Good day, ladies and gentlemen. Thank you for standing by, and welcome to the Cerus Corporation Second 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.

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. Cerus issued a press release today announcing our financial results for the second quarter ended June 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, 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 June 30, 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.

Thank you, Jessica, and good afternoon, everyone. I'd like to open the call with a review of the highlights from a strong second quarter, as well as our positive outlook for the duration of the year. Given the trends we have seen over the first half of this year, we are increasingly confident in our ability to meet and exceed our product revenue expectations. So we are raising our annual product revenue guidance range for the full year to $175 million to $178 million, from our previous range of $172 million to $175 million. Our confidence stems from the growing number of blood centers and hospitals they're using INTERCEPT and the increasingly important role of pathogen inactivation across the globe. Most recently in Barcelona at the International Society of Blood Transfusion, or ISBT Congress, we are delighted to see key opinion leaders present on a broad range of topics relevant to the INTERCEPT blood system from platelets and plasma to INTERCEPT hybrids in complex, and red blood cells. Pathogen inactivation has become a foundational part of blood safety strategies, in addition to testing and donor deferrals. We are seeing more and more members of the global transfusion medicine community recognize this and the need in the context of pandemic preparedness. One clear example is the growing threat from dengue, a transfusion-transmitted arbovirus carried by the mosquito. Earlier this summer, both the U.S. Centers for Disease Control and Prevention and the European Centre for Disease Prevention and Control have issued warnings about the risk -- rising risk of dengue transmission. This has implications for blood safety risks and can lead to regional donor deferral requirements, which are burdensome and limit availability. The INTERCEPT blood system proactively protects the blood supply against this virus, along with many others, and can be an…

Thank you, Obi, and good afternoon to everyone. As Obi mentioned, with now more than half of the year behind us, we are increasingly confident in our sales trajectory for the full year. This is fueled primarily by continued growth in our U.S. platelet business as we have continued to increase INTERCEPT market share in this geography. As we mentioned this time last year, a key focus for our global commercial team was to return to compelling growth and ensure that we are expanding access to INTERCEPT. I am pleased to see so many geographies contributing to our strong first half 2024 growth. Of note, our Q2 performance was led by our U.S. platelet franchise, as the fundamentals of that business strengthened. INTERCEPT treated platelets remained the standard of care for platelet safety in the U.S. During the quarter, we saw steady growth across all customer segments. From an overall market perspective, based on our channel check, there was a slight increase in platelet collections and underlying hospital demand for platelets. Most importantly, with each passing quarter, the volume of real world experience with INTERCEPT grows larger and both blood centers and hospitals realized the benefits of INTERCEPT that extend well beyond mitigating bacterial risk. Moving to the international business. We are thrilled to report that, as expected, Canadian Blood Services or CVS completed implementation of INTERCEPT across its entire platelet production operation and is now at 100% passion in activation. With their platelet implementation now complete, CBS' focus is turning to their intention to validate INTERCEPT for plasma. Simultaneously, the validation efforts at Hema-Quebec continue to advance towards completion. Beyond Canada, we saw solid growth in many international regions. As Obi referenced, we recently attended the ISBT Congress. At that meeting, the strength of our international franchise was on…

Thanks, Vivek. Good afternoon and thank you all for joining us. On today's call, I'll be discussing our financial results for the second quarter of 2024, along with commentary on how those results and our financial outlook for the remainder of 2024, compared to the plan we communicated earlier this year. To start, we posted product revenue of $45.1 million in the second quarter of 2024. This represents year-over-year growth of 16% and brings the first half revenue to $83.4 million, up 20% from the first half of last year. North American platelet sales were the major contributor to our product revenue growth during the quarter. In the U.S., second quarter 2024 product revenues exceeded prior year levels by 19%. As we anticipated, sales to Canadian blood services were also extremely strong and reached 100% across their entire platelet production operation during the quarter. In EMEA, second quarter product revenues were up slightly year-over-year and up 8% compared to the first quarter of 2024. Year-over-year, FX rates were a slight headwind for the UK business of around 1%. Also for Q2, we posted IFC product revenue of $2 million, up from $1.4 million in the prior year period, driven by both the addition of new hospital users as well as increased adoption of existing hospitals. As Vivek mentioned in his comments, expanding clinician experience with the utility of IFC in massive hemorrhage has been and will continue to be key to IFC's growth trajectory. In addition to our product revenue and not included in our guidance, government contract revenue totaled $5.4 million in Q2, compared to $8.9 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 now expect our Turkish site to begin enrolling patients…

