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Post by lakers on Nov 2, 2016 18:04:37 GMT -5
TennCare Preferred Drug List (PDL) Effective November 1, 2016 tenncare.magellanhealth.com/static/docs/Preferred_Drug_List_and_Drug_Criteria/TennCare_PDL.pdfPg. 23 Diabetes: Insulins Humalog® KwikPen® PA Humulin® 70/30® vial Afrezza® PA, QL Novolog® FlexPen® PA Humalog® Mix 50/50® KwikPen® PA Humulin® N® vial Apidra® Solostar® Novolog® Mix 70/30® FlexPen® PA
Humalog® Mix 75/25® KwikPen® PA Humulin® R® vial Apidra® vial Novolog® Mix 70/30® vial Humalog® Mix 50/50® vial Humulin® R® U-500 vial Humalog® U-200 KwikPen® PA Novolog® vial Humalog® Mix 75/25® vial Lantus® Solostar® Humulin® R® U-500 KwikPen® PA Toujeo® Solostar® PAHumalog® vial Lantus® vial Novolin ® 70/30® Tresiba® FlexTouch® PAHumulin® 70/30® KwikPen® PA Levemir® FlexTouch® Novolin® N® Humulin® N® KwikPen® PA Levemir® vial Novolin® R® Diabetes: Meglitinides and Combina
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Post by lakers on Nov 2, 2016 17:53:47 GMT -5
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Post by lakers on Nov 2, 2016 17:38:01 GMT -5
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Post by lakers on Nov 2, 2016 11:28:00 GMT -5
Whatever happens, many are enjoying the Afrezza experience in the meantime, and we're happy to continue sharing their various stories here as part of our #RealWorldAfrezza series. Today, we hear from renowned endocrinologist and type 1 himself Dr. Jeremy Pettus in San Diego, CA, who's just recently decided to start using Afrezza again after a failed first try. Jeremy also works with the beloved Taking Control of Your Diabetes (TCOYD) conference series, and runs the We Are One Diabetes group for PWDs who work professionally in diabetes. A Guest Post on Afrezza by Jeremy Pettus I wanteJeremy Pettusd to write today about Afrezza. My tune on this med has changed slightly after Dr. Steve Edelman and I put on a very interesting focus group on a during the first weekend of December to discuss the medication. The purpose of the group was to learn how successful Afrezza users use Afrezza successfully (say that 10 times fast!) with the intent of designing a clinical trial around this info. Some of the comments we heard during the focus group: A big takeaway from this focus group meeting: There are people out there using this medication very well to achieve crazy-low A1Cs, like in the 5s, along with low rates of hypoglycemia. I mean these people got pissed when their BG was above 130! So how are they doing it? Well, let me back up a second first and explain my first experience with Afrezza. Basically when I first took it, I took 4 units and then ate a sandwich. An hour or so later, my BG was over 250mg/dL, so I thought it didn’t work and never took it again. Turns out my experience is somewhat common. The reason for this is that one unit of Afrezza is NOT equal to one unit of subcutaneous insulin. In fact, inhaling 4 units of Afrezza is closer to injecting 2.5 or 3 units. So basically, I dramatically under-dosed myself. Now that I know that, I have been trying Afrezza for the last couple days, taking the right dose at the start of a meal or even 10 minutes into it and being slightly more aggressive. The really nice thing about the drug is that it works really, really fast but then totally hits the brakes. Yesterday, I had a high of ~250 BG, took 8 units of Afrezza and my BG came screaming down with two down arrows on the CGM. I started to get nervous, but by like an hour into it, my BG totally flattened out without going low. So it truly is rapid-on and rapid-off. Yes, it takes some getting used to the new dosing regimen, inhaling something that can make you cough initially, and whipping out something that resembles a crack pipe in public always makes for some interesting reactions. But overall, it does fit an unmet need and has its place in our world. You should have heard some of these comments from people in the focus group talking about their control. One guy was “complaining” that the high alarm on the Dexcom should let you go lower than 120mg/dL... wow! Can you imagine setting your HIGH alarm at 120?! He was saying this because he really was achieving perfect control, mostly by controlling that annoying post-meal spike. If you can control that, you'll never again have to deal with the all-too-common scenario of correcting for a high post-meal BG which makes you go low, then raiding the fridge, eat everything in sight and yelling at your significant other “don’t tell me what to eat!”... And then going high again, having to rage bolus 20 units of insulin, and then going low again and repeating. I call it being on the rollercoaster, but instead of being fun like an actual rollercoaster, it just sucks. Afrezza seems to take care of this rollercoaster effect (see also glucoastering) very well. www.healthline.com/diabetesmine/afrezza-focus-group-feedback#1
