is confident in meeting the annual guidance for their INTERCEPT Blood System (IFC) business.
- The company expects double-digit growth in product revenue and 25% to 50% growth in IFC revenue.
- Expansion of commercial pipeline and access to INTERCEPT blood system globally is a focus area.
Bearish Highlights
- Government contract revenue declined to $5 million in Q1 from $7.5 million in the same period last year.
- Some EMEA markets outside North America experienced a decline in organic growth last year, although this has since recovered.
Bullish Highlights
- The company has seen increased adoption of IFC within institutions and strong partnerships with large blood centers.
- There is growth potential in new geographies and the plasma business, particularly in the UK and Germany.
- Reimbursement for IFC has seen less price pushback than anticipated.
Misses
- The company reported a net loss of $9.7 million in Q1, though this was a 38% improvement from the prior year.
- Non-GAAP adjusted EBITDA loss for Q1 narrowed to $2.7 million.
Q&A Highlights
- Cerus discussed the CE Mark timing for their RBC product, working closely with the competent authority in the Netherlands.
- They are optimistic about generating operating cash flow, citing improvements in working capital movements.
Cerus Corporation's earnings call showcased a company on the rise, with significant clinical advancements and solid financial growth. The success of the INTERCEPT RBCs trial and the steady increase in product revenue are positive indicators for the company's future. Cerus's strategic focus on expanding their product's global reach while maintaining financial discipline by managing expenses and working capital movements underpins their optimistic outlook for 2024. With the anticipation of further details on the clinical trial results and continued progress toward regulatory milestones, such as the CE Mark for RBCs, Cerus Corporation remains a company to watch in the blood transfusion and safety sector.
InvestingPro Insights
Cerus Corporation (CERS) has demonstrated a strong commitment to advancing its INTERCEPT Blood System, as evidenced by the positive outcomes from its Phase 3 ReCePI clinical trial. As the company looks to the future with expectations of revenue growth and financial stability, key metrics and insights from InvestingPro provide a deeper understanding of its financial health and stock performance.
InvestingPro Tips for Cerus indicate that while the company is not expected to be profitable this year, it has a sound liquidity position with liquid assets surpassing short-term obligations. Moreover, Cerus operates with a moderate level of debt, which could be a stabilizing factor as it continues to invest in its clinical programs and commercial expansion. For investors seeking a comprehensive list of tips, there are an additional 5 tips available on InvestingPro, which can be accessed with a special offer using the coupon code PRONEWS24 for an additional 10% off a yearly or biyearly Pro and Pro+ subscription.
InvestingPro Data highlights include:
- A market capitalization of $318.01 million USD, reflecting the company's current valuation in the market.
- A Price / Book ratio of 6.18 as of the last twelve months ending Q4 2023, indicating that the stock may be trading at a premium compared to its book value.
- Revenue for the last twelve months as of Q4 2023 stood at $156.37 million USD, with a gross profit margin of 55.25%, showcasing the company's ability to retain a significant portion of its sales as gross profit.
These financial metrics, coupled with the strategic initiatives outlined in the company's earnings call, provide investors with a clearer picture of Cerus's potential and the challenges it may face. As the company forges ahead with its growth plans, these InvestingPro Insights can serve as valuable tools for those closely monitoring Cerus's progress in the dynamic blood transfusion and safety sector.
Full transcript - Cerus Corp (CERS) Q1 2024:
Operator: Good day, ladies and gentlemen. Thank you for standing by, and welcome to the Cerus Corporation First Quarter 2024 Earnings Conference Call. After the speakers' presentation, there will be a question-and-answer session. [Operator Instructions] Please be advised that today's conference is being recorded. I would now like to hand the conference over to Jessica Hanover, Cerus Vice President of Corporate Affairs. Dr. Hanover, you may begin.
Jessica Hanover: Thank you, and good afternoon. 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.serus.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 of Regulatory Affairs and Quality. Cerus issued a press release today announcing our financial results for the first quarter ended March 31, 2024 and describing the company's recent business highlights. You can access a copy of this announcement on the company website at www.cerus.com. I'd like to remind you that some of the statements we will make on this call related 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 2024 product revenue guidance, our expectations for operating cash flows and non-GAAP adjusted EBITDA performance and our expected expense levels, expected future growth and our growth trajectory, the availability and related timing of data from clinical trials, planned regulatory commissions and product launches, product expansion prospects and other statements that are not historical facts. These forward-looking statements involve risks and uncertainties that could 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 10-Q for the quarter ended March 31, 2024, 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 non-GAAP financial measures, including non-GAAP adjusted EBITDA. 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, then Kevin to review our financial results and expectations for the rest of 2024 and lastly, closing remarks from Obi. And now, it's my pleasure to introduce Obi Greenman, Cerus' President and Chief Executive Officer.
