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Post by lynn on Nov 23, 2015 16:28:41 GMT -5
I truly cannot believe we are where we are. It almost feels like a dream. I for one would have never anticipated for us to be barely above $2.00 17 months post FDA approval. Meanwhile, KBIO is at $40/share. Friends, and fellow traders, I'm afraid there is no such thing as karma. Look at Shkreli...he's made over $40 million in a week with the entire $KBIO trade. Being an enemy of Wall Street is not a good avenue for a publicly traded company. I'm worn out. Speaking of dreams , I had one about Mannkind last night , it was more like a nightmare actually . In my dream Mannkind was kicked off the Nasdaq & quickly became a penny stock . I was relieved when I woke up as it seemed too real . I'm hanging in there but feeling more frustrated than ever ! I think I'm ready for my tin foil hat ! Lynn
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Post by compound26 on Nov 23, 2015 23:55:01 GMT -5
Well, this is certainly beginning to seem like capitulation with regard to MNKD sentiment, with several long term believers giving up the faith. The only question is whether it is capitulation that might mark a bouncing along a bottom in share price, or wise capitulation with people getting out before the dismal end. Yes, sales are pretty bad, and obviously reflect the fact that the number of doctors proactively prescribing Afrezza is not changing much. $100M in debt is a lot but if tide were to turn it is pretty small in comparison to the revenue potential. Fortunately it is not due for quite some time. Here's hoping that your view is overly pessimistic, though I would have a hard time refuting what you say as the available information really provides no clue as to whether there will be a catalyst to change the trajectory of prescriptions a month from now, 6 months from now or 2 years from now. DBC, I totally agree with you. It is all sentiment. I think the main reason that Afrezza's uptick is slow is because it is a paradigm shifting product. As Sam (not Sam Finta) in Tudiabetes has put it, diabetes is a life-or-death condition, and the existing treatment (RAAs) works (although not as elegantly as Afrezza), therefore, PWDs are naturally very cautious about changing their treatment to something new (and revolutionary). The same goes with the doctors. And Sanofi, I think, as a BP, they just move slowly as all BPs do. Plus they just changed their CEO and then reorganized their diabetes business units. You could not expect them to move much faster. As for cash, $100-200 million (and for that matter the 8% annual interest) isn't that much of a big sum if you look at the big scheme. Think about it, nowadays, it will take you a few billion dollars and ten plus years to develop a new drug. And we have Afrezza, FDA approved, already in market, with overwhelming positive reviews from early adopters. How much should it be worth? If Sanofi or another BP (or a strategic investor like the former CEO of Sanofi or someone like Carl Icahn) buys 5%-10% of Mannkind, everything will change. If any of them provides a loan of $100-200 million, sentiment will also greatly improve. A lot of blockbuster drugs have a humble start. MimiMed's 6th year (1990) into launch of insulin pump only produced revenue of $12.5 million. But today, insulin pumps's annual sales is $2.5 billion. Afrezza currently is at an annual run rate of $16 million, after 10 months of very soft launch, evidenced by the very low awareness of the product among the public. That sales, while not satisfactory, is far from a failure.
Given how well Afrezza is being received by the current users and their prescribing physicians, I have no doubt Sanofi and other BPs should have enough confidence in making this into a blockbuster. So the key to help PPS will be to turn around the sentiment. This could be achieved by any number of the following events: a buy-in (5% to 10%), buy-out, Sanofi publicly announcing commitment of Afrezza, Mannkind securing some additional cash (around $100 million or so), Mannkind announcing a new TS partnership with a a major BP, steady uptick of Afrezza weekly TRx, steady improvement of insurance coverage of Afrezza, Mannkind announcing a successor CEO (with good qualifications). To give you an example how slowly Sanofi moves, we can take a look at how Sanofi launched Apidra.
Apidra was approved by FDA in April 2004 and Sanofi did not launch Apidra in the US until March 2006. If Sanofi had followed the same timeline with Afrezza, it would not launch Afrezza until June 2015.
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Post by compound26 on Nov 24, 2015 0:04:04 GMT -5
And for you consideration, in its annual review of 2007 ( en.sanofi.com/Images/16147_AR_2007_EN.pdf), after one year launch of Apidra in the US (Apidra was launched in UK in October 2005 and then in the US in March 2006), Sanofi barely mentioned Apidra (basically similar treatment to that of Afrezza in the last two conference calls of Sanofi). In that 48 page document, Apidra was mentioned in four places, each mentioning is just one sentence.
