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Post by Deleted on May 20, 2018 14:32:16 GMT -5
MannKind (MNKD) has for quite some time been known as a company founded by a billionaire who was looking for what he envisioned as the best possible solution for getting needed insulin to diabetics. The idea and cause were both noble. Up until this point MannKind has had struggles at every crossroad. From getting Afrezza approved to raising cash, the story has been a frustrating one for investors. Perhaps what MannKind needs is a vision that goes beyond Afrezza. At the moment, other compounds are essentially inklings of ideas. What I am talking about is essentially a reinvention of MannKind. In biopharma, part of the ability to raise money comes from having a good idea that needs to be proven out. Investors will get behind such an idea. It happened with Afrezza. The problem is that Afrezza is no longer viewed as an infant with all the potential in the world anymore. It is viewed (at least by quite a few) as a troubled teenager that sometimes does good, sometimes does bad. Potential exists, but realities point (perhaps) to that potential being limited. What if MannKind were to do with Afrezza what some may consider unthinkable. What if MannKind were to sell it off in exchange for a small royalty and a manufacturing contract? In some ways, this may give Afrezza its best chances at marketing success. seekingalpha.com/article/4175705-new-mannkind-possible
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Post by goyocafe on May 20, 2018 15:44:16 GMT -5
The author does not give enough credit to the pk/pd profile of Afrezza. CEO Mike and Dr Kendall clearly see the direction for Mannkind going almost in the completely opposite direction.
Spencer, you’re good with numbers! Why not write your next article in line with what is being touted as the best prandial insulin and possibly a disruptive force to the status quo of the treatment paradigm for diabetes?
What would the dominant prandial insulin be worth in market cap to the company that owns the complete rights to such a product? More to this point, there is more and more talk of the benefits of early intensive insulin treatment having a lasting and profound affect on slowing the progression of the disease. Coupled with a superior safety profile, leading to the possibility that Afrezza could find a roost somewhere earlier in recommended treatment protocols, what is Afrezza worth if and when these changes occur?
Since that seems to be the way Mannkind is heading and making strides to achieve, it would be refreshing and encouraging to see those numbers in an article by you.
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Post by joeypotsandpans on May 20, 2018 18:51:55 GMT -5
When relative to Arena (Belviq) I get where Spencer is coming from, however, as he states the pipeline right now consists of Afrezza and a phase I possible PAH technosphere treatment. From our gathering last Tues. evening it was clear to me that Mike and the company are 100% focused on the task at hand which is massively increasing the pull side of the equation to get scripts into the hockey stick direction. He stated Trep-T was as black and white as could be as the response they received from the FDA was very clear regarding what would be needed to move it forward and because of that it would be the most sensible next drug to move forward with the least cash drain. With limited resources, as Spencer states they need to be very prudent in threading the needle regarding juggling cash spend in moving a pipeline along while at the same time making sure their pearl/jewel realizes the potential that those believe it has.
One could question although it was a partnership, that had Sanofi actually took the full rights to Afrezza how that would have played out? Do you think MNKD would have been receiving a windfall of royalties by now, personally I doubt it? So regarding the idea of creating a "new Mannkind" and analogizing it to ARNA all things considered it would be safe to say that Belviq was not necessarily threatening a huge direct disruption to specific BP franchises per se ie., NOVO, LLY, SNY, MRK among others. So having said that, I believe there would be an inherent risk associated with giving up the rights to Afrezza, especially to one of the larger companies already in the space that could do what Al had feared if in the wrong hands, and that would be the self-serving interest of burying to preserve the status quo of diabetes care. It would be nice to assume that the BP's would do the noble thing, however we all know what happens when we assume, especially when it comes to bottom lines.
I'm on board with the fact that the label change was not quite what MNKD was looking for. I believe they wanted it in a separate class to distinguish the benefits and helping create the ability to enter as a new class of insulin that would become a Tier 2 on formulary for speed of response and reduced hypo risk...as others have mentioned, that was not possible due to the way the studies were instructed by the FDA and designed and followed by MNKD. However, I believe Spencer is lumping the STAT study and the late breaking submission regarding reduced hypo risk in with the updated label results. After listening to Dr. Kendall regarding both the STAT along with the accepted late breaking study on reduced hypos and what their impact will be on the providers, I am in agreement that it will result in a sharp increasse in pull through from the providers and lead to increased better coverage insurance wise. This is where I see Mike being confident in reaffirming guidance.
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Post by sayhey24 on May 21, 2018 5:28:44 GMT -5
"What if MannKind were to do with Afrezza what some may consider unthinkable. What if MannKind were to sell it off in exchange for a small royalty and a manufacturing contract? In some ways, this may give Afrezza its best chances at marketing success."
The question is, do you believe afrezza is the HUGE market disrupter some think it is? Can it really become the standard of care? If so selling it off is unthinkable.
