Navidea Biopharmaceuticals Announces Third Quarter 2013 Results

  Navidea Biopharmaceuticals Announces Third Quarter 2013 Results

– Business Update / Quarterly Conference Call Today, November 6, 2013 at 8:30
                                  a.m. EST –

Business Wire

DUBLIN, Ohio -- November 6, 2013

Navidea Biopharmaceuticals, Inc. (NYSE MKT: NAVB), a biopharmaceutical company
focused on precision diagnostic radiopharmaceuticals, today announced business
highlights and consolidated results for the third quarter ended September 30,
2013.

“We view the third quarter as continuing on the track toward success that
we’ve envisioned for several years now,” said Dr. Mark Pykett, Navidea CEO.
“We are pleased with the initial stages of Lymphoseek^® commercialization at
launch and believe that Lymphoseek continues to hold the promise to become the
standard of care in lymphatic mapping. In the first several quarters of
launch, we have indicated that success would be measured primarily by
important qualitative evidence of Lymphoseek adoption, especially in advance
of reimbursement. We believe we are seeing good momentum in many of these key
parameters. Our optimism stems from witnessing evidence of progress in many
positive measures, including multi-fold increases in unit sales quarter over
quarter, a high frequency of repeat and multi-dose ordering, an increase in
total accounts ordering, strong new user accrual, and encouraging formulary
placement activity. We anticipate further growth in the current quarter and
going forward facilitated by the October 1^st implementation of the unique
Lymphoseek reimbursement code received from the Centers for Medicare &
Medicaid Services (CMS).”

Dr. Pykett added, “Our recent equity offering enhances our ability to advance
several efforts underway, including commercial opportunities for Lymphoseek
outside the U.S., the continued development of our innovative
neurodegenerative imaging portfolio, and further evaluation of our recently
announced Manocept^TM platform initiatives. During the fourth quarter of 2013,
we expect additional value enhancing events, including submission of the
Lymphoseek sNDA, EMA feedback on our Marketing Authorization Application in
Europe, initiation of the NAV5001 Phase 3 trial in Parkinson’s disease and
additional disclosures regarding the advance of our Manocept platform.”

Third Quarter 2013 Financial Results

For the quarter ended September 30, 2013, Navidea reported a net loss
attributable to common stockholders of $11.3 million, or $0.09 per share,
compared with a net loss attributable to common stockholders of $9.1 million,
or $0.09 per share, for the same period in 2012. For the nine months ended
September 30, 2013, Navidea’s net loss attributable to common stockholders was
$28.9 million, or $0.25 per share, compared to a net loss attributable to
common stockholders of $22.0 million, or $0.23 per share, for the same period
in 2012.

Revenue for the quarter ended September 30, 2013 was $400,000 compared with no
revenue for the same period in 2012. For the nine months ended September 30,
2013, Navidea’s revenue was $596,000, compared to revenue of $72,000 for the
same period in 2012. Revenue for the third quarter of 2013 consisted of
$144,000 derived primarily from the procedural-based sale of Lymphoseek and
$256,000 from various federal and state grants. The increase in procedural
revenue was due to an increase in unit dose sales of over 600% during the
third quarter as compared to the second quarter, which resulted in part from a
high repeat-order rate of approximately 90% coupled with increasing incidence
of multi-dose ordering.

Research and development (R&D) expenses were $6.3 million for the quarter
ended September 30, 2013, compared to $6.1 million for the same period in
2012. The net increase of $151,000 was primarily a result of increased NAV4694
product development costs, compensation and other support costs related to
increased headcount, and Manocept platform product development costs, offset
by decreased NAV5001, Lymphoseek and potential pipeline product development
costs. R&D expenses were $14.3 million for the nine months ended September 30,
2013, compared to $12.5 million for the same period in 2012. The increase of
$1.8 million was attributable to the same primary factors noted for the third
quarter.

Selling, general and administrative (SG&A) expenses were $4.0 million for the
quarter ended September 30, 2013, compared to $2.9 million for the same period
in 2012. The net increase of $1.1 million was primarily a result of increased
medical education costs, compensation and other support costs related to
increased headcount, and legal and professional services costs, offset by
decreased out-of-pocket marketing costs to support the commercial launch of
Lymphoseek. SG&A expenses were $11.5 million for the nine months ended
September 30, 2013, compared to $8.5 million for the same period in 2012. The
SG&A increase of $3.0 million between the two periods was primarily
attributable to increased medical education costs, compensation and other
support costs related to increased headcount, out-of-pocket business
development costs related to NAV4694, investor and public relations costs,
pharmacovigilance costs related to Lymphoseek, and legal and professional
services costs, offset by decreased out-of-pocket marketing costs to support
the commercial launch of Lymphoseek.