Obi Greenman: Thank you, Jessica, and good afternoon, everyone. I'd like to open the call by spending a few minutes reviewing our recent positive performance as well as looking ahead to the key milestones on path for the company. The first quarter of 2024 was an important one in the history of the company as we reported positive top line results from the Phase 3 ReCePI clinical trial, the first of our 2 U.S. BARDA funded trials for INTERCEPT red blood cells or RBCs. We are thrilled that ReCePI met its primary efficacy endpoint of non-inferiority of INTERCEPT RBCs compared to conventional RBCs in complex cardiovascular surgery patients. And while ReCePI was powered specifically for this primary efficacy endpoint, we are nonetheless also very pleased by the outcomes for the safety endpoints that we reported in March. We recognize that there is great interest in the details of the ReCePI results and we look forward to being able to share more by way of media presentations and journal publications targeted for later this year once the publications have been accepted. As we continue to enroll the ReCePI study, our second U.S. BARDA funded Phase 3 trial for INTERCEPT RBCs, we view the ReCePI readout as meaningful for the overall RBC program in supportive of our planned launch in Europe. We are looking forward to meeting with the ReCePI trial investigators next month to review the findings from the study and to gain their insights into the opportunities for how to position this important data set with the transfusion medicine community. In summary, at this stage, the ReCePI data give us confidence in our INTERCEPT RBC program and we look forward to sharing more with you in 2024. On the commercial front, we are increasingly confident in our expectations for 2024 and are reiterating our overall product revenue guidance of $172 million to $175 million inclusive of our INTERCEPT by bridging complex guidance of $8 million to $10 million. Vivek will provide color into the continued traction we see across our portfolio and geographies. Importantly, we also remain committed to adjusted EBITDA breakeven for the full-year 2024. Kevin will provide more insight into our pathway for continued improvement in this metric over time. I would like now to turn the call over to Vivek to discuss our commercial results and progress for the first quarter of 2024 as well as our outlook for the rest of the year.
Vivek Jayaraman: Thank you, Obi, and good afternoon to everyone. We continued our return to growth in Q1 2024. Across both product lines and geographic regions, we delivered strong performance in the quarter and I am pleased with the collaboration and execution of the global commercial team. In the U.S., our core platelet franchise is stabilizing and we witnessed a return to growth in our base U.S. business. Anecdotally, we are hearing from blood center customers that collections are slowly starting to recover and that platelet demand from their hospital customers remains strong. Furthermore, as we announced earlier, we received positive news from the FDA regarding our ability to increase platelet processing set shelf life. While our current forecast does not assume a major rebuilding of inventory at blood centers, the extended shelf life relieves a meaningful amount of pressure from our supply chain. As we work to further increase shelf life on a going forward basis, we would expect to see the benefit across both inventory and service levels. Turning to our efforts internationally, our commercial team delivered a strong performance in the quarter, meeting the way with our continued progress in Canada in partnership with Canadian Blood Services, or CBS. CBS is nearing full implementation of INTERCEPT platelets across their network and pathogen reduction is now the standard of care for platelet safety in Canada. The validation efforts at Hema-Quebec are also going well. As a reminder, the Canadian market is split roughly 80/20 between CBS and Hema-Quebec. Earlier in the quarter, I had the opportunity to attend the annual MedLab Congress in Dubai. Of note, I was pleased to see the strong interest in INTERCEPT across the Middle East. This region is a targeted growth area for our franchise. With a significant increase in healthcare investments in countries such as Saudi Arabia and a clinical focus on blood safety, we believe the Gulf region is an ideal area for market expansion. INTERCEPT is the only pathogen reduction system to be FDA approved and MDR cleared. We believe this regulatory distinction is a clear marker of advantage and really resonated with customers in the region. I'm encouraged by the ongoing cultivation of expansion prospects that will ensure growth for years to come. Our U.S. INTERCEPT Fibrinogen Complex, or IFC, delivered another strong quarter of growth in the period, and we feel confident in our ability to meet or exceed our full year revenue guidance for IFC. During the quarter, we hosted a scientific advisory board meeting for IFC and the uptick in customer experience and enthusiasm for the product was notable. We are beginning to see clear examples of peer to peer marketing on IFC, which is an effective tool for new product adoption. During the quarter, we continued our strong push at clinical conferences and saw an increase in lead generation and physician attendance at our symposia. As noted in prior calls, we are actively partnering with several large blood centers to enable them to offer IFC directly to their hospital customers, and we experienced a notice step up in orders via the blood center channel. This is serving as a strong complement to our direct sales team who are now fully trained and are starting to see their hospital targets convert into ordering customers. Most importantly, we continue to receive strong clinical support for the utility of IFC and for the patient benefit associated with earlier access to Fibrinogen. I look forward to providing more updates on our progress with IFC as well as our global commercial progress overall during future calls. I will now turn the call over to Kevin to review our financial results.
