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Navidea Biopharmaceuticals Reports Second Quarter 2018 Financial Results

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Conference Call to be held Thursday, August 16th,
2018 at 5:00 pm ET following the Annual Meeting

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 second quarter of 2018. Navidea reported total
revenues for the quarter of $542,000. Net loss attributable to common
stockholders was $2.4 million.

Michael Goldberg, M.D., President and Chief Executive Officer of Navidea
Biopharmaceuticals, commented, "During the first half of the year, we
continued to make significant progress executing on our strategy to
develop imaging and therapeutics based on our activated macrophage
targeting technology. We have generated additional clinical data with
our imaging agents and progressed with our development efforts towards
additional regulatory approvals. Macrophage Therapeutics is seeking to
develop treatments for diseases where inflammation is a major
contributing factor. Macrophage Therapeutics has an exclusive license
from Navidea for all therapeutic uses of our propriety Manocept
platform, while our diagnostics business is focused on the development
and commercialization of precision imaging products for a large range of
inflammatory related conditions. With the benefit of these corporate
changes, we are well-positioned to create long-term value for our
stakeholders as we focus the business and execute our mission of
developing innovative immunodiagnostic agents and therapies that improve
patient care."

Second Quarter 2018 Highlights and Subsequent Events

  • Signed exclusive license with Meilleur Technologies, Inc. ("Meilleur")
    a wholly-owned subsidiary of Cerveau Technologies, Inc. to conduct
    research using NAV4694, as well as an exclusive license for the
    development and commercialization of NAV4694 in Australia, Canada,
    China, and Singapore
  • Presented at the 8th Annual LD Micro Invitational Conference
  • Presented at the 2nd Annual NASH conference in Boston, MA

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 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 second quarter of 2018 were $542,000 compared
    to $612,000 in the second quarter of 2017. Total revenues for the
    first six months of 2018 were $819,000 compared to $1.2 million for
    the same period in 2017. License revenue in 2018 was primarily related
    to the sublicense of NAV4694 to Meilleur; license revenue during 2017
    was primarily related to the license of Tc99m tilmanocept to Sayre
    Therapeutics in India. Grant revenue in both 2018 and 2017 was
    primarily related to Small Business Innovation Research ("SBIR")
    grants from the National Institutes of Health ("NIH") supporting
    Manocept development.
  • Research and development ("R&D") expenses for the second quarter of
    2018 were $1.1 million compared to $1.2 million in the second quarter
    of 2017. The net decrease was primarily due to reductions in drug
    project expenses related to NAV4694 and Manocept development costs,
    offset by increased therapeutics and Tc99m tilmanocept development
    costs. R&D expenses for the first six months of 2018 were $2.1 million
    compared to $1.9 million during the same period in 2017. The net
    increase was primarily due to net increases in drug project expenses
    related to NAV4694 and therapeutics development costs, offset by
    decreased Manocept and Tc99m tilmanocept development costs. The change
    in R&D expenses for both periods also included net decreased
    compensation related to decreased headcount.
  • Selling, general and administrative ("SG&A") expenses for the second
    quarter of 2018 were $1.8 million, compared to $4.2 million in the
    second quarter of 2017. SG&A expenses for the first six months of 2018
    were $3.6 million, compared to $7.3 million during the same period in
    2017. The net decrease for both periods was primarily due to decreased
    legal and professional services, a loss on disposal of assets related
    to our previous office space, termination costs related to the
    arbitration award to our former CEO, a loss on termination of our
    previous office lease, and decreased general office expenses such as
    depreciation, insurance and rent.
  • Navidea's net loss attributable to common stockholders for the quarter
    ended June 30, 2018 was $2.4 million, or $0.02 per share (basic),
    compared to a net loss attributable to common stockholders of $5.2
    million, or $0.03 per share, for the same period in 2017. Navidea's
    net loss attributable to common stockholders for the six-month period
    ended June 30, 2018 was $9.1 million, or $0.06 per share (basic),
    compared to net income attributable to common stockholders of $80.4
    million, or $0.50 per share, for the same period in 2017.
  • Navidea ended the second quarter of 2018 with $5.5 million in cash and
    investments, including the accelerated earnout payment of $6.0 million
    from Cardinal Health 414 which was received during the quarter.

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.

