Navidea Biopharmaceuticals, Inc. (NYSE MKT:NAVB) today reported
business and financial highlights for the fourth quarter and year
ended December 31, 2016.
2016 Top Highlights
- Achieved $1 million in Lymphoseek®
(technetium Tc 99m tilmanocept) injection commercial milestones
upon sale of 100,000th patient dose and receipt of European
approval to manufacture a reduced-mass vial
- Completed sale of Lymphoseek to
Cardinal Health 414, LLC (“Cardinal Health 414”) and received
approximately $83 million in upfront payments including an advance
of $3 million of future earnout payments, with up to $227 million
in potential additional earnout payments through 2026
- Initiated intravenous (“IV”) dose
escalation Phase 1 imaging/disease-finding study in rheumatoid
arthritis (“RA”) of ten cohorts with three dose cohorts completed
with major escalations and imaging of active RA
- Completed nine-subject cardiovascular
imaging disease-finding study in HIV/CV patients and published
clinical results in The Journal of Infectious Diseases
- Awarded $1.8 million Fast-track Small
Business Innovation Research (“SBIR”) Grant for Manocept™-based
treatment for Kaposi’s Sarcoma (“KS”)
- Appointed Michael M. Goldberg, M.D., as
President and Chief Executive Officer and Eric K. Rowinsky, M.D.,
as Chairman of the Board of Directors
Business and Product Development Update
This past year and first quarter of 2017 were positively
transformative for us. We refocused Navidea from investing in
developing the commercial infrastructure to sell its sole
commercial imaging product to a late-stage development company
focused on several very large imaging market opportunities, and
through its Macrophage Therapeutics, Inc. (“MT”) subsidiary
successfully advanced a number of novel immunotherapy products
through proof of concept studies in animals. In the process, we
transformed our capital structure by paying down our high interest
and very covenant restrictive debt. The Company has gone from
losing close to $28 million in 2015 to a net loss of $14 million in
2016 to operating at cash flow positive projected for 2017 not
including discretionary research projects. Furthermore the Company,
which had no excess cash flow for discretionary, non grant related
research, now has sufficient cash to advance all of our existing
imaging and MT ongoing initiatives.
While transforming our business model, balance sheet and income
statements, we made significant progress with our technology and
pipeline. We are fortunate that both our imaging and therapeutic
product candidates are based on the same drug delivery system that
targets activated macrophages, even when an additional agent is
chemically attached. In humans, we advanced two new delivery
approaches and confirmed their utility when dosed subcutaneously or
intravenously. In animals, we initiated development of an oral
delivery formulation for our therapeutic product candidates.
Additionally, we confirmed that in humans we can target the
classically-activated or M1 macrophage in patients with RA and
atherosclerosis. This is a major advance, as the alternative
activation state, or M2 macrophage, is well known to have
significantly higher cell surface expression of the mannose
receptor (CD206) than the M1 macrophage in the activated state.
Clinical results clearly demonstrate sufficient CD206 expression on
M1 activated macrophages to target this receptor with our
technology. Our animal studies confirmed as well that targeting
either M1 or M2 macrophages implicated in disease is feasible with
the appropriate therapeutic linked to our delivery system. In
animal models we verified the activity of our product candidates in
both M1-based diseases as well as M2-based diseases. Finally,
working with various academic groups we demonstrated that by
targeting the host macrophage that acts as an incubator we can
eliminate viral reservoirs containing Zika, dengue, human
immunodeficiency virus (“HIV”), human herpesvirus 8 (“HHV8”), and
other infectious agents such as leishmaniosis. We are also
currently working with National Institutes of Health (“NIH”)-funded
labs, at no cost to Navidea, to explore our antiviral and
anti-infective performance in appropriate animal models.
Financial Results
Revenues for the year ended December 31, 2016 were $22.0 million
compared to $13.2 million for 2015. Navidea’s revenues for 2016
consisted of $17.0 million in sales of Lymphoseek, $3.1 million
from various federal grants and other revenue, and $1.8 million
related to license agreements, compared to $10.3 million, $1.9
million and $1.1 million, respectively, for 2015.
Operating expenses for the year ended December 31, 2016 were
approximately $21.9 million compared to $30.0 million for 2015.
