Navidea Biopharmaceuticals, Inc. (NYSE MKT: NAVB), a
biopharmaceutical company focused on precision diagnostic
radiopharmaceuticals, today announced financial results and
business highlights for the second quarter and first half of 2014.
Revenue to Navidea from sales of Lymphoseek® (technetium Tc 99m
tilmanocept) Injection grew to more than $1 million in the second
quarter of 2014, an increase of 67% compared to the first quarter
2014 and an increase of over 700% compared to the second quarter of
2013 when the product was first launched. Based on the sales trends
observed, Navidea reiterates its full-year 2014 Lymphoseek revenue
expectation of $5 to $6 million.
“Lymphoseek sales growth is being driven by favorable product
characteristics, recent CMS reimbursement, as well as commercial
and medical education activities directed at major cancer centers,”
said Michael Goldberg, M.D., Navidea Interim Chief Executive
Officer. “This is resulting in strong customer retention with
positive trends in utilization and account growth. We believe
additional near-term and medium-term revenue growth will be
enhanced in part by our recent label expansion for guiding sentinel
lymph node biopsy in certain head and neck cancers, anticipated
U.S. label expansion stemming from our second sNDA later this year,
as well as increased commercial activities targeting surgical
oncologists, and our international activities.”
Dr. Goldberg continued, “We have significantly advanced our
pipeline by adding a therapeutic application to our Manocept™
platform by having recently entered a partnership with a company
funded by the leading venture capital firm, Essex Woodlands, to
co-develop Manocept to detect and treat Rheumatoid Arthritis and
other arthritic conditions. We continue to aggressively pursue
partnerships for our neurodegenerative disease detection agents to
complete Phase 3 development and registration. Late in the second
quarter, we announced a restructuring to reduce expenses primarily
related to the reprioritization of our product development pipeline
which, coupled with strong gross profit from Lymphoseek, we
anticipate will begin to meaningfully offset our cash burn by Q4
2014.”
Milestones &
Highlights
Select milestones and highlights that the Company has achieved
during the first half of 2014 include the following:
- With our partner, Lymphoseek generated
approximately $2 million in sales, of which just over $1 million in
revenue was recognized by Navidea in the second quarter of 2014, a
67% increase from the prior quarter.
- Realized attractive gross margins on
Lymphoseek revenue of nearly 75% for the second quarter and the
first half of 2014.
- Grew Lymphoseek customer base since
launch to more than 350 hospitals with 123 new accounts added in Q2
2014 alone.
- Received U.S. Food and Drug
Administration (FDA) approval of Lymphoseek for guiding sentinel
lymph node (SLN) biopsy in head and neck cancer patients with
clinically node negative squamous cell carcinoma of the oral
cavity, making Lymphoseek the first and only FDA-approved
radiopharmaceutical for sentinel lymph node detection.
- Presented encouraging positive data and
results from Lymphoseek studies in breast cancer, melanoma, head
and neck or colorectal cancer and Manocept studies in Rheumatoid
Arthritis and Kaposi’s Sarcoma at the Society of Nuclear Medicine
and Molecular Imaging Annual Meeting. Eleven presentations were
made by Navidea and its collaborators which reinforce the
sensitivity, specificity and accuracy of Lymphoseek and the
potential for our macrophage-targeting Manocept platform.
- Formed a joint enterprise, R-NAV, LLC,
with Essex Woodlands-backed Rheumco, LLC to develop and
commercialize radiolabeled diagnostics and therapeutics for
rheumatologic and arthritic diseases using Navidea’s Manocept
macrophage targeting platform and Rheumco’s Tin-117m
technology.
Financial Results
Total recognized revenue for the second quarter of 2014 was $1.1
million compared to $195,000 for the same period in 2013. Product
revenue from sales of Lymphoseek in the second quarter of 2014 was
$1,046,000 compared to $627,000 in the first quarter of 2014. For
the six months ended June 30, 2014, Navidea’s total revenue was
$1,826,000 compared to $195,000 for the same period in 2013.
