Navidea Biopharmaceuticals, Inc. (NYSE MKT:NAVB), today
announced financial results for the first quarter of 2016. Navidea
reported total revenue for the first quarter of 2016 of $4.7
million, including Lymphoseek® (technetium Tc 99m tilmanocept)
injection sales revenue to Navidea of $3.8 million. The net loss
attributable to common stockholders was $3.7 million.
“Since the start of the year there have been numerous changes at
Navidea as we position the company for the best return on the
commercialization of our Lymphoseek immunodiagnostic product and
our exciting Manocept™ therapeutic platform,” said Jed Latkin,
interim Chief Operating Officer. “Lymphoseek Q1 2016 revenue grew
8% quarter-on-quarter and 106% versus the same quarter last year
and we expect much stronger revenue growth in future quarters
reflective of the addition of four key regional sales reps and
positive utilization trends observed in some major medical
accounts. Of note, our operating expenses continue to decline and
are significantly reduced from 2015 as we seek to gain operational
cash flow breakeven in 2016.”
Mr. Latkin continued, “Additionally we are making progress in
expanding the clinical application of Lymphoseek into new solid
tumors in the U.S. and an expected Q4 2016 launch in Europe, as
well as immunodiagnostic indications such as Rheumatoid Arthritis
and cardiovascular diseases. We are also obtaining baseline proof
of concept data for technology in therapeutic applications. These
therapeutic pre-clinical studies will allow us to seek a
foundational partnership in each key therapeutic area to help fund
development while maximizing return and minimizing the dilution to
our shareholders. We look forward to a strong, eventful 2016.”
PRODUCT, PIPELINE & BUSINESS
UPDATES
Lymphoseek
- Grew Lymphoseek revenue 106% in Q1 2016
versus same quarter last year, maintained gross margins on sales of
Lymphoseek in excess of 85%, maintained high reorder rates in
excess of 80% and continued to accelerate trial and adoption in
major cancer centers;
- Added and trained four new regional
sales reps, expanding our sales team from 12 to 16 sales
professionals supported by four Medical Science Liaisons
(MSLs);
- Broadened access to Lymphoseek though
the voucher program and vial consignment program within major
multi-hospital chains who have high potential to adopt
Lymphoseek and who are influential in the practices of other
institutions. These large multi-hospital accounts have the
potential to rapidly increase volume growth; and
- Continued market development clinical
activities with Navidea and investigator-initiated studies in
cervical cancer, pediatric solid tumors, anal-rectal cancer,
endometrial cancer, and for further confirmation of workflow
efficiency compared to sulfur colloid, which are supported in part
by National Institutes of Health (NIH) grant funding.
Manocept Immunodiagnostic Pipeline
- Advanced development efforts for
intravenous (IV) and subcutaneous delivery supported by NIH grant
funds in order to expand the label of tilmanocept;
- Submitted non-clinical data package and
held successful Food and Drug Administration (FDA) meeting in March
with agreed submission of an Investigational New Drug (IND)
amendment to the FDA that will allow initiation of IV clinical
studies of Lymphoseek;
- Awaiting Institutional Review Board
(IRB) approval to begin sub-cutaneous Phase 1 study in Rheumatoid
Arthritis (RA). Expect to begin Phase 1/2 IV study in RA later in
the year;
- Completed enrollment in a pilot
cardiovascular imaging study evaluating detection of vulnerable
plaque at Massachusetts General Hospital. Preliminary results are
very promising and are being prepared for publication in medical
journals; and
- Expect to begin grant-funded Phase 1/2
evaluation of Lymphoseek - IV in Kaposi’s Sarcoma patients in the
second half of 2016.
Manocept Immunotherapeutic Development Pipeline (Macrophage
Therapeutics)
- Completed an 8-week, preclinical mouse
study in an arthritis mouse model with a Manocept anti-inflammatory
targeted therapeutic product, MT2002, with initial results
reporting clear anti-inflammatory activity with no apparent
significant side effects;
- Completed an animal study in an asthma
model that measured the ability of MT2002 to decrease all three
markers of pro-inflammatory markers secreted by disease-causing
macrophages that successfully demonstrates an anti-inflammatory
effect;
- Completed dosing in two studies using a
neuro-inflammation model and an animal model for NASH, nonalcoholic
steatohepatitis, with results expected in coming weeks; and
- Initiated a number of studies
evaluating the performance of compounds from the MT1000 class of
compounds designed to deplete tumor associated macrophages (TAMs)
in a number of different cancer models.
