Good day, ladies and gentlemen. Thank you for standing by, and welcome to the Cerus Corporation Third Quarter 2024 Earnings Conference Call. At this time all participants are in a listen-only mode. 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. Dr. Hanover, 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; and 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 second quarter ended September 30, 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 our product supply expectations and ability to meet customer demand, the potential value of and anticipated activities to be funded under our new BARDA agreement, planned regulatory submissions and product launches, product expansion prospects and other statements that are not historical fact. 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 10Q for the quarter ended September 30, 2024 which we will file short. 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 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.

Thank you, Jessica, and good afternoon, everyone. I would like to open the call with a review of our strong quarterly performance on both commercial and financial fronts, as well as our increasingly positive outlook for the full year 2024. Our North American platelet business drove, our Q3 product revenue result, and our INTERCEPT Fibrinogen Complex or IFC business in the US is gaining momentum at the same time that we are increasing supply capacity for the product. Vivek will provide additional color in his remarks. With this trajectory, we are raising our product revenue guidance to account for the positive trends in both these business segments. We are also executing on the financial measures that we have been targeting for the full year, both on the bottom-line as well as operating cash flows, as you will hear from Kevin shortly. With the growing scale of our business, the leverage of our business model, and the discipline around our operating expenses, we've been able to consistently deliver against our quarterly financial targets at a high level. And on the heels of the annual meeting of the association for the Advancement of Blood and Biotherapies, or ABBAs, earlier this month, it is gratifying to see how pathogen inactivation has become increasingly ubiquitous across the transfusion services in the US and in multiple geographies. From blood centers that manufacture pathogen inactivated components to the hospital clinicians who transfuse them, and sitting in the plenary session at the Houston Convention center with thousands of ABB meeting participants listening to the presentation of the positive recipe phase III clinical trial data was truly a rewarding experience. The further acknowledgement from the recent up to $248 million BARDA contract designed to see the INTERCEPT RBC program through potential regulatory approval and product launch only added…

Thank you, Obi, and good afternoon, everyone. Entering 2024, we committed to a return to growth across our commercial organization. As we exited the first half of 2024, we were back on a growth trajectory and I'm pleased to report that we continued that trend in the recently completed third quarter. As with prior periods in 2024, the strength of our US. platelet franchise led the way and we continue to see encouraging growth in our US IFC business. With respect to US platelets, we estimate that nearly two thirds of all platelets distributed to US hospitals are patched and reduced. We continue to make good headway with customers, both blood centers and hospitals who are ranting their adoption of Intercept platelets while holding strong with customers who are already at 100% intercept platelet adoption. We believe the marketplace views Intercept created platelets as the safest option for patients and this was supported by plenary presentations, posters and symposia activities at the annual AABB meeting earlier this month. The peer-to-peer interaction and support of INTERCEPT adoption was incredibly encouraging to witness. Our team simply had to facilitate introductions and the number of high-volume INTERCEPT platelet users in attendance was significant. This dynamic also played out with international markets where we saw a good number of Canadian, Middle Eastern and European customers at the meeting and they too were eager to share their positive experiences with intersect. Last quarter we saw continued adoption of IFC within the us as we have discussed in past quarterly calls, we are closely monitoring demand increases and working hand in glove with our blood center production partners to ensure they can deliver sufficient supply. We were pleased to see the issuance of three new BLA approvals in the third quarter. This will enable broader interstate…

Thanks Vivek. Good afternoon and thank you all for joining us. On today's call. I'll be discussing our financial results for the third quarter of 2024 as we near the end of the year. I'll also provide some color related to our strong progress on the financial goals we set out at the beginning of the year. To start, we posted product revenue of $46 million for the third quarter of 2024. This represents year over year growth of 16% and brings product revenue for the first nine months of the year to $129.5 million, up 18% from the prior year period. North American platelet sales continued to be the major contributor to our product revenue growth during the quarter. In the US third quarter 2024, product revenues exceeded prior year levels by 17%, with Canadian Blood Services now at 100% entering the third quarter. Sales in this geography were an important contributor to our year over year growth as well. In EMEA third quarter product revenues were relatively stable to slightly higher compared to the prior year period and to the second quarter of 2024. FX rates provided a slight tailwind for the EMEA business of around 1% over the prior year period. On a consolidated basis, FX rates were less impactful, benefiting the top-line results by approximately 40 basis points. Also, for Q3, we posted ISC product revenue of $2.3 million, up from $1.7 million in the prior year period driven by more standing orders and depth within existing accounts. In addition to our product revenue and not included in our guidance, government contract revenue totalled $4.6 million in Q3 compared to $7.5 million for the prior year period. The completion of our US Phase III recipe clinical trial was the primary driver for the decline. As we…

