Navidea Biopharmaceuticals, Inc. (NYSE MKT: NAVB), a biopharmaceutical company focused on precision diagnostic radiopharmaceuticals, today announced business highlights and consolidated results for the second quarter ended June 30, 2013.
“The most significant event for Navidea this quarter was the launch of our first product, Lymphoseek ®. Our launch is off to a great start and we are advancing our innovative portfolio with the initiation of the Phase 3 study of NAV4694 in Alzheimer’s disease. During the second half of 2013, we expect to further enhance our long-term growth with additional value enhancing pipeline events,” said Dr. Mark Pykett, Navidea CEO.
“We are tracking well in the initial weeks of launch and feel strongly that we have the right strategy to drive adoption. The commercialization plan we are executing with our partner is on target based on key measures of success: repeat and multiple dose ordering, adoption at top-tier medical institutions, formulary placement, excellent product performance, and high customer satisfaction,” added Dr. Pykett. “We are looking forward to the expected pass-through C code to further facilitate reimbursement starting in the fourth quarter.”
With the objective of strengthening the existing label and as a result of a recent constructive meeting with the U.S. Food and Drug Administration (FDA), Navidea announced today that it is formally closing its Phase 3 clinical study in subjects with head and neck cancer. The Company plans to submit a supplemental New Drug Application (sNDA) later this year.The Company also continues to make progress related to Lymphoseek outside the U.S.; Navidea received positive Day 120 feedback on its Marketing Authorization Application from the European Medicines Agency and expects a positive opinion by year-end 2013. Second Quarter 2013 Financial Results For the quarter ended June 30, 2013, Navidea reported a net loss attributable to common stockholders of $10.3 million, or $0.09 per share, compared with a net loss attributable to common stockholders of $5.9 million, or $0.06 per share, for the same period in 2012. For the six months ended June 30, 2013, Navidea’s net loss attributable to common stockholders was $17.6 million, or $0.15 per share, compared to a net loss attributable to common stockholders of $12.9 million, or $0.14 per share, for the same period in 2012.