|
|
Post by robsacher on Dec 8, 2015 21:05:51 GMT -5
Here's how I see it:
First, Afrezza is the best mealtime insulin available for both T1 and T2 diabetics. Early adopter results are proving this point.
It is not currently selling because Sanofi has other priorities which need to be addressed before Afrezza can be properly mass marketed. Those priorities are connected to educating health care professionals in regard to how Afrezza works and for which patients it would be best suited, developing and continuing Afrezza studies which may ultimately help redefine the Afrezza label, and gaining tier 2 preferred status for Afrezza in private health insurance plans. This process could take some years before we see success and Sanofi is only several months into the start of this process.
Second, we may now be inside of a constructed scenario which is designed to make it look like MannKind is going out of business. However, MannKind's owner is a billionaire and his demonstrated commitment to his company which bears his name has been previously well demonstrated. Now, I see it as my turn to show and demonstrate my commitment to the company. That's why as the share price falls, I add more shares to my position. I plan on continuing to do so as long as the share price is falling.
Third, MannKind will likely find another company with another drug with whom they will partner for Technosphere development. That news could come in weeks or months.
Fourth, there is a huge Afrezza market for T2 diabetics who have delayed starting injection insulin therapy because they do not want to needle themselves four or five times everyday. I have written a number of articles about subdivisions of this market: senior citizens whose doctors allow the elderly to linger with unhealthy A1C levels because of problems associated with having the elderly inject themselves, significant populations of needle phobic and needle averse diabetics who will use Afrezza when they learn of it and if their doctors are willing to prescribe it, and a worldwide population of diabetics, including over 110 million diabetic Chinese, who will use Afrezza if it is affordable and available.
By the way, Chinese diabetics are not poor. Diabetes, in China, is a disease of the wealthy sedentary single child families of the last twenty or thirty years who can afford the high caloric/carbohydrate Western diet (KFC/Dunkin' Donuts).
Fifth, I am now prepared to follow this scenario through to whatever ending it may lead. I firmly and unequivocally believe this will end in success even if it takes several years.
RS
|
|
|
|
Post by sccrbrg on Dec 8, 2015 21:27:35 GMT -5
That's all well and good but...
If it takes years for MNKD and SNY to clean up the label and get tier 2 status - which is effectively the only major hinderance to better advertising and sales - the script count will continue to be anemic for those years. Seeing that MNKD is already cash poor, that's not a good situation for us to be in as investors.
Alfred Mann may indeed step in and save the day for the company - but at what cost to us? Even if he could afford to throw another billion dollars at it, that would be enough to wipe out our equity almost 2 times over. Unless he issues them some sort of non-dilutive loan, which would come with its own issues.
A TS partnership is going to do nothing for us in the immediate future. After seeing what we were willing to accept from SNY for a drug that MNKD holistically developed on its own, and knowing our current financial position, AND seeing the nightmare roll out that TS has had with SNY, we are almost certainly going to receive offers with crap terms. As I said in a different post, our only hope for a decent TS deal is some smaller pharma being desperately afraid of losing a cash producing brand name to generics after patent expiration and has no other alternatives.
Again, where is this huge market and why aren't they showing in the script numbers? They are waiting for better insurance coverage and for SNY to START the process of global launch. If that's going to be years down the road - retail is still S.O.L.
MNKD may very well become a multi-billion dollar enterprise, but at this point I'm becoming extremely concerned about what is going to happen to current stakeholders to get it there. 2 years is a lot of dilution, potential take overs, and privatization threats away.
A lot of people on this board have fallen in love with the company and fail to see that just because the company will "inevitably"* survive, it does not mean the same for their investment - in many cases the two are mutually exclusive.
