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Mar. 5, 2015, 8:25 AM
- Navidea Biopharmaceuticals (NAVB -1.2%) Q4 results: Revenues: $2.2M (+340.0%); COGS: $0.3M (+50.0%); R&D Expense: $2.3M (-75.5%); SG&A: $4.1M (+2.5%); Operating Loss: ($4.5M) (+65.6%); Net Loss: ($6.9M) (+50.0%); Loss Per Share: ($0.05) (+50.0%).
- FY2014 results: Revenues: $6.3M (+472.7%); COGS: $1.6M (+433.3%); R&D Expense: $16.8M (-29.1%); SG&A: $15.5M (+0.1%); Operating Loss: ($27.6M) (+28.1%); Net Loss: ($35.7M) (+16.4%); Loss Per Share: ($0.24) (+31.4%); Quick Assets: $5.5M (-83.3%).
- 2015 Guidance: Lymphoseek revenue: $10M - 12M.
Mar. 5, 2015, 7:33 AM
- Navidea Biopharm (NYSEMKT:NAVB): Q4 EPS of -$0.05 in-line.
- Revenue of $2.2M (+307.4% Y/Y) beats by $0.1M.
- Shares +16.67% PM.
Mar. 5, 2015, 7:22 AM
- Navidea (NYSEMKT:NAVB) to receive $2M upfront payment on exclusive sublicense agreement for the commercialization and distribution of Lymphoseek 250 microgram kit in the EU.
- NAVB is eligible to receive additional milestone payments of up to $5M, and royalties on EU net sales.
- Lymphoseek is a receptor-targeted, radiopharmaceutical imaging agent approved by the FDA in 2013 and by the EU in November 2014. It is approved in Europe for imaging and intraoperative detection of sentinel lymph nodes in patients with breast cancer, melanoma, or localized squamous cell carcinoma of the oral cavity.
Mar. 4, 2015, 5:30 PM
Feb. 17, 2015, 9:14 AM
Feb. 9, 2015, 8:07 AM
- On a preliminary basis, Navidea Biopharmaceuticals (NYSEMKT:NAVB) generated $6.3M in total revenue in 2014, including $4.2M for Lymphoseek (technetium Tc 99m tilmanocept). For Q4, the results were $2.2M and $1.5M, respectively. Gross profit was $4.7M and $1.9M, respectively.
- Approximately 22K procedures using Lymphoseek were performed last year. Reorder rate was >80%. The number of customers was greater than 500 as of the end of December.
- CEO Rick Gonzalez will be discussing the company's plans and activities this morning at 10:00 am ET at the 17th Annual BIO CEO & Investor Conference in New York City. Interested parties can access it via a live webcast or archived version on the company's website two hours following.
Feb. 2, 2015, 4:06 PM
- Navidea Biopharmaceuticals (NYSEMKT:NAVB) will report preliminary Q4 and full-year results next Monday, February 9, before the open and before CEO Rick Gonzalez's presentation at the 17th Annual BIO CEO Investor Conference at 10:00 am ET.
Jan. 21, 2015, 8:11 AM
- Navidea Biopharmaceuticals (NYSEMKT:NAVB) enters into a non-binding term sheet for an initial round of financing for its subsidiary, Macrophage Therapeutics. Navidea director and newly-named Macrophage Therapeutics CEO Michael Goldberg, M.D, leads the group of investors providing $2.5M for a 0.5% stake (implied enterprise value = $500M).
- Proceeds will fund pipeline development based on Navidea's Manocept technology, working capital and the recruitment of a scientific advisory board.
Jan. 5, 2015, 8:49 AM
- Navidea Biopharmaceuticals (NYSEMKT:NAVB) appoints Thomas J. Klima as SVP and Chief Commercial Officer. Previously, he was Head of Sales for Algeta and Senior Director of Marketing for Dendreon.
- The company also appoints Michael Tomblyn, M.D., M.S. as Executive Medical Director. Previously, he was Senior Medical Director at Algeta.
Nov. 20, 2014, 8:29 AM
- The European Commission clears Navidea Biopharmaceuticals' (NYSEMKT:NAVB) Lymphoseek (technetium Tc 99m tilmanocept) for use in imaging and intraoperative detection of sentinel lymph nodes draining a primary tumor in adult patients with breast cancer, melanoma or localized squamous cell carcinoma of the oral cavity.
- The company plans to launch the product in certain major markets in 2015.
Nov. 11, 2014, 7:55 AM
- The FDA refunds Navidea Biopharmaceuticals' (NYSEMKT:NAVB) $1.1M PDUFA filing fee for Lymphoseek (technetium Tc 99m tilmanocept) pursuant to its granting of Orphan Drug status for its use in sentinel lymph node detection in patients with head and neck cancer.
- Separately, the company's major investor, Platinum Partners, reaffirmed its $31.8M line of credit.
Nov. 10, 2014, 12:59 PM
Nov. 6, 2014, 7:34 AM
- Navidea Biopharm (NYSEMKT:NAVB): Q3 EPS of -$0.05 beats by $0.01.
- Revenue of $2.25M (+462.5% Y/Y) beats by $0.71M.
Nov. 5, 2014, 5:30 PM
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Oct. 15, 2014, 9:18 AM
- Navidea Biopharmaceuticals (NYSEMKT:NAVB) appoints Rick Gonzalez CEO effective October 13. He joins the firm from Spectrum Pharmaceuticals where he was VP of Global Operations.
Oct. 15, 2014, 7:30 AM
- The FDA approves Navidea Biopharmaceuticals' (NYSEMKT:NAVB) Lymphoseek (technetium Tc 99m tilmanocept) sNDA for its expanded use in mapping solid tumors and adding Sentinel Lymph Node detection for breast cancer and melanoma to its approved indications.
- Lymphoseek is now approved 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 and 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.
- The FDA also allowed the expanded utilization of Lymphoseek with or without scintigraphic imaging (lymphoscintigraphy) to enable preoperative imaging and mapping of lymph nodes to facilitate node localization during surgical procedures.
- Lymphoseek is the only FDA-approved agent for lymphatic mapping across solid tumors when used as a component of surgical management.
- NAVB is up 2% premarket on 5,500 shares.
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