Navidea Biopharmaceuticals Reports
First Quarter 2017 Financial Results
Conference call with investment community to be held tomorrow, May
10, 2017, at 8:00 a.m. ET
DUBLIN,
Ohio--(BUSINESS WIRE)—May 9, 2017-- Navidea
Biopharmaceuticals, Inc. (NYSE MKT: NAVB) (“Navidea” or
“the Company”), a company focused on the development
and commercialization of precision immunodiagnostic agents, today
announced its financial results for the first quarter of 2017.
Navidea reported total revenue (excluding discontinued operations)
for the quarter of $580,000. Net income attributable to common
stockholders was $85.6 million.
“Navidea
ended the first quarter with strong momentum built upon the
strategic plan developed over the past two quarters. Our strategy
is designed to maximize the value of our proprietary
macrophage-targeting technology by developing and out-licensing
promising imaging and therapeutic products,” said Michael
Goldberg, M.D., Navidea’s President and CEO. Dr. Goldberg
continued, “Our completed sale of the North American rights
to Lymphoseek® to Cardinal Health 414, LLC ensures that our
focus remains on product development going forward. We are
confident that our Manocept platform, properly developed, will
yield both diagnostics and therapeutics that can generate
significant value for our stockholders.”
Product, Pipeline, and Business Updates
Lymphoseek®
●
On March 3, 2017,
Navidea completed the sale of the North American rights to
Lymphoseek® to Cardinal Health 414, receiving approximately
$82 million at closing.
●
Navidea will have
the opportunity to earn up to $227 million of additional
consideration through 2026, with $17.1 million guaranteed over the
next three years.
●
As a result of this
closing, all liens on Navidea’s assets have been released,
all frozen accounts have been transferred to Navidea’s
control, and the majority of the loan from Platinum Partners has
been repaid.
Manocept Immunodiagnostic Pipeline
The
flexible and versatile Manocept platform acts as an engine for the
design of targeted imaging molecules applicable to a range of
diagnostic modalities, including single photon emission computed
tomography (“SPECT”), positron emission tomography
(“PET”), gamma-scanning (both imaging and topical) and
intra-operative and/or optical-fluorescence detection. We have
active clinical diagnostic programs in cardiovascular disease,
rheumatoid arthritis, Kaposi’s sarcoma and colorectal cancer,
diseases representing both major macrophage activation
states.
Cardiovascular
Disease – The results of a study to evaluate diagnostic
imaging of emerging atherosclerosis plaque with Tc 99m tilmanocept
were published in early release in the Journal of Infectious Diseases on
January 16, 2017, confirming that the Tc 99m tilmanocept product
can both quantitatively and qualitatively target non-calcified
plaque in the aortic arch.
Colorectal
Cancer and Synchronous Liver Metastases – During the first
quarter of 2017, we initiated an imaging study in subjects with
colorectal cancer and liver metastases via intravenous
administration of Tc 99m tilmanocept.
Manocept Immunotherapeutic Development Pipeline (Macrophage
Therapeutics)
Navidea’s
majority-owned subsidiary, Macrophage Therapeutics, Inc.
(“MT”), has developed processes for producing the first
two therapeutic Manocept immunoconstructs consisting of a
therapeutic molecule conjugated to moieties targeting CD206+
macrophages:
1.
MT-1002, designed
to specifically target and kill activated CD206+ macrophages by
delivering doxorubicin; and
2.
MT-2002, designed
to inhibit the inflammatory activity of activated CD206+
macrophages by delivering a potent anti-inflammatory
agent.
In the
first quarter of 2017, MT completed its third vivo study dosing
either MT-1002 or MT-2002 in a well-established mouse model of
nonalcoholic fatty liver disease/nonalcoholic steatohepatitis and
liver fibrosis, in which both compounds significantly reduced key
disease parameters.
Also in
the first quarter of 2017, we completed a series of predictive in
vitro screening tests of the MT-1002 and MT-2002 therapeutic
conjugates against the Zika and Dengue viruses and against
Leishmaniosis. These evaluations were positive and MT will begin in
vivo testing in the second or third quarter of 2017.
Financials
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 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.
We
recorded a net gain on the sale to Cardinal Health 414 of $88.7
million for the first quarter of 2017, including $16.5 in
guaranteed consideration, which was discounted to the present value
of future cash flows. The proceeds were offset by $3.3 million in
estimated fair value of warrants issued to Cardinal Health 414,
$2.0 million in legal and other fees related to the sale, $800,000
in net balance sheet dispositions and write-offs, and $4.6 million
in estimated taxes.
Total
revenues for the quarter ended March 31, 2017 were $580,000
compared to $948,000 in the first quarter of last year. Total
operating expenses for the first quarter of 2017 were $3.7 million,
compared to $4.7 million in the first quarter of last year.
Research and development expenses for the first quarter of 2017
were $705,000, compared to $2.1 million in the first quarter of
last year. The net decrease from 2016 to 2017 was primarily a
result of decreases in NAV4694, Tc 99m tilmanocept and NAV5001
development costs, offset by increases in Manocept and therapeutics
development costs, coupled with decreased compensation and related
support costs. Selling, general, and administrative expenses for
the first quarter of 2017 were $3.0 million, compared to $2.6
million in the first quarter of last year. The net increase was
primarily due to increased legal and professional services, offset
by decreased investor relations services, compensation and related
support costs.
Navidea’s
net income attributable to common stockholders for the quarter
ended March 31, 2017 was $85.6 million, or $0.53 per share (basic),
compared to a net loss of $3.7 million, or $0.02 per share, for the
same period in 2016.
Navidea
ended the quarter with $13.4 million in cash.
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 also.
