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Post by mindovermatter on Feb 11, 2016 12:52:40 GMT -5
Is it possible MNKD is now "sandbagging" their renewed efforts so that they have bargaining leverage (divorce settlement) as the partnership winds down? Once the termination is final MNKD could announce several things (Q2) that could propel things & get BP's & people interested in Afrezza. How can Mannkind be sandbagging what they still do not have the rights to?
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Post by mindovermatter on Feb 11, 2016 9:06:58 GMT -5
240 dollars / 30 days = 8 dollars a day not really much change
Maybe not much change but Afrezza is comparable now cheaper than Humalog in St. Louis by $30! You can make Afrezza free but if no one is aware of it then it won't matter. Mannkind has a lot of ground to make up and the question is whether or not Matt and his staff have the wherewithal to right a lot of wrongs. As for the clinics, I'd have someone dress up as a dream boat and stand out side the clinic waving at drivers.
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Post by mindovermatter on Feb 10, 2016 19:27:39 GMT -5
Bottom line. This is not a company that is going under! They are doing a lot of work. I like it! Read between the lines on insider buying! They have news ! Just my opinion! I didn't see anything about sources of funding so not sure where you see anything regarding future solvency or lack thereof. Also... hate to say I think you can read between the regarding insider buying a "whew, glad we can hide behind SEC as an excuse" just as easily as putting a positive spin on it. They had planned sales that occurred automatically, and those can be used to avoid insider info buying restrictions as well. So in reality if they had conviction, purchases would be possible. I don't blame them for not, however. They have plenty of upside exposure with options they are given and they already have downside exposure in that they'll be out of jobs in the worst case scenario. Some on here believe that Mannkind is like HeLa cells and can survive anything. The company needs cash to survive and so far we haven't seen anything to suggest they will be able survive past this year let alone this year. Hence why the stock is under $1.
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Post by mindovermatter on Feb 10, 2016 7:14:58 GMT -5
It's important that results are released in a peer reviewed publication. Hopefully, MannKind had some say in this process because I don't trust Sanofi to ensure that Afrezza study results are shown in the best light. Makes sense and is usually the way to roll out trial data. But, will it matter? Will the clamp data results make endos/pcps change their mind about Afrezza and embrace it as a viable weapon to fight diabetes? I'm not so sure it will.
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Post by mindovermatter on Feb 10, 2016 7:04:22 GMT -5
Well it's evident that Bernie Sanders is going to focus on the drug companies. He targeted three of them tonight. He didn't say who they are so it's hard to determine if Sanofi was one of them. But you can imagine that drug stocks will tank tomorrow. Bernie's comments below We should not be paying by far the highest prices in the world for prescription drugs at a time -- listen to this, when the top three drug companies in this country made $45 billion dollars in profit last year. That is an obscenity, and let me tell you something. When we make it to the White House, the pharmaceutical industry will not continue to rip-off the American people. Feel the Bern..... If only Socialist Bernie Chavez Sanders was as passionate about going after BIG GOVERNMENT that rips off the American people in a way no other industry can and does.
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Post by mindovermatter on Feb 9, 2016 19:59:29 GMT -5
Assuming Mannkind still owns Afrezza and that Mannkind is still in business. 6 months ago, many people on here would never have believed anyone had it been posted on here SNY would ditch Afrezza, Hakan would be removed as CEO, a new CEO would be named but only last a few weeks, then Matt would become the CEO of last resort and Mannkind would be up s**t creek as it is now.
