- Business Update / Quarterly Conference Call Set for Tomorrow, May
3, 2012, at 8:30 am EDT -
Navidea Biopharmaceuticals, Inc. (NYSE Amex: NAVB), a specialty
pharmaceutical company focused on precision diagnostic
radiopharmaceuticals, today announced business highlights and
consolidated results for the first quarter ended March 31, 2012.
Financial Results and Outlook
For the quarter ended March 31, 2012, Navidea reported a net loss
attributable to common stockholders of $7.0 million, or $0.07 per share,
compared with a net loss attributable to common stockholders of $4.4
million, or $0.05 per share, for the same period in 2011.
During the third quarter of 2011, the Company sold its neoprobe®
GDS line of gamma detection device systems to a third party. As such,
results of operations related to the GDS business reported previously in
various individual financial statement line items (i.e., revenues, cost
of sales and research and development expenses) have been reclassified
to discontinued operations for all periods presented. Navidea non-GDS
revenues for the quarters ended March 31, 2012 and 2011 relate to grants
received in support of the Company's drug development activities. Grant
revenues for the quarter ended March 31, 2012 were $12,000 compared to
$336,000 for the same period in 2011. Costs related to these grants
received in support of development activities are recorded in research
and development expenses.
Research and development (R&D) expenses were $3.9 million for the
quarter ended March 31, 2012, compared to $2.4 million for the same
period in 2011. The increase in R&D expenses in 2012 was attributable to
several primary factors including: (1) Lymphoseek®
development costs increased $306,000 as costs to support the New Drug
Application (NDA) review more than offset decreases in clinical trial
costs; (2) during the first quarter of 2012, the Company paid a $500,000
license option fee related to [123I]-E-IACFT, a neuro-imaging
agent to aid in the diagnosis of Parkinson's disease and movement
disorders; and (3) Navidea incurred approximately $700,000 in increased
R&D costs related to a combination of out-of-pocket costs related to
pipeline development projects, as well as increased headcount to support
these development efforts.
Selling, general and administrative expenses were $2.6 million for the
quarter ended March 31, 2012, compared to $2.9 million for the same
period in 2011. The net decrease of $300,000 between the two periods was
primarily due to the fact that selling, general and administrative
expenses in 2011 included approximately $1.7 million in non-recurring
charges related to the separation of the Company's former CEO that was
partly offset in the first quarter of 2012 by approximately $1.1 million
in increased marketing and business development costs in preparation for
the commercial launch of Lymphoseek and efforts to continue to build the
Company's pipeline, coupled with approximately $300,000 in increases in
other general and administrative headcount and professional services
costs.
As of March 31, 2012, Navidea had cash and cash equivalents totaling
approximately $21.9 million.
Brent Larson, Navidea Senior Vice President and CFO, said, "The
notification in early April from the United States Food and Drug
Administration (FDA) that the Lymphoseek Prescription Drug User Fee Act
(PDUFA) date has been extended by 90 days to September 10, 2012 has not
impacted our business plan objectives. We remain confident that our
strong financial position and experience in program management provides
us with the financial flexibility to reach the point of revenue
generation from Lymphoseek and support program development and growth
for 2012 and beyond."
Dr. Mark Pykett, Navidea President and CEO, stated, "As we reported
previously, we are confident that the clinical data generated for
Lymphoseek to date support a clear safety and efficacy profile that we
believe holds value for patients and their physicians. The updated
chemistry, manufacturing and control (CMC) information we submitted on
March 30, 2012, as requested by the Agency late in the NDA review,
related to one of several drug analytical assays and was a request for
more data on product manufacturing. It did not call into question
Lymphoseek safety, efficacy, or clinical study design, nor was it
related to comparisons with sulfur colloid or our ongoing Phase 3 study
in head and neck cancer. We believe the NDA submission for Lymphoseek
provides a robust portfolio of data and information supporting FDA
approval of this product. Our focus continues to be on supporting the
FDA review and preparing with our partner for anticipated U.S. market
introduction of Lymphoseek."
