Market Overview

Navidea Biopharmaceuticals Reports Third Quarter 2018 Financial Results

Share:

Conference Call to be held Wednesday, November 7th,
2018 at 4:30 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 third quarter of 2018. Navidea reported total
revenues for the quarter of $231,000. Net loss attributable to common
stockholders was $3.8 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. "We also continued to gain recognition from the scientific
and medical communities, receiving acceptance into the National
Institutes of Health's ("NIH") Commercialization Accelerator Program and
presenting encouraging data on Tc99m tilmanocept, the first product
developed and commercialized by the Company based on the Manocept
platform, at the American College of Rheumatology ("ACR") Annual
Meeting. The Company also presented its Phase II data to the U.S. Food
and Drug Administration ("FDA") at the end of September. These
accomplishments reflect the strength of our team and the potential of
our pipeline of innovative diagnostics. Importantly, acceptance into the
NIH's program in addition to a $3 million private placement by a
long-term investor provides us with assistance to advance our Rheumatoid
Arthritis ("RA") program and product portfolio. I am pleased with our
progress and look forward to a strong finish to the year."

Third Quarter 2018 Highlights and Subsequent Events

  • Closed $3 million private placement with an existing investor
  • Announced acceptance into the NIH's Commercialization Accelerator
    Program for 2018-2019
  • Presented data on the Manocept platform at the 2018 ACR Annual Meeting
  • Presented at the 2018 BIO Investor Forum in California
  • Held meeting with the FDA to discuss the results from the Phase II RA
    trial and activated macrophage data and next steps for the program
  • Announced leadership transition in which Dr. Michael Goldberg stepped
    down as CEO and Board member of Navidea and Mr. Jed Latkin was
    appointed CEO of Navidea
  • Held the Annual Shareholder Meeting

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 third quarter of 2018 were $231,000 compared to
    $224,000 in the third quarter of 2017. The increase was primarily due
    to a royalty revenue related to our license agreement with SpePharm in
    Europe as well as a license revenue for activities related to the
    sublicense of NAV4694 to Meilleur Technologies, Inc. and the
    sublicense of Tc99m tilmanocept to Beijing Sinotau Medical Research
    Co., Ltd. No royalty revenue or license revenue was recognized during
    the third quarter of 2017. Total revenues for the first nine months of
    2018 were $1.1 million compared to $1.4 million for the same period in
    2017. Revenue included royalty and license revenue as well as grant
    revenue, primarily related to SBIR grants from the NIH supporting
    Manocept development. Other revenue for the first nine months of 2018
    was from our marketing partners in Europe and China related to
    development work performed at their request.
  • Research and development ("R&D") expenses for the third quarter of
    2018 were $1.2 million compared to $875,000 in the third quarter of
    2017. R&D expenses for the first nine months of 2018 were $3.4 million
    compared to $2.8 million during the same period in 2017. The increase
    was primarily due to net increases in drug project expenses related to
    increased therapeutics development costs from research consulting,
    regulatory consulting, and preclinical testing.
  • Selling, general and administrative ("SG&A") expenses for the third
    quarter of 2018 were $2.7 million, compared to $1.7 million in the
    third quarter of 2017. The net increase was primarily due to increased
    compensation including incentive-based awards as well as termination
    costs associated with the resignation of our former CEO. SG&A expenses
    for the first nine months of 2018 were $6.3 million, compared to $9.0
    million during the same period in 2017. The net decrease was primarily
    due to decreased legal and professional services, as well as decreased
    general office, insurance, depreciation, rent, and travel expenses.
  • Navidea's net loss attributable to common stockholders for the quarter
    ended September 30, 2018 was $3.8 million, or $0.02 per share (basic),
    compared to a net loss attributable to common stockholders of $1.4
    million, or $0.01 per share, for the same period in 2017. Navidea's
    net loss attributable to common stockholders for the nine-month period
    ended September 30, 2018 was $13.0 million, or $0.08 per share
    (basic), compared to net income attributable to common stockholders of
    $79.0 million, or $0.49 per share, for the same period in 2017.
  • Navidea ended the third quarter of 2018 with $6.5 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. Participants who would like to ask
questions during the question and answer session must participate by
telephone.