Thank you, Kevin. We are very pleased to be continuing to execute on the ambitious goals we set out at the beginning of the year. With two months left in 2024, we feel confident about where we stand relative to these goals and are looking forward to sharing our expectations for 2025 with you in just a couple of months. Most importantly, we know that our growth as a company is a direct reflection of the confidence that our customers have in Cerus and the Intercept technology, enabling patients across the globe to have access to safe blood when they need it most and creating a new standard of care in transfusion medicine. It is an honor to partner with our customers as well as organizations like us, Barda, as we continue to focus on meeting this need. Thank you for your continued interest in cris. I will now turn the call over to the operator for questions.

Thank you. [Operator Instructions]. Our first question comes from Ross Osborne with Cantor Fitzgerald.

Your line is open. Hi guys, this is Matthew Park on for Ross. Thanks for taking the questions tonight. I just want to start off talking about the IFC business here. Now that you've added on an additional three BLA approvals, do you anticipate needing additional manufacturing capacity to meet the strong demand, or do you feel comfortable at current levels?

Thanks, Matthew. Vivek, do you want to handle this?

Sure, I'd be happy to. Thanks for the question. We continue to work with flood centers to add manufacturers for IFC, and as demand grows, we anticipate we'll continue to grow supply as well. The addition of the three BLAs in the quarter is certainly significant to ensure that we can continue to meet the demand that we're seeing growing. But we anticipate that demand will continue to grow and as such will continue to recruit and partner with more blood centers to produce IFC.

Great. That makes sense. And then I guess just one more from me with the LED illuminator. Have you guys noticed or obviously you've gotten positive feedback from abb. What does the timeline look like for receiving an approval decision here? And is there a replacement timeline with the legacy device? Thanks.

Yeah, thanks, Matthew. So right now we're targeting a launch for the LED illuminator in Europe in 2025. We really see this sort of a foundational new platform for our business and for the use of plates and plasma in blood centers. Right now, the assumption is that we'll be rolling this out across multiple customers throughout 2025 and 26 in Europe. And then we're still in the process of putting together a PMA submission in the United States for the LED illuminator. That's likely to take place more in the 2026 timeframe. So overall, we're really excited about getting this product to market. It's been a partnership with a lot of our Bud center in the development of this program, and it really also is an important element of our innovating on the technology going forward, allowing us to improve the process in the future.

[Operator Instructions]. Our next question comes from Matt Blackman with Stifel. Your line is open.

Hi, guys. This is Colin on from Matt. I wanted to start with a couple on IFC and what's driving the recent momentum and guidance range. Is this growth primarily from new customers or going deeper into your existing accounts or both? How should we think about the number of accounts you guys are in today versus the potential opportunity for what's out there? Thanks.

Yeah, thanks, Colin, for the question. Vic, would you mind taking this one as well?

Sure, I'd be happy to. So, to answer the question, growth is coming both from death within existing customers as well as new customer acquisition. We estimate that roughly 55, 60% of customers were added this calendar year. So those are new customers. But then those that started last year, we. Many of them started in one clinical area of the hospital, and as they generated evidence of the value of IFC that moved out to other clinical departments. And then there are certain institutions, I referenced Barnes Jewish and St. Louis earlier that are now 100% IFC across all of their clinical departments. So we're seeing good growth in both areas. And for our sales organization and our production partners, really, the focus is on getting existing customers to 100% and then continuing to fill that funnel with new hospital targets and new hospitals that are getting onboarded as each month passes. So it's great to see because we think that provides us, Excuse me. With significant Runway for this therapeutic category.

