Just had a quick read through the latest updates from competitors re delays and potential launch timing:
DR REDDY - received complete response letter from FDA (same as Mayne) in July/August this year (announced in August). No ETA for launch, but based on Mayne receiving this letter Dec 2019 you would expect we are approx. 6 months ahead.
AMNEAL - advised market in July this year that they would be delayed. No ETA and can not find any details as to why the delay.
TEVA - announced in their 3Q results TC last month that launch is pushed to 2020, no further clarification or details.
So at this point, you would have to assume that if there is no problem with the re-submission and we get approved, we will either be first or a close second (behind Teva) to market. This is positive.
In terms of net sales. Current Nuvaring market in USD is just shy of $1B, so equivalent to AUD $1.4B. As a whole I believe generic conversion in the US is around 90%, though it takes some time from a new launch to get there and also takes multiple competitors. Let's say we launch at the same time as TEVA and collectively capture 40% market share in year 1 (20% each) at a discount of 50%, then this is equivalent to net sales of AUD $140M. I have no idea what generic discounting in the US looks like and would assume with only two players initially they would be smart and keep in much lower than 50%, but again, not sure.
Thoughts?
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