NAVB Navidea Biopharmaceuticals Inc

Conference Call to be held Thursday, March 7, 2019 at 5:00 pm ET

Navidea Biopharmaceuticals, Inc. (NYSE American: NAVB) (“Navidea” or the “Company”), a company focused on the development of precision immunodiagnostic agents and immunotherapeutics, today announced its financial results for the fourth quarter and full year of 2018. Navidea reported total revenues for the quarter of $119,000. Net loss attributable to common stockholders was $3.2 million.

“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:

https://webcasts.eqs.com/navidbioph20190307

 

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.

About Navidea

Navidea Biopharmaceuticals, Inc. (NYSE American: NAVB) is a biopharmaceutical company focused on the development of precision immunodiagnostic agents and immunotherapeutics. Navidea is developing multiple precision-targeted products based on its Manocept™ platform to enhance patient care by identifying the sites and pathways of disease and enable better diagnostic accuracy, clinical decision-making, and targeted treatment. Navidea’s Manocept platform is predicated on the ability to specifically target the CD206 mannose receptor expressed on activated macrophages. The Manocept platform serves as the molecular backbone of Tc99m tilmanocept, the first product developed and commercialized by Navidea based on the platform. The development activities of the Manocept immunotherapeutic platform are being conducted by Navidea in conjunction with its subsidiary, Macrophage Therapeutics, Inc. Navidea’s strategy is to deliver superior growth and shareholder return by bringing to market novel products and advancing the Company’s pipeline through global partnering and commercialization efforts.

For more information, please visit www.navidea.com.

Forward-Looking Statements

This release and any oral statements made with respect to the information contained in this release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. We have based these forward-looking statements largely on our current expectations and projections about future events and financial trends affecting the financial condition of our business. These forward-looking statements are subject to a number of risks, uncertainties and assumptions, including, among other things: any future actions by Platinum-Montaur; general economic and business conditions, both nationally and in our markets; our history of losses and uncertainty of future profitability; the final outcome of any pending litigation; our ability to successfully complete research and further development of our drug candidates; the timing, cost and uncertainty of obtaining regulatory approvals of our drug candidates; our ability to successfully commercialize our drug candidates; our expectations and estimates concerning future financial performance, financing plans and the impact of competition; our ability to raise capital sufficient to fund our development and commercialization programs; our ability to implement our growth strategy; anticipated trends in our business; advances in technologies; our ability to comply with the NYSE American continued listing standards; our ability to maintain effective internal control over financial reporting; and other risk factors detailed in our most recent Annual Report on Form 10-K and other SEC filings. You are urged to carefully review and consider the disclosures found in our SEC filings, which are available at www.sec.gov or at http://ir.navidea.com.

Investors are urged to consider statements that include the words “will,” “may,” “could,” “should,” “plan,” “continue,” “designed,” “goal,” “forecast,” “future,” “believe,” “intend,” “expect,” “anticipate,” “estimate,” “project,” and similar expressions, as well as the negatives of those words or other comparable words, to be uncertain forward-looking statements.

You are cautioned not to place undue reliance on any forward-looking statements, any of which could turn out to be incorrect. We undertake no obligation to update publicly or revise any forward-looking statements, whether as a result of new information, future events or otherwise after the date of this report. In light of these risks and uncertainties, the forward-looking events and circumstances discussed in this report may not occur and actual results could differ materially from those anticipated or implied in the forward-looking statements.

            NAVIDEA BIOPHARMACEUTICALS, INC.   CONDENSED CONSOLIDATED BALANCE SHEETS December 31, December 31, 2018 2017 (unaudited)   Assets: Cash and available-for-sale securities $ 4,275,151 $ 4,592,610 Accounts and other receivables 21,151 8,137,872 Other current assets 678,215 1,101,923 Guaranteed earnout receivable - 4,809,376 Other non-current assets   2,034,511   2,139,655 Total assets $ 7,009,028 $ 20,781,436   Liabilities and stockholders' equity: Notes payable, current $ 316,074 $ 2,353,639 Accrued loss for CRG litigation - 2,887,566 Other current liabilities 3,062,445 2,827,198 Deferred revenue 700,000 11,024 Other liabilities   532,549   653,679 Total liabilities   4,611,068   8,733,106 Navidea stockholders' equity 1,729,639 11,379,630 Noncontrolling interest   668,321   668,700 Total stockholders' equity   2,397,960   12,048,330 Total liabilities and stockholders' equity $ 7,009,028 $ 20,781,436       CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS       Three Months Ended Twelve Months Ended December 31, December 31, December 31, December 31, 2018 2017 2018 2017 (unaudited) (unaudited) (unaudited)   Revenue: Royalty revenue $ 5,505 $ 9,126 $ 15,347 $ 9,126 License revenue 29,535 - 307,174 100,000 Grant and other revenue   84,281     386,013     846,830     1,701,311   Total revenue   119,321     395,139     1,169,351     1,810,437   Cost of revenue   22,825     3,651     96,636     3,651   Gross profit   96,496     391,488     1,072,715     1,806,786   Operating expenses: Research and development 854,437 1,748,147 4,221,881 4,513,842 Selling, general and administrative   1,443,661     2,163,226     7,698,135     11,169,951   Total operating expenses   2,298,098     3,911,373     11,920,016     15,683,793   Loss from operations   (2,201,602 )   (3,519,885 )   (10,847,301 )   (13,877,007 ) Other income (expense): Interest (expense) income, net (10,565 ) 24,160 (30,799 ) 168,971 Change in fair value of financial instruments - - - 153,357 Loss on extinguishment of debt (1,026,182 ) (2,887,566 ) (5,291,616 ) (4,201,668 ) Other, net   (509 )   11,917     1,145     (33,339 ) Loss before income taxes (3,238,858 ) (6,371,374 ) (16,168,571 ) (17,789,686 ) (Provision for) benefit from income taxes   62,583     201,333     (2,747 )   4,062,489   Loss from continuing operations (3,176,275 ) (6,170,041 ) (16,171,318 ) (13,727,197 ) Discontinued operations, net of tax effect: Income (loss) from discontinued operations 3,387 (157,920 ) 1,449 (490,758 ) Gain on sale   -     2,269,811     43,053     89,163,811   Net (loss) income (3,172,888 ) (4,058,150 ) (16,126,816 ) 74,945,856 Less loss attributable to noncontrolling interest   (46 )   (18 )   (379 )   (210 ) Net (loss) income attributable to common stockholders $ (3,172,842 ) $ (4,058,132 ) $ (16,126,437 ) $ 74,946,066   (Loss) income per common share (basic): Continuing operations $ (0.02 ) $ (0.04 ) $ (0.09 ) $ (0.08 ) Discontinued operations $ 0.00 $ 0.01 $ 0.00 $ 0.55 Attributable to common stockholders $ (0.02 ) $ (0.03 ) $ (0.09 ) $ 0.47 Weighted average shares outstanding (basic) 190,035,265 162,053,385 170,535,343 161,592,569 (Loss) income per common share (diluted): Continuing operations $ (0.02 ) $ (0.04 ) $ (0.09 ) $ (0.08 ) Discontinued operations $ 0.00 $ 0.01 $ 0.00 $ 0.53 Attributable to common stockholders $ (0.02 ) $ (0.03 ) $ (0.09 ) $ 0.45 Weighted average shares outstanding (diluted) 190,035,265 166,465,741 170,535,343 166,016,458

View source version on businesswire.com: https://www.businesswire.com/news/home/20190307005803/en/

Navidea Biopharmaceuticals, Inc.Jed Latkin, CEO, 614-973-7490jlatkin@navidea.com