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Post by benyiju on Nov 24, 2015 2:11:40 GMT -5
intresting, thanks for digging this up
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Post by mnkdnut on Nov 24, 2015 4:13:37 GMT -5
In hindsight, the slow script growth was mostly baked into the cake when the FDA Study results were unlocked. At that point, commercialization experts at any BP would have realized that the data may be just good enough for FDA approval, but it would be very difficult to make a case with insurers. Large insurers today are setting the clinical evidence bar higher and higher. If you can't prove superiority (or equivalency with lower cost), there's no motivation for them to entertain it. Too many new treatments seeking their attention. Once given an audience, your proof needs to be a rigorously designed study capable of publication in a respectable clinical journal. Even a hundred carefully documented individual case studies would not cut it. I'm not surprised that MNKD could have overlooked this, as they have no commercialization staff in-house - they are an R&D shop. They took their outsourced marketing studies at face value. SNY should have realized this early on, and the proper response would have been to launch such a study (actually separate Type I and Type II studies) by now so we could have the data 1-2 years from now. It would be a significant effort, but no where near as costly or lengthy as waiting for the 8,000 patient lung study. We already know SNY has had to lower their expectations for Afrezza sales, so the going was tougher than they originally expected. By now they know it's going to take better evidence AND a real missionary/evangelist type of sales effort to reach an inflection point in scripts (btw, prescribers want to see solid clinical superiority evidence before going out on a limb too!). SNY hasn't demonstrated to me that they're really up for it. SNY seems satisfied to let it drag out at a pace that would require MNKD to raise more and more funds just to stay alive. They are preoccupied with Toujeo, Lixilan and Praluent, among others. I'm fairly sure Hakan was taken to task for not being able to get SNY to be more of the enthusiastic, capable and constructive partner they hoped and bargained for. Too bad Al couldn't fire Brandicourt! For PPS to recover, we're banking on Al (or his successor) being able to monetize TS in a significant way, sooner rather than later, and turn around SNY's lackluster approach. While I can't bring myself to be too optimistic given how things have progressed to date, I'm glad Al has personally taken the bull by the horns. Given his history, it would be hard to bet against him.
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Post by mnholdem on Nov 24, 2015 6:07:02 GMT -5
AL Mann certainly can fire Brandicourt, in effect, by firing Sanofi. First, MannKind must serve written notice of intent to terminate the License and Collaboration Agreement by claiming that Sanofi is defaulting by not caring out its obligations to use commercially reasonable efforts. Sanofi would then have 90 days to rectify the default or lose Afrezza and all rights, including the GLP-1.
Sanofi is required, by terms of the Agreement, to provide MannKind (via the JAC set up between the two companies) with its 3-year marketing plan for Afrezza. If MannKind does not agree with the plan or if Sanofi is not following the plan, then they could line up another partner and serve the termination notice.
What I wouldn't give to see that detailed 3-year plan! I would like to see the rationale behind applying for ex-U.S. Sales. Is Sanofi building a manufacturing facility for Afrezza? For me, that would be the only justification for Sanofi delaying EU and Japan applications that were talked about immediately following the partnership announcement.
Is this going to plan? I doubt it. Insurance coverage is likely the biggest delay and may be Sanofi's excuse for intentionally delaying DTC. That doesn't excuse not going international. I really do hope that Al kicks some French butts and gets Afrezza rolling.
Afrezza is both a monomer and is non-injectable. Even with the non-inferiority label, Sanofi should be able to market the distinction between Afrezza and RAA insulin. The second post-marketing clinical trial will be completed in a few weeks. The FDA itself has stated that positive data could result in some label changes. If I were with the FDA, I'd use this opportunity to save face for having royally screwed up the Afrezza trials, which will become apparent in the coming years.
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Post by benyiju on Nov 24, 2015 9:38:46 GMT -5
AL Mann certainly can fire Brandicourt, in effect, by firing Sanofi. First, MannKind must serve written notice of intent to terminate the License and Collaboration Agreement by claiming that Sanofi is defaulting by not caring out its obligations to use commercially reasonable efforts. Sanofi would then have 90 days to rectify the default or lose Afrezza and all rights, including the GLP-1. Sanofi is required, by terms of the Agreement, to provide MannKind (via the JAC set up between the two companies) with its 3-year marketing plan for Afrezza. If MannKind does not agree with the plan or if Sanofi is not following the plan, then they could line up another partner and serve the termination notice. What I wouldn't give to see that detailed 3-year plan! I would like to see the rationale behind applying for ex-U.S. Sales. Is Sanofi building a manufacturing facility for Afrezza? For me, that would be the only justification for Sanofi delaying EU and Japan applications that were talked about immediately following the partnership announcement. Is this going to plan? I doubt it. Insurance coverage is likely the biggest delay and may be Sanofi's excuse for intentionally delaying DTC. That doesn't excuse not going international. I really do hope that Al kicks some French butts and gets Afrezza rolling. Afrezza is both a monomer and is non-injectable. Even with the non-inferiority label, Sanofi should be able to market the distinction between Afrezza and RAA insulin. The second post-marketing clinical trial will be completed in a few weeks. The FDA itself has stated that positive data could result in some label changes. If I were with the FDA, I'd use this opportunity to save face for having royally screwed up the Afrezza trials, which will become apparent in the coming years. No one would dispute that Al is a visionary. It is less clear that he has the trench warfare skills needed to deal with a cagey Continental 'partner' like Sanofi. Hopefully we will get a real CEO soon, but unfortunately the dire financial situation of MNKD makes recruitment very difficult. We just have to pray that Al will work his magic one last time and pull a rabbit (i.e. hotshot CEO) out of the hat to save his namesake company before it's too late.
