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Post by EveningOfTheDay on Nov 28, 2015 21:16:42 GMT -5
I've read the partnership agreement pretty thoroughly, and I don't recall seeing anything about Europe or Asia launch timelines. Can you provide a reference? I can't provide reference off the top of my head, but I am almost certain I have read timeframes for introduction in Europe and Japan, provided by MNKD. I will try to dig the info and post it if I find it, but I am almost certain it has been posted here before.
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Post by jeremg on Nov 28, 2015 21:20:54 GMT -5
trenddiver I couldn't agree more, Afrezza is merely a product and a product does not simply sell itself contrary to what some may believe. There is absolutely no guarantee Afrezza will succeed if it's first pass at commercialization is seen as a failure. Metformin was lost for decades before it came back as one of the best selling drugs of all time and a first line therapy. If SNY either does not intend or is incapable of making Afrezza a success in the marketplace, it is very possible we may see another innovative product which obsoletes Afrezza up to bat in the next decade OR if no innovation takes place (unlikely) a revival of Technosphere in 5-10-15yrs under another name with a slight tweak to the FDKP molecule. Execution will make or break Afrezza and so far the execution (both SNY and MNKD) has been terrible.
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Post by bill on Nov 28, 2015 21:23:39 GMT -5
I think we need a way to distinguish between Afrezza success and MNKD success. We keep mixing them together. As I said previously almost everyone feels comfortable that Afrezza will succeed, one way or another. It's just too good to go away. What's confusing us all is whether MNKD can find a way forward that will let them take advantage of that success no matter when it occurs; 2016, 2017, or later. Right now all we know is that they only secured about 1/3 of the funding to persist into 2017. They also removed Hakan as CEO, installed Al as interim CEO, and then retained Hakan until July 2017. Everytime we think we're finishing the last chapter in the novel, the author tells us that a new book will be coming out "real soon." I'm not sure "almost everyone feels comfortable" that Afrezza will succeed. In fact there are short interests representing 125 million shares who feel just the opposite. My own opinion is that Afrezza may succeed or may not succeed. I'm hoping that it will succeed, but 600 scripts a week means it is failing in the market place right now and we have seen very little to indicate that things are getting better. Most doctors either dont know about it or are afraid of the product and most interested patients can't afford it. The are a lot of products that came to market that were great ideas that failed for a multitude of reasons, I hope Afrezza isn't one of those. Trend I respectfully disagree with your assertion that the shorts have a strong opinion and vested interest in whether Afrezza succeeds or not. I believe the shorts are only interested in whether MNKD fails or succeeds. If MNKD fails and goes bankrupt it will have almost no effect on Afrezza's success in the marketplace since SNY will retain all of it's rights to market and produce it. If Afrezza succeeds MNKD may or may not succeed. It depends on how rapidly Afrezza scripts increase versus how rapidly MNKD's financial situation deteriorates. At this point in time, MNKD's success or failure (from the shorts point of view) is almost independent of Afrezza. Scripts are unlikely to increase to the point where MNKD obtains any profit sharing or milestone payments in the near future. Therefore, MNKD's solvency will probably depend on something other than Afrezza's success. That's what I think the shorts are betting on, i.e., MNKD won't remain solvent, or if they do it will come with a large dilution that will provide them with shares they can use to cover.
