Navidea Biopharmaceuticals, Inc. (NYSE MKT:NAVB), a biopharmaceutical company focused on precision diagnostic radiopharmaceuticals, today announced results for the fourth quarter and year ended December 31, 2013.
Key commercial and development milestones achieved by Navidea in 2013 and to date in 2014 include:
Lymphoseek® (technetium Tc 99m tilmanocept) Injection
- Received U.S. approval in March 2013 for use in lymphatic mapping procedures that are performed to aid in the diagnostic evaluation of potential cancer spread for patients with breast cancer and melanoma and initiated sales activities with U.S. distribution partner in May 2013.
- Maintained solid Lymphoseek growth trajectory measured by increasing number of units and growth in key sales metrics.
- Received Centers for Medicare & Medicaid Services (CMS) codes for reimbursement (pass-through C-Code and A-Code).
- Received Fast Track and Priority Review of a Lymphoseek supplemental New Drug Application (sNDA) for expanded indication in sentinel lymph node (SLN) detection in patients with head and neck cancer with Prescription Drug User Fee Act (PDUFA) review date targeted for June 16, 2014. Also received notification of acceptance for review of another Lymphoseek sNDA for a proposed expanded label to support broader and more flexible use in imaging and lymphatic mapping procedures, including lymphoscintigraphy and other optimization capabilities with a PDUFA review date targeted for October 16, 2014.
- Notified that the European Medicines Agency’s (EMA’s) Committee for Medicinal Products for Human Use (CHMP) consideration of Lymphoseek Marketing Authorization Application (MAA) expected in March 2014.
- Initiated enrollment in a global Phase 3 pivotal registration trial in Alzheimer’s disease (AD).
- Selected by the Australian Imaging, Biomarker & Lifestyle (AIBL) study as the sole amyloid tracer for use in their flagship work on AD.
- Enrolled first subjects in a Phase 2b trial in subjects with mild cognitive impairment (MCI).
- Initiated a Phase 3 program for Parkinson’s disease (PD).
- Received two Special Protocol Assessments (SPAs) from FDA for Phase 3 pivotal registration program.
- Published data from collaborative, proof-of-principle studies for multiple disorders, including Kaposi’s Sarcoma, tuberculosis and rheumatoid arthritis (RA), using the Manocept platform in Nature Outlook – Medical Imaging.
- Began a physician-initiated study in Kaposi’s Sarcoma patients at the University of California at San Francisco.
Financial ResultsFull Year Financial Results: Revenues for the year ended December 31, 2013 were $1.1 million compared to $79,000 for 2012. Navidea’s revenues for 2013 consisted of $614,000 in sales of Lymphoseek following its approval in the first quarter of 2013 and initial launch in the second quarter of 2013, and $516,000 from various federal and state grants. Revenues for 2012 related primarily to payments received from our U.S. distribution partner related to the reimbursement of certain Lymphoseek commercialization activities. Operating expenses for the year ended December 31, 2013 were $39.2 million compared to $28.1 million for 2012. Research and development expenses were $23.7 million during 2013 compared to $16.9 million during 2012. The net increase from 2012 to 2013 was primarily a result of net increases in NAV4694, NAV5001 and Manocept platform product development costs and compensation and other support costs related to increased headcount offset by decreases in Lymphoseek development costs and potential pipeline expansion activities. Selling, general and administrative expenses were $15.5 million for 2013 compared $11.2 million for 2012. The net increase from 2012 to 2013 was primarily a result of increased medical education costs, compensation and other support costs related to increased headcount, and legal and professional services costs, offset by decreased out-of-pocket marketing costs to support the commercial launch of Lymphoseek.
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