Good day, ladies and gentlemen. Thank you for standing by. And welcome to Cerus Corporation Fourth Quarter and Full Year 2024 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 Noopur Liffick [ph], Cerus Investor Relations Advisor. Ms. Liffick, you may begin.

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.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 fourth quarter and year ended December 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 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 2024 product revenue guidance, our expectations for bottom line and non-GAAP adjusted EBITDA performance, our operating expense and gross margin expectations, and our expectation for positive operating cash flows for 2025, expected future growth in our growth trajectory, a potential new and enhanced CE Mark submission for INTERCEPT red blood cells, 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-K for the year ended December 31, 2024, which we will file in the coming days. 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 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, Noopur, and good afternoon, everyone. I’d like to open the call by spending a few minutes reflecting on our strong performance in 2024 as well as our expectations for full year 2025 as we continue to establish our INTERCEPT blood system as a standard of care in transfusion medicine. 2024 was a milestone year for the company and its long history in that we successfully achieved positive adjusted EBITDA for the full year. Building off of this will allow us to invest in the continued growth of our business globally and our full INTERCEPT portfolio and product improvements. Our year-over-year double-digit product revenue growth for 2024 was fueled by continued expansion in our global platelets business, along with the rising demand in our INTERCEPT Fibrinogen Complex or IFC business in the U.S. Vivek will provide further insights into the strong demand we are experiencing in the IFC market, where we are providing an important and timely intervention for patients with major bleeding complications. This momentum underscores the critical importance of INTERCEPT treated blood components and highlights the growing impact of our pathogen and activation technology across transfusion services in the U.S. and internationally from blood vendors that manufacture pathogen and activated components to the hospitals and clinicians who transfuse them. For the fourth quarter and full year 2024, we executed our financial strategy effectively, delivering strong bottom line performance and robust operating cash flows. As Kevin will detail shortly, key year-over-year financial highlights include double-digit growth and narrowed GAAP net loss attributable to the company and positive non-GAAP adjusted EBITDA. With that strong foundation and in line with our 2025 product revenue guidance announced earlier this year, we anticipate year-over-year growth of 8% to 11%, while focusing on the forward health of our bottom line results. On the development front, in Europe, we are continuing to collaborate closely with our notified body, TUV SUD, on a potential new and enhanced CE Mark submission for INTERCEPT red blood cells or RBCs. We plan to have a more detailed update on these developments as those plans solidify in the coming months. I would like now to turn the call over to Vivek to discuss our commercial results and progress for the fourth quarter and full year 2024 along with color on the outlook for 2025.

Thank you, Obi and good afternoon everyone. As we entered 2024, we committed to a return to top line growth. While at that time we believed in our ability to deliver compelling growth, we were not without headwinds. We started the year with 6 months shelf life on platelet kits in the U.S. and most of our IFC production partners have yet to receive BLA clearance to enable them to transport IFC across state lines. Thanks to the solid performance of the cross-functional Cerus team, combined with strong partnership with our blood center customers, we were able to successfully address many of these challenges and meet our commitment by delivering 15% top line growth compared to 2023. In addition, we made meaningful progress on key strategic commercial initiatives that will set the stage for compelling growth for the balance of this decade. We delivered strong results in the fourth quarter of 2024 driven primarily by growth in demand for our U.S. IFC business as well as our global platelet franchise. In particular, we saw strong contributions from our international markets. As an example, Canadian Blood Services is now at 100% PR adoption for their platelet production. Overall, our core platelet market stabilized and we witnessed the normalization in donor trends in 2024, which were previously headwinds in 2023. In addition, we made meaningful progress on several of our key growth initiatives. As we start 2025, we are seeing signs of strong platelet traction across our global franchise. As reported last quarter, we had an excellent showing at the annual AABB meeting which took place in Houston, Texas in October. As we predicted, the interest we witnessed at AABB translated into a spike in inbound inquiries both from hospitals and blood centers. During the quarter, a few of our blood center…