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Post by fedakd on Nov 28, 2015 21:30:48 GMT -5
Bill, I think Price/Insurance coverage are two prominent reasons and price undoubtedly is negatively correlated with insurance coverage in this case. My main contention point with all this discussion about "why" is whether the "why" should even matter to us, SNY needs and has a contractual obligation to take care of the "why"s, this is why MNKD partnered with them and gave up 65% of Afrezza revenue. The only "why" which I am now concerned with is "why hasn't SNY taken care of these obstacles?" and "why hasn't MNKD taken steps to protect shareholder value in the meantime". At the very least come out and explain these obstacles in a mature transparent way to investors, instead we've heard blame on the "shorts" and "manipulation" while the keystone issue is [lack of] Afrezza traction/sales. The buck stops with management and ultimately even SNY's actions (for better or worse) are the responsibility of management as these actions [or lack thereof] have destroyed shareholder value and MNKD-management signed the contract after-all. Let me take a crack at your two "why's." Why hasn't SNY taken care of these obstacles? One reply could be that they are taking care of the obstacles; spirometers, DTC advertising, insurance coverage etc. What's bothering us that we don't have any hard data to substantiate whether obstacles have or have not been removed, or how far along SNY is in removing them. MNKD should know, but no one's sharing, i.e., no transparency. Why hasn't MNKD taken steps to protect shareholder value in the meantime? I like that question, because Al Mann has more invested as a shareholder than all of us combined, but it hasn't been until recently that he's taken an active interest in what's happened. I'd like to think that he wasn't overly disturbed by what was happening based on the what he could observe, and what he was being told by Hakan, et al. I suspect though that conversations were had during the recent board meeting that caused Al to decide that the best way for him to preserve his shareholder value was to replace Hakan as CEO. Bad news that Al had to do that, but good news that he did once he realized he needed to get involved. What none of us know is what the proximate cause was for Hakan being removed, or what options Al will be pursuing to maximize his shareholder value. At this point, I guess there's no one I'd rather have as CEO than the "Mann" who has the most to gain or lose. Whatever the situation, I suspect we'll have Al's full attention for the next few weeks or months. Some very good points made here. My guess is that Al's no longer a billionaire as a result of MNKD's share price destruction. If I were 90, and I was a self-made billionaire, I would spend my very last days making sure my life's work wasn't for nothing. The way Al speak's about Afrezza, this is his baby. He's not going down without a fight. What I do wonder about is what it would cost to buy up the rest of the float. Al has ~40%, he could acquire another 30% for what, 250-300 million on the open market? So many possibilities. The Mann Group could easily do a private placement.
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Post by bill on Nov 28, 2015 21:35:31 GMT -5
trenddiver I couldn't agree more, Afrezza is merely a product and a product does not simply sell itself contrary to what some may believe. There is absolutely no guarantee Afrezza will succeed if it's first pass at commercialization is seen as a failure. Metformin was lost for decades before it came back as one of the best selling drugs of all time and a first line therapy. If SNY either does not intend or is incapable of making Afrezza a success in the marketplace, it is very possible we may see another innovative product which obsoletes Afrezza up to bat in the next decade OR if no innovation takes place (unlikely) a revival of Technosphere in 5-10-15yrs under another name with a slight tweak to the FDKP molecule. Execution will make or break Afrezza and so far the execution (both SNY and MNKD) has been terrible. I'm pretty comfortable that SNY will find a way to succeed with Afrezza, but perhaps on a more extended timeline than we'd like. For example, they will have an excellent chance to succeed if the juvenile study is successful. A success there would possibly win in multiple ways; provide first line treatment for juveniles and possibly get a label improvement. SNY could also succeed sooner than that if they can negotiate better Tiered pricing and fewer insurance restrictions, perhaps coupled with a lower price. SNY might also succeed just by improving their advertising campaign. SNY has lots of ways to succeed with Afrezza, but those successes might come too late for MNKD unless it can improve it's financial situation. I see four options; a TS partnership with a substantial up-front payment, an improvement in stock price because the SEC pulls a Rip Van Winkle and wakes up , MNKD successfully dilutes our shares and raises enough cash to wait for Afrezza's success, or SNY and MNKD agree on a buy-out. I can't see anyone but SNY buying MNKD because a buy-out by anyone else would leave SNY with the option to retain all of their Afrezza rights.
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Post by bill on Nov 28, 2015 21:37:35 GMT -5
Let me take a crack at your two "why's." Why hasn't SNY taken care of these obstacles? One reply could be that they are taking care of the obstacles; spirometers, DTC advertising, insurance coverage etc. What's bothering us that we don't have any hard data to substantiate whether obstacles have or have not been removed, or how far along SNY is in removing them. MNKD should know, but no one's sharing, i.e., no transparency. Why hasn't MNKD taken steps to protect shareholder value in the meantime? I like that question, because Al Mann has more invested as a shareholder than all of us combined, but it hasn't been until recently that he's taken an active interest in what's happened. I'd like to think that he wasn't overly disturbed by what was happening based on the what he could observe, and what he was being told by Hakan, et al. I suspect though that conversations were had during the recent board meeting that caused Al to decide that the best way for him to preserve his shareholder value was to replace Hakan as CEO. Bad news that Al had to do that, but good news that he did once he realized he needed to get involved. What none of us know is what the proximate cause was for Hakan being removed, or what options Al will be pursuing to maximize his shareholder value. At this point, I guess there's no one I'd rather have as CEO than the "Mann" who has the most to gain or lose. Whatever the situation, I suspect we'll have Al's full attention for the next few weeks or months. Some very good points made here. My guess is that Al's no longer a billionaire as a result of MNKD's share price destruction. If I were 90, and I was a self-made billionaire, I would spend my very last days making sure my life's work wasn't for nothing. The way Al speak's about Afrezza, this is his baby. He's not going down without a fight. What I do wonder about is what it would cost to buy up the rest of the float. Al has ~40%, he could acquire another 30% for what, 250-300 million on the open market? So many possibilities. The Mann Group could easily do a private placement. Al buying up the float and going private has been mentioned by several people. I'm inclined to discount that option because it would probably be contrary to the TASE dual-listing and their Indices investment, i.e., Al going private with MNKD would probably be viewed very negatively by the Israeli investment community.