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Post by lakers on Nov 2, 2016 11:07:23 GMT -5
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Post by lakers on Nov 2, 2016 3:00:23 GMT -5
Besides raising money via one of the two paths mentioned above, one of the more intriguing ideas that has been making the rounds of social media following the leak last month of what is supposedly a Receptor Life Sciences “About Us”-type document is that MannKind and Receptor Life Sciences might do a “reverse merger” (a reverse merger is a transaction in which a private company acquires/merges with an already public company in order to become a publicly traded company itself without going through the very lengthy and complex process usually associated with “going public”). No, we still do not officially know anything about RLS other than that it is, in fact, working on “cannabis products,” it has signed an agreement with MannKind to develop products using the Technosphere platform, and RLS’ chief scientist happens to be the same woman that was MannKind’s chief scientist until sometime late last year… and, at least in my book, those are three points that provide a nice framework around which to start wondering “what if ___?” Again, without knowing for sure who is behind RLS and what their intentions may be, anecdotal evidence suggests that the group behind it probably does have “deep pockets” that may or may not end up providing upfront cash as part of a transaction… but even if they don’t put money in right out of the gate, a much more intriguing piece of the puzzle is the fact that while MannKind’s stock has been the dumps lately (along with rest of the biotech sector, I might add, even if not to the same degree as MannKind), cannabis stocks have been on a tear lately - and, as mentioned above, when is the best and easiest time for companies to ask investment banks to raise money for them? Why, during bull markets, of course! Please note that I am in NO WAY predicting that a reverse merger is in the works (nor should you invest based solely on this hope, mind you!), but given the relationships that already exists between the two companies… along with where each company finds itself sitting at this point in the market cycle for its respective industry… I think it is certainly a scenario worth pondering for at least a minute or two. Read more: mnkd.proboards.com/thread/6587/nate-piles-latest-thoughts#ixzz4OpuMYOWSRLS could contract Mnkd to manufacture inhaled CBD for them.
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Post by lakers on Nov 1, 2016 18:26:29 GMT -5
With pot on the ballot in nine states, the big winner in next Tuesday's election could be America's legal cannabis industry. By 2020, legal market sales are expected to surpass $22 billion. And for states struggling with budget shortfalls, that extra revenue would be clearly welcome. Voters in five states — Arizona, California, Maine, Massachusetts and Nevada — will decide whether to legalize recreational marijuana for adults. Medical marijuana is on the ballot in Arkansas, Florida, Montana, and North Dakota.Supporters believe the marijuana measures will pass in California and Florida, and possibly several other states, because America's attitude about pot has changed significantly in the last few years. "Legalization of cannabis is one of the greatest business opportunities of our time." "It's well established that the majority of Americans now believe that the responsible use of marijuana by adults should not be a criminal offense," said Paul Armentano, deputy director of NORML, the National Organization for the Reform of Marijuana Laws. Two national surveys released in mid-October confirm that, with the Pew Research Center revealing that 57 percent of U.S. adults say the use of marijuana should be made legal — while 60 percent were opposed a decade ago. The latest Gallup Poll showed that support for legalizing marijuana is at 60 percent, the highest ever recorded in this survey. After Colorado and Oregon became the first states to allow the recreational use of pot, in 2013, support for legalization reached a majority for the first time. www.nbcnews.com/storyline/2016-election-day/big-winner-november-8-could-be-marijuana-n676316Nationally, legal pot sales grew like a weed last year to $5.7 billion, up from $4.6 billion in 2014, according to a recent report from the ArcView Market Research and New Frontier. Recreational sales grew from $374 million in 2014 to $1.2 billion by the end of 2015. The report projects strong sales growth this year, with retail sales hitting $7.1 billion, up about 26 percent from 2015. By 2020, the report says, legal market sales are expected to surpass $22 billion.
