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Post by mrv on Dec 24, 2014 10:05:28 GMT -5
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Post by mnholdem on Dec 24, 2014 12:42:17 GMT -5
He didn't throw in any barbs... nice piece that may help attract investors.
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Post by ezrasfund on Dec 25, 2014 14:03:57 GMT -5
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Post by biotec on Dec 26, 2014 8:36:19 GMT -5
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Post by brentie on Dec 27, 2014 15:09:32 GMT -5
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Post by afrizzle on Dec 28, 2014 17:00:02 GMT -5
Many curious statements in this one "The market potential for diabetes drugs is enormous. According to the latest figures from the Centers for Disease Control and Prevention, 29.1 million people in the United States have diabetes (90%-95% of all cases are type 2 diabetes), with another 86 million in the pre-diabetes state. One or two drug developers likely don't have the capacity to treat all of these people, so Afrezza should have plenty of room to claim significant market share in 2015" who knew we had an insulin capacity problem in the US. This is news to me. "To begin with, no one really has any clue yet of how Afrezza will be priced, which will be a critical component in determining its success or failure." We've received guidance and hints. It's around $2000 to $2200 per year per patient. "Second, MannKind shareholders might be in for a bit of a shock when the first few quarters of revenue are reported" I'm not expecting profits to be reported this early. What I'm looking for is #of scripts and patient acceptance in the short term. Then I'm looking for capacity expansion, tier 2 in formularies and approval beyond the U.S. In the mid term. Then im looking for purple Veyron in the long term
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Post by savzak on Dec 31, 2014 13:00:45 GMT -5
Orelli again: www.fool.com/investing/general/2014/12/31/can-mannkind-corporation-stock-soar-in-2015.aspxTrack the companies that matter to you. It's FREE! Click one of these fan favorites to get started: Apple; Google; Ford. EmailPrint2 Recs 2 Can MannKind Corporation Stock Soar in 2015? By Brian Orelli | More Articles | Save For Later December 31, 2014 | Comments (2) This was pivotal year for MannKind (NASDAQ: MNKD ) in which it gained Food and Drug Administration approval for inhaled insulin Afrezza after multiple attempts. The biotech even signed up a stellar partner, Sanofi (NYSE: SNY ) , to market the drug. But that will all be for naught if the launch, scheduled to begin in the first quarter of the coming year, doesn't go smoothly; 2015 will set the tone for MannKind's long-term future. Expectations If MannKind's shares are to soar in 2015, sales will have to exceed expectations. Fortunately for shareholders, it appears expectations are fairly low. MannKind's enterprise value stands at about $2.5 billion if you use the fully diluted share count and add in debt and subtract its cash. Using the current valuation and figuring a price-to-sales value of five, about $500 million in Afrezza sales are priced into MannKind's valuation. MannKind only owns 35% of Afrezza, having given up the other 65% in the deal with Sanofi, so you could argue MannKind does not really deserve a P/S value of five; however, investors are usually willing to expand a P/S ratio for fast-growing companies. If Afrezza exceeds $500 million in its first year of sales, it seems likely the stock will increase substantially. What that will take The only thing we have to go on is the only previous inhaled insulin device, Exubera, but it isn't much help in determining Afrezza's potential. Pfizer (NYSE: PFE ) managed just $12 million in sales of Exubera during its first nine months on the market back in 2007. The pharma giant eventually handed back rights to developer Nektar Therapeutics (NASDAQ: NKTR ) , which subsequently pulled the drug from the market. Afrezza inhaler. Source: MannKind. While that is not encouraging, Afrezza is a much better product than Exubera was. Afrezza looks like an inhaler for asthmatics, while Exubera was substantially larger and looked like a bong for smoking marijuana. Who wants to bust one of those out in the middle of a restaurant? Afrezza is also theoretically a better drug than Exubera, since it is designed to be a rapid-acting insulin that comes on and off quicker than Exubera or injected insulins. The quick off should decrease the likelihood of hypoglycemia, dangerously low blood sugar levels, triggered by insulin stimulating cells to take up the blood sugar. Unfortunately, the FDA did not include any information about lower incidence of hypoglycemia on the label, so doctors won't see the information unless they dig into the clinical trial data. And even if they do, doctors are likely to determine that the case for lower hypoglycemia is inconclusive, just as the FDA did. Changing the standard of care Even without being touted as a better insulin, Afrezza is still more convenient than injected insulins, so you'd think it would be readily adopted. Unfortunately, Sanofi faces an uphill battle in convincing doctors to change their standard of care. According to the FDA label, patients need to have their lung function checked before starting Afrezza, after six months, and annually after that. While the test is only a minor inconvenience, the FDA's concern about the potential for Afrezza to harm the lungs will likely make some doctors pause before prescribing the inhaled insulin. Also, Exubera was linked -- albeit never conclusively -- with lung cancer, adding to the worry. If there were no other options, doctors would overlook Afrezza's potential issues, but they are comfortable with the injected insulins and will likely take a wait and see approach with Afrezza. Long term, assuming none of the FDA's worries materialize, I think Afrezza can gain traction, but asking for MannKind stock to soar in 2015 might be asking for too much, too soon.
