Conference call with investment community to be
held tomorrow, May 10, 2017, at 8:00 a.m. ET
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:
- MT-1002, designed to specifically
target and kill activated CD206+ macrophages by delivering
doxorubicin; and
- 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 CallDate/Time: Wednesday, May 10, 2017 at
8:00 a.m. ETWebcast Link:
http://edge.media-server.com/m/p/zjm948a2/lan/enDial-In Number
(US): (855) 897-5884Dial-In Number (International):
(720) 634-2940Conference ID: 20720582Replay: A
webcast replay will be available on the Investor Relations section
of our website athttp://ir.navidea.com following the event
About Navidea
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.
NAVIDEA BIOPHARMACEUTICALS, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS March 31,
December 31, 2017 2016 (unaudited) 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
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS Three Months
Ended March 31, March 31, 2017 2016 (unaudited) (unaudited)
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
View source
version on businesswire.com: http://www.businesswire.com/news/home/20170509006641/en/
Navidea BiopharmaceuticalsJed Latkin (investors &
media)Chief Operating Officer & Chief Financial
Officerjlatkin@navidea.comorEdison AdvisorsTirth Patel
(investors)tpatel@edisongroup.com
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