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Post by agedhippie on Sept 22, 2023 22:32:09 GMT -5
When did he say that? At what minute mark? event.webcasts.com/starthere.jsp?ei=1631061&tp_key=eb7eb46fd3&language=en-usWhat Mike has said in the past is lets see what the kids trial, inhale 3 and the pump switch trial results are and then we will make some decisions. What he did say at MS was the Cipla results are in and he did not sound sad. He also said GLP1s in the long run just delay needing insulin so why not replace the hormone they are missing and that GLP1s can not do that. You can take it to the bank that MNKD will do the trial adding afrezza to the GLP1 once we get some trial results in 2024 which is not that far off now. As he said at MS he is not interested in over spending but he is also not interested in hurting future growth by under-spending. He does not want to hurt the pipeline funding but he also does not want to hurt future growth and if the other trial results are great the glp1/afrezza trial is a lay-up. If it were me I would also be calling Albert Bourla and trying to spend some of his money testing Danuglipron on TS. For Al the money is round-off and for Mike he would not have me complaining anymore and it would not cost him anything. I have no idea what minute mark he says things nor do intend to hunt for it - read the transcript instead. He is done with trials for Afrezza beyond what has already been announced and the focus is switching to the pipeline drugs. It's by the 10x section. And I think that's really where we are now as we feel the cash flow positivity, the investments we've made in diabetes will start to come off the P&L next year in terms of the research studies and then clofazimine will kick in and then the nintedanib kicks in.
Obviously we differ on the GLP-1 trails next year. That's just fantasy, and he doesn't mention it as a possibility anywhere. As to Pfizer; they are selling a pill, not an inhaled drug. If MNKD wants to develop a GLP-1 analog then they are going to have to fund it themselves because there is no science to support the idea that it will work.
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Post by agedhippie on Sept 22, 2023 9:10:10 GMT -5
Speaking of being objective I’m perplexed why some are obsessed with this idea that the Morgan Stanley investor conference was all about MS taking a hard look at MNKD and initiating coverage. As agedhippie points out, hundreds of potential investments and investors at the conference. Why should we assume a lack of coverage by MS would be a failure? Does MS cover all of the potential investments that come to their conferences? Is there some other indications in the historical record that points to Morgan Stanley coverage if you’re invited to their conference? Is there some indication that coverage by Morgan Stanley automatically increases your share price and that your fortunes are assured? If we get MS coverage, outstanding, if we don’t, what is the downside? Is the SP going to crash? Is the work of MannKind to improve their outlook with studies and pipeline and manufacturing improvements at risk without MS coverage? Sorry if I interrupted the pity party. As you were. A lack of coverage by Morgan Stanley is not a failure. Likewise presenting at the conference is not an indication of Morgan Stanley's favor. You get to these conferences by asking if you can present and they then stack rank you to decide if they will accept your application. While being covered by Morgan Stanley may be a minor consideration it's not going to get you a place regardless of merit. Morgan Stanley coverage is a red herring at this point. No institutional investor is going to buy on an MS recommendation for a company the size of MNKD. The expectation is that for companies companies with this sort of market cap the best you are going to get is a green analyst and why would you rely on them? The reason recommendations impact the big companies is because the analysts for those companies are seen as more competent. Now, that's not to say that the quality of the analysis pans out like that, but it's what the market believes. There are things like giving an earnings forecast, and diversifying the revenue streams that would have far more tangible impact on the share price and analyst coverage than MS adding MNKD to some junior analyst's mountain of stocks that they cover.
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Post by agedhippie on Sept 18, 2023 8:26:46 GMT -5
All this afrezza talk is off topic for this thread. But I can't resist jumping in. Some of you sound delusional. MC has said things that indicate that he has given up on pursuing afrezza for T2D. If the CEO of the company is not on board it is not going to happen. No thread stays on topic beyond the first page
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Post by agedhippie on Sept 18, 2023 8:20:21 GMT -5
I continue to believe that selling Afrezza is not a marketing problem. Persons With Diabetes (PWDs) do not choose which medications are prescribed to them: their doctor’s do. The doctors are taught what to prescribe. What changes that is labor, time, and money. I am guessing that everyone at MannKind is suffering Afrezza fatigue, and unendingly grateful to be manufacturing and selling Tyvaso DPI, a drug which is outpacing original sales estimates. They want more wins under their belt, and orphan lung diseases are a sweet spot given the size and maturity of MannKind. Will Afrezza ever reach the status so many of us assumed was assured? Perhaps, but additional investment has to be success-based where “success” can be a mix of trial results and correspondingly improved sales results. That’s business. I think there are two different markets, the Type 1 market which is often far more opinionated (my doctor will defer to me if I press) and the Type 2 market where the SoC is far more rigidly followed. This is largely the result of Type 1 being handled by specialists, endos, and Type 2 being seen as less serious and handled by PCPs. This is not a knock on PCPs but rather the result of being able to focus on one topic rather than the whole gamut of medicine. In that case having a standard of care makes perfect sense since it piggybacks on the work done by the endos. That was an incredibly long winded way of saying some PWD do get to chose their medication! I think Afrezza will continue to steadily climb at the current rate. There will be a step up when it becomes available to kids as they get onboarded and then it will continue to the current rate. The Type 2 market will be left as it is. Reading the transcript Mike's take on this is that MNKD need the infrastructure for the expansion so Afrezza effectively becomes a marginal cost; And so, I think when you look out there part of people say, why do you still have Afrezza? Well, part of it is you need a marketing team, you need a sales operations team, you need data integration teams, IT. We have all that infrastructure now. So while one could say, I can get rid of some of those expenses at the end of the day, if we're going to be launching two, three, four products, we need all that backbone infrastructure.
