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Post by sportsrancho on Oct 2, 2018 16:33:37 GMT -5
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Post by Clement on Oct 2, 2018 16:36:18 GMT -5
Thanks, C26!! I especially liked the part about "Recapitalization is now complete." Also, after explaining financial aspects of the UTHR deal, Mike said, at time 17:40,
"We are now in control of our own destiny."
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Post by mnholdem on Oct 2, 2018 16:58:52 GMT -5
A few quick takeaways from Mike’s presentation after listening to it. 1. Mannkind is working with a third party to get Afrezza classified as " ultra-acting" (i.e., its own class); 2. Mannkind will receive another $30 million milestone (plus low double digits royalties) on the second drug they are currently partnering with UT; 3. For Tre-T, Mannkind will receive $25 million milestone in 2019 and another $25 million milestone in 2020. 4. Tre-T’s target market is the whole market (inhale, oral and IV) and potentially “ best in class”. 5. Recapitalization is now complete. There will be no major debt due in the next 36 months. 6. Mannkind has prioritized another four drug candidates that will be further developed in the next 12-18 months. Mike also mentioned something about a (drug) launch every one or two years as a goal towards the end of the presentation. 7. One-drop trial results will be available “ shortly”. 8. Since Mannkind signed contracts with two major PBMs in 2018, they are now working to get local coverage and remove prior-authorizations with respect to these PBMs. 9. For Afrezza, there has been consistent growth since Mannkind launch (Jan. 2017) in numbers of writers (600 to 1100), market share (among Afrezza writers from 3.2% to 4.2%) and cartridge units. 10. Note that, since Mannkind has partnered with UT for two Technosphere drug candidates, in the slide listing the five year growth drivers for the company, Mannkind has added Technosphere Platform as the foundation of the growth drivers. It appears the trial results of Tre-T were really a boost of confidence to Mannkind in their belief of the Technosphere Platform’s potential. Mike referred to the reveal of the trial results as a “flip of the cards” (and the cards turn out to be very favorable).  Your #1 takeaway was mine also. Management told shareholders that the FDA wanted industry input on new classifications of insulin. Michael Castagna's remark gives me great confidence that CMO David Kendall is working with the ADA/AACE to designate that new classification. IMO, this is the first mention of MannKind's strategy in this regard. If successful, a great many obstacles to adoption and sales growth will be removed or circumvented. |
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Post by buyitonsale on Oct 2, 2018 17:31:20 GMT -5
Money we know of in addition to Afrezza US revenue: Received from UT - 10M UT upfront - 45M in 2 weeks Warrants conversion - 33M within 6 months (if you think if will not happen you are not realistic) UT milestone - 25M within 12 months UT Milestone - 25M within 24 months 138M + Afrezza US net sales of 80M minimum for next 24 months = 2+ year runway The goal is to increase Afrezza world net sales to 100M a year within next 24 months. Thanks for the breakdown buyitonsale, those numbers look promising. About the warrants conversion, is my understanding correct that the share price needs to be above a certain level (is it around $2.30, i can't recall) for that to happen? And you're saying someone is NOT being realistic by thinking that won't happen? We're around $1.70 now, so you're basically saying it's a sure thing to be up over 30% within six months. I'm just trying to make sure I understand your assertion. And while i'd quibble with such a confident expectation for that short a time period (if i'm understanding you), i sure as heck hope you're right. Warrants can be exercised at 2.38 between October 11 and April 10 window. There were posts that questioned the possibility of share price staying above 2.38 within that window. I believe that with several catalysts being anticipated (e.g Brazil approval) and with the overall financial outlook changing for the better, the share price will move much higher. |
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Post by lakers on Oct 2, 2018 17:52:02 GMT -5
The cat was out regarding Tobra-T as I had mentioned a few times. Ex-Novartis VP, MC said: Yes, there's two areas in particular. So one is lung diseases I’ll say cystic fibrosis, idiopathic pulmonary fibrosis are two ideal ones I look at. In particular if you look at Tobramycin, there is [indiscernible] from Novartis. We think that's a great opportunity in that market to deliver something more effective to the lungs.The other area I look at is respiratory, there is a lot of inhalers that really just haven't been reinvented. So I think as we forget about the old drugs work really well, but sometimes you don’t always get enough drugs. So when we think about a lot of the inhalers that are out there, we think there is opportunity in the respiratory space. Respiratory is the one that I wouldn't go alone, but you could see an exclusive partnership with someone that's in the respiratory space that want the device powder portfolio that we could do a lot of work for. seekingalpha.com/article/4209479-mannkind-corporation-mnkd-ceo-michael-castagna-cantor-fitzgerald-global-healthcare-conferenceChiesi USA or Dr. Reddy could partner w/ Mnkd Trobramycin was first approved to treat these infection in 1997 under the brand name TOBI by Novartis, and in 2002 as Bethkis by Chiesi USA.
Dr. Reddy acquired Tobramycin Inhalation Solution (generic equivalent to Tobi™) from Teva. in 2016.
