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Cerus Corporation (NASDAQ: CERS) today announced financial results for the third quarter ended September 30, 2012.
Third quarter 2012 results:
Product revenue of $8.3 million, a 6% increase from the $7.8 million recognized during the third quarter of 2011;
No government grant revenue recognized during the third quarter of 2012, compared to $1.5 million recognized during the third quarter of 2011;
Operating expenses of $8.2 million compared to $7.2 million incurred during the third quarter of 2011; and
Cash of $26.7 million at September 30, 2012.
2012 year-to-date results:
Product revenue of $26.2 million, a 26% increase from the $20.7 million recognized during the first nine months of 2011;
Government grant revenue of $0.1 million, compared to $1.9 million recognized during the first nine months of 2011; and
Operating expenses of $24.5 million compared to $22.9 million incurred during the first nine months of 2011.
”Based on recent positive discussions with the FDA, Cerus now plans to move forward with a modular Premarket Approval Application for the INTERCEPT Blood System for plasma in the United States,” said William ‘Obi‘ Greenman, president and chief executive officer of Cerus Corporation. “With regard to our commercial operations, demand for INTERCEPT kits continues to be healthy, and we remain confident in our guidance for 2012 for revenue of $34 million to $36 million.”
INTERCEPT plasma PMA modular submission
Recently, Cerus discussed with the FDA the clinical requirements for proceeding with a Premarket Approval Application, or PMA, for the INTERCEPT plasma system. Based upon those discussions, Cerus believes that existing clinical data is sufficient to begin the PMA submission process and intends to proceed with a modular PMA, pending FDA approval of an application shell. The modular PMA process is a compilation of sections or "modules" submitted at different times that together become a complete PMA. The modular approach increases the likelihood that an applicant will be able to resolve deficiencies identified by the FDA earlier in the review process than would occur with a traditional PMA application.