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Post by agedhippie on Sept 17, 2023 18:17:43 GMT -5
Hmmmmm - "The trials Afrezza needs are those to change the label, and also prove superiority against GLP-1 for Type 2. The current approach from Mike at the conference is that they will align on the Type 1 market for Afrezza, and the Type 2 market for V-Go so combined with the switch in funding focus that's not going to happen." I think we need more than just the label. I think we need T1 and T2 SoC changes. What I thought I heard Mike say was lets see the results from the 3 trials and then leverage those to focus future activity. It seems the kids trial is going better than expected but we will see. For the India trial Mike mentioned that he was expecting to see a 1.5 to 2.0 A1c drop. If he is right then that should put afrezza on par with GLP1s. I am not sure we need GLP1 superiority. I think what we need is the study showing afrezza as an adder to GLP1s. As Mike said the GLP1s are good for 2 years and then they need the afrezza. I think its really going to come down to the sales strategy Mike wants to take in the T2 market. Its pretty clear V-Go is a no go and with $35 Medicare afrezza and the India results I would be shocked if Mike does not to change his T2 strategy. At this point its patience. Mike wants the other trial results before making additional trial moves. OK. I would do the GLP1/afrezza study but if Mike can 10X the pps in 2 years between Tyvaso DPI, afrezza and the pipeline I will be patient. Don't take my word for it, as always read the transcript. Here is Mikes take on it; TLDR; We have done what we can with Afrezza, now we are focusing on the orphan lung market. How does he see the diabetes market? And bear in mind he knows what the India results look like. But V-Go itself has been a great device. We've positioned that for type 2, so I talked about Afrezza for type 1. We think that's going to be differentiating, and the GLPs aren't really going to majorly impact that...
and The type 2 market, most patients are still going to be basal bolus. V-Go has 90 plus percentage of its use in type 2. The majority of that is probably Medicare, maybe 60%, 70%. And that's where we really position our V-Go device.
So Type 2 = V-Go, Type 1 = Afrezza. But what is his vision for Mannkind? Not get Afrezza to a broader market, mine those veins of Afrezza gold, but; And so we really did pivot in 2019 to say, we are going to be fully focused on orphan lung, leverage our technology, help those patients
and And we really pivoted the whole company to focus on orphan lung with kind of diabetes optionality and Tyvaso DPI got approved last year.
(For context this was answering the question I asked - where do you see the future?) His view on Afrezza is that they have done what they can and that they won't discontinue it (he can't, he has his reputation to think), but And I think that's really where we are now as we feel the cash flow positivity, the investments we've made in diabetes will start to come off the P&L next year in terms of the research studies and then clofazimine will kick in and then the nintedanib kicks in.
Not saying they will expand the insulin label, or start any new trials beyond those announced. Rather there will be a switch to the pipeline. None of this is to say that what he is doing is wrong as he is incapable of selling Afrezza so taking a swing at a different target, "fully focused on orphan lung", makes sense for the company. However, it does mean you can forget about GLP-1 because every time he mentioned it he ran it down.
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Post by agedhippie on Sept 17, 2023 10:39:15 GMT -5
UTHR exclusivity duration will be known when Yutrepia is actually on the market. As for Afrezza those other trials are currently being run. Better late than never! The duration of the exclusivity for PH-ILD is known; it was granted in March 2021 and expires in March 2024 (I thought it was a 1 year grant from 2023, but it was 3 years from 2021) regardless of whether or not anyone enters the market. The trials Afrezza needs are those to change the label, and also prove superiority against GLP-1 for Type 2. The current approach from Mike at the conference is that they will align on the Type 1 market for Afrezza, and the Type 2 market for V-Go so combined with the switch in funding focus that's not going to happen.
