- Total Lymphoseek® Q3 revenue of $1.4 million
reported –
- Decrease of ~20% in quarterly R&D
expenses -
- Conference call today at 8:30 a.m. EST -
Navidea Biopharmaceuticals, Inc. (NYSE MKT:NAVB), a
biopharmaceutical company focused on precision diagnostic
radiopharmaceuticals, today announced financial results and
business highlights for the third quarter of 2014. Navidea reported
total revenue for third quarter 2014 of $2.3 million including
Lymphoseek® (technetium Tc 99m tilmanocept) injection sales revenue
of $1.1 million, $300,000 of Lymphoseek milestone revenue and
$849,000 of grant and other revenue.
“As I begin my tenure at Navidea, I am excited by the potential
for global growth that can be achieved as we strive to make
Lymphoseek the standard of care in lymphatic mapping,” commented
Rick Gonzalez, Navidea Chief Executive Officer. “While there have
been initial commercial challenges since the product launch in
2013, Lymphoseek is realizing strong utilization trends including
customer retention, procedural growth, and account growth. We
believe the elements required for commercial success both near term
and long term are coming together at an ideal time, with the strong
label we received last month in the U.S., and the anticipated
European approval later this year. We look forward to implementing
cost-effective strategies to take advantage of these opportunities
to accelerate revenue growth and ensure Lymphoseek can affect the
lives of as many patients as possible.”
Brent Larson, Navidea Chief Financial Officer, commented, “We
are reporting revenue growth from product sales in the third
quarter of approximately 22% quarter on quarter, excluding the
one-time pricing impact adjustment related to inventory re-stocking
at our distributor’s pharmacies that was recorded during the second
quarter of 2014. In addition, as part of our efforts to sharpen our
focus on Lymphoseek and the underlying Manocept™ platform, we have
begun to realize the positive effects of cost containment, already
attaining a nearly 20% decrease in quarterly research and
development expenses from the second quarter of 2014. We believe we
can continue to effectively manage our available cash with our
expected growth of revenue and gross profit from Lymphoseek, our
ability to continue to lower our operating costs and, when or if
needed, with access to our available line of credit.”
Financial Results
Total revenue recognized for the third quarter of 2014 was $2.3
million compared to $400,000 for the same period in 2013. Product
revenue derived from net sales of Lymphoseek in the third quarter
of 2014 was $1.1 million compared to $1 million in the second
quarter of 2014, an increase of 5%. However, after excluding the
impact from an approximately $145,000 positive transfer price
adjustment on inventory re-stocking recognized during the second
quarter of 2014, product sales of Lymphoseek increased over 22%
quarter on quarter. During the third quarter of 2014, we also
recorded $300,000 related to an upfront milestone payment received
by the Company related to the recent Lymphoseek distribution
agreement for China and reported $849,000 of grant and other
revenue. For the nine months ended September 30, 2014, Navidea’s
total revenue was $4.1 million, compared to $596,000 for the same
period in 2013. Based on Lymphoseek revenue year-to-date and
anticipated fourth quarter product sales, Navidea is revising its
Lymphoseek revenue guidance for the full year 2014 to approximately
$4 million.
Third quarter 2014 operating expenses were $6.8 million compared
to $10.2 million for the third quarter of 2013. Operating expenses
were $26.0 million for the nine months ended September 30, 2014,
compared to $25.8 million for the same period in 2013. While total
operating expenses remained flat for the nine months ended
September 30, 2014 compared to the same period in 2013, the
restructuring announced in May 2014 to focus resources on
Lymphoseek and the Manocept pipeline began to be realized in the
third quarter of 2014 resulting in a nearly 20% reduction in
research and development expenses in the third quarter of 2014 as
compared to the second quarter. The marked net decrease in total
operating expenses the third quarter of 2014 was due primarily to a
decline in R&D expenses attributable to the neurology pipeline,
and a reduction in headcount, among other factors.
Third quarter 2014 net loss attributable to common stockholders
was $6.9 million, or $0.05 per share, compared to net loss
attributable to common stockholders of $11.3 million, or $0.09 per
share, in the third quarter of 2013. For the nine months ended
September 30, 2014, Navidea’s net loss attributable to common
stockholders was $28.9 million, or $0.19 per share, compared to a
net loss attributable to common stockholders of $28.9 million, or
$0.25 per share, for the same period in 2013.
Milestones &
Highlights
Select milestones and highlights that the Company has achieved
to date in 2014 include the following:
- Received expanded Lymphoseek approval
on October 15th from the U.S. Food and Drug Administration (FDA),
making Lymphoseek the only agent approved for lymphatic mapping
across all solid tumors when used as a component of surgical
management and the first and only FDA-approved radiopharmaceutical
for sentinel lymph node (SLN) detection for guiding sentinel lymph
node biopsy in breast cancer and melanoma in addition to the
previous approval for certain head and neck cancer patients.
- In September, the Committee for
Medicinal Products for Human Use (CHMP) of the European Medicines
Agency (EMA) adopted a positive opinion recommending marketing
authorization for Lymphoseek for detection of sentinel lymph nodes
in breast cancer, melanoma, or certain head and neck cancer
patients. Final approval by the European Commission is expected by
year end.
- Fast Track NIH Small Business
Innovation Research Grant of up to $1.67M was awarded for a
multicenter study evaluating Lymphoseek in cervical cancer.
