lines 2 & 3 ?

[mnholdem]

It sucks, but usually upgrades in production equipment and/or capacity are not considered material events and so there is seldom any PR associated with that kind of news. Matt will simply address Lines 2 & 3 (and any other equipment/production plans) at the upcoming 2Q15 earnings call.

However, the launch of a 12-unit Afrezza cartridge is material news and a PR will be issued by Sanofi/MannKind when the new Gold cartridge becomes available for prescriptions. Matt has already publicly spoken that Sanofi will be launching the 12-unit cartridge sometime during the 3rd Quarter, so it could be any day, week or month now that we're into 3Q. There will be a PR for that.

[bradleysbest]

But that will not change the share price. We need a TS deal announced, continued rise in script numbers & DTC (TV) for a positive rise in price. I am willing to wait it out. The 12U is just another brick in the Afrezza foundation!

[babaoriley]

It's about anticipation of coming sales, rather than current script counts. So, I'm sure we'd all like to know they are producing from lines 2 & 3 as a confidence builder for us, telling us that MNKD/Sanofi expect robust sales sooner than later.

However, anticipation alone hasn't moved the market for MNKD on any sustainable basis, so it seems actual, reported increased sales are needed. TS licensing news and strong hints of foreign interest would also take us to a higher market cap which we can sustain.

[jimbering]

Jul 7, 2015 8:38:29 GMT -5 bioexec25 said:

Precisely BD. The lines are likely fully validated and operational. Clearly we won't see news flashes about their excess capacity. I yield to the engineers here to estimate where script counts need to be to require the new lines.

Yes, I believe that is it.  You wouldn't really expect them to say we have the lines operational but don't need them because of slow sales.  It is actually worse than that and I hesitate to say but I was told that one line is producing more than than they need right now.  The good news is that Matt is sure this will change he just does not want to guess when.  I think he is correct.  When I have my doubts I read the reviews of Afrezza by the early adopters.  How many products, let alone drugs, get rave reviews like that?  I can't think of any offhand that people say have changed their lives the way Afrezza has.  I suppose an iPhone changes your life but it isn't "life changing" in the same manner.

It is just going to take time before the other two lines are needed.  My plan in the meantime is to buy on the lows and collect interest loaning my shares out to the shorts.

On a side note Matt said that they are considering a 2 unit cartridge even though their research says it is not needed.  However, if patients want it they may go ahead with it.  He did say a 2 unit would make sense for pediatric use.  That led to a discussion of pediatric approval and the difficulties and expense of doing the studies.  He said that financially it probably isn't worth it but morally they should do it mentioning the terror some children have of injections and how difficult it is for parents.  I respect him, MNKD and Sanofi for that.

[bioexec25]

Well said, I do always appreciate the future value versus current or past position point of view.  Furthermore, for those with pharma backgrounds (for our sins) can you imagine the fallout of not being ahead of the growth curve?  The times I recall supply constraint with our therapeutics, it was a fire drill and heads rolled.  It's not Apple playing around with market elasticity to improve demand.  :-))

[benh]

Jul 7, 2015 8:38:29 GMT -5 bioexec25 said:

Precisely BD. The lines are likely fully validated and operational. Clearly we won't see news flashes about their excess capacity. I yield to the engineers here to estimate where script counts need to be to require the new lines.

It took 2months to build up inventory for launch. (1 line). Using that as a guide will help determine how long it will take for an inventory build of the 12u and sitting on shelves.

As for demand. Currently, demand will outstrip supply by q1 '16. However that depends on week on week growth at ~15%. Given what Matt said during the last IR conference, and with trials completion dates etc, I think it will be closer to 2H '16

[parrerob]

Jul 8, 2015 3:47:39 GMT -5 benh said:

Jul 7, 2015 8:38:29 GMT -5 bioexec25 said:

Precisely BD. The lines are likely fully validated and operational. Clearly we won't see news flashes about their excess capacity. I yield to the engineers here to estimate where script counts need to be to require the new lines.

It took 2months to build up inventory for launch. (1 line). Using that as a guide will help determine how long it will take for an inventory build of the 12u and sitting on shelves.

