Brazil

[winstonsmith]

I don't hear too much talk about Brazil.  If Brazil is ready to launch in October and blows up big in a good way, wouldn't that mean lots of cash for Mannkind?

[Thundersnow]

Aug 8, 2019 16:20:24 GMT -5 winstonsmith said:

I don't hear too much talk about Brazil.  If Brazil is ready to launch in October and blows up big in a good way, wouldn't that mean lots of cash for Mannkind?

It's not going to blow up....It's going to be a measured ramp.  BIOMM is not cash rich so they will not be buying huge quantities. Lower your expectations.

[ktim]

I think upper bound of ramp rate would likely be what occurred with SNY before they gave up, and scaled for relative population of Brazil vs US.

Does anyone know if Brazil allows advertising drugs? Not that BIOMM has a lot of cash to throw at advertising, but I'm curious if that is even a possibility.

[sportsrancho]

Since 1962 these ads have been regulated by the Food and Drug Administration (FDA) to ensure that they are not false or misleading. The United States and New Zealand are the only two countries where direct-to-consumer (DTC) advertising of prescription drugs is legal.

[radgray68]

It sounds like we have all the advertising we need with over 60 periodicals and news sites reporting on us. Doctor's blogs too. Sanofi sure as heck didn't float 60 stories out there. Brazil doesn't have the pumps all over like the U.S. Afrezza is big news, apparently. Go figure. Next stop...Paraguay? Maybe we become the David Hasselhof of insulin. Wildly popular outside the U.S.

[ktim]

Aug 8, 2019 19:07:41 GMT -5 radgray68 said:

It sounds like we have all the advertising we need with over 60 periodicals and news sites reporting on us. Doctor's blogs too. Sanofi sure as heck didn't float 60 stories out there. Brazil doesn't have the pumps all over like the U.S. Afrezza is big news, apparently. Go figure. Next stop...Paraguay? Maybe we become the David Hasselhof of insulin. Wildly popular outside the U.S.

Then we'd just need to get Trump to open the borders to South Americans so they could come here and pay US prices for Afrezza

That will be exciting if they indeed ramp faster than what SNY achieved.  Wonder if we'll have any visibility into it short of quarterly conference calls.  Of course we may not get the script count even on those as it might just be a aggregate dollar amounts presented without knowing prices or royalty rate.

[radgray68]

Yeah, I really don't expect any serious money from Brazil THIS year. Maybe in Q2 2020 we can get an idea of the amount of interest and acceptance there. I expect a slow climb no matter where we go so I'm not too disappointed.

You give me the chills to think of how this board will ruminate over script numbers from overseas. U.S. scripts are contested here enough already. It could get crazy.... like 12 clowns in a VW Bug crazy. lol GLTY

[zumiker]

Brazil guarantees health care for all. Since it has been in so many publications isn't there a chance adoption rate increases much quicker than in the US where we're at the mercy of the insurance providers?

[paul]

Aug 9, 2019 2:24:59 GMT -5 zumiker said:

Brazil guarantees health care for all. Since it has been in so many publications isn't there a chance adoption rate increases much quicker than in the US where we're at the mercy of the insurance providers?

I imagine it boils down to price and promotion.  Interesting article about the cost of insulin in third world countries -- experiment.com/u/3ayn7A  Says the cost of a bottle of humalog in Brazil is $35. Will regulatory authorities allow much beyond that for afrezza?

[georgethenight2]

Aug 8, 2019 19:07:41 GMT -5 radgray68 said:

It sounds like we have all the advertising we need with over 60 periodicals and news sites reporting on us. Doctor's blogs too. Sanofi sure as heck didn't float 60 stories out there. Brazil doesn't have the pumps all over like the U.S. Afrezza is big news, apparently. Go figure. Next stop...Paraguay? Maybe we become the David Hasselhof of insulin. Wildly popular outside the U.S.

I would like to revisit this point. During my previous life as georgethenite1 I made a comment similar to this. If we are able to gain traction outside the US yes per unit cost much lower, but compensated with larger volume. So the question is do we become Hof and does that send the share price higher? Additionally, does Brazil require a study to evaluate Afrezza? I would be more interested in a study that shows Afrezza's　ability to stay intact w/o refrigeration.

[Thundersnow]

Aug 9, 2019 2:24:59 GMT -5 zumiker said:

Brazil guarantees health care for all. Since it has been in so many publications isn't there a chance adoption rate increases much quicker than in the US where we're at the mercy of the insurance providers?

Thats true but the cost will be a factor.  MNKD is at the mercy of Brazil's Govt and remember BIOMM takes a cut.  So I'm not expecting a huge sum of revenues. 

[matt]

Aug 9, 2019 6:58:00 GMT -5 paul said:

Aug 9, 2019 2:24:59 GMT -5 zumiker said:

Brazil guarantees health care for all. Since it has been in so many publications isn't there a chance adoption rate increases much quicker than in the US where we're at the mercy of the insurance providers?

I imagine it boils down to price and promotion.  Interesting article about the cost of insulin in third world countries -- experiment.com/u/3ayn7A  Says the cost of a bottle of humalog in Brazil is $35. Will regulatory authorities allow much beyond that for afrezza?

No, Brazil probably won't allow a huge premium over Humalog or other insulins.  Realize that government pricing in South America is about regulating the price of healthcare and it is about controlling the use of dollars and other hard currencies.  Since these countries have to import certain critical materials from the US and Europe and they have limited amounts of hard currency, it doesn't matter what a rich person is willing to pay if the government won't let them use their money to import high priced drugs.

