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Post by mango on May 17, 2023 7:35:19 GMT -5
Old Timeline
MannKind 2023 - 2024 Milestones & Catalysts
🥭 Medicare Part D $35 Co-Pay Coverage for Afrezza 1Q 2023
🥭 Inhale 3 clinical trial Afrezza + Basal + CGM initiation 1H 2023
🥭 Afrezza India Phase 3 clinical trial readout late 1H 2023 for T2D
🥭 BlueHale VIS full launch 2H 2023
🥭 Clofazimine Phase 2/3 clinical trial initiation 2H 2023
🥭 Afrezza Pediatrics Phase 3 clinical trial readout 1H 2024 (includes 3 superiority endpoints)
🥭 Inhale 3 Afrezza Switch trial readout 1H 2024
🥭 MNKD 201 Nintedanib for IPF Phase 1 clinical trial initiation 1H 2024
🥭 MNKD 301 & 501 IND submissions 2H 2024
🥭 Possible VGo platform expansion (biosimilars, buy and bill, clinical improvement with slow infusion)
🥭 At EOY 2022 MannKind had $173 Million in cash
🥭 MannKind has 4 revenue streams: Afrezza, VGo, Tyvaso DPI & Tyvaso DPI manufacturing reimbursements
New Notes from 5/16/23
Clofazimine will be huge. It will be the second only FDA approved treatment for this rare lung disease and it will be a revolutionary medical advancement for these patients (notice the trend here?) We already have a partner for Japan (not named).
Macrophages take the drug deep into the tissue.
We have a dry powder version of Clofazimine. No mention if/when this will be utilized in conjunction with or instead of nebulizer.
MannKind has reduced and de-risked the side effect profile commonly associated with Clofazimine.
TGFbeta possible clinical trial initiation as early as next year—goal is to make this a Phase 1/3 trial, a single clinical trial for approval. High risk, high reward asset.
If any 3 or 4 of the pipeline assets are successful there will be some really RICH shareholders—Mike’s words (paraphrasing).
Diabetes franchise WILL be cash flow break even by the end of this year.
Mike mentioned the India trial. He mentioned 1.5-2% reduction but did not say that was the outcome. He said IF it shows those numbers. Data is coming out soon. Mike probably already knows the data. I think it may be foreshadowing. Could be huge.
Mike is challenging pumps with the Pump switch trial. Large clinical trial. Could be huge.
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Post by dh4mizzou on May 17, 2023 7:43:32 GMT -5
Mango posted "Mike mentioned the India trial. He mentioned 1.5-2% reduction but did not say that was the outcome. He said IF it shows those numbers. Data is coming out soon. Mike probably already knows the data. I think it may be foreshadowing. Could be huge."
I have yet to see a clear answer on whether this 1.5 to 2% reduction is a true percentage drop, which doesn't move the needle for me, or if it's a drop in the actual A1C.
A percentage drop would manifest itself as follows:
Starting with an A1C of 8 a 2% drop would result in an A1C of 7.84 which seems minimal.
An actual 2 point drop in A1C would manifest itself as follows:
Starting with an A1C of 8 a 2 point drop would result in an A1C of 6 which would be a 25% drop which should open a few eyes.
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Post by Clement on May 17, 2023 7:54:09 GMT -5
Mango posted "Mike mentioned the India trial. He mentioned 1.5-2% reduction but did not say that was the outcome. He said IF it shows those numbers. Data is coming out soon. Mike probably already knows the data. I think it may be foreshadowing. Could be huge." I have yet to see a clear answer on whether this 1.5 to 2% reduction is a true percentage drop, which doesn't move the needle for me, or if it's a drop in the actual A1C. A percentage drop would manifest itself as follows: Starting with an A1C of 8 a 2% drop would result in an A1C of 7.84 which seems minimal. An actual 2 point drop in A1C would manifest itself as follows: Starting with an A1C of 8 a 2 point drop would result in an A1C of 6 which would be a 25% drop which should open a few eyes. "The A1C test result is reported as a percentage." www.niddk.nih.gov/health-information/diagnostic-tests/a1c-test#:~:text=The%20A1C%20test%20measures%20the,blood%20glucose%20levels%20have%20been. So, using the example of a 2% drop, we are talking about a drop of A1C from 8 to 6 (ie, from 8% to 6%). |
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Post by mango on May 17, 2023 8:10:36 GMT -5
Mango posted "Mike mentioned the India trial. He mentioned 1.5-2% reduction but did not say that was the outcome. He said IF it shows those numbers. Data is coming out soon. Mike probably already knows the data. I think it may be foreshadowing. Could be huge." I have yet to see a clear answer on whether this 1.5 to 2% reduction is a true percentage drop, which doesn't move the needle for me, or if it's a drop in the actual A1C. A percentage drop would manifest itself as follows: Starting with an A1C of 8 a 2% drop would result in an A1C of 7.84 which seems minimal. An actual 2 point drop in A1C would manifest itself as follows: Starting with an A1C of 8 a 2 point drop would result in an A1C of 6 which would be a 25% drop which should open a few eyes. A1C is a percentage. When we say someone has an A1C of 8 it is actually 8%. So a drop of 1.5%-2% would mean it dropped from 8% to 6.5%-6%. This would be significant results and would need to be updated in the ADA’s SoC. |
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Post by cedafuntennis on May 17, 2023 8:54:24 GMT -5
I think dh4 still makes a very good point. It merits clarification if it's a 1.5% drop in the actual number or in the A1C. It is left wide open to interpretation to me too, regardless of what the A1C definition is.
