Good day and thank you for standing by. Welcome to Cerus Corporation Second Quarter 2023 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 turn the call over to Jessica Hanover, Vice President of Corporate Affairs.

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's Chief Operating Officer; Kevin Green, Cerus' Chief Financial Officer. Cerus issued a press release today announcing our financial results for the third quarter ended September 30, 2023, 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 updated 2023 product revenue guidance, our Q4 adjusted EBITDA commitment and our expected expense, inventory and margin profile, expected future growth and our growth trajectory, expected future product sales, the availability and related timing of data from clinical trials 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, and under Risk Factors in our Form 10-Q for the quarter ended September 30, 2023, 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. We'll begin today with opening remarks from Obi, followed by Vivek to discuss recent business highlights, Kevin to review our financial results and expectations for the rest of 2023 and Obi with closing remarks. 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 provide some commentary about the progress we are continuing to make this year, both on the commercial front and in the pipeline. During the third quarter, we reached and surpassed the $15 million mark for sales of transfusable doses for INTERCEPT kits since our initial launch of the system. I'm very proud of this important milestone, particularly with respect to the global patient impact this figure represents and the thousands of patients in countries around the world that receive INTERCEPT-treated components every day. Importantly, as we cross this $15 million kit sales milestone, we are also approaching a milestone of adjusted EBITDA breakeven in this quarter, even as we invest in the geographic expansion of our business, and our R&D pipeline to sustain our growth long term. Indeed, we are pleased to report that our top line performance stabilized in Q3, returning to levels of Q3 2022 and showing growth from the prior quarter. We expect to see our growth trajectory accelerate into the double digits as we exit 2023 and move into 2024. Three weeks ago, I and many colleagues and customers attended our industry's top conference, the AABB Annual Meeting in Nashville, the first time it has been held in person since 2019 and notably since the FDA guidance for bacterial safety went into effect now two years ago. I was particularly struck by the pervasive and positive sentiment around have reduction. The INTERCEPT Blood System for platelets has clearly been established as an essential tool for safeguarding the blood supply here in the US. Meeting sessions covering IFC were also well attended with standing room-only audiences and overall awareness and interest in the product was very high. In the Sunday morning oral session scheduled by ABB…

Thank you, Obi, and good afternoon, everyone. As Obi mentioned, we posted a sequential uptick in total product revenue for the third quarter of 2023, returning to the levels of Q3 2022. On a global basis, we saw our platelet franchise stabilized in the third quarter and are now witnessing a return to growth as we move through the fourth quarter and towards year end. While some headwinds persist, I'm encouraged by the momentum we see with our global sales team and their continued engagement with our blood center and hospital customers with a focus on ensuring that patients gain access to the safest blood components possible. With respect to the recently completed third quarter, we experienced a strong bounce back in our US platelet franchise. Inventory levels across our key US customers have stabilized, and we are seeing a small upward trend in platelet utilization. As we work to resolve product dating issues, we are seeing a return to more consistent ordering patterns. Our deployment, customer care and supply chain organizations continue to work closely with the operations groups at our blood center partners to ensure that hospitals remain well-serviced and that ultimately, pathogen reduced platelets are getting to patients in need. As Obi noted, the prevailing sentiment around pathogen-reduced platelets at the recent AABB meeting was quite positive and Intercept's leadership position in platelet safety in the U.S. continues to gain strength with each passing quarter. Outside of the US, we have seen platelet volumes in France and Belgium stabilized, consistent with the first half of the year. Recall that these markets are 100% INTERCEPT countries, and we continue to receive their high praise for the quality and efficacy of our technology. We are seeing good growth in new regions such as the Middle East and Canada. Geopolitical…

Thank you, Vivek, and good afternoon to everyone listening. On today's call, I'll be discussing our financial results for the third quarter as well as our product revenue guidance for this. I'm also going to spend some time discussing our unwavering commitment to achieving adjusted EBITDA breakeven in Q4 of this year, and we'll lay out the detailed success factors that will drive our expected achievement of that goal. I'll start with our top line revenue results. We posted third quarter 2023 product revenue of $39.8 million with a return to the historical levels posted during the third quarter of 2022 and up 2% sequentially from Q2. In the US, product revenues were down 6% year-over-year, but sequentially, we saw 3% growth from Q2. In EMEA, product revenues were up 4% year-over-year and around 1% compared to the second quarter of this year. Year-over-year, FX rates provided a benefit for the EMEA business of around 800 basis points. In addition to our product revenue and not included in our guidance, government contract revenue was up 10% and totaled $7.5 million in Q3, compared to $6.8 million for the prior year period. Included in our government contract revenue are the revenues recognized as reimbursement under our contract with BARDA, our agreement with the FDA to further hold blood pathogen reduction, and our milestone-based agreement with the US Department of Defense from LyoIFC. Let's now turn to our product gross profit and gross margins. Our third quarter product gross profit was $21.8 million, consistent with the prior year period. Product gross margins for the quarter were 54.9%, fairly stable when compared to the prior year and Q2, especially when considering the impact of FX rates. We expect the remainder of the year to be reasonably consistent with current margin levels. Moving on,…

Thank you, Kevin. While 2023 has been a challenging year, we remain confident in both the near-term growth trajectory and the longer-term prospects for Cerus. During the third quarter, we started to see a return to topline growth, which continues as we move through the fourth quarter. We made strong progress on key pipeline activities, which bodes well for future technology adoption. Finally, from a bottom-line perspective, thanks to the entire team's focus, we are poised to hit our goal of adjusted EBITDA breakeven in the fourth quarter of this year. The Cerus team has proven quite resilient in the face of many challenges, and I appreciate everyone's unwavering focus on our mission to help safeguard the global blood supply. Thank you for your continued interest in Cerus. I will now turn the call over to the operator for questions.