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Post by kball on Nov 24, 2015 10:04:29 GMT -5
AL Mann certainly can fire Brandicourt, in effect, by firing Sanofi. -snip for effect of my comment- No one would dispute that Al is a visionary. It is less clear that he has the trench warfare skills needed to deal with a cagey Continental 'partner' like Sanofi. -snip for effect of my comment- Anyone besides me, while happy Al is now more involved (at least publicly), worried that because of age and circumstances he is in no shape to even travel to France to confront/meet with Sanofi...they could just put off meeting and put off meeting in the US.
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Post by cathode on Nov 24, 2015 10:08:50 GMT -5
AL Mann certainly can fire Brandicourt, in effect, by firing Sanofi. First, MannKind must serve written notice of intent to terminate the License and Collaboration Agreement by claiming that Sanofi is defaulting by not caring out its obligations to use commercially reasonable efforts. Sanofi would then have 90 days to rectify the default or lose Afrezza and all rights, including the GLP-1. Sanofi is required, by terms of the Agreement, to provide MannKind (via the JAC set up between the two companies) with its 3-year marketing plan for Afrezza. If MannKind does not agree with the plan or if Sanofi is not following the plan, then they could line up another partner and serve the termination notice.What I wouldn't give to see that detailed 3-year plan! I would like to see the rationale behind applying for ex-U.S. Sales. Is Sanofi building a manufacturing facility for Afrezza? For me, that would be the only justification for Sanofi delaying EU and Japan applications that were talked about immediately following the partnership announcement. Is this going to plan? I doubt it. Insurance coverage is likely the biggest delay and may be Sanofi's excuse for intentionally delaying DTC. That doesn't excuse not going international. I really do hope that Al kicks some French butts and gets Afrezza rolling. Afrezza is both a monomer and is non-injectable. Even with the non-inferiority label, Sanofi should be able to market the distinction between Afrezza and RAA insulin. The second post-marketing clinical trial will be completed in a few weeks. The FDA itself has stated that positive data could result in some label changes. If I were with the FDA, I'd use this opportunity to save face for having royally screwed up the Afrezza trials, which will become apparent in the coming years. I don't really understand your argument about MannKind terminating the Sanofi partnership. MannKind and Sanofi came to agreements on the marketing strategy for Afrezza through the JAC. This includes the budget for advertising, marketing, educating, etc. I don't see how MannKind could use their current disagreement with the plan as a good argument for why they want to terminate. Claiming that you are unhappy with the deal/plan you agreed on so you are going to renegue the collaboration agreement seems childish. If Sanofi seriously deviates from the plan and does not communicate that to MannKind management then I would understand the concern and may view that as a signal to start looking for other partners. My view of the EU "delay" is that Sanofi is taking the time to complete and publish the recent post-approval clinical results so they can use that as evidence in the EMA submission. Seems pretty obvious to me that they might as well wait the extra 90(?) days and get the stuff published. "Pending results" doesn't look as good as actually having the results. EMA talks would also be informative to planning the 8000 patient long term safety study, so I understand the delay on starting that as well.
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Post by benyiju on Nov 24, 2015 10:09:43 GMT -5
No one would dispute that Al is a visionary. It is less clear that he has the trench warfare skills needed to deal with a cagey Continental 'partner' like Sanofi. -snip for effect of my comment- Anyone besides me, while happy Al is now more involved (at least publicly), worried that because of age and circumstances he is in no shape to even travel to France to confront/meet with Sanofi...they could just put off meeting and put off meeting in the US. I think Al is a placeholder, a respected name whose interim presence is designed to steady the ship while BOD finds a real CEO. Unfortunately, as I suggested above, that process is complicated by the mess MNKD is in currently, so it could drag on for a while, not to mention the issue of the BOD itself which seems to be somewhat dysfunctional and in need of a shakeup.
