Cerus Corporation Announces Second Quarter 2023 Financial Results

About this update from Cerus Corporation

[{"type":"text","content":" CONCORD, Calif.--(BUSINESS WIRE)--\nCerus Corporation (Nasdaq: CERS) today announced financial results for the second quarter ended June 30, 2023.\n\n\nRecent highlights include:\n\n\n\nSecond quarter 2023 total revenue of $47.7 million was comprised of total product revenue of $38.9 million and government contract revenue of $8.9 million.\n\n\n\nReceived positive feedback for INTERCEPT Red Blood Cells CE Mark submission in clarification meeting with EU competent authority, the Dutch Medicines Evaluation Board (CBG), supporting possible CE Mark approval decision under the EU Medical Device Regulation (MDR) in the second half of 2024.\n\n\n\nPlanned completion of Phase 3 ReCePI study enrollment in cardiovascular surgery patients this year, with top-line data readout expected in Q1 2024.\n\n\n\nAwarded an additional $8.7 million in funding from the U.S. Department of Defense for continued development of lyophilized INTERCEPT Fibrinogen Complex (LyoIFC), increasing total contract value to $17.8 million.\n\n\n\nAdjusting full-year 2023 annual product revenue guidance to the range of $160 million to $165 million from the prior range of $165 million to $170 million given the expected impact of a temporary reduction in U.S. platelet kit shelf life on customer ordering patterns, reduced platelet collections in key regions of EMEA, and new Russia sanctions.\n\n\n\nCash, cash equivalents, and short-term investments were $84.5 million at June 30, 2023.\n\n\n\n“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.”\n\n\n“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 a...

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