Research and development expenses were $8.9 million during 2016
compared to $12.8 million during 2015. The net decrease was
primarily a result of reductions in NAV4694, Lymphoseek and NAV5001
product development costs coupled with reduced headcount and
related support costs, offset by increased Manocept diagnostic and
therapeutic product development costs. Selling, general and
administrative expenses were approximately $13.0 million for 2016
compared to $17.3 million for 2015. The net decrease was primarily
due to reduced headcount and related support costs, contracted
medical science liaisons, business development consulting services,
market development expenses related to Lymphoseek, and investor
relations, offset by increased legal and professional services.
Navidea’s loss from operations for the year ended December 31,
2016 was $2.2 million compared to $18.6 million for 2015. For the
year ended December 31, 2016, Navidea reported a loss attributable
to common stockholders of $14.3 million, or $0.09 per share,
compared to a loss attributable to common stockholders of $27.6
million, or $0.18 per share, for the same period in 2015.
Revenues for the fourth quarter of 2016 were $3.4 million
compared to $4.3 million for the same period in 2015. Navidea’s
revenues for the fourth quarter of 2016 consisted of $2.3 million
in sales of Lymphoseek and $1.0 million from various federal grants
and other revenue, compared to $3.5 million and $541,000,
respectively, coupled with $250,000 related to license agreements,
for the same period in 2015. Additionally, approximately $2 million
in sales of Lymphoseek to Cardinal Health 414 recorded in the third
quarter of 2016 was accelerated to help facilitate the transaction
that was ultimately closed in March 2017. Without acceleration of
such, the related sales would have occurred in the fourth quarter
of 2016.
Fourth quarter 2016 operating expenses were $5.5 million
compared to $6.4 million for the fourth quarter of 2015. Research
and development expenses were $2.4 million during the fourth
quarter of 2016 compared to $2.6 million during the fourth quarter
of 2015. The net decrease from 2015 to 2016 was primarily a result
of reduced headcount and related support costs coupled with
decreased NAV4694 product development costs, offset by increased
Manocept diagnostic and Lymphoseek product development costs.
Selling, general and administrative expenses were $3.1 million for
the fourth quarter of 2016 compared to $3.8 million for the same
period in 2015. The net decrease was primarily due to reduced
headcount and related support costs, market development expenses
related to Lymphoseek and investor relations, offset by increased
legal and professional services.
Navidea’s loss from operations for the fourth quarter of 2016
was $2.4 million compared to $2.6 million for the fourth quarter of
2015. For the fourth quarter of 2016, Navidea reported a loss
attributable to common stockholders of $3.9 million, or $0.02 per
share, compared to a loss attributable to common stockholders of
$2.5 million, or $0.02 per share, for the fourth quarter of
2015.
Detailed Highlights
- Navidea and Cardinal Health 414
- Completed sale of Lymphoseek to
Cardinal Health 414 for lymphatic mapping, lymph node biopsy and
the diagnosis of metastatic spread to lymph nodes for the staging
of cancer in North America
- Received approximately $83 million in
upfront payments including an advance of $3 million of future
earnout payments, with up to $227 million in potential additional
earnout payments through 2026, $17.1 million of which is guaranteed
over the next three years
- CRG et al
- Entered into a Global Settlement
Agreement between the Company, MT, Capital Royalty Partners II L.P.
and its affiliates (“CRG”), and Cardinal Health 414 in which
Navidea repaid $59 million (the “Deposit Amount”) of its
indebtedness and other obligations outstanding under the CRG Term
Loan.
- Platinum et al
- Concurrently with payment of the
Deposit Amount to CRG, the Company also paid to Platinum Partners
Credit Opportunities Master Fund, LP (“PPCO”) an aggregate of $7.7
million in partial satisfaction of the Company’s liabilities,
obligations and indebtedness under that certain Loan Agreement,
dated July 25, 2012 (as amended) by and between the Company and
Platinum-Montaur Life Sciences, LLC, which, to the extent of such
payment, were transferred by Platinum-Montaur to PPCO.
Approximately $1.9 million remains outstanding under the Platinum
Loan Agreement.
