Conference Call to be held Wednesday, November
8, 2017 at 8:30 am ET
Navidea Biopharmaceuticals, Inc. (NYSE MKT: NAVB) (“Navidea” or
the “Company”), a company focused on the development of precision
immunodiagnostic agents and immunotherapeutics, today announced its
financial results for the third quarter of 2017. Navidea reported
total revenues for the quarter of $224,000. Net loss attributable
to common stockholders was $1.5 million. Net revenues do not
include the guaranteed payments from Cardinal Health 414, LLC
(“Cardinal Health 414”) because those are represented on the
balance sheet in accounts receivable and were already included in
the gain on sale of the line of business sold to Cardinal Health
414 for the nine months ended September 30, 2017.
“We’ve made significant advancements in our pipeline, both on
the diagnostic and therapeutics side so far this year. Efforts
undertaken since the closing of the Cardinal Health 414 transaction
to implement the new strategy have enabled the more rapid
development of our proprietary technology. We have demonstrated
significant market expansion potential with our imaging agent. We
are actively pursuing an approval to utilize our activated
macrophage technology as a biomarker. We have formally contacted
the U.S. Food and Drug Administration (“FDA”) and have scheduled
our first meeting with them. In parallel, we are also pursuing an
additional approval for our agent so we can administer it
intravenously (“IV”). The FDA and many major pharmaceutical
companies have indicated their significant interest in developing
biomarkers that can assist in developing new therapeutics and in
enabling objective monitoring of performance of existing therapies.
With our best-in-class activated macrophage targeting system, we
have been able to generate significant human imaging data and
promising animal data with our therapeutic agents, reinforcing our
optimism that this platform holds potential for the diagnosis and
treatment of diseases in which macrophages play an important role,”
said Michael Goldberg, M.D., Navidea’s President and Chief
Executive Officer.
Dr. Goldberg continued, “On the diagnostic side, we have
generated data with both IV and subcutaneous formulations of Tc99m
tilmanocept in rheumatoid arthritis (“RA”). We have completed all
but a few of the control dosings in the Phase 1/2 dose escalation
registrational study and expect to finalize the report on this
study in the fourth quarter of this year. In nonalcoholic
steatohepatitis (“NASH”) and cardiovascular (“CV”) disease, we will
also be initiating dosing of an IV formulation shortly. For CV, we
are working with the same team at Massachusetts General Hospital in
Boston, who designed, managed and published the subcutaneous CV
study that has attracted so much interest. In the IV study, we will
also explore the ability to image central nervous system
inflammation. With Kettering Medical Center in Ohio, we will
shortly be dosing in NASH patients. On the therapeutic side, we
have synthesized and tested delivery backbones that are one-tenth
the size of the existing agents. As we explore formulation
opportunities with our therapeutics, smaller agents provide better
opportunities for creating therapeutics than can be delivered
orally and topically. The newer agents retain the same very high
binding we have achieved with our larger constructs. Finally, we
have dosed in cancer models our MT1000 class of therapeutics, much
more frequently (twice per day as opposed to twice per week) with
the same total dose and as expected this resulted in much improved
activity. “
Third Quarter 2017 Highlights and Subsequent Events
- Executed a letter of intent for a
sublicensing contract for worldwide research and development
results with Cerveau Technologies, Inc. (“Cerveau”) for using
NAV4694, a beta-amyloid imaging agent being evaluated as an aid in
the differential diagnosis of early-onset Alzheimer’s disease
- Executed a letter of intent for an
exclusive license with Cerveau for the development and
commercialization of NAV4694 in Australia, Canada, China, and
Singapore
- Presented a late-breaking poster
presented at the American College of Rheumatology Annual Meeting
detailing the results of an IV-administered study in RA
patients
- Initiated series of regular
investor-focused Q&A conference calls to improve Investor
Relations strategy
- IV-administration RA trial to complete
enrollment in fourth quarter 2017
- Launched NASH imaging study launch this
quarter at Kettering Medical Center in Ohio
- Initiate dosing in Phase 1/2 clinical
imaging study in Kaposi’s Sarcoma
Financial Results
Our consolidated balance sheets and statements of operations
have been reclassified, as required by current accounting
standards, for all periods presented to reflect the line of
business sold to Cardinal Health 414 as a discontinued operation.
Accordingly, this discussion focuses on describing results of our
operations as if we had not operated the discontinued operation
during the periods being disclosed.
- We recorded a $86.7 million net gain on
the line of business sold to Cardinal Health 414 for the nine
months ended September 30, 2017, including $16.5 million in
guaranteed consideration, which was discounted to the present value
of future cash flows. The proceeds were offset by $3.3 million in
estimated fair value of warrants issued to Cardinal Health 414,
$2.0 million in legal and other fees related to the sale, $800,000
in net balance sheet dispositions and write-offs, and $6.5 million
in estimated taxes.
