- Company provides 2016 total revenue guidance
of $23 to $25 Million –
– Management hosting webcast and conference
call on March 23, 2016 at 8:00 a.m. ET –
Navidea Biopharmaceuticals, Inc. (NYSE MKT:NAVB), today
announced results for the fourth quarter and year ended December
31, 2015. Navidea reported total revenue for 2015 of $13.2 million
including Lymphoseek® (technetium Tc 99m tilmanocept) injection
sales revenue of $10.3 million compared to total revenue of $6.3
million for 2014, which included Lymphoseek sales revenue of $4.2
million.
“2015 was marked by a strong turnaround in our commercial
business, more than doubling total brand sales to approximately $20
million and recognizing revenue to Navidea of more than $10
million, meeting guidance for the first time under the leadership
of our new management team,” said Rick Gonzalez, Navidea President
and Chief Executive Officer. “Importantly, we have advanced several
innovative programs in our pipeline and have begun clinical testing
for new large market opportunities, leveraging our Manocept™
immune-cell targeting platform. These achievements were
accomplished while managing our operations within very restrictive
capital constraints. Looking forward to 2016, we will continue our
efforts to aggressively streamline operations and manage expenses
while working towards our goals of doubling sales for the second
year in a row, achieving operational cash flow break-even, and
advancing our development pipeline, which is essential to
sustaining our long-term growth.”
Financial Results
Revenues for the year ended December 31, 2015 were $13.2 million
compared to $6.3 million for 2014. Navidea’s revenues for 2015
consisted of $10.3 million in sales of Lymphoseek, $1.1 million
related to licensing milestones and $1.9 million from various
federal grants and other revenue, compared to $4.2 million,
$300,000 and $1.7 million, respectively, for 2014. The Company also
recorded $1.2 million related to royalties on the gamma detection
device business we sold in 2011 (which is reported net of tax as
income from discontinued operations).
Operating expenses for the year ended December 31, 2015 were
$30.0 million compared to $32.3 million for 2014. Research and
development expenses were $12.8 million during 2015 compared to
$16.8 million during 2014. The net decrease from 2014 to 2015 was
primarily a result of reductions in NAV4694 and NAV5001 product
development costs coupled with reduced headcount and related
support costs, offset by increased Lymphoseek EU-related
manufacturing and regulatory activities, support for our
therapeutics initiatives, and Manocept diagnostic product
development costs. Selling, general and administrative expenses
were $17.3 million for 2015 compared to $15.5 million for 2014. The
net increase is due to increased costs related to the establishment
and operation of our internal sales team coupled with one-time
costs related to the first quarter 2015 reduction in force and
increased professional services, license fees related to
Lymphoseek, and other support costs which were partially offset by
decreased launch-related marketing costs.
Navidea’s loss from operations for the year ended December 31,
2015 was $18.6 million compared to $27.6 million for the same
period in 2014. For the year ended December 31, 2015, Navidea
reported a loss attributable to common stockholders of $27.6
million, or $0.18 per share, compared to a loss attributable to
common stockholders of $35.7 million, or $0.24 per share, for the
same period in 2014.
Fourth Quarter Financial Results:
Revenues for the fourth quarter of 2015 were $4.3 million compared
to $2.2 million for the same period in 2014 representing an
increase of 95% period over period. Navidea’s revenues for the
fourth quarter of 2015 consisted of $3.5 million in sales of
Lymphoseek, $250,000 related to licensing milestones and $541,000
from various federal grants and other revenue, compared to $1.5
million, $0 and $738,000, respectively, for the same period in
2014.
Fourth quarter 2015 operating expenses were $6.4 million
compared to $6.4 million for the fourth quarter of 2014. Research
and development expenses were $2.6 million during the fourth
quarter of 2015 compared to $2.3 million during fourth quarter of
2014. The net increase from 2014 to 2015 was primarily a result of
increased Lymphoseek EU-related manufacturing and regulatory
activities and therapeutics product development costs, offset by
decreased NAV4694 product development costs coupled with reduced
headcount and related support costs. Selling, general and
administrative expenses were $3.8 million for the fourth quarter of
2015 compared to $4.1 million for the same period in 2014 for
reasons consistent with the annual variances discussed above.
