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Navidea Biopharmaceuticals Reports Fourth Quarter and Full Year 2018 Financial Results

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

Navidea Biopharmaceuticals, Inc. (NYSE: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: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

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