Navidea Biopharmaceuticals, Inc. (NYSE MKT: NAVB), a biopharmaceutical company focused on precision diagnostic radiopharmaceuticals, today announced business highlights and consolidated results for the third quarter ended September 30, 2013.
“We view the third quarter as continuing on the track toward success that we’ve envisioned for several years now,” said Dr. Mark Pykett, Navidea CEO. “We are pleased with the initial stages of Lymphoseek ® commercialization at launch and believe that Lymphoseek continues to hold the promise to become the standard of care in lymphatic mapping. In the first several quarters of launch, we have indicated that success would be measured primarily by important qualitative evidence of Lymphoseek adoption, especially in advance of reimbursement. We believe we are seeing good momentum in many of these key parameters. Our optimism stems from witnessing evidence of progress in many positive measures, including multi-fold increases in unit sales quarter over quarter, a high frequency of repeat and multi-dose ordering, an increase in total accounts ordering, strong new user accrual, and encouraging formulary placement activity. We anticipate further growth in the current quarter and going forward facilitated by the October 1 st implementation of the unique Lymphoseek reimbursement code received from the Centers for Medicare & Medicaid Services (CMS).”
Dr. Pykett added, “Our recent equity offering enhances our ability to advance several efforts underway, including commercial opportunities for Lymphoseek outside the U.S., the continued development of our innovative neurodegenerative imaging portfolio, and further evaluation of our recently announced Manocept TM platform initiatives. During the fourth quarter of 2013, we expect additional value enhancing events, including submission of the Lymphoseek sNDA, EMA feedback on our Marketing Authorization Application in Europe, initiation of the NAV5001 Phase 3 trial in Parkinson’s disease and additional disclosures regarding the advance of our Manocept platform.”
Third Quarter 2013 Financial ResultsFor the quarter ended September 30, 2013, Navidea reported a net loss attributable to common stockholders of $11.3 million, or $0.09 per share, compared with a net loss attributable to common stockholders of $9.1 million, or $0.09 per share, for the same period in 2012. For the nine months ended September 30, 2013, Navidea’s net loss attributable to common stockholders was $28.9 million, or $0.25 per share, compared to a net loss attributable to common stockholders of $22.0 million, or $0.23 per share, for the same period in 2012.