|
Post by jpg on Aug 30, 2014 23:42:53 GMT -5
MM,
I ask because I am a 'regular' in Japan. It's one of my favorite destinations and try going every few years.
There are literally millions of vending machines in Japan. Porn shops have, I am certain some weird stuff in them but I doubt this weirdness is specific to Japan. Some tourist or local sucker probably paid 20 (or 200$...) for a 'used' panty maybe but I can assure you this is a rarity. Japan has enough real gender issues to go around without having to pull up urban legends.
I can also attest to the fact they do not like needles... Good for us even if Afrezza is never sold in a vending machine!
JPG
|
|
|
Post by EveningOfTheDay on Aug 31, 2014 18:33:00 GMT -5
Found this article published in Portuguese from a Brazilian Web site, Here is the original site: www.olhosespirituais.com/news/vem-ai-a-insulina-inalavel/This is my own translation in case anybody needs it. After decades of research and disappointments, a new hormone replacement treatment for diabetics has been approved.
For thousands of Brazilian diabetics to maintain control levels is a daily work that requires a balance diet, physical activity, and insulin shots - sometimes up to eight a day. In brief a good number of those shots, if not all, will be substituted by rapid suction to a whistle like device that will deliver an exact dose of hormones to the lungs, and quickly into the blood stream. This is the promise of Afrezza, the new inhaled insulin approved by the FDA, the agency that regulates the sell of drugs in the United States and that acts as a reference for other similar agencies in the whole world.
For the moment, the inhaled insulin was approve for people older than 18, no fumadores and people without pulmonar problems, like asma or bronquitis. Children and adolescents, the principal victims of type 1 diabetes, are not in the group that will benefit.
However, everything would seem to indicate that is just a question of time for Afrezza to be used with this group. Research approval for younger patients and asthmatics has started. The Instituto da Criança com Daibetes (ICD), in Puerto Alegre, should be on of the bank labs for those tests. "Many studies are necessary in order to validate the drug because it uses a delivery way never used before. But our expectations are very optimistic." said Balduíno Tschiedel, an endocrinologist and director of the ICD.
What about insulin in capsules?
Two labs, the Israeli Oramed Pharmaceutical and de Danish Novo Nordisk, are in a race to see who launches the first oral version of the hormone. Oramel is about to launch efficacy studies with humans. Its molecule, already proved, can scape the gastric acid and reach the blood stream - a mayor obstacle for this type of treatment.
Soon we should know if it can compete with traditional treatments.
Last statistics that I found in a quick search say Brazil had 4.6 million diabetics in 2000 and is expected to reach 11 million by 2030. Takeda is actually one of the top ten pharmaceutical companies in the country. But Brazil has also a great level of influence in all other Shout American countries. This should give a little more perspective to the Sanofi - Takeda agreement.
|
|
|
Post by mannmade on Aug 31, 2014 18:57:06 GMT -5
nice work... and thank you...
|
|
|
Post by EveningOfTheDay on Sept 1, 2014 3:04:53 GMT -5
Upps. Sorry my spanish came through. Where it says no fumadores should obviously say non-smokers. Also where it says "Research approval for younger..." should just say Research for younger... Hard to keep it straight with my kids running in and out every two minutes. They are 11 and 8... my boys that is.
By the way, I read in someone's post in the unnamable board that Brazil has, as of 2014, 13.6 million diabetics. If this is true, the country has suffered and explosion in the number of cases, that has greatly surpassed the most pessimistic forecasts.
|
|
|
Post by mannmade on Sept 2, 2014 9:20:37 GMT -5
|
|
|
Post by BD on Sept 2, 2014 10:06:46 GMT -5
Very nice piece from Nate. I think the Afrezza section (most of the piece) is worthy of C/P-ing here:
-----------------------
As you know, literally an hour or so after the August issue was posted to the website last month, MannKind announced that it had partnered with Sanofi (SNY – $54.70) for the commercialization of Afrezza… and, as you are probably all too aware, rather than rising on the news, MannKind’s stock has sold off sharply!
Naturally, the poor performance of the stock has caused a number of you to wonder whether or not the deal is a good one after all… and I hope the following helps you realize the answer is a resounding “yes!”
First off, I believe it is worth noting that there is probably no large pharmaceutical company out there that has become more focused on and aggressive about capturing diabetes market share in recent years than Sanofi – they are “hungry,” they have momentum at this stage of the game, and I have no reason to doubt that they are going to do all they can to educate doctors and patients alike on the benefits of Afrezza.