Tax revenues collected in Colorado, Washington, and Oregon have all exceeded initial estimates. Colorado's legal pot sales of $996 million generated $121 million in combined sales tax and excise tax revenue last year and created 18,000 new jobs, according to the Marijuana Policy Group (MPG). Marijuana tax revenue in Colorado was three times larger than alcohol and 14 percent larger than casino revenue, the report noted. MPG projects that marijuana tax revenue in Colorado will eclipse cigarette tax dollars by 2020. Washington's recreational marijuana industry brought in $427 million in sales and excise tax revenue on sales of $1.1 billion since 2014, according to 502data.com. Oregon's Department of Revenue reported sales of more than $160 million so far this year, which generated more than $40 million in sales taxes. But the extra income is just one drop in a very large bucket, according to Joe Henchman, vice president for legal and state projects at the Tax Foundation. Based on the latest polling, Prop 64 is expected to pass. Cannabis advocates believe a win in California on November 8 could open the floodgates for other states and Congress to legalize the purchase and recreational use of marijuana by adults. Gallup noted, "If recreational marijuana use becomes legal in California this year, many other states will likely follow, because the Golden State often sets political trends for the rest of the U.S." Taylor West, deputy director of the National Cannabis Industry Association, believes this election will be "a tipping point" that makes it impossible for Congress to keep ignoring the issue. "If all nine initiatives were to pass, we'd have approximately 62 percent of the US population living in a state where medical or adult-use cannabis access is legal. That's huge," she said. RLS' GO TO MARKET STRATEGY Establish production in Washington, California, Canada and globally. Capture significant portion of medical and recreational users looking for a faster, safer and more predictable dose. Lead research and new drug development by providing the world’s first standardized cannabis dose. PODS Discrete, immediate, non-toxic, precise drug delivery Pharmaceutical grade delivery; consistent and accurate Vast potential as regulated pharmaceutical drug Protected by a portfolio of over 1,500 worldwide patents and over $2.5 billion invested [by Mnkd]
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Post by lakers on Nov 1, 2016 1:10:20 GMT -5
Pfizer scraps Exubera Pfizer withdraws its inhaleable insulin product Exubera from world markets despite spending significant amounts on manufacturing and marketing the product 30th September 2008 Pfizer has decided to withdraw its inhaleable insulin product Exubera from world markets despite spending significant amounts on manufacturing and marketing the product. Pfizer's CEO Jeffrey Kindler announced the withdrawal of Exubera on 18 October 2007, and the company incurred a USD 2.8bn charge for doing so. According to a report in the Wall Street Journal, while Kindler's decision to axe Exubera has made him popular among analysts for cutting back on costs, it has also caused ructions within the company's co-marketing partner, Nektar Therapeutics, and could undermine a key aspect of Pfizer's recovery strategy. Pfizer did not inform Nektar that it was going to remove Exubera from the market until the 18 October announcement. Nektar, understandably, has been pretty venomous in its criticism of Pfizer. The way in which Pfizer revealed the decision will no doubt make other existing and future partners nervous about doing business with the world's largest pharmaceutical company. A Pfizer spokesman defended the company's track record of partnering, saying that it had a strong record and was committed to building more. Despite the assurances, the lack of sensitivity on the part of Pfizer may come back to haunt it, when vying for other partners to help it plug its failing pipeline. So far in 2007, Pfizer has spent USD 775m to manufacture and promote Exubera, according to an estimate by Credit Suisse analysts. The reason is that insulin, due to its fragile small-molecule structure, costs more to manufacture than regular medicines.Normal business practice sees pharmaceutical companies keep their slow-selling or underperforming products on the market, in order to recoup as much revenue as possible. The present case is unusual, as the removal of any drug from the market is normally reserved for cases involving significant safety concerns, or in response to regulators' demands. Neither of these situations occurred with Exubera. For example, Pfizer's blockbuster cholesterol fighter Lipitor (atorvastatin) costs USD 0.08 for every USD 1 it sells. Exubera, on the other hand, costs Pfizer about USD 0.30 for every USD 1, according to the analysts. The company informed investors that Exubera racked up only USD 12m in sales, which was far from a break-even result. The reason Exubera costs so