NAVB Navidea Biopharmaceuticals Inc

– Management hosting webcast and conference call on March 5, 2015 at 8:30 a.m. EST –

Navidea Biopharmaceuticals, Inc. (NYSE MKT: NAVB), today announced results for the fourth quarter and year ended December 31, 2014. Navidea reported total revenue for 2014 of $6.3 million including Lymphoseek® (technetium Tc 99m tilmanocept) injection sales revenue of $4.2 million. Projected guidance for Navidea’s share of Lymphoseek revenue in 2015 is $10 million to $12 million. Based on expected revenue run rates and consistent with revenue guidance, Navidea expects to achieve break-even cash flow in first quarter 2016 based on our current strategic plans.

“Lymphoseek’s recently expanded U.S. label, our sharpened focus on commercial execution and our new commercial and medical affairs teams strongly position Navidea to accelerate near-term revenue growth. We continue to practice fiscal discipline as evidenced by the nearly 50% reduction in cash used in operations from the first quarter to the fourth quarter of 2014. We believe these actions put us on a solid path toward profitability,” said Rick Gonzalez, Navidea President and Chief Executive Officer. “Lymphoseek’s lymphatic mapping indication in solid tumors beyond breast, melanoma and head & neck cancers, combined with the recent European approval, will be drivers to the medium term revenue growth while, in parallel, Macrophage Therapeutics advances therapeutic applications of our ManoceptTM platform.”

Financial ResultsFull Year Financial Results: Revenues for the year ended December 31, 2014 were $6.3 million compared to $1.1 million for 2013. Navidea’s revenues for 2014 consisted of $4.2 million in sales of Lymphoseek, $300,000 from business development milestones and $1.7 million from various federal grants and other revenue, compared to $614,000, $0 and $516,000, respectively, for 2013.

Operating expenses for the year ended December 31, 2014 were $32.3 million compared to $39.2 million for 2013. Research and development expenses were $16.8 million during 2014 compared to $23.7 million during 2013. The net decrease from 2013 to 2014 was primarily a result of reductions in Lymphoseek, NAV5001 and NAV4694 product development costs coupled with reduced headcount. Selling, general and administrative expenses were $15.5 million for 2014 and 2013. Increased medical education costs, legal and professional services and other support costs were offset by decreased investor relations costs, compensation, and out-of-pocket marketing costs to support the commercial launch of Lymphoseek.

Navidea’s loss from operations for the year ended December 31, 2014 was $27.6 million compared to $38.4 million for the same period in 2013. For the year ended December 31, 2014, Navidea reported a loss attributable to common stockholders of $35.7 million, or $0.24 per share, compared to a loss attributable to common stockholders of $42.7 million, or $0.35 per share, for the same period in 2013.

Fourth Quarter Financial Results: Revenues for the fourth quarter of 2014 were $2.2 million compared to $535,000 for the same period in 2013. Navidea’s revenues for the fourth quarter of 2014 consisted of $1.5 million in sales of Lymphoseek and $738,000 from various federal grants and other revenue, compared to $343,000 and $192,000, respectively, for the same period in 2013.

Fourth quarter 2014 operating expenses were $6.4 million compared to $13.4 million for the fourth quarter of 2013. Research and development expenses were $2.3 million during the fourth quarter of 2014 compared to $9.4 million during fourth quarter of 2013. The net decrease from 2013 to 2014 was primarily a result of reductions in Lymphoseek, NAV5001 and NAV4694 product development costs coupled with reduced headcount and related support costs. Selling, general and administrative expenses were $4.1 million for the fourth quarter of 2014 compared $4.0 million for the same period in 2013. Increased out-of-pocket Lymphoseek marketing costs and medical education costs were offset by decreased compensation and related support costs.

Navidea loss from operations for the fourth quarter of 2014 was $4.5 million compared to $13.1 million for the fourth quarter of 2013. For the fourth quarter of 2014, Navidea reported a loss attributable to common stockholders of $6.9 million, or $0.05 per share, compared to a loss attributable to common stockholders of $13.8 million, or $0.10 per share, for the fourth quarter of 2013.