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Post by savzak on Jan 2, 2015 8:09:06 GMT -5
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Post by itrade on Jan 2, 2015 10:54:13 GMT -5
Just to save time from clicking crap, here is the article from above. Motley Fool.
It's been a wild year for MannKind (NASDAQ: MNKD ) shareholders, who at any time during the year could have seen their shares up well over 100%, or, if they purchased during the summer, down around 60%.
Then again, it's not as if the volatility wasn't expected. MannKind's entire pipeline revolves around Afrezza, the company's revolutionary inhaled diabetes drug, which was reviewed by the Food and Drug Administration's advisory panel and received a PDUFA decision from the FDA. To save everyone the suspense, MannKind's Afrezza was approved by the FDA (which is a good thing, since it has no additional clinical trials under way).
Afrezza offers plenty of potential As you might imagine, there's an abundance of potential surrounding Afrezza. For starters, according to the Centers for Disease Control and Prevention, there are 29.1 million people in the U.S. with diabetes (this includes type 1, which is genetic, and the more common type 2, which develops over a lifetime). Additionally, there are 86 million adults aged 20 and over that have prediabetes. For MannKind, this means a wide moat of potential for its inhaled drug.
Second, there's the potential for Afrezza to become the diabetes treatment of choice due to its convenience. Don't get me wrong, an injection isn't particularly difficult -- but the chance to avoid having to use a needle could be the selling point that pushes Afrezza sales through the roof. Not to mention that Afrezza is available for type 1 and type 2 diabetics.
Finally, the fact that diabetes is a chronic condition is in MannKind's long-term favor. Afrezza isn't a cure for diabetes so much as a mediator of a patients' glycemic balance. As long as biopharmaceutical companies approach treating diabetes from the symptomatic side of the equation rather than trying to attack the underlying cause of the disease, we're liable to see diabetes drug developers benefit in a big way.
Three things standing between MannKind and greatness Of course, MannKind and Afrezza have anything but an easy ride ahead. Afrezza was actually rejected by the FDA in 2011, requiring the company to completely redesign its delivery device and engineer all new clinical studies. Although Afrezza is approved now, MannKind still faces three big hurdles which could derail any attempt at a rally.
1. Afrezza's warning label Perhaps the biggest obstacle or unknown for Afrezza is whether or not physicians will actually prescribe it. In spite of its approval, Afrezza came with a black box warning that states it shouldn't be given to smokers or people with chronic lung diseases such as asthma or chronic obstructive pulmonary disease, or COPD. The warning label points out that acute bronchospasm incidences were observed in patients on Afrezza with asthma or COPD.
Right off the bat this eliminates a notable chunk of the U.S. population. Within the U.S., CDC figures show that 18.1% of adults are smokers, while 6.3% of adults report having COPD. There's the possibility of overlap within these figures (i.e., smokers can have COPD), but this nonetheless removes millions of possible patients from the drug's treatment pool. It's an even tougher hit since smoking is one of the primary risk factors that can contribute to diabetes.
2. A desperate deal with Sanofi Secondly, the licensing deal MannKind negotiated with Sanofi (NYSE: SNY ) was a necessary evil that all but eliminated its upfront cash concerns but potentially killed any significant chance of the company becoming wildly profitable off of Afrezza.
Under the terms of the deal, Sanofi supplied MannKind with $150 million in upfront cash, which was perfect timing considering MannKind was probably on pace to run out of cash by early 2015. In addition, Sanofi agreed to advance MannKind $175 million as part of its expense-sharing collaboration. Sales milestones could wind up netting MannKind $775 million more. On top of these hefty one-time payments, MannKind is eligible to receive a 35% royalty on net Afrezza sales, with the remaining 65% going to Sanofi.
In the extreme short term this looks like a good deal for MannKind, considering how tight on cash it was. However, the company really had to give up a lot of long-term sales potential in order to land Sanofi. If Afrezza winds up being a blockbuster it's possible that MannKind investors won't see very much benefit beyond where the stock is currently priced.