much to produce is that it is manufactured in Germany, shipped to California to be sprayed and turned into a powder, packaged into blisters elsewhere and then inserted into a device in another US state. Also, promoting the drug to primary-care doctors requires a big budget spend. Pfizer also pays licensor Nektar approximately 15 per cent of sales. It also paid the company to manufacture the delivery device and spray-dry the powder. As a result, in Q1 FY07 Pfizer paid Nektar approximately USD 60m.Pfizer has spent in the region of USD 370m so far in 2007 to promote Exubera. Activities have included the sending of special diabetes educators to doctors to teach them how to use the new device, as well as DTC advertising investment. In comparison, say Credit Swiss analysts, the promotion of Pfizer's new cancer drug Sutent (imatinib), only cost Pfizer USD 200m. Nektar may take over sales and marketing Nektar is now free to market Exubera alone, according to WR Hambrecht & Co analysts. They say that Pfizer has manufactured enough of the product to last several years, given current demand. Because Nektar is a smaller company, its marketing costs would be much lower, so it would not have to sell as much Exubera to make a profit. Nektar could launch Exubera as a discounted product and lower the price 30 per cent or more to make it more attractive. Nektar is developing treatments for cystic fibrosis, cancer and a treatment for constipation as a side effect of pain drugs. In 2007, German-headquartered Bayer paid Nektar USD 50m to share the rights to an inhaled antibiotic it was working on, plus up to USD 125m more should Nektar meet development milestones. 30th September 2008 www.pmlive.com/pharma_news/pfizer_scraps_exubera_9168?SQ_DESIGN_NAME=2&
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Post by lakers on Oct 31, 2016 16:13:14 GMT -5
Today's last couple of hours of trading were pretty frightening. Days like this are the norm and will continue until MNKD does something to put a floor under their stock. The stock is manipulated by traders but is easy to drive down when the company can't point to many successes. The market cares about sales and profitability, either real or potential. So far, Afrezza hasn't demonstrated either. Patient testimonials are great but with no demand and insignificant sales, the market will punish any company in MNKDs position. We will be in the thirties by the time a CC is held most likely. Without a R/S, the stock will need a roughly 150% increase just to make Nasdaq compliance. Think about that. I'm still waiting for an announcement of a call, if there is one at all. 3Q16 ER will be on Mon 11/14/16. 10-Q needs to be filed within 45 days of qtr end.
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Post by lakers on Oct 31, 2016 2:07:03 GMT -5
So, if we look at slide 18 starting with the 2017 U.S. payer decisions in diabetes, you can see here a detailed analysis of the formulary status for our two brands in the glargine franchise, Lantus and Toujeo. Based on confirmed U.S. payer decisions for 2017, this slide provides a comparison of the coverage situation for next year compared to this year. Actually, there are two key messages here. Number one, despite the decline in the percentage of covered lives on commercial plans, the overall coverage situation for Lantus and Toujeo will remain favorable with two thirds of commercial lives confirmed to be covered in 2017. Number two, as you can see from the green bars on the bottom of the slide, preferred formulary status of Lantus and Toujeo under Medicare Part D will remain largely unchanged in 2017 with close to 90% coverage in 2017. I remind you that the split in terms of volume between our commercial business and Medicare for the glargine franchise is overall roughly one-third each with the balance being in the government channels. As far as the commercial lives are concerned, coverage decisions from a number of commercial plans are still pending, representing about 15% of commercial lives based on our current account analysis and available third-party data. These pending decisions are illustrated by the gray segments in the bar charts on the top and mainly represented by custom plans under CVS and other smaller regional plans. We continue to be in active discussions with these insurers, but we are optimistic that many of these plans will ultimately decide to cover Lantus and Toujeo. Along these lines, we were recently successful in retaining coverage for the large CVS custom clients, Blue Cross Blue Shield's federal employees, which represents roughly 5.4 million lives. In summary, you can see that the decline in covered lives under commercial plans in 2017 for both brands is mainly due to the previously communicated exclusion decisions by CVS and to a lesser extent United Healthcare. Their decisions will affect many patients who may have been well controlled on Lantus or Toujeo, and may now need to switch therapies or possibly