Mike will continue to build sales and entertain buy-out offers. At some point the offers will start getting serious as sales build and Mike will have to start taking them serious. We are not looking at a sell-off of afrezza. We are looking at a buy-out of MNKD. The question is when? afrezza is just too big and with the right "scientific marketing" by Dr. Kendall BP needs to make a move sooner than later.
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Post by peppy on May 21, 2018 6:28:21 GMT -5
"What if MannKind were to do with Afrezza what some may consider unthinkable. What if MannKind were to sell it off in exchange for a small royalty and a manufacturing contract? In some ways, this may give Afrezza its best chances at marketing success." The question is, do you believe afrezza is the HUGE market disrupter some think it is? Can it really become the standard of care? If so selling it off is unthinkable. Mike will continue to build sales and entertain buy-out offers. At some point the offers will start getting serious as sales build and Mike will have to start taking them serious. We are not looking at a sell-off of afrezza. We are looking at a buy-out of MNKD. The question is when? afrezza is just too big and with the right "scientific marketing" by Dr. Kendall BP needs to make a move sooner than later. Continuous glucose monitors our friend, revealing the Pharma lies to save their franchises. Mike said, paraphrasing, the continuous glucose monitors allow the Afrezza PK profile to be seen as blood glucose levels by physicians. The graph of how effective Afrezza is to control after meal blood glucose levels will be able to be visualized by physicians in about 32 days. I have to believe physicians who over time never see their patients get better: want to see their patients get better. Where was it I read, Kendall is saying, the hypoglycemia data exists. no more trials are needed? Kendall chief scientific and medical officer at the ADA should know. From another thread aged said, That is actually the reason the the risk assessment makes it worth taking Jardiance. It gives a 1/330 chance of an amputation vs. a 1/200 chance of avoiding a major cardiovascular event. To put it another way the numbers for amputation were 6.3 versus 3.4 per 1,000 patient years. Those numbers were all from the CANVAS study. The EMPA-REG OUTCOME study though had 1.9% with SGLT2 and 1.8% without. The numbers from that study were retrospective though - they reviewed the severe outcome reports and identified amputations, apparently sometime toe amputation is not considered severe... The most interesting finding was that the increase in amputations was almost eliminated if the patient was on basal insulin or metformin. The flip side to that was that if you removed the insulin or metformin treated patients the amputation rate rises. Read more: mnkd.proboards.com/user/764/recent#ixzz5G8PCd2uRSO, a 33% less hypoglycemia? That is significant.
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Post by mango on May 21, 2018 6:56:09 GMT -5
Whoever wrote that doesn't understand. When Afrezza becomes the Standard of Care, MannKind will become the most important company in the world. The greatest threat the world faces today is diabetes and it is only going to get worse. Afrezza actually stops does something about that, it halts the disease process and prevents all the diabetes-related complications that are caused from the dysregulation in glucose homeostasis.
Kendall is so blown away by all of it he's using poetic imagery to describe the data, veins of gold.
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Post by joeypotsandpans on May 24, 2018 9:11:37 GMT -5
With reference to the aforementioned article and title I would argue that a case could be made that not only is it possible but it already is "A New Mannkind" and those with the blinders on are either in denial or just haven't realized it yet. Over the last couple of days in the comments section of the article there has been some debate back and forth regarding whether or not SNY made the honest effort with PRIOR mgmt. to honor their joint agreement etc. toward a successful launch of Afrezza. We all have our opinions regarding same so this isn't about that rather more to establish the point about "The Old Mannkind" and how this already is "The New Mannkind" and there are those that still lump the NEW mgmt. team in with the past. For me the time spent to go to the dinner and ASM was invaluable. I queried Mike about his thoughts on SNY and the original launch, in a very diplomatic fashion he retorted about comparing their simultaneous launch of Toujeo with respect to DTC advertising, marketing, and brand awareness. He also mentioned the unfortunate timing of the visionary (my term) Viehbacher's departure who was in alliance with Al regarding what Afrezza could mean to the T1/T2 population with respect to mealtime insulin and the dinosaur (again my term) Brandicourt who had been in charge at the time of Exubera's launch with Pfizer. In essence, it was the "perfect storm" regarding the negative timing for Afrezza's launch at SNY. Couple that with again the "perfect storm" negative timing of SNY leaving MNKD at the alter on it's one year anniversary along with Al's passing just a month later and the "Old Mannkind" picture is easy to see. Mar 2016 just one month after Al's passing and the "New Mannkind" is born: VALENCIA, Calif., March 14, 2016 (GLOBE NEWSWIRE) -- MannKind Corporation (NASDAQ:MNKD) (TASE:MNKD) today announced that Michael E. Castagna, Pharm.D., has joined the company as its Chief Commercial Officer, effective immediately. Dr. Castagna will lead commercialization efforts for Afrezza®, reporting to Matthew Pfeffer, Chief Executive Officer, and will serve on MannKind's executive leadership team. Dr. Castagna has over 20 years