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Post by _neil on Jul 9, 2015 12:09:37 GMT -5
SNY is not the one to blame completely since the team that markets Afrezza is 50:50 MNKD:SNY. I am worknig under the assumption that all the decisions are by consensus. If MNKD members on that board do not sound the alarm bells about the interest level from their SNY counterparts, they are completely unfit to shoulder Afrezza and we fully deserve our losses. I think it might be far fetched to assume SNY will back out next year but given what we have seen so far, this cannot be ruled out. My only hope from MNKD now is that they will plan their finances accordingly and shop around given they have 5 more months in the year before the unthinkable happens. If they do dilute the stock after all the assurances, we will know for a fact that we are dealing with a bunch of amateurs who lucked out by having a great product thrown into their lap. I surely hope this isn't the case.
We have given SNY enough benefit of doubt and IMO, there won't be any appreciable sales for this year. I have already readjusted my holding period to end of 2017. Aside from these wrinkles, I think even as a niche T1 product, MNKD deserves more than 2.5B valuation.
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Post by suebeeee1 on Jul 9, 2015 12:13:59 GMT -5
The biggest problem of all is the silence. It would be nice if management was more forthcoming and gave us an idea of how they were going to proceed, even if it is the barest of an outline. But, we get nothing. Perhaps, that is the most frustrating part of this while we all wait.......
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Post by compound26 on Jul 9, 2015 12:26:20 GMT -5
The SNY partnership was announced several months (6) before the "soft" launch. My question is why didn't the education of Doctor's start sooner? It seems they took a long time to get their Affreza sales team picked & educated. They could have been quicker to the draw with all the money & resources they have at their disposal. Their is no way (IMO) SNY scraps the deal & abandons Afrezza in early 2016! Feeling your pain but hopeful TV ad's are a game changer! Sales are always the determining factor. Scripts need to keep climbing and sales need to increase. We don't want Sanofi to have any other choice then to continue on with Afrezza in 2016. If sales meander as they are, I'd be very worried come early next year. That's why we want to see the urgency of getting the word out. Get it on TV NOW! I have confidence in Sanofi (even though they are based on France . They are experienced in the Diabetes market. Remember that they ditched Exubera to Pfizer. Therefore, Sanofi saw Exubera's weakness before its launch. Then, they chose to partner with Mannkind on Afrezza despite Pfizer's failure in launch Exubera. This shows Sanofi's confidence in Afrezza. We all know that Pfizer's launch of Exubera was a failure, for many reasons. one of the reasons, it was argued was that the CEO at Pfizer did not have drug launch experience. He used to work at McDonald (and therefore I would expect him to see hamburg sales grew everyday (see quote below)). On the other hand, Sanofi knows diabetes and insulin. Its CEO knows drugs and drug launches. They know how long it takes to build a blockbuster insulin drug (Lantus) and how to achieve that. (It appears Lantus US sales does not reach $1 billion until the 9th year of its launch). Plus, they must has learned something from Pfizer's failure in the launch of Exubera. So it will be unimaginable for Sanofi to give Afrezza anything less than 3-5 years time to ramp up. Attachment Deletedbmartinmd.com/2007/12/number-9-exubera-market-withdr/ "The seemingly abrupt decision to pull the Exubera plug by Pfizer’s CEO Jeffrey Kindler, a lawyer whose corporate experience included high-level positions at McDonald’s, was criticized for being misplaced in the steep-investment, slow-development world of the pharmaceutical industry. A prescription pharmaceutical’s not a McDLT (which may have actually been on the nationwide market longer than Exubera). But analysts were quoted as generally supporting the decision to pull the drug." www.ceocfomobile.com/DanceBioPharm15-CEOCFOmobile2.pdfCEOCFO: What have you learned from your prior experience that is helping smooth the process? Dr. Patton: We worked with Pfizer for twelve years on Exubera. Before that we worked four years on our own and then we partnered with them. We partnered early in the development process, so we were the technology supplier and they were running the show. They did a great job until the end. One of the problems in big pharma, at least in this particular experience with Pfizer, was that the personnel kept changing; not so much in the deep science, but more in the marketing and senior management and clinical. The faces kept changing. T hen ultimately the CEO and the senior management changed right when the product was approved. The guy who came in was not about science or medicine. He had a lawyer and accountant background, so they did not really know that much about insulin. Insulin is a serious drug and it takes a couple of years for a new insulin form to take off. Then they usually become multibillion dollar products. Those guys pulled the plug on the product that we had been giving our lives to for almost two decades. They just decided that it was not selling fast enough they never really gave the drug a chance (it was pulled after only about 9 months on the market). One of the things you learn is that when you are building a biotechnology company investors want you to partner with big pharma because they have lots of money and supposedly know what they are doing. Often they do not know what they are doing. It is better for you to hang on to your product and carry it as far as you can, even though investors are driving you to partner or sell out. It is not necessarily the best thing for the product. In this case, here was something that we knew that the patients really wanted and with Pfizer’s mighty help, we had gotten it approved in Europe and the US as effective and safe and then here comes a naive executive team that would rather take a tax write off on the program, had no faith in it and killed a product that would have benefited millions. Therefore, the big lesson there is, “Do not get yourself in that situation again, John!”