|
|
|
|
Post by james on Dec 8, 2015 21:33:13 GMT -5
Here's how I see it: First, Afrezza is the best mealtime insulin available for both T1 and T2 diabetics. Early adopter results are proving this point. It is not currently selling because Sanofi has other priorities which need to be addressed before Afrezza can be properly mass marketed. Those priorities are connected to educating health care professionals in regard to how Afrezza works and for which patients it would be best suited, developing and continuing Afrezza studies which may ultimately help redefine the Afrezza label, and gaining tier 2 preferred status for Afrezza in private health insurance plans. This process could take some years before we see success and Sanofi is only several months into the start of this process. Second, we may now be inside of a constructed scenario which is designed to make it look like MannKind is going out of business. However, MannKind's owner is a billionaire and his demonstrated commitment to his company which bears his name has been previously well demonstrated. Now, I see it as my turn to show and demonstrate my commitment to the company. That's why as the share price falls, I add more shares to my position. I plan on continuing to do so as long as the share price is falling. Third, MannKind will likely find another company with another drug with whom they will partner for Technosphere development. That news could come in weeks or months. Fourth, there is a huge Afrezza market for T2 diabetics who have delayed starting injection insulin therapy because they do not want to needle themselves four or five times everyday. I have written a number of articles about subdivisions of this market: senior citizens whose doctors allow the elderly to linger with unhealthy A1C levels because of problems associated with having the elderly inject themselves, significant populations of needle phobic and needle averse diabetics who will use Afrezza when they learn of it and if their doctors are willing to prescribe it, and a worldwide population of diabetics, including over 110 million diabetic Chinese, who will use Afrezza if it is affordable and available.By the way, Chinese diabetics are not poor. Diabetes, in China, is a disease of the wealthy sedentary single child families of the last twenty or thirty years who can afford the high caloric/carbohydrate Western diet (KFC/Dunkin' Donuts). Fifth, I am now prepared to follow this scenario through to whatever ending it may lead. I firmly and unequivocally believe this will end in success even if it takes several years. RS Rob, this is all quite true. My optimism regarding a near term T2 partnership is rather tempered, however as I think at this stage of development there should not be much expectation of cash up front without giving away the lion's share of future revenue potential. I think any such deal is more likely to come with a small amount of cash up front and an offset to the ongoing development expenses. This would definitely help cash burn and reduce risk. Perhaps that is a current requirement. However, it could be much more beneficial to let this develop for another year or two before entering an agreement. Point five is great, but we perhaps need more confidence that those years are available before the market returns to your way of thinking. |
|
Deleted
Deleted Member
Posts: 0
|
Post by Deleted on Dec 8, 2015 21:34:04 GMT -5
The reasons that cause you to buy are the reasons I am not selling. Unfortunately, I don't have much buying ability left or else I would also be adding.
Thanks for your insight.
|
|
|
|
Post by suebeeee1 on Dec 8, 2015 21:39:35 GMT -5
I bought the last for this year (I think) during the TASE debacle. So, while I would LOVE to take this opportunit to buy more, it is currently not possible for me either. And yes, I am deep in the red with 1000s of shares now in the area of $3.83 each. And, I'll have thousands more when my puts will come due in January and I'll own thousands more at $4.50 or $5.00 each.
Am I worried...no. I'm not selling and MNKD is not going bankrupt (despite all the FUDsters inhabiting this board) so this current loss is not set in stone.
|
|
|
|
Post by chuck on Dec 8, 2015 21:43:15 GMT -5
1. Afrezza maybe the best mealtime insulin, however its not on the label so SNY and MNKD can't say that to healthcare professionals, patients in advertising and insurance companies. So a mute point at this stage. I'm waiting for superiority studies and see none. Maybe they will come in the future some day. Who knows.
2. I don't disagree that al mann will likely step in to finance mnkd should it come to this. I don't see this as a material factor to an investing decision. Mnkd will be funded, it's just a matter of price (and thus the amount of dilution).
3. I don't buy the technosphere dream. They've been in business for many years and have shown nothing to demonstrate there is any interest or value in TS.
4. The T2 market is big but its going to be an uphill battle. Changing the standard of care will be difficult. This market has many products and cost is an issue. SNY has significantly decreased its outlook. I place a lot of weight on that. Their statements, lack of statements and actions point to niche market or losing patience with afrezza. That's concerning.
Discounting all of this, mnkd probably worth about a $1 a share. If SNY bails, mnkd equity is worth nominal value. I don't any compelling reason to buy at this point given SNY's actions.
|
|
|
|
Post by suebeeee1 on Dec 8, 2015 21:48:01 GMT -5
Discounting all of this, mnkd probably worth about a $1 a share. If SNY bails, mnkd equity is worth nominal value. I don't any compelling reason to buy at this point given SNY's actions. Thank you "Chuck", who only registered in October for spreading more FUD. |
|
|
|
Post by mnholdem on Dec 8, 2015 21:56:29 GMT -5
james , Hakan has stated that there are currently two API in the pre-clinical stage in MannKind's TS pipeline. A pulmonary hypertension medication and a pain medication. I would think that when it comes to a partner for the TS pulmonary hypertension med, a substantial upfront payment would be justified for either of these meds.
The current treatment options for PH come with some severe side effects. Unlike insulin, a technosphere-delivered medication that bypasses much of the gastrointestinal issues would be welcomed with open arms in the medical community.