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Post by cathode on Nov 28, 2015 21:39:22 GMT -5
I think we need a way to distinguish between Afrezza success and MNKD success. We keep mixing them together. As I said previously almost everyone feels comfortable that Afrezza will succeed, one way or another. It's just too good to go away. What's confusing us all is whether MNKD can find a way forward that will let them take advantage of that success no matter when it occurs; 2016, 2017, or later. Right now all we know is that they only secured about 1/3 of the funding to persist into 2017. They also removed Hakan as CEO, installed Al as interim CEO, and then retained Hakan until July 2017. Everytime we think we're finishing the last chapter in the novel, the author tells us that a new book will be coming out "real soon." I'm not sure "almost everyone feels comfortable" that Afrezza will succeed. In fact there are short interests representing 125 million shares who feel just the opposite. My own opinion is that Afrezza may succeed or may not succeed. I'm hoping that it will succeed, but 600 scripts a week means it is failing in the market place right now and we have seen very little to indicate that things are getting better. Most doctors either dont know about it or are afraid of the product and most interested patients can't afford it. The are a lot of products that came to market that were great ideas that failed for a multitude of reasons, I hope Afrezza isn't one of those. Trend I am not sure that all 125M of the short position thinks Afrezza will not succeed. I think much of that short position is interested in making MNKD weak and limiting the financing opportunities they have. The reason for their persistence is exactly because they understand how disruptive MNKD technology including Afrezza can be to the disease treatment space. Their efficacy is driven in part by the opacity of MNKD and the slow progress of the flagship product.
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Post by fedakd on Nov 28, 2015 21:43:53 GMT -5
Good point, bill. In agreement there with you after you mention the TASE listing.
I do think that if we get a $100+ million upfront licensing deal for TS, that would change sentiment and take MNKD off the bankruptcy block that most journalists and articles seem to preach. I've never been involved in a stock or a situation with so little transparency. Was the CEO of Sanofi referring in any way to Mannkind when he described the exorbitant valuations some biotech companies were expecting prior to the correction in the IBB index?
I do know that Al Mann stated that he would not sell for $25/share (keep in mind this was many years ago prior to the last 3 CRL and the last major dilution). That valuation of $25 works out to $3.2 billion now. Thus, Al think Afrezza is worth at least $3.2 billion by itself.
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Post by bill on Nov 28, 2015 21:49:26 GMT -5
Good point, bill. In agreement there with you after you mention the TASE listing. I do think that if we get a $100+ million upfront licensing deal for TS, that would change sentiment and take MNKD off the bankruptcy block that most journalists and articles seem to preach. I've never been involved in a stock or a situation with so little transparency. Was the CEO of Sanofi referring in any way to Mannkind when he described the exorbitant valuations some biotech companies were expecting prior to the correction in the IBB index? I do know that Al Mann stated that he would not sell for $25/share (keep in mind this was many years ago prior to the last 3 CRL and the last major dilution). That valuation of $25 works out to $3.2 billion now. Thus, Al think Afrezza is worth at least $3.2 billion by itself. Many of us believe Brandicourt was referring to MNKD when he made that comment. That comment and the omission of Afrezza in SNY's major launch list was what got many of us talking about SNY sand-bagging Afrezza so that MNKD's financial situation would deteriorate to the point where they would agree to a SNY buy-out.