First quarter business highlights include:
Changed corporate name to Navidea Biopharmaceuticals Inc., to
best reflect pipeline and product offerings, began trading under the
ticker symbol NAVB, and launched a new website, www.navidea.com
Entered into an option agreement with Alseres Pharmaceuticals, Inc. to
negotiate a license of [123I]-E-IACFT Injection, an
Iodine-123 radiolabeled imaging agent being developed as an aid in the
diagnosis of Parkinson's disease and other movement disorders
Obtained positive guidance from the European Medicines Agency for
Lymphoseek and announced our intent to file a Marketing Authorization
Application in the EU by the end of 2012 based on already completed
clinical trials and supplementary information
Data on Lymphoseek and AZD4694 presented at major scientific and
medical conference presentations:
Presented data at Sentinel Node Oncology Foundation and
Sentinel Lymph Node Working Group demonstrating a favorable
comparison of Lymphoseek to Sulfur Colloid
First experience data presented by MD Anderson Cancer Center demonstrates
the utility, diagnostic predictive value, and safety of Lymphoseek
for both preoperative lymphoscintigraphy and intraoperative
localization in head and neck squamous cellcancer at the
2012 Society of Surgical Oncology Meeting
Data on AZD4694 presented by the Banner Institute at the 6th
Annual Human Amyloid Imaging Meeting describing the use of [18F]
AZD4694 in the examination of fibrillar A? burden as an aid in the
diagnosis of Alzheimer's Disease
"We continue to move forward to achieve our clinical and regulatory
objectives. Our innovative precision diagnostics portfolio remains
strong and we expect this will drive a number of potential
value-enhancing events going forward," said Dr. Pykett. "We expect U.S.
approval and commercial launch of Lymphoseek later this year, and are
continuing the advancement of the global registration process for
Lymphoseek and our important later-stage clinical pipeline of
candidates."
Conference Call Details
Navidea's President and CEO, Dr. Mark Pykett, Executive Vice President
and Chief Business Officer, Dr. Thomas Tulip, and Senior Vice President
and CFO, Brent Larson, will provide a development and business update
and will discuss the Company's financial results for the first quarter
of 2012 during the conference call. The conference call can be accessed
as follows:
CONFERENCE CALL INFORMATION
TO PARTICIPATE LIVE:
TO LISTEN TO A REPLAY:
Date:
Time:
Toll-free (U.S.) Dial in # :
International Dial in # :
May 3, 2012
8:30 am EDT
(877) 407-8033
(201) 689-8033
Available until:
Toll-free (U.S.) Dial in # :
International Dial in # :
Replay passcode:
Account #:
Conference ID #:
May 17, 2012
(877) 660-6853
(201) 612-7415
286
393568
About Navidea Biopharmaceuticals
Navidea Biopharmaceuticals, Inc. (NYSE Amex: NAVB) is a
biopharmaceutical company focused on the development and
commercialization of precision diagnostics and radiopharmaceutical
agents. Navidea is actively developing three radiopharmaceutical agent
platforms - Lymphoseek®, AZD4694 and RIGScanTM - to help
identify the presence and status of undetected disease and enable better
diagnostic accuracy, clinical decision-making and ultimately patient
care. 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
March 31,
December 31,
2012
2011
(unaudited)
Assets:
Cash
$
21,904,068
$
28,644,004
Other current assets
1,606,852
1,402,517
Non-current assets
1,217,981
1,147,399
Total assets
$
24,728,901
$
31,193,920
Liabilities and stockholders' equity:
Note payable, net of discount, current
$
1,661,681
$
-
Derivative liabilities, current
753,014
568,930
Other current liabilities
2,502,890
2,779,540
Note payable, net of discount
4,848,621
6,456,388
Other liabilities
253,842
257,315
Stockholders' equity
14,708,853
21,131,747
Total liabilities and stockholders' equity
$
24,728,901
$
31,193,920
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
Three Months Ended
March 31,
March 31,
2012
2011
(unaudited)
(unaudited)
Grant revenue
$
11,931
$
335,962
Operating expenses:
Research and development
3,943,714
2,435,598
Selling, general and administrative
2,574,630
2,901,707
Total operating expenses
6,518,344
5,337,305
Loss from operations
(6,506,413
)
(5,001,343
)
Interest expense
(293,671
)
(1,607
)
Change in derivative liabilities
(184,084
)
(953,789
)
Other income, net
4,479
2,806
Loss from continuing operations
(6,979,689
)
(5,953,933
)
Discontinued operations
(9,383
)
1,531,804
Net loss
(6,989,072
)
(4,422,129
)
Preferred stock dividends
(25,000
)
(25,000
)
Loss attributable to common stockholders
$
(7,014,072
)
$
(4,447,129
)
Loss per common share (basic and diluted):
Continuing operations
$
(0.07
)
$
(0.07
)
Discontinued operations
$
(0.00
)
$
0.02
Attributable to common stockholders
$
(0.07
)
$
(0.05
)
Weighted average shares outstanding:
Basic and diluted
94,074,918
85,416,015
Navidea Biopharmaceuticals, Inc. Brent Larson,
614-822-2330 Sr. VP & CFO
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