MannKind Corporation to Participate in the Lytham Partners I

[celo]

Jan 31, 2023 12:54:12 GMT -5 phdedieu12 said:

Jan 31, 2023 12:27:49 GMT -5 cjc04 said:

not trying to make something out of nothing, but is it normal for a CEO to just toss out a time line for 1 specific piece of the company to be CFBE?

I think (without going back to listen to the call to verify) that besides the obvious, (that is, everyone is looking to generate a profit as soon as possible), the board made it a priority. Sounded like this was a specific goal from the board and they are meeting that goal. And that is not to say MC or anyone else was looking at delaying. But it is clear that they certainly wanted to showcase that this part of the company was no longer hemorrhaging money

Afrezza has been a long road.  Mannkind has so many future possible golden eggs, that to show break even after all the trials and tribulations on Afrezza, just makes those future prospects all the more appealing to possible investors

[Thundersnow]

HOLY SHIT....Mike said today Tyvaso DPI hit an Analysts 3RD QUARTER Forecast in the 1ST QUARTER of production!!!!

O M G.......No wonder the stock is skyrocketing

[neil36]

Jan 31, 2023 13:53:23 GMT -5 Thundersnow said:

HOLY SHIT....Mike said today Tyvaso DPI hit an Analysts 3RD QUARTER Forecast in the 1ST QUARTER of production!!!!

O M G.......No wonder the stock is skyrocketing

Exactly.

That’s why I appreciate kippyt being so faithful for posting her Friday morning script numbers and adding in the Tyvaso DPI numbers when I suggested it. Without those numbers, this would be unbearably opaque. Those numbers are telling one helluva story right now.

And he also said they’ve already seen an “uplift” in Afrezza scripts in January due to the new Medicare $35.00 co-pay cap. Mke saying out loud that Afrezza/V-Go will exceed cash-flow-break-even this year is a MAJOR development for anyone who has followed this for (insert your own number here) years.

[letitride]

Thanks Mike!
Lets Ride

[hellodolly]

Jan 31, 2023 21:28:04 GMT -5 letitride said:

Thanks Mike!
Lets Ride

 "Let's Roll."  I appreciate what he stated regarding how they're currently funded well into the future. 

[lennymnkd]

Clinical trial results have shown that once-weekly basal insulins are just as effective at reducing A1C as once-daily insulin. In July 2022, Novo Nordisk announced the results of the ONWARDS 3 and ONWARDS 4 clinical trials, showing that icodec, a once-weekly basal insulin, was just as effective as once-daily insulin.Aug 16, 2022
What Mike was speaking about … I thought that was a big deal / CGM/ Afrezza… 🤔on another note note , was Mike drinking a coke during that interview

[phdedieu12]

Goes best with Pizza! And I agree, I think it's a big deal, I think this is precisely what the pump study will show, and I hope it also opens the door to revisit prescribers

[MnkdWASmyRtrmntPlan]

Lytham 

MNKD is becoming more diversified pipeline:
• Afrezza (revenue)
• V-go (revenue)
• Tyvaso-Dpi (revenue)
• Clofazamine
Next 24-months:
• Nebulizer – purchased a company 12/2020
 o phase 2/3 design for NTM has been agreed to
 o NTM is a rare bacterial lung disease, mainly concentrated along eastern seaboard of US
 o Hopefully be able to start dosing patients second half of this year
 o bacteria that just grows in some endemic regions, so just need a small sales structure
 o About 100,000 patients in each of (east coast of US, Japan and S. Korea)
 o A lot of TB drugs are used off-label and have a lot of diseases. So this will be only the second approved drug
 o Trial will be Approx. 200 people, 6-month end-point, so should have data pretty quickly.
 o 4-weeks dosing, then off 2-weeks, then back on.
Next year for Afrezza
• Afrezza and V-go will be covered by same sales structure – watch and see if one team can sell both products
• V-go is the lowest co-pay
• Medicare is capped for Afrezza at $35 co-pay for patients
• Trial readout from India Type-2 Q2
• Peds trial is more than 1/2-way enrolled and should finish enrollment this year and maybe get results as early as Q1 2023
 o Not only is Afrezza safe for peds, but if dosed properly, Afrezza can give a better outcome and safety profile
 o Properly dosed Afrezza should provide some benefit (hypoglycemia or A1c)
 o Reduce # of jabs per day
• In February, we will be showcasing the results of our Pump switch trial
 o switched 10 people on an insulin pump -> 5 pwd stayed on pump, 5 pwd Afrezza along with pump
 o This will show that you can get off you pump if you want to after receiving Afrezza
 o You don’t need to carb-count
 o Our vision is to treat diabetes with one basil shot per week, plus Afrezza
   So, in the next 12-18 months, we can bring that treatment to reality
   This is a 3-month study that should be done early next year
• Then, depending on the outcome of these 3 trials, they will decide how much to spend on marketing
• They have been challenged by their board to make sure that their diabetes business is Cash-flow-break-even this year
 o They believe it is possible and that is their #1 mandate for this year
 o International – We won’t make a lot of $, but there are 500,000,000 pwd and growing (Brazile=60M, India=80M)
 o This helps us keep our factory more efficient
• Tyvaso Dpi
 o Started 2017
 o We can dose higher: Our phase-1 shows we can go to 150 micrograms in 2018
 o Went from phase 1 to approval in 2022
 o Meantime, UT got approved for ILD subset of PH, and IPF
 o They had space to grow their production, so that will get up and going in 1 to 1-1/2 years (as opposed to 2-3 yrs)
   So with that addition, they will be able to handle their 2 current indications.
   For IPF, that will be 10-times bigger than the other 2
 o UT is working hand-in-hand with them to make sure that will happen-they are supporting that effort (THANK GOD)
• Pipeline
 o OFEV-Treats IPF 100k patients–by putting the drug directly into the lung, we can minimize the systemic side effects
 o Nebulized product for Systic Fibrosis – $800M/yr marketed by Roche. people used to die in their twenties, now into their forties
 o TGF beta – still early, but a high-risk reward. Patients are dieing. Our technology lowers the dose.
• So, between Tyvaso Dpi or Tyvaso nebulizer and IPF with Martine at UT and our OFEV nintedanib and 501, we have 3 shots alone for IPF, which is a huge unmet need for our patients
• We are well-funded and don’t need to raise any more money

