[March 29, 2017] |
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Navidea Provides Corporate Update and Reports Full Year 2016 Results
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
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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
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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
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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
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Awarded $1.8 million Fast-track Small Business Innovation Research
("SBIR") Grant for Manocept™-based treatment for Kaposi's Sarcoma
("KS")
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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
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Navidea and Cardinal Health 414
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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
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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
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CRG (News - Alert) et al
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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.
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Platinum et al
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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.
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U.S. Food and Drug Administration ("FDA")
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Held several discussions/meetings with the FDA significantly
expediting development and approval timelines for Manocept-RA
disease-finding approaches to rheumatoid arthritis
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Cardiovascular ("CV") Initiative
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Completed nine-subject cardiovascular imaging disease-finding
study in HIV/CV patients
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Presented clinical results at CROI-2017 and published in the Journal
of Infectious Disease
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Additional planned studies include a large potential partner
evaluating product in their proprietary animal models
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Rheumatoid Arthritis
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Completed 18-subject subcutaneous ("SC") Manocept RA study
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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
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Appointed strategic clinical and regulatory consulting firm to
optimize clinical development plan for RA imaging candidate
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Non-Alcoholic Steatohepatitis (NASH) Therapy
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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
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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
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Cancer Therapy
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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.
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Cancer Imaging to Treatment
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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.
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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.
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Lipid Storage Disease (Neuro)
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Initiated in vitro cell culture study in which Manocept
conjugates demonstrated substantial protective effect of glial
cells exposed to toxic metabolite
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Anti-Infectives
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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
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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
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Leishmaniosis - Initiated and completed two in vivo studies
demonstrating a highly effective targeting in Leishmaniosis
infectivity and parasite activity by multiple Manocept conjugates
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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
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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
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Human Herpes Virus 8 - The testing of Manocept agents against HHV8
are an integral part of the Kaposi's Sarcoma therapy initiatives
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Human Immunodeficiency Virus - The testing of Manocept agents
against HIV is an integral part of the KS therapy initiatives
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Completed Preclinical FDA requirements for IV administration of
tilmanocept for all radio-diagnostic applications
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Inflammatory Bowel Disease and Crohn's Disease ("BD/C")
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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.
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NAVIDEA BIOPHARMACEUTICALS, INC.
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CONDENSED CONSOLIDATED BALANCE SHEETS
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December 31,
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December 31,
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2016
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2015
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(unaudited)
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Assets:
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Cash
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$
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1,539,325
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$
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7,166,260
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Restricted cash
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5,001,253
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-
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Other current assets
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4,285,691
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5,410,914
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Non-current assets
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1,635,407
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2,387,339
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Total assets
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$
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12,461,676
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$
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14,964,513
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Liabilities and stockholders' deficit:
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Deferred revenue, current
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$
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2,315,037
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$
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1,044,281
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Notes payable, current
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51,957,913
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333,333
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Other current liabilities
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15,588,838
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4,806,236
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Notes payable, net of discount
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9,641,179
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60,746,002
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Other liabilities
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624,922
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1,870,361
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Total liabilities
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80,127,889
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68,800,213
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Navidea stockholders' deficit
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(68,135,123
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)
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(54,305,258
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Noncontrolling interest
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468,910
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469,558
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Total stockholders' deficit
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(67,666,213
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)
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(53,835,700
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)
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Total liabilities and stockholders' deficit
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$
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12,461,676
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$
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14,964,513
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CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
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Three Months Ended
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Twelve Months Ended
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December 31,
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December 31,
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December 31,
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December 31,
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2016
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2015
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2016
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2015
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(unaudited)
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(unaudited)
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(unaudited)
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Revenue:
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Lymphoseek sales revenue
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$
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2,332,609
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$
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3,502,860
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$
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17,037,098
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$
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10,254,352
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Lymphoseek license revenue
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-
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250,000
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1,795,625
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1,133,333
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Grant and other revenue
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1,022,988
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540,806
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3,136,983
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1,861,622
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Total revenue
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3,355,597
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4,293,666
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21,969,706
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13,249,307
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Cost of good sold
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279,554
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515,386
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2,297,040
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1,754,763
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Gross profit
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3,076,043
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3,778,280
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19,672,666
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11,494,544
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Operating expenses:
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Research and development
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2,421,422
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2,607,216
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8,882,576
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12,787,733
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Selling, general and administrative
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3,087,991
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3,771,753
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13,013,565
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17,257,329
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Total operating expenses
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5,509,413
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6,378,969
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21,896,141
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30,045,062
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Loss from operations
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(2,433,370
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(2,600,689
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(2,223,475
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(18,550,518
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Other income (expense):
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Interest expense, net
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(2,573,101
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(2,183,050
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(14,861,270
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(6,873,736
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Equity in the loss of joint venture
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-
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(10,036
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(15,159
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)
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(305,253
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Loss on disposal of joint venture
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-
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-
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(39,732
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-
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Change in fair value of financial instruments
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1,102,535
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1,088,120
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2,858,524
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(614,782
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Loss on extinguishment of debt
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-
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-
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-
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(2,440,714
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Other income (expense), net
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21,997
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708
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(27,919
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26,808
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Net loss
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(3,881,939
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(3,704,947
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(14,309,031
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(28,758,195
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Benefit from income taxes
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|
-
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436,051
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-
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436,051
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Loss from continuing operations
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(3,881,939
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)
|
|
|
|
|
(3,268,896
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|
|
|
|
(14,309,031
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)
|
|
|
|
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(28,322,144
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Income from discontinued operations, net of tax
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|
|
|
-
|
|
|
|
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758,609
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|
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-
|
|
|
|
|
|
758,609
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Net loss
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|
|
|
(3,881,939
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)
|
|
|
|
|
(2,510,287
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)
|
|
|
|
|
(14,309,031
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)
|
|
|
|
|
(27,563,535
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Less loss attributable to noncontrolling interest
|
|
|
|
(132
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)
|
|
|
|
|
(174
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)
|
|
|
|
|
(648
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)
|
|
|
|
|
(855
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)
|
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
|
|
View source version on businesswire.com: http://www.businesswire.com/news/home/20170329006102/en/
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|