Milestones & HighlightsSelect milestones and highlights that the Company achieved in 2014 and year to date in 2015 include:

• A sharpened corporate focus with new management team additions
  • Appointed Rick Gonzalez as CEO, bringing more than 20 years of experience in the pharmaceutical industry with notable global commercial expertise with oncology and radiotherapy products
  • Added Tom Klima as Chief Commercial Officer to lead commercial strategy design and execution and Michael Tomblyn, M.D. as Executive Medical Director to develop, in collaboration with the medical community and potentially other corporate partners, the application of Lymphoseek across multiple tumor types
• Lymphoseek® (technetium Tc 99m tilmanocept) Injection
  • Experienced encouraging sales metrics as measured by increasing number of procedures, account growth and re-order rates
  • Expanded indications in the U.S. for sentinel lymph node biopsy (SLNB) in melanoma, head & neck and breast cancers as well as for lymphatic mapping in all solid tumors
  • Attained European approval of Lymphoseek Marketing Authorization Application for SLNB in melanoma, breast and certain head & neck cancers
  • Executed a sublicense agreement with SpePharm AG, an affiliate of Norgine BV, covering distribution of Lymphoseek in the European Union. In connection with the agreement, the Company received an upfront payment of $2 million and is eligible to receive additional commercial milestone payments up to $5 million, as well as royalties on European net sales
  • Received Orphan Drug designation for head & neck cancers and triggered a $1 million refund of PDUFA fees associated with the head & neck cancer sNDA
  • Signed development and commercialization agreements in China, Taiwan and Hong Kong
  • Published the Lymphoseek Phase 3 head & neck cancer clinical trial results and results of a Lymphoseek comparative study in breast cancer in peer-reviewed journals
  • Supported Lymphoseek lifecycle management efforts with Fast Track NIH Small Business Innovation Research grants and investigator-initiated studies in several cancer types
• Manocept™ Platform
  • Formed Macrophage Therapeutics, Inc. as a subsidiary to explore therapeutic applications of Manocept platform compounds
  • Assembled an expert Scientific Advisory Board to serve as a strategic resource to develop therapeutic applications for the Manocept platform
  • Completed the initial cohort of a physician-initiated study in Kaposi’s Sarcoma patients at the University of California at San Francisco
  • Formed R-NAV joint venture with Essex Woodlands’ Rheumco to explore diagnostic and therapeutic applications in rheumatoid arthritis and canine osteoarthritis
• Neurodegenerative Products
  • Evaluating out-licensing/divestiture proposals for the Phase 3 NAV4694 and NAV5001 assets

Conference CallNavidea will provide a business update and discuss the fourth quarter and full year 2014 financial results during a conference call with the investment community scheduled for Thursday, March 5, 2015 at 8:30 a.m. ET. 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 Q4 and Year-End 2014 Financial Results Conference Call

Date/Time: Thursday, March 5, 2015 at 8:30 a.m. EST Webcast Link:

http://edge.media-server.com/m/p/wnxb6jnn/lan/en

Dial-in Number – US:

1 (800) 708-4540

Dial in Number – Int’l:

