Navidea Biopharmaceuticals, Inc. (NYSE MKT:NAVB), today
announced financial results for the first quarter of 2015. Navidea
reported total revenue for the first quarter of 2015 of $2.1
million, including Lymphoseek® (technetium Tc 99m
tilmanocept) injection sales revenue of $1.84 million. The net
loss attributable to common stockholders was $7.3 million.
“Performance year-to-date reflects our aggressive transformation
into an organization singularly focused on unlocking the value of
our Manocept™ technology as a state-of-the-art cancer imaging agent
and as a novel therapeutic platform,” said Rick Gonzalez, Navidea
Chief Executive Officer. “We executed on our stated objectives to
grow revenues sequentially, continued to take steps to reduce
operating cash burn, strengthened our balance sheet, and are
positioned to begin realizing the impact of a fully deployed
surgical oncology field force in the second half of the year. Based
on this progress, we reaffirm our $10 to $12 million Lymphoseek
revenue guidance for 2015 and our expectation of achieving
cash-flow breakeven from operations during the first quarter of
2016.”
Specific milestones achieved in the first quarter and
year-to-date include the following:
- Achieved sequential quarter-on-quarter
Lymphoseek revenue growth of 26% and continued improvement in key
performance indicator growth targets;
- Hired Lymphoseek field force of 12
representatives which will be fully deployed in the second
quarter;
- Entered a European commercial
partnership for Lymphoseek with Norgine BV and received $2 million
up-front payment;
- Reported additional validating data at
the American Association for Cancer Research (AACR) meeting
demonstrating the potential for our CD206 targeting platform,
Manocept, to target and treat Kaposi’s sarcoma (KS), which is an
ideal model for other tumor types and infectious diseases;
- Signed a new credit facility that will
allow us to restructure our debt and provide us with over $18
million in additional net capital to support the Company’s growth
and plans to reach cash flow breakeven;
- Completed an initial external
investment into Macrophage Therapeutics, Inc. enabling further
development of the promising, early-stage Manocept therapeutic
platform; and,
- Completed the divestiture of the first
of two non-core neuroimaging assets.
FINANCIALS
Total revenues for the quarter ended March 31, 2015 were $2.1
million compared to $752,000 in the first quarter last year. First
quarter product revenues recognized from the sale of Lymphoseek
were $1.84 million, compared to $1.46 million in the fourth quarter
of last year and $627,000 in the first quarter of last year. This
represents a sequential quarter-on-quarter growth of 26% and
year-over-year growth of approximately 200%. During the first
quarter of 2015, the Company also received a $2.0 million up-front
payment related to the execution of a sublicense for Lymphoseek in
the EU with Norgine BV; however, this amount is being amortized
over a two-year period in accordance with applicable revenue
recognition rules.
Gross margins on Lymphoseek product sales remain strong at 76%
for the first quarter of 2015 compared to 69% for the first quarter
of 2014.
Research and development expenses for the first quarter of 2015
were $4.0 million, compared to $5.2 million in the first quarter of
last year. Selling, general and administrative expenses for the
first quarter of 2015 were $5.5 million, compared to $3.9 in the
first quarter of last year. Total operating expenses were $9.5
million, compared to $9.1 million in the first quarter of last
year. Operating expenses for the first quarter of 2015 included
approximately $1.4 million in estimated one-time severance and
stock compensation-related costs associated with the March 2015
reduction in force and approximately $1.5 million in out-of-pocket
costs related to the Company’s neuroimaging programs.
Navidea’s net loss attributable to common stockholders for the
quarter ended March 31, 2015 was $7.3 million, or $0.05 per share,
compared to $11.7 million, or $0.08 per share, for the same period
in 2014.
Navidea ended the quarter with $4.9 million in cash. Subsequent
to the end of the quarter, the Company entered into a loan
agreement with CRG which, after paying off certain outstanding
debt, will increase our cash position by over $18 million. The CRG
loan agreement provides for an initial funding of $50 million with
up to $10 million of additional funding available to Navidea, at
its option, through December 2016, subject to the satisfaction of
certain revenue milestones and other borrowing conditions.
In connection with the CRG financing, the Company also announced
certain amendments to the Company’s existing line of credit
currently in place with Platinum-Montaur Life Sciences, LLC
(Platinum) are being made that allow this facility to remain in
place in a subordinated position to the CRG loan. The amendments
will allow Platinum to convert the Company’s $7.7 million debt
during a time period in which the Company’s average stock price has
exceeded $2.53 per share for 10 consecutive trading days.
The Company reiterates its 2015 Lymphoseek product revenue
estimate of $10 million to $12 million. Additionally, margins on
Lymphoseek product sales are expected to approach and possibly
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.
“Our first quarter results are on track with our operating
budget and are reflective of the Company’s goal to accomplish our
objectives more efficiently,” said Brent Larson, Chief Financial
Officer. “Consistent with this effort, we closed our Boston office,
reduced headcount and have moved forward with our plans to
discontinue development of our non-core neuroimaging products.
These events, coupled with the restructuring of our debt, provide
us with greater financial flexibility than we have enjoyed for some
time. We believe this will not only help us through the point of
achieving our stated goal of reaching cash flow break-even from
operations early next year, but ultimately sets the stage for
achievement of the longer term growth prospects for the Manocept
platform.”
