Cerus reports Q2 EPS (7c), consensus (6c)

Reports Q2 revenue $47.7M, consensus $41.8M. “We are pleased with our recent progress for the INTERCEPT Red Blood Cell program in both the EU and U.S.,” said William “Obi” Greenman, Cerus’ president and chief executive officer. “During the second quarter, we gained additional clarity to a potential CE Mark approval decision in the second half of 2024 and a top-line data readout from our U.S. Phase 3 ReCePI study expected in the first quarter of next year. Given ongoing enrollment in RedeS, our second U.S. Phase 3 study, we plan to begin a modular premarket approval (PMA) application submission to FDA in the second half of 2025, with a final PMA module submission planned for the second half of 2026. On the commercial front, with many of the challenges of the first half of the year behind us, we remain confident in our expectations for growth during the rest of this year and into 2024. We also continue to be committed to achieving adjusted EBITDA breakeven this year. Given some recent ordering pattern modifications related to a temporary INTERCEPT kit shelf-life change in the U.S. and platelet collection dynamics in parts of Europe, along with the impact of recent Russia sanctions, we are adjusting our full-year 2023 product revenue guidance down to a range of $160M to $165M. Despite the adjustment, we are not seeing a change in market share, and we believe new customers and new geographies will fuel growth going forward.”