Thank you, Kevin. The Cerus team continues to advance the INTERCEPT blood system in many markets and is looking forward to the potential product approvals in the year ahead. The focused geographic expansion of our commercial effort, combined with the growing IFC business, is providing for increased confidence in how we continue to ramp penetration and increase revenue. Particularly in the case of IFC, the many positive case studies of routine use now coming from hospitals across the U.S. are validating the target product profile that we developed for IFC to address an unmet clinical need. Our safe and readily available Fibrinogen Complex product that is easy to use by the hospital transfusion service staff has found its place within hospitals and their anesthesiology and surgery teams. Our leadership team recently sat down to review where we have been, where we are, and where we're going. There's so much detail and complexity in our history that it's often easy to overlook the key achievements and what Cerus has evolved to from where it began. With INTERCEPT increasingly becoming the standard of care in multiple countries across the globe, we are committed to achieving our adjusted EBITDA targets to enable the self-funding of our product portfolio and continued geographic expansion that will allow us to realize our important mission as a company. Thank you for your continued interest in Cerus. 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. You may proceed.

Hey guys, thanks for taking questions and congrats on the strong results. Starting off, I would be curious to hear if you saw any rebuilding of inventory following your extended shelf life. As a follow-up, where do you stand on further examining platelet shelf life?

Thanks, Ross. Vivek, would you mind taking this?

Sure, no problem. So we in terms of extending shelf life, we anticipate filing later this year for the 18-month shelf life, so to get back to where we were prior to the dating issues. And in the quarter, we didn't see any significant rebuilding of inventories. What we continue to see driving underlying growth was really just INTERCEPT [Technical Difficulty] and then distributed products, so there was not any material inventory rebuild at the customer level in the second quarter.

Okay. Got it. And then looking at Hema-Quebec, could you provide some more color on exactly where they stand in the validation process and when we could start to see some incremental revenue from them?

Sure. So their validation is effectively complete. They are going to follow a path that's similar to what happened with Canadian Blood Services where they'll have a small portion of their overall inventory that's pathogen reduced, and then upon sort of successful completion of that trial phase move towards full implementation. So we're anticipating that initial piece of their inventory to be passed and reduced in calendar year 2025 with 2026 being the year where we go towards full implementation.

Great. Thanks for taking our questions, and congrats again on the results.

Thank you. Our next question comes from Jacob Johnson with Stephens. You may proceed.

Hey, good afternoon. And I'll add my congrats on the quarter. And maybe starting with the highlight of the quarter, just the positive EBITDA we saw in the quarter. Kevin, as we think about the back half of the year, I know you're talking about breakeven for the fiscal year, but presumably we should see revenues up in the back half of this year. Is there any way or any reason why we wouldn't see better revenue in the back half continue this trend of positive EBITDA that you saw in 2Q?

Yes. Thanks. You're absolutely right as our guidance suggests, we do expect pretty strong growth in the back half of the year. In addition, and as stated in our prepared remarks, we do expect fairly stable gross margins for the balance of the year and continue to expect that we'll get increasing leverage from our operating expenses. So all three of those suggest strength on the non-GAAP adjusted EBITDA results for the back half of the year and give us a lot of confidence in our statements that will achieve our goal.

Got it. Thanks for that, Kevin. And then maybe for Vivek on IFC, I heard you mention a couple things. Just as we think about the growth outlook for that product line, I'm curious about how much of an opportunity there is from expanding within your current hospital customers that you're in today and doing more with them. How impactful could new hospital wins be? And then I'm just curious too, on the capacity side, it sounds like some more blood centers to come online. Is that something that's maybe constraining you, in particular geographies? If you could kind of unpack some of those dynamics. Thanks.

Yes, sure. I'd be happy to, and certainly pleased follow-up if, right, you require more clarification. So, starting with kind of growth from depth with existing customers as opposed to growth with new sort of de novo customers, there's significant opportunity in both. We're just starting to get our first handful of customers that are fully 100% converted to IFC. So same-store sales, if I can express it that way, it provides meaningful opportunity for growth. But we're really early days in terms of customer acquisition. So the fact is that vast majority of candidate hospitals to use IFC that haven't started yet is larger than our current user base. So we're -- it's really a both and approach in terms of maintaining sustained growth. We are seeing a marked increase in demand. And as we've talked about in prior calls, we're always looking to make sure that supply stays ahead of demand, not too far out front of it, but such that it's sufficient supply, so that we don't have to worry about constraining customers. And we now have four blood center production partners who receive BLA, so they can transport product across state lines. We're anticipating two more BLAs here in the very near future. And that combined production capacity supported by the BLAs, we believe, provides sufficient volume to support our growth expectations both through the balance of the year and through 2025. We'll continue to monitor and track that closely. The other thing that's encouraging, and I think I mentioned it earlier is that we're seeing blood centers, we're receiving inbound inquiries from blood centers who are hearing from their key hospital customers that they want to try and see, and they're keen to be the producers who provide them that product. So I anticipate over the near and mid-term we're going to see a pretty significant step up in terms of number of production partners. So on balance, it's still early days, but we're really encouraged principally by the clinical value and utility of IFC and the fact that physicians are, in fact, validating our value proposition.