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Post by dreamboatcruise on Nov 28, 2015 22:49:05 GMT -5
Let me take a crack at your two "why's." Why hasn't SNY taken care of these obstacles? One reply could be that they are taking care of the obstacles; spirometers, DTC advertising, insurance coverage etc. What's bothering us that we don't have any hard data to substantiate whether obstacles have or have not been removed, or how far along SNY is in removing them. MNKD should know, but no one's sharing, i.e., no transparency. We do have some pretty hard data regarding insurance coverage. It has not changed since May. 2016 formularies are now out. So far none that I have seen appear to have improvement. I'm sure the company already has the exact data for 2016 plans. It seems implausible that the data which will soon be available to everyone on sites like formularylookup.com is somehow a strategic secret, so if there really were any meaningful improvement kicking in on Jan 1 it would be a monumental blunder not pointing that out as they were needing to raise money through a share offering. Sure, there is no way of knowing what is going on behind the scenes with SNY negotiating with insurers, but it is pretty clear that come Jan 1 as people look at their updated plans, it is still only about a quarter of people with insurance that can easily get Afrezza... the same as in May.
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Post by rockstarrick on Nov 28, 2015 22:50:42 GMT -5
No, as I stated in an earlier post, I believe Sanofi is test driving afrezza to see if it works as well as Al believes. I also believe the 65/35 split was a temporary agreement for the length of the test drive, hopefully 2016, very likely 2017. Rockstarrick, Do you have anything concrete to back up ridiculous speculation that you put forth on this board? Did you learn your trade on the YMB? Utter nonsense Trend Opinions vary trend, and your opinion of me or my rediculous speculation means nothing to me. I don't need you, or anybody else for that matter, trying to convince me that I am right or wrong. You don't know anything more than me, you just think you do. Thats the difference. I think we've beat this drum long enough. Good Luck to all See you on the other side.
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Post by mnkdnut on Nov 29, 2015 0:34:38 GMT -5
Good point, bill. In agreement there with you after you mention the TASE listing. I do think that if we get a $100+ million upfront licensing deal for TS, that would change sentiment and take MNKD off the bankruptcy block that most journalists and articles seem to preach. I've never been involved in a stock or a situation with so little transparency. Was the CEO of Sanofi referring in any way to Mannkind when he described the exorbitant valuations some biotech companies were expecting prior to the correction in the IBB index? I do know that Al Mann stated that he would not sell for $25/share (keep in mind this was many years ago prior to the last 3 CRL and the last major dilution). That valuation of $25 works out to $3.2 billion now. Thus, Al think Afrezza is worth at least $3.2 billion by itself. Many of us believe Brandicourt was referring to MNKD when he made that comment. That comment and the omission of Afrezza in SNY's major launch list was what got many of us talking about SNY sand-bagging Afrezza so that MNKD's financial situation would deteriorate to the point where they would agree to a SNY buy-out. Based on how SNY's actions lately, it could be that they're playing hardball to be able to buy-out Afrezza at the lowest possible price. If so, it's pretty underhanded IMO, and I think opens them up to a lawsuit later. I think it's more possible that their actions are suggesting that Brandicourt has already decided to give up Afrezza in the new year. Having worked directly with medical device sales forces for over 2 decades, I find it almost impossible to believe that the stagnant script numbers are due only to the various sales barriers (insurance coverage, spirometry, education, etc.) already well discussed. IMO, a motivated US SNY salesforce with a comp plan incentivizing them properly would produce higher script numbers and higher growth just feeding off the low hanging fruit out there right now. Targeting needle-phobic patients, poorly controlled patients with good insurance, progressive/aggressive physicians, etc. should result in much more than 600/week if they are really trying! In other words, Brandicourt has taken his foot off the Afrezza gas pedal and has decided to do the minimum under the Partnership Agreement until he can exit. That would also explain why no large, long term outcomes studies have been announced, no international expansion plans announced, and why Brandicourt gave Afrezza the cold shoulder at the Meet the Management Conference. He knew his partner was drowning and refused to lift even a finger to help. If this is the case, then I think MNKD already knows, and it would help explain the Hakan move. MNKD would have to make a new deal, quickly, to ensure life beyond SNY, and Hakan is not the guy to do that. Prospective partners would be able to close a deal much more quickly with Al because he's the final decision maker anyway. Same for TS negotiations. Hakan stays on just to make sure nothing internally falls through the cracks while Al focuses on the deal making. Hakan takes the fall for letting things get to this sorry point. MNKD desperately needs a partner that will do more than just the minimum short-term activities. I hope there's more under the surface going on in our favor, and a 90-y.o. Al can ride in and save the day. Continuing to use that word "hope" is making me feel more and more foolish every day. The only worse situation would be to sell out at a big loss and then see the PPS recover on some unexpected, positive announcement.
