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Post by prcgorman2 on Aug 26, 2024 15:48:26 GMT -5
Tyvaso production has already had beneficial effect on COGS because expenses of personnel and facilities are now split across a much larger production base. While India might have served that purpose before Tyvaso, I wouldn't expect the impact of it to be large now since the amount of product shipped to India isn't likely to be significant when compared to the total production of Afrezza + Tyvaso. Some incremental positive contribution, but I don't think it's going to jump out in the numbers. Agree for the near term past approval (so next year I suppose). The quantity of potential users in India is huge especially if Afrezza were to be prescribed for T2. I wouldn't expect a big launch and uptake, but then again, not sure what to expect. That is why I've been calling sales of Afrezza in India a wildcard. |
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Post by cretin11 on Aug 26, 2024 16:25:58 GMT -5
Formulary coverage in US is the first, second and third most important thing. Will be interesting if at some point Mike starts talking about that as a realistic goal... perhaps a goal that management's bonuses are tied to. What a common sense concept, one that most non-exec/insider shareholders would support IMO. Too bad it’s not how things are likely to be done. |
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Post by prcgorman2 on Aug 26, 2024 17:14:00 GMT -5
Formulary coverage in US is the first, second and third most important thing. Will be interesting if at some point Mike starts talking about that as a realistic goal... perhaps a goal that management's bonuses are tied to. What a common sense concept, one that most non-exec/insider shareholders would support IMO. Too bad it’s not how things are likely to be done. I disagree coverage is the first most important thing. Coverage isn't material if prescription writers aren't writing prescriptions.
That said, there is headwind for a prescription if a drug isn't covered. Doctors and their staffs don't like Prior Authorization requests.
And when we say "coverage", I think we really mean Tier 1 coverage on an insurance provider's formulary. Lower tiers are often(?) not supported on cheaper insurance plans.
What should be the minimum markup on the unit cost of Afrezza below which a discount to a Pharmacy Branch Manager is costing MannKind more than it is recovering in improved Tier 1 coverage and sales volume? I suspect there is a lot more to the story than simple discounts to PBMs that I don't know.
I'm not against improvements in insurance coverage being a goal tied to management bonuses, but I can't easily gauge what such a performance metric should look like (and doubt whether details of the bonus structure would be made public regardless).
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Post by letitride on Aug 26, 2024 17:19:38 GMT -5
With inhale-1 and Inhale-3 both providing readouts before year end Afrezza may be a a sleeper that no one is counting on. Given the response at the ADA I'm expecting a nice bump in sales thru the 3rd and 4th Qtrs. India would have been welcome yesterday, but will still be appreciated by year end. And then I would like to see just what special project Mr Binder may have worked up on his transition to the Board.
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Post by ktim on Aug 26, 2024 17:26:21 GMT -5
Personally I don't think there is a lot of reason to believe there is a near term path to dramatically better formulary coverage. If something occurs to change that perception, that I think many have, it could be a real catalyst for share price.
It's probably unlikely to be part of management's goals, and we want know one way or the other.
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Post by ktim on Aug 26, 2024 17:29:04 GMT -5
With inhale-1 and Inhale-3 both providing readouts before year end Afrezza may be a a sleeper that no one is counting on. Given the response at the ADA I'm expecting a nice bump in sales thru the 3rd and 4th Qtrs. India would have been welcome yesterday, but will still be appreciated by year end. And then I would like to see just what special project Mr Binder may have worked up on his transition to the Board. Isn't everyone counting on those studies to complete and yet again show Afrezza's speed of action and efficacy in reducing post prandial spikes? |
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Post by cretin11 on Aug 26, 2024 17:45:01 GMT -5
I thought that was the idea.
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Post by agedhippie on Sept 6, 2024 8:17:32 GMT -5
Mike's list from the Wells Fargo call:
Pediatrics readout,
Chronic (?) talks,
Phase 1 Clofazimine,
Inhale 3 30 week data
That was in response to the analysts question on what's coming in Q4.
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Post by Clement on Sept 6, 2024 10:51:07 GMT -5
^ chronic toxicity (nintedanib)
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Post by cppoly on Sept 6, 2024 11:03:11 GMT -5
I think one of these catalysts will be completed this month.
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Post by agedhippie on Sept 6, 2024 12:23:57 GMT -5
^ chronic toxicity (nintedanib)  That's speech to text for you! |
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Post by casualinvestor on Sept 8, 2024 11:40:14 GMT -5
Mike's list from the Wells Fargo call: Pediatrics readout, Chronic (?) talks, Phase 1 Clofazimine, Inhale 3 30 week data That was in response to the analysts question on what's coming in Q4. Phase 3 Clofazimine? |
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Post by prcgorman2 on Sept 8, 2024 14:43:35 GMT -5
Yup, Phase 1 is nintedanib DPI. Phase 2/3 is clofazimine (nebulized).
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Post by cppoly on Oct 2, 2024 10:32:29 GMT -5
Per the Q2 presentation, here's the upcoming milestones in 2024: 1) INHALE-1 top line data readout 2) INHALE-3 30 week readout 3) MNKD-201 (Nintedanib) phase 1 data readout and chronic tox results 4) MNKD-101 (Clofazamine) ICoN-1 trial expansion into international sites Which has the most impact to share price? We can cross Inhale 3 off the list... Hopefully the others have a little bit more market improvement. |
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Post by prcgorman2 on Oct 2, 2024 12:10:32 GMT -5
Per the Q2 presentation, here's the upcoming milestones in 2024: 1) INHALE-1 top line data readout 2) INHALE-3 30 week readout 3) MNKD-201 (Nintedanib) phase 1 data readout and chronic tox results 4) MNKD-101 (Clofazamine) ICoN-1 trial expansion into international sites Which has the most impact to share price? We can cross Inhale 3 off the list... Hopefully the others have a little bit more market improvement. You bring up an important point. You asked "Which as the most impact to share price?" but didn't say over what timeframe. If the question is with respect to immediate and lasting impact, yup, INHALE-3 is now off the list. I'm not sure if any of those milestones will have an immediate and lasting impact. They may all have lasting impacts. The milestone I'm hopeful investors are most interested in and excited about is the MNKD-201 nintedanib DPI phase 1 readout and chronic toxicity results later this quarter. |
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That's speech to text for you!