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Post by mango on May 17, 2022 11:55:17 GMT -5
I believe a major FDA label revision could be in the works following a successful Tyvaso DPI approval.
🥭 Tyvaso DPI approval THIS MONTH
🥭 > $100 Million in annual royalties for Tyvaso DPI
🥭 New acquisition of V-GOinsulin patch pump for T2D
🥭 Over 10,000 patients will now be on MannKind branded products
🥭 Immediate new revenue stream with V-GO
🥭 MannKind also acquired 16 top V-GO sales representatives
🥭 3 ongoing Afrezza clinical trials—Pediatrics Phase 3, International clinical trial in India with Cipla, and the ABC Phase 4 clinical trial Afrezza pump switch trial
🥭 4 revenue streams being establish this coming quarter: Afrezza, Tyvaso DPI sales, Tyvaso DPI manufacturing, and V-GO
🥭 No bronchospasm has been observed in COPD patients and thus the Black Box Warning does not support the evidence—foreshadowing that a major FDA label change is in the works?
🥭 Technosphere is validated with numerous preclinical, clinical and placebo studies from Afrezza to Tyvaso. Only 5 people with uncontrolled asthma demonstrated bronchospasm. Technosphere has been scientifically established as safe and biologically inert. No indications of bronchospasm in over 25,000 patients.
🥭 Tyvaso DPI will have a clean label according to the scientific data
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Post by sayhey24 on May 17, 2022 12:28:39 GMT -5
It seems like a way for MannKind to offer a product that complements traditional RAA injected insulin while Afrezza still competes with RAA insulin. The salesforce would still position Afrezza as the optimal mealtime insulin due to inhalation, ultra rapid acting, etc. But for doctors and patients who still prefer RAA....we can now help with that too! It is not like MannKind purchased an RAA insulin that competes with Afrezza. The company purchased a delivery device that improves experience and outcomes for patients using RAA. MannKind now has an offer for doctors and patients that prefer RAA over Afrezza while they work on educating the same doctors and patients on the benefits of Afrezza to increase adoption. Perhaps not the easiest balance to strike, but doesn't seem like the hardest either. It opens the addressable market of patients tremendously and helps the company stay in front of all doctors. MannKind can not let the new product / solution reduce the company's focus on Afrezza education, promotion and sales. If the company does not...it seems genius to me. Thoughts? What market are they going after? Its only approved for T2s. How big is that market? Why afrezza is competing against RAA's in the T2 market is a headscratcher to me. Thats the very last step in the SoC and there is no money there. IMO few should even know afrezza is insulin. This V-Go device is principally for basal use, not prandial control. The RAA is used in the pump for basal purposes. You can push the button and manually give 2u at a time at mealtime but it is principally a basal tool. By the time T2s are currently prescribed a basal they are in bad shape. Harry posted a good example yesterday of a guy using VDex service. The afrezza goal in the T2 market needs to be "Stopping the Progression" early in the diagnosis before the GLP1s, the Sglt2s before the other stuff and before the basal insulin. If nothing else before the V-Go would be prescribed. V-Go as currently approved is IMO a misfit for MNKD. Repurposing for the T1s with afrezza might have some merit. |
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Post by sayhey24 on May 17, 2022 12:39:35 GMT -5
Mango - help me out here. I saw it was an asset acquisition but did we really pick up the 16 sales guys? What are we going to do with them?
Every V-Go sold today is a money loser. Its like the old "I Love Lucy" where she was making beer and losing on every bottle sold. She was going to make it up in volume??? Mike can never sell enough in the T2 basal market to get the volume.