One of the most commonly prescribed vasodilators (vasodilators open narrowed blood vessels) for pulmonary hypertension is epoprostenol (Flolan). The drawback to epoprostenol is that its effects last only a few minutes. This drug is continuously injected through an intravenous (IV) catheter via a small pump that you wear in a pack on your belt or shoulder. This means that you'll learn to prepare your own medication mixture, operate the pump and care for the IV catheter. You'll need comprehensive follow-up care. Potential side effects of epoprostenol include jaw pain, nausea, diarrhea, leg cramps, as well as pain and infection at the IV site. Other prescribed treatments can cause liver damage and vision problems.
As far as the TS pain medication, we still need to learn what specific area of pain the API will be treating. Many think it will be migraines, an illness important to Al Mann because his wife Claudia suffers migraines. The market for pain meds, in terms of revenue, is larger than diabetes and cancer combined. I would think that a TS medication that effectively treats a migraine in 5-10 minutes would become a blockbuster and warrants a substantial upfront payment for development of the API through FDA approval.
Also significant is that these two TS drugs were selected by the consulting firm hired by MannKind to determine their best pipeline candidates based on the criteria of size of market and the speed in which the API could be brought to market.
Naturally, we'll be guessing right up to the partnership announcement. With Afrezza, at least management told us that they would have a partner within 4 months (as I recall). But that was because Afrezza was approved before a partner signed. This time around, MannKind has stated in recent CC's that they will be looking for a partnership much earlier in the development process.
|
|
|
|
Post by sccrbrg on Dec 8, 2015 22:01:14 GMT -5
Discounting all of this, mnkd probably worth about a $1 a share. If SNY bails, mnkd equity is worth nominal value. I don't any compelling reason to buy at this point given SNY's actions. Thank you "Chuck", who only registered in October for spreading more FUD. If duration was indicative of value, MNKD would be trading at 50 dollars a share. There's just as many long time posters that have fallen so in love with this company their opinions read like the company is infallible and the big bad world is out to get them. It's almost unreadable the amount of pie in the sky logic that's tossed around. There's a lot of people unhappy with the companies performance, especially in recent months. So it's no shock that the frustration level may have made them create an ID for the board and start posting. It doesn't make their points any more or less valid than someone who has 400 posts and their mnkd love affair. |
|
|
|
Post by wmdhunt on Dec 8, 2015 22:08:33 GMT -5
I am right there with you robsacher. I bought yesterday and today. I will continue to hold and buy as I can because I believe in the Mann and his dream. This, of course, is in spite of the losses I have suffered over the last two years. I just pray that Al will be around to see his ultimate victory. I feel he, I, you and a world of diabetics will prevail.
|
|
|
|
Post by mnholdem on Dec 8, 2015 22:48:20 GMT -5
1. Afrezza maybe the best mealtime insulin, however its not on the label so SNY and MNKD can't say that to healthcare professionals, patients in advertising and insurance companies. So a mute point at this stage. I'm waiting for superiority studies and see none. Maybe they will come in the future some day. Who knows. 2. I don't disagree that al mann will likely step in to finance mnkd should it come to this. I don't see this as a material factor to an investing decision. Mnkd will be funded, it's just a matter of price (and thus the amount of dilution). 3. I don't buy the technosphere dream. They've been in business for many years and have shown nothing to demonstrate there is any interest or value in TS. 4. The T2 market is big but its going to be an uphill battle. Changing the standard of care will be difficult. This market has many products and cost is an issue. SNY has significantly decreased its outlook. I place a lot of weight on that. Their statements, lack of statements and actions point to niche market or losing patience with afrezza. That's concerning. Discounting all of this, mnkd probably worth about a $1 a share. If SNY bails, mnkd equity is worth nominal value. I don't any compelling reason to buy at this point given SNY's actions. Regarding #3, isn't Afrezza itself the first graduate of the Technosphere pipeline? Sales aside, it would seem that based on early adopters, the science behind TS has been validated. BPs are not in the habit of ignoring those kinds of developments in the drug industry. Technosphere has the potential to be market disruptive for many different drugs. I'm pretty sure that they are paying attention. While they may not be re-activating the pulmonary R&D that most had started during Pfizer run with Exubera, the BPs are most likely starting to hire pulmonary specialists.
The question will come down to whether it will be cheaper for them to develop their own API with MannKind, or go the more expensive route of developing their own inhalable drug-delivery platform that can match the performance of Technosphere.
Regarding #1 - you may be forgetting that additional trial data for EMA application may have been gathered (or is still being gathered) that will establish Afrezza to be superior to RAA insulin and orals (ie metformin). It's far from clear how near or far we are to that determination.