face much higher out-of-pocket costs. My final comment on this slide is that we now have considerable clarity about our outlook for 2017, which is important for budgeting at both the GBU and the company level. Slide 12 gives a general performance overview of our Diabetes & Cardiovascular franchise. Globally, diabetes performance declined slightly in the third quarter with strong sales in emerging market and stable European sales offsetting the decline in the U.S. With that the launch of Toujeo continued to capture share in key markets and sales reached €167 million. This was supported by a consistent performance in the U.S. where Toujeo now represents 6.6% of total basal insulin market share. In our cardiovascular business, Praluent sales reached €35 million, and Peter will discuss later our latest marketing initiatives. Looking ahead in diabetes, we reaffirm our previous global diabetes franchise guidance for minus 4% to minus 8% compounded annual rate of decline for the period 2015 to 2018. Of course, I'll remind you that we can be above or below this range in any given year. Our assessment of the guidance is based on the global franchise performance to-date and our current view of the U.S. diabetes pricing environment. On LixiLan, in August, we submitted updated information on the LixiLan pen delivery device to the FDA, resulting in an extension of the PDUFA date to November 2016. Based on the positive vote from the FDA Advisory Committee in May, and the updated delivery device information, we are preparing for the launch of this innovative combination product for adults living with Type II diabetes in the U.S. Sanofi (SNY) Q3 2016 Results - Earnings Call Transcript $SNY www.seekingalpha.com/article/4016550The only thing I could add as color there is just a remark on the third quarter, where you see the U.S. let's say glargine business decreasing by 5%. Actually, this is the sum of a roughly 5% uplift in volume, and by default you can calculate that there is a 10% price effect in Q3 and actually this price effect is pure channel mix. So this is really the increase of the Medicaid channel. But you will understand that I cannot disclose moving forward what are the detailed elements of this element. Peter Guenter - Sanofi It's Peter. Hello, Vincent. So, your question is on profitability of Lantus in commercial versus Part D. Of course, again, for competitive reasons I cannot give you the full details, but directionally I can tell you, of course, that the commercial segment is more profitable than the Part D segment for the simple reason that the contribution that you have to face at pharmaceutical company in the coverage gaps in the Part D segment is, of course, hampering them at the relative profitability of the Part D vis-à-vis commercial, but I can tell you that Part D remains an interesting and profitable segment. Your second question was about with pension tactics in the non-preferred, so covered but non-preferred in commercial. So there yes, we feel confident that we can pull through those non-preferred segments. We have done that in the past quite successfully and we are confident that we will do that again in the future. So that is what I can answer to your question Peter Guenter - Sanofi Yeah, Graham. So on the percentage decline, so again taking into account that we basically retain our full coverage for Medicare Part D, and that in commercial you still have the 15% bucket where decisions are pending, but again where we feel relatively confident. So if you would then take, if you would single out, if you will, the CVS commercial non-custom plans and then the United Healthcare, I can give you an indication in terms of volume that represents something, well let's say a high single-digits, nothing more, nothing less. So that gives you an indication of what could be the impact on our volume. Of course, if you would assume that indeed, 100% of those non-covered lives would indeed be leaving Lantus either Toujeo. Your second question is on the, why don't we change our guidance and Novo did. Well, I think I'm not going to comment on the Novo piece of that. But I think it's fair to assume that when we issued our guidance two years ago, the famous minus 4% to minus 8%, that we have taken into account a certain number of things that we felt were coming, and that it's probably a tribute to I would say reasonable and cautious planning when we give our guidances. Now on your third question, not sure I have all the details here, but I would say that last quarter I told you that there were two plans actually that we removed the step edit of Zetia Part D. One of those, and I have some interesting data here to share was OptumRx. And we see indeed that since that step edit was actually taken off, we see a very nice update of the Medicare Part D business in OptumRx, where the volumes have been more than twice the commercial volume since taking a day off Zetia's step edit. That's basically what I can say.