Aug. 31, 2018, Mylan closed an agreement with Novartis to purchase the worldwide rights to commercialize their global cystic fibrosis products consisting of TOBI Podhaler® and TOBI® solution, which will further enhance Mylan’s respiratory portfolio in the U.S., Europe and certain Rest of World markets.
Mylan entered into the agreement on July 30, 2018, for approximately $463 million and the company expects to pay approximately $240 million in 2018. Read more: mnkd.proboards.com/thread/10427/next-potential-apps?page=5#ixzz5Sol4q1LbLike all aminoglycosides, tobramycin does not pass the gastro-intestinal tract, so for systemic use it can only be given intravenously or intramuscularly. Ophthalmic (tobramycin only, Tobrex, or combined with dexamethasone, sold as TobraDex) and nebulised formulations both have low systemic absorption. The formulation for injection is branded Nebcin.
The nebulised formulation (brand name Tobi) is indicated in the treatment of exacerbations of chronic infection with Pseudomonas aeruginosa in patients diagnosed with cystic fibrosis. A proprietary formulation of micronized, nebulized tobramycin has been tested as a treatment for bacterial sinusitis.Tobrex is a 0.3% tobramycin sterile ophthalmic solution is produced by Bausch & Lomb Pharmaceuticals. Benzalkonium chloride 0.01% is added as a preservative. It is available by prescription only in the United States and Canada. In certain countries, it is available over the counter. Tobrex and TobraDex are indicated in the treatment of superficial infections of the eye, such as bacterial conjunctivitis. Tobramycin (injection) is also indicated for various severe or life-threatening gram-negative infections: meningitis in neonates, brucellosis, pelvic inflammatory disease, Yersinia pestis infection (plague). Tobramycin is preferred over gentamicin for Pseudomonas aeruginosa pneumonia due to better lung penetration.Read more: mnkd.proboards.com/thread/10427/next-potential-apps?page=5#ixzz5SolhOy9g |
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Post by seanismorris on Oct 2, 2018 17:54:08 GMT -5
I thought the following was the most interesting.
We also have the Cannabinoid class [ph], so this is a hot space today. But we were in it three years ago before anybody else even really thought about this with a partner called Receptor Life Sciences. And so this is something that people somewhat forgot about the company has been working along the line behind the scenes, they've taken powders, they've formulated them, and we know we can take the tree sap of the leaves and make them into dry powder inhalations that work in fly beautifully.
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Post by churchmouse on Oct 2, 2018 17:57:35 GMT -5
Amgen is a leading respiratory Pharma. Imagine the possibilities.
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Post by cjm18 on Oct 2, 2018 18:08:36 GMT -5
A few quick takeaways from Mike’s presentation after listening to it. 1. Mannkind is working with a third party to get Afrezza classified as " ultra-acting" (i.e., its own class); 2. Mannkind will receive another $30 million milestone (plus low double digits royalties) on the second drug they are currently partnering with UT; 3. For Tre-T, Mannkind will receive $25 million milestone in 2019 and another $25 million milestone in 2020. 4. Tre-T’s target market is the whole market (inhale, oral and IV) and potentially “ best in class”. 5. Recapitalization is now complete. There will be no major debt due in the next 36 months. 6. Mannkind has prioritized another four drug candidates that will be further developed in the next 12-18 months. Mike also mentioned something about a (drug) launch every one or two years as a goal towards the end of the presentation. 7. One-drop trial results will be available “ shortly”. 8. Since Mannkind signed contracts with two major PBMs in 2018, they are now working to get local coverage and remove prior-authorizations with respect to these PBMs. 9. For Afrezza, there has been consistent growth since Mannkind launch (Jan. 2017) in numbers of writers (600 to 1100), market share (among Afrezza writers from 3.2% to 4.2%) and cartridge units. 10. Note that, since Mannkind has partnered with UT for two Technosphere drug candidates, in the slide listing the five year growth drivers for the company, Mannkind has added Technosphere Platform as the foundation of the growth drivers. It appears the trial results of Tre-T were really a boost of confidence to Mannkind in their belief of the Technosphere Platform’s potential. Mike referred to the reveal of the trial results as a “flip of the cards” (and the cards turn out to be very favorable). Your #1 takeaway was mine also. Management told shareholders that the FDA wanted industry input on new classifications of insulin. Michael Castagna's remark gives me great confidence that CMO David Kendall is working with the ADA/AACE to designate that new classification. IMO, this is the first mention of MannKind's strategy in this regard. If successful, a great many obstacles to adoption and sales growth will be removed or circumvented. Dr K once alluded to a small trial to gain an ultra fast designation. Maybe at the stat trial presentation. |
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Post by agedhippie on Oct 2, 2018 18:14:12 GMT -5
Your #1 takeaway was mine also. Management told shareholders that the FDA wanted industry input on new classifications of insulin. Michael Castagna's remark gives me great confidence that CMO David Kendall is working with the ADA/AACE to designate that new classification. IMO, this is the first mention of MannKind's strategy in this regard. If successful, a great many obstacles to adoption and sales growth will be removed or circumvented. Dr K once alluded to a small trial to gain an ultra fast designation. I think it is likely that Mannkind is working with Novo Nordisk to create the ultra-rapid class. They would like to get Fiasp classified as ultra rapid to make it easier to switch people from Novolog before the biosimilars turn up in force. I suspect Lilly might delay to give their Fiasp competitor to get closer to launch, but would ultimately support a new class for the same reasons. |
