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Post by Clement on Aug 7, 2024 15:32:35 GMT -5
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Post by prcgorman2 on Aug 7, 2024 19:49:24 GMT -5
It would be nice if Mike clarified which of the patent expirations MannKind is tracking to. Some expire as soon as 2026.
Another site shows "composition of matter" expires in 2026 and from my earlier reading of the NIH document, that may be the one Mike is focused on.
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Post by Clement on Aug 7, 2024 21:19:40 GMT -5
It would be nice if Mike clarified which of the patent expirations MannKind is tracking to. Some expire as soon as 2026.
Another site shows "composition of matter" expires in 2026 and from my earlier reading of the NIH document, that may be the one Mike is focused on.
Are you talking about the one expiring January 8, 2026? That's not very far in the future and it would fit with Mike's quote "and hopefully that would get us to market right around when OFEV patent would expire". |
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Post by slapshot on Aug 8, 2024 6:05:17 GMT -5
It would be nice if Mike clarified which of the patent expirations MannKind is tracking to. Some expire as soon as 2026.
Another site shows "composition of matter" expires in 2026 and from my earlier reading of the NIH document, that may be the one Mike is focused on.
Are you talking about the one expiring January 8, 2026? That's not very far in the future and it would fit with Mike's quote "and hopefully that would get us to market right around when OFEV patent would expire". It looks like the composition of matter patent, expiring 4/1/2026 is the main patent to worry about. The Mannkind technosphere formulation and/or possibly specific treatment would likely get around the others. Note that other generics (competition), such as those in a viscous lipid suspension formulation would still be blocked by patent until 12/2029. |
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Post by prcgorman2 on Aug 8, 2024 10:43:05 GMT -5
Are you talking about the one expiring January 8, 2026? That's not very far in the future and it would fit with Mike's quote "and hopefully that would get us to market right around when OFEV patent would expire". It looks like the composition of matter patent, expiring 4/1/2026 is the main patent to worry about. The Mannkind technosphere formulation and/or possibly specific treatment would likely get around the others. Note that other generics (competition), such as those in a viscous lipid suspension formulation would still be blocked by patent until 12/2029. Glad you said that. I'm hopeful you have knowledge of BP patent stuff because I don't and I was hoping for some affirmation.
Funny how less than 2 years feels like "soon". It seems very fast in BP years. Almost like tomorrow or next week. |
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Post by casualinvestor on Aug 8, 2024 10:48:29 GMT -5
It would be nice if Mike clarified which of the patent expirations MannKind is tracking to. Some expire as soon as 2026.
Another site shows "composition of matter" expires in 2026 and from my earlier reading of the NIH document, that may be the one Mike is focused on.
Reading through those (fun!), I think the latest relevant date comes from this, assuming SSC-ILD is close enough to PH-ILD? Otherwise it's 4/1/2026 for composition of matter The 2029 patent expirations are on capsule and suspension if I'm reading it right. Their not-yet-approved patents look to be heading in the direction of combo drug formulations. I don't think MNKD is going to be able to hit that 9/6/2026 date, but they could get close. |
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Post by Clement on Aug 8, 2024 11:03:20 GMT -5
^ How does PH-ILD come into play here?
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Post by casualinvestor on Aug 8, 2024 11:19:23 GMT -5
I'm just stuck on Tyvaso. You're right, I don't know how the MNKD-201 phase 2/3 trial will be laid out or for what indications. I assume it's going to overlap OFEV, as it's the same drug but different delivery. So 9/6/2026 sounds like the right date.
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Post by factspls88 on Aug 8, 2024 11:20:11 GMT -5
Listened to a replay of the conference call last night and every single analyst on the call congratulated Mike on a great quarter. In since Al Mann was alive and still hanging on for the long haul. I added when the stock went down to $.96 and now have a nice gain. Still a believer.
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Post by ktim on Aug 8, 2024 11:56:51 GMT -5
On MNKD-201, going back to my touchstone slide for expectations when management presented roadmap of revenue out to 2032, it shows Clofazimine and then it shows "Pipeline" which would logically mean the rest of the pipeline, with MNKD-201 being next up. Based on that it would seem management expects revenue to kick in 2028 at modest level and then meaningful 2029.
Obviously when clinical trials and FDA are involved, timelines can shift, though in general probably much more likely to be delayed. Perhaps those projections were conservative on the timelines.
