[July 30, 2015] |
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Navidea Reports Second Quarter 2015 Financial Results; Reiterates 2015 Lymphoseek® Revenue Guidance
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
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Achieved sequential quarter-on-quarter Lymphoseek revenue growth and
continued improvement in key performance indicators;
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Fully deployed a Lymphoseek-dedicated field force mid-second quarter;
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Exercised pricing leverage, as per plan, resulting in a 39% Lymphoseek
price increase beginning July 31st;
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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
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Awarded NIH grants to explore new applications of the Manocept™
platform for cardiovascular disease and rheumatoid arthritis (RA)
totaling up to $2.0 million;
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Received confirmation of continued development funding under part 2 of
a previously awarded NIH grant for Lymphoseek in cervical cancer
totaling $1.5 million;
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Reported clinical imaging data demonstrating Tc 99m tilmanocept
localizes in Kaposi's sarcoma (KS) tumor lesions including brain
lesions;
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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
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Reduced cash burn by over 40% for the first half of 2015 compared to
the first half of 2014;
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Secured approximately $18 million in additional net capital;
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Completed the divestiture of the Company's investigational imaging
agent for the detection of Parkinson's disease;
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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
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Reported data demonstrating that a Manocept-Doxorubicin (MT-1001)
conjugate selectively targets tumor-associated macrophages and
destroys the cells through an apoptotic mechanism;
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Formed a research collaboration with BIND Therapeutics to engineer
CD206 targeted nanoparticles using Manocept;
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Reported positive Manocept proof-of-concept data demonstrating the
potential for the Manocept platform as a diagnostic and therapeutic
for rheumatologic conditions; and,
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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:
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Navidea Biopharmaceuticals Q2 2015 Financial Results Conference Call
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Date/Time:
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Thursday, July 30, 2015 at 8:30 a.m. EDT
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Webcast Link:
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http://edge.media-server.com/m/p/amn8cqij/lan/en
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Dial-in Number - US:
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(855) 897-5884
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Dial in Number - Int'l:
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(720) 634-2940
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Confirmation Number:
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92935833
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Replay:
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A webcast replay will be available on the Investor Relations
section of our website at http://ir.navidea.com
for 30 days.
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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.
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CONDENSED CONSOLIDATED BALANCE SHEETS
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June 30,
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December 31,
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2015
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2014
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(unaudited)
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Assets:
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Cash
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$
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15,790,235
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$
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5,479,006
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Other current assets
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3,740,817
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3,120,139
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Non-current assets
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2,667,537
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3,321,035
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Total assets
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$
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22,198,589
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$
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11,920,180
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Liabilities and stockholders' deficit:
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Deferred revenue, current
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$
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1,000,000
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$
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-
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Notes payable, net of discount, current
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333,333
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4,383,472
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Other current liabilities
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4,255,359
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4,711,619
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Deferred revenue
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666,667
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-
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Notes payable, net of discount
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58,836,254
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29,539,135
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Other liabilities
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1,725,477
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3,089,420
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Total liabilities
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66,817,090
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41,723,646
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Navidea stockholders' deficit
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(45,088,427
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(29,803,466
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Noncontrolling interest
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469,926
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-
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Total stockholders' deficit
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(44,618,501
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(29,803,466
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Total liabilities and stockholders' deficit
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$
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22,198,589
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$
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11,920,180
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CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
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Three Months Ended
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Six Months Ended
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June 30,
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June 30,
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June 30,
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June 30,
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2015
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2014
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2015
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2014
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(unaudited)
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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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1,963,548
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$
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1,046,257
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$
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3,798,970
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$
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1,672,888
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Lymphoseek license revenue
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250,000
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-
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333,333
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-
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Grant and other revenue
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654,360
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28,433
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844,061
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153,606
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Total revenue
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2,867,908
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1,074,690
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4,976,364
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1,826,494
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Cost of goods sold
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332,730
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270,498
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781,787
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463,718
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Gross profit
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2,535,178
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804,192
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4,194,577
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1,362,776
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Operating expenses:
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Research and development
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2,297,074
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5,112,098
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6,278,362
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10,338,892
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Selling, general and administrative
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4,048,799
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4,907,652
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9,542,967
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8,818,485
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Total operating expenses
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6,345,873
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10,019,750
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15,821,329
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19,157,377
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Loss from operations
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(3,810,695
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(9,215,558
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(11,626,752
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(17,794,601
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Interest expense, net
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(1,575,741
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)
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(909,051
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)
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(2,542,317
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)
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(1,846,096
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)
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Equity in the loss of joint venture
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(6,205
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)
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-
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(268,432
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)
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|
-
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Change in fair value of financial instruments
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(1,852,730
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)
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(92,332
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)
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(125,627
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)
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300,151
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Loss on extinguishment of debt
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(2,440,714
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)
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-
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(2,440,714
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)
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|
|
(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/
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