- Total revenues for the third quarter of
2017 were $224,000, compared to $1.8 million in the third quarter
of 2016. These revenues are grant-related and do not include the
$1.7 million of payments received from Cardinal Health 414.
- Research and development expenses for
the third quarter of 2017 were $875,000, compared to $919,000 in
the third quarter of 2016. The net decrease was primarily a result
of decreases in net compensation costs coupled with decreased
NAV4694 and NAV5001 development costs, offset by increases in
Manocept development costs.
- Selling, general and administrative
expenses for the third quarter of 2017 were $1.7 million, compared
to $1.8 million in the third quarter of 2016. The net decrease was
primarily due to decreases in general support costs such as rent
and depreciation, coupled with decreased net compensation costs,
offset by net increased legal and professional services.
- Navidea’s net loss attributable to
common stockholders for the quarter ended September 30, 2017 was
$1.5 million, or a $0.01 loss per share (basic), compared to a net
loss of $59,000, or a $0.00 loss per share, for the same period in
2016.
- Navidea ended the quarter with $6.6
million in cash and investments, not including the quarterly
guaranteed earnout payment of $1.7 million from Cardinal Health 414
which was received after the quarter ended.
Conference Call Details
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. Participants are encouraged to log-in and/or dial-in
fifteen minutes before the conference call begins.
Event: Q3 2017 Earnings and Business Update
Conference Call
Date: Wednesday, November 8, 2017
Time: 8:30 am (Eastern Time)
U.S. & Canada
Dial-in: 1-866-548-4713 (toll free)
Conference ID:
6714834
Webcast
http://www.audio-webcast.com/cgi-bin/visitors.ssp?fn=visitor&id=5121
A live audio webcast of the conference call will also be
available on the investor relations page of Navidea’s corporate
website at www.navidea.com. In addition, the recorded
conference call can be replayed and will be available for 90 days
following the call on Navidea’s website.
About Navidea
Navidea Biopharmaceuticals, Inc. (NYSE MKT: NAVB) is a
biopharmaceutical company focused on the development of precision
immunodiagnostic agents and immunotherapeutics. Navidea is
developing multiple precision-targeted products based on its
Manocept™ platform to enhance patient care by identifying the
sites and pathways of disease and enable better diagnostic
accuracy, clinical decision-making, and targeted treatment.
Navidea’s Manocept platform is predicated on the ability to
specifically target the CD206 mannose receptor expressed on
activated macrophages. The Manocept platform serves as the
molecular backbone of Tc 99m tilmanocept, the first product
developed and commercialized by Navidea based on the platform. The
development activities of the Manocept immunotherapeutic platform
are being conducted by Navidea in conjunction with its subsidiary,
Macrophage Therapeutics, Inc. 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.
Forward-Looking Statements
This release and any oral statements made with respect to the
information contained in this release contains forward-looking
statements within the meaning of Section 27A of the Securities Act
of 1933, as amended, and Section 21E of the Securities Exchange Act
of 1934, as amended. We have based these forward-looking statements
largely on our current expectations and projections about future
events and financial trends affecting the financial condition of
our business. These forward-looking statements are subject to a
number of risks, uncertainties and assumptions, including, among
other things: general economic and business conditions, both
nationally and in our markets; our history of losses and
uncertainty of future profitability; the final outcome of the CRG
litigation in Texas; our ability to successfully complete research
and further development of our drug candidates; the timing, cost
and uncertainty of obtaining regulatory approvals of our drug
candidates; our ability to successfully commercialize our drug
candidates; our expectations and estimates concerning future
financial performance, financing plans and the impact of
competition; our ability to raise capital sufficient to fund our
development and commercialization programs; our ability to
implement our growth strategy; anticipated trends in our business;
advances in technologies; and other risk factors set forth in this
report and detailed in our most recent Annual Report on Form 10-K
and other SEC filings. You are urged to carefully review and
consider the disclosures found in our SEC filings, which are
available at www.sec.gov or
at http://ir.navidea.com.
Investors are urged to consider statements that include the
words “will,” “may,” “could,” “should,” “plan,” “continue,”
“designed,” “goal,” “forecast,” “future,” “believe,” “intend,”
“expect,” “anticipate,” “estimate,” “project,” and similar
expressions, as well as the negatives of those words or other
comparable words, to be uncertain forward-looking statements. You
are cautioned not to place undue reliance on any forward-looking
statements, any of which could turn out to be incorrect. We
undertake no obligation to update publicly or revise any
forward-looking statements, whether as a result of new information,
future events or otherwise after the date of this report. In light
of these risks and uncertainties, the forward-looking events and
circumstances discussed in this report may not occur and actual
results could differ materially from those anticipated or implied
in the forward-looking statements.