- U.S. Food and Drug Administration
(“FDA”)
- Held several discussions/meetings with
the FDA significantly expediting development and approval timelines
for Manocept-RA disease-finding approaches to rheumatoid
arthritis
- Cardiovascular (“CV”) Initiative
- Completed nine-subject cardiovascular
imaging disease-finding study in HIV/CV patients
- Presented clinical results at CROI-2017
and published in the Journal of Infectious Disease
- Additional planned studies include a
large potential partner evaluating product in their proprietary
animal models
- Rheumatoid Arthritis
- Completed 18-subject subcutaneous
(“SC”) Manocept RA study
- Initiated RA intravenous (“IV”) dose
escalation Phase 1 imaging/disease-finding study of 10 cohorts with
three dose cohorts completed with major escalations and imaging of
active RA
- Appointed strategic clinical and
regulatory consulting firm to optimize clinical development plan
for RA imaging candidate
- Non-Alcoholic Steatohepatitis (NASH)
Therapy
- Completed three in vivo studies
employing two Manocept conjugate agents and three different dosing
regimens demonstrating effectiveness at preventing non-alcoholic
fatty liver disease (“NAFLD”) progression to NASH and NASH’s
progression to liver cirrhosis
- A poster presentation on certain of our
NASH results will be presented at a meeting next week and will be
posted on the MT website
- Cancer Therapy
- Completed three preclinical studies,
two single agent and one in combination with a well-established
therapeutic antibody (two confirmatory in vivo studies – murine
human tumor model). All three studies confirmed a positive impact
on the tumor progression and inhibition/tumor kill.
- Cancer Imaging to Treatment
- Colorectal Cancer and Liver Cancer –
completed preclinical testing for the requirements to administer
the Manocept imaging agent for colorectal cancer and colorectal
cancer with synchronous liver metastases.
- Cervical Cancer – completed a
significant portion of the clinical testing for a new indication
for imaging of metastatic disease (lymph node metastasis) in
cervical cancer. Navidea’s portion of the study will be completed
in Q1 2017.
- Lipid Storage Disease (Neuro)
- Initiated in vitro cell culture study
in which Manocept conjugates demonstrated substantial protective
effect of glial cells exposed to toxic metabolite
- Anti-Infectives
- Zika Virus – Initiated and completed
four in vitro studies in human tissue demonstrating a highly
effective reduction in Zika infectivity and antiviral activity by
multiple Manocept conjugates
- Dengue Virus – Initiated and completed
four in vitro studies in human tissue demonstrating a highly
effective reduction in dengue infectivity and antiviral activity by
multiple Manocept conjugates
- Leishmaniosis – Initiated and completed
two in vivo studies demonstrating a highly effective targeting in
Leishmaniosis infectivity and parasite activity by multiple
Manocept conjugates
- Cytomegalovirus (“CMV”) – Held
discussions with NIH/NIAID on testing of key Manocept conjugates in
CMV infection and disease progression with preclinical studies to
be initiated in H2 2017
- Kaposi’s Sarcoma
- Received NIH/NCI funding to support the
therapeutic development of anticancer (Anti-KS) Manocept
conjugates
- Phase 1 of the grant completed and
Phase 2 clinical protocols are IRB-approved with study initiation
anticipated shortly
- Human Herpes Virus 8 – The testing of
Manocept agents against HHV8 are an integral part of the Kaposi’s
Sarcoma therapy initiatives
- Human Immunodeficiency Virus – The
testing of Manocept agents against HIV is an integral part of the
KS therapy initiatives
- Completed Preclinical FDA
requirements for IV administration of tilmanocept for all
radio-diagnostic applications
- Inflammatory Bowel Disease and
Crohn’s Disease (“BD/C”)
- Initiated partnership with major pharma
group to assess the efficacy of Manocept conjugates in appropriate
in vivo models with results anticipated in the coming months.
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 and platforms including Manocept™ and
NAV4694 to help identify the sites and pathways of undetected
disease and enable better diagnostic accuracy, clinical
decision-making, targeted treatment and, ultimately, patient care.
