Posted On: 08/07/2013 3:18:51 PM
Post# of 63824
NAVB-Ladenburg Thalmann update/hightlights target $7.50:
Quote:
HIGHLIGHTS
On 8/7/13, NAVB reported 2Q13 financial results in line with our forecast and provided
two important updates: 1) planning to submit sNDA filing for Lymphoseek in head and
neck cancer and 2) updated commercial/partnering strategy for Lymphoseek outside the
U.S. Additionally, management provided new details on voucher program and C-code
time for Lymphoseek. Following a successful FDA meeting NAVB has closed the NEO3-
06 study and will submit a sNDA in head and neck cancer. We expect the application to
be filed around yearend with potential label expansion in mid 2014. In terms of
international commercialization, NAVB received positive Day 120 feedback from EMEA
and expects a positive opinion for approval of Lymphoseek in Europe before the end of
2013. Additionally, management has identified a preferred specialty pharmaceutical
partner to commercialize the product in both the EU and other international markets. We
expect the partnership to be finalized before or around potential EMEA approval of
Lymphoseek. Per CMS regulation, NAVB expects to receive a pass through C-code
reimbursement at ASP+6% ($318 for Lymphoseek) in the first week of October. We
expect issuance of the C-code to be major inflection point for Lymphoseek adoption. Prior
to the C-code issuance, NAVB and partner Cardinal Health (CAH, $51.33, Not Rated) are
initiating a voucher program to provide free samples to hospitals. This program will stop
following issuance of the C-code. NAVB provided limited disclosure regarding commercial
metrics. Overall, the launch of Lymphoseek is going well with at least 2 large hospitals
switching solely to Lymphoseek and voucher requests exceeding 100 requests per week.
2Q13 product revenue of $128,000 was slightly ahead of our estimate of $106,000. 2Q13
EPS from continuing operations of ($0.08) was essentially in line with our estimate (and
Street consensus) of ($0.07). Reiterate Buy rating and $7.50 price target.
***thanks to Oldtimers Lounge
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