 
Event: Third Quarter 2018 Earnings and Business Update Conference Call
Date: Wednesday, November 7, 2018
Time: 4:30 pm (Eastern Time)
U.S. & Canada Dial-in: 877-407-0312
Conference ID: 13684819
 

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: 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 the CRG
litigation in Texas and Ohio; 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; 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
 
September 30, December 31,
2018 2017
(unaudited)  
Assets:
Cash and securities $ 6,506,413 $ 4,592,610
Accounts and other receivables 86,928 8,137,872
Other current assets 547,027 1,101,923
Guaranteed earnout receivable - 4,809,376
Other non-current assets   1,968,674   2,139,655
Total assets $ 9,109,042 $ 20,781,436
 
Liabilities and stockholders' equity:
Notes payable, current $ 2,164,330 $ 2,353,639
Accrued loss for CRG litigation - 2,887,566
Other current liabilities 3,682,565 2,827,198
Deferred revenue 700,000 11,024
Other liabilities   552,084   653,679
Total liabilities   7,098,979   8,733,106
Navidea stockholders' equity 1,341,696 11,379,630
Noncontrolling interest   668,367   668,700
Total stockholders' equity   2,010,063   12,048,330
Total liabilities and stockholders' equity $ 9,109,042 $ 20,781,436
 
       

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS

 

Three Months Ended

Nine Months Ended

September 30, September 30, September 30, September 30,
2018 2017 2018 2017
(unaudited) (unaudited) (unaudited) (unaudited)
Revenue:
Tc99m tilmanocept royalty revenue $ 2,382 $ - $ 9,842 $ -
License revenue 19,930 - 277,639 100,000
Grant and other revenue   209,146     223,669     762,549     1,315,298  
Total revenue   231,458     223,669     1,050,030     1,415,298  
Cost of revenue   38,101     -     73,811     -  
Gross profit   193,357     223,669     976,219     1,415,298  
Operating expenses:
Research and development 1,225,770 874,547 3,367,444 2,765,695
Selling, general and administrative   2,688,703     1,734,707     6,254,474     9,006,725  

Total operating expenses

  3,914,473     2,609,254     9,621,918     11,772,420  
Loss from operations   (3,721,116 )   (2,385,585 )   (8,645,699 )   (10,357,122 )
Other income (expense):
Interest (expense) income, net (28,074 ) 76,050 (20,234 ) 144,811
Change in fair value of financial instruments - - - 153,357
Loss on extinguishment of debt - - (4,265,434 ) (1,314,102 )
Other, net   3,540     (6,979 )   1,654     (45,256 )
Loss before income taxes (3,745,650 ) (2,316,514 ) (12,929,713 ) (11,418,312 )
(Provision for) benefit from income taxes   (76,259 )   775,750     (65,330 )   3,861,156  
Loss from continuing operations (3,821,909 ) (1,540,764 ) (12,995,043 ) (7,557,156 )
Discontinued operations, net of tax effect:
Income (loss) from operations - 5,399 (1,938 ) (332,838 )
Gain (loss) on sale   -     145,877     43,053     86,894,000  
Net (loss) income (3,821,909 ) (1,389,488 ) (12,953,928 ) 79,004,006
Less loss attributable to noncontrolling interest   (308 )   (23 )   (333 )   (192 )
Net (loss) income attributable to common stockholders $ (3,821,601 ) $ (1,389,465 ) $ (12,953,595 ) $ 79,004,198  
(Loss) income per common share (basic):
Continuing operations $ (0.02 ) $ (0.01 ) $ (0.08 ) $ (0.05 )
Discontinued operations $ - $ 0.00 $ 0.00 $ 0.54
Attributable to common stockholders $ (0.02 ) $ (0.01 ) $ (0.08 ) $ 0.49
Weighted average shares outstanding (basic) 166,855,420 162,006,646 163,963,940 161,437,276
(Loss) income per common share (diluted):
Continuing operations $ (0.02 ) $ (0.01 ) $ (0.08 ) $ (0.05 )
Discontinued operations $ - $ 0.00 $ 0.00 $ 0.52
Attributable to common stockholders $ (0.02 ) $ (0.01 ) $ (0.08 ) $ 0.47
Weighted average shares outstanding (diluted) 166,855,420 162,006,646 163,963,940 165,914,473

View Comments and Join the Discussion!
 
Lightning Fast
Market News Service
$199 Free 14 Day Trial