Event:   Second Quarter 2018 Earnings and Business Update Conference Call
Date: Thursday, August 16, 2018
Time: 5:00 pm (Eastern Time)
U.S. & Canada Dial-in: 877-407-0312
Conference ID: 13682395
Webcast

https://webcasts.eqs.com/navidea20180816

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.

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 Tc 99m 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: general
economic and business conditions, both nationally and in our markets;
our history of losses and uncertainty of future profitability; the final
outcome of the CRG litigation in Texas; 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;
and other risk factors set forth in this report and 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
 
June 30, December 31,
2018 2017
(unaudited)  
Assets:
Cash and securities $ 5,488,909 $ 4,592,610
Accounts and other receivables 373,876 8,137,872
Other current assets 737,336 1,101,923
Guaranteed earnout receivable - 4,809,376
Other non-current assets   2,060,371   2,139,655
Total assets $ 8,660,492 $ 20,781,436
 
Liabilities and stockholders' equity:
Notes payable, current $ 2,200,353 $ 2,353,639
Accrued loss for CRG litigation - 2,887,566
Other current liabilities 2,428,590 2,827,198
Deferred revenue 700,000 11,024
Other liabilities   544,677   653,679
Total liabilities   5,873,620   8,733,106
Navidea stockholders' equity 2,118,197 11,379,630
Noncontrolling interest   668,675   668,700
Total stockholders' equity   2,786,872   12,048,330
Total liabilities and stockholders' equity $ 8,660,492 $ 20,781,436
 
 
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
       
Three Months Ended Six Months Ended
June 30, June 30, June 30, June 30,
2018 2017 2018 2017
(unaudited) (unaudited) (unaudited) (unaudited)
Revenue:
Tc99m tilmanocept royalty revenue $ 6,665 $ - $ 7,460 $ -
License revenue 257,709 100,000 257,709 100,000
Grant and other revenue   277,753     511,599     553,403     1,091,629  
Total revenue   542,127     611,599     818,572     1,191,629  
Cost of revenue   35,392     -     35,710     -  
Gross profit   506,735     611,599     782,862     1,191,629  
Operating expenses:
Research and development 1,142,718 1,185,874 2,141,674 1,891,148

Selling, general and administrative

  1,789,399     4,249,584     3,565,771     7,272,018  
Total operating expenses   2,932,117     5,435,458     5,707,445     9,163,166  
Loss from operations   (2,425,382 )   (4,823,859 )   (4,924,583 )   (7,971,537 )
Other income (expense):
Interest (expense) income, net (23,547 ) 44,649 7,840 68,761
Change in fair value of financial instruments - 12,872 - 153,357
Loss on extinguishment of debt - - (4,265,434 ) (1,314,102 )
Other, net   2,828     (16,673 )   (1,886 )   (38,277 )
Loss before income taxes (2,446,101 ) (4,783,011 ) (9,184,063 ) (9,101,798 )
Benefit from income taxes   10,929     1,631,234     10,929     3,085,406  
Loss from continuing operations (2,435,172 ) (3,151,777 ) (9,173,134 ) (6,016,392 )
Discontinued operations, net of tax effect:
Loss from operations (1,938 ) (82,376 ) (1,938 ) (338,237 )
Gain (loss) on sale   43,053     (1,953,378 )   43,053     86,748,123  
Net (loss) income (2,394,057 ) (5,187,531 ) (9,132,019 ) 80,393,494
Less (loss) income attributable to noncontrolling interest   (16 )   33     (25 )   (169 )
Net (loss) income attributable to common stockholders $ (2,394,041 ) $ (5,187,564 ) $ (9,131,994 ) $ 80,393,663  
(Loss) income per common share (basic):
Continuing operations $ (0.02 ) $ (0.02 ) $ (0.06 ) $ (0.04 )
Discontinued operations $ 0.00 $ (0.01 ) $ 0.00 $ 0.54
Attributable to common stockholders $ (0.02 ) $ (0.03 ) $ (0.06 ) $ 0.50
Weighted average shares outstanding (basic) 162,716,988 161,910,792 162,494,238 161,147,873
(Loss) income per common share (diluted):
Continuing operations $ (0.02 ) $ (0.02 ) $ (0.06 ) $ (0.04 )
Discontinued operations $ 0.00 $ (0.01 ) $ 0.00 $ 0.52
Attributable to common stockholders $ (0.02 ) $ (0.03 ) $ (0.06 ) $ 0.49
Weighted average shares outstanding (diluted) 162,716,988 161,910,792 162,494,238 165,631,000
 

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