Navidea Biopharmaceuticals, Inc. (NYSE MKT: NAVB), today
announced financial results for the second quarter of 2015. Navidea
reported total revenue for the second quarter of 2015 of $2.9
million, including Lymphoseek® (technetium Tc 99m
tilmanocept) injection sales revenue of $2.0 million. The net
loss from operations was $3.8 million and the net loss attributable
to common stockholders was $9.7 million.
“During the first half of this year we successfully undertook a
strategy to transform the Company and we have been executing to
that plan,” commented Rick Gonzalez, Navidea’s President and CEO.
“We deployed a new commercial strategy, overhauled the Lymphoseek
brand plan reflective of the brand’s clinical value proposition,
optimized operational efficiencies across the organization,
strengthened our financial position and made progress in a
cost-effective fashion to expand our development pipeline of both
imaging and therapeutic programs. Today we are on a clear path,
whereby our revenue growth is quickly converging with our reduced
operating expenses, getting us closer to the goal of achieving cash
flow breakeven in the first quarter of next year.”
Specific events and milestones achieved since the beginning of
the second quarter include the following:
Commercial
- Achieved sequential quarter-on-quarter
Lymphoseek revenue growth and continued improvement in key
performance indicators;
- Fully deployed a Lymphoseek-dedicated
field force mid-second quarter;
- Exercised pricing leverage, as per
plan, resulting in a 39% Lymphoseek price increase beginning July
31st;
- Reported positive Lymphoseek
comparative results from an injection site pain study in breast
cancer presented at the 2015 Society of Nuclear Medicine and
Molecular Imaging annual meeting;
Lymphoseek Lifecycle Management
- Awarded NIH grants to explore new
applications of the Manocept™ platform for cardiovascular disease
and rheumatoid arthritis (RA) totaling up to $2.0 million;
- Received confirmation of continued
development funding under part 2 of a previously awarded NIH grant
for Lymphoseek in cervical cancer totaling $1.5 million;
- Reported clinical imaging data
demonstrating Tc 99m tilmanocept localizes in Kaposi’s sarcoma (KS)
tumor lesions including brain lesions;
- Verified Manocept CD206-targeting
mechanism of action with publication in peer-reviewed Journal of
Immunology providing clear clinical differentiation from other
non-targeted agents and showing future potential for the delivery
of therapeutics for cancer and other macrophage-dependent
diseases;
Operational & Financial
- Reduced cash burn by over 40% for the
first half of 2015 compared to the first half of 2014;
- Secured approximately $18 million in
additional net capital;
- Completed the divestiture of the
Company’s investigational imaging agent for the detection of
Parkinson’s disease;
- Continued partnering/divestiture
efforts for the Company’s investigational imaging agent, NAV4694,
for the detection of amyloid plaques in Alzheimer’s disease;
Therapeutic & Diagnostic Development Pipeline
- Reported data demonstrating that a
Manocept-Doxorubicin (MT-1001) conjugate selectively targets
tumor-associated macrophages and destroys the cells through an
apoptotic mechanism;
- Formed a research collaboration with
BIND Therapeutics to engineer CD206 targeted nanoparticles using
Manocept;
- Reported positive Manocept
proof-of-concept data demonstrating the potential for the Manocept
platform as a diagnostic and therapeutic for rheumatologic
conditions; and,
- Received confirmation of continued
NIH-grant funding for clinical trials of NAV4694 in Alzheimer’s
Disease and Mild Cognitive Impairment totaling $1.7 million.
Financials
Total revenues for the quarter ended June 30, 2015 were $2.9
million compared to $1.1 million in the second quarter of last
year. Second quarter 2015 product revenues recognized from the sale
of Lymphoseek were $2.0 million, compared to $1.8 million in the
first quarter of 2015 and $1.0 million in the second quarter of
last year. During the second quarter of 2015, the Company also
reported $904,000 in grant, licensing and other revenue. For the
six months ended June 30, 2015, Navidea’s total revenue was $5.0
million compared to $1.8 million for the same period in 2014, an
increase of 172%. The primary driver of this increase was revenues
recognized from the sale and license of Lymphoseek which exceeded
$4.1 million for the six months ended June 30, 2015 compared to
$1.7 million for the same period last year.
Gross margins on Lymphoseek product sales grew to 83% for the
second quarter of 2015 compared to 74% for the second quarter of
2014 due in part to our success in lowering our manufacturing costs
coupled with our ability to sell certain previously reserved
inventory.
Research and development (R&D) expenses for the second
quarter of 2015 were $2.3 million, compared to $5.1 million in the
second quarter of last year. R&D expenses were $6.3 million for
the six months ended June 30, 2015 compared to $10.3 million in the
same period of 2014. The net decreases in R&D expenses were
primarily a result of decreased project costs related to the
Company’s neuro assets coupled with decreased headcount costs.