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Post by lakers on Oct 31, 2016 1:45:09 GMT -5
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Post by lakers on Oct 31, 2016 1:37:29 GMT -5
Sanofi, Novo Nordisk Fortunes Diverge Amid Insulin Price Slump Sanofi Chief Executive Olivier Brandicourt, pictured earlier this year, announced improved earnings forecasts and a share buyback after the drug maker reported robust third-quarter results. ENLARGE Sanofi Chief Executive Olivier Brandicourt, pictured earlier this year, announced improved earnings forecasts and a share buyback after the drug maker reported robust third-quarter results. Photo: Reuters By Denise Roland Oct. 28, 2016 7:11 a.m. ET Sanofi SA and Novo Nordisk A/S, two of Europe’s health-care companies most exposed to the falling prices for insulin products in the all-important U.S. market, gave dramatically diverging outlooks in the third quarter, sending their stock prices in opposite directions. The French pharmaceutical giant raised its full-year profit guidance and announced a share buyback while its Danish rival lowered expectations even though both reported lower insulin sales in the U.S. Sanofi’s shares surged nearly 7% whereas shares in Novo Nordisk were down 14% in morning trading. After years of rising prices for insulin, drugmakers are being forced to cut or flatten their prices by powerful middlemen that buy drugs on behalf of insurers and employers. Sanofi and Novo Nordisk, the number one and two insulin makers in the U.S., are at the sharp end of this trend. One difference between the two companies is different expectations of their insulin businesses. Sanofi last year acknowledged that revenue from its insulin franchise would dwindle. By contrast, Novo Nordisk hoped its new insulin, dubbed Tresiba, would drive strong growth because the treatment carries less risk of causing low blood sugar. But Novo Nordisk said Friday that a “significantly more challenging” market in the U.S. would lead to it lowering prices in the future. Sanofi’s brighter outlook also stems from the French drugmaker’s long-drawn-out efforts to cut costs and the benefit of diversity: Its rare-disease drugs are driving revenue growth while its portfolio includes treatments for cancer and cardiovascular ailments, vaccines and over-the-counter drugs. Novo Nordisk, unusual among pharmaceutical companies for its narrow focus, is much more heavily dependent on diabetes, but now plans to broaden its portfolio. It said Friday that it would extend its research and development efforts to include diseases such as fatty liver disease, known as NASH, a form of non-alcoholic fatty liver disease, diabetic kidney disease and cardiovascular disease. That broadening intensifies existing efforts to undertake riskier research in insulin, though the company said its higher threshold for innovation meant it would shelve efforts to develop an oral insulin. Such a product would have been more convenient for diabetes patients by reducing reliance on needles, but wouldn't have brought added medical benefits compared with injected insulins. Friday, Novo Nordisk slashed its long-term annual profit-growth target from 10% to 5%, and narrowed its full-year outlook to the lower end of previous guidance. Management now expects growth this year, measured in local currencies, of 5% to 6% for sales, trimmed from earlier guidance of 5% to 7%, and of 5% to 7% for operating profit, less optimistic than the previous range of 5% to 8%. In the third quarter, Novo Nordisk’s operating profit rose 4% to 12.4 billion Danish kroner ($1.82 billion), while revenue climbed 3% to 27.5 billion kroner. A Novo Nordisk employee controls a machine at an insulin production line in a plant in Kalundborg, Denmark. ENLARGE A Novo Nordisk employee controls a machine at an insulin production line in a plant in Kalundborg, Denmark. Photo: fabian bimmer/Reuters The preliminary outlook for 2017 indicates low single-digit growth in sales and flat to low single-digit growth in operating profit, in local currencies, it said. Sanofi is relatively bullish about its prospects and it plans to complete a €3.5 billion ($3.82 billion) share buyback by the end of 2017. Earnings a share—excluding the impact of acquisitions and divestments—are expected to grow between 3% and 5% in 2016 at constant exchange rates, Sanofi said. The French company previously said earnings a share would remain “broadly stable” this year. In the third quarter, earnings a share increased 12% at local currencies on a 3% rise in revenue to €9.03 billion. --Noemie Bisserbe in Paris and Dominic Chopping in Stockholm contributed to this article Write to Denise Roland at Denise.Roland@wsj.com www.wsj.com/articles/sanofi-novo-nordisk-fortunes-diverge-amid-insulin-price-slump-1477653094
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Post by lakers on Oct 29, 2016 15:42:36 GMT -5