Thanks, Vivek and hello to everyone listening. On today’s call, I’ll be discussing our financial results for the fourth quarter and full year 2024 as well as our product revenue guidance for 2025. Finally, I’ll highlight some of the key success factors that we are focused on as we move forward, building off a 2024 solid base toward continued financial improvement over the long-term. As pre-announced in January, full year 2024 product revenues were $180.3 million ahead of our latest 2024 product revenue guidance and representing 15% growth year-over-year. For the fourth quarter of 2024, we posted product revenue of $50.8 million representing year-over-year growth of 9%. EMEA platelet sales as well as growth from U.S. platelet sales drove the bulk of our product revenue increases this quarter. While our platelet franchise drove much of the growth, we also realized IFC sales expansion. The IFC business was up almost 30% when comparing the fourth quarter of 2024 to the prior year. Full year 2024 North American product revenues were up 23% over 2023 levels and fourth quarter 2024 product revenues exceeded prior year levels by 6%. This growth was driven largely by increased penetration at the top U.S. blood center organizations, where we continue to see significant growth opportunities for INTERCEPT uptake. In EMEA, fourth quarter product revenues were up 16% year-over-year. When looking at Q4 2024 over the prior year, FX rates provided a slight headwind for the EMEA business of around 80 basis points. On a full year basis, FX rates had little impact on our EMEA business. And on a consolidated basis, FX provided a headwind of around 20 basis points when comparing Q4 2024 to that of the prior year period and little to no impact on the full year comparative results. Beyond our platelet and…

Thank you, Kevin. With the first two months of 2025 almost behind us, we remain positive about the rest of the year ahead of us. Our growth reflects the confidence and trust our customers place in Cerus and the INTERCEPT technology, which addresses a significant unmet need in blood safety and availability with a total addressable market estimated to exceed $7 billion annually. While we have realized strong revenue growth for both our platelet and IFC products, we are sub-10% penetrated in those markets globally, meaning there is a lot of runway for continued revenue growth for our existing licensed INTERCEPT product portfolio. With our first mover advantage, superior technology and strong barriers to entry, we are setting a new standard in transfusion medicine. Our concentrated and expanding customer base allows us to drive significant leverage from our SG&A, generating a strong recurring revenue stream. With a solid financial profile and a mature pipeline, I believe Cerus is well positioned for continued success. Thank you for your continued interest in Cerus. I will now turn the call over to the operator for questions.

[Operator Instructions] Our first question comes from the line of Joshua Jennings with TD Cowen. Your line is now open.

Hi. Good afternoon and thanks for taking the questions. Congratulations on the strong performance in 2024. I was hoping to just start on IFC, the foundation for that franchise continues to build. It seems like it’s on the cusp where it’s beginning to inflect just in terms of adoption and utilization, just with customer demand. I was hoping you could just walk us through the steps that are left before kind of full U.S. market access is unlocked. And then kind of secondary to that, just your state of optimism that that Cerus can capture up to 50% of the multi-hundred million dollar U.S. market opportunity in front of you with IFC.

Thanks a lot, Josh, for the question. Vivek, would you like to cover that question?

Sure, I would be happy to. Good to hear from you, Josh. Thanks for the question. I think you categorized the state of the market well. We were excited about the increase in demand, the validation we received coming out of AABB, both on the podium and in peer to peer discussions was certainly a strong boost and added to the momentum we saw at the end of the year and entering into 2025. In parallel, as we mentioned, we received BLAs at a couple of our production partner sites, which will enable them to transport product across state lines that will unlock demand in states where there wasn’t previously an in-state manufacturer. So, in terms of thinking about how we unlock the market and continue to drive forward progress, the key things are making sure we constantly balance demand and supply. So, as we are seeing demand spiking, it’s nice to have avenues with which supply can grow and I think as we add that with continued real world experience, maturing clinical evidence, those are the factors that are going to continue to allow us to penetrate this market. And certainly the user experience from what we are seeing where hospitals may bring it in into one clinical category and then it fairly quickly diffuses across the institution, that gives us confidence that the broad market opportunity that IFC presents in fact, realizable.

Excellent. And maybe one just follow-up on just the China opportunity, I know you have a JV. I think you talked a little bit about this earlier in January. But the next steps to unlocking that China TAM, which is a meaningful piece of that $7 billion global TAM that you referenced in your prepared remarks, it will be just the outlook there and when Cerus could start seeing the China franchise contribute revenues. Thank you.

Yes. Thanks Josh for the question. Yes, we are expecting an NMPA approval sometime this year and subsequent to that Chinese approval, there will be sort of a prudential reimbursement process that we estimate will take about a year to complete. So, we are actively discussing with various prudential blood centers in China, their interest and that will continue on until the NMPA approval happens. It’s really just sort of, how do we sequence the rollout once we have that prudential reimbursement in place. So, it’s not going to contribute meaningfully to revenue this year, but once that prudential reimbursement is in place, once we have the approval and then the prudential reimbursement is in place, we do see that being a very meaningful market opportunity for the company and allows us to continue to penetrate the platelet market that we mentioned in the prepared remarks is we are still sub-10% globally. So, there is a lot of continued opportunity for the platelet business. Thanks Josh.

Thanks Obi.

