E There Is Beta In Protalix Stock Due To PRX-102

 

Protalix (PLX) recently received their Day 74 FDA report on the acceptance of their BLA application applying for market authorization to PRX-102. This was also positive granting priority review for PRX-102 for adult patients with Fabry disease which is a genetic disease that leads to spingolipids building up in blood vessel walls, kidneys, heart, skin, and other places in the body causing pain and lowering life expectancy to close to 60 years old. It is known to cause strokes, bilateral symmetry, and organ failure as well. It is currently treated with Fabrazyme by Genzyme in the US at approximately $300,000 per patient annually in the US. Europe uses Replaggal by Shire for treatment. There is also an oral medication named Galafold by Amicus used globally.   

PRX-102 also known as pegunigalsidase alfa is a designed, long-acting, recombinant, PEGylated, cross-linked α-galactosidase-A treatment. Protalix’s PRX-102 is designed to potentially provide a “significant improvement” in the safety or effectiveness of the treatment of Fabry disease. The FDA has assigned a priority review for this application with a goal date of January 27th, 2021. There is a growing need for new treatments for this disease as the disease also causes kidney failure and even those treated today experience early kidney failure.

With Fabry’s lowest estimate of 19,000 infants or 1 in 80,000 infants alone, there is a substantial potential market for this drug whether or not it is priced at the current market price or at a 20% discount. With onset of this disease also occurring at older ages this estimate is on the conservative side. There are currently 6,700 known patients being treated with Fabry’s and growing. Protalix market cap is currently only about $125 million. Even if PRX-102 doesn’t become the standard of care or not, it will more than justify a price for Protalix to be substantially higher than where it is. Depending on the effectiveness being equal to existing treatments, I estimate gross margins at 30% although it could be higher based on lower cost production and/or potential superiority to existing treatments.

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RichardPerry2 2 months ago Member's comment

Very thorough article.

David Newmark 2 months ago Member's comment

Sounds like a win.

Moon Kil Woong 2 months ago Author's comment

I was mistaken regarding Brazil. They are currently selling Elelyso, which was approved for Gaucher disease in Brazil which is growing their revenue in Brazil and is another income stream for them. This will not be affected if PRX-102 is approved or not.

Stock Profit 2 months ago Member's comment

I'm liking what I see about $PLX!

Moon Kil Woong 2 months ago Author's comment

Thanks.

Alexis Renault 2 months ago Member's comment

Sorry for the total noob question, but what does the headline mean? What is beta in a stock?

Moon Kil Woong 2 months ago Author's comment

It's probably best to start by reading Wikipedia for a more complete definition. en....pedia.org/.../Beta_(finance).

Alexis Renault 2 months ago Member's comment

Thank you, I've learned so much from this site and keep learning more every day. Your link explained it clearly.

Gil Richards 2 months ago Member's comment

Very impressive.

Daniel Charles 2 months ago Member's comment

Are there any other recombinant therapeutics that are in the pipeline for $PLX

Moon Kil Woong 2 months ago Author's comment

There are other recombinant players listed below. I'm not aware one one targeting this exactly but you never know what comes down the pipeline.

Boehringer Ingelheim

Bristol-Myers Squibb

Celldex Therapeutics

Eli Liily

GlaxoSmithKline

Merck

Novartis

Regeneron Pharmaceuticals

Roche

Takeda

Cannabis Stock Buyer 2 months ago Member's comment

I'll be taking a closer look at $PLX, thanks.

Seeking Alpha Reader 2 months ago Member's comment

I have to admit, I've never heard of Fabry disease before this article and am fairly knew to pharma/biotech in general. When talking about market size, how does this compare to some other diseases. Is this a large market?

Moon Kil Woong 2 months ago Author's comment

The other players are listed in the article they are quite big and are conglomerates.

Moon Kil Woong 2 months ago Author's comment

Actually if for some reason it fails I suspect the stock could drop a bit more. That said, feel that risk is mitigated as the stock has already fallen from its highs and I think its existing business will pull it into profitability next year unless they pursue a promising drug needing more R&D. Hopefully, if that is the case it will sustain the stock.

My guess is a 20% downside and more than a 100% upside from here.

Bindi Dhaduk 2 months ago Member's comment

That makes a lot of sense, thank you.