On November 4, 2015 Navidea Biopharmaceuticals (NYSE MKT:NAVB) reported financial results for the quarter ending September 30, 2015 (Press release, Navidea Biopharmaceuticals, NOV 4, 2015, View Source;p=RssLanding&cat=news&id=2106411 [SID:1234507949]). The Company achieved the following financial highlights:
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Third quarter 2015 total revenue of $4 million; comprised of $3 million in Lymphoseek (technetium Tc 99m tilmanocept) injection sales, $550,000 in Lymphoseek license revenue, and $477,000 in grant and other revenue
50% sequential quarterly and 168% year-over-year third quarter Lymphoseek product sales growth
Year-to-date gross margins on product sales of 82%
$6.8 million in 2015 year-to-date product sales, which puts the Company on track to achieve our product revenue guidance.
"We continue to execute on the new commercial strategy we put in place to start the year for our immuno-diagnostic product, Lymphoseek," said Rick Gonzalez, President and Chief Executive Officer. "Sales growth is anticipated to continue in the fourth quarter and into 2016 and beyond based on further penetration of the sentinel lymph node market; expansion to lymphatic mapping with additional solid tumors; and the impact from additional hospital system and institution-wide sales activities."
Mr. Gonzalez continued, "To position us for longer-term growth, clinical development will begin next year for new imaging applications in Kaposi’s sarcoma, rheumatoid arthritis and cardiovascular disease. These pipeline opportunities create a valuable bridge to potential immuno-therapeutics, which, similar to Lymphoseek, would take advantage of the Manocept platform’s ability to selectively target disease-associated immune cells."
PRODUCT & PIPELINE UPDATES
Lymphoseek
Published results in the Annals of Surgical Oncology showing a statistically significant reduction in pain for Lymphoseek vs. sulfur colloid, a key differentiator for patients and physicians
Continued market development activities with Company and investigator-initiated studies in cervical cancer, pediatric solid tumors, anal-rectal cancer, and for further confirmation of workflow efficiency compared to sulfur colloid
Technetium Tc 99m tilmanocept Pipeline
Advanced development efforts for intravenous and subcutaneous delivery
Awarded NIH grants to develop the product for early detection of rheumatoid arthritis (RA) and cardiovascular disease
Academic collaborators continued development for clinical imaging of Kaposi’s sarcoma tumor lesions
Manocept Therapeutic Development Pipeline
Received Manocept-bound Accurins from BIND Therapeutics, Inc. for potential use in targeting analysis of disease-associated macrophages
Reported data demonstrating that a Manocept-doxorubicin (MT-1001) conjugate selectively targets tumor-associated macrophages and destroys the cells through an apoptotic mechanism
FINANCIALS
"Growth in Lymphoseek sales combined with funding from grants and our continued efforts to contain costs have contributed to an overall trend of reduction in our quarterly cash burn," said Brent Larson, Navidea’s Chief Financial Officer. "We remain confident that we will see additional commercial momentum during the fourth quarter and into 2016 as a result of the impact from the field sales force we deployed in May. This expected increase, coupled with an estimated gross margin in excess of 80%, means that each incremental dollar of revenue our sales force generates has a significant positive impact on our cash flow. During 2015, we have continued making limited investment in the NAV4694 clinical trial process based on our expectation that we will be successful in ultimately securing a partnership that will provide us some level of return on this investment. However, in addition to a potential return, the elimination of expenses related to this asset is also expected to have positive near-term contribution to our cash burn."
Revenue & Gross Profit
Total revenue for the quarter ended September 30, 2015 reached $4 million, and for the nine months then ended, reached $9 million. Of these amounts, Lymphoseek sales revenue grew to $3 million for the quarter and $6.8 million for the nine months ended September 30, 2015, which represents 168% and 143% in year over year growth for the respective periods. The primary driver of this increase was increased adoption of Lymphoseek by new customers. Third quarter 2015 margins also remained above 80% contributing to a total gross profit of $3.5 million for the quarter.
Operating Expenses, Income & Balance Sheet
The Company reduced net loss for the quarter and nine months ended September 30, 2015 compared to the same periods in the prior year. Two of the key factors in these reductions were the sales growth and decreased R&D expenses on a year-to-date basis related to the Company’s non-core neuroimaging assets coupled with decreased headcount costs. This was offset by an increase to SG&A expenses due primarily to net increases in commercial headcount costs coming from the addition of the sales force and an increase in professional services costs offset by a decrease in medical science liaison costs. Net losses attributable to common stockholders include the cash interest expense on our outstanding debt, as well as significant non-cash charges related to interest, loss on debt extinguishment and changes in the fair value of financial instruments.
The Company ended the quarter with $11.4 million in cash.
MILESTONES
Select milestones Navidea expects to achieve in the near-term include the following:
Divest or partner the Company’s non-core Phase 3 Alzheimer’s diagnostic imaging candidate, NAV4694
Complete preclinical studies for intravenous delivery of tilmanocept and initiate clinical trials in RA
Achieve $10 to $12 million in Lymphoseek product sales for 2015