[lennymnkd]

o Our vision is to treat diabetes with one basil shot per week, plus Afrezza 👍
   Lot of new science and information … for that ADD someday.

[Thundersnow]

Feb 1, 2023 15:39:44 GMT -5 lennymnkd said:

o Our vision is to treat diabetes with one basil shot per week, plus Afrezza 👍
   Lot of new science and information … for that ADD someday.

I was speaking with a Pediatric Endo and she heard there are problems with NOVO's Once a week Basal Shot. 

[lennymnkd]

Mikes tone of voice seemed optimistic about it ..
is there something he doesn’t know ?
    Maybe Afrezza will correct the problem.

[sayhey24]

Feb 1, 2023 15:33:34 GMT -5 MnkdWASmyRtrmntPlan said:

Lytham 

MNKD is becoming more diversified pipeline:
• Afrezza (revenue)
• V-go (revenue)
• Tyvaso-Dpi (revenue)
• Clofazamine
Next 24-months:
• Nebulizer – purchased a company 12/2020
 o phase 2/3 design for NTM has been agreed to
 o NTM is a rare bacterial lung disease, mainly concentrated along eastern seaboard of US
 o Hopefully be able to start dosing patients second half of this year
 o bacteria that just grows in some endemic regions, so just need a small sales structure
 o About 100,000 patients in each of (east coast of US, Japan and S. Korea)
 o A lot of TB drugs are used off-label and have a lot of diseases. So this will be only the second approved drug
 o Trial will be Approx. 200 people, 6-month end-point, so should have data pretty quickly.
 o 4-weeks dosing, then off 2-weeks, then back on.
Next year for Afrezza
• Afrezza and V-go will be covered by same sales structure – watch and see if one team can sell both products
• V-go is the lowest co-pay
• Medicare is capped for Afrezza at $35 co-pay for patients
• Trial readout from India Type-2 Q2
• Peds trial is more than 1/2-way enrolled and should finish enrollment this year and maybe get results as early as Q1 2023
 o Not only is Afrezza safe for peds, but if dosed properly, Afrezza can give a better outcome and safety profile
 o Properly dosed Afrezza should provide some benefit (hypoglycemia or A1c)
 o Reduce # of jabs per day
• In February, we will be showcasing the results of our Pump switch trial
 o switched 10 people on an insulin pump -> 5 pwd stayed on pump, 5 pwd Afrezza along with pump
 o This will show that you can get off you pump if you want to after receiving Afrezza
 o You don’t need to carb-count
 o Our vision is to treat diabetes with one basil shot per week, plus Afrezza
   So, in the next 12-18 months, we can bring that treatment to reality
   This is a 3-month study that should be done early next year
• Then, depending on the outcome of these 3 trials, they will decide how much to spend on marketing
• They have been challenged by their board to make sure that their diabetes business is Cash-flow-break-even this year
 o They believe it is possible and that is their #1 mandate for this year
 o International – We won’t make a lot of $, but there are 500,000,000 pwd and growing (Brazile=60M, India=80M)
 o This helps us keep our factory more efficient
• Tyvaso Dpi
 o Started 2017
 o We can dose higher: Our phase-1 shows we can go to 150 micrograms in 2018
 o Went from phase 1 to approval in 2022
 o Meantime, UT got approved for ILD subset of PH, and IPF
 o They had space to grow their production, so that will get up and going in 1 to 1-1/2 years (as opposed to 2-3 yrs)
   So with that addition, they will be able to handle their 2 current indications.
   For IPF, that will be 10-times bigger than the other 2
 o UT is working hand-in-hand with them to make sure that will happen-they are supporting that effort (THANK GOD)
• Pipeline
 o OFEV-Treats IPF 100k patients–by putting the drug directly into the lung, we can minimize the systemic side effects
 o Nebulized product for Systic Fibrosis – $800M/yr marketed by Roche. people used to die in their twenties, now into their forties
 o TGF beta – still early, but a high-risk reward. Patients are dieing. Our technology lowers the dose.
• So, between Tyvaso Dpi or Tyvaso nebulizer and IPF with Martine at UT and our OFEV nintedanib and 501, we have 3 shots alone for IPF, which is a huge unmet need for our patients
• We are well-funded and don’t need to raise any more money