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Post by sayhey24 on Aug 8, 2024 18:16:25 GMT -5
Numbers are all good. Everything is increasing at a decent pace. Afrezza Revenue growth continues. Chris Prentice is a decent speaker. Tyvaso royalties increased 34% YoY from 19M to 26M. That was good, and Collaboration & Services is a spectacular 132% increase from 11M in 2Q23 to 26M in 2Q24 (thank you again, Martine). Afrezza grew 20% from 14 to 16M. V-go shrank from 5 to 4M (down 7%). Sayhey will be happy to hear that MNKD is moving their focus from V-go to Afrezza. So, net revenue of Endocrine Business Unit increased 13% from 18 to 21M. Total Revenues increased 49% from 2Q23 to 2Q24, and 55% for YTD 23 to 24 (89M to 139M). 2Q24 net loss of $2M ($.01) - 1 cent loss per share in 2Q24 was due to early repayment of Mann Group Convertible note and Midcap senior secured note, which they completed in April and recorded as an accounting charge of $7M recorded as a loss on establishment of debt. $37M debt was repaid. $72M (+49%) 2Q Total Net Rev vs. 2Q23. YTD revenue is $139M (+55%) YTD vs. 2023 YTD. First, I think we should thank Martine for continuing to pay the bills. I am not sure Mike did. If not I will. On V-Go, what can I say which I have not already. The good news is we are now moving on from V-Go and selling off the inventory. Here are my three take aways from the presentation. 1. "Finally, we will have proper data readouts, proper label updates, and now we have a capital and talent to continue to scale this business. We will wait for the data readouts. We are conducting some independent market research so we can update you in the coming quarters on what our plans are and what to do with the data readouts, as well as the additional indication what that will mean for shareholders." 2. "we're conducting additional research and insights to have some confidence before we make any big decisions here" 3. "hopefully awesome news on international expansion as we go forward Afrezza and continue to drive growth and help more patients" Hopefully when Mike said "independent market research" he meant he is reading Proboards. MNKD needs to do two things asap; the afrezza/glp1 adder trial; and putting Saxenda on Technosphere. There it is. The "awesome news on international expansion" is very exciting. Maybe we will get to hear about Inhale-2 and what Cipla plans. Who knows maybe something even more exciting like a partner for EU approval. There was little mention of the gestation trial which was a little surprising. It was on the slide. |
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Post by ktim on Aug 8, 2024 18:24:59 GMT -5
Hopefully when Mike said "independent market research" he meant he is reading Proboards. MNKD needs to do two things asap; the afrezza/glp1 adder trial; and putting Saxenda on Technosphere. There it is.  I sure hope not!!! That emoji is a huge understatement to the laugh I had. Sometimes I think I don't appreciate your humor enough  |
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Post by sayhey24 on Aug 9, 2024 7:04:40 GMT -5
Hopefully when Mike said "independent market research" he meant he is reading Proboards. MNKD needs to do two things asap; the afrezza/glp1 adder trial; and putting Saxenda on Technosphere. There it is. I sure hope not!!! That emoji is a huge understatement to the laugh I had. Sometimes I think I don't appreciate your humor enough I am glad I can make you laugh. I just don't want to cry again like the last time when Mike hired a marketing firm and we spent $6m on the "Seeing is Believing" campaign. Did you see it? Mike wants to wait for the data readouts. What we do know is afrezza is not a mystery and is highly predictable. It seems to be shocking to some but human insulin works and afrezza mimics pancreatic release. As a result results are highly predictable. What the data readouts will tell us is did the PWDs properly dose. Inhale-3 For those that dosed as directed their results will be superior. For those that were non-compliant their results will be about the same as their current treatment. Lets see if they follow Mango's advice on reporting results. Inhale-1 The kids results will be outstanding as the moms coached and the kids dosed. For a few kids afrezza may not be the best fit but for most it was superior. Gestational This will show superiority as long as the future moms dose properly. OK - there is the data readout. Next up the marketing results; T2 market $50M. Afrezza as a GLP1 adder should take 10%. GLP1 weight loss market with oral solutions $100M+. As a maintenance solution Saxenda DPI should take 5%. That should save Mike $2M in consulting fees, maybe more. |
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Post by Clement on Aug 9, 2024 7:24:53 GMT -5
from the EC, upcoming data readouts in Q4 this year:
-- 30-week readout INHALE-3 (17-week data were presented at ADA)
-- nintedanib Phase 1 readout
-- INHALE-1 (Peds) readout of top-line data
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Post by prcgorman2 on Aug 9, 2024 7:45:38 GMT -5
^^^. Nice summary. sayhey24 - I don’t like to dwell on cost and insurance, but those are still important hurdles. I don’t know how much Afrezza costs to make, so I don’t know how much product would have to sell to be able to drop the price close to cost and make up the difference in volume, but I hope it’s low enough for Afrezza to be sold at a low premium to RAA (less than twice as much?). I don’t know what the sweet spot is there or how to reach it (maybe pilot pricing in regions?) but I think its critical. |
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