Key takeaways:
- Process with FDA established to obtain CLIA waiver, however they haven't submitted for CLIA waiver yet.
- Another major player has FOMO for Febridx and they are in discussions with them now. This came in post HS deal.
- The are getting an average of 8 orders for product a month? Which is positive and they are filling as much as they can sell. They don't foresee an issue expanding the sales when HS takes off. Very bullish on this.
- FFN $5M is received and in hand. They have a pathway to get this off the ground and don't see any issues arising here. Total Available Market for the prenatal tests is 2.5Million annually in the US. FFN is solely Hologic.
Based on my estimates, product cost for FFN is $161/test. Wholesale estimate cost would be ($161- CPT) CPT rebate is $64.41. If we run off 7% annuities of wholesale cost of tests, then revenues from the tests could be $7.2/test.
Not sure how many tests conducted annually, however the latest reports from Hologic showed that total prenatal diagnostics generate $400+M USD annually in revenue.
From what I can understand, the Cytology and Perinatal revenue is from their ThinPrep and FFN tests. Other diagnostics for their Panther product is listed under an alternate revenue stream.
Looking at the total preterm market size by product type, FFN relates to approx. 50% (estimate based on graphic) of total kits by size:
Noting Hologic are exclusive in FFN in the market in the US as well. The market size for our direct revenue is probably based on the quarterly revenue for Hologic. If the report above is correct, then Hologic generated an estimated $197M out of the $480M in revenue just from FFN.
7.5% - 10% of $197M estimate is $14-19Million annually USD in potential ongoing revenues.