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Post by lakers on Oct 29, 2016 13:04:42 GMT -5
Next up in terms of easily identifiable sources of cash is the fact that the company is due to receive what we have been led to believe could be a “significant” milestone payment from Receptor Life Sciences sometime between now and the end of the year… and though we may or may not learn much more about them as part of the transaction, the payment will be a welcome one (and if achieving the milestone allows them to feel more comfortable disclosing what they have been working on, it will only be icing on the cake). Along similar lines, though I do not think the company is actively pursuing any such deals (but might take one if a great one happened to walk through the door unsolicited), it is always possible that that the company could receive upfront payments as part of agreements signed with other companies for either international rights to Afrezza or for rights of some sort to any of the other products currently under development (more on one of these products below). In addition to these “big money” tickets associated with licensing agreements, I think it is also important to keep in mind that not only is MannKind once again receiving 100% of any revenue it generates via the sale of Afrezza (admittedly small, but growing), the company also appears to be in line to receive roughly $3 million per month for quite awhile to come as part of the $50M “insulin put” clause in its agreement with Sanofi… and these two streams together will clearly help to offset some of the monthly expenses currently being incurred by the company. And, speaking of Sanofi, though the company seems to be doing all it can to avoid talking about the situation and instead is trying to keep folks focused on what’s going on with Afrezza today, I continue to believe that there is at least a modest chance that, before all is said and done, there may be some sort of additional payment and/or forgiveness of debt from Sanofi – especially after reading a portion of the testimony of a former Sanofi employee that was called as part of a recently dismissed class action lawsuit against MannKind in which he/she seemed to suggest that Sanofi had, in fact, done very little to promote the product. Again, I am not predicting (nor promising) that such a settlement is on the way (and so you should not count on it), but based on all that has transpired over the past couple of years, such a settlement could end up being quite sizable, indeed, especially if MannKind is able to significantly outpace Sanofi on the sales front over the next several months. And, finally, if sales do start to pick up, there is a chance the stock price will also start to rebound as well (but you never know, given how things have gone for the past couple of years, eh?!)… and, provided the stock gets back above $1.50, I think it is important to keep in mind that there are warrants for 50M shares of stock at that price that will bring in a little over $70M if they are exercised. Inhalable epinephrine – And, finally, to help put things into perspective for those of you who have been wondering about the feasibility of inhalable epinephrine (“how will that work if a patient can’t breathe?!”), I want to point out that while the inhalable product being worked on MannKind admittedly won’t be of much use if you find someone passed out from anaphylactic shock, it represents a fine (and probably preferable alternative) for patients who already carry epi pens because they aware they have a life-threatening allergy – despite what naysayers in social media would have you believe, there is actually a window of several minutes between when a patient starts to realize they might be having a reaction and when their airway will finally close up… and this idea that an inhalable product would be useless is pure rubbish (yep – another claim without merit from our friends on the short side). www.notwallstreet.com/mannkind-redux-10716/www.mannkindcorp.com/assets/FAQ-8-2016.pdfWe expect that the third quarter of 2016 will be the final quarter of our profit and loss sharing arrangement with Sanofi; however, certain aspects of our relationship with Sanofi will continue beyond this date. As examples, our indebtedness under the loan facility with Sanofi will not mature until August 2024 and Sanofi’s obligations under the “Insulin put” will continue until Sanofi’s share of our current and future insulin purchases accumulates to $50 million. Under the terms negotiated with Sanofi, another payment from them is anticipated late this year, and payments will continue to be made periodically for at least the next couple of years.
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Post by lakers on Oct 29, 2016 12:48:13 GMT -5
Halloween a diabetic's worst nightmare until #afrezza + cgm 1. Demand afrezza 2. Learn afrezza (dial it in) 3. Lifetime best A1c's peakabull
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