Sunday, February 04, 2018 9:20:16 AM
I agree with Kronberg that this is a difficult question, but let's have some fun.
By the end of year 2018. Probably not that much different from where we are now.
From the latest company presentation, a key event that would be nice to bring up the PPS would the reporting of the final Phase II results for OPRX-106 in Ulcerative Colitis, that we could expect in the coming months.
But I do not think that PLX will see a big increase based on that news. I believe the PPS will only make a real uptick upon approval of pegunigalsidase and then a second up-tick when we see the first revenues come in.
Pegungalsidase is meant to finalise enrollment in 2018, and estimated completion date for the important Balance study in June 2019 at the earliest, with the data coming out about 3 months later.
Though can be noted that for Balance, EMEA and Rest of World can get the data after 12 months comparability, rather than the FDA 24 months superiority. But still getting the data out in 2019.
2018, hopefully other events will be:
- CFF grant + start of Alidornase next step of Clinical trials.
- Start of OPRX-106 Phase III
And so looks like it will appear to the market that more money will be spent before pegunigalsidase approval and the market will think short term, seeing that as negative, but with the Chiesi and hopefully the CFF money coming in as a positive, with additional general positive Phase II data coming out on OPRX-106, as a positive. Leaving us right where we are for 2018.
However 2019 I think is a completely different story.
If we look at the the products coming through, and the science as well as the all important clinical data supporting them, then we have, as I see it.
- Fabry: All 3 trials are expected to be over in 2019, and with over 1 billion annually, peak sales targeted.
- Alidornase: Hopefully 2019 some good additional next step interim/complete data. About 500 million being targeted by Protalix really?
- Ulcerative colitis: Hopefully some good interim/complete Phase III data. This also looks like a real game changer. About 2 billion for Protalix?
That would make it about 3-4 billionish?
Then the fact that Market Cap is usually a multiple of revenues. Let's say 2-3 times.
Then perhaps with market cap of 7 billion? After these 3 products on the market.
It looks like they have the money to get the company to where it needs to be, and the partnership on Fabry to make the sales happen in Europe quite smoothly and then for themselves just to focus on the USA market. And they have the longer exclusivity on patent from EMEA ODD on Pegunigalsidase. Also EMEA granted Orpahn Drug Designation for pegunigalsidase even though Fabry is no longer an Orphan Disease, with 3 key players already on the market. It's based on the fact that the potential of pegungalsidase benefit far out-does current treatments that the EMEA decided to give the designation anyway. Alidornase fits into the same potential, and OPRX looks like it could really take over for mild/moderate UC.
Fundamentals looking good, I say.
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