These factors include among others, the inherent uncertainties associated with the financial projections, timely and successful implementation of strategic initiatives, the difficulty of predicting the timing or outcome of product development efforts, and FDA or other regulatory approvals or actions, market acceptance and continued demand for new Navidea’s products, clinical and regulatory pathways, the impact of competitive products and pricing, patents or other intellectual property rights held by competitors, the availability and pricing of third-party sourced products and materials, successful compliance of government regulations, and such other risks and uncertainties as detailed in Navidea’s periodic public filings on file with the Securities and Exchange Commission.Now, I’d like to turn the call over to Dr. Mark Pykett, President and Chief Executive Officer of Navidea. Mark? Mark Pykett Thank you, Brent. We appreciate the participation of everyone on today’s call and look forward to sharing business update and quarterly financial results. We have a number of important topics to discuss today including updates on the Lymphoseek NDA, the outlook for Lymphoseek commercialization, the plan filing of the Marketing Authorization Application for Lymphoseek in the EU, progress with our Alzheimer’s disease amyloid imaging program, and a review of the license we completed last week for the CFT neuroimaging agent. Tom, Fred, Brent and I will share these topics. We continue to make very good progress in multiple dimensions of our business. We are executing well and we believe the outlook for Navidea continues to be promising. As one looks at the landscape of biotech companies headed toward important events such as a PDUFA date, a range of factors often contributes to a company’s value. I would like to highlight a number of parameters that we believe put Navidea in a strong position, and which we believe should give investors confidence in the potential of our company.
We have a strong product in Lymphoseek. Lymphoseek has demonstrated encouraging clinical performance not only against the requisite and valid comparator required for U.S. registration, vital blue dye, but also against recognized current standards of care consisting of blue dye plus radiolabeled colloids. The Lymphoseek PDUFA date remains on track. Lymphoseek is used in lymph node mapping procedures that are already widely performed in surgical oncology. This is not a new practice. We believe we are well positioned to address this market with an outstanding partner in the U.S., Cardinal Health.Our partnership with Cardinal Health provides attractive economics to both organizations through our revenue sharing agreement on Lymphoseek sales with mutual incentives to perform to the best of our capabilities. Lymphoseek has attractive cost of goods and gross margins, which we believe will facilitate promising net cash flows to Navidea. In fact, the gross margins on our portion of Lymphoseek revenues are expected to be approximately 75% to 80%, meaning that about 35% to 40% of end customer revenue drops to Navidea’s EBITDA, an encouraging pre-tax return. There are clear avenues to reimbursement for Lymphoseek in the U.S., initially through a statutory pass-through code meaning there are established well recognized Medicare, Medicaid procedures for payment for the agent. We have also advanced and diversified our pipeline of late stage assets. Over the course of the last eight months, we have not only made important progress with our two oncology agents, Lymphoseek and RIGS, but also added two potential best-in-class candidates in the neuroimaging space, 4694 and CFT, providing us with two premier franchises. Encouraging findings for 4694 continue to be generated in Phase II. We are looking forward to commencing our own Phase IIb study later this quarter and to beginning Phase III in early 2013. We are addressing important medical needs in large markets including cancer, Alzheimer’s disease and dementia, and Parkinson’s disease and movement disorders, which we believe will remain medical areas of global significance for years to come. Our technical programs are supported by strong intellectual property and sustainable proprietary positions. Read the rest of this transcript for free on seekingalpha.com