Navidea Biopharmaceuticals Announces Second Quarter 2012 Financial Results

Navidea Biopharmaceuticals Announces Second Quarter 2012 Financial Results

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 and six months ended June 30, 2012.

For the quarter ended June 30, 2012, Navidea reported a net loss attributable to common stockholders of $5.9 million, or $0.06 per share, compared to a net loss attributable to common stockholders of $2.2 million, or $0.02 per share, for the same period in 2011. For the six months ended June 30, 2012, Navidea’s net loss attributable to common stockholders was $12.9 million, or $0.14 per share, compared to a net loss attributable to common stockholders of $6.7 million, or $0.08 per share, for the same period in 2011.

Brent Larson, Navidea Senior Vice President and CFO, said: “In continuing to facilitate the growth and diversification of our business, Navidea achieved a number of milestones during the first half of 2012 that we believe will enhance shareholder value, including activities related to Lymphoseek commercialization and the addition of the [I]-E-IACFT (CFT) neuro-imaging agent to our pipeline. To achieve these accomplishments, we incurred a number of non-recurring expenses including costs related to regulatory support of Lymphoseek registration activities, launch preparation costs, expenses incurred addressing manufacturing matters, and the option fee for the CFT asset. Along the way, we have maintained a strong balance sheet and have taken incremental steps to further strengthen our financial position. Access to a non-dilutive, $50 million credit facility demonstrates yet another facet of the financial flexibility we have established to help ensure that our development programs continue to advance and to support potential additional pipeline growth as we approach revenue generation from Lymphoseek. We will continue to evaluate high-value opportunities to enhance our pipeline and, as with the CFT license, seek to constructively approach these agreements with back-end milestone-driven payments.”

Research and development (R&D) expenses were $2.5 million for the quarter ended June 30, 2012, compared to $1.9 million for the same period in 2011. The increase in R&D expenses was attributable to several factors, including increases in AZD4694 development activities, Lymphoseek manufacturing-related costs, other pipeline and headcount-related costs to support our growing pipeline and development activities, offset by reductions in Lymphoseek clinical trial activities and RIGScan™ development costs.

R&D expenses were $6.4 million for the six months ended June 30, 2012, compared to $4.3 million for the same period in 2011. The increase in R&D expenses was attributable to primarily the same factors as the 2 quarter plus option fee and diligence-related costs associated with our recent license of CFT.

Selling, general and administrative (SG&A) expenses were $3.0 million for the quarter ended June 30, 2012, compared to $1.7 million for the same period in 2011. The net SG&A increase of $1.3 million between the two periods was primarily due to increased marketing and business development costs in preparation for the commercial launch of Lymphoseek and efforts to continue to build the Company’s pipeline, coupled with increased general and administrative headcount and other support costs, offset by decreased professional services costs.

SG&A expenses were $5.5 million for the six months ended June 30, 2012, compared to $4.6 million for the same period in 2011. The net SG&A increase of $917,000 between the two periods was primarily due to increased marketing and business development costs in preparation for the commercial launch of Lymphoseek and efforts to continue to build the Company’s pipeline, coupled with increased general and administrative headcount and other support costs, but was offset by approximately $1.9 million in non-recurring charges related to the separation of the Company’s former President and CEO incurred in the first half of 2011 and decreased professional services costs.

As of June 30, 2012, Navidea had cash and cash equivalents totaling approximately $17.0 million.

“We remain focused on supporting our expected U.S. Lymphoseek approval and commercial launch as well as the planned advancement of its global registration process this year,” said Dr. Mark Pykett, Navidea President and CEO. “In collaboration with our U.S. marketing partner, Cardinal Health, we are making important strides to support commercial introduction and market penetration, completing competitive product and launch analyses, customer surveys, and marketing and medical education plans. We also continue to build relationships with key opinion leaders, early adopters, and patient advocacy groups in support of a successful launch.”

"Navidea’s 2012 accomplishments demonstrate our great momentum as we continue our progress to achieve the Company’s clinical and regulatory objectives,” said Dr. Pykett. “As evidenced in the licensing of our second neuroimaging agent, CFT, we expect to continue efforts to grow the company through robust drug development, global partnering and commercialization efforts, and select licenses and acquisitions. We look forward to commencing additional Phase 2 studies of AZD4694 during 2012 and to beginning Phase 3 clinical studies for this agent in early 2013. As we look toward the remainder of 2012 and beyond, we will continue our efforts to deliver superior growth and shareholder return by bringing novel radiopharmaceuticals through development and registration – and ultimately, to market.”

Navidea's President and CEO, Dr. Mark Pykett, Executive Vice President and Chief Business Officer, Dr. Thomas Tulip, Senior Vice President, Pharmaceutical Research and Clinical Development, Dr. Fred Cope and Senior Vice President and CFO, Brent Larson, will provide a development and business update and will discuss the Company's financial results for the second quarter and first six months of 2012 during the conference call. The conference call can be accessed as follows:

Navidea Biopharmaceuticals, Inc. (NYSE MKT: NAVB) is a biopharmaceutical company focused on the development and commercialization of precision diagnostics and radiopharmaceutical agents. Navidea is actively developing four radiopharmaceutical agent platforms – Lymphoseek®, AZD4694, E-IACFT, and RIGScan – to help identify the presence and status of undetected disease and enable better diagnostic accuracy, clinical decision-making and ultimately patient care. Navidea’s strategy is to deliver superior growth and shareholder return by bringing to market novel radiopharmaceutical agents and advancing the Company’s pipeline through selective acquisitions, global partnering and commercialization efforts. For more information, please visit .

Suggested Articles

The agreement sees Grifols waive a $32 million debt and pay $3 million in cash to take full ownership of three assets.

Astellas’ Xospata and Novartis’ Rydapt may help treat lung cancer that has grown resistant to EGFR inhibitors, researchers discovered.

Kadmon has posted positive and more detailed data out of its so-called ROCKstar pivotal trial of KD025 in chronic graft-versus-host disease.