Kevin Green: Thanks, Vivek. Good afternoon and thank you all for joining us today. On today's call, I'll be discussing our financial results for the first quarter of 2024, highlighting the progress we made on the top-line, the bottom-line and the balance sheet. I'll also be providing some commentary on our positive financial outlook for the rest of the year. To start, we posted product revenue of $38.4 million for the first quarter of 2024. This represents year-over-year growth of 24%, demonstrative of our strong underlying growth in the business and ahead of our Q1 guidance provided back in January. North American platelet sales were the major contributor to our product revenue growth during the quarter. In the U.S., first quarter 2024 product revenues exceeded prior year levels by more than 40%. As we anticipated, sales in Canada to Canadian Blood Services were also extremely strong and are now approaching nearly 100% adoption across their entire platelet production operation. In EMEA, first quarter product revenues were down 9% year-over-year and 8% compared to the fourth quarter of 2023. Certain delays in timing of order fulfillment primarily drove the decline, which is expected to reverse itself over the succeeding quarters. Year-over-year, FX rates provided a benefit for the EMEA business of around 1.1%. On a consolidated basis, FX provided a benefit of around 50 basis points when comparing Q1 2024 to that of the prior year period. As we mentioned on our last quarterly call, we are providing a quarterly breakout of IFC product revenue. For Q1, we posted IFC revenue of $1.9 million, driven by increasing contributions from our national sales agreements with large U.S. blood center partners. As mentioned by Vivek, we believe the expanding recognition of IFC's clinical and operational utility will continue to drive the growth going forward. In addition to our product revenue and not included in our guidance, government contract revenue totaled $5 million in Q1 compared to $7.5 million for the prior year period. The completion of our U.S. Phase 3 ReCePI clinical trial was the primary driver for the decline. We expect this factor will result in government contract revenue remaining near Q1 levels until such time as our Turkish site begins enrollment for the RedeS trial. To remind you, included in our government contract revenue are the revenues recognized as reimbursement under our contract with BARDA, our agreement with the FDA to further whole blood pathogen reduction and our milestone-based agreement with the U.S. Department of Defense for lyophilized IFC. Let's now turn to our product gross profit and gross margins. For first quarter, product gross profit was $21.3 million, compared to $17.3 million during the prior year period, an increase of 23% year-over-year. Product gross margins for the first quarter were 55.4%, relatively stable when compared to the prior year and Q4 2023. These results were consistent with our previous announced expectations and we continue to believe that we will achieve relative consistency in our gross margins this year. Moving on, our first quarter operating expenses, which totaled $34.3 million were $4.6 million lower than the prior year period of $38.9 million, a year-over-year decline of 12%. Q1 2024 operating expenses included $5.9 million in non-cash stock based compensation. By specific expense type, first quarter R&D expenses totaled $14.5 million, compared to $17.4 million during the prior year period. This 17% decline was driven primarily by the completion of the ReCePI clinical trial and the effects of the restructuring implemented in June of last year. First quarter SG&A expenses were $19.8 million, compared to $21.6 million during the prior year period. The decline again driven by last year's restructuring. We believe this level of SG&A expense is sustainable for the remainder of 2024 and will allow us to drive our expected growth and to deliver against our revenue expectations. Let's now focus on the bottom line and non-GAAP adjusted EBITDA results. On the bottom line, reported net loss attributable to Cerus for the three months ended March 31, 2024 improved significantly when compared to the same period in the prior year. Net loss attributable to Cerus for Q1 narrowed by 38% to $9.7 million or $0.05 per diluted share compared to $15.6 million or $0.09 per diluted share for the prior year period. On a non-GAAP adjusted EBITDA basis, Q1 2024 generated a much narrower loss of $2.7 million, compared to a loss of $9.8 million for the prior year period. As we look ahead to the balance of the year, we expect that as we deliver