Thank you. Our next question comes from the line of Jacob Johnson with Stephens. Your line is now open.

Hey. Thanks. Good afternoon everybody. This one is probably for Vivek. Just, Vivek, you mentioned on IFC, bringing on additional supply to meet demand. Can you just talk about that dynamic? And then as we think about the outlook for $12 million to $15 million of IFC revenue this year, how much of that’s predicated on additional supply coming online and do we need to – is there any timing to that that we need to think about as we think about IFC revenues playing out throughout the year? Thanks.

Great. Yes. Thanks for the question. With respect to the benefit of having the BLAs that impact on supply, what that enables us to do is it allows us to address demand that we have known for some time exists in states without an in-state manufacturer. So, now those hospitals have an avenue to access IFC and the blood centers that have the BLAs in hands are now operationalizing that license, so that they can ramp up supply and meet that hospital demand. As we contemplated guidance for the year, we went into the year with line of sight into having sufficient manufacturing supply to meet demand, but we are going to continue to work on increasing supply because we continue to see demand increase as well. But we feel that with the progress we are making, we will be in a good spot where supply shouldn’t be a constraint on a going forward basis.

Got it. That’s helpful. And then maybe Kevin, one for you, just on product gross margins, I heard kind of mid-50s for the year, obviously you called out some kind of couple of items in 4Q that kind of bit you. Can you just talk about whether it’s U.S. dollar, freight costs, discard rates, IFC investments, just any of those that we should be monitoring or keeping in mind this year that could kind of repeat from 4Q or any that were kind of isolated to 4Q, just how should we think about gross margins this year? Thanks.

Yes. Jacob, thanks for the question. I think most of those items that I called out for 4Q were episodic. We don’t expect them to last. The one watch out I would say is FX rates. If the dollar continues to strengthen relative to the euro, obviously that’s going to have an impact across our P&L. What I would say is since most of our product is sourced in euro, as the U.S. becomes a bigger and bigger contributor to the top line and the dollar strengthening, we actually see a bottom line benefit. But it does obviously have a negative impact on our revenue line. So, that’s the one watch out that obviously we don’t have absolute control over. As far as shipping costs, the ancillary product where we saw some discards, those are truly episodic, we don’t expect those to continue.

Okay. That’s helpful. I will leave it there. Thanks for taking the questions.

Thanks Jacob.

Our next question comes from the line of Ross Osborn with Cantor Fitzgerald. Your line is now open.

Sorry. Hey guys. Thanks for taking our questions. So, maybe just one clarifying question on SG&A guidance. I believe you said slightly up and ‘25 relative to ‘24. Does slightly up include the one-time item that occurred during the fourth quarter or is it slightly up versus an adjusted number?

Yes. I think it’s – Ross, sorry, I was going to take that over if that’s okay.

Yes. No please, sorry.

Yes. So, we are really talking about 2024 as a whole. I think clearly we saw this cumulative catch up. I would characterize it as probably roughly a $2 million impact for the quarter that was anomalous. Where we are going to see continued growth is really from inflationary pressures. We are not making significant investments, as we mentioned incremental investments, but we expect that we will be able to generate continued leverage with those investments relative to the top line growth. So, it’s really a comment that was predicated on 2024 as a whole rather than a specific quarter.

Okay. It sounds great. And then, sorry, we are jumping around a bit. I heard the comments around China, but with regards to Brazil, could you walk through that commercialization timeline, the steps you need to take there?

Yes. Vivek, would you like to cover that?

Sure. So, as you are aware, we currently are commercial in the private sector in Brazil, but that’s a small portion of the market. We are in the process of applying to gain access to the public sector, and that’s really a combination of health ministry, our distributor partner and us putting together a dossier and receiving approval from the government agencies to gain access to the public sector. That process is ongoing, and we would anticipate hearing from them later this year. From there, it really becomes about operationalizing of the rollout, so working with our distributor deployment organization, getting devices into the market, and kind of rolling it out there and just similar from what happened in France. But the first step really is awaiting decisions from the government, which we anticipate would happen at some point later this calendar year.

Got it. Thanks for taking our questions.

Thank you, Ross.

Our next question comes from the line of John Wilkin with Craig-Hallum. Your line is now open.

Thank you, guys. I just wanted to ask, it looks like platelet growth in North America started to slowdown pretty meaningfully in the quarter. I was just wondering if that’s – is that due to just tougher year-on-year comps now after some very easy ones early in the year, or are there other reasons driving that?

Yes. Kevin or Vivek, would you guys like to take that?

