Selling, general and administrative (SG&A) expenses were $2.9 million for the quarters ended September 30, 2012 and 2011. During the third quarter of 2012 as compared to the same period in 2011, the Company incurred increased marketing and business development costs related to commercial launch preparations for Lymphoseek and to ongoing activities in support of advancing the Company’s precision diagnostics pipeline. These costs, as well as increased SG&A headcount and other support costs incurred during the third quarter of 2012, were offset by a decrease from the third quarter of 2011 of approximately $817,000 in non-recurring charges related to the separation of the Company’s former President and CEO.SG&A expenses were $8.5 million for the nine months ended September 30, 2012, compared to $7.5 million for the same period in 2011. The factors leading to the net increase in SG&A expenses between the two year-to-date periods were the same as described above for the three-month periods except that the offset due to the non-recurring charges related to the separation of the Company’s former President and CEO totaled approximately $2.7 million for the first nine months of 2011. As of September 30, 2012, Navidea had cash totaling approximately $11.2 million. Brent Larson, Navidea Senior Vice President and CFO, said, “Navidea continues to maintain a strong financial position to support our pipeline development activities in advance of revenue from our first radiopharmaceutical product, Lymphoseek. We retain flexibility in timing of our expenditures and in our access to multiple available funding sources, including borrowing under the line of credit we have in place from our primary investor, Platinum-Montaur Life Sciences, LLC. We plan to work closely with Montaur to determine the optimal timing for accessing the credit facility to maintain financial strength, support the ongoing advances in our pipeline programs and fund commercial preparations for Lymphoseek. We remain focused on the prudent management of our finances as we drive toward Lymphoseek launch and revenue generation.”
Lymphoseek UpdateOn October 30, 2012, Navidea resubmitted its Lymphoseek new drug application (NDA) to the U.S. Food and Drug Administration (FDA) in response to the complete response letter (CRL) the Company received in September 2012. On September 10, 2012, Navidea announced that it had received a CRL from the FDA regarding the NDA for Lymphoseek (technetium Tc 99m tilmanocept) Injection. The CRL focused on current Good Manufacturing Practice (cGMP) deficiencies identified during inspections of third-party manufacturing facilities and did not cite any Lymphoseek clinical efficacy or safety issues. Since receipt of the CRL, the Company has worked diligently with its advisors, contract manufacturers and the FDA to address the deficiencies noted in the CRL. While the Company is unable to predict the timing for FDA review, it does believe that the focused scope of the CRL and the corresponding information provided in the Company’s response will facilitate a timely evaluation of the resubmission. “We continue to believe the FDA review process will involve re-evaluation of only a small portion of the NDA and that the focused information we have provided will support a potentially expeditious review,” said Dr. Mark Pykett, Navidea President and CEO. “Our clear priority continues to be Lymphoseek approval and launch in the U.S. We are committed to providing this novel radiopharmaceutical for use in critical diagnostic procedures for medical professionals, cancer patients and their families.” Other Recent Business and Program Highlights
- Completed the sublicense agreement with Alseres Pharmaceuticals, Inc. for a second promising neuroimaging candidate. NAV5001 is an Iodine-123 radiolabeled imaging agent being developed as an aid in the diagnosis of Parkinson’s disease and other movement disorders and a potential use as a diagnostic aid in dementia.
- Enrolled the first subject in a Phase 2 clinical trial of NAV4694, Navidea’s F-18 PET imaging agent being developed as an aid in diagnosing Alzheimer’s disease.
- Received a Small Business Innovation Research (SBIR) grant from the National Institutes of Health (NIH) for development of our radioimmunoguided surgery (RIGS ®) agent aimed at detecting metastatic cancer, with potential funding of up to $1.5 million over three years if fully funded. The first-year Phase 1 funding of $315,000, which has already been approved, is expected to enable the Company to complete preclinical bridging activities using a RIGS tumor-antigen-targeted monoclonal antibody and prepare a standardized clinical trial protocol.
- Published the results of Lymphoseek Phase 3 clinical trials in melanoma in the online edition of the journal Annals of Surgical Oncology. The data indicated that Lymphoseek met the primary efficacy endpoint in the assessment of lymphatic mapping performance in patients with cutaneous melanoma. The study was titled, “Combined Analysis of Phase III Trials Evaluating [99mTc]Tilmanocept and Vital Blue Dye for Identification of Sentinel Lymph Nodes in Clinically Node-Negative Cutaneous Melanoma,” [DOI 10.1245/s10434-012-2612-z].