Other expenses were $1.4 million for the quarter ended September 30, 2013,
compared to $29,000 for the same period in 2012. Other expenses were $3.6
million for the nine months ended September 30, 2013, compared to $960,000 for
the same period in 2012. The net increases in other expenses between the
quarter and year-to-date periods were primarily the result of accounting
charges classified as loss on extinguishment of debt related to the payoff of
one note payable and the restructuring of another note, the majority of which
were non-cash in nature, coupled with increased interest on higher notes
payable balances.

As of September 30, 2013, Navidea had cash totaling approximately $44.6
million.

“The recent equity transaction provides us with a stronger balance sheet
position than we have had in several years,” said Brent Larson, Navidea CFO.
“This strengthened balance sheet, augmented by our available line of credit,
our ability to control many expenses, and other financial tools at our
disposal, continue to provide us with a great deal of financial strength and
flexibility during the expected ramp up of revenue from Lymphoseek.”

Third Quarter 2013 and Recent Business Highlights

Products and Pipeline

  *Lymphoseek

       *CMS issued a Lymphoseek reimbursement pass-through “C Code” that
         became effective October 1, 2013, establishing a reimbursement
         mechanism for healthcare providers.
       *Researchers highlighted additional results from a Lymphoseek Phase 3
         clinical trial in head and neck cancer at the American College of
         Surgeons 2013 Annual Clinical Congress.  Lymphoseek successfully
         identified Sentinel Lymph Nodes when compared with the pathology Gold
         Standard to meet the primary and secondary endpoints.
       *Independent investigators  at The Ohio State University published
         Lymphoseek Phase 3 clinical trial results in JAMA Otolaryngology Head
         and Neck Surgery.

  *Development Programs

       *Data focused on CD206 receptor-targeted precision diagnostic imaging
         for multiple disorders using agents from the recently announced
         Manocept platform were featured in Nature Outlook: Medical Imaging
         and appeared in the October 31^st issue of Nature.
       *The Manocept Advisory Board was formed and is comprised of renowned
         scientific and medical advisors in the field of macrophage science
         and macrophage-mediated diseases as Navidea seeks to prioritize and
         advance encouraging early stage results.
       *Two National Institutes of Health Small Business Innovation Research
         grants were awarded for studies of NAV4694 in mild cognitive
         impairment and for the Phase 3 program in Alzheimer’s disease. The
         grants  have the potential to provideup to$4.1 million in
         support,if fully funded.
       *Special Protocol Assessments for the NAV5001 Phase 3 program were
         agreed upon with the FDA.
       *U.S. manufacturing and supply agreement for clinical trial doses of
         NAV4694 was signed with Siemens’ PETNET Solutions.

Corporate/Financial

  *A $30 million registered direct offering of common stock  led by Crede CG
    III, Ltd., a wholly-owned subsidiary of Crede Capital Group, LLC, a
    U.S.-based accredited, institutional investor, closed in September.

Conference Call Details

Navidea’s Chief Executive Officer, Dr. Mark Pykett, President and Chief
Business Officer, Dr. Thomas Tulip, and Executive Vice President and Chief
Financial Officer, Brent Larson, will provide a development and business
update and will discuss the Company's financial results for the third quarter
of 2013 during the conference call. The conference call can be accessed as
follows:

Investors and the public are invited to listen to the conference call via
telephone or live webcast.
Event:             Navidea Biopharmaceuticals Q3 2013 Financial Results
                       Conference Call
Date/Time:             Wednesday, November 6, 2013 at 8:30 a.m. ET
Webcast Link:          http://edge.media-server.com/m/p/tarnovqu/lan/en
Dial-in Number         888-713-4214
– US:
Dial in Number         617-213-4866
– Int’l:
Participant            42425304
Passcode:
                       A webcast replay will be available on the Investor
Replay                 Relations section of our website under Calendar of
                       Events until December 6, 2013.
                       

