Navidea Biopharmaceuticals (NYSE MKT:NAVB) reports financial
results for the quarter ending September 30, 2016. Navidea reported
total revenue for the third quarter of 2016 of $8.5
million, including Lymphoseek® (technetium Tc 99m
tilmanocept) injection sales revenue of $6.7 million. The
income from operations was $3.4 million and the net loss
attributable to common stockholders was $59,000.
"We ended the third quarter with a clear plan for Navidea’s
future. With our previously announced Letter of Intent with
Cardinal Health, Inc., we believe that we have successfully
identified an arrangement to extinguish the CRG (Capital Royalty
Partners II L.P) debt and to focus Navidea on several attractive
development efforts outside of lymphatic mapping, lymph node biopsy
and the diagnosis of metastatic spread to lymph nodes for the
staging of cancer in North America. The contemplated transaction
with Cardinal Health, as well as the impending launch of Lymphoseek
in Europe by our partner SpePharm AG (Norgine BV), should provide
additional income for many years to come,” said Dr. Michael
Goldberg, Navidea President and CEO. “Our focus moving forward will
be on expansion and development of Manocept-based diagnostic
markets initially in rheumatoid arthritis and
cardiovascular disease, as well as developing our immunotherapeutic
platform with a strong preclinical pipeline for cancer,
autoimmune, inflammatory and infectious diseases.”
Specific events and milestones achieved since the beginning of
the third quarter include the following:
Operational & Financial
- Entered into Letter of Intent with
Cardinal Health, Inc. for the sale of Lymphoseek in North
America;
- Operating activities provided cash of
$1.3 million during the first nine months of 2016, compared to
$14.9 million cash used in operations during the same period in
2015;
- Reduced cash used in operations by over
100% for the first nine months of 2016 compared to the same period
of 2015; and
- Appointed Michael M. Goldberg, M.D.
President and Chief Executive Officer, and Eric K. Rowinsky, M.D.
Chairman of the Board.
Commercial
- Achieved sequential quarter-on-quarter
Lymphoseek sales revenue growth;
- Earned a $500,000 milestone
payment from Cardinal Health with the sale of the
100,000th Lymphoseek dose;
- Received positive opinion in Europe for
new Lymphoseek reduced-mass vial enabling a single injection per
vial and triggering a $500,000 milestone payment by our partner,
Norgine BV; and
- Continued to support the projected Q4
launch of Lymphoseek in Europe by Norgine BV.
Immunodiagnostic & Immunotherapeutic Development
Pipeline
- Received both Institutional Review
Board at University of California, San Francisco and Western
Institutional Review Board approvals for a tilmanocept subcutaneous
administration clinical trial protocol in rheumatoid arthritis,
allowing subject enrollment to begin. To date, 17 of 18 patients
have been dosed and imaged;
- Received Institutional Review Board
approval for a tilmanocept clinical trial protocol in Kaposi
Sarcoma which is supported by an NIH grant;
- Clinical trial results of tilmanocept
in cardiovascular disease from Massachusetts General Hospital have
been submitted for publication; and
- Completed a number of additional
preclinical animal studies and initiated additional studies with
the MT 1000 and MT 2000 class of compounds.
Financials
“We are pleased with our financial performance despite the
significant disruption in our organization caused by the ongoing
litigation with CRG. Our results demonstrate our commitment to our
commercial efforts and controlling our operating expenses,” said
Jed Latkin, interim Chief Operating Officer and Chief Financial
Officer at Navidea.
