Navidea Biopharmaceuticals (NYSE MKT:NAVB) reports financial
results for the quarter ending September 30, 2015. The Company
achieved the following financial highlights:
- Third quarter 2015 total revenue of $4
million; comprised of $3 million in Lymphoseek® (technetium Tc 99m
tilmanocept) injection sales, $550,000 in Lymphoseek license
revenue, and $477,000 in grant and other revenue
- 50% sequential quarterly and 168%
year-over-year third quarter Lymphoseek product sales growth
- Year-to-date gross margins on product
sales of 82%
- $6.8 million in 2015 year-to-date
product sales, which puts the Company on track to achieve our
product revenue guidance.
“We continue to execute on the new commercial strategy we put in
place to start the year for our immuno-diagnostic product,
Lymphoseek,” said Rick Gonzalez, President and Chief Executive
Officer. “Sales growth is anticipated to continue in the fourth
quarter and into 2016 and beyond based on further penetration of
the sentinel lymph node market; expansion to lymphatic mapping with
additional solid tumors; and the impact from additional hospital
system and institution-wide sales activities.”
Mr. Gonzalez continued, “To position us for longer-term growth,
clinical development will begin next year for new imaging
applications in Kaposi’s sarcoma, rheumatoid arthritis and
cardiovascular disease. These pipeline opportunities create a
valuable bridge to potential immuno-therapeutics, which, similar to
Lymphoseek, would take advantage of the Manocept platform’s ability
to selectively target disease-associated immune cells.”
PRODUCT & PIPELINE
UPDATES
Lymphoseek
- Published results in the Journal of
Surgical Oncology showing a statistically significant reduction in
pain for Lymphoseek vs. sulfur colloid, a key differentiator for
patients and physicians
- Continued market development activities
with Company and investigator-initiated studies in cervical cancer,
pediatric solid tumors, anal-rectal cancer, and for further
confirmation of workflow efficiency compared to sulfur colloid
Technetium Tc 99m tilmanocept Pipeline
- Advanced development efforts for
intravenous and subcutaneous delivery
- Awarded NIH grants to develop the
product for early detection of rheumatoid arthritis (RA) and
cardiovascular disease
- Academic collaborators continued
development for clinical imaging of Kaposi’s sarcoma tumor
lesions
Manocept™ Therapeutic Development Pipeline
- Received Manocept-bound Accurins from
BIND Therapeutics, Inc. for potential use in targeting analysis of
disease-associated macrophages
- Reported data demonstrating that a
Manocept-doxorubicin (MT-1001) conjugate selectively targets
tumor-associated macrophages and destroys the cells through an
apoptotic mechanism
FINANCIALS
“Growth in Lymphoseek sales combined with funding from grants
and our continued efforts to contain costs have contributed to an
overall trend of reduction in our quarterly cash burn,” said Brent
Larson, Navidea’s Chief Financial Officer. “We remain confident
that we will see additional commercial momentum during the fourth
quarter and into 2016 as a result of the impact from the field
sales force we deployed in May. This expected increase, coupled
with an estimated gross margin in excess of 80%, means that each
incremental dollar of revenue our sales force generates has a
significant positive impact on our cash flow. During 2015, we have
continued making limited investment in the NAV4694 clinical trial
process based on our expectation that we will be successful in
ultimately securing a partnership that will provide us some level
of return on this investment. However, in addition to a potential
return, the elimination of expenses related to this asset is also
expected to have positive near-term contribution to our cash
burn.”
Revenue & Gross Profit
Total revenue for the quarter ended September 30, 2015 reached
$4 million, and for the nine months then ended, reached $9 million.
Of these amounts, Lymphoseek sales revenue grew to $3 million for
the quarter and $6.8 million for the nine months ended September
30, 2015, which represents 168% and 143% in year over year growth
for the respective periods. The primary driver of this increase was
increased adoption of Lymphoseek by new customers. Third quarter
2015 margins also remained above 80% contributing to a total gross
profit of $3.5 million for the quarter.
Three Months Ended Nine Months Ended
September30,
September30,
September30,
September30,
2015 2014 2015 2014 (unaudited)
(unaudited) (unaudited) (unaudited) Revenue: Lymphoseek sales
revenue $ 2,952,522 $ 1,101,071 $ 6,751,492 $ 2,773,959 Lymphoseek
license revenue 550,000 300,000 883,333 300,000 Grant and other
revenue 476,755 848,999 1,320,816
1,002,605 Total revenue 3,979,277 2,250,070
8,955,641 4,076,564 Gross profit $ 3,521,687 $
1,442,190 $ 7,716,264 $ 2,804,966
Operating Expenses, Income & Balance Sheet
The Company reduced net loss for the quarter and nine months
ended September 30, 2015 compared to the same periods in the prior
year. Two of the key factors in these reductions were the sales
growth and decreased R&D expenses on a year-to-date basis
related to the Company’s non-core neuroimaging assets coupled with
decreased headcount costs. This was offset by an increase to
SG&A expenses due primarily to net increases in commercial
headcount costs coming from the addition of the sales force and an
increase in professional services costs offset by a decrease in
medical science liaison costs. Net losses attributable to common
stockholders include the cash interest expense on our outstanding
debt, as well as significant non-cash charges related to interest,
loss on debt extinguishment and changes in the fair value of
financial instruments.
