– Management hosting webcast and conference
call on March 6, 2014 at 8:30 a.m. ET –
Navidea Biopharmaceuticals, Inc. (NYSE MKT:NAVB), a
biopharmaceutical company focused on precision diagnostic
radiopharmaceuticals, today announced results for the fourth
quarter and year ended December 31, 2013.
Business Update
Key commercial and development milestones achieved by Navidea in
2013 and to date in 2014 include:
- Lymphoseek® (technetium Tc 99m
tilmanocept) Injection
- Received U.S. approval in March 2013
for use in lymphatic mapping procedures that are performed to aid
in the diagnostic evaluation of potential cancer spread for
patients with breast cancer and melanoma and initiated sales
activities with U.S. distribution partner in May 2013.
- Maintained solid Lymphoseek growth
trajectory measured by increasing number of units and growth in key
sales metrics.
- Received Centers for Medicare &
Medicaid Services (CMS) codes for reimbursement (pass-through
C-Code and A-Code).
- Received Fast Track and Priority Review
of a Lymphoseek supplemental New Drug Application (sNDA) for
expanded indication in sentinel lymph node (SLN) detection in
patients with head and neck cancer with Prescription Drug User Fee
Act (PDUFA) review date targeted for June 16, 2014. Also received
notification of acceptance for review of another Lymphoseek sNDA
for a proposed expanded label to support broader and more flexible
use in imaging and lymphatic mapping procedures, including
lymphoscintigraphy and other optimization capabilities with a PDUFA
review date targeted for October 16, 2014.
- Notified that the European Medicines
Agency’s (EMA’s) Committee for Medicinal Products for Human Use
(CHMP) consideration of Lymphoseek Marketing Authorization
Application (MAA) expected in March 2014.
- NAV4694
- Initiated enrollment in a global Phase
3 pivotal registration trial in Alzheimer’s disease (AD).
- Selected by the Australian Imaging,
Biomarker & Lifestyle (AIBL) study as the sole amyloid tracer
for use in their flagship work on AD.
- Enrolled first subjects in a Phase 2b
trial in subjects with mild cognitive impairment (MCI).
- NAV5001
- Initiated a Phase 3 program for
Parkinson’s disease (PD).
- Received two Special Protocol
Assessments (SPAs) from FDA for Phase 3 pivotal registration
program.
- Manocept™
- Published data from collaborative,
proof-of-principle studies for multiple disorders, including
Kaposi’s Sarcoma, tuberculosis and rheumatoid arthritis (RA), using
the Manocept platform in Nature Outlook – Medical Imaging.
- Began a physician-initiated study in
Kaposi’s Sarcoma patients at the University of California at San
Francisco.
Financial Results
Full Year Financial Results:
Revenues for the year ended December 31, 2013 were $1.1 million
compared to $79,000 for 2012. Navidea’s revenues for 2013 consisted
of $614,000 in sales of Lymphoseek following its approval in the
first quarter of 2013 and initial launch in the second quarter of
2013, and $516,000 from various federal and state grants. Revenues
for 2012 related primarily to payments received from our U.S.
distribution partner related to the reimbursement of certain
Lymphoseek commercialization activities.
Operating expenses for the year ended December 31, 2013 were
$39.2 million compared to $28.1 million for 2012. Research and
development expenses were $23.7 million during 2013 compared to
$16.9 million during 2012. The net increase from 2012 to 2013 was
primarily a result of net increases in NAV4694, NAV5001 and
Manocept platform product development costs and compensation and
other support costs related to increased headcount offset by
decreases in Lymphoseek development costs and potential pipeline
expansion activities. Selling, general and administrative expenses
were $15.5 million for 2013 compared $11.2 million for 2012. The
net increase from 2012 to 2013 was primarily a result of increased
medical education costs, compensation and other support costs
related to increased headcount, and legal and professional services
costs, offset by decreased out-of-pocket marketing costs to support
the commercial launch of Lymphoseek.