Total revenues for the quarter ended September 30, 2016 were
$8.5 million compared to $4.0 million in the third quarter of last
year. Third quarter 2016 product revenues recognized from the sale
of Lymphoseek were $6.7 million, compared to $4.2 million in the
second quarter of 2016 and $3.0 million in the third quarter of
2015. During the third quarter of 2016, the Company also reported
$1.8 million in licensing, grant and other revenue. For the nine
months ended September 30, 2016, Navidea’s total revenue was $18.6
million compared to $9.0 million for the same period in 2015, an
increase of 108%. The primary driver of this increase was revenues
recognized by Navidea from the sale of Lymphoseek which exceeded
$14.7 million for the nine months ended September 30, 2016 compared
to $6.8 million for the same period last year. Third quarter 2016
revenue from the sale of Lymphoseek included $2.0 million of
inventory purchases by Cardinal Health and $500,000 of additional
revenue from a milestone related to the sale of the 100,000th
Lymphoseek dose by Cardinal Health.
Third quarter 2016 margins also remained above 80%, contributing
to a total gross profit of $7.6 million for the quarter, compared
to $3.5 million for the same period last year. For the nine months
ended September 30, 2016, total gross profit rose to $16.6 million
versus $7.7 million for the same period last year, an increase of
115%. The increases in total gross profit in the third quarter and
first nine months of 2016 was primarily due to $2.0 million of
inventory purchases by Cardinal Health, a $500,000 milestone
related to the sale of the 100,000th Lymphoseek dose by Cardinal
Health, and receipt of a $500,000 milestone payment, and
recognition of the remaining $500,000 of the upfront license fee
received from SpePharm related to the positive regulatory opinion
on a reduced-mass vial in Europe.
Research and development (R&D) expenses for the third
quarter of 2016 were $1.3 million, compared to $3.9 million in the
third quarter of last year. R&D expenses were $6.5 million for
the nine months ended September 30, 2016 compared to $10.2 million
in the same period of 2015. The net decreases in year-to-date
R&D expenses were primarily a result of decreased headcount
costs coupled with decreased project costs related to the Company’s
neuro assets and Lymphoseek, offset by increased project costs
related to the Company’s therapeutic programs. Selling, general and
administrative (SG&A) expenses for the third quarter of 2016
were $2.9 million, compared to $3.9 million in the third quarter of
last year. SG&A expenses were $9.9 million for the nine months
ended September 30, 2016, compared to $13.5 million for the same
period in 2015. The net decrease in year-to-date SG&A expenses
was due primarily to decreased headcount coupled with decreased
costs related to business development consulting services,
contracted medical science liaisons, commercialization costs for
Lymphoseek, license fees and investor relations, offset by
increases in commercial and medical headcount costs related to the
addition of our internal sales force and medical science liaisons
coupled with increased legal and professional services. Total
operating expenses were $4.2 million for the third quarter of 2016,
compared to $7.8 million in the third quarter of last year.
Operating expenses were $16.4 million for the nine months ended
September 30, 2016, compared to $23.7 million for the same period
in 2015.
Navidea’s income from operations for the quarter ended September
30, 2016 was $3.4 million compared to a loss from operations of
$4.3 million for the same period in 2015. For the nine months ended
September 30, 2016, Navidea’s income from operations was $210,000
compared to a loss from operations of $15.9 million for the same
period in 2015. Navidea’s net loss attributable to common
stockholders for the quarter ended September 30, 2016 was $59,000,
or $0.00 per share, compared to net loss attributable to common
stockholders of $8.1 million, or $0.05 per share, for the same
period in 2015. For the nine months ended September 30, 2016,
Navidea’s net loss attributable to common stockholders was $10.4
million, or $0.07 per share, compared to a net loss attributable to
common stockholders of $25.1 million, or $0.17 per share, for the
same period in 2015. Net losses attributable to common stockholders
include fees paid to CRG (which the Company is disputing in court),
the interest expense on our outstanding debt, as well as
significant non-cash charges. For the nine-month periods ended
September 30, 2016 and September 30, 2015, net loss attributable to
common stockholders included $10.6 million and $9.1 million,
respectively, in interest, debt-related fees, losses on
extinguishment of debt, and changes in the fair value of financial
instruments.
Navidea ended the quarter with $4.3 million in cash, $3.5
million of which was restricted related to the CRG debt.