Second quarter 2014 operating expenses were $10.0 million
compared to $8.5 million for the second quarter of 2013. Operating
expenses were $19.2 million for the six months ended June 30, 2014,
compared to $15.6 million for the same period in 2013. Research and
development (R&D) expenses were $5.1 million in the second
quarter of 2014 compared to $4.4 million in the same period of
2013. R&D expenses were $10.3 million for the six months ended
June 30, 2014, compared to $8.0 million for the same period in
2013. The net increases in R&D expenses were primarily a result
of NAV4694, NAV5001 and Manocept product development and clinical
trial-related costs incurred prior to our decision late in the
second quarter to reprioritize our development plans to reduce our
cash burn. Selling, general and administrative (SG&A) expenses
for the second quarter of 2014 were $4.9 million compared to $4.2
million in the same period of 2013. SG&A expenses were $8.8
million for the six months ended June 30, 2014, compared to $7.5
million for the same period in 2013. The net increases in SG&A
expenses were due primarily to the one-time separation costs
associated with the Company’s former CEO coupled with costs to
support Lymphoseek medical education efforts.
Second quarter 2014 net loss attributable to common stockholders
was $10.2 million, or $0.07 per share, compared to net loss
attributable to common stockholders of $10.3 million, or $0.09 per
share, in the second quarter of 2013. For the six months ended June
30, 2014, Navidea’s net loss attributable to common stockholders
was $22.0 million, or $0.15 per share, compared to a net loss
attributable to common stockholders of $17.6 million, or $0.15 per
share, for the same period in 2013.
Conference Call Details
Navidea will provide a business update and discuss the second
quarter 2014 financial results during a conference call with the
investment community scheduled for Wednesday, August 6, 2014 at
8:30 a.m. EDT. 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 Q2
2014 Financial Results Conference Call Date/Time: Wednesday, August
6, 2014 at 8:30 a.m. EDT
Webcast Link:
http://edge.media-server.com/m/p/bz3vnygi/lan/en
Dial-in Number – US: 1 (866) 638-3013 Dial in Number – Int’l: 1
(630) 691-2761 Participant Passcode: 37774632 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 (RIGScan™), 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 June 30, December 31, 2014 2013 (unaudited)
Assets: Cash $ 17,471,780 $ 32,939,026 Other current
assets 3,093,473 4,392,156 Non-current assets 3,023,072
2,985,335 Total assets $ 23,588,325
$ 40,316,517 Liabilities and
stockholders' deficit: Notes payable, net of discount,
current $ 782,512 $ 4,095,650 Other current liabilities 5,369,866
7,195,312 Notes payable, net of discount 30,438,739 23,572,603
Derivative liabilities 7,689,550 7,692,087 Other liabilities
3,142,933 1,770,452 Stockholders' deficit (23,835,275 )
(4,009,587 ) Total liabilities and stockholders'
deficit $ 23,588,325 $ 40,316,517
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS Three
Months Ended Six Months Ended June 30, June 30, June 30, June 30,
2014 2013 2014 2013 (unaudited) (unaudited) (unaudited) (unaudited)
Revenue: Net sales $ 1,046,257 $ 127,821 $ 1,672,888 $ 127,821
Grant revenue 28,433 67,456
153,606 67,456 Total revenue 1,074,690
195,277 1,826,494 195,277
Cost of goods sold 270,498
105,438 463,718 105,438
Gross profit 804,192 89,839
1,362,776 89,839 Operating expenses:
Research and development 5,112,098 4,376,833 10,338,892 8,016,590
Selling, general and administrative 4,907,652
4,169,437 8,818,485 7,533,927
Total operating expenses 10,019,750 8,546,270
19,157,377 15,550,517
Loss from operations (9,215,558 ) (8,456,431 )
(17,794,601 ) (15,460,678 ) Interest expense (914,070
) (465,268 ) (1,857,908 ) (828,350 ) Change in fair value of
financial instruments (92,332 ) - 300,151 - Loss on extinguishment
of debt - (1,372,266 ) (2,610,196 ) (1,372,266 ) Other income
(expense), net (274 ) (6,386 ) (233 )
19,924 Net loss attributable to common stockholders $
(10,222,234 ) $ (10,300,351 ) $ (21,962,787 ) $ (17,641,370 )
Loss per common share (basic and diluted) $ (0.07 ) $ (0.09
) $ (0.15 ) $ (0.15 ) Weighted average shares outstanding
(basic and diluted) 150,019,939 118,260,288 147,416,111 116,024,366
Navidea BiopharmaceuticalsBrent Larson, 614-822-2330Executive VP
& CFOorSharon Correia, 978-655-2686Associate Director,
Corporate Communications
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