the top-line growth in our guidance and maintain stable gross margins and operating expenses, we expect to achieve at least breakeven non-GAAP adjusted EBITDA for 2024 as a whole. On the balance sheet and associated cash flows, we ended the first quarter with a cash position of $72.2 million of cash, cash equivalents and short-term investments on the balance sheet. Importantly, as we previously announced was a possibility, we generated positive operating cash flows of $2 million for the first quarter, compared to cash used from operations of $8.5 million during the prior year period. With our expected top-line growth and anticipated declining inventory levels for the remainder of 2024, we continue to believe that with some possible quarterly fluctuations, we can potentially generate positive operating cash flows for 2024 as a whole. Turning now to our guidance. As Obi mentioned, we are increasingly confident in our growth expectations and as such we are reiterating our full-year 2024 product revenue guidance in the range of $172 million to $175 million, reflecting double-digit growth from last year. As we stated previously, we anticipate this growth to be fueled by the continued expansion of the INTERCEPT platelet business both in North America and in Europe as well as continued uptake of IFC in the U.S. We are also reiterating our full-year 2024 revenue guidance for IFC, which we continue to expect to be in the range of $8 million to $10 million, representing growth of roughly 25% to 50% for 2023 IFC sales. I'd now like to turn the call back over to Obi for some closing remarks.
Obi Greenman: Thank you, Kevin. We are pleased with our momentum from the start of 2024 and we expect to see it carried through the rest of the year. The company is making strong progress towards our commercial pipeline and financial goals, allowing us to expand the access to and applicability of the INTERCEPT blood system on a global basis. Thank you for your continued interest in Cerus. I will now turn the call over to the operator for questions.
Operator: [Operator Instructions] Our first question comes from Joshua Jennings with TD Cowen.
Unidentified Analyst: This is Eric on for Josh. Thanks for taking the question. Wanted to start with guidance. I appreciate the commentary that you provided there for 2024. I was hoping to just hear a little bit more about the cadence of revenue growth that you expect to deliver through the remainder of this year.
Obi Greenman: Vivek, would you like to take that question?
Vivek Jayaraman: I'd be happy to. We're pleased with the performance in Q1. As you'll note, you probably recall, Q1 of 2023 was sort of artificially low given some one-time issues that we were dealing with respect to dating and then also some issues internationally. So, we anticipated a fairly solid bounce back in Q1. But as our full year guidance suggests, we believe in our ability to deliver double-digit growth throughout the balance of the year. And so, Q1, both from a core product line standpoint as well as our IFC franchise, were solid results, and we anticipate continuing to deliver that sort of growth at least in the double-digit percentage throughout the balance of 2024. So that's currently our outlook for the year.
Unidentified Analyst: And then on the shelf life extension, I know it was only March that you received that 12-month shelf life approval. But have you and your customers already started to see some of the benefits of that extended life? Or is that something that might take a few quarters to have a real impact here?
Obi Greenman: And Vivek, I think it's right up your alley to take as well.
Vivek Jayaraman: Yes, I'd be happy to. As you probably are aware, there's a little bit of time involved in terms of being able to flow those changes through our manufacturing process and get that new product out. We are able to utilize that dating for product that's already in the field. So that relieves some of the pressure on our supply chain, mitigate some of the risk of product obsoleting on customer shelves. So that's certainly a benefit. But as I indicated earlier, our current forecast doesn't assume a material rebuild of inventory at the customer level. Certainly, as customers get accustomed to longer shelf life, they may feel like they want to rebuild their inventory levels and hold more product at their locations. But I think the relief on the supply chain and sort of avoidance of any acute obsolescence issues is something that certainly benefited customers, and we've heard positive feedback about that.
Operator: Our next question comes from Matt Blackman with Stifel.