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Post by mindovermatter on Feb 9, 2016 17:26:20 GMT -5
Excerpts follow. But others saw more fundamental reasons to scrap the idea: Novo Nordisk said at the time that it couldn't overcome the fact that inhaled insulin wouldn't eliminate the need for injections. That is because only short-acting insulin, which is taken as a boost at mealtimes, could be administered via an inhaler. Most diabetes patients on insulin--those with Type 1 or advanced Type 2-- also take a long-acting version to provide a constant minimum level, which would need to be injected. By ending the agreement when it did, Sanofi capped its 2015 losses at roughly EUR200 million. [ This wouldn't stand as CRE. Pfizer spent $2B+$135M settlement. This is great news for the expected Sanofi's large settlement extending Mnkd runway by a few years.] But Sanofi badly underestimated the toll that safety concerns would have on Afrezza's sales. Existing worries among doctors over links with lung cancer were compounded by the U.S. Food and Drug Administration's warning that inhaled insulin could cause breathing difficulties in people with respiratory problems. The agency also required MannKind to run a follow-on trial to determine whether Afrezza did increase patients' cancer risk. The agency also stipulated that doctors test patients' lung health with a device known as a spirometer before prescribing the drug. As most diabetes doctors don't have a spirometer, they would need to send patients to another physician for the test. Doctors might have been more willing to take on the risk and effort of prescribing Afrezza if MannKind had demonstrated that it is more effective than injected insulin, said Jane Chiang, senior vice president for medical affairs at the American Diabetes Association. But the company's clinical trials for Afrezza proved only that it is as effective as, not better than, the injected alternative, a status that is reflected in Afrezza's FDA label. Further, most payers in the U.S. have Afrezza in a "tier three" reimbursement category. That generally comes with higher copays and requires physicians to explain why they prescribed Afrezza over standard injected insulin. Sanofi also priced Afrezza at a premium to its injectable counterparts. MannKind's Mr. Pfeffer said pricing and reimbursement issues "dramatically outweigh the other factors" related to Afrezza's slow uptake. Without a clinical trial showing that Afrezza worked better than injected insulin [Ground for breach of Commercially Reasonable Effort (CRE). Sanofi should have started Phase 4 Superiority trial in Sept 2014 before PBMs place Afrezza as Tier2 w/o PA, ST.], Sanofi's advertising campaign centered on the novelty of inhaling versus injecting. But the company overestimated the extent to which patients would switch to Afrezza due to a needle aversion, said Eamonn O'Connor, an analyst at the health-care consulting firm Decision Resources Group. Despite these setbacks, Afrezza has gained a small but avid following among patients who say it works significantly better for them than injected insulin. Forty-year-old Mike Parise said his blood sugar starts falling within five to 10 minutes after he takes Afrezza, much quicker than with injected insulin. "For someone who's had Type 1 for 20 years, that's a beautiful thing," he said. Jackie Klass, 52, said using Afrezza had helped her gain control over her blood-sugar levels for the first time since she was diagnosed 17 years ago and had "changed my life." She owns shares in MannKind. But many others didn't stick with it: A Sanofi spokeswoman said that of the 6,000 patients prescribed Afrezza since its launch, only 35% stayed on the treatment. Read more: www.nasdaq.com/article/sanofi-is-forced-to-end-latest-diabetes-effort-20160209-01284#ixzz3zi8y5U3OIt remains to be seen if MNKD will be receiving any sizable settlement check or one at all. I'd love to wake up tomorrow with news of one but this company always finds a way to disappoint.
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Post by mindovermatter on Feb 8, 2016 16:14:56 GMT -5
I still find it unbelievable that the sales are so weak. Even just pulling in rich early adopters, there ought to be more. The past six months I have waited for those weekly numbers and assumed it was going to start soon, but nothing. Flatlined since last summer. The product seems to be good, there is some awareness among social media savvy PWD, it's expensive but (as that unfortunate Lilly exec said) the disease is more expensive. Has this been discussed seriously on another thread? I've really been scratching my head, or I should say I was, late last year. At this point I hardly even check on Fridays any more since I have been conditioned to be disappointed. I think the physicians are afraid of lawsuits should a lung problems occur. (I could not figure it out either.) Also physicians do not seem to understand afrezza.
It was the continuous glucose blood monitors that drew me in, then smart people figured out why and how Afrezza works and told me/us. It really is the phase one insulin response that stops glucose from rising high in the first place. Then the phase two response. screencast.com/t/ZaphFSR2qYT5 Sales representatives can NOT say, Afrezza works by initialing the first phase insulin response so glucose levels do not raise so high in the first place to the physicians.
(That GLP-1 also tells the liver to stop putting out glucose. Interesting the over lap there.)
My thinking is that both fear of law suits and corruption of the system are involved.
Why would doctors fear a lawsuit over prescribing Afrezza when they prescribe many other drugs that have the same or worse side effects?
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Post by mindovermatter on Feb 8, 2016 14:04:33 GMT -5
I am worried that certain Arab countries will end up re-engineering the inhalers into a dreamboat bomb.
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Post by mindovermatter on Feb 6, 2016 15:44:22 GMT -5
My momma always said, "eat the foods you love but always EAT IN MODERATION." So if you haven't, maybe cut down on the portions. Or you could just do what boxers do. Chew the food to get the taste but don't swallow the food. Spit it out!