And, speaking of those benefits, I think it is extremely important to note that while one of the main – and most often cited – selling points of Afrezza is that it can be used by patients (especially newly diagnosed diabetics) who may be averse to giving themselves shots on a regular basis, it is just as important (and perhaps even more important, in the long run) to note that Afrezza’s ultra-rapid acting nature has the potential to redefine how patients control their diabetes, especially when the drug is used in conjunction with other technologies and drugs that will be making their way into the marketplace in the quarters and years ahead… and I believe it is no coincidence that in addition to signing an agreement with MannKind in August, Sanofi also entered into a major diabetes collaboration agreement with Medtronic (MDT – $63.85) back in June.
Not only does it seem clear that Sanofi is planning on putting an awful lot of effort into the diabetes market in the years ahead, I also believe it is worth pointing out that Medtronic is the company that Al Mann sold his last major venture to (MiniMed, maker of insulin pumps and other products, was bought by Medtronic for $3.7 billion in 2001), so there is certainly reason to believe that the pieces of this puzzle may be falling into place with a bigger picture in mind than it might first appear!
Anyhow, getting back to the terms of the deal itself, not only has Sanofi agreed to pay MannKind $150 million upfront for the right to market Afrezza, it will also pay MannKind up to an additional $775 million for various sales and regulatory milestones if/when they are hit. In addition, the two companies will split all profits and losses 65% (Sanofi) – 35% (MannKind), with Sanofi agreeing to advance MannKind up to $175 million if needed.
While short sellers (and other journalists who have had a negative bias against the company for years now) were quick to complain that it was a “horrible” deal for MannKind shareholders, all one needs to do is take out a pencil and piece of paper and run through possible scenarios to realize that it is, in fact, a great deal for MannKind shareholders.
Starting with the worst case scenario (i.e. Afrezza turns out to be a flop), any time an executive can bring in $150 million for “nothing,” I think it is fair to call it a “win” for shareholders.
However, assuming that Sanofi is, in fact, able to sell more than just a few doses of Afrezza, the company’s critics have claimed that “MannKind gave away too much – 35% is far too small a percentage”… but again, when one actually takes the time to look at the math, the deal doesn’t look too shabby at all.
For example, let’s start small and assume that no milestones are hit and Sanofi generates “just” $50 million worth of profit from Afrezza. In this case, MannKind will get it’s 35% cut ($17.5 million), and when this is combined with the $150 million it got upfront, we’re looking at the company receiving $167.5 million for a product that did $50 million in sales.
Moving further along the optimism spectrum, let’s still assume that no milestone payments are triggered but that Sanofi generates $150 million worth of profit from Afrezza. In this case, MannKind will be collecting $52.5 million for its share, plus $150 million, which works out to $202.5 million for a drug that generated $150 million in sales.
Ah, but you’re thinking the critics must have meant it’s a bad deal for MannKind shareholders if Afrezza is actually a blockbuster (which, of course, is an amusing way to look at it since their underlying premise has always been that it will not be a blockbuster… heck, many of them were even convinced it wouldn’t even be approved, never mind find a partner in the world of big pharma), so let’s make our assumptions a bit grander.
Let’s assume that the drug generates $300 million in profits, and because usually at least the first one-third or so of a “milestone” package is meant to be fairly easily attained, let’s also assume that in the process of getting to $300 million, at least a half of that first third is triggered (and, to keep the math simple, we’ll assume the milestone package was for $750 million rather than $775 million).
In this case, MannKind will be receiving it’s cut of the $300 million ($105 million)… plus one-half of one-third of the milestone package (so half of $250 million, or $125 million)… plus the $150 million it received upfront… bringing us to a grand total of $380 million for a drug that generated $300 million in sales!
Of course, we could continue to ratchet up our levels of optimism and see what the numbers look like, but I hope you get the point by now – namely, unless/until Afrezza sales numbers reach the level of being truly “blockbuster,” this deal is actually skewed in favor of MannKind… and even if/when the day comes that Afrezza is doing several billion dollars a year in sales, I don’t think you’ll hear anyone complaining that in addition to the nearly $1 billion in milestone payments MannKind received along the way, the company is still collecting 35% of that revenue stream “in perpetuity.”
To be sure, there will be costs and expenses along the way that will need to be managed in a judicious manner… and those numbers will admittedly impact how much money the company actually earns each quarter… but I think it is fair to say that MannKind did, in fact, find a great partner on great terms.