Emily Christy: This is Emily on for Matt. Just a couple of questions for me on the international business, the weakness there. Just if you could give any additional color if it was certain markets or related to any of the geopolitical things that are happening? Just a little bit more color there, if you could.
Obi Greenman: I think Kevin has some thoughts on that.
Kevin Green: Yes. I think it really is, as we mentioned in the prepared remarks, more of a timing issue than anything. I don't think there's any fundamental weakness in the overseas market. In fact, as we indicated in the prepared remarks, we expect that it will rebound after these timing issues and order patterns for the balance of the year and we expect growth coming out of EMEA as well as the U.S. So it sometimes happens with distributor orders or other factors where there's a timing issue and I think that's what was at play here.
Emily Christy: And then if you could just give us an update on the regulatory progress in China at this time?
Obi Greenman: So we have the profile under review by the NPA. There are obviously a lot of Chinese holidays over the last couple of months. So we're still awaiting any additional questions that they may have. We expect those questions in the second quarter here. And then with those questions, we'll be able to provide a lot more clarity around the likely timing for an approval.
Operator: Our next question comes from Jacob Johnson with Stephens.
Jacob Johnson: I don't know if maybe for Obi or for Kevin on guidance. I heard that they say kind of double-digit growth for the balance of the year. If I run that through my Excel spreadsheet, I get something towards the higher end of the guidance. Obi, you said in the release increasingly confident in the guidance this year. I understand we're just at quarter end, but fair to say kind of expectations now versus the beginning of the year, you're trending maybe towards the higher end of the guidance? And Kevin, maybe any words of caution from a CFO?
Obi Greenman: Maybe a little kick out of the table. But I think we're very optimistic about the growth trajectory for the year. We'd like to sort of get Q2 under our belt just to see how things play out. As Vivek mentioned as well, there's really not a lot factored in at the moment for the extension of the shelf life and any kind of restocking opportunities. So that's sort of the logic behind maintenance of guidance at this time.
Kevin Green: I mean it from my perspective, Jacob, I think that's absolutely right. We don't know what FX rates are going to do, so there's potential downside from that. But I think fundamentally, we are more confident as we sit here today than we were in January when we provided the initial guidance. And as things unfold, we'll be in a better position to provide updates to you.
Jacob Johnson: And then maybe for Vivek, just on the IFC growth, it sounds like maybe some traction with some of the blood, larger blood centers you partnered with. I'm just kind of curious on the IFC side of things, kind of trends on those blood centers you partnered with versus some of the manufacturing partners you have on the IFC side of things.
Vivek Jayaraman: If I think about our IFC business, and I think as we stated earlier, coming out of Q1, we feel even more confident about our ability to deliver against the annual guidance and see strong growth in that franchise. And there are really a few reasons for our sort of increased confidence. The first, we announced late last year that we had formed partnerships with large blood centers for them to distribute IFC directly to their hospital customers. And in Q1, we saw a material step-up in terms of blood center customers who are ordering IFC directly through that channel. So, it's good initial validation of the strength of that channel and our ability to broaden access to IFC. The second area of encouragement for us was in the account that we had opened up in late 2023, we saw a pretty significant increase in youth ad accounts, so sort of same store sales. We may have entered initially through one clinical department, perhaps it was high risk OB or trauma, and what we saw was a broadening out across that institution of availability of IFC as the clinicians started to engage with one another and they sort of saw firsthand the benefit of having that product available. So that's encouraging to because it shows us not only can we get access to more hospitals, but once we get in, we have the ability to go deeper within those accounts. And then lastly, with our manufacturing partners, which you referenced, we have sufficient manufacturing capacity in 2024 to meet or exceed our guidance. So, what we're doing is we're working actively to increase capacity because we want to make sure that as we generate demand, we have supply available to meet it. So similar to what Kevin said about overall product guidance for 2024, specifically the IFC guidance for the calendar year, we feel much better about things here in early May than we did back in January when we issued that guidance. And so that's certainly positive progress.
Jacob Johnson: And if I could just sneak in one more, sorry to keep you on the hot seat, Vivek. But just on the Middle East opportunity, it sounds like there's an opportunity in that region. I'm just kind of curious, are there any areas you need to invest or are there any kind of hoops you need to jump through to kind of better realize that opportunity as we start thinking about that?