Business
- Named Jed Latkin as interim Chief
Operating Officer to direct the Company’s day-to-day operations and
act as principal executive officer and principal financial and
accounting officer until replacements are hired following the
departure of Rick Gonzalez as President and CEO and a medical leave
by Brent Larson, EVP and CFO;
- Named Marcum LLP as corporate
independent registered public accounting firm following resignation
of BDO USA, L.L.P.;
- Announced appointment of Mark I.
Greene, M.D., Ph.D. FRCP, Tony Fiorino, M.D., Ph.D. and Michael
Rice to the Board of Directors and the departure of Brendan Ford,
Anton Gueth, Rick Gonzalez and Gordon Troup; and
- Capital Royalty Partners II L.P. (CRG)
commenced a lawsuit alleging that events of default have occurred
under the Company’s loan agreement with CRG. The Company intends to
vigorously defend against these claims. The Company is evaluating
its options, including the possible assertion of
counterclaims.
FINANCIALS
Total revenues for the quarter ended March 31, 2016 were $4.7
million compared to $2.1 million in the first quarter of last year.
First quarter 2016 product revenues recognized from the sale of
Lymphoseek were $3.8 million, compared to $3.5 million in the
fourth quarter of last year and $1.8 million in the first quarter
of last year. This represents a sequential quarter-on-quarter
growth of 8% and year-over-year growth of approximately 106%. Q1
2016 revenue for licensing milestones, various federal grants and
other revenue were $940,000 compared to $791,000 in the fourth
quarter of last year and $273,000 in the first quarter of last
year.
Gross margins on Lymphoseek product sales remain strong at 86%
for the first quarter of 2016 compared to 76% for the first quarter
of 2015.
Total operating expenses were $6.8 million, compared to $9.5
million in the first quarter of last year. Research and development
expenses for the first quarter of 2016 were $2.7 million, compared
to $4.0 million in the first quarter of last year. The net decrease
from 2015 to 2016 was primarily a result of reductions in NAV4694,
NAV5001 and Lymphoseek product development costs coupled with
reduced headcount and related support costs, offset by increased
therapeutics product development costs. Selling, general and
administrative expenses for the first quarter of 2016 were $4.1
million, compared to $5.5 million in the first quarter of last
year. The net decrease was primarily due to decreased general and
administrative headcount following the first quarter 2015 reduction
in force coupled with decreased costs for contracted medical
science liaisons, business development consulting services, market
development expenses related to Lymphoseek, and license fees,
offset by increased commercial and medical headcount coupled with
increased legal and professional services.
Navidea’s net loss attributable to common stockholders for the
quarter ended March 31, 2016 was $3.7 million, or $0.02 per share,
compared to $7.3 million, or $0.05 per share, for the same period
in 2015.
Based on CRG’s claims that the Company is in default under the
terms of the CRG Loan Agreement, and in accordance with current
accounting guidance, the Company has classified the net balance of
the CRG Term Loan as a current liability on the consolidated
balance sheet as of March 31, 2016.
Navidea ended the quarter with $5.5 million in cash.
The Company reiterates its 2016 total revenue estimate of $23
million to $25 million. Margins on Lymphoseek product sales are
expected to continue to exceed 80% in the coming quarters. The
Company also expects, following completion of the partnering
activities for NAV4694, that cash operating expenses on a quarterly
basis will continue to decrease to the point necessary for the
Company to achieve its goals of cash flow breakeven from
operations. This guidance excludes therapeutic-related research and
development costs for the Manocept platform which are expected to
be funded separately by Macrophage Therapeutics, Inc.
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 Q1 2016 Financial
Results Conference Call Date/Time: Tuesday, May 17, 2016 at 8:00
a.m. ET Webcast Link:
http://edge.media-server.com/m/p/b5ki35y5/lan/en
Dial-in Number – US: 1 (855) 897-5884 Dial in Number – Int’l: 1
(720) 634-2940 Participant Passcode: 11165733 Replay
A webcast replay will be available on the
Investor Relations section of our website at http://ir.navidea.com
for 30 days.
About Lymphoseek
Lymphoseek® (technetium Tc 99m tilmanocept) injection is the
first and only FDA-approved receptor-targeted lymphatic mapping
agent. It is a novel, receptor-targeted, small-molecule
radiopharmaceutical used in the evaluation of lymphatic basins that
may have cancer involvement in patients. Lymphoseek is designed for
the precise identification of lymph nodes that drain from a primary
tumor, which have the highest probability of harboring cancer.
Lymphoseek is approved by the U.S. Food and Drug Administration
(FDA) for use in solid tumor cancers where lymphatic mapping is a
component of surgical management and for guiding sentinel lymph
node biopsy in patients with clinically node negative breast
cancer, melanoma or squamous cell carcinoma of the oral cavity.