Navidea’s loss from operations for the fourth quarter of 2015
was $2.6 million compared to $4.5 million for the fourth quarter of
2014. For the fourth quarter of 2015, Navidea reported a loss
attributable to common stockholders of $2.5 million, or $0.02 per
share, compared to a loss attributable to common stockholders of
$6.9 million, or $0.05 per share, for the fourth quarter of
2014.
“Over the last year and a half, we have made dramatic progress
streamlining operations and cutting expenses. Based on our current
projections and plans, we expect total operating expenses for 2016
to be roughly 25% lower than 2015 levels, while moving Lymphoseek
forward commercially and continuing the development of our Manocept
platform,” said Brent Larson, Chief Financial Officer. “These
measures, coupled with growing revenue, continue to bring us closer
to our goal of cash flow break-even in the second half of 2016,
which will further support the long term sustainability of the
business. In addition, the recently reaffirmed Platinum line of
credit will also provide flexibility in the near-term to ensure we
have ample capital to support interim needs, but we expect the
draws will not exceed $5 million during 2016, leaving us over $20
million of available credit in reserve.”
2016 Financial Guidance
- Navidea expects Total Revenues for 2016
to range from $23 million to $25 million including Lymphoseek
product sales revenue, license revenue, grant and other
revenue.
- Navidea expects its 2016 total
operating expenses, excluding costs related to its Macrophage
Therapeutics subsidiary, to be in the range of $21.5 million to
$23.5 million.
Milestones & Highlights
Select milestones and highlights that the Company achieved in
2015 and year to date in 2016 include:
- Achieved 2015 Lymphoseek revenue
guidance with $10.3 million in sales to NAVB, more than doubling
year-over-year revenue;
- Reduced total operating expenses and,
in combination with record total revenues of $13.2 million, reduced
the overall corporate cash burn by 35% over the prior year;
- Recorded income from discontinued
operations related to royalty payments from the Neoprobe/Devicor
GDS business of $1.2 million;
- Received notice of award for $3.8
million in non-dilutive NIH grants to advance Lymphoseek pipeline
expansion programs through Phase 1/2;
- Advanced our immunodiagnostics
development pipeline, initially into rheumatoid arthritis,
addressing a far greater number of patients than our current
Lymphoseek label;
- Reported investigator initiated
clinical study results demonstrating that Lymphoseek reduces
sentinel lymph node biopsy imaging time, facilitates patient
throughput and workflow efficiencies and enhanced patient
experience;
- Presented promising data demonstrating
that a Manocept-doxorubicin immunotherapeutic conjugate induced
apoptosis in Kaposi’s Sarcoma and tumor associated
macrophages;
- Initiated patient enrollment in
Lymphoseek expansion trials for pediatric cancer and cervical
cancer;
- Published 4 articles in noteworthy
medical journals and presented data on Lymphoseek and Manocept
compounds at 13 scientific and medical meetings; and,
- Strengthened the Board of Directors by
appointing two new shareholder-nominated candidates, Dr. Mark
Greene and Dr. Anthony Fiorino.
Conference Call
Navidea will provide a business update and discuss the fourth
quarter and full year 2015 financial results during a conference
call with the investment community scheduled for Wednesday, March
23, 2016 at 8:00 a.m. ET. 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 Q4 and Year-End 2015
Financial Results Conference Call Date/Time: Wednesday, March 23,
2016 at 8:00 a.m. ET Webcast Link:
http://edge.media-server.com/m/p/ji54i8si
Dial-in Number – US: 1 (855) 897-5884 Dial in Number – Int’l: 1
(720) 634-2940 Participant Passcode: 56356081 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
Navidea Biopharmaceuticals, Inc. (NYSE MKT: NAVB) is a
biopharmaceutical company focused on the development and
commercialization of precision immunodiagnostic agents and
immunotherapeutics. 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. The
development activities of the Manocept immunotherapeutic platform
will be conducted by Navidea in conjunction with its subsidiary,
Macrophage Therapeutics. Navidea’s strategy is to deliver superior
growth and shareholder return by bringing to market novel products
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.