Selling, general and administrative (SG&A) expenses for the
second quarter of 2015 were $4.0 million, compared to $4.9 million
in the second quarter of last year. SG&A expenses were $9.5
million for the six months ended June 30, 2015, compared to $8.8
million for the same period in 2014 and included $765,000 and $1.4
million, respectively, in termination-related costs associated with
reductions in force implemented in the impacted periods. The net
increase in year-to-date SG&A expenses was due primarily to net
increases in commercial headcount costs related to the addition of
our internal sales force offset by decreased costs related to
contracted medical science liaisons. Total operating expenses were
$6.3 million for the second quarter of 2015, compared to $10.0
million in the second quarter of last year. Operating expenses were
$15.8 million for the six months ended June 30, 2015, compared to
$19.2 million for the same period in 2014.
Navidea’s net loss from operations for the quarter ended June
30, 2015 was $3.8 million compared to $9.2 million for the same
period in 2014. For the six months ended June 30, 2015, Navidea’s
net loss from operations was $11.6 million compared to a net loss
from operations of $17.8 million for the same period in 2014.
Navidea’s net loss attributable to common stockholders for the
quarter ended June 30, 2015 was $9.7 million, or $0.06 per share,
compared to $10.2 million, or $0.07 per share, for the same period
in 2014. For the six months ended June 30, 2015, Navidea’s net loss
attributable to common stockholders was $17.0 million, or $0.11 per
share, compared to a net loss attributable to common stockholders
of $22.0 million, or $0.15 per share, for the same period in 2014.
Net losses attributable to common stockholders include the cash
interest expense on our outstanding debt, as well as significant
non-cash charges. For the six month periods ended June 30, 2015 and
June 30, 2014, net loss attributable to common stockholders
included $3.4 million and $2.7 million, respectively, in non-cash
interest, losses on extinguishment of debt, and changes in the fair
value of financial instruments.
Navidea ended the quarter with $15.8 million in cash. The
Company reiterates its 2015 Lymphoseek product revenue estimate of
$10 million to $12 million. The Company also expects, following
completion of the partnering activities for NAV4694, that cash
operating expenses on a quarterly basis will decrease to the point
necessary for the Company to achieve its goals of cash flow
breakeven from operations. This guidance excludes
therapeutic-related research and development costs for the Manocept
platform which are expected to be funded separately by Macrophage
Therapeutics, Inc.
“With each passing quarter, we continue to take steps towards
achieving our goal of cash flow breakeven,” said Brent Larson,
Navidea’s EVP and CFO. “We began this second quarter with a solid
refinancing, positioning our balance sheet to support a pivotal
second half of the year in which we expect to realize the impact of
our new sales force on Lymphoseek’s revenue growth. This growth,
coupled with continued emphasis on controlling our spending, should
put us in a strong position to achieve our goals.”
Commercialization
The new commercialization plan aligns our sales force to target
the oncology treatment team focusing on the surgical oncologist.
Initial commercial efforts are being concentrated in breast cancer,
melanoma, and oral cavity head and neck cancers, where sentinel
lymph node biopsies are already standard of care. The Lymphoseek
clinical value proposition and its highly differentiated label
provide compelling benefits to the oncology treatment team.
“We achieved our full field force deployment during the middle
of the second quarter, positioning us to ramp up Lymphoseek sales
according to plan in the second half of 2015,” said Thomas Klima,
SVP and Chief Commercial Officer. “We are on track with our key
performance indicators including brand revenues, monthly procedure
growth, brand awareness and message recall measurements. We are
ahead of plan in the number of accounts purchasing for the first
time and in our account product re-order rate. Based on the
anticipated impact of the deployment of our sales force, our
positive first half revenues, strong key performance indicators and
a planned July 31st price increase, we remain confident in our
ability to meet our 2015 sales projections.”
Manocept Pipeline
Our future business will be dependent on development of the
Manocept CD206 targeting platform for diagnostic and therapeutic
applications. Recent Manocept presentations have reported
proof-of-concept localization results in humans and early potential
seen in Manocept-drug conjugate delivery resulting in apoptosis of
tumor cells and associated macrophages in a KS pre-clinical study.
At recent medical conferences, the company and its research
collaborators reported the following data:
- Results were presented in RA at EULAR
2015 European Congress of Rheumatology which highlighted the
potential of CD206-targeting Manocept constructs to detect
immune-mediated inflammation in RA which could be used
diagnostically, to monitor therapeutic efficacy or as a potential
therapeutic platform;
- Data were presented at the 18th
International Workshop on Kaposi's Sarcoma Herpesvirus and
Related Agents demonstrating the imaging and therapeutic potential
for our CD206 targeting platform, Manocept, including inducing
apoptosis in KS tumor tissue and tumor associated macrophages.
