Product Revenue Guidance

FY 2025

no prior guidance

$194M to $200M " "

no prior guidance

IFC Revenue Contribution

FY 2025

no prior guidance

$12M to $15M "

no prior guidance

Non-GAAP Adjusted EBITDA

FY 2025

no prior guidance

positive " "

no prior guidance

Gross Margins

FY 2025

mid-50s "

mid-50s "

no change

Operating Cash Flow

FY 2025

no prior guidance

annual positive "

no prior guidance

IFC Demand and Production Challenges

Consistently strong IFC demand was emphasized in Q2, Q3, and Q4 2024, with multiple questions noting robust revenue growth, expanding hospital orders, and production capacity challenges that were being addressed via additional BLA approvals and ramp‐up efforts. " " " "

In Q1 2025, Cerus reported strong and growing demand with U.S. IFC sales increasing ($3M vs. $1.9M previously) while noting that seven of eight production partners now have BLAs. The ramp‐up in production continues, with new interest from blood centers also emerging. " "

Steady and positive demand remains while production capacity is being actively expanded. The number of approved partners has increased, showing a continued emphasis on addressing capacity constraints.

Regulatory Approvals and Product Milestones

Prior quarters (Q2–Q4 2024) discussed regulatory submissions for the INT-200 device and INTERCEPT RBC system, with emphasis on awaiting feedback or pending approvals, along with planned launch timelines (e.g. PMA submissions in 2026) and some European regulatory uncertainties. " " " "

Q1 2025 highlights early CE Mark approval for the INT-200 device and ongoing reviews for the RBC system. Cerus now sees positive momentum from rapid regulatory milestone achievements, while still acknowledging the dual review process and associated uncertainties. " " "

Improved sentiment driven by accelerated approvals for key products; regulatory milestones are being achieved earlier than expected even though some uncertainties (especially for the RBC system) remain.

Expansion of International Markets

Earlier calls, especially in Q2 and Q4 2024, provided detailed discussions on expanding into markets such as China, Brazil, Europe, and the Middle East, supported by emerging distribution data and partnership details. " " " "

Q1 2025 provided less emphasis on markets like China and Brazil. The discussion focused on Europe’s modest revenue decline and generalized international market engagement, with no detailed rollout plans for previously mentioned emerging geographies. " "

Reduced focus on explicit international expansion details; compared to earlier periods, Q1 2025 reflects a potential shift toward consolidating existing markets rather than new, detailed international rollouts.

North American Revenue Growth and Macroeconomic Risks

Q2, Q3, and Q4 2024 discussions highlighted strong North American performance (growth rates between 17% and 23%) and noted macroeconomic risks such as FX impacts and geopolitical uncertainties, though these were not a dominant theme. " " " "

Q1 2025 reported 22% growth in North American product revenue driven by robust U.S. platelet sales and increased IFC demand, while still acknowledging broader geopolitical and macroeconomic uncertainties. " "

Continued robust growth remains a central theme. While external risks are acknowledged, the sentiment remains optimistic with strong performance figures pointing to resilience.

Financial Performance and Operational Leverage

Q2–Q4 2024 earnings calls emphasized steadily improving financial metrics, including positive adjusted EBITDA, improved operating cash flows, narrowing net losses, and better gross margins. " " "

In Q1 2025, Cerus reported a positive adjusted EBITDA (albeit modest) along with improved gross margins (rising to 58.8%, up from 55.4%), increased product revenue, and steady cash flow improvements. " "

Steady improvement is consistent across periods with incremental gains in margins, EBITDA, and cash flow, reinforcing operational leverage and financial discipline.

R&D Expense and Government Funding Dependency

In Q2 and Q3 2024, there were discussions highlighting some uncertainty around R&D expense guidance as well as reliance on BARDA funding to support product development initiatives (e.g. the lyophilized IFC project and LED illuminator work). " "

Q1 2025 reported an increase in R&D expenses (from $14.5M to $16.6M) and maintained the reliance on government funding (BARDA) to support new product development, although it did not explicitly mention uncertainty regarding guidance. "

Reliable reliance on BARDA continues, with R&D spending increasing modestly. The tone has shifted toward a more stable view, with less explicit uncertainty than in earlier periods.

U.S. Platelet Market Emphasis

Across Q2, Q3, and Q4 2024, the U.S. platelet market was consistently highlighted as a core strength, with wide adoption rates in hospitals and strong revenue contributions. " " " "

Q1 2025 maintained this narrative, noting that INTERCEPT-treated platelets remain the standard of care and contributed significantly to the 22% North American revenue growth, with no indication of diminished focus. " "

Consistent focus remains on the U.S. market with a positive tone; there is no diminished emphasis and the growth narrative continues strongly.

LED Illuminator Challenges

Q2 and notably Q3 2024 included discussions about the LED illuminator, addressing concerns over slightly higher COGS and margin neutrality along with staggered launch timelines for Europe and the U.S.. " " " "

In Q1 2025, the focus shifted to positive early regulatory approvals (CE Mark) and excellent initial customer feedback, with no discussion of margin or delay challenges. " " "

Reduced focus on challenges: Earlier concerns about margins and delays have been largely mitigated in Q1 2025, demonstrating improved sentiment and more favorable regulatory outcomes.

Supply Chain and Production Ramp-Up

Q2 2024 highlighted proactive steps to secure production capacity via multiple BLAs and monitoring supply-demand balance. Q3 and Q4 2024 also touched on supply chain efficiency improvements and tactical ramp-ups to meet increased IFC demand. " " "

Q1 2025 reiterated that production ramp-up is proceeding well, with blood center partners expanding output and no significant bottlenecks reported. The company remains confident about meeting growing demand. " "

Consistently positive management of the supply chain and production ramp-up is maintained; improvements are evident year-over-year with increased partner approvals and steady scaling.

Regulatory and Production Challenges & Uncertainties

Earlier periods (Q2–Q4 2024) balanced positive product milestones (like BARDA contracts and regulatory submissions) with lingering regulatory uncertainties (e.g., European reviews, RBC submissions) and production issues (e.g., episodic discard rates, FX risks). " " " "

Q1 2025 continues to balance record product milestones—such as early INT-200 approval and robust IFC production—with acknowledged uncertainties including pending RBC system reviews and macroeconomic risks. The overall tone remains optimistic despite these challenges. " " "

Evolving sentiment: While uncertainties remain, improved milestones and stronger financial and production performance have shifted sentiment toward optimism, even as regulatory review processes and external risks are still in play.