Thank you. That's really helpful. And it does look like IFC is going to exit the year at around a $3 million to 4$ million quarterly run rate. So how should we be thinking about IFC in 2025? What are the key growth drivers for next year in particular? And is something in the $15 million range, a reasonable starting point for the full year number?

Thank you. Yeah, thanks, Tom. Obviously we're not going to be providing guidance today on the call for IFC revenue in 2025. But I think Vivek can give you a little bit more color on sort of why we believe there's momentum growing just based upon the demand we're seeing and our now increasing ability to supply that demand.

Yeah, I think the drivers remain largely the same. You know, we referenced the fact that three BLAs were issued for production partners in the last quarter. There's a little bit of ramp up time once they get the BLA to increase their manufacturing base and start to distribute product. But all of that will drive growth. That also gives both the blood centers and our team greater conviction around opening up new accounts. They know supply will be there, so that'll continue to drive the therapy, adoption and top line growth into 2025. And then what we're seeing as well, if you think about what hospitals went through with COVID in terms of budget crisis and really having tremendous issues staffing, maintaining staff at hospitals, they were really loath to take on new projects. Certain hospitals recovered at a faster rate. What we're seeing now is as more hospitals feel like they're in a stronger financial position and they're fully staffed, they are amenable to starting taking on new projects like IFC. And that dovetails with what they're hearing at conferences like the recently attended ABB where they're seeing podium presentations about the technology. So all of these things are dovetailing together to create what we believe are meaningful tailwinds supporting our business.

[Operator Instructions]. Our next question comes from Jacob Johnson with Stevens. Your line is open.

Hey, thanks. And I'll echo my congrats on the quarter. And a pre-emptive apology for the another 2025 question after Obi. You've mentioned that you'll address that in a couple months. And maybe a bit nitpicky, but if I look at kind of the midpoint of the guidance, what it implies for 4Q, it implies kind of a mid-single digit growth rate in the fourth quarter. Again, understanding it's too early to guide to 2025, but could you maybe just frame up why or why not? That's the best jumping off point for next year and IFC may be the answer. But just any thoughts there?

Yeah, I mean I think as we were looking at the guidance for this quartertwo months left in the year. We just really wanted to provide our best sort of projection for what the growth looked like for the remaining two months. But I think Vivek can sort of give you a sort of a perspective on sort of why we did that and sort of the optimism going into 2025.

Yeah, I think you captured most of it. I mean, at this point, with October nearly done and two months remaining, we have good insight into what orders are out there, what new accounts will open. Things will slow down a little bit as we head into the holidays. So some of those de novo account openings may move to early 2025. But fundamentally, if you look at inventory levels with our key customers, as well as the feedback we're getting from hospitals about their initial experiences with IFC, all of these things right now are trending positive, which is what gives us confidence about how we'll close the year and the fact that we'll have a bit of a tailwind entering into 25. Not to be too demure, butas mentioned earlier, I think we'll, we'll reserve a more detailed discussion about 25 outlook till early next year. But what's encouraging to me is we had committed to returning to growth this year after a challenging 2023. We sort of put the foundational pieces in place with our Q1 and Q2 performance and then we were able to add another solid quarter here in the third quarter and we're sort of heads down sprinting to do it again in Q4.

Got it, thanks for that. And then Obi, just on this next gen illuminator, you mentioned some good feedback from customers and their interest in it. Can you just talk about the value proposition of this next gen illuminator for your customer base?

