CERUS CORP Q3 FY2024 earnings call

• Commercial Performance: US platelet franchise strong, IFC business gaining momentum with new BLA approvals; international markets had seasonality but progress in key geographies.
• Development and Regulatory: Collaborating with TUV SUD on CE mark submission for Intercept RBCs; extending BARDA partnership for Intercept RBCs; completed LED Illuminator regulatory submission in Europe.
• Public Health: Rise in arthropod-borne viruses like EEEV and OROV, highlighting need for precaution and preparedness to mitigate potential blood supply disruptions.

Product revenue for Q3 2024 was $46 million, a 16% year-over-year growth. North American platelet sales were the major contributor. IFC product revenue was $2.3 million in Q3 2024, up from $1.7 million in the prior year period, driven by standing orders and depth within existing accounts. North American platelet sales in the US third quarter 2024 exceeded prior year levels by 17%, with Canadian Blood Services at 100% entering Q3. EMEA third quarter product revenues were relatively stable, with FX rates providing a slight tailwind. Government contract revenue in Q3 was $4.6 million, down from $7.5 million in the prior year period due to completion of the US Phase III recipe clinical trial.

• Raised full year 2024 product revenue guidance to the range of $177 to $179 million, up from prior range of $175 to $178 million.
• Raised the bottom end of full year 2024 IFC revenue guidance to a new range of $9 to $10 million from $8 to $10 million.

• Potential disruption of blood supplies due to arthropod-borne viruses like EEEV and OROV, which could impact local blood supplies.
• Uncertainties in regulatory approvals and submissions, including for Intercept RBCs and LED Illuminator, which could delay product launches or market access.

Q: 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?

A: Thanks, Matthew. Vivek, do you want to handle this? Sure, I'd be happy to. Thanks for the question. We continue to work with blood 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.

Q: 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.

A: Yeah, thanks, Colin, for the question. Vivek, would you mind taking this one as well? Sure, I'd be happy to. So, to answer the question, growth is coming both from deepening 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, 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 with significant runway for this therapeutic category.