Lymphoseek® (technetium Tc 99m tilmanocept) injection, Navidea’s
first commercial product from the Manocept platform, was approved
by the FDA in March 2013 and in Europe in November 2014. The
development activities of the Manocept immunotherapeutic platform
will be conducted by Navidea in conjunction with its subsidiary,
Macrophage Therapeutics. 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 December 31, December 31, 2016 2015
(unaudited)
Assets: Cash $ 1,539,325 $ 7,166,260 Restricted cash
5,001,253 - Other current assets 4,285,691 5,410,914 Non-current
assets 1,635,407 2,387,339 Total assets
$ 12,461,676 $ 14,964,513 Liabilities and
stockholders' deficit: Deferred revenue, current $ 2,315,037 $
1,044,281 Notes payable, current 51,957,913 333,333 Other current
liabilities 15,588,838 4,806,236 Notes payable, net of discount
9,641,179 60,746,002 Other liabilities 624,922
1,870,361 Total liabilities 80,127,889
68,800,213 Navidea stockholders' deficit (68,135,123 )
(54,305,258 ) Noncontrolling interest 468,910
469,558 Total stockholders' deficit (67,666,213 )
(53,835,700 ) Total liabilities and stockholders' deficit $
12,461,676 $ 14,964,513
CONDENSED
CONSOLIDATED STATEMENTS OF OPERATIONS Three Months Ended
Twelve Months Ended December 31, December 31, December 31, December
31, 2016 2015 2016 2015 (unaudited) (unaudited) (unaudited)
Revenue: Lymphoseek sales revenue $ 2,332,609 $ 3,502,860 $
17,037,098 $ 10,254,352 Lymphoseek license revenue - 250,000
1,795,625 1,133,333 Grant and other revenue 1,022,988
540,806 3,136,983 1,861,622
Total revenue 3,355,597 4,293,666
21,969,706 13,249,307 Cost of
good sold 279,554 515,386
2,297,040 1,754,763 Gross profit
3,076,043 3,778,280 19,672,666
11,494,544 Operating expenses: Research and
development 2,421,422 2,607,216 8,882,576 12,787,733 Selling,
general and administrative 3,087,991 3,771,753
13,013,565 17,257,329 Total
operating expenses 5,509,413 6,378,969
21,896,141 30,045,062 Loss from
operations (2,433,370 ) (2,600,689 )
(2,223,475 ) (18,550,518 ) Other income (expense): Interest
expense, net (2,573,101 ) (2,183,050 ) (14,861,270 ) (6,873,736 )
Equity in the loss of joint venture - (10,036 ) (15,159 ) (305,253
) Loss on disposal of joint venture - - (39,732 ) - Change in fair
value of financial instruments 1,102,535 1,088,120 2,858,524
(614,782 ) Loss on extinguishment of debt - - - (2,440,714 ) Other
income (expense), net 21,997 708
(27,919 ) 26,808 Net loss (3,881,939 ) (3,704,947 )
(14,309,031 ) (28,758,195 ) Benefit from income taxes -
436,051 - 436,051
Loss from continuing operations (3,881,939 ) (3,268,896 )
(14,309,031 ) (28,322,144 ) Income from discontinued operations,
net of tax - 758,609 -
758,609 Net loss (3,881,939 ) (2,510,287 )
(14,309,031 ) (27,563,535 ) Less loss attributable to
noncontrolling interest (132 ) (174 ) (648 ) (855 ) Deemed dividend
on beneficial conversion feature - -
- (46,000 ) Net loss attributable to common
stockholders $ (3,881,807 ) $ (2,510,113 ) $ (14,308,383 ) $
(27,608,680 ) Loss per common share (basic and diluted):
Continuing operations $ (0.02 ) $ (0.02 ) $ (0.09 ) $ (0.19 )
Discontinued operations $ - $ 0.00 $ - $ 0.01 Attributable to
common stockholders $ (0.02 ) $ (0.02 ) $ (0.09 ) $ (0.18 )
Weighted average shares outstanding (basic and diluted) 155,516,120
154,591,487 155,422,384 151,180,222
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version on businesswire.com: http://www.businesswire.com/news/home/20170329006102/en/
Navidea BiopharmaceuticalsJed Latkin (investors &
media)Interim COO & CFOjlatkin@navidea.comorEdison
AdvisorsTirth Patel (investors)tpatel@edisongroup.com
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