Navidea’s loss from operations for the year ended December 31,
2013 was $38.4 million compared to $28.0 million for the same
period of 2012. For the year ended December 31, 2013, Navidea
reported a loss attributable to common stockholders of $42.7
million, or $0.35 per share, compared to a loss attributable to
common stockholders of $29.2 million, or $0.29 per share, for the
same period in 2012.
Fourth Quarter Financial Results:
Revenues for the fourth quarter of 2013 were $535,000 compared to
$7,000 for the same period in 2012. Revenues from sales of
Lymphoseek for the fourth quarter of 2013 were $343,000 compared to
$144,000 in the third quarter of 2013. The fourth quarter of 2013
represented the first quarter of Lymphoseek sales under CMS
reimbursement. There were no sales of Lymphoseek in 2012.
Fourth quarter 2013 operating expenses were $13.4 million
compared to $7.0 million for the fourth quarter of 2012. Research
and development expenses were $9.4 million during the fourth
quarter of 2013 compared to $4.3 million during fourth quarter of
2012. The net increase from 2012 to 2013 was primarily a result of
net increases in NAV4694, NAV5001, Lymphoseek and Manocept platform
product development costs, and compensation and other support costs
related to increased headcount. Selling, general and administrative
expenses were $4.0 million for 2013 compared $2.7 million for 2012.
The net increase from 2012 to 2013 was attributable to the same
primary factors noted for the full year comparison.
Navidea’s loss from operations for the fourth quarter of 2013
was $13.1 million compared to $7.0 million for the fourth quarter
of 2012. For the fourth quarter of 2013, Navidea reported a loss
attributable to common stockholders of $13.8 million, or $0.10 per
share, compared to a loss attributable to common stockholders of
$7.2 million, or $0.07 per share, for the fourth quarter of
2012.
Financial Guidance and Commentary:
“We continue to be pleased with the growth in a number of key
Lymphoseek metrics and look forward to growing revenue over the
coming months and years. For 2014, Navidea expects revenues from
Lymphoseek sales to be between $5 and $6 million. Also, based on
the parameters of the non-dilutive financing with Oxford announced
earlier today, we believe we have significantly improved our access
to the capital on our balance sheet enabling us to continue to
pursue the core elements of our business, in particular Lymphoseek
growth, while also advancing our compelling development
initiatives,” said Brent Larson, Navidea CFO.
Management Commentary
“2013 was a pivotal year for Navidea with the approval and
initial launch of Lymphoseek in the U.S.,” stated Dr. Mark
Pykett, Navidea CEO. “We continue to see good momentum in many key
sales metrics, including continuous growth in market penetration,
increases in unit sales month over month and quarter over quarter,
increases in total accounts, outstanding customer retention and
repeat order rates, and encouraging formulary placement activity.
Lymphoseek reimbursement was placed on solid footing with the
implementation of a pass-through C Code from CMS followed by the
granting of a permanent A Code. In addition, with the filing of the
Lymphoseek sNDAs, one of which was granted Fast Track Status and
Priority Review by FDA, we are looking forward to the June 16 and
October 16, 2014 PDUFA target dates and toward potential expansion
of utilization into additional areas of lymphatic mapping.”
Dr. Pykett continued, “Recently, we have realized a number of
important advances on which we aim to capitalize and which are
enabled in part by the non-dilutive financing we announced today.
Our Phase 2b study of NAV4694 in patients with MCI has generated
exciting initial results that suggest that NAV4694 may be a highly
effective agent at detecting low levels of beta-amyloid arising
early in the course of cognitive impairment, an attribute that
would be highly differentiated from other tracers to date and which
would create opportunities in the early-stage diagnosis of
dementia. We therefore are planning to accelerate our study
activities to generate data and complete the trial sooner than
originally projected which, if successful, may enable us to create
important product differentiation. We believe NAV4694 may prove to
be the most effective agent to address the needs of MCI patients, a
demographic larger than the population of people with AD and where
there is intense clinical and commercial pharma interest but for
which no objective diagnostics agents exist.”