Vivek Jayaraman: As I mentioned, I had the opportunity to spend some time in the region at the annual MedLab Conference, which is held in Dubai. And candidly, the most challenging hoops to jump through are ones that we've already cleared and that's receiving both FDA approval and MDR clearance. I'm sure you hear a lot about the onerous nature of the MDD to MDR transition and the fact that we have achieved that milestone in addition to the fact that we're the only path to reduce technology that has an FDA approval, that really resonates with customers in that region. They tend to take their cues from the AABB and look to the U.S. in terms of technology adoption. So that's sort of a major driver of the community and market interest there. It also is tied to an overall, as you're probably aware of investment strategy in Saudi in particular, where they recognize there is a sort of a defined runway in terms of their economy driven by, being driven by natural resources. So, they're investing in healthcare, they're investing in entertainment and the rest. So, there's a big push to invest in healthcare and there's a view to what technologies are approved in the U.S. and MBR cleared as things that they want to bring in locally. And so those are some of the factors that accrue to our benefit when we think about growth in that region.
Operator: Our next question comes from Ross Osborne with Cantor Fitzgerald.
Ross Osborne: So starting off, would you discuss how reimbursement has gone with IFC in terms of accounts being able to receive the NTAP?
Obi Greenman: I think your voice sort of broke up a little bit based on our end. So I think your question was around reimbursement for IFC and the evolution there linked to the NTAP. Is that all correct?
Ross Osborne: Yes, that's correct.
Obi Greenman: Vivek, sorry to put you on this monotone again, but could you address that?
Vivek Jayaraman: I can't hear, you repeat the question. You broke up a little bit.
Obi Greenman: Yes, it's basically around how the reimbursement evolution for IFC has occurred in the context of the NTAP. So really how does IFC reimbursement take place at the hospital level?
Vivek Jayaraman: [indiscernible] is a really an adolescent and the reason it's clear about it and this work. It did allow us to do initially getting the NTAP designation as it created more awareness and interest from clinicians. But fundamentally, the way in which products paid for is through the -- depending upon the case through the associated DRG. So what we've been able to see, which has been encouraging is initially we felt we'd get quite a bit of pushback on price and cost. And once we get through the value analysis committees or in the case of leveraging the blood center relationship with the hospital and flowing through that channel, we've actually seen much less pushback on price than we'd anticipated. So, we're going to have to track that on an ongoing basis. Obviously, we continued to improve the clinical utility, but that hasn't been a governor in terms of getting new accounts onboard. It's really been just getting through the process of getting new products into an institution if we're selling directly and then getting the blood center channel up and trained if we're going through that channel partner.
Obi Greenman: Yes. I'd add that the value proposition around the timely availability of the product to the patient really seems to resonate over time as does the dramatic reduction in wastage that we're seeing at the hospitals that have taken on IFC.
Ross Osborne: And then lastly, I'm looking at smaller geographies for those that could provide some upside, but you do discuss the state of the UK and Germany?
Obi Greenman: Yes, I'll start there and maybe I'll take UK and they can take Germany. So the UK has been a long story as a lot of these accounts that are sort of deferring the decision around improving the safety and availability of the blood supply. That's an increasingly challenging position to take when so many other countries have established pathogen activation and INTERCEPT specifically as the standard-of-care and the results that they're seeing from real world experience with the product. The UK is about ready to release a report on blood safety coming from the HIV and hepatitis epidemics of the 80s, 90s. It's called the infected blood inquiry that's supposed to be published on May 20 in the UK and it's estimated that there'll be multibillion dollar restitutions to the victims. So I think that will have some impact on sort of how the UK looks at blood safety and availability going forward. That being said, it's a single payer system as you know. And so the National Health Service Blood and Tissue has a fairly formal process for how they would take on pathogen activation. But we're optimistic that at some point in time that market will convert. It's just hard to predict when. Vivek, do you mind covering that Germany?
Vivek Jayaraman: Sure. I'd be happy to. For Germany, if you think about the market dynamics, it's more similar to the U.S. as opposed to situation in France where you have a single decision maker and once they decide to go, it really becomes about partnering with them from an operation standpoint around implementation. So we are actively involved in CME in Germany with getting accounts online, working with them to get their MAA and ML and marketing license approvals. And what's been most encouraging is we're starting to get some institutions to start Berlin. We've split up Berlin Charite Hospital Hospital beginning with that reduction, that's one of the top 10 leading hospitals in the world. And so you get these luminary institutions onboard and that's kind of where we see progress driving. So the German Red Cross, DRK is also the other area of customers where we're working towards getting them up on faster reduction. One of the things that we'll need to work through is getting extended day label claim like a 6 day claim in the marketplace. But in terms of where we stand now, Germany continues to be a growth opportunity for us in EMEA. We've got a direct team on the ground there and we're starting to see product adoption. So it's a slower process, like I said, than some geographies where you have a single decision maker. But on balance, we feel good about our growth prospects for Germany through the balance of the decade.