NAVIDEA BIOPHARMACEUTICALS, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS December 31, December
31, 2015 2014 (unaudted) Assets: Cash $ 7,166,260 $
5,479,006 Other current assets 5,410,914 3,120,139 Non-current
assets 2,387,339 3,231,163 Total assets $ 14,964,513
$ 11,830,308 Liabilities and stockholders' deficit: Deferred
revenue, current $ 1,044,281 $ - Notes payable, net of discount,
current 333,333 4,348,678 Other current liabilities 4,806,236
4,711,619 Deferred revenue 192,728 - Notes payable, net of discount
60,746,002 29,484,057 Other liabilities 1,677,633
3,089,420 Total liabilities 68,800,213 41,633,774
Navidea stockholders' deficit (54,305,258) (29,803,466)
Noncontrolling interest 469,558 - Total stockholders'
deficit (53,835,700) (29,803,466) Total liabilities
and stockholders' deficit $ 14,964,513 $ 11,830,308
CONDENSED CONSOLIDATED STATEMENTS OF
OPERATIONS Three Months Ended Twelve Months Ended
December 31, December 31, December 31, December 31, 2015 2014 2015
2014 (unaudited) (unaudited) (unaudited) Revenue: Lymphoseek
sales revenue $ 3,502,860 $ 1,459,994 $ 10,254,352 $ 4,233,953
Lymphoseek license revenue 250,000 - 1,133,333 300,000 Grant and
other revenue 540,806 738,291 1,861,622
1,740,896 Total revenue 4,293,666 2,198,285
13,249,307 6,274,849 Cost of good sold 515,386
314,547 1,754,763 1,586,145 Gross profit
3,778,280 1,883,738 11,494,544 4,688,704
Operating expenses: Research and development 2,607,216 2,282,612
12,787,733 16,779,589 Selling, general and administrative
3,771,753 4,076,995 17,257,329 15,542,071
Total operating expenses 6,378,969 6,359,607
30,045,062 32,321,660 Loss from operations
(2,600,689) (4,475,869) (18,550,518)
(27,632,956) Other income (expense): Interest expense, net
(2,183,050) (925,946) (6,873,736) (3,690,068) Equity in the loss of
joint venture (10,036) (261,611) (305,253) (523,809) Change in fair
value of financial instruments 1,088,120 (1,232,890) (614,782)
(1,342,389) Loss on extinguishment of debt - - (2,440,714)
(2,610,196) Other income (expense), net 708 31,330
26,808 72,749 Net loss (3,704,947) (6,864,986)
(28,758,195) (35,726,669) Benefit from income taxes 436,051
- 436,051 - Loss from continuing operations
(3,268,896) (6,864,986) (28,322,144) (35,726,669) Income from
discontinued operations, net of tax 758,609 -
758,609 - Net loss (2,510,287) (6,864,986) (27,563,535)
(35,726,669) Less loss attributable to noncontrolling interest
(174) - (855) - Deemed dividend on beneficial conversion feature
- - (46,000) - Net loss attributable to
common stockholders $ (2,510,113) $ (6,864,986) $ (27,608,680) $
(35,726,669) Income (loss) per common share (basic and
diluted): Continuing operations $ (0.02) $ (0.05) $ (0.19) $ (0.24)
Discontinued operations $ 0.00 $ - $ 0.01 $ - Attributable to
common stockholders $ (0.02) $ (0.05) $ (0.18) $ (0.24) Weighted
average shares outstanding (basic and diluted) 154,591,487
149,888,696 151,180,222 148,748,396
View source
version on businesswire.com: http://www.businesswire.com/news/home/20160323005416/en/
Navidea BiopharmaceuticalsInvestorsTom Baker,
617-532-0624tbaker@navidea.comorMediaSharon Correia, 978-655-2686Associate
Director, Corporate CommunicationsorDavid Schull,
858-717-2310david.schull@russopartnersllc.com
Navidea Biopharmaceuticals (AMEX:NAVB)
Historical Stock Chart
From Apr 2024 to May 2024
Navidea Biopharmaceuticals (AMEX:NAVB)
Historical Stock Chart
From May 2023 to May 2024