of experience in healthcare, pharmaceutical, biotech and specialty pharmacy industries. He joins MannKind from Amgen, Inc., where he spent over three years as Vice President, Global Commercial Lead for a portfolio of nine biosimilar drugs, and Vice President, Global Lifecycle Management. Prior to Amgen, Dr. Castagna, was Executive Director of Bristol-Myers Squibb's Immunology franchise, where he served as co-lead to relaunch Orencia IV and launch Orencia SC, both rheumatoid arthritis drugs. Before BMS, Dr. Castagna was with Sandoz (Novartis) as Vice President and Division Head for Biopharmaceuticals, North America, where he established the US Biologics Business Unit and relaunched its lead product, Omnitrope, a human growth hormone. Prior to Sandoz, Dr. Castagna held a variety of positions with EMD (Merck), Serono, Pharmasset and DuPont Pharmaceuticals. Dr. Castagna received his Bachelors of Science - Pharmacy degree from Philadelphia College of Pharmacy, his Doctor of Pharmacy from Massachusetts College of Pharmacy, and his MBA from the Wharton School of Business at the University of Pennsylvania. "I'm very pleased to welcome Michael to the MannKind team in this important new role," said Matthew Pfeffer, Chief Executive Officer of MannKind Corporation. "His extensive pharma background, including driving sales and marketing for so many new and relaunched products, will be invaluable as we prepare to reintroduce Afrezza to the market in the coming months." Dr. Castagna said, "I am excited to be joining MannKind at this critical intersection as we transform our future. I am enthusiastic about the commercial opportunity for Afrezza and the potential it has to help adults with diabetes manage this difficult disease." MannKind also announced today that Juergen A. Martens has resigned as its Chief Operating Officer, effective March 18, 2016. Mr. Pfeffer added, "Juergen was instrumental in building the commercial manufacturing infrastructure that we have today in Danbury. We thank Juergen for his many contributions to the company, and we wish him the very best. Operationally, MannKind's Chief Technology Officer and Senior Vice President for Technical Operations, Joseph Kocinsky, will continue his existing responsibilities for the manufacture of Afrezza." Read more: mnkd.proboards.com/thread/5285/mannkind-announces-appointment-michael-castagna#ixzz5GQOmzvFZThe domino's then continue to fall into place: Mike eventually becomes CEO at the end of May 2017....essentially one year ago. Mike brings in a new CCO Pat McCauley and then the new CMO who in turn has some additional key personnel follow. So let's compare the "Old Mannkind" with the "New Mannkind" Old Mannkind: Al Mann, Matt Pfeffer, Hakan Edstrom, Dr. Ray Urbanski, Juergen Martens New Mannkind: Mike Castagna, Pat McCauley, Dr. David Kendall It is as plain as day the differences between the two "companies", the prior one was not meant as a total pharmaceutical company but rather more research and manufacturing, the current one has the complete makeup of a pharmaceutical company. Without going into the resume's and differences between the key players involved outside of Al (one can easily pull up the resume's and backgrounds of each of the individuals mentioned) it is clear the differences between the two companies. Had Mannkind not morphed into a newly formed pharmaceutical company already I would most likely agree and be open minded to the author's concepts regarding his take of a "New Mannkind", however, given the promise of the new leadership and their respective global experience and backgrounds I submit that it already is a "New Mannkind" and vastly different from the "Old Mannkind" and much of this will be recognized in the next few quarters if it already hasn't been. Continuing with the domino's theme:
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Post by hellodolly on May 24, 2018 12:56:56 GMT -5
Very well laid out Joey. The differences are obvious if you take the time to take off the blinders and see the forest through the trees, as you have done. Best regards -
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Post by sportsrancho on May 24, 2018 13:04:11 GMT -5
Joey you are one of a kind! 😎 Great post... completely new company in my opinion also.
I just have a few random thoughts. Mike gets it. He gets it all. He sold his shares when we partnered with SNY. And you guys know that SNY didn’t even show up at any of the doctors offices that I know of! After they dumped us they ran in and left some flyers on the front desk. The doctors I know all read the Wall Street Journal, first time they EVER heard about Afrezza was the story of SNY dumping us!
As far as hurt feelings go, I’ve been called everything in the book lately because I voted for Mike for CEO of the year. I can’t even repeat it here! But we all know that’s part of the deal, if you can’t swim with the sharks don’t get in the water:-)
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Post by agedhippie on May 24, 2018 13:30:17 GMT -5
Joey you are one of a kind! 😎 Great post... completely new company in my opinion also. I just have a few random thoughts. Mike gets it. He gets it all. He sold his shares when we partnered with SNY. And you guys know that SNY didn’t even show up at any of the doctors offices that I know of! After they dumped us they ran in and left some flyers on the front desk. The doctors I know all read the Wall Street Journal, first time they EVER heard about Afrezza was the story of SNY dumping us! As far as hurt feelings go, I’ve been called everything in the book lately because I voted for Mike for CEO of the year. I can’t even repeat it here! But we all know that’s part of the deal, if you can’t swim with the sharks don’t get in the water:-) My personal favorite is - If you’re afraid of wolves, don’t go into the forest.