I absolutely agree with #4. The Type 2 market is the motherlode, but it will be a tough nut to crack until there is enough empirical evidence to convince the ADA that Afrezza should be the standard of care for pre-diabetes and early diabetes. IMO, early intensive insulin therapy has the best chance of achieving that goal, as it can result in remission of diabetes in its early stages. Several universities have already proven it. Some openly stated over a decade ago that they really need a monomeric insulin for the treatment to be most effective. At the time it was unavailable, but now that they have it in the form of Afrezza, I hope these medical universities begin studying the properties that make Afrezza unique among all current insulin.
|
|
|
|
Post by robsacher on Dec 8, 2015 22:57:41 GMT -5
I bought the last for this year (I think) during the TASE debacle. So, while I would LOVE to take this opportunit to buy more, it is currently not possible for me either. And yes, I am deep in the red with 1000s of shares now in the area of $3.83 each. And, I'll have thousands more when my puts will come due in January and I'll own thousands more at $4.50 or $5.00 each. Am I worried...no. I'm not selling and MNKD is not going bankrupt (despite all the FUDsters inhabiting this board) so this current loss is not set in stone. One of the things I like about this board is the ability to block FUDsters which I have been doing diligently over the last several weeks. I have grown weary of endless debate over points I have long ago decided upon one way or another. Therefore, blocking has saved me a considerable amount of time. I can still learn from posters such as yourself and others. And, I still have time for the old guard, the personalities who originally brought me to this forum in the first place. My new purchases are not always going to be large as there will still be an ebb of flow of capital into my endeavors. But, the point of making some sort of a purchase while the s/p drops is important to me in consideration of all the issues of which I listed these five. I am in this for the long term. I believe that the company will survive this awkward period and that Afrezza will be embraced eventually by a significant population of diabetics. What my due diligence has discovered has not changed. If I am wrong then I am wrong in support of a great cause, a great man and mentor, and a great endeavor. But, if I am correct, then I am correct in support of a great cause, a great man and mentor, and a great endeavor. Glad you are here with me. |
|
|
|
Post by rrtzmd on Dec 8, 2015 23:12:33 GMT -5
1. Afrezza maybe the best mealtime insulin, however its not on the label so SNY and MNKD can't say that to healthcare professionals, patients in advertising and insurance companies. So a mute point at this stage. I'm waiting for superiority studies and see none. Maybe they will come in the future some day. Who knows. 2. I don't disagree that al mann will likely step in to finance mnkd should it come to this. I don't see this as a material factor to an investing decision. Mnkd will be funded, it's just a matter of price (and thus the amount of dilution). 3. I don't buy the technosphere dream. They've been in business for many years and have shown nothing to demonstrate there is any interest or value in TS. 4. The T2 market is big but its going to be an uphill battle. Changing the standard of care will be difficult. This market has many products and cost is an issue. SNY has significantly decreased its outlook. I place a lot of weight on that. Their statements, lack of statements and actions point to niche market or losing patience with afrezza. That's concerning. Discounting all of this, mnkd probably worth about a $1 a share. If SNY bails, mnkd equity is worth nominal value. I don't any compelling reason to buy at this point given SNY's actions. If Al Mann had any interest in putting more money into Mannkind, I think he would have done so before now. Even a minimal investment by him back in August could have sent the stock soaring and relieved the pressure and negative publicity of the debt settlement. Even a minimal investment by him ahead of the TASE listing would have generated positive publicity and likely would have improved the reception the Israeli investors gave MNKD. Even a minimal investment now would send the stock soaring up and away from its 52 week lows. I think somewhere along the way Al decided it was time for Al "junior" to stand and walk on his own without any more help from "papa." |
|
|
|
Post by mnkdfann on Dec 9, 2015 1:53:30 GMT -5
Rob, why do you use another Rob Sacher's avatar as your own? It seems a little deceptive, but perhaps that is just me. (I'm assuming you are the same Rob Sacher as on SeekingAlpha. So either here or there you are deceptively fronting.)
|
|
|
|
Post by suebeeee1 on Dec 9, 2015 2:07:27 GMT -5
Rob, why do you use another Rob Sacher's avatar as your own? It seems a little deceptive, but perhaps that is just me. (I'm assuming you are the same Rob Sacher as on SeekingAlpha. So either here or there you are deceptively fronting.) You'll have to explain why you think this is deceptive. Rob has let us all know he is the same person on seeking alpha, even pursuing links to his entries there. As far as I can see, no deception. What is you game? |
|
