Amarin Corp Plc (AMRN)

[Pyrrhonian]

Here are the main catalysts/issues as I see them:

1) Nov 10 AHA data

-hard MACE could be non sig, marginally sig, or very sig, and special attention will be paid to non-fatal vs fatal events (CVD). Market will obviously reward better data, but I personally think estimates beyond 40% jumps in pps are unrealistic even in a best case scenario.
-lipid/lipoprotein levels of mineral oil group vs V group will also be scrutinized. Especially LDL-C and hsCRP, imo. If a very significant increase occurred in mineral oil group vs V group, that could put a damper on the pps for some time, until clarity is given by FDA

2) Large secondary

-could come any moment, and will imo be over $400mm (maybe well over). It will probably be priced below market and depending how far below, and how large it is, will also affect the pps. It may turn out to be a negative that mostly resolves positively, as the market likes it when a co is flush with cash (especially one selling a product that can ramp up).

3) sNDA submission

-early 2019, and if data at AHA are strong and it doesn’t look like there were any sig changes in mineral oil group vs V group in inflammatory markers (except TG of course), it’s probably a shoe-in. They likely get priority review, shortening the standard 10 month approval time to 6 months, and maybe even they get it done in 3-4. Label expansion comes anywhere from mid 2019 to mid 2020.
-however, if mineral oil group shows large jumps in LDL-C and hsCRP, and these occur soon after dosing with mineral oil, then that increases the risk FDA will issue a CRL and require a study be conducted that compares lipid and serum statin levels of subjects stabilized on statins and randomized to corn oil or mineral oil groups (using an assay like this: https://www.sciencedirect.com/science/article/pii/S1021949813000045. ). If that study shows hindered absorption then there’s a big problem. FDA may require an entirely new CVOT with an inert placebo. Not sure how all that would play out, and what sort of public outcry there would be, but either way it wouldn’t be good for the pps.

4) Generics

-either win and come to market in 2022, or they lose and come in 2029. If they come 2022, turn out the lights on your way out.

5) Expanded indications

-If the sNDA comes through and they win their litigation cases, then I could see them running a few studies in dry eye and rheumatoid arthritis. No idea how that will go, but other studies with high dose n-3 weren’t promising.

6) Manufacturing

-I don’t see how their contract manufacturers will be able to ramp up enough to allow AMRN to sell beyond $5B in annual sales during the lifecycle of their patents, best case scenario (10 years from now). It is a natural resource, it is regulated and its market has limitations. They cannot simply haul mega tonnes more out of the sea at will. 4g/d of isolated EPA takes a lot of fish oil to get. And that’s just for one person for one day. For millions? It’s going to take a very long time. And of that, they will net 10% or so at first, and peak around 20%-25%. After 6-7 years of this, and considering other administrative costs, and considering ramp, they will maybe have $3B - $5B cash on hand. So even in a best case scenario, their market cap probably won’t eclipse $12B.

So for me, I might take a flyer if everything looks rosey in the AHA data, but wouldn’t hold for very long. I’d be in for the hype wave, and would get out.

Thoughts on the above?

GLTA