- Lymphoseek was granted Orphan Drug
Designation by the FDA for use in sentinel lymph node detection in
patients with cancer of the head and neck, strengthening Navidea’s
competitive position by providing seven years of market exclusivity
in this indication. The FDA recently notified Navidea the
previously paid filing fees of $1.1 million would be refunded
before the end of the year.
- A development and commercialization
agreement was signed with Hainan Sinotau Pharmaceutical Co., Ltd
(Sinotau) for Lymphoseek in China including expected revenue based
on unit sales to Sinotau, a royalty based on Sinotau’s sales of
Lymphoseek and up to $2.5 million in milestones from Sinotau,
including a $300,000 upfront payment.
- Encouraging positive data and results
were presented from Lymphoseek studies in breast cancer, melanoma
or head and neck cancer at two major European medical meetings,
European Association of Nuclear Medicine and European Society of
Surgical Oncology.
- Rick Gonzalez was appointed Navidea
CEO, bringing more than 20 years of experience in the
pharmaceutical industry with notable global commercial expertise
with oncology and radiotherapy products.
- NIH agreed to repurpose the grant
previously awarded for our RIGS initiative towards the study of
tumor activated macrophages in colorectal cancer using a Manocept
compound.
Conference Call Details
Navidea will provide a business update and discuss the third
quarter 2014 financial results during a conference call with the
investment community scheduled for Thursday, November 6, 2014 at
8:30 a.m. EST. Investors and the public are invited to access the
live webcast through the link below. Participants who would like to
ask questions during the question and answer session following the
presentation 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 2014 Financial
Results Conference Call Date/Time: Thursday, November 6, 2014 at
8:30 a.m. EST Webcast Link:
http://edge.media-server.com/m/p/24azfty4/lan/en
Dial-in Number – US: 1 (800) 446-2782 Dial in Number – Int’l: 1
(847) 413-3235 Participant Passcode: 38384306 Replay A webcast
replay will be available on the Investor Relations section of our
website at http://ir.navidea.com
for 30 days.
About Navidea Biopharmaceuticals Inc.
Navidea Biopharmaceuticals, Inc. (NYSE MKT: NAVB) is a
biopharmaceutical company focused on the development and
commercialization of precision diagnostics and radiopharmaceutical
agents. Navidea is developing multiple precision diagnostic
products and platforms including Manocept™, NAV4694, NAV5001, and
NAV1800, to help identify the sites and pathways of undetected
disease and enable better diagnostic accuracy, clinical
decision-making 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. Navidea’s strategy is to deliver superior growth
and shareholder return by bringing to market novel
radiopharmaceutical agents and advancing the Company’s pipeline
through selective acquisitions, 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, 2014
2013 (unaudited) Assets: Cash $ 10,388,618 $
32,939,026 Other current assets 3,589,110 4,392,156 Non-current
assets 3,664,190 2,985,335 Total assets $ 17,641,918 $
40,316,517 Liabilities and stockholders' deficit:
Notes payable, net of discount, current $ 2,725,107 $
4,095,650 Other current liabilities 5,608,635 7,195,312 Notes
payable, net of discount 29,756,627 23,572,603 Derivative
liabilities 7,697,130 7,692,087 Other liabilities 3,116,188
1,770,452 Stockholders' deficit (31,261,769) (4,009,587)
Total liabilities and stockholders' deficit $ 17,641,918 $
40,316,517
CONDENSED CONSOLIDATED STATEMENTS OF
OPERATIONS Three Months Ended Nine Months Ended
September 30, September 30, September 30, September 30, 2014 2013
2014 2013 (unaudited) (unaudited) (unaudited) (unaudited) Revenue:
Lymphoseek sales revenue $ 1,101,071 $ 143,799 $ 2,773,959 $
271,620 Lymphoseek milestone revenue 300,000 - 300,000 - Grant and
other revenue 848,999 256,575 1,002,605 324,031 Total revenue
2,250,070 400,374 4,076,564 595,651 Cost of good sold
807,880 75,422 1,271,598 180,860 Gross profit 1,442,190
324,952 2,804,966 414,791 Operating expenses: Research and
development 4,158,085 6,278,459 14,496,977 14,295,049 Selling,
general and administrative 2,646,591 3,971,172 11,465,076
11,505,099 Total operating expenses 6,804,676 10,249,631 25,962,053
25,800,148 Loss from operations (5,362,486) (9,924,679)
(23,157,087) (25,385,357) Interest expense (920,905)
(976,226) (2,778,813) (1,804,576) Equity in the loss of R-NAV, LLC
(262,198) - (262,198) - Change in fair value of financial
instruments (409,650) (377,474) (109,499) (377,474) Loss on
extinguishment of debt - - (2,610,196) (1,372,266) Other income
(expense), net 56,343 (27,828) 56,110 (7,904) Net loss
attributable to common stockholders $ (6,898,896) $ (11,306,207) $
(28,861,683) $ (28,947,577) Loss per common share (basic and
diluted) $ (0.05) $ (0.09) $ (0.19) $ (0.25) Weighted
average shares outstanding (basic and diluted) 150,169,712
121,117,562 148,344,064 117,740,754
Navidea BiopharmaceuticalsBrent Larson, 614-822-2330Executive VP
& CFOorSharon Correia, 978-655-2686Associate Director,
Corporate Communications
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