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Post by agedhippie on Oct 22, 2017 10:15:13 GMT -5
Pardon my ignorance. Can someone give me a time frame Of when we might start selling overseas? I know it's hard to say not being on the inside but what is your best guess? Wanna see a purchase order! If Brazil is the first country I would expect sometime in Q3 next year (the guidance is for H2 next year so I am putting it in the early part) based on a simple approval that BIOMM have running at the moment for injected Regular insulin from an approved plant. I am no real hurry to go outside the US. We will not get any upfront money until Afrezza is proven a success in the US which is going to take far higher sales than we have now. The other complication is that the sale price outside the US is far smaller (in the EU around 20%) for example and I would not expect that to be unusual. The smaller sales price reduces the profit margin and with it the amount someone would be prepared to pay upfront. The summary of all that is that in my opinion there is no money coming from upfront payments, any deal like Brazil is essentially a vanity project (there is no significant associated profit), we will have to repeat the whole endo education program in each country, and most of these countries ban drug advertising. I would far rather see us spend our resources in building the lucrative US market and putting our resources there.
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Post by akemp3000 on Oct 22, 2017 10:49:32 GMT -5
International sales are important even if the size of the country's diabetic population and revenue generated is only a fraction of the potential in the U.S. International Afrezza sales, even in one small country, could have a significantly positive impact on scripts, revenue, global exposure and balance sheet improvement. No one should write off or discredit the importance of international sales. The important question is which foreign country will see Afrezza shipments first. One swag guess is that it might be somewhere other than Brazil and could occur in the first half of 2018. Everything is just a guess until an announcement is made.
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Post by Deleted on Oct 22, 2017 11:00:24 GMT -5
The plant has a large fixed cost; any increase from a foreign sale will absorb some of that fixed cost.
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Post by lakers on Oct 22, 2017 14:26:39 GMT -5
MC has delivered the first one. What's next? www.healthline.com/diabetesmine/afrezza-updates-february-2017International Afrezza: MannKind says it's also eyeing international markets such as Brazil, Canada, Mexico, UAE, Australia, and even China. They're also exploring filing possibilities in the European Union. Most of that will be done through partners internationally, though some may remain MannKind-led launches worldwide. Could there be something like this? www.fiercepharma.com/r-d/china-s-wuzhou-says-it-will-take-10-stake-oral-insulin-specialist-oramed-for-52mChina's Guangxi Wuzhou Zhongheng Group disclosed that it intends to purchase a 10% stake in Israeli pharma company Oramed for $52 million, in return for exclusive Chinese distribution rights to its oral insulin following regulatory approval, according to a briefing from Reuters.
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Post by agedhippie on Oct 22, 2017 20:06:35 GMT -5
MC has delivered the first one. What's next? www.healthline.com/diabetesmine/afrezza-updates-february-2017International Afrezza: MannKind says it's also eyeing international markets such as Brazil, Canada, Mexico, UAE, Australia, and even China. They're also exploring filing possibilities in the European Union. Most of that will be done through partners internationally, though some may remain MannKind-led launches worldwide. Could there be something like this? www.fiercepharma.com/r-d/china-s-wuzhou-says-it-will-take-10-stake-oral-insulin-specialist-oramed-for-52mChina's Guangxi Wuzhou Zhongheng Group disclosed that it intends to purchase a 10% stake in Israeli pharma company Oramed for $52 million, in return for exclusive Chinese distribution rights to its oral insulin following regulatory approval, according to a briefing from Reuters. Notice there is no upfront payment there. That capital raise is about the same size Mannkind just pulled off (10% for $50M) and we didn't have to give away any rights.
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Post by patten1962 on Oct 23, 2017 4:12:11 GMT -5
Thank you everyone for your answers!
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Post by otherottawaguy on Oct 23, 2017 7:00:14 GMT -5
I think that EMA requirements which follow an application for marketing approval in Europe may be simply be too expensive for MannKind at this time. The EMA doesn't often accept FDA approval data as sufficient. MN: One needs to remember that the trials used for FDA approval were extended longer to accommodate for submission to EMA. Think it was about an extra month or more to the trial designs to conform to the European requirements. OOG
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