Participants are encouraged to log-in and/or dial-in fifteen
minutes before the conference call begins. The webcast reply is
expected to be available on our investor website, http://ir.navidea.com,
approximately two to four hours after the live event.
Event: Navidea Q1 2017 Financial Results
Conference Call
Date/Time: Wednesday, May 10, 2017 at
8:00 a.m. ET
Webcast Link: http://edge.media-server.com/m/p/zjm948a2/lan/en
Dial-In Number (US): (855) 897-5884
Dial-In Number (International):
(720) 634-2940
Conference ID: 20720582
Replay: A webcast replay will be
available on the Investor Relations section of our website
at
http://ir.navidea.com
following the event
About
Navidea
Biopharmaceuticals, Inc. (NYSE MKT: NAVB) is a biopharmaceutical
company focused on the development and commercialization of
precision immunodiagnostic agents and immunotherapeutics. Navidea
is developing multiple precision-targeted products based on its
ManoceptTM
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.
Financial Tables
Condensed Consolidated Balance Sheets
Condensed Consolidated Statements of Operations
Contact
Navidea
Biopharmaceuticals
Jed
Latkin (investors & media)
Chief
Operating Officer & Chief Financial Officer
jlatkin@navidea.com
or
Edison
Advisors
Tirth
Patel (investors)
tpatel@edisongroup.com
|
NAVIDEA
BIOPHARMACEUTICALS, INC.
|
|
|
|
CONDENSED
CONSOLIDATED BALANCE SHEETS
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Assets:
|
|
|
|
Cash
|
$13,440,618
|
$1,539,325
|
|
Restricted
cash
|
-
|
5,001,253
|
|
Other current
assets
|
8,258,377
|
1,141,444
|
|
Assets associated
with discontinued operations, current
|
-
|
3,144,247
|
|
Guaranteed earnout
receivable
|
9,437,599
|
-
|
|
Other non-current
assets
|
1,788,993
|
1,530,152
|
|
Assets associated
with discontinued operations
|
-
|
105,255
|
|
Total
assets
|
$32,925,587
|
$12,356,421
|
|
|
|
|
|
Liabilities and
stockholders' equity (deficit):
|
|
|
|
Notes payable,
current, net of discount
|
$2,103,000
|
$51,957,913
|
|
Other current
liabilities
|
4,319,104
|
13,038,278
|
|
Liabilities
associated with discontinued operations, current
|
3,554,320
|
4,865,597
|
|
Notes
payable
|
-
|
9,641,179
|
|
Other
liabilities
|
583,849
|
624,922
|
|
Total
liabilities
|
10,560,273
|
80,127,889
|
|
Navidea
stockholders' equity (deficit)
|
21,696,606
|
(68,135,123)
|
|
Noncontrolling
interest
|
668,708
|
468,910
|
|
Total
stockholders' equity (deficit)
|
22,365,314
|
(67,666,213)
|
|
Total liabilities
and stockholders' equity (deficit)
|
$32,925,587
|
$12,461,676
|
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NAVIDEA
BIOPHARMACEUTICALS, INC.
|
|
|
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CONDENSED
CONSOLIDATED STATEMENTS OF OPERATIONS
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|
|
|
|
|
|
|
|
|
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|
|
|
|
|
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Revenue:
|
|
|
|
Tc
99m tilmanocept sales and license revenue
|
$-
|
$262,850
|
|
Grant
and other revenue
|
580,030
|
685,635
|
|
Total
revenue
|
580,030
|
948,485
|
|
Cost of goods
sold
|
-
|
1,489
|
|
Gross
profit
|
580,030
|
946,996
|
|
Operating
expenses:
|
|
|
|
Research
and development
|
705,274
|
2,072,271
|
|
Selling,
general and administrative
|
3,022,434
|
2,633,126
|
|
Total
operating expenses
|
3,727,708
|
4,705,397
|
|
Loss from
operations
|
(3,147,678)
|
(3,758,401)
|
|
Other (expense)
income:
|
|
|
|
Interest income,
net
|
24,112
|
757
|
|
Equity in the loss
of joint venture
|
-
|
(12,239)
|
|
Change in fair
value of financial instruments
|
140,485
|
1,125,359
|
|
Loss on
extinguishment of debt
|
(1,314,102)
|
-
|
|
Other,
net
|
(21,604)
|
(37,292)
|
|
Loss before income
taxes
|
(4,318,787)
|
(2,681,816)
|
|
Benefit from income
taxes
|
1,454,172
|
-
|
|
Loss from
continuing operations
|
(2,864,615)
|
(2,681,816)
|
|
Discontinued
operations, net of tax effect:
|
|
|
|
Loss
from operations
|
(255,861)
|
(1,004,433)
|
|
Gain
on sale
|
88,701,501
|
-
|
|
Net income
(loss)
|
85,581,025
|
(3,686,249)
|
|
Less loss
attributable to noncontrolling interest
|
(202)
|
(241)
|
|
Net income (loss)
attributable to common stockholders
|
$85,581,227
|
$(3,686,008)
|
|
Income (loss) per
common share (basic):
|
|
|
|
Continuing
operations
|
$(0.02)
|
$(0.02)
|
|
Discontinued
operations
|
$0.55
|
$0.00
|
|
Attributable
to common stockholders
|
$0.53
|
$(0.02)
|
|
Weighted average
shares outstanding (basic)
|
160,376,476
|
155,308,094
|
|
Income (loss) per
common share (diluted):
|
|
|
|
Continuing
operations
|
$(0.02)
|
$(0.02)
|
|
Discontinued
operations
|
$0.54
|
$0.00
|
|
Attributable
to common stockholders
|
$0.52
|
$(0.02)
|
|
Weighted average
shares outstanding (diluted)
|
164,871,955
|
155,308,094
|