Participants who would like to ask questions during the question and answer
portion of the call must participate by telephone. For faster service on the
day of the call, participants may pre-register for the telephonic call at:
https://www.theconferencingservice.com/prereg/key.process?key=PLWG4YRTQ.
Pre-registrants will be issued a PIN number to use along with the Passcode
when dialing into the live call which will provide quicker access to the
conference by bypassing the operator upon connection. If not pre-registered,
participants are encouraged to dial-in fifteen minutes before the conference
call begins. Pre-registration is not necessary to listen to the live webcast
or webcast replay. The webcast replay is expected to be available on our
website approximately two to four hours after the live event.

About Navidea Biopharmaceuticals Inc.

Navidea Biopharmaceuticals, Inc. (NYSE MKT: NAVB) is a biopharmaceutical
company focused on the development and commercialization of precision
diagnostics and radiopharmaceutical agents. Navidea is developing multiple
precision diagnostic products and platforms including NAV4694, NAV5001,
Manocept™ and RIGScan^TM, to help identify the sites and pathways of
undetected disease and enable better diagnostic accuracy, clinical
decision-making and, ultimately, patient care. Lymphoseek^® (technetium 99m
tilmanocept) Injection, ^ Navidea’s first commercial product from the Manocept
platform, was approved by the FDA in March 2013. 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
                                                                
                                              September 30,     December 31,
                                              2013              2012
                                              (unaudited)       
Assets:
                                                                
Cash                                          $  44,632,604     $ 9,118,564
Other current assets                             2,990,766        1,498,819
Non-current assets                              2,313,338       1,355,014  
                                                                
Total assets                                  $  49,936,708     $ 11,972,397 
                                                                
                                                                
Liabilities and stockholders' equity
(deficit):
                                                                
Notes payable, net of discount,               $  1,692,091      $ 2,756,718
current
Other current liabilities                        4,613,909        3,433,821
Notes payable, net of discount                   26,087,219       6,930,112
Derivative liabilities                           7,675,446        --
Other liabilities                                1,005,310        257,122
Stockholders' equity (deficit)                  8,862,733       (1,405,376 )
                                                                
Total liabilities and stockholders'           $  49,936,708     $ 11,972,397 
equity (deficit)
                                                                             

               
                 
NAVIDEA BIOPHARMACEUTICALS, INC.
                                                                         
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
                                                                                   
                       Three Months Ended                      Nine Months Ended
                       September 30,       September 30,       September 30,       September 30,
                       2013                2012                2013                2012
                       (unaudited)         (unaudited)         (unaudited)         (unaudited)
Revenue:
Net sales              $ 143,799           $ --                $ 271,620           $ 71,931
Grant and               256,575           --                324,031           --          
other revenue
Total revenue           400,374           --                595,651           71,931      
                                                                                   
Cost of goods           75,422            --                180,860           --          
sold
                                                                                   
Gross profit            324,952           --                414,791           71,931      
                                                                                   
Operating
expenses:
Research and             6,278,459           6,127,546           14,295,049          12,547,373
development
Selling,
general and             3,971,172         2,941,851         11,505,099        8,487,318   
administrative
Total
operating               10,249,631        9,069,397         25,800,148        21,034,691  
expenses
                                                                                   
Loss from               (9,924,679  )      (9,069,397  )      (25,385,357 )      (20,962,760 )
operations
                                                                                   
Interest                 (976,226    )       (315,262    )       (1,804,576  )       (930,338    )
expense
Loss on
extinguishment           --                  --                  (1,372,266  )       --
of debt
Change in fair
value of                 (377,474    )       283,731             (377,474    )       6,842
financial
instruments
Other income            (27,828     )      2,328             (7,904      )      (36,238     )
(expense), net
                                                                                   
Net loss                 (11,306,207 )       (9,098,600  )       (28,947,577 )       (21,922,494 )
                                                                                   
Preferred
stock                   --                (25,000     )      --                (75,000     )
dividends
                                                                                   
Loss
attributable           $ (11,306,207 )     $ (9,123,600  )     $ (28,947,577 )     $ (21,997,494 )
to common
stockholders
                                                                                   
Loss per
common share
(basic and             $ (0.09       )     $ (0.09       )     $ (0.25       )     $ (0.23       )
diluted)
                                                                                   
Weighted
average shares
outstanding
(basic and               121,117,562         102,332,983         117,740,754         97,042,832
diluted)
                                                                                                 

Contact:

Navidea Biopharmaceuticals
Brent Larson, 614-822-2330
Executive VP & CFO
or
Sharon Correia, 978-655-2686
Associate Director, Corporate Communications
 
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