NAVIDEA BIOPHARMACEUTICALS, INC. CONDENSED
CONSOLIDATED BALANCE SHEETS September 30, December 31,
2017 2016 (unaudited) Assets: Cash and securities $
6,618,449 $ 1,539,325 Restricted cash - 5,001,253 Accounts
receivable 8,042,691 203,016 Other current assets 504,971 938,428
Assets associated with discontinued operations, current - 3,144,247
Guaranteed earnout receivable 6,445,390 - Other assets 994,206
1,530,152
Assets associated with discontinued
operations
- 105,255 Total assets $ 22,605,707 $
12,461,676 Liabilities and stockholders' equity
(deficit): Notes payable, current $ 1,981,676 $ 51,957,913 Other
current liabilities 4,026,867 13,038,278 Liabilities associated
with discontinued operations, current 33,141 4,865,597 Notes
payable - 9,641,179 Other liabilities 706,295 624,922
Total liabilities 6,747,979 80,127,889
Navidea stockholders' equity (deficit) 15,189,010 (68,135,123 )
Noncontrolling interest 668,718 468,910 Total
stockholders' equity (deficit) 15,857,728 (67,666,213
) Total liabilities and stockholders' equity (deficit) $ 22,605,707
$ 12,461,676
CONDENSED CONSOLIDATED STATEMENTS OF
OPERATIONS Three
Months Ended Nine Months Ended September 30, September 30,
September 30, September 30, 2017 2016 2017 2016 (unaudited)
(unaudited) (unaudited) (unaudited) Revenue: Tc99m tilmanocept
sales and license revenue $ - $ 1,313,226 $ 100,000 $ 1,826,425
Grant and other revenue 223,669 510,974
1,315,298 2,113,420 Total revenue
223,669 1,824,200 1,415,298
3,939,845 Cost of good sold -
2,889 - 5,185 Gross
profit 223,669 1,821,311
1,415,298 3,934,660 Operating expenses:
Research and development 874,547 919,441 2,765,695 5,010,923
Selling, general and administrative 1,734,707
1,811,680 9,006,725 5,832,623
Total operating expenses 2,609,254 2,731,121
11,772,420 10,843,546 Loss from
operations (2,385,585 ) (909,810 ) (10,357,122
) (6,908,886 ) Other income (expense): Interest income
(expense), net 76,050 159 144,811 (2,076 ) Equity in the loss of
joint venture - - - (15,159 ) Loss on disposal of joint venture - -
- (39,732 ) Change in fair value of financial instruments -
(839,298 ) 153,357 1,755,989 Loss on extinguishment of debt - -
(1,314,102 ) - Other, net (6,979 ) (12,498 )
(45,256 ) (49,916 ) Loss before income taxes (2,316,514 )
(1,761,447 ) (11,418,312 ) (5,259,780 ) Benefit from income taxes
776,068 - 3,861,474
- Loss from continuing operations (1,540,446 )
(1,761,447 ) (7,556,838 ) (5,259,780 ) Discontinued operations, net
of tax effect: Income (loss) from discontinued operations 5,998
1,701,911 (332,239 ) (5,167,312 ) Gain (loss) on sale
(12,486 ) - 86,735,637 -
Net income (loss) (1,546,934 ) (59,536 ) 78,846,560 (10,427,092 )
Less loss attributable to noncontrolling interest (23 )
(159 ) (192 ) (516 ) Net income (loss)
attributable to common stockholders $ (1,546,911 ) $ (59,377 ) $
78,846,752 $ (10,426,576 ) Income (loss) per common share
(basic): Continuing operations $ (0.01 ) $ (0.01 ) $ (0.05 ) $
(0.03 ) Discontinued operations $ (0.00 ) $ 0.01 $ 0.54 $ (0.04 )
Attributable to common stockholders $ (0.01 ) $ (0.00 ) $ 0.49 $
(0.07 ) Weighted average shares outstanding (basic) 162,006,646
155,481,278 161,437,276 155,390,911 Income (loss) per common share
(diluted): Continuing operations $ (0.01 ) $ (0.01 ) $ (0.05 ) $
(0.03 ) Discontinued operations $ (0.00 ) $ 0.01 $ 0.52 $ (0.04 )
Attributable to common stockholders $ (0.01 ) $ (0.00 ) $ 0.47 $
(0.07 ) Weighted average shares outstanding (diluted) 162,006,646
155,481,278 165,914,473 155,390,911
View source
version on businesswire.com: http://www.businesswire.com/news/home/20171107006778/en/
Navidea BiopharmaceuticalsJed Latkin, CFO/COO,
614-551-3416jlatkin@navidea.comorEdison AdvisorsTirth Patel,
646-653-7035tpatel@edisongroup.com
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