“We continue to build growing evidence supporting the potential
of immunotherapeutic applications for Manocept based on these
encouraging results,” said Frederick O. Cope, Ph.D., SVP and Chief
Scientific Officer of Navidea. “Our plans are to continue studies
that will validate Lymphoseek’s ability to identify sites of
disease and, through our Macrophage Therapeutics subsidiary,
evaluate the modulation and/or destruction of macrophages and seek
lucrative partnering and collaboration agreements to develop
promising therapeutic applications.”
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 replay is expected to be available on our investor website,
http://ir.navidea.com, approximately two to four hours after the
live event.
Event: Navidea Biopharmaceuticals Q2 2015 Financial
Results Conference Call Date/Time: Thursday, July 30, 2015
at 8:30 a.m. EDT Webcast Link:
http://edge.media-server.com/m/p/amn8cqij/lan/en
Dial-in Number – US: (855) 897-5884 Dial in Number –
Int’l: (720) 634-2940 Confirmation Number: 92935833
Replay:
A webcast replay will be available on the
Investor Relations section of our website at http://ir.navidea.com
for 30 days.
About Lymphoseek
Lymphoseek® (technetium Tc 99m tilmanocept) injection is the
first and only FDA-approved receptor-targeted lymphatic mapping
agent. It is a novel, receptor-targeted, small-molecule
radiopharmaceutical used in the evaluation of lymphatic basins that
may have cancer involvement in patients. Lymphoseek is designed for
the precise identification of lymph nodes that drain from a primary
tumor, which have the highest probability of harboring cancer.
Lymphoseek is approved by the U.S. Food and Drug Administration
(FDA) for use in solid tumor cancers where lymphatic mapping is a
component of surgical management and for guiding sentinel lymph
node biopsy in patients with clinically node negative breast
cancer, melanoma or squamous cell carcinoma of the oral cavity.
Lymphoseek has also received European approval in imaging and
intraoperative detection of sentinel lymph nodes in patients with
melanoma, breast cancer or localized squamous cell carcinoma of the
oral cavity.
Accurate diagnostic evaluation of cancer is critical, as it
guides therapy decisions and determines patient prognosis and risk
of recurrence. Overall in the U.S., solid tumor cancers may
represent up to 1.2 million cases per year. The sentinel node label
in the U.S. and Europe may address approximately 235,000 new cases
of breast cancer, 76,000 new cases of melanoma and 45,000 new cases
of head and neck/oral cancer in the U.S., and approximately 367,000
new cases of breast cancer, 83,000 new cases of melanoma and 55,000
new cases of head and neck/oral cancer diagnosed in Europe
annually.
Lymphoseek Indication and Important Safety
Information
Lymphoseek is a radioactive diagnostic agent indicated with or
without scintigraphic imaging for:
- Lymphatic mapping using a handheld
gamma counter to locate lymph nodes draining a primary tumor site
in patients with solid tumors for which this procedure is a
component of intraoperative management.
- Guiding sentinel lymph node biopsy
using a handheld gamma counter in patients with clinically node
negative squamous cell carcinoma of the oral cavity, breast cancer
or melanoma.
Important Safety Information
In clinical trials with Lymphoseek, no serious hypersensitivity
reactions were reported, however Lymphoseek may pose a risk of such
reactions due to its chemical similarity to dextran. Serious
hypersensitivity reactions have been associated with dextran and
modified forms of dextran (such as iron dextran drugs).
Prior to the administration of Lymphoseek, patients should be
asked about previous hypersensitivity reactions to drugs, in
particular dextran and modified forms of dextran. Resuscitation
equipment and trained personnel should be available at the time of
Lymphoseek administration, and patients observed for signs or
symptoms of hypersensitivity following injection.
Any radiation-emitting product may increase the risk for cancer.
Adhere to dose recommendations and ensure safe handling to minimize
the risk for excessive radiation exposure to patients or health
care workers. In clinical trials, no patients experienced serious
adverse reactions and the most common adverse reactions were
injection site irritation and/or pain (<1%).
FULL LYMPHOSEEK PRESCRIBING INFORMATION CAN BE FOUND AT:
WWW.LYMPHOSEEK.COM
About Navidea
Navidea Biopharmaceuticals, Inc. (NYSE MKT: NAVB) is a
biopharmaceutical company focused on the development and
commercialization of precision diagnostics, therapeutics and
radiopharmaceutical agents. 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. Navidea’s
strategy is to deliver superior growth and shareholder return by
bringing to market novel radiopharmaceutical agents and
therapeutics, and advancing the Company’s pipeline through global
partnering and commercialization efforts. For more information,
please visit www.navidea.com.
