catalysts to get the PPS over $1:
NOV: FDA NDA submit, announce new device, new sales report
1. A new cold temp dispensing device, with longer out of fridge shelf life (7 days), is shipping and replacing inventory in EU.
2. Ferring, a smaller more committed to Vitaros company like Majorelle, has taken over the Takeda, Sandoz and Latin America territories, and will start selling again in the EU, the Germany launch is important, Germany has officially been transferred to Ferring:
Aug. 10th - “ the transfer of the German marketing authorization to Ferring, a critical step in Ferring’s plan to re-launch Vitaros in this important market, has been completed,” said Richard Pascoe, Chief Executive Officer of Apricus. “Moreover, this marks the first in a series of marketing authorization transfers we anticipate will occur later this quarter(Q3) as Ferring looks to further expand the availability of Vitaros in Europe.”
3. Latin America - Approval in Argentina is in, registration in Mexico and Columbia are in, both should be approved in 2016 -then Brazil for Ferring.
4. NDA in USA submittal in Q4 16, Approval in USA mid 2017, Vitaros only has to prove safety of the permeation enhancer DDAIP, with many world approvals and safety data on 1 million doses, this should not be a problem.
5. Recordati just launched 5 more countries, expect 5 more launches by end of Q1 2017
6. Lebanon approved, expect additional launches in Mid East
7. Rayva Ex-USA or global deal w/ current partner in EU, possible 2H 2016
8. Partner deal in China/Japan
Vitaros revenue has not grown to expected levels over the last two quarters, driven primarily by decisions made by former partners to reduce and/or suspend commercialization activities in key markets.
However, we continue to see sustained Vitaros utilization in France, Italy, and Spain, where marketing efforts have been consistent over time. And we strongly believe that through the commercial efforts of Ferring, Recordati, Majorelle, and Bracco, Vitaros can regain the sales momentum in Europe that we witnessed when Vitaros was first launched.