Three Months Ended Nine
Months Ended
September30,
September30,
September30,
September30,
2015 2014 2015 2014 (unaudited)
(unaudited) (unaudited) (unaudited) Operating expenses: Research
and development 3,902,155 4,158,085 10,180,517 14,496,977 Selling,
general and administrative 3,942,609 2,646,591 13,485,576
11,465,076 Total operating expenses 7,844,764 6,804,676 23,666,093
25,962,053 Loss from operations $(4,323,077) $(5,362,486)
$(15,949,829) $(23,157,087) Net loss attributable to common
stockholders $(8,070,764) $(6,898,896) $(25,098,567) $(28,861,683)
The Company ended the quarter with $11.4 million in cash.
MILESTONES
Select milestones Navidea expects to achieve in the near-term
include the following:
- Divest or partner the Company’s
non-core Phase 3 Alzheimer’s diagnostic imaging candidate,
NAV4694
- Complete preclinical studies for
intravenous delivery of tilmanocept and initiate clinical trials in
RA
- Achieve $10 to $12 million in
Lymphoseek product sales for 2015
CONFERENCE CALL
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 Q3 2015 Financial
Results Conference Call Date/Time: Wednesday, November 4, 2015 at
8:30 a.m. EST Webcast Link:
http://edge.media-server.com/m/p/apewz7w6/lan/en
Dial-in Number – US: (855) 897-5884 Dial in Number – Int’l: (720)
634-2940 Conference ID Number: 64585280 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 immuno-diagnostic agents and
immuno-therapeutics. 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 immuno-diagnostic agents and
immuno-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 September 30,
December 31, 2015 2014 (unaudited) Assets: Cash $ 11,370,420
$ 5,479,006 Other current assets 3,578,242 3,120,139 Non-current
assets 2,518,795 3,321,035 Total
assets $ 17,467,457 $ 11,920,180 Liabilities
and stockholders' deficit: Deferred revenue, current $ 1,002,531 $
- Notes payable, net of discount, current 333,333 4,383,472 Other
current liabilities 4,901,770 4,711,619 Deferred revenue 416,667 -
Notes payable, net of discount 60,946,844 29,539,135 Other
liabilities 1,701,939 3,089,420 Total
liabilities 69,303,084 41,723,646
Navidea stockholders' deficit (52,289,359 ) (29,803,466 )
Noncontrolling interest 469,732 - Total
stockholders' deficit (51,819,627 ) (29,803,466 )
Total liabilities and stockholders' deficit $ 17,483,457
$ 11,920,180
CONDENSED CONSOLIDATED
STATEMENTS OF OPERATIONS
Three Months Ended Nine Months Ended September 30, September 30,
September 30, September 30, 2015 2014 2015 2014 (unaudited)
(unaudited) (unaudited) (unaudited) Revenue: Lymphoseek sales
revenue $ 2,952,522 $ 1,101,071 $ 6,751,492 $ 2,773,959 Lymphoseek
license revenue 550,000 300,000 883,333 300,000 Grant and other
revenue 476,755 848,999
1,320,816 1,002,605 Total revenue
3,979,277 2,250,070 8,955,641
4,076,564 Cost of good sold 457,590
807,880 1,239,377
1,271,598 Gross profit 3,521,687
1,442,190 7,716,264 2,804,966
Operating expenses: Research and development 3,902,155
4,158,085 10,180,517 14,496,977 Selling, general and administrative
3,942,609 2,646,591 13,485,576
11,465,076 Total operating expenses
7,844,764 6,804,676 23,666,093
25,962,053 Loss from operations
(4,323,077 ) (5,362,486 ) (15,949,829 )
(23,157,087 ) Interest expense, net (2,148,369 ) (918,026 )
(4,690,686 ) (2,764,122 ) Equity in the loss of joint venture
(26,785 ) (262,198 ) (295,217 ) (262,198 ) Change in fair value of
financial instruments (1,577,275 ) (409,650 ) (1,702,902 ) (109,499
) Loss on extinguishment of debt - - (2,440,714 ) (2,610,196 )
Other income (expense), net 4,402 53,464
26,100 41,419 Net loss
(8,071,104 ) (6,898,896 ) (25,053,248 ) (28,861,683 ) Net loss
attributable to noncontrolling interest (340 ) - (681 ) - Deemed
dividend on beneficial conversion feature - -
(46,000 ) - Net loss
attributable to common stockholders $ (8,070,764 ) $ (6,898,896 ) $
(25,098,567 ) $ (28,861,683 ) Loss per common share (basic
and diluted) $ (0.05 ) $ (0.05 ) $ (0.17 ) $ (0.19 )
Weighted average shares outstanding (basic and diluted) 150,186,131
150,169,712 150,030,638 148,344,064
View source
version on businesswire.com: http://www.businesswire.com/news/home/20151104005453/en/
Navidea BiopharmaceuticalsInvestorsTom Baker,
617-532-0624tbaker@navidea.comorMediaSharon Correia, 978-655-2686Associate
Director, Corporate Communications
Navidea Biopharmaceuticals (AMEX:NAVB)
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