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Post by tarheelblue004 on May 17, 2022 12:54:57 GMT -5
It seems like a way for MannKind to offer a product that complements traditional RAA injected insulin while Afrezza still competes with RAA insulin. The salesforce would still position Afrezza as the optimal mealtime insulin due to inhalation, ultra rapid acting, etc. But for doctors and patients who still prefer RAA....we can now help with that too! It is not like MannKind purchased an RAA insulin that competes with Afrezza. The company purchased a delivery device that improves experience and outcomes for patients using RAA. MannKind now has an offer for doctors and patients that prefer RAA over Afrezza while they work on educating the same doctors and patients on the benefits of Afrezza to increase adoption. Perhaps not the easiest balance to strike, but doesn't seem like the hardest either. It opens the addressable market of patients tremendously and helps the company stay in front of all doctors. MannKind can not let the new product / solution reduce the company's focus on Afrezza education, promotion and sales. If the company does not...it seems genius to me. Thoughts? What market are they going after? Its only approved for T2s. How big is that market? Why afrezza is competing against RAA's in the T2 market is a headscratcher to me. Thats the very last step in the SoC and there is no money there. IMO few should even know afrezza is insulin. This V-Go device is principally for basal use, not prandial control. The RAA is used in the pump for basal purposes. You can push the button and manually give 2u at a time at mealtime but it is principally a basal tool. By the time T2s are currently prescribed a basal they are in bad shape. Harry posted a good example yesterday of a guy using VDex service. The afrezza goal in the T2 market needs to be "Stopping the Progression" early in the diagnosis before the GLP1s, the Sglt2s before the other stuff and before the basal insulin. If nothing else before the V-Go would be prescribed. V-Go as currently approved is IMO a misfit for MNKD. Repurposing for the T1s with afrezza might have some merit. Thanks for the thoughts Sayhey! Great point that the best position of V-Go is for basal use, where it is complementary to Afrezza and not a competitor. I am not sure what you are saying in talking about the % of T2s that should know Afrezza exists - the fact is that as the disease worsens, some are put on prandial control and therefore there is a market for Afrezza (and V-Go). The T2 market is much bigger than T1, so even if a small % of T2 require insulin, it could still be a meaningful amount. Of course, knowing that % (which I do not) is important to make any point here. Even if the goal of Afrezza is to stop the progression early in the diagnosis, the current SOC isn't there and won't be for a long time. I know you have strong thoughts on the SOC  but I think it would take a long time to change prescriber habits to where they are prescribing Afrezza so early in the course of treatment. In the meantime, T2s will progress and could get value from V-Go and potentially Afrezza - to your point, at a worse stage of their condition. |
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Post by sayhey24 on May 17, 2022 13:26:41 GMT -5
Blue - you ask - I am not sure what you are saying in talking about the % of T2s that should know Afrezza exists - the fact is that as the disease worsens, some are put on prandial control and therefore there is a market for Afrezza
I said - Why afrezza is competing against RAA's in the T2 market is a headscratcher to me. Thats the very last step in the SoC and there is no money there. IMO few should even know afrezza is insulin
The reason I said that is afrezza should not be competing against the RAAs. They should be competing against the GLP1s which are step 2. That is a $15B market. The T2 RAA is very small. A proper trial with proper afrezza dosing and afrezza would crush GLP1 A1c control. It would totally crush TIR. Even the T2 Affinity-2 trial which got afrezza approved was not against any insulin RAA or basal. If doctors are prescribing afrezza to replace RAA use in the T2 the sales guys have failed. Marketing has failed. Sending sales guys with the message to use instead of an RAA is a complete waste of resources. They need to be saying "afrezza first, afrezza always" - which I think is Bill's line from VDex.
Doing a head-to-head trial against Mounjaro is very simple and can be done pretty quickly. The last time I heard Mike talk about the T2 market he said it was on hold. Why? I think he was not sure how to attack it. V-Go is not helping attack the GLP1s.
What I also say is afrezza from Day 1 has been mismarketed. Few should even know its insulin. Everyone views insulin as dangerous and requires needles. When you tell most T2s to go on insulin they think the end is near. The afrezza dosing should not be in units - its should be a simple small medium and large. MNKD needs to put the word insulin in microfont on the box and label. Call it super glucose powder, anything but insulin.
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Post by mango on May 17, 2022 13:39:33 GMT -5
Mango - help me out here. I saw it was an asset acquisition but did we really pick up the 16 sales guys? What are we going to do with them? Every V-Go sold today is a money loser. Its like the old "I Love Lucy" where she was making beer and losing on every bottle sold. She was going to make it up in volume??? Mike can never sell enough in the T2 basal market to get the volume. Mike mentioned in today’s call retaining 16 of the top V-Go sales representatives and how they are going to be the primary sales force at the beginning before rolling it over into the Afrezza force (from what I understood). It’s a great product with great clinical data backing it up. We will make our money back plus generate a new revenue stream in the first year. Let’s see what MannKind has in store. |
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Post by agedhippie on May 17, 2022 18:02:06 GMT -5
