Navidea Biopharmaceuticals Reports Fourth Quarter and Full Year 2017 Financial Results

“It’s been quite a transition year for Navidea going from a commercial operation, with its own dedicated sales force, to a development-focused company leveraging its best-in-class activated macrophage targeting system,” said Michael Goldberg, M.D., Navidea’s President and Chief Executive Officer.

Dr. Goldberg continued, “I am more excited today than I have ever been as we push forward on the three key pillars of our business; CD206 biomarker identification, diagnostic imaging and therapeutics. I expect that the coming year will be characterized by the release of data that confirms our strategy that focusing on the targeting of activated macrophages with our proprietary imaging agents in humans and our proprietary therapeutics in animals has the potential to generate significant commercial opportunities for Navidea in the short term.”

Fourth Quarter 2017 Highlights and Subsequent Events

• Selected as 1 of 25 from 1100 applicants to present a late-breaking poster at the American College of Rheumatology Annual Meeting detailing the results of an intravenous (“IV”)-administered study in rheumatoid arthritis (“RA”) patients;
• Completed the Phase 2 IV RA study;
• Commenced dosing and imaging in the 12-subject nonalcoholic steatohepatitis (“NASH”) diagnostic study at Kettering Medical Center in Ohio;
• Commenced dosing and imaging in the 24-subject visceral Kaposi’s Sarcoma (“KS”) diagnostic study at the University of California, San Francisco;
• Commenced dosing and imaging in the 24-subject HIV+ Cardiovascular trial at Massachusetts General Hospital-Harvard University under the direction of Dr. Steven Grinspoon;
• Commenced dosing and imaging in the 12-subject colorectal cancer trial with synchronous liver metastases at the University of Alabama at Birmingham;
• Submitted an extensive grant to support broad expansion of both Navidea’s and the Massachusetts General Hospital’s work in Cardiovascular imaging;
• The National Cancer Institute awarded Navidea a Fast Track Small Business Innovation Research (“SBIR”) grant that will provide up to $1.8 million to fund preclinical and subsequent clinical studies examining the safety and efficacy of IV Tc 99m tilmanocept to identify and quantify both skin- and organ-associated KS lesions;
• Completed regulatory strategies for imaging and inflammation for Phase 3 trials (pending meeting with the U.S. Food & Drug Administration); and
• Appointed Claudine Bruck, Ph.D. as a member of the board of directors of the Company effective March 5, 2018.

Financial Results

Our consolidated balance sheets and statements of operations have been reclassified, as required by current accounting standards, for all periods presented to reflect the line of business sold to Cardinal Health 414, LLC (“Cardinal Health 414”) on March 3, 2017 as a discontinued operation. Accordingly, this discussion focuses on describing results of our operations as if we had not operated the discontinued operation during the periods being disclosed.

• We recorded a $89.2 million net gain on the line of business sold to Cardinal Health 414 for the year ended December 31, 2017, including $16.5 million in guaranteed consideration, which was discounted to the present value of future cash flows. The proceeds were offset by $3.3 million in estimated fair value of warrants issued to Cardinal Health 414, $2.0 million in legal and other fees related to the sale, $800,000 in net balance sheet dispositions and write-offs, and $4.1 million in estimated taxes.
• Total revenues for the fourth quarter of 2017 were $395,000, compared to $1.0 million in the fourth quarter of 2016. Revenues for the full year of 2017 were $1.8 million, compared to $5.0 million in 2016. Revenues were primarily related to grants and licenses, and do not include the guaranteed earnout payments received from Cardinal Health 414 during 2017.
• Research and development (“R&D”) expenses for the fourth quarter of 2017 were $1.7 million, compared to $2.1 million in the fourth quarter of 2016. R&D expenses for the full year of 2017 were $4.5 million, compared to $7.1 million in 2016. The net decrease was primarily a result of decreases in Tc99m tilmanocept, NAV4694 and NAV5001 development costs coupled with decreased net compensation costs, offset by increases in Manocept platform development costs.
• Selling, general and administrative (“SG&A”) expenses for the fourth quarter of 2017 were $2.2 million, compared to $2.1 million in the fourth quarter of 2016. SG&A expenses for the full year of 2017 were $11.2 million, compared to $7.9 million in 2016. The net increase was primarily due to several non-recurring charges, including a $2.0 increase in legal expenses due to CRG and other concluded legal matters, $949,000 of other items including the FTI settlement, the Cardinal deal completion bonuses, severance payouts and asset disposal costs.
• Navidea’s net loss attributable to common stockholders for the quarter ended December 31, 2017 was $4.1 million, or $0.03 per share (basic), compared to a net loss of $3.9 million, or $0.02 per share (basic), for the same period in 2016. Navidea’s net income attributable to common stockholders for the year ended December 31, 2017 was $74.9 million, or $0.47 per share (basic), compared to a net loss of $14.3 million, or $0.09 per share (basic), for the same period in 2016.
• Navidea ended the quarter with $4.6 million in cash and investments.

Full Year 2017 Highlights and Subsequent Events

• On March 3, 2017, Navidea completed the sale of the North American rights to Lymphoseek® to Cardinal Health 414, receiving approximately $82 million at closing;
• Presented two papers at the Society of Nuclear Medicine and Molecular Imaging Annual Meeting detailing initial results from the SC-administered study in RA;
• Initiated Biomarker Qualification with FDA biomarker division;
• Selected by NIH/NIAMS as one of 24 from 1200 awardees to present business development and RA clinical results at the International Biotechnology Innovation Organization 2017 meeting in June, 2017;
• Initiated series of regular investor-focused Q&A conference calls to strengthen investor relations;
• Presented a late-breaking poster presented at the American College of Rheumatology Annual Meeting detailing the results of an IV-administered study in RA patients;
• Transferred three clinical trials in sentinel node biopsy to Cardinal Health 414, including cervical, anal/rectal and pediatric trials;
• Completed filings or disclosures on multiple new intellectual property constructs and usages; and
• Completed preclinical testing of therapeutic constructs in Zika, Dengue, leishmaniosis, KS, tumor models and NASH model systems.

Conference Call Details

Investors and the public are invited to access the live audio webcast through the link below. Participants who would like to ask questions during the question and answer session must participate by telephone. Participants are encouraged to log-in and/or dial-in fifteen minutes before the conference call begins.

A live audio webcast of the conference call will also be available on the investor relations page of Navidea’s corporate website at www.navidea.com. In addition, the recorded conference call can be replayed and will be available for 90 days following the call on Navidea’s website.