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Post by mnholdem on Nov 24, 2015 10:32:33 GMT -5
My rambling on about "firing" Sanofi was simply an illustration in response to mnkdnut's "too bad Al couldn't fire Brandicourt" comment posted above. Either side can terminate the agreement.
I'm not expecting it will happen, nor endorsing it. However, if MannKind is meeting every one of its obligations set forth by the JAC, but Sanofi is not, which has resulted in layoffs and financial difficulties for MannKind Corporation, then I absolutely believe that Al might verbally kick some derriere.
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Post by Deleted on Nov 24, 2015 10:33:07 GMT -5
Are you at this point in time not concerned with Mannkind's cash position? Week over week NRx is poor? Even with a TS deal which I suspect may be further down the road than management has led us to believe, if we continue to burn $8 - $10mm / month, things get more dire and dilution accelerates. Where are we in 4,6 or 8 months if we do not have significant NRx growth and a TS deal? Is it realistic that every 6 months, Al puts another $48mm - $60mm into Mannkind? I will not sell my shares but the flat NRx numbers week to week is a canary in a coal mine that is making more noise with the passing of each Friday's Rx numbers. I have been and always remain concerned about the MNKD cash position. However, the uptick in scripts is not going to be a linear curve. Either it is going to go exponential at some point based on insurance coverage and awareness or it will go to zero based on the fact that the company goes under and won't be producing the product. My risk analysis says the former is more likely than the latter at the present moment and I have put the appropriate stack of chips on the table accordingly. When and if that analysis changes, I will look to weight or lighten my position. Making any sort of rash decision due to the sentiment of the moment has never been my idea of good investing. NRx week over week is going to have to start to show some serious growth in the Feb - March timeframe. Serious being at least 12%. That and a few gap ups in NRx count along the way will build confidence. Without this, a TS deal or commercialization of Afrezza in another country or two, it will be a very difficult road to travel. Al Mann at 90 is far more effective than most people are at 60 so perhaps he has a bullet or two left beyond just economic resources.
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Post by patryn on Nov 24, 2015 12:05:06 GMT -5
I have been and always remain concerned about the MNKD cash position. However, the uptick in scripts is not going to be a linear curve. Either it is going to go exponential at some point based on insurance coverage and awareness or it will go to zero based on the fact that the company goes under and won't be producing the product. My risk analysis says the former is more likely than the latter at the present moment and I have put the appropriate stack of chips on the table accordingly. When and if that analysis changes, I will look to weight or lighten my position. Making any sort of rash decision due to the sentiment of the moment has never been my idea of good investing. NRx week over week is going to have to start to show some serious growth in the Feb - March timeframe. Serious being at least 12%. That and a few gap ups in NRx count along the way will build confidence. Without this, a TS deal or commercialization of Afrezza in another country or two, it will be a very difficult road to travel. Al Mann at 90 is far more effective than most people are at 60 so perhaps he has a bullet or two left beyond just economic resources. It would have to for Afrezza to be successful. Blockbuster drugs don't scale linearly - nor do most blockbusters. They have some 'aha' moment where the convergence of luck, fate, kismet, karma, or perhaps divine intervention yields a confluence of events that gets the sales to a new level. I have personally seen this in some of the products we sell and have seen this in quite a few of the breakthrough companies of our times. Therefore, I am willing to risk my money to see if Afrezza can hit the milestone. I truly believe that if it does, it will happen sometime in the next year, and I know that MNKD has the financial wherewithal to survive the next year so I am willing to be patient. I don't have the same blind trust in Al or Afrezza that some others do as I do not necessarily think that the steps taken by Al to protect his investment would line up with the long term interests of his minor shareholders, however my investment thesis remains that an inflection point will be coming and I want to be along for that ride.
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Post by kc on Nov 24, 2015 12:11:37 GMT -5
Patryn, we need all of the mentioned items. "'aha' moment where the convergence of luck, fate, kismet, karma, or perhaps divine intervention " My Thanksgiving pray before the feast will innclude your words of need.
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Post by Chris-C on Nov 24, 2015 12:23:40 GMT -5
Anyone besides me, while happy Al is now more involved (at least publicly), worried that because of age and circumstances he is in no shape to even travel to France to confront/meet with Sanofi...they could just put off meeting and put off meeting in the US. I think Al is a placeholder, a respected name whose interim presence is designed to steady the ship while BOD finds a real CEO. Unfortunately, as I suggested above, that process is complicated by the mess MNKD is in currently, so it could drag on for a while, not to mention the issue of the BOD itself which seems to be somewhat dysfunctional and in need of a shakeup.@ Benyiju Not sure how you come to the conclusion that the BOD is somewhat dysfunctional. They had the judgment to remove a non-performing CEO and the wisdom to name the most appropriate interim CEO. Please explain... TIA, Chris C
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