Sure. I would be happy to jump in, and Kevin, certainly, if you have any other thoughts. So, it had a little bit to do with comps. We also, one of the things that we had talked about potentially addressing when we came towards, we knew we were going to have a shelf life issues through the balance of this year. We knew that there was some stocking taking place at the end of last year, and so that we would seek to get to more normal inventory levels through the course of 2025. We potentially thought we might do that towards 2024, but we did not. But we continue to capture share in the North American market through the course of 2024, and anticipate doing so in 2025. So, you think about underlying adoption trends and where our business is heading. That continues to be a strengthening business for us. But there was no – beyond that, there was sort of really no underlying issue within our North American platelet franchise. We certainly benefited from a full year of 100% with Canadian blood services. So, you will see that as Hema-Québec comes on board, you will see a little bit of growth in Canada, but fundamentally, we anticipate the U.S. market will continue to capture share.

Got it. Thanks. That’s helpful. And then any other updates around other specific countries or geographies that are maybe in the early stages or potentially adopting INTERCEPT in the near future?

Sure. As we have talked about previous in this call, we have got a joint venture partnership in China. There are some steps that need to walk through there, but we are encouraged by not only the progress we are making, but the caliber of our partner, as well as the level of clinical interest and enthusiasm in that marketplace. I think we have mentioned previously that early days for us in terms of progress in Germany that represents the single largest remaining market in the Western Europe. And then we recently had a number of our folks at the Annual MEDLAB Congress in Dubai and the market opportunity for us in the Middle East in particular in Saudi Arabia continues to be quite strong. There is quite a bit of investment in healthcare happening in the kingdom and they tend to mirror off of AABB and FDA standards. So there is a lot of awareness of interest and enthusiasm to adopt INTERCEPT. So those would be some examples of geographies where we feel there is a reasonable path towards growth and that could represent growth drivers to the balance of, really over the course of the next couple of years.

Great. Thanks guys.

Yes. Thank you, John.

Thank you. [Operator Instructions] Our next question comes from the line of Mark Massaro with BTIG. Your line is now open.

Hey, guys. This is Vivian on for Mark. Thanks for taking the questions and congrats on a nice quarter. Could you just discuss in terms of the major, the five major blood centers in the U.S.? I think I heard you call out that you drove some increased penetration there. So could you just walk us through what the level of penetration stands at currently and just how you are thinking about that remaining opportunity? Thanks.

Thanks, Vivian. Vivek, this is another one for you, I think.

Thanks, Obi and thanks for the question, Vivian. There continues to be upside with U.S. blood centers in particular with and as we see consolidation of markets, some of the larger blood center families. I don’t think today we’ve provided share levels at those centers with the exception when the American Red Cross announced of their own volition publicly their intention to move to 100% PR. So really out of respect for those centers, we sort of keep that information internal. But what I can say is if you just look at our overall penetration in the U.S. and where the opportunities exist as well as what we’re seeing in terms of continuing maturity of our real world evidence in support of INTERCEPT is not only in the context of compliance with the bacterial guidance from the FDA, but more importantly, in terms of pandemic preparedness and other financial and operational benefits that confers the blood centers, we are seeing continued inbound inquiries from blood centers to adopt INTERCEPT, which is why even long past the guidance compliance period, we are seeing share capture and increased PR penetration in the total market. So, it was a big contributor to 2024 performance and we anticipate that being the case as well in 2025.

Perfect. Thanks for the color there. And then just one on government contract revenue, I understand you guys don’t guide to this. I think it came in a little bit above our model in the quarter. Do you think that $5.9 million would be a good run-rate for 2025 or were there any one-timers in that? Thanks.

Thank you. Kevin, do you want to cover this one?

Yes, sure. Yes, Vivian, I don’t know that it’s a good baseline for 2025. As you’ll recall, we were awarded 2024 BARDA agreement late in the year. Some of those activities have started, but they are not really contributing meaningfully towards the overall government contract revenue. We do expect in 2025 that all of the awards will be running concurrently and that we’ll see a bump up in the overall government contract revenue and the initiatives that we are spending on those contracts. So I wouldn’t model it off of Q4. I think it’s going to continue to grow as those initiatives kick away and contribute.

Okay, great. Thanks so much for taking the questions.

Thank you.

Thank you. And I am currently showing no further questions at this time. I’d like to hand the call back over to Obi Greenman for closing remarks.

Well, thank you all again for joining us today and for your interest in Cerus. Next month, we will be participating in the 45th Annual TD Cowen Healthcare Conference. And we look forward to sharing our progress with you throughout 2025, should be a great year. Thank you.

This concludes today’s conference call. Thank you for your participation. You may now disconnect.