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Post by dudley on Jul 9, 2015 13:11:02 GMT -5
The SNY partnership was announced several months (6) before the "soft" launch. My question is why didn't the education of Doctor's start sooner? It seems they took a long time to get their Affreza sales team picked & educated. They could have been quicker to the draw with all the money & resources they have at their disposal. Their is no way (IMO) SNY scraps the deal & abandons Afrezza in early 2016! Feeling your pain but hopeful TV ad's are a game changer! Sales are always the determining factor. Scripts need to keep climbing and sales need to increase. We don't want Sanofi to have any other choice then to continue on with Afrezza in 2016. If sales meander as they are, I'd be very worried come early next year. That's why we want to see the urgency of getting the word out. Get it on TV NOW! "If sales meander as they are" You must be privy to some information the rest of us poor ignorami do not have. You nor anyone else have any idea whatsoever what sales are. You nor anyone else have any idea what actual script counts are. Even the extrapolated Symphony results are running at least 8 weeks behind the actual demand curve - it cannot be otherwise with the well-established 8 week (or more) delay between the time a patient begins pursuing a prescription and the time they actually obtain the prescription and take it to the pharmacy where it gets captured in Symphony. Do you know how many prescriptions are underway right now waiting to be completed? No. Barely 5 months into a launch - everyone in the world knows there is an effective 6 month moratorium on DTC for new drug launches. That is well established - I was personally surprised to see even the magazine ads this early. This is essentially a 5-month old infant and you folks are expecting it to be reading, writing, and running like a ten year old. As any investor who has made REAL money in the market knows, it takes time and patience. I personally have zero sympathy for anyone who cannot go even a few months without crying about how incompetent and useless management is. The very same management who have brought one of the most phenomenal drugs ever devised to market against great odds, and without whom the investment would not even be possible. Sanofi is a world class organization and just because they are not catering to the impatient "needs" of short term oriented "investors" does not mean they are not doing what they view as appropriate at this stage of the launch. I'm not even going to reply to any other replies - it is just a waste of effort because there is no patience on the part of all too many posters and I have no patience for people who do not have patience. I guarantee you Al Mann is not concerned about whether or not he sees a TV ad next week.
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Post by newmnkdinvestor on Jul 9, 2015 14:11:29 GMT -5
I do not think that commercials are the answer especially geared towards seniors. As I have said I work in reverse mortgage and deal with seniors all day long and have been doing so for ten years. My company has been apart of commercials towards seniors and the conversion takes a long time. Another example when we bought Senator Fred TV leads ( they sell there surplus leads to other companies) one of the first things they tell you when you buy them is the conversion takes months. This is with a sales force. Dr's are not sales people.
We procrastinate and become disinterested in things as we get older. Its a fact of life. I can tell you with complete confidence. If there is a commercial geared towards seniors, they are not going to call in by the masses and schedule a Dr's appointment and start Afrezza. You are not going to see a commercial for awhile. The more and more this plays out and I see how difficult it is to market this product I get why it was a good short at FDA approval.
If you take a look at the thread where Spiro breaks down his friends or look at the dates of when his Dr first warned him and when he finally acted. It puts things into perspective. Spiro no offense to you!!!!
There are so many spectators, so many people want this to fail and if they come guns blazing with marketing. They will fail. IMO Type 2 seniors are going to come from Dr's. I do not know the market well. I am still learning. However I have a decade of experience of trying to sell to seniors of ages 62-85.
Just my two cents
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Post by dreamboatcruise on Jul 9, 2015 14:26:15 GMT -5
dudley... lots of data has delays. Doesn't mean it's meaningless. Do you harass people for mentioning their A1c because that in no way indicates what their blood sugar level is at the very moment. Sorry... but the script data from IMS and Symphony is what we have to go on, and lots of people use it, and in fact pay good money for it. I think it is implicit in anybody talking about the script numbers that if there is a change in trajectory coming it would first occur with change in doctor behavior only to show up in script numbers sometime later. What nccapitalist said is that he'll be worried "early next year" if the script numbers don't improve. So even assuming your 8 wk delay in the numbers, what he is saying is that if by end of Oct there isn't a significant increase in patients getting started on Afrezza, he will be worried when he realizes it in the delayed script data in early 2016. Is that unreasonable?