Mango - help me out here. I saw it was an asset acquisition but did we really pick up the 16 sales guys? What are we going to do with them? Every V-Go sold today is a money loser. Its like the old "I Love Lucy" where she was making beer and losing on every bottle sold. She was going to make it up in volume??? Mike can never sell enough in the T2 basal market to get the volume. Mike mentioned in today’s call retaining 16 of the top V-Go sales representatives and how they are going to be the primary sales force at the beginning before rolling it over into the Afrezza force (from what I understood). It’s a great product with great clinical data backing it up. We will make our money back plus generate a new revenue stream in the first year. Let’s see what MannKind has in store. As a product it sucks. Why anyone would use it other than Tresiba is beyond me - have a pump stuck to me all day (pump is daily and single use), vs. a single shot. The only benefit would be that you had RAA with you all the time for meals, but presumably people should be using Afrezza for that. It generates a positive gross profit of around $15M from what I can piece together. That is before SGA. There is a reason Valeritas went bust trying to sell this... On the other hand if Mannkind can reduce the SGA bill (and they should be able to) this could well be cash-flow positive. Strategically I don't see the alignment though, and I think it will shed market share to the weekly basals and non-insulin drugs. |
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Post by pbaumgarten on May 17, 2022 18:05:08 GMT -5
🥭 No bronchospasm has been observed in COPD patients and thus the Black Box Warning does not support the evidence—foreshadowing that a major FDA label change is in the works? I thought COPD patients were excluded from taking afrezza by the "black label." Are there any documented COPD patients taking the drug? |
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Post by awesomo on May 17, 2022 18:15:17 GMT -5
Mike mentioned in today’s call retaining 16 of the top V-Go sales representatives and how they are going to be the primary sales force at the beginning before rolling it over into the Afrezza force (from what I understood). It’s a great product with great clinical data backing it up. We will make our money back plus generate a new revenue stream in the first year. Let’s see what MannKind has in store. As a product it sucks. Why anyone would use it other than Tresiba is beyond me - have a pump stuck to me all day (pump is daily and single use), vs. a single shot. The only benefit would be that you had RAA with you all the time for meals, but presumably people should be using Afrezza for that. It generates a positive gross profit of around $15M from what I can piece together. That is before SGA. There is a reason Valeritas went bust trying to sell this... On the other hand if Mannkind can reduce the SGA bill (and they should be able to) this could well be cash-flow positive. Strategically I don't see the alignment though, and I think it will shed market share to the weekly basals and non-insulin drugs. My calculations have it as a gross profit of $10M. It is also important that Zealand spent $44.4M on sales and marketing in 2020. So to automatically think this will be profitable is a big mistake. 2020 V-Go Revenue: 161.3M DKK 2020 Cost of Goods Sold: 90.57M DKK Gross Profit: 70.73M DKK = $10M |
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Post by sayhey24 on May 17, 2022 19:52:59 GMT -5
Mike mentioned in today’s call retaining 16 of the top V-Go sales representatives and how they are going to be the primary sales force at the beginning before rolling it over into the Afrezza force (from what I understood). It’s a great product with great clinical data backing it up. We will make our money back plus generate a new revenue stream in the first year. Let’s see what MannKind has in store. As a product it sucks. Why anyone would use it other than Tresiba is beyond me - have a pump stuck to me all day (pump is daily and single use), vs. a single shot. The only benefit would be that you had RAA with you all the time for meals, but presumably people should be using Afrezza for that. It generates a positive gross profit of around $15M from what I can piece together. That is before SGA. There is a reason Valeritas went bust trying to sell this... On the other hand if Mannkind can reduce the SGA bill (and they should be able to) this could well be cash-flow positive. Strategically I don't see the alignment though, and I think it will shed market share to the weekly basals and non-insulin drugs. From listening to the "talk" which is still available Mike's words left me with the impression at best they might break even but it sounded like it was not making money. To me its a waste of resources but worse, its the wrong focus. Afrezza to the T2 market should not be sold as an insulin product. As Bill from VDex has said "afrezza first, afrezza always". It should be positioned as a GLP1 replacement. Its not injected, it does not have a PK profile of other insulins and its not dangerous like the other insulins with T2s. Its a mealtime treatment which controls the post prandial glucose spike like nothing else. GLP1s can not do what afrezza does. It also does not have all the downside side issues of the GLP1s which seems to be a growing list. Picking up 15 sales reps who are selling a pump and don't understand the potential of afrezza are not what we need. If fact we don't need many sales guys until we complete a reputable trial against Mounjaro and crush Mounjaro's A1c control. Until then we need maybe 10 total reps hitting the T2 market focused on large corporate GPs with "Seeing is Believing" demonstrations trying to get them to be early adopters of the future SoC where afrezza is step 2. |
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Post by peppy on May 17, 2022 20:10:28 GMT -5
🥭 No bronchospasm has been observed in COPD patients and thus the Black Box Warning does not support the evidence—foreshadowing that a major FDA label change is in the works? I thought COPD patients were excluded from taking afrezza by the "black label." Are there any documented COPD patients taking the drug? COPD patients in the UTHR trials had no bronchospasms. Initially the letter from the FDA for Trept/ Tyvaso DPI had no black box warning. Then the FDA letter regarding the citizen's concern, sayhay pointed out has to do with the black box warning.... as big Pharma sees an advantage to keep the black box warning. It is a dirty game. The winner makes more revenue and earnings per share. It has nothing to do with health outcomes, it is a money game. Catch and kill is a surreptitious technique. |
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but I think it would take a long time to change prescriber habits to where they are prescribing Afrezza so early in the course of treatment. In the meantime, T2s will progress and could get value from V-Go and potentially Afrezza - to your point, at a worse stage of their condition.