Operator: [Operator Instructions] Our next question comes from William Bonello with Craig-Hallum Capital Group.
William Bonello: Just trying to understand a little bit more about EMEA outside North America. I get the quarter and what you said there. But just more generally, I mean, it's been sort of a several year trend of sort of declining revenue. What sort of the underlying dynamic that's happening there? And how does that change? Does it only change by more countries coming onboard? Are you pretty much not expecting growth where you already are? Or how do we think about that?
Obi Greenman: Well, I think last year was somewhat of an anomaly in that we traditionally see sort of single-digit or low-single-digit organic growth in markets where we have 100% penetration, for example, in France and Belgium. And last year, we don't know if it was a function of sort of COVID or just change in transfusion practices around transfusion thresholds for platelets, but we saw a decline last year in the organic growth or in the overall platelet demand in those markets. That's recovered this year as we mentioned in our prepared remarks. I think as far as longer term growth trajectory, it really is about new geographies as well as ultimately having some growth in the plasma business which has been lagging the platelet adoption. So I think we feel pretty confident about the geographic opportunities for us in Europe. And that being said, it's really hard to predict exactly when these large accounts will come online. So I don't know if that answers your question, Bill.
William Bonello: Yes, no, absolutely. That's really helpful. And then just on CE Mark, is there anything more you can tell us there? I think you've said hopeful expected timing by the end of this year, but just what sort of has to happen between now and then? And any other color you can give us on timing would be great on red blood cell obviously.
Obi Greenman: So your question is specific to CE Mark timing under the MDR process and fortunately Carol Moore is on the call with us. So I'll turn it over to Carol. She's our Senior Vice President of Regulatory and Quality.
Carol Moore: We are working closely with our competent authority, which is in the Netherlands, to finish up any questions they might have on the responses we provided earlier this year. We have not heard back from them, but we did provide a complete response. And between receiving some feedback from our competent authority, we still will go back and talk to our notified body, which is the TUV and determine what the next steps are towards completing the application. So we'll be in a better position once we hear back from our competent authority about the responses that we provided earlier this year.
William Bonello: And based on what you know thus far though, I mean, any change to your thinking and timing?
Carol Moore: Well, I think we're just in active -- we're just in an active review process. So at times, it's hard to predict what might come up next, but I think we're working hard to make sure that we fulfill any request that we receive in the most timely way.
William Bonello: That's helpful. And then just one last question on cash flow and happy to hear your thoughts about potentially being operating cash flow for the year and obviously seeing it for Q1. Just anything particularly unusual, I think we had some unusual working capital moves in Q4 probably that hurt operating cash flow. Did we sort of see a reverse of that helping Q1 or how do we sort of think about it in the future quarters?
Kevin Green: So you're right. In Q4, actually 2023 at large, we saw kind of atypical working capital movements with increased inventory and rapidly declining payables. I think when we ended the year, we felt like we were in a position where we could reverse that. Q1 was really the first time, I think that you see the inventories coming down. Obviously, our receivables have come down, for that matter payables have come down. I think we're cautiously optimistic for the balance of the year. Obviously, there could be chop in any given quarter. But if you think about our guidance in Q1 being kind of the low watermark for the year, I think we expect to see continued growth in the top-line. We'll continue to work down inventory levels. And then really it comes down to managing the payables and the receivables at the current DSO and DPO levels, which we think is manageable. So I think there's a lot of fundamental reasons to be confident that we can generate operating cash flow and we'll manage towards that.
Operator: I would now like to turn the call back over to Obi Greenman for any closing remarks.
Obi Greenman: Well, thank you again for joining us today and for your interest in Cerus. We look forward to keeping you informed of our progress throughout the rest of 2024. Thank you.
Operator: Thank you. This concludes the conference. Thank you for your participation. You may now disconnect.
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