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Post by mytakeonit on Mar 17, 2021 13:29:41 GMT -5
Did you say April  What nonsense. Guess I'll have to listen to it later on the Mannkind website. But, that's mytakeonit |
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Post by longliner on Mar 17, 2021 13:32:16 GMT -5
Mike spent a lot of time discussing Afrezza. He seems to believe they have the potion to deliver shareholder value now....we will see.
Mike also indicated that Wall Street does not believe in the message yet.
If the first of these can be proven out, and the second one convinced there should be strong upside.
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Post by sayhey24 on Mar 17, 2021 13:41:43 GMT -5
I'm finding this unlistenable. Too much echo. I didn't have so much echo (an indication that one of their mics is too close to their speaker, i.e., audio-in is too close to audio-out), but there was a lot of drop out which I attributed to my network connection. I'm going to relisten to it later since it is only about 30 minutes. I think that was the best I have heard Mike as he brought some clarity to a few things like the royalty with UTHR. Was that the 12.5%? Also, did he mention molecules being worked on for UTHR and say that they had not announced them publicly yet? Again, I'm going to go back and listen later. Yes and Yes. He also indicated that RLS kept going and forth on recreational use but is now focused on FDA drugs and TS provides that approved solution. |
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Post by longliner on Mar 17, 2021 13:49:55 GMT -5
I was unclear if the 12.5% from UTHR was for both manufacturing and sales royalties combined. Mike did indicate that 12.5% was fairly accurate.
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Post by wsulylecoug on Mar 17, 2021 13:58:39 GMT -5
There was also mention of potential/possible future business innovations with diabetes focused clinics...along the lines of Davita Dialysis. Maybe there's a model of interest in existence now...hmmmmmmmm.
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Post by longliner on Mar 17, 2021 14:07:03 GMT -5
There was also mention of potential/possible future business innovations with diabetes focused clinics...along the lines of Davita Dialysis. Maybe there's a model of interest in existence now...hmmmmmmmm. I believe Mannkind filed a trademark name for this a couple years ago. |
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Post by mytakeonit on Mar 17, 2021 14:11:07 GMT -5
Hmmm ... the Mannkind website video play back seems to lock up at 15:20. Not sure why, but I pretty much have heard most of this before.
But, that's mytakeonit
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Post by longliner on Mar 17, 2021 14:19:51 GMT -5
Hmmm ... the Mannkind website video play back seems to lock up at 15:20. Not sure why, but I pretty much have heard most of this before. But, that's mytakeonit Oh man...you should have heard what he said at 15:21!   |
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Post by wsulylecoug on Mar 17, 2021 14:48:27 GMT -5
Hmmm ... the Mannkind website video play back seems to lock up at 15:20. Not sure why, but I pretty much have heard most of this before. But, that's mytakeonit It was much of the same, other than a few tidbits like the implied confirmation of the 12.5%, RLS now FDA focused vs. recreational, future Mdex diabetes centers and the like. MC made a comment that neither UTHR or MNKD could afford a Tyvaso DPI "sneeze" which confirms to me that the weight of it's success (or not) isn't lost on him. UTHR would march on, MNKD might do a faceplant with TyPDI hiccup. By the end of April, PDUFA will be filed (one sigh of relief) and by the end of December approval granted for 38,000 potential TyDPI users (second sigh of relief). |
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Post by sla55 on Mar 17, 2021 17:17:47 GMT -5
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Post by thekid2499 on Mar 17, 2021 17:34:53 GMT -5
There was a ton of good information in this presentation. And Mike seemed very relaxed.
1. Sale leaseback is a done deal.
2. By end of April, MNKD should have almost $400 million in the coffers.
3. What will money be used for: a) immediate, reduce high yield debt, b) near term, 1) fund pediatric trial ($10 to $20 million), 2) build out manufacturing, 3) file for Afrezza approval in Europe, 4) take strategic bets on Afrezza, and 5) fund pipeline (Clopazamine, DNAse Alpha, 2 other opps).
4. It was hard to understand the royalty amount for Tyvaso DPI - the 12.5% was mentioned but hard to understand if that number includes our manufacturing cost
5. RLS - FDA route for their drugs
6. 3 to 5 other assets (Epi, Sumatripan, etc...) - deciding whether to partner now or fund through Phase 1 and then look to partner, they are are hiring people to think about these things strategically
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Post by Chris-C on Mar 17, 2021 17:46:23 GMT -5
I thought it was positive and it clarified or confirmed some things for me. My audio feed was not the best either but I think (but will not warrant) that my summary is accurate. Here are some bullets from my notes. Some have been expressed earlier in the thread. I would describe the presentation as more of a casual conversation with a few questions, and it was reassuring to see that MNKD isn't wasting cash on fancy furniture or lavish offices. Here is my Cliff Note bulleted summary:
• Mike gave a really nice description of why technosphere works better than other inhaled therapies because it has better absorption since the particles penetrate more deeply into the lungs and the delivery gets more powder past the upper airway.