The Company has also made important recent strides with its
Manocept platform, the status of which has advanced more rapidly
than anticipated, particularly in the area of RA where
collaborators have demonstrated the ability to identify the
underlying inflammatory component of RA in human disease, thereby
differentiating it from other joint diseases. Just five months
after unveiling the platform in a supplement of the journal Nature,
near-term opportunities are being explored to begin initial
clinical study in RA, a large incidence population both in the U.S.
and worldwide where many patients present atypically and for whom
diagnostic uncertainty remains high.
Conference Call:
Navidea will provide a business update and discuss the fourth
quarter and full year 2013 financial results during a conference
call with the investment community scheduled for Thursday, March 6,
2014 at 8:30 a.m. ET. 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 Q4 2013 and
Full-Year Financial Results Conference Call Date/Time:
Thursday, March 6, 2014 at 8:30 a.m. ET Webcast Link:
http://www.media-server.com/m/p/dh2x4bbc
Dial-in Number – US:
1 (800) 708-4539
Dial in Number – Int’l: 1 (847) 619-6396 Participant
Passcode: 36792037 Replay
A webcast replay will be available on the
Investor Relations section of our website at
http://ir.navidea.com
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 NAV4694, NAV5001, Manocept™ 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.
NAVIDEA BIOPHARMACEUTICALS, INC.
CONDENSED CONSOLIDATED BALANCE
SHEETS December 31, December 31, 2013
2012
(unaudted) Assets: Cash $ 32,939,026 $ 9,118,564
Other current assets 4,392,156 1,498,819 Non-current assets
2,985,335 1,355,014 Total assets $
40,316,517 $ 11,972,397 Liabilities and
stockholders' deficit: Notes payable, net of discount,
current $ 4,095,650 $ 2,756,718 Other current liabilities 7,195,312
3,433,821 Notes payable, net of discount 23,572,603 6,930,112
Derivative liabilities 7,692,087 - Other liabilities 1,770,452
257,122 Stockholders' deficit (4,009,587 ) (1,405,376
) Total liabilities and stockholders' deficit $ 40,316,517
$ 11,972,397
CONDENSED CONSOLIDATED
STATEMENTS OF OPERATIONS Three Months Ended Twelve
Months Ended December 31, December 31, December 31, December 31,
2013 2012 2013 2012 (unaudited) (unaudited) (unaudited)
Revenue: Net sales $ 342,803 $ - $ 614,423 $ - Grant and other
revenue 192,176 6,807 516,207
78,738 Total revenue 534,979
6,807 1,130,630 78,738
Cost of good sold 151,955 -
332,815 - Gross profit
383,024 6,807 797,815
78,738 Operating expenses: Research and development
9,415,134 4,343,109 23,710,183 16,890,482 Selling, general and
administrative 4,020,847 2,690,241
15,525,946 11,177,559 Total operating
expenses 13,435,981 7,033,350
39,236,129 28,068,041 Loss from
operations (13,052,957 ) (7,026,543 )
(38,438,314 ) (27,989,303 ) Interest expense (974,204
) (235,994 ) (2,778,780 ) (1,166,332 ) Loss on extinguishment of
debt - - (1,372,266 ) - Change in fair value of financial
instruments 265,401 25,268 (112,073 ) 32,110 Other income
(expense), net 9,879 2,559 1,975
(33,679 ) Net loss (13,751,881 ) (7,234,710 )
(42,699,458 ) (29,157,204 ) Preferred stock dividends
- 31,667 - (43,333 )
Loss attributable to common stockholders $ (13,751,881 ) $
(7,203,043 ) $ (42,699,458 ) $ (29,200,537 ) Loss per common
share (basic and diluted) $ (0.10 ) $ (0.07 ) $ (0.35 ) $ (0.29 )
Weighted average shares outstanding (basic and diluted)
133,881,021 105,067,640 121,808,986 99,059,997
Navidea BiopharmaceuticalsBrent Larson, 614-822-2330Executive VP
& CFOorSharon Correia, 978-655-2686Associate Director,
Corporate Communications
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