There are three prices set by the government as follows:

PF: This is the factory price or in other words the maximum amount that the importer (BIOMM) can charge to pharmacies.
PMC:  This is the maximum retail price that a pharmacy can charge a consumer.
PMVG:  This is the price that can be charged to certain government owned hospitals and government entities, and it is always lower than the PMC.

Each of the prices is different depending on the state where the buyer lives since the sales tax is included and ranges from 12% to 20%.  Most states are 18% or 20%.

The one that is important for MNKD is the PF price because MNKD will get a portion of the PF.  Since Biomm has to cover their costs and can charge pharmacies no more than PF, the PF must be split between the manufacturer (MNKD) and the importer (Biomm).  The government sets the PF price and all the other prices are derived from there depending on allowed markups.  Brazil, in principal, will not import any new drug at a higher price that treats the same condition already served by another licensed drug.  However, the government does allow a modest premium for certain innovations such as a premium for pre-filled injector pens and improved formulations.

What are the market prices for competitive products (updated from the August 1st, 2019 official price list and today's Real / dollar exchange rate)?:

Humulin R (100U/ml, 10ml vial)                             37.63 Reals (US$9.57)
Humulin Kwikpens (100U/ml, 3ml pen, 5 pens)      136.10 Reals (US$34.62)
Novolin R (100U/ml, 10ml vial)                               37.36 Reals (US$9.50)
Novolin Pens (100U/ml, 3ml pen, 5 pens)                93.39 Reals (US$23.76)
NovoRapid (100U/ml, 10ml vial)                             77.25 Reals (US$19.65)     <<< Novorapid is the name used in Brazil for FIASP
NovoRapid Pens (100U/ml, 3ml pen, 5 pens)          147.34 Reals (US$37.48)    <<< Novorapid is the name used in Brazil for FIASP

Again these are the maximum prices that the importer (competitors of Biomm) can charge the pharmacies.  The PF price is split between the manufacturer and the importer and must cover the product, freight to Brazil, any marketing by the importer, and distribution costs within Brazil.  My guess is that Biomm will want at least a 30% discount from the PF price to cover their costs, so MNKD will get a  around 70% of the PF.

All things considered, I don't think it is realistic to expect a PF for Afrezza that is significantly more than the other products in the market.  Obviously there is some art in the negotiation of the price, Biomm get 220 Reals for a 10 ml vial of their insulin glargine versus 167 Reals for Sanofi Lantus, but overall CMED is going to follow the rules pretty closely.

If you are wondering, the maximum prices to consumers are roughly 65% higher than the PF prices in places like Rio de Janeiro where the sale tax rate is 20% (PMC price includes the sales tax).

[agedhippie]

Aug 9, 2019 8:17:22 GMT -5 matt said:

...

What are the market prices for competitive products (updated from the August 1st, 2019 official price list and today's Real / dollar exchange rate)?:

Humulin R (100U/ml, 10ml vial)                             37.63 Reals (US$9.57)
Humulin Kwikpens (100U/ml, 3ml pen, 5 pens)      136.10 Reals (US$34.62)
Novolin R (100U/ml, 10ml vial)                               37.36 Reals (US$9.50)
Novolin Pens (100U/ml, 3ml pen, 5 pens)                93.39 Reals (US$23.76)
NovoRapid (100U/ml, 10ml vial)                             77.25 Reals (US$19.65)     <<< Novorapid is the name used in Brazil for FIASP
NovoRapid Pens (100U/ml, 3ml pen, 5 pens)          147.34 Reals (US$37.48)    <<< Novorapid is the name used in Brazil for FIASP

Again these are the maximum prices that the importer (competitors of Biomm) can charge the pharmacies.  The PF price is split between the manufacturer and the importer and must cover the product, freight to Brazil, any marketing by the importer, and distribution costs within Brazil.  My guess is that Biomm will want at least a 30% discount from the PF price to cover their costs, so MNKD will get a  around 70% of the PF.

All things considered, I don't think it is realistic to expect a PF for Afrezza that is significantly more than the other products in the market.  Obviously there is some art in the negotiation of the price, Biomm get 220 Reals for a 10 ml vial of their insulin glargine versus 167 Reals for Sanofi Lantus, but overall CMED is going to follow the rules pretty closely.

If you are wondering, the maximum prices to consumers are roughly 65% higher than the PF prices in places like Rio de Janeiro where the sale tax rate is 20% (PMC price includes the sales tax).

A minor point, Novorapid is what the rest of the world calls Novolog. It's not really material because Novo Nordisk are selling FIASP at the same price point.

To your earlier point, I wonder if the premium BIOMM gets for their glargine is because it doesn't involve foreign currency as it is locally produced.

[mnholdem]

lpmnews.com/diabetes-aprovada-a-primeira-insulina-inalavel-do-brasil/

[mnkdfann]

Sept 20, 2019 8:50:47 GMT -5 mnholdem said:

lpmnews.com/diabetes-aprovada-a-primeira-insulina-inalavel-do-brasil/

Translation suggests it is still a case of hurry up and wait. 

"According to Biomm, the company responsible for manufacturing and distributing the product in Brazil, inhaled insulin should be available for purchase from the fourth quarter of the year, depending on the price registration process by the Drug Market Regulation Chamber (CMED)."