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Post by agedhippie on Sept 16, 2023 17:59:32 GMT -5
Do people understand exactly how large this conference is? There are seven tracks, three days, 200+ companies. You apply to present and then they stack rank and slot you. In Mannkind's case got the 8:10am slot on the lower level (it could have been worse, there is a 7:30am slot).
The time slot is a bit of a killer, but being out of the mainstream (UTHR got a midday slot in one of the 2nd floor ballrooms) is not necessarily bad. There are investors there fishing for up and coming companies and those less favored rooms are where they go. This is about exposure and that works in this case as anyone who was there really wanted to be there.
Will Morgan Stanley initiate coverage? Probably at some point, coverage is not as big deal as people think when you are Mannkind's size. Most of the companies in Mannkind's track are covered by Morgan Stanley and their share price doesn't really react to downgrades or upgrades. Professional investors care far more about who the analyst is than who the financial is - a good analyst at Wainwright has more influence than a poor analyst at Morgan Stanley.
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Post by agedhippie on Sept 16, 2023 17:07:58 GMT -5
It's a shame, but at least we now know. Thanks for reporting that, Aged. I haven't tuned into the MS conference yet. If you can get a copy it's better to read the transcripts and then listen to just the bits that interest you. The transcripts are typically machine generated and not perfect (I am pretty certain that the Alvin that got mentioned was Al Mann...)
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Post by agedhippie on Sept 16, 2023 11:40:23 GMT -5
I think we can safely put GLP-1 on TS to bed at this point. At the MS conference Mike said they were not going to do any more trials with Afrezza beyond those already announced and instead concentrate the funding on getting the two pipeline candidates to market.
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Post by agedhippie on Sept 16, 2023 11:36:37 GMT -5
I remember when Tyvaso DPI was an idea that could not be sold to. Tyvasso DPI is being sold and is being sold while doing more extended trials for more indications.😎 I feel like LQDA is slipstreaming behind UTHR in those trials. The PH-ILD trial is a good example; UTHR does the trial and LQDA argues equivalence and gets FDA approval for PH-ILD. UTHR gets a period of exclusivity (a year I think) so they get a lead in the market though (in the case of PH-ILD that exclusivity expires in March or May 2024). UTHR provide the perfect example of what to do when you get the basic approval - run other trials expanding the label which is what was never done with Afrezza.
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Post by agedhippie on Sept 15, 2023 22:31:51 GMT -5
Tyvaso DPI VS Yutrepia Everyone knows what Tyvaso DPI is Yutrepia not so much. Ask me again when they actually have more than an idea to sell. What are you looking for? They have completed all the regulatory trials, FDA granted tentative approval, and a 24 month extension trial (if nothing else the lawsuits allowed for extended trials ) so they have all the material for the medical world, and they have presented their finding at the 2023 American Thoracic Society. Yutrepia definitely exists and would be on sale now except for the UTHR lawsuits!
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Post by agedhippie on Sept 15, 2023 15:48:27 GMT -5
Don't shoot me, but less api required probably means less money for mnkd. Or more cost for Liquidia to get the same medicinal effect. I think that's unlikely. They have already said they will price competitively (it would be suicide to do otherwise). This is the same mistake people made about Afrezza with the argument that Afrezza needs more insulin than RAA (it's a lot more if you look back to the early days before the reindexed the units) but overlooks the point that the active ingredient is a very small part of the cost. In other words Afrezza can afford to be wildly inefficient with insulin compared to injectables because the incremental cost is minimal. The same is true of trepostinil, the key for both Afrezza and Yutrepia is whether you can get therapeutic dosing with the delivery system and the answer in both cases is yes.
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Post by agedhippie on Sept 15, 2023 15:24:22 GMT -5
Anyone knows why LQDA is nose diving on high volume today?? A lot of 6.50 options? The question is whether it stays down on Monday, if so maybe something leaked although it's hard to see what right now.
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Post by agedhippie on Sept 15, 2023 15:20:28 GMT -5
Anyone knows why LQDA is nose diving on high volume today?? Could it possibly be the start of the dump following the pump Stock manipulation? Surely not.
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Post by agedhippie on Sept 12, 2023 8:37:53 GMT -5
... Morgan Stanley currently has well over 15,000 Financial Representatives who cover client assets totaling Trillions of dollars. What will happen when even a small amount of the in house financial representatives begin purchasing shares of MNKD for their accounts ? ... That doesn't happen. It's an SEC violation, there has to be a hard separation of risk (rating) and investment banking (sales). No investment bank will do this because the SEC will land on them like a ton of bricks. (The SEC felt that analysts were changing ratings to drive sales - basically insider trading) I will go out on a limb here and say that MS is not going to open a recommendation for MNKD. What I think is more likely is that RBC, who is a heavyweight that already covers MNKD, will upgrade MNKD to a buy from a hold. That would have a positive effect in itself.
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