As we think about adoption upon potential approval, I think fundamentally for our customers, what they really depend on is our supply chain continuity and also the performance of our system. Because as you might imagine, since they've adopted our technology at 100% in many markets, if for whatever reason, supply chain wasn't solid. And that means bothon the kit side, but also on the operational side with the device, that would shut down their blood supply. Historically, we've had a very reliable system with the current Int 100 Illuminator and then moving into a new platform, if you will, with this LED based illuminator, we had to have something that was equally robust, but also provided them with the assurance that this is something that they can rely on day in, day out. And so as we were Developing this with their input. We were really looking at how do we make it easier for them to use as they're processing hundreds of units of planets and plasma every day. And then sort of just thinking about in the context of decades, how do we have something that they feel is state of the art and is not going to create problems for them in the future with regard to supply chain continuity. So the great thing about it is just the throughput and ease of use feedback that we've gotten now as we've had numerous discussions with the European customers who will be receiving the led illuminator in 25. The feedback is uniformly positive and it's easier for them from a staffing and day to day operational perspective. And then I also mentioned this. I do think it's a foundational platform for how we evolve the technology going forward that was built into it so that we have flexibility on how to improve the system and iterate on sort of the process, if you will, so that we ultimately have something that increases ease of use but ultimately potentially impacts our COGS profile as well.

[Operator Instructions] Our next question comes from Joshua Jennings with TD Cowan. Your line is open.

Hi, good afternoon. Thanks for the questions and it's great to see continued momentum. One of two follow ups, one on IFC. Sorry if I didn't capture this, but just wanted to get a sense of the rollouts of future BLA approvals. Are there any other blood center partners that are where blas are pending? Should we expect more BLA approval announcements in the next 612 months?

Yeah. Thanks Josh. And again, I'll turn over to the day for coverage on IFC.

So you have other blood center production partners who are in the process of pulling together BLA applications. Obviously timing on that can vary, but we do anticipate more blas to come through'25 and beyond. And but what was most exciting about the recent approvals iswe believe that there with these approvals, there's sufficient capacity in terms of production headroom to allow us to continue to be aggressive in terms of driving demand. And that was something that we were always laser focused on because we knew once we got to the fall Congress season with the papers that were being submitted for publication and the podium presentations that were being accepted, that there was going to be a flurry of new information released, both single center experience as well as broader data sets that supported IFC. So we wanted to make sure that we were in a position that we could offer up the product once people would start to say, hey, I want to bring that into my institution. So we'll continue to monitor this and work in lock stuff to make sureone thing doesn't run too far ahead of the other. But right now we feel like we're in a pretty solid position.

Excellent. And just wanted to just get a refresh on ASP for the LED illuminator. And just thinking about once that approval hits and there is this replacement cycle kicking in, will that have an impact on gross margins? I believe this is a gross margin accretive system, but I just wanted to check that box. Thanks for taking the questions.

Yeah, thanks a lot, Josh. I'll let Kevin.

Yeah, thanks, Josh. We haven't really commented. I think it's a bit premature since we don't have approval yet for the Ladd illuminator. With that said, the technology is newer, thethe cogs will be slightly higher and as a result they we expect the ASPs will be slightly higher. As far as a booster to overall gross margins, I think in and of itself you shouldn't expect that. We expect thatthe margins on that product will be neutral to our current margin business. However, it does provide us with a platform for future growth, geographical expansion and in the futurepotentially product iterations of because of that platform. So hopefully that answers your question.

It does. Just one quick follow up just on the IP side. This kind of extends some of that IP protection timeline is my understanding too, but can you just refresh there? Thanks.

Thanks again. Yeah, clearly there's a lot of IP that we've developed for this system over the course of the last five years. And it does extend, I think the moat that we're building for the business. And it's obviously IP that we filed globally as well. So it improves the IP profile for the product for our global business.

[Operator Instructions] Our next question comes from Mark Massar with BTIG. Your line is open

Hey guys, this is Vivian on for Mark. Thanks for taking the questions. So just on the government contract revenue, I heard your remarks on why Q3 was a little bit light. How should we just think about the run rate or a good baseline here? And I just wanted to clarify, the newer BARDA contract should flow into our models more. So looking at 2025. Thanks.

Yeah, thanks a lot. Vivek and Kevin, you want to handle that?

Sure, yes. So let's take the 2016 contract in isolation. We had year over year lighter revenues because of the study completion. As the new sites with REDIS begin. Well, they have begun, but as they ramp up production, we expect that the revenues and the expenses associated will ramp up over the course of the next 12 to 15 months. At that same timeless so in Q4, but really in 2025, activities under the new 2024 BARDA contract will begin in earnest. There's 32 million committed over several years. And while we're not giving guidance on that, the activity certainly will start in 2025 and will ramp up at the same time. The REDIS trial will complete, the 2016 contract will conclude, and then we'll be at a more plateaued level with ongoing initiatives under the new agreement.