The Private Securities Litigation Reform Act of 1995 (the Act)
provides a safe harbor for forward-looking statements made by or on
behalf of the Company. Statements in this news release, which
relate to other than strictly historical facts, such as statements
about the Company’s plans and strategies, expectations for future
financial performance, new and existing products and technologies,
anticipated clinical and regulatory pathways, and markets for the
Company’s products are forward-looking statements within the
meaning of the Act. The words “believe,” “expect,” “anticipate,”
“estimate,” “project,” and similar expressions identify
forward-looking statements that speak only as of the date hereof.
Investors are cautioned that such statements involve risks and
uncertainties that could cause actual results to differ materially
from historical or anticipated results due to many factors
including, but not limited to, the Company’s continuing operating
losses, uncertainty of market acceptance of its products, reliance
on third party manufacturers, accumulated deficit, future capital
needs, uncertainty of capital funding, dependence on limited
product line and distribution channels, competition, limited
marketing and manufacturing experience, risks of development of new
products, regulatory risks and other risks detailed in the
Company’s most recent Annual Report on Form 10-K and other
Securities and Exchange Commission filings. The Company undertakes
no obligation to publicly update or revise any forward-looking
statements.
FINANCIAL TABLES TO FOLLOW
NAVIDEA BIOPHARMACEUTICALS, INC.
CONDENSED
CONSOLIDATED BALANCE SHEETS June 30, December 31, 2015
2014 (unaudited) Assets: Cash $ 15,790,235 $
5,479,006 Other current assets 3,740,817 3,120,139 Non-current
assets 2,667,537 3,321,035 Total
assets $ 22,198,589 $ 11,920,180
Liabilities and stockholders' deficit: Deferred revenue,
current $ 1,000,000 $ - Notes payable, net of discount, current
333,333 4,383,472 Other current liabilities 4,255,359 4,711,619
Deferred revenue 666,667 - Notes payable, net of discount
58,836,254 29,539,135 Other liabilities 1,725,477
3,089,420 Total liabilities 66,817,090
41,723,646 Navidea stockholders' deficit
(45,088,427 ) (29,803,466 ) Noncontrolling interest 469,926
- Total stockholders' deficit
(44,618,501 ) (29,803,466 ) Total liabilities and
stockholders' deficit $ 22,198,589 $ 11,920,180
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
Three Months Ended Six Months Ended June 30, June 30, June
30, June 30, 2015 2014 2015 2014 (unaudited) (unaudited)
(unaudited) (unaudited) Revenue: Lymphoseek sales revenue $
1,963,548 $ 1,046,257 $ 3,798,970 $ 1,672,888 Lymphoseek license
revenue 250,000 - 333,333 - Grant and other revenue 654,360
28,433 844,061 153,606
Total revenue 2,867,908 1,074,690
4,976,364 1,826,494 Cost
of goods sold 332,730 270,498
781,787 463,718 Gross profit
2,535,178 804,192 4,194,577
1,362,776 Operating expenses: Research and
development 2,297,074 5,112,098 6,278,362 10,338,892
Selling, general and administrative
4,048,799 4,907,652 9,542,967
8,818,485 Total operating expenses
6,345,873 10,019,750 15,821,329
19,157,377 Loss from operations
(3,810,695 ) (9,215,558 ) (11,626,752 )
(17,794,601 ) Interest expense, net (1,575,741 ) (909,051 )
(2,542,317 ) (1,846,096 ) Equity in the loss of joint venture
(6,205 ) - (268,432 ) - Change in fair value of financial
instruments (1,852,730 ) (92,332 ) (125,627 ) 300,151 Loss on
extinguishment of debt (2,440,714 ) - (2,440,714 ) (2,610,196 )
Other income (expense), net (4,834 ) (5,293 )
21,698 (12,045 ) Net loss (9,690,919 )
(10,222,234 ) (16,982,144 ) (21,962,787 ) Net loss attributable to
noncontrolling interest (387 ) - (487 ) - Deemed dividend on
beneficial conversion feature - -
(46,000 ) - Net loss attributable to
common stockholders $ (9,690,532 ) $ (10,222,234 ) $ (17,027,657 )
$ (21,962,787 ) Loss per common share (basic and diluted) $
(0.06 ) $ (0.07 ) $ (0.11 ) $ (0.15 ) Weighted average
shares outstanding (basic and diluted) 150,107,148 150,019,939
149,951,603 147,416,111
View source
version on businesswire.com: http://www.businesswire.com/news/home/20150730005398/en/
Navidea BiopharmaceuticalsInvestorsTom Baker,
617-532-0624tbaker@navidea.comorMediaSharon Correia, 978-655-2686Associate
Director, Corporate Communications
Navidea Biopharmaceuticals (AMEX:NAVB)
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