Thank you. I will now open the line for questions. [Operator Instructions] And our first question is from the line of Matt Blackman with Stifel. Please proceed.

Hi, this is Emily on for Matt. Just on the red blood cells in Europe, wondering if we're still on track there for second half 2024 CE Mark? And if so, just how we think through the adoption curve for that product, in particular, places where you have strong presence now like France and Belgium, what does the demand look like there? Thanks.

Thanks a lot, Emily, for the question. So, we -- as we discussed on the last call, we are planning to respond to the CBG MEB questions, which is our competent authority in The Netherlands in Q4 of this year. And then we are still on track for a possible approval in the second half of next year. As it relates to demand, we've actually done a number of interviews with various customers who are currently using the INTERCEPT platelet system and there is strong interest from our existing customers, particularly the focus on replacing gamma radiation of red cells, which leads to a shortened shelf-life of red cells of about two weeks compared to a normal 42-day shelf life for red cells. And so we're looking to roll out that product then post-approval initially in the context of a hemovigilance study that's being required by TEVR, our notified body in Europe. And then ultimately to a broader rollout across multiple countries. Just to remind you, there are going to be some in-country approvals required in countries like France, Germany and Switzerland. The CE mark will allow us to commercialize elsewhere without additional regulatory approvals.

Great. Thanks. And just one more, if I could. On the platelet rollout in other geographies, wondering if there's any update on Germany and kind of how far along you are there? And then the longer-term prospects, China, South Korea, et cetera.

Thanks for that question. So obviously, Germany has been a long story. I think they are very influenced by what's happening around them, specifically in the DACH region. You've got Austria now, which is almost at 100% INTERCEPT platelet Switzerland, obviously, France. And so we are continually filing MAAs in partnership with our blood center partners in Germany, and those are getting approved. Still working through sort of the reimbursement/value justification at the hospital level, but we are optimistic about 2024 and 2025 and beyond, just given the overall use of INTERCEPT platelets across Europe. Then beyond Germany, obviously, a big focus of ours is the approval process in China and NMPA submission and review is still underway. Nothing has really changed from the previous quarter comments on that, but we are on track for what we expected out of that process. And then obviously, a number of different opportunities around the globe that will come on when we have something more to say.

Great. Thank you.

Thanks, Emily.

Thank you. [Operator Instructions] One moment for our next question and it's from the line of Jacob Johnson with Stephens. Please proceed.

Good afternoon. This is Mac on for Jacob. Just quickly, I appreciate the directional commentary on 4Q in 2024. And understanding it's like too soon to guide here but how much of a headwind will inventory management be in 2023? And just kind of thinking about this from a comp perspective, if these revenues return next year?

Yes. Thanks for the question. I don't know, Vivek, would you like to try and address that? Just I think the question relates to the current shelf life of the kits and sort of our progress on working through that with our customers.

Sure, I'd be happy to. In terms of the shelf life serving as a headwind through 2024, as we indicated previously, we believe most of those issues are now behind us and that platelet levels are stabilizing both from a collections perspective, but also from an inventory management perspective at the -- at our blood center customers. So we don't anticipate that being a headwind as we enter into 2024. And obviously, we'll continue to work to increase shelf life on a going-forward basis as we get real-time data. So as we look towards the finish of this quarter and the beginning of the next calendar year, we anticipate that those headwinds have been largely believed at this point.

Thank you. And just quickly, it sounds like you're making good progress on IFC as well. With the commercial strategy in place, how should we think about the uptake of that product in the coming years? And what are some of the key milestones you're keeping an eye on?

Yes. Thanks, again, for that question. Vivek, I think that's up your alley as well. So..

Sure, yes, happy to address that. One of the key milestones was getting under contract with large blood centers here in the US. We're currently under contract for IFC with blood centers that represent roughly 60% of the cryoprecipitate market in the US. The key thing now is just continuing to translate clinician level demand into committed hospital interest and having the ability for those hospitals to receive product from their blood supply the current good supplier is a huge enabler in that regard. So we feel pretty enthusiastic about that business, given the combination of these key contracts that have not been executed a fully staffed and trained hospital sales force that's getting in and having a number of meetings with clinicians and directly with hospitals. And then the continued sort of clinical uptake and peer-to-peer marketing opportunities we see as we bring more hospitals on board in terms of IFC users. So on balance, the combination of all those factors leads us to be very optimistic about this business heading into the next calendar year.

Thanks for taking my questions.

Thank you. [Operator Instructions] I don't see any further questions in queue. I would like to turn the call over to Obi Greenman for closing comments.

Well, thank you again for joining us today and for your interest in Cerus. We look forward to updating you on our continued progress this year and next. Thanks very much.

And with that, we thank you for participating in today's conference. You may now disconnect.