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
- 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 provide up 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.
- A $30 million registered direct offering of common stock led by Crede CG III, Ltd., a wholly-owned subsidiary of Crede Capital Group, LLC, a U.S.-based accredited, institutional investor, closed in September.
|Investors and the public are invited to listen to the conference call via telephone or live webcast.|
|Event:||Navidea Biopharmaceuticals Q3 2013 Financial Results Conference Call|
|Date/Time:||Wednesday, November 6, 2013 at 8:30 a.m. ET|
|Dial-in Number – US:||888-713-4214|
|Dial in Number – Int’l:||617-213-4866|
|Replay||A webcast replay will be available on the Investor Relations section of our website under Calendar of Events until December 6, 2013.|
|NAVIDEA BIOPHARMACEUTICALS, INC.|
|CONDENSED CONSOLIDATED BALANCE SHEETS|
|September 30,||December 31,|
|Other current assets||2,990,766||1,498,819|
|Liabilities and stockholders' equity (deficit):|
|Notes payable, net of discount, current||$||1,692,091||$||2,756,718|
|Other current liabilities||4,613,909||3,433,821|
|Notes payable, net of discount||26,087,219||6,930,112|
|Stockholders' equity (deficit)||8,862,733||(1,405,376||)|
|Total liabilities and stockholders' equity (deficit)||$||49,936,708||$||11,972,397|
|NAVIDEA BIOPHARMACEUTICALS, INC.|
|CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS|
|Three Months Ended||Nine Months Ended|
|September 30,||September 30,||September 30,||September 30,|
|Grant and other revenue||256,575||--||324,031||--|
|Cost of goods sold||75,422||--||180,860||--|
|Research and development||6,278,459||6,127,546||14,295,049||12,547,373|
|Selling, general and administrative||3,971,172||2,941,851||11,505,099||8,487,318|
|Total operating expenses||10,249,631||9,069,397||25,800,148||21,034,691|
|Loss from operations||(9,924,679||)||(9,069,397||)||(25,385,357||)||(20,962,760||)|
|Loss on extinguishment of debt||--||--||(1,372,266||)||--|
|Change in fair value of financial instruments||(377,474||)||283,731||(377,474||)||6,842|
|Other income (expense), net||(27,828||)||2,328||(7,904||)||(36,238||)|
|Preferred stock dividends||--||(25,000||)||--||(75,000||)|
|Loss attributable to common stockholders||$||(11,306,207||)||$||(9,123,600||)||$||(28,947,577||)||$||(21,997,494||)|
|Loss per common share|
|(basic and diluted)||$||(0.09||)||$||(0.09||)||$||(0.25||)||$||(0.23||)|
|Weighted average shares outstanding|
|(basic and diluted)||121,117,562||102,332,983||117,740,754||97,042,832|