Navidea garners $30 million loan, expects EU approval for Lymphoseek in March

Navidea Biopharmaceuticals ($NAVB) is hopeful the expected European Union approval of its Lymphoseek injectable diagnostic imaging agent later this month and a $30 million loan will help stanch its financial hemorrhaging, which saw losses from operations spike to $38.4 million for the year compared to $28 million for the same period in 2012.

Navidea did, however, experience a revenue increase to $1.1 million in 2013 versus $79,000 the previous year due to sales of Lymphoseek after gaining FDA approval and initial launch of the product last year. The Dublin, OH, company said in its fourth-quarter and full-year report that revenues for the fourth quarter of 2013 were $535,000 compared to $7,000 for the same period the year before, and revenue from sales of Lymphoseek were $343,000 compared to $144,000 in the third quarter of 2013.

The company also announced it received a $30 million loan from Oxford Finance, which will be used to support Lymphoseek activities.

A key milestone for Navidea came in August when the Centers for Medicare & Medicaid Services approved reimbursement for the Lymphoseek diagnostic imaging aid for cancer. The "pass through" billing code for the product took effect Oct. 1.

Navidea also has its eyes set on Alzheimer's imaging with its NAV4694 agent, but a July Medicare reimbursement roadblock at Eli Lilly ($LLY) with its Amyvid product raises doubts in that field. 

Navidea Chairman Dr. Mark Pykett called 2013 a "pivotal year" for the company with the approval and launch of Lymphoseek in the U.S. "We continue to see good momentum in many key sales metrics, including continuous growth in market penetration," he said in a statement.

Pykett also said the company is now looking toward the June and October Prescription Drug User Fee Act target dates that could expand use of the company's lymphatic mapping products into other areas.

- read the annual report release
- see the loan announcement

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