Perfect, understood. And then just one on the bottom line, I think adjusted EBITDA beat us. We saw some nice leverage there. It looks like you did maintain the full year guidance on that front, which seems a little bit conservative maybe. Is there any reason for that trend to Change looking at Q4 or just I guess, what's driving the conservatism there? Thanks. Yeah, Vidyan. Well, our guidance was neutrality and we're tracking to slightly better than that. As you pointed out, no real reason for the conservatism other than there's a lot of moving parts and we don't want to get out ahead of ourselves. What we do expect is that with the increased revenue guidance, we would expect obviously growth there sustaining our gross margins and continued leverage and operating expenses. There is variability in operating expenses and margins, as you know, though, so we really want to hedge that as much as possible. But we are trending in the right direction and are optimistic about the future.

[Operator Instructions] Our next question comes from Bill Bolno with Craig Hallam. Your line is open.

Hey guys, a little bit of a similar question to what you just got, but not in the context of guidance, just. Kevin, can you help us think about sort of the sustainability of the cash flow from this point forward? Obviously there'll be quarterly variability given working capital and whatnot. But are we sort of tracking to a $16 million cash flow run rate? What are, what are sort of the puts and takes as we move forward here?

Yeah, thanks Bill. Ask you to go Back to our Q4, Q1 calls. Where we thought we would end this year was having the opportunity to generate operating cash flows. And that was a function of growth in the top line management of Our margins and OPEX getting continued leverage out of the investments that we've made. That's all happening. In addition, we felt like we had built so much inventory over the course of 2023 that we'd be in a position where we could convert some of those components and raw materials into finished kits without having to replenish that, and that would help the cash flows. That certainly has played out as you look at our balance sheet. We also said at that time in 2025, we'll have to rebuild the working capital and the inventory to meet growing demand. But we also expect that the business will be at a run rate where those investments in working capital will be offset with just natural operating bottom line. So I don't want to comment on what you should expect as far as cash flow generation long term, just the qualitative levers that we're looking at and that we're pulling to make sure that we're managing things appropriately and that our balance sheet remains healthy.

And do we think of in terms of product development of tech, do we think of that as almost being to what degree is that fully funded because of your BARDA relationship? And to what degree do you bear the burden of additional R&D expenses?

Well, it's certainly a significant almost a majority of our R&D expenses are funded by BARDA. That's especially true today with multiple BARDA agreements. We also have the whole blood initiative with the FDA and the Lyophilized IFC. So that is a major component of our overall R&D expense. The remaining items are initiatives that are foundational to our future growth and revenue trajectory, like the LED illuminator. I expect that that mix will continue as we move forward. We don't, we don't think there's going to be drastic swings in R&D expense as we move into 2025. But we're not done planning and we're not providing guidance today.

Okay. And then just other and again, not guidance, but other uses of cash that we should be thinking about going forward in terms of capital expense or et cetera?

Well, clearly the working capital items that we commented on, we maintain the revolving line of credit for that exact reason. It's down year over year as we ended 9/30/24. We'll continue to look at the opportunities to leverage that and offset any balance sheet cash that we would have to fund for that. And then beyond probably capex on cogs reduction initiatives and capacity expansion initiatives. Lastly, I'd say geographic expansion to the extent that we have the opportunity to expand geographically, place devices those are, those are all high return investments that we think would be beneficial to shareholders.

Thanks a lot, Bill. And I'm not showing any further questions this time. I'd like to turn the call back over to Obi I for any closing remarks.

Well, thank you all again for joining us today and for your interest in Cerus. Later this year, we'll be participating in investor conferences hosted by Stifel Stephenson and Craig Hallam, after which we look forward to speaking with you again in the new year. Thanks again. Ladies and gentlemen.

This does conclude today's presentation. You may now disconnect and have a wonderful day.