Based on today's weakness, it looks like Biocartis might revisit the 52 week lows in the 9's. It got absolutely no traction from the BMY CDx collaboration announcement. I see a variety of late 2019-2020 catalysts but probably not a lot in the near term. Possible catalysts include: 1) A press release from Wondfo (China Partner) or Nichirei Bioscience (Japan Partner) indicating progress with registration and providing a launch date would be a major catalyst. I understand that the Wondfo collaboration will include manufacturing in China. However, why must this preclude launching with cartridges a consoles manufactured in Belgium while the China manufacturing facility is being constructed; 2) Information on the Onco Dx Breast assay validation and specifically when EU approval might be expected will be major news. 3) Similarly, the Onco Dx prostate status will also be welcome news since both of the OncoDx products will serve large markets in the EU and US. 4) Finally, updates on the status of FDA negotiations for approvals of MSI, BRAF, KRAS etc would probably be the biggest momentum maker since this would allow the product to be used for diagnostic purposes rather than RUO. Such an authorization would allow the tests to be reimbursed by insurers. This would undoubtedly allow the sales to ramp in the US.
One of the things I like most about BCART is that they can leverage the staff and technical resources of their partners (CDx Pharma and content partners like GHDX) to expedite FDA approvals. If FDA makes progress revamping the 510K pathway, I don't see why some of these approvals might not move faster than the guidance. I think the FDA process will eventually get to where the EU Marking procedure has gotten (i.e., about 6 months from filing to approval), but this will likely take a few years.
In the short term, my best guess is that BCART could go as low as 9.7 and will probably have difficulty breaking 12 without one of the aforementioned catalysts. I've pretty much loaded up, but I may add a little more to my share count.
Any-one know the reason for the apparent downgrade by one of the analysts?
FL