In fact, though I was certainly not part of the negotiations, I don’t think I am out of line in summarizing the situation as follows:
In a nutshell (and admittedly taking a few percentage points of liberty here and there to help keep the math really simple), Al Mann has put a little over $900 million of his own money into the company and still owns a third of it (actually more than that, but again, I’m trying to keep the math simple). He believes he is sitting on at least one blockbuster (Afrezza), and he has convinced his partner to put roughly the same amount of money into the company as he has put into it… but the partner will not end up with any equity in the company in exchange for its $900+ million; instead, the companies will split the revenue stream from the product into three pieces, with both companies taking one piece for their involvement, and Sanofi keeping the third piece in lieu of getting any equity (i.e. Al got a third of the whole company for his $900 million, Sanofi gets “just”a bonus third of Afrezza).
As pointed out above, if Afrezza flops, MannKind comes out ahead in the partnership, and if Sanofi turns Afrezza into a wild success, all parties involved go home winners… with the bonus for MannKind shareholders being the fact that Al Mann will quite likely utilize the revenue stream coming in from Afrezza to move other products through the pipeline on the Technosphere platform (and these products, in turn, will have the potential to be licensed and/or partnered along the way, further increasing the size of the revenue stream coming in for shareholders).
While I want to remind you yet again that it is never a good idea to put all your eggs in a single basket… and there are no guarantees that Afrezza will ever generate the types of sales numbers that will be required to help produce another 10-bagger for us in the newsletter… I believe the deal with Sanofi has placed the odds firmly in our favor, and with over 70 million shares still sold short, not only do those “investors” (sic) represent a pool of buyers that will likely help keep a floor under the stock for us, they also represent an awful lot of fuel (i.e. buying pressure) that will be poured on the fire IF the stock does start to rally in the months ahead.
Add to this the possibility (but not a promise – I’m not calling the shots at the company) that, at some point, the company may do a reverse split to help bring the share count more in line with what some critics are looking for, and things could get even uglier for the shorts.
No, it won’t change the valuation of the company (fewer shares outstanding times a correspondingly higher stock price will still be the same market cap), but as any poker player will tell you, it is much harder to engineer a betting strategy when you have 10 chips in front of you rather than 100… and though I doubt the company would do a full 1-for-10 reverse split, the idea is the same in terms of how reverse-splitting the stock would force the short sellers to change their approach regardless of the size of the split. Again, I am not predicting this will happen, but it wouldn’t surprise me if it hasn’t at least been considered as part of the company’s longer-term plans.
Anyhow, it has admittedly been a long, frustrating last three weeks to be a MannKind shareholder, but as was mentioned in the blog entry I posted shortly after the partnership agreement was announced, I have seen this happen before in my 25+ years following the biotech sector… and in the long run, the fundamentals always win out over short-term emotions and artificial price depression (so please don’t let the short-term action deter you from sticking to our game plan!).
I think a big part of the sell-off was due to disappointment on the part of traders that an outright buyout of the company did not occur, and, as mentioned above, the usual cast of characters were also quick out of the gate to utilize their soapboxes for criticizing the deal as a bad one.
However, the stock seems to be finding some traction, and I hope the above has helped you understand that the deal is actually a far richer one than all but the most bullish of bulls could have hoped for… never mind how great a partnership it is relative to the “rent-a-sales force” deals that were being called for by the more vocal skeptics (the same folks who, I might add, have yet to be right about a single major call related to the Afrezza story – are you starting to notice a pattern?).
Hang in there – it is still to early to say for sure, but it looks like the worst may finally be behind us!
|
|
|
Post by daduke38 on Sept 2, 2014 13:34:41 GMT -5
Evening of the day: Didn't want to attach this to your interesting and great news post. However, in translating the article, surely the meant approved in the USA, correct. Reading it sounds like it is approved in Brazil, which doesn't seem likely YET! Could you clarify? It does sound like they are going to follow the USA lead, so it may not be long. Starting to think SNY's biggest problem may be supply.
