On March 7, 20019 Navidea Biopharmaceuticals, Inc. (NYSE American: NAVB) ("Navidea" or the "Company"), a company focused on the development of precision immunodiagnostic agents and immunotherapeutics, reported its financial results for the fourth quarter and full year of 2018 (Press release, Navidea Biopharmaceuticals, MAR 7, 2019, View Source [SID1234534123]). Navidea reported total revenues for the quarter of $119,000. Net loss attributable to common stockholders was $3.2 million.
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"Navidea had a productive quarter as we advanced the business and our novel imaging pipeline," said Mr. Jed A. Latkin, Chief Executive Officer of Navidea. "While we had many successes this past quarter, we will continue to work hard to advance the science and seek the go ahead from the FDA to commence our pivotal RA diagnostic trials. Our newly reconstituted board and the addition of our new Chief Medical Officer have reinvigorated our efforts to make this company a success."
Fourth Quarter 2018 Highlights and Subsequent Events
Filed a comprehensive three-part clinical trial proposal for imaging of rheumatoid arthritis with the U.S. Food and Drug Administration ("FDA"), following end-of-Phase 2 discussions
Presented corporate overviews at the 2018 BIO Investor Forum and the 2018 LD Micro Annual Event
Presented data on the Manocept platform at the 2018 ACR Annual Meeting and at the 2018 Radiological Society of North American Scientific Assembly and Annual Meeting
Received notification of acceptance by the NYSE American of the Company’s plan to regain compliance with continued listing standards; also received an extension of the deadline to remedy the low stock price to March 31, 2019
Won dismissal of Platinum litigation
Announced release of a letter by the FDA to the U.S. Patent and Trademark Office ("USPTO") indicating that the USPTO is allowed to extend the patent for Lymphoseek through May 2025
Appointed Adam D. Cutler and S. Kathryn Rouan, Ph.D. to the Navidea Board of Directors
Hired Michael S. Rosol, Ph.D. as Navidea’s Chief Medical Officer
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 in March 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.
Total revenues for the fourth quarter of 2018 were $119,000, compared to $395,000 in the same period of 2017. The decrease was primarily due to a reduction in grant revenue related to SBIR grants from the NIH supporting Manocept development. Total revenues for the full year of 2018 were $1.2 million, compared to $1.8 million in 2017. The decrease was primarily due to a reduction in grant revenue, offset by increased license revenue related to the sublicense of NAV4694 to Meilleur. Revenue in both years included other revenue from our marketing partners in Europe and China related to development work performed at their request.
Research and development ("R&D") expenses for the fourth quarter of 2018 were $854,000, compared to $1.7 million in the same period of 2017. R&D expenses for the full year of 2018 were $4.2 million, compared to $4.5 million in 2017. The decrease in both periods was primarily due to net decreases in Manocept development costs for clinical trials, coupled with decreased compensation costs resulting from headcount reduction.
Selling, general and administrative ("SG&A") expenses for the fourth quarter of 2018 were $1.4 million, compared to $2.2 million in the same period of 2017. SG&A expenses for the full year of 2018 were $7.7 million, compared to $11.2 million during 2017. The net decrease in both periods was primarily due to decreased legal and professional services, as well as decreased general office, insurance, depreciation, rent, and travel expenses, offset by termination costs associated with the resignation of our former CEO in 2018.
Navidea’s net loss attributable to common stockholders for the fourth quarter of 2018 was $3.2 million, or $0.02 per share (basic), compared to a net loss attributable to common stockholders of $4.1 million, or $0.03 per share, for the same period in 2017. Navidea’s net loss attributable to common stockholders for the full year of 2018 was $16.1 million, or $0.09 per share (basic), compared to net income attributable to common stockholders of $74.9 million, or $0.47 per share, in 2017.
Navidea ended the fourth quarter of 2018 with $4.3 million in cash and investments.
Conference Call Details
Investors and the public are invited to dial into the earnings call through the information listed below, or participate via the audio webcast on the company website. Participants who would like to ask questions during the question and answer session will be prompted by the moderator, who will provide instructions.
Event:
Fourth Quarter 2018 Earnings and Business Update Conference Call
Date:
Thursday, March 7, 2019
Time:
5:00 pm (Eastern Time)
U.S. & Canada Dial-in:
877-407-0312
Conference ID:
13687788
Webcast Link:
The recorded conference call can be replayed and will be available for 90 days following the call, available on the investor relations page of Navidea’s corporate website at www.navidea.com.