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 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 Q3 2016
Financial Results Conference Call Date/Time: Thursday, November 3,
2016 at 8:30 a.m. ET Webcast Link:
http://edge.media-server.com/m/p/on2557gm/lan/en
Dial-in Number – US: (855) 897-5884 Dial in Number – Int’l: (720)
634-2940 Conference ID Number: 3723903 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, our
ability to repay our debt, the outcome of the CRG litigation,
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
September 30,
December 31, 2016 2015 (unaudited) Assets: Cash $ 810,425 $
7,166,260 Restricted cash 3,501,247 - Other current assets
5,119,189 5,410,914 Non-current assets 1,758,739
2,387,339 Total assets $ 11,189,600 $
14,964,513 Liabilities and stockholders' deficit:
Deferred revenue, current $ 15,037 $ 1,044,281 Notes payable,
current 51,652,209 333,333 Other current liabilities 12,096,593
4,806,236 Deferred revenue 26,061 192,728 Notes payable, net of
discount 10,549,405 60,746,002 Other liabilities 624,896
1,677,633 Total liabilities 74,964,201
68,800,213 Navidea stockholders' deficit
(64,243,643 ) (54,305,258 ) Noncontrolling interest 469,042
469,558 Total stockholders' deficit
(63,774,601 ) (53,835,700 ) Total liabilities and
stockholders' deficit $ 11,189,600 $ 14,964,513
CONDENSED CONSOLIDATED STATEMENTS OF
OPERATIONS Three Months Ended Nine Months Ended
September 30, September 30, September 30, September 30, 2016 2015
2016 2015 (unaudited) (unaudited) (unaudited) (unaudited) Revenue:
Lymphoseek sales revenue $ 6,690,090 $ 2,952,522 $ 14,704,489 $
6,751,492 Lymphoseek license revenue 1,295,625 550,000 1,795,625
883,333 Grant and other revenue 511,359
476,755 2,113,995 1,320,816
Total revenue 8,497,074 3,979,277
18,614,109 8,955,641 Cost of good sold
921,817 457,590 2,017,486
1,239,377 Gross profit 7,575,257
3,521,687 16,596,623 7,716,264
Operating expenses: Research and development 1,276,053 3,902,155
6,461,154 10,180,517 Selling, general and administrative
2,940,773 3,942,609 9,925,574
13,485,576 Total operating expenses 4,216,826
7,844,764 16,386,728
23,666,093 Income (loss) from operations 3,358,431
(4,323,077 ) 209,895 (15,949,829
) Interest expense, net (2,566,171 ) (2,148,369 ) (12,288,169 )
(4,690,686 ) Equity in the loss of joint venture - (26,785 )
(15,159 ) (295,217 ) Loss on disposal of joint venture - - (39,732
) - Change in fair value of financial instruments (839,298 )
(1,577,275 ) 1,755,989 (1,702,902 ) Loss on extinguishment of debt
- - - (2,440,714 ) Other income (expense), net (12,498 )
4,402 (49,916 ) 26,100 Net loss
(59,536 ) (8,071,104 ) (10,427,092 ) (25,053,248 ) Net loss
attributable to noncontrolling interest (159 ) (340 ) (516 ) (681 )
Deemed dividend on beneficial conversion feature -
- - (46,000 ) Net loss
attributable to common stockholders $ (59,377 ) $ (8,070,764 ) $
(10,426,576 ) $ (25,098,567 ) Loss per common share (basic
and diluted) $ (0.00 ) $ (0.05 ) $ (0.07 ) $ (0.17 ) Weighted
average shares outstanding (basic and diluted) 155,481,278
150,186,131 155,390,911 150,030,638
View source
version on businesswire.com: http://www.businesswire.com/news/home/20161103005461/en/
Navidea BiopharmaceuticalsInvestors &
MediaJed Latkin, 614-973-7490Interim COO &
CFOjlatkin@navidea.com
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