A couple points most people have missed about the deal

[beardawg]

I'm starting to suspect that MannKind took a little less money up front and went with the better marketing/sales Pharma just to get Afrezza out there and accepted by the masses. This is to open the door for all other partnerships/licenses for Technosphere applications (can make it up then). I think it was a calculated move to take a minor hit now (which I really don't think is a hit), only to reap major rewards in the long run. The first step was the validation by BP picking it up.

Also, I think the deal isn't as bland as some make it out to be. Many aren't considering the costs that Mannkind won't have to pay. For instance, (correct me if I'm wrong) wouldn't the agreement mean that Sanofi will now pay for the agreement with Amphastar?  All they have to do now is make Afrezza, and even that will be sold to Sanofi at cost, so Mannkind actually has no manufacturing costs. Even further, trials and meeting regulations now falls under Sanofi's costs. On top of all that, Mannkind has NOL to carry over against any profits made, so no taxes will be levied against the first profits. By the time the NOL is used up, Afrezza will be profitable enough on its own that it won't need that extra propping up.

[4Balance]

Aug 12, 2014 21:52:46 GMT -5 beardawg said:

I'm starting to suspect that MannKind took a little less money up front and went with the better marketing/sales Pharma just to get Afrezza out there and accepted by the masses. ... I think it was a calculated move to take a minor hit now (which I really don't think is a hit), only to reap major rewards in the long run. The first step was the validation by BP picking it up.

Also, I think the deal isn't as bland as some make it out to be. ... By the time the NOL is used up, Afrezza will be profitable enough on its own that it won't need that extra propping up.

You may be onto something, beardawg.  It was essential that the first Technosphere application succeed.  And with no track record in this inhaled arena...assuming that would have mattered...MNKD might have had to settle for "newcomer" profits.

There still are a lot of unknowns, including how well docs will take to Afrezza.  The marketing strategy will be key...I do hope the major Diabetes forums will see Afrezza advertised, and soon, so patients will ask for it. Many folks are "ok" with needles.

The "innovation adoption" curve typically takes a while...we'll see how long.

[abcschuetze]

Hello, I am new to this board but invested for a while and reading here daily.

I just have one question as I understand the deal which has not yet been clearly mentioned.

The split 35/65 is for Afrezza only but not for Technosphere right? What about the "whistle" which will be sold together with Afrezza, will this be under the split as well?

Or does Mannkind gets 100% for it?

Might be a stupid question, but this isn't clear for me yet.

[4Balance]

Aug 13, 2014 2:03:08 GMT -5 abcschuetze said:

Hello, I am new to this board but invested for a while and reading here daily.

I just have one question as I understand the deal which has not yet been clearly mentioned.

The split 35/65 is for Afrezza only but not for Technosphere right? What about the "whistle" which will be sold together with Afrezza, will this be under the split as well?

Or does Mannkind gets 100% for it?

Might be a stupid question, but this isn't clear for me yet.

First....there are no stupid questions!

I think the answer to your question is, Technosphere is not sold separately.  So far, it is only sold in combination with insulin....as Afrezza.

I believe Sanofi has first right of refusal for subsequent Technosphere applications, but someone needs to confirm that. 

Re Dreamboat (the whistle), I would expect the sales split to be 65/35 there as well.  And the manufacturing expense would also be shared in that ratio.  But that, too, needs to be verified.

[liane]

Off the top of my head, Sanofi has right of 1st refusal only on GLP-1 application. MNKD can still license Technosphere to any other drug application.

[vissertrades]

Sanofi also gets first in line to negotiate a buy-out if MNKD BOD chooses to have a change of control. I think this is a perfect deal to get the word out and prove AFREZZA.

[mannmade]

Liane it is my understanding you are correct regrading rights on Sanofi's for Technosphere.

[novafett]

Aug 12, 2014 23:25:36 GMT -5 4Balance said:

...I do hope the major Diabetes forums will see Afrezza advertised, and soon, so patients will ask for it.

This comment made me curious.  Does anyone have a pulse on the reaction of those on major diabetes forums on the partnership and release of this drug?  It may have been discussed before but i've not seen it and up until now i had not even thought about a diabetes forum.  Just curious.

[brentie]

This was before the partnership, the earlier threads linked in one of the replies got more responses.


www.tudiabetes.org/forum/topics/fda-approval-of-afrezza-inhaled-quick-acting-insulin?page=1&commentId=583967%3AComment%3A3474810&x=1#583967Comment3474810

[kc]

You can imagine that 30 to 60 days before the launch in 2015 that Sanofi will be hitting the Web and Medical journals directed towards Doctors and Diabetics with marketing material. MannKind will be producing some samples by the millions for distribution to the Dr's. So you can't expect much of earnings the first 2 quarters as the investment in advertising and PR, Samples will eat up any of the profits coming in. but then you should have great opportunity the rest of 2015.