As for demand. Currently, demand will outstrip supply by q1 '16. However that depends on week on week growth at ~15%. Given what Matt said during the last IR conference, and with trials completion dates etc, I think it will be closer to 2H '16

Thanks to all for the really good discussion.
As I was starting this tread with a question I will try now to make a summary fromthe interesting points in the tread:

Questions/doubts I had before (not clearly exposed, my error, as I was a bit concerned onour management way of communication)
1) Do lines 2&3 need or not a “formal” approval from FDA and in case we get it or not ?
2)Do lines 2&3 are completed and operationally ready to start or not ?
3) Do lines 2&3 are running and producing nowadays ?
4) Is there any statement done from MannKind in order we know clearlywhich is the operational status today of lines 2&3 ?
Deduced from the thread:
1) point not covered. Seems to me that a “formal” approval fromFDA is no needed. Still a black hole (from my side) on the authorization process ! Seems from Jefferies statement (reported here below under point 3) that the 12u process has been approved (instead of the lines ?)
2) Yes. From a statement by Matt and also during factory tour lines 2&3 were clearly ready to operate.
3) Not clear yet. Sure they were not producing during yearly shareholders meeting. Are they running now ? An interesting point is also the relation with 12u cartridge .... When we will see 12u in pharmacies it means lines 2&or3 have been running at least to produce them.
So I am expecting that they are running now (since days) in order to produce 12u stock... (I hopefully believe 12u will be launched this summer.. so stock production should be needed NOW)
This was the transcript from Jefferies conference last month “We started out with just one line in operation and we now have three lines in operation and the 12-unit cartridge which was recently approved will be the first thing that’s coming off the two new lines. So those would be, starting to be produced shortly if they aren’t today, I’m not sure if they are today but they aren’t, they will be any moment, and Sanofi says they will launch them into the market next quarter”
4) No, at least for me. Even if someone seems sure it was a clear statement during Jefferies conf. (it was during Q&A).
Someone suggested that is correct to be silent about lines 2&3 because it is not good to communicate that lines 2&3 are ready to operate but still waiting the demand.
Personally I don’t agree. Starting producing 12u cartridge should help sales and penetration. And should be an important step achieved to be communicate (as well the 2 lines ready!)

Only hope that FDA is not strictly in the process, but seems not ! and strongly hope that our management, stillin the middle of a big start-up, is not so comfortable with what they can or cannot (could or could't) communicate (and communication to shareholder quite sure is not their first priority now).
OK instead of reading MNKD web site investor page daily for news it is much more better to take a look daily in pharmaciesor to go by car in the Danbury factory parking to count employees cars... 
My problem is that in my country I will have to spend 4-5 years patrolling pharmacies before founding 12u.... 
Apologies for my initial claim against management. Yes I decided to invest in a company practically owned by insiders, and I knew it, so now I cannot claim loss of attention and communication to shareholders !
Apologies too for my wrong bet on last week scripts ! I was optimistic but I was nicely surpassed by the numbers !

Forza Italia.Viva la nostra pastasciutta, la nostra pizza, il nostro caffè (quello ristretto!, non il vostro), e le nostre donne!
E soprattutto Forza MannKind
Go Italy. Fantastic pastasciutta, fantastic pizza and OUR fantastic coffe (our short coffe, not Your glass full of dirty water )and fantastic women.
And mainly Go MannKind Go !

[ezrasfund]

The story on certification of lines 2 and 3 by the FDA is this. MNKD must perform all mandated test to validate the production lines. Documentation of those tests is on file (at MNKD) and available for inspection by the FDA at any time. The FDA does not need to actually come and inspect the plant for those lines to begin operation.

As an aside, imagine the manpower the FDA would need across the pharmaceutical industry if they were required to physically inspect or even just review documentation for every production line before it went into operation. I take this information from answers given by MNKD QC employees who spoke during the ASM plant tour.

[parrerob]

Jul 8, 2015 9:59:44 GMT -5 ezrasfund said:

The story on certification of lines 2 and 3 by the FDA is this. MNKD must perform all mandated test to validate the production lines. Documentation of those tests is on file (at MNKD) and available for inspection by the FDA at any time. The FDA does not need to actually come and inspect the plant for those lines to begin operation.

As an aside, imagine the manpower the FDA would need across the pharmaceutical industry if they were required to physically inspect or even just review documentation for every production line before it went into operation. I take this information from answers given by MNKD QC employees who spoke during the ASM plant tour.

Thanks a lot. very clear and reasonable too !