COMMERCIALIZATION
2015 commercialization efforts will focus initially on breast
cancer, melanoma, and oral cavity head and neck cancers, where
sentinel lymph node biopsies are already standard of care.
Lymphoseek has a highly differentiated label, and the product
provides a compelling clinical value proposition.
“Our commercial business achieved its stated objectives this
quarter, which position us to realize the full effect of our new
field force and commercial strategy,” said Thomas Klima, Chief
Commercial Officer. “We have recruited a seasoned and
highly-motivated sales team who will cover territories that capture
more than 80% of Lymphoseek-applicable cancer diagnoses in the U.S.
They will execute a new brand strategy reflective of Lymphoseek’s
expanded label directed to the oncology treatment team with a focus
on surgeons and other decision makers within the hospital. Based on
the anticipated impact of the deployment of this sales force and
our positive first quarter revenues and key performance indicators,
we remain confident in our 2015 sales projections.”
MANOCEPT PIPELINE
The core Manocept CD206 targeting platform, upon which
Lymphoseek is based, is central to our future business. As part of
this effort, several critical new datasets have been, or are
expected to be, reported at recent or upcoming medical conferences.
Most recently, the company reported the following data at the AACR
meeting:
- The Manocept molecule selectively binds
to, and is continuously internalized by, tumor-associated
macrophages and KS tumor cells in a preclinical model; and
- A single, subcutaneous injection of
Lymphoseek, a product based on the Manocept platform, detects and
localizes in both KS tumors and lymph nodes involved in draining
the KS tumor fields.
“Our collective body of data reinforces our belief that the
modulation or destruction of macrophage and KS expression profiles
represents a potential for a paradigm-shifting immunotherapeutic
strategy,” said Frederick O. Cope, Ph.D., Chief Scientific Officer
of Navidea. “We believe these results indicate KS could serve as a
model system for future immunotherapeutic development. We look
forward to reporting additional data supporting the development of
these efforts at upcoming medical conferences.”
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 2015
Financial Results Conference Call Date/Time: Tuesday, May 12, 2015
at 8:30 a.m. EDT Webcast Link:
http://edge.media-server.com/m/p/yafuo9zw/lan/en
Dial-in Number – US: 1 (855) 897-5884 Dial in Number – Int’l: 1
(720) 634-2940 Confirmation Number: 39734236 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 it
guides therapy decisions and determines 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 235,000 new cases
of breast cancer, 76,000 new cases of melanoma and 45,000 new cases
of head and neck/oral cancer in the U.S., and approximately 367,000
new cases of breast cancer, 83,000 new cases of melanoma and 55,000
new cases of head and neck/oral cancer diagnosed in Europe
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 diagnostics, therapeutics and
radiopharmaceutical agents. 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. Navidea’s
strategy is to deliver superior growth and shareholder return by
bringing to market novel radiopharmaceutical agents and
therapeutics, 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, 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, 2015 2014
(unaudited) Assets: Cash $ 4,884,189 $ 5,479,006
Other current assets 3,133,589 3,120,139 Non-current assets
2,900,131 3,321,035 Total assets $
10,917,909 $ 11,920,180 Liabilities and
stockholders' deficit: Deferred revenue, current $ 1,000,000
$ - Notes payable, net of discount, current 6,092,442 4,383,472
Other current liabilities 5,803,976 4,711,619 Deferred revenue
916,667 - Notes payable, net of discount 29,306,751 29,539,135
Other liabilities 3,161,885 3,089,420 Navidea stockholders' deficit
(35,846,713 ) (29,803,466 ) Noncontrolling interest 482,901
- Stockholders' deficit (35,363,812 )
(29,803,466 ) Total liabilities and stockholders'
deficit $ 10,917,909 $ 11,920,180
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS Three
Months Ended March 31, March 31, 2015 2014 (unaudited) (unaudited)
Revenue: Lymphoseek sales revenue $ 1,835,422 $ 626,631 Lymphoseek
license revenue 83,333 - Grant and other revenue 189,701
125,173 Total revenue 2,108,456
751,804 Cost of goods sold 449,057
193,220 Gross profit 1,659,399
558,584 Operating expenses: Research
and development 3,981,288 5,226,794 Selling, general and
administrative 5,494,168 3,910,833
Total operating expenses 9,475,456 9,137,627
Loss from operations (7,816,057 )
(8,579,043 ) Interest expense (966,859 ) (943,838 ) Equity
in the loss of joint venture (262,227 ) Change in fair value of
financial instruments 1,727,103 392,483 Loss on extinguishment of
debt - (2,610,196 ) Other income (expense), net 26,815
41 Net loss (7,291,225 ) (11,740,553 )
Net loss attributable to noncontrolling interest (100 ) - Deemed
dividend on beneficial conversion feature (46,000 ) -
Net loss attributable to common stockholders $
(7,337,125 ) $ (11,740,553 ) Loss per common share (basic
and diluted) $ (0.05 ) $ (0.08 ) Weighted average shares
outstanding (basic and diluted) 149,794,331 144,783,351
Navidea BiopharmaceuticalsInvestorsTom Baker,
617-532-0624tbaker@navidea.comorMediaSharon Correia, 978-655-2686Associate
Director, Corporate Communications
Navidea Biopharmaceuticals (AMEX:NAVB)
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