Lymphoseek has also received European approval in imaging and
intraoperative detection of sentinel lymph nodes in patients with
melanoma, breast cancer or localized squamous cell carcinoma of the
oral cavity.
Accurate diagnostic evaluation of cancer is critical, as results
guide therapy decisions and determine patient prognosis and risk of
recurrence. Overall in the U.S., solid tumor cancers may represent
up to 1.2 million cases per year. The sentinel node label in the
U.S. and Europe may address approximately 600,000 new cases of
breast cancer, 160,000 new cases of melanoma and 100,000 new cases
of head and neck/oral cancer diagnosed annually.
Lymphoseek Indication and Important Safety
Information
Lymphoseek is a radioactive diagnostic agent indicated with or
without scintigraphic imaging for:
• Lymphatic mapping using a handheld gamma counter to locate
lymph nodes draining a primary tumor site in patients with solid
tumors for which this procedure is a component of intraoperative
management.
• Guiding sentinel lymph node biopsy using a handheld gamma
counter in patients with clinically node negative squamous cell
carcinoma of the oral cavity, breast cancer or melanoma.
Important Safety Information
In clinical trials with Lymphoseek, no serious hypersensitivity
reactions were reported, however Lymphoseek may pose a risk of such
reactions due to its chemical similarity to dextran. Serious
hypersensitivity reactions have been associated with dextran and
modified forms of dextran (such as iron dextran drugs).
Prior to the administration of Lymphoseek, patients should be
asked about previous hypersensitivity reactions to drugs, in
particular dextran and modified forms of dextran. Resuscitation
equipment and trained personnel should be available at the time of
Lymphoseek administration, and patients observed for signs or
symptoms of hypersensitivity following injection.
Any radiation-emitting product may increase the risk for cancer.
Adhere to dose recommendations and ensure safe handling to minimize
the risk for excessive radiation exposure to patients or health
care workers. In clinical trials, no patients experienced serious
adverse reactions and the most common adverse reactions were
injection site irritation and/or pain (<1%).
FULL LYMPHOSEEK PRESCRIBING INFORMATION CAN BE FOUND
AT:WWW.LYMPHOSEEK.COM
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 March
31, December 31, 2016 2015 (unaudited) Assets: Cash $
5,484,083 $ 7,166,260 Other current assets 4,552,041 5,410,914
Non-current assets 2,247,557 2,387,339 Total assets $
12,283,681 $ 14,964,513 Liabilities and stockholders'
deficit: Deferred revenue, current $ 945,190 $ 1,044,281 Notes
payable, current, net of discount 50,179,537 333,333 Other current
liabilities 5,968,108 4,806,236 Deferred revenue 26,061 192,728
Notes payable, net of discount 10,672,265 60,746,002 Other
liabilities 1,653,328 1,677,633 Total liabilities
69,444,489 68,800,213 Navidea stockholders' deficit
(57,630,124) (54,305,258) Noncontrolling interest 469,316
469,558 Total stockholders' deficit (57,160,808)
(53,835,700) Total liabilities and stockholders' deficit $
12,283,681 $ 14,964,513
CONDENSED
CONSOLIDATED STATEMENTS OF OPERATIONS Three Months Ended March
31, March 31, 2016 2015 (unaudited) (unaudited) Revenue: Lymphoseek
sales revenue $ 3,782,680 $ 1,835,422 Lymphoseek license revenue
254,050 83,333 Grant and other revenue 685,825
189,701 Total revenue 4,722,555 2,108,456 Cost of
goods sold 534,929 449,057 Gross profit
4,187,626 1,659,399 Operating expenses: Research and
development 2,659,520 3,981,288 Selling, general and administrative
4,096,660 5,494,168 Total operating expenses
6,756,180 9,475,456 Loss from operations (2,568,554)
(7,816,057) Other income (expense): Interest expense, net
(2,193,523) (966,576) Equity in the loss of joint venture (12,239)
(262,227) Change in fair value of financial instruments 1,125,359
1,727,103 Loss on extinguishment of debt - - Other income
(expense), net (37,292) 26,532 Net loss (3,686,249)
(7,291,225) Less loss attributable to noncontrolling interest (241)
(100) Deemed dividend on beneficial conversion feature -
(46,000) Net loss attributable to common stockholders $
(3,686,008) $ (7,337,125) Loss per common share (basic and
diluted) $ (0.02) $ (0.05) Weighted average shares
outstanding (basic and diluted) 155,308,094 149,794,331
View source
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Investors & MediaNavidea
BiopharmaceuticalsSharon Correia, 978-655-2686Associate Director,
Corporate Communications
Navidea Biopharmaceuticals (AMEX:NAVB)
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