The other thing we need to explore is the time line for EU approval. How long will it take Sanofi to gear up to submit to the EMA? will they have to do studies there or will they be able to prove the validity of the testing done in the FDA approval process. I am sure MannKind picked Sanofi because they are skilled in working in the EU market and dealing with the regulatory forces in the 120 nations that Sanofi does business in. Does anybody know what countries if any automatically accept FDA approval? This could be another source of production if there are countries that will accept the FDA label. 

Has anybody researched FDA and International Reciprocity?
www.fda.gov/InternationalPrograms/Agreements/MemorandaofUnderstanding/default.htm

[liane]

MNKD designed their trials to be applicable to the EU. Once filed, count on a year (or more) for approval.

[novafett]

Aug 13, 2014 9:25:00 GMT -5 brentie said:

This was before the partnership, the earlier threads linked in one of the replies got more responses.


www.tudiabetes.org/forum/topics/fda-approval-of-afrezza-inhaled-quick-acting-insulin?page=1&commentId=583967%3AComment%3A3474810&x=1#583967Comment3474810

Thanks for that link.  I read through about 40 pages of replies and didn't get an overwhelming sense that the forum base was ALL-IN for Afrezza.. got a 40/60 or 50/50 feel of for/against when i read it, but i think the majority of people on there were Type 1.

[abcschuetze]

Aug 13, 2014 2:54:45 GMT -5 4Balance said:

Aug 13, 2014 2:03:08 GMT -5 abcschuetze said:

Hello, I am new to this board but invested for a while and reading here daily.

I just have one question as I understand the deal which has not yet been clearly mentioned.

The split 35/65 is for Afrezza only but not for Technosphere right? What about the "whistle" which will be sold together with Afrezza, will this be under the split as well?

Or does Mannkind gets 100% for it?

Might be a stupid question, but this isn't clear for me yet.

First....there are no stupid questions!

I think the answer to your question is, Technosphere is not sold separately.  So far, it is only sold in combination with insulin....as Afrezza.

I believe Sanofi has first right of refusal for subsequent Technosphere applications, but someone needs to confirm that. 

Re Dreamboat (the whistle), I would expect the sales split to be 65/35 there as well.  And the manufacturing expense would also be shared in that ratio.  But that, too, needs to be verified.

Thanks a lot.

[mnkdd]

From the YMB-- no guarantees, but it makes a lot of sense to me. Any opinions?

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"1. The projections being presented in the media at the moment are based on short acting insulin analogs (Humalog and Novolog)
2. If you know diabetics, or work in a doctors office, or work in a hospital, or any medical job that deals with diabetes you would understand that those people injecting insulin at the moment are the worst case scenario or the very responsible and diligent patient. The responsible and diligent patients are a small minority. The truth is that most patients will avoid insulin injection as long as they can and resort to taking other medications and reserve insulin last. Many doctors that treat diabetes see this as a problem and would often try to convince their patients to take insulin early on the progression of their disease.
3, Afrezza will allow doctors to agressively treat diabetes and treat it earlier. The biggest obstacle of injecting is now gone. They do not have to go to other oral agents to prolong taking insulin.

So if the market they are projecting is roughly $6 billion in sales for short acting insulin, believe me that market can now be worth $20 billion. Why you ask:
a. PPG is the main problem early in the disease progression. Guess what treats that, correct MEAL TIME Insulin. Before Afrezza, patients would take a cocktail of diabetes medications which will eventually stop working and then they will eventually have to inject.
b. GLP1 and SGLT2 Inhibitors: These markets are toast! Although once MNKD has GLP1 in inhalable form then this is another blockbuster in the making. Why do you think Sanofi included that in their negotiations
c. Long Acting Insulin Market: Guess what if you can control PPG youre good to go! If not Sanofi has Lantus.

As ive said dont worry, the 1st quarter numbers of 2015 will blow through projections. Sanofi is an agrgessive marketer and believe me they will make Afrezza a blockbuster in no time."

[retailinvestor360]

Sanofi already the sales/marketing team infrastructures for Lantus, which has already established excellent long term relationships with clinics, hospitals, doctors offices, and etc. All the powerhouse sales/marketing team has to do now is a little introduction for Afrezza. I am highly optimistic since MannKind's partner is Sanofi rather other firms.