Thanks for the great summary.  I had a hard time understanding what he was saying sometimes and was going to have to go back and listen a few more times.  I know Mike apologized for his voice at the end but a better microphone would have help too.  IDK but I think presentation is really important and dressing like John Fetterman is not a good look especially when you are an Eagle fan and Fetterman is a Steeler fan.

They have been challenged by their board to make sure that their diabetes business is Cash-flow-break-even this year.  They believe it is possible and that is their #1 mandate for this year.

I thought that was interesting as in a previous call either the last or Q3 Mike said afrezza was already breakeven which made sense now sharing factory expenses with Tyvaso DPI.  However on this call he added V-Go which I found interesting.  Lets see what happens being his #1 mandate.

International – We won’t make a lot of $, but there are 500,000,000 pwd and growing (Brazile=60M, India=80M)
I think that is what some on this board have been saying for awhile.  While its great helping people we need to set proper expectations on revenue.

The Pump switch trial sounded like a good start and I am sure Aged will be happy to hear a bigger trial is coming.  For us here as predicted afrezza would kick a.. or so it seems it did based on Mikes comments.  You don’t need to carb-count may be a bridge too far for Aged but we will see.

Our vision is to treat diabetes with one basil shot per week, plus Afrezza

Mike has said that before.  I have not figured out if thats for the T1s or T2s.  If for the T1s adding afrezza to a once weekly or once daily is pretty much the same thing.  Maybe the pump study will help jump start some sales but they should not be waiting on this to figure out how to sell to T1s.  For the T2s using once weekly basal is really interesting.  I would think that would be step 2 before the antiglycemics, before Ozempic???  What a cat fight that will be with Mounjaro.  We will have to see how that plays out but adding afrezza to the basal maybe an easier sell than adding to the antiglycemics.  I think Novo Nordisk should be funding a study with afrezza.  Maybe they reposition their GLP1 for weight loss and go after Mounjaro with icodec for T2s???  Who knows.  Here is a T2 study

www.nejm.org/doi/full/10.1056/nejmoa2022474

Nothing on Robert Ford who wants to break into the T2 market and is hoping once daily basal gets Medicare approval for his CGM while there is no need to wait when afrezza is $35 and qualifies for Medicare CGMs.  Who knows.  No mention of the TS GLP1 patent they filed for.  No afrezza/GLP1 study.  Continued super news on Tyvaso DPI which is expected but still great to hear.

[longliner]

Three positive comments for MC, from an older someone on your side;

1)  You can never (or rarely) overdress.
2)  Don't be to proud to take a public speaking class.  Toastmasters used to be a thing. (To be fair, on this count, you have improved.)
3)  Make sure going forward that YOUR IT support, confirms everything works properly, prior to you speaking. 

[lennymnkd]

Dress ; are you referring to mike wearing
A hoodie during the call . A hoodie and a coke.

[agedhippie]

Feb 1, 2023 20:04:28 GMT -5 sayhey24 said:

...

The Pump switch trial sounded like a good start and I am sure Aged will be happy to hear a bigger trial is coming.  For us here as predicted afrezza would kick a.. or so it seems it did based on Mikes comments.  You don’t need to carb-count may be a bridge too far for Aged but we will see.

...

The pump trial in itself is insignificant (5 people per arm...) but the outcome will be a guide to whether it's worth rerunning the trial properly. A full trial could potentially be expensive because of the pumps. In the current trial they are using whatever pumps people have, but not the new 780G pumps. They would need to standardize to prove that the results aren't an artifact of the pump itself. On the plus side I think they could dump the Afrezza and pump arm because in real life nobody would do that (if I have to wear a pump I am going to use the pump for everything - it's a convenience thing).

Carb counting will always matter, and Mannkind have the trial data to show how badly that goes off the rails when you ignore it (the trial they abandoned where the entire Type 1 arm had hypos).