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Post by trenddiver on Nov 29, 2015 1:22:14 GMT -5
Rockstarrick, Do you have anything concrete to back up ridiculous speculation that you put forth on this board? Did you learn your trade on the YMB? Utter nonsense Trend Opinions vary trend, and your opinion of me or my rediculous speculation means nothing to me. I don't need you, or anybody else for that matter, trying to convince me that I am right or wrong. You don't know anything more than me, you just think you do. Thats the difference. I think we've beat this drum long enough. Good Luck to all See you on the other side. Rock, I don't have any opinion of you personally, only your post regarding this being a temporary agreement. You know there is a big difference between one's opinion of a situation or a set of facts and someone speculating about what the facts are. And yes I agree with you that we've beat this drum long enough. Hope we meet on the other side. Trend
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Post by gwb on Nov 29, 2015 1:54:47 GMT -5
Let me take a crack at your two "why's." Why hasn't SNY taken care of these obstacles? One reply could be that they are taking care of the obstacles; spirometers, DTC advertising, insurance coverage etc. What's bothering us that we don't have any hard data to substantiate whether obstacles have or have not been removed, or how far along SNY is in removing them. MNKD should know, but no one's sharing, i.e., no transparency. We do have some pretty hard data regarding insurance coverage. It has not changed since May. 2016 formularies are now out. So far none that I have seen appear to have improvement. I'm sure the company already has the exact data for 2016 plans. It seems implausible that the data which will soon be available to everyone on sites like formularylookup.com is somehow a strategic secret, so if there really were any meaningful improvement kicking in on Jan 1 it would be a monumental blunder not pointing that out as they were needing to raise money through a share offering. Sure, there is no way of knowing what is going on behind the scenes with SNY negotiating with insurers, but it is pretty clear that come Jan 1 as people look at their updated plans, it is still only about a quarter of people with insurance that can easily get Afrezza... the same as in May. Dreamboatcruise , you are making a factual statement regarding insurance for 2016 ?( It has not changed since May. 2016 formularies are now out ) Lakers had just posted a number of 2016 plans covering Afrezza in 2016 . Many had no PA and no ST , with tier three . Are you saying theses plans posted by Lakers had the same coverage in May 2015 ? Where do you get information to make that statement ? mnkd.proboards.com/user/1882/recent
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Post by silentknight on Nov 29, 2015 7:30:36 GMT -5
I think you covered it pretty well. It's impossible to know what the strategy is for Afrezza, but from the outside looking in, the one they seem to be employing looks to be ineffective or underhanded. I find it hard to believe that a global BP like SNY can't manage more than a few hundred scripts per week for a drug that is effective as Afrezza, unless it's intentional. It may be because of their phased roll out strategy or it may be because of something more sinister but everyone here knows that Afrezza is more effective than anything on the market, and its users know that too. Even if SNY can't say that based on the label, a good sales rep (and I'm guessing SNY has several based on their sales and revenue) should be able to educate and convince doctors to a greater extent than what we're seeing even with all of the hurdles associated with it's use. We should be seeing more than ~600 scripts out of large states like California or New York alone, not nationwide.
This isn't soft bashing as many would like to claim, but a part of me hopes that SNY or maybe MNKD terminates the deal in January. The product works and it works well and perhaps I'm naive, but I think another BP would be interested in marketing it for real given how effective it is. We know it works, SNY knows it, Al knows it and anyone else who has used or follows it knows it too. If their plan all along was to starve MNKD until they capitulated into a BO deal on the cheap and their intentions are truly that dastardly, turn the tables on them, revoke their rights to the drug and renegotiate a better deal with a more willing partner. I think they're out there. Hell, Al may already be reaching out to them if he knows it's coming. I feel more comfortable with Al in charge than Hakan, that's for sure, especially approaching what may be a watershed moment at the beginning of next year. Whatever the outcome, I'm with MNKD until the end.
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