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
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version on businesswire.com: https://www.businesswire.com/news/home/20190307005803/en/
Navidea Biopharmaceuticals, Inc.Jed Latkin, CEO,
614-973-7490jlatkin@navidea.com
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