• He described Afrezza as a disruptive technology that is poorly understood by some physicians who don't fully appreciate its efficacy or safety profile. He observed that MNKD has considerable unpublished safety data that needs to get into the scientific literature so physicians can see it first hand and trust the source. He acknowledged that the company itself did not understand optimal dosing at the time of approval and that this lack of understanding resulted in underdosing in trials which then yielded data that understated Afrezza's effectiveness. He believes that as CGM use grows, the benefits of Afrezza will become more widely appreciated.
• He recognizes that the market does not think Afrezza can generate revenue, but he is convinced that the company can continue moving Afrezza toward profitability with the insights and cash they now have. He did mention the potential value of alternative models of diabetes management focusing on patient education and support as another possibility (without mentioning any specific models).
• He believes that the company knows how to overcome barriers to script growth, and mentioned prior authorization requests as one example. He pointed out that physicians often fail to document that a patient was unsuccessful with basals and has uncontrolled disease as a justification for requesting Afrezza.
• Discussed Tyvaso DPI and the partnership with UTHR. Confirmed that they have discussed other potential collaborations but are focused on getting FDA approval for Tyvaso as a first priority. He emphasized that the data from the DPI Breeze study was VERY good. Confirmed royalties in the low double digits and the expectation that a sizeable portion of the $500M market would lead to royalty payments. He also discussed agreement for manufacturing Tyvaso, which he expects will be a 24/7 production line in Danbury, with product beginning to roll out in early Fall (Oct). UTHR will pay MNKD 12.5% over COGS, which will make the factory more efficient.
• Spent some time discussing having resources now to pursue European approval (ideally with a partner), and the pediatric study ($10-20M) with revenue expected in 3 years. Discussed the drugs in the pipeline, especially advancing the QRumPharma orphan drugs for CF and interstitial pulmonary fibrosis to FDA approval.
• Suggested that some higher cost debt would be reduced with cash now available.
• Discussed the partnership with Receptor Life Sciences, and confirmed that they have decided to focus their efforts on an FDA direction. Confirmed that epinephrine and migraine are still on the table as potential conditions for product advancement.
• Suggested that they are now positioned to improve awareness of technosphere and their products through targeted effective marketing- he specifically mentioned targeted digital (online) strategies.
* Confirmed that they have reached out to companies about partnering in the COVID space, and left the impression that this may be a possibility in the future, although no specifics were mentioned, of course. He emphasized that the urgency of the past year has not created a climate where companies have much time to mull over potential new partnerships.
Overall,IMO there were few new revelations, but I came away with better clarity and confirmation of my own understanding. I do credit MC with projecting more confidence and optimism than ever before. I have been critical of this, so I was pleased. He sounded like a man with plan intent on proving that he can increase shareholder value now that the company has the resources to actually move forward on pipeline products and increased sales of Afrezza. I'm adding more to my position since shares are still on sale.
GTAL
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Post by sportsrancho on Mar 17, 2021 18:47:08 GMT -5
Thanks Chris great news on all fronts. 😎👍🏻
(. He acknowledged that the company itself did not understand optimal dosing at the time of approval and that this lack of understanding resulted in underdosing in trials which then yielded data that understated Afrezza's effectiveness. He believes that as CGM use grows, the benefits of Afrezza will become more widely appreciated. )
👍🏻❣️
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Post by sportsrancho on Mar 17, 2021 18:48:39 GMT -5
Hmmm ... the Mannkind website video play back seems to lock up at 15:20. Not sure why, but I pretty much have heard most of this before. But, that's mytakeonit It was much of the same, other than a few tidbits like the implied confirmation of the 12.5%, RLS now FDA focused vs. recreational, future Mdex diabetes centers and the like. MC made a comment that neither UTHR or MNKD could afford a Tyvaso DPI "sneeze" which confirms to me that the weight of it's success (or not) isn't lost on him. UTHR would march on, MNKD might do a faceplant with TyPDI hiccup. By the end of April, PDUFA will be filed (one sigh of relief) and by the end of December approval granted for 38,000 potential TyDPI users (second sigh of relief). Thanks and I agree... April -December👍🏻 |
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Post by babaoriley on Mar 17, 2021 18:57:52 GMT -5
There was a ton of good information in this presentation. And Mike seemed very relaxed. 1. Sale leaseback is a done deal. 2. By end of April, MNKD should have almost $400 million in the coffers. 3. What will money be used for: a) immediate, reduce high yield debt, b) near term, 1) fund pediatric trial ($10 to $20 million), 2) build out manufacturing, 3) file for Afrezza approval in Europe, 4) take strategic bets on Afrezza, and 5) fund pipeline (Clopazamine, DNAse Alpha, 2 other opps). 4. It was hard to understand the royalty amount for Tyvaso DPI - the 12.5% was mentioned but hard to understand if that number includes our manufacturing cost 5. RLS - FDA route for their drugs 6. 3 to 5 other assets (Epi, Sumatripan, etc...) - deciding whether to partner now or fund through Phase 1 and then look to partner, they are are hiring people to think about these things strategically No mention of being able to fund well-deserved mid-year bonuses?? LOL |
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What nonsense. Guess I'll have to listen to it later on the Mannkind website.