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Post by hellodolly on May 25, 2018 6:00:21 GMT -5
Joey you are one of a kind! 😎 Great post... completely new company in my opinion also. I just have a few random thoughts. Mike gets it. He gets it all. He sold his shares when we partnered with SNY. And you guys know that SNY didn’t even show up at any of the doctors offices that I know of! After they dumped us they ran in and left some flyers on the front desk. The doctors I know all read the Wall Street Journal, first time they EVER heard about Afrezza was the story of SNY dumping us! As far as hurt feelings go, I’ve been called everything in the book lately because I voted for Mike for CEO of the year. I can’t even repeat it here! But we all know that’s part of the deal, if you can’t swim with the sharks don’t get in the water:-) My personal favorite is - If you’re afraid of wolves, don’t go into the forest. I'm afraid of bears!
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Post by hellodolly on May 25, 2018 6:02:10 GMT -5
Joey you are one of a kind! 😎 Great post... completely new company in my opinion also. I just have a few random thoughts. Mike gets it. He gets it all. He sold his shares when we partnered with SNY. And you guys know that SNY didn’t even show up at any of the doctors offices that I know of! After they dumped us they ran in and left some flyers on the front desk. The doctors I know all read the Wall Street Journal, first time they EVER heard about Afrezza was the story of SNY dumping us! As far as hurt feelings go, I’ve been called everything in the book lately because I voted for Mike for CEO of the year. I can’t even repeat it here! But we all know that’s part of the deal, if you can’t swim with the sharks don’t get in the water:-) Angered that you were ridiculed . But, I don't think it had any impact on you whatsoever.
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Post by boca1girl on May 25, 2018 8:07:56 GMT -5
Joey you are one of a kind! 😎 Great post... completely new company in my opinion also. I just have a few random thoughts. Mike gets it. He gets it all. He sold his shares when we partnered with SNY. And you guys know that SNY didn’t even show up at any of the doctors offices that I know of! After they dumped us they ran in and left some flyers on the front desk. The doctors I know all read the Wall Street Journal, first time they EVER heard about Afrezza was the story of SNY dumping us! As far as hurt feelings go, I’ve been called everything in the book lately because I voted for Mike for CEO of the year. I can’t even repeat it here! But we all know that’s part of the deal, if you can’t swim with the sharks don’t get in the water:-) Sports, I’m a bit older than you, but when I was a kid, we had a little rhyme we used when we were called names...”sticks and stones can break my bones, but names can never hurt me”. I can can relate. Everyone of my investment buddies, keep telling me that I’m crazy to keep holding and committing new money to MNKD. There is no guarantee that the science will prevail, but I’ll continue to ignore the naysayers, and hold on tight for this rollercoaster ride. Congratulations on spearheading the drive to get Mike elected Pharma CEO of the Year. As one of the “cult members”, I appreciate all your efforts to spread the word on Afrezza.
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Post by peppy on May 25, 2018 8:15:02 GMT -5
Joey you are one of a kind! 😎 Great post... completely new company in my opinion also. I just have a few random thoughts. Mike gets it. He gets it all. He sold his shares when we partnered with SNY. And you guys know that SNY didn’t even show up at any of the doctors offices that I know of! After they dumped us they ran in and left some flyers on the front desk. The doctors I know all read the Wall Street Journal, first time they EVER heard about Afrezza was the story of SNY dumping us! As far as hurt feelings go, I’ve been called everything in the book lately because I voted for Mike for CEO of the year. I can’t even repeat it here! But we all know that’s part of the deal, if you can’t swim with the sharks don’t get in the water:-) Sports, I’m a bit older than you, but when I was a kid, we had a little rhyme we used when we were called names...”sticks and stones can break my bones, but names can never hurt me”. I can can relate. Everyone of my investment buddies, keep telling me that I’m crazy to keep holding and committing new money to MNKD. There is no guarantee that the science will prevail, but I’ll continue to ignore the naysayers, and hold on tight for this rollercoaster ride. Congratulations on spearheading the drive to get Mike elected Pharma CEO of the Year. As one of the “cult members”, I appreciate all your efforts to spread the word on Afrezza. Did American Pharmacy Purchasing Alliance get MIKE C picture and corporation affiliation poster correct now? Is it up? (Triple check system)
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Post by sportsrancho on May 25, 2018 9:18:05 GMT -5
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