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Post by mindovermatter on Feb 6, 2016 9:04:33 GMT -5
Informative opinions will be appreciated. Short answer - yep, mnkd can indeed survive. Stop reading here if good enough, or, read on for my thoughts on the subject. Steps to survival - mnkd needs to survive at least 5 yrs or more and during those years get the trials done or moving forward to completion, work out a plan to get the most sales for the least cost, reduce expenses to match available cash/debt, and continue to work afrezza into the mindset of a few docs and a few patients at a time. A grass roots approach. Keep it low cost while building a base. SNY tried it and this is what they produced. Unless mnkd gets a pile of cash, they will have to do the same slog. MNKD can survive without a BO just like any other entity - if expenses can be reduced to match income. At this point it's pretty clear that there's been reductions in mnkd's workforce from top to bottom. That's a good start. In the last two CC's, matt points out what they can do for very little cost (skeptical on that but, for now, but ok). All good ideas given their situation. But sales as they are will not cover mnkd's monthly nut no matter how much they cut expenses largely due to costs out of their control (FDA required trials, marketing/sales costs, manufacturing costs to name a few). They will need to increase sales. Rough number crunching suggests mnkd needs revs around 300 mil to cover their monthly burn rate of 8-10 mil. Less rev requirements if they can cut costs deeper. So, what happens in the interim while sales are ramping up? Debt or other cash raising events. I believe this is where the trouble is for mnkd. MNKD is already in a deal with the devil (deerfield - which, by the way, is not a wells fargo or citibank, they are a small step above loan sharks for the biotech industry), they have already tried to raise money in more traditional ways and met significant market resistance, the tase event was very unusual (details for another post as to why), no cash generating partnerships are appearing, and until we learn otherwise it would appear al is on the sidelines. Anyone thinking mnkd could issue more shares in their current condition is in for an education in business finance. Any loans will likely require collateral given the poor sales of afrezza and I'm pretty sure they are mostly tapped out of assets to put up as collateral. So where does the debt come from to move forward beyond 2016? At some point when a company runs out of cash/debt, that's pretty much it. Time to file BK and either restructure or simply sell off all remaining assets and dissolve. Matt says they have plenty of cash but that's all smokescreen from the very guy who can't say anything else other than they have plenty of cash. Where the cash comes from to continue moving forward beyond 2016 is why the stock is trading where it's trading and until that question is resolved, the weight around mnkd's neck will remain. To the idea that online advertising will fix mnkd's "get the word" out problem, not likely and in a more direct way, just not possible. Docs don't take their cue's from online advertising, nor should they, and people are quickly becoming more and more numb to all those ads popping up when simply trying to surf their favorite websites. Adding to that, there's a significant amount of education required to use afrezza vs popping a pill which requires help from a doc. And lets not forget that online advertising won't solve the insurance coverage issue or out of pocket expenses vs competing insulins. And while saying that mnkd can reduce the pricing (which I have advocated long before the launch), pricing alone isn't the answer nor is it the whole problem. For starters, if there's any signs that that approach is taking hold ALL competitors will simply reduce the price of their products and attempt to run mnkd out of business so they can raise their prices later on. Can mnkd survive a price war? Mannkind's 2nd choice CEO has alluded to the strategy of selling Afrezza in volume to one or a few foreign nations to help its cause while it tries to establish a US foothold for the drug. We will have to wait to see if this works. I do not expect Mannkind to find a suitable partner again for Afrezza until Mannkind can show there is a marker for it in the US. I also think Mannkind should work with a Mexican Cartel to develop safer inhaled illegal drugs on the side to help its cash flow issue. I know for a fact a junkie would rather inhale than inject. Customers that OD are not good for business
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Post by mindovermatter on Feb 4, 2016 13:41:39 GMT -5
I think any relation between RLS and Alphabet/Verily is quite unfounded. All the information we know about the MNKD-RLS agreement is that it is for compounds related to inflammation, spasticity, pain, and nervous system disorders. These are not related to the diabetes space at all, which is the first disease candidate Verily has its sights on. Further speculation on a RLS-Alphabet relation is wasted time in my opinion. It would be better to put the effort into some fact finding about the RLS VPs and their prior dealings/accounts. Leave it to Mannkind, the new and improved transparent biotech to partner with RLS, the most secretive and unkown biotech in the business! But I do agree with you. All of this speculation is is just that. No one really knows who RLS is.
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Post by mindovermatter on Feb 4, 2016 9:41:08 GMT -5
No one should read this. Everyone should listen. I read and listened over again. I felt ok when reading it but didnt feel the same when I listened a second time. Transcripts can not convey how Matt seemed to be on the defensive and reflect his nervous tone. Again, Mannkind proves that it is always capable of screwing up things that shouldn't be screwed up.
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Post by mindovermatter on Feb 4, 2016 6:51:46 GMT -5
The product cost is highly sensitive to volume, they plan to lower the price to parity with competitors, there are 8 weeks left before they can do this They intend to target volume in international markets where no further filings or studies are required They have the cash to take a run at this new strategy That's a half full glass to me Since past execution has been less than stellar, shareholders can only HOPE that they can get it right now. But that is the problem. A management team that has been ineffective in the past doesn't have great odds of executing well in the future.
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Post by mindovermatter on Feb 4, 2016 6:49:26 GMT -5
I am NOT a money guy but I did not get the impression from listening to Matt that they will be running out of money right after Sanofi deal is over in April. Sounds like he has plans in place restructuring debt and making some money and foreign markets. If I am incorrect please explain. 4 things. Seems the only thing outside of SNY moving Afrezza up to the split day is the clinic that hopefully will open soon that will be successful and help slowly increase Afrezza scripts. Next, possible negotiation of money from Sanofi (not a sure bet). And then your points of restructuring debt (if that happens) and hopefull "in place and ready to run" deals with foreign countries to increase volume.
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