|
|
|
Post by 4Balance on Sept 3, 2014 11:45:16 GMT -5
The other board highlighted this new article in USA TODAY. 11 companies fighting for survival"Some companies themselves declare they may not be able to continue being a going concern. Medical developer MannKind issued unaudited financial statements that went into detail on why the company’s longevity could be threatened. The company’s most promising product is Afrezza, an inhalable insulin the company says was approved by the U.S. Food and Drug Administration on June 27 for the treatment of diabetes. However, the company frankly states in its financials it has net losses of $2.4 billion and cash and cash equivalents as of June 30 of $41.2 million. The company points out its survival hinges on raising additional money either by selling debt or stock, striking business deals or cutting costs. Until the company tops these hurdles “there will be continued substantial doubt about our ability to continue as a going concern,” the company said in its filing. And lately investors have focused on the negatives:" (chart follows) americasmarkets.usatoday.com/2014/09/03/11-companies-fighting-for-survival/....and a little over a month after the financials are filed, MNKD cuts a "business deal" with SNY. Derek mentioned that MNKD has been making these statements for years. If so, and subsequently did what it said it needed to do, it seems like no clear reason for concern. Why didn't the review take that into consideration? Do we think that article is the primary reason for today's PPS weakness..??
|
|
|
Post by EveningOfTheDay on Sept 3, 2014 12:41:07 GMT -5
Daduke, if you are referring to "This is the promise of Afrezza, the new inhaled insulin approved by the FDA, the agency that regulates the sell of drugs in the United States and that acts as a reference for other similar agencies in the whole world. That is what the article literally says, but the way I understand it is that although the FDA acts as a reference for similar agencies on other countries, those agencies still need to approve it. Having said this, it would seem that whatever the regulatory agency is in Brazil, considering Afrezza's approval in the US, approval in Brazil should be a sure thing.
|
|
|
Post by jpg on Sept 3, 2014 14:22:47 GMT -5
The other board highlighted this new article in USA TODAY. 11 companies fighting for survival"Some companies themselves declare they may not be able to continue being a going concern. Medical developer MannKind issued unaudited financial statements that went into detail on why the company’s longevity could be threatened. The company’s most promising product is Afrezza, an inhalable insulin the company says was approved by the U.S. Food and Drug Administration on June 27 for the treatment of diabetes. However, the company frankly states in its financials it has net losses of $2.4 billion and cash and cash equivalents as of June 30 of $41.2 million. The company points out its survival hinges on raising additional money either by selling debt or stock, striking business deals or cutting costs. Until the company tops these hurdles “there will be continued substantial doubt about our ability to continue as a going concern,” the company said in its filing. And lately investors have focused on the negatives:" (chart follows) americasmarkets.usatoday.com/2014/09/03/11-companies-fighting-for-survival/....and a little over a month after the financials are filed, MNKD cuts a "business deal" with SNY. Derek mentioned that MNKD has been making these statements for years. If so, and subsequently did what it said it needed to do, it seems like no clear reason for concern. Why didn't the review take that into consideration? Do we think that article is the primary reason for today's PPS weakness..?? MNKD and many other biotechs are routinely going concerns. That is part of being a startup biotech... That the article picked MNKD as part of that list as opposed to any other biotexh with a MK above 300 million is possibly because MNKD has the larger MK then mot biotechs. Is the list/ information still valid after the deal with Sanofi? No but I doubt the writer of the article cares. Then again the aim of the article could have been to bring down the price of MNKD and or DryShips (the other company they mentiovery to me every piece of financial information is ad priori not neutral. Some would say that is being a tad paranoid but then again when dealing with markets every angle is or wil be used for the aim of making money. It would be good timing after EXEL's news yesterday. How many people reas this stuff? It obviously seems to get around. Is it causing today's price move? I certainly don't know. JPG
|
|
|
Post by daduke38 on Sept 3, 2014 15:09:27 GMT -5
Daduke, if you are referring to "This is the promise of Afrezza, the new inhaled insulin approved by the FDA, the agency that regulates the sell of drugs in the United States and that acts as a reference for other similar agencies in the whole world. That is what the article literally says, but the way I understand it is that although the FDA acts as a reference for similar agencies on other countries, those agencies still need to approve it. Having said this, it would seem that whatever the regulatory agency is in Brazil, considering Afrezza's approval in the US, approval in Brazil should be a sure thing. Thank ya very much!