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Post by cjm18 on May 17, 2023 9:02:18 GMT -5
It’s absolute %. 7.0 to 6.0 is 1.0 improvement.
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Post by phdedieu12 on May 17, 2023 10:01:43 GMT -5
I think dh4 still makes a very good point. It merits clarification if it's a 1.5% drop in the actual number or in the A1C. It is left wide open to interpretation to me too, regardless of what the A1C definition is. I got confirmation, 2% drop would be from 8 to 6% (as an example) |
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Post by mango on May 17, 2023 10:20:26 GMT -5
A few more quick notes:
The Peds trial also has superiority endpoints in the Secondary Outcomes. Chance to show superiority. This could be HUGE.
No Tyvaso DPI supply constraints. Next 4 weeks they will be ready to start meeting UT’s desire for 2 years worth of inventory.
Extremely low drop out rate due to side effects for Afrezza. We’ve known this it’s the safest insulin on the market.
MannKind and UT continue to explore a SECOND molecule.
UT has been a PHENOMENAL partner so far. Great partnership.
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Post by anderson on May 17, 2023 10:35:02 GMT -5
I remember reading decades ago that one of the biggest challenges that faced Steve Jobs and Apple in the early days was the disasterous possibility of demand far outstripping supply. This is even prior to the iPhone. Mike’s comments in the last earnings call regarding expansion of production capabilities for Tyvaso DPI and the “up to 5 years” for bringing another full-scale Danbury-equivalent production facility on-line actually has me concerned. We all want the hockey stick of sales for Afrezza. What is the plan if that actually came to fruition in the next 3 years? New production is coming online this year and next to meet all the PAH demand and help build the 2 year reserve that UT likes to keep. So it sounds like MNKD will be producing at full capacity to build reserves just for that eventuality. MNKD will have the ability to serve 25k patients when at full capacity, so if UT somehow doubles patients each year that is 2 years worth of growth. I believe UT does not project the patient base to grow that fast which will give them time to build inventory for the next indication and about the time they should run into supply chain issues their factory should be up and running. |
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Post by mango on May 17, 2023 10:38:35 GMT -5
Guys, I’ve never been more bullish on MannKind. These past two calls have been phenomenal and MannKind has pivoted itself for great, great things to come. Good things are in the works, just need to be patient. Lots of moving parts in play, things will happen quick.  |
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Post by akemp3000 on May 17, 2023 10:40:57 GMT -5
Mannkind is on such a good path to success with multiple opportunities. Not all need to be successful but it's certainly possible. Hard to believe there's still over 30M shares shorted. The day will come soon enough where these will either exit or get crushed, most likely the prior. That day can't come soon enough!
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Post by prcgorman2 on May 17, 2023 10:54:04 GMT -5
The pipeline eggs have been laid (boy have they) and 2 have hatched of which 1 is thriving with the other threatening to thrive, and a 3rd still in the incubator with more beside it. Production of Tyvaso DPI helps offset (subsidizes?) Afrezza, and demand for more production seems likely. If you have to build another Danbury, separate from the UTHR facility (or lease capacity in the UTHR facility), how much does that cost???
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Post by wiscdh on May 17, 2023 10:54:22 GMT -5
Is there an expiration date on Tyvaso DPI? Just wondering since UTHR goal is to have 2 years worth of inventory.
Thanks.
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Post by prcgorman2 on May 17, 2023 11:30:40 GMT -5
Is there an expiration date on Tyvaso DPI? Just wondering since UTHR goal is to have 2 years worth of inventory. Thanks. You can probably safely assume UTHR took expiration in to consideration when they stated a goal of 2 years worth of inventory. |
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Post by mango on May 17, 2023 11:45:03 GMT -5
Is there an expiration date on Tyvaso DPI? Just wondering since UTHR goal is to have 2 years worth of inventory. Thanks. 18 months from the date of manufacture. |
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