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Post by newmnkdinvestor on Jul 9, 2015 14:42:45 GMT -5
The biggest problem of all is the silence. It would be nice if management was more forthcoming and gave us an idea of how they were going to proceed, even if it is the barest of an outline. But, we get nothing. Perhaps, that is the most frustrating part of this while we all wait....... Some times now news is good news. Part of me thinks that if they did tell us everything we would wish they didnt. Kinda similar to if we really know what goes on behind the scenes with terroirsts.
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Post by nylefty on Jul 9, 2015 19:20:23 GMT -5
I worked in radio and television for more than 40 years and still keep up with developments by subscribing to an industry message board. It's an absolute article of faith in that industry that people over 54 are very resistant to advertising and that's why programming is aimed at people between 25 and 54.
I agree that seniors tend to accept whatever their doctors tell them and that for Afrezza to succeed it will be mostly because doctors have been convinced that it's better than the alternatives -- and not because seniors will be demanding it because of TV advertising.
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Post by mnholdem on Jul 9, 2015 19:26:42 GMT -5
Newmn... I think your 'terrorists" descriptor is pretty doggone funny...and quite possibly an accurate description for health insurance companies and government health care nowadays. I find myself thinking along these lines: If I have what I know is a game changing drug, I'm not going to concede to payers' demands to discount Afrezza pricing right out of the gate, especially if I know that I'll soon have evidence of Afrezza's superiority. Insurance companies don't give a karp about convenience, which is why the Lantus pen (I think it may be called Solostar) is not covered or has a Tier 3 w PA while Lantus vial is Tier 2 in several formularies I've found. Afrezza is currently proving among patients and physicians that it can meet an unmet medical need better than the competing prandials and oral medications. Sanofi is probably unwilling to slash profits for a game changer that they believe will become the gold standard in diabetes treatment, so they must present the evidence that Afrezza is the superior choice. Sanofi probably has a negotiations team for dealing with insurers and will, over the next several months, be presenting Arrezza's benefits. Again, some insurers won't care about convenience over $$$ savings. Sanofi must convince them that Afrezza will lower other costs associated with hypo- and hyperglycemia. That means they need to present post-launch evidence, which also will take time to gather enough to build a presentable case. The one bright spot that I've learned from the FDA website, is that it appears that Sanofi (in fact, all drug companies) has the right to present anecdotal evidence to physicians and insurers, even if the FDA will not permit certain anecdotal evidence to be used in DTC marketing. I believe Afrezza will get better coverage by payers, but how many during this 2nd half of 2015 remains to be seen. Certainly, in what is a very crowded market, Afrezza appears to be distinguishing itself among early adopters. Now Sanofi must see to it that Afrezza distinguishes itself to the insurance companies, health plan committees and all the other types of 3rd party payers. - - - - - On that note: I read recently (was the article posted here?) that there is a bill being considered in Washington related to the allowance of certain anecdotal evidence to be used for post-approval labeling revisions and to speed up what is currently a very cumbersome and costly FDA drug approval process. I still think that Sanofi may not talk much about it, but they are currently working very hard at negotiating with insurers.
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Post by od on Jul 9, 2015 19:42:16 GMT -5
Why is Stefan Schwarz in charge if SNY is not committed to Afrezza? He is a global SNY player - he would not be running a small brand for the organization. For all intents, inhaled insulin is a new therapeutic modality -- SNY also must manage provider perceptions created by the Exubera debacle (reasonable or not); - anyone on the board ever launch a pharmaceutical product with similar challenges? No doubt, mistakes made, but I am quite sure marketing decisions are not based on MNKD shareholder's advice (as good as it often is).
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hawk1969
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Post by hawk1969 on Jul 9, 2015 19:58:14 GMT -5
I am not a diabetes patient but my brother is a type 2 diabetic and gives himself a shot 3 times a day before meals. He has been doing this for years and is wiling to try Afrezza if his doctor will prescribe it. However, he has not made an appointment to see his Doctor about a prescription because he does not know anyone that has been prescribed Afrezza. I sincerely believe that If he saw advertisement with a patient on Afrezza sharing his experience on television, it would encourage him to take the initiative to setup an appointment and discuss Afrezza with his doctor.
Please note that living in rural Mississippi (my childhood home which I love) there are many diabetic patients and television is definitely the best and maybe only way to reach potential Afrezza users. Word of mouth was great for a launch of a new product in a big city but it does not work in small cities and towns that does not have the media coverage of a large city.
Good health to all diabetic patients and their relatives in getting help with their diabetes. I originally invested in the stock of Mannkind because I not only believe in the product, I believe that it will help my older brother.
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Post by nccapitalist on Jul 9, 2015 21:02:37 GMT -5
I'm very glad I started this thread. Thank you for all your comments. Very interesting and insightful board to say the least.