1 (847) 619-6397

Participant Passcode: 39040655 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 Biopharmaceuticals Inc.Navidea Biopharmaceuticals, Inc. (NYSE MKT: NAVB) is a commercial stage precision medicine 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™, NAV4694, and NAV5001, 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 by the EMA 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, 2014 2013 (unaudited)   Assets:   Cash $ 26,006,463 $ 32,939,026 Other current assets 3,516,469 4,392,156 Non-current assets   3,116,544     2,985,335     Total assets $ 32,639,476   $ 40,316,517       Liabilities and stockholders' deficit:   Notes payable, net of discount, current $ - $ 4,095,650 Other current liabilities 5,445,579 7,195,312 Notes payable, net of discount 30,939,076 23,572,603 Derivative liabilities 7,693,351 7,692,087 Other liabilities 3,169,656 1,770,452 Stockholders' deficit   (14,608,186 )   (4,009,587 )   Total liabilities and stockholders' deficit $ 32,639,476   $ 40,316,517       CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS Three Months Ended March 31, March 31, 2014 2013 (unaudited) (unaudited) Revenue: Net sales $ 626,631 $ - Grant revenue   125,173     -   Total revenue   751,804     -     Cost of goods sold   193,220     -     Gross profit   558,584     -     Operating expenses: Research and development 5,226,794 3,639,757 Selling, general and administrative   3,910,833     3,364,490   Total operating expenses   9,137,627     7,004,247     Loss from operations   (8,579,043 )   (7,004,247 )   Interest expense (943,838 ) (363,082 ) Change in fair value of financial instruments 392,483 - Loss on extinguishment of debt (2,610,196 ) - Other income, net   41     26,310     Net loss attributable to common stockholders $ (11,740,553 ) $ (7,341,019 )   Loss per common share (basic and diluted) $ (0.08 ) $ (0.06 )   Weighted average shares outstanding (basic and diluted) 144,783,351 113,763,600           NAVIDEA BIOPHARMACEUTICALS, INC.   CONDENSED CONSOLIDATED BALANCE SHEETS June 30, December 31, 2014 2013 (unaudited)   Assets:   Cash $ 17,471,780 $ 32,939,026 Other current assets 3,093,473 4,392,156 Non-current assets   3,023,072     2,985,335     Total assets $ 23,588,325   $ 40,316,517       Liabilities and stockholders' deficit:   Notes payable, net of discount, current $ 782,512 $ 4,095,650 Other current liabilities 5,369,866 7,195,312 Notes payable, net of discount 30,438,739 23,572,603 Derivative liabilities 7,689,550 7,692,087 Other liabilities 3,142,933 1,770,452 Stockholders' deficit   (23,835,275 )   (4,009,587 )   Total liabilities and stockholders' deficit $ 23,588,325   $ 40,316,517       CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS   Three Months Ended Six Months Ended June 30, June 30, June 30, June 30, 2014 2013 2014 2013 (unaudited) (unaudited) (unaudited) (unaudited) Revenue: Net sales $ 1,046,257 $ 127,821 $ 1,672,888 $ 127,821 Grant revenue   28,433     67,456     153,606     67,456   Total revenue   1,074,690     195,277     1,826,494     195,277     Cost of goods sold   270,498     105,438     463,718     105,438     Gross profit   804,192     89,839     1,362,776     89,839     Operating expenses: Research and development 5,112,098 4,376,833 10,338,892 8,016,590 Selling, general and administrative   4,907,652     4,169,437     8,818,485     7,533,927   Total operating expenses   10,019,750     8,546,270     19,157,377     15,550,517     Loss from operations   (9,215,558 )   (8,456,431 )   (17,794,601 )   (15,460,678 )   Interest expense (914,070 ) (465,268 ) (1,857,908 ) (828,350 ) Change in fair value of financial instruments (92,332 ) - 300,151 - Loss on extinguishment of debt - (1,372,266 ) (2,610,196 ) (1,372,266 ) Other income (expense), net   (274 )   (6,386 )   (233 )   19,924     Net loss attributable to common stockholders $ (10,222,234 ) $ (10,300,351 ) $ (21,962,787 ) $ (17,641,370 )   Loss per common share (basic and diluted) $ (0.07 ) $ (0.09 ) $ (0.15 ) $ (0.15 )  

Weighted average shares outstanding (basic and diluted)

150,019,939 118,260,288 147,416,111 116,024,366           NAVIDEA BIOPHARMACEUTICALS, INC.   CONDENSED CONSOLIDATED BALANCE SHEETS September 30, December 31, 2014 2013

(unaudited)