Sounds like a bunch of white space. Good luck with that, Vivek, and thanks for taking the questions.

Great. Thank you.

Thank you.

Thank you. Our next question comes from Josh Jennings with TD Cowen. You may proceed.

Hi guys, this is Eric on for Josh. Thank you for taking the question. As a follow-up on IFC there, congratulations on the progress. If I could -- I was just wondering if you could lay out sort of roadmap of how you're thinking about growth for IFC in 2025. I think the Street has total Cerus sales at the 190 to 200 ballpark. Could IFC be 10% of sales next year? Is that you think a good starting point? Just curious with all the growth here. Thanks.

Kevin, I'll defer to you in terms of quantifying the number. I certainly know the expectations we have in the event.

Well, I mean, clearly we're not providing guidance for 2025 here, but I think you can speak to sort of the growth opportunity that's in front of us and sort of calibrate our range; obviously we're guiding Eric, as you know, $8 million to $10 million for this year. And there is, as we just discussed a lot of white space in front of us. Anything else you'd add, Vivek?

No. I mean, once we get to 2025 numbers here in future quarters, I think that's kind of a rough rule of thumb. I think that percentage is probably in range we've got. The key focus for us has been as we support demand with increased supply and capacity, really working closely with our blood center production partners to ensure that they can produce sufficient volume that allows us to really push on the demand piece and grow unconstrained. And we feel confident that we're putting the building blocks in place to be able to do that. The peer-to-peer interaction has really ramped up in the last quarter. And we anticipate as we get through the summer and into the fall conference season, we're going to have many more opportunities to share the -- with the single center and then the developing clinical evidence we're getting and we anticipate that we'll start to drive more demand as well. And now we're -- we have a fully trained and staff sales organization who cultivated existing customers. So a lot of the investments, a lot of the things that we had put into place are really now starting to bear fruit. And so we anticipate that IFC not just for 2025 but really for the next few years will be a meaningful contributor to allowing us to continue to grow, to drive compelling growth on the top-line.

And just if I could, I'd be remiss if I didn't say that we expect that growth to be largely leverageable, right. So not all the hot of incremental investments that Vivek just mentioned that we've made those in the past and then how bearing fruit. So I think that bodes well for the bottom line impact as well.

Understood. That makes sense. And for the INTERCEPT red blood cell program, I was hoping to hear an update on your progress in the EU there. Just what are the remaining steps between where we stand now and a potential clearance? I think last quarter you mentioned that you guys had completed -- a complete response with the notified body. I was just wondering what the update is there. Thank you.

Yes, Eric. So just to remind you and others about the process, so I have -- we still have to hear back from our competent authority, which is the CBG-MEB based out of the Netherlands. We still have not heard back from them yet. And it may be due to the summer holidays, so we do expect to hear something after the European holidays are over so possibly before the end of the quarter. And then once they get back to us with sort of their definitive opinion, then it goes back to our notified body, which is TUV, and then that moves on to an approval decision. So I think at this point in time, its -- we're still waiting for the CBG-MEB response. But as you mentioned, we did feel like we provided a complete response to their questions earlier in the year.

Understood. Thank you guys for taking the questions.

Thanks, Eric.

Thank you. [Operator Instructions]. One moment for question. Our next question comes from Mark Massaro with BTIG. You may proceed.

Hey guys, this is Vidyun on for Mark. Thanks for taking the questions. To understand that the business is stabilizing here off of 2023 and sort of returning to growth. Just how are you thinking about sources of upside to the 2024 guide? Just any additional variables to consider like restocking inventory or recovery of platelet donors. Thanks.

Thanks, Vidyun. Vivek, would you like to handle this one as well?

