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Post by longliner on Mar 30, 2023 14:00:54 GMT -5
Anyone else see the Mannkind patent dated 3/30/23? In highlights section (0011) if refers to lung transplant. Now who in the world would grow lungs for transplant?
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Post by prcgorman2 on Mar 30, 2023 14:02:16 GMT -5
Anyone see Mannkind's patent dated 3/30/23? In highlights section 0011 if refers to lung transplant. Now who in the world would grow lungs for transplant? I assume you're joking, but if not, check out UTHR. They have pig farms (or did) for just such an adventure. I believe Dr. Rothblatt refers to using "scaffolding" for growing organs.
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Post by longliner on Mar 30, 2023 14:05:07 GMT -5
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Post by sayhey24 on Mar 30, 2023 14:13:03 GMT -5
RLS has also been dropped. MC finally admitted that we won't see any money from RLS. I don't remember his exact words. I though MC meant no money any time soon. Seems like they are trying to clean up the filler they use to have on the slides and use only meaningful content so as not to have distractions. I think it is a good move to clean this up. Why have a lot of stuff that they dont directly control on MNKD's pipeline(MNKD does control the production of Tyvaso-DPI so it belong on the pipeline page, Fosun and RLS really don't). You will notice that RLS is still on partners page where they belong. mannkindcorp.com/partnering/ . Fosun is not, but that was not a partnership but a selling of an asset with a royalty component. So I can see why that isn't on the webpage as well. RLS seems a couple years away from approval - they are in a Phase1b/2a for acute anxiety and submitted an NDA with the FDA for epileptic seizure. Both using RLS103 - aka Technosphere Pot. Hope springs eternal with both RLS and afrezza. IMO, it would have been a better investment for MNKD providing the $10M in funding RLS got last April than buying V-Go but we will see. www.receptorlife.com/
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Post by mango on Mar 31, 2023 5:53:04 GMT -5
MannKind 2023 - 2024 Milestones and Catalysts
🥭 Medicare Part D $35 Co-Pay Coverage for Afrezza 1Q 2023
🥭 Inhale 3 clinical trial Afrezza + Basal + CGM initiation (pump switch trial) 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 primary 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)
🥭 A second molecule can be initiated between MannKind and United Therapeutics partnership
🥭 At EOY 2022 MannKind had $173 Million in cash
🥭 MannKind has 4 revenue streams: Afrezza, VGo, Tyvaso DPI and Tyvaso DPI manufacturing reimbursements
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Post by mango on Mar 31, 2023 14:29:59 GMT -5
I think it’ll be interesting to see what they will do with VGo in terms of expansion beyond insulin. In the recent slides Mike has biosimilars, buy and bill and clinical improvement with slow infusion.
Mike was Vice President, Global Commercial Lead, Biosimilar Business at Amgen for over 3 years so he has knowledge of biosimilar markets, etc.
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Post by cppoly on Apr 7, 2023 8:31:15 GMT -5
Can someone help with how quarterly earnings work.
Q4 2022 was reported 2/23/2023.
Does MNKD Q1 2023 end on 3/31/2023 or another date? Then this won't be reported several months later?
Are we lagging 2 months behind?
Thanks
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Post by akemp3000 on Apr 7, 2023 8:42:12 GMT -5
Quarterly earnings are not reported the month after close but typically around the second week of the following month. Q1 ended March 31 and therefore should be reported somewhere around May 10th. Q4 which is also year-end or annual reporting typical lags about two weeks further back probably because of all the accounting work required. Hope this helps.
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Post by cppoly on Apr 7, 2023 8:50:54 GMT -5
Interesting thank you. So something that stands out to me in MNKD's case is that they are potentially experiencing very significant growth in Tyvaso DPI scripts. So if on May 10th they are reporting Q1 results that ended on March 31st, then there's several weeks of better data with DPI scripts that aren't reported?
Is MNKD allowed to talk about these unreported numbers or they can only stick to exactly what happened in Q1?
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Post by prcgorman2 on Apr 7, 2023 10:44:16 GMT -5
Mike has explained before that they don’t report Tyvaso DPI sales because those are tracked and reported by United Thereapeutics which is who markets and sells Tyvaso DPI.
What MannKind tracks and reports is the royalties and manufacturing revenue from Tyvaso DPI. The royalties “fall straight to the bottom line”. I agree with akemp3000 and assume MNKD will provide a readout on 1st quarter financial performance sometime around middle of May.
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Post by cppoly on Apr 7, 2023 11:15:55 GMT -5
Yes thank you for clarifying royalties but these results would still be several weeks behind so we don't get to see the significant growth that we are seeing in the script numbers uptick right? In other words, I'm trying to say we see more growth rate now compared to six weeks in the past.
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Post by prcgorman2 on Apr 7, 2023 11:46:29 GMT -5
We may not ever see any more script numbers for Tyvaso DPI. UTHR doesn't share them, and the numbers reported by Symphony were a fraction of the total and even that has stopped as of a couple of weeks ago. Instead of 52 inaccurate data points per year to track, we'll now get 4 accurate data points from UTHR whenever they release their earnings, but it won't include Rx counts, only revenue information. Note that the revenue UTHR gets and the money that MNKD gets as a result is not a clear 1:1 linear relationship because of inventory purchases versus Rx sales, and there is MNKD deferred revenue which is being recognized over an extended period of time as an accounting choice (but I forget the reason)s.
The bottom-line hasn't changed, we'll learn what MNKD earned when they report it.
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Post by cretin11 on Apr 7, 2023 13:44:26 GMT -5
cppoly, the answer to your initial question is yes. But it doesn’t mean it’ll happen, of course.
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Post by akemp3000 on Apr 7, 2023 16:55:46 GMT -5
cppoly, I agree with cretin the answer is yes and that it doesn't mean it'll happen. I also agree with your perspective in that it's likely it will happen. Best for all of us to wait and see. If we see a nice pop in the pps a week or two before the next earnings report, it very well could foreshadow that true insiders are seeing what you describe. Let's hope!
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Post by Clement on Apr 9, 2023 6:35:26 GMT -5
May 5, 2022 was the date of the Mannkind earnings call for Q1 last year.
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