- Presented data on Lymphoseek at major scientific and medical conferences:
- Lymphoseek Phase 3 meta-analysis data on Lymphoseek and radiolabeled colloidal agents presented at the 32 nd Congress of the European Society of Surgical Oncology by Dr. Frederick Cope.
- Additional podium and poster presentations highlighting similar Lymphoseek Phase 3 results were made at: the American Association of Pharmaceutical Scientists , the European Association of Nuclear Medicine , and the American Society for Radiation Oncology.
- Cornelia Reininger, M.D., Ph.D., joined Navidea as Chief Medical Officer. Previously, Dr. Reininger had a central role in the development of diagnostic radiopharmaceuticals for Alzheimer’s and Parkinson’s diseases for Bayer Healthcare Pharmaceuticals and GE Healthcare and Amersham Health – Diagnostic Imaging.
Conference Call DetailsNavidea's President and CEO, Dr. Mark Pykett, Executive Vice President and Chief Business Officer, Dr. Thomas Tulip, and Senior Vice President and CFO, Brent Larson, will provide a development and business update, including responding to investor questions regarding the recent Lymphoseek NDA resubmission, and will discuss the Company's financial results for the third quarter and first nine months of 2012 during the conference call. The conference call can be accessed as follows:
|CONFERENCE CALL INFORMATION|
|TO PARTICIPATE LIVE:||TO LISTEN TO A REPLAY:|
|Date:||November 8, 2012||Available until:||November 22, 2012|
|Time:||5:00 PM ET||Toll-free (U.S.) Dial in #:||(877) 660-6853|
|International Dial in #:||(201) 612-7415|
|Toll-free (U.S.) Dial in #:||(877) 407-8031|
|International Dial in #:||(201) 689-8031||Replay passcode|
|NAVIDEA BIOPHARMACEUTICALS, INC.|
|CONDENSED CONSOLIDATED BALANCE SHEETS|
|September 30,2012||December 31,2011|
|Other current assets||962,687||1,402,517|
|Liabilities and stockholders' equity:|
|Note payable, net of discount, current||$||2,425,973||$||-|
|Derivative liabilities, current||509,687||568,930|
|Other current liabilities||4,073,702||2,779,540|
|Note payable, net of discount||3,593,660||6,456,388|
|Total liabilities and stockholders' equity||$||13,607,718||$||31,193,920|
|CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS|
|Three Months Ended||Nine Months Ended|
|September 30,2012||September 30,2011||September 30,2012||September 30,2011|
|Research and development||6,127,546||3,858,141||12,547,373||8,159,992|
|Selling, general and administrative||2,941,851||2,870,603||8,487,318||7,499,454|
|Total operating expenses||9,069,397||6,728,744||21,034,691||15,659,446|
|Loss from operations||(9,069,397||)||(6,473,112||)||(20,962,760||)||(15,061,717||)|
|Change in derivative liabilities||283,731||7,208||6,842||(956,933||)|
|Other income (expense), net||2,328||6,653||(36,238||)||12,058|
|Loss before income taxes||(9,098,600||)||(6,459,815||)||(21,922,494||)||(16,009,821||)|
|Benefit from income tax||-||6,403,928||-||6,403,928|
|Loss from continuing operations||(9,098,600||)||(55,887||)||(21,922,494||)||(9,605,893||)|
|Discontinued operations, net of tax effect||-||19,887,820||-||22,826,807|
|Net (loss) income||(9,098,600||)||19,831,933||(21,922,494||)||13,220,914|
|Preferred stock dividends||(25,000||)||(25,000||)||(75,000||)||(75,000||)|
|(Loss) income attributable to common stockholders||$||(9,123,600||)||$||19,806,933||$||(21,997,494||)||$||13,145,914|
|(Loss) income per common share (basic and diluted):|
|(Loss) income attributable to common stockholders||$||(0.09||)||$||0.21||$||(0.23||)||$||0.15|
|Weighted average shares outstanding:|
|Basic and Diluted||102,332,983||93,070,235||97,042,832||89,410,150|