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Post by lakers on Oct 2, 2018 18:38:36 GMT -5
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Post by tomtabb on Oct 2, 2018 18:43:05 GMT -5
I thought the following was the most interesting. We also have the Cannabinoid class [ph], so this is a hot space today. But we were in it three years ago before anybody else even really thought about this with a partner called Receptor Life Sciences. And so this is something that people somewhat forgot about the company has been working along the line behind the scenes, they've taken powders, they've formulated them, and we know we can take the tree sap of the leaves and make them into dry powder inhalations that work in fly beautifully. Somewhere -- I think this forum -- I read RLS lost their name in a trademark dispute with some other company. Have they gotten a new one? |
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Post by peppy on Oct 2, 2018 19:21:08 GMT -5
A few quick takeaways from Mike’s presentation after listening to it. 1. Mannkind is working with a third party to get Afrezza classified as " ultra-acting" (i.e., its own class); 2. Mannkind will receive another $30 million milestone (plus low double digits royalties) on the second drug they are currently partnering with UT; 3. For Tre-T, Mannkind will receive $25 million milestone in 2019 and another $25 million milestone in 2020. 4. Tre-T’s target market is the whole market (inhale, oral and IV) and potentially “ best in class”. 5. Recapitalization is now complete. There will be no major debt due in the next 36 months. 6. Mannkind has prioritized another four drug candidates that will be further developed in the next 12-18 months. Mike also mentioned something about a (drug) launch every one or two years as a goal towards the end of the presentation. 7. One-drop trial results will be available “ shortly”. 8. Since Mannkind signed contracts with two major PBMs in 2018, they are now working to get local coverage and remove prior-authorizations with respect to these PBMs. 9. For Afrezza, there has been consistent growth since Mannkind launch (Jan. 2017) in numbers of writers (600 to 1100), market share (among Afrezza writers from 3.2% to 4.2%) and cartridge units. 10. Note that, since Mannkind has partnered with UT for two Technosphere drug candidates, in the slide listing the five year growth drivers for the company, Mannkind has added Technosphere Platform as the foundation of the growth drivers. It appears the trial results of Tre-T were really a boost of confidence to Mannkind in their belief of the Technosphere Platform’s potential. Mike referred to the reveal of the trial results as a “flip of the cards” (and the cards turn out to be very favorable). Yippee the ultra acting. 6. Mannkind has prioritized another four drug candidates that will be further developed in the next 12-18 months. Mike also mentioned something about a (drug) launch every one or two years as a goal towards the end of the presentation. one of these probably the undisclosed compound?  |
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Post by sayhey24 on Oct 2, 2018 19:21:47 GMT -5
I thought the following was the most interesting. We also have the Cannabinoid class [ph], so this is a hot space today. But we were in it three years ago before anybody else even really thought about this with a partner called Receptor Life Sciences. And so this is something that people somewhat forgot about the company has been working along the line behind the scenes, they've taken powders, they've formulated them, and we know we can take the tree sap of the leaves and make them into dry powder inhalations that work in fly beautifully.
I thought this was HUGE news. If just one of the RLS developments is announced in the next 3 months, no one needs to worry about the $2.38 warrants being exercise.
When Matt P first talked about RLS he talked about both medical and recreational products. I think there may even be a slide around mentioning this. How big would it be if the RLS recreational product was sold in a place like Starbucks? You can't get more mainstream than that. Just saying, $100pps or am I just delusional?
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Post by ryster505 on Oct 2, 2018 19:32:49 GMT -5
I thought the following was the most interesting. We also have the Cannabinoid class [ph], so this is a hot space today. But we were in it three years ago before anybody else even really thought about this with a partner called Receptor Life Sciences. And so this is something that people somewhat forgot about the company has been working along the line behind the scenes, they've taken powders, they've formulated them, and we know we can take the tree sap of the leaves and make them into dry powder inhalations that work in fly beautifully.
I thought this was HUGE news. If just one of the RLS developments is announced in the next 3 months, no one needs to worry about the $2.38 warrants being exercise.
When Matt P first talked about RLS he talked about both medical and recreational products. I think there may even be a slide around mentioning this. How big would it be if the RLS recreational product was sold in a place like Starbucks? You can't get more mainstream than that. Just saying, $100pps or am I just delusional?
Delusional....But I like it  |
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Post by letitride on Oct 2, 2018 19:56:35 GMT -5
Great presentation by Mike. But even better is he had plenty to present and it was all good!
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