  Assets:   Cash $ 10,388,618 $ 32,939,026 Other current assets 3,589,110 4,392,156 Non-current assets   3,664,190     2,985,335     Total assets $ 17,641,918   $ 40,316,517       Liabilities and stockholders' deficit:   Notes payable, net of discount, current $ 2,725,107 $ 4,095,650 Other current liabilities 5,608,635 7,195,312 Notes payable, net of discount 29,756,627 23,572,603 Derivative liabilities 7,697,130 7,692,087 Other liabilities 3,116,188 1,770,452 Stockholders' deficit   (31,261,769 )   (4,009,587 )   Total liabilities and stockholders' deficit $ 17,641,918   $ 40,316,517       CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS   Three Months Ended Nine Months Ended September 30, September 30, September 30, September 30, 2014 2013 2014 2013 (unaudited) (unaudited) (unaudited) (unaudited) Revenue: Lymphoseek sales revenue $ 1,101,071 $ 143,799 $ 2,773,959 $ 271,620 Lymphoseek milestone revenue 300,000 - 300,000 - Grant and other revenue   848,999     256,575     1,002,605     324,031   Total revenue   2,250,070     400,374     4,076,564     595,651     Cost of good sold   807,880     75,422     1,271,598     180,860     Gross profit   1,442,190     324,952     2,804,966     414,791     Operating expenses: Research and development 4,158,085 6,278,459 14,496,977 14,295,049 Selling, general and administrative   2,646,591     3,971,172     11,465,076     11,505,099   Total operating expenses   6,804,676     10,249,631     25,962,053     25,800,148     Loss from operations   (5,362,486 )   (9,924,679 )   (23,157,087 )   (25,385,357 )   Interest expense (920,905 ) (976,226 ) (2,778,813 ) (1,804,576 ) Equity in the loss of R-NAV, LLC (262,198 ) - (262,198 ) - Change in fair value of financial instruments (409,650 ) (377,474 ) (109,499 ) (377,474 ) Loss on extinguishment of debt - - (2,610,196 ) (1,372,266 ) Other income (expense), net   56,343     (27,828 )   56,110     (7,904 )   Net loss attributable to common stockholders $ (6,898,896 ) $ (11,306,207 ) $ (28,861,683 ) $ (28,947,577 )   Loss per common share (basic and diluted) $ (0.05 ) $ (0.09 ) $ (0.19 ) $ (0.25 )  

Weighted average shares outstanding (basic and diluted)

150,169,712 121,117,562 148,344,064 117,740,754           NAVIDEA BIOPHARMACEUTICALS, INC.   CONDENSED CONSOLIDATED BALANCE SHEETS December 31, December 31, 2014 2013

(unaudited)

  Assets:   Cash $ 5,479,006 $ 32,939,026 Other current assets 3,120,139 4,392,156 Non-current assets   3,321,035     2,985,335     Total assets $ 11,920,180   $ 40,316,517       Liabilities and stockholders' deficit:   Notes payable, net of discount, current $ 4,383,472 $ 4,095,650 Other current liabilities 4,711,619 7,195,312 Notes payable, net of discount 29,539,135 23,572,603 Derivative liabilities - 7,692,087 Other liabilities 3,089,420 1,770,452 Stockholders' deficit   (29,803,466 )   (4,009,587 )   Total liabilities and stockholders' deficit $ 11,920,180   $ 40,316,517       CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS   Three Months Ended Twelve Months Ended December 31, December 31, December 31, December 31, 2014 2013 2014 2013 (unaudited) (unaudited) (unaudited)   Revenue: Lymphoseek sales revenue $ 1,459,994 $ 342,803 $ 4,233,953 $ 614,423 Lymphoseek milestone revenue - - 300,000 - Grant and other revenue   738,291     192,176     1,740,896     516,207   Total revenue   2,198,285     534,979     6,274,849     1,130,630     Cost of good sold   314,547     151,955     1,586,145     332,815     Gross profit   1,883,738     383,024     4,688,704     797,815     Operating expenses: Research and development 2,282,612 9,415,134 16,779,589 23,710,183 Selling, general and administrative   4,076,995     4,020,847     15,542,071     15,525,946   Total operating expenses   6,359,607     13,435,981     32,321,660     39,236,129     Loss from operations   (4,475,869 )   (13,052,957 )   (27,632,956 )   (38,438,314 )   Interest expense (927,357 ) (974,204 ) (3,706,170 ) (2,778,780 ) Equity in the loss of R-NAV, LLC (261,611 ) - (523,809 ) - Change in fair value of financial instruments (1,232,890 ) 265,401 (1,342,389 ) (112,073 ) Loss on extinguishment of debt - - (2,610,196 ) (1,372,266 ) Other income (expense), net   32,741     9,879     88,851     1,975     Net loss attributable to common stockholders $ (6,864,986 ) $ (13,751,881 ) $ (35,726,669 ) $ (42,699,458 )   Loss per common share (basic and diluted) $ (0.05 ) $ (0.10 ) $ (0.24 ) $ (0.35 )  

Weighted average shares outstanding (basic and diluted)

149,888,696 133,881,021 148,748,396 121,808,986

Navidea BiopharmaceuticalsBrent Larson, 614-822-2330Executive VP & CFOOrSharon Correia, 978-655-2686Associate Director, Corporate Communications