Replies to post #358524 on Innovation Pharmaceuticals Inc (IPIX)

[snayeman]

Nice post! Hope you are correct

[MackG]

CMC, nice overview of a likely scenario.

[Jhawker]

Nice post thank you

[LilyGDog]

Very well thought out.... I also believe that finding a manufacturing partner will not be a problem. If there is money, they will come.

Go Leo & IPIX!

After B-COVID EUA Award - WHAT NEXT?

Gilead's Remdesivir scored an FDA emergency use authorization in May 2020 and a full approval in October 2020. Remdesivir generated $2.8B in 2020 and is projecting $2B-$3B in Remdesivir sales in 2021.

Regeneron's monoclonal antibody-cocktail treatment (Casirivimab and imdevimab t) was awarded an EUA on 11/21/2020, halfway through the 4Q/2020, and still rung-up $144M in U.S. government sales and added $1.6B to their 2021 revenue projections.

Lilly's monoclonal antibody-cocktail treatment (Bamlanivimab and Etesevimab) was awarded an EUA on 02/09/2021. The drugmaker made $810 million from the two drugs combined in the first quarter this year (2021) and estimates $1 billion to $1.5 billion in revenue from the treatments through 2021.

This brings us to the "WHAT NEXT"?

I cite these 3 COVID-EUA examples to show how quickly, with sufficient pharmaceutical manufacturing capacity (PMC), IPIX could generate billion$ in sales in a mere 3-12 months from the date of issuance an EUA.

IPIX has no PMC, but Leo is definitely in the "driver's seat" when it comes to lining-up manufacturing partners. Drug companies know that...in this moment...COVID-19 is the most lucrative of all indications and any way they can get into the game will probably result in hundreds of millions...if not billions for their revenues.

This is not news to Leo and, IMO, he has already been busy scouring the planet for excess PMC. Unlike the mRNA vaccines that have over 200-steps in their mfg process, my understanding is that "B" is relatively simple to make with low cost materials.

IMO, once B-COVID is awarded an EUA, Leo should, at the least, have a billion-dose PMC in place. The U.S., EU, UK, WHO and others will want to stockpile B-COVID in the same way they did remdesivir. Some of this stockpiling will be for national defense purposes. This is how Gilead made $2.8B 8 months after receiving an EUA and projected 2021 sales of $3B, all from a drug, remdesivir, that a major 5K WHO-study that found it had little to no effect on COVID-19.

B-COVID COULD GENERATE A BILLION OR MORE IN $ALES BEFORE A P-3 STARTS

People like to judge Leo from past events/happennings, but I submit my billion-dose PMC metric is a way to see if Leo is truly on top of one of the most important things that will lead to billion-dollar profits for IPIX. When (not if) B-COVID receives a EUA be sure to note Leo's comments pertaining to PMC and his plans to quickly mfg & disseminate B-COVID.

If I know Leo (and I think I do), the award of the EUA will not be a "start your engines" moment, the engines will already be running.

[Lemoncat]

You know what the best part about your numbers are?

If we manage 1% of them we become a solid, semi-funded phase 2-3 company once again.

If we manage 5-10% of them we will be a multi-billion dollar market cap in no time.

Go IPIX!

[Minnesinger]

I keep returning to the Seqens article...

and want to believe that it was more than hypothetical that they chose to use Brilacidin as an example of their refined manufacturing processes.

What flow chemistry and biocatalysis bring to synthesize a typical small molecule candidate against Covid-19 epidemic

While the results of the clinical trials are critical to the fate of the candidates being studied by drug developers such as Innovation Pharmaceuticals Inc., it is equally critical to develop, since the earliest stages of development, a robust and competitive chemical synthesis process to anticipate large-scale production if successful and plan marketing needs.

The Importance of a Global Leader in Small Molecule Manufacturing During the COVID-19 Pandemic

Seqens was formed in December 2018 when Novacap merged with PCI Synthesis, PCAS, Uetikon, and Proteus. With 24 manufacturing plants and three R&D centers in Europe, North America, and Asia, we are an integrated global leader in pharmaceutical synthesis and specialty ingredients.

[Empiricst1]

And, from the americaspharmacy.com website, the efficacy of the combination of bamlanivimab and etesevimab is questionable, despite all of the sales. A proven effective B would be a real profit generator.

[PJ007]

Great Post CMC.....worthy of a sticky!!!!

After B-COVID EUA Award - WHAT NEXT?

Gilead's Remdesivir scored an FDA emergency use authorization in May 2020 and a full approval in October 2020. Remdesivir generated $2.8B in 2020 and is projecting $2B-$3B in Remdesivir sales in 2021.

Regeneron's monoclonal antibody-cocktail treatment (Casirivimab and imdevimab t) was awarded an EUA on 11/21/2020, halfway through the 4Q/2020, and still rung-up $144M in U.S. government sales and added $1.6B to their 2021 revenue projections.

Lilly's monoclonal antibody-cocktail treatment (Bamlanivimab and Etesevimab) was awarded an EUA on 02/09/2021. The drugmaker made $810 million from the two drugs combined in the first quarter this year (2021) and estimates $1 billion to $1.5 billion in revenue from the treatments through 2021.

This brings us to the "WHAT NEXT"?

I cite these 3 COVID-EUA examples to show how quickly, with sufficient pharmaceutical manufacturing capacity (PMC), IPIX could generate billion$ in sales in a mere 3-12 months from the date of issuance an EUA.

IPIX has no PMC, but Leo is definitely in the "driver's seat" when it comes to lining-up manufacturing partners. Drug companies know that...in this moment...COVID-19 is the most lucrative of all indications and any way they can get into the game will probably result in hundreds of millions...if not billions for their revenues.

This is not news to Leo and, IMO, he has already been busy scouring the planet for excess PMC. Unlike the mRNA vaccines that have over 200-steps in their mfg process, my understanding is that "B" is relatively simple to make with low cost materials.

IMO, once B-COVID is awarded an EUA, Leo should, at the least, have a billion-dose PMC in place. The U.S., EU, UK, WHO and others will want to stockpile B-COVID in the same way they did remdesivir. Some of this stockpiling will be for national defense purposes. This is how Gilead made $2.8B 8 months after receiving an EUA and projected 2021 sales of $3B, all from a drug, remdesivir, that a major 5K WHO-study that found it had little to no effect on COVID-19.

B-COVID COULD GENERATE A BILLION OR MORE IN $ALES BEFORE A P-3 STARTS

People like to judge Leo from past events/happennings, but I submit my billion-dose PMC metric is a way to see if Leo is truly on top of one of the most important things that will lead to billion-dollar profits for IPIX. When (not if) B-COVID receives a EUA be sure to note Leo's comments pertaining to PMC and his plans to quickly mfg & disseminate B-COVID.

If I know Leo (and I think I do), the award of the EUA will not be a "start your engines" moment, the engines will already be running.

[steelyeye]

Great post, and with those kind of revenues possible/probable given other EUA company revenues, it will be interesting to see if our CEO entertains:

1) buyout offers for the company

2) buyout offers for Brilacidin and All its indications, or

3) if he continues with trials for B-UC, Crohns, etc. as well as advancing Kevetrin for various cancer indications.

Exciting weeks ahead regardless of what MMs are up to.