3. A competitive price Lastly, there has to be some worry over whether or not consumers will be willing to pay a premium for the convenience of an inhalable medication. I personally am a needle-phobe, so I can certainly understand the allure of Afrezza, but if the cost of the product is markedly higher than that of an insulin shot, or if consumers are simply turned off by the side effects of the drug, which can include a cough or throat irritation, they could just pass it up in favor of a traditional insulin shot.
Afrezza isn't even scheduled to launch until the first quarter of 2015, so it'll still be some time before we have a direct apples-to-apples comparison on price between Afrezza and a standard insulin injection.
Tough sledding ahead The truth is that getting a drug approved by the FDA is only half the battle these days. The remaining half is determined by how successfully a drug is launched. Given the aforementioned challenges, I'd wager that MannKind is in for some tough sledding this winter. That doesn't mean Afrezza won't succeed, but it could mean that MannKind is already fully valued right here.
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Post by in search of the truth on Jan 2, 2015 10:55:44 GMT -5
In an article today from Seeking Alpha entitled: Sanofi Faces Serious Competitive Challenges: Is It Time To Buy Or Sell?
by Trevor Lowenthal, the following paragraph is included....
Afrezza
The biopharmaceutical company, MannKind (NASDAQ:MNKD), recently won approval for Afrezza, an ultra-rapid acting pulmonary insulin that closely approximates the normal early insulin release seen in healthy patients. In completed Phase III studies for the treatment of diabetes, Afrezza has shown similar efficacy to standard care, thereby demonstrating the great potential of the product to replace available therapeutics. The insulin recently received regulatory approval, and is expected to launch in Q1 2015. This represents a significant opportunity for Sanofi, which established a license agreement for Afrezza with MannKind late last year. I believe Sanofi got the better end of the deal, since it will receive the majority of profits and losses. The thing is, Afrezza is one of the rising stars of the fast-acting insulin markets. While Sanofi currently dominates the basal market with Lantus, it has an opportunity to capture a significant market share in the fast-acting insulin market with Afrezza. Some analysts believe Afrezza could generate up to $2 billion a year. And given that Sanofi is entitled to the majority of profits, this opportunity could prove lucrative.
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Post by Deleted on Jan 2, 2015 11:16:58 GMT -5
Why is the fool so actively bringing up all the old nonsense they have spewed to date? Makes you wonder
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Post by thekindaguyiyam on Jan 2, 2015 12:51:20 GMT -5
Why is the fool so actively bringing up all the old nonsense they have spewed to date? Makes you wonder It doesn't make me wonder. Whenever there is a fortune to be found a stock like this becomes Deadwood like the gold town where there is no law. Cramer needs articles like this to justify the huge swings by short interest and he'll get any crappy writer to write his directive intent to stroke fear of investors. Silence from the companies as they gear up has been his leverage with the help of imbeciles like AF. They are losing their grasp.
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Post by mnholdem on Jan 2, 2015 14:15:48 GMT -5
So many lies here. The 2nd CRL did NOT require the company to redesign the inhaler device. It required that MannKind test their new and improved inhaler to prove it worked as well as the original. The FDA was coerced by that hedge fund manager (Shrleki?)who had $millions shorted on MNKD.
Another falsehood. The image of the blackbox shows asthma & COPD, but the author throws in smokers and claims this eliminates 18% of patients, along with another 6% with COPD.
Sanofi deal is a "necessary evil"? MannKind is not giving up long term sales potential... they put it into the hands of the largest diabetes pharma in the world.
Pricing we don't know yet. I doubt patients will be charged a premium for convenience. Both MNKD and SNY management have been quoted as saying Afrezza will be comparably priced.
You must register with Fools in order to reply... I won't waste my time registering for anything on that rag and its crew of misfits.
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Post by babaoriley on Jan 2, 2015 18:36:25 GMT -5
Oh, I totally agree with the Fool (I not only normally agree with fools, but more often than not, I am the fool-in-chief), it is "tough sledding" ahead. We would have been way better off if AdCom had trashed us and the FDA followed suit, and we had ended up with a partnership agreement with a major pot grower in Washington and/or Colorado for the manufacture and distribution of "mini-bongs." We could claim less weight gain as the result of the munchies if one uses the inhaler. At least we wouldn't have to face this "tough sledding." It's a dirty business, very, very dirty. Today, though, I did very much enjoy the "tough sledding."
Someday, I dream that we will rise above it all.
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Post by brentie on Jan 2, 2015 23:27:51 GMT -5
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