NC
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Post by newmnkdinvestor on Jul 9, 2015 21:52:31 GMT -5
I worked in radio and television for more than 40 years and still keep up with developments by subscribing to an industry message board. It's an absolute article of faith in that industry that people over 54 are very resistant to advertising and that's why programming is aimed at people between 25 and 54. I agree that seniors tend to accept whatever their doctors tell them and that for Afrezza to succeed it will be mostly because doctors have been convinced that it's better than the alternatives -- and not because seniors will be demanding it because of TV advertising. Awesome post nylefty. It's great to be able to put our career knowledge together and give people an understanding of behind scenes.
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Post by newmnkdinvestor on Jul 9, 2015 21:56:32 GMT -5
I'm very glad I started this thread. Thank you for all your comments. Very interesting and insightful board to say the least.
NC
We are all in this together. I appreciate this board. There are a lot of people to bounce things off of. Great thread
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Post by Chris-C on Jul 9, 2015 23:54:13 GMT -5
Sales are always the determining factor. Scripts need to keep climbing and sales need to increase. We don't want Sanofi to have any other choice then to continue on with Afrezza in 2016. If sales meander as they are, I'd be very worried come early next year. That's why we want to see the urgency of getting the word out. Get it on TV NOW! "If sales meander as they are" You must be privy to some information the rest of us poor ignorami do not have. You nor anyone else have any idea whatsoever what sales are. You nor anyone else have any idea what actual script counts are. Even the extrapolated Symphony results are running at least 8 weeks behind the actual demand curve - it cannot be otherwise with the well-established 8 week (or more) delay between the time a patient begins pursuing a prescription and the time they actually obtain the prescription and take it to the pharmacy where it gets captured in Symphony. Do you know how many prescriptions are underway right now waiting to be completed? No. Barely 5 months into a launch - everyone in the world knows there is an effective 6 month moratorium on DTC for new drug launches. That is well established - I was personally surprised to see even the magazine ads this early. This is essentially a 5-month old infant and you folks are expecting it to be reading, writing, and running like a ten year old. As any investor who has made REAL money in the market knows, it takes time and patience. I personally have zero sympathy for anyone who cannot go even a few months without crying about how incompetent and useless management is. The very same management who have brought one of the most phenomenal drugs ever devised to market against great odds, and without whom the investment would not even be possible. Sanofi is a world class organization and just because they are not catering to the impatient "needs" of short term oriented "investors" does not mean they are not doing what they view as appropriate at this stage of the launch. I'm not even going to reply to any other replies - it is just a waste of effort because there is no patience on the part of all too many posters and I have no patience for people who do not have patience. I guarantee you Al Mann is not concerned about whether or not he sees a TV ad next week. dudleyThanks for posting your sentiments about impatient investors. I agree completely. My hunch is that Al Mann wanted to partner with Sanofi all along. SNY has invested considerable $$$ already, and they are executing the controlled launch that they have been very appropriately open about describing. Sanofi has the reputation as a global leader in the insulin/diabetes sector for a reason-—they know what they are doing. Would they partner with Mannkind for an inhalable insulin without having assured themselves that the drug had blockbuster potential? SNY is not a company that would make frivolous decisions about Afrezza given the well known history of Exubera. People also forget that the logistics of planning and executing a long term marketing and distribution plan with a corporate partner headquartered in France is a significant undertaking under the best of circumstances. Mannkind is not an experienced pharma, having just launched its first approved drug. Add to this the reality that Sanofi was in the process of hiring a new CEO about the time that Afrezza was approved. It defies logic that this leadership change would not slow things down a bit. Yet, overall, I'm impressed with how rapidly they have put the pieces in place given the constraints. It is also worth mentioning that Sanofi has many other irons in the fire, including the launch of their new once daily basal insulin, Toujeo. Toujeo was just approved in February of this year. Actually, I feel better about my investment knowing that there is a plan, and it is being executed in a deliberate, strategic manner that is geared toward the long term success of the partnership. I don't want SNY or MNKD to reveal more of their game plan to investors or the competition; since it would be unwise, and certainly uncharacteristic of Mannkind, which seems to believe that focusing on getting the job done is more important than talking about the job that needs to get done. I take comfort that the current advertising blitz by Novo Nordisk is an implicit recognition that they have some serious competition on their hands with the launch of Afrezza. Despite these considerations, it seems that AF has been successful in getting his FUD into the heads of some of the investors on this board. Add to that the national obsession with instant gratification, and you have the board equivalent of the guy who passes you when you are driving 5 miles over the speed limit so that s/he can reach the red light at the intersection ahead before you do. Sadly, impatience and instant gratification is a national malady. What else would explain the incredible popularity of Instagram and Twitter?
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