Sure, I'd be happy to. So in terms of how our outlook for the full year and our confidence sort of underpinning the raise in full year guidance. So we are not currently forecasting any rebuild of customer level inventory to be a driver of the revenue upside. We want to make sure that we can maintain healthy safety stock at our customers, but we're not anticipating an inventory rebuild at this time. It's kind of a one-time revenue driver. We are seeing signals of a stabilizing collection and utilization market, so increased hospital demand for platelets and then some stabilization at the blood center level in terms of collections. But what's really driving the growth is a continued enthusiasm for an adoption of the INTERCEPT platelets and our ability to see those products produced and ultimately distributed to hospitals, so. And then in addition, as we talked about in some of the prior questions, the demand on the IFC side continues to grow, and in parallel, our ability through our production partners to produce supply is growing as well. So we see continued growth in the IFC franchise in the second half of the year. So it's really the combination of those factors that give us confidence in our ability to continue to see top-line progress.

Perfect. Understood. And then I think I heard you guys briefly touch a little bit on the next-gen illuminator. So could you just help us think about some of the features and help us sort of quantify the planned improvements there? And if you could also remind us what the thinking is on in terms of timing of the regulatory submissions.

Yes. Thanks, Vidyun. So one of the key things we are trying to achieve with the next-gen illuminator, we call it INT- 200 is that it just would increase the operational ease of use for blood center customers and also reduce the space that they needed because a lot of these blood centers are very space constrained. So right now, the current illuminator INT-100 will take some space of three INT-200. So it really is a space saver for these blood centers. But it's also a lot easier to use with regard to sort of the graphical user interface and just sort of the reliability of the system. So as I mentioned in the prepared remarks, we're really happy to see sort of the feedback from customers at ISBT in Barcelona. It was the customers who we engaged early on in the development of this device and they were really happy with how their feedback led to this final result. We are looking to file for approval here in the relatively near-term, and it's roughly going to be about 180-day review cycle for CE mark approval in Europe. So that product we expect to launch in 2025.

Understood. Thanks for taking the questions.

Thanks, Vidyun.

Thank you. Thanks. Our next question comes from William Bonello with Craig-Hallum Capital Group. You may proceed.

Hey guys, just wondering if you can give an update on international and any sort of pending opportunities outside of North America.

Yes. Thanks, Bill. Vivek, would you mind taking this as well?

Sure, happy to. So we have, and I think we've talked about this previously, but we continue to make good progress on our joint venture in China. We anticipate learning by the end of this year whether or not there'll be a need for a local clinical study. But the underlying clinical demand and interest in INTERCEPT remains quite high in that geography. So that will be that's a fantastic growth opportunity for us really materializing towards the back part of this decade. Similarly, the strong distributor partner in the Middle East, there's a significant push towards healthcare investment in the kingdom of Saudi Arabia and we're seeing strong growth there. And a lot of practice patterns in the Middle East here what happens in the U.S. since the -- they fall sort of the ABB FDA standards. And then we continue the single largest unit opportunity in Western Europe is Germany. And what's encouraging there is the largest blood centers and hospitals are going through the marketing authorization and marketing the regulatory process. So those are sort of three snapshot examples of geographies where we think can drive significant international growth. We have a strong team on the ground in EMEA and they really have been executing well through the first half of this year. So the international franchise certainly is a significant component of our future growth plans. It's also going to be the initial commercial geography for the products in our pipeline. So it's where we'll introduce the LED illuminator first as well as INTERCEPT red cell. So really continues to be a valuable part of our franchise.

And when you think about some of those opportunities and as you start to look out sort of to next year and you think about the magnitude, I mean, are these the kinds of things that could actually drive an accelerating growth rate for you, or do you look at it as more no, we have to add some of these big old non-North American clients to just sort of keep up with the growth that we got out of adding Canada and whatnot over the past couple of years.

It's a little bit of both, candidly, because part of it is a function of the size of the geographic opportunity and the potential ramp. If you look in our history, you have some geographies that are significantly sized, but they have more of sort of vulcanized customer base, and so it takes a while to get on Board. Other countries that have significant volume have a single decision maker, and once they decide to go, then it really becomes about operations and partnering with our deployment organization. And in those geographies I mentioned, there's kind of a mix of both customer types, but part of it is who goes when and how quickly we can ramp up. That's why in parallel, I mentioned -- I referenced it in the context of IFC, but also across our platelet franchise, we're trying to make sure that we have sufficient supply to stay ahead of demand. But I think you're going to see certainly in the U.S., the IFC franchise is a significant growth opportunity. But internationally, some of these geographies that they come on, it's not merely sort of maintaining our growth rate, but if they go well, we could certainly see some upside there.

Okay. Thank you. Very helpful.

Thanks, Bill.

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

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 through quarterly calls and upcoming investor conferences. Thanks very much.

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