|
|
|
Post by mannmade on Sept 3, 2014 15:54:47 GMT -5
Is Mannkind finally oversold? www.theonlineinvestor.com/www.theonlineinvestor.com/MannKind Becomes Oversold (MNKD) By The Online Investor Staff, Wednesday, September 3, 4:34 PM ET Start slideshow:10 Oversold Stocks You Should Know About » Legendary investor Warren Buffett advises to be fearful when others are greedy, and be greedy when others are fearful. One way we can try to measure the level of fear in a given stock is through a technical analysis indicator called the Relative Strength Index, or RSI, which measures momentum on a scale of zero to 100. A stock is considered to be oversold if the RSI reading falls below 30. In trading on Wednesday, shares of MannKind Corp (NASDAQ:MNKD) entered into oversold territory, hitting an RSI reading of 29.8, after changing hands as low as $7.00 per share. By comparison, the current RSI reading of the S&P 500 ETF (SPY) is 62.0. A bullish investor could look at MNKD's 29.8 RSI reading today as a sign that the recent heavy selling is in the process of exhausting itself, and begin to look for entry point opportunities on the buy side. The chart below shows the one year performance of MNKD shares: MannKind Corp 1 Year Performance Chart Looking at the chart above, MNKD's low point in its 52 week range is $3.80 per share, with $11.48 as the 52 week high point — that compares with a last trade of $7.04. Find out what 9 other oversold stocks you need to know about » According to the ETF Finder at ETF Channel, MNKD makes up 2.03% of the PowerShares DWA Healthcare Momentum Portfolio ETF (AMEX:PTH) which is trading lower by about 0.1% on the day Wednesday. See what other ETFs contain MNKD » See what other stocks are held by PTH » Can your brain be trained to become a chart-predicting wizard? Click here to find out Find the right mix of model portfolios today at PortfolioChannel.com This Article's Word Cloud: Buffett Definition ETFs Index Know Looking MNKD Price Relative Stocks Strength Warren Wednesday about analysis below changing chart comparison entered fearful greedy heavy investor last look makes other others oversold point raquo reading selling share shares slideshow stock stocks technical territory that trading week what when which with your zero
|
|
|
Post by EveningOfTheDay on Sept 3, 2014 17:17:30 GMT -5
Daduke, if you are referring to "This is the promise of Afrezza, the new inhaled insulin approved by the FDA, the agency that regulates the sell of drugs in the United States and that acts as a reference for other similar agencies in the whole world. That is what the article literally says, but the way I understand it is that although the FDA acts as a reference for similar agencies on other countries, those agencies still need to approve it. Having said this, it would seem that whatever the regulatory agency is in Brazil, considering Afrezza's approval in the US, approval in Brazil should be a sure thing. Thank ya very much! You are very welcomed.
|
|
|
Post by EveningOfTheDay on Sept 3, 2014 17:27:04 GMT -5
The other board highlighted this new article in USA TODAY. 11 companies fighting for survival"Some companies themselves declare they may not be able to continue being a going concern. Medical developer MannKind issued unaudited financial statements that went into detail on why the company’s longevity could be threatened. The company’s most promising product is Afrezza, an inhalable insulin the company says was approved by the U.S. Food and Drug Administration on June 27 for the treatment of diabetes. However, the company frankly states in its financials it has net losses of $2.4 billion and cash and cash equivalents as of June 30 of $41.2 million. The company points out its survival hinges on raising additional money either by selling debt or stock, striking business deals or cutting costs. Until the company tops these hurdles “there will be continued substantial doubt about our ability to continue as a going concern,” the company said in its filing. And lately investors have focused on the negatives:" (chart follows) americasmarkets.usatoday.com/2014/09/03/11-companies-fighting-for-survival/....and a little over a month after the financials are filed, MNKD cuts a "business deal" with SNY. Derek mentioned that MNKD has been making these statements for years. If so, and subsequently did what it said it needed to do, it seems like no clear reason for concern. Why didn't the review take that into consideration? Do we think that article is the primary reason for today's PPS weakness..?? I know we are all MNKD believers, but I would like to know if any of you sees even the slightest chance to a dilution. This is something I used to worry a great deal about before approval and then considerably less after approval. When partnership was announced I was convinced we had put the spectrum of dilution behind us for good. I still do, but I am curious as to what others in the board think. After all, it would not be the first time my assessment proves wrong, probably no the last either. Thanks.
|
|
|
Post by mannmade on Sept 3, 2014 19:02:00 GMT -5
Eveningoftheday, I do suppose anything is possible and one thing I have learned when it comes to Mannkind is "never say never..." However, unless I am missing something (anyone else free to chime in) with $150m in upfront payments and most of the R&D costs transferring to Sanofi's books as part of this deal (although I do not know when) I can't see how they could need to dilute further. The R&D costs were the largest percentage of the monthly burn of 12 to 15m the last couple of years. Also they are getting an additional amount (loan) of up to $175m to cover initial costs on their end. There are other reasons but these would be my main points up front as to why I don't think so.
|
|